Medical systems, devices, and related methods

Abstract

The present invention provides medical systems, apparatus, and methods for medical procedures using endoscopes to close wounds or treat tissues. [Solution] The medical system includes a material supply source, a first tube, and a second tube. The material is configured to expand to form a porous body after being 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 perform suction on the porous body.

Description

Technical Field

[0001] The present invention relates to medical systems, devices, and related methods used to treat patients. More particularly, the present invention relates to medical systems, devices, and methods for medical procedures using an endoscope to close wounds or treat tissue.

Background Art

[0002] Open surgeries using an endoscope of the gastrointestinal (GI) tract include colectomy, obesity surgery, esophagectomy, gastric bypass, and sleeve gastrectomy. As a result of these procedures, there is a possibility of perforation of the gastrointestinal tract, postoperative leakage, or other wounds. There are limited treatment options for such wounds with significant mortality and failure rates. The options include surgical reoperation and placement of a stent or clip using an endoscope. Surgery is relatively invasive and has high mortality and failure rates. Placement of a stent using an endoscope is a less invasive option. However, the placed stent may move from the intended position or surround the infected part at the treatment site, interfering with drainage.

[0003] The systems, devices, and methods of the present invention correct some of the above drawbacks 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 a medical system and device. Each example disclosed herein may include one or more of the features described in relation to any of the other disclosed examples.

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

[0006] The medical system may include one or more of the following features: A first tube is connected to a material source 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 the first tube, through different lumens of the two lumens, which solidify upon contact with each other to form a porous body. The material may expand to take the shape of a pocket into which the material is delivered. The porous body may be at least partially biodegradable.

[0007] The medical system may further include a removal device having multiple arms that are expandable to form a cage. The arms may be self-expanding and made of shape memory alloy. At least one of the arms may include a bend such that at least one arm expands radially outward and the distal portion of at least one arm bends radially inward. The cage may be movable within the lumen of the insertion device, and the cage may be at least partially contracted by proximal movement of the cage within the lumen of the insertion device. The porous material 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 each lumen of the catheter. The removal device and the second tube may be positioned such that the porous material surrounds at least the distal portion of the cage and the second tube.

[0008] The medical system may further include a rod that is movable within the second tube. The rod may form a seal that prevents material from entering the distal end of the second tube. In an alternative example, a medical device may include a porous body comprising multiple layers having biodegradable material. The outermost layer of the multiple layers may be configured to decompose faster within body tissue than the inner layers of the multiple layers. The different layers of the porous body may be formed from different materials, different densities of the same material, or different mixtures of the same material.

[0009] The medical device may include one or more of the following features: The outermost layer may be configured to decompose within 12 to 36 hours after insertion of the porous material into body tissue, and the inner layer may be configured to decompose within 36 to 60 hours after insertion of the porous material into body 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 negative pressure to the porous material.

[0010] In a further 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 retained within the porous bag. The 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.

[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 positioned with the lumen during delivery of the porous bag to the treatment site. The treatment material may be granular or porous and may help to form a semi-rigid surface that contracts when negative pressure is applied. The medical system may help to allow changes in at least one of the size and shape of the porous bag at the treatment site.

[0012] In an alternative example, the 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] Both the general description above and the detailed description below are illustrative and descriptive, and do not limit the invention as described in the claims. The accompanying drawings incorporated herein and constituting part thereof illustrate exemplary embodiments of the present invention and, together with the detailed description, serve to illustrate the principles of the present invention. [Brief explanation of the drawing]

[0014] [Figure 1] A cross-sectional view showing an exemplary medical device according to an aspect of the present invention. [Figure 2A] A diagram showing the medical device of Figure 1 at various stages of use within a patient's body, according to the aspects of this disclosure. [Figure 2B] A diagram showing the medical device of Figure 1 at various stages of use within a patient's body according to an aspect of the present invention. [Figure 2C] A diagram showing the medical device of Figure 1 at various stages of use within a patient's body according to an aspect of the present invention. [Figure 2D] A diagram showing the medical device of Figure 1 at various stages of use within a patient's body according to an aspect of the present invention. [Figure 3] Cross-sectional view of an alternative exemplary medical device according to an aspect of the present invention. [Figure 4A] Diagram showing the medical device of FIG. 3 at various stages of use within a patient's body, according to an aspect of the present invention. [Figure 4B] Diagram showing the medical device of FIG. 3 at various stages of use within a patient's body, according to an aspect of the present invention. [Figure 4C] Diagram showing the medical device of FIG. 3 at various stages of use within a patient's body, according to an aspect of the present invention. [Figure 4D] Diagram showing the medical device of FIG. 3 at various stages of use within a patient's body, according to an aspect of the present invention. [Figure 5A] Diagram showing an exemplary medical system at various stages of use within a patient's body, according to an aspect of the present invention. [Figure 5B] Diagram showing an exemplary medical system at various stages of use within a patient's body, according to an aspect of the present invention. [Figure 5C] Diagram showing an exemplary medical system at various stages of use within a patient's body, according to an aspect of the present invention. [Figure 6A] Diagram showing another exemplary medical system at various stages of use within a patient's body, according to an aspect of the present invention. [Figure 6B] Diagram showing another exemplary medical system at various stages of use within a patient's body, according to an aspect of the present invention. [Figure 7A] Diagram showing yet another exemplary medical system at various stages of use, according to an aspect of the present invention. [Figure 7B] Diagram showing yet another exemplary medical system at various stages of use, according to an aspect of the present invention. [Figure 7C] Diagram showing yet another exemplary medical system at various stages of use, according to an aspect of the present invention.

