Medical systems, devices, and related methods

Abstract

A medical system includes a source of material, a first tube, and a second tube. The material is configured to expand and form a porous body after the material is deployed in a body lumen. The first tube is configured to deliver the material into the body lumen, and the second tube is configured to apply suction to the porous body.

Description

Technical Field

[0001] Various aspects of this disclosure relate generally to medical systems, devices, and related methods that can be used to treat subjects. For example, aspects of this disclosure relate to medical systems, devices, and methods for endoscopic medical procedures, such as closing wounds or otherwise treating tissue. Background Technology

[0002] Endoscopic and open surgeries of the gastrointestinal tract (GI) include procedures such as colectomy, bariatric surgery, esophagectomy, gastric bypass, and sleeve gastrectomy, among others. These procedures can lead to perforation, postoperative leakage, or other gastrointestinal trauma. Limited treatment options exist for managing such trauma, with significant morbidity and mortality rates. Options include surgical reoperation and endoscopic placement of stents or clips. Surgical procedures are relatively invasive and also have high morbidity and mortality rates. Endoscopic stent placement is a less invasive option. However, the placed stent may migrate from its intended location and / or become septally blocked at the treatment site, thus inhibiting drainage.

[0003] The systems, apparatus, and methods disclosed herein can correct some of the defects described above, or solve other aspects of the prior art. Summary of the Invention

[0004] Examples of this disclosure relate to systems, apparatuses, and methods for performing one or more medical procedures using the medical system and apparatus. Each of the examples disclosed herein may include one or more features described in conjunction with any of the other disclosed examples.

[0005] In one example, the medical system may include a source of material, a first tube, and a second tube. The material may be configured to expand and form a porous body after it is deployed into a body cavity. The first tube may be configured to deliver the material into the body cavity, and the second tube may be configured to apply suction to the porous body.

[0006] The medical system may include one or more of the following features: A first tube may be coupled to a source of material and configured to spray material into a body cavity. The material may include a liquid-phase polyurethane foam that expands and / or cures upon contact with moisture or air. The material may include an open-cell foam. The first tube may include at least two lumens, and the material may include two liquids delivered through the different lumens of the two lumens through the first tube, which cure and form a porous body when the two liquids come into contact with each other. The material may expand to form a depression into which the material is delivered. The porous body may be at least partially biodegradable.

[0007] The medical system may also include a removal device having multiple arms that expandable to form a cage. The arms may be self-expanding and may be formed of a shape memory alloy. At least one arm may include a bend such that the at least one arm expands radially outward and a distal portion of the at least one arm bends radially inward. The cage may be movable within the lumen of the insertion device, and proximal movement of the cage within the lumen of the insertion device may cause the cage to at least partially collapse. The porous body may be removed from a body cavity via the cage and the insertion device. The removal device and the second tube may be movable within the respective lumens of the catheter. The removal device and the second tube may be positionable such that the porous body surrounds at least the distal portion of the cage and the second tube.

[0008] The medical system may also include a rod that is movable within the second tube. The rod can form a seal to prevent material from entering the distal end of the second tube.

[0009] In another example, the medical device may include a porous body comprising multiple layers of a biodegradable material. The outermost layer of the multiple layers may be configured to degrade more rapidly within body tissue than the inner layers. The different layers of the porous body may be formed from different materials, different densities of the same material, or different blends of the same material.

[0010] The medical device may include one or more of the following features: The outermost layer may be configured to degrade within 12 to 36 hours after insertion of the porous body into body tissue, and the inner layer may be configured to degrade within 36 to 60 hours after insertion of the porous body into body tissue. The medical device may also include an inner core and an aspiration port having an opening connected to the inner core. The inner core and the aspiration port may be configured to apply negative pressure to the porous body.

[0011] In yet another example, the medical system may include a porous bag, a therapeutic material, and a tube connected to the porous bag. The therapeutic material may be configured to be delivered to and held within the porous bag. Delivery of the therapeutic material to the porous bag may be configured to expand the bag from a compressed state to an expanded state. The tube may be configured to deliver the therapeutic material to the porous bag and to apply negative pressure to the porous bag.

[0012] The medical system may include one or more of the following features. The medical system may also include a catheter having a lumen. At least a portion of the porous bag may be configured to be positioned within the lumen during delivery of the porous bag to the treatment site. The treatment material may be particulate or porous and may help form a semi-rigid surface that collapses when negative pressure is applied. The medical system may help allow for variations in the size and / or shape of the porous bag at the treatment site.

[0013] In another example, the medical system may include a delivery tube and a medical device. The delivery tube may be configured to deliver material that expands within a body cavity to form a sponge. The medical device may be configured to support and / or remove at least a portion of the sponge.

[0014] It should be understood that the foregoing general description and the following detailed description are merely exemplary and explanatory, and do not limit the scope of the claimed disclosure. Attached Figure Description

[0015] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate exemplary aspects of this disclosure and, together with the description, serve to explain the principles of this disclosure.

[0016] Figure 1 A cross-sectional view of an exemplary medical device is shown according to aspects of this disclosure;

[0017] Figures 2A to 2D According to aspects shown in this disclosure Figure 1 Views of the medical device in the body of the subject at various stages of use;

[0018] Figure 3 A cross-sectional view of an alternative exemplary medical device is shown according to aspects of this disclosure;

[0019] Figures 4A to 4D According to aspects shown in this disclosure Figure 3 Views of the medical device in the body of the subject at various stages of use;

[0020] Figures 5A to 5C Exemplary medical systems for various stages of use in a subject are shown according to aspects of this disclosure;

[0021] Figure 6A and Figure 6B According to aspects of this disclosure, another exemplary medical system is shown in various stages of use in a subject;

[0022] Figures 7A to 7C Further exemplary medical systems at various stages of use are shown according to aspects of this disclosure. Detailed Implementation

[0023] The terms “proximal” and “distal” are used herein to refer to the relative locations of components in the exemplary medical systems and devices. When used herein, “proximal” refers to a location relatively closer to the exterior of the body or closer to a medical professional using the medical system or device. In contrast, “distal” refers to a location relatively farther from a medical professional using the medical system or device, or closer to the interior of the body. As used herein, the terms “comprises,” “comprising,” “having,” “including,” or other variations thereof are intended to cover non-exclusive inclusion, such that a system, apparatus, or method that includes a list of elements may include not only those elements but may also include other elements not expressly listed or inherent to the list. Unless otherwise indicated, the term “exemplary” is used in the sense of “example” rather than “ideal.” As used herein, the terms “about,” “generally,” and “approximately” indicate a numerical range of + / - 10% of the stated values.

