Patent Description:
This disclosure relates generally to medical treatment systems, devices, and related methods thereof. Embodiments of the disclosure relate to endoluminal wound treatment systems, and medical devices for negative pressure wound therapy.

Endoscopic and open surgical procedures of the gastrointestinal (GI) tract include, for example, colonic resection, bariatric surgery, esophagectomy, gastric bypass, and sleeve gastrectomy, among others. These procedures may result in perforation, post-surgical leaks, or other wounds of the tract. Limited treatment options exist for managing such wounds, which have significant morbidity and mortality rates. Options include surgical re-operation and endoscopic placement of a stent or clips. Surgery is relatively invasive and also has high morbidity and mortality rates. Endoscopic stent placement is a less invasive option. The placed stent, however, can migrate from the intended location and/or wall off infection at the treatment site, inhibiting drainage.

<CIT> relates to a medical-technical suction body, in particular for removing wound fluids from human and/or animal body cavities, comprising an envelope for the suction body, the envelope holding the suction body together in a compressed form.

<CIT> relates to a system for a vacuum wound device. The vacuum device includes a compressible sponge, vacuum tubing, and a delivery tube sized to house the wound vacuum device. The wound vacuum device is connected to a vacuum pump which creates and delivers vacuum.

According to an example, a medical system may comprise 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.

In another example, the medical system may further comprise 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 a suction to the compressible device.

In another example, the compressible device may be porous and absorbent.

In another example, not forming part of the claimed invention, the covering may be a capsule. The capsule may be removable via exposure to a fluid.

According to the invention as claimed, the covering is be a netting. The medical system further comprises a thread or a wire coupled to the netting, wherein the thread or the wire is configured to remove the netting via a force applied to the thread or the wire. The netting may be configured to be removable when the compressible device pushes against a breaking point of the netting. The netting may be configured to be tightened to further compress the compressible device.

In another example, not forming part of the claimed invention, the covering 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 via exposure to a fluid. The membrane may be configured to be removable when the compressible device pushes against a breaking point of the membrane.

In another example, the covering may completely cover the compressible device.

According to another example, a medical system may comprise a compressible device, a covering over the compressible device, a first tube connected to a proximal portion of the compressible device, and a second tube including a lumen containing the first tube, wherein a proximal end of the lumen is configured to be in communication with a suction source, wherein the covering is fixed to a distal portion of the second tube to contain and seal the compressible device within a cavity of the covering, and the covering is configured to collapse onto the compressible device via a suction supplied to the cavity, thereby compressing the compressible device. According to an embodiment not forming part of the invention as claimed, the covering may be an impermeable membrane. The compressible device may be configured to compress so that the compressible device fits within the lumen of the second tube. The covering may be configured to be removable from the second tube.

According to another example, not forming part of the invention as claimed, a method of endoluminal wound treatment via a medical device, the medical device including a compressible device, a covering over the compressible device, and a tube connected to the compressible device, may comprise positioning the medical device within a cavity of a wound, removing the covering over the compressible device, and providing a suction throughout the compressible device via the tube.

Reference will now be made in detail to aspects of the disclosure, examples of which are illustrated in the accompanying drawings. Wherever possible, the same or similar reference numbers will be used through the drawings to refer to the same or like parts. The term "distal" refers to a portion farthest away from a user when introducing a device into a subject (e.g., patient). By contrast, the term "proximal" refers to a portion closest to the user when placing the device into the subject.

Both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the features, as claimed. As used herein, the terms "comprises," "comprising," "having," "including," or other variations thereof, are intended to cover a non-exclusive inclusion such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements, but may include other elements not expressly listed or inherent to such a process, method, article, or apparatus. In this disclosure, relative terms, such as, for example, "about," "substantially," "generally," and "approximately" are used to indicate a possible variation of ±<NUM>% in a stated value or characteristic.

Embodiments of this disclosure include devices, systems, and methods for endoluminal vacuum therapy (EVAC). In examples, EVAC includes endoluminal placement of a sponge or other like material into a wound site, including a perforation, a leak, an anastomosis, etc. Placement of the material may be via a catheter, scope (endoscope, bronchoscope, colonoscope, gastroscope, duodenoscope, etc.), tube, or sheath, inserted into the GI tract via a natural orifice. The orifice can be, for example, the nose, mouth, or anus, and the placement can be in any portion of the GI tract, including the esophagus, stomach, duodenum, large intestine, or small intestine. Placement also can be in other organs reachable via the GI tract. Then, negative pressure may be delivered to the wound site in the GI tract, via a vacuum source.

