Porous medical device and method of use

Abstract

The present invention provides minimally invasive (e.g., endoscopic and / or laparoscopic) medical devices and related methods of use. Specifically, it provides one or more devices for removing fluids, debris, and other materials from perforations, leaks, or wounds in the gastrointestinal tract, methods for forming such devices, and related methods of use. [Solution] A medical system comprising a tube defining a lumen and a porous body connected to the distal end of the tube so as to be advanced to a target site within the object. The porous body defines multiple openings, which communicate with the lumen, and the porous body contains a first substance and a second substance, the second substance eluting from the porous body into the object.

Description

Technical Field

[0001] The present disclosure relates to minimally invasive (e.g., endoscopic and / or laparoscopic) medical devices and related methods of use. In embodiments, the present disclosure relates to one or more devices for removing fluids, debris, and other substances from perforations, leaks, or wounds in the gastrointestinal tract, methods for forming such devices, and related methods of use.

Background Art

[0002] Endoscopic and open surgical procedures of the gastrointestinal (GI) tract include, for example, colectomy, bariatric surgery, esophagectomy, gastric bypass, and sleeve gastrectomy. These procedures can result in perforations of the tube, postoperative leaks, or other wounds. Such wounds have a sufficiently high morbidity and mortality, and limited treatment options exist to address the wounds. The options include surgical re-opening and endoscopic placement of stents or clips. Surgery is relatively invasive and also has a high morbidity and mortality. Endoscopic stent placement is a minimally invasive option. However, the placed stent may move from the planned position and / or may prevent infection at the treatment site and inhibit drainage.

Summary of the Invention

[0003] According to an aspect, a medical system includes a tube defining a lumen, and a porous body coupled to a distal end of the tube and configured to be advanced to a target site within a subject. The porous body defines a plurality of openings that communicate with the lumen, the porous body includes a first substance and a second substance, and the second substance is configured to elute from the porous body into the subject.

[0004] The first substance may include a polymer, and the second substance may include one or more growth factors or antibiotics.

[0005] The first substance may include a hygroscopic substance, and the porous body may be configured to be in a compressed state during insertion into the target site.

[0006] The porous body may be configured to expand from a compressed state to an expanded state when the porous body comes into contact with a fluid.

[0007] The first substance may include a thermally responsive material, and the porous body may be configured to be compressed during insertion into the target site.

[0008] The porous body may be configured to expand from a compressed state to an expanded state when the porous body is heated to a temperature higher than a temperature threshold.

[0009] The plurality of openings can be isolated from each other when the porous body is in the compressed state, and can communicate with each other when the porous body expands from the compressed state to the expanded state.

[0010] The porous material may contain nanoparticles having antibacterial properties.

[0011] The plurality of openings may be formed using a crystalline material, and the size and shape of the openings may be approximately equal to the size and shape of the crystals of the crystalline material.

[0012] The system may further include a vacuum source, which may be connected to the tube and configured to supply negative pressure to the lumen and porous body of the tube.

[0013] In another embodiment, a method for manufacturing the system may include mixing a polymer with a reagent to form a mixture; forming the porous body using the mixture; and attaching the porous body to the tube by using one or more sutures or adhesives, or by directly forming the porous body on the tube.

[0014] The porous body can be formed by using one or more three-dimensional (3D) printing or electrospinning methods.

[0015] The size of the aforementioned multiple openings can range from approximately 50 μm to approximately 1 mm in diameter.

[0016] The above method may further comprise coating the porous body with an antimicrobial substance.

[0017] The method described above may further include compressing the porous body from an expanded structure to a compressed structure after it has been attached to the pipe.

[0018] According to yet another embodiment, a method for producing a porous body for a medical system comprises forming a mixture of a water-insoluble substance and a water-soluble substance, curing the mixture, immersing the cured mixture in a water bath, and removing a skeleton from the water bath, wherein the skeleton comprises the water-insoluble substance.

[0019] Immersing the curing mixture in the water bath allows for the formation of multiple openings in the framework to form the porous body.

[0020] The water-soluble substance may contain crystals, and the size of the plurality of openings may be substantially equal to the size of the crystals.

