Endoluminal treatment devices and related methods

Abstract

A distal end of a medical device is disclosed. The distal end includes a tube. The distal end includes a sponge located at the distal end of the tube. The sponge includes a first flange, a second flange, and a saddle-shaped portion located between the first flange and the second flange.

Description

Cross-reference to related applications

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 589,481, filed October 11, 2023, the entire contents of which are incorporated herein by reference. Technical Field

[0002] Various aspects of this disclosure relate generally to minimally invasive medical devices and methods. More specifically, several 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 tract (GI) include, for example, colectomy, bariatric surgery, esophagectomy, gastric bypass, and sleeve gastrectomy. These procedures can result in gastrointestinal perforation, postoperative leakage, or other wounds. Patients with gastrointestinal perforation, postoperative leakage, and / or other wounds have high mortality rates and limited treatment options. Treatment options include endoscopic clip or stent placement, endoscopic sutures or sealant treatment, 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 encapsulate infection at the treatment site, thus obstructing drainage.

[0004] The medical device 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 relate to apparatus and methods for treating endocavitary wounds and may include one or more features described in combination with any other disclosed aspect.

[0006] This disclosure includes medical devices and related methods for EVAC procedures. For example, this disclosure includes a distal end of a medical device comprising a tube and a sponge located at the distal end of the tube. The sponge may include a first flange, a second flange, and a saddle-shaped portion located between the first flange and the second flange. The saddle-shaped portion may be a first saddle-shaped portion. The sponge may include a third flange between the first flange and the second flange. The first saddle-shaped portion may be between the first flange and the third flange. The sponge may further include a second saddle-shaped portion between the third flange and the second flange. The diameter of the first saddle-shaped portion may be smaller than the diameter of each of the first flange, the second flange, and the third flange. The diameter of the second saddle-shaped portion may be smaller than the diameter of each of the first flange, the second flange, and the third flange. The outer surface of the first saddle-shaped portion tapers radially inward in a distal direction. The diameter of the first flange may be larger than the diameter of the second flange. The diameter of the first flange may be larger than the diameter of the third flange. The diameter of the second flange may be approximately equal to the diameter of the third flange. The sponge may include a circular portion extending distally from the second flange. One of the first or second flanges may be more flexible than the other. At least one of the first or second flanges may have an outer surface that tapers radially inward in the distal direction. The distal end may include a distal tip having an outer surface that tapers radially inward in the distal direction. The most distal end of the distal tip may be pointed. The same line may extend along the outer surfaces of the first flange, the second flange, and the distal tip. The first and second flanges may be joined to form a spiral. A single curve may extend along a first surface and a second surface of the spiral.

[0007] This disclosure includes a distal end of a medical device comprising a tube and a sponge located at the distal end of the tube. The sponge may include a flange and a portion extending distally toward the flange. The outer surface of the portion extending distally toward the flange may taper radially inward in a distal direction. The flange may be a first flange. The distal end may further include a second flange distal to the first flange. The outer surface of the portion extending distally toward the first flange tapers between the first flange and the second flange. The outer surface of the portion extending distally toward the first flange may have a circular shape, forming the distalmost circular end of the sponge. The outer surface of the portion extending distally toward the first flange may be the outer surface of the second flange. A saddle-shaped portion may extend between the first flange and the second flange.

[0008] This disclosure also includes a medical method. The medical method may include: moving a sponge connected to the distal end of a tubing proximally such that the sponge changes from a first configuration to a second configuration, wherein in the first configuration, a first flange and a second flange of the sponge are within a cavity of a body cavity, and a third flange of the sponge is outside the cavity; and in the second configuration, the first flange is within the cavity of the body cavity, and the second and third flanges are outside the cavity. The medical method may further include applying negative pressure to the sponge using the tubing. Attached Figure Description

[0009] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate various aspects of this disclosure and, together with the specification, serve to explain the principles of this disclosure.

[0010] Figure 1 The distal end of an exemplary medical device is shown.

[0011] Figure 2 Show Figure 1 The medical device is located at the distal end of the target site.

[0012] Figure 3A The distal end of an exemplary medical device is shown.

[0013] Figure 3B Show Figure 3A A cross-sectional view of a medical device.

[0014] Figure 4A The distal end of an exemplary medical device is shown.

[0015] Figure 4B Show Figure 4A A cross-sectional view of a medical device.

[0016] Figure 5 A cross-sectional view of the distal end of an exemplary medical device is shown.

[0017] Figure 6A An exemplary medical device is shown at the distal end of a first configuration.

[0018] Figure 6B Show Figure 6A The medical device is located at the distal end of the second configuration.

[0019] Figure 7 A cross-sectional view of the distal end of an exemplary medical device is shown.

[0020] Figure 8 The distal end of an exemplary medical device is shown. Detailed Implementation

[0021] 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.

[0022] The terms “proximal” and “distal” are used herein to refer to the relative positions of the constituent elements of the exemplary medical device. As used herein, “proximal” refers to a position relatively closer to the exterior of the body or closer to the operator using the medical device. In contrast, “distal” refers to a position relatively farther from the operator using the medical device or closer to the interior of the body. The term “diameter” also includes the width of elements that are not circular or do not have a circular cross-section.

[0023] As used herein, the terms “comprises,” “comprising,” “including,” “includes,” “having,” “has,” or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article of manufacture, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed or inherent to such process, method, article of manufacture, or apparatus. The term “exemplary” is used in the sense of “example” rather than “ideal.”

