Guide to puncture devices for ultrasound probes

Abstract

A disposable puncture device guide for use with an ultrasound probe is described. The puncture device guide includes a fixed portion configured to be attached directly or indirectly to the probe body, and a deflection portion connected to the fixed portion by at least one living hinge. The deflection portion has at least one groove configured to support the puncture device. Outward pressure on at least one groove rotates the deflection portion outward relative to the fixed portion so as to support the puncture device over an entire range of angles.

Description

Technical Field

[0001] The present invention generally relates to medical devices and methods of use, and more particularly to a method of use involving a puncture device guide device (e.g., a needle guide) and an ultrasonic transducer. It is a common medical practice to use a guide for releasable attachment onto an ultrasonic transducer in order to percutaneously guide a puncture device, such as a needle, cannula, trocar, or some other puncture device, to a desired location within a patient's body. A puncture device guide is arranged to enable a physician or other healthcare provider to guide a puncture device to a desired location within a patient's body.

Background Art

[0002] Since a puncture device guide is used under aseptic conditions, a reusable puncture device guide must be sterilized and repackaged after each use. A disposable puncture device guide eliminates the cost and logistics effort of sterilization after each use. However, in order to be economically viable, a disposable product must have a simple design and be easily produced at a low cost. The present design achieves these objectives by greatly simplifying the mounting of the device onto an ultrasonic probe and by fabricating the puncture device guide itself as a single component. However, embodiments consistent with the implementations described herein may also be formed using multi-component constructs.

Summary of the Invention

Means for Solving the Problems

[0003] The implementations described herein relate to a guiding device for facilitating the placement of a puncture device (e.g., a needle) at a defined position relative to an ultrasonic probe.

Brief Description of the Drawings

[0004] [Figure 1]Figure 1 is an isometric view illustrating one embodiment of a puncture device guidance device disposed on an ultrasound probe, consistent with the embodiments described herein. [Figure 2] Figure 2 is another isometric view of the puncture device guide in Figure 1, illustrating deflected or bent orientations. [Figure 3] Figure 3 is yet another isometric view of the puncture device guide from Figure 1, illustrating additional details. [Figure 4] Figure 4 is an isometric view of the mounting sheet positioned on the ultrasound probe to which the puncture device guide shown in Figure 1 is attached. [Figure 5] Figures 5, 6, and 7 are isometric, side, and top views, respectively, of further embodiments of a puncture device guide and mounting sheet consistent with the implementation described herein. [Figure 6] Figures 5, 6, and 7 are isometric, side, and top views, respectively, of further embodiments of a puncture device guide and mounting sheet consistent with the implementation described herein. [Figure 7] Figures 5, 6, and 7 are isometric, side, and top views, respectively, of further embodiments of a puncture device guide and mounting sheet consistent with the implementation described herein. [Figure 8] Figures 8, 9, 10, and 11 are isometric, rear, bottom, and front views, respectively, of yet another embodiment of a puncture device guide consistent with the implementation described herein. [Figure 9] Figures 8, 9, 10, and 11 are isometric, rear, bottom, and front views, respectively, of yet another embodiment of a puncture device guide consistent with the implementation described herein. [Figure 10] Figures 8, 9, 10, and 11 are isometric, rear, bottom, and front views, respectively, of yet another embodiment of a puncture device guide consistent with the implementation described herein. [Figure 11]Figures 8, 9, 10, and 11 are isometric, rear, bottom, and front views, respectively, of yet another embodiment of a puncture device guide consistent with the implementation described herein. [Figure 12] Figures 12, 13, and 14 are cross-sectional views obtained along lines AA, BB, and CC in Figure 11, respectively. [Figure 13] Figures 12, 13, and 14 are cross-sectional views obtained along lines AA, BB, and CC in Figure 11, respectively. [Figure 14] Figures 12, 13, and 14 are cross-sectional views obtained along lines AA, BB, and CC in Figure 11, respectively. [Figure 15] Figures 15A, 15B, and 15C are a front isometric view, a front view, and a bottom view, respectively, of another embodiment of the mounting plate for use in securing the puncture device guide of Figure 8. [Figure 16] Figures 16A and 16B are isometric front views of the mounting plate shown in Figures 15A-15C, which is positioned on top of the probe cover consistent with the implementation described herein. [Figure 17] Figure 17 is a front isometric view of the mounting sleeve of Figures 15A-15C, which is positioned on top of the ultrasonic probe interface pad consistent with the implementation described herein. [Figure 18] Figures 18, 19, 20, and 21 are isometric, rear, bottom, and front views, respectively, of yet another embodiment of a puncture device guide consistent with the implementation described herein. [Figure 19] Figures 18, 19, 20, and 21 are isometric, rear, bottom, and front views, respectively, of yet another embodiment of a puncture device guide consistent with the implementation described herein. [Figure 20] Figures 18, 19, 20, and 21 are isometric, rear, bottom, and front views, respectively, of yet another embodiment of a puncture device guide consistent with the implementation described herein. [Figure 21]Figures 18, 19, 20, and 21 are isometric, rear, bottom, and front views, respectively, of yet another embodiment of a puncture device guide consistent with the implementation described herein. [Figure 22] Figures 22, 23, and 24 are cross-sectional views obtained along lines AA, BB, and CC in Figure 21, respectively. [Figure 23] Figures 22, 23, and 24 are cross-sectional views obtained along lines AA, BB, and CC in Figure 21, respectively. [Figure 24] Figures 22, 23, and 24 are cross-sectional views obtained along lines AA, BB, and CC in Figure 21, respectively. [Figure 25] Figures 25A, 25B, and 25C are a front isometric view, a front view, and a bottom view, respectively, of another embodiment of the mounting structure for use when fixing the puncture device guide of Figure 18. [Figure 26] Figures 26A and 26B are isometric front views of the mounting structure shown in Figures 25A-25C, which is mounted on a probe cover consistent with the implementation described herein. [Figure 27] Figures 27A and 27B are isometric front views of the mounting structure of Figures 15A-15C, which is mounted on an ultrasonic probe interface pad consistent with the implementation described herein. [Modes for carrying out the invention]

[0005] Detailed description of preferred embodiments The following detailed description refers to the accompanying drawings. The same reference numerals in different drawings may indicate the same or similar elements. Furthermore, the following detailed description is not intended to limit the invention.

