WO2019108724A1 - Needle assembly having a stylet transducer and injection capability - Google Patents

Abstract

A needle assembly for an ultrasound imaging system 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 a stylet configured to be received within the lumen of the needle. The stylet includes a proximal end and a distal end. The distal end of the stylet includes a transducer and a lens for diverting signals of the transducer through the distal end of the needle.

Description

NEEDLE ASSEMBLY HAVING A STYLET

TRANSDUCER AND INJECTION CAPABILITY

RELATED APPLICATIONS

The present invention claims priority relates to U.S. Provisional Application No.: 62/592,013 filed on November 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 a needle assembly of an ultrasound imaging system having a transducer and injection capability.

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, where a needle and stylet is used, it can be challenging to inject a fluid while the stylet is in place.

Accordingly, the present disclosure is directed to a needle assembly of an ultrasound imaging system having a stylet transducer and injection capability that i 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 article configured to be received within the lumen of the needle. The article includes a proximal end and a distal end. The distal end of the article includes a transducer and a lens for diverting signals of the transducer through the distal end of the needle.

In one embodiment, the article may be a stylet or a catheter. In another embodiment, the needle may further include a window at the distal end thereof, the lens of the article being aligned with the window, wherein the transducer is configured to transmit signals through the window via the lens. In another embodiment, the lens of the article may be positioned at a predetermined angle with respect to a longitudinal axis of the transducer. For example, in certain

embodiments, the predetermined angle may include angles ranging from greater than zero (0) degrees to about 90 degrees. More specifically, in one embodiment, the predetermined angle may be about 45 degrees.

In another embodiment, the transducer may be connected to a power source via one or more wires that extend through the article.

In further embodiments, the article may include one or more fluid exit holes at the proximal end thereof. As such, when the article is positioned within the lumen of the needle, fluid exits through the one or more fluid exit holes at the proximal end of the article and flows through the lumen of the needle through one or more exit holes in the needle.

In particular embodiments, the article may include an article hub. In such embodiments, the one or more fluid exit holes may be located on the article hub. In addition, the needle may include a needle hub at its proximal end. As such, the article hub may be sized to fit within the needle hub. In addition, the article may include an injection port in fluid communication with the one or more fluid exit holes.

In yet another embodiment, the transducer may correspond to a flat unidirectional transducer or a 3D multidirectional transducer, such as a pyramid.

In another aspect, the present invention is directed to a method for enhancing ultrasound imaging capability of a needle assembly of an ultrasound imaging system. The method includes inserting an article into a lumen of a needle. The article has a proximal end and a distal end. The distal end of the article has a transducer and a lens for diverting signals of the transducer through the distal end of the needle. The method also includes inserting the needle and the article together into a patient. While viewing the patient using the ultrasound imaging system, the method further includes routing the needle and the article together to a target site. Thus, the transducer and the lens are configured to enhance visualization of the needle when viewed by the ultrasound imaging system. In addition, the method includes injecting a fluid through the article such that the fluid exits the needle at the target site.

In one embodiment, as mentioned, the article may include a stylet or a catheter. In another embodiment, the method may include aligning the lens of the article with a window of the needle, the transducer being configured to transmit signals through the window via the lens.

In several embodiments, the method may include positioning the lens of the article at a predetermined angle with respect to a longitudinal axis of the transducer. For example, in certain embodiments, the predetermined angle may include angles ranging from greater than zero (0) degrees to about 90 degrees. More specifically, in one embodiment, the predetermined angle may be about 45 degrees.

In further embodiments, the method may include connecting the transducer to a power source via one or more wires that extend through the article.

In additional embodiments, the step of injecting the fluid through the article such that the fluid exits the needle at the target site may include injecting the fluid through an injection port of the article and allowing the fluid to exit the article through one or more fluid exit holes at the proximal end of the article and flow through the lumen of the needle through one or more exit holes in the needle.

In several embodiments, as mentioned, the article may have an article hub with the one or more fluid exit holes being located on the article hub. In such embodiments, the method may further include inserting the article hub into the needle hub and securing the article hub within the needle hub. It should also be understood that the method may further include any of the additional steps and/or features as described herein.

