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 described in, inter alia, the related application U.S. provisional No. 61/106,287, filed Oct. 17, 2008, set forth above.
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,” U.S. Ser. No. 12/088,870, filed Oct. 6, 2006, U.S. Patent Application Publication no. 2008/0234700, Sep. 25, 2008, which is incorporated in its entirely 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.
The result of planning is preferably
Certain areas for improvement remain with respect to the existing method and apparatus. For instance, trauma to patient tissues could be reduced by adjusting the specification of the set of concentric cannulas after it is planned, taking into account expected interactions of the tubes responsive to curvature affecting properties of the tubes. Such curvature affecting properties include radius of curvature, elasticity modulus, and moment of inertia.
Further objects and advantages will be apparent in the following.
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 phrases “radius of curvature,” “radius of bending,” and “tube curvature” will all be used interchangeably to refer to the curvature of a tube. The terms “radius,” “diameter,” “tube radius,” and “tube diameter” will all be used to refer to geometrical dimensions of a cross section of a tube. “Net curvature” will be used to refer to the curvature of an assembly of tubes resulting from individual properties of each component tube.
The fields of applicability of the invention are envisioned to include many types of procedures including imaging, chemotherapy, chemoembolization, radiation seeds, photodynamic therapy, neurosurgery, laparoscopy, vascular surgery, and cardiac surgery. It is also possible that concentric cannula in accordance with the invention could be used for non-medical applications where there are difficult to reach spaces, perhaps at the interior of a machine to be repaired.
A model of how cannulas interact mechanically with each other is to be found in the Webster et al. article cited below in the Bibliography. From this article, it can be seen that concentric cannulas will have curvatures and elasticities that are a result of combined effects of all the cannulas in areas of overlap. As Active Cannulas rotate with respect to each other, both their joint curvature and curvature plane change. Therefore, the cannulas perform two movements: tip movement and lateral movement of the device. Whereas tip advancement is a desired feature, lateral movement of component cannulas of the device might cause a collision with tissue, possibly causing damage.
One approach to creating concentric cannula devices is to consider tube interaction during planning. More about such a model is discussed in a co-pending application applicants' docket no. 011868, filed concurrently herewith.
Another approach is to define the shapes of the component cannulas based on a path, post hoc. This requires performing calculations relating to tube interaction after the path is determined. A procedure for doing this is shown in
At 501, path planning occurs, for instance per U.S. application Ser. No. 12/088,870 of Trovato et al.
The result, at 502, is a concentric cannula configuration, e.g. a path including n alternating straight and arc segments. This configuration may take the form of n sets of {
At 503, a calculation is performed correcting the deployment plan in view of elastic interaction between the cannulas.
The absolute value of the curvature of a tube in a plane is defined as the reciprocal value of the bending radius. The “curvature vector” is oriented perpendicular to the bending plane.
Interaction between n tubes (or wires) with the same angular rotation is defined as follows:
where
F
i
=E
i
·I
i, (2)
where Ei is elasticity modulus (i.e. Young's modulus) of the i-th tube and Ii is the moment of inertia of the cross section of i-th tube.
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
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. Hence:
F
i
=E·I
i=const·(ro4−ri4). (3)
Where const is a constant numer, const=const1*E. If the curvatures of the tubes are angularly rotated with respect to each other, the angular interaction has to be considered, and the resulting curvature has two planar components. The generalized form of the elastic interaction between two tubes is given as:
Angles α1 and α2 are rotation angles around a reference axis. The resulting curvature vector ({right arrow over (
where
The more general case is to compute physical curvatures and angles of tubes (κi i=0 . . . n−1 and αi i=0 . . . n−1). Once the device is deployed, the physical curvature of the smallest and therefore most distal tube will be unaffected by other tubes, since it will extend alone. This most distal tube is designated as the “zero” tube and becomes an input to the model in the form:
κ0=
meaning that for the “zero” tube, net curvature and net angle are equal to physical curvature and physical angle. 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 starting with outermost tube. To simplify computation, the resulting curvature will be computed using Eq. (4) using the fact that two nested tubes (e.g. i and i+1), if interacting with a third one act as one tube, having the moment of inertia I1=Ii+I+1, and curvature κ1=
Equation (4) can be rewritten in the following form:
Given that initial values (κ0 and α0) are known, the problem reduces to interactively solving n−1 sets of two equations (Eq. (6)) with two values unknown (κ2 and α2) and given that E can be canceled out. Notice that other components (κ1 and α1) are computed in the previous iteration.
