Medical system and method related thereto

Abstract

A medical system includes a compressible device and a covering over the compressible device, wherein the covering includes 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 wherein 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

[0001] Cross-references to related applications

[0002] This application claims the benefit of priority to U.S. Provisional Application No. 62 / 982,206, filed February 27, 2020, which is incorporated herein by reference in its entirety. Technical Field

[0003] This invention generally relates to medical systems, devices, and related methods. Embodiments of this invention relate to endocavitary wound treatment systems and medical devices for negative pressure wound therapy. Background Technology

[0004] Endoscopic and open surgical procedures of the gastrointestinal tract (GI) include, for example, colectomy, bariatric surgery, esophagectomy, gastric bypass, and sleeve gastrectomy. These procedures can result in perforation, postoperative leakage, or other wounds in the duct. Limited treatment options exist for managing such wounds, which have significant morbidity and mortality rates. Options include surgical reoperation and endoscopic placement of stents or clips. Surgery is relatively invasive and also has high morbidity and mortality rates. Endoscopic stent placement is a less invasive option. However, the placed stent may migrate from its intended location and / or isolate infection at the treatment site, thus inhibiting drainage. Summary of the Invention

[0005] According to one example, a medical system may include a compressible device and a cover on the compressible device, wherein the cover includes a delivery mode and an unfolded mode, wherein in the delivery mode, the cover at least partially covers the compressible device to keep the compressible device in a compressed state, and wherein in the unfolded mode, the cover can be released from the device to change the compressible device from a compressed state to an expanded state.

[0006] In another example, the medical system may also include a suction tube connected to a proximal portion of the compressible device, and the suction tube is configured to apply suction to the compressible device.

[0007] In another example, the compressible device can be porous and absorbent.

[0008] In another example, the covering can be a capsule. The capsule can be removed by exposing it to fluid.

[0009] In another example, the covering can be a net. The medical system may also include wires or cables connected to the net, wherein the wires or cables are configured to remove the net by force applied to the wires or cables. The net may be configured to be removed when a compressible device pushes the net to a break point. The net may be configured to tighten to further compress the compressible device.

[0010] In another example, the covering can be a membrane. The membrane can be impermeable. The membrane can be configured to compress the compressible device via a vacuum seal. The membrane can be removed by exposure to a fluid. The membrane can be configured to be removed when the compressible device pushes against the membrane's fracture point.

[0011] In another example, the covering could completely cover the compressible device.

[0012] According to another example, a medical system may include a compressible device, a cover on the compressible device, a first tube connected to a proximal portion of the compressible device, and a second tube, the second tube including a lumen containing the first tube, wherein a proximal end of the lumen is configured to communicate with a suction source, wherein the cover is secured to a distal portion of the second tube to contain and seal the compressible device within the cavity of the cover, and the cover is configured to collapse onto the compressible device via suction applied to the cavity, thereby compressing the compressible device. The cover may be an impermeable membrane. The compressible device may be configured to compress such that the compressible device fits within the lumen of the second tube. The cover may be configured to be removable from the second tube.

[0013] According to another example, an endocavitary wound treatment method via a medical device may include positioning the medical device within the cavity of the wound, removing a covering on a compressible device, and providing suction throughout the compressible device via a tube, the medical device including the compressible device, a covering on the compressible device, and a tube connected to the compressible device. Attached Figure Description

[0014] 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.

[0015] Figure 1 This is a side view of a portion of the axis of an endoscope comprising a medical device for treating endocavitary wounds according to one embodiment;

[0016] Figures 2A to 2B These are, respectively, perspective and cross-sectional views of a compression medical device for intracavitary vacuum therapy according to one embodiment;

[0017] Figure 3 This is a perspective view of a compression medical device for intracavitary vacuum therapy according to another embodiment;

[0018] Figures 4A to 4B This is a cross-sectional view of a medical device for intracavitary vacuum therapy, which is in an expanded and compressed state, respectively, according to another embodiment. Detailed Implementation

[0019] Reference will now be made in detail to various aspects of the invention, examples of which are illustrated in the accompanying drawings. Wherever 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 furthest from the user when the device is introduced into the body of a subject (e.g., a patient). Conversely, the term "proximal" refers to the part closest to the user when the device is placed into the body of a subject.

[0020] The foregoing general description and the following detailed description are exemplary and explanatory only, and not intended to limit the features of the claims. As used herein, the terms “comprising,” “containing,” “having,” “including,” or other variations thereof are intended to cover non-exclusive contents such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements, but may also include other elements not expressly listed or not inherent to such process, method, article, or apparatus. In this disclosure, relative terms such as, for example, “about,” “substantially,” “roughly,” and “about” are used to indicate possible variations of ±10% in said values ​​or characteristics.