[0006] FIG. 1 is an isometric view of a puncture device guide 100 consistent with the implementations described herein and mounted on an ultrasonic probe 10. FIG. 2 is another isometric view of the puncture device guide 100 illustrating a deflected or bent orientation. FIG. 3 is yet another isometric view of the puncture device guide 100 illustrating additional details. FIG. 4 is an isometric view of a mounting sheet 110 positioned on the ultrasonic probe 10 for attaching the puncture device guide 100 to the probe 10.

[0007] As shown, the puncture device guide 100 includes a fixed portion 111 and a deflectable portion 112 for supporting a needle or other puncture device (e.g., needle 20 in FIGS. 1 and 2) at a range of angular orientations relative to the fixed portion 111. As shown in FIG. 3, the fixed portion 111 includes a frame-like configuration having side rails 114 and 116, four legs 118, 120, 122, and 124 projecting perpendicularly from the side rails 114 and 116, and cross members 126 and 128. In one implementation, as shown in FIG. 3, the proximal cross member 126 may connect legs 120 and 122, and the distal cross member 128 may connect the distal ends of the side rails 114 and 116. Such a configuration provides a space 130 between legs 120 and 122 and between side rails 114 and 116 to accommodate the receipt of needle 20 therein, as described below. As shown in the figures, each of the legs 118 - 124 includes a free end that engages and attaches to the surface of the ultrasonic probe 10, as described in further detail below.

[0008] Consistent with the implementations described herein, the distal intersection member 128 may form a base of a living hinge or spring hinge component 132 for coupling the deflection portion 112 to the fixed portion 111. As shown in FIG. 3, the deflection portion includes a pair of deflection side rails 134 and 136 that project proximally from the distal intersection member 128 and are parallel to side rails 114 and 116. An intersection member 138 connects the proximal ends of the deflection side rails 134 and 136. In some implementations, the deflection side rails 134 and 136 have a length that is shorter than the length of the side rails 114 and 116 such that the deflection portion 112 is completely contained within the fixed portion 111.

[0009] As shown in FIG. 3, an inwardly facing groove 140 is formed within a central portion of the intersection member 138 and an outwardly facing groove 142 is formed within a portion of the distal intersection member 128 between the deflection side rails 134 and 136. The grooves 140 and 142 are sized to accommodate various needle gauge sizes. For example, one or both of the grooves 140 and 142 may be a V-shaped groove (commonly referred to as a "v-groove"). In other implementations, the grooves 140 / 142 may have different configurations such as cylindrical, slot-shaped, etc.

[0010] Consistent with the implementations described herein, the puncture device guide 100 is formed from a suitably elastic or flexible material such as a plastic or polymeric material and has a thickness or overall dimension within the region of the living hinge component 132 and / or the deflection portion 112 that allows at least a portion of the living hinge component 132 and / or the deflection portion 112 to bend or rotate in response to the application of a rotational load.

[0011] As shown in Figures 1 and 2, during use, the needle 20 may be inserted into grooves 140 and 142. To achieve a desired needle angle, an outward pivot force may be applied to the proximal end of the needle 20. This force causes the needle 20 to propel the crossing member 138 outward relative to the side rails 114 and 116, which in turn causes the side rails 134 and 136 to rotatably deflect or deform relative to the distal crossing member 128. Such a one-piece structure may be referred to as a "living hinge," given that there are no discrete and independent movable hinge components or mechanisms.

[0012] Furthermore, consistent with several implementations, the deflection side rails 134 / 136 and / or crossing members 128 of the living hinge component 132 may be formed to provide a neutral bias to the deflection portion 112. Thus, the deflection portion 112 can rotate in response to the pressure applied by the needle 20 onto the inwardly facing groove 140, but the dimensions and thickness of the components in question may be such that the deflection portion 112 is biased to return to its neutral position and thus able to maintain pressure on the needle 20 throughout its entire range of motion.

[0013] As shown, the two grooves 140 and 142 are configured to guide the needle 20 along the scanning plane 14 of the probe 10. The grooves are oriented in opposing directions, and as a result, as pressure is applied by the needle 20, causing the deflection portion 112 to rotate around the living hinge and adjust the angle with respect to the fixed portion 111 of the guide, the needle 20 is pushed into both grooves simultaneously. The grooves 140 / 142 allow the physician complete control of the needle angle in the scanning plane while enabling the puncture device guide to work with needles of various sizes and hold them in the scanning plane of the ultrasound probe. Figure 1 illustrates the needle 20 positioned in the grooves 140 / 142 and oriented to a first (e.g., neutral or unbent) angular position. Figure 2 illustrates the needle guide 100 and probe 10 with a deflection portion 112 that is bent to allow the needle 20 to be at a sharper angle with respect to the probe surface 11.

[0014] According to embodiments described herein, the puncture device guide 100 may be formed as a single plastic or as a similarly flexible or elastic component. Exemplary manufacturing processes include injection molding of the component from acetal (polyoxymethylene), polypropylene, or any other suitable plastic material.

[0015] As shown in the figure, in one implementation, the puncture device guide 100 may be attached to the ultrasound probe 10 following the manufacture of the probe 10, and no configuration of the ultrasound probe 10 is required to adapt to the attachment of the puncture device guide 100. In one implementation, the puncture device guide 100 is attached via an adhesive mounting sheet 110. As shown in Figure 4, the mounting sheet 110 may be similarly sized with respect to the edges of the puncture device guide 100 and may include a back surface 144 and a front surface 146. To attach the puncture device guide 100 to the ultrasound probe 10, the mounting sheet 110 may include an adhesive layer 147 on the back surface 144 and adhesive pads 148a-148d at four positions on the front surface 146 corresponding to the free ends of the legs 118-124 on the puncture device guide 100.