[0024] Embodiments of this disclosure include devices, systems, and methods for endocavitary vacuum therapy (EVAC). In examples, EVAC includes endocavitary placement of a porous body (e.g., a sponge) or other similar material to a wound site, including perforations, cysts, leaks, anastomoses, etc. The material can be placed through a natural orifice, via a catheter, endoscope (endoscope, bronchoscope, colonoscope, etc.), tube, or sheath, into the gastrointestinal tract. The orifice 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. Placement can also be in other organs accessible via the gastrointestinal tract.

[0025] Endocavitary vacuum therapy (EVAC) has been proposed. In EVAC, negative pressure is delivered to the site of injury in the gastrointestinal tract, for example, via a nasogastric tube with a sponge at its distal end. The sponge is placed endoscopically into the perforation, leakage, or other wound. Negative pressure is then applied. However, suitable devices and systems for EVAC are limited.

[0026] Reference will now be made in detail to the examples of this disclosure described above and illustrated in the accompanying drawings. Wherever possible, the same reference numerals will be used in all figures to refer to the same or similar parts.

[0027] Figure 1A cross-sectional view of an exemplary medical device (e.g., a porous and absorbent body, or sponge 10) is shown, which can be used to assist in the healing of internal wounds or anastomoses in a subject, or otherwise assist in the treatment of tissue. Sponge 10 includes multiple layers, such as an outer layer 12, a middle layer 14, and an inner layer 16. As discussed below, one or more of layers 12, 14, 16 may be biocompatible and / or may degrade to different degrees (i.e., the various layers may degrade at different rates). For example, as... Figures 2A to 2D As shown, the outer layer 12 degrades faster in the subject 30 than the intermediate layer 14, and the intermediate layer 14 degrades faster in the subject 30 than the inner layer 16. In one aspect, the inner layer 16 may not degrade (i.e., may be biostable) and may be removed by a physician. Furthermore, although... Figure 1 Three layers 12, 14, 16 are shown, but this disclosure is not so limiting. The sponge 10 may include any number of layers, and the thickness of these layers may vary based on the desired size and / or shape of the sponge 10, the desired degradation time of the sponge 10 as a whole, the desired degradation time of each layer, etc.

[0028] In addition, the sponge 10 may include one or more antimicrobial or antimicrobial layers 18, such as on the outer layer 12, between the outer layer 12 and the intermediate layer 14, and / or between the intermediate layer 14 and the inner layer 16. The one or more antimicrobial layers 18 may assist in limiting and / or reducing bacterial growth during wound healing. Alternatively or additionally, one or more layers of the sponge 10 may include an antimicrobial or antimicrobial material (e.g., a gel) that can be delivered to the wound, for example, by secretion or exudation from one or more layers of the sponge 10. For example, the antimicrobial or antimicrobial material may be embedded in one or more layers, or may be, for example, a pill located within one or more layers.

[0029] Furthermore, in embodiments of this disclosure, the sponge 10 may be formed from any suitable biocompatible material capable of absorbing liquids and / or allowing liquids to pass through by applying suction / negative pressure to the sponge 10. The material may be flexible, compressible, porous, hydrophilic, sterile, and / or disposable. The sponge material may be an open-cell foam (or formed therefrom). Suitable materials include collagen, polyurethane, esters, ethers, composite materials, polyethylene glycol, polyethylene oxide, polysaccharides, silver-based materials, and / or any medical-grade material. In some aspects, the sponge 10 may include biomaterials (e.g., biocompatible and / or biomaterial-derived materials) that may be at least partially or completely bioabsorbable, such as chitosan (e.g., chitosan acetate and / or chitosan lactate), extracellular matrix, or combinations thereof.

[0030] Furthermore, in some aspects, layers 12, 14, and 16 of the sponge 10 can be formed from different materials, different material densities, blends of different materials, etc., to control the degradation rate of layers 12, 14, and 16. For example, layer 12 can be formed from a first material, layer 16 can be formed from a second material, and layer 14 can be formed from a blend of the first and second materials. Alternatively, layers 12, 14, and 16 can be formed from a first material and a second material, wherein the blend or ratio of the first material to the second material is different between each layer.

[0031] Furthermore, the respective thickness of each of layers 12, 14, 16 may vary and / or depend on, for example, the size and / or shape of the sponge 10, the size of the wound, the material of the sponge 10, the desired degradation of the sponge 10, and so on. In one example, the outer layer 12 may completely or at least substantially completely degrade after approximately 12 to 36 hours (a first time period) (e.g., 24 hours) of the placement of the sponge 10; and the middle layer 14 may completely or at least substantially completely degrade after approximately 36 to 60 hours (a second time period longer than the first time period) (e.g., 48 hours) of the placement of the sponge 10. Additionally, in this example, the inner layer 16 may completely or at least substantially completely degrade after approximately 60 to 84 hours (a third time period approximately the second time period) (e.g., 72 hours) of the placement of the sponge 10. In these respects, the sponge 10 may comprise as many layers as intended for wound recovery and / or healing. For example, if a wound is expected to take five days to heal, the sponge 10 may comprise five layers, each of which degrades within approximately one day after the placement of the sponge 10 or after the degradation of the previous outermost layer. In some respects, the innermost layer may not degrade during the expected treatment period and may be removed by the physician. For example, the innermost layer may be biodegradable, but may degrade at the rate at which the innermost layer has not yet degraded when the physician removes the sponge 10.

[0032] Figures 2A to 2D Views of the internal cavities (e.g., esophagus 32) of the subject 30 during various recovery phases of surgery (e.g., bariatric surgery) are shown. Figures 2A to 2D Views of the esophagus 32 and sponge 10 at various stages of surgical recovery are shown, including the formation of trauma in the pit 34. Although Figures 2A to 2D A sponge 10 is shown for treating trauma in a pit 34 of the esophagus 32, but this disclosure is not so limiting. The sponge 10 and the surgery discussed herein can be used to treat trauma, leakage, perforation, etc., in the upper gastrointestinal tract, lower gastrointestinal tract, other lumens or chambers within the subject's body, or external sites of the subject.

