Navigation trocar with internal camera

Abstract

The present invention relates to a trocar for insertion into an organ of a patient, the trocar comprising a cannula, a channel within the cannula, and a camera. The cannula has a longitudinal axis, and the channel within the cannula is arranged parallel to the longitudinal axis. The camera is disposed at a distal end of the channel and is configured to provide an image in the direction of the distal opening of the cannula.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application is related to U.S. Patent Application entitled "Trocar with Modular Trocar Obturator Head" filed on even date herewith and having Attorney Docket No. BIO6225USNP1, the disclosure of which is incorporated herein by reference. Technical Field

[0003] The present invention relates generally to invasive medical tools, and particularly to invasive medical tools incorporating cameras. Background Art

[0004] Techniques for image-guided exploration of patient organs have been previously proposed in the patent literature. For example, U.S. Patent Application Publication 2011 / 0160535 describes a disposable access port for endoscopic procedures, including laparoscopic procedures. The access port includes a cannula with an embedded external camera that communicates with an external control box. The camera can be fixedly or adjustably mounted on the port. The external camera can also be mounted on a trocar used with the access port. The trocar can include irrigation and suction channels to facilitate clear visualization of the anatomical site.

[0005] As another example, U.S. patent application publication 2013 / 0282041 describes an observation trocar assembly comprising: a tubular body having a proximal end and a distal end, and an opening disposed at the distal end; and at least one external imaging device positioned on an outer wall of the distal end of the tubular body, wherein the at least one imaging device is adjacent to the outer wall of the distal end of the tubular body when in an unactivated position, and wherein the at least one imaging device extends further away from the outer wall of the distal end of the tubular body when in an activated position than when in an unactivated position.

[0006] Various trocars have been previously proposed in the patent literature. For example, U.S. Patent No. 5,807,338 describes a modular trocar system comprising an obturator assembly and a cannula assembly defining a longitudinal passageway therethrough, the longitudinal passageway being configured and dimensioned to slidably receive the obturator assembly. An assembly method is also provided.

[0007] As another example, U.S. Patent No. 5,405,328 describes a kit assembly for constructing a desired trocar obturator for use during a surgical procedure. The kit includes a proximal portion of the obturator and a plurality of different distal end portions. The proximal portion is releasably attachable to the distal portion via a detent mechanism. Reusable proximal portions offer potential cost savings. The multiple distal end portions allow surgeons to select between different trocar tips, allowing the trocar to be customized for a specific surgical procedure. Summary of the Invention

[0008] One embodiment of the present invention provides a trocar for insertion into an organ of a patient, the trocar comprising a cannula, a channel within the cannula, and a camera. The cannula has a longitudinal axis, and the channel within the cannula is arranged parallel to the longitudinal axis. The camera is disposed at a distal end of the channel and is configured to provide an image in the direction of the distal opening of the cannula.

[0009] In some embodiments, the camera is tilted relative to the longitudinal axis to have a viewing direction that captures the distal opening of the cannula.

[0010] In some embodiments, the trocar further comprises a position sensor disposed at the distal end of the channel without obstructing the field of view of the camera and configured to generate a signal indicative of the position of the distal end in the organ.

[0011] In one embodiment, the position sensor is a magnetic position sensor.

[0012] According to another embodiment of the present invention, a system is also provided, comprising a trocar and a processor. The trocar is configured to be inserted into an organ of a patient and comprises a cannula, a channel inside the cannula, a camera, and a position sensor. The cannula has a longitudinal axis, and the channel inside the cannula is assembled parallel to the longitudinal axis. The camera is disposed at the distal end of the channel and is configured to provide an image in the direction of the distal opening of the cannula. The position sensor is disposed at the distal end of the channel without blocking the field of view of the camera, and is configured to generate a signal indicating the position of the distal end in the organ. The processor is configured to estimate the position of the distal end of the trocar in the organ using the signal generated by the position sensor.