[0024] In addition, relative terms such as “about,” “substantially,” and “approximately” are used to indicate that the stated value or range may vary by ±10%.

[0025] Endocaval vacuum therapy (EVT or EVAC, and referred to herein as EVAC) is a surgical procedure used to treat wounds, such as postoperative leaks or perforations in the gastrointestinal tract (GI) following surgical or endoscopic procedures (e.g., colectomy, bariatric surgery, or IVF). In EVAC, negative pressure is delivered to the wound site in the GI, for example via a nasogastric tube with a sponge / foam (e.g., vacuum-sealed foam) at its distal end. The proximal end of the tube may be connected to a collection container. The foam is placed into the perforation, leak, or other wound via an endoscope. In some examples, EVAC involves the endocaval placement of foam or other similar materials into the wound site (e.g., target site), which may include perforations, leaks, cysts, anastomoses, etc. The material can be placed into the GI via catheters, endoscopes (endoscopes, bronchoscopes, colonoscopes, duodenoscopes, gastroscopes, etc.), tubes, or sheaths inserted through natural orifices. The opening can be, for example, the nose, mouth, or anus, and the placement can be in any part of the gastrointestinal tract, including the esophagus, stomach, duodenum, large intestine, or small intestine. The material can also be placed in other organs accessible via the gastrointestinal tract (e.g., the colon). Negative pressure is then applied.

[0026] Foam in the wound, along with negative pressure, can accelerate healing by promoting local granulation tissue formation at the wound site. As the wound heals and closes, the foam can be replaced with smaller and smaller foams. Applicable devices and systems for EVAC are limited. For example, EVAC typically requires foam replacement every 3 to 5 days to reduce the risk of ingrown tissue. Furthermore, wound infection can occur, which may prolong wound treatment. It should be understood that the terms "sponge" and "foam" as used in this disclosure are interchangeable and refer to the same structure.

[0027] Currently, physicians manually shape (e.g., cut) sponges (such as Granufoam™ sponges) and manually suture them to vacuum tubes (such as nasogastric tubes). This process can introduce several sources of uncertainty for physicians, especially if they lack experience performing EVAC. Physicians may be unsure how large or small the sponge should be adjusted to fit the target cavity / site, and they may be unsure at what depth the sponge should be placed within the target cavity / site.

[0028] This disclosure includes devices and methods for using sponges of various shapes. The sponge may be attached to a vacuum tube. Some of the disclosed sponges may include one or more flanges spaced apart by one or more intermediate portions, the diameter of which is smaller than the diameter of the one or more flanges. The one or more flanges and the one or more intermediate portions may be stretchable to create space for wound healing. Some sponges may taper gradually from the proximal end of the sponge to the distal end. Other sponges may include specific shapes (e.g., a rounded or pointed distal end) to achieve a desired patient therapeutic effect. Any features of the sponge may be combined in any suitable manner.

[0029] Reference will now be made in detail to the examples of this disclosure described above and shown in the accompanying drawings. Wherever possible, the same reference numerals will be used throughout the drawings to refer to the same or similar parts.

[0030] Figure 1 and Figure 2 The distal end 112 of a medical device 110 according to an example of this disclosure is shown. In the example, the device 110 can be used to perform an EVAC procedure. The device 110 can be inserted into a patient to treat a wound using negative pressure via a vacuum device. The device 110 typically includes a foam or sponge 130 (or other mesh-like material or porous body) and a vacuum tube 140. The sponge 130 can be formed from Granufoam™ or any other suitable material.

[0031] Sponge 130 may be attached to the distal end 141 of vacuum tube 140. Vacuum tube 140 may include an outer wall 142 defining one or more lumens 144. Lumens 144 may be open at both the proximal end 146 and the distal end 141 of vacuum tube 140. As disclosed herein, the outer wall 142 may optionally include additional openings (e.g., around the circumference of the distal end 141 of vacuum tube 140 and in fluid communication with the lumen 144), which may increase flow or fluid or material into the lumen 144. Sponge 130 may cover all holes / openings at the distal end 141 of vacuum tube 140. Sponge 130 may surround the entire circumference of vacuum tube 140.

[0032] The distal end 141 of the vacuum tube 140 can be attached to the sponge 130 via stitching, heat bonding, adhesive, connectors (e.g., quick-connect couplings), etc. In one example, a recess can be provided in the sponge 130 to receive the distal end 141 of the vacuum tube 140. The vacuum tube 140 can be attached within the recess of the sponge 130, which can provide additional structural support between the sponge 130 and the vacuum tube 140. Alternatively, the sponge 130 can be extruded or cast onto the vacuum tube 140 as described herein.

[0033] The sponge 130 may include openings 122 extending through it. Openings 122 can be any pores, openings, or channels that provide a continuous pathway connecting channels and pores throughout the sponge 130. Openings 122 may include different sizes and shapes and can be selected according to the treatment location within the body. For example, openings 122 may be spheres, cubes, irregular shapes, or any other shape. The size of openings 122 can be from approximately 50 μm in diameter to approximately 1 mm.

