System for wound treatment

Abstract

A medical device includes a tube having a sidewall defining a lumen within the tube with a plurality of openings extending through a distal portion of the sidewall and in fluid communication with the lumen; a support structure coupled to the distal portion of the sidewall, the support structure having a contracted configuration and an expanded configuration, and the support structure having a support opening through a wall of the support structure; and a porous body over at least a portion of the support structure.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority under 35 U.S.C. §119 to U.S. Provisional Application No. 63 / 364,934, filed on May 18, 2022, which is incorporated herein by reference in its entirety. Technical Field

[0002] The present invention generally relates to medical systems, devices and methods related thereto. Embodiments of the present invention relate to intracavitary wound treatment systems and medical devices for negative pressure wound therapy. Background Art

[0003] Endoscopic and open surgical procedures of the gastrointestinal tract (GI) include, for example, colectomy, bariatric surgery, esophagectomy, gastric bypass, and sleeve gastrectomy. These operations may result in perforation, postoperative leakage, or other wounds of the duct. There are limited treatment options for managing such wounds, which have significant morbidity and mortality. Options include surgical reoperation and endoscopic placement of stents or clips. Surgery is relatively invasive and has high morbidity and mortality. Endoscopic stent placement is a less invasive option. However, the placed stent may migrate from the intended position and / or isolate infection at the treatment site, thereby inhibiting drainage. Summary of the invention

[0004] Aspects of the invention relate to systems, devices, and methods, among other things, for treating a target treatment site using negative pressure with an expandable member. Each of the aspects disclosed herein may include one or more of the features described in conjunction with any of the other disclosed aspects.

[0005] According to one example, a medical device includes a tube having a sidewall defining a lumen within the tube, wherein a plurality of openings extend through a distal portion of the sidewall and are in fluid communication with the lumen. The medical device includes a support structure coupled to the distal portion of the sidewall, the support structure having a collapsed configuration and an expanded configuration, and the support structure having a support opening through the wall of the support structure. The medical device includes a porous body over at least a portion of the support structure.

[0006] Any of the medical devices described herein may include one or more of the following features. The distal portion of the sidewall may extend along the interior of the wall of the support structure. A plurality of openings may be spaced apart 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 may rotate relative to the support structure and the porous body around the axis of the tube. A plurality of openings may be spaced apart about 180 degrees circumferentially on the sidewall of the tube. The support structure may also include an open proximal end through which the tube extends. The support structure in the expanded configuration may include a distal spherical region, a proximal region, and a lip region between the distal spherical region and the proximal region, wherein the cross-sectional dimensions of the lip region are smaller than the cross-sectional dimensions of the spherical region and the cross-sectional dimensions of 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 also include a plurality of stacked layers of porous material that can be removed separately through the distal openings in the support structure and the interior of the support structure. The porous body may also include a strip of material extending from the distal end of the support structure to the proximal end. The medical device may also include a tear line between adjacent stacked layers. In some embodiments, at least one of the stacked layers may be removed through the distal opening by pulling a pull line.

[0007] According to another example, a medical device includes a sheath; a tube having a sidewall, the sidewall defining a cavity within the tube, wherein a plurality of openings extend through a distal portion of the sidewall and are in fluid communication with the cavity such that application of suction within the cavity results in suction through the plurality of openings, wherein the tube includes a distal portion having a contracted configuration within the sheath and an expanded configuration distal to the sheath; and a porous body at least above the distal portion such that suction through the supporting openings results in suction through the pores of the porous body.

[0008] Any of the medical devices described herein may include one or more of the following features. The distal portion of the tube may be substantially straight in the contracted configuration and at least partially helical, spherical, elliptical, pyramidal, or cubical in the expanded configuration. A plurality of openings may be spaced apart along the distal portion of the tube.