[0021] Embodiments of the present invention include apparatus, systems, and methods for endocavitary vacuum therapy (EVAC). In examples, EVAC involves intracavitary placement in a sponge or other similar material at the wound site, including perforations, leaks, anastomoses, etc. The material can be placed via a catheter, endoscope (endoscope, bronchoscope, colonoscope, gastroscopy, duodenoscope, etc.), tube, or sheath (inserted into the GI tract through a natural orifice). The orifice can be, for example, the nose, mouth, or anus, and placement can occur in any part of the GI tract, including the esophagus, stomach, duodenum, large intestine, or small intestine. Placement can also occur in other organs accessible via the GI tract. Subsequently, negative pressure can be delivered to the wound site within the GI tract via a vacuum source.

[0022] Furthermore, in embodiments of the present invention, the sponge in the EVAC device can be any suitable biocompatible material capable of absorbing liquids and / or allowing liquids to pass through it via negative pressure. The material can be flexible, compressible, porous, hydrophilic, sterile, and / or disposable. The sponge material can be open-cell foam. Suitable materials include polyurethane, esters, ethers, composite materials, and any medical-grade material.

[0023] In the embodiments described below, the compressible sponge is compressed via various means and mechanisms, such as covers, films, etc. This allows the compressed sponge to be more easily delivered through the working channel of the endoscope and through the subject's natural body cavity. The covers are configured to be released or removed in any suitable manner, such as cutting, breaking, dissolving / degrading, so that the compressed sponge can unfold and expand once delivered to the target site.

[0024] refer to Figure 1 The image illustrates a medical system 5 according to one embodiment, which includes a mirror, such as an endoscope. The medical system 5 includes a flexible shaft 50 (e.g., a catheter) and a handle 52 connected 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 tool or device associated with the medical system 5, includes first and second actuating devices 42, 43 that control the hinge of the flexible shaft 50 and / or a hinge joint located at the distal end of the flexible shaft 50 in multiple directions. Devices 42, 43 may be, for example, rotatable knobs that rotate about their axis to push / pull an actuating element (not shown). The actuating element, such as a cable or wire suitable for medical procedures (e.g., medical-grade plastic or metal), extends distally from the proximal end of the medical system 5 and is connected to the flexible shaft 50 to control its movement. Alternatively or additionally, a user can 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 hinge joint and / or distal tip of the flexible shaft 50. For example, one or more actuating elements may be connected to the articulated joint, and actuation of the actuating elements may control the articulated joint or distal end of the flexible shaft 50 to move in multiple directions.

[0025] Additionally, one or more cables (not shown) may extend from the proximal end of system 5 to the distal end of flexible shaft 50, and may provide electrical control for imaging, illumination, and / or other electrical devices at the distal end of flexible shaft 50, and may transport imaging signals proximally from the distal end of flexible shaft 50 for processing and / or display on a monitor. 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 46 may be used for introducing tools. Ports 54 and / or 46 may also connect to an umbilical cord for introducing fluids, aspiration, and / or wiring for electronic components. For example, as... Figure 1 As shown, port 54 receives tube 100, which extends from the proximal end to the distal end of flexible shaft 50 via working channel 50a of shaft 50.

[0026] like Figure 1As shown, system 5 can be a device through which tube 100 and medical device 10 can be delivered within 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 its proximal end. The distal end of tube 100 is coupled to medical device 10. Thus, the lumen of tube 100 can establish communication between the vacuum source and medical device 10. This communication can be established after medical device 10 and tube 100 have been delivered within the subject and removed from medical system 5. Alternatively, this communication can be established while medical device 10 and tube 100 remain within medical system 5. In other embodiments, tube 100 remains within the subject and exits the subject via a nasogastric tube. The placement and delivery method is not limited. Medical device 10 can then apply negative pressure to the surrounding wound, thereby assisting device 10 in absorbing and aspirating any fluid from the wound. Furthermore, applying negative pressure to the wound via device 10 can be therapeutic and accelerate wound healing. The vacuum source is not particularly limited and can be any suitable source.

[0027] refer to Figures 2A to 2B It also describes Figure 1 One embodiment of the medical device 10. The medical device 10 can be a device for treating intracavitary wounds, such as an EVAC device. Therefore, the medical device 10 can be in a configuration that allows delivery to a wound, such as a leak, cyst, perforation, etc., via a tube 100. Once delivered to the wound, the device 10 can then be converted to a configuration in which the device 10 is deployed and ready for treatment.