Mode for Carrying Out the Invention

[0015] The terms "proximal" and "distal" are used herein to refer to the relative positions of the components of an exemplary medical system and an exemplary medical device. As used herein, "proximal" refers to a position that is relatively closer to the outside of the body or closer to the medical professional using the medical system or medical device. In contrast, "distal" refers to a position that is relatively farther away from the medical professional using the medical system or medical device or closer to the inside of the body. As used herein, the terms "comprises", "comprising", "having", "including" or other variations thereof cover non-exclusive inclusion such that a system, device or method that includes a list of elements may include not only those elements but also other elements not expressly listed or inherent to them. Unless otherwise stated, 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 an example, endoluminal vacuum therapy includes placing a porous body, such as a sponge or other similar material, into the lumen at a wound site that includes a perforation, cyst, leak, anastomosis, etc. Placement of the material can be via a catheter, scope (endoscope, bronchoscope, colonoscope, etc.), tube, or sheath inserted into the GI tract through a natural opening. The opening can be, for example, the nose, mouth, or anus, and placement can be performed at any part of the GI tract including the esophagus, stomach, duodenum, large intestine, or small intestine. Placement can also be performed in other organs accessible via the GI tract.

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

[0018] Hereinafter, examples of the present invention described above and shown in the attached drawings will be referenced in detail. Wherever possible, the same reference numerals will be used throughout all drawings to refer to the same or similar parts.

[0019] Figure 1 is a cross-sectional view showing an exemplary medical device, for example, a porous absorbent, i.e., a sponge 10, which may be used to aid in the healing of wounds or anastomoses in a patient's body, or in the treatment of tissue. The sponge 10 comprises several layers, for example, an outer layer 12, an intermediate layer 14, and an inner layer 16. As described below, one or more of the layers 12, 14, and 16 have biocompatibility and / or varying degrees of degradation (i.e., the different layers may degrade at different rates). For example, as shown in Figures 2A to 2D, the outer layer 12 may degrade faster than the intermediate layer 14 in the patient's body 30, and the intermediate layer 14 may degrade faster than the inner layer 16 in the patient's body 30. In one embodiment, the inner layer 16 may be non-degradable (i.e., biostable) and may be removed by a physician. Furthermore, although three layers 12, 14, and 16 are shown in Figure 1, the present invention is not limited thereto. The sponge 10 may contain any number of layers, and the thickness of the layers may be changed based on at least one of the desired size and shape of the sponge 10, the desired overall decomposition time of the sponge 10, the desired decomposition time of each layer, and so on.

[0020] Furthermore, the sponge 10 may include one or more antibacterial layers, i.e., antimicrobial layers 18, in at least one of the following: the outer layer 12, between the outer layer 12 and the intermediate layer 14, and between the intermediate layer 14 and the inner layer 16. The one or more antimicrobial layers 18 help to limit or reduce bacterial growth while the wound is healing. Alternatively or additionally, one or more layers of the sponge 10 may include an antibacterial or antimicrobial material (e.g., a gel) delivered to the wound, for example, the antibacterial or antimicrobial material may be secreted or seeped out from one or more layers of the sponge 10. For example, the antibacterial or antimicrobial material may be embedded across one or more layers or located, for example, within one or more intralayer boluses.

[0021] Furthermore, in embodiments of the present invention, the sponge 10 may be formed from any suitable biocompatible material that absorbs liquid from the inside or allows liquid to pass through the inside by applying suction / negative pressure to the sponge 10. This material may be flexible, compressible, porous, hydrophilic, sterile, and / or disposable. The sponge material may be open-cell foam (or formed by open-cell foam). Suitable materials include collagen, polyurethane, esters, ethers, composite materials, polyethylene glycol, polyethylene oxide, polysaccharides, silver-based materials, and / or any medical-grade materials. In some embodiments, the sponge 10 may contain a biomaterial (e.g., a material that is biocompatible and derived from a biological material, or a material that is biocompatible or derived from a biological material) which may be at least partially or completely bioabsorbable, such as chitosan (e.g., at least one of chitosan acetate and chitosan lactate), extracellular matrix, or a combination thereof.

[0022] Furthermore, in some embodiments, layers 12, 14, and 16 of the sponge 10 may be formed of different materials, different material densities, different mixtures of materials, etc., in order to control the rate of decomposition of layers 12, 14, and 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 mixture of the first and second materials. Alternatively, layers 12, 14, and 16 may be formed of a first material and a second material, with the mixture or ratio of the first material to the second material varying between each layer.

[0023] Furthermore, the respective thicknesses of layers 12, 14, and 16 may be modified or determined in accordance with at least one of the size and shape of the sponge 10, the size of the wound, the material of the sponge 10, the desired decomposition of the sponge 10, etc. In one example, the outer layer 12 may decompose completely or at least almost completely after approximately 12 to 36 hours (first period), for example 24 hours, from the placement of the sponge 10, and the middle layer 14 may decompose completely or at least almost completely after approximately 36 to 60 hours (second period longer than the first period), for example 48 hours, from the placement of the sponge 10. Furthermore, in this example, the inner layer 16 may decompose completely or at least completely after approximately 60 to 84 hours (third period longer than the second period), for example 72 hours, from the placement of the sponge 10. In these embodiments, the sponge 10 may contain as many layers as are expected for wound recovery and / or healing. For example, if it is predicted that the wound will take 5 days to heal, the sponge 10 may consist of 5 layers, each layer decomposing over approximately 1 day after the placement of the sponge 10 or after the decomposition of the preceding outermost layer. In some embodiments, the innermost layer may not decompose during the predicted healing period and may be removed by the physician. For example, the innermost layer may be biodegradable, but may decompose at a rate that does not cause it to decompose by the time the physician removes the sponge 10.

