Surgery – Endoscope – With guide means for body insertion
Reexamination Certificate
1998-11-30
2001-05-22
Leubecker, John P. (Department: 3739)
Surgery
Endoscope
With guide means for body insertion
C600S106000, C600S115000
Reexamination Certificate
active
06234958
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to the field of medical devices used in surgical operations and, more particularly, to medical devices and methods for introducing scopes, instruments, and/or fluids into a body cavity.
BACKGROUND OF THE INVENTION
Over the past few 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 both by patients, physicians, and various medical industry administrators. To accomplish these desires and demands, various medical devices and instrumentation has been developed such as cannulas or micro-cannulas, various catheter devices including steerable catheters, micro-surgical instrumentation and implants, medical introducers, fiber optic scopes and other imaging devices, and other endoscopic related devices.
In situations where minimally invasive procedures are being used, space within an opening, a cavity, a passageway, or a vessel of a patient's body becomes more and more constrained. Conventionally, a medical introducer is often used during a surgical or other medical procedure. An example of a hemostatic sheath introducer having a single lumen formed therein can be seen in U.S. Pat. No. 5,755,702 by Hillstead et al. titled “Adjustable Angular Sheath Introducer” which allows a main body lumen thereof to be at a different angle than a rotating section lumen. Even with the use of a single lumen medical introducer such as shown and described in U.S. Pat. No. 5,755,702, operating within tight or small spaces with a plurality of medical devices, such as instruments, scopes, fluids, catheters, implants, and the like, becomes difficult to manage by physicians and medical assistants. This is especially true where a single physician wants to perform a procedure in his office to reduce or prevent the need(s) for hospitalization.
Additionally, when performing a procedure with a plurality of medical devices, positioning, controlling, manipulating, and handling the various medical devices during the procedure can prevent physicians from performing as well as capable. In other words, the construction and design of the medical device becomes a system constraint, e.g., reduces or inhibits system flexibility, for the physician. For example, such constraints can require physicians to perform an exploratory procedure, a diagnostic procedure, and/or an actual surgical operation as two, three, or more different patient visits. To respond to some of these problems, various catheters and endoscopic devices have been developed which attempt to perform an “all-in-one” type function or which attempt to combine steering and other functions. Some examples of such attempts can be seen in U.S. Pat. No. 5,083,549 by Cho et al. titled “Endoscope With Tapered Shaft,” U.S. Pat. No. 5,484,407 by Osypka titled “Catheter With Steerable Distal End,” U.S. Pat. No. 5,772,628 by Bacich et al. titled “Surgical Access Device And Method Of Construction Same,” U.S. Pat. No. 5,488,960 by Toner titled “Coronary Sinus Catheter Introducer System,” U.S. Pat. No. 5,377,668 by Ehmsen et al. '668 titled Apparatus And Method For Endoscopic Diagnostics And Therapy,” U.S. Pat. No. 5,443,454 by Tanabe et al. titled Catheter For Embolectomy,” U.S. Pat. No. 5,342,299 by Snoke et al. titled “Steerable Catheter,” and U.S. Pat. No. 5,354,266 by Snoke titled “Method Of Epidural Surgery.”
One of the basic problems with these prior attempts, however, has been that by bundling too many features into a single medical device makes the device complex to manufacture and handle, expensive, and relatively large within a confined space. Also, when performing a procedure, the physician is often still limited by the devices capabilities, and if the physician attempts a procedure using additional devices, similar problems related to space and degrees of freedom arise again. In other words, the physical and structural constraints of the device can severely limit the physicians abilities to view, move around within the space, transition between procedures, and perform additional procedural function.
SUMMARY OF THE INVENTION
With the foregoing in mind, the present invention advantageously provides a medical device introduction system, a medical introducer, and associated methods which provide physician flexibility and increase the degrees of freedom for physicians during various medical procedures. The present invention also provides a simplified medical device introduction system and associated methods which allow an imaging device to be separably and independently controlled from a steerable working channel device, as well as from a medical introducer itself, and thereby enhance viewing within a portion of a body. The present invention additionally provides a medical device introduction system and associated methods which have flexible uses for various medical procedures so that more than one procedure can be performed during a single invasive event and thereby reduces the number of invasive events necessary to improve a patient's health. The present invention also provides a medical device introduction system and associated methods which enhances visibility by physicians or other health care professionals within a portion of a patient's body during a medical procedure. The present invention further provides a medical introducer which pivots to various positions to enhance medical procedure approaches and thereby expands the uses of the medical introducer. The present invention still further provides a medical introducer with expandable lumen so that the overall size or outside diameter of the introducer can be reduced for insertion during selected procedures and then increase if desired when additional medical devices or fluid are positioned therein to thereby reduce trauma to patients during multiple procedures.
More particularly, the present invention provides a medical device introduction system which preferably includes a medical introducer having an introducer body and a plurality of lumen formed therein, an imaging device positioned in a predetermined one of the plurality of lumen of the medical introducer so that the imaging device is separately controllable independent of the medical introducer, and a separate steerable working channel device positioned in at least one other of the plurality of lumen of the medical introducer so that the separate steerable working channel device and the imaging device are separately controllable by a user thereof independent of each other. The separate steerable working channel device is preferably provided by a separate multiple lumen device which includes an elongate tube portion having at least one lumen formed therein which defines the working channel and steering means associated with the elongate tube portion for steering the elongate tube portion.
A medical introducer for introducing medical devices therethrough and into a portion of a body according to the present invention preferably includes an introducer body, a plurality of lumen formed in the introducer body, and imaging device position maintaining means associated with at least an inner surface of a predetermined one of the plurality of lumen for maintaining a rotational position of a distal end portion of an imaging device when positioned within the predetermined one of the plurality of lumen.
An alternative embodiment of a medical introducer for introducing medical devices therethrough and into a portion of a patient's body according to the present invention preferably includes an introducer body including at least one inflatable portion associated with an outer surface of a predetermined distal end portion thereof for inflating the outer surface of the predetermined distal end portion from a collapsed to an enlarged position and a plurality of lumen formed therein. At least one of the plurality of lumen advantageously transitions from a smaller inside diameter in a distal end portion of the introducer body to a l
Finch Marcus E.
Hasslinger Randall J.
Mark Michael J.
Snoke Phillip Jack
Allen Dyer Doppelt Milbrath & Gilchrist, P.A.
Leubecker John P.
Medical Access Systems, LLC
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