[0021] The method described above may further comprise coating the skeleton with a plurality of nanoparticles containing an antimicrobial substance.

[0022] The method described above may further include dehydrating the skeleton and deforming the skeleton from an expanded structure to a compressed structure. [Brief explanation of the drawing]

[0023] The accompanying drawings, incorporated and constituting parts of this specification, illustrate various exemplary embodiments together with the description and are useful for illustrating the principles of the disclosed embodiments.

[0024] [Figure 1] This is a schematic diagram of an intraluminal vacuum therapy (EVAC) system according to the embodiment.

[0025] [Figure 2] It is a schematic diagram of the EVAC system of FIG. 1 disposed in the body according to an embodiment.

Mode for Carrying Out the Invention

[0026] For ease of explanation, portions of the disclosed devices and / or their components are referred to as proximal and distal portions. Note that the term "proximal" is intended to indicate the portion closer to the user of the device, and the term "distal" is used herein to indicate the portion farther from the user. Similarly, "extends distally" indicates that the component extends in the distal direction, and "extends proximally" indicates that the component extends in the proximal direction. Further, as used herein, the terms "about", "approximately", and "substantially" indicate a range of values within + / - 10% of the stated or implied value. Terms indicating the geometric shape of a component / surface indicate both the exact shape and approximate shapes. The present disclosure may be understood with reference to the following description and the accompanying drawings, in which like elements are denoted with the same reference numerals.

[0027] Endoluminal vacuum therapy (EVAC) has been proposed. In EVAC, negative pressure is delivered to the wound site in the GI tract, for example, by a nasogastric tube having a sponge or porous body at its distal end. The sponge is placed endoscopically within a perforation, leak, or other wound. Next, negative pressure is applied. However, devices and systems suitable for EVAC are limited.

[0028] Embodiments of this disclosure include devices, systems, and methods for intraluminal vacuum therapy (EVAC), and device formation for performing EVAC. For example, EVAC involves intraluminal placement of a sponge or other similar material into a wound site (e.g., a target site), including perforations, cysts, leaks, or anastomoses. Placement of the material may be performed by a catheter, scope (endoscope, bronchoscope, coloscope, duodenoscope, gastroscopy, etc.), tube, or sheath, which is inserted into the GI duct through a natural opening. The opening may be, for example, the nose, mouth, or anus, and placement may be in any part of the GI duct, including the esophagus, stomach, duodenum, large intestine, or small intestine. Placement of the material may also be in other tissues that can be reached through the GI duct (e.g., the pancreas).

[0029] Figure 1 shows the distal end of an EVAC system 10 according to an example of this disclosure. The system 10 may be inserted into a patient for the treatment of chronic wounds using vacuum negative pressure. The system 10 generally comprises a sponge 30 (or other mesh-like material or porous material) and a vacuum tube 40. The sponge 30 is attached to the distal end of the vacuum tube 40. The vacuum tube 40 may include an outer wall 42 defining one or more lumens 44. The lumens 44 open at both the proximal and distal ends of the vacuum tube 40. The outer wall 42 may include a plurality of holes around the outer circumference of the distal end of the vacuum tube 40 and may communicate with the lumens 44, thereby increasing the flow rate of fluid or substance in the lumens 44 as described herein. The distal end of the vacuum tube 40 may be attached to the sponge 30 by suture or adhesive, etc. In some examples, a recess (not shown) may be provided in the sponge 30 to receive the distal end of the vacuum tube 40. The vacuum tube 40 may be mounted in a recess of the sponge 30, providing additional structural support between the sponge 30 and the vacuum tube 40. Alternatively, the sponge 30 may be formed on the vacuum tube 40 as described herein. The proximal end of the vacuum tube 40 may be connected to a vacuum source (not shown) that can supply negative pressure to the sponge 30. For example, a negative pressure of approximately 125 mmHg (16.7 kPa), i.e., approximately 2.5 pounds per square inch (PSI) (17.2 kPa), may be supplied to the sponge 30. Other appropriate amounts of negative pressure may be used. This negative pressure may draw fluid, material, and / or other debris into the lumen 44 of the vacuum tube 40 through the opening 32, thereby accelerating the healing of the target site 70 (Figure 2).

