News Column

Patent Application Titled "Medical Device Introduction Systems and Methods" Published Online

August 5, 2014



By a News Reporter-Staff News Editor at Life Science Weekly -- According to news reporting originating from Washington, D.C., by NewsRx journalists, a patent application by the inventors Snoke, Phillip Jack (Winston-Salem, NC); Allred, Philip Morrison (Kernersville, NC), filed on January 16, 2014, was made available online on July 24, 2014 (see also Patents).

No assignee for this patent application has been made.

Reporters obtained the following quote from the background information supplied by the inventors: "In recent years, medical procedures have advanced to stages where less and less invasive, or minimally invasive, surgeries, diagnostic procedures, exploratory procedures, or other medical procedures have been desired and demanded by patients, physicians, and payers. To accomplish these desires and demands, various medical devices and instrumentation have been developed, such as cannulas or micro-cannulas, various catheter devices, micro-surgical instrumentation and implants, medical introducers, imaging devices such as fiber optic scopes, and other related endoscopic devices.

"In situations in which minimally invasive procedures are used, space within an interior body region, for example, an organ, opening, cavity, passageway, or vessel, can become more and more constrained. As a result, operating within small spaces with a plurality of medical devices, such as scopes, dilating and cutting instruments, fluids, catheters, implants, and the like, can become difficult to manage. When performing a procedure with a plurality of medical devices, positioning, controlling, manipulating, and handling the various medical devices during the procedure can limit a physician's ability to perform as well as capable. That is, the design and construction of a medical device can limit a physician's ability to view a target site, maneuver within a space, transition between procedures, and/or perform additional procedures. Managing the use of multiple devices in a procedure can pose even greater difficulty to a single physician who desires to perform a procedure, often without assistance or with limited assistance, in an office or outpatient setting so as to avoid the time and expense of hospital utilization for such procedures.

"Conventional medical devices having optical capabilities, such as conventional endoscopes, can have other disadvantages. The optical capabilities can be limited due to various factors, including, for example, the anatomical structures about which the scopes are maneuvered, and the movement and/or control together of both the imaging device and a delivery device and the resulting loss in orientation in an interior body region. For example, optical capabilities with conventional endoscopes typically used in hysteroscopy procedures are often limited in such ways, making it difficult for the physician to know whether what is being viewed is up or down. Such conventional endoscopes and associated delivery devices are often complex and require extended learning to operate effectively. In addition, many conventional endoscopes and delivery devices are reusable and can be very expensive to purchase and to re-sterilize after each use. As a result, physicians often elect not to perform diagnostic and/or therapeutic procedures in a medical office or outpatient setting that could otherwise be performed to the patient's advantage in those settings.

"During use in medical procedures, introducer instruments, sheaths, endoscopes, and working catheters and cannula can be exposed to various bacteria, viruses, and other microorganisms, and to potentially disease carrying media. These microorganisms can be trapped in such devices, particularly in lumens, and transferred to subsequent patients or users. Sterilization methods can be employed on such devices that are reusable in an attempt to disinfect and eliminate microorganisms for subsequent use of the devices. However, some surgical devices contain very small and/or narrow working channels or lumens for performing intricate medical procedures. These small and/or narrow working channels can be difficult to clean and sterilize. If not effectively eliminated, these materials may be transferred to, and potentially cause harmful infections to, other patients or medical personnel through subsequent use of the devices.

"In addition to the problems of potential disease transmission and lack of disposability, conventional reusable medical introducer, endoscopes, and the like are subjected to repeated use over prolonged periods. The precision of manipulation and movement in endoscopes and steerable medical devices is often essential for conducting complicated diagnostic and therapeutic medical procedures generally performed with such devices. Some reusable devices containing steering mechanisms often require precision calibration. Further, these devices are regularly subjected to sterilization with heat or chemicals. To accomplish these objectives, conventional reusable devices are often made of stainless steel or other durable materials that are costly. In addition, despite being designed for repeated use, such conventional intricate reusable devices, in particular, such devices that incorporate visualization components, often require regular replacement, further adding to the cost of such devices."

In addition to obtaining background information on this patent application, NewsRx editors also obtained the inventors' summary information for this patent application: "Some embodiments of an medical device introduction system and method of the present invention can include a medical introducer, a separate imaging device, and/or a separate working channel device. The medical introducer can include a handle and an elongate introducer tube extending from the handle. The introducer tube can include a plurality of lumens extending longitudinally therein. The medical introducer may be inserted into an interior body region of a patient. The separate imaging device may be inserted through the handle and positioned in a predetermined one of the plurality of lumens. The imaging device can have an interface with the handle such that each of the imaging device and the medical introducer is movable independent of the other. The separate working channel device can include an elongate working channel tube and a position controller. The working channel tube can include at least one lumen extending the length thereof defining a working channel. The position controller can be configured to control positioning of the working channel device or tube. The working channel device may be removably connectable to the handle and positioned in another predetermined one of the plurality of lumens. In some embodiments of the present invention, each of the medical introducer, the imaging device, and the working channel device can be movable independent of the other.

