System for Wound Treatment

Abstract

The medical device is a tube having a side wall that defines a lumen inside the tube, the tube having a plurality of openings penetrating a distal portion of the side wall and in fluid communication with the lumen; a support structure coupled to the distal portion of the side wall, the support structure having a contracted configuration and an expanded configuration and having support openings passing through a wall of the support structure; and a porous body covering at least a portion of the support structure.

Description

Technical Field

[0001] The present disclosure generally relates to medical treatment systems, medical treatment devices, and related methods. Embodiments of the present disclosure relate to a treatment system for luminal wounds and a medical device for negative pressure wound treatment.

Background Art

[0002] Endoscopic and open surgeries of the gastrointestinal (GI) tract include, among others, colectomy, bariatric surgery, esophagectomy, gastric bypass, and sleeve gastrectomy. These procedures can result in perforations, postoperative leaks, or other wounds in the tract. Although there are some treatment options for such wounds, these treatments have significantly high morbidity and mortality rates. The options include surgical reoperation and endoscopic placement of stents or clips. Surgery is relatively invasive and also has a high morbidity and high mortality rate. Endoscopic stent placement is a less invasive option. However, the placed stent may move from the intended position and / or build a wall around the infection at the treatment site, inhibiting drainage.

Summary of the Invention

[0003] Aspects of the present disclosure relate, among other things, to systems, devices, and methods for treating a target treatment site using negative pressure with an expandable member. Each of the aspects disclosed herein may comprise one or more of the features described in combination with any of the other disclosed aspects.

[0004] According to one example, a medical device comprises a tube having a sidewall defining a lumen inside the tube, a plurality of openings penetrating a distal portion of the sidewall and in fluid communication with the lumen. The medical device comprises a support structure coupled to the distal portion of the sidewall, the support structure having a contracted configuration and an expanded configuration and having support openings through the wall of the support structure. The medical device comprises a porous body covering at least a portion of the support structure.

[0005] Any of the medical devices described herein may have one or more of the following features. The distal portion of the sidewall may extend along the inside of the wall of the support structure. A plurality of openings may be spaced along the distal length of the tube. The tube may be movably coupled to the distal portion of the support structure. In some embodiments, the tube is rotatable about the axis of the tube with respect to the support structure and the porous body. A plurality of openings may be circumferentially spaced about 180° apart on the sidewall of the tube. The support structure may further comprise a proximal end of the opening through which the tube passes. The support structure may, in an expanded configuration, comprise a distal bulbous region, a proximal region, and a lip region between the distal bulbous region and the proximal region, the cross-sectional dimensions of the lip region being smaller than the cross-sectional dimensions of the bulbous region and the proximal region. The porous body may be a flexible sponge. The porous body may surround at least a portion of the circumference of the support structure. The porous body may be attached to the support structure. The porous body may further comprise a plurality of laminations of porous material that can be individually removed through the distal opening of the support structure and through the inside of the support structure. The porous body may further include a plurality of strip members extending from the distal end to the proximal end of the support structure. The medical device may further include a tear line between adjacent laminations. In some embodiments, at least one of the laminations may be removed through the distal opening by pulling a pull wire.

[0006] According to another example, a medical device comprises a sheath and a tube having a sidewall defining a lumen inside the tube, a plurality of openings passing through the distal portion of the sidewall, and being in fluid communication with the lumen such that suction through the plurality of openings occurs when suction is applied inside the lumen, the tube having a distal portion having a contracted configuration inside the sheath and an expanded configuration distal to the sheath, and a porous body covering at least the distal portion, the porous body having suction through the pores of the porous body occurring by suction through the support opening.

[0007] Any of the medical devices described herein may comprise one or more of the following features. The distal portion of the tube may be substantially linear in the contracted configuration and at least partially helical, spherical, elliptical, pyramidal, or cubic in the expanded configuration. A plurality of openings may be spaced along the distal portion of the tube.

