The present invention relates to surgical instruments, and particularly to a tissue-identifying surgical instrument that includes a tissue-identifying component with integrated multiple functions for more efficient, accurate and safer execution of a surgical procedure.
When performing any type of sensitive and delicate surgical procedures such as skull base surgery, neck dissections, carotid endarterectomy, and the like, the surgeon, with the help of a team of technicians, must determine the nature of the tissue under observation to avoid unintended damage to sensitive tissues such as nerves. Typically, the surgeon employs an electrically powered probe wired to a power source and monitoring device to electrically stimulate the tissue of interest in order to determine whether the tissue is a nerve, blood vessel, muscle or other type of tissue. This helps the surgeon map the anatomical section so that any incisions or resections may be performed with some degree of confidence that the procedure will not result in unintended and irreparable harm resulting in functional impairment. For the patient's well-being and ultimate recovery it is imperative to preserve the integrity of nerve tissues as well as vascular support for the tissues as much as possible in these delicate surgical procedures. Any damage to nerve tissue or compromise of blood flow may prolong recovery and/or cause further complications detrimental to the patient's health.
A constant threat to the safety of sensitive tissues in the surgery field is the tedious and time consuming process involved in the dissection of tissues. To avoid unintentionally damaging delicate tissues, the surgeon conventionally employs the use of a probe to identify different tissues in the surgery field before commencing or continuing the process of tissue dissection. The surgeon may hold the probe in one hand while the other hand is occupied with another surgical instrument such as a scalpel. It is also typical that the surgeon grasping the probe will attempt to determine the type of tissue and upon making a determination will set aside the probe, take up the surgical scalpel, and proceed with the tissue dissection. As the surgery progresses, the constant back and forth between the probe and the other surgical instruments delays the surgery and increases the risk of unintended damage to the tissues, thus negatively affecting the safety of the patient. The longer the surgical procedure lasts, the more likely a mistake will be made by the surgeon due to fatigue or lapse in focus. Moreover, a lengthy surgery greatly increases the expense of the procedure and may result in a lengthy recovery time for the patient, which also adds to the resulting increased medical expense.
The requirement for the surgeon to repeatedly manipulate the cumbersome probe and its cable connections during the surgical procedure also has the potential of creating problems or difficulties for the surgeon in his efforts to focus on the surgical procedure without distractions. The typical probe is connected by a probe cable to a monitor, which displays the information obtained by the probe to a member of the surgical team who verbally communicates observations to the surgeon manipulating the probe to tissue of interest within the surgical site. The surgeon's complete dependence on the other man in the loop inherently creates delays between the time the probe contacts the tissue of interest and the time when the surgeon knows what type of tissue he has contacted. Some probes are also operated by the surgeon using external actuators, such as foot pedals. During the surgical procedure, the surgeon is often distracted from his primary purposes by his need to be cognizant of the location of the probe cable and to adjust the position of the probe cable to avoid its interference or entanglement with the surgeon's manipulation of other surgical instruments. In addition, any handling or effort to relocate the probe cable to a safer or less interfering location during the surgical procedure serves to unnecessarily increase the time spent in surgery as well as increase the chances of accidental damage to the tissue in the surgery field due to the surgeon's attention being diverted thereby. Repeated attempts to move the probe cable may lead to aggravation, which negatively impacts the surgeon's focus, and extensive operation of the foot pedal may cause unnecessary fatigue or accidental misplacement. Moreover, the cables associated with the foot pedal can result in the same potential problems as the probe cable.
