Medical systems, devices and related methods

Abstract

The medical system includes a source of material, a first tube, and a second tube, the material configured to expand to form a porous body after deployment within a body lumen, the first tube configured to deliver the material within the body lumen, and the second tube configured to apply suction to the porous body.

Description

[Technical Field]

[0001] The present invention relates to medical systems, devices and related methods used to treat patients, and more particularly to medical systems, devices and methods for endoscopic medical procedures such as wound closure and tissue treatment. [Background technology]

[0002] Endoscopic open gastrointestinal (GI) tract procedures include colectomy, bariatric surgery, esophagectomy, gastric bypass, and sleeve gastrectomy. These procedures can result in perforation of the GI tract, postoperative leaks, or other wounds. Limited treatment options exist to address such wounds, with significant mortality and failure rates. Options include surgical revision and endoscopic placement of stents or clips. Surgery is relatively invasive and has a high mortality and failure rate. Endoscopic placement of stents is a less invasive option. However, placed stents can migrate from their intended location or surround infection at the treatment site, interfering with drainage.

[0003] The systems, devices, and methods of the present invention remedy some of the above-mentioned shortcomings or address other aspects of the art. Summary of the Invention

[0004] Examples of the present invention relate to systems, devices, and methods for performing one or more medical procedures using medical systems and devices. Each example disclosed herein may include one or more of the features described in association with any of the other disclosed examples.

[0005] In one example, a medical system includes a source of material, a first tube, and a second tube. The material is configured to expand to form a porous body after being deployed within a body lumen. The first tube is configured to deliver the material within the body lumen, and the second tube is configured to apply suction to the porous body.

[0006] The medical system may include one or more of the following features: The first tube is connected to a source of material and configured to spray the material into a body lumen. The material may include a liquid-phase polyurethane foam that expands or solidifies upon contact with moisture or air. The material may include an open-cell foam. The first tube includes at least two lumens, and the material may include two liquids delivered through different ones of the first tubes, the two liquids solidifying upon contact with each other to form a porous body. The material may expand to take the shape of the pocket into which it is delivered. The porous body may be at least partially biodegradable.

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

[0008] The medical system may further include a rod movable within the second tube, the rod forming a seal to prevent material from entering the distal end of the second tube. In another example, the medical device may include a porous body including multiple layers having biodegradable materials, where an outermost layer of the multiple layers may be configured to degrade faster in body tissue than an inner layer of the multiple layers, and 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.

[0009] The medical device may include one or more of the following features: The outermost layer may be configured to degrade 12 to 36 hours after the porous body is inserted into bodily tissue, and the inner layer may be configured to degrade 36 to 60 hours after the porous body is inserted into bodily tissue. The medical device may further include an inner core having an opening and a suction port connected to the inner core. The inner core and the suction port may be configured to apply a negative pressure to the porous body.

[0010] In yet another example, a medical system may include a porous bag, a therapeutic material, and a tube coupled to the porous bag. The therapeutic material may be configured to be delivered to and retained within the porous bag. Delivery of the therapeutic material to the porous bag may be configured to expand the bag from a compressed configuration to an expanded configuration. The tube may be configured to deliver the therapeutic material to the porous bag and to apply a negative pressure to the porous bag.

[0011] The medical system may include one or more of the following features: The medical system may further include a catheter having a lumen; At least a portion of the porous bag may be configured to be disposed with the lumen during delivery of the porous bag to the treatment site; The treatment material may be granular or porous and may assist in forming a semi-rigid surface that contracts when negative pressure is applied; The medical system may assist in allowing the porous bag to change size and / or shape at the treatment site.

[0012] In another example, a medical system may include a delivery tube and a medical device. The delivery tube may be configured to deliver a material that expands within a body lumen to form a sponge. The medical device may be configured to support or remove at least a portion of the sponge.

[0013] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention, as claimed. The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate exemplary embodiments of the invention and, together with the detailed description, serve to explain the principles of the invention. [Brief explanation of the drawings]

[0014] [Figure 1] 1 is a cross-sectional view illustrating an exemplary medical device, in accordance with aspects of the present invention. [Figure 2A] 2A-2C illustrate the medical device of FIG. 1 at various stages of use within a patient's body, according to an embodiment of the present disclosure. [Figure 2B] 2A-2C illustrate the medical device of FIG. 1 at various stages of use within a patient's body, according to an embodiment of the present invention. [Figure 2C] 2A-2C illustrate the medical device of FIG. 1 at various stages of use within a patient's body, according to an embodiment of the present invention. [Figure 2D] 2A-2C illustrate the medical device of FIG. 1 at various stages of use within a patient's body, according to an embodiment of the present invention. [Figure 3] 1 is a cross-sectional view of an alternative exemplary medical device, in accordance with an aspect of the present invention. [Figure 4A] 4A-4D illustrate the medical device of FIG. 3 at various stages of use within a patient's body, according to an embodiment of the present invention. [Figure 4B] 4A-4D illustrate the medical device of FIG. 3 at various stages of use within a patient's body, according to an embodiment of the present invention. [Figure 4C] 4A-4D illustrate the medical device of FIG. 3 at various stages of use within a patient's body, according to an embodiment of the present invention. [Figure 4D] 4A-4D illustrate the medical device of FIG. 3 at various stages of use within a patient's body, according to an embodiment of the present invention. [Figure 5A] 1A-1D illustrate an exemplary medical system at various stages of use within a patient's body, in accordance with aspects of the present invention. [Figure 5B] 1A-1D illustrate an exemplary medical system at various stages of use within a patient's body, in accordance with aspects of the present invention. [Figure 5C] 1A-1D illustrate an exemplary medical system at various stages of use within a patient's body, in accordance with aspects of the present invention. [Figure 6A] 1A-1C illustrate another exemplary medical system at various stages of use within a patient's body, in accordance with aspects of the present invention. [Figure 6B] 1A-1C illustrate another exemplary medical system at various stages of use within a patient's body, in accordance with aspects of the present invention. [Figure 7A] 10A-10C illustrate yet another exemplary medical system in various stages of use, in accordance with aspects of the present invention. [Figure 7B] 10A-10C illustrate yet another exemplary medical system in various stages of use, in accordance with aspects of the present invention. [Figure 7C] 10A-10C illustrate yet another exemplary medical system in various stages of use, in accordance with aspects of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0015] The terms "proximal" and "distal" are used herein to refer to the relative locations of components of exemplary medical systems and exemplary medical devices. As used herein, "proximal" refers to a location relatively closer to the exterior of the body or closer to the medical professional using the medical system or device. In contrast, "distal" refers to a location relatively further away from the 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 a non-exclusive inclusion, such that a system, device, or method that includes a list of elements does not include only those elements, but may also include other elements not expressly listed or inherent thereto. Unless otherwise noted, the term "exemplary" is used in the sense of "example" rather than "ideal." As used herein, the terms "about," "substantially," and "approximately" indicate a range of values ​​within ±10% of the stated value.