[0008] In another example, for instance, according to a method of applying suction to tissue, the method comprises inserting the distal portion of a medical device in an unexpanded state into a cavity, the medical device comprising a tube and the distal portion, the distal portion comprising a support structure attached to the tube and a porous body attached to the support structure, the inserting step; expanding the distal portion such that the porous body contacts the inner wall of the cavity; and applying suction to the tissue through a plurality of openings in the tube and a plurality of pores in the porous body. The method may further comprise removing at least a portion of the porous body from the support structure without removing the remainder of the distal portion from the cavity.

[0009] The foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention as claimed.

Brief Description of the Drawings

[0010] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate exemplary aspects of the present disclosure and, together with the description, serve to explain the principles of the present disclosure.

Figure 1A

Figure 1B

Figure 2A

Figure 2B

Figure 2C

Figure 3

Figure 4A

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Figure 5

Figure 6

Figure 7

DETAILED DESCRIPTION OF THE INVENTION

[0011] Endoscopic vacuum-assisted closure (EVAC) has been proposed. In EVAC, negative pressure is applied to a wound site in the gastrointestinal tract through, for example, a nasogastric tube having a sponge at its distal end. This sponge is placed endoscopically over a perforation, leak, or other wound, and then negative pressure is applied. However, devices and systems suitable for EVAC are limited.

[0012] Examples of the present disclosure include systems, devices, and methods for removing substances from a target site within a subject (e.g., a patient) by creating a negative pressure thereat. Embodiments of the present disclosure include devices, systems, and methods for endoscopic vacuum-assisted closure (EVAC). For example, EVAC includes endoluminally disposing a porous body (e.g., a sponge or other similar material) at a wound site (including perforations, cysts, leaks, anastomoses, etc.). The placement of this material may be facilitated using a catheter, scope (e.g., an endoscope, bronchoscope, colonoscope, etc.), tube, or sheath, which may be inserted into the GI tract through a natural orifice. The natural orifice may be, for example, the nasal cavity, oral cavity, or anus, and the placement may be made at any portion of the GI tract (including the esophagus, stomach, duodenum, large intestine, or small intestine). The placement may also be made at other organs accessible through the GI tract.

[0013] Furthermore, in embodiments of the present disclosure, the sponge of the EVAC device may be any suitable biocompatible material that absorbs liquid and / or permits liquid to pass through the material under negative pressure. For example, the negative pressure may be used to draw body fluid and / or other substances at the treatment site of the tissue through the porous body. The material may be flexible, compressible, porous, hydrophilic, sterile, and / or disposable. The sponge material may be an open-cell foam. Suitable materials include polyurethane, esters, ethers, composite materials, and any medical grade material. Additionally, in some aspects, the sponge may be referred to interchangeably with the porous body. Therapeutic additives in the sponge, such as hydrogen peroxide, steroids, and various wound sprays, may be used to assist in the treatment of eosinophilic esophagitis and other esophageal defects or to assist the applied treatment in another way.

[0014] The following specifically refers to aspects of the present disclosure. Some examples of those aspects are illustrated in the accompanying drawings. Wherever possible, the same or similar reference numerals are used throughout the several drawings to refer to the same or similar parts. The term "distal" refers to the part that is farthest from the user when the device is inserted into the patient's body. In contrast, the term "proximal" refers to the part that is closest to the user when the device is placed in the patient's body. As used herein, the terms "comprising," "including," or any variation thereof are intended to cover non-exclusive inclusion, such that a process, method, description, or apparatus that comprises a list of elements does not include only those elements but may also include other elements not expressly listed or inherent to such process, method, description, or apparatus. The term "exemplary" is used in the sense of "example" rather than "ideal." Further, relative terms such as "about," "substantially," "approximately," etc. are used to indicate the possible variation of ±10% of the recited numerical value or range of description.

