Patent Publication Number: US-2020289084-A1

Title: System and Method for Mounting an Ultrasound Transducer on a Needle

Description:
RELATED APPLICATIONS 
     The present invention claims priority to U.S. Provisional Application No. 62/591,995 filed on Nov. 29, 2017, which is incorporated herein by reference in its entirety. 
    
    
     FIELD OF THE INVENTION 
     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. 
     BACKGROUND 
     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. 
     SUMMARY OF THE INVENTION 
     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. The needle assembly includes a needle defining a lumen from a proximal end to a distal end thereof. The needle includes an outer wall defined by an inner diameter and an outer diameter. Further, the needle assembly includes an ultrasound transducer mounted to the outer wall of the needle at the distal end. Moreover, the ultrasound transducer does not increase the outer diameter of the needle. As such, the needle and the ultrasound transducer can be easily inserted into a patient. 
     In one embodiment, the ultrasound transducer is mounted within a cavity defined within the outer wall of the needle. In such embodiments, the cavity may include a bottom surface defining a predetermined angle with respect to a longitudinal axis of the needle. As such, the ultrasound transducer is configured to sit atop the bottom surface at the predetermined angle. In addition, in certain embodiments, the predetermined angle may be adjustable. 
     In another embodiment, the ultrasound transducer may be mounted to a flap formed with the outer wall of the needle. In such embodiments, the flap extends within the lumen of the needle. Further, the flap may be positioned at a predetermined angle with respect to a longitudinal axis of the needle. As such, the ultrasound transducer is configured to sit atop the flap at the predetermined angle. 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, 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. The method includes machining an outer wall of a needle to accommodate the ultrasound transducer at a distal end of the needle. Further, the method includes mounting the ultrasound transducer to the outer wall of the needle at the machined location such that the ultrasound transducer does not increase the outer diameter of the needle. 
     In one embodiment, the step of machining the outer wall of the needle to accommodate the ultrasound transducer may include forming a cavity within the outer wall of the needle and placing the ultrasound transducer into the cavity. 
     In another embodiment, the method may include forming an angled bottom surface in the cavity and placing the ultrasound transducer atop the angled bottom surface. In such embodiments, the method may also include adjusting an angle of the angled bottom surface. 
     In alternative embodiments, the step of machining the outer wall of the needle to accommodate the ultrasound transducer may include forming a flap in the outer wall of the needle and placing the ultrasound transducer atop the flap. 
     In still another embodiment, 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. 
     These and other features, aspects and advantages of the present invention will become better understood with reference to the following description and appended claims. The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and, together with the description, serve to explain the principles of the invention. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       A full and enabling disclosure of the present invention, including the best mode thereof, directed to one of ordinary skill in the art, is set forth in the specification, which makes reference to the appended figures, in which: 
         FIG. 1  illustrates a perspective view of one embodiment of an imaging system according to the present disclosure; 
         FIG. 2  illustrates a block diagram one of embodiment of a controller of an imaging system according to the present disclosure; 
         FIG. 3  illustrates a cross-sectional view of one embodiment of a needle assembly according to the present disclosure, particularly illustrating an ultrasound transducer mounted to an outer wall of a needle; 
         FIG. 4  illustrates a detailed, side view of one embodiment of a needle assembly according to the present disclosure, particularly illustrating an ultrasound transducer mounted to an angled bottom surface of a cavity within an outer wall of a needle; 
         FIG. 5  illustrates a cross-sectional view of another embodiment of a needle assembly according to the present disclosure, particularly illustrating an ultrasound transducer mounted to a flap formed of an outer wall of a needle; 
         FIG. 6  illustrates a top view of the needle assembly of  FIG. 5 ; 
         FIG. 7  illustrates a perspective view of yet another embodiment of a needle assembly according to the present disclosure, particularly illustrating an ultrasound transducer mounted around an outer wall of a needle; 
         FIG. 8  illustrates a cross-sectional view of still another embodiment of a needle assembly according to the present disclosure, particularly illustrating an ultrasound transducer mounted around an outer wall of a needle with a needle tip mounted adjacent to the transducer; and 
         FIG. 9  illustrates a flow diagram of one embodiment of a method for mounting an ultrasound transducer of an ultrasound imaging system on a needle to be inserted into a patient according to the present disclosure. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     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. It is intended that the invention include these and other modifications and variations as coming within the scope and spirit of the invention. 