[0016] Embodiments of the present invention include devices, systems, and methods for endoluminal vacuum therapy (EVAC). In examples, endoluminal vacuum therapy involves intraluminal placement of a porous body, such as a sponge or other similar material, at a wound site, including a perforation, cyst, leak, anastomosis, etc. Placement of the material may be via a catheter, scope (endoscope, bronchoscope, colonoscope, etc.), tube, or sheath inserted into the GI tract via a natural orifice. The orifice may be, for example, the nose, mouth, or anus, and placement may occur in any portion of the GI tract, including the esophagus, stomach, duodenum, large intestine, or small intestine. Placement may also occur in other organs accessible via the GI tract.

[0017] Intraluminal vacuum therapy has been proposed. In intraluminal vacuum therapy, negative pressure is delivered to a wound site in the GI tract, for example, through a nasogastric tube with a sponge at its distal end. The sponge is placed endoscopically into the perforation, leak, or other wound. Negative pressure is then applied. However, devices and systems suitable for intraluminal vacuum therapy are limited.

[0018] Reference will now be made in detail to the examples of the invention described above and illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts.

[0019] FIG. 1 is a cross-sectional view of an exemplary medical device, e.g., a porous absorbent body or sponge 10, that may be used to aid in wound or anastomotic healing or tissue treatment within a patient. Sponge 10 includes multiple layers, e.g., an outer layer 12, a middle layer 14, and an inner layer 16. As described below, one or more of layers 12, 14, and 16 may be biocompatible and / or have varying degrees of degradation (i.e., the various layers may degrade at different rates). For example, as shown in FIGS. 2A-2D , outer layer 12 may degrade faster within a patient 30 than middle layer 14, which may degrade faster within a patient 30 than inner layer 16. In one embodiment, inner layer 16 may not degrade (i.e., may be biostable) and may be removed by a physician. Furthermore, although three layers 12, 14, and 16 are shown in FIG. 1 , the present invention is not so limited. The sponge 10 may include any number of layers, and the thickness of the layers may vary based on the desired size and / or shape of the sponge 10, the desired overall degradation time of the sponge 10, the desired degradation time of each layer, etc.

[0020] Additionally, sponge 10 may include one or more bacteriostatic or antibacterial layers 18, for example, on outer layer 12, between outer layer 12 and middle layer 14, and / or between middle layer 14 and inner layer 16. One or more antibacterial layers 18 help limit or reduce bacterial growth during wound healing. Alternatively or additionally, one or more layers of sponge 10 may include a bacteriostatic or antibacterial material (e.g., a gel) that is delivered to the wound; for example, the bacteriostatic or antibacterial material may be secreted or exuded from one or more layers of sponge 10. For example, the bacteriostatic or antibacterial material may be embedded across one or more layers or located within a bolus, for example, within one or more layers.

[0021] Furthermore, in embodiments of the present invention, sponge 10 may be formed from any suitable biocompatible material that can absorb liquid from or allow liquid to pass through it by applying suction / negative pressure to sponge 10. The material may be flexible, compressible, porous, hydrophilic, sterile, and / or disposable. The sponge material may be (or be formed by) an open-cell foam. Suitable materials include collagen, polyurethane, ester, ether, composite material, polyethylene glycol, polyethylene oxide, polysaccharide, silver-based material, and / or any medical-grade material. In some aspects, sponge 10 may include a biomaterial (e.g., a biocompatible and biologically derived material, or a biocompatible or biologically derived material), which may be at least partially or completely bioabsorbable, such as chitosan (e.g., chitosan acetate and / or chitosan lactate), extracellular matrix, or a combination thereof.

[0022] Additionally, in some embodiments, layers 12, 14, 16 of sponge 10 may be formed of different materials, different material densities, different blends of materials, etc., to control the rate of degradation of layers 12, 14, 16. For example, layer 12 may be formed of a first material, layer 16 may be formed of a second material, and layer 14 may be formed of a blend of the first and second materials. Alternatively, layers 12, 14, 16 may be formed of a first material and a second material, where the blend or ratio of the first material to the second material varies between each layer.

[0023] Additionally, the respective thicknesses of each of layers 12, 14, 16 may vary and may depend on the size and / or shape of sponge 10, the size of the wound, the material of sponge 10, the desired degradation of sponge 10, etc. In one example, outer layer 12 may completely or at least nearly completely degrade after approximately 12 to 36 hours (a first period), e.g., 24 hours, following placement of sponge 10, and middle layer 14 may completely or at least nearly completely degrade after approximately 36 to 60 hours (a second period longer than the first period), e.g., 48 hours, following placement of sponge 10. Further, in this example, inner layer 16 may completely or at least completely degrade after approximately 60 to 84 hours (a third period longer than the second period), e.g., 72 hours, following placement of sponge 10. In these embodiments, sponge 10 may include as many layers as are anticipated for wound recovery and / or healing. For example, if a wound is expected to take five days to heal, sponge 10 may include five layers, each of which degrades over approximately one day after placement of sponge 10 or after degradation of the preceding outermost layer. In some embodiments, 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 a rate such that the innermost layer has not yet degraded by the time the physician removes sponge 10.