Furthermore, in embodiments of this disclosure, the sponge of the EVAC devices may be any suitable biocompatible material that may absorb liquids and/or permit liquid to pass therethrough via 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 polyurethanes, esters, ethers, composite materials, and any medical-grade material.

In the embodiments described below, the compressible sponge is in a compressed state, via varying means and mechanisms, e.g., a covering, a membrane, etc. This is so that the compressed sponge may be more easily deliverable through a working channel of a scope, and through a natural body lumen of a subject. The covering is configured to be releasable or removable in any suitable manner, e.g., sheared, broken, dissolved/degraded, so that the compressed sponge may deploy and expand once delivered to a targeted site.

Referring to <FIG>, a medical system <NUM> including a scope, e.g., an endoscope, according to an embodiment is shown. Medical system <NUM> includes a flexible shaft <NUM> (e.g., a catheter) and a handle <NUM> connected at a proximal end of flexible shaft <NUM>. Handle <NUM>, or some other device for actuating or controlling medical system <NUM> and any tool or devices associated with medical system <NUM>, includes first and second actuating devices <NUM>, <NUM>, which control articulation of flexible shaft <NUM>, and/or an articulation joint at a distal end of flexible shaft <NUM>, in multiple directions. Devices <NUM>, <NUM>, may be, for example, rotatable knobs that rotate about their axes to push/pull actuating elements (not shown). The actuating elements, such as cables or wires suitable for medical procedures (e.g., medical grade plastic or metal), extend distally from a proximal end of medical system <NUM> and connect to flexible shaft <NUM> to control movement thereof. Alternatively, or additionally, a user may operate actuating elements independently of handle <NUM>. Distal ends of actuating elements may extend through flexible shaft <NUM> and terminate at an articulation joint and/or a distal tip of flexible shaft <NUM>. For example, one or more actuating elements may be connected to an articulation joint, and actuation of actuating elements may control the articulation joint or the distal end of flexible shaft <NUM> to move in multiple directions.

In addition, one or more electrical cables (not shown) may extend from the proximal end of system <NUM> to the distal end of flexible shaft <NUM> and may provide electrical controls to imaging, lighting, and/or other electrical devices at the distal end of flexible shaft <NUM>, and may carry imaging signals from the distal end of flexible shaft <NUM> proximally to be processed and/or displayed on a display. Handle <NUM> may also include ports <NUM>, <NUM> for introducing and/or removing tools, fluids, or other materials from the patient. Ports <NUM> and/or <NUM> may be used to introduce tools. Ports <NUM> and/or <NUM> may also be connected to an umbilicus for introducing fluid, suction, and/or wiring for electronic components. For example, as shown in <FIG>, port <NUM> receives a tube <NUM>, which extends from the proximal end to the distal end of flexible shaft <NUM>, via a working channel 50a of shaft <NUM>.

As shown in <FIG>, system <NUM> may be a means by which tube <NUM> and a medical device <NUM> may be delivered within the body of a subject. Tube <NUM> is not particularly limited. For example, tube <NUM> 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 <NUM> is coupled to medical device <NUM>. Thus, the lumen of tube <NUM> may establish communication between a vacuum source and medical device <NUM>. This communication may be established after medical device <NUM> and tube <NUM> are delivered within the body of a subject, and removed from medical system <NUM>. Alternatively, this communication may be established while medical device <NUM> and tube <NUM> remain within medical system <NUM>. In other embodiments, tube <NUM> remains in the body of the subject, exiting the subject through a nasogastric tube. The method of placement and delivery is not limited. The medical device <NUM> then may administer negative pressure to a surrounding wound, thereby assisting device <NUM> in absorbing and suctioning any fluids from the wound. Furthermore, the application of negative pressure to a wound, via device <NUM>, may be therapeutic and expedite the healing of the wound. The vacuum source is not particularly limited, and may be any suitable source.

Referring to <FIG>, an embodiment of medical device <NUM> of <FIG> is further described. Medical device <NUM> may be a device used for endoluminal wound treatment, e.g., an EVAC device. Thus, medical device <NUM> may be in a configuration in which it is deliverable to a wound, e.g., a leak, cyst, a perforation, etc., via tube <NUM>. Device <NUM>, once delivered to the wound, may subsequently transition into a configuration in which it is deployed, and ready for treatment.

