This patent is directed to a system and method for electrically coupling a surgical system or part thereof, and in particular to a system and method for electrically coupling at least one light emitter and at least one light sensor disposed at a distal end of a tubular shaft to the remainder of the surgical system.
Systems and methods that identify artifacts, and in particular vessels, in the surgical field during a surgical procedure provide valuable information to the surgeon or surgical team. U.S. hospitals lose billions of dollars annually in unreimbursable costs because of inadvertent vascular damage during surgery. In addition, the involved patients face a mortality rate of up to 32%, and likely will require corrective procedures and remain in the hospital for an additional nine days, resulting in tens, if not hundreds, of thousands of dollars in added costs of care. Consequently, there is this significant value to be obtained from methods and systems that permit accurate determination of the presence of vessels, such as blood vessels, in the surgical field, such that these costs may be reduced or avoided.
Systems and methods that provide information regarding the presence of blood vessels in the surgical field are particularly important during minimally-invasive surgical procedures. Traditionally, surgeons have relied upon tactile sensation during surgical procedures both to identify blood vessels and to avoid inadvertent damage to these vessels. Because of the shift towards minimally-invasive procedures, including laparoscopic and robotic surgeries, surgeons have lost the ability to use direct visualization and the sense of touch to make determinations as to the presence of blood vessels in the surgical field. Consequently, surgeons must make the determination whether blood vessels are present in the surgical field based primarily on convention and experience. Unfortunately, anatomical irregularities frequently occur because of congenital anomalies, scarring from prior surgeries, and body habitus (e.g., obesity). Systems and methods that would permit surgeons to determine the presence and/or the characteristics of vessels in the surgical field during surgery (potentially in real time or near real time) under such conditions would be a significant advantage.
On the other hand, while it would be advantageous to include systems and methods that provide information regarding the presence of blood vessels in the surgical field, the adoption of such systems and methods would be impeded if these systems and methods were to complicate the manufacture and/or use of the associated surgical instruments. This is particularly true in the field of minimally-invasive surgery, where surgical instrument design involves a complex balance of competing interests, and space for the integration of new technologies is at a considerable premium.
As set forth in more detail below, the present disclosure describes a system and method for electrically coupling a surgical system or part thereof embodying advantageous alternatives to the existing systems and methods, which may provide for improved identification for avoidance or isolation of the vessel without undue complication of the surgical instrument.
According to an aspect of the present disclosure, a surgical system including a tubular shaft having a wall defining an outer surface and an inner surface disposed about an inner space, the tubular shaft having a proximal end and a distal end. The system also includes a light emitter and a light sensor disposed at the distal end of the tubular shaft, and one or more conductors electrically coupled to the light emitter or the light sensor. The one or more conductors extend from the distal end of the tubular shaft to the proximal end of the shaft, and are disposed radially outward of the inner surface of the tubular shaft.
According to another aspect of the present disclosure, the tubular shaft defines part of a surgical instrument.
According to still another aspect of the present disclosure, the surgical system includes a surgical instrument, and the tubular shaft is disposed about an elongated element (such as a shaft or rod) of the surgical instrument.
The disclosure will be more fully understood from the following description taken in conjunction with the accompanying drawings. Some of the figures may have been simplified by the omission of selected elements for the purpose of more clearly showing other elements. Such omissions of elements in some figures are not necessarily indicative of the presence or absence of particular elements in any of the exemplary embodiments, except as may be explicitly delineated in the corresponding written description. None of the drawings is necessarily to scale.
A surgical system according to an embodiment of the present disclosure includes at least one light emitter, at least one light sensor, and a controller. The system may also include a surgical instrument as well.
The surgical system 100 includes at least one light emitter 110 (or simply the light emitter 110), at least one light sensor or detector 112 (or simply the light sensor 112), and a controller 114 coupled to the light emitter 110 and the light sensor 112. As noted above, the system 100 also may include the surgical instrument 106.
The light emitter 110 is disposed at the working end 104 of the surgical instrument 106. The light sensor 112 is also disposed at the working end 104 of the surgical instrument 106. As illustrated in
The light emitter 110 is adapted to emit light of at least one wavelength. For example, the light emitter 110 may emit light having a wavelength of 660 nm. This may be achieved with a single element, or a plurality of elements (which elements may be arranged or configured into an array, for example, as explained in detail below). In a similar fashion, the light sensor 112 is adapted to detect light at the at least one wavelength (e.g., 660 nm). According to the embodiments described herein, the light sensor 112 includes a plurality of elements, which elements are arranged or configured into an array.