[0024] 2A-2D are diagrams illustrating a body lumen, e.g., esophagus 32, of a patient 30 at various stages of recovery from a procedure (e.g., bariatric surgery). For example, FIGS. 2A-2D show views of esophagus 32 with sponge 10 at various stages of recovery from a procedure that includes the formation of a wound in pocket 34. While FIGS. 2A-2D show sponge 10 being used to treat a wound in pocket 34 in esophagus 32, the invention is not so limited. Sponge 10 may also be used to treat wounds, leaks, perforations, etc. in the patient's upper gastrointestinal tract, the patient's lower gastrointestinal tract, other lumens or cavities within the patient's body, on the surface of the patient's body, etc.

[0025] As shown in FIG. 2A , the sponge 10 is inserted into a wound or pocket 34 within the esophagus 32. For example, a procedure on the esophagus 32 may create the pocket 34, and the sponge 10 is inserted as part of the healing process. The endoscope may be, for example, a bronchoscope, colonoscope, hysteroscope, cystoscope, tube, sheath, or any similar insertion device. The sponge 10 may be inserted via the endoscope, for example, through the inner lumen of the endoscope used to perform the procedure. The sponge 10 may be sized and / or shaped to fit within or correspond to the pocket 34. In one embodiment, the sponge 10 may be sized, shaped, and / or rigidified to maintain the size and / or shape of the pocket 34, for example. As noted above, the thickness, shape, and / or number of the layers 12, 14, and 16 of the sponge 10 may vary. For example, in one embodiment, the outer layer 12 is generally oval-shaped to fit within the pocket 34, and the middle and inner layers 14 and 16 may also be generally oval-shaped or, alternatively, generally circular.

[0026] As shown in FIG. 2B , sponge 10 degrades over time. The degradation may be approximated to correspond to the estimated healing time of the wound forming pocket 34. For example, as the wound heals and pocket 34 shrinks in size, one or more layers 12, 14, 16 (e.g., outer layer 12) degrade, reducing the size of sponge 10. In this embodiment, the degradation (and shrinkage) of sponge 10 allows sponge 10 to shrink as the wound heals, thereby shrinking pocket 34. The size, shape, thickness, material, etc. of layers 12, 14, 16 of sponge 10 may be selected to match the shrinking size and / or shape change of pocket 34. In one embodiment, outer layer 12 may be degraded in FIG. 2B , and pocket 34 may have decreased in size or changed shape.

[0027] 2C illustrates further degradation of sponge 10 during healing and a reduction in the size of pocket 34. In this embodiment, middle layer 14 may have degraded in FIG. 2C, and pocket 34 may have further reduced in size. Additionally, sponge 10 may be formed of a material that aids in retention of sponge 10 within pocket 34 or in the sponge's grip on esophagus 32 as pocket 34 reduces in size. For example, one or more layers 12, 14, 16 may include a bioadhesive material (e.g., chitosan, which has properties that allow it to bond to negatively charged surfaces, such as mucosa).

[0028] 2D illustrates the final stage of the healing process. For example, as shown, the pocket 34 may further shrink, e.g., disappear. In this embodiment, the inner layer 16 may have degraded. At least some portions of the sponge 10 may be biocompatible and degrade so that a physician does not need to insert an endoscope to adjust, replace, or remove the sponge 10. Alternatively, as discussed above, the inner layer 16 may not be completely degradable, and the physician may insert an endoscope to remove the inner layer 16. Additionally, in one embodiment, the physician may insert a smaller sponge, which helps promote healing if the pocket 34 has not yet disappeared or shrunk sufficiently.

[0029] Figures 3 and 4A-4D show an alternative embodiment according to the present invention, in which elements similar to sponge 10 and patient 30 are designated by reference numerals increased by 100.

[0030] 3, sponge 110 includes multiple layers, e.g., outer layer 112, middle layer 114, and inner layer 116, which may degrade at different rates as described above with respect to layers 12, 14, and 16. Indeed, sponge 110 may include any of the features described with respect to sponge 10. Sponge 110 may include one or more bacteriostatic or antibacterial layers 118, for example, on outer layer 112, between outer layer 112 and middle layer 114, and / or between middle layer 114 and inner layer 116. Additionally, sponge 110 includes an innermost layer, i.e., inner core 140, and suction port 142. Inner core 140 may be formed of a non-degradable material within inner layer 116. Alternatively, inner core 140 may be formed of a degradable material in inner layer 116, which degrades at a slower rate than inner layer 116 (and other layers of sponge 110). In either embodiment, inner core 140 may include one or more openings 144 in communication with suction port 142 such that fluid can enter inner core 140 through opening 144 and be removed from the patient's body through suction port 142 when negative pressure is applied through suction port 142.

[0031] The suction port 142 may be a lumen formed from a biocompatible material, such as a plastic (e.g., polyethylene), a metal (e.g., stainless steel), a composite material, or the like. As shown, the suction port 142 is coupled to the inner core 140. In one embodiment, the suction port 142 may extend outside the patient's 130, for example, through an opening (e.g., the mouth) as shown in FIGS. 4A-4C. Thus, a suction source may be coupled to the suction port 142 to apply negative pressure to the sponge 110. In another embodiment, the suction port 142 may extend from the sponge 110 but not outside the patient's 130. In this embodiment, a suction tube is inserted into an opening (e.g., the mouth) and coupled to the suction port 142 to apply negative pressure to facilitate the removal of excess fluid and / or degraded material from the sponge 110. The application of negative pressure assists in the removal of excess fluid and / or degraded material from one or more layers of the sponge 110. Additionally, applying negative pressure may assist in reducing the size of the pocket 134 and aid in wound healing.

