Medical systems, devices, and related methods for vacuum and / or sponge therapy

Abstract

A medical device includes a handle, an end cap, a sponge, one or more wires, and one or more actuation elements. The handle includes a main body and a movable body, and the movable body is movable relative to the main body. The end cap includes a fixed portion and an extendable portion, and the fixed portion includes one or more through holes. At least a portion of the sponge surrounds a portion of the extendable portion of the end cap. The one or more actuation elements are connected to a portion of the extendable portion of the end cap. Movement of the movable body of the handle controls movement of the wires and the extendable portion of the end cap. Proximal movement of the actuation elements controls another movement of the extendable portion of the end cap to separate the extendable portion of the end cap from the sponge.

Description

Cross-references to related applications

[0001] This application claims priority to U.S. Provisional Application No. 63 / 582,568, filed September 14, 2023, pursuant to 35 USC §119, which is incorporated herein by reference in its entirety. Technical Field

[0002] Various aspects of the present invention generally relate to medical systems, devices, and related methods for vacuum and / or sponge therapy that can be used to treat subjects. For example, various aspects of the present invention relate to medical systems, 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 tract perforation, postoperative leakage, or other wounds. Treatment options for managing such wounds are limited, and these wounds have significant morbidity and mortality rates. Options include surgical reoperation and endoscopic placement of stents or clips. Surgery is relatively invasive and has high morbidity and mortality rates. Endoscopic stent placement is a less invasive option. However, the placed stent may migrate from its intended location and / or form an infection cascade at the treatment site, thus inhibiting drainage. In some respects, sponges, absorbent materials, and / or vacuum tubes can be positioned at the treatment site to aid recovery, but the positioning and deployment of sponges, absorbent materials, and / or vacuum tubes can be time-consuming, difficult, or dangerous for the patient.

[0004] The systems, apparatus, and methods of the present invention can correct some of the above-mentioned defects or solve other aspects of the present technology. Summary of the Invention

[0005] Examples of the present invention relate, among others, to systems, apparatus, and methods for performing one or more medical procedures using medical systems and devices. Each of the examples disclosed herein may include one or more of the features described in conjunction with any of the other disclosed examples.

[0006] In one example, a medical device may include a handle, an end cap, a sponge, one or more wires, and one or more actuating elements. The handle may include a body and a movable part, the movable part being movable relative to the body. The end cap may include a fixed portion and an extendable portion, the fixed portion including one or more through-holes. At least a portion of the sponge may surround a portion of the extendable portion of the end cap. One or more wires may extend from the movable part of the handle, through the fixed portion of the end cap, and to the extendable portion of the end cap. One or more actuating elements may be connected to a portion of the extendable portion of the end cap. Movement of the movable part of the handle may control movement of one or more wires and the extendable portion of the end cap. Proximal movement of one or more actuating elements may control another movement of the extendable portion of the end cap to separate the extendable portion of the end cap from the sponge.

[0007] The medical device may include one or more of the following aspects: An extendable portion of the end cap may include a band, and the sponge may be radially positioned around the band. One or more wires may be coupled to the band to extend and / or retract the band and the sponge. The body may include a longitudinally extending slot, and a movable body may be movable along at least a portion of the longitudinally extending slot. The medical device may also include a vacuum tube. The distal end of the vacuum tube may be coupled to a proximal portion of the sponge. The distal end of the vacuum tube may be embedded within that portion of the sponge. The proximal end of the vacuum tube may be coupled to a vacuum source or a negative pressure source.

[0008] The medical device may also include one or more tubes extending from the body of the handle to a fixed portion of the end cap. One or more wires may each move within a corresponding one of the one or more tubes. The distal ends of the one or more tubes may be secured to the fixed portion of the end cap at through-holes. The one or more through-holes may include two through-holes. One or more wires may include two wires, and one or more tubes may include two tubes. The two through-holes may be evenly spaced around the fixed portion of the end cap. The sponge may expand radially inward when separated from the extendable portion of the end cap. The handle may include a ring located at the proximal end of the handle. The end cap may be configured to be coupled to the exterior of the distal portion of the insertion shaft of the insertion device. The medical device may also include an actuator. The proximal end of each of the one or more actuating elements may be coupled to the actuator such that rotation of the actuator retracts one or more wires proximally to retract the extendable portion and deploy the sponge.

[0009] In another aspect, a medical system may include an insertion device, a suction device, and a medical device. The insertion device may include an insertion shaft having a distal end. The suction device may include a suction cannula. The medical device may include a handle, an end cap, a sponge, one or more filaments, and one or more actuating elements. The handle may include a body and a movable body, and the movable body may be movable relative to the body. The end cap may be positioned about a distal portion of the insertion shaft, and the end cap may include an extendable portion. At least a portion of the sponge may surround a portion of the extendable portion of the end cap. One or more filaments may extend from the movable body of the handle, through one or more holes in a fixed portion of the end cap, and to the extendable portion of the end cap. One or more actuating elements may be connected to a portion of the extendable portion of the end cap. Movement of the movable body of the handle may control movement of one or more filaments and the extendable portion of the end cap. Proximal movement of one or more actuating elements may control another movement of the extendable portion of the end cap to disengage the extendable portion of the end cap from the sponge.

[0010] The medical system may include one or more of the following aspects. The distal end of the insertion device may include a working channel opening, one or more lighting devices, and one or more visualization devices. The medical system may also include an actuator. The proximal end of each of one or more actuating elements may be coupled to the actuator, such that rotation of the actuator retracts one or more actuating elements proximally to retract the extendable portion and deploy the sponge.