It would greatly facilitate the work of the surgeon and provide a much higher level of patient safety to provide a method and/or device that would eliminate the problems attendant to the use of conventional tissue identification probes as described above. In addition to reducing distractions and improving conditions for the surgeon, the device by eliminating the problems discussed above could also substantially decrease the time spent in surgery and significantly increase the safety of the surgical procedure for the patient. Thus, a tissue-identifying surgical instrument solving the aforementioned problems is desired
The tissue-identifying surgical instrument includes a surgical instrument having a proximal base or handle, a distal operative end, and a tissue identification probe integrated with or adjacent to the distal operative end of the instrument. The probe is provided with at least one and preferably multiple stimulating and/or sensing elements that can be selectively employed by the surgeon to identify the type of tissue, e.g., nerve, muscle, vein or other tissue that has been stimulated or touched by the probe. The base or handle of the instrument includes a probe control assembly connected to a power source. The power source for the instrument is preferably located entirely within the base or handle and more preferably is a rechargeable power cell or battery capable of providing prolonged use. The control assembly is capable of wireless transmission of data collected through its tissue sensing function to a data collection, interpretation, and recording workstation from where tissue identification information can be monitored by a member of the surgical team and simultaneously provided to the surgeon by wirelessly communication. Tissue identification information can also be directly provided to the surgeon through visual indicators that are provided on the handle as well as by wireless transmissions to a heads-up display (HUD) provided for the surgeon on a framework configured to be worn by the surgeon; that framework being similar to surgical loupes, surgical headlights, eye glasses, surgical head bands, and the like. Electrical power sources employed in the components and elements of the invention are preferably rechargeable and more preferably rechargeable by magnetic induction means. Sensor data collection can be immediately provided to the surgeon and medical team as well as saved as a time-line data collection for later recall and analysis if necessary.
These and other features of the present invention will become readily apparent upon further review of the following specification and drawings.
Similar reference characters denote corresponding features consistently throughout the attached drawings.
The tissue-identifying surgical instrument, generally shown at 10, includes an integrated tissue identification probe, generally shown at 12, with wireless transmission and/or reception capabilities to improve and expedite tissue identification during surgery and thereby substantially reduce surgery time and many potential hazards to the patient during the operation. In a surgical procedure a dissection can require a plurality of different surgical instruments, many of which could be more beneficial to the surgeon if provided with the additional capability of quick and reliable tissue identification as described herein. Provided herein are descriptions of various examples of common surgical instruments that can include, in addition to their primary function, the additional capability of assisting the surgeon in the identification of tissue types encountered during the surgical procedure. The non-limiting examples of these multifunctional surgical instruments 10 described below are discussed in detail with the understanding that the teachings thereof can apply to virtually all surgical instruments as required. The following non-limiting descriptions are directed toward hand manipulated tissue-identifying surgical instruments 10; however, the base or handle 14 of the surgical instrument 10 can be easily adapted for operable connection to a robotic surgical system.
In the exemplary embodiment shown in
A first exemplary embodiment of the instrument 10 is shown in
A power source 42 can be provided as a detachable battery pack; however it is preferred that the power source 42 is provided as located entirely within the base or handle 14. Preferably the internally located power source 42 is provided as a rechargeable power cell or battery capable of providing sufficient power to support prolonged use of the instrument 10. Most preferable, the power source 42 is sealed within the handle 14 and is rechargeable by magnetic induction means to ensure the moisture proof environment of the interior of the handle 14. In addition to powering the data collection, interpretation, data display, and data transmission operations of the instrument 10, the power source 42 is required to energize the electrical probe 40 to accomplish its tissue stimulating and response sensing functions for the tissue of interest. To maximize electrical conduction through the probe tip 26 to the tissue it is preferred that a highly conductive material such as gold, silver or the like be used on at least a portion of the probe tip 26 although any electrically conductive material would be suitable for manufacture of the probe tip 26 and operation of the electrical probe 40.