According to certain embodiments, the light emitter 110 may be configured to emit light of at least two different wavelengths, and the light sensor 112 may be configured to detect light at the at least two different wavelengths. As one example, the light emitter 110 may emit and the light sensor 112 may detect light in the visible range and light in the near-infrared or infrared range. Specifically, the light emitter 110 may emit and the light sensor 112 may detect light at 660 nm and at 910 nm. Such an embodiment may be used, for example, to ensure optimal penetration of blood vessel V and the surrounding tissue T under in vivo conditions.
Depending upon the effect of changes in blood flow, light of a third wavelength may also be emitted and sensed. That is, if the method of detection is found to be sensitive to varying rates of blood flow in the vessel of interest, light at 810 nm (i.e., at the isobestic point) may be emitted and sensed to permit normalization of the results to limit or eliminate the effects of changes in blood flow rate.
According to certain embodiments of this disclosure, the individual light sensor 112 is adapted to generate a signal comprising a first pulsatile component and a second non-pulsatile component. It will be recognized that the first pulsatile component may be an alternating current (AC) component of the signal, while the second non-pulsatile component may be a direct current (DC) component. Where the light sensor 112 is in the form of an array, the pulsatile and non-pulsatile information may be generated for each element of the array, or at least for each element of the array that defines the at least one row of the array.
As to the pulsatile component, it will be recognized that a blood vessel may be described as having a characteristic pulsation of approximately 60 pulses (or beats) per minute. While this may vary with the patient's age and condition, the range of pulsation is typically between 60 and 100 pulses (or beats) per minute. The light sensor 112 will produce a signal (that is passed to the controller 114) with a particular AC waveform that corresponds to the movement of the blood through the vessel. In particular, the AC waveform corresponds to the light absorption by the pulsatile blood flow within the vessel. On the other hand, the DC component corresponds principally to light absorption and scattering by the surrounding tissues.
According to such embodiments, the controller 114 is coupled to the light sensor 112, and thus may include a splitter 116 to separate the first pulsatile component from the second non-pulsatile component for each element of the light sensor array 112. The controller 114 may also include an analyzer 118 to determine the presence of the and/or characteristic(s) of the vessel V within the region 102 proximate to the working end 104 of the surgical instrument 106 based (at least in part) on the pulsatile component. To display, indicate or otherwise convey the size of the vessel V within the region 102, the controller 114 may be coupled to an output device or indicator 130 (see
According to certain embodiments, the splitter 116 and the analyzer 118 may be defined by one or more electrical circuit components. According to other embodiments, one or more processors (or simply, the processor) may be programmed to perform the actions of the splitter 116 and the analyzer 118. According to still further embodiments, the splitter 116 and the analyzer 118 may be defined in part by electrical circuit components and in part by a processor programmed to perform the actions of the splitter 116 and the analyzer 118.
For example, the splitter 116 may include or be defined by the processor programmed to separate the first pulsatile component from the second non-pulsatile component. Further, the analyzer 118 may include or be defined by the processor programmed to determine the presence of (or to quantify the size of, for example) the vessel V within the region 102 proximate to the working end 104 of the surgical instrument 106 based on the first pulsatile component. The instructions by which the processor is programmed may be stored on a memory associated with the processor, which memory may include one or more tangible non-transitory computer readable memories, having computer executable instructions stored thereon, which when executed by the processor, may cause the one or more processors to carry out one or more actions.
While the foregoing general discussion of the system 100 made reference to the light emitter 110 and the light sensor 112, as recognized above, the actual specifics of the implementation of the light emitter 100 and light sensor 112 may include more than a single element or component.
For example, referring to the embodiment of
As to those embodiments wherein the light emitter 110 is in the form of and array including one or more light emitting diodes, as is illustrated in
The light sensor 112 also may include one or more elements. According to an embodiment illustrated in
In fact, where the array of light sensors 112 includes a row of light sensors (such as in
While the arrangement of the light emitter 110 and the light sensor 112 may vary relative to the reflectance-based embodiments of
Contrasting the arraignment illustrated in
Further, it is believed that the spacing between the emitter 110 and the sensor 112 may influence the light received by the sensor 112. For example, it has been determined that a spacing between the emitter 110 and the sensor 112 of 5 mm may permit detection of vessels from 0 mm to 12 mm from the surface of the tissue. It is believed that increasing the spacing between the emitter 110 and the sensor 112 may permit the light to penetrate even deeper into the tissue, permitting vessel detection at even greater depths.
On the other hand, the emitter 110 and sensor 112 may be disposed so as to be mounted in a fixed relationship to each other, or a moveable or adjustable relationship. In particular,
As mentioned above, the light emitter 110 of either
As to those embodiments wherein the light emitter 110 is in the form of an array including one or more light emitting diodes, the diodes may be arranged in the form of a one-dimensional, two-dimensional or three-dimensional array. An example of a one-dimensional array may include disposing the diodes along a line in a single plane, while an example of a two-dimensional array may include disposing the diodes in a plurality of rows and columns in a single plane. Further example of a two-dimensional array may include disposing the diodes along a line on or in a curved surface. A three-dimensional array may include diodes disposed in more than one plane, such as in a plurality of rows and columns on or in a curved surface.