[0028] The medical device 10 includes a compressible porous body / sponge 12 and a capsule cover 14 as described above. The sponge 12 can be compressed to a degree that it, together with the capsule 14, can be fitted into the working channel of any suitable endoscope and can be delivered through the subject's natural body cavity. The manner in which the compressed sponge 12 is fitted into the capsule 14 is not particularly limited and can be any suitable manner. For example, after compression, the sponge 12 can be inserted into a pre-formed capsule cover 14. In another example, during compression, the sponge 12 can be coated with the capsule coating that forms the capsule cover 14.

[0029] The capsule 14 completely encapsulates, but is not limited to, the compressed sponge 12. In other exemplary embodiments, the capsule 14 may partially cover the sponge 12. The capsule 14 may be any suitable material capable of withstanding the expandable properties of the compressed sponge 12 and the outward forces generated therefrom. Additionally, the capsule 14 may be any suitable material configured to dissolve upon exposure to any type of fluid, including fluids having a predetermined pH. Thus, for example, the capsule 14 may dissolve immediately or gradually upon contact with a fluid inserted into and from the subject via the gastrointestinal tract. Alternatively, the capsule 14 may dissolve when exposed to a fluid from an external source, such as saline, via tube 100 or another tool. Suitable materials for the capsule 14 include gelatin or other collagen derivatives, hydroxypropyl methylcellulose (HPMC) or other cellulose derivatives, starch, and absorbable polysaccharides. In other exemplary embodiments, the capsule 14 may be formed from sutures or a mesh material wound around the compressed sponge 12, as described below. The thickness of the capsule 14 layer is not particularly limited, as long as it allows for the delivery of the device 10 and the unfolding of the sponge 12. A suitable thickness of the capsule 14 may depend on the material of the capsule 14 and may include a thickness greater than, for example, 100 micrometers. Therefore, the device 10 may include a delivery configuration in which the compressed sponge 12 is contained within the capsule 14; and an unfolding configuration in which the capsule 14 is removed or dissolved and the sponge 12 unfolds.

[0030] The medical device 10 also includes an opening 16 through which the end of the tube 100 can be inserted and thus connected to the device 10. The opening 16 extends through the capsule 14 and the sponge 12. The opening 16 may be on the proximal / proximal surface of the device 10. The opening 16 may have any suitable diameter that allows for a secure fit on the tube 100. Additionally, the opening 16 may have any suitable depth that also allows for a secure fit on the tube 100, while also allowing a sufficient amount of negative pressure to be distributed throughout the device 10 when expanded in the wound. The sponge 12 may be connected to the tube 100 such that interconnecting channels, openings, or continuous passages in the sponge 12 allow fluid and material to be aspirated into the tube 100.

[0031] The manner and sequence of forming the medical device 10 are not particularly limited. In some exemplary embodiments, an opening 16 may be formed in the sponge 12 before compression, and a tube 100 may be inserted into the opening 16. The sponge 12 may then be compressed, for example, by dehydrating the sponge 12 and / or by applying suction to the sponge 12 to close the pores and channels within the sponge 12. During or after compression, a capsule 14 may be fitted or formed on the compressed sponge 12 while simultaneously accommodating the tube 100. The capsule may be placed on the sponge 12 by any suitable method, including coating, e.g., spraying, dipping, etc., or wrapping.

[0032] refer to Figure 1 and Figures 2A to 2B The following further discusses examples of how the medical device 10 can be delivered and used. The user can deliver the device 10 into the body of a subject in its delivery configuration, for example, via a natural orifice (such as the mouth or anus). The device 10 can pass through the subject's tortuous natural body cavities, such as the esophagus, stomach, colon, etc. The device 10 via the tube 100 can be delivered in any suitable manner, for example, through the working channel 50a of the endoscope 5, by inserting the device 10, including the tube 100, into the port 54 of the endoscope 5. Alternatively, the device 10 and the tube 100 can be placed in the patient's body via a nasogastric tube. The user can guide / position the device 10 within wounds, such as perforations, leaks, cysts, or cavities, for endocavitary wound treatment. The user can then convert the device 10 to an expanded configuration by exposing the cyst 14 to fluid within the body or fluid from an external source, thereby removing the cyst coating 14. The compression sponge 12 can then be expanded within the wound, for example, until it applies suitable pressure against the wound wall. The user can then remove the endoscope 5 from the delivery tube 100 and the device 10. The user can then connect the proximal end of the tube 100 to a vacuum source and subsequently turn on the vacuum source at any suitable time to supply suction and negative pressure to the sponge 12 through the lumen of the tube 100. Alternatively, the user can begin supplying suction while the device 10 is in delivery mode.