[0013] In some embodiments, the processor is further configured to: align the image acquired by the camera with a reference medical image based on the estimated position, and present the image acquired by the camera and the reference medical image that are aligned with each other to a user.

[0014] According to another embodiment of the present invention, a method is also provided, the method comprising inserting a trocar into an organ of a patient, the trocar comprising a cannula, a channel inside the cannula, a camera, and a position sensor. The cannula has a longitudinal axis, and the channel inside the cannula is assembled parallel to the longitudinal axis. The camera is disposed at the distal end of the channel and is configured to provide an image in the direction of the distal opening of the cannula. The position sensor is disposed at the distal end of the channel without blocking the field of view of the camera and is configured to generate a signal indicating the position of the distal end in the organ. Using the generated signal, the position of the distal end of the trocar in the organ is estimated.

[0015] In some embodiments, the method further comprises registering the image acquired by the camera with a reference medical image based on the estimated position, and presenting the registered image acquired by the camera and the reference medical image to a user.

[0016] Another embodiment of the present invention provides a trocar for insertion into an organ of a patient, the trocar comprising a cannula, an obturator body, and two or more interchangeable obturator tips. The cannula has a longitudinal axis. The obturator body is configured to be inserted into the cannula. The two or more interchangeable obturator tips are each configured to be detachably mounted at a distal end of the obturator body.

[0017] In some embodiments, the obturator head has different respective geometries for penetrating different respective tissue types.

[0018] In some embodiments, the interchangeable obturator tip is configured for use in invasive brain procedures.

[0019] In one embodiment, the trocar further comprises a channel within the cannula, a camera, and a position sensor. The channel within the cannula is mounted parallel to the longitudinal axis. The camera is disposed at the distal end of the channel and is configured to provide an image in the direction of the distal opening of the cannula. The position sensor is disposed at the distal end of the channel without obstructing the field of view of the camera and is configured to generate a signal indicating the position of the distal end within the organ.

[0020] In another embodiment, the camera is tilted so that the central viewing direction of the camera is directed toward the center of the distal opening of the cannula. In yet another embodiment, the position sensor is a magnetic position sensor.

[0021] In some embodiments, the obturator body includes a recessed portion to conform to a passageway within the cannula when the obturator body is inserted into the cannula.

[0022] In some embodiments, the interchangeable obturator tips each include a recessed portion to fit within a passageway within the cannula when the obturator is inserted into the cannula.

[0023] According to another embodiment of the present invention, a method is provided, comprising selecting an obturator tip from two or more interchangeable obturator tips, removably attaching the selected obturator tip to a distal end of an obturator body to form an obturator, assembling a trocar by attaching the obturator to a cannula, and inserting the trocar into an organ of a patient to perform a medical procedure on the patient.

[0024] In some embodiments, the method further comprises acquiring an image in the direction of the distal opening of the cannula by a camera disposed at the distal end of the cannula, generating a signal indicating the position of the distal end in the organ using a position sensor disposed at the distal end of the channel so as not to obstruct the field of view of the camera, and estimating the position of the distal end of the trocar in the organ using the generated signal.

[0025] In some embodiments, the method further comprises registering the image acquired by the camera with a reference medical image based on the estimated position, and presenting the registered image acquired by the camera and the reference medical image to a user.

[0026] The present invention will be more fully understood through the following detailed description of embodiments of the present invention in conjunction with the accompanying drawings, in which: BRIEF DESCRIPTION OF THE DRAWINGS

[0027] Figure 1 is a schematic illustration of a brain procedure performed using a surgical device including a trocar that includes a camera and a position sensor, according to an embodiment of the present invention;

[0028] Figure 2 According to an embodiment of the present invention Figure 1 Schematic illustration of the trocars used in the brain protocol;

[0029] Figure 3 is a schematic diagram showing a method for converting a Figure 2A flowchart of a method and algorithm for registering a visual image of a trocar camera with a reference medical image;

[0030] Figure 4 According to another embodiment of the present invention Figure 1 Schematic illustration of a trocar used in a brain protocol; and