[0030] The sponge 30 may include openings 32 on its outer surface. The openings 32 may be any holes, holes, or channels that provide continuous access to interconnected channels and pores throughout the sponge 30. The openings 32 may include different sizes and shapes and may be selected based on the location of the procedure in the body. For example, the openings 32 may be spherical, cubic, irregular, or any other shape. The size of the openings 32 may range from approximately 50 μm to approximately 1 mm in diameter. Although the sponge 30 is shown as spherical, it may be any shape, including cylindrical, cubic, or irregular. As described herein, the sponge 30 may also include a substance (e.g., a reagent) that is eluted from the sponge 30 when the sponge 30 is placed on the target site 70. For example, the reagent may elute at different rates and may be customizable based on various factors, including the expected lifespan of the sponge 30 and the length of time until the sponge 30 is replaced with a new sponge 30. Additionally, or alternatively, the sponge 30 may be coated with nanoparticles having microbial properties, such as silver nanoparticles, which can improve the activity of substances eluted from the sponge 30 by altering cell membrane permeability and / or improving drug delivery.

[0031] An example of system 10 positioned at a target site 70 within the body is shown in Figure 2. The sponge 30 is positioned within the target site 70. The distal end of the vacuum line 40 is attached to the sponge 30 and extends proximally into the GI tube 80 and out of the body. A vacuum source (not shown) may be attached to the proximal end of the tube 40 to supply negative pressure to the lumen 44 and the sponge 30 to draw fluids and substances from the target site 70.

[0032] A method for forming a sponge 30 is described. For example, the sponge 30 may be formed by electrospinning. Additional substances such as growth factors, antibiotics, and / or other treatment-improving substances may be mixed with the skeletal material before electrospinning of the sponge 30. Unlike conventional stents, the stent is coated with a growth factor or antibiotic after the stent is formed, and the substance used to form the skeletal (e.g., polymer) of the sponge 30 is mixed with the growth factor or antibiotic, including any substance that may promote healing and / or inhibit the growth of microorganisms (e.g., harmful microorganisms) before the skeletal structure is formed. The amount of eluting substance to the substance used to form the sponge 30 may be approximately 1:5 to 1:20. For example, the mixture of polymer and eluting substance may be electrospinned to form a sponge 30 having openings 32 communicating with channels.

[0033] The sponge 30 may be post-processed by cutting it into various shapes as described herein. Additional post-processing may include introducing a recess within the sponge 30 into which a vacuum tube 40 can be introduced and secured, for example, by adhesive or sutures. The sponge 30 may also be cut almost in half, and channels may be formed on each side of the sponge 30 to correspond to the branched ends of the vacuum tube 40. The branched ends of the vacuum tube 40 may remain stationary within the channels, and the sponge 30 may be reassembled, for example, using adhesive or sutures. The branching of the tube 40 may provide an additional pathway through which fluids and / or substances drawn up by the sponge 30 can enter the lumen 44, potentially reducing the healing time of the target site 70. It will be understood that this post-processing treatment may be performed after any method of forming the sponge 30.

[0034] According to another embodiment, the sponge 30 may be formed using a polymer and / or a polymer mixture (e.g., a polymer and one or more eluting substances), and the openings may be formed within the sponge 30 by casting or three-dimensional (3D) printing. For example, a 3D printer may be programmed to produce the polymer mixture in a pattern that forms a plurality of openings, holes, or pores 32 within the sponge 30. Thus, the shape and / or size of the openings can be controlled. A mold may be used to cast the sponge 30 having the openings. Mold casting and / or 3D printing of the sponge 30 may form a plurality of openings, holes, or pores 32 of nearly uniform shape and / or size within the sponge 30.