[0033] like Figure 2AAs shown, the sponge 10 can be inserted into a wound or recess 34 in the esophagus 32. For example, surgery on the esophagus 32 may create a recess 34, and the sponge 10 can be inserted as part of the recovery process. The endoscope can be, for example, a bronchoscope, colonoscope, hysteroscope, cystoscope, tube, sheath, or any similar insertion device. The sponge 10 can be inserted via an endoscope, for example, through the internal lumen of the endoscope used to perform the surgery. The size and / or shape of the sponge 10 can be configured to fit within and / or correspond to the recess 34. In one aspect, the sponge 10 can be sized, shaped, and may have stiffness, etc., to help maintain the size and / or shape of the recess 34. As mentioned above, the thickness, shape, and / or number of the layers 12, 14, 16 of the sponge 10 can be varied. For example, in one aspect, the outer layer 12 may be generally oval to fit into the recess 34, and the middle layer 14 and the inner layer 16 may also be generally oval, or alternatively, generally circular.

[0034] like Figure 2B As shown, the sponge 10 degrades over time. This degradation can be approximated to correspond to the estimated healing time of the wound that forms a depression 34. For example, as the wound heals and the size of the depression 34 shrinks, one or more layers 12, 14, 16 (e.g., outer layer 12) degrade to reduce the size of the sponge 10. In this respect, the degradation (and shrinkage) of the sponge 10 allows the sponge 10 to shrink as the wound heals and thus the depression 34 shrinks. The size, shape, thickness, material, etc., of the layers 12, 14, 16 of the sponge 10 can be selected to match the shrinkage size and / or shape change of the depression 34. In one aspect, the outer layer 12 in Figure 2B It may have degraded, and the size of the pit 34 may have been reduced and / or its shape may have changed.

[0035] Figure 2C This shows further degradation of the sponge 10 and a reduction in the size of the pits 34 during the recovery period. In this respect, the intermediate layer 14... Figure 2C The sponge 10 may be degradable, and the size of the pit 34 may be further reduced. Furthermore, the sponge 10 may be formed of a material that helps the sponge 10 remain within the pit 34 and / or grip the esophagus 32 as the size of the pit 34 decreases. For example, one or more layers 12, 14, 16 may include a bioadhesive (e.g., chitosan, which has properties that enable it to bind to negatively charged surfaces, such as mucous membranes).

[0036] Figure 2DThe final stage of the healing process is shown. For example, as shown, the pit 34 may have been further reduced, e.g., eliminated. In this respect, the inner layer 16 may have been degraded. Because at least some portions of the sponge 10 are biocompatible and degraded, it is not necessary for a physician to insert an endoscope to adjust, replace, and / or remove the sponge 10. Alternatively, as discussed above, the inner layer 16 may not be completely degraded, and the physician may insert an endoscope and remove the inner layer 16. Furthermore, in one aspect, the physician may insert a smaller sponge; this smaller sponge may help promote healing if the pit 34 has not yet been eliminated or has not yet shrunk sufficiently.

[0037] Figure 3 and Figures 4A to 4D Alternative examples according to this disclosure are shown. Figure 3 and Figures 4A to 4D Elements similar to sponge 10 and subject 30 are shown, with the reference numerals for these elements increased by 100 accordingly.

[0038] like Figure 3 As shown, sponge 110 includes multiple layers, such as an outer layer 112, a middle layer 114, and an inner layer 116, which can degrade at different rates as discussed above with respect to layers 12, 14, and 16. In fact, sponge 110 may include any of the features discussed with respect to sponge 10. Sponge 110 may include one or more antimicrobial or antimicrobial layers 118, such as those on the outer layer 112, between the outer layer 112 and the middle layer 114, and / or between the middle layer 114 and the inner layer 116. Furthermore, sponge 110 includes an innermost layer, or core 140, and a suction port 142. Core 140 may be formed of a non-degradable material within the inner layer 116. Alternatively, core 140 may be formed of a degradable material within the inner layer 116, and the degradable material of core 140 may degrade at a lower rate than that of the inner layer 116 (and the other layers of sponge 110). In either case, the inner core 140 may include one or more openings 144 fluidly coupled to the suction port 142, such that when a negative pressure is applied through the suction port 142, fluid can enter the inner core 140 through the openings 144 and be removed from the subject through the suction port 142.

[0039] The suction port 142 may be a lumen formed of a biocompatible material, such as plastic (e.g., polyethylene), metal (e.g., stainless steel), composite material, etc. As shown, the suction port 142 is coupled to the inner core 140. In one aspect, the suction port 142 may extend to the outside of the subject 130, for example, away from an opening (e.g., mouth), such as... Figures 4A to 4CAs shown. Therefore, a suction source can be coupled to suction port 142, and negative pressure can be applied to sponge 110. In another aspect, suction port 142 can extend from sponge 110, but not to the outside of subject 130. In this aspect, a suction tube can be inserted through an orifice (e.g., mouth) and coupled to suction port 142 to apply negative pressure to help remove excess fluid and / or degrading material from sponge 110. Applying negative pressure can help remove excess fluid and / or degrading material from one or more layers of sponge 110. In addition, applying negative pressure can help reduce the size of pit 134 and / or help wound healing.

[0040] In some aspects, a removable and / or releasable connector may be included, for example, proximal to the inner core 140. The connector allows a physician to attach, disconnect, and / or reattach the suction cannula and / or suction port 142 to the inner core 140. Alternatively or additionally, in some aspects, the suction port 142 may include a breakable link or connection 146 located on a portion of the suction port 142. For example, the breakable link or connection 146 may be located on the suction port 142 proximal to a portion of the sponge 110 (e.g., the outer layer 112). In these aspects, the breakable link or connection 146 may maintain the connection between the inner core 140 and the suction port 142 for a period of time, for example, during which negative pressure / suction may be applied to the sponge 110. Then, after another period of time, the breakable link or connection 146 may disconnect at least a portion of the suction port 142 from the inner core 140. The suction port 142 can be removed from the subject, and the inner core 140 (e.g., having one or more layers 112, 114, 116 of sponge 110) can remain in the subject's body. As discussed herein, the inner core 140 and one or more layers 112, 114, 116 of sponge 110 can be biodegradable.

