Surgical trajectory alignment device

A surgical trajectory alignment device is disclosed, including an alignment trajectory guide holding portion shaped to receive and secure an alignment trajectory guide along a longitudinal patient entry axis, the longitudinal patient entry axis falling within a plane. The surgical trajectory alignment device further includes a first alignment trajectory guide holding portion activator operable to rotate an alignment trajectory guide secured by an alignment arm holding portion within the plane; and a second alignment trajectory guide holding portion activator operable to translate an alignment trajectory guide secured by the alignment arm holding portion in a direction away from the plane.

FIELD OF THE INVENTION

The present invention relates generally to an alignment device, and, more particularly, relates to a surgical trajectory alignment device for performing trajectory alignment of a medical device during a medical procedure.

BACKGROUND OF THE INVENTION

Medical procedures, such as deep brain stimulation, deep brain infusion, and biopsy procedures, often require mapping the trajectory of a medical device to reach a target point within a patient during the medical procedure. The target point may be, for example, a brain tumor that must be removed by the physician during surgery. A known system for performing trajectory alignment involves the use of a Navigus trajectory guide. A fluid filled stem is placed within the Navigus trajectory guide to monitor the trajectory using images displayed on a medical imaging viewing system, such as a Magnetic Resonance Imaging (MRI) viewing system connected to an MRI scanner. The Navigus trajectory guide is placed over the burr hole and is secured to the skull with three bone screws. Normally, a physician, located at the MRI scanner, manually adjusts the Navigus trajectory guide secured to the patient at the MRI scanner, while using instructions provided by the medical imaging technologist located at the MRI viewing system, to align the medical device with the trajectory defined by the target point. Once the adjustment is made, an additional MRI scan is performed to view the results of the adjustment. This process may take several attempts before the physician is able to appropriately align the medical device to reach the target point within the patient. Consequently, this process is time consuming because the physician performs the alignment based on the guidance of the medical technologist, each of whom are typically located in a separate room. This process is also dangerous for the patient due to possible negative long term effects of prolonged exposure to anesthesia.

A known system of performing trajectory alignment is stereotaxic targeting. With this system, the target point is determined using preoperative MRI images. From the images, the burr hole location is determined to accommodate insertion of the medical device along a generally vertical axis. Preferably, the burr hole is placed over non-essential brain tissue. The medical device is inserted through the burr hole using a micromanipulator on a stereotaxic frame. Unfortunately, this system does not accommodate off axis trajectories for placement of the medical device in irregularly shaped targets, such as the putamen, located at the base of the forebrain. An additional problem presented by this method is that the trajectory is determined based upon preoperative images, rather that images produced in real time.

Another known system, the arc-phantom system (a type of sterotaxic targeting) also involves several lengthy steps in performing the trajectory alignment. Using the arc-phantom system, initially, an aiming bow is attached to a head ring that is fixed to the patient's skull. The aiming bow can be transferred to a similar ring that contains a replicated target. The aiming bow is then adjusted to reach the desired replicated target. Once the replicated target is reached with the aiming bow, the system is placed back on the patient's skull.

Additional problems presented by many known trajectory alignment systems are difficult assembly and difficult adjustment of the trajectory alignment systems. Many of the known trajectory alignment systems involve several components that must be assembled prior to using the system. Likewise, many of the known targeting systems involve several steps and manipulation of components in order to perform the trajectory alignment of the medical device to reach the target point within the patient.

SUMMARY OF THE INVENTION

The invention provides a surgical trajectory alignment device that overcomes the hereinafore-mentioned disadvantages of the heretofore-known devices of this general type, and that provides a surgical trajectory alignment device for performing trajectory alignment of a medical device during a medical procedure.

With the foregoing and other objects in view, there is provided, in accordance with the invention, a surgical trajectory alignment device including an alignment trajectory guide holding portion shaped to receive and secure an alignment trajectory guide along a longitudinal patient entry axis. The longitudinal patient entry axis falls within a plane. A first alignment trajectory guide holding portion activator is operable to rotate an alignment trajectory guide secured by an alignment arm holding portion within the plane. A second alignment trajectory guide holding portion activator is operable to translate an alignment trajectory guide secured by the alignment arm holding portion in a direction away from the plane.