[0031] Figure 5 is a schematic diagram illustrating the use of a device with interchangeable obturator heads according to an embodiment of the present invention. Figure 4 Flowchart of the trocar method. DETAILED DESCRIPTION

[0032] Overview

[0033] In some invasive procedures, a trocar, which serves as a portal of entry, is first placed in an access position to insert a medical probe or other instrument into the patient's body. In addition to serving as an access point for the probe, the trocar, including the cannula, is also used to flush and drain bodily fluids and other fluids. Typically, an obturator is first inserted through the cannula, allowing it to penetrate the body and establish a path for the probe.

[0034] Such invasive medical procedures often require the use of specialized imaging to guide a medical probe to and / or into an organ such as the brain; for example, using an X-ray system and / or a camera mounted to the probe. In some cases, for example, brain procedures may require navigating the distal end of a probe inserted into the brain through a hole formed in the skull. The therapeutic probe must be advanced through a trocar and guided to treat target brain tissue, such as infected or bleeding brain tissue.

[0035] However, treatment probes are spatially constrained and, regardless of any other probe navigation techniques, typically require visual guidance of the probe. Furthermore, the trocar itself is typically inserted "blind," so the physician performing the insertion does not know exactly where the distal tip of the trocar is located. The physician also cannot see the tissue that the trocar contacts.

[0036] Embodiments of the present invention described below provide a trocar having a camera for viewing target tissue and / or a therapeutic probe mounted within the cannula wall. In some embodiments, a position sensor is also mounted within the cannula wall. Sensor wiring that provides position data from the sensor is transferred from the sensor to a processor using camera wiring, which provides the position data of the distal end of the trocar to a physician, for example, to register an image captured from the camera with a reference medical image (e.g., an MRI image).

[0037] Thus, an internal camera and position sensor (e.g., a magnetic position sensor operating in conjunction with a position tracking system) within the disclosed cannula enables the physician to visualize the tissue penetrated by the trocar, and the sensor allows the distal end of the trocar to be tracked. The camera can then be used for visual guidance of the treatment probe.

[0038] The disclosed technology can improve the quality of minimally invasive medical procedures by optimizing visual image acquisition using a trocar's internal camera.

[0039] Trocars are generally relatively expensive because they are also typically delicate instruments and must be sterilizable (by autoclaving or other methods). There are many different types of trocars, depending on the task they are designed to perform. For example, a trocar with an obturator for penetrating muscle or bone may have a very sharp obturator tip, while a trocar for penetrating brain tissue will have a smooth obturator tip so as to open access to the brain as "gently" as possible. As mentioned above, there would be considerable expense involved in producing each of these different trocars with cameras and position sensors.

[0040] In some embodiments of the present invention, a modular trocar is provided wherein the obturator tip of the trocar can be selected by the physician based on the desired obturator task. The obturator tip is sterilizable and reusable. The proximal tip, which includes a camera and position sensor, is a low-cost, disposable item but can be used multiple times in the same procedure by replacing the obturator tip, as described below.

[0041] System Description

[0042] Figure 1 is a schematic illustration of a brain procedure performed using a surgical device 28 including a trocar 38 that includes a camera 50 and a position sensor 48, in accordance with an embodiment of the present invention. In some embodiments, the brain diagnostic and therapeutic system 20 including the surgical device 28 is configured to perform a brain procedure, such as treating an infection in the brain tissue of a patient 22. In the illustrated embodiment, the trocar 38 is used to penetrate the skull so that the physician 24 can insert a probe 39 into the head 41 of the patient 22 (insertion not shown) to access the brain tissue. The probe 39 can then be operated using the camera 50 to which the trocar is attached. Typically, the therapeutic probe 39 can be further operated by a second physician (not shown).

[0043] In the illustrated embodiment, the cable 32 enters the proximal end of the trocar 38 and is electrically coupled to the camera 50 and the position sensor 48 at its distal end.

