WO2026020165A1

WO2026020165A1 - Scissor-like needle holder for fluoroscopy-guided procedures

Info

Publication number: WO2026020165A1
Application number: PCT/US2025/038427
Authority: WO
Inventors: Mohammad GHASEMI RAD
Original assignee: Baylor College of Medicine
Current assignee: Baylor College of Medicine
Priority date: 2024-07-19
Filing date: 2025-07-21
Publication date: 2026-01-22
Anticipated expiration: 2027-01-19

Abstract

A needle positioning device. The device includes a first jaw member and a second jaw member. The device further includes a handle component operatively coupled to the first and the second jaw members, configured to move at least one of the jaw members with respect to the other between an open position and a closed position. The jaws and the handle component are made of a radiotransparent material. The device further includes a first needle localizing component operatively coupled to the first jaw member and a second needle localizing component operatively coupled to the second jaw member. The needle localizing components are made of a radioopaque material. The first needle localizing component and the second needle localizing component are configured to align in the closed position to define a hole.

Description

SCISSOR-LIKE NEEDLE HOLDER FOR FLUOROSCOPY-GUIDED PROCEDURES

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims benefit of U.S. Provisional Application No. 63/673,333 filed July 19, 2024, the specification of which is incorporated herein in its entirety by reference.

FIELD OF THE INVENTION

[0002] The present invention pertains to a plastic scissor-like needle holder. This tool is engineered to enhance the accuracy of needle placement during fluoroscopy-guided medical procedures. Its design aims to reduce radiation exposure and offers the potential for facilitating remote procedures.

BACKGROUND OF THE INVENTION

[0003] Fluoroscopy-guided procedures utilize real-time X-ray imaging to capture visuals of the body's internal structures. Achieving precise needle placement is imperative, yet often proves to be challenging. Multiple attempts can result in amplified radiation exposure to both the patient and the operator. Such guidance is critical in various procedures, including lumbar punctures, kyphoplasty, vertebroplasty, joint injections, and more.

[0004] Data from 2018 in American healthcare trends revealed 92,533 lumbar punctures. Radiologists conducted more than half of these (52.3%) under fluoroscopy guidance. Another report from 2014 recorded 19,420 kyphoplasties and 6,130 vertebroplasties performed nationwide in the USA. Low back pain (LBP) and lumbosacral radicular pain are prevalent ailments, incurring more than USD 100 billion per year in expenditure in the U.S. Epidural steroid injections, often under fluoroscopic guidance, serve as one of the interventions for these conditions. A 2001 study documented rates between 44-103 epidural injections per 1000 annually across various U.S. states. 42% of these were fluoroscopy-guided. In our center, all epidural steroid injections are executed under fluoroscopic guidance.

[0005] Furthermore, thousands of fluoroscopy-guided joint injections are conducted daily in the U.S. to manage joint-related pain. These are essential for patients with conditions like arthritis and are carried out by radiologists, pain management specialists, and orthopedic surgeons, among other healthcare professionals. Certain devices exist to aid with these procedures, but these devices are unwieldy to use, bring the user in unnecessary contact with radiation, and are generally made entirely from radioopaque materials, which makes it difficult to identify the injection location in a fluorescent image, obscures the view, and could potentially damage or kink the needle.

[0006] For example, prior systems exist that implement a scissor-like structure to grip a needle in order to facilitate wound repair by allowing for both suture needle maneuvering and suture thread clipping. However, these designs lack components to provide the needle precision required for allowing injection locations to be identified in X-ray images. Other prior systems provide similar scissor-like structures for fluoroscopy imaging with a guide component that extends from the scissors to the surface of the body for lining up the needle. While this provides marginally more control than the aforementioned example, the scissors themselves fail to provide a guiding shape for the needle, instead simply gripping the needle. This results in a lack of control in maneuvering the needle, making this device inefficient for use in scenarios requiring the utmost precision of injection.

[0007] Other prior systems exist for holding needles in image-guided interventions, comprising a base component with holes to guide a needle and radioopaque arrows surrounding a region in which the needle will be injected. However, these base components are bulky and expensive, and the size of the device reduces the areas in which the device can be made useful on the body. Furthermore, the radioopaque markers implemented in these prior systems do not provide a clear point at which the needle should be injected, only a general area. Thus, there exists a present need for a scissor-like needle holder that minimizes exposure to radiation in fluoroscopy-guided procedures while providing a clear singular point at which a needle is to be injected in said procedure.

