Medical treatment system and related method

Abstract

A medical system comprising a compressible device and a covering on the compressible device, the covering having a delivery configuration and a deployed configuration, wherein in the delivery configuration the covering at least partially covers the compressible device to maintain the compressible device in a compressed state, and in the deployed configuration the covering is releasable from the device to transition the compressible device from the compressed state to an expanded state.

Description

Technical Field

[0001] The present disclosure generally relates to medical treatment systems, devices, and related methods. Embodiments of the present disclosure relate to intraluminal wound treatment systems and medical devices for negative pressure wound closure.

Background Art

[0002] Endoscopic and open surgeries of the gastrointestinal (GI) tract include, among others, for example, colectomy, bariatric surgery, esophagectomy, gastric bypass, and sleeve gastrectomy. These surgeries can lead to perforations, postoperative leaks, or other wounds of the tube. To address such wounds, there are limited treatment options with significant morbidity and mortality. The options include surgical reoperation and endoscopic placement of stents or clips. Surgical procedures are relatively invasive and have high morbidity and mortality. Endoscopic stent placement is a less invasive option. However, the placed stent may move from the intended location and / or may surround an infection at the treatment site and inhibit drainage.

Summary of the Invention

[0003] According to one example, a medical system may include a compressible device and a coating on the compressible device, the coating including a delivery configuration and a deployed configuration, in the delivery configuration the coating at least partially covers the compressible device to maintain the compressible device in a compressed state, and in the deployed configuration the coating is releasable from the device to transition the compressible device from the compressed state to an expanded state.

[0004] In another example, the medical system may further include a suction tube, the suction tube being connected to a proximal portion of the compressible device, the suction tube being configured to apply a suction force to the compressible device.

[0005] In another example, the compressible device may be porous and absorbent. In another example, the coating may be a capsule. The capsule may be removable by exposure to a fluid.

[0006] In another example, the coating may be a net. The medical system may further include a thread or wire coupled to the net, and the thread or wire is configured to remove the net via a force applied to the thread or wire. The net may be configured to be removable when the compressible device is pushed against the breaking point of the net. The net may be configured to be tightened to further compress the compressible device.

[0007] In another example, the coating may be a membrane. The membrane may be impermeable. The membrane may be configured to compress the compressible device via a vacuum seal. The membrane may be removable by exposure to a fluid. The membrane may be configured to be removable when the compressible device is pushed against the breaking point of the membrane.

[0008] In another example, the coating may completely cover the compressible device. According to another example, a medical system may include a compressible device, a coating on the compressible device, a first tube coupled to a proximal portion of the compressible device, and a second tube including a lumen that houses the first tube. The proximal end of the lumen is configured to communicate with a suction source. The coating is fixed to a distal portion of the second tube to house and seal the compressible device within a cavity of the coating. The coating is configured to be crushed onto the compressible device via a suction force supplied to the cavity, thereby compressing the compressible device. The coating may be an impermeable membrane. The compressible device is configured to be compressed while fitting within the lumen of the second tube. The coating may be configured to be removable from the second tube.

[0009] According to another example, a method of treating an intraluminal wound via a medical device including a compressible device, a coating on the compressible device, and a tube coupled to the compressible device may include placing the medical device within a cavity of the wound, removing the coating on the compressible device, and providing a suction force through the tube to the entire compressible device.

Brief Description of the Drawings

[0010] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate various exemplary embodiments and, together with the description, serve to explain the principles of the disclosed embodiments.

Figure 1

Figure 2A

Figure 2B

Figure 3

Figure 4A

Figure 4B

Modes for Carrying Out the Invention

[0011] Aspects of the present disclosure will now be referred to in detail, examples of which are shown in the accompanying drawings. As far as possible, the same or similar reference numerals will be used throughout the drawings to refer to the same or similar parts. The term "distal" refers to the part that is farthest from the user when introducing the device into a subject (e.g., a patient). Conversely, the term "proximal" refers to the part that is closest to the user when installing the device into the subject.