[0035] In yet another embodiment, the sponge 30 may comprise a hydrogel, a hygroscopic material such as cellulose, or other superabsorbent polymers such as poly(N-isopropylacrylamide) (ply(n-isopropylacrylamide)) (PNIPAM), copolymers of PNIPAM, polyacrylic acid, polyacrylamide, polyurethane foam, polyacrylic acid and polyacrylate, partially crosslinked water-swellable polymers such as carboxymethylcellulose, polyethylene oxide and polyacrylamide, and isobutylene maleate copolymer. The sponge 30 may be formed using any method described herein and may comprise one or more additives in some cases. These substances are permitted to be introduced into the sponge 30 in a low-profile or compressed state by dehydrating the sponge 30 before insertion into the body. Once inserted, the sponge 30 may expand when in contact with a fluid. For example, the fluid may be introduced into the sponge 30 at the target site 70 via a catheter or other associated instrument, or via the lumen 44. Alternatively, or in addition, the fluid at the target site 70 may be useful in expanding the sponge 30 from a dehydrated state to an expanded state. Once the sponge 30 is expanded, the fluid may be removed from the target site 70 using the vacuum tube 40.

[0036] According to another embodiment, the sponge 30 may include a thermoresponsive polymer such as poly(N-isopropylacrylamide) (PNIPAM), a copolymer of PNIPAM, polyacrylic acid, and / or polyacrylamide. Similar to the sponge 30 containing a hygroscopic material, the sponge 30 containing a thermoresponsive polymer may expand from a low-profile or compressed state. Before expanding, the sponge 30 may be compressed such that the openings 32 are closed and / or compressed, thereby preventing communication. When the sponge 30 is introduced to the target site 70, if the sponge 30 is heated by heat from the body to a temperature threshold of approximately 30°C or approximately 35°C, the sponge 30 may expand into an expanded state. The temperature threshold is not limited to these temperatures and may be modified by copolymerization of other polymers with the sponge 30 and / or the incorporation of various substances eluting from the sponge 30. Once the sponge 30 has expanded, the openings 32 are open, allowing fluid to be received by the sponge 30. It will be understood that the substance is not limited to thermoresponsive or hygroscopic materials. In some embodiments, the material of sponge 30 may utilize the body's pH, chemicals produced in the body (e.g., at the target site 70), and / or any other properties of the material of sponge 30 for expanding sponge 30 from a compressed state to an expanded state.

[0037] Another example of forming a sponge may involve saturating a substance with crystals. For example, a water-insoluble substance, such as silicone, and / or any substance having variable mechanical properties such as flexibility or rigidity, can be mixed with water-soluble crystals, such as sugar, salt, or any substance containing crystals that are water-soluble but insoluble in non-organic solvents. For example, Sylgard silicone can be mixed with 10% by weight of a crosslinking agent to form a silicone mixture. This silicone mixture is insoluble in water. The silicone mixture can then be mixed with a water-soluble substance. The ratio of the water-insoluble substance to the water-soluble substance is approximately 50% by mass. Once the water-insoluble substance is sufficiently saturated with the water-soluble substance, the mixture can be cured, for example, using a curing furnace. Alternatively, the mixture may be any shape, such as settling at the bottom of a mixing vessel to form a shape corresponding to the shape of the mixing vessel. Once the mixture has cured or settled at the bottom of the mixing vessel, the cured mixture resulting from the water-insoluble and water-soluble substances can be placed in a water bath. The water is approximately 50°C to 100°C, and the curing mixture can remain in the water bath for approximately 12 hours. During this time, the water dissolves substantially all of the water-soluble substance, forming pores, channels, and / or openings 32 in the areas of the sponge 30 where the water-soluble substance is dissolved. The size and shape of these pores, channels, and / or openings 32 are approximately equal to the size and shape of the crystals of the water-soluble substance. Once the water-soluble substance is dissolved, the sponge 30 may be flexible and / or compressible.

[0038] The method of using System 10 is further described. The sponge 30 may be introduced through an opening (e.g., a natural opening) and advanced to the target site 70 using a catheter or other known mechanism. Once the sponge 30 is positioned at the target site 70, a fluid may be supplied to the sponge 30, for example, via a catheter. Alternatively, the fluid at the target site 70 activates and expands the sponge 30. In the case where the sponge 30 contains a thermally activated material, the sponge 30 may expand when the sponge 30 is heated by the body at the target site 70 above a temperature threshold. Once the sponge 30 has expanded from a compressed state to an expanded state, the vacuum tube 40 may be attached to a vacuum source and a negative pressure of approximately 125 mmHg (16.7 kPa), or approximately 2.5, may be supplied to the sponge 30.