[0015] Figures 1A and 1B are side views of an exemplary device 120 in an extended configuration (1A) and a collapsed configuration, i.e., a closed configuration (1B), according to aspects of the present disclosure. The medical device 120 may include a negative pressure conduit 105, which may comprise a tube (e.g., a flexible tube or a nasal tube, etc.). The negative pressure conduit 105 may be connected to a vacuum source 107 (shown in FIG. 3), which is, for example, a portable or centralized pump or other mechanism for creating a negative pressure within the conduit 105, and is disposed at the proximal end of the sponge delivery system 100 of FIG. 3 (e.g., near the operator of the sponge delivery system 100). The negative pressure may be transmitted through a supply tube or other transport mechanism to the conduit 105. Referring back to FIGS. 1A and 1B, the negative pressure conduit 105 may have one or more openings (not shown) at the distal portion of the conduit 105 and is in fluid communication with one or more pores (or other types of openings) of the sponge 115, whereby the negative pressure from the negative pressure conduit 105 can be applied through the sponge 115 to the surrounding tissue or other anatomical structures of the patient. The vacuum source 107 and the negative pressure conduit 105 may apply a constant negative pressure or a variable negative pressure according to the needs of the medical treatment.

[0016] The medical device 120 may comprise an end effector 122 coupled to the distal end of the negative pressure conduit 105. The end effector 122 may comprise a hollow expandable frame 110, which has support openings through the side walls of the expandable frame 110. The expandable frame 110 may comprise any suitable material that can be crushed and expanded to any original shape (e.g., nitinol). Further, the expandable frame 110 may enable suction or negative pressure to pass through the support openings in the side walls of the expandable frame 110. The expandable frame 110 may comprise, for example, baskets, meshes, cages, loops, braids, scaffolds, wires, filaments, cables, strings, threads, coils or other support structures that may facilitate the transition between a crushed configuration and an expanded configuration. The expandable frame 110 may have shape memory properties and / or may be biased to assume an expanded configuration. Alternatively or in addition, a secondary medical device (e.g., a balloon) (not shown) may be used to expand the frame to a desired size / diameter.

[0017] Referring to the end effector 122 of the extended configuration (FIG. 1A), the extended frame 110 may have a bulbous region 130, and the overall diameter or cross-sectional dimension of the bulbous region 130 is greater than the overall diameter or cross-sectional dimension at the neck region of the proximal end 135 of the extended frame 110, or greater than the overall diameter or cross-sectional dimension at the tapered region of the distal end 125 of the extended frame 110. The distal end 125 of the extended frame 110 may include a terminal opening 126 where there is no frame material. The terminal opening 126 may face distally. Alternatively or in addition, the distal end 125 may include the most distal point where the frame material converges and / or terminates. Similarly, the proximal end 135 of the extended frame 110 may include an opening facing proximally and without frame material, and / or may include the most proximal point where the frame material converges and / or terminates. In some embodiments, the terminal opening 126 is sized sufficiently such that a tube or guidewire can pass through the extended frame 110 from the distal end 125 to the proximal end 135. The terminal opening 126 may be appropriately sized and shaped to allow passage of secondary devices, such as biopsy devices, injectable contrast agents, and / or one or more pharmaceuticals and / or cleaning agents. Distal to the proximal end 135, the extended frame 110 may include a lip 140, i.e., a constricted region, the overall diameter or cross-sectional dimension of which is smaller compared to the overall diameter or cross-sectional dimension of any region of the extended frame 110 at the bulbous region 130 and the proximal end 135. The lip 140 assists, inter alia, in the placement and retention of the device within a cavity (shown in more detail in FIGS. 2A-2C and described in further detail herein).

[0018] As described previously, the expandable frame 110 may be braided, knitted, or made in a similar manner comparable to or similar to expandable stents well-known in the art. The expandable frame 110 may further comprise a coating or additive to assist with the therapeutic application of the device 120. For example, the expandable frame 110 may be partially or completely coated with a fluoroscopic substance to assist with imaging during a particular procedure, or may be partially or completely composed of the fluoroscopic substance. Alternatively or in addition, the expandable frame 110 may be partially or completely coated with a therapeutic agent to aid or assist with the treatment being performed.

