SELF-CONTAINED STERILIZABLE SURGICAL SYSTEM
A self-contained surgical system includes a sterilizable shaft having a light source and/or an image capture device mounted at the distal end of the shaft or connected to the distal end of the shaft by fiber optics. The light source is a light emitting diode or an array of light emitting diodes, and has its own power source located at the distal end of the shaft. The shaft includes a working channel, an irrigation/aspiration channel, and an electric cable. The shaft is coupled at its proximal end to a control module having a video processor and an integrally-mounted display screen for displaying image data from the image capture device. The control module includes an irrigation/aspiration system, a control unit, and a controller. The power module includes steering motors connected to steering cables in the shaft and drive motors and a power source.
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The present application is a continuation of U.S. patent application Ser. No. 10/676,046, filed on Sep. 30, 2003, which claims priority to and benefit from U.S. Provisional Patent Application Ser. No. 60/415,313, filed on Sep. 30, 2002, the entire contents of each of which being incorporated herein by reference.
FIELD OF THE INVENTIONThe present invention relates to a surgical system. More specifically, the present invention relates to a self-contained, sterilizable surgical system, such as an endoscope system.
BACKGROUNDThere are various different surgical systems that enable a surgical procedure or a surgical site to be viewed. One such type of surgical device is an endoscope. Such a device may be inserted into a patient's body during a surgical procedure to illuminate, view and/or manipulate a surgical site within the patient's body. Conventional endoscopes typically employ a flexible endoscope shaft, a first end of which is insertable into a patient's body. The shaft has a camera mounted at the first end and is connected at its second end to a power source for providing power to the camera. In addition, the shaft has a fiberoptic bundle that runs therethrough and connects to a light source outside of the patient's body. The light source is powered by another power source and the light from the light source is conveyed from the second end, through the fiber-optic bundle in the shaft, to the first end in order to illuminate a surgical site within the patient's body. In addition, the second end of the endoscope is connected to a television monitor, having still another power source, in order to display the images received by the camera.
Thus, conventional surgical systems of this type, e.g., endoscope systems, are typically bulky, complex and difficult to maneuver.
SUMMARYThe present invention relates to a surgical system, e.g., an endoscope system. According to one embodiment, an endoscope system includes a shaft having a light source and/or an image capture device, e.g., a camera, each of which may be mounted at the distal end of the shaft or which may be connected to the distal end of the shaft by fiber optics. The light source may be a light emitting diode or an array of light emitting diodes, and may have its own power source located at the distal end of the shaft. The shaft has a sheath that is sealed so as to be sterilizable, e.g., autoclavable. Advantageously, the light source and/or the image capture device are also sealed within the distal end of the shaft so as to be sterilizable, e.g., autoclavable. The shaft also includes a working channel for permitting the passage of tools through the shaft, an irrigation/aspiration channel for permitting fluid to be transmitted through the shaft, and an electric cable for transmitting data or power through the shaft.
The shaft is coupled, either fixedly or detachably, at its proximal end to a control module having a video processor. Preferably, the control module is sterilizable, e.g., autoclavable. Image data received by the image capture device is transmitted via a data transfer cable of the electric cable in the shaft to the video processor and is displayed on an display screen integrally mounted to the control module. The control module may include an irrigation/aspiration system for conveying fluid through the irrigation/aspiration channel of the shaft. The control module may also include a control unit, which enables a user to control certain functions of the endoscope system, as well as a controller, which automatically controls certain functions of the endoscope system.
The control module is coupled to a power module. The power module includes steering motors connected to steering cables in the shaft. In addition, the power module includes drive motors for driving, e.g., the irrigation/aspiration system, the steering motors, etc. The power module may also include a power source for providing power to the motors, the controller, the light source, the image capture device, etc. In one embodiment, the control module and the power module are contained in a single unit.
One example embodiment of a surgical system, in this case an endoscope system 10, according to the present invention is illustrated in
According to one embodiment, the shaft 12 includes a tubular sheath 13, which may include a coating or other sealing arrangement to provide a fluid-tight seal between an interior region of the shaft 12 and the environment. The sheath 13 may be formed of a tissue-compatible, sterilizable elastomeric material. Preferably, the sheath 13 may be formed of a material that is autoclavable. In addition, the sheath 13 may be formed of a material having a high or relatively high lubricity. For instance, the sheath 13 may be formed of a material such as Teflon™ (i.e., a fluoropolymer, e.g., polytetrafluoroethylene—“PTFE”), silicone, a Teflon™/silicone combination, such as, for example, SIL-KORE™ (made by W. L. Gore & Associates), “EPTFE”, e.g., expanded teflon, etc. Other suitable materials and sealing arrangements that may be employed are described in further detail in Applicants' co-pending U.S. patent application Ser. No. 10/099,634, filed on Mar. 15, 2002, now issued as U.S. Pat. No. 7,951,071, which is expressly incorporated herein by reference in its entirety.