[0044] The system 20 includes a magnetic position tracking system configured to track the position of a sensor 48 in the brain. The magnetic position tracking system includes a positioning board 40 including a field generator 44 fixed to a frame 46. Figure 1 In the exemplary configuration shown, the pad 40 includes five field generators 44, but may alternatively include any other suitable number of generators 44. The pad 40 also includes a pillow (not shown) that is placed under the head 41 of the patient 22 so that the generators 44 are positioned at known locations external to the head 41. The position sensor generates a position signal in response to sensing the external magnetic field generated by the field generators 44, thereby enabling the processor 34 to estimate the position of the sensor 50, and therefore the position of the distal edge of the trocar 38, within the head of the patient 22.

[0045] This position sensing technology is implemented in various medical applications, such as in the CARTO ® manufactured by Biosense Webster Inc. (Irvine, CA). TM The present invention is implemented in a system and is described in detail in U.S. Patents 5,391,199, 6,690,963, 6,484,118, 6,239,724, 6,618,612 and 6,332,089, PCT Patent Publication WO 96 / 05768, and U.S. Patent Application Publication Nos. 2002 / 0065455A1, 2003 / 0120150A1 and 2004 / 0068178A1, which are hereby incorporated by reference in their entirety into this application as if set forth in their entirety.

[0046] In some embodiments, system 20 includes a console 33 including a memory 49 and a driver circuit 42 configured to drive a field generator 44 with appropriate signals via a cable 37 to generate a magnetic field in a predefined working volume in the space surrounding the head 41.

[0047] The console 33 may also include additional control elements that assist the physician 24 in performing the procedure, such as command buttons that capture an image from the camera 50 and register it with a reference medical image using the position obtained by the magnetic position tracking system.

[0048] Processor 34 is typically a general purpose computer having suitable front-end and interface circuitry for receiving images from camera 50 and signals from position sensor 48 via cable 32 and for controlling the other components of system 20 described herein.

[0049] In some embodiments, the processor 34 is configured to register the image produced by the camera 50 with a medical image, such as an MRI image. The processor 34 may also record the position of the distal tip estimated using the position sensor 48. The processor 34 can register the camera 50 image by estimating the position of the distal edge of the trocar 38 using the position sensor 48. The processor 34 is configured to register the camera image with the reference medical image in the coordinate system of the magnetic position tracking system and / or in the coordinate system of the reference medical image.

[0050] In some embodiments, system 20 includes a video display 52 that displays an image 55 captured by camera 50. In the image shown, the distal end of treatment probe 39 can be seen engaging brain tissue.

[0051] In some embodiments, processor 34 is configured to receive one or more anatomical images, such as a reference MRI image depicting two-dimensional (2D) slices of head 41, via an interface (not shown). Processor 34 is configured to select one or more slices from the MRI image, perform registration with a real-time camera image, such as image 55, to produce a combined image, such as image 35, and display the selected combined slices to physician 24 on user display 36. Figure 1 In the example of FIG. 3 , the combined image 35 depicts a cross-sectional coronal view of the anterior brain tissue of the patient 22 .

[0052] The console 33 also includes input devices such as a keyboard and mouse for controlling the operation of the console and a user display 36 that is configured to display data (e.g., images) received from the processor 34 and / or display input inserted by a user (e.g., by the physician 24) using the input devices.

[0053] For simplicity and clarity, Figure 1 Only the elements relevant to the disclosed technology are shown. System 20 typically includes additional or alternative modules and elements that are not directly related to the disclosed technology and are therefore intentionally omitted. Figure 1 and the corresponding descriptions are omitted.

[0054] The processor 34 may be programmed with software to perform the functions used by the system and store data in the memory 49 to be processed or otherwise used by the software. For example, the software may be downloaded to the processor in electronic form over a network, or the software may be provided on non-transitory tangible media, such as optical, magnetic, or electronic storage media. Alternatively, some or all of the functions of the processor 34 may be performed by dedicated or programmable digital hardware components. Specifically, the processor 34 operates as described herein (including in Figure 3), which enables the processor 34 to perform the disclosed steps, as further described below.

