Systems, methods, and apparatus for needle positioning

Abstract

Multiple needle injection devices are disclosed, including devices that implement fixed or variable insertion angles. Fixed insertion angle devices may include a channel guide with a stopper for limiting injection to a desired depth. Fixed insertion angle devices may also include a rack and pinion that maintain the geometric relationships related to injection in order to reach a desired depth. Variable insertion angle designs may include a channel guide with a stopper for limiting injection to a desired depth. Variable insertion angle devices may also implement a depth cam configured to correlate the injection angle with the injection depth. Improvements to these designs are also disclosed.

Description

[Technical Field]

[0001] Cross-Reference to Related Applications This application claims priority to U.S. Provisional Application No. 63 / 534081, entitled "Systems, Methods, And Devices for Needle Positioning", filed on August 22, 2023.

[0002] This application is also related to PCT Application No. PCT / US2022 / 036009, entitled "Systems, Methods, and Devices Directed to Ultrasonic Needle Positioning Apparatus", filed on July 1, 2022, and to U.S. Provisional Application No. 63 / 218191, entitled "Systems, Methods, And Devices Directed to Ultrasonic Needle Positioning Apparatus", filed on July 2, 2021. The entire contents of each of these applications are incorporated herein by reference in their entireties.

[0003] Technical Field The present application relates to systems, methods, and devices for needle positioning in medical procedures. [Background Art]

[0004] The approaches described in this section are approaches that could be pursued, but not necessarily approaches that have been previously conceived or pursued. Therefore, unless otherwise specified, it should not be assumed that any of the approaches described in this section qualify as prior art merely by virtue of their inclusion in this section.

[0005] Many medical procedures may require the insertion of needles, catheters, or other devices into a patient's body (e.g., intravenously). However, proper insertion can be difficult, especially in obese patients or those receiving intravenous medications. Insertion failures can cause frustration and discomfort. Ultrasound imaging can be used to identify the target area (e.g., a vein), increasing the likelihood of successful placement. However, failures can still occur frequently. Furthermore, some ultrasound-assisted methods can be cumbersome or offer only partial solutions. For example, in needle insertion, it is crucial to keep the patient, the ultrasound probe, and the needle stable during the insertion procedure. Additionally, inserting the needle at the correct angle and depth can also be important.

[0006] The present invention can be better understood by referring to the following drawings. The components in the drawings are not necessarily to scale, and the emphasis is on clearly illustrating exemplary embodiments of the invention. In the drawings, the same reference numerals indicate corresponding parts across different drawings and / or across embodiments. Furthermore, various features of different disclosed embodiments can be combined to form additional embodiments that constitute part of this disclosure. In order to better illustrate the invention, it should be understood that certain components and details may not appear in the drawings. [Brief explanation of the drawing]