[0012] The above general description and the following detailed description are both exemplary and for illustrative purposes only, and do not limit the features as claimed. As used herein, the terms "comprise", "comprising", "having", "including" or other variations thereof are intended to cover the contents non-exclusively, so a process, method, item, or device comprising a list of elements does not include only these elements, but may also include other elements explicitly described or other elements inherent to such a process, method, item, or device. In the present disclosure, relative terms such as "about", "substantially", "generally", and "approximately" are used to indicate a possible variation of ±10% in the described value or property.

[0013] Embodiments of the present disclosure include devices, systems, and methods for endoluminal vacuum therapy (EVAC). In an example, EVAC includes the intraluminal placement of a sponge or other similar material at a wound site including perforations, leaks, anastomoses, etc. The placement of the material may be inserted into the GI tract through a natural opening by a catheter, scope (endoscope, bronchoscope, colonoscope, gastric camera, duodenoscope, etc.), tube, or sheath. The opening may be, for example, the nose, mouth, or anus, and the placement may be in any part of the GI tract including the esophagus, stomach, duodenum, large intestine, and small intestine. The placement may also be in other organs accessible through the GI tract. Thereafter, negative pressure may be delivered to the wound site within the GI tract via a vacuum source.

[0014] Furthermore, in embodiments of the present disclosure, the sponge of the EVAC device may be any suitable biocompatible material that can absorb liquid and / or allow liquid to pass through it by negative pressure. The material may be flexible, compressible, porous, hydrophilic, sterile, and / or disposable. The sponge material may be an open-cell foam. Suitable materials include polyurethane, ester, ether, composite materials, and any medical material.

[0015] In the embodiments described below, the compressible sponge is in a compressed state by various means and mechanisms such as, for example, coatings, membranes, etc. Thereby, the compressed sponge may be deliverable more easily through the working channel of the scope and through the natural body lumen of the target. The coating is configured to be releasable or removable by any suitable method such as, for example, shearing, breaking, dissolving / degrading, etc., so that the compressed sponge can expand and expand when delivered to the target site.

[0016] Referring to FIG. 1, a medical system 5 including a scope such as an endoscope, for example, is shown according to an embodiment. The medical system 5 includes a flexible shaft 50 (such as a catheter) and a handle 52 coupled to the proximal end of the flexible shaft 50. The handle 52, or some other device for actuating or controlling the medical system 5 and any tools or devices associated with the medical system 5, includes a first actuating device 42 and a second actuating device 43 that control the joints of the flexible shaft 50 and / or the articulation joint at the distal end of the flexible shaft 50 in a plurality of directions. The devices 42, 43 may be, for example, rotatable knobs that rotate about an axis to push / pull an actuating element (not shown). An actuating element such as a cable or wire suitable for a medical procedure (such as medical plastic or medical metal) extends distally from the proximal end of the medical system 5 and is coupled to the flexible shaft 50 to control its operation. Alternatively, or in addition, the user may operate the actuating element independently of the handle 52. The distal end of the actuating element may extend through the flexible shaft 50 and terminate at the articulation joint and / or the distal tip of the flexible shaft 50. For example, one or more actuating elements may be coupled to the articulation joint, and by actuation of the actuating element, the distal end of the articulation joint or the flexible shaft 50 may be controlled to move in a plurality of directions.

[0017] In addition, one or more electrical cables (not shown) may extend from the proximal end of the system 5 to the distal end of the flexible shaft 50, provide electrical control to imaging, illumination, and / or other electrical devices at the distal end of the flexible shaft 50, and transmit imaging signals proximally from the distal end of the flexible shaft 50 to be processed and / or displayed on a display. The handle 52 may also include ports 54, 46 for introducing and / or removing tools, fluids, or other materials from the patient. Ports 54 and / or port 46 may be used to introduce tools. Ports 54 and / or port 46 may also be centrally connected for introducing fluids, suction, and / or wiring electrical components. For example, as shown in FIG. 1, port 54 receives a tube 100 that extends through the working channel 50a of shaft 50 from the proximal end to the distal end of the flexible shaft 50.