[0034] The proximal end 146 of the vacuum tube 140A can be connected to a vacuum source (not shown) that can provide negative pressure to the sponge 130 and / or the distal end 141 of the vacuum tube 140. For example, a negative pressure of about 125 mmHg, or approximately 2.5 pounds per square inch (PSI), can be applied to the sponge 130. Other suitable amounts of negative pressure can be used. This negative pressure can draw fluids, materials, and / or other debris through the opening 122 into the lumen 144 of the vacuum tube 140, the distal opening 145 of the vacuum tube 140, and / or other openings of the distal end 141, which can promote healing of the wound / cavity 151 at the target site 150.

[0035] The sponge 130 may include a first flange 131 (which may be a proximal flange), a second flange 133 (which may be a distal flange), and a middle portion 132 (e.g., a saddle shape). The sponge 130 may have a dumbbell shape. The middle portion 132 may be positioned between the first flange 131 and the second flange 133. The middle portion 132, the first flange 131, and the second flange 133 may be arranged along the longitudinal axis of the vacuum tube 140 (e.g., along the central longitudinal axis). In some examples, the first flange 131, the middle portion 132, and the second flange 133 may have a central longitudinal axis that is substantially coaxial with each other and / or substantially coaxial with the central longitudinal axis of the vacuum tube 140.

[0036] The intermediate portion 132 may have a cylindrical shape; however, the intermediate portion 132 is not limited to a particular shape. In an alternative, the intermediate portion 132 may be any prismatic shape. In other alternatives, the intermediate portion 132 may have a convex shape (radially convex) or a concave shape (similar to a hyperboloid). In a further alternative, the intermediate portion 132 may have a reduced shape, with a larger width / diameter near the first flange 131 and a smaller width / diameter near the second flange 133. The diameter / width of the intermediate portion 132 may be smaller than the diameter / width of the first flange 131 and / or the second flange 133. In some aspects, the first flange 131 and the second flange 133 may have the same diameter / width. In other aspects, the first flange 131 may have a different (larger or smaller) diameter compared to the second flange 133.

[0037] The first flange 131 may include a proximal surface 155. The sponge 130 may include a proximal protrusion 160 that protrudes from the proximal surface 155. The protrusion 160 may be a tube configured to cover / enclose a portion of the tube 140. The protrusion 160 may have a smaller diameter / width than the flanges 131, 133, and the intermediate portion 132.

[0038] In some aspects, the sponge 130 may have a solid cross-section except for the recess for receiving the distal end 141 of the tube 140. For example, the sponge 130 may have a solid cross-section in each of the first flange 131, the intermediate portion 132, and the second flange 133, except for the recess for receiving the distal end 141. In other examples, the sponge 130 may have a centrally hollow portion to accommodate insertion into a narrow cavity 151. In such an example, the sponge 130 may include a wall portion comprising a double-walled portion at the first flange 131 and the second flange 133 (i.e., the wall portion may fold backward at the first flange 131 and the second flange 133). In such an example, the first flange 131 and the second flange 133 may include a hollow toroidal shape or a portion of such a hollow toroidal shape. In such an example, the walls of the sponge 130 may be interconnected at the distal end of the sponge 130 to form a closed distal end. For example, the distal wall of the second flange 133 may extend across the entire diameter of the sponge 130 to form a closed distal end. In other words, one or more of the first flange 131, the intermediate portion 132, and the second flange 133 may be hollow. One or more of the first flange 131 and the second flange 133 may be a hollow toroidal shape. The more proximal portion of the sponge 130 may be hollow. The protrusion 160 may be sealed around the distal end 141 of the tube 140. In some examples, the pores may have different sizes / diameters. For example, the pore 122 of the intermediate portion 132 may be larger than the pore 122 of the first flange 131 and the pore 122 of the second flange 133. The pore 122 may be preferentially exposed. When the sponge 130 is initially placed within the cavity 151 of the target site 150, the pores 122 of the first flange 131, the intermediate portion 132, and the second flange 133 are exposed and receive drainage from the cavity 151. After a predetermined period of time, the size of the cavity 151 may shrink, or the properties of the cavity 151 may change. When the size of the cavity 151 shrinks, the second flange 133 may be folded along the intermediate portion 132 or (e.g., by a medical professional) to accommodate the smaller cavity 151 and to stop / terminate contact between the pores 122 of the intermediate portion 132 and the cavity 151 (e.g., surrounding tissue). The size and shape of the second flange 133 may be designed so that when the second flange 133 is folded along the intermediate portion 132, it can completely or partially cover the intermediate portion 132. The relatively smaller pores 122 of the second flange 133 (e.g., pores on the distal side of the second flange 133) can replace the relatively larger pores 122 of the intermediate portion 132. Replacing the larger pores 122 of the intermediate portion 132 with the smaller pores 122 of the second flange 133 allows for continuous drainage, but reduces the risk of tissue ingrowth over time.Inward growth of the tissue poses a greater risk to the larger pores 122 in the middle portion 132.

[0039] Flanges 131 and 133 can be used as indicators of the depth at which the sponge 130 is inserted into the target cavity 151. For example... Figure 2 As shown, flange 131 can be held outside (e.g., proximal) of target cavity 151, and flange 133 can be positioned inside target cavity 151. Such positioning of flanges 131 and 133 helps prevent sponge 130 from migrating outside cavity 151. For example, flange 133 can have structures / features to prevent migration.

[0040] Figures 3A to 3B The distal end 312 of the exemplary medical device 310 is shown. Unless otherwise stated, the distal end 312 may have any of the features of the distal end 112. Where feasible, the reference number of the distal end 312 is the reference number of the distal end 112 plus 200 to identify the corresponding structure.