BRIEF SUMMARY OF THE INVENTION

[0008] It is an objective of the present invention to provide devices and methods that allow for a scissor-like needle holder that minimizes exposure to radiation in fluoroscopy-guided procedures, as specified in the independent claims. Embodiments of the invention are given in the dependent claims. Embodiments of the present invention can be freely combined with each other if they are not mutually exclusive.

[0009] The present invention features a needle positioning device. The device may comprise a first jaw member comprising a radiotransparent material. The device may further comprise a second jaw member comprising a radiotransparent material. The device may further comprise a handle component comprising a radiotransparent material, operatively coupled to the first jaw member and the second jaw member, configured to move at least one of the first jaw member and the second jaw member with respect to the other between an open position and a closed position upon actuation. The device may further comprise a first needle localizing component comprising a radioopaque material, operatively coupled to the first jaw member. The device may further comprise a second needle localizing component comprising a radioopaque material, operatively coupled to the second jaw member. The first needle localizing component and the second needle localizing component may be configured to align in the closed position to define a hole.

[0010] One of the unique and inventive technical features of the present invention is the implementation of radiotransparent materials for the handle and jaws of the device and radioopaque materials for the needle localizing components. Without wishing to limit the invention to any theory or mechanism, it is believed that the technical feature of the present invention advantageously provides for efficient localization of the needle localizing components in an X-ray image. None of the presently known prior references or work has the unique inventive technical feature of the present invention.

[0011] Another one of the unique and inventive technical features of the present invention is the implementation of a handle and jaws with lengths that extend outside of the range of the radiation field required for X-ray imaging. Without wishing to limit the invention to any theory or mechanism, it is believed that the technical feature of the present invention advantageously provides for the minimization of radiation exposure on the user’s hands while positioning and inserting a needle for a medical procedure. None of the presently known prior references or work has the unique inventive technical feature of the present invention.

[0012] Another one of the unique and inventive technical features of the present invention is the implementation of a cylindrical guide formed by two half-cylinders at the tip of a scissor-like device for acting as radioopaque markers, such that the cylinder defines an exact diameter for the needle to enter. Without wishing to limit the invention to any theory or mechanism, it is believed that the technical feature of the present invention allows for precise and efficient guidance of needles in fluoroscopy procedures with low-cost materials and configured for use on any part of the body.

[0013] Furthermore, the inventive technical feature of the present invention is counterintuitive. The reason that it is counterintuitive is because it contributed to a surprising result. One of ordinary skill in the art would expect that providing no space for the needle to be adjusted, as well as a radioopaque marker that almost entirely blocks the point in which the needle is to be injected, save for a small dot, would result in needle damage, missing the injection point, or both. Surprisingly, the maneuverability provided by the scissor-like apparatus upon which the marker is disposed allows for the injection point to be efficiently lined up and for the injection to be applied accurately in a majority of cases. Thus, the inventive technical feature of the present invention contributed to a surprising result.

[0014] Any feature or combination of features described herein are included within the scope of the present invention provided that the features included in any such combination are not mutually inconsistent as will be apparent from the context, this specification, and the knowledge of one of ordinary skill in the art. Additional advantages and aspects of the present invention are apparent in the following detailed description and claims.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S)

[0015] The features and advantages of the present invention will become apparent from a consideration of the following detailed description presented in connection with the accompanying drawings in which:

[0016] FIG. 1A shows the needle positioning device of the present invention in an open position.

[0017] FIG. 1 B shows the needle positioning device of the present invention in a closed position.

[0018] FIG. 1 C shows a flow chart of a method for positioning a needle implementing the device of the present invention. [0019] FIG. 2 shows a plurality of needle positioning devices with different needle localizing components suited for different needle sizes.

[0020] FIG. 3 shows a plurality of needle sizes compatible with the needle positioning device of the present invention.

[0021] FIG. 4 shows an example X-ray image showing the needle localizing components clearly.

DETAILED DESCRIPTION OF THE INVENTION

[0022] Following is a list of elements corresponding to a particular element referred to herein:

[0023] 100 device

[0024] 110 first jaw member

[0025] 120 second jaw member

[0026] 130 handle

[0027] 140 first needle localizing component

[0028] 150 second needle localizing component

[0029] The term “radiotransparent” is defined herein as permitting the passage of radiation and especially X-rays, thus appearing transparent in X-ray images.