[0024] Figures 2A to 2D illustrate the body lumen of a patient 30, such as the esophagus 32, at various stages of recovery from a procedure (e.g., bariatric surgery). For example, Figures 2A to 2D show the esophagus 32 with a sponge 10 at various stages of recovery from a procedure, including the formation of a wound in a pocket 34. While Figures 2A to 2D show the sponge 10 used to treat a wound in a pocket 34 located within the esophagus 32, the invention is not limited thereto. The sponge 10 may be used to treat wounds, leaks, perforations, etc., in the upper gastrointestinal tract of a patient, the lower gastrointestinal tract of a patient, other lumens or body cavities in the patient's body, on the surface of the patient's body, etc.

[0025] As shown in Figure 2A, the sponge 10 is inserted into a wound or pocket 34 within the esophagus 32. For example, a procedure on the esophagus 32 forms a pocket 34, and the sponge 10 is inserted as part of the recovery 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 internal lumen of the endoscope used to perform the procedure. The sponge 10 may be sized and / or shaped to fit into or correspond to the pocket 34. In one embodiment, the sponge 10 may be sized and shaped and given rigidity, for example, to maintain the size and / or shape of the pocket 34. As described above, the thickness, shape, and / or number of layers 12, 14, 16 of the sponge 10 may be modified. For example, in one embodiment, the outer layer 12 is substantially oval-shaped to fit into the pocket 34, and the middle layer 14 and inner layer 16 are also substantially oval-shaped, or alternatively, substantially circular.

[0026] As shown in Figure 2B, the sponge 10 decomposes over time. The decomposition may be estimated to correspond to the estimated healing time of the wound forming the pocket 34. For example, as the wound heals and the size of the pocket 34 shrinks, one or more layers 12, 14, 16 (e.g., outer layer 12) decompose, reducing the size of the sponge 10. In this embodiment, the decomposition (and shrinkage) of the sponge 10 allows the sponge 10 to shrink along with the healing of the wound, and consequently the pocket 34 to shrink. The size, shape, thickness, material, etc., of the layers 12, 14, 16 of the sponge 10 may be selected to match at least one of the shrinking size and shape changes of the pocket 34. In one embodiment, the outer layer 12 may be decomposed in Figure 2B, and the pocket 34 may shrink in size or change shape.

[0027] Figure 2C shows further decomposition of the sponge 10 during recovery and reduction in the size of the pocket 34. In this embodiment, the intermediate layer 14 may be decomposed in Figure 2C, and the pocket 34 may be further reduced in size. In addition, the sponge 10 may be formed of a material that helps the sponge 10 to be held within the pocket 34 or to grasp the esophagus 32 as the size of the pocket 34 is reduced. For example, one or more layers 12, 14, 16 may contain a bioadhesive material (e.g., chitosan having properties that enable it to bond to negatively charged surfaces such as mucous membranes).

[0028] Figure 2D shows the final stage of the healing process. For example, as shown, the pocket 34 may shrink further and, for example, disappear. In this embodiment, the inner layer 16 may disintegrate. At least some portion of the sponge 10 may be biocompatible and disintegrate so that the physician does not need to insert an endoscope to adjust, replace, or remove the sponge 10. Alternatively, as described above, the inner layer 16 may not be completely disintegrable, and the physician may insert an endoscope to remove the inner layer 16. Furthermore, in one embodiment, the physician may insert a smaller sponge, which helps to accelerate healing if the pocket 34 has not yet disappeared or has not shrunk sufficiently.

[0029] Figures 3, 4A to 4D show alternative examples according to the present invention. In Figures 3, 4A to 4D, elements similar to those of sponge 10 and patient 30 are indicated with the reference numeral 100.

[0030] As shown in Figure 3, the sponge 110 comprises multiple layers, for example, an outer layer 112, an intermediate layer 114, and an inner layer 116, which may decompose at different rates, as described above with respect to layers 12, 14, and 16. In fact, the sponge 110 may include any of the features described with respect to the sponge 10. The sponge 110 may include one or more antibacterial or antimicrobial layers 118, for example, on the outer layer 112, between the outer layer 112 and the intermediate layer 114, and between the intermediate layer 114 and the inner layer 116. Furthermore, the sponge 110 comprises an innermost layer, i.e., an inner core 140 and a suction port 142. The inner core 140 may be formed of a non-degradable material within the inner layer 116. Alternatively, the inner core 140 may be formed of a biodegradable material within the inner layer 116, and the biodegradable material of the inner core 140 may decompose more slowly than the inner layer 116 (and other layers of the sponge 110). In either embodiment, the inner core 140 may include one or more openings 144 communicating with the suction port 142, such that fluid can enter the inner core 140 through the openings 144 and, when negative pressure is applied through the suction port 142, the fluid can be removed from the patient's body through the suction port 142.