[0007] [Figure 1A1] Figure 1A1 is a perspective view of one embodiment of a needle insertion device. [Figure 1A2] Figure 1A2 shows an extension that can be added to the embodiment of Figure 1A1 to extend the needle insertion depth. [Figure 2A] Figure 2A is a perspective view of the base of the embodiment shown in Figure 1A1. [Figure 2B] Figure 2B is a perspective view of the base of the embodiment shown in Figure 1A1. [Figure 2C] Figure 2C is a side view of the base of the embodiment shown in Figure 1A1. [Figure 3A]Figure 3A shows the angle fixture of the embodiment shown in Figure 1A1. [Figure 3B] Figure 3B is an angle fixture of the embodiment shown in Figure 1A1. [Figure 4] Figure 4 shows a needle stopper with rails and stopper tabs used in the embodiment of Figure 1A1. [Figure 5A] Figure 5A is a perspective view of the needle support arm in the embodiment shown in Figure 1A1. [Figure 5B] Figure 5B is a side view of the needle support arm in the embodiment shown in Figure 1A1. [Figure 6] Figure 6 is a side view of the angle fixture according to the embodiment shown in Figure 1A1. [Figure 7A] Figure 7A shows an exemplary process for configuring and using the insertion device shown in Figure 1A1. [Figure 7B] Figure 7B shows an exemplary process for configuring and using the insertion device shown in Figure 1A1. [Figure 8] Figure 8 is a flowchart for using the insertion device. [Figure 9] Figure 9 shows the packaging for the insertion device shown in Figure 1A1. [Figure 10] Figure 10 shows the probe inserted into the bag to maintain sterility. [Figure 11] Figure 11 shows the probe, inserted into the bag to maintain sterility, from a downward view. [Figure 12] Figure 12 is a perspective view of a needle insertion device according to another embodiment. [Figure 13] Figure 13 is another perspective view of the embodiment shown in Figure 12. [Figure 14] Figure 14 is a perspective view of the base of the embodiment shown in Figure 12. [Figure 15] Figure 15 shows various components of the embodiment shown in Figure 12. [Figure 16] Figure 16 shows one of the components shown in Figure 15 individually. [Figure 17] Figure 17 shows one of the components shown in Figure 15 individually. [Figure 18] Figure 18 individually shows one of the components shown in Figure 15. [Figure 19] Figure 19 is a side view of the embodiment of Figure 12. [Figure 20] Figure 20 shows the adjustment knob of the embodiment of Figure 12. [Figure 21] Figure 21 is a rear view of another embodiment of a needle insertion device that automatically adjusts the position of the main needle carriage. [Figure 22] Figure 22 is a perspective view of the embodiment of Figure 21. [Figure 23] Figure 23 is a rear view of another embodiment of a needle insertion device that automatically adjusts the position of the main needle carriage. [Figure 24] Figure 24 is a side view of the embodiment of Figure 23. [Figure 25] Figure 25 shows an exemplary embodiment of a structure that can be used for adjusting needle insertion parameters (e.g., insertion angle, insertion depth). [Figure 26] Figure 26 shows an exemplary embodiment of a structure that can be used for adjusting needle insertion parameters (e.g., insertion angle, insertion depth). [Figure 27A] Figure 27A is a side view of an insertion device that enables easy adjustment of needle insertion depth. [Figure 27B] Figure 27B shows components of the embodiment of Figure 27A. [Figure 28A] Figure 28A shows a first step for using the embodiment of Figure 27A. [Figure 28B] Figure 28B shows a second step for using the embodiment of Figure 27A. [Figure 28C] Figure 28C shows a third step for using the embodiment of Figure 27A. [Figure 28D] Figure 28D shows a fourth step for using the embodiment of Figure 27A. [Figure 28E] Figure 28E shows a fifth step for using the embodiment of Figure 27A. [Figure 28F]Figure 28F shows the sixth step for using the embodiment shown in Figure 27A. [Figure 29] Figure 29 shows a needle insertion device of another embodiment, which includes a self-centering device. [Figure 30] Figure 30 is another diagram of the embodiment shown in Figure 29. [Figure 31] Figure 31 is another diagram of the embodiment shown in Figure 29. [Figure 32] Figure 32 is another diagram of the embodiment shown in Figure 29. [Figure 33] Figure 33 shows a self-centering device having three different length slots to accommodate different needle sizes. [Figure 34] Figure 34 shows an exemplary embodiment of an electric needle insertion device. [Figure 35A] Figure 35A shows the coupling between the motor and the worm drive. [Figure 35B] Figure 35B shows examples of needles and carriages that can be used in the embodiment shown in Figure 34. [Figure 36A] Figures 36A to 36K illustrate the procedure for using the embodiment shown in Figure 12. [Figure 36B] Figures 36A to 36K illustrate the procedure for using the embodiment shown in Figure 12. [Figure 36C] Figures 36A to 36K illustrate the procedure for using the embodiment shown in Figure 12. [Figure 36D] Figures 36A to 36K illustrate the procedure for using the embodiment shown in Figure 12. [Figure 36E] Figures 36A to 36K illustrate the procedure for using the embodiment shown in Figure 12. [Figure 36F] Figures 36A to 36K illustrate the procedure for using the embodiment shown in Figure 12. [Figure 36G] Figures 36A to 36K illustrate the procedure for using the embodiment shown in Figure 12. [Figure 36H] Figures 36A to 36K illustrate the procedure for using the embodiment shown in