[0009] According to another example, for example, a method of applying suction to tissue, the method may include inserting a distal portion of a medical device in an unexpanded state into a cavity, the medical device comprising a tube and a distal portion, wherein the distal portion comprises a support structure attached to the tube, and a porous body attached to the support structure; expanding the distal portion so that an outer wall of the porous body contacts an inner wall of the cavity; and applying suction to the tissue through a plurality of openings in the tube and holes in the porous body. The method may also include removing at least a portion of the porous body from the support structure without removing the remainder of the distal portion from the cavity.

[0010] It is to be understood that both 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

[0011] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate exemplary aspects of the present invention and, together with the description, serve to explain the principles of the present invention.

[0012] Figure 1A and Figure 1B are side views of exemplary devices according to aspects of the present invention in an expanded configuration (1A) and in a collapsed or closed configuration (1B).

[0013] Figure 2A , Figure 2B and Figure 2C In an exemplary treatment method according to aspects of the present invention, Figure 1A and Figure 1B View of medical device.

[0014] Figure 3 is a cross-sectional view of an exemplary delivery system according to aspects of the present invention.

[0015] Figure 4A and Figure 4B Alternative embodiments of exemplary medical devices are depicted in a first configuration (4A) and a second configuration (4B).

[0016] Figure 5 is a perspective view of an alternative embodiment of an exemplary medical device according to aspects of the present invention.

[0017] Figure 6 is a perspective view of an alternative embodiment of an exemplary medical device according to aspects of the present invention.

[0018] Figure 7 is a side view of an alternative embodiment of an exemplary medical device according to aspects of the present invention. DETAILED DESCRIPTION

[0019] Endocavity vacuum therapy (EVAC) has been proposed. In EVAC, negative pressure is delivered to the wound site in the GI tract, for example, through a nasogastric tube with a sponge at its terminal end. The sponge is placed endoscopically in the perforation, leak, or other wound. Then, negative pressure is applied. However, devices and systems suitable for EVAC are limited.

[0020] Examples of the present invention include systems, devices and methods for removing material from a target site within a subject (e.g., a patient) by generating negative pressure therein. Embodiments of the present invention include devices, systems and methods for intracavitary vacuum therapy (EVAC). In an example, EVAC includes intracavitary placement in a porous body, such as a sponge or other similar material, to a wound site, including a perforation, cyst, leak, anastomosis, etc. The material can be placed via a catheter, a scope (endoscope, bronchoscope, colonoscope, etc.), a tube or a sheath (which is inserted into the GI tract via a natural orifice). The orifice can be, for example, the nose, mouth or anus, and the placement can be in any part of the GI tract, including the esophagus, stomach, duodenum, large intestine or small intestine. The placement can also be in other organs that can be reached via the GI tract.

[0021] In addition, in embodiments of the present invention, the sponge of the EVAC device can be any suitable biocompatible material that can absorb liquid and / or allow liquid to pass through via negative pressure. For example, negative pressure can be used to draw body fluids and / or other materials present at the tissue treatment site through a porous body. The material can be flexible, compressible, porous, hydrophilic, sterile and / or disposable. The sponge material can be an open-cell foam. Suitable materials include polyurethanes, esters, ethers, composites, and any medical grade materials. In addition, in some aspects, the sponge can be synonymously referred to as a porous body. Therapeutic additives in the sponge, such as, for example, hydrogen peroxide, steroids, and various wound sprays can be used to help treat eosinophilic esophagitis and other defects of the esophagus or otherwise assist in ongoing treatment.

[0022] Reference will now be made in detail to various aspects of the present invention, examples of which are shown in the accompanying drawings. Whenever possible, the same or similar reference numerals will be used in all drawings to refer to the same or similar parts. The term "distal" refers to the part farthest from the user when the device is introduced into the patient's body. Conversely, the term "proximal" refers to the part closest to the user when the device is placed in the patient's body. As used herein, the terms "include", "comprise" or any other variation thereof are intended to cover non-exclusive contents, so that the process, method, article or device including a list of elements not only includes those elements, but may include other elements that are not explicitly listed or are not inherent to such process, method, article or device. The term "exemplary" is used in the sense of "example" rather than "exemplary". In addition, relative terms such as, for example, "approximately", "substantially", "about" are used to indicate a possible change of ±10% of a specified value or range.