In accordance with a further feature of the present invention, an alignment arm supports the alignment trajectory guide holding portion.

In accordance with an additional feature of the present invention, the first alignment trajectory guide holding portion activator and the second alignment trajectory guide holding portion activator are coupled to and manipulate the alignment arm.

In accordance with another feature of the present invention, the alignment arm defines an arm axis, and the direction away from the plane is a longitudinal direction of the arm axis.

In accordance with another feature, an embodiment of the present invention includes a surgical trajectory alignment device for guiding a medical device to a target area within a subject through an entry point on the subject. The surgical trajectory alignment device includes a base couplable to a subject, a medical device extending through the base and into the subject and an arm coupled to the base. The arm includes a receiving portion shaped to receive and secure at least a portion of the medical device. The arm is operably configured to rotate the medical device through the base and upon an alignment axis for aligning the medical device with a target area within the subject. The arm is also operably configured to translate the medical device through the base and along the axis for aligning the medical device with the target area within the subject.

In accordance with another feature of the present invention, the base defines an opening operably configured to receive an alignment trajectory guide holding portion shaped to receive and secure an alignment trajectory guide.

In accordance with another feature of the present invention, a rotation device is coupled to the arm and operable to rotate the arm about the alignment axis. A translation device coupled to the arm and operable to translate the arm along a linear path from a first point to a second point along the alignment axis.

In accordance with yet another feature of the present invention a first cable couples the rotation device to a first actuator located at a remote control station outside a magnetic field of a magnetic resonance imaging device.

In accordance with an additional feature of the present invention, at least one gear is coupled to the rotation device.

In accordance with another feature of the present invention, the rotation device and the translation device are on a single side of the base.

In accordance with another feature of the present invention, the arm is configured to align the medical device to the target area within the subject by one of a rotational and a translational motion.

In accordance with an additional feature of the present invention, the arm includes a first end and a second end, opposite the first end. The arm includes at least one finger at the first end. The finger forms an opening for receiving the medical device therethrough. The finger is operably configured to receive a portion of a guide tube and the guide tube is configured to receive the medical device. The arm is coupled to a rotation device at the second end.

In accordance with an additional feature of the present invention, the arm is disposed in a horizontal position, substantially perpendicular to the entry point defined by the medical device.

In accordance with an additional feature of the present invention, the base and the arm are of at least one of a plastic and a ceramic material.

In accordance with another feature of the present invention, an embodiment of the present invention includes a surgical trajectory alignment device for guiding a medical device to a target area within a subject through an entry point on the subject. The surgical trajectory alignment device includes a body having a base having a portion couplable to a subject, a first arm, and a second arm. The first arm is coupled to the base and includes a receiving end defining a first opening for receiving at least a portion of the medical device therethrough for insertion of the medical device through an entry point on the subject. The first arm is operably configured to rotate about a first axis substantially parallel to a longitudinal length of the first arm for aligning an entry axis defined by the medical device to a target area with the subject. The second arm is coupled to the base and includes a receiving end defining a second opening for receiving at least a portion of the medical device therethrough for insertion of the medical device through the entry point on the subject. The second arm is operably configured to rotate about a second axis for aligning the entry axis to the target area with the subject. The second axis is substantially parallel to a longitudinal length of the second arm, and substantially perpendicular to the first axis. The receiving end of the first arm overlaps the receiving end of the second arm for jointly guiding movement of the medical device therein.

In accordance with another feature of the present invention, the body further includes a first rotation device having a first end and a second end. The first end is coupled to the first arm, and the second end is coupled to an actuator at a remote control station in close proximity to a medical imaging display. The body further includes a second rotation device having a first end and a second end. The first end is coupled to the second arm, and the second end is coupled to the actuator at a remote control station in close proximity to a medical imaging display.

