Ultrasound-assisted puncture guide

Abstract

The present invention relates to an ultrasound-assisted puncture guide comprising a guide front wall (30), a right side wall (20), and a left side wall (10). Said side walls (10, 20) and said front wall (30) form a cavity containing and retaining a sound conducting gel that is open to the surface or skin to be punctured and to the transducer (50), and through which the needle (40) passes, said needle guided by the ultrasound to successfully puncture the vein.

Description

[0001] ULTRASOUND-ASSISTED PUNCTURE GUIDE

[0002] SCOPE

[0003] The present invention relates to the healthcare industry. In particular, to medical devices for assisting in intravascular puncture.

[0004] BACKGROUND

[0005] Intravascular puncture is an essential medical technique for accessing the lumen of arteries and veins to obtain blood samples for testing and / or administer medications, vasoactive drugs, parenteral nutrition, hemodynamic monitoring, and chemotherapy or hemodialysis catheters, among other procedures. This intervention is referred to as central venous puncture, peripheral venous puncture, or peripheral arterial puncture.

[0006] The use of ultrasound to guide venipuncture has revolutionized these techniques, providing real-time visualization of the target area, improving procedural accuracy, and reducing complications. However, continuous visualization of the target vessel and needle presents significant challenges. During ultrasound-guided procedures, the transducer can only display one plane at a time, requiring critical alignment between the transducer and needle to achieve adequate visualization. This forces the practitioner to balance needle insertion with the need to maintain adequate visualization of the target vessel, which can lead to complications or injury if the image is misinterpreted.

[0007] Preliminary art

[0008] International patent document W02020040701A1 describes an apparatus for facilitating the acquisition of medical images of a subject. The apparatus comprises a medical imaging device receiver configured to receive a medical imaging device, at least one auxiliary equipment receiver configured to receive auxiliary equipment for placement on a target portion of the subject, and a sound wave manipulation module arranged to direct the transmission of sound waves. In particular, the medical imaging device is an ultrasound transducer, the auxiliary equipment is a needle, catheter, or endoscope, while the sound wave manipulation module comprises a sound wave deflection surface arranged to alter the direction of at least a portion of the sound waves. However, this design presents significant challenges.The ultrasound image may be oriented in a different plane than necessary, requiring specific training for its effective use. Lack of conformability to curved surfaces is also a problem, potentially leaving a gap between the transducer and the skin that compromises image quality due to air entrapment.

[0009] International patent document W02008024515A2 describes a sterile sheath for an ultrasound guidance system. The sterile sheath can be included as part of a sterile kit for an ultrasound transducer. The kit includes the sterile sheath and a needle guide for use with the sterile sheath. The sterile sheath comprises a housing and a sleeve attached to the housing. The housing receives the transducer head and needle clip. The sleeve covers the rest of the transducer. The needle guide is used to guide a needle into the body using the ultrasound transducer. Although this solution provides a robust structure for guiding and holding needles, its applicability on curved surfaces, such as an ankle, is limited. Conformability is poor, resulting in separation between the transducer and the skin, affecting image quality.Furthermore, during the puncture operation, the ultrasound conductive gel tends to spread across the surface, decreasing the visibility of the needle and increasing the risk of complications by compromising adequate visibility.

[0010] US Patent No. 2024008893A1 describes a needle support structure and a needle guide support. The needle support structure comprises an angle control plate, a needle slotted plate, and a locking device. The needle slotted plate includes a plurality of semi-open needle feed channels. The angle control plate is mounted on the needle slotted plate to form a closed needle feed channel. It is also noted that while this solution provides a robust structure for guiding and holding needles during biopsy procedures, its applicability on curved surfaces, such as an ankle, is limited. Furthermore, conformability is poor, resulting in separation between the transducer and the skin, which affects image quality. The device does not accommodate different transducer designs.Also, during the puncture operation, the ultrasound conductive gel tends to spread across the surface, decreasing the visibility of the needle and increasing the risk of complications.

[0011] Technical problem addressed by the invention

[0012] Despite advances in ultrasound-guided puncture technology, current systems have significant limitations, including lengthy setup times, high costs, and inadequate preservation of the ultrasound gel at the puncture site, which reduces needle visibility and increases the risk of complications. Therefore, there is a need for a rapid-to-assemble central venous and peripheral arterial and venous puncture assistance system that preserves echogenicity, is adaptable to a variety of transducers, and conserves the gel by preventing its spread.