[0016] In the shown embodiment, the front surface 146 is generally white with black markings within the four corners 148a-148d. Other colors may be used, or the adhesive film may be clear with only the corners and alignment stripes marked. The adhesive layer 147 on the back surface 144 may cover the entire surface or be installed only at the four marked positions. In addition to the markings for the four corners, the mounting sheet 110 may include two alignment stripes 150, 152 used to allow the user to align the mounting sheet 110 to the centerline 12 on the ultrasound probe 10 corresponding to the scanning plane of the probe. In this implementation, a release layer (not shown) is first provided on the adhesive layer 147 and adhesive pads 148a-148d. Prior to the use of the puncture device guide 100, the release layer is removed and the mounting sheet 110 is attached to the ultrasound probe 10 via the adhesive layer 147 using the alignment stripes 150 / 152. The free ends of the legs 118-124 of the puncture device guide 100 are then attached to the adhesive pads 148a-148d, thereby fixing the puncture device guide 100 to the probe 10.

[0017] In further embodiments of the present invention (not shown), the puncture device guide 100 may be adapted for use with a probe cover or sheath. In this embodiment, adhesive pads may be provided on the free ends of the legs 118-124. In this configuration, the mounting sheet 110 is attached to the probe 10, and a transparent or translucent probe cover is positioned over the probe 10 and over the mounting sheet 110. The mounting sheet 110 is bonded to the probe cover. Subsequently, the adhesive pads on the legs 118-124 are then bonded to the probe cover directly above the adhesive pads 148a-148d, thereby bonding the puncture device guide 100 to the probe cover.

[0018] Figures 5, 6, and 7 illustrate isometric, side, and top views, respectively, of further embodiments of the puncture device guide 500 and mounting sheet 110 mounted on the ultrasound probe 10.

[0019] As shown, the puncture device guide 500 includes a fixed portion 510 and a deflection portion 512 for supporting a needle or other puncture device (e.g., the needle 20 in Figures 5 and 6) in a range of angular orientations relative to the fixed portion 510. Consistent with the illustrated embodiments, the fixed portion 510 includes a frame-like configuration, the frame-like configuration having a pair of curved side rails 514 and curved side rails 516, distal legs 518 and distal legs 520 projecting perpendicularly from the distal portions of the side rails 514 and side rails 516, and crossing members 522 and crossing members 524. Rather than including proximal legs projecting perpendicularly, as provided in the embodiments of Figures 1-3, the curved side rails 514 / 516 of the puncture device guide 500 include proximal portions 526 and proximal portions 528 that curve downward, as shown in Figures 5 and 6. The proximal portions 526 / 528 and distal legs 518 / 520 each include a free end that engages with the mounting sheet 110 (or probe cover), as described above.

[0020] As shown in Figure 5, the proximal crossing member 522 connects the curved proximal portions 526 and 528, and the distal crossing member 524 connects the distal ends of the side rails 514 and 516. As described below, such a configuration provides a space 530 between the curved proximal portions 526 and 528, the space 530 being adapted for receiving the needle 20 therein. Similar to the embodiments of Figures 1-4 described above, during use, the free ends of the legs 518 / 520 and the proximal portions 526 / 528 of the puncture device guide 500 are attached to adhesive pads 148a-148d in the mounting sheet 110 (or to a probe cover positioned across such pads), thereby securing the puncture device guide 500 to the probe 10.

[0021] The distal crossing member 524 may form the base of a living hinge component 532 for connecting the deflection portion 512 to the fixed portion 510. As shown in Figure 5, the deflection portion 512 comprises a pair of deflection side rails 534 and 536 projecting proximal to the side rails 514 and 516 from the distal crossing member 524. The crossing member 538 connects the proximal ends of the deflection side rails 534 and 536. In some implementations, the deflection side rails 534 and 536 are shorter than the length of the side rails 514 and 516 so that the deflection portion 512 is fully contained within the fixed portion 510.

[0022] In accordance with the implementations described herein, the puncture device guide 500 may be formed from a preferably elastic or flexible material such as plastic or polymer material, and may have a thickness or overall dimension within the area of ​​the living hinge component 532 and / or deflection portion 512 that allows at least a portion of the living hinge component 532 and / or deflection portion 512 to bend or rotate in response to the application of a rotational load.

[0023] Furthermore, consistent with several implementations, the deflection portion 512 and / or cross member 524 of the living hinge component 532 may be formed to provide a neutral bias to the deflection portion 512. Thus, the deflection portion 512 can rotate in response to pressure applied by the needle 20, but the dimensions and thickness of the components in question may be such that the deflection portion 512 is biased to return to its neutral position and thus able to maintain pressure on the needle 20 throughout its entire range of motion.

[0024] As shown in Figure 5, an inward-facing groove 540 is formed within the central portion of the intersecting member 538, and an outward-facing groove 542 is formed within a portion of the distal intersecting member 524 between the deflection side rails 534 and 536. The grooves 540 and 542 are sized to accommodate various puncture device gauge sizes. For example, one or both of the grooves 540 and 542 may be V-grooves, similar to the grooves 140 / 142 described above, but in other implementations, the grooves 540 / 542 may have different configurations, such as cylindrical or slotted.

[0025] As shown in Figures 5 and 6, during use, the needle 20 may be inserted into grooves 540 and 542. To achieve a desired needle angle, an outward pivot force may be applied to the proximal end of the needle 20. This force causes the needle 20 to propel the crossing member 538 outward relative to the side rails 514 and 516, which in turn causes the deflecting side rails 534 and 536 to rotatably deflect or deform relative to the distal crossing member 524.