[0023] Figure 1A and Figure 1B 1 is a side view of an exemplary device 120 in accordance with aspects of the present invention in an expanded configuration ( 1A) and in a collapsed or closed configuration ( 1B).

[0024] The medical device 120 may include a negative pressure conduit 105, which may include, for example, a tube, such as a flexible tube or a nasal cannula. The negative pressure conduit 105 may be connected to a vacuum source 107 (e.g., Figure 3 ), such as a portable or centralized pump or a device for generating negative pressure in the conduit 105 and located Figure 3 Other mechanisms of the sponge delivery system 100 proximal end (eg, near the operator of the sponge delivery system 100). Negative pressure can be delivered to the catheter 105 via a supply tube or other delivery mechanism. Return to Reference Figure 1A and Figure 1B , the negative pressure conduit 105 may have one or more openings (not shown) in the distal portion of the conduit 105 and in fluid communication with one or more holes (or other types of openings) of the sponge 115, so that negative pressure from the negative pressure conduit 105 can be applied to surrounding tissue or other patient anatomical structures through the sponge 115. The vacuum source 107 and the negative pressure conduit 105 may apply a constant negative pressure or a variable negative pressure, depending on the needs of the medical procedure.

[0025] The medical device 120 may include an end effector 122 coupled to the distal end of the negative pressure catheter 105. The end effector 122 may include a hollow expansion frame 110, wherein the expansion frame 110 has a support opening through the side wall of the expansion frame 110. The expansion frame 110 may be composed of any suitable material (e.g., nitinol) that can collapse and expand to any original shape. In addition, the expansion frame 110 may be capable of allowing suction or negative pressure to pass through the support opening of the side wall of the expansion frame 110. The expansion frame 110 may include, for example, a basket, mesh, cage, ring, braid, stent, wire, filament, cable, string, wire, coil or other support structure that can facilitate the transition between the collapsed and expanded configurations. The expansion frame 110 may have shape memory properties and / or may be biased to the expanded configuration. Alternatively or additionally, a secondary medical device (e.g., a balloon) (not shown) may be used to expand the frame to a desired size / diameter.

[0026] Refer to the end effector in the expanded configuration ( Figure 1A), the expansion frame 110 can have a bulbous region 130, wherein the overall diameter or cross-sectional dimension of the bulbous region 130 is greater than the overall diameter or cross-sectional dimension of the neck region at the proximal end 135 of the expansion region 110 or the tapered region at the distal end 125 thereof. The distal end 125 of the expansion frame 110 can include a terminal opening 126, wherein no framework material is present. The terminal opening 126 can face distally. Alternatively or additionally, the distal end 125 can include a distal-most point at which framework material meets and / or terminates. Similarly, the proximal end 135 of the expansion frame 110 can include a proximally facing opening, wherein no framework material is present and / or can include a proximal-most point at which framework material meets and / or terminates. In some embodiments, the size of the terminal opening 126 is sufficient to allow a tube or guidewire to pass from the distal end 125 through the expansion frame 110 to the proximal end 135. The terminal opening 126 may also be of a suitable size and shape to allow passage of secondary devices, such as a biopsy device, an injectable contrast agent, and / or one or more medicaments or cleaning agents. Distal to the proximal end 135, the expansion frame 110 may include a lip 140 or narrow region where the overall diameter or cross-sectional dimension is smaller than both the bulbous region 130 and the region of the expansion frame 110 at the proximal end 135. The lip 140 helps place and retain the device in the cavity (at FIG. 2A to FIG. 2C and will be described in further detail herein), etc.

[0027] As previously described, the expansion frame 110 can be braided, knitted, or similarly constructed in a manner comparable or similar to expandable stents generally known in the art. The expansion frame 110 can also include coatings or additives to assist in therapeutic applications of the device 120. For example, the expansion frame 110 can be partially or fully coated with, or partially or entirely composed of, a fluoroscopic material to assist in visualization in certain procedures. Alternatively or additionally, the expansion frame 110 can be partially or fully coated with a therapeutic agent to assist or assist in the delivered therapy.