[0018] As shown in FIG. 1, system 5 may be means for delivering tube 100 and medical device 10 into the body of a subject. Tube 100 is not particularly limited. For example, tube 100 may have a single lumen (not shown) configured to be connected to a vacuum source (not shown) at the proximal end. The distal end of tube 100 is coupled to medical device 10. Thus, communication between the vacuum source and medical device 10 can be established by the lumen of tube 100. This communication may be established after medical device 10 and tube 100 have been delivered into the body of the subject and removed from medical system 5. Alternatively, this communication may be established while medical device 10 and tube 100 are maintained within medical system 5. In other embodiments, tube 100 is maintained within the body of the subject and exits the subject through a nasogastric tube. The methods of placement and delivery are not limited. Medical device 10 may apply negative pressure to the surrounding wound, thereby assisting the device 10 in absorbing and suctioning any fluid from the wound. Additionally, the application of negative pressure to the wound via device 10 may be therapeutic and may promote wound healing. The vacuum source is not particularly limited and may be any suitable source.

[0019] Referring to FIGS. 2A through 2B, an embodiment of the medical device 10 of FIG. 1 will be further described. The medical device 10 can be a device used for intraluminal wound treatment, such as an EVAC device, for example. Thus, the medical device 10 may be in a form that can be delivered to a wound, such as a leak, cyst, perforation, etc., via a tube 100. When the device 10 is delivered to the wound, it may then transition to a deployed form in preparation for treatment.

[0020] The medical device 10 includes the compressed porous body / sponge 12 and the capsule coating 14 as described above. Since the sponge 12 can be compressed to some extent, together with the capsule 14, it can fit within any suitable scope of the working channel and can be delivered through the natural body lumen of the subject. The method by which the compressed sponge 12 fits within the capsule 14 is not particularly limited and may be by any suitable method. For example, the sponge 12 may be inserted after compression into the already formed capsule coating 14. In another example, the sponge 12 may be coated during compression by the capsule coating that forms the capsule coating 14.

[0021] Capsule 14 encloses the compressible sponge 12 entirely, but is not limited thereto. In other typical embodiments, capsule 14 may partially cover sponge 12. Capsule 14 may be composed of any suitable material that can withstand the expandable property of the compressed sponge 12 and the outward force generated by the compressed sponge 12. Additionally, capsule 14 may be composed of any suitable material configured to dissolve when exposed to any type of fluid containing a fluid having a predetermined pH. Thus, for example, capsule 14 may dissolve immediately or gradually when placed in the subject's body via the gastrointestinal tract and when in contact with the fluid in the subject's body. Alternatively, capsule 14 may dissolve when exposed to a fluid such as physiological saline from an external factor via tube 100 or another tool. Suitable materials for capsule 14 include gelatin or other collagen derivatives, hypromellose (HPMC) or other cellulose derivatives, starch, and absorbent polysaccharides. In other typical embodiments, capsule 14 may be formed from a suture or mesh material wrapped around sponge 12 to compress it, as described below. The thickness of the layer of capsule 14 is not particularly limited as long as it allows both the delivery of device 10 and the deployment of sponge 12. A suitable thickness of capsule 14 may depend on the material of capsule 14 and may include, for example, a thickness of 100 μm (100 microns) or more. Thus, device 10 may include a delivery configuration in which the compressed sponge 12 is housed within capsule 14 and a deployment configuration in which capsule 14 is removed or dissolved and sponge 12 is expanded.

