Endoluminal treatment device

Abstract

A distal end of a medical device can include a tube configured to be coupled to a suction source, and a porous body coupled to the tube. The porous body can have a wall with an inner surface and an outer surface. The distal end can include a cavity such that a gap extends from an outer surface of the tube to an inner surface of the porous body.

Description

Cross-references to related applications

[0001] This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 627,138, filed January 31, 2024, the entire contents of which are incorporated herein by reference. Technical Field

[0002] Various aspects of this disclosure generally relate to minimally invasive medical devices and methods. More specifically, many aspects of this disclosure relate to medical devices and methods for endoscopic medical procedures, such as closing wounds or otherwise treating tissue. Background Technology

[0003] Endoscopic and open surgical procedures of the gastrointestinal (GI) tract include procedures such as colectomy, bariatric surgery, esophagostomy, gastric bypass, and sleeve gastrectomy. These procedures can lead to gastrointestinal perforation, postoperative anastomotic leakage, or other wounds. Patients with gastrointestinal perforation, postoperative anastomotic leakage, and / or other wounds have high mortality rates and limited treatment options. Treatment options include endoscopic clip or stent placement, endoscopic suturing or sealing, or reoperation. Surgical procedures are highly invasive and have high morbidity and mortality rates. While endoscopic stent placement is a less invasive option, the stent may shift from its intended location and / or seal the infection at the treatment site, obstructing drainage.

[0004] The medical devices and methods disclosed herein can correct some of the defects described above or address other aspects of the art. Summary of the Invention

[0005] Each aspect disclosed herein may include one or more aspects of the features described in relation to any other disclosed aspect.

[0006] This disclosure relates to various aspects of medical devices and related methods for intracavitary vacuum therapy. These aspects may include one or more features described below.

[0007] For example, this disclosure includes a distal end of a medical device comprising a tube configured to be coupled to a suction source, and a porous body coupled to the tube. The porous body may have a wall having an inner surface and an outer surface. The distal end may include a cavity such that a gap can extend from the outer surface of the tube to the inner surface of the porous body.

[0008] According to some aspects, the distal end may include a cap located within the cavity. The cap may include a porous material. The proximal surface of the cap may be the distal end of the cavity. The distal end may include a rib extending from the outer surface of the fitting to the inner surface of the porous body. The distal end may include a second rib extending from the outer surface of the fitting to the inner surface of the porous body. The rib may define a first portion of the cavity proximal to the rib and a second portion of the cavity distal to the rib. The distal portion of the porous body may be connected to the distal portion of the fitting. In a relaxed configuration, the porous body may be radially tapered proximally from the location where it is connected to the fitting. In a relaxed configuration, the porous body may have a bell shape. The porous body may have a tubular shape from a first axial position to a second axial position. The cavity may have a uniform radial width from the first axial position to the second axial position. The porous body may have a prismatic shape from the first axial position to the second axial position. The porous body may have multiple ridges and multiple valleys. In some respects, the distal end can be configured such that, when the distal end is located within the patient's body and the fitting is connected to the aspiration source, bodily fluids flow through the pores of the porous body, through the cavity, and into the fitting.

[0009] This disclosure also includes a distal end of a medical device comprising a tube configured to be coupled to a suction source, and a porous body coupled to the tube. The distal end may include a cavity between the porous body and the tube. A cap may be located on a distal portion of the porous body such that the proximal surface of the cap is the distal end of the cavity.

[0010] Depending on some aspects, the cap may include a porous material. The cavity may be configured to receive material from the external environment of the porous body through the pores of the porous body.

[0011] This disclosure also includes a distal end of a medical device comprising a tubing configured to be coupled to a suction source, and a porous body coupled to the tubing. The distal end may include a cavity between the porous body and the tubing. Ribs may extend from an outer surface of the tubing to an inner surface of the porous body, such that the ribs define a first portion of the cavity proximal to the ribs and a second portion of the cavity distal to the ribs. According to some aspects, the distal end may further include at least a second rib extending from the outer surface of the tubing to the inner surface of the porous body. Attached Figure Description

[0012] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate various aspects of this disclosure and, together with the written description, serve to explain the principles of this disclosure.

[0013] Figures 1A-1C Several aspects of an exemplary medical device according to some aspects of this disclosure are shown.

[0014] Figure 2 A cross-sectional view of another exemplary medical device according to some aspects of this disclosure is shown.

[0015] Figure 3A cross-sectional view of another exemplary medical device according to some aspects of this disclosure is shown.

[0016] Figures 4A-4B A cross-sectional view of another exemplary medical device according to some aspects of this disclosure is shown.

[0017] Figures 5A-5B Several aspects of another exemplary medical device according to some aspects of this disclosure are shown. Detailed Implementation

[0018] Specific aspects of this disclosure will be described in more detail below. The terms and definitions provided herein shall prevail in the event of any conflict with terms and / or definitions incorporated herein by reference.

