Patent Description:
The present invention relates to generally to medical imaging, and more particularly, to systems and methods for mounting an ultrasound transducer of an ultrasound imaging system on a needle to be inserted into a patient.

Detection of anatomical objects using medical imaging is an essential step for many medical procedures, such as regional anesthesia nerve blocks, and is becoming the standard in clinical practice to support diagnosis, patient stratification, therapy planning, intervention, and/or follow-up. Various systems based on traditional approaches exist for anatomical detection and tracking in medical images, such as computed tomography (CT), magnetic resonance (MR), ultrasound, and fluoroscopic images.

For example, ultrasound imaging systems utilize sound waves with frequencies higher than the upper audible limit of human hearing. Further, ultrasound imaging systems are widely used in medicine to perform both diagnosis and therapeutic procedures. In such procedures, sonographers perform scans of a patient using a hand-held probe or transducer that is placed directly on and moved over the patient.

Ultrasonic transducers come in a variety of different shapes and sizes for use in making cross-sectional images of various parts of the body. The transducer may be passed over the surface and in contact with the body or may be inserted into a patient. Oftentimes, however, it can be difficult to locate the transducer within a patient at a desired target site. In addition, it can be challenging to maintain the transducer at a certain angle that allows for optimal signal processing of the sound waves.

Accordingly, the present disclosure is directed to a system and method for mounting an ultrasound transducer on a needle to be inserted into a patient that addresses the aforementioned issues.

A prior art needle assembly, having the features of the preamble of claim <NUM>, is disclosed in <CIT>. Further prior art needle assemblies are disclosed in <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT> and <CIT>.

Objects and advantages of the invention will be set forth in part in the following description, or may be obvious from the description, or may be learned through practice of the invention.

In one aspect, the present invention is directed to a needle assembly for an ultrasound imaging system, in accordance with claim <NUM>. In addition, in certain embodiments, the predetermined angle may be adjustable.

In additional embodiments, the ultrasound transducer may be a flat unidirectional transducer. Alternatively, the ultrasound transducer may include a cylindrical transducer. In such embodiments, the distal end of the needle may include a small outer diameter than the proximal end. Thus, the cylindrical transducer fits around the small outer diameter of the distal end of the needle.

In further embodiments, which are not claimed, a portion of the distal end of the needle may extend beyond the cylindrical transducer. In such embodiments, the needle assembly may include a needle tip secured to the portion of the distal end of the needle that extends beyond the cylindrical transducer.

In yet another embodiment, the outer wall may include one or more grooves for receiving one or more wires associated with the ultrasound transducer. In such embodiments, the groove(s) may be embedded within the outer wall of the needle.

In another aspect, the present invention is directed to a method for mounting an ultrasound transducer of an ultrasound imaging system on a needle to be inserted into a patient, in accordance with claim <NUM>. In some embodiments, the method may also include adjusting an angle of the angled bottom surface.

In still another embodiment, not falling within the scope of the invention, the step of machining the outer wall of the needle to accommodate the ultrasound transducer may include removing a cylindrical portion of the outer wall of the needle to decrease the outer diameter of the needle and placing the ultrasound transducer around the reduced outer diameter.

In additional embodiments, the method may include forming one or more grooves in the outer wall of the needle and routing one or more wires associated with the ultrasound transducer through the one or more grooves. It should also be understood that the method may further include any of the additional steps and/or features as described herein.

Reference will now be made in detail to one or more embodiments of the invention, examples of the invention, examples of which are illustrated in the drawings. Each example and embodiment is provided by way of explanation of the invention, and is not meant as a limitation of the invention. For example, features illustrated or described as part of one embodiment may be used with another embodiment to yield still a further embodiment, as far as this embodiment falls within the scope of the appended claims.