[0022] Medical device 10 also includes an opening 16 through which the end of tube 100 is inserted and thus can be connected to the device 10. The opening 16 extends through both the capsule 14 and the sponge 12. The opening 16 may be on the proximal end / surface of the device 10. The opening 16 may have any suitable diameter that allows a snug fit over the tube 100. Additionally, the opening 16 may have any suitable depth that allows a sufficient amount of negative pressure to be distributed throughout the device 10 when the device 10 is deployed to a wound while allowing a snug fit over the tube 100. Since the sponge 12 is connected to the tube 100, the interconnected channels, open cells, or continuous pores of the sponge 12 allow fluid and material to be suctioned into the tube 100.

[0023] The method and order in which the medical device 10 is formed are not particularly limited. In some exemplary embodiments, the opening 16 may be formed in the sponge 12 prior to compression of the sponge 12, and the tube 100 may be inserted into the opening 16. Thereafter, the sponge 12 may be compressed, for example, by drying the sponge 12 and / or applying a suction force to the sponge 12 to close the pores and channels in the sponge 12. During or after compression, the capsule 14 may conform or be formed over the compressed sponge 12 while adapting to the tube 100. The capsule may be placed over the sponge 12 by any suitable method including coatings or wrappings including, for example, spray coating, dip coating, etc.

[0024] Referring to FIGS. 1 and 2A - 2B, an example of a method by which the medical device 10 can be delivered and used is further described below. The user may deliver the device 10 into the subject's body through a natural opening (such as the mouth or anus, etc.) while in the delivery configuration. The device 10 may move through the tortuous natural body lumen of the subject, such as the esophagus, stomach, colon, etc. The device 10 may be delivered by inserting the device 10 including the tube 100 into the port 54 of the endoscope 5 in any suitable manner, such as through the working channel 50a of the endoscope 5 via the tube 100. Alternatively, the device 10 and the tube 100 may be placed into the patient via a nasogastric tube. The user may move / position the device 10 for intraluminal wound treatment within a wound such as a perforation, leak, cyst, cavity, etc. The user may then expose the capsule 14 to a fluid, either in the body or external, thereby removing the capsule coating 14 to transition the device 10 to the deployed configuration. The compressed sponge 12 may then expand within the wound, for example, until an appropriate pressure is applied against the wall of the wound. The user may then remove the endoscope 5 from the delivered tube 100 and device 10. Thereafter, the user may couple the proximal end of the tube 100 to a vacuum source and then activate the vacuum source at any suitable time to supply suction or negative pressure to the sponge 12 through the lumen of the tube 100. Alternatively, while the device 10 is in the delivery configuration, the user may initiate the supply of suction.

[0025] Medical device 10’ as shown in FIG. 3 is similar to device 10 in many respects. Like reference numerals refer to like parts. The differences between device 10 and device 10’ are described below. Instead of a capsule coating, device 10’ includes a net 24 wrapped around a sponge 12. Similar to capsule 14 of device 10, net 24 can be implemented to compress sponge 12 and accommodate sponge 12 via the mechanical pressure of net 24 while maintaining its shape. Since net 24 compresses and accommodates sponge 12, device 10’ can be deliverable through the working channel of a scope such as endoscope 5, for example. Net 24 may be composed of any suitable material and is not particularly limited. Suitable materials for net 24 include any suitable polymer such as nylon or polypropylene. Further, the method by which net 24 is knitted is not particularly limited. Net 24 may be applied in a spiral, cross, irregular, or other pattern by any suitable method.

[0026] Device 10’ further includes a control thread or wire 26 coupled to net 24. Wire 26 is coupled to, but not limited to, the proximal portion of net 24 in FIG. 3. Control wire 26 may be a thread of net 24 or an individual thread or wire component. Wire 26 may be configured to strip or remove net 24 by an appropriate force applied to wire 26 such as a pulling force. Wire 26 may extend through the lumen of tube 100 (not shown) or may extend outside the lumen of tube 100 as shown, and the proximal end of wire 26 may be coupled to a controller or mechanism (not shown) configured to apply the necessary force to wire 26 to remove net 24. Alternatively, the proximal end of wire 26 may be free and pulled proximally by a user. Thus, wire 26 can assist in transitioning device 10’ from a delivery configuration to a deployed configuration. In an embodiment, the net may be formed from a material that will decompose or dissolve upon contact with a fluid.

