Patent Application
20080064960
The invention relates to a high frequency ultrasound transducer holder and adjustable fluid interface.
High frequency ultrasound (HIFU) is a recognized method of delivering treatment energy to subcutaneous lesions in the body. Most of the transducers that have been developed for this purpose have focal zones that are at a fixed distance from the face of the transducer where the sound waves are focused to achieve the energy concentration for treatment. This feature requires that either the transducer or the patient be moved for the treatment area to be shaped to a treatment volume as desired. In addition, some fluid medium must be present between the patient and the transducer that allows the ultrasound energy to be efficiently transmitted. Typically this fluid medium has been degassed water held within a flexible container. Since it is highly desirable to prevent immersion of the HIFU transducer and to be able to adjust the depth of the focal zone in relation to the patient, treatment tables for supporting the patient, the fluid interface and the transducer have been developed for these purposes. There remains a need for an improved HIFU transducer holder.
The invention relates to an ultrasound transducer positioning system including a curvilinear articulating arm, an ultrasound transducer, and a holder comprising a first region for receiving the transducer and a second region for a fluid interface disposed adjacent the first region, the holder being coupled to the curvilinear articulating arm. The second region is adjustable in size.
The first region may be defined by a generally circular clamp which may be a split ring. A lead screw may be coupled to the clamp. The second region may be defined between the clamp and an opposing members and the lead screw may extend to the opposing member. The opposing member may be a ring. The transducer may be retained by at least one member coupled to the clamp and abutting a portion of the transducer. In some embodiments, the at least one member may abut a portion of a face of the transducer. The fluid interface may be a flexible member. The system may further include at least one rail with indexing thereon, the rail extending between a bracket coupled to the curvilinear articulating arm and a clamp defining the first region.
The present invention is designed to provide a portable, self contained, adjustable fluid interface and HIFU transducer holder that will perform the required functions for accurate and effective treatment and keep the treatment field and transducer dry. This design obviates the need for a specialized table to support the transducer and fluid interface and to move the transducer and patient in a controlled relationship.
Among the advantageous features of the present invention are: it is readily attachable to a supporting positioning arm that has six degrees of freedom for initial positioning of the device; it has a receptacle for securely grasping the transducer; it has a generally cylindrical cage for supporting and aiding in the shaping and positioning of a disposable balloon that may be filled with a fluid interface medium such as degassed water.
The cage may be adjusted in length with both rapid and fine adjustment mechanisms which determine the distance of the transducer from the patient contacting surface of the device (thus controlling the depth of the focal zone). The balloon may be easily purged of air and is made of elastic material that causes minimal attenuation of the ultrasound energy. Depending on the position of the transducer in relation to the patient contacting surface of the device (i.e. the length of the balloon cage), the fluid volume in the balloon may be adjusted to achieve full contact of the balloon with both the entire active surface of the transducer and the patient. The end of the balloon cage opposite the transducer may have a circular lipped opening to allow for a large contact surface for the balloon with the patient. The lip may be smooth and tapered to contain the balloon in the cage while permitting desired patient contact with minimal chance for air gaps. Ultrasound gel or some equivalent may be used on the interface surfaces of the balloon where it comes in contact with the transducer and the patient to optimize energy transmission. In addition to a manual fine adjustment mechanism for the length of the cylindrical balloon cage that can account for the depth of the focal zone in the patient (Z axis), this device may also include a fine adjustment mechanism that allows manual position adjustment in the X-Y plane. This allows the operator to create a shaped treatment volume for a lesion in a patient.
Preferred features of the present invention are disclosed in the accompanying drawings, wherein:
Words of orientation as used herein such as “front,” “back,” “top,” and “vertical” are used for exemplary convenience only as non-limiting examples of the orientation of features and are not intended to have any particular limiting effect.
Referring initially to
For movement of clamp 12 with respect to ring 14 in the Z-axis, both gross and fine movements may be achieved. As shown for example in
As shown in
As shown for example in
In a preferred exemplary embodiment, balloon 52 is stretchy, strong, and causes minimal attenuation of the signal from transducer 50 when gel is coated on both the transducer contact and patient contact surfaces; preferably, balloon 52 is filled with degassed water with air purged therefrom.