[0019] The end effector 122 may comprise a sponge 115, and the sponge 115 may surround the outermost wall of the expansion frame 110. The sponge 115 may be attached to the expansion frame 110 by an adhesive, friction fit, or other means well known in the art. The lip 140 may assist in the retention and placement of the sponge 115 on the expansion frame 110. The sponge 115 may extend to cover the end opening 126. Alternatively, the sponge 115 may be present to cover the end opening 126 and may comprise an opening (not shown) that communicates with the end opening 126. The sponge 115 may be present around the expansion frame 110 with any desired thickness. For example, one or more dimensions of the sponge 115 (e.g., length, height / thickness, width, diameter, etc.) may correspond to the size of the wound. Similarly, the sponge 115 may mimic or otherwise replicate the size and shape of the expansion frame 110. For example, when the expansion frame 110 is in a collapsed state, the sponge 115 may also be in a collapsed state as shown in FIG. 1B for a fixed connection between the sponge 115 and the expansion frame 110. In some embodiments, the user may also vary or modify the desired shape of the sponge 115 by cutting, tearing, pressing, or otherwise manipulating the sponge 115. The adjustability of the sponge 115 may facilitate achieving the desired size of the sponge when it is desirable for the sponge 115 to have dimensions that substantially correspond to the dimensions of the cavity or wound (e.g., the orifice size of the corresponding wound). Further, as the wound or cavity heals or while under vacuum, the size of the wound or cavity may change, and thus different sized sponges 115 may be required or desirable.

[0020] The negative pressure conduit 105 may extend adjacent to and in contact with the inner wall of the expansion frame 110 from the proximal end 135 to the distal end 125. As shown in FIGS. 1A and 1B, the conduit 105 may then extend in a proximal direction from the distal end 125 towards the proximal end 135 and may terminate at the terminal end 105' of the conduit 105. The conduit 105 may extend around or across the terminal opening 126. The conduit 105 may be attached to the expansion frame 110 with an adhesive or other means well known in the art. The negative pressure conduit 105 may have a plurality of holes (not shown) randomly or stepwise dispersed along the desired length of the conduit 105 in the portion of the conduit 105 inside the expansion frame 110. The plurality of holes allows for suction at the target wound site. Although one negative pressure conduit 105 is shown in FIGS. 1A and 1B, additional conduits may be used to enhance and / or distribute the suction through the expansion frame 110 and the sponge 115. Additionally or alternatively, one or more negative pressure conduits may be splittable, for example, one conduit may split inside the expansion frame 110 into two, three, four, etc. conduits, which is similar to fingers emanating from a hand / arm. The negative pressure conduit 105 may surround the inner wall of the expansion frame (like a tube within a stent) at a particular location. Alternatively, a more expansive arrangement may be envisioned, and the negative pressure conduit 105 may surround the inner wall of the expansion frame over a larger area.

[0021] In the closed configuration, i.e., the compressed configuration (FIG. 1B), the longitudinal length of the end effector 122 may increase while its height or width may decrease compared to the expanded state (similar to a stent) of FIG. 1A. The compressibility of the frame 110 may facilitate the delivery of the medical device 120. For example, the medical device 120 may be delivered to the target site in its compressed configuration. The compressed configuration may be small enough such that at least a portion of the medical device 120 may fit within the working channel of an endoscope or otherwise be deliverable endoscopically. Upon placement, the medical device 120, particularly the end effector 122, may transition to the expanded configuration in which the end effector 122 may engage the subject's tissue (e.g., a wound).

[0022] Figures 2A - 2C illustrate the medical device 120 during various stages of use. More specifically, Figures 2A - 2C illustrate an esophageal lumen 255 having a wound, puncture, or cavity 260 in the esophageal wall 250. As shown in Figure 2A, the medical device 120 or at least the distal portion of the medical device 120 (e.g., the portion distal to the lip 140) is delivered into the cavity 260 of the esophageal lumen 255 in a non - expanded state. The medical device 120 can be delivered by advancing the device 120 over a guide wire or tube (not shown) or within the lumen of a scope, sheath, or other similar device. Once positioned, the medical device 120 is expanded as shown in Figure 2B. The device 120, specifically the end effector 122, may be expanded once the end effector 122 is positioned outside the sheath, thanks to the material of the frame 110, and / or the end effector 122 may be expanded by a secondary device (e.g., a balloon (not shown) that expands inside the frame 110). The end effector 122 fills the cavity 260 such that the outer wall of the sponge 115 contacts the inner wall of the cavity 260. The lip 140 further assists in holding the end effector 122 in position within the cavity 260 by sandwiching tissue adjacent to each side of the lip 140 by the larger - diameter portion of the end effector 122 and / or by contacting both sides of the tissue, such that the end effector 122 does not move further into or out of the cavity 260.