In yet another embodiment, the present disclosure 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 further includes an outer wall defined by an inner diameter and an outer diameter. The outer wall includes at least one window extending therethrough. Further, the needle assembly includes at least one transducer positioned within the lumen of the needle and at least one lens positioned within the lumen of the needle adjacent to the transducer(s) for diverting signals of the transducer through the window of the needle. It should also be understood that the needle assembly may further include any of the additional 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 schematic diagram of one embodiment of a needle assembly according to the present disclosure;

FIG. 4 illustrates a cross-sectional view of one embodiment of a needle of the needle assembly of FIG. 3;

FIG. 5 illustrates a side view of one embodiment of a stylet of the needle assembly of FIG. 3;

FIG. 6 illustrates a cross-sectional view of one embodiment of a needle assembly according to the present disclosure;

FIG. 7 illustrates a cross-sectional view of one embodiment of a catheter of the needle assembly according to the present disclosure, particularly illustrating the transducer and associated lens mounted within the catheter;

FIG. 8 illustrates a cross-sectional view of another embodiment of a needle assembly according to the present disclosure;

FIG. 9 illustrates a cross-sectional view of still another embodiment of a needle assembly according to the present disclosure; and

FIG. 10 illustrates a flow diagram of one embodiment of a method for enhancing ultrasound imaging capability of a needle assembly of an ultrasound imaging system 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 one or more nerves or nerve bundles. More specifically, in another 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. Flowever, 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 the figures, FIGS. 3-8 illustrate various components of a needle assembly 32 for the ultrasound imaging system 10 according the present disclosure. More particularly, FIGS. 3 and 5-6 illustrate one embodiment of the needle assembly 32 for the ultrasound imaging system 10 having a needle 34 and a transducer stylet 46 that is configured to enhance visualization of the needle tip during a medical procedure, such as a nerve block procedure. Alternatively, as shown in FIGS. 7 and 8, one embodiment of the needle assembly 32 for the ultrasound imaging system 10 having a needle 34 and a catheter stylet 46 that is configured to enhance visualization of the needle tip during a medical procedure is illustrated. In other words, it should be understood that any suitable article may be used for mounted the transducer thereto. In addition, as shown in FIG. 9, the article may be omitted altogether, which is further explained herein.

Referring particularly to FIGS. 3 and 4, the needle 34 described herein generally defines a lumen 40 extending from a proximal end 35 to a distal end 36 thereof. In addition, as shown particularly in FIG. 4, the needle 34 includes an outer wall 38 defined by an inner diameter 42 and an outer diameter 44. Thus, as shown in the embodiment of FIG. 3, the stylet 46 is designed to be received within the lumen 40 of the needle 34. More specifically, as shown, the stylet 46 also has a proximal end 37 and a distal end 38. Further, as shown in FIGS. 4 and 5, the ultrasound transducer 30 may be mounted within the stylet 46, e.g. at the distal end 48 thereof. As such, during use, the distal end 38 of the stylet 46 can be inserted into the lumen 40 of the needle 34 that can then together be inserted into a patient.

Further, as shown in particularly in FIG. 5, the stylet 46 may also include a lens 50 for diverting signals of the transducer 30 through the distal end 36 of the needle 34. In such embodiments, as shown, the lens 50 of the stylet 46 may be positioned at a predetermined angle 52 with respect to a longitudinal axis 54 of the transducer 30. For example, in certain embodiments, the predetermined angle 52 may include angles ranging from greater than zero (0) degrees to about 90 degrees. More specifically, as shown, the predetermined angle 52 may be about 45 degrees. As used herein, terms of degree, such as“about,” are meant to encompass a range of +/- 10% from the value set forth. In addition, in certain embodiments, the predetermined angle 52 may be adjustable. Thus, the predetermined angle 52 described herein can be chosen to change and/or maximize the signal return and receive from the transducer 30.

Referring particularly to FIGS. 3 and 6, the needle 34 further may include at least one window 56 or opening in an outer wall thereof. Thus, as shown, the lens 50 of the stylet 46 can be aligned with the window(s) 56 when the stylet 46 is inserted into the lumen 40 of the needle 34. In such embodiments, the ultrasound transducer 30 is configured to transmit or divert signals 58 through the window(s) 56 by reflecting the signals 58 through the lens 50.

Referring now to FIGS. 7-8, rather than using the stylet 46, the transducer 30 may be mounted within a catheter 55. In such embodiments, as shown, the transducer 30 may be mounted within the catheter 55. As such, during use, the distal end of the catether can be inserted into the lumen 40 of the needle 34 that can then together be inserted into a patient. Further, as shown, the catheter 55 may also include the lens 50 for diverting signals of the transducer 30 through the distal end 36 of the needle 34. In such embodiments, as mentioned, the lens 50 may be positioned at a predetermined angle 52 with respect to a longitudinal axis 54 of the transducer 30. For example, as mentioned, the predetermined angle 52 may include angles ranging from greater than zero (0) degrees to about 90 degrees.

More specifically, as shown, the predetermined angle 52 may be about 45 degrees. In addition, as shown in FIG. 8, the lens 50 of the catheter 55 can be aligned with the window 56 when the catheter 55 is inserted into the lumen 40 of the needle 34.

In such embodiments, the transducer 30 is configured to transmit or divert signals 58 through the window 56 by reflecting the signals 58 through the lens 50.

