Device to Reduce and Redirect Leaks

Abstract

The device which may be attached inside or outside the pancreas/abdomen during surgery addresses leaks of pancreatic juice or pancreatic effluent (PE) after resection by redirecting and inactivating PE. Specifically the PE enzymes (proteases) are inactivated. Redirection is through an internal biodegradable self powered self eliminating drain with increasing gradient and then targeting or inactivating the effluent with active pharmaceutical ingredients (API) such as-protease inhibitors which are contained in graduated micro-encapsulated particles (GMEPs) coated with pH and time release shells which the device locates at optimum locations in the pancreas/abdomen. Another iteration is redirecting PE by containing the device within a mesh filled with GMEP comprising protease inhibitors (antiprotease) to inactivate PE before flowing out via openings in the mesh into the abdominal cavity as an inactivated innocuous fluid.

Claims

1. A method to reduce, redirect and inactivate pancreatic leaks after pancreatic sections comprising: Use of a material around within or outside the anastomosis area which contains graduated micro encapsulated particles with pH sensitive biodegradable shells containing active pharmaceutical ingredients; a device to reduce and redirect leaks after surgery comprising: a hydrophobic permeable shell at one end of the device acting as a drain that is placed close to a source of leaks of pancreatic effluent; villi, small “finger like” protrusions from the outer end of the hydrophobic permeable shell acting as a drain that attaches to super absorbent particles that attach to the wall of the hydrophobic permeable shell; a series of cellulose repositories on the other end of the device attached to time release, pH sensitive biodegradable shells that contain active pharmaceutical agents including at least one of these or a combination of antproteases, super absorbent particles, antibiotics that degrades based on the alkaline level of the pancreatic fluid; the cellulose repositories containing an open area for receiving PE and graduated micro-encapsulated particles containing active pharmaceutical ingredients; the repositories separated by anchoring sutures which attach to the outer hydrophobic shell; whereby when the device is positioned for in areas where leakage is expected and the device villi and the hydrophobic permeable shell attracts leakage through the device to the end where it can absorbed or treated by the active pharmaceutical ingredients in the cellulose depositories as those ingredients are released by the graduated microencapsulated particles; whereby the device is self-powered by means of internal intermolecular forces, diffusion gradients and osmosis; whereby the device is biodegradable; whereby the device is self-eliminating with bowel movements.

2. The method of claim 1 where the method is used without the material around within or outside of the anastomosis area.

3. The method of claim 1 where the method is used without the device.

4. The device in the method of claim 1 where the hydrophobic permeable part at one end of the device may also include, graduated micro-encapsulated particles containing active pharmaceutical ingredients.

5. The method of claim 1 where wall thicknesses of the pH sensitive biodegradable covering vary to allow different time releases points for each repositories.

6. The device method of claim 1 where the inner shells are not pH sensitive, but instead enzyme sensitive, ion sensitive or have another sensitivity to activate the biodegradable process,

7. The device in the method of claim 1 where the mini-repositories and inner pH sensitive shells are not attached inner lining of the intestine.

8. The device in the method of claim 1 where redirection is increased with the increased use or different properties of in the hydrophobic shell of desiccants, super absorbent particles, polymers, hydrogel, cellulose derivatives or other absorbent material.

9. The device in the method of claim 1 where redirection is varied with varying properties of the hydrophobic shell of desiccants, super absorbent particles, polymers, hydrogel, cellulose derivatives or other absorbent material.

10. The device in the method of claim 1 where inactivating the PE can be increased with particles in the repositories such as protease inhibitors, water saline solutions and other materials that can inactivate or dilute leaks.

11. The device in the method of claim 1 where inactivating the PE can be varied with varying particles in the repositories such as protease inhibitors, water saline solutions and other materials that can inactivate or dilute leaks.

12. The device in the method of claim 1 where wound healing can be varied due to varying particles in the repositories such as antibiotics, protease inhibitors, antibiotics, water saline solutions and other materials that can vary wound healing.

13. The drain section of device in the method of claim 1 consisting of the hydrophobic permeable shell and the villi for use in other applications.

Description

BRIEF DESCRIPTION OF DRAWINGS

[0027] FIG. 1 shows the pancreatic duct which exits through the connection or opening (anastomoses) into the small intestine and the placement of the device as well as the device components.