[0019] The terms “proximal” and “distal” are used herein to refer to the relative positions of components of the exemplary medical device. As used herein, “proximal” refers to a position relatively closer to the outside of the body or closer to the operator using the medical device. In contrast, “distal” refers to a position relatively farther away from the operator using the medical device or closer to the inside of the body.

[0020] The terms “comprising,” “containing,” “including,” “having,” or any other variations thereof, as used herein, are intended to cover non-exclusive contents such that a process, method, article, or apparatus that comprises a list of elements may include not only those elements but also other elements not expressly listed or inherent to such process, method, article, or apparatus. The term “exemplary” is used in the sense of “example” rather than “ideal.”

[0021] In addition, relative terms such as “approximately,” “basically,” and “roughly” are used to indicate that the stated value or range may vary by ±10%.

[0022] Endocavitary vacuum therapy (EVT or EVAC, referred to herein as EVAC) is a wound treatment procedure, such as treating postoperative fistulas or perforations in the gastrointestinal (GI) tract following surgical or endoscopic procedures (such as colectomy, bariatric surgery, or esophagostomy). In EVAC, negative pressure is delivered, for example, through a nasogastric tube having a porous body, such as a sponge or sponge-like material, or foam (e.g., vacuum-sealed foam), sutured at its distal end. The proximal end of the tube may be connected to a collection container. The porous body is placed into the perforation, fistula, or other wound via an endoscope. In some examples, EVAC includes the placement of foam or other similar materials into the lumen of a wound (e.g., a target site or wound cavity), including perforations, fistulas, cysts, anastomoses, etc. The porous body can be placed via catheters, endoscopes (endoscopes, bronchoscopes, colonoscopes, duodenoscopes, gastroscopes, etc.), tubes, or sheaths inserted into the gastrointestinal tract through natural orifices. The opening may be, for example, the nose, mouth, or anus, and the placement may be in any part of the gastrointestinal tract, including the esophagus, stomach, duodenum, large intestine, or small intestine. The porous body may also be placed in other organs accessible via the gastrointestinal tract (e.g., the colon).

[0023] Mouse-tooth forceps or other auxiliary devices can extend through the working channel of the endoscope and be used to guide foam to the wound site as the endoscope navigates to it. Negative pressure is then applied. The porous body in the wound, along with the negative pressure, can accelerate healing by promoting local granulation tissue formation at the wound site. As the wound heals and closes, the porous body can be replaced with a porous body of gradually decreasing size.

[0024] Current devices suitable for EVAC have limitations. For example, the tortuous and often narrow structure of the gastrointestinal tract makes it difficult to deliver conventional porous materials to the target site. Conventional porous materials may lack compressibility, which hinders the navigation of delivery devices through narrow body cavities / openings. Furthermore, the fluids typically encountered in EVAC can be viscous and may clump together within the tortuous pore structure of the porous material, causing blockages or reduced suction.

[0025] The medical devices and methods described herein feature features that improve aspiration, deliver porous bodies to target sites, and / or provide porous bodies with different properties and / or characteristics suitable for treating wound sites or incision cavities of various sizes. Furthermore, the components of the medical devices described herein can be packaged as kits. The features of the devices described below can be combined with each other in any combination or sub-combination manner.

[0026] According to some aspects of this disclosure, a medical device may include a distal portion having a porous body (e.g., foam or sponge) coupled to the distal portion of a tube. The porous body may have an outer wall surrounding the distal portion of the tube. The distal portion of the medical device may include a cavity (e.g., an empty or hollow space) disposed between the foam outer wall and the tube. For example, the porous body may include a hollowed-out portion forming a cavity to receive the tube. Thus, the distal portion of the medical device may include a foam shell while providing a gap between the tube and the porous body. The outer wall of the porous body may radially surround the cavity. The diameter / width of the cavity and the thickness of the outer wall may vary depending on, for example, the size of a wound.

[0027] Compared to the distal portion of a conventional EVAC device, the distal portion disclosed herein can have a similar overall outer diameter while incorporating a thinned porous body (e.g., foam) thickness. The cavity allows for improved suction performance and reduces the risk of clumping within the porous body. Furthermore, the cavity reduces the overall volume of the porous body, allowing for increased compressibility.

[0028] Figures 1A-1C An exemplary medical device 100 that can be used in EVAC procedures is shown. Figure 1A A perspective view of the medical device 100 is shown. Figure 1B A cross-sectional view of the medical device 100 taken along the central longitudinal axis of the medical device 100 is shown. Figure 1C A cross-sectional view of the medical device 100 taken perpendicular to its central longitudinal axis is shown. The medical device 100 may include a distal end 102. The distal end 102 may include a porous body 104 (e.g., foam, sponge, or other honeycomb structure) that can be coupled to the distal portion 108 of the tube 106.