In this embodiment, the shaft 12 has a distal end 12a, which is insertable into a patient's body, and a proximal end 12b, which is coupled, e.g., either fixedly or detachably, to the control module 14. In this embodiment, both a light source 26 and an image capture device 28 are mounted on the distal end 12a of the shaft 12. In other example embodiments, the light source 26 and/or the image capture device 28 are mounted in the control module 14. If the light source 26 is mounted in the control module 14, the light may be transmitted from the light source 26 to the distal end 12a of the shaft 12 via fiber optics. If the image capture device 28 is mounted in the control module 14, the image data (including light reflected within a body, for example) may be transmitted to the image capture device 28 from the distal end 12a of the shaft 12 via fiber optics.
The image capture device 28 may include a lens and an image sensor, e.g., a light sensitive device such as a CCD or CMOS-type image sensor, that is positioned to capture an image via the lens. In one embodiment, the image capture arrangement 28 may further include a cleaning arrangement for cleaning debris from the lens. Advantageously, the light source 26 and the image capture device 28 are sealed within the distal end 12a of the shaft 12 such that the light source 26 and the image capture device 28 are also sterilizable, e.g., autoclavable.
According to the embodiment shown in
Alternatively or additionally, an additional power source may be mounted at the distal end 12a of the shaft 12 adjacent to the light source 26 and the image capture device 28, and may provide power to the light source 26 and/or the image capture device 28. For instance,
It should be understood that, according to various other embodiments of the present invention, the power source for the light source 26 and the image capture device 28 may be located at any position along the shaft 12, or may be located at any other position. In those embodiments in which the power source for the light source 26 and the image capture device 28 are located at a position along the shaft 12, the power transfer cable 22 may extend within the shaft 12 between the light source 26 and/or the image capture device 28 and the power source. For instance,
Referring back to
As mentioned above, the electric cable 20 in the shaft 12 may also include a data transfer cable 24. A distal end of the data transfer cable 24 is coupled to the image capture device 28 that is mounted on the distal end 12a of the shaft 12. A proximal end of the data transfer cable 24 is coupled to a video processing module 30 disposed within the control module 14. In this embodiment, the video processor 30 is configured to receive data signals from the image capture device 28 via the data transfer cable 24. Alternatively, the shaft 12 may not have a data transfer cable 24 but rather a wireless receiver and transmitter arrangement that enables the data to be transferred wirelessly.
According to one embodiment of the present invention, the shaft 12 may also include a working channel 16 that extends from the distal end 12a of the shaft 12 to the proximal end 12b of the shaft 12. At the distal end 12a of the shaft 12 is a working channel orifice 16a that leads into the working channel 16. The working channel 16 communicates with a working channel passage 16c disposed in the control module 14, so that the working channel 16 is accessible to a user via the working channel passage 16c in the control module 14. The working channel 16 may be configured to permit the passage of small endoscopic tools or the like, such as a cutting blade, thereby enabling a user to manipulate tissue positioned adjacent to the distal end 12a of the shaft 12 through the shaft 12 and without removing the distal end 12a of the shaft 12 from the patient's body.
According to one embodiment of the present invention, the shaft 12 also includes an irrigation/aspiration channel 32 that extends from the distal end 12a of the shaft 12 to the proximal end 12b of the shaft 12. At the distal end 12a of the shaft 12 is an irrigation/aspiration channel orifice 32a that leads into the irrigation/aspiration channel 32. The irrigation/aspiration channel 32 may be coupled to or in communication with an irrigation/aspiration system 19 disposed in the control module 14 and/or the power module 50 (described below in connection with
According to one embodiment of the present invention, the shaft 12 also defines at least one steering cable for steering at least a portion of the shaft 12. In one embodiment, the entire length of the shaft 12 is steerable, while according to other embodiments, only a portion of the shaft 12, such as a portion adjacent to the distal end 12a of the shaft 12, is steerable. In the example embodiment shown, the shaft 12 includes a first steering cable 34 and a second steering cable 36. The first steering cable 34 is configured to steer the shaft 12 in first and second directions that are 180 degrees apart relative to each other, e.g., north-south, while the second steering cable 36 is configured to steer the shaft 12 in third and fourth directions that are 180 degrees apart relative to each other and that are 90 degrees apart relative to the first and second directions, e.g., east-west. It should be understood that reference herein to north, south, east and west is made to a relative coordinate system. Advantageously, each of the first steering cable 34 and the second steering cable 36 extends from the distal end 12a of the shaft 12, or from a location near to the distal end 12a of the shaft 12, to the proximal end 12b of the shaft 12. It should be understood, however, that while a single steering cable is shown and described herein for steering the shaft 12 in each of the above-mentioned directions, other embodiments of the present invention may employ more than one steering cable for these purposes, as is described below. The steering cables may be arranged and configured as described, for example, in U.S. patent application Ser. No. 09/510,923, entitled “A Carriage Assembly for Controlling a Steering Wire Mechanism Within a Flexible Shaft,” now issued as U.S. Pat. No. 6,517,565, which is expressly incorporated herein in its entirety by reference thereto.