[0041] In any of these aspects, Figures 4A to 4D Views of the internal lumen (e.g., esophagus 132) of the subject 130 during various recovery phases of surgery (e.g., bariatric surgery) are shown. Figures 4A to 4D Views of the esophagus 132 and sponge 110 at various stages of surgical recovery are shown, including the formation of trauma in the pit 134.

[0042] like Figure 4AAs shown, a sponge 110 (having an inner core 140 and a suction port 142) can be inserted into a recess 134 of the esophagus 132. For example, a surgical procedure on the esophagus 132 may create a recess 134, and the sponge 110 may be inserted as part of the recovery process. The sponge 110 can be inserted via an endoscope, for example through the internal lumen of an endoscope used to perform the procedure. The size and / or shape of the sponge 110 may be configured to fit within the recess 134 and / or correspond to the recess 34. Furthermore, negative pressure may be applied via the suction port 142 to help remove fluid and / or degraded portions of the sponge 110 during treatment.

[0043] like Figure 4B As shown, multiple portions of the sponge 110 degrade over time. This degradation can be approximated to correspond to the estimated healing time of a wound that forms a depression 134. For example, as the wound heals and the size of the depression 134 shrinks, one or more layers 112, 114, 116 (e.g., outer layer 112) degrade to reduce the size of the sponge 110. In this respect, the degradation (and shrinkage) of the sponge 110 allows the sponge 110 to shrink as the wound heals and thus the depression 134 shrinks. As discussed above, the size, shape, thickness, material, etc., of the layers 112, 114, 116 of the sponge 110 can be selected to match the shrinkage size and / or shape change of the depression 134. In one aspect, the outer layer 112 in Figure 4B The material may have degraded, and the size of the pit 134 may have been reduced and / or its shape altered. For example, one or more layers 112, 114, 116 may include a bioadhesive (e.g., chitosan, which has properties that enable it to bind to negatively charged surfaces, such as mucous membranes).

[0044] Figure 4C This shows further degradation of the sponge 110 and a reduction in the size of the pits 134 during the recovery process. In this respect, the intermediate layer 114... Figure 4C The material can be degraded, and the size of the pit 134 can be further reduced. In addition, the sponge 110 can be formed of a material (e.g., a bio-adhesive) that helps the sponge 110 stay within the pit 34 and / or grip the esophagus 132.

[0045] Figure 4D The final stage of the healing process is shown. For example, as shown, the pit 134 may have been further reduced, e.g., eliminated. The inner layer 116 may have been degraded. The inner core 140 and the aspiration port 142 may then be removed by a physician, e.g., by retracting the aspiration port 142 proximally or by inserting an endoscope and removing the inner core 140 and the aspiration port 142. In another aspect, in embodiments where the inner core 140 is biodegradable, the inner core 140 may also have been degraded.

[0046] As discussed above, the continuous layers of sponge 110 help close the pit 134 (and thus aid wound healing). Furthermore, applying suction to sponge 110 helps close the pit 134 (and thus aid wound healing). Once the pit 134 is closed (or nearly closed), the doctor can remove the remaining portions of sponge 110, such as the inner core 140 and the suction port 142.

[0047] In these examples, the dimensions of sponges 10,110 may be set (e.g., cut to) approximate and / or correspond to the dimensions and / or shape of pits 34,134. In any of the aspects discussed herein, the sponge may be removed, and a new sponge may be delivered or formed. For example, if a wound takes approximately 30 days to heal completely, then the sponge may be removed, and a new sponge may be delivered approximately five to seven times.

[0048] In another aspect, as discussed below, one or more layers of the sponge 110 may be formed of foam. In this aspect, for example, the inner core 140 and the suction port 142 may be positioned within the recess 134, and the foam may be delivered (e.g., sprayed) around the inner core 140 and the suction port 142. The foam may be pumped onto and / or around a portion of the suction port 142 and the inner core 140 to form a foam sponge. For example, the foam may be pumped and / or delivered to the recess 134 via one or more of the openings 144. In this aspect, the suction tube 142 may include two or more separate lumens coupled to the inner core. For example, although not shown, the suction tube 142 may include a first lumen coupled to a negative pressure / suction source, and the suction tube 142 may also include a second lumen coupled to a foam source to deliver foam to form a foam sponge. The foam may be a custom-sized material, for example, expandable to the size and / or shape of the recess 134. The foam sponge may include chitosan (e.g., chitosan acetate and / or chitosan lactate), silver-based materials, and / or any medical-grade materials, and / or formed therefrom. The foam sponge may include antimicrobial materials and / or formed therefrom (e.g., expandable antimicrobial materials). The foam sponge may be at least partially or completely biodegradable. Alternatively, the foam sponge may be biostable and periodically removable, for example, every few days or weekly. The foam may be an open-cell foam, such that interconnected channels allow fluid or material to flow through the foam when negative pressure is applied by the suction source.

[0049] Figures 5A to 5C Another exemplary medical system 200 is shown, wherein the reference numerals for elements similar to the sponge 10 and the subject 30 are correspondingly increased to 200. Figures 5A to 5C The sponge 210 is shown in various stages of use within the body of subject 230, for example, in the esophagus 232 and in wounds or anastomoses, such as trauma or pits 234. In some aspects, system 200 can be packaged as a kit. Figure 5AAs shown, system 200 includes an insertion device (such as, for example, catheter 250) and a delivery tube 252. Catheter 250 may be a double-lumen catheter having a first lumen 254 and a second lumen 256. Catheter 250 may be delivered to a treatment site, for example, via an orifice (e.g., mouth or nose) and along the esophagus 232 to a recess 234. In this respect, system 200 may include a medical device (e.g., cage 258) and a suction tube 260 that may assist in supporting and / or removing the sponge 210. Note that catheter 250 is shown as transparent to improve the clarity of the figures.