[0029] The fitting 106 may be a vacuum fitting, which may include a lumen for delivering aspiration to achieve suction and removal of unwanted material from a target site. The fitting 106 may be composed of a material compatible with medical applications and providing a degree of flexibility. The fitting 106 may extend from a proximal end (not shown) to a distal portion 108 of the fitting 106. The proximal end of the fitting may be connected to a vacuum or aspiration source (not shown, and having any characteristics of a vacuum or aspiration source known in the art), which may supply negative pressure to the porous body 104. The negative pressure may draw fluids, substances, and / or other debris into the fitting 106, allowing substances drawn into the distal portion 108 of the fitting 106 to flow proximally. The distal portion 108 of the fitting 106 may have a distal opening 109 and one or more lateral openings (not shown, but similar) on the radially outer wall of the fitting 106. Figures 5A-5B (Showing the lateral opening 507).

[0030] The distal end 102 may include a porous body 104 (e.g., foam, sponge, or other honeycomb structure) that can be coupled to the distal portion 108 of the tube 106. The porous body 104 may have an outer wall 120. The wall 120 may have a generally tubular shape, such that the wall 120 has a generally annular cross-sectional shape, although such a shape is merely exemplary. The wall 120 may have an outer surface 122 (e.g., a radially outer surface) and an inner surface 124 (e.g., a radially inner surface). Figure 1B and Figure 1C As shown, the wall 120 may have a thickness or width “T” between the outer surface 122 and the inner surface 124. The thickness “T” may be measured in a direction perpendicular to the central longitudinal axis of the tube 106 (e.g., radial direction). The thickness or width “T” of the wall may be consistent and uniform throughout the porous body 104. Alternatively, the thickness “T” may vary along the length and / or circumference of the porous body 104. The porous body 104 may be of any suitable size or thickness; the size or thickness “T” of the porous body 104 may be selected based on the treatment location within the anatomical structure, the nature of the wound to be treated, the stage of treatment, or any other relevant factors.

[0031] The porous body 104 (including wall 120) may comprise any suitable material, such as sponge, foam, or other porous structures that promote suction and reduce the risk of clumping or blockage. Suitable materials may include polyvinyl alcohol (PVA), polyurethane, polyester-based polyurethane, polyether-based polyurethane, silicone rubber, or the like. Multiple pores may extend through the porous body 104. The pores may form pathways from the outer surface 122 through wall 120 to the inner surface 124. Within the porous body 104, the pores may form a network of interconnected pathways. These pathways can serve as channels for the movement of fluids, gases, or other substances. Foam structures may include a variety of pore sizes and densities. For example, regions with larger pores may facilitate the suction of larger debris, while smaller pores may prevent clumping.

[0032] The porous body 104 can be connected to the fitting 106 via, for example, a fastener 126. The fastener 126 can be a stitch or any other suitable fastening mechanism known in the art (e.g., a staple, strap, crimping member, etc.). The fastener can be located on the porous body 104, for example, on the proximal portion 128 of the porous body 104 and / or near the nearest end of the porous body 104. Figure 1A and Figure 1B As shown, fastener 126 can be tightened such that inner surface 124 abuts against fitting 106 at the location of fastener 126. The proximal portion 128 of porous body 104 near fastener 126 can flare outwards to form a skirt shape. Alternatively, as described below, fastener 126 can be movable and / or located at multiple locations on porous body 104. For example, fastener 126 can be located on the distal portion of porous body 104, such as... Figures 5A-5BAs shown. The farthest end of the fitting 106 may be proximal to the farthest end of the porous body 104, flush with the farthest end of the porous body 104, or distal to the farthest end of the porous body 104.

[0033] The distal end 102 may include a lumen or cavity 130 extending between the inner surface 124 of the wall 120 of the tube 106 and the porous body 104. The cavity 130, formed between the tube 106 and the wall 120, may be a gap or an empty space. By having a cavity 130 between the tube 106 and the wall 120 of the porous body 104, the tube 106 may not contact the porous body 104 distal to the fastener 126 / proximal portion 128. In other words, an open space may extend between the tube 106 and the wall 120 to form the cavity 130. In some examples, the cavity 130 may form a gap between the tube 106 and the wall 120 along the entire length of the wall 120 distal to the fastener 126 / proximal portion 128. As described below, the cavity 130 particularly contributes to the overall compressibility of the porous body 104. This compressibility facilitates navigation through narrow body cavities or openings, providing flexibility during EVAC procedures. Furthermore, the presence of cavity 130 helps improve suction function. Cavity 130 provides a more direct and unobstructed path for the suction fluid or substance through fitting 106, minimizing the risk of blockage or obstruction during suction.

