System and method for guided port insertion to minimize trauma
10307181 ยท 2019-06-04
Inventors
- Cameron Anthony Piron (Toronto, CA)
- Michael Frank Gunter Wood (Toronto, CA)
- Murugathas Yuwaraj (Toronto, CA)
- Joshua Lee RICHMOND (Toronto, CA)
Cpc classification
A61B2090/3784
HUMAN NECESSITIES
A61B90/11
HUMAN NECESSITIES
A61B17/3476
HUMAN NECESSITIES
A61M25/0113
HUMAN NECESSITIES
A61B2034/301
HUMAN NECESSITIES
International classification
A61M25/01
HUMAN NECESSITIES
Abstract
The present invention provides a system and method for inserting a surgical port to minimize trauma. The system includes an access port and a guiding mechanism on the distal end of the access port, wherein the guiding mechanism has an adaptive atraumatic tip. The system also includes an introducer probe with a handle on the proximal end of the introducer probe, an atraumatic tip on the distal end of the introducer probe and a flexible body for insertion through the access port, the flexible body comprising one or more bendable elbows along the length of the introducer probe, wherein the introducer slidably engages the interior of the surgical access port to define an access path. The method includes inserting an access port down a sulcal path, inserting an introducer probe through the access port, and navigating the sulcal path with the introducer to the target.
Claims
1. A surgical access port for navigating down a sulcal path of a neurosurgical procedure comprising: a. a cylindrical body having a proximal end and a distal end; and b. a guiding mechanism with an adaptive atraumatic tip for navigating down the sulcal path on a distal end of the access port; wherein the adaptive atraumatic tip comprises a plurality of collapsible rigid concentric rings, each concentric ring having a proximal edge closest to the access port and a distal edge furthest from the access port and wherein a distal ring has a smaller outer diameter than a proximal ring such that the plurality of concentric rings provides a conical shape in an extended configuration; wherein one or more of the plurality of concentric rings has a sharp distal edge to penetrate tissue.
2. The surgical access port as in claim 1, wherein the access port is attached to a high frequency vibration source.
3. The surgical access port as in claim 2, wherein the high frequency vibration source is a collar located around the body of the access port.
4. The surgical access port as in claim 2, wherein the vibration source comprises a driver, circuit, amplifier, oscillator and power supply.
5. The surgical access port as in claim 2, wherein a frequency and amplitude of the vibration source are activatable by a user.
6. The surgical access port as in claim 1, wherein the access port outer surface is coated with a low-friction coating.
7. The surgical access port as in claim 1, wherein one or more inflatable balloons are attached to the outer surface of the access port.
8. The surgical access port as in claim 1, wherein the access port has attached one or more sensors for guiding the surgical access port using a navigation system.
9. The surgical access port as in claim 8, wherein the one or more sensors are selected from a list comprising of an ultrasound, optical coherence tomography, fiber optics, light guides, Raman, PET, MRI, vibration, optical, strain or stress sensors.
10. The surgical access port as in claim 1, wherein the concentric rings are joined by a flexible membrane.
11. The surgical access port as in claim 10, wherein the flexible membrane includes a living hinge.
12. The surgical access port as in claim 10, wherein the flexible membrane is constructed of medical grade silicone.
13. The surgical access port as in claim 1, wherein the atraumatic tip has attached strain gauges to measure shear strength.
14. The surgical access port as in claim 1, wherein the atraumatic tip has attached strain and stress sensors.
15. The surgical access port as in claim 14, wherein the strain and stress sensors are used to guide the atraumatic tip using a navigation system.
16. A surgical access port for navigating down a sulcal path of a neurosurgical procedure comprising: a cylindrical body; and a guiding mechanism with an adaptive atraumatic tip for navigating down the sulcal path attached to the cylindrical body; wherein the adaptive atraumatic tip comprises a plurality of collapsible rigid concentric rings and a distal ring has a smaller outer diameter than a proximal ring such that the plurality of concentric rings provides a conical shape in an extended configuration; wherein one or more of the plurality of concentric rings has a sharp distal edge to penetrate tissue.
17. The surgical access port as in claim 16, wherein the access port has attached one or more sensors for guiding the surgical access port using a navigation system.
18. The surgical access port as in claim 17, wherein the one or more sensors are selected from a list comprising of an ultrasound, optical coherence tomography, fiber optics, light guides, Raman, PET, MRI, vibration, optical, strain or stress sensors.