[0026] As shown, the two grooves 540 and 542 are configured to guide the needle 20 along the scanning plane 14 of the probe 10. The grooves are oriented in opposing directions, and as a result, pressure is applied by the needle 20, causing the deflection portion 512 to rotate around the living hinge and adjust the angle with respect to the fixed portion 510 of the guide 500, the needle 20 is pushed into both grooves simultaneously. The grooves 540 / 542 allow the physician complete control of the needle angle in the scanning plane while enabling the puncture device guide to work with puncture devices of various sizes and hold them in the scanning plane of the ultrasound probe. Figures 5 and 6 illustrate the needle 20 positioned in the grooves 540 / 542 and oriented to a first (e.g., neutral or unbent) angular position. Similar to the puncture device guide 100 described above, the puncture device guide 500 may also be formed as a single piece of injection-molded plastic such as acetal, polypropylene, or a similarly flexible or elastic component. In addition, the puncture device guide 500 may be consistently attached to the probe 10 or probe cover in the manner described above in relation to Figure 4.

[0027] Figures 8, 9, 10, and 11 illustrate front isometric, rear isometric, bottom, and front views, respectively, of yet another embodiment of the puncture device guide 800 consistent with the implementation described herein. Figures 12, 13, and 14 illustrate cross-sectional views obtained along lines AA, BB, and CC in Figure 11, respectively. As shown, the puncture device guide 800 includes a fixed portion 810 and a deflection portion 812 for supporting a puncture device (e.g., the needle 20 described above) in a range of angular orientations relative to the fixed portion 810.

[0028] Consistent with the illustrated embodiments, the fixed portion 810 includes a U-shaped configuration, the U-shaped configuration having a pair of side rails 814 and 816 and a crossing member 818 connecting the side rails 814 and 816. In contrast to the embodiments of Figures 1-3 and 5-7, rather than including right-angled protruding legs, the side rails 814 / 816 of the puncture device guide 800 are substantially planar elements configured to directly engage with the ultrasound probe 10, probe cover, or adhesive mounting sheet (such as mounting sheet 110).

[0029] As shown in Figures 8 and 11, the side rails 814 and 816 and the cross member 818 each include a raised edge or lip portion 820 around at least a portion of their respective periphery, increasing the rigidity or structural strength of these elements. As shown in Figure 9, the rear surfaces of the side rails 814 and 816 may be substantially flat. As shown in Figure 12, the central portions of the side rails 814 and 816 may have a thickness T1, and the lip portion 820 may have a thickness T2 that is about 50% thicker than T1. Exemplary dimensions of T1 and T2 are about 0.5 millimeters (mm) and 0.75 millimeters (mm), respectively.

[0030] In accordance with the implementations described herein, the crossing member 818 may form the base of a living hinge component 822 for connecting the deflection portion 812 to the fixed portion 810. For example, the deflection portion 812 may be formed with dimensions suitable for the crossing member 818 so as to allow the deflection portion 812 to rotate or pivot about the crossing member 818 in response to the application of a rotational load.

[0031] Furthermore, consistent with several implementations, the deflection side rails 812 and / or cross members 818 of the living hinge component 822 may be formed to provide a neutral bias to the deflection portion 812. Thus, the deflection portion 812 may rotate outward in response to pressure applied by the needle 20, but the dimensions and thickness of the components in question may be such that the deflection portion 812 is biased to return to its neutral position and thus maintain pressure on the needle 20 throughout its entire range of motion, as described below.

[0032] As shown in Figures 8-10, the deflection portion 812 comprises a pair of deflection side rails 824 and 826 projecting proximal to the crossing member 818 and parallel to the side rails 814 and 816. Consistent with one implementation, as shown in Figure 13, the deflection side rails 824 / 826 may project in a relaxed angular orientation 81 relative to the side rails 814 / 816. One exemplary angle 81 may be about 10°, but any preferred relaxed orientation in the range of about 0° to 15° may also be provided.

[0033] A deflection crossing member 830 connects the proximal ends of the deflection side rails 824 and 826. In some implementations, the deflection side rails 824 and 826 are shorter than the lengths of the side rails 814 and 816, so that the deflection portion 812 is completely contained within the fixed portion 810. As shown in Figure 13, the deflection side rails may have a thickness T3 sufficient to allow at least a portion of them to bend relative to the crossing member 818. An exemplary dimension of the thickness T3 is about 0.35 mm.

[0034] The deflection cross member 830 includes a latching portion 832 that projects outward perpendicularly from the deflection side rails 824 / 826. As shown, the latching portion 832 includes an access opening 834 and an inward-facing groove 836 accessible through the access opening 834. The groove 836 may be centrally located between the deflection rails 824 / 826.

[0035] As shown in Figures 8-11, the deflection portion 812 further includes a rigid guide portion 838. The rigid guide portion 838 protrudes both distally and proximal from the intersecting member 818 between the deflection side rails 824 / 826. As shown in Figure 14, the rigid guide portion 838 is formed to have a similar angular orientation 81 with respect to the side rails 814 / 816, as described above in relation to the displacement side rails 824 / 826 in their relaxed state. The rigid guide portion 838 includes a distal portion 840 and a proximal portion 842. The distal portion 840 and the proximal portion 842 each include an outward-facing groove 844, which is formed within its central portion and aligned with an inward-facing groove 836 within the locking portion 832. As shown in Figure 14, the rigid guide portion 838 may be formed from a thickness T4 that exceeds the thickness T3 of the deflection side rails 824 / 826. An exemplary dimension of the thickness T4 is approximately 0.6 mm.

[0036] As shown in Figures 8 and 14, the distal portion 840 of the rigid guide portion 838 may include a groove wall 846 projecting forward relative to the proximal portion 842. As shown in Figure 14, the groove wall 846 provides a groove 844 in the distal portion 840, the groove 844 in the distal portion 840 having an increased depth D2 compared to the depth D1 of the groove 844 in the proximal portion 842. Such an increased depth in the distal portion 840 allows the groove 844 to more completely support the puncture device through various angular orientations, as described below.