[0011] In another aspect, a method of applying suction to a target site includes coupling one or more portions of an insertion device, a medical device, and a suction device to form a medical system. The medical device may include a handle having a movable body, an end cap including a fixed portion and an extendable portion, and a porous body releasably positioned around a portion of the extendable portion. The suction device may include a vacuum tube coupled to the porous body. The method may further include delivering the portions of the medical system to the target site, positioning and / or deploying the porous body, and applying negative pressure or suction to the target site.

[0012] The method may also include one or more of the following aspects: Positioning the porous body may include moving an extendable portion of the end cap by a movable part of the movable shank. Deploying the porous body may include retracting one or more actuating elements proximally to the extendable portion of the end cap.

[0013] It is understood that the foregoing general description and the following detailed description are exemplary and explanatory only, and are not intended to limit the invention to the scope claimed. Attached Figure Description

[0014] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate exemplary aspects of the invention and, together with the description, serve to explain the principles of the invention.

[0015] Figure 1 An exemplary medical system comprising an insertion device, a medical device, and a vacuum device according to various aspects of the present invention is shown.

[0016] Figure 2A A perspective view of the distal portion of a medical device according to various aspects of the present invention is shown, and Figure 2B A perspective view of the distal portion of a medical device, connected to the distal portion of an insertion device, according to various aspects of the present invention, is shown.

[0017] Figure 3 A perspective view of a medical device and insertion device according to various aspects of the present invention is shown.

[0018] Figure 4A and Figure 4B A corresponding perspective view of the distal portion of a medical device in an extended configuration relative to an insertion device, according to various aspects of the present invention, is shown.

[0019] Figure 5 The distal portion of a medical device in a released state according to various aspects of the present invention is shown.

[0020] Figure 6 The proximal portion of a medical device, according to various aspects of the invention, is shown as a manipulation of the distal portion of a medical device for releasing the distal portion of the medical device.

[0021] Figure 7 The proximal portion of another exemplary medical device is shown, illustrating manipulation of the distal portion of the medical device for releasing the distal portion according to various aspects of the invention.

[0022] Figure 8A and Figure 8B Different views of the sponge portion of a medical device according to various aspects of the present invention are shown.

[0023] Figure 9 This is a flowchart illustrating exemplary methods that can be performed using one or more aspects of the invention according to various aspects of the invention. Detailed Implementation

[0024] The terms “proximal” and “distal” are used herein to refer to the relative positions of components of exemplary medical systems and devices. When used herein, “proximal” refers to a position relatively closer to the exterior of the body or closer to a medical professional using the medical system or device. Conversely, “distal” refers to a position relatively further away from a medical professional using the medical system or device or closer to the interior of the body. As used herein, the terms “comprises,” “comprising,” “has,” “having,” “includes,” “including,” or other variations thereof are intended to cover non-exclusive inclusion, such that a system, apparatus, or method that includes a list of elements includes not only those elements but may include other elements not expressly listed or inherent to it. The term “diameter” may refer to the width of an element when it is not circular. The term “top” refers to the direction or side of the device relative to its orientation during use, and the term “bottom” refers to the direction or side of the device relative to its orientation, opposite to “top,” during use. The term “distal” refers to the direction away from the user / towards the treatment site, and the term “proximal” refers to the direction towards the user. Several accompanying figures include arrows labeled “P” and “D”, indicating directions toward the proximal and distal sides, respectively. Unless otherwise stated, the term “exemplary” is used in the sense of “example” rather than “ideal.” As used herein, the terms “approximately,” “substantially,” and “approximately” refer to a range of values ​​within + / -10% of the stated value.

[0025] Embodiments of the present invention include systems, apparatus, and methods for endocavitary vacuum therapy (EVAC), a surgical procedure for treating wounds. For example, EVAC can be used to treat postoperative leakage or perforation 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 in the GI tract, for example, through a porous body, such as, for example, a sponge / porous body (e.g., a vacuum-sealed porous body) located distal to a nasogastric tube. The sponge is placed endoscopically into the perforation, leakage, or other wound. The proximal end of the nasogastric tube may be connected to a collection container.

[0026] In some examples, EVAC involves placing a porous body, such as a sponge or other similar material, into the wound site, including perforations, cysts, leaks, anastomoses, etc. Placement of the material can be achieved via catheters, endoscopes (endoscopes, bronchoscopes, colonoscopes, duodenoscopes, gastroscopes, etc.), tubes, or sheaths (inserted into the GI tract through a natural orifice). The orifice 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. In some examples, placement can be made within or through the wall of the GI tract. The material can also be placed into other organs accessible via the GI tract, such as the colon. Negative pressure is then applied through the tube or porous body.

[0027] In EVAC, negative pressure is delivered to the wound site in the GI tract, for example, via a nasogastric tube with a sponge or other absorbent material at its end. The sponge is placed into the perforation, leakage, or other wound via endoscopy. Negative pressure is then applied. Applying negative pressure through the sponge in the wound can help accelerate healing, for example, by promoting local tissue granulation at the wound site and / or helping to reduce the risk of infection. However, there are limitations to the devices and systems suitable for EVAC. For example, during EVAC, the sponge can be delivered to the target site using an endoscope, forceps, and a suture loop at the distal end of the sponge. For example, forceps can extend through the working channel of the endoscope and be used to grasp the loop at the distal end of the sponge. The forceps can be used to move and / or position the sponge to the target site as the endoscope navigates to it, which can be challenging. In some cases, the sponge may obstruct the visualization of the endoscope when the user uses forceps to move the sponge through the GI tract and / or reach the target site. The sponge may also occupy space and / or snag tissue (e.g., in the GI tract) when the endoscope is manipulated to the target site. It may be difficult to accurately position the sponge relative to the target site.