[0034] like Figure 1B and Figure 1C As shown, the cavity 130 may have a width "C". The width "C" may extend in the same direction as the thickness "T" of the wall 120 described above. The width "C" may be perpendicular to the central longitudinal axis of the tube 106 (e.g., in the radial direction). The width "C" may be measured from the inner surface 124 to the outer surface of the tube 106. In this embodiment, the width "C" of the cavity 130 is greater than the thickness "T" of the wall 120. However, the thickness "T" of the wall 120 may be greater than the width "C" of the cavity 130. In some examples, the width "C" may be approximately equal to the diameter of the tube 106.

[0035] Cavity 130 may extend from the location of fastener 126 to the distal end of porous body 104. Cavity 130 may provide a continuous channel along the entire length of porous body 104 distal to fastener 126. In some examples, cavity 130 may have a uniform width “C” along at least a portion of the axial length of cavity “C”. For example, cavity 130 may have a substantially uniform width “C” from the middle portion 134 (first axial position) of distal end 102 to the distal portion 136 (second axial position) of distal end 102 (see [link to documentation]). Figure 1BA portion of the wall 120 located proximal to the intermediate portion 134 of the distal end 102 may taper inward toward the fastener 126 in the proximal direction. Therefore, a portion of the cavity 130 located proximal to the intermediate portion 134 may have a width “C” that tapers inward toward the fastener 126 in the proximal direction. The cavity 130 may have a distal opening 132, such that the cavity 130 is open to the external environment on the distal portion 108 of the fitting 106.

[0036] As in Figure 1C As specifically shown, the cavity 130 may have an annular cross-sectional shape. The distal opening 132 may also have an annular shape. The radially inner side of the cavity 130 may have a shape corresponding to the shape of the outer surface of the tube 106. The radially outer side of the cavity 130 may have a shape corresponding to the shape of the inner surface 124 of the wall 120 of the porous body 104.

[0037] As in Figure 1C Specifically, the medical device 100 may have a total radius “D”. The radius “D” may be half the diameter / width of the medical device 100. The term “radius” herein is not limited to referring only to the radius of a tubular device with a circular cross-section, but also includes half the total width of a device with a non-circular cross-section. The width “D” of the medical device 100 may be equal to the radius of the tube 106 plus the width “C” plus the thickness “T”. Compared to the distal end of an EVAC device without cavity 130 and having the same total width or radius “D” (i.e., an EVAC device characterized by a porous body immediately adjacent to a vacuum tube), the porous body 104 occupies less total volume, radial thickness, and / or width at the distal end 102. In other words, the distal end 102 has more empty space (in the form of cavity 130) compared to the distal end of other EVAC devices. It should be understood that the thickness “T”, width “C”, and radius “D” may have any suitable values, which may be constant along the entire axial length of the medical device 100 or may vary along the length of the medical device 100.

[0038] In some examples, and as described above, the porous body 104 may have a tubular shape that is tightened by the fastener 126 and flares outward from the fastener 126 proximally and distally. For example, the porous body may have a tapered shape (which may be tapered in the proximal or distal direction). In these examples, a cavity 130 may be formed because the inner diameter of the wall 120 (extending between opposite sides of the inner surface 124) is larger than the outer diameter of the tube 106. When not positioned in a wound, the porous body 104 may have a tubular shape from the middle portion 134 of the distal end 102 to the distal portion 136 of the distal end 102. The cavity 130 may have a uniform radial width from the middle portion 134 of the distal end 102 to the distal portion 136 of the distal end 102. The porous body 104 may also have other shapes suitable for certain wound types, wound shapes, or anatomical features. When positioned at or within a wound in a patient's body, body tissue can act on the porous body 104 to alter the shape shown in the figures and as described above.

[0039] Alternatively or additionally, the cavity 130 within the porous body 104 can be a hollowed-out space, reducing the overall volume of the porous body 104 while maintaining its total radius "D". For example, the user can form the cavity 130 by removing material from the porous body 104, leaving a hollowed-out area corresponding to the cavity 130. The user can choose the size and shape of the cavity 130 according to their preferences or the nature of the wound. Alternatively, the cavity 130 can be formed by preforming the porous body 104.

[0040] The medical device 100 (particularly the distal end 102) reduces the risk of blockage and increases aspiration due to the presence of the cavity 130. During medical procedures (such as EVAC) in which the distal end 102 is located within the patient, the distal end 102 receives material from the EVAC site (which is the environment outside the porous body) via the thickness “T” of the wall 120 of the porous body 104, which is the distance between the outer surface 122 and the inner surface 124. The material then travels through the width “C” of the cavity 130. Thus, a portion of the material travels is through the open space (cavity 130) rather than through the porous body 104. This reduces the risk of clumping or blockage at the distal end 102 and improves aspiration. The reduced risk of blockage helps maintain negative pressure at the EVAC site, promotes granulation tissue growth, and can accelerate the wound healing process.