Medical device <NUM> includes a compressed porous body/sponge <NUM>, as described above, and a capsule covering <NUM>. Sponge <NUM> may be compressed to an extent so that it, along with capsule <NUM>, may fit within a working channel of any suitable scope and may be deliverable through a natural body lumen of a subject. The manner by which compressed sponge <NUM> is fit within capsule <NUM> is not particularly limited, and may be by any suitable manner. For example, sponge <NUM>, after compression, may be inserted into an already formed capsule covering <NUM>. In another example, sponge <NUM>, while compressed, may be coated with a capsule coating which forms capsule covering <NUM>.

Capsule <NUM> encapsulates compressed sponge <NUM> in its entirety, but is not limited thereto. In other exemplary embodiments, capsule <NUM> may cover sponge <NUM> partially. Capsule <NUM> may be of any suitable material that may withstand the expandable nature of, and outward forces generated by, compressed sponge <NUM>. In addition, capsule <NUM> may be of any suitable material configured to dissolve when exposed to fluids of any sort, including fluids having a predetermined pH. Thus, for example, capsule <NUM> may instantly or gradually dissolve when placed into, and coming into contact with fluids within the body of a subject, via the gastrointestinal tract. Alternatively, capsule <NUM> may dissolve when capsule <NUM> is exposed to fluid, e.g., saline, from an external source, via tube <NUM> or another tool. Suitable materials for capsule <NUM> include gelatin or other collagen derivatives, hypromellose (HPMC) or other cellulose derivatives, starch, and absorbable polysaccharides. In other exemplary embodiments, capsule <NUM> may be formed of a suture wrapped to compress the sponge <NUM>, or a mesh material, as described below. The thickness of the layer of capsule <NUM> is not particularly limited, so long as it allows for both the delivery of device <NUM> and the deployment of sponge <NUM>. Suitable thicknesses of capsule <NUM> may be dependent on the material of capsule <NUM>, and may include thicknesses greater than, for example, <NUM> microns. Thus, device <NUM> may include a delivery configuration, in which compressed sponge <NUM> is contained within capsule <NUM>, and a deployed configuration, in which capsule <NUM> is removed or dissolved and sponge <NUM> is expanded.

Medical device <NUM> also includes an opening <NUM>, through which an end of tube <NUM> may be inserted and thus connected to device <NUM>. Opening <NUM> extends through both capsule <NUM> and sponge <NUM>. Opening <NUM> may be on a proximal end/surface of device <NUM>. Opening <NUM> may be of any suitable diameter that allows for a secure fit over tube <NUM>. Additionally, opening <NUM> may be of any suitable depth that also allows for a secure fit over tube <NUM>, while also allowing for a sufficient amount of negative pressure to be distributed throughout device <NUM> when deployed in a wound. The sponge <NUM> may be connected to the tube <NUM> such that the interconnected channels, open cells, or continuous passages in the sponge <NUM> allow for fluid and materials to be suctioned into the tube <NUM>.

The manner and order in which medical device <NUM> is formed is not particularly limited. In some exemplary embodiments, opening <NUM> may be formed in sponge <NUM>, prior to compression of sponge <NUM>, and tube <NUM> may be inserted into opening <NUM>. Sponge <NUM> may then be compressed, for example by dehydrating sponge <NUM> and/or applying suction to sponge <NUM>, to close pores and channels within sponge <NUM>. During or after compression, capsule <NUM> may be fitted or formed over compressed sponge <NUM>, while accommodating for tube <NUM>. Capsule may be placed over sponge <NUM> via any suitable method, including coating, e.g., spray coating, dip coating, etc., or wrapping.