[0041] The distal end 312 may include a sponge 330 and a tube 140. The sponge 330 may be located at the distal end 141 of the tube 140. The sponge 330 may include a first (proximal) flange 331, a second (intermediate) flange 333, and a first intermediate portion 332 (e.g., a first saddle). The first intermediate portion 332 may be located between the first flange 331 and the second flange 333. The sponge 330 may further include a third (distal) flange 335 and a second intermediate portion 334 (e.g., a second saddle). The second flange 333 may be located between the first flange 331 and the third flange 335. The second intermediate portion 334 may be located between the second flange 333 and the third flange 335. The first flange 331 may be located proximal to the second flange 333 and the third flange 335, such that the first flange 331 is the nearest flange of the sponge 330. The third flange 335 may be located distal to the first flange 331 and the second flange 333, such that the third flange 335 is the farthest flange. The second flange 333 may be located between the first flange 331 and the third flange 335. The first flange 331, the second flange 333, the third flange 335, the first intermediate portion 332, and the second intermediate portion 334 may be arranged along the longitudinal axis (e.g., the central longitudinal axis) of the vacuum tube 140. In some examples, the central longitudinal axis of the flanges 331, 333, 335, and the intermediate portions 332 and 334 may be coaxial with the central longitudinal axis of the vacuum tube 140.

[0042] refer to Figure 3BThe diameter 332D of the first intermediate portion 332 may be smaller than the diameter 33ID of the first flange 331, the diameter 333D of the second flange 333, and / or the diameter 335D of the third flange. The diameter 334D of the second intermediate portion 334 may be smaller than the diameter 33ID of the first flange 331, the diameter 333D of the second flange 333, and / or the diameter 335D of the third flange. Diameters 332D and 334D may be the same or approximately the same. Diameters 33ID, 333D, and / or 335D may be the same or approximately the same.

[0043] Similar to intermediate portion 132, the first intermediate portion 332 and the second intermediate portion 334 may be generally cylindrical in shape; however, the first intermediate portion 332 and the second intermediate portion 334 are not limited to a particular shape. In some respects, the first intermediate portion 332 and / or the second intermediate portion 334 may be any prismatic shape. It should be understood that when the first intermediate portion 332 and the second intermediate portion 334 are prismatic, the dimensions of each of the intermediate portions 332 and 334 may be similar to each other. The first flange 331 may include a proximal-facing surface 355. The sponge 330 may include a proximal-facing protrusion 360 that protrudes from the proximal-facing surface 355 and has any of the features of the protrusion 160.

[0044] In one or more embodiments, the diameter 332D of the first intermediate portion 332 and the diameter 334D of the second intermediate portion 334 may be different from each other. In some embodiments, one or more of the diameters 33ID, 333D, and 335D of flanges 331, 333, and 335 may be different from the diameters of one or more other flanges. In some embodiments, each value of diameters 33ID, 333D, and 335D may be different. The first intermediate portion 332 and the second intermediate portion 334 may have the same axial / longitudinal length or may have different axial / longitudinal lengths. For example, the second intermediate portion 334 may have a shorter / smaller axial / longitudinal length than the first intermediate portion 332.

[0045] Figures 4A to 4B The distal end 412 of an exemplary medical device 410 is shown. Unless otherwise stated, the distal end 412 may have any of the features of the distal end 112 and the distal end 312. Where feasible, the reference number of the distal end 312 is the reference number of the distal end 112 plus 200 to make it the reference number of the distal end 312, in order to identify the corresponding structure.

[0046] The distal end 412 may include a sponge 430 and a tube 140. The sponge 430 may be located at the distal end 141 of the tube 140. The sponge 430 may include a first (proximal) flange 431, a second (intermediate) flange 433, and a first intermediate portion 432 (e.g., a saddle). The first intermediate portion 432 may be located between the first flange 431 and the second flange 433. The sponge 430 may include a third (distal) flange 435 and a second intermediate portion 434 (e.g., a saddle). The second intermediate portion 434 may be located between the second flange 433 and the third flange 435. The first flange 431 may be located proximal to the second flange 433 and the third flange 435. The third flange 435 may be located distal to the first flange 431 and the second flange 433. The second flange 433 may be located between the first flange 431 and the third flange 435. The first flange 431, second flange 433, third flange 435, first intermediate portion 432, and second intermediate portion 434 may be arranged along the longitudinal axis (e.g., the central longitudinal axis) of the vacuum tube 140. In some examples, the central longitudinal axis of flanges 431, 433, 435, and intermediate portions 432 and 434 may be coaxial with the central longitudinal axis of the vacuum tube 140. The first flange 431 may include a proximal surface 455. The sponge 430 may include a proximal projection 460 having any of the features of the projection 160.

[0047] The diameter 43ID of the first flange 431 can be larger than the diameter 433D of the second flange 433 and can be larger than the diameter 435D of the third flange 435. In some examples, the diameter 433D of the second flange 433 can be larger than the diameter 435D of the third flange 435. Alternatively, the diameter 433D of the second flange 433 can be approximately equal to the diameter 435D of the third flange 435.