In accordance with another feature of the present invention, the first arm and the second arm are operably configured to align the entry axis to the target area by rotational movements.

In accordance with yet another feature of the present invention, the body is comprised of a non-metallic material, the non-metallic material compatible with a Magnetic Resonance Imaging (MRI) scanner.

In accordance with an additional feature of the present invention, the base defines a third opening operably configured to receive a base member of a Navigus trajectory guide. The opening is disposed below an intersection area. The intersection area is defined by the area where the receiving end of the first arm overlaps the receiving end of the second arm.

In accordance with another feature of the present invention, the base defines a third opening for receiving a base member coupled to a locking ring. The locking ring includes a diameter less than a diameter of the base member. The locking ring is sized to be received through a top opening of the base member and frictionally retained within the base member.

Before the present invention is disclosed and described, it is to be understood that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting. The terms “a” or “an,” as used herein, are defined as one or more than one. The term “plurality,” as used herein, is defined as two or more than two. The term “another,” as used herein, is defined as at least a second or more. The terms “including” and/or “having,” as used herein, are defined as comprising (i.e., open language). The term “coupled,” as used herein, is defined as connected, although not necessarily directly, and not necessarily mechanically.

As used herein, the terms “about” or “approximately” apply to all numeric values, whether or not explicitly indicated. These terms generally refer to a range of numbers that one of skill in the art would consider equivalent to the recited values (i.e., having the same function or result). In many instances these terms may include numbers that are rounded to the nearest significant figure. In this document, the term “longitudinal” should be understood to mean in a direction corresponding to an elongated direction of an axis.

DETAILED DESCRIPTION

The present invention provides a novel and efficient surgical targeting alignment device for aligning an instrument with a designated area in a precise and rapid manner. Embodiments of the invention provide a surgical targeting alignment device that is simple to assemble, and which is operable for guiding a medical device to a target area within a subject through an entry point on the subject, during various medical procedures. In addition, embodiments of the invention provide a surgical targeting alignment device that is of a material does not affect magnetic resonance imaging (MRI) readings or procedures.

Referring now toFIG. 1, one embodiment of the present invention is shown in a downward-looking perspective view.FIG. 1shows several advantageous features of the present invention, but, as will be described below, the invention can be provided in several shapes, sizes, combinations of features and components, and varying numbers and functions of the components. The surgical trajectory alignment device100is shown having a base102including a first end106and a second end108, opposite the first end106.

Referring now primarily toFIG. 2, the base102is a frame that is removably couplable to a subject200. In use, the base102is coupled to the subject200to align an instrument, such as a medical device104, along an entry axis204to reach a target area202within the subject200. The “entry axis” is defined herein as an axis of a trajectory defined by the target area202within the subject200and an entry point on the subject200, through which the medical device104must enter the subject200to reach the target area202. The “target area” is defined herein as an area, a point, or a region within the subject200that the surgeon desires the medical device104to reach for operating thereon, such as, for example, a brain tumor.

The medical device104can be seen extending through the base102and into the subject200. The type of medical device104varies depending upon the type of procedure for which the surgical trajectory alignment device100is being used. For example, the medical device104may be a catheter, with a portion capable of delivering drugs to the subject200. In another example, for use during needle biopsy, the medical device104may be a needle that is inserted into the subject200to extract a portion of a tumor or tissue.

Referring back toFIG. 1, the surgical trajectory alignment device100is shown in an assembled mode. The surgical trajectory alignment device100has an alignment trajectory guide holding portion110removably coupled to the base102at the first end106. In an embodiment, the alignment trajectory guide holding portion110includes a locking device from the Navigus trajectory guide1400as manufactured by Medtronic® (seeFIG. 14).FIG. 1illustrates the alignment trajectory guide holding portion110including a locking ring112. The alignment trajectory guide holding portion110is shown coupled to the base102. In embodiments, the alignment trajectory guide holding portion110may be coupled to the base by a bolt, lug, nail, tab, male-female fasteners, or other similar fasteners. The alignment trajectory guide holding portion110is a platform secured to the subject200and which is operable for insertion of at least a portion of the medical device104therethrough. The alignment trajectory guide holding portion110includes multiple embodiments, as shown inFIG. 14andFIG. 15, and discussed in more detail below. The embodiments shown inFIG. 14andFIG. 15are not exclusive embodiments, rather, the alignment trajectory guide holding portion110may include other embodiments, as well.