[0028] The end effector 122 also includes a sponge 115, wherein the sponge 115 can surround the outermost wall of the expansion frame 110. The sponge 115 can be attached to the expansion frame 110 by an adhesive, a friction fit, or other means generally known in the art. The lip 140 can also assist in holding and placing the sponge 115 to the expansion frame 110. The sponge 115 can extend above the terminal opening 126. Alternatively, the sponge 115 can include an opening (not shown) located above the terminal opening 126 and connected to the terminal opening 126. The sponge 115 can have any desired thickness surrounding the expansion frame 110. For example, one or more dimensions of the sponge 115 (e.g., length, height / thickness, width, diameter, etc.) can correspond to the size of the wound. Similarly, the sponge 115 can 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, due to the fixed connection between the sponge 115 and the expansion frame 110, the sponge 115 is also in a collapsed state, such as Figure 1B In some embodiments, the user can change or alter the desired shape of the sponge 115 by cutting, tearing, pressing, or otherwise manipulating the sponge 115. The adjustability of the sponge 115 can facilitate achieving the desired size of the sponge, as the size of the sponge 115 needs to substantially correspond to the size of the cavity or wound, for example, the size of the orifice of the wound. In addition, as the wound or cavity heals or when the vacuum is turned on, the size of the wound or cavity may change, and a sponge 115 of a different size may be necessary or desired.

[0029] The negative pressure conduit 105 may extend from the proximal end 135 to the distal end 125 adjacent to the inner wall of the expansion frame 110 and contact it. Figure 1A and Figure 1B As shown, the catheter 105 then extends proximally from the distal end 125 toward the proximal end 135 and terminates at a terminal end 105' of the catheter 105. The catheter 105 can extend around or across the terminal opening 126. The catheter 105 can be attached to the expansion frame 110 by an adhesive or other means generally known in the art. The negative pressure catheter 105 can have a plurality of holes (not shown) randomly or incrementally dispersed along the desired length of the catheter 105 in the portion of the catheter 105 within the expansion frame 110. The plurality of holes enables suction at the target wound site. Although Figure 1A and Figure 1BOne negative pressure conduit 105 is shown, but additional conduits may be utilized to increase suction and / or distribute suction throughout the expansion frame 110 and sponge 115. Additionally or alternatively, one or more negative pressure conduits may be split, for example, one conduit splits into two, three, four, etc. conduits within the expansion frame 110, much like fingers extending from a hand / arm. The negative pressure conduits 105 may wrap around the inner wall of the expansion frame at certain points, like a tube in a stent. Alternatively, a more extensive arrangement may be envisioned in which the negative pressure conduits 105 more extensively wrap around the inner wall of the expansion frame.

[0030] In closed or compressed form ( Figure 1B ), and Figure 1A Compared to the expanded state, the longitudinal length of the end effector 122 can be increased, while the height or width can be reduced, similar to a stent. The compressibility of the frame 110 can facilitate the delivery of the medical device 120. For example, the medical device 120 can be delivered to a target site in a compressed state. The compressed state can be small enough that at least a portion of the medical device 120 can be fitted in a working channel of an endoscope or can be otherwise delivered endoscopically. When deployed, the medical device 120 and particularly the end effector 122 can be converted to an expanded state, wherein the end effector 122 can engage with tissue (e.g., a wound) of a subject.

