Apparatus for delivering high intensity focused ultrasound energy to a treatment site internal to a patient's body

Abstract

An apparatus for delivering HIFU energy may include a probe with a plurality of leaves that provide a bowl-shaped HIFU therapy transducer. In once case, pins may slide within grooves in the leaves to deploy the leaves. In another case, spines may be configured to slide in a channel defined in each leaf. In other cases, a spring or a shape memory alloy may be used to deploy the leaves. In another implementation, a probe may be fitted with a flexible material that couples the HIFU therapy transducer to the probe and allows the transducer to be drawn to the side of the probe for insertion. In another implementation, a probe may have one or more inflatable bladders that form the HIFU therapy transducer. In yet another implementation, a probe may have an imaging component and a HIFU therapy transducer disposed thereon that rotate, as a unit, about a hinge.

1 . An apparatus for delivering high intensity focused ultrasound (HIFU) energy to a treatment site internal to a patient's body, comprising:
 an elongate probe having a proximal end and a distal end, the proximal end having a section adapted for positioning the distal end of the probe at a desired location within the patient's body;   wherein the distal end of the probe has a HIFU therapy transducer coupled thereto, the HIFU therapy transducer comprising a plurality of leaves, each leaf having a proximal end, a distal end, and a deployment mechanism, wherein the proximal end of each leaf is coupled to the distal end of the probe,   each leaf further having a front surface adapted to direct HIFU energy to the treatment site when the probe is inserted in the patient's body and the deployment mechanism is activated;   wherein, when activated, the deployment mechanism is configured to deploy the leaves by directing the distal end of the leaves in a radially outward direction, the leaves thus deployed collectively providing a bowl-shaped HIFU therapy transducer having an outer edge with a diameter that is larger than the diameter of the probe and an aperture of a size sufficient to direct therapeutic HIFU energy to the treatment site; and   wherein, to facilitate insertion of the probe in the patient's body, the plurality of leaves are configured to collapse when the deployment mechanism is not activated, the collapsed leaves occupying a space having a diameter smaller than the diameter of the outer edge of the HIFU therapy transducer when the leaves are deployed.   
   
   
       2 . The apparatus of  claim 1 , wherein the elongate probe includes a sleeve disposed around a shaft, the sleeve having a proximal end, a distal end, and a longitudinal axis extending therebetween, and the shaft being configured to slide within the sleeve from a retracted position to an extended position along the longitudinal axis. 
   
   
       3 . The apparatus of  claim 2 , wherein the proximal end of each leaf is coupled to a distal end of the shaft, wherein the deployment mechanism of each leaf includes a pin coupled to the sleeve, the pin being configured to slide within a groove defined in the leaf, and wherein activation of the deployment mechanism comprises sliding the shaft within the sleeve toward the extended position, such activation causing each leaf to be pushed outward from the distal end of the sleeve, the pin sliding within the groove in each respective leaf to direct the distal end of the leaf radially outward to a desired position to provide the bowl-shaped HIFU transducer. 
   
   
       4 . The apparatus of  claim 3 , wherein the leaves are held within the sleeve next to the shaft when the deployment mechanism is not activated and the shaft is in the retracted position. 
   
   
       5 . The apparatus of  claim 4 , wherein at least a portion of a leaf in the plurality of leaves is configured to overlap at least a portion of another leaf when the leaves are held within the sleeve. 
   
   
       6 . The apparatus of  claim 3 , wherein the distal end of the shaft extends beyond the distal end of the sleeve when the shaft is in the extended position, thus exposing the distal end of the shaft outside the sleeve. 
   
   
       7 . The apparatus of  claim 3 , wherein the pin includes a detent configured to secure the pin within the groove in the respective leaf. 
   
   
       8 . The apparatus of  claim 3 , wherein the groove in each leaf is defined at an angle relative to the longitudinal axis of the sleeve. 
   