[0041] The presence of a cavity 130 within the distal end 102 of the medical device 100 increases the compressibility (e.g., radial compressibility) of the distal end 102. This compressibility facilitates insertion of the medical device 100 into tubular or other delivery devices (e.g., delivery devices smaller than the distal end 102 without the cavity 130). The distal end 102 can also be compressed to pass through the working channel of an endoscope or other similar insertion device.

[0042] The configuration of device 100 allows for an increase in the diameter of fitting 106 (including the inner diameter of fitting 106) and the distal opening 109 of fitting 106. The larger inner diameter allows for a higher fluid flow rate through fitting 106. Because the larger inner diameter of fitting 106 improves suction capacity, the risk of material agglomeration or blockage within fitting 106 is minimized.

[0043] The configuration of the medical device 100 maintains the external surface area of ​​the porous body 104, which provides a high contact surface area with surrounding tissue and a distribution of suction force. When tissue is drawn into this area, the cavity 130 can collapse, allowing tissue growth and healing. Due to the compressibility provided by the cavity 130, the outer diameter of the porous body 104 can be increased relative to other EVAC devices. Furthermore, the porous body 104 can have a longer axial length relative to other types of EVAC devices while maintaining the compressibility of the distal end 102 of the medical device 100. Additionally, the open space within the cavity 130 allows guidewires or other medical accessories to pass through the cavity, enabling physicians to more easily navigate through anatomical structures (e.g., by pushing out tissue or allowing navigation along a guidewire).

[0044] Figure 2 A cross-sectional view of an exemplary alternative distal end 202 of the medical device 200 is shown. Figure 2 The cross-sectional view is taken perpendicular to the longitudinal axis of the tube 106. Unless otherwise stated herein, the medical device 200 may have any of the characteristics of the medical device 100. Although the porous body 104 of the medical device 100 may have a generally annular cross-section, the porous body 204 of the medical device 200 may have a prismatic shape with a polygonal cross-section. For example, the porous body 204 may have a prismatic shape from a first axial position to a second axial position. As used herein, the term "prismatic" refers to the shape of the wall 220, which does not necessarily have prismatic end faces. In other words, the porous body 204 may have alternating multiple V-shaped channels and multiple V-shaped ridges. In other words, the wall 220 may include multiple portions with herringbone cross-sections. As with the medical device 100, the cavity 230 extends between the tube 106 and the porous body 104. The cavity 230 may have any of the characteristics of the cavity 130.

[0045] Figure 2 A wall 220 is shown having a porous body 204 with a heptagonal cross-section (i.e., having 14 sides). However, such a shape is merely exemplary, and the porous body 204 can have any cross-sectional shape. The inner surface 224 of the wall 220 can be similar to the outer surface 222 of the wall 220, and includes the same shape but different dimensions. The inner surface 224 and the outer surface 222 of the wall 220 can have similar geometric configurations. For example, the inner surface 224 can replicate a particular curvature, profile, or pattern of the outer surface. Alternatively, the inner surface 224 and the outer surface 222 can also have different shapes.

[0046] The outer surface 222 may have multiple ridges 242 and multiple valleys 244. A ridge 242 may be a protrusion or raised portion of the outer surface 222 (the radially outermost portion of the outer surface 222). In other words, a ridge 242 may project radially outward from the outer surface 222. A valley 244 may be a depression or groove in the outer surface 222 (the radially innermost portion of the outer surface 222). The inner surface 224 may also have multiple ridges 252 and valleys 254. A ridge 252 of the inner surface 224 may project radially inward (e.g., the radially innermost portion of the inner surface 224), and a valley 254 may be the radially outermost portion of the inner surface 224. Ribs 242 and 252 may alternate with valleys 244 and 254, respectively. A first radius extending through the porous body 204 may extend through one ridge 242 and one valley 254. The second radius extending through the porous body can extend through a valley 244 and a ridge 252. The ridges 242, 252 and the valleys 244, 254 can give the porous body 204 a folded shape.

[0047] Ridges 242 and 252 and valleys 244 and 254 may extend parallel to the longitudinal axis of the medical device 200. Each of the ridges 242, 252 and valleys 244, 254 may be parallel to all others. The ridges 242, 252 and valleys 244, 254 may facilitate the collapse of the porous body 204 to deliver the porous body 204 to a target body cavity or cavity. For example, valleys 244 may form predetermined flexible points in the structure of the porous body 204 so that the porous body 204 collapses radially inward. In other words, the porous body 204 may collapse radially inward along the folds of the porous body 204.