[0033] like Figure 3 The medical device 10' shown is similar to device 10 in many respects. The same reference numerals refer to the same parts. The differences between device 10 and device 10' will be described below. Instead of a capsule coating, device 10' includes a mesh 24 wrapped around a sponge 12. Similar to the capsule 14 of device 10, the mesh 24 can be implemented to compress and contain the sponge 12 via mechanical pressure while maintaining its shape. The mesh 24 can be compressed and contain the sponge 12 so that device 10' can be delivered through the working channel of a scope, such as an endoscope 5. The mesh 24 can be any suitable material and is not particularly limited. Suitable materials for the mesh 24 include any suitable polymer, such as nylon or polypropylene. Furthermore, the manner in which the mesh 24 is laid is not particularly limited. The mesh 24 can be applied by any suitable method in a spiral, cross, irregular, or other pattern.

[0034] Device 10' also includes a control line or cable 26 connected to network 24. Cable 26 is connected to... Figure 3The net 24 is located near its proximal portion, but is not limited to this. The control wire 26 can be a strand of the net 24 or a separate wire or wire component. The wire 26 can be configured to cut or remove the net 24 by applying a suitable force, such as tension, to the wire 26. As shown, the wire 26 can extend through a cavity (not shown) of the tube 100 or extend outside the cavity of the tube 100, and the proximal end of the wire 26 can be connected to a controller or mechanism (not shown) configured to apply the necessary force to the wire 26 to remove the net 24. Alternatively, the proximal end of the wire 26 can be free and pulled proximally by a user. Thus, the wire 26 can help convert the device 10' from a delivery configuration to a deployment configuration. In embodiments, the net can be formed of a material that degrades or dissolves upon contact with a fluid.

[0035] However, the device 10' is not limited to including the control wire 26. In some other exemplary embodiments, the device 10' may be without the wire 26 and may include other suitable mechanisms configured to remove the mesh 24 and unfold the sponge 12. For example, the mesh 24 may include a break point, such as a stress enhancer, such that the mesh 24 may break when the sponge 12 advances and presses against the break point. In some exemplary embodiments, such a break point may be found at the distal end of the mesh 24. Alternatively, the mesh 24 may be cut from the sponge 12 via endoscopic scissors or other tools.

[0036] Similar to device 10, the manner and order in which medical device 10' is formed are not particularly limited. In some exemplary embodiments, an opening 16 may be formed in sponge 12 before compression, and tube 100 may be inserted into the opening 16. Subsequently, sponge 12 may be compressed, for example, by applying suction. After compression, net 24 may be fitted onto the compressed sponge 12, simultaneously accommodating tube 100. In other exemplary embodiments, net 24 may be fitted onto sponge 12 before compression, and net 24 may be tightened to mechanically compress and contain sponge 12.

[0037] Device 10' can be used in a similar manner to device 10, except that the user can remove net 24 via wire 26 or any other suitable means / mechanism to convert device 10' to unfolded form.

[0038] like Figures 4A to 4BAs shown, medical device 10” is similar to device 10 in many respects. The same reference numerals refer to the same parts. The differences between device 10 and device 10” will be described below. Instead of a capsule coating, device 10” includes a membrane 34. The membrane 34 is not particularly limited and can be any suitable impermeable material, such as flexible plastic, latex, etc. The membrane 34 can be flexible and / or elastic. The thickness of the membrane 34 is also not particularly limited. The membrane 34 encapsulates the sponge 12 by being fixed to the distal portion of the delivery tube / catheter 102. The membrane 34 can be fixed around the full circumference of the distal portion of the catheter 102. The catheter 102 can be flexible and sized to fit within the working channel 50a of the endoscope 50. The catheter 102 includes an inner channel 102a of a receiving tube 100. The tube 100 moves axially within the channel 102a. Figure 4A As shown, the thin film 34 can form a cavity 36, which contains the sponge 12 in an uncompressed state.