[0013] Technical Solution of the present invention

[0014] An object of the present invention is an ultrasound-assisted puncture guide whose flexible side walls and front wall form a cavity containing and retaining acoustically conductive gel, open to the skin surface to be punctured and to the ultrasound transducer. The needle, guided by ultrasound for successful vessel puncture, travels through this cavity. Advantages of the present invention

[0015] An advantage of the present invention is that it allows for rapid central venous and peripheral venous and arterial punctures, preserving echogenicity, adapting to a variety of transducer models used according to the need and type of puncture or depth thereof, without specific training and very comfortable to handle.

[0016] Advantageously, the present invention allows the formation of a cavity that retains the ultrasound gel, allowing the transducer to be supported at a suitable angle and requiring only one operator.

[0017] Advantageously, the present invention allows for improved needle visibility, thanks to its gel-retaining cavity that stabilizes the gel, preventing its dispersion, allowing for a better ultrasound image and improved visibility in the puncture area.

[0018] Advantageously, the present invention allows for better applicability on curved surfaces of the human body thanks to its flexibility, which allows it to be supported on the entire surface, preventing the gel from running and avoiding air pockets that affect the image quality produced, making the procedure difficult.

[0019] BRIEF DESCRIPTION OF THE FIGURES

[0020] The accompanying figures are briefly described below to exemplify and illustrate the present invention. It should be appreciated that the figures are provided for illustrative purposes only and that the invention is not limited by these illustrations.

[0021] Figure 1 illustrates, in a perspective view, an assembled ultrasound-assisted puncture guide according to the present invention.

[0022] Figure 2 illustrates, in a front and exploded view, the ultrasound-assisted puncture guide of Figure 1.

[0023] Figure 3 illustrates, in a left-side exploded view, the ultrasound-assisted puncture guide of Figure 1.

[0024] Figure 4 illustrates, in a right-side exploded view, the ultrasound-assisted puncture guide of Figure 1.

[0025] Figure 5 illustrates, in a top and exploded view, the ultrasound-assisted puncture guide of Figure 1.

[0026] Figure 6 illustrates, in a perspective view, the ultrasound-assisted puncture guide of Figure 1, assembled around an ultrasound transducer and a syringe needle guided for a puncture.

[0027] Figure 7 illustrates, in a front view, an alternative way of arranging the guide holes 34 in the front wall of the ultrasound-assisted puncture guide of the present invention.

[0028] Figure 8 illustrates, in a front view, an additional form of the ultrasound-assisted puncture guide of the present invention.

[0029] Figure 9 shows an ultrasound image of an ultrasound-assisted puncture using the ultrasound-assisted puncture guide of the present invention.

[0030] DETAILED DESCRIPTION OF THE INVENTION

[0031] The present invention is described below in detail and with reference to the accompanying figures. Well-known components, materials, or methods are not necessarily described in great detail to avoid obscuring the present description. Any specific structural and functional details described herein should not be construed as limiting, but merely as a basis for the claims and as a representative basis for teaching a person skilled in the art how to employ the invention in various ways.

[0032] With reference to Figures 1 to 6, an ultrasound-assisted puncture guide is provided comprising: a front guide wall (30); a right side wall (20) of flexible material; and a left side wall (10) of flexible material, wherein said side walls (10, 20) comprise an externally projecting curved lower edge (13, 23) on a support wall with a concave lower surface, said side walls (10, 20) and said front wall (30) form a cavity containing and retaining acoustically conductive gel, open to the surface or skin to be punctured and to the transducer (50), through which runs the path of the needle (40) that is guided for a puncture.

[0033] Additionally, said front guide wall (30) is removable with a positioning means comprising a male member (31) and a coupling means comprising at least one female member (32); and said left and right side walls (10, 20) are removable and each comprises: a female member (11, 21) of said positioning means; and at least one male member (12, 22) of said coupling means, effectively retaining the side walls and the front wall assembled together during the pressure exerted during the puncturing operation.

[0034] Alternatively, said ultrasound-assisted puncture guide can be formed with said front wall and said left and right side walls as a single piece or integrally, made of flexible material.