In use, the base102and the alignment trajectory guide holding portion110are operable for placement on a surface of the subject200(seeFIG. 2). In order to couple the alignment trajectory guide holding portion110and the base102to the subject200, in an embodiment, the alignment trajectory guide holding portion110defines at least one aperture1500(as illustrated inFIG. 15), operable to receive a screw or other fastener. In this embodiment, in order to couple the base102to the subject200, the screw is inserted through the at least one aperture1500and screwed into the subject200. In another embodiment, the alignment trajectory guide holding portion110and the base102may be removably coupled to the subject200using a burr hole and a screw, for example, when the subject200includes a human skull. In the embodiment ofFIG. 14andFIG. 15, the alignment trajectory guide holding portion110is operable to allow an operator to select a burr hole on the human skull. The burr hole configuration allows the operator to select an area on the subject200that may be least traumatic to the brain tissue, while aligning the medical device104with the target area202. Advantageously, because the alignment trajectory guide holding portion110ofFIG. 15does not include the prior art locking ring112, depicted inFIG. 14, which includes a diameter larger than a diameter of the locking ring112ofFIG. 15, the presently inventive surgical trajectory alignment device100allows the operator to rotate the medical device104up to approximately 25° from a vertical axis402, as best illustrated inFIG. 4. When the prior art locking ring112of the Navigus trajctory guide1400ofFIG. 14is used, the device100is only able to rotate the medical device104up to approximately 15° from the vertical axis402. In other embodiments, the alignment trajectory guide holding portion110ofFIG. 15may be operable to rotate the medical device104a number of degrees outside of this range.

The presently inventive surgical trajectory alignment device100is envisioned for use with various types of medical procedures and on various subjects. In one embodiment, the subject200is a human. In an alternative embodiment, the subject may be, for example, an animal being operated on in a veterinary surgical procedure. The various embodiments of the presently inventive surgical trajectory alignment device, however, are not limited to any particular surgical procedure.

Referring again toFIG. 2, an arm116is shown coupled to the base102. The arm116is a device configured to align the medical device104to the target area202within the subject200. The arm116is disposed in a horizontal position, substantially perpendicular to the entry axis204defined by the medical device104. In use, the arm116is operable to align the medical device104to the target area202within the subject200by one of a rotational and a translational motion. The rotational motion is identified by element120inFIG. 1. The “rotational motion,” as used herein, is intended to indicate movement in an arc motion120about an arm axis122. The arc motion120provides adjustment of the medical device104about the vertical axis402. The translational motion is identified by element124inFIG. 1. The “translational motion,” as used herein, is intended to indicate movement along a linear path, e.g. a horizontal axis. Advantageously, this motion provides an operator with a simple configuration for performing trajectory alignment of the medical device104with the entry axis204(as illustrated inFIG. 5) to the target area202, because the operator need only choose to perform at least one of the rotational and translation motion using the arm116.

In an embodiment, the base102and the arm116are at least one of a plastic and a ceramic material. Advantageously, this material is compatible with a medical imaging scanner610(as illustrated inFIG. 6), such as an MRI scanner, so that the subject200can remain within the medical imaging scanner610during the manipulation of the surgical trajectory alignment device100. Because the subject200does not have to be removed from the medical imaging scanner610to perform the trajectory alignment, the overall time for performing the trajectory alignment is reduced, thereby decreasing the labor costs in performing the medical procedure.