Referring now to FIG. 9, rather than using the various articles described herein, the stylet 46 and the catheter 55 may be omitted altogether. In such embodiments, as shown, the transducer 30 may be mounted within the lumen 40 of the needle 34. Further, as shown, the lens 50 may also be mounted within the lumen 40 of the needle 34 adjacent to the transducer 30 for diverting signals of the transducer 30 through the distal end 36 of the needle 34, e.g. via one or more windows 56 or opening in the needle wall, which may be spaced radially around the needle wall.

The ultrasound transducer 30 described herein may have any suitable configuration. For example, as shown particularly in FIG. 5, the ultrasound transducer 30 corresponds to a flat unidirectional transducer. Alternatively, the ultrasound transducer 30 may also correspond to a cylindrical transducer. In addition, as shown in FIG. 9, the ultrasound transducer 30 may correspond to a pyramid-shaped transducer for providing signals in multiple directions.

Referring to FIGS. 5 and 6, the ultrasound transducer 30 may be connected to a power source (e.g. controller 12) via an electrical connector 76 electrically coupled to one or more wires 60 that extend through the stylet 46. In addition, as mentioned, the ultrasound transducer 30 may be communicatively coupled to the controller 12 via a wireless connection.

In addition to providing enhanced visualization of the needle 34 under ultrasound, the stylet 46 may also allow a fluid 64 (such as a medicine or anesthetic) to be injected into the needle 34 while the stylet 46 is inserted into the lumen 40 of the needle 34. For example, as shown in FIG. 3, the stylet 46 may have an article hub 62 at its proximal end 47 thereof. In such embodiments, the article hub 62 may have one or more fluid exit holes 66 in fluid communication with a fluid source (not shown). As such, when the stylet 46 is positioned within the lumen 40 of the needle 34, fluid 64 exits through the exit hole(s) 66 of the article hub 62 and flows through the lumen 40 of the needle 34 through exit hole(s) in the needle 34. In alternative embodiments, the fluid exit hole(s) 66 may be located in the stylet body. In addition, the stylet 46 may include an injection port 70 in fluid communication with the fluid exit hole(s) 66 and the fluid source.

Still referring to FIG. 3, the needle 34 may also include a needle hub 68 at its proximal end 35. Thus, in certain embodiments, the article hub 62 may be sized to fit within the needle hub 35. In addition, as shown, the stylet and needle hubs 62,

68 may each be configured with one or more locking features 72, 74 configured to secure the article hub 62 to the needle hub 68. More specifically, the locking features 72, 74 may correspond to one or more of ribs, protrusions, fasteners, or similar or combinations thereof. For example, as shown, the protrusion 72 of the article hub 62 may be configured to snap fit with the recess 74 of the needle hub 68.

Referring now to FIG. 10, a flow diagram of one embodiment of a method 100 for enhancing ultrasound imaging capability of the needle assembly 32 of the ultrasound imaging system 10 is illustrated. In general, the method 100 will be described herein with reference to the needle assembly 32 shown in FIGS. 1 -9. Flowever, it should be appreciated that the disclosed method 100 may be

implemented with any other suitable needl assembly having any other suitable configurations. In addition, although FIG. 10 depicts steps performed in a particular order for purposes of illustration and discussion, the methods discussed herein are not limited to any particular order or arrangement. One skilled in the art, using the disclosures provided herein, will appreciate that various steps of the methods disclosed herein can be omitted, rearranged, combined, and/or adapted in various ways without deviating from the scope of the present disclosure.

As shown at (102), the method 100 includes inserting the article (e.g. the stylet 46 or the catheter 55) into the lumen 40 of the needle 34. As mentioned, the article includes the transducer 30 and the lens 50 for diverting signals of the transducer 30 through the outer wall of the needle 34. Thus, as shown at (104), the method 100 includes inserting the needle 34 and the article together into a patient. While viewing the patient using the ultrasound imaging system, as shown at (106), the method 100 includes routing the needle 34 and the article together to a target site. Thus, the transducer 30 and the lens 50 are configured to enhance

visualization of the needle 34 when viewed by the ultrasound imaging system 10. For example, in several embodiments, the method 100 may further include aligning the transducer 30 with the window 56 of the needle 34. In such embodiments, the transducer 30 is configured to transmit signals 58 through the window 56 via the lens 50.

As shown at (108), the method 100 also includes injecting a fluid 64 through the article such that the fluid 64 exits the needle 34 at the target site. For example, in one embodiment, the step of injecting the fluid 64 through the article such that the fluid 64 exits the needle 34 at the target site may include injecting the fluid 64 through the injection port 70 of the article and allowing the fluid 64 to exit the article through the fluid exit hole(s) 66 at the proximal end 47 of the article. In such embodiments, the method 100 further includes allowing the fluid 64 to flow through the lumen 40 of the needle 34 through one or more exit holes in the needle 34.