     Referring now to the drawings,  FIGS. 1 and 2  illustrate a medical imaging system  10  for scanning, identifying, and navigating anatomical objects of a patient according to the present disclosure. As used herein, the anatomical object(s)  22  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)  22  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)  22  may include upper and lower extremities, as well as compartment blocks. More specifically, in such embodiments, the anatomical object(s)  22  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)  22  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)  22  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  10  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  10  may generally include a controller  12  having one or more processor(s)  14  and associated memory device(s)  16  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  18  configured to display an image  20  of an anatomical object  22  to an operator. In addition, the imaging system  10  may include a user interface  24 , such as a computer and/or keyboard, configured to assist a user in generating and/or manipulating the user display  18 . 
     Additionally, as shown in  FIG. 2 , the processor(s)  14  may also include a communications module  26  to facilitate communications between the processor(s)  14  and the various components of the imaging system  10 , e.g. any of the components of  FIG. 1 . Further, the communications module  26  may include a sensor interface  28  (e.g., one or more analog-to-digital converters) to permit signals transmitted from one or more probes (e.g. the ultrasound transducer  30 ) to be converted into signals that can be understood and processed by the processor(s)  14 . It should be appreciated that the ultrasound transducer  30  may be communicatively coupled to the communications module  26  using any suitable means. For example, as shown in  FIG. 2 , the ultrasound transducer  30  may be coupled to the sensor interface  28  via a wired connection. However, in other embodiments, the ultrasound transducer  30  may be coupled to the sensor interface  28  via a wireless connection, such as by using any suitable wireless communications protocol known in the art. As such, the processor(s)  14  may be configured to receive one or more signals from the ultrasound transducer  30 . 
     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)  14  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)  14  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)  16  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)  16  may generally be configured to store suitable computer-readable instructions that, when implemented by the processor(s)  14 , configure the processor(s)  14  to perform the various functions as described herein. 
     Referring now to  FIGS. 3-8 , various embodiments of a needle assembly  32  for the ultrasound imaging system  10  are illustrated. More specifically, as shown, the needle assembly  32  includes a needle  34  and the ultrasound transducer  30  mounted thereto. The ultrasound transducer  30  described herein may have any suitable configuration. For example, as shown in  FIGS. 3-6 , the ultrasound transducer  30  corresponds to a flat unidirectional transducer. Alternatively, as shown in  FIGS. 7 and 8 , the ultrasound transducer  30  may correspond to a cylindrical transducer. Further, as shown, the needle  34  defines a lumen  40  from a proximal end (not shown) to a distal end  36  thereof. In addition, as shown particularly in  FIGS. 3 and 5 , the needle  34  includes an outer wall  38  defined by an inner diameter  42  and an outer diameter  44 . Moreover, as shown, the ultrasound transducer  30  is mounted to the outer wall  38  of the needle  34  at the distal end  36 . 
     More specifically, as shown in the embodiment of  FIGS. 3 and 4 , the ultrasound transducer  30  is mounted within a cavity  46  defined within the outer wall  38  of the needle  34 . In such embodiments, the cavity  46  may include a bottom surface  48  defining a predetermined angle  50  with respect to a longitudinal axis  52  of the needle  34 . As such, the ultrasound transducer  30  is configured to sit atop the bottom surface  48  of the cavity  46  at the predetermined angle  50 . In addition, in certain embodiments, the predetermined angle  50  may be adjustable. For example, as shown, the predetermined angle  50  may be adjusted as shown by the dotted lines. Thus, the predetermined angle  50  described herein can be chosen to change and/or maximize the signal return and receive from the ultrasound transducer  30 . 
     In additional embodiments, where the transducer  30  includes one or more wires  57  connected to the sensor interface  28 , the outer wall  38  may also include one or more grooves  55  for receiving the wire(s)  57 . In such embodiments, as shown, the groove(s)  55  may be embedded within the outer wall  38  of the needle  34 . 
