News Column

Researchers Submit Patent Application, "Cranial Evacuation System and Use Thereof", for Approval

June 16, 2014



By a News Reporter-Staff News Editor at Pharma Business Week -- From Washington, D.C., NewsRx journalists report that a patent application by the inventor Abrahams, John M. (Scarsdale, NY), filed on January 31, 2014, was made available online on June 5, 2014 (see also Patents).

No assignee for this patent application has been made.

News editors obtained the following quote from the background information supplied by the inventors: "Occasionally undesirable solid matter develops in brain tissue, and can include, a blood clot (also known as an intracranial hemorrhage), tumor tissue, a cyst, a brain lesion or infected brain tissue. Depending upon the size and location of the solid matter, and the condition of the subject, it may be necessary to remove the solid matter via surgical intervention.

"Given the fluid, non-self supporting and pliable nature of brain tissue, especially in the brain cortex, one of the problems associated with this type of surgery is that, once the solid matter has been exposed it can be difficult to maintain visual and physical contact of the solid matter in a working cavity because the brain tissue naturally moves or flows into the working cavity and re-covers the solid matter. Furthermore, once the solid matter has been removed, the brain tissue surrounding the cavity created by resection of the solid matter typically tries to flow into the cavity, making it difficult to visualize the cavity (similar to looking into a collapsed bag or balloon). Keeping both the working cavity and the cavity created by removal of the solid matter open for manipulation and visible, especially when trying to identify the source of bleeding, can be difficult if the surgeon is operating without an assistant.

"Another problem associated with the surgery is stopping bleeding that occurs once the solid matter has been removed. Typically, the working cavity is irrigated and then the surgeon looks for the source of blood flowing from the surrounding brain tissue. Often, the surgeon may use one hand to insert a hand-held retractor into the cavity while using the other hand to suction the area white looking for bleeding. Occasionally, the surgeon may use bipolar electrocautery to stop bleeding, which may require releasing the retractor. Alternatively, an absorbent material such as Gelfoam (Pfizer, Inc., New York, N.Y.) soaked in thrombin, can be packed into the cavity. The material may be left in place and irrigated until it peels away from the cavity walls once bleeding has stopped. The process can be repeated until bleeding stops. However, it is important to remove the absorbent material before closing the surgical site.

"There remains a need for improved methods and systems to facilitate the removal of solid matter from brain tissue, such as by allowing a surgeon to access a cavity without an assistant, and by providing a way to effectively stop bleeding once the solid matter has been removed."

As a supplement to the background information on this patent application, NewsRx correspondents also obtained the inventor's summary information for this patent application: "In one aspect, the invention provides a method of removing solid matter (for example, tumor tissue, a blood clot, a cyst, a brain lesion, or infected brain tissue (e.g., an abscess or a bacterial or fungal infection)) disposed within brain tissue of a subject, and then controlling bleeding once the solid matter has been removed. The method involves securing a cranial anchor to an opening in a skull of the subject, where the anchor defines an anchor passage running therethrough. Then a channel member is passed through the anchor passage of the anchor to facilitate displacement of brain tissue and to expose the solid matter. The channel member has a first end and a second end and defines a working channel passing through the channel member from the first end to the second end. Optionally, a removable, solid trocar can be inserted into the working channel to displace the brain tissue and to expose the solid matter. The trocar, if used, then is removed to leave the working channel open for subsequent manipulations by the surgeon. The solid matter is removed via the working channel to create a cavity where the solid matter used to reside. In other words, the cavity is defined by the brain tissue that surrounded the solid matter prior to removal of the solid matter. A flowable hemostat is introduced into the cavity via the working channel to contact the brain tissue that surrounded the solid matter prior to its removal. An inflatable balloon introduced via the working channel is inflated such that the wall of the inflated balloon compresses the hemostat against the brain tissue that surrounded the solid matter prior to its removal thereby to stop the bleeding from blood vessels disposed within the brain tissue surrounding the cavity.

"The method can also include removing a portion of skull from the subject to create an opening that exposes a region of brain tissue containing the solid matter. Thereafter a cranial anchor is secured to the opening. Furthermore, depending upon the procedure being implemented, the flowable hemostat can be introduced into the cavity before, during, and/or after the inflation of the balloon.

"The anchor passage may have an internal diameter of from 1 mm to 100 mm, from 2 mm to 80 mm, from 3 mm to 75 mm, from 4 mm to 65 mm, from 5 mm to 50 mm, from 6 mm to 45 mm, 7 mm to 40 mm, from 8 mm to 35 mm, or from 10 mm to 30 mm. Furthermore, if desired, the channel member can further include a removable, solid trocar disposed within the working channel. The trocar can further facilitate the displacement of brain tissue to expose the solid matter. When a trocar is used, it is removed from the working channel to permit the surgeon to remove the solid matter via the working channel. The working channel can be from 2 cm to 15 cm long, from 3 cm to 12 cm long, from 4 cm to 11 cm long, or from 5 cm to 10 cm long, and can have an internal diameter of between 7 mm and 40 mm, or between 10 mm and 30 mm. The trocar, when used, is dimensioned to be inserted within the working channel.

"Depending upon the surgical procedure, a catheter may be inserted into the working channel after the solid matter is removed. The catheter can be a dual lumen catheter that permits the introduction of the hemostat via a first lumen and the introduction of the inflatable balloon via a second lumen. Depending upon the procedure, the balloon can be inflated for 30 seconds to 72 hours, 30 seconds to 48 hours, 30 seconds to 24 hours, 30 seconds to 12 hours, 30 seconds to 6 hours, 30 seconds to 3 hours, 30 seconds to 2 hours, 30 seconds to 1 hour, 30 seconds to 30 minutes, 30 seconds to 20 minutes or 30 seconds to 10 minutes after initial inflation to compress the hemostat against the wall of the cavity. In certain procedures, for example, when there is significant bleeding, the catheter can be left in place within the brain from 12 to 72 hours.