[0023] Once the end effector 122 is positioned and expanded (as shown in FIG. 2B), a vacuum source is activated and the inner wall of the cavity 260 is slowly drawn by vacuum towards the sponge 115 as shown in FIG. 2C. The device 120 is then left in place for a period ranging from approximately less than one day to approximately seven days or more. Once the size of the cavity 260 is sufficiently reduced, the sponge 115 and the frame 110 are withdrawn from the cavity 260 and, if necessary, a new device 120 having the sponge 115 and the frame 110 is repositioned to fill the reduced cavity 260. This procedure can then be repeated with new devices 120 as many times as necessary.

[0024] FIG. 3 is a cross-sectional view of an exemplary delivery system 100 for delivering the device 120. The proximal portion of the delivery system 100 comprises a handle 155. The handle 155 may comprise an inner tubular member 103 and an outer tubular member 112. The knob 106 may project radially outwardly from the proximal portion of the outer tubular member 112. Similarly, the knob 108 may project radially outwardly from the proximal portion of the inner tubular member 103. The outer tubular member 112 may comprise an inner lumen 111 for receiving a portion of the inner tubular member 103 and for facilitating axial movement of the inner tubular member 103 within the outer tubular member 112. The knobs 106 and 108 facilitate the user to axially push the inner tubular member 103 into the lumen 111 of the outer tubular member 112. The outer surface of the inner tubular member 103 and / or the inner surface of the outer tubular member 112 may be coated with a smooth material (e.g., polytetrafluoroethylene, i.e., PTFE) to assist with the movement of the inner tubular member 103 within the outer tubular member 112.

[0025] The inner lumen 113 of the inner tubular member 103 can function as at least a portion of the conduit 105 of the device 120. The end effector 122 can be fixed to the distal end of the inner tubular member 103. The lumen 113 may be connected to a tube 150 extending from the proximal end of the handle 155, and both the tube 150 and the lumen 113 together form the conduit 105. The tube 150 includes a proximal end connected to a vacuum source 107. In an exemplary embodiment, the opening 102 is in the most proximal portion of the inner tubular member 103. The opening 102 can be removably coupled to the tube 150 by, for example, a luer lock or other removable fitting means well known in the art. The opening 102 can facilitate the flow of fluid from the vacuum source 107 through the lumen 113 of the inner tubular member 112.

[0026] Alternatively, the tube 150 can pass through the opening 102 and the lumen 113 and may be connected to the end effector 122. The tube 150 then functions as the conduit 105. In this embodiment, the tube 150 and the end effector 122 may move axially with respect to the lumen 113.

[0027] The distal portion of the delivery system 100 may comprise a distal opening 101 disposed at the most distal end. The opening 101 may enable the medical device 120, specifically its end effector 122, to be removed or released from the outer tubular member 112. For example, when the inner tubular member 103 is transitioned from a first proximal configuration to a second distal configuration inside the outer tubular member 112, the end effector 122 may be pushed out or removed from outside the distal opening 101. Removal from the opening 101 allows the end effector 122 to transition to its expanded configuration.

[0028] Figures 4A and 4B illustrate alternative embodiments of the medical device 420. As shown for the medical device 120, the medical device 420 includes a negative pressure conduit 405 and an expansion frame 410 having a proximal end 435 and a distal end 425. The distal end 425 of the expansion frame 410 may also include a terminal opening 426 where there is no frame material. Similarly, the expansion frame 410 may have a bulbous region 430 and a lip 440. Such portions may have any of the structures and / or functions described in combination with the same or similar portions of the device 120.