[0048] The first intermediate portion 432 (proximal to the second intermediate portion 434) may taper from a larger diameter 432D near (e.g., adjacent to / contacting) the first flange 431 to a smaller diameter 432D' near (e.g., adjacent to / contacting) the second flange 433. The smaller diameter 432D' may be the same diameter or approximately the same diameter as the diameter 434D of the second intermediate portion 434. The larger diameter 432D may be larger than the diameter 434D of the second intermediate portion 434. The larger diameter 432D may be smaller than the diameter 433D of the second flange 433. The first intermediate portion 432 may be in the shape of a truncated cone; however, the first intermediate portion 432 is not limited to a specific shape and may be any tapered shape. In some examples, the first intermediate portion 432 may have a linear taper. In other examples, the first intermediate portion 432 may have a non-linear taper.

[0049] In some embodiments, the diameter of the second intermediate portion 434 may taper from proximal to distal or from distal to proximal. In such examples, the second intermediate portion 434 may taper at the same angle as the first intermediate portion 432, at a steeper angle, or at a gentler angle. In examples, the proximal end of the second intermediate portion 434 may have a diameter equal to or substantially equal to a smaller diameter 432D', and smaller than the diameter 433D of the second flange 433. In some examples, the intermediate portions 432 and 434 may have substantially equal axial / longitudinal lengths. In other examples, the intermediate portions 432 and 434 may have different axial / longitudinal lengths. For example, the second intermediate portion 434 may have a smaller axial length than the first intermediate portion 432.

[0050] During surgery using distal end 312 or distal end 412, sponge 330 or sponge 430 can be inserted into the target cavity. For example, sponge 330 or sponge 430 can be inserted such that the first intermediate portion 332, the first intermediate portion 432, and the second intermediate portion 334, the second intermediate portion 434 are within the cavity. The second flange 333, the second flange 433, and the third flange 335, the third flange 435 can also be accommodated within the cavity. The first flange 331, the first flange 431 can be proximal to / outside the cavity. Over time, the size of the cavity may shrink, or the nature of the cavity may change. The operator can pull distal end 312 or distal end 412 proximally to remove the first intermediate portion 332, the first intermediate portion 432 from the target cavity. Distal end 312 or distal end 412 can be partially or completely retracted in the proximal direction by pulling tube 140. Alternatively, the distal ends 312 and 412 can be partially or completely retracted by pulling them proximally using an auxiliary device, such as, but not limited to, a clamp (e.g., endoscopic rat-tooth forceps). The reduced shape of the first intermediate portion 432 of the sponge 430 can facilitate such repositioning of the sponge 430. In some examples, the second flanges 333 and 433 may remain within the cavity after the first intermediate portion 332 and 432 have been removed. Alternatively, the second flanges 333 and 433 can be removed from the cavity to provide anchoring proximally and outside the cavity. The second intermediate portion 334 and 434 may have a smaller diameter and / or axial / longitudinal length than the first intermediate portion 332 and 432, which can be adapted to smaller target cavities over time.

[0051] Although sponges 330 and 430 are described as having two intermediate portions (e.g., saddle-shaped), it should be understood that sponges 330 and 430 may have more than two intermediate portions. In some examples, the more distal intermediate portions may have progressively smaller diameters (and may have a tapered shape, such as the first intermediate portion 432 of sponge 430) to accommodate further reductions in the target cavity size. The operator may continuously pull sponges 330 and 430 distally as described above to obtain additional intermediate portions 332 and 432.

[0052] Figure 5 A cross-sectional view of the distal end 512 of an exemplary medical device 510 is shown. The distal end 512 may include a sponge 530 and a tube 140. The sponge 530 may be located at the distal end of the tube 140. Unless otherwise stated, the sponge 530 may have any of the characteristics of sponges 130, 330, and 430 as described above.

[0053] The sponge 530 may include a first (proximal) flange 531, a second (intermediate) flange 533, and a distal tip 535. A first intermediate portion 532 may be located between the first flange 531 and the second flange 533, and a second intermediate portion 534 may be located between the second flange 533 and the distal tip 535. The first flange 531 and the second flange 533 may be truncated pyramidal in shape; however, as further explained below, the first flange 531 and the second flange 533 are not limited to a truncated pyramidal shape and may be of any shape (e.g., any reduced shape). The first flange 531 may be located proximal to the second flange 533 and the distal tip 535. The distal tip 535 may be located distal to the first flange 531 and the second flange 533. The second flange 533 may be located between the first flange 531 and the distal tip 535. The first flange 531, the second flange 533, the distal tip 535, the first intermediate portion 532, and the second intermediate portion 534 may be arranged along the longitudinal axis (e.g., the central longitudinal axis) of the vacuum tube 140. The central longitudinal axis of the flanges 531, 533, the distal tip 535, and the intermediate portions 532 and 534 may be substantially coaxial with the central longitudinal axis of the vacuum tube 140. Although two flanges 531, 533 and one distal tip 535 are disclosed, it should be understood that the sponge 530 may include any suitable number of flanges.

[0054] The proximal end of the first flange 531 may have a maximum diameter 53ID and a minimum diameter 53ID'. The first flange 531 may radially taper inward from the maximum diameter 53ID to the minimum diameter 53ID' in the distal direction. The first flange 531 may taper linearly or non-linearly. The proximal end of the second flange 533 may have a maximum diameter 533D and a minimum diameter 533D'. The second flange 533 may radially taper inward from the maximum diameter 533D to the minimum diameter 533D' in the distal direction. The second flange 533 may taper linearly or non-linearly. The first flange 531 may include a proximal-facing surface 555. The sponge 530 may include a proximal-facing protrusion 560 that protrudes from the proximal-facing surface 555. The protrusion 560 may have any feature of the protrusion 160.

