The present disclosure relates generally to orthopedic surgery and, more particularly, to a system and method for laser-assisted placement of orthopedic implants.
Many orthopedic surgeries, such as those involving the spine, are complex procedures that require a high degree of precision. For example, the spine is in close proximity to delicate anatomical structures such as the spinal cord and nerve roots. Pedicle screw placement is among the most effective schemes for stabilizing the spine. With pedicle diameters ranging from 4 to 20 mm, screw fixation into the pedicle requires great precision to avoid skiving, cortex violation and damage to surrounding nerves and/or spinal cord. Compounding the problem is limited surgical exposure and visibility, particularly in the case of minimally invasive procedures. Consequently, the risk of misplaced implants or other complications is high.
Current means of implant placement relies on preparation (cannulation) of the implant site using rudimentary mechanical instrumentation such as needles, drills, and/or burrs and is highly dependent on the skill/experience level of the surgeon. The reaction forces such mechanical instrumentation encounter when in contact with bony surfaces can cause skiving and deviations from the desired trajectory. Rotary drills and burrs can tend to wander off trajectory and require anti-skiving and soft-tissue protection strategies such as use of drill guides and/or sleeves. For the above reasons current methods of implant placement lack consistency and precision and/or require time consuming preparatory steps. Such uncertainty in implant placement has a negative impact on long term clinical outcomes, patient quality of life, and the ability to predict and control costs associated with surgery, recovery, and rehabilitation.
To overcome the above issues associated with mechanical methods for placing implants, use of alternate high precision technologies such as lasers that improve placement accuracy and are compatible with existing standard procedures would be advantageous. The presently disclosed systems and associated methods for laser-assisted placement of orthopedic implants are directed at overcoming one or more of the problems set forth above and/or other problems in the art.
According to one aspect, the present disclosure is directed to a method for laser-assisted placement of implants. The method includes delivering laser radiation via an optical cable or fiber passed through a cannulated instrument and/or screw to a region of the bone that is targeted for removal and/or is being prepared for implant placement. In an alternate embodiment the laser radiation is delivered through air without an optical cable or fiber by aligning the laser to the cannula of the instrument. The instrument can either be aligned in the direction of the target region on the bone and/or be in close proximity or in contact with it. The method further includes selection of an appropriate laser wavelength and controlling the laser power, pulse duration, pulse frequency, and/or beam diameter such that removal rate and area of bone removed is tailored to the specific goals of the procedure. The method further includes switching between or combining mechanical and laser modes of bone removal so as to achieve optimal placement of the implant.
In accordance with another aspect, the present disclosure is directed to an instrument for laser-assisted placement of an implant. In one embodiment, the instrument includes a cannula through which an optical cable or fiber capable of transmitting laser radiation is passed. The optical cable is used to deliver laser radiation to the bone. In another embodiment the laser radiation is delivered through air through the cannula without an optical cable. In some embodiments the tool is a cannulated cylindrical tube. In other embodiments the instrument is one of standard cannulated surgical instruments such as a Jamshidi needle, awl, probe or tap. This allows the user to use the mechanical abilities of the tool along with laser radiation to accomplish the surgical goals. In yet another embodiment the tool is a cannulated screw driver configured to couple to a cannulated screw. The laser radiation is passed through both the screw driver and screw in this case. This also allows for laser radiation to be utilized along with the normal functionality of a traditional surgical screw driver.
In accordance with another aspect, the present disclosure is directed to a system for laser assisted placement of an orthopedic implant. The system includes a cannulated instrument and a laser sub-system including laser source, electronics, mechanical components, cooling sub-systems for both the laser source and irradiated bone, optics, and in certain embodiments articulating arms. The cannulated surgical instrument through which the laser radiation is passed and allows utilization of laser radiation in conjunction with mechanical means to place the implant into the bony anatomy. The laser sub-system generates, transmits, and focuses laser radiation of a selected wavelength in the desired direction and/or location after passage through the cannula of the instrument. The passage of laser radiation through the cannula can be through air or via optical cable or fiber that is coupled to the laser sub-system and passed through the cannula. The laser sub-system is equipped with a means to control the laser power, beam diameter, duration, pulse rate, and/or duty cycle. The laser sub-system further has means for a user to interact with it for the purpose on controlling the laser such as buttons, foot pedals, input/output (I/O) devices, and/or a user interface on a computer monitor. The system can also include tubular retractors or tissue protectors for minimally invasive procedures. The system can also include a navigation system and/or robotically controlled arm and/or guide for guidance and/or precise positioning of the instrument.
An example tool for laser-assisted placement of an orthopedic implant is described herein. The tool includes a cannulated body having a proximal end and a distal end, where the cannulated body has an inner channel extending between the proximal and distal ends. The tool also includes an optical cable arranged within the inner channel of the cannulated body, and a tip arranged at the distal end of the cannulated body, where the tip is configured to allow passage of laser radiation through the distal end of the cannulated body.