At the proximal end 12b of the shaft 12, the first steering cable 34 and the second steering cable 36 are coupled to drive elements of the control module 14 and/or the power module 50. One such arrangement, which is shown and described in
As mentioned above,
According to the example embodiment of the present invention, the control module 14 includes a video processor 30 that receives data signals from the image capture device 28 via the data transfer cable 24 of the shaft 12 or via the wireless arrangement. The control module 14 may also include an integral display screen 46 that is coupled to the video processor 30. Upon receiving signals from the image capture device 28 via the data transfer cable 24, the video processor 30 is configured to process the signals and to display an image on the display screen 46 corresponding to the image received by the image capture device 28. According to one embodiment, the display screen 46 is moveable, e.g., rotatable, slidable, etc., relative to the control module 14. In this manner, the display screen 46 may be hidden from view when in the retracted position and may be viewable by a user when in an extended position. As previously mentioned, the control module 14 may be configured with appropriate materials and seals such that, when the display screen 46 in the retracted position, the control module 14 is sterilizable, e.g., autoclavable. Thus, the control module 14 including the display screen 46 may be protected from any environment which they may be employed in.
In addition to the video data received from the image capture device, the display screen 46 may display data corresponding to the operation of the endoscopic system 10. For instance, according to one embodiment, the display screen 46 provides an indication, via indicators such as indicators 18a and 18b (shown in
The control module 14 may also include an irrigation/aspiration system 19, such as a pump, that is configured to pump fluid in a first direction through the irrigation/aspiration channel 32 toward the distal end 12a of the shaft 12 in order to irrigate a surgical site. In addition, the control module 14 may include a second, or the same, pump (not shown) that is configured to pump fluid in the opposite direction through the irrigation/aspiration channel 32 away from the distal end 12a of the shaft 12 so as to aspirate the surgical site. The operation of the irrigation/aspiration system may be controlled by an irrigation/aspiration control switch 39 of a control unit 150 of the control module 14. The pump may be powered by the power source 44 in the control module 14, by the power source 62 in the power module 50, or by any other power source.
The control module 14 is coupled to one end 48a of a power transfer cable 48. The power transfer cable 48 may be fixedly or detachably coupled to the control module 14. Additional features of the power transfer cable 48 are described in connection with
The control module 14 may also include, as part of the control unit 150, a steering controller 1300, a switch 312 and a two-way rocker 314. The steering controller 1300, the switch 312 and the two-way rocker 314 are described in more detail below in connection with
The control module 14 is coupled to the power module 50 via a power transfer cable 48. As illustrated in
Advantageously, the power module 50 also houses steering and drive motors. For instance, according to one embodiment of the present invention, the power module 50 houses several steering motors for operating the steering cables 34, 36 of the shaft 12. One example embodiment of such an arrangement of steering motors is illustrated in
In addition, the power module 50 may include a fluid reservoir 60 and a power source 62, such as a battery. According to one embodiment, the fluid reservoir 60 and the power source 62 are removable from the power module 50. In this manner, the fluid reservoir 60 may be refilled with fluid, e.g., water, as needed. According to one embodiment of the present invention, the fluid reservoir 60 may provide fluid to be pumped to a surgical site by an irrigation/aspiration system 19. Alternatively, the fluid reservoir 60 may store fluid removed from a surgical site by the irrigation/aspiration system 19. In this embodiment, the fluid reservoir 60 may be removed from the power module 50 in order to be emptied of its contents. In addition, the power source 62 may be removable from the power module 50 in order to be recharged as needed. As previously mentioned, the power source 62 may provide power, according to various embodiments of the present invention, to the light source 26 and the image capture device 28. In this embodiment, however, the power source 62 provides power to the controller 122 and/or the irrigation/aspiration system 19 and/or the steering and drive motors, etc. disposed in the control module 14 and the power module 50. According to still another embodiment, the power module 50 includes a power cord 59 that enables the power module 50 to be plugged into an electrical socket (not shown) or other conventional power source, thereby eliminating the need for the power source 62 or providing back-up power for the power source 62.
