Medical device introduction system and associated imaging system and method

Abstract

A medical device introduction system includes an introducer comprising a handle. An introducer tube extends from the handle to a distal end and defines longitudinally-extending lumens. An imaging system, engageable with the introducer, comprises a body member having a light source and receivable by the handle. A proximal portion of a flexible tubular member is engaged with the body member, and is positionable in one lumen. An imaging device, engaged with the distal portion and in communication with the body member, is directed in an imaging direction to capture an image outwardly of the distal portion. A plurality of light transmission devices extends through the tubular member from the light source, and distal ends thereof are arranged about the imaging device about the distal portion of the tubular member to direct the light transmitted from the light source in the imaging direction. An associated system and method are also provided.

That which is claimed: 
     
         1 . A medical device introduction system adapted to be at least partially insertable into an interior body region of a patient, the system comprising:
 a medical introducer comprising a handle and an elongate introducer tube extending from the handle to a distal end, the introducer tube defining a plurality of lumens extending longitudinally therein from the handle to the distal end; and   a medical imaging system configured to be operably engageable with the medical introducer, and comprising:
 a body member including a light source configured to emit light, the body member being configured to be received by the handle; 
 a flexible elongate tubular member having a proximal portion operably engaged with the body member, and extending to an opposed distal portion, the tubular member being configured to be insertable through the handle and positionable in one of the lumens so as to extend to the distal end of the introducer tube; 
 an imaging device engaged with the distal portion of the tubular member and configured to be in communication with the body portion, the imaging device being arranged so as to be directed, and to be capable of capturing an image, in an imaging direction outwardly of the distal portion; and 
 a plurality of light transmission devices extending from the light source and through the tubular member to respective distal ends thereof disposed about the distal portion of the tubular member, the light transmission devices being configured to receive the light from the light source and to transmit the light to the distal ends thereof, the distal ends of the light transmission devices being arranged about the imaging device about the distal portion of the tubular member so as to direct the light transmitted from the light source in the imaging direction. 
   
     
     
         2 . The system of  claim 1 , comprising a rigid conduit engaged between the body member and the flexible elongate tubular member so as to be capable of transmitting torque between the body member and the flexible elongate tubular member, the conduit being configured to be received by the handle and the tubular member being configured to be received by the one of the lumens of the introducer tube. 
     
     
         3 . The system of  claim 1 , comprising a securing device engaged with the handle of the medical introducer and configured to receive the tubular member therethrough, the securing device being configured to secure the tubular member such that the imaging device is disposed in a selected longitudinal position along the introducer tube and such that the tubular member is rotatable about a longitudinal axis thereof within the introducer tube. 
     
     
         4 . The system of  claim 3 , wherein the securing device comprises a compression fitting engaged with the handle, coaxially with the longitudinal axis, so as to be rotatable about the longitudinal axis. 
     
     
         5 . The system of  claim 1 , wherein the light transmission devices comprise fiber optic elements or light delivery fibers. 
     
     
         6 . The system of  claim 1 , wherein the imaging device comprises an active-pixel sensor array or a Complementary Metal-Oxide Semiconductor (CMOS) sensor. 
     
     
         7 . The system of  claim 1 , wherein the imaging device is configured as a quadrilateral, and is received within a lumen defined by an inner wall of the tubular member, perpendicularly to a longitudinal axis of the tubular member, with the lumen being configured to have a circular, oval, or ovate cross-section. 
     
     
         8 . The system of  claim 1 , wherein the imaging device is configured as a square, and is received within a lumen defined by an inner wall of the tubular member, perpendicularly to a longitudinal axis of the tubular member, with the lumen being configured to have a circular cross-section, and wherein the light transmission devices comprise fiber optic elements or light delivery fibers having the distal ends thereof arranged about the imaging device in the segments of the circular lumen unoccupied by the imaging device. 
     
     
         9 . The system of  claim 1 , comprising a power source operably engaged with the body member, wherein the power source is arranged to be in electrical communication with the light source. 
     
     
         10 . The system of  claim 9 , wherein the power source is removably secured to the body member via a magnetic connector arrangement. 
     
     
         11 . The system of  claim 9 , comprising a heat shield surrounding the power source. 
     
     
         12 . The system of  claim 1 , comprising a communication element operably engaged with the body member, the communication element being in signal communication with the imaging device so as to receive an image signal therefrom associated with the image captured thereby or to communicate electrical power to the imaging device. 
     
     
         13 . The system of  claim 12 , comprising a display device for displaying the image or a computer device for storing or analyzing the image, the display device or the computer device being in communication with the communication element via a wired communication arrangement or a wireless communication arrangement. 
     
