US20130123582A1 - Tissue monitoring surgical retractor system - Google Patents

Abstract

An apparatus for monitoring the characteristics of tissue adjacent a surgical site and communicating that information to a health care provider includes a retractor, a sensor, and a processing system. The sensor is disposed on the retractor and is configured to measure a parameter indicative of at least one characteristic of the tissue adjacent the first or the second blade. The processing system is in communication with the sensor and configured and arranged to receive information from the sensor indicative of the measured parameter. It includes a threshold stored therein indicative of excessive trauma to the tissue and it is configured in a manner such that it compares the received information to the stored threshold and communicates information to the health care provider regarding the comparison.

Description

FIELD OF THE INVENTION
• The present disclosure is directed to a surgical retractor system. More particularly, the present disclosure is directed to a retractor system that monitors parameters indicative of the state of a patient's tissue adjacent a retractor of the retractor system.
BACKGROUND
• Side effects of anterior cervical decompression and fusion procedures may include post-operative dysphagia. This condition, making swallowing difficult or impossible, can be relatively long lasting, with up to twelve percent of patients with dysphagia symptoms still having those symptoms a year after surgery. Surgeons and scientists are researching whether the incidence and recovery from dysphagia corresponds with the size of the surgical dissection, the trauma induced by retractors, and the length of the time the retractors are used to maintain an open surgical site.
• Conventional retractors are placed at a surgical site and used to retract tissue based solely upon a surgeons preference and experience. A surgeon conventionally attempts to “feel” when the retractor applies excessive loading to the tissue. If the loading links to the incidence of dysphagia, it would be helpful to have a system for monitoring loading or other parameters indicative of the state of the tissue.
• The systems and methods disclosed herein address one or more of the shortcomings of the prior art.
SUMMARY
• These and other aspects, forms, objects, features, and benefits of the present invention will become apparent from the following detailed drawings and description.
• The present disclosure is directed to a surgical retractor system for monitoring the characteristics of tissue adjacent a surgical site and communicating that information to a health care provider. The surgical retractor system may include a retractor, a sensor, and a processing system. The retractor may include a first blade for interfacing with tissue on a first side of a surgical site, a second blade for interfacing with tissue on a second side of the surgical site opposite the first side of the surgical site, and a body portion supporting the first blade relative to the second blade. The body portion may be adjustable in situ in a manner that changes tissue parameters by displacing the first blade relative to the second blade to displace tissue and provide access to a surgical site. The sensor is disposed on the retractor and is configured to measure a parameter indicative of at least one characteristic of the tissue adjacent the first or the second blade. The processing system is in communication with the sensor and configured and arranged to receive information from the sensor indicative of the measured parameter. The processing system includes a threshold stored therein indicative of excessive trauma to the tissue. The processing system is configured in a manner such that it compares the received information to the stored threshold and communicates information to the health care provider regarding the comparison.
• In another aspect, the present disclosure is directed to a sensor system for use on surgical retractor system. The sensory system includes a detector for receiving a signal or stimulus that creates a signal based on the received signal or stimulus and an anchor portion shaped to removably attach to a portion of the surgical retractor system. In some aspects, the sensor system is one of a sleeve configured to receive a portion of the retractor therein, a C-shaped clip configured to clip onto the retractor, and a flexible patch having an adhesive layer therein.