Referring to <FIG> and <FIG>, an example of how medical device <NUM> may be delivered and used is further discussed below. A user may deliver device <NUM>, while in its delivery configuration, into the body of a subject, e.g., via a natural orifice (such as a mouth or anus). Device <NUM> may traverse through a tortuous natural body lumen of the subject, such as an esophagus, stomach, colon, etc. Device <NUM>, via tube <NUM>, may be delivered in any suitable way, for example, through working channel 50a of endoscope <NUM>, by inserting device <NUM>, including tube <NUM>, into port <NUM> of endoscope <NUM>. Alternatively, device <NUM> and tube <NUM> may be placed in a patient via a nasogastric tube. A user may direct/position device <NUM> within the wound, e.g., perforation, leak, cyst, cavity, for endoluminal wound treatment. A user may then transition device <NUM> to a deployed configuration by exposing capsule <NUM> to fluid within the body or from an external source, thereby removing capsule coating <NUM>. Compressed sponge <NUM> may subsequently expand within the wound, for example, until it applies suitable pressure against the walls of the wound. A user may then remove endoscope <NUM> from the delivered tube <NUM> and device <NUM>. Subsequently thereafter, a user may couple the proximal end of tube <NUM> to a vacuum source, and then turn on the vacuum source at any suitable time to supply suction or negative pressure to sponge <NUM>, via a lumen of tube <NUM>. Alternatively, a user may start supply of suction while device <NUM> is in a delivery configuration.

Medical device <NUM>', as shown in <FIG>, is similar to device <NUM> in many respects. Like reference numerals refer to like parts. Differences between device <NUM> and device <NUM>' will be described below. Instead of a capsule coating, device <NUM>' includes a netting <NUM> wrapped around sponge <NUM>. Like capsule <NUM> of device <NUM>, netting <NUM> may be implemented to compress sponge <NUM> and to contain sponge <NUM>, via the mechanical pressure of netting <NUM>, while holding its shape. Netting <NUM> may compress and contain sponge <NUM> so that device <NUM>' may be deliverable through a working channel of a scope, e.g., endoscope <NUM>. Netting <NUM> may be of any suitable materials and is not particularly limited. Suitable materials for netting <NUM> include any suitable polymer, such as nylon or polypropylene. Furthermore, the manner in which netting <NUM> is netted is not particularly limited as well. Netting <NUM> may be applied in a spiral, criss-cross, irregular, or other pattern, via any suitable method.

Device <NUM>' further includes a control thread or wire <NUM> that is coupled to netting <NUM>. Wire <NUM> is coupled to a proximal portion of netting <NUM> in <FIG>, but is not limited thereto. Control wire <NUM> may be a strand(s) of netting <NUM>, or a separate thread or wire component. Wire <NUM> may be configured to shear or remove netting <NUM> by a suitable force applied to wire <NUM>, e.g., a pulling force. Wire <NUM> may extend through a lumen of tube <NUM> (not shown) or outside a lumen of tube <NUM> as shown, and a proximal end of wire <NUM> may be connected to a controller or mechanism (not shown) configured to exert the necessary force on wire <NUM> to remove netting <NUM>. Alternatively, the proximal end of wire <NUM> may be free and pulled proximally by the user. Thus, wire <NUM> may assist in transitioning device <NUM>' from a delivery configuration to a deployed configuration. In embodiments, the netting may be formed of a material that will degrade or dissolve upon contact with fluid.

However, device <NUM>' is not limited to including a control wire <NUM>. In some other exemplary embodiments, device <NUM>' may be without wire <NUM>, and may include other suitable mechanisms configured to remove netting <NUM> and deploy sponge <NUM>. For example, netting <NUM> may include a breaking point, e.g., a stress riser, so that netting <NUM> may fracture when sponge <NUM> is advanced and pressed against said breaking point of netting <NUM>. In some exemplary embodiments, such a breaking point may be found on the distal end of netting <NUM>. Alternatively, netting <NUM> may be severed from sponge <NUM> via an endoscopic scissor or other tool.

Like device <NUM>, the manner and order in which medical device <NUM>' is formed is not particularly limited. In some exemplary embodiments, opening <NUM> may be formed in sponge <NUM>, prior to compression of sponge <NUM>, and tube <NUM> may be inserted into opening <NUM>. Sponge <NUM> may then be compressed, for example by application of suction. After compression, netting <NUM> may be fitted over compressed sponge <NUM>, while accommodating for tube <NUM>. In other exemplary embodiments, netting <NUM> may be fitted over sponge <NUM> prior to compression, and netting <NUM> may be tightened to mechanically compress and contain sponge <NUM>.

Device <NUM>' may be used in a similar manner as device <NUM>, except a user may transition device <NUM>' to a deployed configuration by removing netting <NUM>, via wire <NUM> or any other suitable manner/mechanism.