[0031] The suction port 142 may be a lumen formed from a biocompatible material, such as plastic (e.g., polyethylene), metal (e.g., stainless steel), or composite material. As shown in the figure, the suction port 142 is connected to the inner core 140. In one embodiment, the suction port 142 may extend outside the patient 130's body, for example, outside an opening (e.g., the mouth), as shown in Figures 4A-4C. Thus, a suction source can be connected 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 130's body. In this embodiment, a suction tube is inserted into an opening (e.g., the mouth) and connected to the suction port 142 to apply negative pressure and facilitate the removal of at least one of the excess fluid and decomposed material from the sponge 110. Applying negative pressure assists in the removal of at least one of the excess fluid and decomposed material from one or more layers of the sponge 110. Furthermore, applying negative pressure helps reduce the size of pocket 134 and aids in wound healing.

[0032] In some embodiments, a removable and / or detachable connector may be included, 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 fragile link or connector 146 positioned on a portion of the suction port 142. For example, the fragile link or connector 146 may be positioned on the suction port 142 in close proximity to a portion of the sponge 110, for example, the outer layer 112. In these embodiments, the fragile link or connector 146 maintains the connection between the inner core 140 and the suction port 142 for a period of time, for example, over the time that negative pressure / suction is applied to the sponge 110. Then, after another period, the fragile link or connector 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 the patient's body, for example, together 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 disassembled.

[0033] In any of these embodiments, Figures 4A to 4D show the internal lumen of patient 30, for example, the esophagus 132, at various stages of recovery from a procedure (for example, bariatric surgery). For example, Figures 4A to 4D show the esophagus 132 with sponge 110 at various stages of recovery from a procedure, including wound formation within a pocket 134.

[0034] As shown in Figure 4A, the sponge 110, along with the inner core 140 and suction port 142, is inserted into a pocket 134 of the esophagus 132. For example, a procedure on the esophagus 132 forms the pocket 134, and the sponge 110 is inserted as part of the recovery process. The sponge 110 may also be inserted via an endoscope, for example, through the internal lumen of the endoscope used to perform the procedure. The sponge 110 may be formed to fit inside or correspond to the pocket 134, at least one of the size and shape. Furthermore, by applying negative pressure through the suction port 142, at least one of the fluid and the disintegrated portion of the sponge 110 may be removed during the course of treatment.

[0035] As shown in Figure 4B, portions of the sponge 110 decompose over time. The decomposition may be estimated to correspond to the estimated healing time of the wound forming the pocket 134. For example, as the wound heals and the size of the pocket 134 shrinks, one or more layers 112, 114, 116 (e.g., outer layer 112) decompose, reducing the size of the sponge 110. In this embodiment, the decomposition (and shrinkage) of the sponge 110 allows the sponge 110 to shrink along with the healing of the wound, and consequently the pocket 134 to shrink. As described above, the size, shape, thickness, material, etc., of the layers 112, 114, 116 of the sponge 110 may be selected to match at least one of the shrinking size and shape changes of the pocket 134. In one embodiment, the outer layer 112 may decompose in Figure 4B, and the pocket 134 may shrink in size or change shape. For example, one or more layers 112, 114, 116 may contain a bioadhesive material (for example, chitosan having properties that enable it to bond to negatively charged surfaces such as mucous membranes).

[0036] Figure 4C shows further decomposition of the sponge 110 and reduction in the size of the pocket 134 during recovery. In this embodiment, the intermediate layer 114 may be decomposed in Figure 4C, and the pocket 134 may be further reduced in size. Furthermore, the sponge 110 may be formed of a material (e.g., a bioadhesive material) that helps the sponge 10 to be held within the pocket 134 or to grasp the esophagus 132.

[0037] Figure 4D shows the final stage of the healing process. For example, as shown, the pocket 134 may shrink further and, for example, disappear. The inner layer 116 may decompose. The inner core 140 and suction port 142 may then be removed by a physician, for example, by the suction port 142 being retracted proximally, or by inserting an endoscope to remove the inner core 140 and suction port 142. In another embodiment, in an embodiment where the inner core 140 is biodegradable, the inner core 140 may also decompose.

[0038] As described above, the continuous layers of sponge 110 may assist in closing the pocket 134 (and thus assist in wound healing). Furthermore, suction on the sponge 110 may assist in closing the pocket 134 (and thus assist in wound healing). Once the pocket 134 is closed (or nearly closed), the physician may remove the remaining parts of the sponge 110, such as the inner core 140 and the suction port 142.

[0039] In these examples, sponges 10, 110 are sized (e.g., cut) to approximate and / or correspond to at least one of the size and shape of pockets 34, 134. In any of the embodiments described herein, the sponge may be removed and a new sponge delivered or formed. For example, if the wound takes approximately 30 days to heal completely, the sponge may be removed and a new sponge delivered approximately 5 to 7 times.

[0040] In another embodiment, one or more layers of the sponge 110 may be formed of foam, as described below. In this embodiment, the inner core 140 and suction port 142 are located within the pocket 134, and foam may be delivered (e.g., sprayed) around the inner core 140 and suction port 142. The foam may cover and / or be dispensed around the inner core 140 and part of the suction port 142 to form a foam sponge. For example, the foam may be dispensed or delivered into the pocket 134 through one or more openings 144. In this embodiment, the suction tube 142 may include two or more separate lumens connected to the inner core. For example, although not shown, the suction tube 142 may include a first lumen connectable to a negative pressure source / suction source, and the suction tube 142 may also include a second lumen connectable to a foam supply source for delivering foam to form a foam sponge. The foam may be a self-sizing material, for example, expanding to at least one of the size and shape of pocket 134. The foam sponge may be formed from or contain at least one of the following: chitosan (e.g., at least one of chitosan acetate and chitosan lactate), silver-based materials, and / or any medical-grade material. The foam sponge may be formed from an antimicrobial material (e.g., a swelling antimicrobial material). The foam sponge may be at least partially or completely biodegradable. Alternatively, the foam sponge may be biostable and removed regularly, for example, every few days or every week. 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] Figures 5A–5C show another exemplary medical system 200, in which elements similar to the sponge 10 and patient 30 are indicated with the reference numeral 200. Figures 5A–5C show the sponge 210 at various stages of use in the body of patient 230, for example, in the esophagus 232, and in wounds or anastomoses, for example, in a wound or pocket 234. In some embodiments, the system 200 may be packaged as a kit. As shown in Figure 5A, the system 200 includes an insertion device, for example, a catheter 250 and a delivery tube 252. The catheter 250 may be a dual-lumen catheter having a first lumen 254 and a second lumen 256. The catheter 250 may be delivered down the esophagus 232 through an opening (for example, mouth or nose) to a treatment site, for example, a pocket 234. In this embodiment, the system 200 may also include a medical device to assist in supporting or removing the sponge 210, for example, a cage 258 and a suction tube 260. Please note that catheter 250 is shown as transparent in the diagram for clarity.