In a preferred exemplary embodiment, transducer 50 focuses ultrasound about 10 centimeters away from the bottom surface 50a thereof. In order to change the depth in the patient to which the energy is directed and focused, the spacing of clamp 12 and ring 14 with respect to each other is adjustable for example between about 1 centimeter and about 9 centimeters. Spacing of clamp 12 and transducer 50 retained in ring 14 for example may be adjusted with reference to numerical indicia 20a such as shown in
A coupling 60 may be used to couple holder 10 to a curvilinear articulating arm as will be described.
Referring next to FIGS. 1J-1-O, a variant exemplary embodiment of the first embodiment is shown. In particular, a high frequency ultrasound transducer holder 60 for providing an adjustable fluid interface includes an ultrasound probe clamp 62 and an opposing bottom ring 64. A plurality of rods 66 are fixed circumferentially about ring 64 and extend through aligned holes 67 in clamp 62. In addition, a pair of guide rails 68, 70 are fixed circumferentially about ring 64 and extend through aligned holes 72, 74, respectively, in clamp 62. Each of rails 68, 70 may include indexing 68a, 70a such as scoring, grooves, indicia including numerical indicia, etc, which for example may indicate the separation distance between portions of transducer holder 60 as will be described. A lead screw 76 (show in
For movement of clamp 62 with respect to ring 64 in the Z-axis, as with the previous embodiment both gross and fine movements may be achieved. Turning for example in
Due to the spring-loading provided by biasing member 88, button 86 is biased such that partial threads 87a, 87b thereof engage the threads of lead screw 76 when button 86 is not depressed. When a user depresses button 86 and compresses spring 88, bore 87 of button 86 accommodates movement of partial threads 87a, 87b away from engagement with the threads of lead screw 76 so that gross movement of clamp 62 with respect to ring 64 may be permitted in the Z-axis. In particular, by depressing button 86 proximate spring 88, a portion of face 86a of button 86 “rocks” against clamp 62 to permit pivoting of button 86 with respect to lead screw 76, thereby permitting disengagement of their respective threads and allowing gross movement. Conversely, gross movement may be arrested when the respective threads are engaged.
Fine movement of clamp 62 with respect to ring 64 may be permitted in the Z-axis when the partial threads 87a, 87b of button 86 are engaged with the threads of lead screw 76 and a user rotates lead screw 76 about or parallel to the E-axis by rotating lead screw 76 with knob 90. In summary, vertical adjustment screw 76 allows fine tuning of the focal zone depth associated with transducer 92, while button 86 may be depressed for making larger rapid vertical adjustments.
Unlike the first embodiment, holder 10, the exemplary variant embodiment includes a clamp 62 that preferably is not in the form of a split ring. Instead, an ultrasound transducer 92, such as a HIFU transducer, is secured within clamp 62, as shown for example in
As shown for example in
Finally, a coupling 99 may be used to couple holder 10 to a curvilinear articulating arm as will be described.
Preferably, holder 60 is formed of materials so that it is substantially radiolucent and magnetic resonance imaging compatible (the use of stainless steel is kept minimal, for example by only using stainless steel screws and springs).
Advantageously, as may be seen by comparing
Turning to
Holder 100 differs from holder 10 in that positioning adjustment may be achieved in the X-Y plane using a fine adjustment system 180. While vertical adjustment screw 126 allows fine tuning of the focal zone depth associated with transducer 150 about or parallel to the Z-axis, fine adjustment system 180 provides additional positioning ability in the X-Y plane. In the exemplary embodiment shown, coupling 160 is fixed to fine adjustment system 180 instead of primary bracket 128 as was the case with respect to holder 10 and its primary bracket 28 and coupling 60.
As shown for example in
Referring to
Turning to
In the exemplary preferred embodiment, three additional balls 656a and three additional sleeves 654a are provided to the arm assembly 212 shown in
A base handle 660 is coupled to central arm 652 on a first end thereof, preferably adjacent a ball 656a. In addition, a free handle 662 is coupled to central arm 652 on a second end thereof, preferably adjacent a ball 656b.