Medical device <NUM>", as shown in <FIG>, is also similar to device <NUM> in many respects. Like reference numerals refer to like parts. Differences between device <NUM> and device <NUM>" will be described below. Instead of a capsule coating, device <NUM>" includes a membrane <NUM>. Membrane <NUM> is not particularly limited, and may be of any suitable impermeable material, e.g., flexible plastic, latex, etc. Membrane <NUM> may be flexible and/or elastic. The thickness of membrane <NUM> is not particularly limited as well. Membrane <NUM> encapsulates sponge <NUM> by being fixed to a distal portion of the outside of a delivery tube/catheter <NUM>. Membrane <NUM> may be fixed around a complete circumference of the distal portion of catheter <NUM>. Catheter <NUM> may be flexible and sized to fit within working channel 50a of scope <NUM>. Catheter <NUM> includes an inner channel 102a that receives tube <NUM>. Tube <NUM> moves axially within channel 102a. As shown in <FIG>, membrane <NUM> may form a cavity <NUM> containing sponge <NUM>, in a non-compressed state.

Catheter <NUM> may be connected to a vacuum source so that channel 102a is in fluid communication with cavity <NUM> formed by membrane <NUM>. To transition device <NUM>" from a default, expanded configuration to the compressed, delivery configuration, the vacuum source may transmit suction distally, through channel 102a and down to cavity <NUM> of device <NUM>". As a result of the suction and impermeable membrane <NUM> being fixed to catheter <NUM>, membrane <NUM> collapses onto sponge <NUM>, thereby compressing sponge <NUM> uniformly, as shown in <FIG>. Compressed sponge <NUM> may then be retracted into channel 102a to maintain its compressed state, by pulling tube <NUM> proximally. Membrane <NUM> may subsequently be removed or may be maintained. Device <NUM>" may be placed into such a delivery configuration during the manufacture of the device. This may enable sponge <NUM> to be loaded into a delivery system with reduced tensile forces, thus potentially preventing damage. Alternatively, device <NUM>" may be maintained in the state as illustrated in <FIG>. However, maintaining device <NUM>" in the delivery configuration shown in <FIG> may require that suction, through working channel 50a, be continuously transmitted, if sponge <NUM> does not tolerate compression for an extended duration. Alternatively, membrane <NUM> may be of such a material that maintains its compressed configuration of <FIG> in the absence of suction.

The deployed configuration of device <NUM>" is not particularly limited. For example, when compressed sponge <NUM> is retracted within channel 102a, as described above, sponge <NUM> may be extended distally out of catheter <NUM> to be deployed within the targeted wound. In instances in which membrane <NUM> is maintained, the distal end of membrane <NUM> may be slit (e.g. perforated or having a weakened region) so that sponge <NUM> may be deployed through the slit. In other examples, when device <NUM>" is maintained in the configuration as shown in <FIG>, membrane <NUM> may be removed when device <NUM>" is delivered to the targeted wound. The manner by which membrane <NUM> may be removed is not particularly limited, for example an additional tool (such as a grasper) may be used. In some exemplary embodiments, membrane <NUM> may be of a biodegradable material, so that membrane <NUM> may dissolve as it reaches the targeted wound. In other exemplary embodiments, membrane <NUM> may include a means by which it may break or rupture, e.g., perforations or thinned portions, so that membrane <NUM> may break or rupture as sponge <NUM> is driven forward (distally). Compressed sponge <NUM>, once deployed, may naturally expand to its pre-compressed state until it reaches its fully expanded state and/or applies pressure against the walls of the wound area. In another embodiment, catheter <NUM> may be omitted from the embodiment of <FIG>, and membrane <NUM> may be fixed around a complete circumference of a distal portion of tube <NUM>. Suction applied through tube <NUM> will collapse membrane <NUM> and compress sponge <NUM>.

Device <NUM>" may be used in a similar manner as device <NUM>, except a user may transition device <NUM>" to a deployed configuration by removing or breaking membrane <NUM>, via the above described manners or mechanisms.

Claim 1:
A medical system (<NUM>), comprising:
a compressible device (<NUM>);
a covering (<NUM>) 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,
wherein the covering is a netting; and
a thread or a wire (<NUM>) coupled to the netting, wherein the thread or the wire is configured to remove the netting via a force applied to the thread or the wire.