Patent Application
20200386772
Adhesions or scar tissue in humans typically results from abdominal and pelvic surgeries or acute traumatic injury, or infections and can develop between any abdominal surfaces, structures or organs during the healing process. Adhesions can cause intestinal, fallopian tube, or bowel obstruction, chronic pain, infertility or can cause complications when further surgery is required. There are no specific laboratory tests associated with adhesion disease. Current testing for adhesions in the abdomen or pelvic area utilize costly imaging procedures such as MRI. Laparoscopy can also diagnose and perhaps provide treatment of adhesions, but such surgery may be unnecessary if the laparoscopy finds that subject does not have adhesions.
Thus, there is a need to provide a cost-effective diagnostic test determine if adhesions are present in a patient by identifying at least one adhesion marker in circulating bodily cells, body fluids, or plasma, and to permit treatment of the adhesions without surgery.
An objective of the embodiment is to fulfill the need referred to above. In accordance with the principles of an embodiment, this objective is achieved by providing a method that identifies an adhesion in a human subject by obtaining a sample of a bodily fluid derived from the subject, and assaying the sample for activity of a biomarker specific for an adhesion in internal tissue of the subject to thereby determine whether the subject has an internal adhesion.
In accordance with another aspect of an embodiment, a method identifies an adhesion in a human subject by administering an imaging agent to the subject with the imaging agent identifying a biomarker specific for an adhesion in internal tissue of the subject, and utilizing imaging equipment to locate the adhesion identified by the imaging agent.
Other objectives, features and characteristics of the present embodiment, as well as the methods of operation and the functions of the related elements of the structure, the combination of parts and economics of manufacture will become more apparent upon consideration of the following detailed description and appended claims with reference to the accompanying drawings, all of which form a part of this specification.
The invention will be better understood from the following detailed description of the preferred embodiments thereof, taken in conjunction with the accompanying drawing.
After abdominal or pelvic surgery, internal scar tissue (adhesions) may form between two tissue surfaces during healing. The scar tissue forms since the rejoining tissue does not grow the collagen back the same way it was originally, or the scar tissue forms as a result of disordered reaction of myofibroblasts due to tissue manipulation. Thus, scar tissue is a disordered, benign tissue growth process than can cause pain, create an obstruction, and cause complications when further surgery is required. This disclosure provides methods for identifying internal adhesions and treating or reducing such adhesions without the need for surgery.
Fibroblast cells transition to myofibroblasts cells during scaring in an acute development phase of scaring. Biomarkers in the myofibroblasts cells can be identified in the subject's bodily fluid such as blood, plasma and/or at the site of the adhesion. The biomarkers can include circulating cells, proteins or end products as result of transition. The proteins are preferably chemokines or cytokines (TGF-β1, IL-6 and IL-8). Other indicators of adhesions can include the expression of α-SNA stress fibers during the transition of fibroblast cells to myofibroblast cells, excessive collagen and fibonectin secretion, expression of fibrotic ECM proteins such as SPARC and Tenascin, low MMP secretion, and immune cells such as mast cells, monocytes, T cells, etc.). Also, the involvement of the TGF-β/SMAD and Wnt/β-catenin pathways are known to be important in developing scars and can be considered biomarkers.
In accordance with an embodiment and with reference to
In accordance with another aspect of an embodiment and with reference to
The myofibroblast cells are intermediate cells and may not be available to identify a chronic adhesion in the subject. Chronic, unhealthy wounds or adhesions have been found to include biomarkers such as the proteins IL1, IL6, and matrix metalloproteinases (MMPs). Thus, the above methods of identifying an adhesion can be employed to identify chronic adhesions by identifying these or other biomarkers indicative of a chronic adhesion.
Once an adhesion or adhesions are identified by the methods disclosed, this information can be used by a physician to determine if surgery or other treatment would be beneficial to alleviate pain or other issues caused by the adhesions. To treat the identified internal adhesions without surgery, the methods disclosed can further include targeting the internal adhesion that provides the biomarker by injecting into a vein, artery, or body cavity of the subject, chemicals, such as steroids, antibodies or other substances that can destroy or reduce the cells defining the adhesion and/or prevent collagen formation at the adhesion site. In addition, knowing that subject has adhesions can be valuable pre-operative information for a surgeon performing open or laparoscopic surgery near the adhesions.
Thus, the methods disclosed advantageously provide a way to determine if a human subject has adhesions by monitoring biomarkers and thus, does not require surgery to determine and locate internal bodily adhesions. Furthermore, non-surgical reduction treatment of internal adhesions is also possible.
The foregoing preferred embodiments have been shown and described for the purposes of illustrating the structural and functional principles of the present invention, as well as illustrating the methods of employing the preferred embodiments and are subject to change without departing from such principles. Therefore, this invention includes all modifications encompassed within the spirit of the following claims.
| Number | Date | Country | |
|---|---|---|---|
| 62857297 | Jun 2019 | US |
