Patent Application
20160375231
This invention relates generally to fecal matter transplant kits and more particularly to a fecal matter transplant kit that includes a fecal matter storage container having a fecal matter filter, a fecal matter/saline container connected to the fecal matter storage container for mixing the fecal matter and the saline to create a suspension and a suspension delivery device for transplanting the suspension into the patient.
Prior to the present invention, as set forth in general terms above and more specifically below, it is known, to treat gastro-intestinal disorders such as Clostridium difficile, often called C. difficile or C. diff, through bacteriotherapy such as antibiotics, probiotics or fluids. See for example, U.S. Pat. No. 8,197,805 to Lin et al., U.S. Pat. No. 8,110,177 to Lin et al., U.S. Pat. No. 6,645,530 to Borody, U.S. Pat. No. 6,635,260 to Gerding, U.S. Pat. No. 5,443,826 to Borody, U.S. Patent Application No. 2013/0045274 to Hlavka, U.S. Pat. No. 8,371,306 to Haines, et al., U.S. Pat. No. 8,322,345 to West, U.S. Pat. No. 8,100,130 to Allen, et al., U.S. Pat. No. 7,958,894 to Katoh, et al., U.S. Pat. No. 7,114,500 to Bonutti, U.S. Pat. No. 6,843,252 to Harrison, et al., U.S. patent, and The Therapeutic Advances in Gastroenterology to Rohlke et al., which was published in 2012, and relates to Fecal Microbiota Transplantation in Relapsing Clostridium difficile Infection. While the use of bacteriotherapy to treat gastro-intestinal disorders such as Clostridium difficile may have been generally satisfactory, there is nevertheless a need for a fecal matter transplant kit that is safe and efficient to use and that includes a standardized system to collect and transplant fecal matter from one individual to another individual.
It is a purpose of this invention to fulfill this and other needs in the art in a manner more apparent to the skilled artisan once given the following disclosure.
A feature of the present invention is a fecal matter transplant kit that includes a fecal matter storage container having a fecal matter filter, a fecal matter/saline container connected to the fecal matter storage container for mixing the fecal matter and the saline to create a suspension, and a suspension delivery device for transplanting the suspension into the patient.
Another feature of the present invention is the provision of a fecal matter storage container including a sealable bag.
Another feature of the present invention is the provision of a medical grade polymeric sealable bag.
Another feature of the present invention is the provision of a fecal matter storage container having a sealable opening located at one end of the fecal matter storage container.
Another feature of the present invention is the provision of a fecal matter storage container including a fluid flow port located at the other end of the fecal matter storage container.
Another feature of the present invention is the provision of a fecal matter storage container having a fluid flow shut off means located substantially adjacent to the fluid flow port.
Another feature of the present invention is the provision of a fecal matter filter including a net filter.
Another feature of the present invention is the provision of a fecal matter/saline container including a fecal matter/saline bag.
Another feature of the present invention is the provision of a medical grade polymeric fecal matter/saline bag.
Another feature of the present invention is the provision of a fecal matter/saline container having a fluid flow port located at one end of the fecal matter/saline container.
Another feature of the present invention is the provision of a fecal matter/saline container including a fluid flow shut off means located substantially adjacent to the fluid flow port.
Another feature of the present invention is the provision of a fecal matter/saline container having a sterile solution port located substantially adjacent to the fluid flow port.
Another feature of the present invention is the provision of a suspension delivery device having a fecal matter and saline suspension fluid conduit.
Another feature of the present invention is the provision of a fecal matter and saline suspension fluid conduit including polymeric tubing.
Another feature of the present invention is the provision of a suspension delivery device having a fecal matter/saline container connector located at one end of the conduit.
Another feature of the present invention is the provision of a suspension delivery device including a colonoscope or nasogastric tube connector located at another end of the conduit.