• In another aspect, the present disclosure is directed to a surgical retractor system for monitoring the characteristics of tissue adjacent a surgical site and communicating that information to a health care provider. The surgical retractor system may include a retractor and a tissue parameter detecting system. The retractor includes a first blade for interfacing with tissue on a first side of a surgical site, a second blade for interfacing with tissue on a second side of the surgical site opposite the first side of the surgical site, and a body portion comprising a first arm and a second arm and an adjustment element adjustably connecting the first and second arms. The first and second arms respectively support the first blade and the second blade. The adjustment element is adjustable in situ in a manner that changes tissue parameters by displacing the first blade relative to the second blade to displace tissue and provide access to a surgical site. The tissue parameter detecting system is structurally configured and arranged to measure a parameter indicative of at least one characteristic of the tissue adjacent the first or the second blade. The tissue parameter detecting system has a threshold stored therein indicative of excessive trauma to the tissue. The tissue parameter detecting system is structurally configured and arranged in a manner such that it compares the measured information to the stored threshold and communicates information to the health care provider regarding the comparison.
BRIEF DESCRIPTION OF THE DRAWINGS
• The accompanying drawings serve to exemplify some of the embodiments of this invention.
• FIG. 1 is an illustration of a perspective view of a surgical retractor of the present disclosure with a sensor for detecting data indicative of the state of tissue adjacent the retractor.
• FIG. 2 is an illustration of a top view of two surgical retractors in a surgical application, one of the surgical retractors having a sensor thereon and in communication with a retraction monitor and system in accordance with the disclosure ofFIG. 1.
• FIG. 3 is an illustration of an exemplary retraction monitor connectable to the sensor inFIGS. 1 and 2.
• FIG. 4 is an illustration of a sensor system in the form of a sensor sleeve having a built-in sensor in accordance with the present disclosure.
• FIG. 5 is an illustration of a sensor system in the form of a clip having a built-in sensor in accordance with the present disclosure.
• FIG. 6 is an illustration of the sensor system inFIG. 5.
• FIG. 7 is an illustration of a sensor system in the form of an adhesive patch having a built-in sensor in accordance with the present disclosure.
• FIG. 8 is an illustration of a perspective view of a surgical retractor of the present disclosure with a sensor for detecting data indicative of the state of tissue adjacent the retractor usable in a wireless environment.
• FIG. 9 is a diagram of an exemplary wireless transmission system using inductive coupling.
DETAILED DESCRIPTION
• The present disclosure relates generally to the field of orthopedic surgery, and more particularly to devices, systems and methods for monitoring tissue displaced by a retractor system. For the purposes of promoting an understanding of the principles of the invention, reference will now be made to embodiments or examples illustrated in the drawings, and specific language will be used to describe these examples. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended. Any alteration and further modifications in the described embodiments, and any further applications of the principles of the invention as described herein are contemplated as would normally occur to one skilled in the art to which the disclosure relates.
• This disclosure is directed to instruments and methods for performing percutaneous surgery, including spinal surgeries that include one or more techniques such as laminotomy, laminectomy, foramenotomy, facetectomy, discectomy, interbody fusion, spinal nucleus or disc replacement, and implant insertion including plates, rods, and bone engaging fasteners, for example. A retractor system, including a retractor, permits a surgeon to perform through a working channel or passageway through skin and tissue of the patient. The retractor is adjustable in situ to increase the size of the working channel to facilitate access to the working space at the distal end of the retractor while minimizing trauma to tissue surrounding the retractor. The retractor can be used with any surgical approach to the spine, including anterior, posterior, posterior mid-line, lateral, postero-lateral, and/or antero-lateral approaches, and in other regions besides the spine.
• FIG. 1 shows an exemplary aretractor system100, including aretractor102 and aprocessing system103 that, in this embodiment, includes amonitor104 and a console, such as acomputer system106. Theretractor102 includes a variable widthmain body tube108 formed of afirst blade110 and asecond blade112. It also includes afirst arm114 and asecond arm116 extending from themain body tube108. These are adjustably connected to each other at a proximal end by anadjustment element118. Theadjustment element118 adjusts the distance between the first andsecond arms114,116, and likewise, adjusts the distance between the first andsecond blades110,112.