The light sensor 112 according to the embodiments of
In addition, the system 100 may include hardware and software in addition to the emitter 110, sensor 112, and controller 114. For example, where more than one emitter 110 is used, a drive controller may be provided to control the switching of the individual emitter elements. In a similar fashion, a multiplexer may be provided where more than one sensor 112 is included, which multiplexer may be coupled to the sensors 112 and to an amplifier. Further, the controller 114 may include filters and analog-to-digital conversion as may be required.
As a consequence, there are a considerable number of electrical connections that need to be made between the components that define the light emitter 110 and the light sensor 112 and the other electrical components of the system 100. Considering that the light emitter 110 and the light sensor 112 are located at the working end 104 of the surgical instrument 106, while the controller 114 and the other components of the system 100 are generally located at a distance to the working end 104 of the instrument 106, these electrical connections will need to extend over that distance as well. This is particularly true relative to minimally-invasive surgery, where the working end 104 of the surgical instrument 106 is disposed at a distal end of an elongated member, while the controller 104 is typically located no closer than the proximal end of the elongated member 204. The elongated member may be in the form of a tubular shaft through which, for example, the actuation mechanism responsible for the opening and closing of the jaws 180, 182 is passed from the proximal end to the distal end of the shaft.
As mentioned above, complicating the instrument 106 through the incorporation of the system 100 may well impede adoption of the technology. Consequently, a system that permits electrical coupling between the light emitter 110/light sensor 112 and the controller 114 without requiring redesign or repackaging of the operating mechanisms, such as the actuation mechanism, of the surgical instrument 106 would be preferable. Moreover, it is desirable if such a solution does not require the inclusion of additional lumens in the elongated member or shaft, because the inclusion of such additional lumens would disturb the arrangement of the existing structures within the shaft. Furthermore, the creation of an elongated member, such as a tubular shaft or a rod, with lumens that extend from the distal end to a proximal end with sufficient precision to permit a wire or other conductor to be disposed along the lumen may present a difficult, if not impossible, manufacturing problem. Consequently, a number of embodiments for electrical coupling the light emitter 110/light sensor 112 and the remainder of the electrical components are proposed that may enhance the adoptability of such technology.
In general terms, the surgical system 100 according to these embodiments includes a tubular shaft having a wall defining an outer surface and an inner surface disposed about an inner space, the tubular shaft having a proximal end and a distal end. The system 100 also includes the aforementioned light emitter 110 and light sensor 112 disposed at the distal end of the tubular shaft. Further, the system 100 includes one or more conductors electrically coupled to the light emitter or the light sensor, the one or more conductors extending from the distal end of the tubular shaft to the proximal end of the shaft, The one or more conductors disposed radially outward of the inner surface of the tubular shaft.
In doing so, the structure of the surgical system 100 maintains the inner space free of any equipment required by the surgical system 100 to determine the presence and/or characteristics of, for example, blood vessels in the surgical field. As such, the technology may be adopted without altering the design of a surgical instrument that is also part of the surgical instrument. Moreover, certain embodiments disclosed below may also permit the electrical coupling between the light emitter 110/light sensor 112 and the remainder of the electrical components to occur without altering either the inner or the outer diameter of a shaft that is part of the surgical instrument. Furthermore, this is done without introducing lumens into the wall of the tubular shaft that might weaken the shaft or complicate its manufacturability.
Such a surgical system may provide similar advantages even if the detection modality is not an optical system, such that the system 100 includes, for example, a sensor disposed at the distal end of the tubular shaft.
As illustrated in
An alternative embodiment is illustrated in
The disposition of the light emitter 110 and light sensor 112 at the distal end 202 of the shaft 200 may be achieved, for example, as a consequence of the relative lengths of the shaft 200 and the shaft 206.
The light emitter 110 and the light sensor 112 may be fixedly attached to the remainder of the surgical instrument 106 so that the emitter 110 and sensor 112 are fixedly disposed at the distal end 202 of the shaft 200 by providing a connector (such as an external threading) at a proximal end 208 of the shaft 206 and providing a mating connector (e.g., a recess with an internal threading) at a proximal end of the shaft 200. While providing a fixed attachment (under operational conditions), the connectors may permit the shaft 206 and associated equipment to be removable (and thus disposable separate from the remainder of the instrument 106) or permanently attached. This connection may also mechanically couple the jaws 180, 182 to the remainder of the actuation mechanism.