An example system for laser-assisted placement of an orthopedic implant is also described herein. The system includes a laser sub-system comprising a laser source, and a cannulated tool having a proximal end and a distal end. The cannulated tool has an inner channel extending between the proximal and distal ends. The laser source is configured to deliver laser radiation through the inner channel of the cannulated tool. In some implementations, the system optionally further includes an optical cable arranged within the inner channel of the cannulated body, where the optical cable is coupled to the laser source and configured to deliver the laser radiation through the inner channel of the cannulated tool.
In some implementations, the system optionally further includes a surgical robot including a robotic arm, where the cannulated tool is attached to the robotic arm. Optionally, the system further includes a guide attached to the robotic arm, where the cannulated tool is configured to slide in the guide.
In some implementations, the system optionally further includes a navigation system configured to guide the cannulated tool during a surgical procedure.
An example method for laser-assisted placement of an orthopedic implant is also described herein. The method includes providing a cannulated tool, aligning the cannulated tool with a target location on a bone, and delivering laser radiation through the cannulated tool to the target location on the bone, where the laser radiation is configured to cause removal of the bone in proximity to the target location.
Other systems, methods, features and/or advantages will be or may become apparent to one with skill in the art upon examination of the following drawings and detailed description. It is intended that all such additional systems, methods, features and/or advantages be included within this description and be protected by the accompanying claims.
The components in the drawings are not necessarily to scale relative to each other. Like reference numerals designate corresponding parts throughout the several views.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. Methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present disclosure. As used in the specification, and in the appended claims, the singular forms “a,” “an,” “the” include plural referents unless the context clearly dictates otherwise. The term “comprising” and variations thereof as used herein is used synonymously with the term “including” and variations thereof and are open, non-limiting terms. The terms “optional” or “optionally” used herein mean that the subsequently described feature, event or circumstance may or may not occur, and that the description includes instances where said feature, event or circumstance occurs and instances where it does not. Ranges may be expressed herein as from “about” one particular value, and/or to “about” another particular value. When such a range is expressed, an aspect includes from the one particular value and/or to the other particular value. Similarly, when values are expressed as approximations, by use of the antecedent “about,” it will be understood that the particular value forms another aspect. It will be further understood that the endpoints of each of the ranges are significant both in relation to the other endpoint, and independently of the other endpoint. Throughout the present disclosure, the terms “bone” and “vertebrae” may be used interchangeably. The bone depicted in
Different configurations of tool are contemplated. In some implementations, the tool is a surgical implement. A surgical screwdriver is a non-limiting example of a surgical implement. According to some implementations, the tool can be a surgical screwdriver that is configured to couple to a cannulated screw. Other tools and surgical instruments are contemplated, including Jamshidi needles, awls, probes and taps.
Optionally, a reflective material can be arranged on a portion of the inner channel 130c of the cannulated tool 130 in some implementations. For example, the reflective material can be provided on the surface (or portions thereof) of the inner channel 130c. This disclosure contemplates that the reflective material can be any material capable of reflecting the laser radiation. In an exemplary embodiment the optical cable 120 is a hollow glass tube whose internal surfaces are coated with a reflective material. For example, in the case where the laser is CO2 laser a coating of silver (Ag) may be utilized. It should be understood that Ag is only provided as an example reflective material. This disclosure contemplates using other reflective materials with the systems and methods described herein, for example, a reflective material capable of the laser radiation produced by the laser source. In another embodiment the optical cable 120 is a fiber optic cable made of a material such as sapphire or silica. Non-limiting examples of optical cable 120 diameters include the range from about 0.2 to 5 mm.
The laser sub-system 110 can include any laser source suitable for ablation of bone. Different wavelengths of laser are contemplated by the present disclosure, including ultra-violet laser sources and infra-red laser sources. Example wavelengths suitable for bone ablation are infra-red wavelengths such as those produced by excitation of CO2, Er:YAG, Ho:YAG, and Nd:YAG. In some cases ultra-violets wavelengths such as those produced by excitation of XeCl can be utilized. The laser sub-system 110 can include appropriate solid-state or gas-based laser sources with associated control circuitry. It should be understood that materials excited to produce the infra-red and ultra-violet wavelengths above are only provided as non-limiting examples. Some embodiments described herein include a user interface 145 configured to receive commands from the users. The user interface 145 can be coupled to the laser sub-system 110. The laser sub-system 110 and user interface 145 discussed above can be coupled through one or more communication links. This disclosure contemplates the communication links are any suitable communication link. For example, a communication link can be implemented by any medium that facilitates data exchange between the laser sub-system 110 and user interface 145 including, but not limited to, wired, wireless and optical links. Additionally, the user interface 145 can include an input device such as a touch screen and/or foot pedal.