Now referring toFIG. 3, the arm116can be seen having a first end300and a second end302, opposite the first end300. The first end300has a receiving portion304shaped to receive and secure at least a portion of the medical device104(seeFIG. 1). In an embodiment, the receiving portion304does not directly receive the medical device104, rather, the receiving portion304is operable to receive a guide tube400(as illustrated inFIG. 4) for insertion of the medical device104within the guide tube400. In another embodiment, the receiving portion304may directly receive the medical device104. The guide tube400is a housing for securing the medical device104therein. Advantageously, the guide tube400creates a barrier on all sides of the medical device104to fix the medical device104in a stationary position.

The receiving portion304is shown having at least one finger306, wherein the at least one finger306forms the opening308for receiving the guide tube400. In another embodiment, the receiving portion304may include a plurality of fingers306, operable to receive and secure the guide tube400. In another embodiment, the receiving portion304may include a plurality of fingers306, operable to receive and secure the medical device104. The opening308defines a u-shaped cavity sized to accommodate the medical device104. In one embodiment, the opening308is sized to accommodate a catheter having a circumference between approximately 0.1572 inches-0.3406 inches. In other embodiments, the receiving portion304may be shaped to receive and secure the medical device104having a circumference outside of these ranges. In another embodiment, the receiving portion304may define a round cavity, though the u-shaped cavity is preferred.

To accomplish the rotational motion, in an embodiment, a rotation device310is coupled to at least one gear and the at least one gear is coupled to the arm116. In another embodiment, the rotation device310may be coupled to a single gear and the single gear may be coupled to the arm116. In the embodiment ofFIG. 3, the rotation device310is shown coupled to a first gear312and a second gear314. The gears312,314are shown coupled to a rod316, wherein the rod316is coupled to the arm116at the second end302. The gears312,314are shown as rotationally coupled, such that, in use, the rotation device310rotates and causes the first gear312to rotate, which causes the second gear314to rotate. The gears312,314are coupled to the rod316, such that, as the gears312,314rotate, the rod316is operable to rotate the arm116at the second end302, to accomplish the rotational motion.

Referring now primarily toFIGS. 3 and 6, the gears312,314advantageously provide an operator with a precise and predictable ratio between the rotational motion and the operator's movements at a second actuator606. The rotational device310is shown inFIG. 6coupled to the first actuator602by a first cable600. In an embodiment, the first actuator602may include a knob for controlling the rotational device310from a remote control station608. The operator may choose, for example, to turn the knob two degrees from the first actuator602which may result in rotating the arm116two degrees to rotate the medical device104two degrees about the vertical axis402, illustrating a predictable correlation between the control input from the operator and the rotational, output motion of the medical device104. This example is provided for illustrative purposes only, and the ratio between the rotational motion of the medical device104and the control input from the operator may vary outside of these ranges. The gears312,314are also advantageous, because, if the operator stops turning the knob, the gears312,314are operable to provide traction and stop the rotational motion of the arm116.

A translation device322is shown coupled to the arm116at the second end302to accomplish the translation motion. The translation device322is shown coupled to the arm116by a screw318inserted into the second end302. In use, as the translation device322is turned, the screw318is operable to turn and propel the arm116in precise minor increments along a linear path324from a first point326to a second point328along an alignment axis500(FIG. 5). The “alignment axis,” as used herein, is intended to indicate a horizontal axis defined by a longitudinal length of the arm116. In another embodiment, the translation device322may be coupled to the arm116at the second end302by a rod, bolt, or other fastener, as appreciated by one of ordinary skill in the art.

To facilitate the simple and rapid setup of the surgical trajectory alignment device100, the rotation device310and the translation device322are shown coupled to the base102on a single side of the base102. The operator, physician, or other medical personnel, can focus on coupling the first cable600and the second cable604(both shown inFIG. 6) to the single side of the base102.