The handle 14 provides the structural foundation for the surgical instrument 10 and also provides a probe housing 24 for the components needed to operating the probe, such as the insulated, moisture proof housing 24, the probe tip 26, the electrical probe 40 and other types of probes, such as for example optical or light probes 29, radio frequency 62, and acoustic (passive acoustic, or ultrasound) probes 34. As shown in
In the first exemplary embodiment of
The processor 46, a component of the sensor module 32 is operatively connected to the sensor module 32 and serves to convert the sensed data into a transmittable form, which is subsequently passed on to the transmitter 48. The transmitter 48 is capable of wireless communication and can send the processed data simultaneously to multiple possible receivers. The data is wirelessly transmitted to a monitoring workstation 56, which is under close observation by a surgical team member or technician who normally stands by to alert the surgeon of the results. The tissue identification data can also be simultaneously displayed on the tissue type display 58 provided on the handle 14 of the instrument 10 to immediately and automatically inform the surgeon of the tissue type currently being probed. As shown in
The wireless transmission of data can be facilitated by a Bluetooth™ type transmission or any other radio frequency transmissions. A Bluetooth™ type transmission system is preferred due to the limited, localized range, security, and the range of digitized data that can be transmitted thereby. The security aspect of the wireless features can include a unique signature for that instrument as a means of identifying the instrument for monitoring purposes. Most important, that unique signal signature can be used to lock into a channel on any medical team receiving station so that subsequently used instruments will not be confused with any other instrument and thereby protect against receiving errant signals from other transmitting devices nearby. The transmitter 48 may also function as a receiver whereby the results from the technician monitoring workstation 56 can be relayed back to the tissue type display 58 on the handle 14 and to the HUD 60 worn by the surgeon as an assurance of the accuracy of data sent to those additional tissue type display sites through other data transfer channels. The provision of multiple channels of data transmission to the surgeon provides redundancy to ensure that the selected probe 12 and the tissue type information provided to the surgeon is correct prior to the surgeon deciding to proceed with the tissue dissection. The tissue identification function of the surgical instrument 10 is rapid, accurate, and safe due to the integrated tissue probe, control assembly, data transmission capabilities, and redundant indicators provided for the surgeon and surgical team.
The prior art tissue identification and dissection procedures practiced by surgeons involves setting aside the surgical instrument in order to use a separate probe device that is hard wired to a remote technician monitored workstation. The surgeon must then wait for the technician to consider the data and verbally report the type of tissue that the technician believes was stimulated by the surgeon. The surgeon then must set aside the cumbersome wired-probe and again take up the first surgical instrument before he can begin to dissect the tissue of interest. In contrast, using the surgical instrument 10 with an integrated wireless tissue-identifying probe, the surgeon, with little hesitation after using that instrument 10 to probe the tissue of interest, can confidently continue the surgical procedure knowing the type of tissue the surgical instrument is touching. The distinct superiority in safety, accuracy, and time management of the surgical procedure is more than beneficial to the surgeon and the patient.
The control assembly 44 includes a manually operated probe selector/actuator 36 that, as shown in
The handle 14 may include a plurality of operating indicator lights 64 for visual confirmation of various functions of the scalpel. A non-limiting, preferred example of operating indicator lights 64 that can be used for the instrument 10 are Light Emitting Diode (LED) indicator lights 64. As a non-limiting example of the possible use for such indicator operating lights 64, one or both of the indicator lights 64 may turn yellow upon a single depression of the actuator 36 to indicate that the probe is powered on and ready for identifying the tissue. For multi-function sensing, the actuator 36 may be depressed repeatedly to cycle through the various sensing functions, that is the types of probes available. In response, one of the indicator lights 64 may turn blue for electric, red for IR, or green for laser, It should be understood that other color code and button-press combinations can be used in addition to the examples discussed herein. The lights 64 may be flush with the outer surface of the handle 14 or be disposed underneath a protective, translucent covering on the handle 14. In the latter case, the translucency permits the colored light to shine through with minimal degradation of the intensity, vibrancy and color of the LED. As an alternative, the indicator lights 64 may also be used to indicate the type of tissue identified by the probe with a color code being assigned to indicate different types of tissue sensed. Preferably, the instrument 10 can be provided with a separate easily observed bank of tissue type identification lights 94 so as not to confuse the meaning of the operating indicator lights 64 with the tissue type identification lights 94.