19. The surgical access port as in claim 16, wherein the concentric rings are joined by a flexible membrane.
20. The surgical access port as in claim 16, wherein the atraumatic tip has attached strain gauges to measure shear strength.
21. The surgical access port as in claim 16, wherein the atraumatic tip has attached strain and stress sensors.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
(1) Embodiments will now be described, by way of example only, with reference to the drawings, in which:
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DETAILED DESCRIPTION
(16) Various embodiments and aspects of the disclosure will be described with reference to details discussed below. The following description and drawings are illustrative of the disclosure and are not to be construed as limiting the disclosure. Numerous specific details are described to provide a thorough understanding of various embodiments of the present disclosure. However, in certain instances, well-known or conventional details are not described in order to provide a concise discussion of embodiments of the present disclosure.
(17) As used herein, the terms, comprises and comprising are to be construed as being inclusive and open ended, and not exclusive. Specifically, when used in the specification and claims, the terms, comprises and comprising and variations thereof mean the specified features, steps or components are included. These terms are not to be interpreted to exclude the presence of other features, steps or components.
(18) As used herein, the term exemplary means serving as an example, instance, or illustration, and should not be construed as preferred or advantageous over other configurations disclosed herein.
(19) As used herein, the terms about and approximately are meant to cover variations that may exist in the upper and lower limits of the ranges of values, such as variations in properties, parameters, and dimensions. In one non-limiting example, the terms about and approximately mean plus or minus 10 percent or less.
(20) Unless defined otherwise, all technical and scientific terms used herein are intended to have the same meaning as commonly understood to one of ordinary skill in the art. Unless otherwise indicated, such as through context, as used herein, the following terms are intended to have the following meanings:
(21) As used herein, the phrase access port refers to a cannula, conduit, sheath, port, tube, or other structure that is insertable into a subject, in order to provide access to internal tissue, organs, or other biological substances. The access port can include a sheath (the port that is left behind to access surgical area) and an obturator (introducer). In some embodiments, an access port may directly expose internal tissue, for example, via an opening or aperture at a distal end thereof, and/or via an opening or aperture at an intermediate location along a length thereof. In other embodiments, an access port may provide indirect access, via one or more surfaces that are transparent, or partially transparent, to one or more forms of energy or radiation, such as, but not limited to, electromagnetic waves and acoustic waves.
(22) As used herein the phrase intraoperative refers to an action, process, method, event or step that occurs or is carried out during at least a portion of a medical procedure. Intraoperative, as defined herein, is not limited to surgical procedures, and may refer to other types of medical procedures, such as diagnostic and therapeutic procedures.
(23) Embodiments of the present disclosure provide imaging devices that are insertable into a subject or patient for imaging internal tissues, and methods of use thereof. Some embodiments of the present disclosure relate to minimally invasive medical procedures that are performed via an access port, whereby surgery, diagnostic imaging, therapy, or other medical procedures (e.g. minimally invasive medical procedures) are performed based on access to internal tissue through the access port.
(24) An example of an access port is an intracranial access port which may be employed in neurological procedures in order to provide access to internal tissue pathologies, such as tumors. One example of an intracranial access port is the BrainPath surgical access port provided by NICO, which may be inserted into the brain via an obturator with an atraumatic tip in the brain. Such an access port may be employed during a surgical procedure, by inserting the access port, via the obturator that is received within the access port, through the white matter fibers of the brain to access a surgical site.
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(26) The opening through which surgeon 102 inserts and manipulates instruments is provided by an access port 106. Access port 106 typically includes a hollow cylindrical device with open ends. During insertion of access port 106 into the brain (after a suitable opening has been drilled in the skull), an introducer, also referred to as an obturator (not shown) is generally inserted into access port 106. The introducer is typically a cylindrical device that slidably engages the internal surface of access port 106 and bears a conical atraumatic tip to allow for insertion of access port 106 into the brain. Following insertion of access port 106, the introducer may be removed, and access port 106 may then enable insertion and bimanual manipulation of surgical tools into the brain. Examples of such tools include suctioning devices, scissors, scalpels, cutting devices, imaging devices (e.g. ultrasound sensors) and the like.