[0028] 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 throughout the drawings to refer to the same or similar parts.

[0029] Figure 1 An exemplary medical system 100 is shown, which includes, for example, an insertion device 102, a medical device 104, and a suction or vacuum device 106. In some aspects, the various parts of the system 100 may be formed and / or packaged or provided as a kit. The insertion device 102 includes an insertion shaft 108, the insertion shaft 108 including a distal end 110 (… Figure 3Medical device 104 includes a handle 104A and an insertion portion 104B, for example, extending distally from the distal end of the handle 104A. As discussed in detail below, the insertion portion 104B of medical device 104 includes a distal portion 112, for example, an end cap or other connecting element formed on the distal portion (e.g., distal end 110) of the insertion shaft 108. The distal portion 112 includes an adapter 130 and a foam or other porous or absorbent body (e.g., a sponge 132). The adapter 130 may be a fixed portion of the distal portion 112, and the sponge 132 may be a movable or extendable portion of the distal portion 112. Additionally, one or more control elements, such as cables, wires 134, etc., and one or more coils, tubes, or sheaths 136, may extend from various portions of the distal portion 112 to the handle 104A. Although in Figure 1 Not shown, but the distal portion 112 may include one or more actuating elements, such as one or more cables, wires, or wires 138. Figure 3 ).

[0030] The adapter 130 can be coupled to the distal portion of the insertion shaft 108, and movement of one or more wires 134 (e.g., by one or more manipulations of the handle 104A) can control the position of the sponge 132 relative to the adapter 130, the distal end 110 of the insertion shaft 108, and the target site. Furthermore, another manipulation of the handle 104A can facilitate the deployment of the sponge 132, for example, via movement of the actuating element or wire 138 or other manipulations. A vacuum device 106 is coupled to a vacuum tube 140, and the vacuum tube 140 can extend from the vacuum device 106 to a portion of the sponge 132. Additionally, suction or negative pressure can be applied to the sponge 132 and thus to the target site to aid in the absorption and / or removal of fluids, particles (e.g., from the target site and / or when the sponge 132 degrades), etc., which can aid in the treatment of the target site (e.g., for leakage, bleeding, etc., at one or more endovascular anastomoses).

[0031] Although not shown, one or more portions of the medical system 100 may be at least partially enclosed within an outer sheath or tube. For example, the outer sheath or tube (not shown) may radially surround at least a portion of the insertion shaft 108, wire 134, sheath 136, and / or vacuum tube 140. The outer sheath or tube may facilitate the delivery or positioning of the insertion shaft 108, wire 134, sheath 136, and / or vacuum tube 140 to a target site, while also allowing relative movement (e.g., longitudinal movement) of the various portions or components of the medical system 100.

[0032] Insertion device 102 includes an insertion shaft 108, which may include a generally cylindrical shaft to be delivered to a target site. Although not shown, insertion device 102 may include a handle having one or more ports, controls, actuators (e.g., for controlling deflection or hinge of a distal portion of insertion device 102), electronic components, etc. Insertion device 102 may be an endoscope. Although the invention may refer to insertion device 102 as an endoscope in many places, the scope of the invention is not limited thereto. For example, unless otherwise specified, a duodenoscope, endoscope, gastroscope, endoscopic ultrasound (“EUS”) endoscope, colonoscope, ureteroscope, bronchoscope, laparoscope, cytoscope, aspiration endoscope, sheath, catheter, or any other suitable delivery or insertion device may be used in conjunction with the systems, devices, elements, components, methods, etc., described herein. Additionally, although the treatment site discussed herein is in the GI tract of a subject, the invention is not limited thereto, as the treatment site may be any cavity, organ, hollow, or other tissue within the subject's body.

[0033] As mentioned, the medical device 104 includes a handle 104A and an insertion portion 104B. The handle 104A includes a body 114, which may include, for example, a ring 116 (e.g., a thumb ring) at the proximal end of the body 114. The handle 104A also includes a first movable member or reel 118. The reel 118 may be an actuator and may include a recessed portion 118A (e.g., having a relatively small lateral cross-section) and one or more (e.g., two) ridges or extensions 118B (e.g., having a relatively large lateral cross-section). In these respects, the recessed portion 118A may receive one or more of the user's fingers, such that movement of the user's fingers controls movement of the reel 118. The body 114 may include a slot 120, for example, extending longitudinally through a portion of the body 114, for example, extending distally from a position spaced apart from the ring 116. A portion of reel 118 may extend into a portion of slot 120, allowing reel 118 to move along slot 120 (e.g., longitudinally, distally and / or proximally). In these respects, slot 120 may define a range of movement of reel 118. As discussed in detail below, reel 118 may move within slot 120, e.g., proximally and / or distally, to control one or more aspects of the distal portion 112 of medical device 104. Additionally, although not shown, one or more biasing elements or springs may be positioned within slot 120, e.g., to bias the distal and / or proximal movement of reel 118.