In one preferred exemplary embodiment, a series of larger balls 656a is provided proximate base handle 660 to provide stability to curvilinear articulating arm assembly 212. If for example a user such as a surgeon orients assembly 212 by grasping it proximate free handle 662, substantial bending forces may be exerted on central arm 652 proximate base handle 660. Thus, the use of larger balls 656a proximate base handle 660 as compared to smaller balls 656b proximate free handle 662 provides a system with larger surface area balls near base handle 660 for additional resistance to rotational movement in that portion of central arm 652 and thus more stability. In alternate embodiments, more than two different sizes of balls 656 or more than two sets of sizes of balls 656 may be used, preferably increasing in size toward base handle 660. In one alternate embodiment, each of the balls 656 in central arm 652 is of increasingly larger size from free handle 662 to base handle 660. The use of only two sizes of balls 656 advantageously facilitates manufacture and construction of arm assembly 212 because of the need to only stock two sizes as compared to a larger number of sizes and concomitantly greater ease of construction because only two sizes need be assembled to form central arm 652. In yet another alternate embodiment, central arm 652 may be formed of balls 656 that all are the same size.
Turning to
Coupling 663 is disposed proximate a first free end 664a of a stainless steel shaft 664 which extends therethrough and is provided with a head that abuts a shoulder disposed in end 663c of coupling 663. Preferably, rotation of coupling 663 is independent of rotation of shaft 664. Shaft 664 preferably extends through a hole in extension 660b.
Lever 666 is pivotably coupled to rocker arm 672 with a pin 666a that is disposed such that rotation of lever 666 results in eccentric movement of rocker arm 672. As shown for example in
As seen particularly in
When coupling 663 is threaded into a like threaded hole by rotation of extension 660b, arm assembly 212 is relatively loosely coupled by the connection of coupling 663 to the hole. To firmly couple arm assembly 212, lever 666 may be pivoted in direction K so that threaded portion 663d of coupling 663 also moves in direction M and bears against the threads of the hole in which it is received. The leverage created by even slight movement of the threads against the threaded holes, on the order of tens of thousandths of an inch, creates a wedging effect that strongly locks arm assembly 212 to the hole.
Lever 668 of base handle 660 also is pivotably coupled to a rocker arm 670 with a pin 668a that is disposed such that rotation of lever 668 results in eccentric movement of rocker arm 670. As shown for example in
A forked member 676, which for example may be formed of stainless steel, is coupled to rocker 670 and includes substantially parallel prongs 676a, 676b which mate with side walls of rocker 670 as shown. Rocker 670 is pivotably associated with forked member 676, with a shaft 677 extending through aligned holes in prongs 676a, 676b and rocker 670. Shaft 677 may be provided with a head 677a and an external retaining ring 677b secured in a shaft groove proximate an end opposite head 677a to retain forked member 676 in association therewith and thus with rocker 670. An axial through hole 676c is provided in tubular portion 676d of forked member 676. Tensioning wire 658 is coupled to forked member 676 by inserting an end portion of wire 658 in hole 676c and swaging tubular portion 676d so that wire 658, which extends out of open end 660a5 of body portion 660a, is retained by compression within tubular portion 676d.
When lever 668 is rotated in direction N, shaft 676 translates along the longitudinal axis M1 toward coupling 663 creating substantial tension in tensioning wire 658 such that movement of curvilinear articulating arm assembly 212 may be substantially resisted. In particular, actuation of second lever 668 may increase or decrease the tension in wire 658 as desired by acting on rocker arm 670. By increasing tension in wire 658, central arm 652 preferably becomes increasingly resistant to movement although central arm 652 preferably still may be moved through its full range of motion. Thus, a user may orient curvilinear articulating arm assembly 212 as desired, and then increase the tension of wire 658 so that the orientation of arm 652 is releasably fixed. Lever 668 preferably has an angular range of movement about pin 668a of up to about 180° to permit substantial tension to be generated in tensioning wire 658.
Rockers 670, 672 preferably are associated with each other as with a spring plunger 679 extending from within one rocker 670 into a hole in the other rocker 672. Spring plunger for example may be a stainless steel spring plunger with a round Delrin nose, without a lock element, with ¼″-20 threading, and 3-13 lb. end force (McMaster-Carr part number 84765A33). Spring plunger 679 is used as shown because under the force of gravity, first lever 666 may otherwise tend to move toward a closed position with in the direction of arrow K. Instead, spring plunger 679 applies pressure to rocker arm 672 to set lever 666 to tend to a default open position in which shaft 664 has not otherwise been raised toward open end 660a5 of body portion 660a.