[0048] Cavity 230 extends from inner surface 224 to fitting 106. The outer edge of cavity 230 can also be prismatic, with the polygonal cross-section of the outer edge corresponding to the shape of inner surface 224. The inner edge of cavity 230 can have a circular cross-section, corresponding to the outer surface of fitting 106. However, Figure 2 The shapes shown and described are merely exemplary. The cavity 230 may have any shape depending on the shape of the porous body 204 and the tube 106.

[0049] The shapes of porous bodies 104 and 204 are merely exemplary, and porous bodies 104 and 204 can have any suitable shape. For example, porous body 204 can have any prismatic or non-prismatic (e.g., irregular) shape. Irregular shapes can be tailored to specific anatomical features or wound sizes to provide more customized solutions for various medical conditions. The cross-sections of porous bodies 104 and 204 can also have any suitable shape. For example, the cross-sections of porous bodies 104 and 204 can be regular polygons with uniform sides and angles, such as triangles, squares, or hexagons. Alternatively, the cross-sections of porous bodies 104 and 204 can be irregular polygons with sides and angles of varying lengths and measures. The cross-sections of porous bodies 104 and 204 can be concave polygons (as shown in porous body 204) or convex polygons.

[0050] Figure 3 The distal end 302 of another medical device 300 is shown, which may have the characteristics of the medical devices 100 and 200 described above, unless otherwise stated herein. Figure 3 This is a cross-sectional view taken along the central longitudinal axis of the medical device 300. The medical device 300 may include a porous body 304 disposed around the tube 106, which includes any characteristics of porous bodies 104 and 204. The medical device 300 may include a cavity 330, which includes any characteristics of cavities 130 and 230. The medical device 300 may further include a cap 360 at the distal end of the porous body 304, which will be described in more detail below.

[0051] The cap 360 may be positioned within the porous body 304 at the furthest end of the porous body 304. The cap 360 may be made of the same porous material as the porous body 304 (e.g., polyvinyl alcohol (PVA), polyurethane, polyester-type polyurethane, polyether-type polyurethane, silicone rubber, or the like). Alternatively, the cap 360 may be composed of a non-porous material or a porous material different from that of the porous body 304.

[0052] The cap 360 may be integrally formed with the porous body 304, and may be integrally formed from the same piece of material as the porous body 304. Alternatively, the cap 360 may be a separate piece of material attached to the porous body 304. For example, the cap 360 may be held within the porous body 304 by friction fit, adhesive, sutures, or other mechanisms. In some examples, the cap 360 may be included in a kit along with other parts of the medical device 300. The user may selectively use the cap 360 with components of the medical device 300 or integrate the cap 360 with components of the medical device 300. Alternatively, the medical device 300 may be packaged and secured to the porous body 304 together with the cap 360.

[0053] like Figure 3As shown, the cap 360 can be received within the cavity 330 such that the radially outer surface of the cap 360 abuts against the inner surface 324 of the wall 320 of the porous body 304. In one aspect, the distal end 362 of the cap 360 can be axially aligned with the distal end 326 of the porous body 304. Alternatively, the distal end 362 of the cap 360 can extend beyond the distal end 326 of the porous body 304 in a distal direction. In this configuration, the cap 360 can protrude or extend beyond the porous body. Alternatively, the distal end 362 of the cap 360 can be proximal to the distal end 326 of the porous body 304. Alternatively, the cap 360 can be fixed to the distal end of the porous body 304 such that the proximal end of the cap 360 abuts against the distal end of the wall 320.

[0054] The cavity 330 may have a distal end aligned with the proximal surface 364 of the cap 360, or a distal end reaching the proximal surface 364 of the cap 360. The distal end of the tube 106 may be proximal to the proximal end of the cap 360, or the tube 106 may have a distal end in contact with the cap 360. Alternatively, the tube 106 may extend into the cap 360.

[0055] The hat 360 can have any suitable shape. For example, such as... Figure 3 As shown, the cap 360 may have a cylindrical shape. The distal surface of the cap 360 may be circular. The cap 360 may have a radially outer surface that is complementary to the inner surface 324 of the wall 320. The cap 360 may have any suitable axial length.

[0056] The cap 360 prevents substances from freely flowing into the cavity 330 through the distal end of the porous body 304. Therefore, during EVAC processes, the cap 360 allows for more controlled fluid entry into the fitting 106. The cap 360 also acts as a barrier, reducing the risk of contamination by preventing unwanted substances or materials from entering the cavity 330.

[0057] Figures 4A-4B Cross-sectional views of the distal ends 402, 402' and alternative medical devices 400, 400', respectively, taken along the central longitudinal axis of medical devices 400, 400', are shown. Unless otherwise stated below, medical devices 400 and 400' may have any of the same features. Furthermore, unless otherwise stated, medical devices 400 and 400' may have any of the features of medical devices 100, 200, or 300 described above.