[0034] Figure 2A and Figure 2B Various details of the medical device 104 are shown. Figure 2A The distal portion of the insertion portion 104B of the medical device 104, which is separate from the insertion device 102, is shown. Figure 2B The distal portion of the insertion portion 104B of a medical device 104, coupled to the insertion shaft 108 of the insertion device 102, is shown. The insertion portion 104B of the medical device 104 includes an adapter 130 and a sponge 132, for example, located in the distal portion 112. Additionally, one or more control elements or wires 134, one or more coils, tubes or sheaths 136, and / or one or more actuating elements or wires 138 may extend from the distal portion 112 to the handle 104A. The adapter 130 may be coupled to the distal portion of the insertion shaft 108, for example, it may be fixedly coupled to a portion of the insertion shaft 108. For example, the adapter 130 may be coupled to the insertion shaft 108 via an interference fit, adhesive, press fit, crimp, or any other suitable coupling mechanism (e.g., at a position proximal to the distal end 110). Figure 3 In these respects, the adapter 130 and other components of the medical device 104 form a sheath (endoscope sheath) structure relative to the insertion shaft 108 (e.g., the distal portion of the insertion shaft 108).

[0035] The adapter 130 may be generally annular, for example, circular, for attachment to the outside of the insertion shaft 108. The adapter 130 includes one or more through-holes 150, for example, extending longitudinally through corresponding portions of the adapter 130. In some aspects, such as Figure 2A and Figure 2B As shown, adapter 130 may include two through holes 150. However, adapter 130 may include one, three, four, or more through holes 150. Additionally, the through holes 150 may be evenly spaced (e.g., separated by approximately 180 degrees, as shown), or may be unevenly spaced around adapter 130. In either of these aspects, the distal end of a coil, tube, or sheath 136 may be coupled to, adjacent to, or otherwise terminated at or within the proximal end of the corresponding through hole 150. For example, if two through holes 150 are present, the distal end of one coil, tube, or sheath 136 may be coupled to, adjacent to, or otherwise terminated at or within one through hole 150, and the distal end of the other coil, tube, or sheath 136 may be coupled to, adjacent to, or otherwise terminated at or within the other through hole 150. Although not shown, the proximal end of a coil or sheath 136 may be coupled to, adjacent to, or otherwise terminated at or within the distal portion of the handle 104A. In these respects, the coil, tube, or sheath 136 may be fixed relative to the handle 104A and / or the insertion shaft 108 (i.e., longitudinally fixed). However, the coil, tube, or sheath 136 may be bent, folded, rotated, or otherwise moved with the movement of one or more of the handle 104A and / or the insertion shaft 108.

[0036] like Figure 2A and Figure 2BAs shown, a control element or wire 134 extends through a corresponding coil, tube, or sheath 136. Additionally, each wire 134 extends longitudinally through a corresponding through-hole 150. Each wire 134 extends distally to the through-hole 150 and the adapter 130. Furthermore, the distal end or distal portion of each wire 134 is coupled (e.g., directly or indirectly coupled to) the proximal end or proximal portion 132A of the sponge 132. For example, the medical device 104 may include one or more bands 152 (…). Figure 3 , Figure 4A , Figure 4B and Figure 8A ), rings, caps, support structures, etc., or positioned around them, and the sponge 132 can be positioned around the hoop 152, for example, in an unexpanded form (e.g., Figure 8A In some aspects, the distal end or distal portion of each wire 134 may be coupled to the proximal end or proximal portion of the clamp 152. In another aspect, the distal end of each wire 134 may be releasably coupled to the proximal end or proximal portion 132A of the sponge 132. Alternatively, the distal end of each wire 134 may be releasably embedded within a portion of the sponge 132 (e.g., the proximal portion 132A). Furthermore, although not shown, the proximal end of each wire 134 may be coupled to (e.g., directly or indirectly coupled to) the reel 118. Thus, in either of these aspects, movement of the wire 134 (e.g., distal or proximal movement as controlled by the reel 118) may control the position of the sponge 132 relative to the distal end 110 and the adapter 130 (e.g., distal extension and / or proximal retraction).

[0037] Sponge 132 may comprise any suitable biocompatible material that can absorb liquids and / or allow liquids or other materials, for example, to pass through it via negative pressure applied to sponge 132. The material of sponge 132 may be flexible, compressible, porous, hydrophilic, sterile, and / or disposable. Suitable materials include polyurethane, esters, ethers, composites, and / or other medical-grade materials. For example, sponge 132 may be formed from polyurethane foam. Additionally or alternatively, sponge 132 may comprise one or more drugs (e.g., incorporated into it, treated with it, injected with it, etc.), for example, to help promote tissue growth, prevent infection, assist in pain management, etc.

[0038] As discussed below and as Figure 3As shown, the movement or positioning of the sponge 132 can be visualized via various features of the distal end 110. For example, the movement or positioning of the sponge 132 can be visualized using one or more illumination devices 168 (e.g., one or more LEDs, fiber optics, and / or other illuminators) and / or one or more visualization devices 170 (e.g., one or more cameras, one or more image sensors, endoscopic viewing elements, optical assemblies including one or more image sensors and one or more lenses, etc.) on the distal end 110 of the insertion device 102. Furthermore, as discussed below, one or more other manipulations of the handle 104A (e.g., of the reel 118) can facilitate the release, disconnection, or otherwise deployment of the sponge 132 from the medical device 104.