(27) Also shown in
(28) Equipment tower 108 also supports a tracking system 112. Tracking system 112 is generally configured to track the positions of one or more reflective markers (not shown) mounted on access port 106, any of the above-mentioned surgical tools, or any combination thereof. Such markers, also referred to as fiducial markers, may also be mounted on patient 104, for example at various points on the head of patient 104. Tracking system 112 may therefore include a camera (e.g. a stereo camera) and a computing device (either the same device as mentioned above or a separate device) configured to locate the fiducial markers in the images captured by the camera, and determine the spatial positions of those markers within the operating theatre. The spatial positions may be provided by tracking system 112 to the computing device in equipment tower 108 for subsequent use.
(29) The nature of the markers and the camera are not particularly limited. For example, the camera may be sensitive to infrared (IR) light, and tracking system 112 may include one or more IR emitters (e.g. IR light emitting diodes (LEDs)) to shine IR light on the markers. In other examples, marker recognition in tracking system 112 may be based on radio frequency (RF) radiation, visible light emitted from devices such as pulsed or un-pulsed LEDs, electromagnetic radiation other than IR or visible light, and the like. For RF and EM-based tracking, each object can be fitted with markers having signatures unique to that object, and tracking system 112 can include antennae rather than the above-mentioned camera. Combinations of the above may also be employed.
(30) Each tracked object generally includes three or more markers fixed at predefined locations on the object. The predefined locations, as well as the geometry of each tracked object, are configured within tracking system 112, and thus tracking system 112 is configured to image the operating theatre, compare the positions of any visible markers to the pre-configured geometry and marker locations, and based on the comparison, determine which tracked objects are present in the field of view of the camera, as well as what positions those objects are currently in. An example of tracking system 112 is the Polaris system available from Northern Digital Inc.
(31) Also shown in
(32) Before a procedure such as that shown in
(33) Preoperative images may be used for planning purposes. Examples of planning activities include marking, in the preoperative images, the location of a target portion of patient tissue. Such a target portion may include a tumor to be resected, for example. During the procedure, additional images (referred to as intraoperative images) may be collected of the brain of patient 104 using any suitable one of the above-mentioned modalities (it will be apparent to those skilled in the art that some imaging modalities are less suitable or unsuitable for preoperative use, while other imaging modalities are less suitable or unsuitable for intraoperative use). In addition, as will be discussed below in greater detail, further images may be acquired during the procedure (or after the procedure has concluded) of tissue samples resected from patient 104.
(34) As will be described in further detail below, the computing device housed in equipment tower 108 can perform various actions to employ the above-mentioned preoperative images and intraoperative images to automatically evaluate the accuracy of a resection procedure, in comparison with the planned resection.
(35) Before a discussion of the functionality of the computing device, a brief description of the components of the computing device will be provided. Referring to
(36) Processor 202 and memory 204 are generally comprised of one or more integrated circuits (ICs), and can have a variety of structures, as will now occur to those skilled in the art (for example, more than one CPU can be provided). Memory 204 can be any suitable combination of volatile (e.g. Random Access Memory (RAM)) and non-volatile (e.g. read only memory (ROM), Electrically Erasable Programmable Read Only Memory (EEPROM), flash memory, magnetic computer storage device, or optical disc) memory. In the present example, memory 204 includes both a volatile memory and a non-volatile memory. Other types of non-transitory computer readable storage medium are also contemplated, such as compact discs (CD-ROM, CD-RW) and digital video discs (DVD).
(37) Computing device 200 also includes a network interface 206 interconnected with processor 202. Network interface 206 allows computing device 200 to communicate with other computing devices via a network (e.g. a local area network (LAN), a wide area network (WAN) or any suitable combination thereof). Network interface 206 thus includes any necessary hardware for communicating over such networks, such as radios, network interface controllers (NICs) and the like.
(38) Computing device 200 also includes an input/output interface 208, including the necessary hardware for interconnecting processor 202 with various input and output devices. Interface 208 can include, among other components, a Universal Serial Bus (USB) port, an audio port for sending and receiving audio data, a Video Graphics Array (VGA), Digital Visual Interface (DVI) or other port for sending and receiving display data, and any other suitable components.
(39) Via interface 208, computing device 200 is connected to input devices including a keyboard and mouse 210, a microphone 212, as well as scope 116 and tracking system 112, mentioned above. Also via interface 208, computing device 200 is connected to output devices including illumination or projection components 214 (e.g. lights, projectors and the like), as well as display 110 and robotic arm 114 mentioned above. Other input (e.g. touch screens) and output devices (e.g. speakers) will also occur to those skilled in the art.