[0055] Navigation trocar with internal camera

[0056] Figure 2 According to an embodiment of the present invention Figure 1 Schematic illustration of a trocar 38 used in a brain procedure. Trocar 38 includes a cannula 69 and an obturator 60. As shown, trocar 38 includes a channel 70 within cannula 69, with a distal edge on which camera 50 and position sensor 48 are mounted. Channel 70 also provides a track for routing cable 32.

[0057] In one embodiment, the camera 50 is tilted relative to the longitudinal axis of the trocar 38 so as to have a central distal viewing direction directed toward the center of the distal opening 78 of the cannula 69. At the same time, the sensor 48 is mounted so that the sensor does not obstruct the field of view of the camera 50.

[0058] For the sake of conceptual clarity, the Figure 2 In other embodiments, additional elements may be included, such as additional ports in the trocar 38 for inserting medical tools into the target brain location.

[0059] Figure 3 is a schematic diagram showing a method for converting a Figure 2 Flowchart of a method and algorithm for registering a visual image of the camera 50 of the trocar 38 with a reference medical image. The process begins in a trocar placement step 80 where the physician 24 places the trocar 38 into the brain.

[0060] Next, in a trocar position tracking step 82, the physician 24 operates the system 20 to magnetically track the position in the brain of the distal end of the trocar 38 using signals from the sensor 48. Next, in an image capture step 84, the physician 24 captures an image via the camera 50 for registration with the reference medical image.

[0061] In an image registration step 86, based on the tracked position of the distal end of the trocar 38 (using the sensor 48), the processor 34 registers the captured image (via the camera 50) with a corresponding reference medical image (such as from an MRI scan) stored in the memory 49 to produce a combined image 35. In one embodiment, for example, if the treatment is to remove brain tissue, the processor 34 is further configured to correct the reference medical image based on the registered image. In another embodiment, the processor is further configured to alert the user to any differences detected between the visual image and the reference image, such differences being caused by, for example, a larger tumor size detected by the camera 50 due to tumor growth since the reference image was taken.

[0062] Next, in a trocar adjustment step 88, using the combined image 35, the physician 24 adjusts the alignment of the trocar 38, e.g., to best allow for optimal access to target brain tissue, such as infected tissue. Then, in a probe insertion step 90, the physician 24 inserts the treatment probe 39 to treat the target tissue under visual guidance provided by the camera 50.

[0063] Figure 3 The exemplary flow chart shown in is chosen purely for conceptual clarity. In alternative embodiments, physician 24 may perform additional steps, such as employing additional monitoring steps (e.g., fluoroscopy) to verify the successful outcome of the procedure, and / or applying irrigation to clearly view camera 50.

[0064] Navigational trocar with internal camera and modular obturator head

[0065] Figure 4 According to another embodiment of the present invention Figure 1 Schematic illustration of a trocar 38 used in a brain procedure. Trocar 38 includes a cannula 69 and an obturator 60. As shown, trocar 38 includes a modular obturator 60 including an obturator body 79 configured to be inserted into cannula 69 of trocar 38. Obturator head 102 of obturator 60 is configured to penetrate the body and establish a pathway for the probe.

[0066] The obturator body 79 of the modular obturator 60 is configured so that different obturator tips can be interchangeably mounted thereto, a few of which are shown by way of example in an insert 110 that can be used during invasive medical procedures. In the insert 110, the obturator tip 114 has a sharp tip and is typically used to penetrate muscle or bone. On the other hand, the obturator tip 116 has a smooth tip and can be used to penetrate brain tissue.

[0067] As further shown, the obturator body 79 and the interchangeable obturator tips 114 and 116 are designed with recesses 113, 115, and 117, respectively, so that they can be easily adapted (e.g., inserted) into the cannula 69, wherein the recesses 113, 115, and 117 match the contour of the passageway 70 (see FIG. Figure 2 ).

