This disclosure relates to minimally invasive (e.g., endoscopic and/or laparoscopic) medical devices and related methods of use. In embodiments, the disclosure relates to one or more devices for sealing perforations, leaks, or wounds in the gastrointestinal tract, devices for advancing these sealing devices, and related methods of use, among other aspects.
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.
According to an aspect, a medical system includes a porous body connected to a distal end of a vacuum tube, and a patch defining a lumen therethrough for accommodating the vacuum tube, wherein the patch is configured to fluidly seal the porous body from a body lumen when the patch is deployed in a subject.
A diameter of the lumen of the patch may be approximately equal to an outer diameter of the vacuum tube, and the patch may be slidable along an exterior of the vacuum tube.
The patch may include a patch tube extending from a first surface of the patch, wherein the patch tube may define a tube lumen in fluid communication with the lumen of the patch, and wherein the patch tube may be configured to seal around a circumference of the vacuum tube when the patch is deployed in the subject.
The patch may include Chitosan.
The medical system may further comprise a sealing fluid configured to be applied to an intersection between the patch and a tissue of the subject.
A diameter of the lumen of the patch may be greater than an outer diameter of the vacuum tube, and wherein a gap may be formed between the patch and the vacuum tube when the patch and the vacuum tube are deployed in the body.
A sealing fluid may be configured to be supplied to the gap to seal the body lumen from the porous body.
The patch may define a plurality of recesses on a surface of the patch facing the porous body, and wherein at least one recess of the plurality of recesses may be configured to overlap a tissue of the body lumen in the deployed configuration.
The plurality of recesses may be in fluid communication with a lumen of the vacuum tube.
The plurality of recesses may communicate with a lumen of the vacuum tube via one or more channels in the patch.
The porous body may include a sponge.
The medical system may further comprise an overtube configured to contact the patch during a deployment of the patch.
The overtube may be configured to be releasably attached to the patch during the deployment of the patch, and wherein the overtube may be configured to be disconnected from the patch when the patch is deployed in the subject.
The porous body may include a plurality of holes, pores, or channels which may permit fluid outside of the porous body to flow through the porous body and into a lumen of the vacuum tube.
The medical system may further comprise a vacuum device configured to be attached to a proximal end of the vacuum tube and may be configured to supply a negative pressure to the porous body.
According to another aspect, a medical system comprises a flexible tube having a central vacuum lumen, a porous body attached to a distal end of the flexible tube, and a patch extending radially outward from the flexible tube, wherein the patch includes a plurality of recesses in fluid communication with the central lumen.
The porous body may configured to be placed at a target site in a subject, and wherein a negative pressure may be supplied to the central vacuum lumen and may be configured to cause the patch to adhere to a tissue of a body lumen of the subject via the plurality of recesses.
A fluid disposed at the target site may be configured to pass through holes, pores, or channels in the porous body and at least one recess of the plurality of recesses in the patch toward a proximal end of the flexible tube.
According to yet another aspect, a method of treating a target site of a body lumen of a subject comprises advancing a porous body to the target site, wherein the porous body is attached to a distal end of a flexible tube defining a central lumen, advancing a patch over the flexible tube, connecting the patch to a tissue of the body lumen, and removing a fluid from the target site when the patch is connected to the tissue.
The method may further comprise supplying a negative pressure to the central lumen, wherein the negative pressure is configured to one or more of remove the fluid from the target site or connect the patch to the tissue of the body lumen.
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.
For ease of description, portions of the disclosed devices and/or their components are referred to as proximal and distal portions. It should be noted that the term “proximal” is intended to refer to portions closer to a user of the devices, and the term “distal” is used herein to refer to portions further away from the user. Similarly, “extends distally” indicates that a component extends in a distal direction, and “extends proximally” indicates that a component extends in a proximal direction. Further, as used herein, the terms “about,” “approximately,” and “substantially” indicate a range of values within +/−10% of a stated or implied value. Terms that indicate the geometric shape of a component/surface refer to exact and approximate shapes. This disclosure may be understood with reference to the following description and the appended drawings, wherein like elements are referred to with the same reference numerals.
Endoluminal vacuum therapy (EVAC) has been proposed. In EVAC, negative pressure is delivered to the wound site in the GI tract, for example through a nasogastric tube having a sponge at its terminal end. The sponge is placed endoscopically into the perforation, leak, or other wound. Negative pressure then is applied. Devices and systems suited for EVAC are limited, however.
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 the wound site (e.g., a target site), including a perforation, a leak, a cyst, an anastomosis, etc. Placement of the material may be via a catheter, scope (endoscope, bronchoscope, colonoscope, duodenoscope, gastroscope, 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 of the material also can be in other organs (e.g., pancreas) reachable via the GI tract.
EVAC device 20 may include a sponge 30 (or other mesh-like material or porous body) and a vacuum tube 40. Sponge 30 is attached to a distal end of vacuum tube 40. Sponge 30 may include openings 32 on an outer surface thereof. Openings 32 may be any hole, pore, or channel which provides access to interconnecting channels and pores throughout sponge 30. Openings 32 may include different sizes and shapes, and may be selected based on a location of treatment within the body. Sponge 30 is illustrated as having a spherical shape, but may be any shape, including cylindrical (see, e.g.,
In embodiments of this disclosure, sponge 30 may be any suitable biocompatible material that may absorb liquids and/or permit liquid or other materials 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 other medical-grade materials.
