The invention relates to the field of planning insertion of concentric cannulas into a body, for instance a human body of a medical patient.
In
The scanning device will include a processor 103 for gathering and processing data from the scan. The processor may be of any suitable type and will typically include at least one machine readable medium for storing executable program code and data. There may be multiple processors and multiple storage media of one or more different types. The processor will often have some way of communicating with outside devices. This processor is illustrated with an antenna 105 for wireless communication, but the communication might equally well be wired such as to the Internet, infrared, via optical fiber, or via any suitable method. The scanning device will also include at least one user interface 104, including one or more of: a display, a touch sensitive screen, a keyboard, a pointer device, a microphone, a loudspeaker, a printer, and/or any other user interface peripheral. The invention is not limited to any particular peripherals for communicating with a user or with outside equipment.
While all processing may occur within the scanning device, there may also be an outside processor 106 for performing planning of a path, and an assumed set of ‘net shapes’ to follow the path. The processor 106 will be associated with at least one medium 107 for storing data and program code. The medium 107 may include various types of drives such as magnetic, optical, or electronic, and also memory such as cache where executing code and data structures may reside. The output of the planning process is illustrated schematically and includes a technical specification 108 in any appropriate format and also the concentric cannulas 109 themselves.
Tubular devices, such as Active Cannulas, have been proposed, see e.g. R. J. Webster et al., “Toward Active Cannulas: Miniature Snake-like Surgical Robots” 2006 IEEE/RSJ (October 2006, Beijing, China) pp. 2857-2863. These devices rely on the interaction between two or more tubes to cause lateral motion as they rotate relative to one another. As they extend from one another, they can also cause various lateral motions, particularly if they have different curvatures along a single tube. If the motion is carefully characterized, these motions can be used to reach multiple locations, similar to a robot in free space. However these devices can have difficulty when extended translumenally, if the lateral motion is greater than the available maneuver space. While the Webster article considers interactions of tubes during deployment, it lacks consideration of issues relating to making Active Cannulas follow a planned path.
Such devices may assist in gathering data, gathering tissue, or performing other procedures. Based on a patient image for example, a set of tubes can be extended, from largest to smallest so that, when deployed, they have a structure where at least a portion of each cannula will remain at the proximal end of the patient while smaller cannulas will extend into the patient interior space in reverse order of diameter. Thus the fattest cannulas will end more proximally, while the thinnest cannulas will extend more distally. Herein a cannula will be considered more distal if it ends more distally when deployed—and more proximal if it ends more proximally when deployed.
Nested Cannulas are somewhat different from Active Cannulas, since they are configured to reach specific locations in a specific environment with minimal lateral motion (wiggle). In one variety of Nested Cannula, the tubes are interlocked so that they do not rotate with respect to one another. Insertion should minimize trauma to the tubular passageways or other tissues. Such trauma can result from movements of the cannulas. Nested Cannulas are, for example, described in prior, co-pending U.S. provisional application No. 61/106,287 of Greenblatt et al., filed Oct. 17, 2008 (Interlocking Nested Cannula), which is International application no. PCT/IB2009/054474, filed Oct. 12, 2009.
Given the flexibility of modern technology, many of these operations may be performed remotely. For instance, data may be processed into a model of the interior space (e.g. segmented) in one location. A path through the space and a device suitable for following that path may be planned in a second location. Then the device may be assembled in a third location, before being returned to the technician or physician for insertion into the patient. Preferably, assembly of the nested cannula device will be performed in a manufacturing facility with good quality and sanitary controls; nevertheless, it might be that all these steps could be performed in a single location with the physician herself assembling the device to be inserted.
It has been proposed to use A* style path planning to facilitate deployment of active cannulas, see e.g. “3D TOOL PATH PLANNING, SIMULATION AND CONTROL SYSTEM,” prior, co-pending US application Ser. No. 12/088,870 of Trovato et al., filed Oct. 6, 2006, U.S. Patent Application Publication no. 2008/0234700, Sep. 25, 2008, which is incorporated by reference herein and made a part of this application. This type of planning makes use of a “configuration space.” A “configuration space” is a data structure stored on at least one machine readable medium. The configuration space represents information about a physical task space. In this case, the physical task space is the interior structure of the patient's body into which the active cannulas are to be inserted. The configuration space includes many “nodes” or “states,” each representing a configuration of the device during insertion.