[0032] In some embodiments, the sponge 110 may include a removable and / or detachable connector, for example, proximal to the inner core 140. The connector allows a physician to attach, detach, and reattach the suction tube and / or suction port 142 to the inner core 140. Alternatively or additionally, in some embodiments, the suction port 142 may include a frangible link or connection 146 disposed on a portion of the suction port 142. For example, the frangible link or connection 146 may be disposed on the suction port 142 adjacent a portion of the sponge 110, such as the outer layer 112. In these embodiments, the frangible link or connection 146 maintains a connection between the inner core 140 and the suction port 142 for a period of time, for example, the time that negative pressure / suction is applied to the sponge 110. Then, after another period of time, the frangible link or connection 146 may detach at least a portion of the suction port 142 from the inner core 140. The suction port 142 may be removed from the patient's body, and the inner core 140 may be left in place within the patient's body, for example, along with one or more layers 112, 114, 116 of the sponge 110. As described herein, the inner core 140 and one or more layers 112, 114, 116 of the sponge 110 may be degradable.

[0033] In any of these embodiments, Figures 4A-4D illustrate an internal body lumen, such as esophagus 132, of patient 30 during various stages of recovery from a procedure (e.g., bariatric surgery). For example, Figures 4A-4D illustrate esophagus 132 with sponge 110 during various stages of recovery from a procedure that includes the formation of a wound within pocket 134.

[0034] As shown in FIG. 4A , the sponge 110, along with the inner core 140 and suction port 142, is inserted into the pocket 134 of the esophagus 132. For example, a procedure on the esophagus 132 creates the pocket 134, and the sponge 110 is inserted as part of the healing process. The sponge 110 may be inserted via an endoscope, for example, through the inner lumen of the endoscope used to perform the procedure. The sponge 110 may be sized and / or shaped to fit within or correspond to the pocket 134. Additionally, negative pressure may be applied via the suction port 142 to remove fluids and / or degraded portions of the sponge 110 during treatment.

[0035] As shown in FIG. 4B , portions of sponge 110 degrade over time. The degradation may be approximated to correspond to an estimated healing time for the wound forming pocket 134. For example, as the wound heals and pocket 134 shrinks in size, one or more layers 112, 114, 116 (e.g., outer layer 112) degrade, reducing the size of sponge 110. In this embodiment, the degradation (and contraction) of sponge 110 allows sponge 110 to contract as the wound heals, thereby allowing pocket 134 to contract. As discussed above, the size, shape, thickness, material, etc. of layers 112, 114, 116 of sponge 110 may be selected to match the contracting size and / or shape change of pocket 134. In one embodiment, outer layer 112 may be degraded in FIG. 4B , and pocket 134 may have reduced in size or changed in shape. For example, one or more of the layers 112, 114, 116 may include a bioadhesive material (eg, chitosan, which has properties that allow it to bind to negatively charged surfaces such as mucous membranes).

[0036] Figure 4C illustrates further degradation of sponge 110 and a reduction in size of pocket 134 during healing. In this embodiment, middle layer 114 may have degraded in Figure 4C, and pocket 134 may have further reduced in size. Additionally, sponge 110 may be formed from a material (e.g., a bioadhesive material) that aids in retention of sponge 110 within pocket 134 and in the sponge's grip on esophagus 132.

[0037] 4D shows the final stage of the healing process. For example, as shown, pocket 134 may have further shrunk, e.g., disappeared. Inner layer 116 may have degraded. Inner core 140 and suction port 142 may then be removed by the physician, e.g., by suction port 142 being retracted proximally or by inserting an endoscope to remove inner core 140 and suction port 142. Alternatively, in embodiments in which inner core 140 is biodegradable, inner core 140 may also have degraded.

[0038] As explained above, the continuous layer of sponge 110 may aid in closing pocket 134 (and thus aid in wound healing). Additionally, applying suction to sponge 110 may also aid in closing pocket 134 (and thus aid in wound healing). Once pocket 134 is closed (or nearly closed), the physician may remove the remaining portions of sponge 110, such as inner core 140 and suction port 142.

[0039] In these examples, the sponge 10, 110 is sized (e.g., cut) to approximate and / or correspond to the size and / or shape of the pocket 34, 134. In any of the embodiments described herein, the sponge may be removed and a new sponge delivered or created. For example, if a wound takes approximately 30 days to fully heal, the sponge may be removed and a new sponge delivered approximately 5-7 times.

[0040] In another embodiment, as described below, one or more layers of sponge 110 may be formed of foam. In this embodiment, inner core 140 and suction port 142 are disposed within pocket 134, and foam may be delivered (e.g., sprayed) around inner core 140 and suction port 142. The foam may be dispensed over and / or around portions of inner core 140 and suction port 142 to form a foam sponge. For example, foam may be dispensed or delivered to pocket 134 through one or more of openings 144. In this embodiment, suction tube 142 may include two or more separate lumens coupled to the inner core. For example, although not shown, suction tube 142 may include a first lumen connectable to a negative pressure / suction source, and suction tube 142 may also include a second lumen connectable to a source of foam for delivering foam to form the foam sponge. The foam may be a self-sizing material, e.g., it expands to the size and / or shape of the pocket 134. The foam sponge may be formed of or include chitosan (e.g., chitosan acetate and / or chitosan lactate), a silver-based material, and / or any medical-grade material. The foam sponge may be formed of an antimicrobial material (e.g., a swellable antimicrobial material). The foam sponge may be at least partially or completely degradable. Alternatively, the foam sponge may be biostable and removed periodically, e.g., every few days or weeks. The foam may be an open-cell foam, allowing fluids or materials to flow through the foam by interconnecting channels when negative pressure is applied by a suction source.

[0041] 5A-5C illustrate another exemplary medical system 200, in which similar elements to sponge 10 and patient 30 are designated with the addition of the reference numeral 200. FIGS. 5A-5C illustrate sponge 210 in various stages of use within a patient 230, e.g., within esophagus 232, and within a wound or anastomosis, e.g., wound or pocket 234. In some embodiments, system 200 may be packaged as a kit. As shown in FIG. 5A, system 200 includes an insertion device, e.g., catheter 250 and delivery tube 252. Catheter 250 may be a dual-lumen catheter having first and second lumens 254 and 256. Catheter 250 may be delivered through an orifice (e.g., the mouth or nose) down esophagus 232 to a treatment site, e.g., pocket 234. In this embodiment, system 200 may include medical devices, e.g., cage 258 and suction tube 260, to assist in supporting and removing sponge 210. Note that catheter 250 is shown as transparent for clarity of illustration.