It is also possible for the tubular shaft 200 to be a structure that is separate from the surgical instrument 106. For example,
In particular, the shaft 200 is intended to be disposed about the elongated shaft 210 by passing the shaft 210 through the interior of the shaft 200. Where the tubular shaft 200 has a continuous cross-section, this may require that the shaft 200 be installed about the shaft 210 before the jaws 180, 182 are attached to the shaft 210. However, if the tubular shaft 200 has a discontinuity (such as a split) in its cross-section, the shaft 200 may be partially deformed to permit the shaft 210 to be disposed within the shaft 200, and then the shaft 200 may be allowed to resume its original shape (for example, as a natural consequence of the material used to manufacture the shaft 200).
The discontinuity may be of such a limited nature that the shaft 200 appears to be continuous in its original shape or after it has been disposed about the shaft 210. Alternatively, the discontinuity may be of a more extreme nature, such that the shaft 200 retains its tubular, hollow appearance, but appears less like a continuous annulus or ring-shape in cross-section and more like a c-shape, for example (compare
As discussed above, according to the embodiments of the system 100, the tubular shaft 200 has a wall that defines an outer surface and an inner surface disposed about an inner space, the tubular shaft having a proximal end and a distal end. Further, the system 100 includes one or more conductors electrically coupled to the light emitter or the light sensor, the one or more conductors extending from the distal end of the tubular shaft to the proximal end of the shaft, the one or more conductors disposed radially outward of the inner surface of the tubular shaft. To better illustrate these concepts, reference is now made to the embodiments illustrated in
In the embodiments of
As illustrated in
As illustrated in
As illustrated in
As illustrated in
Instead of being disposed on an outer surface 214 of the wall 216 of the tubular shaft 210, the one or more conductors 212 may be disposed in the wall 216, for example to define an inner surface of the wall 216 of the tubular shaft 200, as in the embodiments of
As illustrated in
In the alternative, as illustrated in
As a still further alternative, the one or more conductors 212 may be formed within the wall 216. As illustrated in
The conductors 212 and the light emitter 110/light sensor 112, as well as the conductors 212 and the remainder of the electrical components, may be directly coupled by joining the conductors to the leads of the light emitter 110, light sensor 112, or other components. This joining may be permanent, in that a tool or considerable force may be required to break or sever the connection, and that the connection will require repair to reform the connection. An example of such a connection may be a soldered junction. Alternatively, where a removable connection is desired (such as may be desired for the embodiments illustrated in
As mentioned above, the system 100 may include other equipment as well. For example, relative to the indicator 130 used in conjunction with controller 114, a variety of output devices have been illustrated in
As mentioned above, the surgical system 100 may also include the surgical instrument 106 with the working end 104, to which the light emitter 110 and light sensor 112 are attached (in the alternative, removably/reversibly or permanently/irreversibly). The light emitter 110 and the light sensor 112 may instead be formed integrally (i.e., as one piece) with the surgical instrument 106. It is further possible that the light emitter and light sensor be attached to a separate instrument or tool that is used in conjunction with the surgical instrument or tool 106.
As noted above, the surgical instrument 106 may be a thermal ligature device in one embodiment. In another embodiment, the surgical instrument 106 may simply be a grasper or grasping forceps having opposing jaws. According to still further embodiments, the surgical instrument may be other surgical instruments such as surgical staplers, clip appliers, and robotic surgical systems, for example. According to still other embodiments, the surgical instrument may have no other function that to carry the light emitters/light sensors and to place them within a surgical field. The illustration of a single embodiment is not intended to preclude the use of the system 100 with other surgical instruments or tools 106.
In conclusion, although the preceding text sets forth a detailed description of different embodiments of the invention, it should be understood that the legal scope of the invention is defined by the words of the claims set forth at the end of this patent. The detailed description is to be construed as exemplary only and does not describe every possible embodiment of the invention since describing every possible embodiment would be impractical, if not impossible. Numerous alternative embodiments could be implemented, using either current technology or technology developed after the filing date of this patent, which would still fall within the scope of the claims defining the invention.
It should also be understood that, unless a term is expressly defined in this patent using the sentence “As used herein, the term ‘______’ is hereby defined to mean . . . ” or a similar sentence, there is no intent to limit the meaning of that term, either expressly or by implication, beyond its plain or ordinary meaning, and such term should not be interpreted to be limited in scope based on any statement made in any section of this patent (other than the language of the claims). To the extent that any term recited in the claims at the end of this patent is referred to in this patent in a manner consistent with a single meaning, that is done for sake of clarity only so as to not confuse the reader, and it is not intended that such claim term be limited, by implication or otherwise, to that single meaning. Finally, unless a claim element is defined by reciting the word “means” and a function without the recital of any structure, it is not intended that the scope of any claim element be interpreted based on the application of 35 U.S.C. §112(f).
Filing Document | Filing Date | Country | Kind |
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PCT/US2017/017468 | 2/10/2017 | WO | 00 |
Number | Date | Country | |
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62295005 | Feb 2016 | US |