In another embodiment, as shown in FIGS. 5 and 7, the method 100 may include positioning the lens 50 of the article at a predetermined angle 52 with respect to a longitudinal axis 54 of the transducer 30. As mentioned, the

predetermined angle 52 may include angles ranging from greater than zero (0) degrees to about 90 degrees. More specifically, as shown, the predetermined angle 52 may be about 45 degrees.

In further embodiments, as shown in FIGS. 3 and 5-7, the method 100 may include connecting the transducer 30 to a power source (not shown) via the electrical connector 76 via one or more wires 60 that extend through the article.

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.

Claims

WHAT IS CLAIMED IS:

1. A needle assembly for an ultrasound imaging system, the needle assembly comprising:

a needle defining a lumen from a proximal end to a distal end thereof, the needle comprising an outer wall defined by an inner diameter and an outer diameter; and,

an article configured to be received within the lumen of the needle, the article comprising a proximal end and a distal end, the distal end of the article comprising a transducer and a lens for diverting signals of the transducer through the distal end of the needle.

2. The needle assembly of claim 1 , wherein the article comprises at least one of a stylet or a catheter.

3. The needle assembly of claims 1 or 2, wherein the needle further comprises a window at the distal end thereof, the lens of the article being aligned with the window, wherein the transducer is configured to transmit signals through the window via the lens.

4. The needle assembly of any of the preceding claims, wherein the lens of the article is positioned at a predetermined angle with respect to a longitudinal axis of the transducer.

5. The needle assembly of claim 4, wherein the predetermined angle comprises angles ranging from greater than zero (0) degrees to about 90 degrees.

6. The needle assembly of claim 5, wherein the predetermined angle is about 45 degrees.

7. The needle assembly of any of the preceding claims, wherein the transducer is connected to a power source via one or more wires that extend through the article.

8. The needle assembly of any of the preceding claims, wherein the article further comprises one or more fluid exit holes at the proximal end thereof, and wherein, when the article is positioned within the lumen of the needle, fluid exits through the one or more fluid exit holes at the proximal end of the article and flows through the lumen of the needle through one or more exit holes in the needle.

9. The needle assembly of claim 8, wherein the article further comprises an article hub mounted at the proximal end thereof, the one or more fluid exit holes are located on the article hub.

10. The needle assembly of claim 9, wherein the needle further comprises a needle hub mounted at the proximal end thereof, the article hub sized to fit within the needle hub.

11. The needle assembly of claim 8, wherein the article further comprises an injection port in fluid communication with the one or more fluid exit holes.

12. The needle assembly of any of the preceding claims, wherein the transducer comprises at least one of a flat unidirectional transducer or a

multidirectional transducer.

13. A method for enhancing ultrasound imaging capability of a needle assembly of an ultrasound imaging system, the method comprising:

inserting an article into a lumen of a needle, the article having a proximal end and a distal end, the distal end of the article having a transducer and a lens for diverting signals of the transducer through the distal end of the needle;

inserting the needle and the article together into a patient;

while viewing the patient using the ultrasound imaging system, routing the needle and the article together to a target site, the transducer and the lens configured to enhance visualization of the needle when viewed by the ultrasound imaging system; and,

injecting a fluid through the article such that the fluid exits the needle at the target site.

14. The method of claim 13, wherein the article comprises at least one of a stylet or a catheter.

15. The method of claims 13 or 14, further comprising aligning the lens of the article with a window of the needle, the transducer being configured to transmit signals through the window via the lens.

16. The method of claims 13, 14, or 15, further comprising positioning the lens of the article at a predetermined angle with respect to a longitudinal axis of the transducer.

17. The method of claim 16, wherein the predetermined angle comprises angles ranging from greater than zero (0) degrees to about 90 degrees.

18. The method of claims 13, 14, 15, 16, or 17, further comprising connecting the transducer to a power source via one or more wires that extend through the article.

19. The method of claims 13, 14, 15, 16, 17, or 18, wherein injecting the fluid through the article such that the fluid exits the needle at the target site further comprises:

injecting the fluid through an injection port of the article;

allowing the fluid to exit the article through one or more fluid exit holes at the proximal end of the article and flow through the lumen of the needle through one or more exit holes in the needle.

20. A needle assembly for an ultrasound imaging system, the needle assembly comprising:

a needle defining a lumen from a proximal end to a distal end thereof, the needle comprising an outer wall defined by an inner diameter and an outer diameter, the outer wall comprising at least one window extending therethrough; and,

at least one transducer positioned within the lumen of the needle; and at least one lens positioned within the lumen of the needle adjacent to the at least one transducer for diverting signals of the transducer through the window of the needle.