   
       9 . The apparatus of  claim 2 , wherein the shaft includes an actuator configured to drive the shaft between the retracted and extended positions. 
   
   
       10 . The apparatus of  claim 2 , wherein the proximal end of each leaf is coupled to a distal end of the sleeve, wherein the deployment mechanism of each leaf includes a spine coupled to the shaft, the spine being configured to slide within the sleeve into a channel defined in the leaf, and wherein activation of the deployment mechanism comprises sliding the shaft within the sleeve toward the extended position, such activation causing the spine for each leaf to be pushed into the channel of the respective leaf to direct the distal end of the leaf radially outward to a desired position to provide the bowl-shaped HIFU transducer. 
   
   
       11 . The apparatus of  claim 10 , wherein the spine for each leaf is held within the sleeve when the deployment mechanism is not activated and the shaft is in the retracted position. 
   
   
       12 . The apparatus of  claim 10 , wherein the leaves, when collapsed, are capable of being grouped together to occupy a space having a diameter that is equal to or smaller than the diameter of the sleeve. 
   
   
       13 . The apparatus of  claim 2 , wherein the proximal end of each leaf is coupled to a distal end of the shaft, wherein the deployment mechanism of each leaf includes a spring having a first end coupled to the shaft and a second end disposed within the leaf, and wherein activation of the deployment mechanism comprises sliding the shaft within the sleeve toward the extended position, such activation causing each leaf to be pushed outward from the distal end of the sleeve, the second end of the spring in each leaf being configured to bias the distal end of the respective leaf in a radially outward direction to a desired position to provide the bowl-shaped HIFU transducer when the shaft is in the extended position. 
   
   
       14 . The apparatus of  claim 1 , wherein the distal end of the probe further has an imaging component coupled thereto, the imaging component being adapted to produce an image of a portion of the patient's body that includes the treatment site to help guide the delivery of HIFU energy to the treatment site. 
   
   
       15 . The apparatus of  claim 14 , wherein the imaging component is configured to use reflected ultrasound energy to produce the image of the portion of the patient's body. 
   
   
       16 . The apparatus of  claim 14 , wherein the imaging component is configured to use reflected light to produce the image of the portion of the patient's body. 
   
   
       17 . The apparatus of  claim 14 , wherein the image further includes a portion of the HIFU therapy transducer to assist in positioning the HIFU therapy transducer within the patient's body and in monitoring HIFU therapy at the treatment site. 
   
   
       18 . The apparatus of  claim 1 , wherein the HIFU therapy transducer is coupled to the distal end of the probe via a hinge having an axis about which the transducer can rotate to aim the HIFU energy toward the treatment site. 
   
   
       19 . The apparatus of  claim 1 , wherein at least a portion of the leaves are formed of an energy-activated shape memory alloy and the deployment mechanism includes a coupling of the shape memory alloy to an energy source, wherein activation of the deployment mechanism comprises delivering energy from the energy source to the shape memory alloy of each leaf to cause the shape memory alloy to take a predefined shape in which the distal end of the leaves are directed radially outward to provide the bowl-shaped HIFU transducer. 
   
   
       20 . The apparatus of  claim 19 , wherein the portion of the leaves formed of a shape memory alloy is configured as a spine in each leaf. 
   
   
       21 . The apparatus of  claim 1 , further comprising an active element disposed on the front surface of at least one of the leaves, wherein the active element is operable to generate the HIFU energy that is directed to the treatment site. 
   
   
       22 . The apparatus of  claim 1 , wherein the front surface of at least one of the leaves is configured to reflect HIFU energy toward the treatment site, said HIFU energy being received from a source that is remote from the leaf. 
   