[0050] The cage 258 can be delivered through a first lumen 254 of the conduit 250 and can be movable relative to the conduit 250 (e.g., extending distally beyond the distal end of the conduit 250). The cage 258 may include a plurality of self-expanding arms 262, which are formed, for example, of biocompatible and shape memory metals (e.g., nitinol). The cage 258 can be formed of a material having forces biased toward an expanded morphology. For example, as... Figures 2A to 2B As shown, the cage 258 may include four arms 262. Alternatively, the cage 258 may include two, three, five, or more arms 262. In this respect, as the cage 258 extends from the first lumen 254, the arms 262 extend radially outward to form the cage 258. Once the catheter 250 is positioned at the treatment site (e.g., recess 234), the cage 258 may deploy or extend into the chamber (e.g., recess 234).

[0051] The suction tube 260 can deliver through a second lumen 256 of the catheter 250 and can also be movable relative to the catheter 250 (e.g., extending distally beyond the distal end of the catheter 250). The suction tube 260 can be a plastic tube, such as a nasogastric tube, and can be coupled to a suction source (not shown) such that the distal end 264 of the suction tube 260 can apply suction to the recess 234. When the catheter 250 is in place, the suction tube 260 can be advanced distally into the recess 234, for example, into or adjacent to the cage 258.

[0052] Delivery tube 252 may be a foam dispenser that delivers foam that forms a sponge or other similar porous and / or absorbent body, such as... Figure 5B and Figure 5C As shown. The delivery tube 252 may be coupled to the catheter 250, or may be delivered separately to the recess 234, for example, by advancing along the outside of the catheter 250 (effectively using the catheter 250 as a guidewire). Alternatively, the delivery tube 252 may be advanced through a first lumen 254 or a second lumen 256, or through another lumen of the catheter 250. Figure 5BAs shown, sponge material can be delivered to recess 234 via delivery tube 252 to form sponge 210. The proximal end of delivery tube 252 can be coupled to a source 268 of sponge material, for example, a pressurization source for the sponge material; such that the sponge material can be delivered through delivery tube 252 and, for example, sprayed (atomized) into recess 234. Sponge 210 can be formed in recess 234 to at least partially surround the distal portion of conduit 250 and / or delivery tube 252, as... Figure 5B As shown. Alternatively, the sponge 210 may be formed distal to one or more of the conduit 250 and / or delivery tube 252, such that the sponge 210 surrounds only a portion of the cage 258 and the suction tube 260.

[0053] The sponge material can be a sponge foam, such as a liquid-phase polyurethane (PU) foam, which expands and / or cures upon contact with moisture and / or air to form a sponge 210 within the recess 234. The sponge material can also be an injectable open-cell foam, for example, used to treat intraperitoneal bleeding. In another aspect, the sponge material can be a two-phase polyurethane (PU) foam. For example, the delivery tube 252 may include two lumens, with the proximal end of each lumen connected to different sources of liquid-phase polyurethane (PU) foam. When the two liquids are delivered into the recess 234 through the delivery tube 252, the two liquids can come into contact and cure to form the sponge 210. The sponge 210 can be formed from the contacting and curing two-phase polyurethane (PU) foam. In these aspects, when vacuum pressure / suction is applied to the sponge 210, the nature of the foam forming the sponge material (e.g., open-cell) allows fluid to drain through the struts or openings of the foam (e.g., polyurethane struts). Furthermore, because the sponge 210 is formed from a delivery sponge material, the sponge 210 can expand to form the shape of the pit 234.

[0054] like Figure 5B As shown, when delivering the sponge material, the cage 258 and the suction tube 260 can extend into the recess 234. In this respect, at least a distal portion (e.g., arm 262) of the cage 258 and at least a distal portion (e.g., distal end 264) of the suction tube 260 can be located within the sponge 210. When the sponge material cures to form the sponge 210, portions of both the cage 258 and the suction tube 260 can be secured within and to the sponge 210. Furthermore, in one example, the distal end 264 of the suction tube 260 can be located within the cage 158, such that the arm 262 at least partially surrounds the distal end 264.

[0055] In these respects, delivering the sponge material into the recess 234 allows the sponge material to expand and form the shape of the recess 234, eliminating the need for the physician to guess the size and / or shape of the recess 234 and then deliver a sponge corresponding to that size and / or shape. Furthermore, since the distal end 264 of the suction tube 260 is located within the sponge 210, suction can be applied through the suction tube 260, and fluid and / or degradable material from the sponge 210 can be removed from the recess 234 through the suction tube 260.

[0056] like Figure 5C As shown, once the size of the pit 234 has decreased, for example, as the wound or anastomosis has at least partially healed, the sponge 210 may need to be removed and / or replaced. It is worth noting that, as... Figure 2C As shown, before removing and / or replacing the sponge 210, the suction cannula 260 can be retracted proximally from the sponge 210 into a position within the catheter 250. Furthermore, as... Figure 2C As shown, the delivery tube 252 has been removed from the subject 230 before the removal and / or replacement of the sponge 210. For example, the delivery tube 252 may be removed from the subject 232 after the formation of the sponge 210.

[0057] After the delivery tube 252 is removed from the sponge 210, the cage 258 can retract proximally (e.g., retract through the first lumen 254). Because the arms 262 of the cage 258 are secured within the sponge, proximal movement of the cage 258 also retracts the sponge 210. Proximal movement can cause the arms 262 to collapse at least partially, for example, as the arms 262 enter the first lumen 254. Furthermore, each arm 262 may include a bend or curve 266, for example, in the middle portion of the arm 262. The arms 262 can expand radially outward, and the distal portion of the arms 262 can be bent radially inward. Thus, as the cage 258 retracts proximally, the arms 262 with the curves 266 can hook onto portions of the sponge 210 and also cause the sponge 210 to retract proximally. As described, the sponge 210 can be formed of any suitable material (e.g., shape memory alloy) and is collapsible, allowing the sponge 210 and cage 258 to be removed through the first lumen 254. Note that the first lumen 254 can be appropriately sized to deliver the cage 28 and allow the cage 258 and sponge 210 to retract. Without removing the conduit 250 or otherwise affecting its position, the cage 258, together with the sponge 210, can retract proximally and withdraw away from the conduit 250.