[0042] The cage 258 may be delivered through the first lumen 254 of the catheter 250 and be movable relative to the catheter 250 (for example, extend distally beyond the distal end of the catheter 250). The cage 258 may include a plurality of self-expanding arms 262 formed of, for example, a biocompatible shape-memory metal (e.g., nitinol). The cage 258 may be formed of a material having a bias toward an expanded form. For example, as shown in Figures 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, as the cage 258 extends from the first lumen 254, the arms 262 expand radially outward to form the cage 258. When the catheter 250 is in place at the treatment site (e.g., pocket 234), the cage 258 may be deployed or extended into the cavity (e.g., within pocket 234).

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

[0044] The delivery tube 252 may be a foam dispenser, which may deliver foam forming a sponge or other similar porous and / or absorbent material, as shown in Figures 5B and 5C. The delivery tube 252 may be connected to the catheter 250 or may be delivered separately to the pocket 234 and advanced along the outside of the catheter 250, for example (effectively using the catheter 250 as a guidewire). Alternatively, the delivery tube 252 may be advanced through the first lumen 254 or the second lumen 256, or through another lumen of the catheter 250. As shown in Figure 5B, the sponge material may be delivered through the delivery tube 252 to the pocket 234 to form the sponge 210. The proximal end of the delivery tube 252 may be connected to a sponge material source 268, for example, a pressurized sponge material source, so that the sponge material can be delivered through the delivery tube 252 and sprayed (aerosolized) into the pocket 234. The sponge 210 may be formed within the pocket 234 so as to partially surround the distal portion of at least one of the catheter 250 and the delivery tube 252, as shown in Figure 5B. Alternatively, the sponge 210 may be formed distal to at least one of the catheter 250 and the delivery tube 252 so that the sponge 210 surrounds only the 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 or solidifies upon contact with at least one of moisture and / or air to form a sponge 210 within the pocket 234. The sponge material may be, for example, an injectable open-cell foam used to treat intra-abdominal bleeding. In another embodiment, the sponge material may be a two-part polyurethane (PU) foam. For example, a delivery tube 252 may include two lumens, the proximal end of each lumen of which may be connected to different liquid polyurethane (PU) foam sources. When the two liquids are delivered into the pocket 234 by the delivery tube 252, the liquids come into contact with each other and solidify to form a sponge 210. The sponge 210 may be formed of a two-part polyurethane (PU) foam that solidifies upon contact. In these embodiments, the properties of the foam forming the sponge material (e.g., open-cell) may allow the fluid to be discharged through struts or openings (e.g., polyurethane struts) of the foam when vacuum pressure / suction is applied to the sponge 210. Furthermore, since the sponge 210 is formed by the delivered sponge material, it may expand to take the shape of the pocket 234.

[0046] As shown in Figure 5B, when the sponge material is delivered, the cage 258 and suction tube 260 are extended into the pocket 234. In this embodiment, at least the distal portion of the cage 258 (e.g., the arm 262) and at least the distal portion of the suction tube 260 (e.g., the distal end 264) may be positioned within the sponge 210. Once the sponge material solidifies to form the sponge 210, both portions of the cage 258 and suction tube 260 can be fixed within and to the sponge 210. Furthermore, in one example, the distal end 264 of the suction tube 260 may be positioned within the cage 158 such that the arm 262 at least partially surrounds the distal end 264.

[0047] In these embodiments, by delivering the sponge material to the pocket 234, the sponge material is allowed to expand and take the shape of the pocket 234, eliminating the need for the physician to guess at least one of the size and shape of the pocket 234 and deliver a sponge corresponding to at least one of that size and shape. Furthermore, with the distal end 264 of the suction tube 260 positioned inside the sponge 210, suction may be performed through the suction tube 260 to remove at least one of the fluid and decomposed material from the sponge 210 through the suction tube 260 from the pocket 234.

[0048] As shown in Figure 5C, for example, as the size of the pocket 234 decreases as the wound or anastomosis heals at least partially, it may become necessary to remove or replace the sponge 210. Before removing and / or replacing the sponge 210, the suction tube 260 may be retracted out of the sponge 210 and proximal to its position within the catheter 250, as shown in Figure 2C. Furthermore, as shown in Figure 2C, the delivery tube 252 may be removed from the patient 230's body before removing and / or replacing the sponge 210. For example, the delivery tube 252 may be removed from the patient 232's body after the sponge 210 has formed.