[0039] like Figure 1 As shown, the suction or vacuum device 106 includes a vacuum source 124 coupled to a vacuum tube 140, and the vacuum tube 140 extends from the vacuum source 124 to a portion of the sponge 132. The vacuum tube 140 may include one or more portions. For example, a proximal portion 140A of the vacuum tube 140 may be coupled to the vacuum source 124, and a distal portion 140B of the vacuum tube 140 may extend adjacent to one or more portions of the insertion shaft 108 and / or may be coupled to the sponge 132. In some aspects, one or more segments of the distal portion 140B of the vacuum tube 140 may be more flexible than the proximal portion 140A of the vacuum tube 140, for example, to help allow the distal portion 140B to traverse a tortuous path to be delivered to and positioned at the target site.

[0040] The distal end 140C of the vacuum tube 140 may be coupled (e.g., directly or indirectly coupled to) the proximal or proximal portion of the sponge 132. For example, the distal end 140C may be coupled to the proximal or proximal portion 132A of the sponge 132 via one or more adhesives, epoxy resins, etc. Alternatively or additionally, the distal end 140C of the vacuum tube may be at least partially overmolded or otherwise embedded within a portion of the sponge 132 (e.g., the proximal portion 132A). In these respects, the vacuum tube 140 (i.e., the distal end 140C and the distal portion 140B) may move with the movement of the sponge 132 (e.g., extend distally, retract proximally, rotate, deflect, etc.). Additionally, suction pressure or negative pressure may be applied to the sponge 132 and thus to the target site to aid in the absorption and / or removal of fluids, particles, etc., from the target site, which may be helpful in treating the target site (e.g., for leakage, bleeding, etc. at one or more endoluminal anastomoses).

[0041] Figure 3This is, for example, a perspective view of the distal portion of system 100 viewed from the distal end to the proximal end. The insertion shaft 108 of the insertion device 102 may include one or more cavities or working channels. For example, the insertion shaft 108 may include a working channel 160 terminating distally at a working channel opening 162 located at the distal end 110. The insertion shaft 108 may also include one or more auxiliary cavities 164, each having a corresponding auxiliary cavity opening 166. Fluid and / or negative pressure may be delivered or applied to a target site via the auxiliary cavities 164. The insertion shaft 108 may have a diameter of about 9 mm to about 15 mm, for example, about 10.5 mm to about 12 mm. The working channel 160 may have a diameter of about 2 mm to about 4 mm, for example, about 2.8 mm. Furthermore, the distal end 110 of the insertion shaft 108 may include one or more lighting devices 168 (e.g., one or more LEDs, fiber optics, and / or other illuminators). Alternatively or additionally, the remote end 110 may include one or more visualization devices 170 (e.g., one or more cameras, one or more image sensors, endoscopic viewing elements, optical components including one or more image sensors and one or more lenses, etc.).

[0042] Additionally, it should be noted that the various figures depict the distal end 110 of the insertion device 102 as "forward-facing." In the forward-facing embodiment, the working channel opening 162, the auxiliary cavity opening 166, the illumination device 168, and the visualization device 170 face distally (i.e., in front of the farthest surface of the distal end 110). However, in other respects, the distal end 110 of the insertion device 102 can be "lateral." In other words, features of the distal end 110 (e.g., the working channel opening 162, the auxiliary cavity opening 166, the illumination device 168, and the visualization device 170) can be positioned radially outward of the distal end 110 such that they point in a radially outward direction, substantially perpendicular to the longitudinal axis of the distal end 110 of the insertion shaft 108. The invention also covers other configurations of the distal end 110 as "lateral." The insertion device 102 may additionally include some forward-facing components and other lateral components.

[0043] like Figure 3As shown, one or more actuating elements or wires 138 may extend through the working channel 160, for example, protruding from the working channel opening 162 at its distal side. Furthermore, sponge 132 may be coupled to clamp 152. For example, sponge 132 may be positioned around the exterior (e.g., radially outward) of clamp 152. Additionally, one or more actuating elements, such as wire 138, may be coupled to a portion of clamp 152. For example, the distal end of wire 138 may be coupled (e.g., fixedly coupled) to a proximal or distal portion of clamp 152. As discussed below, movement or manipulation of wire 138 (e.g., via one or more proximal actuating elements or controls) may facilitate the separation of sponge 132 from clamp 152, for example, to facilitate the deployment of sponge 132.

[0044] Additionally, when the sponge 132 and the band 152 are positioned externally around the insertion shaft 108, the sponge 132 and the band 152 will not impair or obstruct visualization of the target area using the illumination device 168 and the visualization device 170. Furthermore, the control element or cable 134 can be moved through the through-hole 150 of the adapter 130 to position the sponge 132 and the band 152, and the movement and positioning of the sponge 132 and the band 152 can be visualized using the illumination device 168 and the visualization device 170. In some aspects, one or more of the other components or features of the sponge 132, band 152, suction cannula, cable 134, sheath 136, or the distal portion 112 of the medical device 106 may include radiopaque materials (e.g., one or more markings, one or more gradients, etc.) or otherwise assist the user in visualizing the sponge 132, band 152, etc.