Referring now to the drawings, <FIG> and <FIG> illustrate a medical imaging system <NUM> for scanning, identifying, and navigating anatomical objects of a patient according to the present disclosure. As used herein, the anatomical object(s) <NUM> and surrounding tissue described herein may include any anatomical structure and/or surrounding tissue of a patient. For example, in one embodiment, the anatomical object(s) <NUM> may include an interscalene brachial plexus of the patient, which generally corresponds to the network of nerves running from the spine, formed by the anterior rami of the lower four cervical nerves and first thoracic nerve. As such, the surrounding tissue of the brachial plexus generally corresponds to the sternocleidomastoid muscle, the middle scalene muscle, the anterior scalene muscle, and/or similar. It should be understood, however, that the system and method of the present disclosure may be further used for any variety of medical procedures involving any anatomical structure in addition to those relating to the brachial plexus. For example, the anatomical object(s) <NUM> may include upper and lower extremities, as well as compartment blocks. More specifically, in such embodiments, the anatomical object(s) <NUM> of the upper extremities may include interscalene muscle, supraclavicular muscle, infraclavicular muscle, and/or axillary muscle nerve blocks, which all block the brachial plexus (a bundle of nerves to the upper extremity), but at different locations. Further, the anatomical object(s) <NUM> of the lower extremities may include the lumbar plexus, the fascia Iliac, the femoral nerve, the sciatic nerve, the abductor canal, the popliteal, the saphenous (ankle), and/or similar. In addition, the anatomical object(s) <NUM> of the compartment blocks may include the intercostal space, transversus abdominus plane, and thoracic paravertebral space, and/or similar.

More specifically, as shown, the imaging system <NUM> may correspond to an ultrasound imaging system or any other suitable imaging system that can benefit from the present technology. Thus, as shown, the imaging system <NUM> may generally include a controller <NUM> having one or more processor(s) <NUM> and associated memory device(s) <NUM> configured to perform a variety of computer-implemented functions (e.g., performing the methods and the like and storing relevant data as disclosed herein), as well as a user display <NUM> configured to display an image <NUM> of an anatomical object <NUM> to an operator. In addition, the imaging system <NUM> may include a user interface <NUM>, such as a computer and/or keyboard, configured to assist a user in generating and/or manipulating the user display <NUM>.

Additionally, as shown in <FIG>, the processor(s) <NUM> may also include a communications module <NUM> to facilitate communications between the processor(s) <NUM> and the various components of the imaging system <NUM>, e.g. any of the components of <FIG>. Further, the communications module <NUM> may include a sensor interface <NUM> (e.g., one or more analog-to-digital converters) to permit signals transmitted from one or more probes (e.g. the ultrasound transducer <NUM>) to be converted into signals that can be understood and processed by the processor(s) <NUM>. It should be appreciated that the ultrasound transducer <NUM> may be communicatively coupled to the communications module <NUM> using any suitable means. For example, as shown in <FIG>, the ultrasound transducer <NUM> may be coupled to the sensor interface <NUM> via a wired connection. However, in other embodiments, the ultrasound transducer <NUM> may be coupled to the sensor interface <NUM> via a wireless connection, such as by using any suitable wireless communications protocol known in the art. As such, the processor(s) <NUM> may be configured to receive one or more signals from the ultrasound transducer <NUM>.

As used herein, the term "processor" refers not only to integrated circuits referred to in the art as being included in a computer, but also refers to a controller, a microcontroller, a microcomputer, a programmable logic controller (PLC), an application specific integrated circuit, a field-programmable gate array (FPGA), and other programmable circuits. The processor(s) <NUM> is also configured to compute advanced control algorithms and communicate to a variety of Ethernet or serial-based protocols (Modbus, OPC, CAN, etc.). Furthermore, in certain embodiments, the processor(s) <NUM> may communicate with a server through the Internet for cloud computing in order to reduce the computation time and burden on the local device. Additionally, the memory device(s) <NUM> may generally comprise memory element(s) including, but not limited to, computer readable medium (e.g., random access memory (RAM)), computer readable non-volatile medium (e.g., a flash memory), a floppy disk, a compact disc-read only memory (CD-ROM), a magneto-optical disk (MOD), a digital versatile disc (DVD) and/or other suitable memory elements. Such memory device(s) <NUM> may generally be configured to store suitable computer-readable instructions that, when implemented by the processor(s) <NUM>, configure the processor(s) <NUM> to perform the various functions as described herein.