"In certain embodiments, the medical introducer handle can comprise an oval-shaped ring of material having an open interior. The handle can have a proximal end configured to receive at least one fluid tube and the imaging device therethrough. The handle can further include a distal end adapted to connect to the introducer tube. In certain embodiments, the plurality of lumens in the introducer tube can include a scope lumen, at least one working lumen, and at least one fluid lumen separate from the scope lumen and the working lumen(s). In an illustrative embodiment, the medical introducer can further include a fluid inflow tube routed through the proximal end of the handle and in fluid communication with a fluid lumen, and a fluid outflow tube routed through the proximal end of the handle and in fluid communication with another fluid lumen. In some embodiments, the medical introducer can include a modular manifold integrally formed on the proximal end of the introducer tube and have a corresponding plurality of lumens aligned with the plurality of lumens in the introducer tube. The manifold can be removably connected to the introducer handle such that the manifold and introducer tube are interchangeable in the handle with other manifolds and introducer tubes.

"In some embodiments, the medical introducer and/or the working channel device can be disposable. In some embodiments, at least a portion of the medical introducer and/or at least a portion of the working channel, device can be translucent such that passage of materials therethrough is viewable.

"In some embodiments, one or more of the introducer tube, the working channel tube, and the endoscopic cannula can include a proximal portion having a first durormeter and a distal portion having a second durometer. The second durometer is lower than the first durometer so as to allow deflection of the distal portion of the respective tube or cannula for controllable access to a target area in the interior body region. In some embodiments further durometer(s) may be utilized to enhance steering.

"In certain embodiments, the working channel device can be a steerable working channel device. In such an embodiment, the working channel tube can comprise a flexible distal portion adapted for steering to selected positions. The position controller can be operably connected to the working channel tube distal portion and slidable within the introducer handle for moving the working channel tube distal portion in distal and proximal directions. In addition, the position controller can be actuated to steer the flexible distal portion of the working channel tube in predetermined directions and amounts.

"In some embodiments, the imaging device can include an endoscopic cannula, a light delivery mechanism, and a imaging system. The light delivery system can comprise light emitting diodes and/or light delivery fibers. The imaging system can be an optical scope, an ultrasound instrument, or a camera.

"In some embodiments, a medical introducer and/or a working channel device are configured to provide a user an ability to establish a predetermined route of delivery. The medical introducer and/or working channel device may be further configured to provide alternative routes of delivery. The delivery route and/or routes may be established, for example visually, using components of the medical introducer and/or working channel device, for example through locking, braking or fixing of components.

"The present invention can include embodiments of a method. For example, a medical introducer comprising a handle and an elongate introducer tube extending therefrom and having a plurality of lumens extending longitudinally therein can be inserted into an interior body region of a patient. A separate imaging device can be inserted through the handle and in a predetermined one of the plurality of lumens. The imaging device can be positioned in a selected position within the interior body region. Then, an image can be produced from within the interior body region. A separate working channel device and position, controller can be removably connected to the medical introducer. The working channel device can include an elongate working channel tube having at least one lumen extending the length thereof defining a working channel. The position controller for controlling the position of the working channel tube can be positioned in the working channel in another predetermined one of the plurality of lumens. In such embodiments, one of the group of the medical introducer, the imaging device, and the working channel device may be moved independently of the others of the group.

"In some embodiments of a method, the medical introducer handle can comprise an oval-shaped ring of material having an open interior. The method can further include connecting a distal end of the handle to the introducer tube. In some embodiments of a method, the medical introducer can include a modular manifold integrally formed on a proximal end of the introducer tube and have a corresponding plurality of lumens aligned with the plurality of lumens in the introducer tube. In such an embodiment, the manifold can be removably connected to the introducer handle. The manifold and introducer tube may be interchanged in the handle with other manifolds and introducer tubes.

"Certain embodiments of a method of the present invention include performing a medical procedure in an interior body region through the working channel device. For example, the medical procedure can be a gynecological procedure, a spinal procedure, or other procedure.

BRIEF DESCRIPTION OF THE DRAWINGS

"FIG. 1 is a perspective view of a medical device introduction system in an embodiment of the present invention.

"FIG. 2 is a perspective view of the medical introducer shown in FIG. 1, showing a plug seal in the working channel in an embodiment of the present invention.