• In this embodiment, theblades110,112 have an arcuate cross section with a concave inner surface and a convex outer surface. In other embodiments, the blades have other configurations such as flat, curved, or other geometries. Thefirst blade110 has adistal end120 and an oppositeproximal end122. Thesecond blade112 has adistal end124 and an oppositeproximal end126. Thedistal ends120,124 may be beveled to facilitate insertion, although non-beveled ends are also contemplated. A workingchannel128 is formed between the first andsecond blades110,112. After insertion into a patient, the workingchannel128 is enlarged by spreading the first andsecond blades110,112 apart using theadjustment element118. In this embodiment, theadjustment element118 is a rack and pinion assembly, although outer adjustment elements are contemplated. In some examples, theadjustment element118 comprises a motor, such as an electric, hydraulic, or pneumatic motor that spreads apart the first and second blades.
• The first andsecond blades110,112 are respectively coupled with the first andsecond arms114,116 which are engaged withadjustment element118. It should be appreciated that theblades110,112 may be coupled with thearms114,116 in any suitable arrangement, including dovetail connections, fasteners, threaded coupling members, clamping members, snap rings, compression bands, straps, ball-detent mechanisms, releasably interlocking cams or tabs, welding, fusing, and/or adhering, just to name a few possibilities. In some embodiments, theblades110,112 are integrally formed with thearms114,116. Still further, theblades110,112 may be removably coupled with thearms114,116, and alternative retractor blades may be chosen from a plurality of retractor blades to replaceretractor blades110,112 to better suit a particular application in which theretractor102 may be used. In addition, it should be noted that alternative embodiments use more than two plates, and in further alterative embodiments, a single blade may be used.
• In use, after insertion into the patient, the workingchannel128 can be enlarged by separatingfirst retractor blade110 andsecond retractor blade112. Separation of theretractor blades110,112 increases the size of workingchannel128. However, as with any invasive surgery, this separation applies some level of stress and trauma to the tissue about the surgery site.
• FIG. 2 is a top view showing tworetractors140,142, respectively, in use at a surgical site to maintain or retract tissue in a position providing surgical access according to an exemplary aspect of the present disclosure. Here, theretractors140,142 are similar in many respects to theretractor102 described above, and for efficiency, will not be re-described in great detail. It is sufficient to note that theretractors140,142 each include first and second blades, arms, and an adjustment element that controls the separation between the arms and blades.
• To quantify the level of stress and trauma to the tissue at the surgical site, each of theretractor102 inFIG. 1 and theretractor140 inFIG. 2 includes asensor150 associated therewith. Thesensor150 provides information indicative of one or more parameters of the loading stress, trauma, status, or other parameter of the tissue at the surgical site. For example, thesensor150 may provide information including mechanical, thermal, chemical fluidity (such as pressure, time, heat, blood flow, lactid acid build-up, or other parameters) determined to be useful in a surgical setting. In the embodiment inFIG. 1, thesensor150 is disposed upon theblade110 of theretractor102. Accordingly, in addition to sensing the pressure on theblade110, the sensor may interface directly with the tissue and may provide information relating to either the state of the retractor or directly measure parameters of the tissue. In some examples, asensor150 may be used on each blade. In other examples, thesensor150 may be used only on a single blade. The blade may be the medial blade, responsible for retracting the midline structures from the anterior aspect of the spine. For example only, thesensor150 may be a strain sensor, a thermocouple, a flow meter such as a Transonic VLF-21 Laser Doppler Flowmeter, other sensors, or a plurality of sensors arranged in a manner known in the art.
• In the embodiment inFIG. 2, thesensor150 is disposed upon a retractor arm of theretractor142. In this embodiment, thesensor150 is a strain sensor arranged to sense the arm strain indicative of pressure applied to theretractor blade110 by patient tissue during use.
• In either case, themonitor104 is structurally configured to receive information from thesensor150. In the embodiment shown, themonitor104 is connected to thesensor150 via awired connection134. Signals transmitted over thewired connection134 provide information that may be filtered or processed to identify information gathered by thesensor150.
• FIG. 3 shows anexemplary monitor104. It includes both adisplay portion160 and aninput portion162. The display portion includes avisual indicator164 labeled “Normal,” avisual indicator166 labeled “Alarm,” and avisual indicator168 labeled “Blade Size.” Thedisplay portion160 provides real time feedback based on information received from the sensor indicative of the level of tissue trauma. For example, themonitor104 may indicate that the received information indicates that the tissue at the surgical site is subject to trauma above or below a pre-established threshold. In some embodiments, themonitor104 is configured to be operable with different blade sizes, and the threshold value may be different based on the retractor blade size.