[0055] The distal tip 535 can be a truncated cone or a conical shape. However, the distal tip 535 is not limited to having a truncated cone or conical shape and can have any shape (e.g., a tapered shape). The distal tip 535 can include a base 535B and a tip / apex 535T. The base 535B can have a circular cross-section perpendicular to the longitudinal axis of the sponge 530. The base 535B can have a diameter 535D. The tip 535T can be located more distally than the base 535B and can be the most distal end of the sponge 530. The tip 535T can be pointed (e.g., the tip of the distal tip 535 in a conical shape). In other examples, the tip 535T can have a smaller diameter than the diameter 535D of the base 535B but is not pointed. The base 535B can taper linearly or non-linearly to the tip 535T.

[0056] The maximum diameter 53ID of the first flange 531 can be greater than the maximum diameter 533D of the second flange 533 and the diameter 535D of the base 535B. The minimum diameter 53ID' of the first flange 531 can be greater than the maximum diameter 533D of the second flange 533, and the minimum diameter 533D' of the second flange 533 can be greater than the diameter 535D of the base 535B. In some examples, the sponge 530 can have an overall conical shape, so that a straight line can be drawn along the outer surfaces of the first flange 531, the second flange 533, and the distal tip 535.

[0057] Compared to sponges 130, 330, and 430, the intermediate portions 532 and 534 can have smaller diameters, so that the outer surfaces of the intermediate portions 532 and 534 are closer to the vacuum tube than the intermediate portions of sponges 130, 330, and 430. In some examples, such as Figure 5As shown, the intermediate portions 532 and 534 may have a diameter approximately equal to that of the protrusion 560.

[0058] When used in surgery, the sponge 530 is initially fully inserted into the target cavity, such that the distal tip 535, the second flange 533, and the first flange 531 are completely contained within the cavity. As the target cavity (e.g., a wound) begins to heal and close, the sponge 530 can be partially removed (retracted proximally) so that only the second flange 533 and the distal tip 535 remain within the target cavity, while the first flange 531 is no longer present. In some examples, this retraction of the sponge 530 may occur after a predetermined time (e.g., 3 to 5 days) or may depend on the healing rate of the cavity. The partial removal of the sponge 530 accommodates the shrinking size of the cavity, allowing it to continue to shrink. Furthermore, the partial removal of the sponge 530 prevents tissue growth into the sponge 530. As the cavity continues to heal and close, the sponge 530 can be further removed from the cavity 151 such that only the distal tip 535 remains within the cavity, while the first flange 531 and the second flange 533 are both located outside the cavity (proximal). As described above, the sponge 530 may include flanges other than the first flange 531 and the second flange 533, and the above method can be reused for any number of flanges. In an alternative embodiment, each flange may include a visual identifier to help identify these flanges, and the insertion and removal of the sponge 530.

[0059] Figures 6A to 6B The distal end 612 of an exemplary medical device 610 is shown. The distal end 612 may include a sponge 630 and a tube 140. Unless otherwise stated herein, the sponge 630 may have any of the characteristics of sponge 130, sponge 330, sponge 430, or sponge 530.

[0060] Sponge 630 may be located at the distal end of tube 140. Sponge 630 may include a first (proximal) flange 631, a second (distal) flange 633, and an intermediate portion 632 (e.g., a saddle). The intermediate portion 632 may be located between the first flange 631 and the second flange 633. The distal end of sponge 630 may include a protrusion 635. Protrusion 635 may project distally from the distally facing surface 665 of the second flange 633. Protrusion 635 may form the distally circular end of sponge 630. Protrusion 635 may be part of a sphere. For example, protrusion 635 may have a hemispherical shape, wherein the base of the hemisphere is close to the pole of the hemisphere and adjacent to the second flange 633. The first flange 631, the second flange 633, and protrusion 635 may be arranged along the longitudinal axis (e.g., the central longitudinal axis) of vacuum tube 140. In some examples, the central longitudinal axes of flanges 631, 633, intermediate portion 632, and protrusion 635 may be substantially coaxial with the central longitudinal axis of vacuum tube 140. First flange 631 may include a proximal-facing surface. Sponge 630 may include a proximal-facing protrusion 660 that projects from the proximal-facing surface of first flange 631. Protrusion 660 may have any of the characteristics of protrusion 160.

[0061] The second flange 633 may be more flexible than the first flange 631 (i.e., the first flange 631 may be more rigid than the second flange 633). For example, the second flange 633 may be configured to be curved in the distal and / or proximal directions. The first flange 631 may be configured to be relatively rigid and not flexible in either the distal or proximal directions. For example, the first flange 631 may be more dense than the second flange 633. Additionally or alternatively, the second flange 633 may have a smaller longitudinal / axial length than the first flange 631 to make it more flexible. Additionally or alternatively, the shape of the second flange 633 may further make it more flexible than the first flange 631. The second flange 633 may be more porous than the first flange 631 (e.g., having larger pores or a greater number of pores). The higher porosity of the second flange 633 may result in the second flange 633 being more flexible than the first flange 631. Under negative pressure, the width / size of the second flange 633 may be further reduced relative to the first flange 631. If both the first flange 631 and the second flange 633 comprise a hollow toroidal shape with double walls (e.g., if the first flange 631 and the second flange 633 are hollow), wherein the distal flange 633 has a more porous structure than the proximal flange 631, under vacuum, a significant portion of the width of the second flange 633 may be further reduced compared to the first flange 631. Therefore, the second flange 633 can be more flexible than the proximal flange 631.