Figure 12. [Figure 36I]Figures 36A to 36K illustrate the procedure for using the embodiment shown in Figure 12. [Figure 36J] Figures 36A to 36K illustrate the procedure for using the embodiment shown in Figure 12. [Figure 36K] Figures 36A to 36K illustrate the procedure for using the embodiment shown in Figure 12. [Figure 37] Figure 37 shows another example of an electric needle insertion device. [Figure 38] Figure 38 shows the geometric relationships of various angles and depths in needle insertion. [Figure 39A] Figure 39A is a perspective view of a needle insertion device according to another embodiment. [Figure 39B1] Figure 39B1 is a perspective view of the embodiment shown in Figure 39A. [Figure 39B2] Figure 39B2 is a plan view of the embodiment shown in Figure 39A. [Figure 39C] Figure 39C shows the base of the embodiment shown in Figure 39A in more detail. [Figure 39D] Figure 39D shows an exploded view of various components of the embodiment shown in Figure 39A. [Figure 39E] Figure 39E shows an exploded view of various components of the embodiment shown in Figure 39A. [Figure 39F] Figure 39F shows the relative movement of the components in the embodiment shown in Figure 39A. [Figure 39G] Figure 39G is an enlarged rear perspective view of the embodiment shown in Figure 39A. [Figure 40A] Figure 40A is a perspective view of a needle insertion device according to another embodiment. [Figure 40B] Figure 40B is a perspective view of the embodiment shown in Figure 40A. [Figure 40C] Figure 40C is an enlarged rear perspective view of the embodiment shown in Figure 40A. [Figure 40D] Figure 40D shows an exploded view of various components of the embodiment shown in Figure 40A. [Figure 40E] Figure 40E shows an exploded view of various components of the embodiment shown in Figure 40A. [Figure 40F]Figure 40F is a rear perspective view of the embodiment shown in Figure 40A. [Figure 40G] Figure 40G is a side perspective view of the embodiment shown in Figure 40A. [Figure 40H] Figure 40H is an enlarged view of the angle-down multi-channel guide in the embodiment shown in Figure 40A. [Figure 40I] Figure 40I is an enlarged view of the angle-down multichannel guide used in the embodiment shown in Figure 40A. [Figure 40J] Figure 40J consists of various diagrams of the angle-down multi-channel guide used in the embodiment of Figure 40A. [Figure 40K] Figure 40K is an enlarged view of the angle-down multi-channel guide and associated gear used in the embodiment shown in Figure 40A. [Figure 40L] Figure 40L consists of various diagrams of the angle-down multi-channel guide and associated gear used in the embodiment of Figure 40A. [Figure 40M] Figure 40M is a top perspective view of the internal components of the embodiment shown in Figure 40A. [Figure 40N] Figure 40N is a side view of the internal components of the embodiment shown in Figure 40A. [Figure 40O] Figure 40O is a bottom perspective view of the internal components of the embodiment shown in Figure 40A. [Figure 41A] Figure 41A is a perspective view of a needle insertion device according to another embodiment. [Figure 41B] Figure 41B is a side view of the embodiment shown in Figure 41A. [Figure 41C] Figure 41C is a side view of the embodiment shown in Figure 41A, with an insertion depth of 10-12 mm. [Figure 41D] Figure 41D is a side view of the embodiment shown in Figure 41A, with the insertion depth set to 10-12 mm, and the needle angle-down. [Figure 41E] Figure 41E is a side view of the embodiment shown in Figure 41A, with an insertion depth of 1 to 3 mm. [Figure 41F]Figure 41F is a side view of the embodiment shown in Figure 41A, with the insertion depth set to 1-3 mm, and the needle angled downwards. [Figure 42A] Figure 42A is a side view of a needle insertion device according to another embodiment. [Figure 42B] Figure 42B is a perspective view of the embodiment shown in Figure 42A. [Figure 42C] Figure 42C is a bottom perspective view of the embodiment shown in Figure 42A. [Figure 42D] Figure 42D is a front perspective view of the embodiment shown in Figure 42A. [Figure 42E1] Figure 42E1 is a top perspective view of the base of the embodiment shown in Figure 42A. [Figure 42E2] Figure 42E2 is a bottom perspective view of the base of the embodiment shown in Figure 42A. [Figure 42F] Figure 42F is a top perspective view of the alternative base in the embodiment shown in Figure 42A. [Figure 42G1] Figure 42G1 shows the needle carriage guide pin used in the embodiment shown in Figure 42A. [Figure 42G2] Figure 42G2 shows a needle carriage guide pin with a wrap-around clip for improved stability. [Figure 42G3] Figure 42G3 shows a needle carriage guide pin with a wrap-around clip for improved stability. [Figure 42H] Figure 42H shows the needle carriage guide pin used in the embodiment shown in Figure 42A. [Figure 42I] Figure 42I shows the needle anchor point used in the embodiment shown in Figure 42A. [Figure 42J] Figure 42J shows a guide card in which the channel has only a needle insertion section. [Figure 42K1] Figure 42K1 shows a guide card with a channel extended at the angle-down section. [Figure 42K2] Figure 42K2 shows that a single channel may have its own angle-down / forward section. [Figure 42L]Figure 42L shows a guide card with the channel extended in the angled-down and forward sections. [Figure 43A1] Figure 43A1 shows a needle insertion device of another embodiment. [Figure 43A2] Figure 43A2 shows various interchangeable probe mount inserts that fit several different