[0035] With reference to Figures 1 to 6, an ultrasound-assisted puncture guide is provided comprising: a detachable front guide wall (30) with a positioning means comprising a male member (31), such as a rail arranged across the rear face and with a tapered cross-section, and a coupling means comprising at least one female member (32) as a groove arranged across the rear face and with a tapered cross-section; a detachable right side wall (20); and a detachable left side wall (10), wherein the left and right side walls (10, 20) each comprise: a female member (11, 21) of said positioning means such as a recess in its front edge with a tapered cross-section, as seen in plan view in Figures 3 and 4, complementary to said male member (31) of said front wall (30) for easy sliding positioning;at least one male member (12, 22) of said coupling means such as a rail segment arranged across the front edge of each left and right side wall (10, 20) with a cross-section, as seen in plan view in Figures 3 and 4, fitted and complementary to said female member (32) of said front wall for easy adjustment and sliding coupling, effectively retaining the side walls and the front wall assembled together during the pressure exerted during the puncture operation; and a curved lower edge projecting outwards (13, 23) into a support wall with a concave lower surface; wherein said side walls (10, 20) and said front wall (30), assembled, form a cavity containing and retaining acoustically conductive gel, open to the surface or skin to be punctured and to the transducer (50), through which the needle (40) is guided for a puncture.

[0036] Preferably, said coupling means of said front wall (30) comprises a coupling means comprising an upper female member (32), a middle female member (32) and a lower female member (32), and said female members (32) are grooves arranged along the rear wall of said front wall (30).

[0037] Preferably, and as can be seen in Figure 2, said coupling means of said left and right side walls (10, 20) comprises an upper male member (12, 22), a middle male member (12, 22) and a lower male member (12, 22), and said male members (12, 22) are rail segments of a length greater than the front edge of said side walls.

[0038] According to one form of the present invention, said cross-sectional profile of the male member (32) of said positioning means has a larger area than said cross-sectional profile of a male member (11, 21) of said coupling means, which allows for easier manipulation and positioning of the side walls and the front wall when assembling the guide.

[0039] As shown in Figure 5 and according to the invention, said left and right side walls (10, 20) also comprise groove segments (14, 24) through the externally projecting curved lower edge (13, 23) which allows for the evacuation of excess acoustic conductive gel during the puncturing operation, better adhesion to the surface to which the puncture is applied, and better handling of the assembled guide.

[0040] Additionally, the left and right side walls (10, 20) comprise reinforcing ribs (15, 25) arranged across the width.

[0041] As shown in Figures 3 to 5 and according to the invention, the left and right side walls (10, 20) also include tactile reference recesses (16, 26) for improved handling of the assembled guide. For example, tactile reference recesses (16, 26) can be included in a portion near each end of the left and right side walls (10, 20). An additional tactile reference recess (16, 26) can also be added to the front portion of the left and right side walls (10, 20) for improved orientation of the assembled guide.

[0042] Furthermore, thanks to the positioning means and sliding coupling means, the width of the guide can be adjusted to fit a wide variety of transducers used for ultrasound-assisted puncture.

[0043] According to the present invention, the material of the front wall (30) and the left and right side walls (10, 20) is a translucent or transparent material, to allow visualization of the syringe needle (40) within said cavity containing and retaining acoustic conductive gel, when performing the puncture.

[0044] According to the present invention, the material of the left and right side walls (10, 20) is a flexible material to more easily conform to the curvature of the human body surface. According to the present invention, the front wall (30) and the left and right side walls (10, 20) are manufactured by 3D printing or injection molding.

[0045] Preferably, the material of the left and right side walls (10, 20) has the following mechanical properties, with the indicated values ​​being approximate:

[0046] • Hardness from 85 to 90 Shore A;

[0047] • Tensile strength of 6 to 8 MPa;

[0048] • Elongation at break of 100 to 150%;

[0049] • Tear resistance of 390 to 320 kN / m;

[0050] • Flexural strength of 77 MPa;

[0051] • Flexural modulus of 2350 MPa; and

[0052] • IZOD impact resistance of 44 J / m

[0053] Preferably, the front wall material (30) has the following mechanical properties, with the indicated values ​​being approximate:

[0054] • Hardness of 76 Shore D;

[0055] • Tensile strength of 30 to 45 MPa;

[0056] • Elongation at break of 30 to 50%;

[0057] • Flexural strength of 50 to 60 MPa;

[0058] • Flexural modulus of 900 to 1200 MPa; and

[0059] • IZOD impact resistance of 50 to 60 J / m

[0060] For example, the material of the left and right side walls (10, 20) is a translucent elastic resin (eSun elastic resin / F80 elastic resin), and the material of the front wall (30) is a tough translucent resin (Anycubic clear tough resin).