Referring now to
The controller 122 is further connected to the display screen 46 via line 154 and to the indicators 18a, 18b via respective lines 156, 158. Lines 124, 126, 128 electrically and logically connect controller 122 to motors 84, 90, 96, respectively, the function of which is described in greater detail below. A control unit 150, which may include the control features of the control module 14 such as a steering controller 1300, the irrigation/aspiration system switch 39, etc. is electrically and logically connected to controller 122 via line 152. Additional features of the control unit 150 are illustrated in
As described above, the power module 50 includes motors configured to drive the steering cables 34, 36.
According to one embodiment of the present invention, at the proximal end 12b of the shaft 12, the first steering cable 34 and the second steering cable 36 are coupled to drive elements (not shown) of the control module 14 that in turn are coupled to drive shafts 86, 92 of steering motors 84, 90, located in the power module 50. It should be appreciated that, according to various other embodiments of the present invention, drive shafts 86, 92 and steering motors 84, 90 may instead be located in the control module 14.
Referring to
Referring now to
Referring now to
Furthermore, the control unit 150 may include a switch 312, which further controls certain functions of the endoscope system 10 in accordance with an operating program or algorithm employed by the controller 122. For instance, the operation of switch 312 may control the operation of the motor 96 to selectively engage and disengage the steering mechanism, or may control the activation of the light source 26 or the image capture device 28. The control unit 150 may also be provided with a switch 39, the operation of which may further control other functions of the endoscope system 10 in accordance with the operating program or algorithm employed by the controller 122. For example, operation of the switch 39 may control the activation of the irrigation/aspiration system 19. The control unit 150 may also include a two-way rocker 314 having first and second switches 316, 318 operable thereby. The operation of these switches 316, 318 may control still other functions of the endoscope system 10 in accordance with the operating program or algorithm employed by the controller 122. For example, operation of the two-way rocker 314 may control a zoom or magnification function of the image capture device 28.
The control unit 150 may include a separate controller 322, which is electrically and logically connected with the switches 302, 304, 306, 308 via line 324, with the switches 316, 318 via line 326, with switch 312 via line 328 and with switch 39 via line 330. The indicators 18a, 18b and the display device 46 may be electrically and logically connected to the controller 322 rather than controller 122.
According to one embodiment of the present invention, one or more of the shaft 12, the control module 14 and the power module 50 may include a memory unit, such as memory unit 174 illustrated schematically in
While the present invention has been described hereinabove in connection with endoscope systems, it should be recognized that other types of surgical systems may be employed for various different types of surgical procedures, e.g., proctoscopy, anoscopy, etc. For instance,
The present invention, in accordance with various embodiments thereof, provides advantages over conventional surgical, e.g., endoscope, systems. For instance, a conventional endoscope is typically cleaned or disinfected prior to use within a patient in conformance with a standard referred to as high-level disinfectance, rather than sterilization. Sterilization provides a greater degree of cleanliness, and thus a high standard of patient safety, than high-level disinfectance. Conventional endoscopes typically can not be sterilized prior to use within a patient because the materials employed in the manufacture of conventional endoscopes are not sterilizable, and because conventional endoscope are typically not adequately sealed to withstand a sterilization process. Unlike conventional endoscope systems, various components of the endoscope system 10 of the present invention, most particularly the shaft 12, the light source 26, the image capture device 28, the control module 14 and in some instances the power module 50, may be sterilizable or autoclavable, thereby providing a higher level of safety to a patient. Furthermore, because various components of the endoscope system 10 of the present invention, e.g., the shaft 12, the light source 26, the image capture device 28, the control module 14 and the power module 50, may be sterilizable or autoclavable, these components can be used more than once and on more than one patient, providing significant cost savings as compared to conventional endoscope systems that must be discarded after one use.