This disclosure contemplates that the laser sub-system 110 can be further configured to control at least one of power, pulse duration, pulse frequency, or beam width of the laser radiation. This disclosure contemplates that a user can use the laser sub-system 110 and tool 130 to deliver laser radiation of sufficient power, characteristics, and duration necessary for a particular surgical procedure, for example, to remove bone in and around the location 155 of laser radiation delivery, e.g., in proximity to the pedicle 150a in
The laser sub-system 110 can optionally include a cooling system for cooling the region of laser ablation on the bone. For example, the laser sub-system 110 can be equipped with compressed air or other suitable gas that is passed through the cannula of tool 130 or through optical cable 120 or directly delivered to the ablated site.
In another embodiment sterile fluid such as saline instead of gas can be utilized. An exemplary laser sub-system 110 that can used in system 100 is the Ultra MD Series CO2 Laser by Laser Engineering, Nashville Tenn. It should be understood that other laser sub-systems can be used with the tool, systems, and methods described herein. Optical cable 120 is passed through tool 130 and delivers laser radiation to the desired target location 155 on bone 150. The laser radiation is turned on for a sufficient duration to ablate the target location 155 to a depth necessary to facilitate placement of an orthopedic implant (not shown) into pedicle 150a. Typical radiation times can range from about 3 to 30 seconds for ablations depths of about 3-30 mm. For example, the system can be used to breach or indent the cortex of vertebra 150 to open up an entry point for a pedicle screw. The tool 130 can be a generic tubular instrument of inner diameter in the range of about 0.5 to 2 mm and outer diameter in the range of about 1-5 mm. Alternatively, tool 130 can be a customized instrument with sufficient cannular diameter for passage of laser radiation. The inner surfaces of tool 130 can optionally be coated with reflective material to aid in the transmission of laser radiation.
Alternatively, sub-system 110 can include a pointing laser such as a low power HeNe for targeting and alignment. This disclosure contemplates that the laser sub-system 110 can be further configured to control at least one of power, pulse duration, pulse frequency, or beam width of the laser radiation as described herein. The tool 130 can be used to remove bone in and around the location 155 of laser radiation delivery, e.g., in proximity to the pedicle 150a in
The normal function of surgical instrument 330 can be combined with laser radiation can be utilized to remove bone at a desired location and/or depth. For example, as shown in
The robotic sub-system can include a computer-controlled robotic system and a robotic arm 170. Any surgical robotic system that is designed to position an end effector relative to the patient's anatomy can be utilized in system 600. In an exemplary embodiment the robotic arm 170 is used to position the precisely position guide 160 which then facilitates proper placement of screw driver 430 with or without screw 140. Screw driver 430 can also be directly attached to the robot end effector in which case the robot motion is controlled along the desired trajectory and/or to the desired position. A non-limiting example of an attachment technique is a quick connect mechanism. Alternatively, the screw driver 430 slides through a guide 160 as shown in
In another exemplary embodiment as shown in
With reference to
According to some implementations of the present disclosure, the laser radiation is delivered through the cannulated tool or instrument using an optical cable 120 arranged within an inner channel of the cannulated tool or instrument. Additionally, this disclosure contemplates delivering laser radiation through the cannulated tool or instrument by aligning a laser source to an inner channel of the cannulated tool or instrument (e.g., through air without use of optical cable). The laser source can be part of a laser sub-system 110. The present disclosure also contemplates controlling at least one of a wavelength, power, pulse duration, pulse frequency, or beam width of the laser radiation based on the surgical procedure. Use of different wavelengths of laser radiation are contemplated by the present disclosure, including ultraviolet laser radiation and infrared laser radiation. According to some implementations of the present disclosure, the cannulated tool is a surgical instrument. Different surgical instruments are contemplated, including Jamshidi needles, awls, probes, and taps. The surgical instrument may also include a surgical screw driver configured to couple to a cannulated screw. The use of surgical robots to perform implementations of the method is also contemplated by the present disclosure. The surgical robot may include a robotic arm 170. For example, the cannulated tool or instrument can be controlled with the surgical robot. According to some implementations of the present disclosure, the cannulated tool or instrument can be guided during the procedure using a surgical navigation system. The surgical navigation system may include a camera 185 and/or a fiducial 180 that are used to position the tool or instrument.
Although the subject matter has been described in language specific to structural features and/or methodological acts, it is to be understood that the subject matter defined in the appended claims is not necessarily limited to the specific features or acts described above. Rather, the specific features and acts described above are disclosed as example forms of implementing the claims.
This application claims the benefit of U.S. provisional patent application No. 62/791,492, filed on Jan. 11, 2019, and entitled “SYSTEMS AND METHODS FOR LASER-ASSISTED PLACEMENT OF ORTHOPEDIC IMPLANTS,” the disclosure of which is expressly incorporated herein by reference in its entirety.
Number | Date | Country | |
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62791492 | Jan 2019 | US |