types of ultrasound probes. [Figure 43B1] Figure 43B1 shows the depth cam used in the embodiment shown in Figure 43A1. [Figure 43B2] Figure 43B2 is an enlarged view of the anti-slip mechanism used in the embodiment shown in Figure 43A1. [Figure 43B3] Figure 43B3 shows how the circumference of the depth cam is calculated. [Figure 43C1] Figure 43C1 shows various diagrams of the depth cam used in the embodiment shown in Figure 43A1. [Figure 43C2] Figure 43C2 shows the track used in the arm receiver. [Figure 43C3] Figure 43C3 shows the track used in the arm receiver. [Figure 43D1] Figure 43D1 shows the needle calibration process for the adjustable carriage in the embodiment shown in Figure 43A1. [Figure 43D2] Figure 43D2 shows the depth and needle calibration of the adjustable plunger carriage. [Figure 43E1] Figure 43E1 shows the fixed needle assembly carriage used in the embodiment shown in Figure 43A1. [Figure 43E2] Figure 43E2 shows the hole / channel needle stabilization structure. [Figure 43F1] Figure 43F1 shows the fixed needle assembly carriage used in the embodiment shown in Figure 43A1. [Figure 43F2] Figure 43F2 shows the various interchangeable needle / catheter mounts available for use with the insertion device. [Figure 43F3] Figure 43F3 shows the needle mount for the plunger. [Figure 43F4] Figure 43F4 shows a needle / catheter mount for a catheter. [Figure 43G] Figure 43G is a plan view of the embodiment shown in Figure 43A1. [Figure 43H] Figure 43H is a perspective view of the embodiment shown in Figure 43A1, excluding the base. [Figure 43I] Figure 43I is a side view of the embodiment shown in Figure 43A1, with the base removed. [Figure 43J] Figure 43J is a bottom perspective view of the embodiment of Figure 43A1, excluding the base. [Figure 43K] Figure 43K shows various finger rest positions and shapes. [Figure 44A] Figure 44A shows an electrically operated needle insertion device of another embodiment. [Figure 44B] Figure 44B is an exploded view of the embodiment shown in Figure 44A. [Figure 44C] Figure 44C shows the detachable motor assembly of the embodiment shown in Figure 44A. [Figure 44D] Figure 44D is a side view of the needle assembly carriage in the embodiment shown in Figure 44A. [Figure 44E] Figure 44E is a schematic diagram showing the processor control of the electric motor in the embodiment shown in Figure 44A. [Figure 45A] Figure 45A is a top perspective view of a needle insertion device according to another embodiment. [Figure 45B] Figure 45B is a bottom perspective view of the embodiment shown in Figure 45A. [Figure 45C] Figure 45C consists of various diagrams of the embodiment shown in Figure 45A. [Figure 46A] Figure 46A shows a segmented robotic snake having an ultrasonic segment and a needle insertion segment. [Figure 46B] Figure 46B is a side view of the robot in Figure 46A while the needle insertion device is puncturing the patient. [Figure 46C] Figure 46C is a top perspective view of the robot in Figure 46A when the needle insertion device is puncturing a patient. [Figure 46D] Figure 46D is an enlarged side perspective view of the robot in Figure 46A as the needle insertion device punctures the patient. [Figure 46E] Figure 46E is an enlarged top perspective view of the robot in Figure 46A as the needle insertion device punctures the patient. [Figure 46F] Figure 46F is an enlarged top perspective view of the robot in Figure 46A when the needle insertion device is puncturing a patient. [Figure 47A] Figure 47A shows a needle insertion device of another embodiment having an angle-down structure. [Figure 47B1] Figure 47B1 shows the angled down arch of the embodiment shown in Figure 47A. [Figure 47B2] Figure 47B2 is a side view of the embodiment shown in Figure 47A. [Figure 47C] Figure 47C is a magnified view showing how the needle mount is released from the needle carriage. [Figure 47D] Figure 47D is a side view of the embodiment shown in Figure 47A, illustrating the needle insertion angle and catheter insertion angle. [Figure 47E] Figure 47E is an isometric view of the embodiment shown in Figure 47A, illustrating the needle insertion angle and catheter insertion angle. [Figure 48A] Figure 48A shows a needle insertion device of another embodiment having an angle-down structure and an automatic needle mount. [Figure 48B] Figure 48B is a magnified view showing how the needle mount is released from the needle carriage. [Figure 48C] Figure 48C is a side view of the embodiment shown in Figure 48A, illustrating the needle insertion angle and catheter insertion angle. [Figure 48D] Figure 48D shows a needle insertion device of another embodiment having an arch spring. [Figure 49A] Figure 49A is a cross-sectional view of the automatic needle mount. [Figure 49B] Figure 49B shows the spring trigger component of the automatic needle mount shown in Figure 49A. [Figure 49C] Figure 49C shows the spring trigger component of the automatic needle mount shown in Figure 49A. [Figure 49D] Figure 49D shows the internal components of the automatic needle mount in Figure 49A in a non-triggered state. [Figure 49E] Figure 49E shows the internal components of the automatic needle mount shown in Figure 49A immediately before the trigger state is initiated. [Figure 49F] Figure 49F shows the internal components of the automatic needle mount shown in Figure 49A in the triggered state. [Figure 49G] Figure 49G shows the needle insertion device of Figure 48A in the triggered state. [Modes for carrying out the invention]

