Patent Application
20080091190
Various embodiments of the subject instrument are described herein with reference to the drawings wherein:
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Endoscopic mucosal resection (EMR) is a promising technique for local management of mucosal cancer, e.g., Barrett's high grade dysplasia (HGD). Recent studies have indicated that different techniques of EMR are feasible and safe for this indication. The procedure can be used to obtain large biopsies for diagnosis and local tumor staging. Local complete remission can be achieved in the majority of patients with focal lesions so that EMR is potentially curative provided that there is no evidence of submucosal tumor infiltration.
Several endoscopic techniques have been advocated in the past for mucosal resection. It is difficult to compare the efficacy and safety among the various techniques. For example, one of the easiest but not necessarily the most effective method involves simply snaring tissue by use of a stiff snare and applying suction to remove the abnormal tissue once resected. A so-called “polypectomy technique” involves initially injecting a solution, e.g., an epinephrine solution, into the submucosal layer to facilitate snaring and resection of the abnormal tissue lesions. Other techniques such as a “lift and cut technique” involve dual-channel endoscopes: a biopsy forceps is inserted through the second endoscopic channel to lift the lesion into the opened snare which is subsequently closed around the lesion. Still other known techniques involve the creation of an artificial polyp at the site by suction, which allows a polypectomy snare to be positioned around the lesion for resection purposes. A variety of other methods involve the use of so-called overtubes that provide an external instrumentation channel for insertion of forceps and snares. This technique allows resection of a large specimen but has been associated with an increased risk of perforation.
Another popular technique called “Endoscopic mucosal resection cap (EMRC) procedure” is performed with a specially designed thin snare that is pre-looped in a cap mounted on the tip of a forward-view endoscope. To decrease the potential risk of perforation, saline solution is injected into the submucosal layer to separate the mucosa from the muscle layer. The mucosal lesion is sucked into the cap and firmly strangulated by the snare wire. The polyp is resected by electrocautery and removed by suction. It is also common to separate the submucosa and mucosa layers from muscle by injecting a solution between the submucosa and the muscle. Moreover, some procedures also involve excising both mucosa and submucosa layers, e.g., polypectomy procedure.
The presently disclosed patch 40 and surgical technique may be suited for endoscopic mucosa resection type procedures which, as described above, involves the resection of a portion of the mucosal tissue layer to remove an abnormal tissue lesion or polyp via the use of an endoscope. As best shown in
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Sealant material 40′ may be formulated from a material that expands during the transition from an uncured configuration to a cured configuration further lifting and separating the tissue layers 20, 30 and facilitating resection of excision of the abnormal tissue growth 10. It is envisioned that a sealant 40′ may also be formulated as a substantially solid material or fluid-like material to accomplish the same or similar purpose. It is also envisioned that the sealant 40′ may be formulated from a material that does not necessarily cure but acts to readily separate and seal the two tissue layers 20 and 30 immediately upon injection.
The sealant material 40′ may be curable upon selective application of temperature, electrosurgical energy, ultrasonic energy, light and/or combinations thereof. For example, the sealant material 40′ may be formulated with any of the following characteristics or combinations of characteristics:
1) to cure on contact or exposure to the submucosal layer 30;
2) to cure by a change in temperature, i.e., upon contact with the higher body temperature of the submucosal layer 30 or additional temperature or heat applied relative to the tissue site;
3) to cure upon application of energy, e.g., RF, ultrasonic or microwave; and/or
4) to cure upon application of light, e.g., laser, ultraviolet, etc.
During the curing process, and especially when heat or electrical application is applied to resect or excise the abnormal tissue growth 10, the sealant material 40′ may be formulated to provide thermal insulation for adjacent tissue layers, e.g., mucosal layer 20 or submucosal layer 30. More particularly, the sealant material 40′ may be formulated to regulate, e.g., maximize, minimize and/or maintain the sealant's material 40′ relative impedance during the application of thermal or electrosurgical energy to protect surrounding tissue layers.
The sealant material 40′ may include collagen, liposomes, elastin and/or combinations thereof. Moreover, the sealant may be formulated to include a collagen or elastin (or combination) material that is designed to react or cooperate with native collagen to form a high strength seal once cured. The sealant material 40′ may also be formulated to include an antibiotic solution, an antibacterial solution, hemostatic solution, antibodies and/or combinations thereof. The term “hemostatic solution” is defined herein to mean any formulation or solution which causes or facilitates hemostasis after an excision.
The present disclosure also relates to a method for excising abnormal tissue and includes the steps of: providing a sealant material 40′ adapted to transition from an uncured configuration, wherein the sealant material 40′ is allowed to be injected between an abnormal tissue growth 10 and underlying tissue, e.g., submucosal tissue layer 30, and a cured configuration, wherein the sealant material 40″ acts as a substantially solid barrier between the abnormal tissue growth 10 and underlying tissue 30. The method may also includes the steps of: injecting the sealant material 40′ between the abnormal tissue growth 10 and the underlying tissue 30 to initially separate the abnormal tissue growth 10 relative to the underlying tissue 30 and allowing the sealant material 40′ to cure (now sealant material 40″). Thereafter, the abnormal tissue growth 10 is excised via a snare 60, wire loop, forceps, knife, scissors and/or combinations thereof. After excision of the target tissue 10, the sealant material 40″ acts to seal the underlying tissue 30 from the surrounding environment.
As mentioned above, the sealant material 40′ may be formulated to expand during the transition from an uncured configuration to a cured configuration. Moreover, the step of curing the sealant material 40′ may include the step of selectively applying temperature, electrosurgical energy, ultrasonic energy and/or light and/or combinations thereof to cure the sealant material 40′.
Also as mentioned above, the sealant material 40′ may be formulated to include collagen, liposomes, elastin and/or combinations thereof. The sealant material 40′ may also be formulated to include an antibiotic solution, an antibacterial solution, antibodies and/or combinations thereof. Moreover, the sealant material 40′ may be formulated to include a material that regulates the sealant's material 40′ impedance during excision (e.g., the application of energy) to regulate the temperature of surrounding tissue layers.
From the foregoing and with reference to the various figure drawings, those skilled in the art will appreciate that certain modifications can also be made to the present disclosure without departing from the scope of the same. While only one particularly-envisioned embodiment of the disclosure has been shown in the drawings, it is not intended that the disclosure be limited thereto, as it is intended that the disclosure be as broad in scope as the art will allow and that the specification be read likewise. Therefore, the above description should not be construed as limiting, but merely as exemplifications of particular embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.