[0037] In addition, consistent with the implementations described herein, the distal portion 840 of the rigid guide portion 838 includes a probe surface engagement portion 848 that projects rearward relative to the crossing member 818. The probe surface engagement portion 848 is configured to engage with the front surface 11 of the ultrasound probe during deployment to ensure that the puncture device guide 800 is properly positioned relative to the surface. As shown in Figure 12, in some implementations, the probe surface engagement portion 848 may be angled with respect to the side rails 814 and 816 at an angle 82 to more closely match the front surface of the ultrasound probe. One exemplary angle 82 is about 100°, but any angle corresponding to the radius of curvature or configuration of the front surface of the ultrasound probe may be used depending on the particular implementation.

[0038] During use, the puncture device may be inserted into grooves 836 and 844. To achieve a desired angle, an outward pivot force may be applied to the proximal end of the puncture device. This force propels the hook portion 832 of the puncture device outward relative to the side rails 814 and 816, which in turn deflects or deforms the deflection side rails 824 and 826 rotatably relative to the distal crossing member 818.

[0039] As shown, the two grooves 836 and 844 are configured to guide the puncture device along the scanning planar ultrasound probe. The grooves are oriented in opposite directions, and as a result, pressure is applied by the puncture device, causing the deflection portion 812 to rotate around the living hinge and adjust its angle relative to the fixed portion 810. As briefly discussed above, in some embodiments, the living hinge component 822 may include a spring-like configuration that propels the deflection portion 812 back to its neutral position throughout its entire range of motion. In such an implementation, groove 836 maintains a positive engagement with the needle 20 throughout its entire rotation.

[0040] According to embodiments described herein, the puncture device guide 800 may be formed as a single plastic or as a similarly flexible or elastic component. Exemplary manufacturing processes include injection molding of the component from acetal (polyoxymethylene), polypropylene, or any other suitable plastic material.

[0041] Figures 15A, 15B, and 15C illustrate isometric, front, and bottom views, respectively, of another embodiment of the mounting sleeve 1500 for use when securing the puncture device guide 800 to the ultrasound probe 10. Figure 16A is an isometric front view of the mounting sleeve 1500 attached to a probe cover 15 which is positioned on top of the ultrasound probe 10. In one implementation, the probe cover 15 comprises a tubular structure 16 having a planar end portion 17 to which it is fixed to form a closed end. In another implementation, the probe cover 15 comprises a one-piece sock-like structure which has a closed end and an open end. In any case, consistent with the implementations described herein, the mounting sleeve 1500 may be fixed to the closed end to provide an interface for receiving the puncture device guide 800, as shown. Figure 16B is a front view isometric of the assembly in Figure 16A, illustrating how the puncture device guide 800 is connected to the mounting sleeve 1500.

[0042] Figure 17 is a front isometric view of a mounting sleeve 1500 attached to an ultrasonic probe interface pad 18 which is positioned on top of an ultrasonic probe 10. As shown, the ultrasonic probe interface pad 18 includes a substantially planar film, the substantially planar film having a patient-facing side 19 and a probe-facing side. The mounting sleeve 1500 is positioned on the patient-facing side 19 (e.g., by welding, gluing, etc.) to provide an interface for receiving the puncture device guide 800, as shown.

[0043] In accordance with the implementations described herein, the mounting sleeve 1500 comprises a substantially flat structure having adhesive portions 1502a, 1502b, and 1502c and a puncture device guide receiving slot 1504. As shown in Figures 15A and 15C, each of the puncture device guide receiving slots 1504 has a relative spacing and thickness (indicated as T5) generally corresponding to the thickness of the side rails 814 / 816, including the lip portion 820. In one implementation, the mounting sleeve 1500 may be formed from a flexible polyurethane material, such as a material similar to that forming the remainder of the probe cover 15 or interface pad 18. In other implementations, semi-rigid or rigid materials may also be used. The adhesive portions 1502a-1502c are adjacent puncture device guide receiving slots 1504 and have a substantially planar configuration for engaging with the surface of a probe covering device, such as the probe cover 16 or probe interface pad 17, as shown in Figures 16 and 17. In accordance with the implementations described herein, the adhesive portions 1502a-1502c may be permanently bonded to a predetermined location on the probe cover 16 or probe interface pad 17 by heat welding, permanent bonding, etc. Prior to use, the side rails 814 / 816 may be slid into the puncture device guide receiving slot 1504 so that the probe surface engaging portions 848 abut against the front surface 11 of the ultrasound probe (with the probe cover 6 or probe interface pad 17 positioned between them).

[0044] For further implementation and consistency, the probe cover 16 or probe interface pad 17 may be provided with an adhesive inner surface for fixing the probe cover or probe interface pad 17 to the front surface 11 prior to use.

[0045] As shown in Figures 16A, 16B, and 17, in some implementations, the probe cover 16 and probe interface pad 17 may be provided with alignment fringes 1506, which can be used to assist the user in aligning the mounting sleeve 1500 onto both the probe cover or probe interface pad and positioning the probe cover or probe interface pad on the ultrasound probe 10 using a pre-placed puncture device guide 800 therein. As shown, the alignment fringes may include vertical alignment fringes configured to align with a desired plane on the probe, such as the scanning plane, as shown in the figure. In other implementations, the vertical alignment fringes may be aligned with the central plane of the probe 10 to accommodate out-of-plane guidance. In some implementations, the alignment fringes may also include horizontal alignment fringes that can assist the user in positioning the probe cover / interface pad in the correct location on the probe 10.

[0046] Figures 18, 19, 20, and 21 illustrate front isometric, rear isometric, bottom, and front views, respectively, of yet another embodiment of the puncture device guide 1800 consistent with the implementation described herein. Figures 22, 23, and 24 illustrate cross-sectional views obtained along lines AA, BB, and CC in Figure 21, respectively. As shown, the puncture device guide 1800 includes a fixed portion 1810 and a deflection portion 1812 for supporting a puncture device (e.g., the needle 20 described above) in a range of angular orientations relative to the fixed portion 1810.