[0042] The cage 258 is delivered through the first lumen 254 of the catheter 250 and may be movable relative to the catheter 250 (e.g., extendable distally beyond the distal end of the catheter 250). The cage 258 may include a plurality of self-expanding arms 262, for example, formed of a biocompatible shape-memory metal (e.g., nitinol). The cage 258 may be formed of a material having a bias toward the expanded configuration. For example, as shown in FIGS. 2A and 2B , the cage 258 may include four arms 262. Alternatively, the cage 258 may include two, three, five, or more arms 262. In this embodiment, when the cage 258 is extended from the first lumen 254, the arms 262 expand radially outward to form the cage 258. Once the catheter 250 is in position at the treatment site (e.g., pocket 234), the cage 258 may be deployed or extended within the cavity (e.g., within pocket 234).

[0043] Suction tube 260 is delivered through second lumen 256 of catheter 250 and may be movable relative to catheter 250 (e.g., extendable distally beyond the distal end of catheter 250). Suction tube 260 may be a plastic tube, such as a nasogastric tube, and may be coupled to a suction source (not shown) such that a distal end 264 of suction tube 260 applies suction to pocket 234. With catheter 250 in place, suction tube 260 may be advanced distally into pocket 234, for example, to a position within or adjacent cage 258.

[0044] Delivery tube 252 may be a foam dispenser that may deliver a foam forming sponge or other similar porous and / or absorbent body, as shown in FIGS. 5B and 5C. Delivery tube 252 may be coupled to catheter 250 or may be delivered separately to pocket 234 and advanced, for example, along the exterior of catheter 250 (effectively using catheter 250 as a guidewire). Alternatively, delivery tube 252 may be advanced through first lumen 254 or second lumen 256, or through another lumen of catheter 250. As shown in FIG. 5B, sponge material may be delivered to pocket 234 through delivery tube 252 to form sponge 210. The proximal end of delivery tube 252 may be coupled to a source 268 of sponge material, for example, a pressurized source of sponge material, so that the sponge material may be delivered through delivery tube 252 and sprayed (aerosolized) into pocket 234. 5B, the sponge 210 may be formed within the pocket 234 to at least partially surround a distal portion of the catheter 250 and / or delivery tube 252. Alternatively, the sponge 210 may be formed distal to the catheter 250 and / or delivery tube 252 such that the sponge 210 surrounds only a portion of the cage 258 and the suction tube 260.

[0045] The sponge material may be a sponge foam, such as a liquid-phase polyurethane (PU) foam, that expands and solidifies upon contact with moisture and / or air to form the sponge 210 within the pocket 234. The sponge material may be, for example, an injectable open-cell foam used to treat intraperitoneal bleeding. In another embodiment, the sponge material may be a two-component polyurethane (PU) foam. For example, the delivery tube 252 may include two lumens, with the proximal end of each lumen connected to a different liquid polyurethane (PU) foam source. When two liquids are delivered into the pocket 234 by the delivery tube 252, the liquids come into contact and solidify to form the sponge 210. The sponge 210 may also be formed from a two-component polyurethane (PU) foam that solidifies upon contact. In these embodiments, the nature of the foam forming the sponge material (e.g., open-cell) may allow fluid to drain through struts or openings (e.g., polyurethane struts) in the foam when vacuum pressure / suction is applied to the sponge 210. Additionally, the sponge 210 may expand to take the shape of the pocket 234 as it is formed by the sponge material being delivered.

[0046] 5B , when the sponge material is delivered, cage 258 and suction tube 260 are extended within pocket 234. In this embodiment, at least a distal portion of cage 258 (e.g., arms 262) and at least a distal portion of suction tube 260 (e.g., distal end 264) may be disposed within sponge 210. When the sponge material solidifies to form sponge 210, portions of both cage 258 and suction tube 260 may be secured within and relative to sponge 210. Furthermore, in one example, distal end 264 of suction tube 260 may be disposed within cage 158 such that arms 262 at least partially surround distal end 264.

[0047] In these embodiments, delivering sponge material to pocket 234 allows the sponge material to expand and take the shape of pocket 234, eliminating the need for the physician to estimate the size and / or shape of pocket 234 and deliver a sponge corresponding to that size and / or shape. Furthermore, with distal end 264 of suction tube 260 positioned within sponge 210, suction may be applied through suction tube 260 to remove fluid and / or decomposed material from sponge 210 through suction tube 260 and out of pocket 234.

[0048] As shown in FIG. 5C , it may be necessary to remove or replace sponge 210, for example, as pocket 234 decreases in size as the wound or anastomosis at least partially heals. Prior to removing and / or replacing sponge 210, suction tube 260 may be retracted proximally out of sponge 210 to a position within catheter 250, as shown in FIG. 2C . Furthermore, as shown in FIG. 2C , delivery tube 252 may be removed from the patient 232 prior to removing and / or replacing sponge 210. For example, delivery tube 252 may be removed from the patient 232 after sponge 210 is formed.

[0049] After removing delivery tube 252 from sponge 210, cage 258 may be retracted proximally (e.g., through first lumen 254). Because arms 262 of cage 258 are anchored within the sponge, proximal movement of cage 258 may also retract sponge 210. Proximal movement at least partially contracts arms 262, for example, as arms 262 enter first lumen 254. Furthermore, arms 262 may each include a curved or bent portion 266, for example, in a central portion of arm 262. Arms 262 may expand radially outward, while distal portions of arms 262 bend radially inward. Thus, as cage 258 is retracted proximally, arms 262 may catch on portions of sponge 210 via bent portions 266, causing sponge 210 to also retract proximally. As mentioned, sponge 210 may be formed of any suitable material (e.g., a shape memory alloy) and may be contractible to remove sponge 210 and cage 258 through first lumen 254. Note that first lumen 254 may be appropriately sized to deliver cage 258 and retract cage 258 and sponge 210. Cage 258, along with sponge 210, may be retracted proximally and out of catheter 250 without removing or affecting the position of catheter 250.