[0061] Other materials can be used to produce the left and right side walls (10, 20) such as polydimethylsiloxane (PDMS).

[0062] As shown in Figure 8, it can be added to a sterile bag (60) for intraoperative procedure, and said ultrasound-assisted puncture guide is disassembled, sterile, and in a sterile bag (60).

[0063] As can be seen in Figure 9, an ultrasound illustrates a puncture with a visible needle during a puncture performed with the guide of the present invention.

[0064] Although embodiments of the invention have been illustrated and described in detail in the drawings and description above, such illustration and description should be considered illustrative or exemplary and not restrictive; the invention is not limited to the examples particularly described. Persons skilled in the art understand and can make other variations of the examples particularly described from a study of the drawings, description, and claims. In the specification and claims, the terms "comprising" and "including" are open-ended and do not exclude other elements or steps, and the indefinite article "a" does not exclude a plurality.

Claims

CLAIMS 1. Ultrasound-assisted puncture guide, CHARACTERIZED in that it comprises: a front guide wall (30); a right side wall (20) of flexible material; and a left side wall (10) of flexible material, wherein said side walls (10, 20) comprise a curved lower edge projecting outwards (13, 23) on a support wall with a concave lower surface, said side walls (10, 20) and said front wall (30) form a cavity containing and retaining acoustic conductive gel, open to the surface or skin to be punctured and to the transducer (50), through the interior of which runs the path of the needle (40) that is guided for a puncture.

2. Puncture guide according to claim 1, CHARACTERIZED in that said front guide wall (30) is detachable with a positioning means comprising a male member (31) and a coupling means comprising at least one female member (32); and said left and right side walls (10, 20) are detachable and each comprises: a female member (11, 21) of said positioning means; and at least one male member (12, 22) of said coupling means, effectively retaining the side walls and the front wall assembled together during the pressure exerted during the puncture operation. 3.- Puncture guide according to claim 2, CHARACTERIZED in that said coupling means of said front wall (30) comprises a coupling means comprising an upper female member (32), a middle female member (32) and a lower female member (32), and said female members (32) are grooves arranged along the rear wall of said front wall (30). 4.- Puncture guide according to claim 3, CHARACTERIZED in that said coupling means of said left and right side walls (10, 20) comprises an upper male member (12, 22), a middle male member (12, 22) and a lower male member (12, 22), and said male members (12, 22) are rail segments of a length greater than the front edge of said side walls.

5. Puncture guide according to claim 2, CHARACTERIZED in that, in said detachable front guide wall (30), said male member (31) is a rail arranged across the width of the rear face and with a tapered cross-sectional profile and, in said left and right side walls (10, 20), said female member (11, 21) is a recess in the front edge with a tapered cross-sectional profile complementary to said male member (31) of said front wall (30) for easy sliding positioning 6. Puncture guide according to claims 4 and 5, CHARACTERIZED in that said transverse profile of the male member (32) of said positioning means is of a larger area than said transverse profile of a male member (11, 21) of said coupling means.

7. Puncture guide according to claim 1, CHARACTERIZED in that said left and right side walls (10, 20) also comprise groove segments (14, 24) through the externally projecting curved lower edge (13, 23).

8. Puncture guide according to claim 1, CHARACTERIZED in that the material of the front wall (30) and of the left and right side walls (10, 20) is a translucent or transparent material.

9. Puncture guide according to claim 1, CHARACTERIZED in that the material of the left and right side walls (10, 20) is a flexible material with an elongation at break property of 100 to 150%.

10. Puncture guide according to claim 2, CHARACTERIZED in that it comprises a sterile bag (60) for intraoperative procedure and said ultrasound-assisted puncture guide is disassembled, sterile and in a sterile bag (60).

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