[0045] Figure 4A and Figure 4B A perspective view is shown of the distal end 110 away from the insertion shaft 108 and the corresponding extensions of the sponge 132 and the band 152 away from the adapter 130, for example, based on the movement (i.e., extension to the distal side) of the control element or wire 134. As mentioned above, the reel 118 ( Figure 1 The movement of the reel 118 distally extends the wire 134 distally. In these respects, the movement of the reel 118 distally extends the wire 134 distally, and the movement of the reel 118 proximally retracts the wire 134 proximally. Therefore, the sponge 132 and the hoop 152 can also extend distally and / or retract proximally accordingly, for example, to position the sponge 132 relative to the insertion shaft 108 and / or the target location. The slot 120 can create a range of movement of the reel 118, and thus also a range of movement of the wire 134, the sponge 132, and the hoop 152. As mentioned, the movement and / or positioning can be observed, for example, using a lighting device 168 and / or a visualization device 170, since the sponge 132 and / or the hoop 152 are within the field of view of the visualization device 170.

[0046] Figure 5 A perspective view of a sponge 132 deployed or otherwise separated from the clamp 152 is shown. As shown, the sponge 132 can expand upon deployment or separation from the clamp 152. For example, as discussed below, the sponge 132 may include a greater thickness (e.g., radial thickness) or otherwise increase in size upon deployment or separation from the clamp 152. For example, the sponge 132 may be in a contracted or unexpanded state when positioned around the clamp 152, and separating the sponge 132 from the clamp 152 may allow the sponge 132 to switch to an expanded state, such as... Figure 5 As shown. For example, as discussed above, wire 138 may be attached to a portion of the clamp 152, and retracting wire 138 proximally may help separate the sponge 132 from the clamp 152. Alternatively or additionally, as mentioned, the proximal portion of the clamp 152 may be attached to one or more wires 134. As shown, wire 134 may be retracted proximally, thereby pushing the clamp 152 proximally, while the sponge 132 may remain extended distally. In these respects, the clamp 152 may be retracted to a position radially outside the distal portion of the insertion shaft 108, or otherwise adjacent to or surrounding it. Additionally, in some respects, vacuum tube 140 may be used to assist in the deployment and / or positioning of the sponge 132. For example, in some respects, the user may retract wire 134 proximally to retract the clamp 152 proximally, while also pushing vacuum tube 140 distally to assist in the deployment of the sponge 132. In addition, in some respects, the user can manipulate the vacuum tube 140 (e.g., push it distally, pull it proximally, etc.) to help position (e.g., translate) the sponge 132 relative to the distal end 110 and / or the target area.

[0047] Figure 6 A side view of the handle 104A of the medical device 106 is shown. As mentioned, the handle 104A includes a reel 118 movable within a slot 120. In some respects, the user can move the reel 118 proximally (e.g., toward the ring 116) to aid in the deployment of the sponge 132 and the vacuum tube 140. Figures 1 to 5 For example, moving or pushing reel 118 proximally can retract wire 134 proximally. In some aspects, moving or pushing reel 118 proximally can retract wire 138 proximally. Retracting wire 138 proximally can also retract clamp 152 proximally, for example, by pulling clamp 152 or otherwise separating clamp 152 from sponge 132.

[0048] Figure 7 This illustrates a portion of the handle 180 of another medical device, or it may be included in system 100. Figure 1A side view of a portion of a medical device in the insertion device 102. For example, handle 180 may be part of or coupled to the handle of insertion device 102, and / or part of or coupled to the handle 104A of medical device 104. For example, handle 180 may be coupled to port 144 on a portion of the handle of insertion device 102. Handle 180 may include actuator 182 (e.g., a rotatable knob) and retaining portion 184 (e.g., a housing). In these respects, a portion of wire 138 may extend through working channel 160 of insertion shaft 108. Figure 3 The wire 138 extends through a portion of the handle of the insertion device 102 and from a port 144 on the handle of the insertion device 102. Additionally, a proximal or proximal portion of the wire 138 may be coupled to the actuator 182. For example, the wire 138 may extend from the port 144 and be at least partially wound around the actuator 182, such that rotation of the actuator 182 in a first direction (e.g., in direction R) retracts the wire 138 proximally. In these respects, rotation of the actuator 182, for example, relative to the fixed portion 184, can facilitate the proximal retraction of the wire 138 to separate the clamp 152 from the sponge 132. Figure 6 In some respects, actuator 182 can rotate in direction R to retract line 138 proximally and separate band 152 from sponge 132.

[0049] Figure 8A and Figure 8B Various forms of sponge 132 are shown. As mentioned, line 138 ( Figure 5 It can be attached to a portion of the hoop 152 to control the movement of the hoop 152, for example, the movement relative to the sponge 132, to deploy the sponge 132. Figure 8A The image shows a sponge 132 in a contracted or unexpanded configuration when positioned around or at least partially around the hoop 152. In some aspects, the hoop 152 may be generally cylindrical or tubular and may be sized to be positioned around the distal portion of the insertion shaft 108. Figure 5 The sponge 132 may also be generally cylindrical or tubular, wherein the inner surface of the sponge 132 is positioned around the outer surface of the band 152 in a contracted or unexpanded form. Figure 8B The image shows the sponge 132 in a deployed or expanded configuration, for example, when separated from the clamp 152. As mentioned, the clamp 152 can retract proximally relative to the sponge 132, for example, via the movement of one or more wires 138. Figure 5 Once the sponge 132 separates from the band 152, the sponge 132 can expand. For example, the inner diameter of the sponge 132 (e.g., formed by the sponge opening 142) can be reduced in size, for example, causing the sponge 132 to expand radially inward. In some aspects, the sponge 132 can remain in a never-expanded form ( Figure 8ASwitch to expanded form ( Figure 8B When the sponge expands inward, it reduces the size (e.g., diameter) of the sponge opening 142. In these respects, the sponge 132 in its unexpanded form ( Figure 8A ) and expansion forms ( Figure 8B Both can maintain their outer diameter or profile. In other respects, although not shown, the sponge 132 can also expand outwards, for example, by radially increasing its size when separated from the band 152. In any of these respects, the sponge 132 in its expanded form ( Figure 8B It can be positioned at the target site and help absorb and / or remove fluids, particles, etc. from the target site (e.g., using a vacuum tube 140 that provides suction or negative pressure).