[0058] like Figure 4A As shown, the distal end 402 of the medical device 400 may include a distal portion 108 of the tube 106 and a porous body 404. The porous body 404 may have any of the features of porous bodies 104, 204, and 304. The distal end 402 may include at least one rib 470 that can support the porous body 404.

[0059] Rib 470 may extend between the outer surface of fitting 106 and the inner surface 424 of wall 420 of porous body 404. Rib 470 may be integrally formed with porous body 404 (formed from a single piece of material). Alternatively, rib 470 may be separate from porous body 404. In this respect, rib 470 may be attached to porous body 404 using any suitable mechanism (e.g., adhesive, stitching, other mechanical structure, friction fit). Rib 470 may be formed from any material similar to cap 360.

[0060] In one aspect, rib 470 may extend around the entire circumference or periphery of the fitting 106 and the inner surface 424. Thus, rib 470 may be continuous and completely surround the fitting 106 and the inner surface 424. In such an example, rib 470 may be washer-shaped, having a flat, generally circular configuration with a central opening. The washer shape is merely exemplary, and rib 470 may be any suitable shape. Alternatively, rib 470 may extend only around the periphery or a portion of the circumference of the fitting 106 and / or the inner surface 424. In such an example, more than one rib 470 may be located in the same axial position along the distal end 402, wherein each rib extends partially around the circumference of the fitting 106 / inner surface 424.

[0061] Unless otherwise stated, cavity 430 may have any of the features of cavities 130, 230, and 330 described above. Rib 470 extends only along a portion of the longitudinal length of porous body 404, causing cavity 430 to extend between porous body 404 and fitting 106 at the portion of distal end 402 where rib 470 is not provided. Cavity 430 may be subdivided into multiple portions / segments, for example, into a distal portion 434 and a proximal portion 436. In some examples, rib 470 may include openings that facilitate fluid communication between distal portion 434 and proximal portion 436 in addition to the fluid communication provided by the pores of porous body 404 and the pores of rib 470. Rib 470 may be provided as a modular component, included as part of a user-assembleable kit. The user may assemble rib 470 onto porous body 404 during assembly. Alternatively, rib 470 may also be already assembled onto porous body 404 during delivery of medical device 400.

[0062] like Figure 4B As shown, the medical device 400' may have a distal end 402', which has any of the characteristics of the distal end 402' except that the distal end 402' may include a plurality of ribs 470. For example, as Figure 4BAs shown, the distal end 402' may include at least two ribs 470. The ribs 470 may be spaced evenly or unevenly along the longitudinal length of the porous body 404. In one embodiment, the ribs 470 may divide or define the cavity 430' into three parts: a distal portion 434', a proximal portion 436', and an intermediate portion 438. In yet another embodiment, additional ribs 470 may be configured to further subdivide the medical device 400'.

[0063] Multiple ribs 470 provide structural support by increasing outward radial forces on the porous body 404. For example, the ribs can help prevent the porous body 404 from collapsing or deforming and can keep the cavities 430, 430' open. Furthermore, depending on the orientation and design of the multiple ribs 470, the flow of fluids or substances within the porous body 404 and the cavities 430 can be controlled or regulated. The multiple ribs 470 can divide the open space within the cavity 430 into multiple independent pockets, which is helpful when one segment (e.g., the proximal portion 436') becomes blocked and ensures that other segments are not affected during EVAC procedures.

[0064] Figures 5A-5B Another exemplary medical device 500 is shown in a relaxed configuration. Figure 5A ) and insertion configuration ( Figure 5B The distal end 502 of the medical device 500. Unless otherwise stated, the medical device 500 may have any of the features of the medical devices 100, 200, 300, 400, 400', and any of the aforementioned features (e.g., ribs 470, caps 360) may be used in conjunction with the medical device 500. The medical device 100 may be fixed to the tube 106 at the proximal portion of the porous body 104, and the porous body 504 of the medical device 500 may be coupled to the tube 506 at or near the distal end of the porous body 504.

[0065] The porous body 504 may include a wall 520. The wall 520 may be similar to, for example, wall 120, and may have an annular cross-sectional shape, although this shape is exemplary. The wall 520 may have any shape of any of the preceding examples described above. In a naturally relaxed state ( Figure 5A The porous body 504 may have a narrower distal end and a wider proximal end near the fastener 526 that connects the porous body 504 to the fitting 506. The wall 520 of the porous body 504 may be tapered radially outward from the fastener 526 in the proximal direction. For example, the porous body 504 may have a bell shape.

[0066] The porous body 504 may be coupled to the fitting 506 at or near the distal end of the porous body 504 and / or the fitting 506. The fastener 526 may be a stitch or any other suitable fastening mechanism known in the art (e.g., a staple, strap, crimp, etc.). The fastener 526 may have any of the characteristics of the fastener 126. The fastener 526 may be positioned on the porous body 504, for example, on the distal portion 528 of the porous body 504 and / or near the distal end of the porous body 504. A portion of the porous body 504 distal to the fastener 526 may flare outwards, forming a skirt shape. The distal end of the fitting 506 may be proximal to, distal to, or axially flush with the distal end of the porous body 504.