"In another aspect, the invention provides a device or system for removing solid matter disposed within brain tissue of a subject and for controlling bleeding once the solid matter has been removed. The device or system includes (a) a cranial anchor defining an anchor passage running therethrough and adapted to be secured to a skull of a subject, (b) a channel member adapted for insertion through the anchor passage of the anchor, wherein the channel member has a first end and a second end and defines a working channel passing through the channel member from the first end to the second end, an optional removable, solid trocar adapted to be introduced within the working channel of the channel member for displacing brain tissue and exposing the solid matter, and (d) a catheter adapted to pass through the working channel optionally once the optional trocar has been removed and to introduce into the brain tissue surrounding the solid matter, once the solid matter has been removed, a flowable hemostat and an inflatable balloon.

"In certain embodiments, the anchor passage may have an internal diameter of from 1 mm to 100 mm, from 2 mm to 80 mm, from 3 mm to 75 mm, from 4 mm to 65 mm, from 5 mm to 50 mm, from 6 mm to 45 mm, 7 mm to 40 mm, from 8 mm to 35 mm, or from 10 mm to 30 mm. The anchor can optionally further comprise a flange dimensioned to overlap a region of the skull when the anchor is secured onto the skull adjacent and over an opening in the skull that exposes the brain tissue. The flange can define one or more apertures dimensioned to receive a fastener, for example, a bone screw. In certain embodiments, the working channel is from 2 cm to 15 cm long, from 3 cm to 12 cm long, from 4 cm to 11 cm long, or from 5 cm to 10 cm long, and can have an internal diameter of between 7 mm and 40 mm, or between 10 mm and 30 mm.

"In certain other embodiments, the trocar has a proximal end that can be gripped by the surgeon and a distal end for contacting the brain tissue. The distal end can be dimensioned to define a convex brain tissue contacting surface.

"The catheter can be a dual lumen catheter that permits the introduction of the hemostat via a first lumen and the introduction of the inflatable balloon via a second lumen. Optionally, the catheter can include an actuator that facilitates introduction of the inflatable balloon into the subject, and/or an actuator for inflating the balloon within the subject, and/or an actuator for introducing the hemostat into the subject.

"The foregoing aspects and embodiments of the invention may be more fully understood by reference to the drawings, detailed description and claims.

BRIEF DESCRIPTION OF THE DRAWINGS

"FIG. 1A is a schematic, perspective representation of certain components of a device for removing solid matter in brain tissue in accordance with one embodiment of the invention. FIG. 1B is a schematic, exploded representation of the components depicted in FIG. 1A. FIG. 1C is a schematic, cross-sectional representation of the device depicted in FIG. 1A.

"FIG. 2A is a schematic, perspective representation of a cranial anchor for use with the device depicted in FIG. 1A. FIG. 2B is a schematic, cross-sectional representation of the anchor depicted in FIG. 2A. FIG. 2C is a schematic, plan representation of various components of the anchor depicted in FIG. 2A.

"FIG. 3A is a schematic, perspective representation of a channel member for use with the device depicted in FIG. 1A. FIG. 3B is a schematic, cross-sectional representation of the channel member depicted in FIG. 3A.

"FIG. 4A is a schematic, perspective representation of a trocar for use with the device depicted in FIG. 1A. FIG. 4B is a schematic, cross-sectional representation of the trocar depicted in FIG. 4A.

"FIG. 5A is a schematic, perspective, exploded representation of certain components of a device for removing solid matter from brain tissue in accordance with one embodiment of the invention. FIG. 5B is a schematic, cross-sectional representation of the device depicted in FIG. 5A when assembled.

"FIG. 6A is a schematic, perspective, exploded representation of a balloon catheter for use with the device depicted in FIG. 5A. FIG. 6B is a schematic, cross-sectional representation of the balloon catheter depicted in FIG. 6A. FIG. 6C is a schematic, cross-sectional representation of the balloon catheter depicted in FIG. 6A taken along the line C-C.

"FIG. 7A is a schematic, perspective representation of a seal in accordance with one embodiment of the invention for use with the device depicted in FIG. 5A. FIG. 7B is a schematic, cross-sectional representation of the seal depicted in FIG. 7A.

"FIG. 8 is a schematic, perspective representation of a template for creating an aperture in the skull of a subject.

"FIG. 9A is a schematic, cross-sectional representation of a solid matter (e.g., a blood clot) in brain tissue. FIG. 9B is a schematic, cross-sectional representation of an anchor disposed within, and secured to the skull to provide access to the solid matter depicted in FIG. 9A. FIG. 9C is a schematic, cross-sectional representation of the anchor and a working channel to provide access to the solid matter depicted in FIG. 9A. FIG. 9D is a schematic, cross-sectional representation of the use of a balloon and hemostat to stop bleeding in the cavity formed upon removal of the solid matter depicted in FIG. 9A. In FIG. 9D, the balloon is inflated to compress the hemostat against the cavity."

For additional information on this patent application, see: Abrahams, John M. Cranial Evacuation System and Use Thereof. Filed January 31, 2014 and posted June 5, 2014. Patent URL: http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&u=%2Fnetahtml%2FPTO%2Fsearch-adv.html&r=1500&p=30&f=G&l=50&d=PG01&S1=20140529.PD.&OS=PD/20140529&RS=PD/20140529

Keywords for this news article include: Patents.

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Source: Pharma Business Week


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