In a preferred exemplary embodiment, rocker 670 moves with substantially greater eccentricity than rocker 672.
Clamp 216 for use with base handle 660 may be demountably attached to surgical table rail 218. As previously discussed, actuation of first lever 666 permits a user to apply a force on coupling 663 so that movement is resisted (e.g., in response to an 8 or 10 pound force applied to arm 652). In an alternate embodiment which will be further described later, screw coupling 664 as shown in
A preferred exemplary embodiment of clamp 216 is shown in
Next turning to
Lever 682 is pivotably coupled to rocker arm 684 with a pin 686a that is disposed such that rotation of lever 682 results in eccentric movement of rocker arm 684. Cylindrical projections 682a of lever 682 are received and rotate in arcuate cradle portions 662a1 of body portion 662a, while cylindrical projections 684a of rocker arm 684 are received and rotate in arcuate cradle portions 662a2 of body portion 662a. Rotation of lever 682 toward wire receiving portion 680 in direction T lifts pin 686a, and because rocker arm 684 rests on pin 686a, rocker arm 684 is rotated in direction U in an eccentric fashion.
Rocker arm 684 includes a hole in which a self-aligning setup washer 690 (a two-piece washer with one portion that rocks in another portion) is disposed. Setup washer 690 for example may be an 18-8 stainless steel self-aligning setup washer, ¼ inch in size, 17/64 inch inner diameter, ½ inch outer diameter, and 0.250 inch to 0.281 inch thick (McMaster-Carr part number 91944A028). A nut 692 also may abut setup washer 690 on the flat upper surface thereof and rock thereon. A threaded stud (not shown) may 30 be swaged to the end of tensioning wire 658 opposite the end attached to forked member 676, thus coupling wire 658 to the threaded stud by compression. The threaded stud may in turn be threadably associated with nut 692. Wire 658 is provided with suitable length to span from forked member 676 to nut 692.
Pivoting of lever 682 in direction T causes rotation of rocker arm 684, and with tensioning wire 658 coupled to nut 692 and nut 692 abutting insert 690, tension in wire 658 may be increased. In particular, actuation of lever 682 may increase or decrease the tension in wire 658 as desired. By increasing tension in wire 658, central arm 652 preferably becomes increasingly resistant to movement although central arm 652 preferably still may be moved through its full range of motion. Thus, a user may orient curvilinear articulating arm assembly 212 as desired, and then increase the tension of wire 658 so that the orientation of arm 652 is releasably fixed. Lever 668 preferably has an angular range of movement about pin 686a of up to about 90° to permit tension to be generated in tensioning wire 658.
In the preferred exemplary embodiment, actuation of lever 682 free handle 662 permits initial tensioning of central arm 652 while still permitting restricted movement. And, actuation of lever 668 of base handle 660 permits substantially greater tensioning of central arm 652 while also still permitting restricted movement thereof, Advantageously, with tension created in wire 658 of central arm 652 to restrict movement thereof, the orientation of lever 668 such as with respect to a patient still may readily be reset or adjusted before lever 666 in base handle 660 is actuated to create sufficient force to prevent rotation of threaded portion 663d of coupling 663 in the hole in which it is received.
As shown in
In use, in order for example to couple articulating arm assembly 212 to an end effector such as a holder 214, 100, by capturing post 102 of holder 100 in end effector receiving portion 681 of free handle 662, post 102 is inserted therein while interface lock 683 is disposed in the aforementioned disengaged position. While lock 683 is in the disengaged position, post 102 may freely rotate about the central axis of receiving portion 681. Once a desired orientation is set, lock 683 may be translated along the major axis defined by slot 683a so that a portion of cylindrical post 683b of lock 683 is disposed in an engaged position and bears against post 102. Such interference between post 102 of holder 100 and post 683b of lock 683 provides sufficient pressure so that post 102 will remain fixed in rotational position and translation along the longitudinal axis thereof against the inner cylindrical contour of end effector receiving portion 681.