In accordance with an embodiment of the present invention, the first cable600is shown coupling the rotation device310to a first actuator602. Likewise, the second cable604is shown coupling the translation device322to a second actuator606. In the embodiment ofFIG. 6, the cables600,604are shown as electrical cables. In other embodiments, the cables600,604may be mechanical cables, fiber optic cables, or a similar type of connection mechanism. The embodiment showing the cables600,604as electric cables is preferred due to reduced friction when compared to using other types of cables600,604. The “actuator” is defined herein as a device that is operable to allow an operator to initiate movement of at least one of a rotation device and a translation device. InFIG. 6, the actuators602,606are shown as electrical actuators. In another embodiment, the actuators602,606may be mechanical actuators operable to convert rotary motion to linear motion.

In one embodiment, the actuators602,606may be in the form of a pair of knobs provided on a distal end of the cables600,604located in the room with the medical imaging display612. The first actuator602and the second actuator606are shown at a remote control station608outside of the magnetic field of a magnetic imaging scanner610, such as the MRI scanning device. The remote control station608is essentially the room where the medical imaging display612is located, and which is separate from the room where the medical imaging scanner610and the subject200are located. From the remote control station608, the operator can view the medical imaging system, and manipulate the actuators602,606to move at least one of the rotation device310and the translation device322, which, in turn, perform at least one of the rotational and the translation motion, to align the medical device104(FIG. 1) with the target area202within the subject200. Advantageously, the operator can rapidly perform the trajectory alignment because he or she only has to focus on performing at least one of the rotational motion and the translation motion to align the medical device104in a precise manner.

FIG. 7illustrates a surgical trajectory alignment device700showing an alignment arm712, substantially identical to the alignment arm116illustrated inFIG. 1, except described with reference to a plane708defined by a longitudinal patient entry axis706and a horizontal plane extending across a width of an alignment arm holding portion702. The surgical trajectory alignment device700includes an alignment trajectory guide holding portion714and an alignment arm holding portion702. The alignment trajectory guide holding portion714is shaped to receive and secure an alignment trajectory guide704along the longitudinal patient entry axis706falling within the plane708. With reference primarily toFIG. 7andFIG. 16, the “longitudinal patient entry axis”706is defined herein as an axis of a trajectory between the target area202within the subject1600and an entry point914on the subject1600, through which the medical device104must enter the subject1600to reach the target area202. This longitudinal patient entry axis706, as illustrated inFIG. 7, lies with the plane708. The alignment trajectory guide704, similar to the guide tube400, is configured to receive and support the medical device104(FIG. 1) for use during the surgical procedure. The alignment arm712is shown supporting the alignment trajectory guide holding portion714.

Similar to the rotational device310ofFIG. 3,FIG. 8illustrates the surgical trajectory alignment device700having a first alignment trajectory guide holding portion activator800. The first alignment trajectory guide holding portion activator800is operable to rotate the alignment trajectory guide704secured by the alignment arm holding portion702within the plane708. Likewise, a second alignment trajectory guide holding portion activator802is shown. The second alignment trajectory guide holding portion activator802is operable to translate the alignment trajectory guide704secured by the alignment arm holding portion702in a direction away from the plane708. The first alignment trajectory guide holding portion activator800and the second alignment trajectory guide holding portion activator802are shown as coupled to and operable to manipulate the alignment arm712. The alignment arm712defines an arm axis804, which is similar to the alignment axis500ofFIG. 5. The “arm axis” is defined herein as a horizontal axis defined by a longitudinal length of the alignment arm712.

FIG. 9provides another illustrated embodiment of the present invention, showing a surgical trajectory alignment device900utilizing two arms, as opposed to one arm, as with the embodiments ofFIG. 1andFIG. 7.FIG. 9illustrates a body902having a base904with a first arm906and a second arm908. Another difference between the embodiment ofFIG. 9and the embodiments ofFIG. 1andFIG. 7, is that the first arm906and the second arm908are operably configured to align the entry axis204to the target area202(FIG. 2) by rotational movements, as opposed to both rotational and the translational movements illustrated in the embodiment ofFIG. 1andFIG. 7. The base904is removably couplable to the subject1600, in the same or a similar manner as that described in reference to the embodiments ofFIGS. 1 and 7. In one embodiment, the body902is comprised of a non-metallic material, such as a polymer material. In another embodiment, the material may be another type of non-metallic material, as would be appreciated by one of ordinary skill in the art. In yet another embodiment, the body902includes a metallic material, such as silver, copper and gold. Advantageously, the non-metallic material is compatible with the MRI scanner, so that the surgical trajectory alignment device900does not have to be removed from the subject200when the subject is placed within the MRI scanner.