In addition, according to some embodiments, the surgical systems of the present invention employ a light emitting diode or an array of light emitting diodes as the light source 26 at the distal end 12a of the shaft 12. Thus, the surgical systems of the present invention may provide for a more efficient use of the light as compared to conventional surgical, e.g., endoscope, systems employing a light source outside of the patient's body and a fiber-optic bundle to transport the light through the shaft, since these conventional surgical, e.g., endoscope, systems lose a large portion of the light before the light reaches the surgical site. In addition, the use by the present invention of a light emitting diode or an array of light emitting diodes provides satisfactory illumination of a surgical site while requiring very little power. Thus, according to one embodiment, a power source may be provided at the distal end 12a of the shaft 12, or at any other location along the shaft 12, in the control module 14 or in the power module 50.
In addition, according to some embodiments, the surgical system of the present invention employs a display screen 46 that is integral with the hand-held control module 14, thereby replacing the bulkiness and complexity of a separate television monitor for this purpose. Furthermore, according to some embodiments, the surgical system of the present invention employs power sources, motors, etc. that are integral with either the shaft 12, the control module 14 or the power module 50, enabling the surgical system to be self-contained, e.g., requiring no additional external power supplies, drive mechanisms, etc.
Thus, the several aforementioned objects and advantages of the present invention are most effectively attained. Those skilled in the art will appreciate that numerous modifications of the exemplary embodiment described hereinabove may be made without departing from the spirit and scope of the invention. Although a single exemplary embodiment of the present invention has been described and disclosed in detail herein, it should be understood that this invention is in no sense limited thereby.
Claims
1-20. (canceled)
21. A surgical system, comprising:
- a shaft including proximal and distal ends and defining an interior between the proximal and distal ends, the interior being sealed from the environment such that the shaft is sterilizable by a sterilizing fluid without penetration of the interior by the sterilizing fluid;
- an image capture device disposed in the interior of the shaft and configured to receive image data from the distal end of the shaft; and
- a light source disposed in the interior of the shaft and configured to provide light adjacent the distal end of the shaft.
22. The system of claim 21, wherein the entirety of the shaft is sealed.
23. The system of claim 21, wherein the entirety of the system is sealed.
24. The system of claim 21, wherein the shaft is flexible.
25. The system of claim 24, wherein the shaft is steerable.
26. The system of claim 25, further including a power module disposed within the shaft, the power module configured to steer the shaft.
27. The system of claim 24, further comprising a control module configured to control the system, the proximal end of the shaft coupled to the control module, the control module defining an interior space sealed from the environment such that the control module is sterilizable by a sterilizing fluid without penetration of the interior space by the sterilizing fluid.
28. The system of claim 27, further comprising a video processing module disposed within the interior space.
29. The system of claim 27, wherein the control module includes a display screen having an extended position and a retracted position, wherein in the retracted position the control module is sterilizable.
30. The system of claim 21, wherein the sterilizing fluid is at least one of steam or pressurized steam.
31. A method of surgery comprising:
- inserting a distal end of a shaft of a surgical system into a body cavity of a patient, the surgical system including: the shaft including a proximal end and the distal end, the shaft defining an interior between the proximal and distal ends; an image capture device disposed in the interior of the shaft; and a light source disposed in the interior of the shaft;
- providing light to a surgical site adjacent the distal end of the shaft with the light source;
- receiving image data of the surgical site within the body cavity with the image capture device;
- removing the shaft from the body cavity; and
- sterilizing the surgical system with a sterilizing fluid, the sterilizing fluid not contacting the image capture device and the light source disposed in the interior of the shaft.
32. The method of claim 31, further comprising steering the shaft with a power module of the surgical system disposed in the interior of the shaft to the surgical site, the power module connected to first and second steering cables also disposed in the interior of the shaft.
33. The method of claim 31, further comprising irrigating the surgical site through an irrigation channel disposed through the shaft.
34. The method of claim 31, further comprising aspirating the surgical site through an aspiration channel disposed through the shaft.
35. The method of claim 31, further comprising displaying the image data of the surgical site on a display of a control module, the proximal end of the shaft coupled to the control module.
36. The method of claim 35, wherein sterilizing the surgical system includes sterilizing the control module with the proximal end of the shaft coupled to the control module.
37. The method of claim 35, further comprising coupling a power transfer cable to the control module.
38. The method of claim 31, wherein sterilizing the surgical system includes autoclaving the surgical system.
Type: Application
Filed: Feb 28, 2014
Publication Date: Jun 26, 2014
Applicant: COVIDIEN LP (MANSFIELD, MA)
Inventor: Michael P. Whitman (New Hope, PA)
Application Number: 14/193,387
International Classification: A61B 1/12 (20060101); A61B 1/015 (20060101); A61B 1/005 (20060101); A61B 1/00 (20060101); A61B 1/05 (20060101); A61B 1/06 (20060101);