[0050] Various aspects of the present invention can be used to perform method 900, for example, to position and deploy a sponge and vacuum tube at a target site, for example, to aid in the absorption and / or removal of fluids, particles, etc. Initial step 902 includes coupling one or more portions of the insertion device 102, medical device 104, and aspiration device 106, for example, to form a medical system 100. For example, step 902 may include coupling an adapter 130 to a distal portion of the insertion shaft 108 (e.g., proximal to the distal end 110). In some aspects, step 902 may include coupling the distal end of the vacuum tube 140 to a portion of the sponge 132. Alternatively, the distal end of the vacuum tube 140 may be fixedly coupled to the sponge 132. Furthermore, in some aspects, step 902 may include coupling a filament 134 to the sponge 132 and / or a band 152, and / or positioning at least a portion of the sponge 132 around the band 152 (e.g., switching from an expanded form to an unexpanded form for delivery to the target site). In some respects, step 902 includes coupling wire 138 to a portion of clamp 152 and / or feeding wire 138 proximally, for example, through working channel 160 of insertion shaft 108.

[0051] Next, step 904 includes delivering various portions of the medical system to a target site, such as an intracavitary anastomosis or other cavity. As mentioned, one or more portions of the medical system 100 may be delivered to the target site via an outer sheath or cannula. Additionally, the distal portion of the medical system 100 may be positioned relative to the target site using one or more visualization techniques (e.g., one or more translucent markings on the insertion shaft 108, adapter 130, and / or sponge 132) and / or using one or more visualization devices (e.g., illumination device 168 and / or visualization device 170 on the distal end 110 of the insertion shaft 108). Although not shown, the handle of the insertion device 102 may include one or more knobs, levers, etc., to aid in hinged or otherwise positioned of the distal end 110 relative to the target site. The distal portion 112 of the medical device 104 may be hinged or otherwise positioned together with the distal end 110.

[0052] Step 906 includes positioning and / or deploying the porous body (e.g., sponge 132). As mentioned, sponge 132 can be extended and / or retracted relative to adapter 130 and distal end 110 via movement of thread 134 (e.g., as controlled by reel 118). Furthermore, the movement and / or positioning of sponge 132 can be visualized, for example, using one or more visualization devices (e.g., illumination device 168 and / or visualization device 170 on the distal end 110 of insertion shaft 108). Once sponge 132 is positioned at the desired location relative to the target area and / or distal end 110, the user can manipulate one or more features of medical device 104 to deploy sponge 132. For example, as mentioned above, the user can retract reel 118 proximally to retract thread 138 and assist in deploying sponge 132, as per relevant... Figure 6 The discussion continues. Alternatively, the user can rotate actuator 182 to retract line 138 and assist in deploying sponge 132, as per the relevant provisions. Figure 7 The following are discussed aspects. In any of these aspects, when the sponge 132 is separated from the clamp 152, the line 138 can remain attached to the clamp 152. The clamp 152 can retract to assemble around a portion of the insertion shaft 108, as... Figure 5 As shown. Additionally, the sponge 132 can be in its unexpanded state surrounding the hoop 152 ( Figure 8A Switch to the expanded state separated from the hoop 152. Figure 8B Although not shown or discussed in detail, step 906 may also include one or more other treatments or assessments of the target site.

[0053] Next, step 908 includes applying negative pressure or suction to the target site. Step 908 may include applying negative pressure or suction to the target site via suction device 106 and sponge 132. For example, as discussed above, vacuum tube 140 may be connected to sponge 132 such that negative pressure or suction from suction device 106 is applied to sponge 132 and the target site. In these respects, fluids, particles (e.g., from the target site and / or when sponge 132 degrades), etc., may be absorbed by sponge 132 and / or removed from the target site via suction device 106, and thus removed from the subject via vacuum tube 140. Step 908 may include periodically applying negative pressure or suction to the target site, such as every hour, every two hours, every six hours, every twelve hours, once a day, once every two days, once every four days, once a week, etc. Alternatively, step 908 may include consistently or continuously applying negative pressure or suction to the target site for a specific duration, such as one minute, two minutes, five minutes, ten minutes, twenty minutes, one hour, etc.

[0054] Finally, step 910 includes removing the porous body (e.g., sponge 132) and the vacuum tube (e.g., vacuum tube 140) from the target site. For example, step 910 may include pulling or pushing the vacuum tube 140 proximally. Since the distal end of the vacuum tube 140 is attached to a portion of the sponge 132, pulling or pushing the vacuum tube 140 proximally can help remove both the vacuum tube 140 and the sponge 132 from the target site (e.g., from the subject). In some respects, the user may repeat one or more steps of method 900, for example, to further treat the target site (or another target site). Step 910 may be performed at a time following step 908 (e.g., 3-5 days later or any other suitable timeframe).