[0031] FIG. 2A to FIG. 2C The medical device 120 is depicted during different stages of use. More specifically, FIG. 2A to FIG. 2C An esophageal lumen 255 is depicted having a wound, perforation, or cavity 260 in the esophageal wall 250. Figure 2A As shown, the medical device 120 or at least the distal portion of the medical device 120, such as the portion distal to the lip 140, is delivered in the cavity 260 of the esophageal cavity 255 in an unexpanded state. The medical device 120 can be delivered by advancing the device 120 over a guide wire or tube (not shown) or within the cavity of a scope, sheath, or other similar device. Once in the proper position, the medical device 120 is expanded, such as Figure 2B Once the end effector 122 is deployed from the sheath, the device 120, and in particular the end effector 122, can be expanded with the aid of the material of the frame 110, and / or the end effector 122 can be expanded by a secondary device, such as a balloon (not shown), that expands within the interior of 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 can also help to maintain the end effector 122 in a proper position within the cavity 260, which is achieved by the larger diameter portion of the end effector 122 clamping the tissue adjacent to each side of the lip 140 and / or contacting both sides of the tissue so that the end effector 122 does not move further into or out of the cavity 260.

[0032] Once the end effector 122 is in position and expanded (eg, Figure 2B As shown), the vacuum source is turned on and the inner wall of the cavity 260 is sucked toward the sponge 115 by the vacuum, as shown in FIG. Figure 2C As shown. The device 120 is then left in place for a period of time ranging from about less than a day to about 7 days or more. Once the size of the cavity 260 is sufficiently reduced, the sponge 115 and frame 110 are retracted from the cavity 260 and replaced with a new device 120 having a sponge 115 and frame 110 to fill the smaller cavity 260, if necessary. The process can then be repeated with new devices 120 as many times as needed.

[0033] Figure 3 1 is a cross-sectional view of an exemplary delivery system 100 for use with a delivery device 120. The proximal portion of the delivery system 100 can include a handle 155. The handle 155 can include an inner tubular member 103 and an outer tubular member 112. A finger grip 106 can protrude radially outward from a proximal portion of the outer tubular member 112. Similarly, a finger grip 108 can protrude radially outward from a proximal portion of the inner tubular member 103. The outer tubular member 112 can include a lumen 111 to receive a portion of the inner tubular member 103 and facilitate axial movement of the inner tubular member 103 within the outer tubular member 112. The finger grips 106, 108 facilitate a user pushing the inner tubular member 103 within the lumen 111 of the outer tubular member 112 and in an axial direction. 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 lubricating material (eg, polytetrafluoroethylene or PTFE) to assist in the movement of the inner tubular member 103 within the outer tubular member 112 .

[0034] The lumen 113 of the inner tubular member 103 can be used 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 can be connected to a tube 150 extending from the proximal end of the handle 155, and the tube 150 and the lumen 113 together form the conduit 105. The tube 105 includes a proximal end connected to the vacuum source 107. In an exemplary embodiment, the opening 102 is located at 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 fittings generally 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.

[0035] Alternatively, tube 150 may extend through opening 102 and through lumen 113 and connect to end effector 122. Tube 150 would then serve as catheter 105. In this embodiment, tube 150 and end effector 122 may be axially movable relative to lumen 113.

[0036] The distal portion of the delivery system 100 may include a distal opening 101 disposed at the distal-most end. The opening 101 enables the medical device 120, and in particular its end effector 122, to be ejected or released from the outer tubular member 112. For example, when the inner tubular member 103 is transformed from a first proximal configuration to a second distal configuration within the outer tubular member 112, the end effector 122 may be pushed out or ejected from the distal opening 101. Ejection from the opening 101 allows the end effector 122 to be transformed to its expanded configuration.

[0037] Figure 4A and Figure 4B An alternative embodiment of a medical device 420 is shown. As in the case of medical device 120, 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 in which no frame material is present. Similarly, the expansion frame 410 may have a bulbous region 430 and a lip 440. These portions may have any of the structures and / or functions associated with the same or similar portions of device 120.