[0029] The device 420 differs in that a number of separate separable sponge layers 415a, 415b, 415c are either over or surround the expansion frame 410. In such a manner, the separable sponge layers 415a, 415b, 415c may be laminated. The number of sponge layers may be two, three, four or any desired number. For example, multiple layers of sponge (e.g., 415a, 415b, 415c) may be used such that during the course of treatment, the sponge material can be refreshed without redelivery or repositioning of the various devices. For example, once the outermost sponge layer 415a is used, the user can retract it using a drawstring 445 (e.g., a thread made of suture material, etc.) or other means (i.e., forceps, snares, etc.), resulting in the removal of the outer sponge layer 415a and the exposure of the second layer 415b (which was previously under the sponge layer 415a and between the sponge layer 415a and the sponge layer 415c). In such a manner, the separable sponge layers 415a, 415b, 415c can be individually removed. For example, the sponge layer 415a can be removed without removing the remainder of the medical device 420 (e.g., the distal portion of the medical device 420) from its cavity. This is accomplished by pulling the sponge layer 415a proximally (P) through the terminal opening 426, thereby exposing the sponge layer 415b. The sponge layer 415a can then be extracted for analysis if necessary.

[0030] The step of removing the sponge layer 415a can also be accomplished, for example, by using a hot snare to excise a portion of the sponge layer 415a for removal and / or analysis. Alternatively or in addition, the sponge layers 415a, 415b, etc. may include puncture portions or tear lines, such that once a predetermined force is applied onto the outermost sponge layer, the (one or more) sponge layers can be peeled off from the remaining (one or more) sponge layers.

[0031] In addition, in multiple sponge layers, multiple pull lines 445 can be used. For example, a second pull line (not shown) may be attached to the sponge layer 415b, and a third pull line (not shown) may be attached to the sponge layer 415c, etc. Such pull lines may be coated with color or marked in other ways to indicate which pull line 445 corresponds to which sponge layer 415a, 415b, 415c, etc. For example, a green pull line may correspond to the sponge layer 415a, a yellow pull line may correspond to the sponge layer 415b, and a blue pull line may correspond to the sponge layer 415c.

[0032] In some embodiments, each separated sponge layer 415a, 415b, 415c may differ from each other in one or more characteristics (e.g., degree of frame coverage, pore size, dimensions, material, color, etc.). For example, the sponge layer 415a may have a certain dimension, while the sponge layer 415b and / or the sponge layer 415c may have another dimension different from the first dimension. Similarly, the sponge layer 415a may be made of a certain material, while the sponge layer 415b, 415c may be made of another material different from the first material. Additionally or alternatively, in some embodiments, each sponge layer 415a, 415b, etc. may be coated with color or have various fluorescence markers to indicate that the sponge layer 415a, 415b has been used or removed. Various combinations of dimensions, materials, and colors are possible in such embodiments.

[0033] FIG. 5 illustrates an alternative medical device 520 having an end effector 522. As shown for medical device 120, medical device 520 includes a negative pressure conduit 505 and an expansion frame 510 having a proximal end 535 and a distal end 525. These portions may have any of the structures and / or functions described in combination with the same or similar portions of device 120. Medical device 520 has elongated strips 515a, 515b, 515c, 515d of sponge material extending longitudinally (from proximal to distal) across expansion frame 510 from distal end 525 to proximal end 535 of expansion frame 510. In some embodiments, portions of expansion frame 510 may be exposed. In other embodiments (not shown), expansion frame 510 may be completely covered by strips of sponge material.

[0034] Strips 515a - d converge at the most distal end 525. Strips 515a - d may overlap and / or be alternately arranged. Strips 515a - d are sponges of a smaller volume than, for example, a solid conical sponge, allowing for easy placement and re - contraction if necessary. Each of strips 515a, 515b, 515c, 515d may be constructed with the same or different properties from each other. For example, the material, pore size, and / or dimensional properties of each strip may be different from each other. For example, strip 515a may be of one material and one thickness, and strip 515b may be of a second material and / or a second thickness. Different thicknesses may allow for easy removal of the device due to the sponges being of a smaller volume compared to a solid conical sponge. Similarly, the number of strips may vary in alternative embodiments. For example, there may be one, two, three, four, or more strips per sponge. Further, the formation of strips 515a - d is not limited to extending longitudinally. For example, the strips of sponge may be helical (not shown) around expansion frame 510 or may extend horizontally around expansion frame 510 like a ring. The strips of sponge may, in addition or instead, be layered, for example, combining aspects of the embodiments of FIGS. 4A - B with this embodiment.