A further feature of the present invention is the provision of a method for transplanting a fecal matter/saline suspension within a patient, wherein the method includes the steps of: collecting a specimen of fecal matter; determining if the specimen is healthy enough to be transplanted into the patient; depositing the specimen into a fecal matter storage container; sealing the fecal matter storage container; introducing an amount of a sterile solution into the fecal matter storage container; mixing the fecal matter specimen and the amount of sterile solution in the fecal matter storage container to create a fecal matter and sterile solution mixture; transferring the fecal matter and sterile solution mixture into a fecal matter/saline container; mixing the fecal matter and sterile solution mixture with another amount of the sterile solution in the fecal matter/saline container to create a fecal matter and sterile solution suspension; and using a suspension delivery device to transplant the fecal matter/saline solution suspension within the patient.
Another feature of the present invention is the provision of a saline sterile solution.
Another feature of the present invention is the provision of a method for transplanting a fecal matter/saline suspension within a patient, wherein the step of using a suspension delivery device further includes the steps of: using a fluid pump to withdraw the fecal matter/saline solution suspension from the fecal matter/saline container and to transfer the fecal matter/saline solution suspension to a colonoscope or nasogastric tube; and using the colonoscope or nasogastric tube to deliver the fecal matter/saline solution suspension into the patient.
A still further feature of the present invention is the provision of a fecal matter transplant kit including: a fecal matter storage container having a fecal matter filter; a fecal matter/saline container operatively connected to the fecal matter storage container for mixing the fecal matter and the saline to create a suspension; and a suspension delivery device for transplanting the suspension into the patient, wherein the suspension delivery device includes a colonoscope.
The preferred fecal matter transplant kit, according to various embodiments of the present invention, offers the following advantages: ease of use, economy of design, transplant personnel do not have to contact the fecal matter, fecal matter odor is substantially eliminated, the need to blend the fecal matter suspension is eliminated, and a safe, standardized system to collect and transplant the fecal matter is utilized.
The above mentioned features and steps of the invention and the manner of attaining them will become apparent, and the invention itself will be best understood by reference to the following description of the embodiments of the invention in conjunction with the accompanying drawings, wherein like characters represent like parts throughout the several views and in which:
To provide some perspective that will be helpful in understanding and appreciating the inventive concepts of the present invention, it is well known that Clostridium difficile (C. Diff.) causes severe diarrhea and other intestinal diseases. Interestingly, it is not uncommon for individuals to accidentally ingest spores of Clostridium difficile while they are patients in a hospital or other care giving facility including long term care facilities. In fact, over 14,000 people a year in the United States alone die as a result. This is because as the bacteria overgrow, they release toxins that attack the lining of the intestines. If the normal gut flora in the patient has been destroyed through the use of antibiotics, the person's digestive system becomes devoid of the bacteria needed to fight off these harmful toxins. If not properly treated, these toxins can become life threatening. The present invention can be used to treat Clostridium difficile by transplanting a healthy stool specimen within a patient affected with Clostridium difficile such that the patient's digestive system is infiltrated with the bacteria needed to fight off these harmful toxins.
As is known in past bacteriotherapy treatments for Clostridium difficile, the medical personnel may inadvertently come into contact with fecal matter. Also, prior, known bacteriotherapy treatments for Clostridium difficile do not necessarily use sealed containers which can result in a fecal matter odor being noticed by the medical personnel and the patient. Also, previous bacteriotherapy treatments for Clostridium difficile require a blending or mechanical mixing of the fecal matter and the saline solution which then requires costly sanitation procedures to properly clean the mixing equipment. Therefore, there is clearly a need for a safe, standardized system to collect and transplant the fecal matter.
The present invention addresses the need for a safe, standardized system to collect and transplant the fecal matter by allowing the medical personnel to create a fecal matter and saline suspension without having to physically contact the fecal matter. Also, once the fecal matter has been placed within the fecal matter transplant kit 2, the fecal matter odor should be substantially reduced because the fecal matter is now located within sealed containers. Finally, the present invention does not require that the medical professional to blend or otherwise mechanically mix the fecal matter with the saline solution. This elimination of the blending step significantly reduces the clean-up time and possible likelihood of the medical personnel being contaminated by fecal matter.