[0062] For example, when used in EVAC procedures, the medical device 610 (e.g., the distal end of the tube 140 and the sponge 630) can be inserted into a target site (e.g., a wound within a patient's gastrointestinal tract). When the second flange 633 is inserted into the cavity, it can bend proximally to aid in the insertion of the sponge 630 into the cavity. The second flange 633 may be elastic so that it can return to its unbent shape when inserted into the cavity. Once inserted into the cavity, the second flange 633 can bend distally to help retain the protrusion 635 within the target site and prevent the sponge 630 from spontaneously leaving the cavity. The first flange 631 may be rigid to seal or help seal the cavity, preventing leakage from the cavity and preventing debris and other contaminants from entering the cavity. In several respects, the second flange 633 may serve as an indicator to the user that the sponge 630 is properly positioned within the cavity, and the first flange 631 may serve as a retention mechanism for holding the sponge 630 in the desired position.

[0063] As described above with respect to flanges 631 and 633, any flange of medical device 110, medical device 310, medical device 410, and medical device 510 may be rigid or flexible. In some aspects, the distal flange of the medical device may be flexible, and the remainder of the flange may be rigid. In alternative embodiments, the proximal flange of the medical device may be rigid, and the remainder of the flange may be flexible. A flexible flange may be configured to bend only in the distal direction, only in the proximal direction, or in either direction.

[0064] Figure 7 The distal end 712 of an exemplary medical device 710 is shown. The distal end 712 may include a sponge 730 and a tube 140. Unless otherwise stated herein, the sponge 730 may have any of the characteristics of sponge 130, sponge 330, sponge 430, sponge 530, or sponge 630.

[0065] The sponge 730 may be in the shape of a corkscrew, an auger, and / or a helix. The sponge 730 may extend along the longitudinal axis of the tube 140. The sponge 730 may include a proximal end 731 and a distal end 735. The sponge 730 may include a central core 733 that may extend along the tube 140 from a proximal protrusion 760 (having any features of the protrusion 160) to a distal tip 737 of the sponge 730. The proximal core 733 of the distal tip 737 may have a constant diameter. As described below, at the distal tip 737, the sponge 730 may taper inward in the distal direction (e.g., to the tip).

[0066] The sponge 730 may further include a sponge body 732 that is wound around the core 733. The body 732 and the core 733 may be a single continuous piece of material. The body 732 may have a helical shape. A spacer 734 may extend between adjacent turns 739 of the body 732. The spacer 734 may be of any spacing, and different spaces 734 of the sponge 730 may have different spacings. Along the spacer 734, the outer surface of the core 733 may form a saddle-shaped portion between adjacent turns 739. Figure 7 The diagram shows the body 732 winding around the core 733 four times, but it should be understood that any suitable number of turns 739 can be used. The sponge 732 may be provided with multiple flanges interconnected in a spiral shape.

[0067] The overall outline of the main body 732 can taper radially inward from the proximal end 731 to the distal end 735, such that the loops 739 of the main body 732 gradually taper radially between the proximal end 731 and the distal tip 737. The overall outline of the main body 732 can be curved, such that the outer surface of the sponge 730 can be convex between the proximal end 731 and the distal end 735. In other words, the curve drawn between the proximal end and the distal end 735, extending radially inward along the longitudinal direction, can contact the outer surface of the main body 732 along each loop 739.

[0068] The distal tip 737 of the sponge 730 may taper to the tip of the furthest end 735. Alternatively, the distal tip 737 may have a rounded distal shape. As the body 732 is closer to the side portion, the distal surface 738 of the distal tip 737 may have a curved outer surface.

[0069] The proximal surface 755 can be approximately perpendicular to the central longitudinal axis of the vacuum tube 140. The proximal surface 736 and distal surface 738 of the coil 739 of the body 732 can be non-perpendicular to the vacuum tube 140. All proximal surfaces 736 and distal surfaces 738 of the coil 739 of the body 732 can have approximately the same angle relative to the central longitudinal axis, as shown, or they can have different angles. Figure 7 As shown, the proximal surface 736 and distal surface 738 of the loop 739 of the body 732 can be curved. For example, the proximal surface 736 of each loop can have a concave shape, and the distal surface 738 of each loop can have a convex shape.

[0070] Similar to sponge 530, sponge 730 can be gradually removed from cavity 151 as the wound gradually heals and closes. Initially, sponge 730 can be fully inserted into cavity 151 so that the proximal end 731 is located within the cavity, and then sponge 730 can be gradually removed from cavity 151.

[0071] Figure 8 The distal end 812 of an exemplary medical device 810 is shown. The distal end 812 may include a sponge 830 and a tube 140. Unless otherwise stated, the sponge 830 may have any of the characteristics of the sponges 130, 330, 430, 530, 630, and 730 described above.

[0072] The sponge 830 may be generally mushroom-shaped or bell-shaped. The sponge 830 may include a lip portion 832 and a dome portion 834. The lip portion 832 and the dome portion 834 may be arranged along the longitudinal axis (e.g., the central longitudinal axis) of the pipe fitting 140. For example, the central longitudinal axis of the lip portion 832 and the dome portion may be generally coaxial with the central longitudinal axis of the pipe fitting 140.