[0039] The conduit 102 can be connected to a vacuum source, allowing the channel 102a to be in fluid communication with the cavity 36 formed by the membrane 34. To convert the device 10” from its default expansion mode to a compression delivery mode, the vacuum source can deliver suction distally, through 102a, and downwards to the cavity 36 of the device 10”. Due to suction and the impermeable membrane 34 being secured to the conduit 102, the membrane 34 collapses onto the sponge 12, thereby uniformly compressing the sponge 12, such as... Figure 4B As shown. The compressed sponge 12 can then be retracted into the channel 102a by pulling the tube 100 proximally to maintain its compressed state. The film 34 can then be removed or can be retained. The device 10” can be placed in this conveying configuration during the manufacture of the device. This allows the sponge 12 to be loaded into the conveying system with reduced tension, thus potentially preventing damage. Alternatively, the device 10” can be held as Figure 4B In the state shown. However, if the sponge 12 cannot withstand compression during the extended duration, the device 10” is held in place. Figure 4B In the conveying configuration shown, the suction may need to be continuously transported via the working channel 50a. Alternatively, the film 34 may be held in place without suction. Figure 4B This material is in a compressed form.

[0040] The deployment configuration of device 10” is not particularly limited. For example, when the compressed sponge 12 retracts within channel 102a, as described above, the sponge 12 can extend distally out of the conduit 102 to deploy within the target wound. While retaining the membrane 34, the distal end of the membrane 34 may have a slit (e.g., a perforation or a weakened area) allowing the sponge 12 to deploy through the slit. In other examples, when device 10” is held as... Figure 4BIn the illustrated configuration, the film 34 can be removed as the device 10” is delivered to the target wound. The manner in which the film 34 can be removed is not particularly limited; for example, additional tools (such as grippers) can be used. In some exemplary embodiments, the film 34 can be a biodegradable material, such that the film 34 dissolves upon reaching the target wound. In other exemplary embodiments, the film 34 may include means that can cause it to break or rupture, such as perforations or thinning portions, so that the film 34 can break or rupture as the sponge 12 is driven forward (distally). The compressed sponge 12, once unfolded, can naturally expand to its pre-compressed state until it reaches its fully expanded state and / or applies pressure against the wall of the wound area. In another embodiment, it can be removed from… Figures 4A to 4B In this embodiment, the conduit 102 is omitted, and the membrane 34 can be fixed around the full circumference of the distal portion of the tube 100. Suction applied through the tube 100 will cause the membrane 34 to collapse and compress the sponge 12.

[0041] Device 10” can be used in a similar manner to device 10, except that the user can remove or break the film 34 by means of the above-described method or mechanism to convert device 10” into an unfolded form.

[0042] 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 invention. Other embodiments of the invention will be apparent to those skilled in the art based on consideration of the description and practice of the invention disclosed herein. The description and examples are intended to be illustrative only, and the true scope and spirit of the invention are indicated by the following claims.

Claims

1. A medical system comprising: Compressible device; A cover on the compressible device, wherein the cover has a conveying form and an unfolding form, and wherein the cover is a net; as well as A wire or cable connected to the network, wherein the wire or cable is configured to cut the network by a force applied to the wire or cable; In the aforementioned conveying configuration, the cover at least partially covers the compressible device to keep the compressible device in a compressed state; and In the unfolded state, the covering can be released from the compressible device to change the compressible device from the compressed state to the expanded state.

2. The medical system of claim 1, further comprising a suction tube, wherein the suction tube is connected to a proximal portion of the compressible device, and the suction tube is configured to apply suction to the compressible device.

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

4. The medical system of claim 1, wherein the mesh is configured to be removed when the compressible device pushes the mesh at a break point.

5. The medical system of claim 1, wherein the net is configured to tighten to further compress the compressible device.

6. The medical system of claim 1, wherein the covering completely covers the compressible device.

7. The medical system of claim 1, wherein the force applied to the wire or the wire material is a tensile force.

8. The medical system of claim 7, wherein the wire or the wire material is configured to be pulled proximally.

9. The medical system of claim 1, wherein the wire or the cable is coupled to a controller or mechanism, the controller or the mechanism being configured to apply the force applied to the wire or the cable.

10. The medical system of claim 9, wherein the wire or the cable is coupled to the controller or the mechanism at its proximal end.

11. The medical system of claim 1, wherein the wire or the cable is coupled to the proximal portion of the mesh.

12. The medical system of claim 1, wherein the wire or the wire is part of the mesh.

13. The medical system of claim 1, wherein the mesh comprises a polymer material.

14. The medical system of claim 1, wherein the mesh comprises a material configured to degrade or dissolve upon contact with a fluid.

15. The medical system of claim 1, wherein the mesh is applied to the compressible device in a spiral pattern, a cross pattern, or an irregular pattern.

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