[0068] For the sake of conceptual clarity, the Figure 4 In other embodiments, additional elements may be included, such as additional types of interchangeable obturator tips.

[0069] Figure 5 is a schematic diagram illustrating the use of a device having interchangeable obturator heads (114, 116) according to an embodiment of the present invention. Figure 4 The process begins in a trocar selection step 120 where the physician 24 selects a brain trocar 38 to access the brain.

[0070] Next, in an obturator head selection step 122, the physician 24 selects an interchangeable obturator capable of penetrating bone, such as the interchangeable obturator head 114. In an obturator preparation step 124, the physician installs the selected obturator head 114 on the obturator 60.

[0071] In treatment step 126 , physician 24 uses the assembled obturator to begin an invasive procedure, such as using the obturator to penetrate the skull.

[0072] To continue placing the obturator in the brain, the physician 24 selects the obturator tip 116, which is configured to enter brain tissue, in an obturator tip selection step 128. In an obturator tip replacement step 130, the physician 24 replaces the obturator tip 114 with the obturator tip 116. Finally, in a treatment step 132, the physician 24 continues the invasive procedure using the reassembled obturator by advancing the obturator through the brain tissue.

[0073] Figure 5 The exemplary flow chart shown in is chosen purely for conceptual clarity. In a typical embodiment, the doctor 24 will perform additional steps, such as advancing the cannula 69 while tracking the position of the cannula.

[0074] Although the embodiments described herein are primarily directed to brain procedures, the methods and systems described herein may also be used in other applications where it is necessary to guide medical devices in other organs, such as those located in the abdomen or chest.

[0075] It should therefore be understood that the embodiments described above are cited by way of example, and that the present invention is not limited to what is specifically shown and described above. On the contrary, the scope of the present invention includes combinations and subcombinations of the various features described above, as well as variations and modifications thereof, which will occur to those skilled in the art upon reading the above description and which are not disclosed in the prior art. The documents incorporated by reference into this patent application are considered an integral part of this application, except that if any term defined in these incorporated documents conflicts with a definition explicitly or implicitly given in this specification, only the definition in this specification shall be considered.

Claims

1. A trocar for insertion into an organ of a patient, the trocar comprising: a cannula having a longitudinal axis; a passage inside the cannula, wherein the passage is arranged parallel to the longitudinal axis; a camera disposed at a distal end of the channel and configured to provide an image in the direction of the distal opening of the cannula; as well as An obturator includes an obturator body configured to be inserted into the cannula of the trocar and designed with a recess located along a portion of the length of the obturator body, the recess configured to match the contour of the channel of the trocar.

2. The trocar according to claim 1, wherein The camera is tilted relative to the longitudinal axis to have a viewing direction that captures the distal opening of the cannula.

3. The trocar of claim 1 , and comprising a position sensor disposed at the distal end of the channel without obstructing the field of view of the camera and configured to generate a signal indicative of the position of the distal end in the organ.

4. The trocar according to claim 3, wherein: The position sensor is a magnetic position sensor.

5. A system comprising: A trocar for insertion into an organ of a patient, the trocar comprising: a cannula having a longitudinal axis; a passage inside the cannula, wherein the passage is arranged parallel to the longitudinal axis; a camera disposed at a distal end of the channel and configured to provide an image in the direction of the distal opening of the cannula; a position sensor disposed at a distal end of the channel without obstructing a field of view of the camera and configured to generate a signal indicative of a position of the distal end within the organ; an obturator comprising an obturator body configured to be inserted into the cannula of the trocar and designed with a recess positioned along a portion of the length of the obturator body, the recess configured to match the contour of the channel of the trocar; and A processor is configured to estimate the position of the distal end of the trocar in the organ using the signal generated by the position sensor.

6. The system according to claim 5, wherein: The processor is further configured to: registering an image acquired by the camera with a reference medical image based on the estimated position; and The image acquired by the camera and the reference medical image are presented to a user in registration with each other.

7. The system according to claim 5, wherein: The position sensor is a magnetic position sensor.

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