[0008] This specification refers to several specific examples of the invention, including the best mode envisioned by the inventors for carrying out the invention. Examples of these specific embodiments are shown in the accompanying drawings. While the invention is described in relation to these specific embodiments, it should be understood that the invention is not intended to be limited to the embodiments described or illustrated. Rather, the invention is intended to encompass alternatives, variations, and equivalents that may fall within the spirit and scope of the invention as defined by the accompanying claims.

[0009] In the following description, numerous specific details are provided to provide a full understanding of the invention. Exemplary embodiments of the invention may be carried out without using some or all of these specific details. In other examples, detailed descriptions of process operations well known to those skilled in the art are omitted so as not to unnecessarily obscure the invention. Various techniques and mechanisms of the invention may be described in the singular for clarity. However, unless otherwise stated, it should be noted that some embodiments may include iterations of techniques or multiple mechanisms. Similarly, various steps of the methods shown and described herein may not necessarily be carried out in the order shown, and in some embodiments, they may not be carried out at all. Accordingly, some embodiments of the methods discussed herein may include more or fewer steps than shown or described. Furthermore, the techniques and mechanisms of the invention may describe connections, relationships, or communications between two or more entities. It should be noted that connections or relationships between entities do not necessarily mean direct and uninterrupted connections, and various other entities or processes may exist or occur between the two entities. Accordingly, unless otherwise stated, the connections shown do not necessarily mean direct and uninterrupted connections.