The first arm906is shown in this embodiment coupled to the base902by a first rod926. In another embodiment, the first arm906may be coupled to the base902by a bolt, screw, or other fastener. The first arm906has a receiving end910defining a first opening912.FIG. 9shows the first opening912having at least a portion of the guide tube400inserted therethrough. In another embodiment, the first opening912is operable for receiving at least a portion of the medical device104therethrough, for insertion of the medical device104(FIG. 1) through an entry point914on the subject200(FIG. 2). The “entry point”914is defined herein as an opening on the subject200through which the medical device104(FIG. 1) passes through in order to reach the target area202within the subject200.

The first arm906is operably configured to rotate about a first axis916. “Rotate” is defined herein as movement in an arc motion. The first axis916is shown substantially parallel to a longitudinal length924of the first arm906. “Substantially parallel” is defined herein as having equal, or approximately equal, distances separating the two lines from each other in more than one point along the lines. “Longitudinal length” as used herein is intended to indicate a length extending along a longest direction of the respective arm906,908. The first axis916is operable for aligning the first arm906with the entry point914defined by target area202(FIG. 2).

The second arm908is shown coupled to the base904by a second rod928. In another embodiment, the second arm908may be coupled to the base904by a bolt, a screw, or another fastener. The second arm908has a receiving end918defining a second opening920.FIG. 9shows the second opening920having at least a portion of the guide tube400inserted therethrough. The second opening920is operable for receiving at least a portion of the medical device104(FIG. 1) therethrough for insertion of the medical device104through the entry point914on the subject200.

The second arm908is operably configured to rotate about a second axis922for aligning the entry axis204to the target area202within the subject200(FIG. 2). The second axis922can be seen as substantially parallel to a longitudinal length930of the second arm908and substantially perpendicular to the first axis916. “Substantially perpendicular” is defined herein as forming a right angle, or approximately a right angle, with another line, plane, or surface.

The receiving end910of the first arm906is shown overlapping the receiving end918of the second arm908. In use, this configuration facilitates jointly guiding movement of the medical device104to align with the target area202. In other words, as the first arm906rotates about the first axis916and the second arm908rotates about the second axis922, the medical device104is able to be moved about in a precise manner to align with the target area202. Advantageously, this configuration provides a simple configuration for guiding the medical device104because the operator need only manipulate the first arm906and/or the second arm908in order to align the entry axis204to the target area202within the subject200(FIG. 2).

Referring now primarily toFIG. 10, the body902is shown having a first rotation device1000and a second rotation device1006in order to accomplish the jointly guiding movement of the medical device104. The first rotation device1000is shown having first end1002and a second end1004. The first end1002is shown coupled to the first arm906by a first shaft1012. The first shaft1012is operable to rotate the first arm906. In another embodiment, the first end1002may be coupled to the first arm906by a screw or other fastener. In another embodiment, the first end1002may be coupled to the first arm906by a gear, operable to rotate the first arm906, similar to the gear configuration described in reference toFIG. 3.

A second rotation device1006is shown couple to the second arm908. The second rotation device1006is shown having a first end1008and a second end1010. The first end1008is shown coupled to the second arm908by a second shaft1014. The first shaft1012is operable to rotate the first arm906. In another embodiment, the first end1008may be coupled to the second arm908by a screw or other fastener. In another embodiment, the first end1008may be coupled to the second arm908by a gear, operable to rotate the second arm908, similar to the gear configuration described in reference toFIG. 3.