[0058] Because the sponge 210 is removable without affecting the position of the catheter 250, the above steps can be repeated to deliver and / or form a new sponge within the recess 234. For example, the cage 258 can be reinserted through the first lumen 258, and the suction cannula 260 can extend distally into or adjacent to the cage 258. The delivery cannula 252 can then be reinserted, and sponge material can be delivered again into the recess 234 to form a new sponge that can shape the size and / or shape of the recess 234, and the size and / or shape of the recess 234 can be smaller and / or different from its size and shape at the start of the procedure, for example, because the size of the recess 234 has decreased and / or its shape has changed. The above steps can be performed multiple times as needed until the recess 234 has closed, healed, or otherwise no longer requires the sponge 210.

[0059] Figure 6A and Figure 6B Another exemplary medical system 300 is shown, wherein the reference numerals for elements similar to the sponge 10 and the subject 30 are correspondingly increased to 300. Figure 6A and Figure 6B The image shows the sponge 310 within the body of a subject 330 and various stages of use, such as in the esophagus 332 and in wounds or anastomoses, such as pits 334. In some aspects, the system 300 can be packaged as a kit. Figure 6A As shown, system 300 includes a delivery tube 352 and a suction tube 360. In some embodiments, system 300 does not include a separate endoscope or other insertion device. However, the suction tube 360 ​​may help support at least a portion of the sponge 310 and / or remove it.

[0060] The suction cannula 360 can be delivered to a treatment site, for example, to the pit 334 in any manner. In one aspect, the suction cannula 360 may include a rod 370, which is located within the suction cannula 360 during delivery. For example, the suction cannula 360 with the rod 370 can be delivered via an orifice (e.g., the mouth) and along the esophagus 332 to a treatment site, for example, to the pit 334. Alternatively or additionally, the suction cannula 360 with the rod 370 can be delivered to the pit 334 via a guidewire. Furthermore, in one aspect, the suction cannula 360 can be delivered to the pit 334, and then the rod 370 can be inserted into the suction cannula 360.

[0061] The rod 370 may be at least partially rigid and / or may be formed of a shape memory alloy. When located within the suction tube 360, the rod 370 may occupy all or most of the internal lumen of the suction tube 360. For example, when the rod 370 is located within the suction tube 360, the rod 370 may help form a seal (or at least a partial seal) within the suction tube 360.

[0062] Delivery tube 352 may be a foam dispenser that delivers foam that forms a sponge 310 or other similar porous and / or absorbent body, such as Figure 6A As shown. The delivery tube 352 can be coupled to the suction tube 360, or can be delivered separately to the recess 358, for example, by advancing along the outside of the suction tube 360, via a guidewire. Figure 6A As shown, sponge material can be delivered to recess 358 via delivery tube 352 to form sponge 310. As discussed above, the proximal end of delivery tube 352 can be connected to a source 368 of sponge material, for example, a pressurization source for the sponge material; allowing the sponge material to be delivered through delivery tube 352 and, for example, sprayed (atomized) into recess 334. The sponge material can be referenced above. Figures 5A to 5C Any of the materials discussed.

[0063] The sponge material can expand and solidify into a porous and / or absorbent body, such as sponge 310. Sponge 310 can expand to form the shape of a recess 334 and can also surround the distal end 364 of the suction tube 360. The distal end 364 of the suction tube 360 ​​can be at least partially secured within the sponge 310. However, as the delivery tube 352 delivers the sponge material into the recess 334, the rod 370 helps prevent the sponge material from flowing into the suction tube 360, and thus helps prevent the sponge material from forming a blockage in the suction tube 360. Furthermore, the rod 370 can be manipulated, for example, extending distally to and / or away from the distal end 364 of the suction tube 360 ​​to push the sponge material away from and / or away from the distal end 364 of the suction tube 360.

[0064] like Figure 6B As shown, delivery tube 352 and rod 370 are removable. Suction can then be applied to sponge 310 via suction tube 360. Suction can help remove excess fluid from pit 334. Furthermore, as discussed above, sponge 310 can be biodegradable, and suction via suction tube 360 ​​can help remove material that has degraded over time.

[0065] If the sponge 310 needs to be replaced (e.g., the pit 334 has changed size and / or shape, the sponge 310 has degraded, etc.), then the sponge 310 can be at least partially removed, and additional sponge material can be delivered. For example, suction from the suction tube 360 ​​can help remove degraded material from the sponge 310. Alternatively or additionally, a separate tube, catheter, gripper, retrieval device, etc., can be delivered to the pit 334 to remove one or more portions of the sponge 310, as discussed above with respect to the catheter 250 and the cage 258. Furthermore, in another aspect, for example, if the sponge 310 is non-biodegradable or has not yet sufficiently degraded, then the suction tube 360 ​​can be retracted proximally away from the subject 330, thereby also removing the sponge 310 attached to the suction tube 360. In this aspect, the suction tube 360 ​​(or a new suction tube 360) can be delivered to the pit 334 and properly positioned. After the sponge 310 has been removed (and the suction tube 360 ​​has been positioned, if necessary), the delivery tube 352 can deliver to the recess 334 and deliver additional sponge material to form a new sponge 310, as discussed above. Additionally, the rod 370 can deliver through the suction tube 360 ​​to help ensure that the new sponge 310 does not obstruct the distal end 364 of the suction tube 360.

[0066] In one respect, the non-degradable portion of the sponge 310 does not need to be removed. In this respect, the degradable portion of the sponge 310 can be removed via suction through the suction tube 360. Then, the delivery tube 352 can deliver to the recess 334 and deliver additional sponge material. The additional sponge material can replace the degradable portion of the sponge 310. In addition, as described above, the rod 370 can deliver through the suction tube 360 ​​to help ensure that the new sponge material does not block the distal end 364 of the suction tube 360.

[0067] The above steps may be performed multiple times as needed until the pit 334 has closed, healed, or is otherwise no longer required to use the sponge 310. Furthermore, the above steps may be performed without removing the suction tube 360 ​​or otherwise affecting its position. Additional sponge material (by forming a new sponge or by replacing degraded sponge material) may be used to form a continuous sponge 310, which may be, for example, smaller and / or of a different shape, because the size of the pit 334 has been reduced and / or its shape has been altered.