[0047] Consistent with the illustrated embodiments, the fixed portion 1810 includes a pair of side rails 1814 and 1816, including a U-shaped configuration, and a crossing member 1818 connecting the side rails 1814 and 1816. In contrast to the embodiments of Figures 8-14, generally, rather than including flat side rails, the side rails 1814 / 1816 of the puncture device guide 1800 are three-dimensionally molded to assist in fixing the side rails 1814 / 1816 within the mounting structure 2500, which is described in detail below. In addition, the three-dimensional configuration can further provide increased strength and rigidity of the side rails 1814 / 1816. For example, as most clearly shown in Figures 18 and 20, the side rails 1814 / 1816 may include a crossing or star configuration, the crossing or star configuration having opposing vertical ribs 1819 and opposing horizontal ribs 1820 oriented perpendicular to the vertical ribs 1819. In one implementation, ribs 1819 and 1820 include a common or shared depth such that the virtual radial circumference of each side rail forms a circle having a diameter substantially similar to the depth of each rib. If more or fewer than four ribs 1819 / 1820 are provided, such a common radial circumference may be maintained. As shown in the figure, the side rails 1814 / 1816 may include a rounded proximal end 1822 to assist in positioning or mounting the puncture device guide 1800, as described below.

[0048] In accordance with the implementations described herein, the crossing member 1818 may form the base of a living hinge component 1822 for connecting the deflection portion 1812 to the fixed portion 1810. For example, the deflection portion 1812 may be formed with dimensions suitable for the crossing member 1818 so as to allow the deflection portion 1812 to rotate or pivot about the crossing member 1818 in response to the application of a rotational load.

[0049] Furthermore, consistent with several implementations, the deflection portion 1812 and / or cross member 1818 of the living hinge component 1822 may be formed to provide a neutral bias to the deflection portion 1812. Thus, the deflection portion 1812 may rotate outward in response to pressure applied by the needle 20, but the dimensions and thickness of the components in question may be such that the deflection portion 1812 is biased to return to its neutral position and thus able to maintain pressure on the needle 20 throughout its entire range of motion, as described below.

[0050] As shown in Figures 18-21, the deflection portion 1812 comprises a pair of deflection side rails 1824 and 1826 that project proximally from the crossing member 1818 and parallel to the side rails 1814 and 1816. Consistent with one implementation, as shown in Figure 13, the deflection side rails 1824 / 1826 may project in a relaxed angular orientation 81 relative to the side rails 1814 / 1816. One exemplary angle 81 may be about 10°, but any preferred relaxed orientation in the range of about 0° to 15° may also be provided.

[0051] A deflection crossing member 1830 connects the proximal ends of the deflection side rails 1824 and 1826. In some implementations, the deflection side rails 1824 and 1826 have a length shorter than the lengths of the side rails 1814 and 1816, so that the deflection portion 1812 is fully contained within the fixed portion 1810. As shown in Figure 23, the deflection side rails 1824 / 1826 may have a thickness T3 sufficient to allow at least a portion of them to bend relative to the crossing member 1818. An exemplary dimension of the thickness T3 is about 0.35 mm.

[0052] The deflection cross member 1830 includes a latching portion 1832 that projects outward perpendicularly from the deflection side rails 1824 / 1826. As shown, the latching portion 1832 includes an access opening 1834 and an inward-facing groove 1836 accessible through the access opening 1834. The groove 1836 may be centrally located between the deflection rails 1824 / 1826.

[0053] As shown in Figures 18-21, the deflection portion 1812 further includes a rigid guide portion 1838. The rigid guide portion 1838 protrudes both distally and proximal from the cross member 1818 between the deflection side rails 1824 / 1826. As shown in Figure 24, the rigid guide portion 1838 is formed to have a similar angular orientation 81 with respect to the side rails 1814 / 1816 in relation to the displacement side rails 1824 / 1826 in their relaxed state, as described above. The rigid guide portion 1838 includes a distal portion 1840 and a proximal portion 1842. The distal portion 1840 and the proximal portion 1842 each include an outward-facing groove 1844 formed within their central portion and aligned with an inward-facing groove 1836 within the locking portion 1832. As shown in Figure 14, the rigid guide portion 1838 may be formed from a thickness T4 that exceeds the thickness T3 of the deflection side rails 1824 / 1826. An exemplary dimension of thickness T4 is approximately 0.6 mm.

[0054] As shown in Figures 18 and 24, the distal portion 1840 of the rigid guide portion 1838 may include a groove wall 1846 projecting forward relative to the proximal portion 1842. As shown in Figure 24, the groove wall 1846 provides a groove 1844 in the distal portion 1840, the groove 1844 in the distal portion 1840 having an increased depth D2 compared to the depth D1 of the groove 1844 in the proximal portion 1842. Such an increased depth in the distal portion 1840 allows the groove 1844 to more completely support the puncture device through various angular orientations, as described below.

[0055] In addition, consistent with the implementations described herein, the distal portion 1840 of the rigid guide portion 1838 includes a probe surface engagement portion 1848 that projects rearward relative to the crossing member 1818. The probe surface engagement portion 1848 is configured to engage with the front surface of the ultrasound probe during deployment, ensuring that the puncture device guide 1800 is properly positioned relative to the surface. As shown in Figure 22, in some implementations, the probe surface engagement portion 1848 may be angled at an angle 82 with respect to the side rails 1814 and 1816 to more closely match the front surface of the ultrasound probe. One exemplary angle 82 is about 100°, but any angle corresponding to the radius of curvature or configuration of the front surface of the ultrasound probe may be used depending on the particular implementation.

[0056] During use, the puncture device may be inserted into grooves 1836 and 1844. To achieve a desired angle, an outward pivot force may be applied to the proximal end of the puncture device. This force propels the hook portion 1832 of the puncture device outward relative to the side rails 1814 and 1816, which in turn deflects or deforms the deflection side rails 1824 and 1826 rotatably relative to the distal crossing member 1818.

[0057] As shown, the two grooves 1836 and 1844 are configured to guide the puncture device along the scanning planar ultrasound probe. The grooves are oriented in opposite directions, and as a result, pressure is applied by the puncture device, causing the deflection portion 1812 to rotate around the living hinge and adjust its angle relative to the fixed portion 1810.