[0049] After removing the delivery tube 252 from the sponge 210, the cage 258 may be retracted proximally (for example, through the first lumen 254). Since the arms 262 of the cage 258 are fixed within the sponge, the proximal movement of the cage 258 may also retract the sponge 210. The proximal movement causes the arms 262 to contract at least partially, for example, as they enter the first lumen 254. Furthermore, each arm 262 may include a curved or bent portion 266, for example, in the central portion of the arm 262. The arms 262 may expand radially outward, and the distal portion of the arm 262 may bend radially inward. Thus, as the cage 258 is retracted proximally, the arms 262 may catch on a portion of the sponge 210 by the bends 266, causing the sponge 210 to retract proximally as well. As stated, the sponge 210 may be formed from any suitable material (e.g., a shape memory alloy) and is retractable so as to remove the sponge 210 and cage 258 through the first lumen 254. Note that the first lumen 254 may be of an appropriate size to deliver the cage 258 and to retract the cage 258 and sponge 210. The cage 258, together with the sponge 210, can be retracted proximal and outward from the catheter 250 without removing the catheter 250 or affecting its position.

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

[0051] Figures 6A and 6B show another exemplary medical system 300, in which elements similar to the sponge 10 and patient 30 are indicated by the addition of reference numeral 300. Figures 6A and 6B show the sponge 310, as well as various stages of use within the body of the patient 330, for example, in the esophagus 332 and in wounds or anastomoses (e.g., pockets 334). In some embodiments, the system 300 may be packaged as a kit. As shown in Figure 6A, the system 300 includes a delivery tube 352 and a suction tube 360. In some embodiments, the system 300 does not include a separate endoscope or other insertion device. Nevertheless, the suction tube 360 ​​assists in supporting or removing at least a portion of the sponge 310.

[0052] The suction tube 360 ​​may be delivered to the treatment site (e.g., pocket 334) by any means. In one embodiment, the suction tube 360 ​​may include a rod 370 that is placed inside the suction tube 360 ​​during its delivery. For example, the suction tube 360 ​​may be delivered together with the rod 370 down the esophagus 332 through an opening (e.g., a mouth) to the treatment site (e.g., pocket 334). Alternatively or additionally, the suction tube 360 ​​may be delivered to the pocket 334 together with the rod 370 via a guidewire. Furthermore, in one embodiment, the suction tube 360 ​​may be delivered to the pocket 334, and then the rod 370 may be inserted into the suction tube 360.

[0053] The rod 370 is at least partially rigid and / or may be formed of a shape memory alloy. When positioned 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 positioned within the suction tube 360, the rod 370 helps to form a seal (or at least a partial seal) within the suction tube 360.

[0054] The delivery tube 352 may be a foam dispenser, which may deliver foam forming sponge 310 or at least one of other similar porous and absorbent materials, as shown in Figure 6A. The delivery tube 352 may be connected to the suction tube 360 ​​or delivered separately to pocket 358, for example, by being advanced along the outside of the suction tube 360 ​​or by being delivered via a guide wire or the like. As shown in Figure 6A, the sponge material is delivered to pocket 358 via the delivery tube 352 to form sponge 310. As described above, the proximal end of the delivery tube 352 may be connected to a sponge material supply source 368, for example, a pressurized sponge material supply source, so that the sponge material can be delivered through the delivery tube 352 and sprayed (aerosolized) into pocket 334. The sponge material may be any of the materials described above with respect to Figures 5A to 5C.

[0055] The sponge material may expand and solidify to become porous and / or absorbent, such as sponge 310. The sponge 310 may expand to take the shape of a pocket 334 and may also surround the distal end 364 of the suction tube 360. The distal end 364 of the suction tube 360 ​​may be at least partially fixed within the sponge 310. Nevertheless, when the delivery tube 352 delivers the sponge material into the pocket 334, the rod 370 assists in preventing the sponge material from flowing into the suction tube 360, thereby helping to prevent the formation of an obstruction within the suction tube 360 ​​by the sponge material. Furthermore, the rod 370 may be manipulated to extend, for example, distal to the distal end 364 of the suction tube 260 and / or outward from the distal end 364 of the suction tube 260, pushing the sponge material outward from the distal end 364 of the suction tube 360 ​​and / or away from the distal end 364 of the suction tube 360.

[0056] As shown in Figure 6B, the delivery tube 352 and rod 370 may be removed. Next, suction may be applied to the sponge 310 through the suction tube 360. Suction helps to remove excess fluid from the pocket 334. Furthermore, as described above, the sponge 310 may be biodegradable, and suction through the suction tube 360 ​​helps to remove material that has decomposed over time.

[0057] If the sponge 310 requires replacement (for example, if at least one of the size and shape of the pocket 334 has changed, or if the sponge 310 has decomposed), the sponge 310 may be removed at least partially and additional sponge material delivered. For example, suction through the suction tube 360 ​​may assist in removing the material that has decomposed from the sponge 310. Alternatively or additionally, as described above with respect to the catheter 250 and cage 258, 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. Furthermore, in another embodiment, for example, if the sponge 310 is not biodegradable or has not yet fully decomposed, the suction tube 360 ​​is retracted proximal to the patient 330 to also remove the sponge 310 attached to the suction tube 360. In this embodiment, the suction tube 360 ​​(or a new suction tube 360) may be delivered to the pocket 334 and appropriately positioned. After the sponge 310 has been removed (and after the suction tube 360 ​​has been placed if necessary), the delivery tube 352 may be delivered to the pocket 334 as described above to deliver additional sponge material to form a new sponge 310. Furthermore, to ensure that the new sponge 310 does not obstruct the distal end 364 of the suction tube 360, the rod 370 may be delivered through the suction tube 360.