• When the Normalvisual indicator164 is active, the sensor information is indicative of trauma levels below a preset threshold. In some instances the threshold value level is configured to automatically adjust over time. For example, themonitor104 may be programmed so that the threshold decreases over a surgical period, such that even a lower level of trauma is not maintained too long.
• When the Alarmvisual indicator166 is active, the sensor information is indicative of trauma levels above a preset threshold. This alerts the surgeon to reduce the pressure on the tissue at least for a period of time. In addition to a visual Alarm indicator, the monitor includes an audible indictor. Further, some embodiments include a tactile indicator where themonitor104 vibrates as an alarm indicator. Also, in some embodiments, the visual indicators have color-based lighting schemes, for example, with green indicating that measured parameters are below a threshold, red indicating that measured parameters are above a threshold, and flashing red or yellow indicating that tissue should be relaxed for a period of time. Other alarm schemes are also contemplated. Accordingly, the surgeon may be alerted to over-trauma levels in any of multiple ways.
• Theinput portion162 of themonitor104 includes apower selector170, ablade selector172, arecord selector174, and amute selector176. These are shown as buttons, but may be icons on a touch screen, or may be selectable by a mouse, keyboard, or other input device. Therecord selector174 turns on a recorder that records the feedback from thesensor150. The recorder may be a microcomputer or chip capable of receiving, recording, or processing information communicated by thesensor150 on theretractor102.
• In some examples, themonitor104 is configured to monitor retraction force/pressure and force/pressure vs. time. In other examples the monitor is configured to monitor temperature, chemical fluidity (e.g., pressure, time, heat, blood flow, lactid acid build-up) or other parameters.
• In some embodiments, themonitor104 is also a safety mechanism. For example, when a detected sensor signal exceeds a pre-established threshold, then in addition to the alarm system being activated as described above, a safety mechanism may be activated. This may include automatically controlling the retractor to relieve pressure on the tissue. This may cooperate with retractors having an automatic distraction control as is disclosed in U.S. Patent Publication No. 2009/0306480, filed Jun. 6, 2008, incorporated herein by reference. The automatic control may provide a gradual reduction in pressure by distracting the blades, may provide oscillation, or massaging vibration, or other safety mechanisms that provide relief to the tissue. As the pressure decreases, the alarm function on themonitor104 may likewise adjust, such as changing from a solid light indicator to a flashing indicator, for example.
• In the embodiment shown, themonitor104 connects to thecomputer system106. This may be a personal computer or other computer system, and may include its own input devices, such as a keyboard, mouse, and other standard input devices. Thecomputer system106 may further process the sensor signal and may provide graphs or additional information indicative of the information detected by the sensor. In some embodiments, thecomputer system106 is component that records the detected information when the record input is selected on themonitor104. In some embodiments themonitor104 andcomputer system106 are combined into a single unit that monitors the tissue. In other embodiments, the computer and the monitor are used independently of each other, without being attached together.
• FIGS. 4-7 disclose sensor systems for removably attaching thesensor150 to theretractor102. Accordingly, in some embodiments, the sensor system may be removed and discarded after use and before the retractor is sterilized.
• FIG. 4 discloses asensor system200 including an anchor portion for attachment to theretractor102 and thesensor150. In this embodiment, the anchor portion is asleeve202. Thesleeve202 includes at least one end with anopening204 for receiving at least part of theretractor102. Accordingly, thesleeve202 may be sock-like, with a single open end, or may be tube-like, with two open ends. In this embodiment, thesleeve202 is sized and shaped to receive at least a part of thefirst blade110. In some embodiments, it is formed to have a particular shape matching theretractor202, while in other embodiments, thesleeve202 is configured of a conformable material, such as a fabric, that may conform to the shape of theretractor102. Thedisposable sleeve202 can be made of any suitable material, including flexible or elastic polymers, such as polyurethane, silicone, and rubber, among many others.