[0035] FIG. 6 illustrates an alternative embodiment of a medical device 620 having an end effector 622. This embodiment of the medical device 620 includes a suction conduit 605, which may have any of the characteristics of the suction conduits described in other embodiments, except as described below. The medical device 620 further includes a sponge 615 having an array of discrete strips 615a, 615b, 615c, 615d, etc., each strip extending axially in a proximal-to-distal direction. The discrete strips 615a - 615d converge and join at the most distal end 625 of the end effector 622. The end effector 622 may include any number of strips 615a, 615b, 615c, etc. (e.g., one, two, three, four, or more) spaced evenly or unevenly around the conduit 605. The embodiment shown in FIG. 6 includes four strips 615a - 615d spaced evenly around the conduit 605. Strips 615a and 615c are respectively at the top and bottom of the page, and strips 615b and 615d are respectively oriented towards the front and back of the page. Each strip 615a - 615d faces radially inward towards the conduit 605. Each strip 615a - d may or may not include a scaffold (not shown) that helps to hold their shape (similar to the extended frames described in previous embodiments).

[0036] The suction conduit 605 includes a threaded fitting 675 corresponding to a threaded fitting 672 within the distal wall of the sponge 615. For example, the conduit 605 may include a male or female threaded fitting 675, and the inside of the distal wall of the sponge 615 may include a corresponding female or male threaded fitting 672. There may be alternative attachment methods as long as relative rotational movement between the sponge 615 and the conduit 605 is permitted. For example, press fitting or other methods well known in the art may be utilized to movably couple the sponge 615 to the conduit 605.

[0037] The conduit 605 may include a plurality of holes 660a and 660c that pass through the sidewall of the conduit 605. The holes 660a may be spaced 180° apart from the holes 660c. The plurality of holes 660a and 660c align with a plurality of suction locations 665a - 665d strategically arranged on the strips 615a - 615d. The suction locations 665a - 665d partially penetrate the thickness of their respective corresponding strips 615a - 615c. In this embodiment, for example, in a first configuration, the holes 660a and 660c align with the holes or suction locations 665a and 665c respectively, thereby being configured to affect the application of suction to the surrounding tissue adjacent to or near their corresponding strips 615a and 615c. In a second configuration, torque is applied to the conduit 605 (e.g., rotated 90° about the axis relative to the sponge 615), and the suction holes 660a or 660c align with the suction location 665d. In the second configuration, applying suction affects the surrounding tissue adjacent to or near the corresponding strips 615b and 615d. When the holes 660a and 660c align such that they match the second positions 665a and 665c (and their corresponding strips 615a and 615c) respectively, the holes 660a and 660c do not match the second positions 665b and 665d (and their corresponding strips 615b and 615c) respectively (and vice versa), and the holes 660a and 660c may be misaligned.

[0038] Similar to the previous embodiments, a fluorescence - permeable marker, a colored coating, or other markers may be utilized to assist the user in identifying whether the holes 660a, 660c and the second positions 665a - 665d are properly arranged. For example, one marker or color may indicate when the holes 660a and 660c align with the positions 665a and 665c (and their strips 615a and 615c) in the first configuration, and a second marker or color different from the first marker or color may indicate when the holes 660a and 660c align with the positions 665b and 665d (and their strips 615b and 615d).

[0039] FIG. 7 illustrates a side view of an exemplary medical device 720 comprising an end effector 722 that includes a suction conduit 705 and a porous body (e.g., sponge 715). Like other embodiments of the medical devices described in this disclosure, the medical device 720 may be flexible and may be configured to move through a tortuous passage of a patient's body lumen.

[0040] The suction conduit 705 may comprise a plurality of holes 760 through the wall of the conduit 705. The holes 760 may be randomly or stepwise circumferentially arranged around the suction conduit 705 at a given distance to enable suction at the target site. The distal most end of the suction conduit 705 may comprise a rounded tip portion 725 configured to be non-invasive so that movement of the end effector 722 inside the patient's body lumen does not cut or damage tissue. In an alternative embodiment, the suction conduit 705 may further comprise a central lumen (not shown), and when a coiled wire (not shown) is placed inside its central lumen, a desired shape is imparted to its central lumen and thus to the suction conduit 705. For example, this desired shape may be spherical, elliptical, pyramidal, cubic, or other shapes.