[0010] The following list of exemplary features corresponds to the attached drawings, and the same reference numerals throughout the specification and drawings indicate the corresponding features; this list is provided for ease of reference.

[0011] 100 Insertion device

[0012] 102 Bass

[0013] 104 stabilization holes

[0014] 106 Ultrasonic Mount

[0015] 108 Tower

[0016] 110 Rails / Tracks

[0017] 112 Insertion Ruler

[0018] 114 Angle Fixture

[0019] 115 Depth extension device

[0020] 115A Base extension

[0021] 115B Extension Tower

[0022] 115C Angle Fixture Extension

[0023] 115D Extension Rail

[0024] 118 Needle stopper

[0025] 120 Stopper Tabs

[0026] 122 Needle support arm

[0027] 124 Thumbscrew

[0028] 126 Alignment holes

[0029] 130 Movable Lever / Pull

[0030] 132 channels

[0031] 134 posts

[0032] 136 rails

[0033] 138 Needle guide section

[0034] 140 Joint

[0035] 142 rails

[0036] 144 Marking

[0037] 146 Joint

[0038] 148 Thumb screw holes

[0039] 150 position index

[0040] 152 Needle receiving area

[0041] 154 Supporting Platforms

[0042] 156 Thumbscrew

[0043] 158 Stopper

[0044] 160 Packaging

[0045] 162 Bags

[0046] 164 Handle

[0047] 165 Access Ports

[0048] 300 Insertion device

[0049] 302 Base

[0050] 304 stabilization holes

[0051] 306 Ultrasonic Mount

[0052] 308 Arm Receiver

[0053] 310 Swingarm

[0054] 312 Main Needle Carriage

[0055] 314 Needle Support Carriage

[0056] 316 Pivot mounting section

[0057] 318 Thumbscrew

[0058] 320 Lever

[0059] 322 Lever

[0060] 324 racks

[0061] 326 Adjustment Knob

[0062] 328 pinion

[0063] 330 belt

[0064] 332 Adjustment Knob

[0065] 334 Stopper

[0066] 336 Worm Drive

[0067] 400 Insertion device

[0068] 402 Post

[0069] 404 Adjustment and control structure

[0070] 406 Cylinder

[0071] 408 Arm

[0072] 410 Needle Carriage

[0073] 412 Stopper

[0074] 414 Needle Holder

[0075] 500 base

[0076] 502 Post

[0077] 504 Needle Pusher

[0078] 506 Needle Holder

[0079] 508 Lever Lock

[0080] 510 Lever Lock

[0081] 512 Insertion Depth Selection Wheel

[0082] 514 Slider

[0083] 516 pins

[0084] 518 Needle Stopper

[0085] 520 Latch

[0086] 600 Self-centering device

[0087] 602 Needle insertion slit / wedge

[0088] 604 Ultrasonic Cavity

[0089] 606 Latch

[0090] 700-712 Process

[0091] 802-824 Process

[0092] 900 Motor-driven insertion device

[0093] 902 Bass

[0094] 904 Motor-driven tower

[0095] 906 Shaft section

[0096] 908 End Cap

[0097] 910 Coupling mechanism

[0098] 914 needle

[0099] 916 Catheter Sheath

[0100] 918 Receiver

[0101] 920 Needle Holder

[0102] 1000 Insertion device

[0103] 1005 needle

[0104] 1007 Insertion area

[0105] 1010 Base

[0106] 1011 Patient contact surfaces

[0107] 1012 Ultrasonic probe mount

[0108] 1014 Finger Grip

[0109] 1015 Needle Depth Gauge

[0110] 1020 depth index

[0111] 1025 Operating structure

[0112] 1030 Upper Assembly

[0113] 1040 Needle Carriage

[0114] 1045 Needle rack support

[0115] 1046 Needle Carriage Assembly

[0116] 1047 Needle Rack

[0117] 1048 Needle Rack and Pinion

[0118] 1050 Adjustment slide path

[0119] 1055 Lock Thumb Screw

[0120] 1060 Upper assembly main support

[0121] 1062 Base groove

[0122] 1065 Base Rack

[0123] 1067 Base rack pinion

[0124] 1070 Needle carriage insertion lateral movement

[0125] 1075 Upper assembly lateral movement

[0126] 1100 Insertion device

[0127] 1105 needle

[0128] 1110 Base

[0129] 1112 Ultrasound probe

[0130] 1115 Needle depth gauge

[0131] 1120 Depth index

[0132] 1125 Operating structure

[0133] 1130 Upper Assembly

[0134] 1140 Needle Carriage

[0135] 1142 Release button

[0136] 1144 Release latch

[0137] 1145 Latch rotation path / direction

[0138] 1147 Needle Rack

[0139] 1148 Needle Rack and Pinion

[0140] 1149 Angle-down needle carriage

[0141] 1150 Latch receiver

[0142] 1160 Upper assembly main support

[0143] 1165 Base Rack

[0144] 1167 Base rack pinion

[0145] 1170 Angle-down multi-channel guide (sand dollar shape)

[0146] 1170A Multi-channel guide unit

[0147] 1172 Angle Down Gear

[0148] 1175 Central Channel Guide

[0149] 1176 Central Channel

[0150] 1176A Central Channel Section

[0151] 1180 Angle-down needle carriage path

[0152] 1185 Discrete channels for needle depth selection

[0153] 1200 Insertion device

[0154] 1203 Base

[0155] 1205 Needle Assembly

[0156] 1207 Needle Carriage

[0157] 1207.1 Needle carriage insertion sliding direction

[0158] 1207.2 Needle Carriage Guide

[0159] 1207.3 Needle carriage angle downward direction

[0160] 1210 needle

[0161] 1230 Needle Carriage Multichannel Guide

[0162] 1230.1 Venous depth gauge

[0163] 1230.2 Adjustable venous depth stopper

[0164] 1230.3 Depth index

[0165] 1230.4 Insertion needle carriage channel

[0166] 1230.5 Angle-down needle carriage channel

[0167] 1235 Vein

[0168] 1240 Needle insertion

[0169] 1245 Needle insertion angle

[0170] 1250 needle reduction angle

[0171] 1300 Insertion device

[0172] 1302 needle

[0173] 1305 Base

[0174] 1310 Multi-channel guide card

[0175] 1315 Needle Carriage

[0176] 1316 Wrap-around clip

[0177] 1317A Carriage Path for First Channel

[0178] 1317AA Needle Path for First Channel

[0179] 1317B Carriage Path for Second Channel

[0180] 1317BB Needle Path for Second Channel

[0181] 1318A Final Needle Depth for First Channel

[0182] 1318B Final Needle Depth for Second Channel

[0183] 1320 Needle Window

[0184] 1325A Ultrasound Window (First Direction)