• In some embodiments, thesensor150 is built into or embedded within thesleeve202 such that thesensor150 is applied against theretractor102, and configured to measure a particular parameter of theretractor102. For example, thesensor150 may be configured to measure, for example only, force, displacement, contact stress, torque deflection, tension, compression, strain, and pressure on theretractor102. In other embodiments, the sensor is associated with the sleeve in a manner that enables it to measure parameters of the tissue adjacent the sleeve. For example, thesensor150 may be configured to measure temperature, pressure, blood flow, lactid acid build-up, or other parameters. When placed on the retractor, thesleeve202 and thesensor150 are configured to cooperate with theprocessing system103 to record and/or process the pressure or strain information communicated from thesensor150 during the surgery.
• It is worth noting that the more than one disposable sleeve may be used with theretractor102 at a single time. For example, theblades110,112 may each by outfitted with a sleeve-type sensor system200. Further, eachsleeve202 may include more than onesensor150 disposed thereon for measuring more than one parameter. These may be sensors of the same or different types. As explained above, thesensors150 may include one or more of any those that measure the following data: temperature, force, displacement, contact stress, torque deflection, tension, compression, pressure, and strain, among others. Thedisposable sensors150 may track, record, transmit, or store the above data as a function of time.
• FIG. 5 shows another embodiment of aretractor102 with afirst arm114, asecond arm116, and asensor system210 for removable attachment to the retractor. In this embodiment, thesensor system210 includes an anchor portion as a flexible C-shaped clip that snaps onto the retractor. InFIG. 5, thesensor system210 is attached to thefirst arm114, but may be configured to attach to any suitable portion on theretractor102.FIG. 6 shows thesensor system210 in greater detail. As can be seen, thesensor system210 comprises theclip body212, asensor150, and in this embodiment, acoil213 for wireless transmission using inductive coupling, explained further below. Here, theclip body212 includes twolegs214,216 and aside218 that together form a C-shape. Alip220 at the ends of thelegs214,216 permits theclip body212 to snap onto theretractor102, securing it in place. Theclip body212 can be made of any suitable material, including flexible or elastic polymers, such as polyurethane, silicone, and rubber, among many others.
• In some embodiments, thesensor150 is built into or embedded within thebody212 such that thesensor150 is applied against theretractor102 and configured to measure a particular parameter of theretractor102, as explained above. In other embodiments, thesensor150 is associated with theclip body212 and theretractor102 in a manner that enables it to measure parameters of the tissue adjacent the clip body, as explained above. When placed on the retractor, thesleeve202 and thesensor150 are configured to cooperate with theprocessing system103 to record and/or process the pressure or strain information communicated from thesensor150 during the surgery.
• FIG. 7 shows anothersensor system220 as an adhesive patch. Thissensor system220 includes an anchor portion for removable attachment to theretractor102 in the form of anadhesive layer222. The adhesive patch includes theadhesive layer222, abacking layer224, and thesensor150. Theadhesive layer222 may be formed of any adhesive that securely holds thesensor150 in place and that can be removed from theretractor102 prior to sterilization. Thebacking layer224 may be a flexible woven or non-woven material. Thesensor system220 may be placed either on the blade to be contact with tissue or on the retractor arm, out of contact with the tissue. Thissensor system220 may be removed from a sterile packet and attached to an appropriate location on the retractor.
• In all the embodiments in this disclosure, more than one sensor may be used at the same time in the same region or different regions of the retractor, for measuring the same parameter or for measuring different parameters. Accordingly, the sensor systems as well as directly placed sensors as inFIG. 1, may include a plurality ofsensors150. As explained above, thesensors150 may include one or more of any sensors that measure the following data: temperature, force, displacement, contact stress, torque deflection, tension, compression, pressure, and strain, among others. Thedisposable sensors150 may track, record, transmit, or store the above data as a function of time.
• FIG. 8 shows another embodiment of the of the retractor inFIG. 2. In this embodiment, instead of employing a wired communication system, the device employs a wireless communication between the sensor130 and themonitor104. Accordingly, the information collected by the sensor130 may be communicated via a wireless transmission themonitor104. This wireless communication may be accomplished via any suitable wireless method, including RF, Bluetooth, inductive, coupling, transmissions via ultrasound, microwave, or other ranges and frequencies.