Referring now to <FIG>, various embodiments of a needle assembly <NUM> for the ultrasound imaging system <NUM> are illustrated. The embodiments shown in <FIG> and <FIG> do not fall within the wording of the claims but help to illustrate features of the invention in accordance with the embodiment shown in <FIG>. More specifically, as shown, the needle assembly <NUM> includes a needle <NUM> and the ultrasound transducer <NUM> mounted thereto. The ultrasound transducer <NUM> described herein may have any suitable configuration. For example, as shown in <FIG>, the ultrasound transducer <NUM> corresponds to a flat unidirectional transducer. Alternatively, as shown in <FIG>, the ultrasound transducer <NUM> may correspond to a cylindrical transducer. Further, as shown, the needle <NUM> defines a lumen <NUM> from a proximal end (not shown) to a distal end <NUM> thereof. In addition, as shown particularly in <FIG> and <FIG>, the needle <NUM> includes an outer wall <NUM> defined by an inner diameter <NUM> and an outer diameter <NUM>. Moreover, as shown, the ultrasound transducer <NUM> is mounted to the outer wall <NUM> of the needle <NUM> at the distal end <NUM>.

More specifically, as shown in the embodiment of <FIG>, the ultrasound transducer <NUM> is mounted within a cavity <NUM> defined within the outer wall <NUM> of the needle <NUM>. The cavity <NUM> includes a bottom surface <NUM> defining a predetermined angle <NUM> with respect to a longitudinal axis <NUM> of the needle <NUM>. As such, the ultrasound transducer <NUM> is configured to sit atop the bottom surface <NUM> of the cavity <NUM> at the predetermined angle <NUM>. In addition, in certain embodiments, the predetermined angle <NUM> may be adjustable. For example, as shown, the predetermined angle <NUM> may be adjusted as shown by the dotted lines. Thus, the predetermined angle <NUM> described herein can be chosen to change and/or maximize the signal return and receive from the ultrasound transducer <NUM>.

In additional embodiments, where the transducer <NUM> includes one or more wires <NUM> connected to the sensor interface <NUM>, the outer wall <NUM> may also include one or more grooves <NUM> for receiving the wire(s) <NUM>. In such embodiments, as shown, the groove(s) <NUM> may be embedded within the outer wall <NUM> of the needle <NUM>.

Referring particularly to <FIG>, in an example outside the wording of the claims, the ultrasound transducer <NUM> may be mounted to a flap <NUM> formed with the outer wall <NUM> of the needle <NUM>. In such embodiments, as shown, the flap <NUM> extends within the lumen <NUM> of the needle <NUM>. Further and similar to the embodiment of <FIG>, the flap <NUM> may be positioned at the predetermined angle <NUM> with respect to the longitudinal axis <NUM> of the needle <NUM>. As such, the ultrasound transducer <NUM> is configured to sit atop the flap <NUM> at the predetermined angle <NUM>. In addition, in certain embodiments, the predetermined angle <NUM> may be adjustable. Further, as shown, the predetermined angle <NUM> may be limited by the outer wall <NUM> of the needle <NUM>.