Referring now primarily toFIGS. 6 and 10, the second end1004may be coupled to the actuator606at the remote control station608by the first cable600. In another embodiment, the second end1004may be coupled to the actuator606at the remote control station608by an electrical wire, or another similar connection mechanism. Similar to the second end1004of the first rotation device1000, in an embodiment, the second end1010of the second rotation device1006may be coupled to the actuator606at the remote control station608by the second cable604. The medical imaging display612is located within the remote control station608. From the remote control station608, the operator can view the medical imaging display612, and manipulate the actuators602,606to move the first rotation device1000and the second rotation device1006, which in turn rotate the arms906,908about the first axis916and the second axis922, respectively, to align the medical device104with the target area202within the subject200.

FIG. 11shows that the base904defines a third opening1100operably configured to receive the alignment trajectory guide holding portion110.FIG. 11shows the third opening1100disposed below an intersection area1104defined by the region where the receiving end910of the first arm906overlaps the receiving end918of the second arm908.

FIGS. 12 and 13show the alignment trajectory guide holding portion110having a base member1200coupled to the locking ring112. The alignment trajectory guide holding portion110may include a ball joint configuration that provides rotary movement of the medical device104in all directions through the movement of the guide tube400within the locking ring112.

FIGS. 14 and 15illustrate various embodiments of the alignment trajectory guide holding portion110. InFIG. 14, the exemplary implementation of the alignment trajectory guide holding portion110is utilized with a locking ring112from the Navigus trajectory guide1400as manufactured by Medtronic®. Advantageously, the presently inventive surgical trajectory alignment device100,700,900is operable to couple to different embodiments of the alignment trajectory guide holding portion110. The surgical trajectory alignment device100,700,900may be coupled to pre-existing Navigus trajectory guides1400for access to a wider, more accurate range of motion during trajectory alignment. In an embodiment, the Navigus trajectory guide1400is operable to adjust the guide tube400and the medical device104(FIG. 1) by at least 15° from the vertical axis. In another embodiment, the Navigus trajectory guide1400may be operable to adjust the guide tube400within a range of degrees outside of this range.

FIG. 15shows the preferred embodiment of the alignment trajectory guide holding portion110operable to securely hold the guide tube400in place. The locking ring112is shown as an annular ring having a diameter1502less than a diameter1504of the base member1200, and less than a diameter1402of the locking ring112depicted inFIG. 14. The locking ring112is sized to be received through a top opening1202of the base member1200. In other words, the locking ring112is sized to fit within the base member1200. Advantageously, this size allows the locking ring112to be frictionally retained within the base member1200. “Frictionally retained” is defined herein as tightly held in place. Additionally, providing the locking ring112with the diameter1502less than the diameter1504of the base member1200is advantageous because the smaller diameter facilitates rotation of the guide tube400and the medical device104by approximately 25° from the vertical axis402(FIG. 4). In contrast, the wider locking ring112depicted inFIG. 14, allows rotation by approximately 15° from the vertical axis402. Accordingly, the locking ring112ofFIG. 15provides a wider range of motion for the trajectory of the medical device104. In other embodiments, the diameter1502may be operable to facilitate adjustment of the guide tube400and the medical device104by a number of degrees outside of these ranges.

FIG. 16shows the alignment trajectory guide holding portion110coupled to the subject1600. In this embodiment, the base102is shown removably coupled to the alignment trajectory guide holding portion110.

A surgical trajectory alignment device has been disclosed that is operable for aligning an instrument with a designated area, in a precise and rapid manner. Embodiments of the invention disclose a surgical targeting alignment device that is simple to assemble, use, and manufacture, and which is operable for guiding a medical device to a target area within a subject through an entry point on the subject, utilizing dual-arm rotational motion and without requiring the physician to be at the MRI scanner. In addition, embodiments of the invention have been disclosed that provide a surgical trajectory alignment device that utilizes both rotational and translational motion of a singular alignment arm to align the medical device to the target area.