[0027] However, device 10' is not limited to including control wire 26. In some other embodiments, device 10' may not have wire 26 and may include other suitable mechanisms configured to remove net 24 and deploy sponge 12. For example, net 24 may include a breaking point such as a stress riser so that net 24 is broken when sponge 12 advances and is pushed in against the breaking point of net 24. In some exemplary embodiments, such a breaking point may be found at the distal end of net 24. Alternatively, net 24 may be severed from sponge 12 by an endoscopic forceps or other tool.

[0028] The method and order in which medical device 10' is formed, such as medical device 10, are not particularly limited. In some exemplary embodiments, aperture 16 may be formed in sponge 12 prior to compression of sponge 12, and tube 100 may be inserted into aperture 16. Thereafter, sponge 12 may be compressed, for example, by applying a suction force. After compression, net 24 may be adapted to the compressed sponge 12 while also being adapted to tube 100. In other exemplary embodiments, net 24 may be adapted onto sponge 12 prior to compression, and net 24 may be tightened to mechanically compress and contain sponge 12.

[0029] Device 10' can be used in a manner similar to device 10, except that device 10' can be transitioned to a deployed configuration by the user removing net 24 via wire 26 or any other suitable method / mechanism.

[0030] Medical device 10", as shown in FIGS. 4A through 4B, is also similar to device 10 in many respects. Like reference numerals refer to like parts. The differences between device 10 and device 10" are described below. Instead of a capsule coating, device 10" includes a membrane 34. Membrane 34 is not particularly limited and may be composed of any suitable impermeable material such as, for example, flexible plastic, latex, etc. Membrane 34 may be flexible and / or elastic. The thickness of membrane 34 is also not particularly limited. Membrane 34 encloses sponge 12 by being fixed to the distal portion outside delivery tube / catheter 102. Membrane 34 may be fixed around the entire circumference of the distal portion of catheter 102. Catheter 102 is flexible and may be sized to fit within working channel 50a of scope 50. Catheter 102 includes an inner channel 102a that receives tube 100. Tube 100 moves axially within channel 102a. As shown in FIG. 4A, membrane 34 may form a cavity 36 that houses sponge 12 in a non-compressed state.

[0031] Since the catheter 102 can be connected to a vacuum source, the channel 102a communicates with the cavity 36 formed by the membrane 34. To transition the device 10” from its default deployed configuration to a compressed delivery configuration, the vacuum source may transmit a suction force distally through the channel 102a to reach the cavity 36 of the device 10”. As a result of the suction force and the impermeable membrane 34 being fixed to the catheter 102, the membrane 34 collapses onto the sponge 12, thereby uniformly compressing the sponge 12 as shown in FIG. 4B. The compressed sponge 12 can then be stored in the channel 102a by proximally pulling the tube 100, maintaining its compressed state. The membrane 34 may then be removed or maintained. The device 10” may be left in such a delivery configuration during the manufacture of the device. This may potentially enable the sponge 12 to be attached to the delivery system with reduced tension, thus potentially avoiding damage. Alternatively, the device 10” may be maintained in the state as shown in FIG. 4B. However, to maintain the device 10” in the delivery configuration shown in FIG. 4B, continuous transmission of the suction force through the working channel 50a may be required if the sponge 12 cannot withstand prolonged compression. Alternatively, the membrane 34 may be composed of a material that maintains the compressed configuration of FIG. 4B when the suction force is present.