A* or ‘cost wave propagation,’ when applied to the configuration space, will search the configuration space, leaving directions, such as a pointer, leading to the ‘best path to the seed’ at every visited state. “Propagation of cost waves” involves starting from a search seed, often a target point. Propagation of cost waves through the configuration space data structure makes use of an additional type of data structure embodied on a medium known as a “neighborhood.” The neighborhood is a machine-readable representation of permissible transitions from one state in the configuration space to other states within the configuration space. For example in
Propagation of cost waves also involves a “metric,” which is a function that evaluates the cost incurred due to transitioning from one state to a neighboring state.
The term “concentric cannulas” will be used herein to include Active Cannulas and Nested Cannulas, as described above. The present invention is applicable to both types.
An advantageous material for use in Active Cannulas is Ni—Ti alloy (nitinol). Nitinol has “memory shape”, i.e. the shape of a nitinol tube/wire can be programmed or preset at high temperatures. Therefore, at lower temperatures (e.g. room or body temperature) if a smaller tube extends from a larger one, it returns to its ‘programmed shape’. Another advantage of nitinol is that it can be used within an MRI machine. It is a relatively strong material and therefore can be made thin walled, enabling the nesting of several tubes. Tubes with an outer diameter from 5 mm down to 0.2 mm of 0.8 mm and below are readily available in the market. Other materials, such as polycarbonate may also be used, particularly for low cost, interlocking Nested Cannulas.
Concentric cannulas in accordance with the state of the art came in two general types:
The present invention is applicable to both types. Preferably, though, the angular orientation of the tubes remains fixed throughout deployment as rotation can cause tissue damage.
An advantageous material for use in active cannulas is Ni—Ti alloy (nitinol). Nitinol has “memory shape”, i.e. the shape of a nitinol tube/wire can be programmed or preset at high temperatures. Therefore, at lower temperatures (e.g. room temperature) if a smaller tube extends from a larger one, it assumes its programmed shape. Another advantage of nitinol is that it can be used within an MRI machine. It is a relatively strong material and therefore can be made thin walled, enabling the nesting of several tubes. Tubes with an outer diameter from 5 mm down to 0.2 mm of 0.8 mm and below are readily available in the market. Nevertheless, other materials, such as various sorts of plastics might also be used.
The result of planning is preferably
Certain areas for improvement remain with respect to the existing method and apparatus, e.g. better dexterity of the nested cannulas could be achieved if more radii of curvature could be used. Trauma to patient tissues could be further reduced by taking into account combined curvature affecting properties of several cannulas in the set.
It is desirable to achieve one or more of these goals using adaptive neighborhoods and improved calculations. Various objects and embodiments will become apparent in the rest of the text.
The following figures illustrate the invention by way of non-limiting example.
Herein, the terms “tube” and “cannula” will be used interchangeably to refer to components of the device to be deployed. The terms “goal” and “target” will also be used interchangeably.
The smallest tube in a concentric set of tubes will be the central tube. This smallest tube will also be referred to herein as the “most distal” tube, since in typical use it can extend farther than the others. Similarly, the largest tube in the set is on the outside of the concentric set and will be referred to as the “most proximal” tube. This terminology expresses that, once the tubes are deployed, the largest tube will end closest to the point of insertion. The smallest tube will extend from the point of insertion, through an entire path, to a goal.
The fields of applicability of the invention are envisioned to include many types of procedures including imaging, chemotherapy, chemoembolization, radiation seeds, and photodynamic therapy, neurosurgery, ablation, laparoscopy, vascular surgery, and cardiac surgery. Concentric cannulas in accordance with the invention might be applicable to other situations, such as exploring the interior of a complex machine. Generalized versions of adaptive neighborhoods described herein may have applicability in the broader field of robotics.