[0058] According to embodiments described herein, the puncture device guide 1800 may be formed as a single plastic or as a similarly flexible or elastic component. Exemplary manufacturing processes include injection molding of the component from acetal (polyoxymethylene), polypropylene, or any other suitable plastic material.

[0059] Figures 25A, 25B, and 25C illustrate isometric, front, and bottom views, respectively, of another embodiment of the mounting structure 2500 for use when attaching the puncture device guide 800 to the ultrasound probe 10. Figure 26A is an isometric front view of the mounting structure 2500 positioned on a probe cover 25 positioned on the ultrasound probe 10. In one implementation, the probe cover 25 comprises a tubular structure 26 having a planar end portion 27 to which it is fixed to form a closed end. In another implementation, the probe cover 25 comprises a one-piece sock-like structure, the one-piece sock-like structure having a closed end and an open end. In any case, consistent with the implementations described herein, the mounting structure 2500 is fixed to the closed end to provide an interface for receiving the puncture device guide 1800, as shown. Figure 26B is a front view isometric of the assembly in Figure 26A, illustrating how the puncture device guide 1800 is connected to the mounting structure 2500.

[0060] Figures 27A and 27B are front isometric views of a mounting structure 2500 disposed on an ultrasonic probe interface pad 28 which is disposed on an ultrasonic probe 10. As shown, the ultrasonic probe interface pad 28 includes a substantially planar film, which has a patient-facing side 29 and a probe-facing side. The mounting structure 2500 is disposed on the patient-facing side 19 (e.g., by welding, gluing, etc.) to provide an interface for receiving the puncture device guide 1800, as shown.

[0061] In accordance with the implementations described herein, the mounting structure 2500 comprises a pair of substantially tubular side rail receiving elements 2502 and 2504. As shown in Figures 25A and 25C, the side rail receiving elements 2502 and 2504 each have an inner diameter substantially similar to the height of the ribs 1819 / 1820, so that the side rails 1814 / 1816 can be received within the side rail receiving elements 2502 and 2504. In one implementation, the side rail receiving elements 2500 may be formed from a flexible polyurethane material, such as a material similar to that forming the probe cover 25 or the remainder of the interface pad 28. In other implementations, semi-rigid or rigid materials may also be used.

[0062] In accordance with the implementations described herein, the side rail receiving elements 2502 and 2504 may be permanently bonded to a predetermined location on the probe cover 25 or probe interface pad 28 by means of heat welding, permanent bonding, etc. Prior to use, the sliding rails 1814 / 1816 may be slid within the side rail receiving elements 2502 and 2504 so that the probe surface engaging portion 1848 abuts against the front surface 11 of the ultrasonic probe (with the probe cover 25 or probe interface pad 28 positioned between them). In accordance with further implementations, the probe cover 25 or probe interface pad 28 may be provided with an adhesive inner surface for fixing the probe cover or probe interface pad 25 / 28 to the front surface 11 prior to use.

[0063] As shown in Figures 26A, 26B, 27A, and 27B, in some implementations, the probe cover 25 and probe interface pad 28 may be provided with alignment fringes 2506, which can be used to assist the user in aligning the mounting structure 2500 onto both the probe cover or the probe interface pad and in positioning the probe cover or probe interface pad on the ultrasound probe 10 using a pre-placed puncture device guide 1800 therein. As shown, the alignment fringes 2506 may include vertical alignment fringes configured to align with a desired plane on the probe, such as the scanning plane, as shown in the figure. In other implementations, the vertical alignment fringes may be aligned with the central plane of the probe 10 to adapt to out-of-plane puncture device guidance. In some implementations, the alignment fringes 2506 may also include horizontal alignment fringes that can assist the user in positioning the probe cover / interface pad in the correct location on the probe 10.

[0064] The foregoing description of exemplary implementations provides illustration and explanation, but is not intended to be exhaustive or to limit the embodiments described herein to the precise forms disclosed. Modifications and variations may be considered possible in light of the foregoing teachings or may be derived from the practice of the embodiments.

[0065] While the present invention has been described in detail above, it should be clearly understood that it will be obvious to those skilled in the art that the present invention can be modified without departing from the spirit of the invention. Various changes in form, design, or arrangement can be made to the present invention without departing from the spirit and scope of the invention. Accordingly, the description given above should be considered illustrative and not limiting, and the true scope of the invention is defined in the following claims. The puncture device guide devices described above include combinations of features described, but not all feature inclusions are required to be incorporated into each embodiment. For example, puncture device guide device 100, puncture device guide device 500, puncture device guide device 800, and puncture device guide device 1800 each include a living hinge base configuration, but other guide structures can also be employed, as claimed, without departing from the spirit of the invention. Implementation. In particular, other types of puncture device guide structures, including fixed plates, multi-part pivot components, etc., can also be used.

[0066] Any element, act, or command used in this description should not be construed as being material to or essential to the invention unless expressly described as such. Furthermore, as used herein, the article "a" is intended to include one or more articles. In addition, the phrase "based on" is intended to mean "based, at least in part, on" unless expressly stated otherwise.

[0067] The use of ordinal terms such as "first," "second," and "third" within a claim to modify a claim element does not in itself imply any priority, superiority, or order of any one claim element over other claim elements, such as another temporal order in which the actions of the method are performed or the temporal order in which instructions performed by a device are performed. Rather, it is used merely as a mark to distinguish one claim element having a certain name from another element having the same name (except for the use of ordinal terms) and to differentiate the claim elements.

Claims

1. A puncture device guide for use with an ultrasound probe, wherein the ultrasound probe comprises a probe body and a probe surface arranged at the distal end of the probe body, the ultrasound probe surface being configured to be positioned close to the patient's outer surface, the ultrasound probe forming a scanning plane perpendicular to the probe surface, and the puncture device guide is A fixed portion configured to be attached directly or indirectly to the probe body, A deflection portion connected to the fixed portion by at least one spring or living hinge and Equipped with, The deflection portion comprises at least one groove, and the at least one groove is configured to support a puncture device therein. The outward pressure on at least one groove causes the deflected portion to rotate outward relative to the fixed portion so as to support the puncture device over the entire range of angles. Guide to puncture devices.