Then, the system from Eq. (6) becomes:
C
s
=B
s+κ2·I2·sin α2 (12)
C
c
=B
c+κ2·I2·*cos α2 (13)
The full model can be computed iteratively: In the first step, κ1 is and α1 are computed from κ0 and α0, in the second step κ2 and α2 are computed from κ1 and αi, . . . , finally κn−1 and αn−1 are computed from Kn−2 and an−2.
The computed curvatures κi and rotation angles α, can be used to assemble the active cannula configuration per WO 2007/042986. The compensation effected by the above calculation improves conformity of behavior of the deployed active cannula device with the planned path. The planned path having been calculated in turn to conform to body tissues.
Then, at 504 a corrected set of cannulas with defined curvatures and orientations is produced. This corrected set of cannulas will be produced responsive to an output specification resulting from the correction 503. The outputs specification will preferably include:
a plane. In reality, the deployed device will have a three dimensional shape, in which various curvatures are in different planes.
In the next pararaphs, some alternate embodiments are proposed to simplify the model. Listing some examples of alternate embodiments is not intended to limit the application—as the skilled artisan might come up with other alternatives to simplify calculations.
Modification 1
If the planned path includes alternating straight-curve segments, interaction can be precomputed pairwise for any combination of N planned segments.
Segments that are straight are shown with net curvature equal zero, e.g.
This modification simplifies premanufacturing of tubes per U.S. application Ser. No. 12/088,870 of Trovato et al.
To improve modification 1, tubes can be selected to have balanced moments of inertia—Ii=I for every i. In this case, if two curved tubes compensate for each other to yield a straight segment they have the same curvature—with opposite orientations. In such cases, the number of prefabricated tubes could be reduced by factor 2, as compared to Modification 1 alone.
There are a number of properties that might affect net curvature. These include angular rotation, tube radius of curvature, modulus of elasticity (elasticity modulus), and moment of inertial. While it may be that all each tube in an assembly of concentric cannulas may have a distinct value for each of these properties, calculation or manufacturing may be simplified by having all tubes share at least one of the properties.
Generally, there may be manufacturing advantages to having device tube(s) include alternating sequences of straight and curved segments. Tubes may have more than one curvature along their length, as shown in
Realistically, in an assembly with more than about three tubes, the innermost tubes will stop having a significant effect on the total curvature of the device in areas where there is overlap. 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 threshold percentage of the moment of inertia of some outer tube. One such threshold percentage might be 10%. Another threshold might be to consider, in region of overlap, only a predetermined number of outer tubes, such as three.
The result of the preceding calculations should be a tube specification, typically in the form of a list of tubes with sequence numbers. Each sequence number will be correlated with a diameter of the tube and accompanied by tube specifications such as curvature, length, and orientation. The output may be in the form of an animation or some other graphic output.
Manufacturers of such cannulas will likely be making many assemblies at a time using automated processes responsive to multiple individual requests from multiple medical providers.
Generally, planning concentric cannula devices may start with a discrete set of pre-ordered and stored tubes 1005. This discrete set reduces manufacturing costs by reducing the number of tubes, especially the number of specific curvatures a manufacturer has to have in stock. The method in accordance with the invention allows for a more varied set of tube curvatures to be used, since the type of tube needed to make an adjustment in accordance with the calculations performed above would only be requested at 1006 after calculations are performed. Preferably, customized tube orders could be minimized by starting from a concentric cannula device composed of tubes selected from a discrete set; then performing an adjustment calculation as described above; and finally only ordering a custom tube when calculation reveals a need for adjustment that differs from the starting device by an amount that exceeds some threshold. A set of concentric cannula devices produced in accordance with the invention will accordingly normally have a greater diversity of component tubes than might be expected in the prior art. Alternatively, modification 1 will allow discrete set of pre-ordered and stored tubes.
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 invention relates to the field of planning and construction of telescoping concentric cannulas for insertion into a patient. 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, U.S. 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, U.S. provisional applications no.'s 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/IB2009/052650, filed Jun. 19, 2009.Prior, 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, 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, U.S. Provisional application No. 61/075,401 of Trovato, filed Jun. 25, 2008 (Nested Cannulae for Minimally Invasive Surgery)), which is 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 |
---|---|---|---|---|
PCT/IB2009/054995 | 11/10/2009 | WO | 00 | 6/28/2011 |
Number | Date | Country | |
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61141130 | Dec 2008 | US |