[0185] 1325B Ultrasound Window (Second Direction)

[0186] 1330 Guide Card Support

[0187] 1335 Mounting Pin

[0188] 1335A Mounting Pin

[0189] 1338 Mounting Magnet

[0190] 1340 Pin Receiver

[0191] 1340A Pin Receiver

[0192] 1342 Slide Channel

[0193] 1344 Guide Pin

[0194] 1345 Needle Anchor Point

[0195] 1350 Needle Carriage Guide (Pin)

[0196] 1352 Needle loading section of the route

[0197] 1355 Needle insertion section of the route

[0198] 1360 Angle-down section of the route

[0199] 1365 The forward section of the route

[0200] 1400 Needle Insertion Device

[0201] 1405 Base

[0202] 1407.1 Base insert receiver

[0203] 1408.1-1408.4 Interchangeable probe mount inserts

[0204] 1410 Depth Cam

[0205] 1415 Anti-slip structure

[0206] 1420 Insertion point line

[0207] 1422 needle

[0208] 1424 Needle insertion depth

[0209] 1425 Angle Position Rack

[0210] 1426.1 Replaceable Arm Receiver

[0211] 1426.2 Track

[0212] 1426.3 Swingarm Interface

[0213] 1426.4 Track Tab

[0214] 1426.5 Swing arm post

[0215] 1426.6 Swing arm

[0216] 1426.7 Track horizontal displacement

[0217] 1426.8 Track vertical displacement

[0218] 1426.9 Track horizontal extension

[0219] 1427 Swing arm assembly

[0220] 1428 Swing arm movement

[0221] 1430 Depth selection pinion

[0222] 1432 Needle holder

[0223] 1435 Adjustable needle carriage

[0224] 1436 Needle carriage path

[0225] 1436.1 Needle carriage stop point

[0226] 1436.2 Needle depth

[0227] 1437 Needle

[0228] 1438 Needle carriage lever lock

[0229] 1440 Adjustable needle insertion stopper

[0230] 1442 Needle insertion stopper lever lock

[0231] 1456 Needle calibration structure

[0232] 1460.1 Needle calibration step 1

[0233] 1460.2 Needle Calibration Process 2

[0234] 1460.3 Needle Calibration Process 3

[0235] 1460.4 Needle Calibration Process 4

[0236] 1460.5 Needle Calibration Process 5

[0237] 1460.6 Needle Calibration Process 6

[0238] 1460.7 Needle Calibration Process 7

[0239] 1465 Needle carriage (non-adjustable)

[0240] 1467 holes / channel stabilizer

[0241] 1470 Needle Carriage (Non-adjustable, Non-catheter type)

[0242] 1475 Needle insertion stopper (non-adjustable)

[0243] 1476 Plunger

[0244] 1477 Plunger Holder

[0245] 1477.1 Hole / Channel Stabilizer

[0246] 1477.2 Plunger Carriage

[0247] 1480 Slide Arm

[0248] 1500 Insertion device

[0249] 1503 Base

[0250] 1505 Needle Carriage

[0251] 1510 Catheter Carriage

[0252] 1515 needle

[0253] 1517 Gear Housing

[0254] 1520 Needle Carriage Worm Drive

[0255] 1525 Catheter Carriage Worm Drive

[0256] 1530 Detachable Motor Assembly

[0257] 1535 Needle Carriage Motor

[0258] 1540 Catheter Carriage Motor

[0259] 1545 Insertion Angle Motor

[0260] 1550 Motor Assembly Lock

[0261] 1555 Processor

[0262] 1560 Linear position sensor

[0263] 1565 Angle position sensor

[0264] 1570 Venous Depth Input Device

[0265] 1600 Insertion device

[0266] 1605 High-Position Ultrasonic Probe Mount

[0267] 1610 Sound-conducting material (pad)

