Concave phased array imaging catheter

The field of the invention relates to medical devices, and more particularly to phased array imaging catheters.

Intraluminal, intracavity, intravascular, and intracardiac treatments and diagnosis of medical conditions utilizing minimally invasive procedures are effective tools in many areas of medical practice. These procedures are typically performed using imaging and treatment catheters that are inserted percutaneously into the body and into an accessible vessel of the vascular system at a site remote from the vessel or organ to be diagnosed and/or treated, such as the femoral artery. The catheter is then advanced through the vessels of the vascular system to the region of the body to be treated. The catheter may be equipped with an imaging device, typically an ultrasound imaging device, which is used to locate and diagnose a diseased portion of the body, such as a stenosed region of an artery. For example, U.S. Pat. No. 5,368,035, issued to Hamm et al., the disclosure of which is incorporated herein by reference, describes a catheter having an intravascular ultrasound imaging transducer.

An imaging transducer generally includes an imaging element configured to emit energy pulses. During operation, the imaging element is electrically excited, thus causing an energy pulse to be emitted. The pulse is directed to a surface where imaging is desired and reflected back to the transducer. Two desirable features of the emitted energy pulse are that the energy pulse be focused and steerable. One known approach known in the art to obtain these features is to utilize an array of imaging elements instead of just one element. FIG. 1 shows an array 10 of two imaging elements, A and B, side-by-side. As is known in the art, if both elements, A and B, are excited simultaneously, then the energy pulses are combined to form a beam that is parallel to the direction that the elements, A and B, are facing, so that the beam travels directly away from the array 10 . However, if a linear timing excitation gradient (a time delay based on a coherence theory) is used across the array 10 , the beam can be steered in the azimuthal direction. By sending a short acoustic pulse and receiving the echo at each azimuthal direction, the array 10 may scan a sector area and construct an image. The image resolution is primarily determined by the beam 20 width in the lateral direction and the acoustic pulse length in the axial direction.

To focus the beam, i.e., adjust the beam width, time delays for each element may also be utilized. At a certain spatial location, the acoustic pulses from all elements may be coherently enhanced when they are in phase. The phase of the pulse is determined by the distance from the element to the destination location. To focus the beam at a spatial point, appropriate time delays are applied to all of the elements, A and B. These compensating delays ensure that the arrival of the acoustic pulses from different elements, A and B, are in coincidence at the desired spatial location.

The array of imaging elements configured to enable a beam to be focused and steered is known in the art as a “phased array.” Though only two imaging elements, A and B, are shown in FIG. 1 , a typical phased array may include as many as 256 elements. In the case of ultrasound imaging elements, each element, A and B, is generally small enough to be treated as an acoustic point source that generates a propagating wave with a spherical front. Collectively, the elements, A and B, form an acoustic field that can be enhanced when the elements, A and B, are in phase at a certain spatial location.

The elements, A and B, are typically rectangular and are typically evenly spaced across a flat plane. For ultrasound elements, each element has a pitch size equal to half a wavelength at the working ultrasound frequency. The pitch size is defined as the distance between two adjacent element, A and B, centers. With this typical configuration, when the beam 20 is steered and focused to a particular point F, the beams of the individual elements, A and B, are emitted at different angles, α and β, with respect to the flat plane. This will cause the beams of the individual elements, A and B, to have different amplitudes, which can undesirably result in a widened beam 20 , even if an accurate time delay compensation is used. This is particularly so when the beam 20 is steered to the maximum azimuthal direction. Accordingly, an improved phased array imaging catheter would be desirable.

The present invention generally relates to medical devices, and more particularly to an improved intravascular device. In one embodiment, an intravascular device includes a catheter having proximal and distal portions, and a phased array of imaging elements located in the distal portion of the catheter, wherein the phased array is concaved.

Other systems, methods, features and advantages of the invention will be or will become apparent to one with skill in the art upon examination of the following figures and detailed description. It is intended that all such additional systems, methods, features and advantages be included within this description, be within the scope of the invention, and be protected by the accompanying claims.

In order to better appreciate how the above-recited and other advantages and objects of the present inventions are obtained, a more particular description of the invention briefly described above will be rendered by reference to specific embodiments thereof, which are illustrated in the accompanying drawings. It should be noted that the components in the figures are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the invention. Moreover, in the figures, like reference numerals designate corresponding parts throughout the different views. However, like parts do not always have like reference numerals. Moreover, all illustrations are intended to convey concepts, where relative sizes, shapes and other detailed attributes may be illustrated schematically rather than literally or precisely.

FIG. 1 is a cross-sectional side view of a phased array of imaging transducers known in the art.

FIG. 2 is a cross-sectional side view of a phased array of imaging transducers in accordance with a preferred embodiment of the present invention.

FIG. 3 is a cross-sectional view of an imaging wire in accordance with a preferred embodiment of the present invention.

FIG. 4 is a diagram of a medical imaging system in accordance with a preferred embodiment of the present invention.

As described above, prior art phased array assemblies 10 consist of a series of small rectangular elements, A and B, that are evenly spaced in a flat plane. This configuration causes the elements to emit energy beams at different angles when the phased array beam 20 is steered and focused. This can undesirably cause a widened phased array beam 20 .