2. The puncture device guide according to claim 1, wherein the fixed portion and the deflection portion are manufactured as a single component.

3. The puncture device guide according to claim 1, wherein the fixed portion and the rotatable portion are formed from a flexible material.

4. The puncture device guide according to claim 1, wherein the fixed portion comprises a first side rail and a second side rail joined to the first side rail by a crossing member.

5. The puncture device guide according to claim 4, wherein the deflection portion comprises at least one flexible member protruding from the crossing member.

6. The first side rail and the second side rail protrude at a right angle from the opposing ends of the intersecting member, The flexible member of the deflection portion protrudes between the first side rail and the second side rail, The puncture device guide according to claim 5.

7. The puncture device guide according to claim 6, wherein the flexible member comprises a first deflection side rail and a second deflection side rail joined to the first deflection side rail by a deflection crossing member.

8. The at least one groove is, A first groove in the intersecting member, wherein the first groove, when installed, is configured to face outward from the probe body, A second groove formed within the deflection crossing member, wherein the second groove, when installed, is configured to face inward from the probe body, and Equipped with, The first groove is aligned with the second groove. The puncture device guide according to claim 7.

9. The puncture device guide according to claim 7, wherein the deflection crossing member comprises a latching portion adjacent to the second groove, the latching portion providing an access opening in the second groove so as to enable the puncture device guide to be removed from the puncture device without requiring the withdrawal of the puncture device inserted into the first groove and the second groove.

10. The puncture device guide according to claim 7, wherein the flexible member protrudes in a relaxed angular orientation relative to the first side rail and the second side rail.

11. The puncture device guide according to claim 10, wherein the relaxed angular orientation includes an angular orientation in the range of about 0° to 15°.

12. The system further comprises a rigid guide portion protruding from the intersecting member between the first deflection side rail and the second deflection side rail, The at least one groove is, The puncture device guide according to claim 7, further comprising a first outward-facing groove formed within the rigid guiding portion.

13. The puncture device guide according to claim 12, wherein the rigid guiding portion protrudes at a certain angular orientation relative to the first side rail and the second side rail.

14. The rigid guide portion includes a distal portion that protrudes distally from the crossing member and a proximal portion that protrudes proximal to the crossing member. The aforementioned rigid guide portion includes a groove wall, The groove wall in the proximal portion has an increased depth compared to the groove wall in the distal portion. The puncture device guide according to claim 12.

15. The puncture device guide according to claim 14, wherein the proximal portion of the rigid guide portion protrudes rearward with respect to the crossing member and forms a probe surface engagement portion configured to engage with the front surface of the ultrasonic probe during installation.

16. The puncture device guide according to claim 15, wherein the probe surface engagement portion is angled with respect to the first side rail and the second side rail so as to coincide with the front surface of the ultrasound probe.

17. The puncture device guide according to claim 5, wherein the first side rail and the second side rail include a planar configuration.

18. The puncture device guide according to claim 17, wherein the first side rail and the second side rail are configured to be attached via adhesive to either the ultrasound probe body or a sterile cover installed over the ultrasound probe body.

19. The puncture device guide according to claim 17, wherein the first side rail and the second side rail are configured to be coupled to the ultrasound probe body or a sterile cover installed across the ultrasound probe body, or to be received in corresponding slots within a puncture device guide mounting sleeve that is integrated with the ultrasound probe body or the sterile cover installed across the ultrasound probe body.

20. The first side rail and the second side rail include a non-planar three-dimensional configuration. The first side rail and the second side rail are configured to be coupled to the ultrasound probe body or a sterile cover installed across the ultrasound probe body, or to be received in corresponding side rail receiving elements within a puncture device guide mounting structure that is integrated with the ultrasound probe body or the sterile cover installed across the ultrasound probe body. The puncture device guide according to claim 5.

21. A puncture device guide system, wherein the puncture device guide system is An ultrasonic probe cover, wherein the ultrasonic probe cover is A tubular portion having a first end and a second end, A planar portion fixed to the first end of the tubular portion in order to close the first end of the tubular portion, A puncture device guide mounting structure fixed to the aforementioned planar portion and An ultrasonic probe cover equipped with, A puncture device guide, wherein the puncture device guide is A fixed portion configured to be attached directly or indirectly to the probe body, A deflection portion connected to the fixed portion by at least one living hinge or spring and A puncture device guide equipped with Equipped with, The aforementioned fixed portion is configured to be attached to the puncture device guide mounting structure during use. The deflection member comprises at least one groove, and the at least one groove is configured to support a puncture device therein. The outward pressure on at least one groove causes the deflected portion to rotate outward relative to the fixed portion so as to support the puncture device over the entire range of angles. Puncture device guide system.

22. The puncture device guide system according to claim 21, wherein the inner surface of the planar portion is provided with an adhesive layer for promoting the adhesion of the probe cover to the ultrasound probe.

23. A puncture device guide system, wherein the puncture device guide system is An ultrasonic probe interface pad, wherein the ultrasonic probe interface pad is The surface facing the probe and the surface facing the patient, A puncture device guide mounting structure fixed to the surface facing the patient, An ultrasonic probe interface pad equipped with, This is a guide for puncture devices, A fixed portion configured to be attached directly or indirectly to the probe body, A deflection portion connected to the fixed portion by at least one spring or living hinge and A puncture device guide equipped with Equipped with, The aforementioned fixed portion is configured to be attached to the puncture device guide mounting structure during use. The deflection portion comprises at least one groove, and the at least one groove is configured to support a puncture device therein. The outward pressure on at least one groove causes the deflected portion to rotate outward relative to the fixed portion so as to support the puncture device over the entire range of angles. Puncture device guide system.

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