     Referring particularly to  FIGS. 5 and 6 , the ultrasound transducer  30  may be mounted to a flap  54  formed with the outer wall  38  of the needle  34 . In such embodiments, as shown, the flap  54  extends within the lumen  40  of the needle  34 . Further and similar to the embodiment of  FIGS. 3 and 4 , the flap  54  may be positioned at the predetermined angle  50  with respect to the longitudinal axis  52  of the needle  34 . As such, the ultrasound transducer  30  is configured to sit atop the flap  54  at the predetermined angle  50 . In addition, in certain embodiments, the predetermined angle  50  may be adjustable. Further, as shown, the predetermined angle  50  may be limited by the outer wall  38  of the needle  34 . 
     Referring now to  FIGS. 7 and 8 , where in the ultrasound transducer  30  corresponds to a cylindrical transducer, the distal end  36  of the needle  34  may include a small outer diameter  56  than the diameter  58  at the proximal end. Thus, as shown particularly in  FIG. 8 , the cylindrical transducer  30  fits around the small outer diameter  56  of the distal end  36  of the needle  34 . In further embodiments, a portion  60  of the distal end  36  of the needle  34  may extend beyond the cylindrical transducer  30 . In such embodiments, as shown in  FIG. 8 , the needle assembly  32  may include a needle tip  62  secured to the portion  60  of the distal end  36  of the needle  34  that extends beyond the cylindrical transducer  30 . For example, in one embodiment, the needle tip  62  may be secured to the distal portion  60  of the needle  34  via laser or spot welding. Such a configuration secures the transducer  30  to the needle  34 . 
     In particular embodiments, as generally shown in the figures, the ultrasound transducer  30  does not increase the outer diameter  44  of the needle  34 . As such, the needle  34  and the ultrasound transducer  30  can be easily inserted into a patient. 
     Referring now to  FIG. 9 , a flow diagram of one embodiment of a method  100  for mounting the ultrasound transducer  30  of the ultrasound imaging system  10  on the needle  34  to be inserted into a patient is illustrated. As shown at  102 , the method  100  includes machining the outer wall  38  of the needle  34  to accommodate the ultrasound transducer  30  at the distal end  36  of the needle  34 . As shown at  104 , the method  100  includes mounting the ultrasound transducer  30  to the outer wall  36  of the needle  34  at the machined location. 
     For example, in one embodiment, the step of machining the outer wall  38  of the needle  34  to accommodate the ultrasound transducer  30  may include forming the cavity  46  ( FIGS. 3 and 4 ) within the outer wall  38  of the needle and placing the ultrasound transducer into the cavity  46 . In another embodiment, the method  100  may include forming an angled bottom surface  48  in the cavity  46  and placing the ultrasound transducer  30  atop the angled bottom surface  48 . In such embodiments, the method  100  may also include adjusting the angle  50  of the angled bottom surface  48 . 
     In alternative embodiments, the step of machining the outer wall  38  of the needle  34  to accommodate the ultrasound transducer  30  may include forming the flap  54  in the outer wall  38  of the needle  34  and placing the ultrasound transducer  30  atop the flap  54 . In still another embodiment, the step of machining the outer wall  38  of the needle  34  to accommodate the ultrasound transducer  30  may include removing a cylindrical portion of the outer wall  38  of the needle  34  ( FIGS. 7 and 8 ) to decrease the outer diameter of the needle  34  at the distal end  36  thereof and placing the ultrasound transducer  30  around the reduced outer diameter  56 . 
     In additional embodiments, the method  100  may include forming one or more grooves  55  in the outer wall  38  of the needle  34  and routing one or more wires  57  associated with the ultrasound transducer  30  through the groove(s)  55 . 
     This written description uses examples to disclose the invention, including the best mode, and also to enable any person skilled in the art to practice the invention, including making and using any devices or systems and performing any incorporated methods. The patentable scope of the invention is defined by the claims, and may include other examples that occur to those skilled in the art. Such other examples are intended to be within the scope of the claims if they include structural elements that do not differ from the literal language of the claims, or if they include equivalent structural elements with insubstantial differences from the literal languages of the claims.