Vacuum tube 40 may include an outer wall 42 defining one or more lumens 44. Lumen 44 is open at both a proximal end and the distal end of vacuum tube 40. Outer wall 42 may include a plurality of holes around a circumference of the distal end of vacuum tube 40 and in fluid communication with lumen 44, which may increase the flow of fluid or material into lumen 44 as disclosed herein. The distal end of vacuum tube 40 may be attached to sponge 30 via sutures, an adhesive, or the like. In one example, a recess (not shown) may be provided in sponge 30 to receive the distal end of vacuum tube 40. Vacuum tube 40 may be attached within the recess of sponge 30, which may provide additional structural support between sponge 30 and vacuum tube 40. The proximal end of vacuum tube 40 may be connected to a vacuum source (not shown), which may supply a negative pressure to sponge 30. For example, a negative pressure of approximately 125 mm Hg, or approximately 2.5 pounds per square inch (PSI), may be supplied to sponge 30. Other suitable amounts of negative pressure may be used. This negative pressure may pull fluid, material, and/or other debris into lumen 44 of vacuum tube 40 via openings 32, which may promote healing of target site 70 (
With continued reference to
Patch 50 may be any size and shape sufficient to seal an opening between a GI tract 80 (e.g., a body lumen) and target site 70 (
Overtube 60 may include an outer wall 62 defining a central lumen 64, and central lumen 64 may extend from a distal end of overtube 60 to a proximal end thereof. As will be explained herein, overtube 60 may be configured to be placed over vacuum line 40 to push patch 50 into the correct position at target site 70. A diameter of lumen 64 may be greater than the diameter of the outer surface of outer wall 42 of vacuum tube 40, which may allow overtube 60 to be moved in distal and proximal directions relative to vacuum tube 40. Overtube 60 may be made of any medical grade material, and may include a columnar strength suitable to push patch 50 along vacuum line 40 toward sponge 30. According to an example, a handle or other gripping member may be provided at the proximal end of overtube 60, which may assist in moving overtube 60 relative to vacuum line 40. In this manner, the distal end of overtube 60 may push patch 50 along vacuum line 40 to target site 70.
An example of system 10 disposed in the body at target site 70 is shown in
An example of patch 50 sealing target site 70 from GI tract 80 is shown in
A method of using system 10 will now be described. Sponge 30 may be introduced through an orifice (e.g., a natural body orifice) and advanced to target site 70 using a catheter or other known mechanism. Once sponge 30 is disposed at target site 70, a proximal end of vacuum tube 40 is placed into lumen 54 of patch 50. The proximal end of vacuum tube 40 is subsequently placed into a distal end of central lumen 64 of overtube 60. Overtube 60 is pushed distally, causing patch 50 to move distally relative to vacuum tube 40. As patch 50 approaches target site 70, the user may urge or push patch 50 against the tissue surrounding target site 70. According to examples, the fluid of GI tract 80 may activate an adhesive on patch 50 to adhere patch 50 to the tissue. Alternatively, fluid may be introduced to patch 50 via a tool or an instrument to activate the adhesive of patch 50. After patch 50 is attached to the tissue surrounding target site 70, overtube 60 may be moved proximally and removed from the body via the orifice. As discussed herein, overtube 60 may be connected to patch 50 via an adhesive, snap fit, or the like. In this example, overtube 60 may be rotated about the longitudinal axis to overcome a connection force between overtube 60 and patch 50, thereby disconnecting overtube 60 from patch 50. Once overtube 60 has been removed from the body, vacuum line 40 may be attached to a vacuum source and a negative pressure of approximately 125 mm Hg, or approximately 2.5, may be supplied to sponge 30.
EVAC device 20, including sponge 30 and vacuum tube 40, and patch 50 in
When deployed, a space or a gap may be created between patch 50″ and vacuum tube 40, such that target site 70 is not completely sealed from GI tract 80. A seal 92 may be disposed in the space created between vacuum tube 40 and the wall defining the lumen of patch 50″ to seal target site 70 from GI tract 80. For example, seal 92 may be similar to fluid 90 and may be, e.g., Chitosan or other material suitable for creating a seal between vacuum tube 40 and patch 50″. Seal 92 may be deployed in a similar manner as fluid 90, e.g., via a catheter or the like. Alternatively, seal 92 may be a silicone seal (or other suitable material) placed between the wall defining the lumen of patch 50″ and tube 40, and may be deployed using a catheter having an end effector capable of grasping seal 92 or other similar device.
Sponge 30 and patch 50″ may be deployed in a manner similar to that described with respect to
It will be understood that any of the patches described herein may be used alone or in combination with one or more sponges described herein. It will also be understood that features of any of the patches described herein may be used with any other patches described herein.
While different medical systems have been described, it will be understood that the particular arrangements of elements in these systems are not limited. Moreover, a size, a shape, and/or the materials of the sealing devices in the EVAC system are not limited. As described herein, there are included patches or sealing devices for sealing a sponge and a target site from a body lumen. For example, performing various medical procedures may be improved by ensuring a proper seal between the target site and any debris or materials in a body lumen. This seal may prevent these materials (e.g., fecal matter) from entering the target site and passing into another body organ through, e.g., a post-surgical leak, and causing infections or other medical issues.
It will be apparent to those skilled in the art that various modifications and variations can be made to the disclosed device without departing from the scope of the disclosure. Other embodiments of the disclosure will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the invention being indicated by the following claims.
This application claims the benefit of priority from U.S. Provisional Application No. 62/981,745, filed on Feb. 26, 2020, which is incorporated by reference herein in its entirety.
Number | Date | Country | |
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62981745 | Feb 2020 | US |