[0058] In one embodiment, the non-disassemblable portion of the sponge 310 does not need to be removed. In this embodiment, the disassemblable portion of the sponge 310 may be removed by suction through the suction tube 360. Next, the delivery tube 352 may be delivered to the pocket 334 to deliver additional sponge material. The additional sponge material may replace the disassemblable portion of the sponge 310. Furthermore, as described above, a rod 370 may be delivered through the suction tube 360 ​​to help ensure that the new sponge material does not obstruct the distal end 364 of the suction tube 360.

[0059] The above steps may be repeated as many times as necessary until the pocket 334 closes, heals, or no longer requires the sponge 310. Furthermore, the above steps may be performed without removing the suction tube 360 ​​or affecting its position. Additional sponge material (by forming a new sponge or replacing the disassembled sponge material) may form a continuous sponge 310, and since the size of the pocket 334 has decreased or its shape has changed, the continuous sponge may be smaller and / or have a different shape.

[0060] Figures 7A–7C show another exemplary medical system 400, in which elements similar to those of the system described above are indicated by the addition of the reference numeral 400. Figures 7A–7C show the porous bag 480 and therapeutic material 482 at various stages of use in the patient's body, e.g., in the esophagus (or GI tube) and in wounds, anastomoses, or pockets, as described above. In some embodiments, the system 400 may be packaged as a kit. As shown in Figure 7A, the system 400 also includes a tube 484 that is connected to or supports the bag 480. The tube 484 and bag 480 are delivered via an endoscope or catheter 450 (e.g., to the treatment site), for example, the tube 484 may be connected to the catheter 450 via one or more connecting elements 486 (e.g., adhesive, hook, clip, etc.). Furthermore, at least a portion of the bag 480 may be placed in the lumen 454 of the catheter 450 while the bag 480 is being delivered or positioned. Additionally, a portion of the bag 480 extends outside the catheter 450. For example, in some embodiments, the bag 480 is positioned within the distal portion of the tube 484 but not within the proximal portion of the tube 484.

[0061] As shown in Figure 7B, the bag 480 may be removed from the lumen 454 of the catheter 450 and extended, for example, into a wound, anastomosis, or pocket. In one embodiment, a gripping device 490 may be used to control, manipulate, or position the bag 480. Additionally or alternatively, therapeutic material 482 may be delivered into the bag 480, for example, via a source 468, to extend, inflate, or position the bag 480. For example, the therapeutic material 482 may be delivered into the bag 480 via a tube 484. The therapeutic material 482 may assist in extending the bag 480 (for example, by removing a portion of the bag 480 from the lumen 454), and the bag 480 may expand (from a contracted or compressed form to an expanded form) to take on at least one of the size and 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 be porous for fluids that can be discharged through a wound, anastomosis, or pocket (e.g., blood, pus, saline solution, etc.), or for fluids that can be delivered to the wound or treatment site. Similarly, the pores of the bag 480 may be small enough to hold the treatment material 482 within the bag 480 (i.e., the diameter of the particles of the treatment material 482 is larger than the diameter of the pores of the bag 480). The bag 480 may be compressed to provide a semi-rigid surface (which may be in contact with tissue in the wound, for example, as described above), while allowing the fluid and / or treatment material 482 to be removed from the bag 480 by vacuum through the tube 484. In one embodiment, the bag 480 may be formed from a fine mesh, nylon, or other suitable material.

[0063] Therapeutic material 482 may be at least one of a sponge-like material and a material similar to the sponges described herein. For example, therapeutic material 482 may contain one or more of salts, sugars, antimicrobial materials, etc. Therapeutic material 482 may contain any suitable biocompatible material that absorbs or allows liquids to pass through by 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 one formed by an open-cell foam). Suitable materials include collagen, polyurethane, esters, ethers, composite materials, polyethylene glycol, polyethylene oxide, polysaccharides, silver-based materials, and / or any medical-grade materials. In some embodiments, the therapeutic material 482 may include a biomaterial (for example, at least one of a biocompatible material and a material derived from a biological material), which may be at least partially or completely bioabsorbable, such as chitosan (for example, at least one of chitosan acetate and chitosan lactate), an extracellular matrix, or a combination thereof.

[0064] As shown in Figure 7C, the bag 480 and tube 484 may be separated from the catheter 450. For example, the catheter 450 may be removed from the patient's body, while the bag 480 and tube 484 remain in the patient's body. For example, the bag 480 may be placed in a wound, anastomosis, or pocket. Therapeutic material 482 may be delivered to the bag 480, for example, through the tube 484. Therapeutic material 482 can expand the bag 480 to at least one of the sizes and shapes corresponding to, for example, a wound, anastomosis, or pocket. The bag 480 and therapeutic material 482 assist in absorbing fluids and assist in the healing of the wound, anastomosis, or pocket, as described above with respect to the sponge.