It is desirable that a number of interdependent factors should be considered in planning the concentric cannula device and path. These include:
A model of how cannulas interact mechanically with each other is found in the Webster et al. article cited below in the Bibliography. This article explains that concentric cannulas have curvatures that are a result of combined effects of all the cannulas.
As active cannulas rotate with respect to each other, both their joint curvature and curvature plane are changing. Therefore, the cannulas perform two movements: tip movement and lateral movement of the device. Whereas tip advancement is a desired feature, lateral movement of the body of the device might cause a collision with obstacles.
One approach to planning with various cannula elasticities is to make a full inverse kinematic model. Such a model may be advantageous in terms of elegance, but may also involve difficulties in terms of obstacle avoidance.
Another approach is to perform elasticity related calculations—after the path and a set of nested cannulas are planned—as a post hoc correction. This is discussed in co-pending application applicants's docket no. 012139US1, filed concurrently herewith.
A third approach is to use curvature affecting properties of the tubes as part of an artificial intelligence type search algorithm for path planning. An example of this is searching a configuration space using A* and an appropriately selected neighborhood, for instance as discussed below.
A description of a set of concentric cannulas can take the form of n sets of {κi, αi, Ii}, where κi is the curvature of the i-th segment, αi is the angular orientation of i-th tube with respect to tube i−1, and is moment of inertia of the i-th tube cross-section.
Some example angular orientations of curved segments (sometimes called threads) are shown in
A tube i can achieve a minimum ‘turning radius’, or equivalently, a maximum curvature Ki, where Ri=1/Ki, which depends upon the maximum strain value for the tube. This maximum strain is a property of the material. It is desirable to ensure that the tubes maintain their elastic ability to return to their original shape after they are extended from an enclosing tube, and to ensure that multiple manipulations are possible. These factors reduce the acceptable amount of strain further. The achievable curvature is a function of the tube's outer diameter and the strain. As described in
In general, the maximum curvature, i.e. minimum radius of curvature, of each tube can be calculated in accordance with following equation:
where di is the outer diameter of i-th tube, εi is the strain of i-th tube (for tubes having the same material, ε will be the same for all tubes), κimax is the maximum curvature, see the Webster article cited below in the bibliography at p. 2858
For the purpose of this simulation, based on a computer model of a porcine lung, the diameter of the tube was not considered as a limitation from a collision viewpoint. During path planning calculations, as long as the path lay within the lung, the point was considered theoretically ‘reachable’ by wider tubes—absent the turning radius issues.
While simulations with respect to the effect of turning radius on reachability are given here with respect to a lung, advantageous results could be achieved with respect to other body areas, such as vasculature.
By customizing a path planner in accordance with the incorporated patent documents to use, as an option, the tightest possible curvature for each size of tube, sets of concentric cannulas of greater dexterity can be planned. However, the curvature of i-th tube might be selected to have any value in the allowed range κi∈[0,κimax] where zero curvature defines a straight tube.
As the set of concentric cannulas is assembled, the number of the cannula defines the outermost diameter of the tube. The number of the tube will be accompanied by a specific curvature of the tube and orientation, which results from the neighbor selected by the planner.
An “adaptive” neighborhood is one that can change as a function of state in the configuration space. These changes will usually be based on values associated with one or more adjacent states and usually occur dynamically during cost wave propagation. In the case of concentric cannulas, the neighborhood will change as a function of tube number, and also as a function of tubes previously visited during cost wave propagation.
If two tubes with different curvatures are angularly rotated with respect to each other, their angular and curvature interaction has to be considered. The resulting curvature has two planar components. The generalized form of the resulting ‘net curvature’ relies on the elastic interaction between two tubes, and is given as:
where α1 and α2 are rotation angles around a reference axis, κ1 and κ2 are curvatures of tubes, and E1I1 and E2I2 are the products of the Young's modulus and moment of inertia for each tube, respectively.