[0068] Figures 7A to 7C Another exemplary medical system 400 is also shown, wherein the reference numerals for elements similar to those in the aforementioned system are correspondingly increased to 400. Figures 7A to 7C A porous bag 480 and therapeutic material 482 are shown for use in various stages within the body of subject 230, for example, in the esophagus (or gastrointestinal tract) and in wounds, anastomoses, or pits, as discussed above. In some aspects, system 400 can be packaged as a kit. Figure 7AAs shown, system 400 also includes a tube 484 connected to and / or supporting the bag 480. The tube 484 and bag 480 can be delivered via an endoscope or catheter 450 (e.g., to a treatment site). For example, the tube 484 can be connected to the catheter 450 via one or more connecting elements 486 (e.g., adhesive, hooks, clamps, etc.). Furthermore, at least a portion of the bag 480 can be located within the lumen 454 of the catheter 450 during delivery and / or positioning of the bag 480. Additionally, a portion of the bag 480 extends externally into the catheter 450. For example, in some aspects, the bag 480 is provided with a distal portion through the tube 484 and no proximal portion through the tube 484.

[0069] like Figure 7B As shown, the bag 480 can be removed from the lumen 454 of the catheter 450 and extends, for example, into a wound, anastomosis, or pit. In one aspect, a grasper 490 can be used to control, manipulate, and / or position the bag 480. Additionally or alternatively, therapeutic material 482 can be delivered into the bag 480 (e.g., via source 468) to extend, expand, or otherwise position the bag 480. For example, therapeutic material 482 can be delivered into the bag 480 via tube 484. The therapeutic material 482 can help extend the bag 480 (e.g., remove a portion of the bag 480 from the lumen 454), and the bag 480 can expand (from a collapsed or compressed form to an expanded form) to form the size and / or shape of the wound, anastomosis, or pit.

[0070] The bag 480 may be formed of a porous material, and the pores of the bag 480 may be large enough to be porous for fluids that may be secreted from the wound, anastomosis, or pit (e.g., blood, pus, saline, etc.) or delivered to the wound or treatment site. Similarly, the pores of the bag 480 may be small enough to retain the treatment material 482 within the bag 480 (i.e., the particle diameter of the treatment material 482 is larger than the pore diameter of the bag 480). The bag 480 may compress the treatment material 482 and may provide a semi-rigid surface (e.g., allowing tissue to be adjacent to the wound, as discussed above) while also allowing a vacuum to be applied through the tube 484 and for fluid and / or treatment material 482 to be removed from the bag 480. In one aspect, the bag 480 may be formed of a fine mesh, nylon, or other suitable material.

[0071] Therapeutic material 482 may be a sponge-like material and / or a material similar to the sponge discussed herein. For example, therapeutic material 482 may include one or more of salts, sugars, antimicrobial materials, etc. Therapeutic material 482 may include any suitable biocompatible material that can absorb liquids and / or allow liquids to pass through via negative pressure / suction. Therapeutic material 482 may be flexible, compressible, porous, hydrophilic, sterile, and / or disposable. Therapeutic material 482 may be an open-cell foam (or formed therefrom). Suitable materials include collagen, polyurethane, esters, ethers, composites, polyethylene glycol, polyethylene oxide, polysaccharides, silver-based materials, and / or any medical-grade material. In some aspects, therapeutic material 482 may include biomaterials (e.g., biocompatible and / or biomaterial-derived materials) that may be at least partially or completely bioabsorbable, such as chitosan (e.g., chitosan acetate and / or chitosan lactate), extracellular matrix, or combinations thereof.

[0072] like Figure 7C As shown, the bag 480 and tube 484 can be disconnected from the catheter 450. For example, the catheter 450 can be removed from the subject, and the bag 480 and tube 484 can remain inside the subject. For example, the bag 480 can be located within a wound, anastomosis, or pit. Therapeutic material 482 can be delivered to the bag 480, for example, through the tube 484. Therapeutic material 482 can expand the bag 480 to a size and / or shape corresponding, for example, to a wound, anastomosis, or pit. The bag 480 and therapeutic material 482 can help absorb fluids, as discussed above relative to a sponge, which can aid in the healing of the wound, anastomosis, or pit.

[0073] In some aspects, negative pressure / suction can be applied to the bag 480 and treatment material 482 via tube 484 (e.g., via vacuum 492 coupled to tube 484) to remove fluid from the wound, anastomosis, or pit. Furthermore, as the wound, anastomosis, or pit heals and / or shrinks, suction can be applied to the bag 480 and treatment material 482 via tube 484 to reduce the size of the bag 480 and / or change its shape, for example, by removing fluid and / or treatment material 482 from the bag 480. In this aspect, the bag 480 may change size and / or shape as the wound, anastomosis, or pit heals or otherwise changes size and / or shape. Additionally or alternatively, additional treatment material 482 can be delivered to the bag 480 via tube 484 (e.g., from source 468) to change the size and / or shape of the bag 480. Furthermore, in some aspects, suction can be applied to the bag 480 (e.g., via vacuum 492) to remove all or most of the treatment material 482. In these respects, additional therapeutic material 482 can be delivered via tube 484 to bag 480 (e.g., from source 468) to refill bag 480, which can be sized and / or shaped to fit the wound, anastomosis, or pit. These steps can be repeated multiple times as needed to aid in the healing and / or shrinkage of the wound, anastomosis, or pit. Furthermore, bag 480 can be emptied and refilled without removing and / or repositioning bag 480 or tube 484.

[0074] like Figure 7C As shown, tube 484 may include a regulating device 488, for example, at a proximal portion of tube 484. In some aspects, the regulating device 488 may be a filter. For example, after treatment material 482 has been delivered to bag 480, the filter may be selectively located within a portion of tube 484. In this aspect, the filter may assist in negative pressure / suction (e.g., from vacuum 492) to remove fluid from bag 480 or tube 484 without removing treatment material 482 from bag 480 or tube 484. The filter may be removable and / or selectively located in a non-filtering configuration, for example, when treatment material 482 is re-delivered through tube 484 and bag 480. In another aspect, the regulating device 488 may be a valve. The valve may be located within or around a portion of tube 484. The valve may allow treatment material 482 to be delivered through the valve and into tube 484 and bag 480. The valve may also help retain treatment material 482 within tube 484 and bag 480. For example, in some aspects, due to the application of a first level pressure (e.g., positive or negative pressure / suction), the valve allows fluid to pass through the valve but not the treatment material 482. Furthermore, in some aspects, due to the application of a second level pressure greater than the first level pressure (e.g., positive or negative pressure / suction), the valve allows both fluid and the treatment material 482 to pass through the valve.