   
       23 . An apparatus for delivering high intensity focused ultrasound (HIFU) energy to a treatment site internal to a patient's body, comprising:
 an elongate probe having a proximal end, a distal end, and a longitudinal axis extending therebetween, the proximal end of the probe having a section adapted for positioning the distal end of the probe at a desired location within the patient's body;   wherein the distal end of the probe is fitted with a flexible material that couples a HIFU therapy transducer to the probe, the HIFU therapy transducer having a major axis across its face and an aperture of a size sufficient to direct therapeutic HIFU energy to the treatment site, the flexible material having a resting state in which the transducer is deployed in a therapy position wherein the major axis of the transducer is non-parallel to the longitudinal axis of the probe;   wherein, to facilitate insertion of the probe in the patient's body, the flexible material is configured to stretch and allow the transducer to be drawn to the side of the probe to an insertion position wherein the major axis of the transducer is generally parallel to the longitudinal axis of the probe, the flexible material exhibiting a bias to return toward its resting state after the probe has been inserted in the patient's body and the transducer has been released.   
   
   
       24 . The apparatus of  claim 23 , further comprising an actuator coupled to the transducer that can be manipulated to draw the transducer to the side of the probe and to deploy the transducer to the therapy position. 
   
   
       25 . The apparatus of  claim 23 , wherein the distal end of the probe further includes an imaging component adapted for producing an image of a portion of the patient's body that includes the treatment site to help guide the delivery of HIFU energy to the treatment site. 
   
   
       26 . The apparatus of  claim 25 , wherein the imaging component is configured to use reflected ultrasound energy to produce the image of the portion of the patient's body. 
   
   
       27 . The apparatus of  claim 25 , wherein the imaging component is configured to use reflected light to produce the image of the portion of the patient's body. 
   
   
       28 . The apparatus of  claim 25 , wherein the image further includes a portion of the HIFU therapy transducer to assist in positioning the HIFU therapy transducer within the patient's body and in monitoring HIFU therapy at the treatment site. 
   
   
       29 . The apparatus of  claim 23 , wherein the flexible material is comprised of a resilient non-metal material. 
   
   
       30 . The apparatus of  claim 23 , wherein the flexible material is comprised of a shape memory alloy having a stretched state or resting state dependent on energy activation of the alloy. 
   
   
       31 . The apparatus of  claim 23 , further comprising an active element disposed on the HIFU therapy transducer, wherein the active element is operable generate the HIFU energy that is directed to the treatment site. 
   
   
       32 . The apparatus of  claim 23 , wherein the HIFU therapy transducer is configured to reflect HIFU energy toward the treatment site, said HIFU energy being received from a source that is remote from the transducer. 
   
   
       33 . An apparatus for delivering high intensity focused ultrasound (HIFU) energy to a treatment site internal to a patient's body, comprising:
 an elongate probe having a proximal end and a distal end, the proximal end of the probe having a section adapted for positioning the distal end of the probe at a desired location within the patient's body;   wherein the distal end of the probe is fitted with a flexible material having one or more inflatable bladders that, when inflated, provide a HIFU therapy transducer having an aperture of a size sufficient to direct therapeutic HIFU energy to the treatment site, the inflatable bladders extending radially outward from the distal end of the probe, and wherein, to facilitate insertion of the probe in the patient's body, the bladders are not inflated until after the probe is inserted in the patient's body;   the flexible material further having a front surface adapted to direct HIFU energy to the treatment site when the probe is inserted in the patient's body and the bladders are inflated, and   wherein, when inflated, the bladders provide lateral support to the HIFU therapy transducer and the transducer has an aperture that is larger than the diameter of the probe.   
   
   
       34 . The apparatus of  claim 33 , wherein the bladders comprise one or more inflatable channels that extend radially outward from the distal end of the probe, and wherein the front face of the flexible material extends between the inflatable channels. 
   
   
       35 . The apparatus of  claim 34 , wherein the inflatable channels terminate in an inflatable ring that forms an outer edge of the HIFU therapy transducer. 
   
   
       36 . The apparatus of  claim 35 , wherein when inflated, the diameter of the ring is larger than the diameter of the probe. 
   