The resulting curvature (
with and =tan−1(κrx/κry) as the final (net) curvature and orientation. Values {
During deployment, there will typically be an interaction between more than two tubes, e.g. three tubes with moments Ii, Ii+1, Ii+2, curvatures κi, κi+1, κi+2, and angles αi, αi+1, αi+2, where i represents the outermost tube. To simplify computation, the resulting curvature will be computed using Eq. (1) using the fact that two nested tubes (e.g. i and i+1), act as one tube when interacting with a third tube. The two have the moment of inertia I1=Ii+Ii+1, and curvature κ1=
If this adaptive neighborhood model is used to compute the threads of the ‘neighborhood of permissible motions’ in U.S. Provisional No. 60/725,185 (WO 2007/042986), then in each propagation step it is possible to account for tube interaction as A* algorithm propagates. The propagation preferably occurs from the ‘seed’ located where the smallest tube will extend, typically to the target, so that tubes can be layered sequentially.
To simplify calculation herein, it will be assumed that all the tubes are made of the exactly same material, so that Ei=E, ∀i and Ii=const1·(ro4−ri4), where ro4 and ri4, are outer and inner radius of the tube, respectively, and const1 is a constant number, with
In this case, Eq. (1) can be simplified cancelling out all Ei and const1, thus using Ii*=Ii/const1. The skilled artisan might alter the device to include different materials. In such a case, the calculation would have to be altered to reflect that.
Tube 0 is the smallest tube, having the smallest outer diameter (OD), which typically contacts the target (seed location for the search). Tube 0 has a turning radius of 18 mm (curvature=0.056 mm−1) and angular orientation of 45° (0.7854 rad). Tube 1 is the next physical tube, which has a curvature 0.036 mm−1 (radius=28 mm). Tube 2 has a curvature of 0.029 mm−1.
From the interaction model of Equation (1) for Tube 0 and Tube 1, it is possible to compute the resultant interactions to define net curvatures and angles. This is shown in the table of
The asymmetry can be observed from the table of
In the example of
In
In the THREADNODEs of the neighborhood data structure, the values of the variables alpha, n, cost, theta and phi change as the algorithm propagates.
However, it is necessary to maintain the orientation between segments of the nested tubes, for example, to be able to use interlocking mechanisms as proposed in prior, co-pending U.S. provisional application No. 61/106,287 of Greenblatt et al., filed Oct. 17, 2008. This ensures that the angle inserted at one end of the tube remains consistently oriented throughout the tube. If the interlock used is a hexagonal shape for example, and tubes are bent along the flat faces, then a second tube could be conveniently locked into any one of the 6 possible orientations. The neighborhood of ‘net threads’ would then be computed based on the current tube curvature and interactions with six arc-shaped tubes, and optionally a straight tube.
A net neighborhood is therefore computed based on the first tube and some number of possible orientations for physical tubes to be set. These orientations might be evenly distributed, or may be unevenly or preferentially clustered in certain directions, depending upon the application. For example, it may be preferable to avoid tubes that lead in the exact opposite direction from the current tube.
To achieve evenly distributed angles covering the full rotation, assuring a fixed discrete relative angle between the segments, n threads are computed with a nominal 2π/n angle between them. Assuming there is interaction between the tubes, resulting angles
An example adaptive neighborhood is computed next, using the above set of tubes (Tube0, Tube1 and Tube2), and assuming they have an octagonal cross section. The planner creates the neighborhood when the lowest cost node is ‘opened’. In our example, we will assume the ‘best path so far’ has followed an arc marked 1401 in
As the algorithm explores the space of possible tube sets within the configuration space, which might also be thought of as an obstacle space, the neighborhood is being adapted to the best tube series used ‘so far’. The computation of an adaptive neighborhood uses the previous net curvature (0.039), the previous net angle (1.48 radians), the previous moment of inertia, the next tube's curvature (0.029), and the next tube's moment of inertia to compute the next adapted neighborhood.
There are two different approaches to obtain the parent's parameters, i.e. curvature (
In this method, a node structure as described in U.S. Provisional 61/075,886 and
In this method, the curvature of previous parent is not saved, but rather computed ‘on the fly’. The interaction is computed by extracting the characteristics of all prior tubes, starting with the pointer to the parent, the pointer being the variable vector,
αi=(thread−1)·2·π/(N−1),
where N is the number of threads in the neighborhood.