[0055] Various aspects of system 100 and / or method 900 can assist in the treatment of one or more target sites. For example, insertion shaft 108 can be used to position sponge 132 and vacuum tube 140 at the target site. The user can use the hinge or movement of insertion shaft 108 to position sponge 132 and vacuum tube 140. The user can also use one or more visualization techniques (e.g., one or more radiopaque markings on insertion shaft 108, adapter 130, sponge 132) and / or use one or more visualization devices (e.g., illumination device 168 and / or visualization device 170 on distal end 110 of insertion shaft 108) to position sponge 132 and vacuum tube 140. Additionally, handle 104A (and / or handle 180) of medical device 104 can be used to position and / or deploy sponge 132 at the target site, which also allows sponge 132 to expand. Once sponge 132 is positioned, negative pressure or suction can be applied to sponge 132 and / or target site via vacuum tube 140. For example, the proximal portion 140A of the vacuum tube 140 may extend to the exterior of the subject, for example, from an opening (e.g., mouth, nose, etc.). Thus, the vacuum source 124 can be activated to apply negative pressure or suction to the sponge 132, for example, to help remove excess fluid and / or particles (e.g., from the target site and / or when the sponge 132 degrades) from the sponge 132 and / or the target site. In these respects, applying negative pressure or suction to the sponge 132 may help reduce the size of one or more wounds, leaks, etc., at the target site and / or aid in their healing.

[0056] The aspects discussed herein can contribute to improving the efficacy of treatment and / or recovery from surgery, such as bariatric surgery. These aspects can help reduce and / or minimize recovery time, reduce and / or minimize patient discomfort, reduce and / or minimize physician intervention, and reduce and / or minimize the need for and / or dependence on imaging or visualization to locate sponges. For example, the aspects discussed herein allow for the delivery of porous and / or absorbent bodies, such as sponges or therapeutic materials, to the treatment site, and allow for the removal of sponges or therapeutic materials (degradation, physical removal, or a combination thereof). Additionally, the aspects discussed herein can be packaged into kits for use in treating subjects.

[0057] Although the aspects of the medical systems discussed above are used to treat treatment sites in the esophagus, stomach, duodenum, large intestine (colon), or small intestine, these aspects and methods can be used to treat any part of the subject and can help reduce total recovery time, component costs, and risks to the subject.

[0058] While the principles of the invention have been described with reference to illustrative aspects applicable to various applications, it should be understood that the invention is not limited thereto. Those skilled in the art and who are able to access the teachings provided herein will recognize that additional modifications, applications, aspects, and substitutions of equivalents fall within the scope of the aspects described herein. Therefore, the invention should not be considered as limited to the foregoing description.

Claims

1. A medical device comprising: A handle, wherein the handle includes a main body and a movable body, wherein the movable body is movable relative to the main body; An end cap, wherein the end cap includes a fixed portion and an extendable portion, wherein the fixed portion includes one or more through holes; A sponge, wherein at least a portion of the sponge surrounds a portion of the extendable portion of the end cap; One or more wires extending from the movable part of the handle, passing through the fixed portion of the end cap, and reaching the extendable portion of the end cap; and One or more actuating elements connected to a portion of the extendable portion of the end cap. The movement of the movable body of the handle controls the movement of the one or more wires and the extendable portion of the end cap, and The proximal movement of one or more actuating elements controls another movement of the extendable portion of the end cap to separate the extendable portion of the end cap from the sponge.

2. The medical device according to claim 1, wherein, The extendable portion of the end cap includes a band, wherein the sponge is radially positioned around the band.

3. The medical device according to claim 2, wherein, One or more wires are connected to the hoop to extend and / or retract the hoop and the sponge.

4. The medical device according to any one of the preceding claims, wherein, The body includes a longitudinally extending slot, and the movable body is movable along at least a portion of the longitudinally extending slot.

5. The medical device according to any one of the preceding claims further includes a vacuum tube, wherein the distal end of the vacuum tube is coupled to the proximal portion of the sponge.

6. The medical device according to claim 5, wherein, The distal end of the vacuum tube is embedded within the portion of the sponge.

7. The medical device according to claim 6, wherein, The near end of the vacuum tube is connected to a vacuum source or a negative pressure source.

8. The medical device according to any one of the preceding claims, further comprising one or more tubes extending from the body of the handle to the fixing portion of the end cap, wherein, Each of the one or more wires can move within a corresponding one of the one or more tubes.

9. The medical device according to claim 8, wherein, The distal ends of the one or more tubes are fixed at the through-hole to the fixing portion of the end cap.

10. The medical device according to claim 8 or 9, wherein, The one or more through holes include two through holes, wherein the one or more wires include two wires, and wherein the one or more tubes include two tubes.

11. The medical device according to claim 10, wherein, The two through holes are evenly spaced around the fixing portion of the end cap.

12. The medical device according to any one of the preceding claims, wherein, When separated from the extendable portion of the end cap, the sponge expands radially inward.

13. The medical device according to any one of the preceding claims, wherein, The handle includes a ring located at the proximal end of the handle.

14. The medical device according to any one of the preceding claims, wherein, The end cap is configured to connect to the outside of the distal portion of the insertion shaft of the insertion device.

15. The medical device according to any one of the preceding claims, further comprising an actuator, wherein, Each of the one or more actuating elements is connected proximal to the actuator, such that rotation of the actuator retracts one or more wires proximal to retract the extendable portion and deploy the sponge.

Images