[0038] The difference of device 420 is that a plurality of discrete detachable sponge layers 415a, 415b, 415c are located above or around expansion frame 410. In this way, detachable sponge layers 415a, 415b, 415c can be stacked. The number of sponge layers can be two, three, four, or any desired number. For example, multiple sponge layers (e.g., 415a, 415b, 415c) can be utilized so that during the treatment process, the sponge material can be renewed without re-delivering or repositioning various devices. For example, once the outermost sponge layer 415a is used, the user can use a pull line 445 (such as a line made of suture material, etc.) or other devices (i.e., forceps, snares, etc.) to retract the sponge layer 415a, so that the outer sponge layer 415a is removed and the second layer 415b (previously located below the sponge layer 415a and between the sponge layer 415a and the sponge layer 415c) is exposed. In this manner, the detachable sponge layers 415a, 415b, 415c can be removed individually. 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 the cavity. This can be accomplished by pulling the sponge layer 415a through the terminal opening 426 in a proximal direction (P), thereby exposing the sponge layer 415b. The sponge layer 415a can then be extracted for analysis, if desired.

[0039] Removal of the sponge layer 415a may also be accomplished by, for example, using a thermal snare to cut off sections of the sponge layer 415a for removal and / or analysis. Alternatively or additionally, the sponge layers 415a, 415b, etc. may include perforated sections or tear lines that enable the sponge layer to be torn away from the remaining sponge layers once a predetermined force is applied to the outermost sponge layer.

[0040] Additionally, for multiple sponge layers, multiple pull cords 445 may be used. For example, a second pull cord (not shown) may be attached to sponge layer 415b, a third pull cord (not shown) may be attached to sponge layer 415c, etc. The pull cords may be colored or otherwise marked to indicate which pull cord 445 corresponds to which sponge layer 415a, 415b, 415c, etc. For example, a green pull cord may correspond to sponge layer 415a, a yellow pull cord may correspond to sponge layer 415b, and a blue pull cord may correspond to sponge layer 415c.

[0041] In some embodiments, each discrete sponge layer 415a, 415b, 415c can differ from one another in one or more characteristics (e.g., coverage of the frame, aperture, size, material, color, etc.). For example, sponge layer 415a can have one size, while sponge layer 415b and / or sponge layer 415c can have another size different from the first size. Similarly, sponge layer 415a can have one material, while sponge layers 415b, 415c can have another material different from the first material. Additionally or alternatively, in some embodiments, each sponge layer 415a, 415b, etc. can be painted with a color or have a different fluoroscopic mark to indicate the sponge layer 415a, 415b being used or removed. In this embodiment, various combinations of size, material, and color are possible.

[0042] Figure 5 An alternative medical device 520 having an end effector 522 is shown. As in the case of 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 associated with the same or similar portions of device 120. Medical device 520 differs in that strips of sponge material 515a, 515b, 515c, 515d extend longitudinally (proximal to distal) across the expansion frame 510 from the distal end 525 of the expansion frame 510 to the proximal end 535. In some embodiments, portions of the expansion frame 510 may be exposed. In other embodiments (not shown), the expansion frame 510 may be completely covered by the strips of sponge material.

[0043] The strips 515a-d meet at the farthest end 525. The strips 515a-d can overlap and / or stagger. Since the volume of the sponge is smaller than, for example, a solid conical sponge, the strips 515a-d allow for easy deployment and re-constraint when necessary. Each strip 515a, 515b, 515c, 515d can be composed of the same or different characteristics from each other. For example, the material, pore size and / or size characteristics of each strip can be different from each other. For example, the strip 515a can have one material and one thickness, and the strip 515b can have a second material and / or a second thickness. Due to the smaller volume of the sponge material compared to the solid conical sponge, different thicknesses can also allow for easy removal of the device. Similarly, in alternative embodiments, the number of strips can be different. For example, there can be one, two, three, four or more sponge strips. In addition, the formation of the strips 515a-d is not limited to longitudinal extension. For example, the sponge strips may be spiraled around the expansion frame 510 (not shown) or extend laterally around the expansion frame 510 like a ring. The sponge strips may additionally or alternatively be layered, for example, so that Figure 4A -Aspects of the embodiment of B are combined with this embodiment.