[0050] To remove sponge 210 without affecting the position of catheter 250, the above steps may be repeated to deliver and form a new sponge within pocket 234. For example, cage 258 may be reinserted through first lumen 258, and suction tube 260 may be extended distally to a position within or adjacent cage 258. Delivery tube 252 may then be reinserted to again deliver sponge material to pocket 234 to form a new sponge, which may take the size and / or shape of pocket 234, which may be smaller and / or different in shape compared to the size and shape at the start of treatment, for example, because pocket 234 has decreased in size or changed in shape. The above steps may be repeated any number of times until pocket 234 is closed, healed, or no longer needed.

[0051] 6A and 6B illustrate another exemplary medical system 300, in which similar elements to sponge 10 and patient 30 are designated by the addition of the reference numeral 300. FIGS. 6A and 6B illustrate sponge 310 and various stages of use within a patient 330, for example, within the esophagus 332 and a wound or anastomosis (e.g., pocket 334). In some aspects, system 300 may be packaged as a kit. As shown in FIG. 6A, 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. Nevertheless, suction tube 360 ​​aids in supporting and removing at least a portion of sponge 310.

[0052] Suction tube 360 ​​may be delivered to the treatment site (e.g., pocket 334) in any manner. In one embodiment, suction tube 360 ​​may include rod 370 that is disposed within suction tube 360 ​​during delivery of suction tube 360. For example, suction tube 360, together with rod 370, may be delivered through an opening (e.g., the mouth) down esophagus 332 to the treatment site (e.g., pocket 334). Alternatively or additionally, suction tube 360, together with rod 370, may be delivered to pocket 334 over a guidewire. Furthermore, in one embodiment, suction tube 360 ​​may be delivered to pocket 334, and then rod 370 may be inserted within suction tube 360.

[0053] Rod 370 may be at least partially rigid and / or formed of a shape memory alloy. When rod 370 is disposed within suction tube 360, it may occupy all or a majority of the interior lumen of suction tube 360. For example, when rod 370 is disposed within suction tube 360, rod 370 helps to form a seal (or at least a partial seal) within suction tube 360.

[0054] Delivery tube 352 may be a foam dispenser that may deliver foam to form sponge 310 or other similar porous and / or absorbent materials, as shown in FIG. 6A . Delivery tube 352 may be coupled to suction tube 360 ​​or may be delivered separately to pocket 358, for example, advanced along the exterior of suction tube 360, or delivered via a guidewire or the like. As shown in FIG. 6A , sponge material is delivered through delivery tube 352 to pocket 358 to form sponge 310. As described above, the proximal end of delivery tube 352 may be connected to a source 368 of sponge material, for example, a pressurized source of sponge material, such that the sponge material may be delivered through delivery tube 352 and sprayed (aerosolized) into pocket 334. The sponge material may be any of the materials described above with respect to FIGS. 5A-5C .

[0055] The sponge material may expand and solidify into a porous and / or absorbent body, e.g., sponge 310. Sponge 310 may expand to take the shape of pocket 334 and may also surround distal end 364 of suction tube 360. Distal end 364 of suction tube 360 ​​may be at least partially secured within sponge 310. Nevertheless, as delivery tube 352 delivers the sponge material into pocket 334, rod 370 helps prevent the sponge material from entering suction tube 360 ​​and helping to prevent the sponge material from forming a blockage within suction tube 360. Additionally, rod 370 may be manipulated, for example, to extend distally to and / or outward from distal end 364 of suction tube 360 ​​to push sponge material out and / or away from distal end 364 of suction tube 360.

[0056] 6B, delivery tube 352 and rod 370 may be removed. Suction may then be applied to sponge 310 through suction tube 360. The suction assists in removing excess fluid from pocket 334. Additionally, as discussed above, sponge 310 may be biodegradable, and suction through suction tube 360 ​​assists in removing material that degrades over time.

[0057] If the sponge 310 requires replacement (e.g., the size and / or shape of the pocket 334 has changed, the sponge 310 has degraded, etc.), the sponge 310 may be at least partially removed and additional sponge material delivered. For example, suction through the suction tube 360 ​​may assist in removing degraded material from the sponge 310. Alternatively or additionally, a separate tube, catheter, grasping device, retrieval device, etc., may be delivered to the pocket 334 to remove one or more portions of the sponge 310, as described above with respect to the catheter 250 and cage 258. Furthermore, in another embodiment, for example, if the sponge 310 is not biodegradable or has not yet sufficiently degraded, the suction tube 360 ​​may be retracted proximally outside the patient 330, thereby also removing the sponge 310 coupled thereto. In this embodiment, the suction tube 360 ​​(or a new suction tube 360) may be delivered to the pocket 334 and positioned appropriately. After the sponge 310 is removed (and the suction tube 360 ​​is placed, if necessary), a delivery tube 352 may be delivered to the pocket 334, as described above, to deliver additional sponge material to form a new sponge 310. Additionally, a rod 370 may be delivered through the suction tube 360 ​​to ensure that the new sponge 310 does not block the distal end 364 of the suction tube 360.

[0058] In one embodiment, the non-degraded portion of sponge 310 may not require removal. In this embodiment, the degraded portion of sponge 310 may be removed by suction through suction tube 360. Delivery tube 352 may then be delivered to pocket 334 to deliver additional sponge material. The additional sponge material may replace the degraded portion of sponge 310. Additionally, as noted above, a rod 370 may be delivered through suction tube 360 ​​to help ensure that the new sponge material does not block the distal end 364 of suction tube 360.

[0059] The above process may be performed as many times as necessary until the pocket 334 closes, heals, or no longer requires the sponge 310. Furthermore, the above process may be performed without removing or affecting the position of the suction tube 360. Additional sponge material (by forming new sponges or replacing degraded sponge material) may form a continuous sponge 310, which may be smaller and / or have a different shape as the pocket 334 shrinks in size or changes shape.