Although an exemplary curvilinear articulating arm assembly is described herein, it should be understood that other preferably, curvilinear articulating arm assemblies instead may be used which preferably provide six degrees of freedom of movement and permit relatively rigid positioning such as described herein.
In some embodiments of the present invention, a transducer holder system such as system 200 may be coupled to a patient support other than a rail of a table. For example, referring next to
In one preferred exemplary embodiment, tray 712 may include two pairs of hold regions 730, each pair being disposed proximate a free cranial end 732 or free caudal end 734 of tray 712. In alternate embodiments, other numbers of hold regions 730 may be provided such as two or more, and hold regions 730 may be provided in other regions of tray 712 such as intermediate ends 732, 734 proximate sides 736, 738. Hold regions 730 may be configured as hand holds, or alternatively may be configured to receive strapping so that tray 712 may be releasably coupled to another object such as an ambulance stretcher, hospital bed, operating room table, or imaging scanner table. In some embodiments, handles may be coupled to tray 712. As also shown in
Turning to
In a preferred exemplary embodiment, tray 712 is formed of natural finish carbon fiber, R-51 foam core, and phenolic. Attenuation preferably is less than 1 mm Al equivalency. Thus, tray 712 is radiolucent and suitable for use with computed axial tomography (CT) scanners. In other embodiments, tray 712 is formed of a material suitable for use with magnetic resonance imaging (MR) scanners. In addition, tray 712 preferably supports a load of 900 lbs. evenly distributed along centerline 746, about which tray 712 may be substantially symmetric as shown. Indicia 748 optionally may be provided, as shown for example proximate ends 732, 734. The indicia may for example indicate preferred orientation of tray 712 with respect to a patient lying thereon.
In the preferred exemplary embodiment, attachment regions 740 on each side of tray 712 are evenly spaced from each other by about 6 inches between centers thereof. To accommodate patients and equipment attached to tray 12, in one preferred embodiment tray 712 has a length of about 78 inches, a width of about 21 inches, a generally uniform thickness of about 0.9 inch, and a height h of about 2.5 inches. Comers may be provided with a radius R1 of about 2 inches. In the preferred exemplary embodiment, attachment regions 740 preferably accommodate threaded inserts, which may be formed of aluminum.
In some embodiments, tray 712 is sized to hold an adult patient, and may be between about 180 cm and about 200 cm long. However, it will be appreciated that longer and shorter trays may be provided. In order to accommodate an adult patient, tray 712 may support an overall weight capacity of at least about 200 pounds, and preferably at least about 300 pounds. However, if a tray 712 is sized for use with a pediatric patient, tray 712 may only accommodate weights that do not exceed 200 pounds, and more preferably do not exceed 100 pounds.
Although the surface of portion 742 of tray 712 is substantially smooth in the preferred exemplary embodiment, in alternate embodiments the surface may be textured to provide additional resistance to motion of objects and/or a patient placed thereon.
Tray 712 thus is suitable for use in multiple environments, and thus may “move” with the patient from one environment (e.g., ambulance) to the next (e.g., CT scanner) without removing a patient supported thereon.
While various descriptions of the present invention are described above, it should be understood that the various features can be used singly or in any combination thereof. Therefore, this invention is not to be limited to only the specifically preferred embodiments depicted herein.
Further, it should be understood that variations and modifications within the spirit and scope of the invention may occur to those skilled in the art to which the invention pertains. For example, although a balloon 52 is disclosed herein for filling with a fluid interface medium such as degassed water to permit energy transmission, other types of fluid reservoirs and configurations may be used. Furthermore, any of a variety of couplings may be used to releasably attach holders 10, 100, 214 as disclosed herein to an articulating arm; such couplings should provide secure attachment. Accordingly, all expedient modifications readily attainable by one versed in the art from the disclosure set forth herein that are within the scope and spirit of the present invention are to be included as further embodiments of the present invention. The scope of the present invention is accordingly defined as set forth in the appended claims.
The benefits of Provisional Application No. 60/746,887 filed May 9, 2006 and entitled “High Frequency Ultrasound Transducer Holder and Adjustable Fluid Interface” are claimed under 35 U.S.C. §119(e), and the entire contents of this provisional application are expressly incorporated herein by reference thereto.
| Number | Date | Country | |
|---|---|---|---|
| 60746887 | May 2006 | US |