   
       37 . The apparatus of  claim 33 , further comprising an active element disposed on the front surface of the flexible material, wherein the active element is operable generate the HIFU energy that is directed to the treatment site. 
   
   
       38 . The apparatus of  claim 33 , wherein the front surface of the flexible material is configured to reflect HIFU energy toward the treatment site, said HIFU energy being received from a source that is remote from the flexible material. 
   
   
       39 . The apparatus of  claim 33 , wherein the distal end of the probe further includes an imaging component adapted for producing an image of a portion of the patient's body that includes the treatment site to help guide the delivery of HIFU energy to the treatment site. 
   
   
       40 . The apparatus of  claim 39 , wherein the imaging component is configured to use reflected ultrasound energy to produce the image of the portion of the patient's body. 
   
   
       41 . The apparatus of  claim 39 , wherein the imaging component is configured to use reflected light to produce the image of the portion of the patient's body. 
   
   
       42 . The apparatus of  claim 39 , wherein the image further includes a portion of the HIFU therapy transducer to assist in positioning the HIFU therapy transducer within the patient's body and in monitoring HIFU therapy at the treatment site. 
   
   
       43 . The apparatus of  claim 33 , wherein the bladders, when not inflated, occupy a space having a diameter smaller than the diameter of the HIFU therapy transducer when the bladders are inflated. 
   
   
       44 . The apparatus of  claim 33 , wherein the bladders are inflated using a fluid that is circulated to and from the bladders to control a temperature of the HIFU therapy transducer and tissue adjacent to the HIFU therapy transducer when the probe is inserted into the patient. 
   
   
       45 . An apparatus for delivering image-guided high intensity focused ultrasound (HIFU) energy to a treatment site internal to a patient's body, comprising:
 an elongate probe having a proximal end, a distal end, and a longitudinal axis extending therebetween, the proximal end of the probe having a section adapted for positioning the distal end of the probe at a desired location within the patient's body;   a support structure having an imaging component and a HIFU therapy transducer disposed thereon; and   a hinge connecting the support structure to the distal end of the probe,   wherein the imaging component is adapted for producing an image of a portion of the patient's body that includes the treatment site,   wherein the HIFU therapy transducer has an aperture of a size sufficient to direct therapeutic HIFU energy to the treatment site and is disposed on the support structure in defined relation to the imaging component, and   wherein, to facilitate insertion of the probe in the patient's body, the support structure is capable of rotating about the hinge to an insertion position generally parallel to the longitudinal axis of the probe, and after insertion of the probe in the patient's body, the support structure is capable of rotating about the hinge to a position non-parallel to the longitudinal axis of the probe, the hinge providing an articulation that enables the imaging and therapy transducers as a unit to be positioned relative to the treatment site in the patient's body.   
   
   
       46 . The apparatus of  claim 45 , wherein the HIFU therapy transducer is bowl-shaped and the imaging component is disposed within the interior of the therapy transducer. 
   
   
       47 . The apparatus of  claim 45 , wherein the imaging component is disposed on the support structure to the exterior of the HIFU therapy transducer. 
   
   
       48 . The apparatus of  claim 45 , wherein the imaging component is configured to use reflected ultrasound energy to produce the image of the portion of the patient's body. 
   
   
       49 . The apparatus of  claim 48 , wherein the imaging and delivery of HIFU therapy are performed using same transducer. 
   
   
       50 . The apparatus of  claim 45 , wherein the imaging component is configured to use reflected light to produce the image of the portion of the patient's body. 
   
   
       51 . The apparatus of  claim 45 , wherein the image produced by the imaging component includes a portion of the HIFU therapy transducer to assist in positioning the HIFU therapy transducer within the patient's body and in monitoring HIFU therapy at the treatment site. 
   
   
       52 . The apparatus of  claim 45 , wherein the dimension of the therapy transducer in its insertion position and measured perpendicular to the longitudinal axis of the probe is smaller than the dimension of the transducer measured parallel to the longitudinal axis.