[0060] 7A-7C illustrate another exemplary medical system 400, in which similar elements to those described above are designated by the additional reference numeral 400. FIGS. 7A-7C illustrate a porous bag 480 and a treatment material 482 in various stages of use within a patient's body, e.g., in the esophagus (or GI tract) and at a wound, anastomosis, or pocket, as described above. In some embodiments, the system 400 may be packaged as a kit. As shown in FIG. 7A, the system 400 also includes a tube 484 coupled to or supporting the bag 480. The tube 484 and bag 480 are delivered (e.g., to a treatment site) through an endoscope or catheter 450; for example, the tube 484 may be coupled to the catheter 450 via one or more coupling elements 486 (e.g., adhesives, hooks, clips, etc.). Furthermore, at least a portion of the bag 480 may be disposed within the lumen 454 of the catheter 450 during delivery or deployment of the bag 480. Additionally, a portion of bag 480 extends outside of catheter 450. For example, in some embodiments, bag 480 is disposed through a distal portion of tubing 484 and not through a proximal portion of tubing 484.

[0061] As shown in FIG. 7B , bag 480 may be removed from lumen 454 of catheter 450 and extended into, for example, a wound, anastomosis, or pocket. In one embodiment, a gripping device 490 may be used to control, manipulate, or position bag 480. Additionally or alternatively, therapeutic material 482 may be delivered into bag 480, e.g., via source 468, to stretch, expand, or position bag 480. For example, therapeutic material 482 may be delivered into bag 480 via tube 484. The therapeutic material 482 may aid in stretching bag 480 (e.g., removing a portion of bag 480 from lumen 454), and bag 480 may expand (from a contracted or compressed configuration to an expanded configuration) to assume the size and / or shape of the wound, anastomosis, or pocket.

[0062] The bag 480 may be formed from a porous material, and the pores of the bag 480 may be large enough to allow the bag 480 to be porous to fluids that may be drained by the wound, anastomosis, or pocket (e.g., blood, pus, saline, etc.) or to fluids that may be delivered to the wound or treatment site. Similarly, the pores of the bag 480 may be small enough to retain the therapeutic material 482 within the bag 480 (i.e., the diameter of the particles of the therapeutic material 482 is larger than the diameter of the pores of the bag 480). The bag 480 may compress the therapeutic material 482 to provide a semi-rigid surface (e.g., that may abut tissue within the wound, as described above) while allowing a vacuum to be applied through the tube 484 to remove the fluid and / or therapeutic material 482 from the bag 480. In one embodiment, the bag 480 may be formed from a fine mesh, nylon, or other suitable material.

[0063] The therapeutic material 482 may be a sponge-like material and / or a sponge-like material as described herein. For example, the therapeutic material 482 may include one or more of salts, sugars, antimicrobial materials, etc. The therapeutic material 482 may include any suitable biocompatible material that absorbs or allows liquid to pass through under negative pressure / suction. The therapeutic material 482 may be flexible, compressible, porous, hydrophilic, sterile, and / or disposable. The therapeutic material 482 may be an open-cell foam (or one formed by an open-cell foam). Suitable materials include collagen, polyurethane, esters, ethers, composites, polyethylene glycol, polyethylene oxide, polysaccharides, silver-based materials, and / or any medical-grade material. In some embodiments, the therapeutic material 482 may include a biomaterial (e.g., a biocompatible material and / or a material derived from a biological material), which may be at least partially or completely bioabsorbable, such as chitosan (e.g., chitosan acetate and / or chitosan lactate), extracellular matrix, or a combination thereof.

[0064] As shown in FIG. 7C , bag 480 and tube 484 may be separated from catheter 450. For example, catheter 450 may be removed from the patient's body, and bag 480 and tube 484 may remain in the patient's body. For example, bag 480 may be placed in a wound, anastomosis, or pocket. Therapeutic material 482 may be delivered to bag 480, for example, through tube 484. Therapeutic material 482 may cause bag 480 to expand to a size and / or shape corresponding to, for example, the wound, anastomosis, or pocket. Bag 480 and therapeutic material 482 may aid in absorbing fluids and aid in healing of the wound, anastomosis, or pocket, as described above with respect to the sponge.

[0065] In some embodiments, negative pressure / suction may be applied to bag 480 and therapeutic material 482 through tube 484, e.g., via vacuum 492 coupled to tube 484, to remove fluid from the wound, anastomosis, or pocket. Additionally, suction may be applied to bag 480 and therapeutic material 482 through tube 484 to, for example, remove fluid and / or therapeutic material 482 from bag 480, causing bag 480 to reduce in size or change in shape as the wound, anastomosis, or pocket heals or shrinks. In this embodiment, bag 480 may change in size and / or shape as the wound, anastomosis, or pocket heals or changes in size and / or shape. Additionally or alternatively, additional therapeutic material 482 may be delivered to bag 480 through tube 484 (e.g., from source 468) to change the size and / or shape of bag 480. Additionally, in some embodiments, suction may be applied to bag 480 (e.g., via vacuum 492) to remove all or most of the therapeutic material 482. In these embodiments, additional therapeutic material 482 may be delivered through tube 484 (e.g., from source 468) to bag 480 to refill bag 480, which may assume the size and / or shape of the wound, anastomosis, or pocket. These processes may be repeated as many times as necessary to aid in healing or shrinkage of the wound, anastomosis, or pocket. Additionally, bag 480 may be emptied and refilled without removing or repositioning bag 480 or tube 484.

[0066] As shown in FIG. 7C , the tube 484 may include a regulator 488, for example, at a proximal portion of the tube 484. In some embodiments, the regulator 488 may be a filter. The filter may be selectively placed within a portion of the tube 484, for example, after the therapeutic material 482 has been delivered to the bag 480. In this embodiment, the filter aids in the removal of fluid from the bag 480 or the tube 484 without negative pressure / suction (e.g., from the vacuum 492) removing the therapeutic material 482 from the bag 480 or the tube 484. The filter may be removable or selectively placed in a non-filtering configuration, for example, when redelivering the therapeutic material 482 through the tube 484 and the bag 480. In another embodiment, the regulator 488 may be a valve. The valve may be placed within the tube 484 or around a portion of the tube 484. The valve may allow the therapeutic material 482 to be delivered through the valve and into the tube 484 and the bag 480. The valve also helps retain the therapeutic material 482 within the tube 484 and bag 480. For example, in some embodiments, when a first pressure level (e.g., either positive pressure or negative pressure / suction) is applied, the valve allows fluid to pass through the valve but not the therapeutic material 482. Furthermore, in some embodiments, when a second pressure level (e.g., either positive pressure or negative pressure / suction) that is higher than the first pressure level is applied, the valve allows fluid and the therapeutic material 482 to pass through the valve.