[0044] Figure 6 An alternative embodiment of a medical device 620 having an end effector 622 is shown. This embodiment of the medical device 620 includes an aspiration catheter 605, which may have any of the characteristics of the aspiration catheter described in other embodiments, except as described below. The medical device 620 also includes a sponge 615 having an arrangement of discrete strips 615a, 615b, 615c, 615d, etc., each extending axially in a proximal to distal direction. The discrete strips 615a-615d meet and connect at the distal-most end 625 of the end effector 622. The end effector 622 may include any number of strips 615a, 615b, 615c, etc., such as one, two, three, four or more, which are evenly spaced or unevenly spaced around the catheter 605. Figure 6 The embodiment shown in Figure 6 Four strips 615a-615d are included that are evenly spaced around the catheter 605. Strips 615a, 615c are located at the top and bottom of the page, respectively, and strips 615b, 615d are oriented outward and inward of the page, respectively. Each strip 615a-615d faces radially inward toward the catheter 605. Each strip 615a-d may or may not include a stent (not shown) to help maintain its shape, similar to the expandable frame described in the previous embodiment.

[0045] The suction catheter 605 includes a screw fitting 675 that corresponds to the screw fitting 672 on the inner distal wall of the sponge 615. For example, the catheter 605 may include a male or female screw fitting 675, and the inner distal wall of the sponge 615 may include a corresponding female or male screw fitting 672. Alternative attachment methods are also possible, so long as they allow relative rotational movement between the sponge 615 and the catheter 65. For example, the sponge 615 and the catheter 605 may be movably coupled using a press fit or other methods generally known in the art.

[0046] Conduit 605 can include multiple holes 660a, 660c through conduit 605 sidewalls.Hole 660a can be spaced 180 degrees from hole 660c.Multiple holes 660a, 660c are aligned with multiple corresponding strategically placed suction sites 665a-665d on strip 615a-615d.Suction sites 665a-665d partially extend through the thickness of each corresponding strip 615a-615c.This embodiment can be configured as, for example, in a first form, holes 660a and 660c are aligned with holes or suction sites 665a, 665c respectively, thereby affecting the application of suction to the surrounding tissues adjacent to or close to corresponding strips 615a, 615c.In a second form, wherein conduit 605 is twisted (for example, rotated 90 degrees around the axis relative to sponge 615), suction holes 660a, 660c are aligned with suction sites 665d. In the second configuration, the application of suction affects surrounding tissue adjacent to or proximate to the corresponding strips 615b, 615d. The apertures 660a, 660c may be offset so that when the apertures 660a, 660c are aligned with the secondary sites 665a, 665c (and their corresponding strips 615a, 615c), respectively, the apertures 660a, 660c are not aligned with the secondary sites 665b, 665d (and their corresponding strips 615b, 615d), respectively, or vice versa.

[0047] Similar to the previous embodiments, fluoroscopic markings, color coatings, or other markings may be utilized to help the user determine whether the apertures 660a, 660c and the secondary sites 665a-665d are properly aligned. For example, when the apertures 660a, 660c are aligned with the sites 665a, 665c (and their strips 615a, 615c) in the first configuration, one marking or color may be displayed, and when the apertures 660a, 660c are aligned with the sites 665b, 665d (and their strips 615b, 615d), a second marking or color different from the first marking or color may be displayed.

[0048] Figure 7 A side view of an exemplary medical device 720 is shown, which includes an end effector 722 including an aspiration catheter 705 and a porous body, such as a sponge 715. As with other embodiments of medical devices described herein, the medical device 720 can be flexible and configured to move through a tortuous path of a patient's body cavity.

[0049] The suction catheter 705 may include a plurality of holes 760 through the wall of the catheter 705. The holes 760 may be randomly or incrementally placed at a specified distance around the suction catheter 705 circumferentially so that suction can be performed at the target site. The farthest end of the suction catheter 705 may include a circular top portion 725, which is configured to be non-traumatic so that the movement of the end effector 722 in the patient's body cavity will not cut or otherwise damage tissue. In an alternative embodiment, the suction catheter 705 may also include a central cavity (not shown) so that when the coiled wire (not shown) is placed inside the central cavity, the desired shape is given to the central cavity, and thereby the suction catheter 705. For example, the desired shape may be spherical, elliptical, pyramidal, cubic or other shapes.