[0041] The sponge 715 may have any of the structures, properties, and / or functions described in combination with the same or similar parts of the device 120. For example, the sponge 715 may be of any suitable size and shape to fit inside a patient's anatomical structure. The sponge 715 may include a number or one large piece that attaches to the outer surface / wall of the suction conduit 705. The sponge 715 may be removably coupled to the suction conduit 705 by means of a central lumen (not shown) extending through the sponge 715, the central lumen being sized to receive the suction conduit 705 and being similar to a sock on a foot or a sleeve on an arm. In one embodiment, the sponge 715 may be connected to the suction conduit 705 by glue, friction fit, or any alternative means well known in the art.

[0042] In use, medical device 720 is advanced through sheath 718. The end effector 722 of medical device 720, particularly the end effector 722, may be straight or substantially straight in a first configuration, where the sponge 715 and conduit 705 are within the sheath 718. Next, in an expanded configuration, the end effector 722 may coil outside of the delivery sheath 718 (e.g., when advanced distally towards the delivery sheath 718). At least a portion of the end effector 722 may take on many shapes or forms (helical, spherical, elliptical, pyramidal, cubic, and others) in a second configuration. This expanded shape may be due to being biased naturally towards the expanded shape, for example, via a shape memory material used in at least the distal portion of the conduit 705. Once the end effector 722 is in a desired location (e.g., a cavity, puncture, or wound), the user may apply suction or negative pressure to the device 720. As in previous embodiments, the suction is applied for a desired length of time. Once the procedure is complete, the medical device 720 is removed from the patient and a new medical device is inserted if necessary.

[0043] It will be apparent to those skilled in the art that various modifications and variations can be made to the devices and methods of this disclosure without departing from the scope of the disclosure. Other aspects of the disclosure will be apparent to those skilled in the art in view of the specific examples and implementations of the features disclosed herein. The specific examples and embodiments are intended to be considered as illustrative only.

Claims

1. It is a medical device, The tube having a side wall that defines a lumen inside the tube, wherein a plurality of openings penetrate the distal portion of the side wall and communicate with the lumen, A support structure connected to the distal portion of the side wall, wherein the support structure has a contraction configuration and an expansion configuration, and the support structure has a support opening passing through the wall of the support structure, A porous body covering at least a portion of the support structure, A medical device equipped with the following features.

2. The medical device according to claim 1, wherein the distal portion of the side wall extends along the inside of the wall of the support structure.

3. The medical device according to claim 1 or 2, wherein the plurality of openings are spaced apart along the distal length of the tube.

4. The medical device according to claim 1 or 2, wherein the tube is movably coupled to the distal portion of the support structure.

5. The medical device according to claim 4, wherein the tube is rotatable about the axis of the tube with respect to the support structure and the porous body.

6. The medical device according to claim 5, wherein the plurality of openings are located on the side wall of the tube at intervals of approximately 180° apart in the circumferential direction.

7. The medical device according to claim 1 or 2, wherein the support structure further comprises a proximal opening through which the tube passes.

8. The device according to claim 1 or 2, wherein the support structure, in the extended configuration, comprises a distal bulbous region, a proximal region, and a lip region between the distal bulbous region and the proximal region, and the cross-sectional dimensions of the lip region are smaller than the cross-sectional dimensions of the bulbous region and the cross-sectional dimensions of the proximal region.

9. The medical device according to claim 1 or 2, wherein the porous body is a flexible sponge.

10. The medical device according to claim 1 or 2, wherein the porous body surrounds at least a portion of the circumference of the support structure.

11. The medical device according to claim 1 or 2, wherein the porous body is attached to the support structure.

12. The medical device according to claim 1 or 2, further comprising a plurality of layers of porous material which can be individually removed through the distal opening of the support structure and the inside of the support structure.

13. The medical device according to claim 1 or 2, further comprising a plurality of strips of material extending from the distal end to the proximal end of the support structure.

14. The medical device according to claim 12, further comprising tear lines between adjacent layers.

15. The medical device according to claim 12, wherein at least one of the multiple layers can be removed through the distal opening by drawing a line.

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