Considering now the fecal matter transplant kit 2 in greater detail with reference to
Considering now the container or bag assembly 10, the container assembly 10 generally comprises a closable container or bag 20 which includes a net filter 14 located substantially within bag 20 and a shut off port 22. As more clearly shown in
Also, net filter 14 is attached to the interior of bag 20 by conventional techniques such as thermal welding or other similar techniques. Volume markings 15 are utilized to determine the amount of fecal matter and sterile solution within bag 20. Located at the other end of bag 20 is shut off port 22. A conventional shut off valve or pinch clamp 24 is located adjacent to shut of port 22 in order to keep any fecal matter from leaving bag 20 while the fecal matter is being placed within bag 20. Pinch clamp 24, preferably, is constructed of polypropylene. A connector 26 is attached to port 22 so that connector 26 interacts with a saline bag port 54 formed in the fecal matter/saline container assembly 50, as will be described in greater detail later. Connector 26, preferably, is constructed of polypropylene.
Regarding
With respect to
With reference to
Once the fecal matter specimen has been sealed within bag 20 (step 206), bag 20 is connected to saline bag or container assembly 50 by attaching port 22 on bag 20 to port 54 on saline bag 52 (
After the fecal matter specimen and the sterile solution have been mashed up, shut off valve 24 is opened so that the pulverized fecal matter specimen and the sterile solution is transferred from the bag 20 into saline bag or container assembly 50 through connector 26. During this step, net filter 14 (
Once the fecal matter specimen and the sterile solution have been completely transferred into saline bag or container assembly 50, shut off valve 60 (
In order to transport the fecal matter and sterile solution suspension from bag 52 into the patient, suspension delivery assembly 100 is utilized (step 216). More precisely, connector 62 on tubing 102 (
The preceding merely illustrates the principles of the invention. It will thus be appreciated that those skilled in the art will be able to devise various arrangements which, although not explicitly described or shown herein, embody the principles of the invention and are included within its spirit and scope. Furthermore, all examples and conditional language recited herein are principally intended expressly to be only for pedagogical purposes and to aid the reader in understanding the principles of the invention and the concepts contributed by the inventors to furthering the art, and are to be construed as being without limitation to such specifically recited examples and conditions. Moreover, all statements herein reciting principles, aspects, and embodiments of the invention, as well as specific examples thereof, are intended to encompass both structural and functional equivalents thereof. Additionally, it is intended that such equivalents include both currently known equivalents and equivalents developed in the future, i.e., any elements developed that perform the same function, regardless of structure.
This description of the exemplary embodiments is intended to be read in connection with the figures of the accompanying drawing, which are to be considered part of the entire written description. In the description, relative terms such as “lower,” “upper,” “horizontal,” “vertical,” “above,” “below,” “up,” “down,” “top” and “bottom” as well as derivatives thereof (e.g., “horizontally,” “downwardly,” “upwardly,” etc.) should be construed to refer to the orientation as then described or as shown in the drawing under discussion. These relative terms are for convenience of description and do not require that the apparatus be constructed or operated in a particular orientation. Terms concerning attachments, coupling and the like, such as “connected” and “interconnected,” refer to a relationship wherein structures are secured or attached to one another either directly or indirectly through intervening structures, as well as both movable or rigid attachments or relationships, unless expressly described otherwise.
All patents, publications, scientific articles, web sites, and other documents and materials referenced or mentioned herein are indicative of the levels of skill of those skilled in the art to which the invention pertains, and each such referenced document and material is hereby incorporated by reference to the same extent as if it had been incorporated by reference in its entirety individually or set forth herein in its entirety. Applicants reserve the right to physically incorporate into this specification any and all materials and information from any such patents, publications, scientific articles, web sites, electronically available information, and other referenced materials or documents to the extent such incorporated materials and information are not inconsistent with the description herein.
The written description portion of this patent includes all claims. Furthermore, all claims, including all original claims as well as all claims from any and all priority documents, are hereby incorporated by reference in their entirety into the written description portion of the specification, and Applicant(s) reserve the right to physically incorporate into the written description or any other portion of the application, any and all such claims. Thus, for example, under no circumstances may the patent be interpreted as allegedly not providing a written description for a claim on the assertion that the precise wording of the claim is not set forth in haec verba in written description portion of the patent.