• FIG. 9 discloses one example of awireless system300 for communicating between thesensor150 and themonitor104. This embodiment uses inductive coupling to wirelessly power the sensor and retrieve data. Here, the sensor or sensor system comprises thesensor150, circuitry302, and atransmission coil304. Themonitor104 comprises areader coil306 as an inductive antenna. Thereader coil306 need not be contained within the monitor housing, but may extend from the housing for placement somewhere adjacent the surgical site. Thereader coil306 and thetransmission coil304 cooperate by transfer data and energy. In use, thereader coil306 supplies energy to thetransmission coil304. This in turn powers the circuit302 and retrieves data from thesensor150. This information maybe processed at the sensor or may be wirelessly transmitted from thetransmission coil304. Once received, the information may be processed as described above.
• Wireless communications other than those described above also may be used. For example, thesensor150 may be associated with a power source and transmitter disposed on theretractor102. Accordingly, the range of the wireless transmitted signals may be greater than when inductive coupling is used. In some instances, thesensor150 may be a passive sensor, while in other embodiments, thesensor150 may be an active sensor. In addition, the sensor may be either a one way or two way sensor, and may be internally powered or externally powered. In some aspects, the sensors are connected to an antenna for improved wireless signaling. As described above, thesensor150 may be either disposable or non-disposable. All the features described above are also relevant when wireless technology is used to transmit and process information. For example, even using wireless technology, themonitor104 orcomputer system106 may, record and interpret data.
• In use, a surgeon makes an incision into a patient. If a sensor is not attached to the retractor, the surgeon may attach the sensor. As described above, this may be accomplished by attaching a removable and flexible sleeve including the sensor about a portion of the retractor, attaching a clip including the sensor, or adhering an adhesive patch including the sensor. Other attachment methods are contemplated.
• With the retractor prepared, the surgeon inserts the retractor blades into the incision. In some examples, the blades are formed to create a working channel between them. In other examples, the adjustment element spreads apart the arms and blades, and the spreading blades spread the tissue, creating a working channel. During this spreading step and/or with the blades in place against the tissue, the sensor detects changes in measurable parameters indicative of the state of the tissue adjacent the blades. As described above, the measurable parameter may be strain on the blades or arm, direct force on the blades, pressure, temperature, or any of the other listed or unlisted parameters.
• The monitor receives signals from the sensor with information indicative of the measured parameter. In some embodiments, the monitor stores a threshold value for the retractor that coincides with a value beyond which there is an increased risk of tissue damage. The monitor may compare the received information with the stored threshold. If the received information exceeds the threshold, the monitor may give a warning as discussed above. For example, the warning may be activated with a pressure greater than 100 mmHg has been sustained for more than 15 minutes or when a pressure greater than 50 mmHg has been sustained for more than 30 minutes.
• The monitor or an associated computer system also may record the information and display graphs or charts indicative of the measured parameters of the status of the tissue.
• While the present invention has been illustrated by the above description of embodiments, and while the embodiments have been described in some detail, it is not the intention of the applicant to restrict or in any way limit the scope of the invention to such detail. Additional advantages and modifications will readily appear to those skilled in the art. Therefore, the invention in its broader aspects is not limited to the specific details, representative apparatus and methods, and illustrative examples shown and described. Accordingly, departures may be made from such details without departing from the spirit or scope of the applicant's general or inventive concept. It is understood that all spatial references, such as “longitudinal axis,” “horizontal,” “vertical,” “top,” “upper,” “lower,” “bottom,” “left,” and “right,” are for illustrative purposes only and can be varied within the scope of the disclosure.

Claims (6)

1-14. (canceled)

15. A sensor system for use on surgical refractor system comprising:

a detector for receiving a signal or stimulus that creates a signal based on the received signal or stimulus;

an anchor portion shaped to removably attach to a portion of the surgical retractor system.

16. The sensor system ofclaim 15, wherein the anchor portion comprises a sleeve configured to receive a portion of the retractor therein.

17. The sensor system ofclaim 15, wherein the anchor portion is a C-shaped clip configured to clip onto the refractor.

18. The sensor system ofclaim 15, wherein the anchor portion is a flexible patch having an adhesive layer therein.

19-20. (canceled)

Images