As briefly discussed earlier, the power source 42 is preferably a rechargeable and reusable battery to minimize environmental impact and permit the power source 42 to be included within the moisture proof handle 14. Non-limiting examples of acceptable battery types include lead-acid, nickel cadmium (NiCd), nickel metal hydride (NTMI-I), lithium ion (Li-ion), and lithium ion polymer (Li-ion polymer) batteries. The long operating life of currently produced batteries assure their successful operation for the duration of even the longest of surgeries; however, as a precaution, if necessary during the course of a surgical procedure, replaceable multiple batteries can be available to be switched out when the initial battery expends its charge. In the event that a single charge for the operating power source, i.e., the battery, is insufficient for the duration of a surgical procedure, it is preferred as more expeditious and reliable to begin the surgical procedure with multiple fully charged scalpels, some of which may be positioned on a battery recharging device and available to be substituted for instruments 10 that have expended their available power prior to the conclusion of the surgical procedure. The foregoing contingencies for prolonged surgeries are only precautionary and not considered necessary for normal operation of the instrument 10.
As mentioned previously, the selected probe may include other sensing and/or identifying functions. As a non-limiting example, the probe type can be an infrared emitter of the type taught in U.S. Pat. No. 6,285,902, issued to Kienzle III et al., which is hereby incorporated in its entirety. Such a probe can be used to image and thereby map the target anatomical area. Another example of a probe type that can be used in the instrument 10 to facilitate the identification of tissue types is a laser probe as taught in U.S. Patent Publication No. 2005/0099824, published May 12, 2005, which is hereby incorporated in its entirety. This type of probe can also be used to illuminate as well as map the tissue of interest. Other types of tissue probes can also be easily adapted for use in the instrument 10. As shown in
As shown in
An alternative embodiment of a scalpel, generally shown at 200 in
As mentioned above, the tissue-identifying surgical instrument 10 can have multiple embodiments in the form of a variety of surgical instruments, which are used for performing dissections during surgery. Some of the commonly used dissector instruments include forceps 66 and hemostats 96, which are described with reference to
The forceps 66 is very similar to the conventional forceps as known in the art except for the configuration of the forceps first handle 72 and the forceps probe 92 extending from the forceps first jaw 74. The forceps first handle 72 houses the components for the control assembly 44. For that reason, as shown in
As shown in
The hemostat 96 is very similar to the conventional hemostat as known in the art except for the configuration of the hemostat first handle 102 and the hemostat probe 118, which extends from the hemostat first jaw 104. The hemostat first handle 102 houses the components of the control assembly 44. As shown in
Thus, it can be seen that the tissue-identifying instrument 10 provides substantial timesaving and safety features. The integrated probe or multiple probes in the surgical instruments provide significant efficiencies and reduce the time and effort required the conventional practice of using a surgical instrument and handling a separate probe. The wireless transmission of the sensed data frees the surgeon from extraneous and potentially hazardous concerns such as the physical interference caused by the location of probe power and data transfer wires. Moreover, the surgeon's concentration on the tissue under examination would be fully engaged with minimal to no potential interruption from operating a separate probe device. The instrument located LED operating lights 64 and the provision of a HUD 60 further enhances the benefits and efficiencies provided by the instrument 10 because the surgeon is able to operate the probe 12 and determine the tissue type without being distracted from the surgical site.
It is to be understood that the tissue-identifying surgical instrument 10 encompasses a variety of surgical instrument embodiments. For example, the tissue identification probe and wireless features are not limited to dissection instruments. These features may be integrated in other surgical instruments such as endoscopes, clamps, scissors, etc. The handle, probe, and the control assembly 44 may be constructed in modular form such that various components may be interchangeable or replaceable with other components depending on the specific sensing function required by the user. Furthermore, the instrument 10 can easily be constructed in modular form to allow the surgical working section of the instrument, e.g., blade or jaws, to be easily changed with different working sections, which would also have the additional tissue-identifying capability.
It is to be understood that the present invention is not limited to the embodiments described above, but encompasses any and all embodiments within the scope of the following claims.
This application claims the benefit of U.S. Provisional Patent Application Ser. No. 61/510,408, filed Jul. 21, 2011.
Number | Date | Country | |
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61510408 | Jul 2011 | US |