"FIG. 3 is a view of the medical introducer shown in FIG. 1, showing a plug adapter with seal in the working channel in an embodiment of the present invention.

"FIG. 4 is a close-up, perspective view of the manifold of the medical introducer shown in FIG. 1, in an embodiment of the present invention.

"FIG. 5 is a cross-sectional view taken along the lines 5-5 of the lumens in the manifold shown in FIG. 4, in an embodiment of the present invention.

"FIG. 6 is a close-up, perspective view of the steerable working channel device position controller shown in FIG. 1, in an embodiment of the present invention.

"FIG. 7 is a cross-sectional view taken along the lines 7-7 in FIG. 6 of the internal components of the steerable working channel device position controller in an embodiment of the present invention.

"FIG. 8 is a close-up perspective view of the steerable working channel device proximal port shown in FIGS. 1 and 6 in an embodiment of the present invention.

"FIGS. 9A-9E are top views of the medical introducer and steerable working channel device shown in FIG. 1, in an embodiment of the present invention. FIG. 9A shows the position controller in distal position and the distal end portion deflected to the left. FIG. 9B shows the position controller in medial position and the distal end portion deflected to the left.

"FIG. 9C shows the position controller in proximal position and the distal end portion fully retracted. FIG. 9P shows the position controller in medial position and the distal end portion deflected to the right. FIG. 9E shows the position controller in distal position and the distal end portion deflected to the right.

"FIG. 10 is a view of the medical introducer and steerable working channel device shown in FIG. 1, illustrating positioning of the steerable working channel tube in a uterine cavity in an embodiment of the present invention.

"FIG. 11 is a close-up view of the endoscope and camera shown in FIG. 1, in an embodiment of the present invention.

"FIG. 12 is a cross-sectional view of a steerable working channel showing steering wire lumens and areas of the working channel tube having different relative durometers in an embodiment of the present invention.

"FIG. 13 is a view of a medical introducer tube having a lift wire lumen in an embodiment of the present invention.

"FIG. 14 is a view of a medical introducer tube showing a lumen configuration having a large scope lumen and three smaller lumens for delivering a medical device and for fluids in an embodiment of the present invention.

"FIG. 15 is a side view of a medical device introduction system having an accessory device support attached thereto, the accessory device support supporting an implant delivery device, in an embodiment of the present invention.

"FIG. 16 is a view of a continuous flow examination sheath useful in an embodiment of the present invention, showing both assembled and unassembled views.

"FIG. 17 is a view of a single flow examination sheath useful in an embodiment of the present invention, showing both assembled and unassembled views.

"FIG. 18 is a view of a preformed delivery tube useful in an embodiment of the present invention, showing both assembled and unassembled views.

"FIG. 19 is a view of a medical device that has a slider and a rail associated with the medical device.

"FIG. 20 is a view of a bent introducer tube.

"FIG. 21 is a view of the introducer tube with an accompanying bent sheath.

"FIG. 22 is a view of the introducer tube with an accompanying bent sheath wherein distal tip of the introducer tube and the working channel medical device are visible.

"FIG. 23 is a view of the a uterus wherein the introducer tube is accessing the left osteum and fallopian tube.

"FIG. 24 is a view of the a uterus wherein the introducer tube is accessing the right osteum and fallopian tube.

"FIG. 25 is a view of a manifold wherein the manifold contains a seal that is present at the location where the working channel is.

"FIGS. 26A and B show an 'r' curve and an 's' curve tip, respectively.

"FIG. 27 shows an embodiment of the medical introducer device.

"FIG. 28 shows a perspective view of the various lumens as they enter into the modular manifold.

"FIG. 29 shows a perspective view of the various parts of the modular manifold, the manifold base, the seal and the manifold cover.

"FIG. 30 shows the modular manifold in an unassembled state and an assembled state, with the manifold base and the manifold cover separated and then joined.

"FIG. 31 shows the modular manifold with lumen core pins as they are used in the process of assembling the modular manifold.

"FIG. 32 shows the modular manifold in a vertical position, which shows an embodiment of a process that allows the gluing of the manifold base and the manifold cover (with or without a seal)."

For more information, see this patent application: Snoke, Phillip Jack; Allred, Philip Morrison. Medical Device Introduction Systems and Methods. Filed January 16, 2014 and posted July 24, 2014. Patent URL: http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&u=%2Fnetahtml%2FPTO%2Fsearch-adv.html&r=1476&p=30&f=G&l=50&d=PG01&S1=20140717.PD.&OS=PD/20140717&RS=PD/20140717

Keywords for this news article include: Patents.

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Source: Life Science Weekly


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