[0075] In one aspect, tube 484 can be used to control and / or manipulate the position and / or orientation of bag 480. For example, tube 484 can be used to control (e.g., position, rotate, twist, etc.) bag 480, deliver material and / or fluid to bag 480, and / or apply suction to remove material and / or fluid from bag 480. Furthermore, in some aspects, fluid can be delivered distally into bag 480 (e.g., via tube 484), which can help to disconnect bag 480 from wounds, anastomoses, or pits where they may engage. In some aspects, the delivered fluid can be at least partially pressurized. Additionally or alternatively, tube 484 can be twisted to disengage bag 480 from wounds, anastomoses, or pits.

[0076] These steps can be repeated multiple times as needed to aid in the healing and / or shrinkage of wounds, anastomoses, or pits. Furthermore, bag 480 can be emptied and refilled without removing and / or repositioning bag 480 or tube 484.

[0077] The aspects discussed herein can help improve the treatment and / or recovery outcomes of surgeries (e.g., bariatric surgery). These aspects can help reduce or minimize recovery time, reduce and / or minimize patient discomfort, reduce and / or minimize physician intervention, reduce and / or minimize the need for and reliance on and / or minimize the use of imaging or visualization for positioning the sponge, and so on. For example, the aspects discussed herein allow for the delivery of porous and / or absorbent propellants (e.g., sponges) or therapeutic materials to the treatment site, allow for the removal of sponges or therapeutic materials (degradation, physical removal, or combinations thereof) for removal, and allow for the delivery of another sponge or additional therapeutic material to the treatment site without the need for re-delivery or repositioning of various insertion devices. Furthermore, the aspects discussed herein can be packaged into kits for use in treating subjects.

[0078] In some respects, the sponges discussed herein can be biocompatible and biodegradable. Furthermore, different layers or portions of the sponge can degrade at different rates. For example, different layers or portions of the sponge can be formed from different thicknesses, different materials, different densities, blends of different materials, etc. Thus, the sponge can change its size and / or shape over time, and these changes in size and / or shape can correspond to changes in the size and / or shape of wounds, anastomoses, pits, etc. Therefore, there may be a reduced need for physicians to remove and / or replace the sponge. In addition, the sponge may include one or more antimicrobial layers and / or materials, which can help reduce the risk of infection and / or help promote healing and size reduction of wounds, anastomoses, pits, etc.

[0079] Furthermore, the sponge (e.g., formed from sprayed foam) or therapeutic material (in bag 480) can be shaped to fit the wound, anastomosis, or pit. In this respect, there can be a reduction and / or minimization of the need for and / or reliance on imaging or visualization used to size and position the sponge, etc. For example, the physician may not need to cut the sponge or otherwise shape it to fit the wound, anastomosis, or pit. All therapeutic material does not need to be delivered or removed in a single session through the subject's orifice. Furthermore, in some aspects of this disclosure, the sponge or therapeutic material can fit the wound, anastomosis, or pit even as the size and / or shape of the wound, anastomosis, or pit changes during the healing process.

[0080] While the aspects of the medical systems discussed above are for treating sites in the esophagus, stomach, duodenum, large intestine (colon), or small intestine, these aspects and methods can be used to treat any part of the subject and can help reduce overall recovery time, component costs, and risks to the subject, among other things.

[0081] While the principles of this disclosure are described herein with reference to illustrative aspects of various applications, it should be understood that this disclosure is not limited thereto. Those skilled in the art and those familiar with the teachings provided herein will recognize that additional modifications, applications, aspects, and equivalent substitutions fall within the scope of the aspects described herein. Therefore, this disclosure should not be construed as being limited by the foregoing detailed embodiments.

Claims

1. A medical system comprising: A source of material, wherein the material is configured to expand and form a porous body after the material is deployed in a body cavity; A first tube, configured to deliver the material into the body cavity; A second tube, configured to apply suction to the porous body; and A removal device comprising a plurality of arms configured to remove the porous body from the body cavity, wherein the removal device is configured to be deployed in the body cavity before the material is deployed in the body cavity, and wherein each of the plurality of arms of the removal device is wholly located within the porous body.

2. The medical system of claim 1, wherein the first tube is coupled to the source of the material and configured to spray the material into the body cavity.

3. The medical system of claim 2, wherein the material comprises liquid polyurethane foam that expands and / or solidifies upon contact with moisture or air.

4. The medical system according to any one of the preceding claims, wherein the material comprises open-cell foam.

5. The medical system of claim 1, wherein the first tube comprises at least two lumens, and wherein the material comprises two liquids delivered through different lumens of the two lumens through the first tube, wherein the two liquids solidify and form the porous body when they come into contact with each other.

6. The medical system of claim 1, wherein the material expands to form the shape of a recess, and the material is delivered into the recess.

7. The medical system of claim 1, wherein the porous body is at least partially biodegradable.

8. The medical system of claim 1, wherein the plurality of arms are expandable to form a cage, and wherein each of the plurality of arms is self-expandable and is formed of a shape memory alloy.

9. The medical system of claim 1, wherein at least one of the plurality of arms includes a bend such that the at least one arm expands radially outward and the distal portion of the at least one arm bends radially inward.

10. The medical system of claim 8, further comprising an insertion device, wherein the cage is movable within the lumen of the insertion device, and wherein proximal movement of the cage within the lumen of the insertion device causes the cage to at least partially collapse.

11. The medical system of claim 10, wherein the porous body can be removed from the body cavity via the cage and the insertion device.

12. The medical system of claim 1, further comprising a catheter, wherein the removal device and the second tube are movable within the respective lumen of the catheter.

13. The medical system of claim 8, wherein the removal device and the second tube are positionable such that the porous body surrounds at least the distal portion of the cage and the second tube.

14. The medical system of claim 1 further includes a rod, the rod being movable within the second tube.

15. The medical system of claim 14, wherein the rod forms a seal to prevent the material from entering the distal end of the second tube.

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