(40) It is contemplated that I/O interface 208 may be omitted entirely in some embodiments, or may be used to connect to only a subset of the devices mentioned above. The remaining devices may be connected to computing device 200 via network interface 206.
(41) Computing device 200 stores, in memory 204, a resection evaluation application 216 (also referred to herein as application 216) comprising a plurality of computer readable instructions executable by processor 202. When processor 202 executes the instructions of application 216 (or, indeed, any other application stored in memory 204), processor 202 performs various functions implemented by those instructions, as will be discussed below. Processor 202, or computing device 200 more generally, is therefore said to be configured or operating to perform those functions via the execution of application 216.
(42) Also stored in memory 204 are various data repositories, including a patient data repository 218. Patient data repository can contain surgical planning data, preoperative and intraoperative images, and the like, as will be seen below. As mentioned above, computing device 200 is configured, via the execution of application 216 by processor 202, to perform various functions to evaluate the accuracy of a resection procedure in order to confirm whether the planned target portion of the brain of patient 104 (or other tissue volume) was actually resected during the procedure. Those functions will be described in further detail below.
(43) Further contents of this disclosure will be provided in two sections: Mechanisms to Define a Port Path and Mechanisms to Drive a Port Down a Path.
(44) 1. Mechanisms to Define a Port Path
(45) Steerable Probe
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(47) During port-based or corridor based surgery, a straight (linear) access port 310 is typically guided down a sulci path of the brain. However, sulci paths of the brain are typically non-linear and may deviate/curve in multiple directions which makes it challenging to navigate to the target internal brain tissue.
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(49) Probe 420 enters the brain 300 at sulci entry opening 440 to navigate to targeted internal tissue 450. Ideally, probe 420 should follow sulci path 410, however, due to the linear and rigid nature of probe 420, a linear path 430 to targeted internal tissue 450 is mapped out. The linear and rigid nature of the probe may result in trauma to the brain matter due to stress or shear of the tissue.
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(51) Flexible probe 510 enters the brain 300 at sulci entry opening 440 and would like to navigate to targeted internal tissue 450. Because of bendable elbows 540, flexible probe 510 may twist/turn into multiple directions to create an optimal path 520 to reach targeted internal tissue 450.
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(53) In the preferred embodiment shown in
(54) As seen in
(55) In addition to supporting imaging sensors 620, the distal end 610 of flexible probe 510 may also be equipped with alternate tools. In
(56) In an alternate embodiment as seen in
(57) 2. Mechanisms for Driving Port Down to Target
(58) Once an access port path has been defined, the next step is to insert the access port down the desired path to the target tissue (i.e., cancerous tissue to be resected). Insertion of the access port can be obstructed by the brain structures and forceful insertion may result in trauma, thus it is desirable to pursue various port insertion mechanisms that may minimize trauma.
(59) Inflatable Balloon
(60) One port insertion mechanism is an inflatable balloon probe.
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(62) In an alternate embodiment, inflatable balloons may be placed on the outer walls of the access port where the balloons can be inflated. This enables a small port to be inserted whose diameter can be increased once inserted to allow for a larger operating channel.
(63) High Frequency Vibration
(64) A second mechanism to assist in access port insertion is to use high frequency vibration to reduce friction as an access port is inserted down a path.
(65) Vibration source 880 uses high frequency vibrations, typically working in the ultrasonic range of 20 KHz-1 MHz, to reduce the friction caused by the insertion of the access port 800. In a further embodiment, vibrating obturator 880 may vibrate in resonance to increase efficiency and power transfer. Vibration source 880 may be enabled by a surgeon or robotic surgical system and may be adjustable in frequency and amplitude. An example of an ultrasonic vibration mechanism may be a piezo-electric transducer that is actuated by electrical pulses. Vibration source 880 may comprise a driver circuit, amplifier, oscillator and a power supply.
(66) The access port 800 and vibration source 880 may be made of biocompatible material such as inert polymers (Kevlar, liquid crystal polymer). Alternatively, the mechanism may be made of sterilizable material such as stainless steel. The cylindrical barrel 820 may further be coated with a low-friction coating.
(67) Adaptive Tip
(68) A further mechanism to ease port insertion is provided by an access port with an introducer (also referred to as an obturator) that bears an adaptive atraumatic tip, wherein the tip configuration may be changed depending on the context or stage of surgery. The introducer is typically a cylindrical device that slidably engages the internal surface of a port and bears an atraumatic tip.