[0032] The deployed form of the device 10” is not particularly limited. For example, when the compressed sponge 12 is stored in the channel 102a as described above, the sponge 12 may extend distally outside the catheter 102 and be deployed in the targeted wound. In an example where the membrane 34 is maintained, the distal end of the membrane 34 may be provided with a slit (e.g., having a perforated or fragile region) so that the sponge 12 can be deployed through the slit. In other examples, when the device 10” is maintained in the form shown in FIG. 4B, the membrane 34 can be removed when the device 10” is delivered to the targeted wound. The method for the membrane 34 to be removable is not particularly limited, and for example, additional tools (such as grasping tools) may be used. In some typical embodiments, the membrane 34 may be composed of a biodegradable material so that it can be dissolved when it reaches the targeted wound. In other typical embodiments, the membrane 34 may include means such as perforations or thinning portions for it to be destructible or rupturable, so that the membrane 34 can be destroyed or ruptured when the sponge 12 is carried forward (distally). Once deployed, the compressed sponge 12 can naturally expand back to its pre-compression state until it reaches a fully expanded state and / or applies pressure to the walls of the wound area. In another embodiment, the catheter 102 may be omitted from the embodiments of FIGS. 4A to 4B, and the membrane 34 may be fixed around the entire circumference of the distal portion of the tube 100. The membrane 34 will be crushed and the sponge 12 will be compressed by the suction force applied through the tube 100.

[0033] Except that the user can transition the device 10” to the deployed form by removing or destroying the membrane 34 through the methods or mechanisms described above, the device 10” can be used in a manner similar to the device 10.

[0034] It will be apparent to those skilled in the art that various modifications and variations can be made to the disclosed apparatus without departing from the scope of the present disclosure. Other embodiments of the present disclosure will be apparent to those skilled in the art upon consideration of the specification and practice of the invention disclosed herein. The specification and examples are intended to be considered exemplary only, with the true scope and spirit of the invention being indicated by the following claims.

Claims

1. A compressible device, A covering on the compressible device, the covering including a delivery configuration and a deployment configuration, the covering being a net, A thread or wire coupled to the net, the thread or wire configured to remove the net via a force applied to the thread or the wire, Comprising, In the delivery configuration, the covering at least partially covers the compressible device to maintain the compressible device in a compressed state, In the deployment configuration, the covering is releasable from the compressible device and causes the compressible device to transition from the compressed state to an expanded state, a medical system.

2. Further comprising a suction tube, the suction tube being coupled to a proximal portion of the compressible device, the suction tube configured to apply a suction force to the compressible device, the medical system according to claim 1.

3. The compressible device is porous and absorbent, the medical system according to claim 1 or claim 2.

4. A compressible device, A covering on the compressible device, the covering including a delivery configuration and a deployment configuration, the covering being a net, Comprising, In the delivery configuration, the covering at least partially covers the compressible device to maintain the compressible device in a compressed state, In the deployment configuration, the covering is releasable from the compressible device and causes the compressible device to transition from the compressed state to an expanded state, The net is configured to be removable when the compressible device is pushed against a breaking point of the net, a medical system.

5. The net is configured to be tightened to compress the compressible device, the medical system according to claim 1.

6. The force applied to the thread or the wire is a pulling force, the medical system according to claim 1.

7. The thread or the wire is configured to be pulled proximally, the medical system according to claim 1.

8. The thread or the wire is coupled to a controller or mechanism configured to exert the force applied to the thread or the wire, the medical system according to claim 1.

9. The thread or the wire is coupled to the controller or the mechanism at a proximal end of the thread or the wire, the medical system according to claim 8.

10. The medical system according to claim 1, wherein the thread or the wire is coupled to a proximal portion of the net.

11. The medical system according to claim 1, wherein the thread or the wire is part of the net.

12. The medical system according to claim 1, wherein the net comprises a polymeric material.

13. The medical system according to claim 1, wherein the net is configured to decompose or dissolve when contacted with a fluid.

14. The medical system according to claim 1, wherein the net is applied onto the compressible device in a spiral pattern, a cross pattern, or an irregular pattern.

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