[0073] Sponge 830 may include a proximal end 831 and a distal end 835. A lip portion 832 may be adjacent to a dome portion 834. The dome portion 834 may project distally from the lip portion 832. The dome portion 834 may be circular and may be part of a sphere; for example, the dome portion 834 may be generally hemispherical, with the base of the hemisphere near the pole of the hemisphere. The base of the hemisphere may be adjacent to the lip portion 832. The dome portion 834 may taper radially outward, moving proximally from the proximal end 831 (and may taper radially inward, moving distally toward the distal end 835). Sponge 830 may include a proximal-facing surface 855. Sponge 830 may include a proximal-facing protrusion 860 that protrudes from the proximal-facing surface 855. The protrusion 860 may have any of the features of the protrusion 160.

[0074] When the sponge 830 is inserted into the target site 150, the lip portion 832 prevents fluid from leaving the target site 150 by blocking the opening of the cavity in the target site 150. The lip portion 832 can be used as a visual or tactile indicator for a medical professional to place the sponge 830 into the cavity 151. The lip portion 832 can be configured (sized and shaped) to prevent the sponge 830 from spontaneously leaving the target site 150 without intervention. Figure 8 The lip portion 832 shown is a uniformly circular shape; however, the lip portion 832 is not limited to this shape. In alternative embodiments, the lip portion 832 may include a plurality of protrusions (not shown) extending radially outward and / or proximally. The plurality of protrusions may be evenly arranged around the circumference of the lip portion 832. The plurality of protrusions may project radially outward, proximally, or radially outward in a proximal direction. The circular / conical shape of the dome portion 834 allows the sponge 830 to be more easily inserted into the cavity 151 of the target portion 150.

[0075] Although sponges 130, 330, 430, 530, 630, 730, and 830 are described as different aspects of this disclosure, it should be understood that any of sponges 130, 330, 430, 530, 630, 730, and 830 may have any characteristics of the other sponges. Furthermore, any characteristic of any of sponges 130, 330, 430, 530, 630, 730, and 830 may be combined with any characteristic of the other sponges. For example, but not as a limitation, sponge 830 may be attached to the distal end of sponge 430. As another example, but not as a limitation, the distal tip 535 of sponge 530 may replace the third flange 435 of sponge 430.

[0076] Although the aforementioned sponges are described as being fixedly attached to the fitting, it should be understood that the sponges can be detachably attached to the fitting via connectors (e.g., quick-connect fittings). Such connectors allow for sponge replacement during treatment to accommodate changing wound sizes. It should also be understood that the sponges can be pre-sutured or otherwise fixedly attached to the fitting 140. Furthermore, sponges 130, 330, 430, 530, 630, 730, and 830 can be available in various sizes to accommodate different cavity sizes and reduce the burden on surgeons to otherwise reduce sponge size.

[0077] Although the principles of this disclosure have been described herein with reference to illustrative examples for a particular application, it should be understood that this disclosure is not limited thereto. Those skilled in the art and who have access to the teachings provided herein will recognize that additional modifications, applications, embodiments, and equivalent substitutions fall within the scope of the features described herein. Therefore, the claimed features should not be considered as limited by the foregoing description.

Claims

1. A distal end of a medical device, comprising: Pipe fittings; as well as The sponge located at the distal end of the tube, The sponge includes a first flange, a second flange, and a saddle-shaped portion located between the first flange and the second flange.

2. The distal end of claim 1, wherein the saddle-shaped portion is a first saddle-shaped portion, wherein the sponge includes a third flange between the first flange and the second flange, wherein the first saddle-shaped portion is between the first flange and the third flange, and wherein the sponge further includes a second saddle-shaped portion between the third flange and the second flange.

3. The distal end according to claim 2, wherein the diameter of the first saddle-shaped portion is smaller than the diameter of each of the first flange, the second flange, and the third flange.

4. The distal end according to any one of claims 2-3, wherein the diameter of the second saddle-shaped portion is smaller than the diameter of each of the first flange, the second flange, and the third flange.

5. The distal end according to any one of claims 2-4, wherein the outer surface of the first saddle-shaped portion tapers radially inward in the distal direction.

6. The distal end according to any one of claims 2-5, wherein the diameter of the first flange is greater than the diameter of the second flange, and wherein the diameter of the first flange is greater than the diameter of the third flange.

7. The distal end of claim 6, wherein the diameter of the second flange is substantially equal to the diameter of the third flange.

8. The distal end according to any one of claims 1-6, wherein the sponge includes a circular portion extending distally from the second flange.

9. The distal end according to any one of claims 1-6, wherein one of the first flange or the second flange is more flexible than the other of the first flange or the second flange.

10. The distal end according to any one of claims 1-6, wherein at least one of the first flange or the second flange has an outer surface that tapers radially inward in the distal direction.

11. The distal end of claim 10, further comprising a distal tip having an outer surface that tapers radially inward in the distal direction.

12. The distal end of claim 11, wherein the most distal end of the distal tip is pointed.

13. The distal end of claim 12, wherein the same line extends along the outer surfaces of the first flange, the second flange, and the distal tip.

14. The distal end according to any one of claims 1 to 6, wherein the first flange and the second flange are connected to form a helix.

15. The distal end of claim 14, wherein a single curve extends along the first and second surfaces of the spiral.

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