[0030] The term “radioopaque” is defined herein as absorbing or reflecting the passage of radiation and especially X-rays, thus appearing opaque in X-ray images.

[0031] The term “jaw component” is defined herein as an elongated structure configured to press against another elongated structure in a pinching motion. In some embodiments, the jaw components may be attached by a pivot such that the jaw components press together by pivoting towards each other.

[0032] The term “handle component” is defined herein as any structure configured to be gripped by a user. For example, the handle component may comprise a rod for the user to wrap their hand around, one or more loops for the user to direct their finger(s) through, or a combination thereof.

[0033] Referring now to FIGs 1A-1 B, the present invention features a needle positioning device (100). In some embodiments, the device (100) may comprise a first jaw member (110) comprising a radiotransparent material. The device (100) may further comprise a second jaw member (120) comprising a radiotransparent material. The device (100) may further comprise a handle component (130) comprising a radiotransparent material, operatively coupled to the first jaw member (110) and the second jaw member (120), configured to move at least one of the first jaw member (110) and the second jaw member (120) with respect to the other between an open position and a closed position upon actuation. The device (100) may further comprise a first needle localizing component (140) comprising a radioopaque material, operatively coupled to the first jaw member (110). The device (100) may further comprise a second needle localizing component (150) comprising a radioopaque material, operatively coupled to the second jaw member (120). The first needle localizing component (140) and the second needle localizing component (150) may be configured to align in the closed position to define a hole having a diameter configured to direct a needle in a straight line.

[0034] In some embodiments, the radiotransparent material may comprise plastic. In some embodiments, the plastic may comprise fiberglass, nylon, plastic, kevlar, carbon fiber, resin, or a combination thereof. In some embodiments, the radioopaque material may comprise metal. In some embodiments, the metal may comprise silver, gold, iron, copper, nickel, nitinol, steel, aluminum, or a combination thereof. In some embodiments, the hole may have a diameter configured to accept a needle having a size of 12 to 25 gauge. In some embodiments, the handle component (130) may have a length of 5 to 50 cm. In some embodiments, the first jaw member (110) and the second jaw member (120) may have a length of 3 to 15 cm.

[0035] The present invention features a needle positioning device (100). In some embodiments, the device (100) may comprise a first plastic jaw member (110). The device (100) may further comprise a second plastic jaw member (120). The device (100) may further comprise a first plastic handle member operatively coupled to the first plastic jaw member (110) by a pivot such that moving the first plastic handle member moves the first plastic jaw member (110) with respect to the second plastic jaw member (120) between an open position and a closed position. The device (100) may further comprise a second plastic handle member operatively coupled to the second plastic jaw member (120) by the pivot such that moving the second plastic handle member moves the second jaw member (120) with respect to the first plastic jaw member (110) between an open position and a closed position.

[0036] The device (100) may further comprise a first metallic needle localizing component (140) comprising a radioopaque material, operatively coupled to the first plastic jaw member (110), the first metallic needle localizing component (140) comprising a half-cylinder shape. The device (100) may further comprise a second metallic needle localizing component (150) comprising a radioopaque material, operatively coupled to the second plastic jaw member (120), the second metallic needle localizing component (150) comprising a half-cylinder shape. The first metallic needle localizing component (140) and the second metallic needle localizing component (150) may be configured to align in the closed position to form a full cylinder shape defining a hole having a diameter configured to direct a needle in a straight line.

[0037] In some embodiments, a material of the first plastic jaw member (110), the second plastic jaw member (120), the first plastic handle member, the second plastic handle member, or a combination thereof may comprise fiberglass, nylon, plastic, kevlar, carbon fiber, resin, or a combination thereof. In some embodiments, the first metallic needle localizing component (140), the second metallic needle localizing component, or a combination thereof may comprise silver, gold, iron, copper, nickel, nitinol, steel, aluminum, or a combination thereof. In some embodiments, the hole may have a diameter configured to accept a needle having a size of 12 to 25 gauge. In some embodiments, the first plastic handle member and the second plastic handle member may have a length of 5 to 50 cm. In some embodiments, the first plastic jaw member (110) and the second plastic jaw member (120) may have a length of 3 to 15 cm.