[0067] In one embodiment, tube 484 may be used to control or manipulate the attitude and / or orientation of bag 480. For example, tube 484 may be used to control (e.g., position, rotate, twist, etc.) bag 480, deliver materials and / or fluids to bag 480, or apply suction to remove materials and / or fluids from bag 480. Additionally, in some embodiments, fluid may be delivered distally into bag 480 (e.g., via tube 484) to assist in detaching bag 480 from a wound, anastomosis, or pocket in situations where a wound, anastomosis, or pocket engages bag 480. In some embodiments, the delivered fluid may be at least partially pressurized. Additionally or alternatively, tube 484 may be twisted to detach bag 480 from a wound, anastomosis, or pocket.

[0068] These steps are repeated as many times as necessary to aid in healing or shrinkage of the wound, anastomosis, or pocket. Additionally, bag 480 may be emptied and refilled without removing or repositioning bag 480 or tube 484.

[0069] The various embodiments described herein may help improve the effectiveness of treatment and / or recovery from treatment, for example, bariatric surgery. The various embodiments described herein may help shorten or minimize recovery time, reduce or minimize patient discomfort, reduce or minimize physician intervention, and / or reduce or minimize the need for and / or reliance on imaging or visualization for sponge placement. For example, the various embodiments described herein allow for the delivery of a porous and / or absorbent body, such as a sponge or therapeutic material, to a treatment site, removal of the sponge or therapeutic material (either by degradation, physical removal, or a combination thereof), and delivery of another sponge or additional therapeutic material to the treatment site without the need for redeployment or redeployment of various insertion devices. Furthermore, the various embodiments described herein may be packaged as kits for use in treating patients.

[0070] In some embodiments, the sponges described herein may be biocompatible and degradable. Furthermore, different layers or portions of the sponge may degrade at different rates. For example, different layers or portions of the sponge may be formed of different thicknesses, different materials, different densities, different blends of materials, etc. In this manner, the sponge changes size and / or shape over time, and this change in size and / or shape corresponds to the change in size and / or shape of the wound, anastomosis, pocket, etc., thereby reducing the need for a physician to remove and replace the sponge. Additionally, the sponge may include one or more antimicrobial layers and / or materials, which may help reduce the risk of infection or promote healing or reduction in size of the wound, anastomosis, pocket, etc.

[0071] Additionally, the sponge (e.g., formed by spray foam) or the treatment material (within bag 480) may assume the shape of the wound, anastomosis, or pocket. This embodiment reduces or minimizes the need for or reliance on imaging or visualization to size, position, etc. the sponge. For example, a physician may not need to cut or form the sponge to the size and / or shape of the wound, anastomosis, or pocket. The entire treatment material does not need to be delivered or removed all at once through the patient's opening. Furthermore, in some embodiments of the invention, the sponge or treatment material may assume the size and / or shape of the wound, anastomosis, or pocket, even as the size and / or shape of the wound, anastomosis, or pocket changes during the healing process.

[0072] Although aspects of the medical system are described above as being used to treat treatment sites in the esophagus, stomach, duodenum, large intestine (colon), or small intestine, these aspects and methods may be used to treat any part of a patient, helping to reduce overall recovery time, component costs, lower risks to the patient, etc.

[0073] While the principles of the present invention have been described herein with reference to illustrative embodiments for various applications, it should be understood that the invention is not limited thereto. Those skilled in the art and having access to the teachings provided herein will recognize further modifications, applications, embodiments, and equivalent substitutions, all of which fall within the scope of the embodiments described herein. Accordingly, the present invention should not be deemed limited by the foregoing description.

Claims

1. a source of material that expands to form a porous body after deployment within a body lumen; a first tube for delivering the material into the body lumen; a second tube that performs suction on the porous body; a removal device having a plurality of arms configured to remove the porous body from the body lumen; The medical system, wherein the removal device is configured to be deployed within the body lumen before the material is deployed within the body lumen, and wherein each of the plurality of arms of the removal device is entirely disposed within the porous body.

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

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

4. The medical system of any one of claims 1 to 3, wherein the material comprises an open-cell foam.

5. 5. The medical system of claim 1, wherein the first tube includes at least two lumens, and the material includes two liquids delivered through the first tube, within different lumens of the at least two lumens, and the two liquids solidify upon contact with each other to form the porous body.

6. The medical system of any one of claims 1 to 5, wherein the material expands to take the shape of the pocket into which it is delivered.

7. The medical system according to any one of claims 1 to 6, wherein the porous body is at least partially biodegradable.

8. A medical system according to any one of claims 1 to 7, wherein each of the plurality of arms is expandable to form a cage, and each of the plurality of arms is formed of a shape memory alloy and is self-expanding.

9. 9. The medical system of claim 8, wherein at least one arm of the plurality of arms includes a bend such that at least one arm of the plurality of arms expands radially outward and a distal portion of the at least one arm bends radially inward.

10. 10. The medical system of claim 8 or 9, wherein the cage is movable within a lumen of an insertion device, and wherein proximal movement of the cage within the lumen of the insertion device at least partially retracts the cage.

11. The medical system of claim 10 , wherein the cage and the insertion device are configured to remove the porous mass from the body lumen.

12. The medical system of any one of claims 8 to 10, wherein the removal device and the second tube are movable within respective lumens of the catheter.

13. The medical system of any one of claims 8 to 12, wherein the removal device and the second tube are positionable such that the porous body surrounds at least a distal portion of the cage and the second tube.

14. The medical system of any one of claims 1 to 13, further comprising a rod movable within the second tube.

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

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