[0067] The distal end 502 may include a lumen or cavity 530 extending between the wall 520 and the fitting 506 in a portion proximal to the fastener 526. The cavity 530 formed between the fitting 106 and the wall 520 may be a gap or space and may have any characteristics of cavities 130, 230, 330, 430, and 430'. The cavity 530 may extend from the location of the fastener 526 to the proximal end of the porous body 504. The cavity 530 may provide a continuous passage through the porous body 504 proximal to the fastener 526. The cavity 530 may have an orifice or opening 532 such that the cavity 530 is open to the external environment at the proximal end of the porous body 504. Alternatively, the distal end 502 may have a cap, such as cap 360. The cap (e.g., cap 360) may be positioned within the porous body 504 at the proximal end of the porous body 504 to, for example, prevent free flow of material into the proximal end of the cavity 530. The distal end 502 may include an optional distal opening at the distal end 509.

[0068] The fitting 506 may have a closed (e.g., blocked) distal end 509 and an opening 507 along the sidewall of the fitting 506. Thus, bodily fluids and other substances can flow into the central lumen of the fitting 506 through the opening 507. The opening 507 is located distal to the proximal end of the porous body 504, allowing bodily fluids and substances to first flow through the porous body 504 before entering the opening 507.

[0069] When the distal end 502 of the medical device 500 is distal ( Figure 5B As the porous body 504 moves through the body (e.g., being dragged distally by a clamp or other device in the direction indicated by the middle arrow), it is radially compressed inward due to the force exerted on it by the body cavity. In other words, the radial thickness of the porous body 504 can decrease during insertion of the distal end 502. Therefore, the medical device 500 can help prevent the porous body 504 from wrinkling during insertion. When the distal end 502 is in the treatment position, it can return to its relaxed bell shape. Figure 5A ).

[0070] Therefore, compared to devices where the porous body is connected at the proximal end of the porous body, the characteristics of the medical device 500 facilitate its insertion. Furthermore, the medical device 500 can be more easily loaded into a delivery device. For example, the distal end 502 can be loaded into the delivery device / carrier using a front-end insertion method, rather than a rear-end insertion method.

[0071] It will be apparent to those skilled in the art that various modifications and variations can be made to the disclosed apparatus and methods without departing from the scope of this disclosure. Other aspects of this disclosure will also be apparent to those skilled in the art in light of the specification and practical features disclosed herein. The specification and examples should be considered as exemplary only.

Claims

1. A distal end of a medical device, comprising: A fitting constructed to connect to a suction source; as well as A porous body connected to the pipe fitting, wherein the porous body has a wall having an inner surface and an outer surface. The distal end includes a cavity such that the gap extends from the outer surface of the tube to the inner surface of the porous body.

2. The distal end according to claim 1, wherein the cap is located in the cavity.

3. The distal end according to claim 2, wherein the cap comprises a porous material.

4. The distal end according to any one of claims 2 or 3, wherein the proximal surface of the cap is the distal end of the cavity.

5. The distal end according to any one of claims 1 to 4, further comprising a rib extending from the outer surface of the tube to the inner surface of the porous body.

6. The distal end of claim 5, further comprising at least a second rib extending from the outer surface of the tube to the inner surface of the porous body.

7. The distal end of claim 5, wherein the rib defines a first portion of the cavity proximal to the rib and a second portion of the cavity distal to the rib.

8. The distal end according to any one of claims 1 to 7, wherein the distal portion of the porous body is connected to the distal portion of the tube.

9. The distal end according to any one of claims 1 to 8, wherein, In the relaxed configuration, the porous body is tapered radially outward from the position where the porous body is connected to the pipe fitting in the proximal direction.

10. The distal end according to any one of claims 1 to 9, wherein the porous body has a bell shape in a relaxed configuration.

11. The distal end according to any one of claims 1 to 9, wherein the porous body has a tubular shape from a first axial position of the porous body to a second axial position of the porous body.

12. The distal end of claim 11, wherein the cavity has a uniform radial width from the first axial position to the second axial position.

13. The distal end according to any one of claims 11 or 12, wherein the porous body has a prism shape from the first axial position to the second axial position.

14. The distal end of claim 13, wherein the porous body has a plurality of ridges and a plurality of valleys.

15. The distal end according to any one of claims 1 to 14, wherein the distal end is configured such that, when the distal end is located within the patient's body and the fitting is connected to the aspiration source, bodily fluid flows through the pores of the porous body, through the cavity, and into the fitting.

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