Referring now to <FIG>, which is a further example not falling within the scope of the invention, where in the ultrasound transducer <NUM> corresponds to a cylindrical transducer, the distal end <NUM> of the needle <NUM> may include a small outer diameter <NUM> than the diameter <NUM> at the proximal end. Thus, as shown particularly in <FIG>, the cylindrical transducer <NUM> fits around the small outer diameter <NUM> of the distal end <NUM> of the needle <NUM>. In further embodiments, a portion <NUM> of the distal end <NUM> of the needle <NUM> may extend beyond the cylindrical transducer <NUM>. In such embodiments, as shown in <FIG>, the needle assembly <NUM> may include a needle tip <NUM> secured to the portion <NUM> of the distal end <NUM> of the needle <NUM> that extends beyond the cylindrical transducer <NUM>. For example, in one embodiment, the needle tip <NUM> may be secured to the distal portion <NUM> of the needle <NUM> via laser or spot welding. Such a configuration secures the transducer <NUM> to the needle <NUM>.

In accordance with the invention, as generally shown in the figures, the ultrasound transducer <NUM> does not increase the outer diameter <NUM> of the needle <NUM>. As such, the needle <NUM> and the ultrasound transducer <NUM> can be easily inserted into a patient.

Referring now to <FIG>, a flow diagram of one embodiment of a method <NUM> for mounting the ultrasound transducer <NUM> of the ultrasound imaging system <NUM> on the needle <NUM> to be inserted into a patient is illustrated. As shown at <NUM>, the method <NUM> includes machining the outer wall <NUM> of the needle <NUM> to accommodate the ultrasound transducer <NUM> at the distal end <NUM> of the needle <NUM>. As shown at <NUM>, the method <NUM> includes mounting the ultrasound transducer <NUM> to the outer wall <NUM> of the needle <NUM> at the machined location.

The step of machining the outer wall <NUM> of the needle <NUM> to accommodate the ultrasound transducer <NUM> includes forming the cavity <NUM> (<FIG>) within the outer wall <NUM> of the needle and placing the ultrasound transducer into the cavity <NUM>. The method <NUM> includes forming an angled bottom surface <NUM> in the cavity <NUM> and placing the ultrasound transducer <NUM> atop the angled bottom surface <NUM>. In such embodiments, the method <NUM> may also include adjusting the angle <NUM> of the angled bottom surface <NUM>.

In an example outside the wording of the claims, the step of machining the outer wall <NUM> of the needle <NUM> to accommodate the ultrasound transducer <NUM> may include forming the flap <NUM> in the outer wall <NUM> of the needle <NUM> and placing the ultrasound transducer <NUM> atop the flap <NUM>. In still another embodiment, not falling within the scope of the invention, the step of machining the outer wall <NUM> of the needle <NUM> to accommodate the ultrasound transducer <NUM> may include removing a cylindrical portion of the outer wall <NUM> of the needle <NUM> (<FIG>) to decrease the outer diameter of the needle <NUM> at the distal end <NUM> thereof and placing the ultrasound transducer <NUM> around the reduced outer diameter <NUM>.

In additional embodiments, the method <NUM> may include forming one or more grooves <NUM> in the outer wall <NUM> of the needle <NUM> and routing one or more wires <NUM> associated with the ultrasound transducer <NUM> through the groove(s) <NUM>.

Claim 1:
A needle assembly (<NUM>) for an ultrasound imaging system (<NUM>), the needle assembly (<NUM>) comprising:
a needle (<NUM>) suitable to be inserted into a patient, the needle (<NUM>) defining a lumen (<NUM>) from a proximal end to a distal end (<NUM>) thereof, the needle (<NUM>) comprising an outer wall (<NUM>) defined by an inner diameter and an outer diameter; and,
an ultrasound transducer (<NUM>) mounted to the outer wall (<NUM>) of the needle (<NUM>) at the distal end, wherein the ultrasound transducer (<NUM>) does not increase the outer diameter of the needle (<NUM>),
wherein a cavity (<NUM>) is defined within the outer wall (<NUM>) of the needle (<NUM>), characterized in that the cavity (<NUM>) comprises an angled bottom surface (<NUM>) defining a predetermined angle (<NUM>) with respect to a longitudinal axis (<NUM>) of the needle (<NUM>), and the ultrasound transducer (<NUM>) is mounted within the cavity (<NUM>) to sit atop the angled bottom surface (<NUM>).