[0039] It will be understood that some of the substances, coatings, or eluents described herein may be used alone or in combination to form medical sponges. It will also be understood that some of the features of the sponges described herein may be used in conjunction with any other EVAC system and / or any other medical system.

[0040] While various medical systems are described, it will be understood that the specific arrangement of elements in these systems is not restricted. Furthermore, the size, shape, and / or material of the sponge in the EVAC system are not restricted. The sponge is used to access and treat a target site inside or outside the lumen of the GI duct. For example, performing various medical procedures in a particular case may be improved by using a sponge containing a substance such as growth hormone and / or antibiotics that is eluted from the sponge at the target site to prevent infection or other medical problems in organs outside the GI duct.

[0041] It will be apparent to those skilled in the art that various modifications and changes can be made to disclose the device without departing from the scope of this disclosure. Other embodiments of this disclosure will also be apparent to those skilled in the art by considering this specification and the practice of the invention disclosed herein. This specification and examples are intended to be considered merely as examples, together with the true scope and spirit of the invention as set forth by the following claims.

Claims

1. It is a medical system, A tube that defines the lumen, having multiple branch ends at its distal end, The apparatus comprises a porous body connected to the distal end of the tube and configured to advance toward a target site within the object, wherein the porous body defines a plurality of openings and a plurality of channels, the plurality of openings communicating with the plurality of branch ends and the lumen, the porous body contains a first substance and a second substance, and the second substance is configured to elute from the porous body into the object. A medical system in which each of the multiple branch ends is stationary within a corresponding channel among the multiple channels.

2. The medical system according to claim 1, wherein the first substance comprises a polymer, and the second substance comprises one or more growth factors or antibiotics.

3. The medical system according to claim 1 or claim 2, wherein the first substance comprises a hygroscopic substance, and the porous body is configured to be compressed during insertion into the target site.

4. The medical system according to claim 3, wherein the porous body is configured to expand from a compressed state to an expanded state when the porous body comes into contact with a fluid.

5. The medical system according to claim 1 or 2, wherein the first substance comprises a thermally responsive material, and the porous body is configured to be compressed during insertion into the target site.

6. The medical system according to claim 5, wherein the porous body is configured to expand from a compressed state to an expanded state when the porous body is heated to a temperature higher than a temperature threshold.

7. The medical system according to claim 4 or 6, wherein the plurality of openings do not communicate when the porous body is in the compressed state, and the plurality of openings communicate when the porous body expands from the compressed state to the expanded state.

8. The medical system according to any one of claims 1 to 7, wherein the porous body includes nanoparticles having antibacterial properties.

9. The medical system according to any one of claims 1 to 8, further comprising a vacuum source, the vacuum source being connected to the tube and configured to supply negative pressure to the lumen and porous body of the tube.

10. A method for manufacturing the medical system described in any one of claims 1 to 9, Mixing the polymer with the reagent to form a mixture, The porous body is formed using the aforementioned mixture, and the porous body has multiple openings. A channel is formed in the porous body, and the channel communicates with the opening. A method comprising attaching the porous body to the distal end of the tube using one or more sutures or adhesives, and resting the branch end of the tube within the channel of the porous body.

11. The method according to claim 10, wherein the porous body is formed by using one or more three-dimensional (3D) printing or electrospinning methods.

12. The method according to claim 10 or claim 11, wherein the size of the plurality of openings is approximately 50 μm to approximately 1 mm in diameter.

13. The method according to any one of claims 10 to 12, further comprising coating the porous body with an antimicrobial substance.

14. The method according to any one of claims 10 to 13, further comprising compressing the porous body from an expanded structure to a compressed structure after the porous body has been attached to the distal end of the pipe.

15. The medical system according to claim 1, wherein the first substance expands the porous body from a compressed state to an expanded state in accordance with the pH inside the body of the subject.

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