[0065] In some cases, negative pressure / suction may be applied to the bag 480 and the treatment material 482 through the tube 484, for example, through a vacuum 492 connected to the tube 484, to remove fluid from the wound, anastomosis, or pocket. Furthermore, as the wound, anastomosis, or pocket heals or shrinks, suction may be applied to the bag 480 and the treatment material 482 through the tube 484 to reduce the size of the bag 480 or change its shape, for example, by removing at least one of the fluid and the treatment material 482 from the bag 480. In this embodiment, the bag 480 may change its size and shape as the wound, anastomosis, or pocket heals or changes at least one of its size and shape. Additionally or alternatively, further treatment material 482 may be delivered to the bag 480 through the tube 484 (for example from a source 468) to change at least one of the size and shape of the bag 480. Furthermore, in some embodiments, suction may be applied to the bag 480 (for example, via a vacuum 492) to remove all or most of the healing material 482. In these embodiments, additional healing material 482 may be delivered to the bag 480 through the tube 484 (for example, from a source 468) to refill the bag 480, which may take at least one of the size and shape of the wound, anastomosis, or pocket. These steps may be repeated as many times as necessary to assist in the healing or shrinkage of the wound, anastomosis, or pocket. Furthermore, the bag 480 may be emptied and refilled without removing or repositioning the bag 480 or the tube 484.

[0066] As shown in Figure 7C, the tube 484 may include, for example, a regulator 488 in the proximal portion of the tube 484. In some embodiments, the regulator 488 may be a filter. The filter may be selectively located inside 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 assists in the removal of fluid from the bag 480 or tube 484 without negative pressure / suction (e.g., from a vacuum 492) removing the therapeutic material 482 from the bag 480 or tube 484. The filter may be removable or selectively located in a non-filtration configuration when re-delivering the therapeutic material 482, for example, through the tube 484 and bag 480. In another embodiment, the regulator 488 may be a valve. The valve may be located inside 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 into the tube 484 and bag 480. The valve also assists in holding 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 or negative pressure / suction) is applied, the valve allows fluid, rather than the therapeutic material 482, to pass through the valve. Furthermore, in some embodiments, when a second pressure level (e.g., either positive or negative pressure / suction) higher than the first pressure level is applied, the valve allows both fluid and therapeutic material 482 to pass through the valve.

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

[0068] These steps are repeated as many times as necessary to help the wound, anastomosis, or pocket heal or shrink. Furthermore, bag 480 is emptied and refilled without removing or repositioning bag 480 or tube 484.

[0069] The various embodiments described herein may help improve at least one of the efficacy of treatment and recovery from the procedure, for example, in 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 reduce or minimize at least one of the need for or reliance on imaging or visualization for sponge placement. For example, the various embodiments described herein allow for the delivery of porous and / or absorbent materials, such as sponges or therapeutic materials, to the treatment site, the removal of sponges or therapeutic materials (either by disassembly, physical removal, or a combination thereof), and the delivery of another sponge or further therapeutic material to the treatment site without the redelivery or repositioning of various insertion devices. Furthermore, the various embodiments described herein may be packaged as a kit used to treat a patient.

[0070] In some embodiments, the sponges described herein may be biocompatible and biodegradable. Furthermore, different layers or parts of the sponge may decompose at different rates. For example, different layers or parts of the sponge may be formed of different thicknesses, different materials, different densities, different mixtures of materials, etc. Thus, the sponge changes in at least one of its size and shape over time, and this change in at least one of its size and shape corresponds to a change in at least one of its size and shape of a wound, anastomosis, pocket, etc. This may reduce the need for physicians to remove or replace the sponge. Additionally, the sponge may contain one or more antimicrobial layers and / or materials, thereby aiding in reducing the risk of infection or promoting healing and size reduction of wounds, anastomosis, pockets, etc.

[0071] Furthermore, the sponge (formed, for example, by spray foam) or the therapeutic material (in bag 480) may take the shape of the wound, anastomosis, or pocket. In this embodiment, the need for or reliance on imaging or visualization for sizing, positioning, etc., of the sponge is reduced or minimized. For example, a physician may not need to cut or shape the sponge to fit at least one of the size and shape of the wound, anastomosis, or pocket. The entire therapeutic material does not need to be delivered or removed in one go through the patient's opening. Moreover, in some embodiments of the present invention, the sponge or therapeutic material may take the shape of at least one of the size and shape of the wound, anastomosis, or pocket, even if at least one of the size and shape of the wound, anastomosis, or pocket changes during the healing process.

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

[0073] While the principles of the present invention have been described herein with reference to exemplary embodiments relating to various applications, it should be understood that the present invention is not limited thereto. Those skilled in the art and those utilizing the teachings provided herein will be able to understand further modifications, applications, embodiments, and substitutions of equivalents, all of which fall within the scope of the embodiments described herein. Therefore, the present invention should not be considered limited by the foregoing description.

Claims

1. A source of material that expands after being deployed in the body lumen to form a porous body, A first tube for delivering the material into the body lumen, A second tube for applying suction to the porous body, A medical system equipped with these features.

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

3. The medical system according to claim 2, wherein the material includes a liquid-phase polyurethane foam that expands or solidifies upon contact with moisture or air.

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

5. The medical system according to any one of claims 1 to 4, wherein the first tube comprises at least two lumens, the material comprises two liquids delivered through the first tube and through different lumens of the two lumens, and the two liquids solidify upon contact with each other to form the porous body.

6. The medical system according to any one of claims 1 to 5, wherein the material expands to take the shape of a pocket into which the material 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, further comprising a removal device having a plurality of arms that are expandable to form a cage, wherein the arms are formed of a shape memory alloy and are self-expanding.

9. The medical system according to claim 8, wherein at least one of the arms includes a bent portion such that at least one of the arms extends radially outward and the distal portion of the at least one arm bends radially inward.

10. The medical system according to claim 8 or 9, wherein the cage is movable within the lumen of the insertion device, and proximal movement of the cage within the lumen of the insertion device causes at least partial contraction of the cage.

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

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

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

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

15. The medical system according to 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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