     
         14 . The system of  claim 1 , wherein the flexible elongate tubular member comprises a braided elastic filiform material configured to transmit torque between the proximal and distal portions of the tubular member. 
     
     
         15 . The system of  claim 14 , wherein the tubular member comprises an external polymeric sheath disposed externally to the braided filiform material or an internal polymeric sheath disposed internally to the braided filiform material. 
     
     
         16 . The system of  claim 15 , wherein the external polymeric sheath and the internal polymeric sheath are opaque to preserve the light transmitted by the light transmission devices. 
     
     
         17 . The system of  claim 14 , wherein the tubular member comprises a terminal member engaged with the braided filiform material about the distal portion of the tubular member, the terminal member being configured to receive and secure the imaging device and the distal ends of the light transmission devices. 
     
     
         18 . The system of  claim 1 , comprising a mounting interface operably engaged with the handle and configured to receive and secure at least the body member of the medical imaging system such that the medical imaging system and the medical introducer are movable relative to each other. 
     
     
         19 . The system of  claim 1 , wherein the distal end of the medical introducer is configured as a compound curve, and wherein at least the distal portion of the tubular member is configured to flex during longitudinal movement of the tubular member within the one of the lumens to conform to the compound curve of the distal end of the medical introducer. 
     
     
         20 . A medical imaging system adapted to be at least partially insertable into an interior body region of a patient, the system comprising:
 a body member including a light source configured to emit light;   a flexible elongate tubular member having a proximal portion operably engaged with the body member, and extending to an opposed distal portion;   an imaging device engaged with the distal portion of the tubular member and configured to be in communication with the body member, the imaging device being arranged so as to be directed, and to be capable of capturing an image, in an imaging direction outwardly of the distal portion; and   a plurality of light transmission devices extending from the light source and through the tubular member to respective distal ends thereof disposed about the distal portion of the tubular member, the light transmission devices being configured to receive the light from the light source and to transmit the light to the distal ends thereof, the distal ends of the light transmission devices being arranged about the imaging device about the distal portion of the tubular member so as to direct the light transmitted from the light source in the imaging direction.   
     
     
         21 . The system of  claim 20 , comprising a rigid elongate conduit engaged between the body member and the flexible elongate tubular member so as to be capable of transmitting torque between the body member and the flexible elongate tubular member. 
     
     
         22 . The system of  claim 20 , wherein the light transmission devices comprise fiber optic elements or light delivery fibers. 
     
     
         23 . The system of  claim 20 , wherein the imaging device comprises an active-pixel sensor array or a Complementary Metal-Oxide Semiconductor (CMOS) sensor. 
     
     
         24 . The system of  claim 20 , wherein the imaging device is configured as a quadrilateral, and is received within a lumen defined by an inner wall of the tubular member, perpendicularly to a longitudinal axis of the tubular member, with the lumen being configured to have a circular, oval, or ovate cross-section. 
     
     
         25 . The system of  claim 20 , wherein the imaging device is configured as a square, and is received within a lumen defined by an inner wall of the tubular member, perpendicularly to a longitudinal axis of the tubular member, with the lumen being configured to have a circular cross-section, and wherein the light transmission devices comprise fiber optic elements or light delivery fibers having the distal ends thereof arranged about the imaging device in the segments of the circular lumen unoccupied by the imaging device. 
     
     
         26 . The system of  claim 20 , comprising a power source operably engaged with the body member, wherein the power source is arranged to be in electrical communication with the light source. 
     
     
         27 . The system of  claim 26 , wherein the power source is removably secured to the body member via a magnetic connector arrangement. 
     
     
         28 . The system of  claim 26 , comprising a heat shield surrounding the power source. 
     
     
         29 . The system of  claim 26 , comprising a communication element operably engaged with the body member, the communication element being in signal communication with the imaging device so as to receive an image signal therefrom associated with the image captured thereby or to communicate electrical power to the imaging device. 
     
     
         30 . The system of  claim 29 , comprising a display device for displaying the image or a computer device for storing or analyzing the image, the display device or the computer device being in communication with the communication element via a wired communication arrangement or a wireless communication arrangement. 
     
     
         31 . The system of  claim 20 , wherein the flexible elongate tubular member comprises a braided elastic filiform material configured to transmit torque between the proximal and distal portions of the tubular member. 
     
     
         32 . The system of  claim 31 , wherein the tubular member comprises an external polymeric sheath disposed externally to the braided filiform material or an internal polymeric sheath disposed internally to the braided filiform material. 
     