[0050] The sponge 705 may have any of the structures, characteristics and / or functions mentioned in combination with the same or similar parts of the device 120. For example, the sponge 715 may have any suitable size and shape so as to fit within the patient's anatomical structure. The sponge 715 may include multiple components or one large component that is connected to the space (e.g., outer surface / wall) of the suction conduit 705. The sponge 715 may be removably connected to the suction conduit 705 by means of a central cavity (not shown) extending through the sponge 715, wherein the size of the central cavity may be set to receive the suction conduit 705, 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 means of glue, friction fit or any alternative generally known in the art.

[0051] During use, the medical device 720 is advanced through the sheath 718. The end effector 722 of the medical device 720 and in particular the end effector 722 can be straight or substantially straight in the first configuration, with the sponge 715 and the catheter 705 located inside the sheath 718. In the second expanded configuration, the end effector 722 can be coiled outside the delivery sheath 718 (e.g., when advanced distally to the delivery sheath 718). At least a portion of the end effector 722 can take a variety of shapes or forms in the second configuration, including spiral, spherical, elliptical, pyramidal, cubic, etc. The expanded shape may be due to a natural bias to the expanded shape via, for example, a shape memory material for at least the distal portion of the catheter 705. Once the end effector 722 is in a desired location, such as in a cavity, perforation, or wound, the user can apply suction or negative pressure to the device 720. Similar to the previous embodiment, suction is delivered for a desired period of time. Once the procedure is complete, the medical device 720 is removed from the patient and a new medical device can be inserted if necessary.

[0052] It will be apparent to those skilled in the art that various modifications and variations may be made to the disclosed apparatus and methods without departing from the scope of the invention. Other aspects of the invention will be apparent to those skilled in the art from consideration of the description and practice of the features disclosed herein. It is intended that the description and examples be considered exemplary only.

Claims

1. A medical device comprising: a tube having a sidewall defining a lumen within the tube, wherein a plurality of openings extend through a distal portion of the sidewall and are in fluid communication with the lumen; a support structure coupled to the distal portion of the sidewall, the support structure having a collapsed configuration and an expanded configuration, and the support structure having a support opening through a wall of the support structure; as well as A porous body overlies at least a portion of the support structure.

2. The medical device of claim 1, wherein the distal portion of the side wall extends along an interior of the wall of the support structure.

3. The medical device of any preceding claim, wherein the plurality of openings are spaced apart along the distal length of the tube.

4. The medical device of any preceding claim, wherein the tube is movably coupled to a distal portion of the support structure.

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

6. The medical device of claim 5, wherein the plurality of openings are circumferentially spaced approximately 180 degrees apart on the sidewall of the tube.

7. The medical device of any preceding claim, wherein the support structure further comprises an open proximal end, the tube extending through the open proximal end.

8. A medical device according to any of the preceding claims, wherein the support structure in the expanded form includes a distal spherical region, a proximal region, and a lip region between the distal spherical region and the proximal region, wherein the cross-sectional dimension of the lip region is smaller than the cross-sectional dimension of the spherical region and the cross-sectional dimension of the proximal region.

9. The medical device according to any preceding claim, wherein the porous body is a flexible sponge.

10. The medical device of any preceding claim, wherein the porous body surrounds at least a portion of the circumference of the support structure.

11. The medical device of any preceding claim, wherein the porous body is attached to the support structure.

12. The medical device of any preceding claim, wherein the porous body further comprises a plurality of stacked layers of porous material that are individually removable through the distal opening in the support structure and the interior of the support structure.

13. The medical device of any preceding claim, wherein the porous body further comprises a strip of material extending from a distal end to a proximal end of the support structure.

14. The medical device of claim 12, further comprising a tear line between adjacent stacked layers.

15. The medical device of claim 12, wherein at least one of the stacked layers is removable by pulling a pull wire through the distal opening.

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