[0028] FIG. 1a, shows the device in more detail, but also highlights Repository A and Repository B.

[0029] FIG. 1b shows the inner configuration of a repository with a hydroscopic outer shell, ph sensitive biodegradable shell, and the active pharmaceutical ingredients.

[0030] FIG. 1c shows a close-up of the PDS hydrophobic outer shell and the villi that pull the PE into the device. The villi are attached to superabsorbent particles (not shown) that attach to the PDS hydrophobic outer shell.

[0031] FIG. 2 shows the anastomosis mesh, names as it is placed around the anastomosis,

[0032] FIG. 2a shows a view of half of the mesh, highlighting the GMEP with API within the mesh.

SHORT DESCRIPTION OF THE NUMBERS WITHIN THE DRAWINGS

[0033] 1. pancreatic duct. [0034] 2. anastomosis. [0035] 3. Intestine [0036] 4. villi of repository, fingerlike or threadlike projections from the surface of the device. [0037] 5. hydrophobic PDS shell. [0038] 6. anastomosis active pharmaceutical agents—super absorbent particles/antibiotic/protease inhibitors inside of anastomosis mesh. [0039] 7. pH sensitive shell that surround the active pharmaceutical agents. [0040] 8. cellulose or biodegradable material that composes the pH sensitive shell. [0041] 9. connecting suture to the pancreas wall. [0042] 10. suture for the repository pieces, separating repositories from each other [0043] 13. the anastomosis mesh with perforated openings [0044] 15. graduated micro-encapsulated particles (GMEP) [0045] 16. the repository which holds the GMEP and API. [0046] 17. active pharmaceutical ingredients (API) [0047] 18. one location of PE (pancreas effluent) [0048] 19. one location of possible leak [0049] 20. Repository A [0050] 21. Repository B [0051] 22. mesh around the mini-repositories

DETAILED DESCRIPTION

[0052] FIG. 1 shows broad over view of the device as it is placed within the body, The pancreatic duct 1 and the anastomoses lead into the intestine 3 the device villi 4, are near the connection of the pancreatic duct and intestines, pulling the PE into the device. The hydrophobic shell 5 also assists in pulling the PE away from the MSS. Active pharmaceutical ingredients 6 also may be include in GMEP is in the front section of the device, the back of the drawing shows the pH sensitive shells, 7 which are made from biodegradable material 8, the drawing also shows anchoring sutures 9 and the sutures that separate the pH sensitive shells 10.

[0053] FIG. 1a shows a more detailed look at the first embodiment of the placement of the device when it is placed into the inside of the intestine. The device is held in place by connecting sutures to the bowel wall 10. The device is placed after the pancreatic duct 1, anastomoses 2 in the intestine adjacent to the anastomoses such that the pancreatic effluent steam connects with the device. Since the device has “villi” 4 (—small protrusions from the device), the villi 4 are the part of the device that interact with the steam of pancreatic effluent directly in the front section of the device, Repository A, 20. The hydrophobic PDS shell) allows PE to be drawn through the shell into an area that can hold effluent flow 16 so the PE can interact with the active pharmaceutical agents 17. The active pharmaceutical agents 17 are within graduated micro encapsulated particles 15, that are held in repositories within the inside of a series pH sensitive shells 7, Repository B, 21, the shells are composed on biodegradable material of varying thicknesses for each shell to allow the active pharmaceutical agents 17 to be released at varying times. The series of pH sensitive shells 7 that are separated by anchoring sutures 10, which attach to the outer mesh (22)

[0054] FIG. 1a shows the inside of a repository, the hydrophobic PDS outer shell 5, the area for effluent flow inside of repository 16, the inner pH biodegradable shell 7, the graduated micro-encapsulated particles (GMEP)15 that contain the active pharmaceutical ingredients 17.

[0055] FIG. 1b shows the opening of the hydrophobic PDS shell 5 with the villi 4, which together such the PE effluent down towards the repositories. The villi 4 are attached to superabsorbent particles that attach to the all of the hydrophobic PDS shell 5 (not shown).

[0056] FIG. 2 shows the anastomosis mesh with perforated openings 13, which is placed where there are likely leaks 19, and also the active pharmaceutical ingredient within the mesh 19.

[0057] FIG. 2a shows a view of half of the anastomosis mesh 13, highlighting API 6 inside of the pH sensitive shells 7 within the anastomosis mesh 13.