The claims will be interpreted according to law. However, and notwithstanding the alleged or perceived ease or difficulty of interpreting any claim or portion thereof, under no circumstances may any adjustment or amendment of a claim or any portion thereof during prosecution of the application or applications leading to this patent be interpreted as having forfeited any right to any and all equivalents thereof that do not form a part of the prior art.
All of the features disclosed in this specification may be combined in any combination. Thus, unless expressly stated otherwise, each feature disclosed is only an example of a generic series of equivalent or similar features.
It is to be understood that while the invention has been described in conjunction with the detailed description thereof, the foregoing description is intended to illustrate and not limit the scope of the invention, which is defined by the scope of the appended claims. Thus, from the foregoing, it will be appreciated that, although specific embodiments of the invention have been described herein for the purpose of illustration, various modifications may be made without deviating from the spirit and scope of the invention. Other aspects, advantages, and modifications are within the scope of the following claims and the present invention is not limited except as by the appended claims.
The specific methods and compositions described herein are representative of preferred embodiments and are exemplary and not intended as limitations on the scope of the invention. Other objects, aspects, and embodiments will occur to those skilled in the art upon consideration of this specification, and are encompassed within the spirit of the invention as defined by the scope of the claims. It will be readily apparent to one skilled in the art that varying substitutions and modifications may be made to the invention disclosed herein without departing from the scope and spirit of the invention. The invention illustratively described herein suitably may be practiced in the absence of any element or elements, or limitation or limitations, which is not specifically disclosed herein as essential. Thus, for example, in each instance herein, in embodiments or examples of the present invention, the terms “comprising”, “including”, “containing”, etc. are to be read expansively and without limitation. The methods and processes illustratively described herein suitably may be practiced in differing orders of steps, and that they are not necessarily restricted to the orders of steps indicated herein or in the claims.
The terms and expressions that have been employed are used as terms of description and not of limitation, and there is no intent in the use of such terms and expressions to exclude any equivalent of the features shown and described or portions thereof, but it is recognized that various modifications are possible within the scope of the invention as claimed. Thus, it will be understood that although the present invention has been specifically disclosed by various embodiments and/or preferred embodiments and optional features, any and all modifications and variations of the concepts herein disclosed that may be resorted to by those skilled in the art are considered to be within the scope of this invention as defined by the appended claims.
The invention has been described broadly and generically herein. Each of the narrower species and sub-generic groupings falling within the generic disclosure also form part of the invention. This includes the generic description of the invention with a proviso or negative limitation removing any subject matter from the genus, regardless of whether or not the excised material is specifically recited herein.
It is also to be understood that as used herein and in the appended claims, the singular forms “a,” “an,” and “the” include plural reference unless the context clearly dictates otherwise, the term “X and/or Y” means “X” or “Y” or both “X” and “Y”, and the letter “s” following a noun designates both the plural and singular forms of that noun. In addition, where features or aspects of the invention are described in terms of Markush groups, it is intended and those skilled in the art will recognize, that the invention embraces and is also thereby described in terms of any individual member or subgroup of members of the Markush group.
Other embodiments are within the following claims. Therefore, the patent may not be interpreted to be limited to the specific examples or embodiments or methods specifically and/or expressly disclosed herein. Under no circumstances may the patent be interpreted to be limited by any statement made by any Examiner or any other official or employee of the Patent and Trademark Office unless such statement is specifically and without qualification or reservation expressly adopted in a responsive writing by Applicants.
Although the invention has been described in terms of exemplary embodiments, it is not limited thereto. Rather, the appended claims should be construed broadly, to include other variants and embodiments of the invention, which may be made by those skilled in the art without departing from the scope and range of equivalents of the invention.
Other modifications and implementations will occur to those skilled in the art without departing from the spirit and the scope of the invention as claimed. Accordingly, the description hereinabove is not intended to limit the invention, except as indicated in the appended claims.
| Number | Date | Country | |
|---|---|---|---|
| Parent | 14142866 | Dec 2013 | US |
| Child | 15263457 | US |