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(70) The atraumatic tip 920 may be considered as a collapsible salad bowl concept wherein the atraumatic tip can be collapsed and expanded based on use. The atraumatic tip 920 may have either a mechanical or electrical drive that can be controlled by a linear drive motor to pull up (collapse) or push down (extend) the atraumatic tip.
(71) In a preferred embodiment, the atraumatic tip 920 includes a series of rigid concentric rings with successively smaller diameters, thus providing a conical shape. In a further preferred embodiment, the concentric rings are shaped as truncated cones with decreasing base diameter. Each concentric ring may be connected to the adjacent concentric ring with a flexible membrane, such as surgical-grade silicone. The flexible membrane may include living hinges in the membrane perimeter abutting the concentric rings, which are more likely than the rest of the membrane to fold under force and cause the membrane to fold inward when the atraumatic tip is in the collapsed position. The flexible membrane further helps maintain a waterproof barrier between the tissue that is being penetrated and the introducer or obturator.
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(73) The atraumatic tip 920 of access port 900, or more generally the introducer or obturator, is able to adapt in its properties as it is inserted into the body.
(74) The adaptive tip mechanism shown as atraumatic tip 920 may be further adapted from a blunt to a sharp configuration. A blunt configuration is suitable for penetrating softer tissue while a sharp configuration may be used to penetrate stiffer portions of the tissue. As illustrated in
(75) In a preferred embodiment, the atraumatic tip may use strain gauges to provide feedback in order to measure shear strength. In other embodiments, strain and stress sensors may be placed on the outside of the cylindrical barrel 820 of the access port 800, so measurements can be taken as the access port is inserted into the brain 300. This information provides feedback as the access port is inserted, which can be used to minimize stress/strain on critical structures. Sensors can also provide functional information (i.e., electrical pulses from the nerve fibres, or blood flow from vessels) from the tissues adjacent to the access port or adaptive tip. Furthermore, an access port and/or adaptive tip provided with sensors can utilize the measurements taken by the sensors to direct the access port along the least invasive pathway into the brain toward the target tissue, In instances where an adaptive tip is extended into tissue, the adaptive tip can use the sensor or imaging information to direct its pathway.
(76) The adaptive tip mechanism may be expanded in further embodiments to address multiple stages of insertion to traverse to a tumor location. These stages include:
(77) 1) Sulcus engagementDuring sulcus engagement, the distal end of the adaptive tip is similar to the tip of the port, that is, not too sharp to cut through grey matter, but sharp enough to separate the gyri. Imaging can be used to view the overall sulci structure or, when the sulcus is engorged, where the entrance to the sulcus is.
(78) 2) Sulci insertionOnce in the sulci, the tip can be more blunt. The blunt tip reduces the chance of puncturing through the adjacent gyrus. At this stage, imaging to envision the sulci and the blood vessels at a larger scale is important.
(79) 3) Bottom of sulci engagementAfter traversing sulci, the adaptive tip needs to puncture through the base of a sulcus. Here having a very high resolution image of the anatomy is important. For instance a high resolution ultrasound, or OCT image, or polarized light OCT (to view nerves) is valuable to locate the optimal incision site while avoiding nerves or vessels. Optimally a small controlled incision point should be made, based on imaging or based on sensor information. The incision may be made manually by inserting an instrument through a small orifice in the end of the introducer or by removing one of the introduced components in the introducer (multiple lumen)to introduce a specific cutting tip.
(80) To embody this, a variable tip access portparticularly one that can have a different angle of engagement, or openings to allow for small dilation devices, or cutting tools is envisioned.
(81) 4) Traversing the white matterIn order to traverse the white matter,a particular cutting tip can be used, depending on tissue stiffness or where the adaptive tip is situated relative to major nerve bundles. A sharp tip can be used to make incisions through tissue, or a blunt tip can be used to separate natural separation points in the tissue, such as nerve fibers.
(82) 5) Puncture of the tumorDepending on how well defined the edge of the tumor is, an appropriate tip can be selected to cut through the surface of the surrounding tissue, a suction device can be used to immobilize the tissue, or a blunt tip can be used to immobilize the tumor by encircling it. When the probe is close to the tumor, the appropriate device can be selected and used.
(83) The specific embodiments described above have been shown by way of example, and it should be understood that these embodiments may be susceptible to various modifications and alternative forms. It should be further understood that the claims are not intended to be limited to the particular forms disclosed, but rather to cover all modifications, equivalents, and alternatives falling within the spirit and scope of this disclosure.