EP-4739233-A1 - DEVICES, SYSTEMS, AND METHODS FOR NEEDLE ACCESS

Abstract

Medical devices and related methods useful for needle access during medical procedures are described. The medical device may include a needle and a handle coupled to the needle, wherein the handle includes a body comprising a radiolucent material, a first marker proximate a proximal end of the body and a second marker proximate a distal end of the body. Each of the first marker and the second marker may include a radiopaque material, and the first marker may have a shape complementary to the second marker to align a position of the needle relative to a subject when visualized by X-ray imaging.

Inventors

• LIM, Kian S.
• RAUNIYAR, Niraj Prasad

Assignees

• Boston Scientific Scimed, Inc.

Dates

Publication Date

20260513

Application Date

20240703

Claims (1)

1. Attorney Docket No.: 09423-0395-00304 CLAIMS What is claimed is: 1. A medical device comprising: a needle; and a handle coupled to the needle, wherein the handle includes a body comprising a radiolucent material, a first marker proximate a proximal end of the body and a second marker proximate a distal end of the body, each of the first marker and the second marker comprising a radiopaque material, wherein the first marker has a shape complementary to the second marker to align a position of the needle relative to a subject when visualized by X-ray imaging. 2. The medical device of claim 1, wherein the needle includes a plurality of measurement marks distributed along a length of the needle. 3. The medical device of claim 1 or 2, wherein the first marker and the second marker are visible from a proximal-most end of the handle through the radiolucent material. 4. The medical device of any one of the preceding claims, wherein the first marker and the second marker are oriented perpendicular to a longitudinal axis defined by the needle. 5. The medical device of any one of the preceding claims, wherein one of the first marker or the second marker is a shaded shape and the other of the first marker or the second marker is a perimeter of the shaded shape. Attorney Docket No.: 09423-0395-00304 6. The medical device of any one of the preceding claims, wherein the radiolucent material comprises glass or a polymer. 7. The medical device of any one of the preceding claims, wherein the needle is at least 10 cm in length. 8. The medical device of any one of the preceding claims, wherein the handle includes a hub at a distalmost end of the body between the second marker and the needle. 9. A medical system comprising the medical device of any one of the preceding claims and a camera configured to observe the needle. 10. The medical system of claim 9, further comprising a fixture configured to receive the needle and maintain a position of the needle relative to the fixture during a medical procedure. 11. The medical system of claim 10, wherein the fixture includes the camera. 12. Use of the medical device of any one of claims 1-8 or the medical system of any one of claims 9-11 to remove a stone from a urinary tract of a subject. 13. The use of the medical device or the medical system of claim 12, wherein the needle accesses a kidney of the subject for removal of the stone. Attorney Docket No.: 09423-0395-00304 14. The use of the medical device or the medical system of claim 12 or 13, wherein the first marker and the second marker are aligned with each other along the longitudinal axis by X-ray imaging before the needle accesses the kidney. 15. The use of the medical device or the medical system of any one of claims 12-14, wherein a depth of the needle inserted into the subject is determined according to a plurality of measurement marks on the needle.

Description

Attorney Docket No.: 09423-0395-00304 DEVICES, SYSTEMS, AND METHODS FOR NEEDLE ACCESS CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application claims the benefit of priority to U.S. Provisional Application No.63/512,087, filed on July 6, 2023, which is incorporated by reference herein in its entirety. TECHNICAL FIELD [0002] Aspects of the present disclosure generally relate to medical devices, systems, and procedures related thereto. In particular, some aspects relate to medical systems, devices, and methods for needle access to the urinary tract for removal of a stone. BACKGROUND [0003] Minimally-invasive and non-invasive surgical procedures allow a medical professional to treat an internal area of a body through a natural body orifice or minimizing an incision of the body. Percutaneous nephrolithotomy (PCNL), for example, is a procedure wherein a needle is inserted through the skin and into a kidney for removal of a kidney stone. Precise placement of the needle aided by medical imaging techniques is required to avoid damaging the kidney or surrounding tissues. PCNL procedures often necessitate multiple medical professionals having significant experience not only with anatomy in and around the kidney but also with imaging to ensure the accurate location and angle of access of the access needle. For example, in the Bulls Eye Technique, a C-arm with an X-ray generator is used to determine angle of access for PCNL. The C-arm is rotated between 0 degrees and 30 degrees to align the X-ray generator and check the depth at which the needle is inserted into the patient. SUMMARY [0004] The present disclosure includes medical devices and related methods useful for needle access during medical procedures. For example, the present Attorney Docket No.: 09423-0395-00304 disclosure includes a medical device comprising a needle and a handle coupled to the needle, wherein the handle includes a body comprising a radiolucent material, a first marker proximate a proximal end of the body and a second marker proximate a distal end of the body, each of the first marker and the second marker comprising a radiopaque material, wherein the first marker has a shape complementary to the second marker to align a position of the needle relative to a subject when visualized by X-ray imaging. The needle may include a plurality of measurement marks distributed along a length of the needle. In some examples, the needle is at least 10 cm in length. According to some aspects, the first marker and the second marker may be visible from a proximal-most end of the handle through the radiolucent material. Additionally or alternatively, the first marker and the second marker may be oriented perpendicular to a longitudinal axis defined by the needle. In some examples, one of the first marker or the second marker is a shaded shape and the other of the first marker or the second marker is a perimeter of the shaded shape. The radiolucent material of the body of the handle may comprise glass or a polymer. Optionally, the handle may include a hub at a distalmost end of the body, e.g., between the second marker and the needle. [0005] Also disclosed herein is a medical system comprising a medical device as described above and/or elsewhere herein. For example, the medical system may further comprise a camera configured to observe the needle of the medical device and/or a fixture configured to receive the needle and maintain a position of the needle relative to the fixture during a medical procedure. According to some aspects, the fixture includes the camera. The medical device and/or medical system may be used to remove a stone from a urinary tract of a subject, e.g., during a PCNL procedure. For example, the needle may access a kidney of the subject for removal of the stone. During the use, the first marker and the second marker of the medical device may be aligned with each other along the longitudinal axis by X-ray imaging before the needle accesses the kidney. Attorney Docket No.: 09423-0395-00304 Further, for example, a depth of the needle inserted into the subject may be determined according to a plurality of measurement marks on the needle. [0006] The present disclosure also includes a medical system comprising: a medical device comprising a needle including a plurality of measurement marks distributed along a length of the needle; and a handle coupled to the needle, wherein the handle includes a body comprising a radiolucent material, a first marker proximate a proximal end of the body, and a second marker proximate a distal end of the body, each of the first marker and the second marker comprising a radiopaque material; and the system further comprising a fixture configured to receive the needle and maintain a position of the needle relative to a subject during a medical procedure. The first marker may have a shape complementary to the second marker to align a position of the needle relative to the fixture and relative to the subject whe