By contrast, the improved phased array in this patent specification reduces the undesired wideness by placing a phased array in a concaved configuration, as shown in FIG. 2 . FIG. 2 shows a phased array 100 of imaging elements, A and B. The elements, A and B, are situated along a concave 130 path having a radius R. The phased array 100 can have additional imaging elements along the concave path 130 (not shown). The phased array 100 has a length, L, and a maximum steering angle in the azimuthal direction, θ. F represents a focal point at the maximum steering angle in the azimuthal direction. The phased array 100 is shown focusing an energy beam, such as an acoustic pulse, 120 at focal point F. α and β, represent the tangential angles for elements A and B to the focal point F respectively. α 1 and β 1 , represent the flat plane angles for elements A and B to the focal point F respectively. Point O represents the origin of the horizontal and vertical axis, X and Y.

In the case of a phased array 100 having a large number of imaging elements, wherein elements A and B represent the edge elements of the array 100 , at focal point F, element B will have the largest angle β 1 , to the focal point F, whereas element A will have the smallest angle α 1 , to the focal point F. The concaving of the array 100 will decrease the tangential angle β, for element B by β 2 , and increase the tangential angle α for element A by α 2 . One of ordinary skill in the art would appreciate that by concaving the array 100 , elements A and B will have the most significant impact on the resulting beam 120 as compared to any imaging elements in between elements A and B, and the center imaging elements will be least affected.

The following is an approach to calculating the radius of curvature R of a concave phased array 100 that enables the tangential angles α and β, to be equal at the maximum azimuthal direction θ. From FIG. 2 , the following is true:

α=α1+α2,  (1)

and

β=β1−β2  (2)

and because of geometric symmetry, we have:

α2=β2=α3,  (3)

To obtain α=β, the following is deduced:

α1+α3=β1−α3,  (4)

which means:

α3=(β1−α1)/2,  (5)

Since:

sin(α3)=( L/ 2)/ R   (6)

and:

tan(α1)= OF cos(θ)/( OF sin(θ)+ L/ 2)  (7)

and:

tan(β1)= OF cos(θ)/( OF sin(θ)− L/ 2)  (8).

Combining equations (5)-(8), the radius of curvature R can be expressed as:

In the case of a 10 MHz, 64 element phased array, wherein the length of the array is 5 mm, if the array's maximum angle in the azimuthal direction is 45°, and the focal depth is 5 mm, then the radius of curvature R is preferably approximately 7 mm.

Equation (9) expresses the radius of curvature of a concave array, R, as a function of a desired focal depth if the other parameters in the array design, such as image range, have been provided. For an image range from OF 1 to OF 2 , an average radius of curvature R a may be determined by:

The concave array 100 may have a uniform pitch, wherein the space from element center to element, A and B, is uniform; however, it can be non-uniform as well. An element's width can be varied to maximize the beam quality, as one of ordinary skill in the art would appreciate. For example, the element width can conform to a Gaussian, Bessel, or sinusoidal function using an element index number calculated from the array 100 center to an edge element, e.g., A or B.

For an ultrasound phased array 100 , the array 100 can be fabricated by a variety of available active acoustic material, such as piezo-ceramics, piezo-films (thin or thick), 2-2 or 1-3 piezoceramic composites, 2-2 or 1-3 piezocrystal materials, or cMUT. Further, other imaging devices may be used, instead of, or in addition to imaging transducers, such as light based apparatuses for obtaining images through optical coherence tomography (OCT). Image acquisition using OCT is described in Huang et al., “Optical Coherence Tomography,” Science, 254, Nov. 22, 1991, pp 1178-1181, which is hereby incorporated by reference in its entirety. A type of OCT imaging device, called an optical coherence domain reflectometer (OCDR) is disclosed in Swanson U.S. Pat. No. 5,321,501, which is incorporated herein by reference. The OCDR is capable of electronically performing two- and three-dimensional image scans over an extended longitudinal or depth range with sharp focus and high resolution and sensitivity over the range.

Such an array 100 is useful for intracardiac applications, and may be used for other applications, such as any kind of B-scanner medical applications, ophthalmic ultrasound, HIFU and/or NDT.

Turning to FIG. 3 , the phased array 100 may be used in a catheter, as described above, and can also be placed in a distal portion 520 of a guidewire 500 . The guidewire 500 may comprise a guidewire body 302 in the form of a flexible, elongate tubular member, having an outer wall 301 . The guidewire body 302 may be formed of any material known in the art including composite materials, plastics, braided polyimide, polyethylene, PEEK braids, stainless steel, other superelastic materials, or metal alloys, such as a nitinol hypertube,

Turning to FIG. 4 , a proximal portion 510 of the guidewire 500 , shown in FIG. 3 , may be adapted to connect to circuitry 600 that processes imaging signals from the phased array 100 , such circuits being well known.

In the foregoing specification, the invention has been described with reference to specific embodiments thereof. It will, however, be evident that various modifications and changes may be made thereto without departing from the broader spirit and scope of the invention. For example, the reader is to understand that the specific ordering and combination of process actions described herein is merely illustrative, and the invention can be performed using different or additional process actions, or a different combination or ordering of process actions. As a further example, each feature of one embodiment can be mixed and matched with other features shown in other embodiments. Additionally and obviously, features may be added or subtracted as desired. Accordingly, the invention is not to be restricted except in light of the attached claims and their equivalents.