     
         33 . The system of  claim 32 , wherein the external polymeric sheath and the internal polymeric sheath are opaque to preserve the light transmitted by the light transmission devices. 
     
     
         34 . The system of  claim 31 , wherein the tubular member comprises a terminal member engaged with the braided filiform material about the distal portion of the tubular member, the terminal member being configured to receive and secure the imaging device and the distal ends of the light transmission devices. 
     
     
         35 . A method of forming a medical imaging system adapted to be at least partially insertable into an interior body region of a patient, the method comprising:
 operably engaging a proximal portion of a flexible elongate tubular member with a body member including a light source configured to emit light, the tubular member extending to an opposed distal portion;   engaging an imaging device with the distal portion of the tubular member such that the imaging device is in communication with the body member, and such that the imaging device is arranged to be directed, and to be capable of capturing an image, in an imaging direction outwardly of the distal portion; and   engaging a plurality of light transmission devices with the light source such that the light transmission devices extend through the tubular member to respective distal ends thereof disposed about the distal portion of the tubular member, the light transmission devices being configured to receive the light from the light source and to transmit the light to the distal ends thereof, and such that the distal ends of the light transmission devices are arranged about the imaging device about the distal portion of the tubular member to direct the light transmitted from the light source in the imaging direction.   
     
     
         36 . The method of  claim 35 , comprising engaging a rigid elongate conduit between the body member and the flexible elongate tubular member for transmitting torque between the body member and the flexible elongate tubular member. 
     
     
         37 . The method of  claim 35 , wherein engaging the plurality of light transmission devices with the light source comprises engaging fiber optic elements or light delivery fibers with the light source. 
     
     
         38 . The method of  claim 35 , wherein engaging the imaging device with the distal portion of the tubular member comprises engaging an active-pixel sensor array or a Complementary Metal-Oxide Semiconductor (CMOS) sensor with the distal portion of the tubular member. 
     
     
         39 . The method of  claim 35 , wherein engaging the imaging device with the distal portion of the tubular member comprises engaging the imaging device, configured as a quadrilateral, with a lumen defined by an inner wall of the tubular member, perpendicularly to a longitudinal axis of the tubular member, the lumen being configured to have a circular, oval, or ovate cross-section. 
     
     
         40 . The method of  claim 35 , wherein engaging the imaging device with the distal portion of the tubular member comprises engaging the imaging device, configured as a square, with a lumen defined by an inner wall of the tubular member, perpendicularly to a longitudinal axis of the tubular member, with the lumen being configured to have a circular cross-section, such that the light transmission devices, comprising fiber optic elements or light delivery fibers, have the distal ends thereof arranged about the imaging device in the segments of the circular lumen unoccupied by the imaging device. 
     
     
         41 . The method of  claim 35 , comprising operably engaging a power source with the body member, such that the power source is in electrical communication with the light source. 
     
     
         42 . The method of  claim 41 , wherein operably engaging the power source with the body member comprises removably securing the power source to the body member via a magnetic connector arrangement. 
     
     
         43 . The method of  claim 41 , comprising engaging a heat shield with the power source so as to surround the power source. 
     
     
         44 . The method of  claim 35 , comprising engaging a communication element with the body member, in signal communication with the imaging device, for receiving an image signal therefrom associated with the image captured thereby or for communicating electrical power to the imaging device. 
     
     
         45 . The method of  claim 44 , comprising engaging a display device for displaying the image, or a computer device for storing or analyzing the image, into communication with the communication element via a wired communication arrangement or a wireless communication arrangement. 
     
     
         46 . The method of  claim 35 , wherein operably engaging the proximal portion of the flexible elongate tubular member comprises operably engaging the proximal portion of the flexible elongate tubular member, comprising a braided elastic filiform material, with the body member, the braided filiform material being configured to transmit torque between the proximal and distal portions of the tubular member. 
     
     
         47 . The method of  claim 46 , comprising engaging an external polymeric sheath with an external portion of the braided filiform material or engaging an internal polymeric sheath with an internal portion of the braided filiform material. 
     
     
         48 . The method of  claim 47 , wherein engaging a polymeric sheath with the braided filiform material comprises engaging an opaque polymeric sheath with the braided filiform material to preserve the light transmitted by the light transmission devices. 
     
     
         49 . The method of  claim 46 , comprising engaging a terminal member with the braided filiform material about the distal portion of the tubular member, wherein the terminal member is configured to receive and secure the imaging device and the distal ends of the light transmission devices.