Using Equations 1 and 2 iteratively for each segment, the net curvature to reach the i-th node can be computed.
This method does not require more memory than described in U.S. Provisional 61/075,886. The computation time at each expansion is O((N+currentTubeNumber−1)*t), which is an increase of O((currentTubeNumber−1)*t) for each expansion.
In some cases, it may be easier to manufacture tubes that contain both a straight portion and a curved portion, as shown in
Typically, in an assembly with more than three tubes, the innermost tubes will stop having a significant effect on the total curvature of the device in areas where there are more than 3 overlapping tubes. The calculation may be simplified by applying a threshold to determine how many tubes are considered to contribute to a net curvature. One type of threshold might relate to determining when an inner tube has a moment of inertia that is less than some predetermined percentage of the moment of inertia of some outer tube. One such predetermined percentage might be 10%. Another threshold might be to consider, in the region of overlap, only a predetermined number of outer tubes, such as three.
The result of the preceding calculations is a tube set specification, typically in the form of a list of tubes with sequence numbers. Each sequence numbered tube will also specify a diameter, curvature, length, and orientation: for example as shown in
The output may be in the form of an animation or some other graphic output.
From reading the present disclosure, other modifications will be apparent to persons skilled in the art. Such modifications may involve other features which are already known in the design, manufacture and use of medical robotics and which may be used instead of or in addition to features already described herein. Although claims have been formulated in this application to particular combinations of features, it should be understood that the scope of the disclosure of the present application also includes any novel feature or novel combination of features disclosed herein either explicitly or implicitly or any generalization thereof, whether or not it mitigates any or all of the same technical problems as does the present invention. The applicants hereby give notice that new claims may be formulated to such features during the prosecution of the present application or any further application derived therefrom.
The word “comprising”, “comprise”, or “comprises” as used herein should not be viewed as excluding additional elements. The singular article “a” or “an” as used herein should not be viewed as excluding a plurality of elements. The word “or” should be construed as an inclusive or, in other words as “and/or”.
The following related applications and patent documents are incorporated herein by reference: U.S. Pat. No. 4,949,277, issued Aug. 14, 1990 to Trovato et al.U.S. Pat. No. 5,879,303, issued Mar. 9, 1999 to Averkiou et al.U.S. Pat. No. 6,604,005, issued Aug. 5, 2003 to Dorst et al.Prior, co-pending US application Ser. No. 12/088,870 of Trovato et al., filed Oct. 6, 2006 (3D Path Planning, Simulation and Control System), U.S. Patent Application Publication no. 2008/0234700, Sep. 25, 2008.Prior, co-pending U.S. provisional applications nos. 61/075,886, Jun. 26, 2008 and 61/099,223, Sep. 23, 2008, of Trovato et al. (Method and System for Fast, Precise Path Planning), which is International application no. PCT/IB2009/05250, filed Jun. 16, 2009.Prior, co-pending U.S. provisional application No. 61/106,287 of Greenblatt et al., filed Oct. 17, 2008 (Interlocking Nested Cannula), which is International application no. PCT/IB2009/054474, filed Oct. 12, 2009.Prior, co-pending International application no. IB2007/053253 of Trovato, filed Aug. 15, 2007 (Active Cannula Configuration for Minimally Invasive Surgery), International Publication no. WO 2008/032230 A1, Mar. 20, 2008.Prior, co-pending U.S. Provisional application No. 61/075,401 of Trovato, filed Jun. 25, 2008 (Nested Cannulae for Minimally Invasive Surgery)), which International application no. PCT/IB2009/052521, filed Jun. 12, 2009. These documents, when taken cumulatively, describe a medical application, which will be roughly summarized as follows:
Filing Document | Filing Date | Country | Kind | 371c Date |
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PCT/IB2009/054996 | 11/10/2009 | WO | 00 | 6/28/2011 |
Number | Date | Country | |
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61141119 | Dec 2008 | US |