[0038] Referring now to FIG. 1 C, the present invention features a method for positioning a needle in a fluoroscopy-guided medical procedure of a patient. The method may comprise providing a needle positioning device (100). The device (100) may comprise a first jaw member (110) comprising a radiotransparent material. The device (100) may further comprise a second jaw member (120) comprising a radiotransparent material. The device (100) may further comprise a handle component (130) comprising a radiotransparent material, operatively coupled to the first jaw member (110) and the second jaw member (120), configured to move at least one of the first jaw member (110) and the second jaw member (120) with respect to the other between an open position and a closed position upon actuation. The device (100) may further comprise a first needle localizing component (140) comprising a radioopaque material, operatively coupled to the first jaw member (110). The device (100) may further comprise a second needle localizing component (150) comprising a radioopaque material, operatively coupled to the second jaw member (120). The first needle localizing component (140) and the second needle localizing component (150) may be configured to align in the closed position to define a hole having a diameter configured to direct a needle in a straight line.

[0039] The method may further comprise positioning the patient beneath a fluoroscopy system emitting a radiation field. The method may further comprise generating, by the fluoroscopy system, a real-time image of the patient showing an internal injection location. The method may further comprise maneuvering the needle positioning device in the closed position such that the hole aligns with the internal injection location. The method may further comprise directing the needle through the hole into the patient such that the needle contacts the internal injection location.

[0040] In some embodiments, the radiotransparent material comprises plastic. In some embodiments, the radioopaque material comprises metal. In some embodiments, the hole may have a diameter configured to accept a needle having a size of 12 to 25 gauge. In some embodiments, the handle component (130) may have a length of 5 to 50 cm. In some embodiments, the first jaw member (110) and the second jaw member (120) may have a length of 3 to 15 cm. In some embodiments, the needle-localization components may form a cylinder shape, a rectangular prism, a cube, or any other shape.

[0041] This needle holder addresses the complexities of needle placement in fluoroscopy-guided operations. The device features a plastic design comprising a sterilized, disposable plastic scissor-shaped holder, equipped with precision jaws and a radioopaque opening, firmly holding the needle. This design ensures controlled movement and precise adjustments for spot-on needle positioning. The device also features radiation shielding. The holder's length is beneficial as it keeps the operator's hand out of the radiation field. The device also features remote procedure capabilities. The ergonomic design allows even less experienced operators, such as medical students, residents, fellows, physician assistants, and nurse practitioners, to use it effectively. Its capabilities also extend to the realm of remote procedures, such as robotic fluoroscopy-guided surgeries. The present invention also features real-time visual feedback to enhance alignment precision.

[0042] Directing the needle in a straight line may comprise providing a path in which the needle can travel without enough room for the needle to stray far from its path. For example, the hole may provide a diameter suitable for the exact diameter of the needle that it is to accept, plus a multiple of the diameter of the needle, one half of the diameter of the needle, or any value in between. This allows for the hole defined by the device of the present invention to essentially define a single point at which the needle is to be directed, improving the accuracy of the device.

[0043] Although there has been shown and described the preferred embodiment of the present invention, it will be readily apparent to those skilled in the art that modifications may be made thereto which do not exceed the scope of the appended claims. Therefore, the scope of the invention is only to be limited by the following claims. In some embodiments, the figures presented in this patent application are drawn to scale, including the angles, ratios of dimensions, etc. In some embodiments, the figures are representative only and the claims are not limited by the dimensions of the figures. In some embodiments, descriptions of the inventions described herein using the phrase “comprising” includes embodiments that could be described as “consisting essentially of” or “consisting of”, and as such the written description requirement for claiming one or more embodiments of the present invention using the phrase “consisting essentially of” or “consisting of” is met.

[0044] The reference numbers recited in the below claims are solely for ease of examination of this patent application, and are exemplary, and are not intended in any way to limit the scope of the claims to the particular features having the corresponding reference numbers in the drawings.

Claims

WHAT IS CLAIMED IS:

1 . A needle positioning device (100) comprising: a. a first jaw member (110) comprising a radiotransparent material; b. a second jaw member (120) comprising a radiotransparent material; c. a handle component (130) comprising a radiotransparent material, operatively coupled to the first jaw member (110) and the second jaw member (120), configured to move at least one of the first jaw member (110) and the second jaw member (120) with respect to the other between an open position and a closed position upon actuation; d. a first needle localizing component (140) comprising a radioopaque material, operatively coupled to the first jaw member (110); and e. a second needle localizing component (150) comprising a radioopaque material, operatively coupled to the second jaw member (120); wherein the first needle localizing component (140) and the second needle localizing component (150) are configured to align in the closed position to define a hole.

2. The device (100) of claim 1 , wherein the radiotransparent material comprises plastic.

3. The device (100) of claim 2, wherein the plastic comprises fiberglass, nylon, plastic, kevlar, carbon fiber, resin, or a combination thereof.

4. The device (100) of claim 1 , wherein the radioopaque material comprises metal.

5. The device (100) of claim 4, wherein the metal comprises silver, gold, iron, copper, nickel, nitinol, steel, aluminum, or a combination thereof.

6. The device (100) of claim 1 , wherein a diameter of the hole is configured to accept a needle having a size of about 12 to 25 gauge.

7. The device (100) of claim 1 , wherein the handle component (130) has a length of about 5 to 50 cm.

8. The device (100) of claim 1 , wherein the first jaw member (110) and the second jaw member (120) have a length of about 3 to 15 cm.

9. A needle positioning device (100) comprising: a. a first plastic jaw member (110); b. a second plastic jaw member (120); c. a first plastic handle member operatively coupled to the first plastic jaw member (110) by a pivot such that moving the first plastic handle member moves the first plastic jaw member (110) with respect to the second plastic jaw member (120) between an open position and a closed position; d. a second plastic handle member operatively coupled to the second plastic jaw member (120) by the pivot such that moving the second plastic handle member moves the second jaw member (120) with respect to the first plastic jaw member (110) between an open position and a closed position; e. a first metallic needle localizing component (140) comprising a radioopaque material, operatively coupled to the first plastic jaw member (110), the first metallic needle localizing component (140) comprising a first groove; and f. a second metallic needle localizing component (150) comprising a radioopaque material, operatively coupled to the second plastic jaw member (120), the second metallic needle localizing component (150) comprising a second groove; wherein the first metallic needle localizing component (140) and the second metallic needle localizing component (150) are configured to align in the closed position such that the first and second grooves form a through-hole configured to direct a needle in a straight line.

10. The device (100) of claim 9, wherein a material of the first plastic jaw member (110), the second plastic jaw member (120), the first plastic handle member, the second plastic handle member, or a combination thereof comprises fiberglass, nylon, plastic, kevlar, carbon fiber, resin, or a combination thereof.

11 . The device (100) of claim 9, wherein the first metallic needle localizing component (140), the second metallic needle localizing component, or a combination thereof comprises silver, gold, iron, copper, nickel, nitinol, steel, aluminum, or a combination thereof.

12. The device (100) of claim 9, wherein a diameter of the through hole is configured to accept the needle having a size of about 12 to 25 gauge.

13. The device (100) of claim 9, wherein the first and second grooves are each a half-cylinder shape such that they form a cylindrical through-hole when in the closed position.

14. The device (100) of claim 9, wherein the first plastic jaw member (110) and the second plastic jaw member (120) have a length of about 3 to 15 cm.

15. A method for positioning a needle in a fluoroscopy-guided medical procedure of a patient, the method comprising: a. providing a needle positioning device (100) comprising: i. a first jaw member (110) comprising a radiotransparent material; ii. a second jaw member (120) comprising a radiotransparent material; iii. a handle component (130) comprising a radiotransparent material, operatively coupled to the first jaw member (110) and the second jaw member (120), configured to move at least one of the first jaw member (110) and the second jaw member (120) with respect to the other between an open position and a closed position upon actuation; iv. a first needle localizing component (140) comprising a radioopaque material, operatively coupled to the first jaw member (110); and V. a second needle localizing component (150) comprising a radioopaque material, operatively coupled to the second jaw member (120); wherein the first needle localizing component (140) and the second needle localizing component (150) are configured to align in the closed position to define a hole configured to direct the needle in a straight line; b. positioning the patient beneath a fluoroscopy system emitting a radiation field; c. generating, by the fluoroscopy system, a real-time image of the patient showing an internal injection location; d. maneuvering the needle positioning device in the closed position such that the hole aligns with the internal injection location; and e. directing the needle through the hole into the patient such that the needle contacts the internal injection location.

16. The method of claim 15, wherein the radiotransparent material comprises plastic.

17. The method of claim 15, wherein the radioopaque material comprises metal.

18. The method of claim 15, wherein the hole has a diameter configured to accept a needle having a size of about 12 to 25 gauge.

19. The method of claim 15, wherein the handle component (130) has a length of about 5 to 50 cm.

20. The method of claim 15, wherein the first jaw member (110) and the second jaw member (120) have a length of about 3 to 15 cm.