[0268] 1615 Needle insertion slit / wedge

[0269] 1620 needles

[0270] 1700 Robot Snake

[0271] 1705 Robot Snake Segment

[0272] 1710 Ultrasound probe segment

[0273] 1715 Needle insertion segment

[0274] 1720 Sensor-equipped head segment

[0275] 1725 patient

[0276] 1730 Disinfectant spray nozzle

[0277] 1730 Peg and Hole Connection Structure

[0278] 1800 Insertion device

[0279] 1802 Base

[0280] 1804 Ultrasonic Mount

[0281] 1806 Ultrasound Probe

[0282] 1808 Swingarm

[0283] 1808.1 Swingarm movement

[0284] 1809 Needle insertion stopper

[0285] 1810 Arm Receiver

[0286] 1812 Needle Carriage

[0287] 1812.1 Needle carriage movement

[0288] 1813 Needle / Catheter Mount

[0289] 1813.1 Negative shape

[0290] 1814 Depth Cam

[0291] 1816 Angle-down arch

[0292] 1816.1 Arch movement

[0293] 1818 Angle Down Arch Slot

[0294] 1820 Archrock

[0295] 1820.1 Carriage Rock

[0296] 1822 Lock receiver

[0297] 1825 needle

[0298] 1826 Catheter

[0299] 1826 Catheter Mount

[0300] 1830 Arch Operating Structure

[0301] 1832 Needle insertion angle

[0302] 1834 Catheter insertion angle

[0303] 1900 Insertion device

[0304] 1902 Bass

[0305] 1913 Automatic Needle / Catheter Mount

[0306] 1918 Teeth

[0307] 1930 Release Spear

[0308] 1931 Pinion Latch

[0309] 1932 Pre-tension pinion

[0310] 1932.1 Pinion shift

[0311] 1933 Arch spring

[0312] 1934 spring

[0313] 1940 Catheter spring

[0314] 1940.1 Catheter spring transfer

[0315] 1941 Catheter spring window

[0316] 1942 Needle Spring

[0317] 1942.1 Needle spring movement

[0318] 1943 Needle spring window

[0319] 1944 Spring trigger

[0320] 1944.1 Spring trigger movement

[0321] 1946 Needle Slot

[0322] 1948 Spring support

[0323] As briefly mentioned above, difficulties can arise when attempting to insert a needle into a patient's vein or when precise needle placement is required within the patient's body. Failure can lead to dissatisfaction for both the healthcare provider and the patient, patient discomfort, and an overall negative experience for both parties. Errors or failures can result in bruises, bleeding, discomfort, etc.

[0324] In some cases, locating a vein and successfully inserting a needle into it (or similarly, into other desired locations in the body, such as a tumor site during biopsy sample collection) can be difficult. Therefore, there is a need for methods and devices that can increase the likelihood of success when inserting a needle into a patient. Such methods and devices can offer many advantages. For example, they can help healthcare providers locate a vein (or other target), ensure that the needle is not inserted too deeply or too shallowly, and ensure that it is inserted at the correct angle. In some embodiments, the insertion device may be relatively simple and low-cost, and may consist entirely or substantially entirely of mechanical components. In some embodiments, the insertion device may include one or more electronic components to measure the needle (which may be done using a printed circuit board with sensors, for example, by (1) mechanical means such as a mechanical sliding mechanism, for example; 2) optical means such as a laser, for example; or 3) ultrasound, or to set the needle insertion angle. In some embodiments, the devices and methods herein may be manual, mainly manual, partially automatic, mainly automatic, or fully automatic (e.g., the actual needle insertion is automatic). They may also have a WiFi connection with an ultrasound probe.

[0325] The apparatus and methods described herein may be used in a wide range of situations, but may be particularly useful in challenging patients, such as those undergoing chemotherapy, those with arteriosclerosis, or intravenous drug users whose veins are easily found but insertion is difficult due to scarring. Some patients may be difficult due to swelling or obesity. In some cases, critically ill patients and / or trauma patients may also be difficult to insert needles into. While this specification primarily describes needle insertion into veins, this is for illustrative purposes only and should not be interpreted restrictively. The apparatus and methods described herein can be used in a variety of procedures, such as thoracentesis, paracentesis, central venous line placement, arterial line placement, or other procedures that require or benefit from precise needle placement. The methods and apparatus described herein may be used by physicians, nurses, clinical laboratory technicians, veterinarians, etc. Furthermore, the systems, methods and apparatus described herein are not limited to human use but may also be used for precise placement of needles or catheters in pets, livestock, and other animals.

[0326] The systems, methods, and apparatus described herein may have many advantages and can be used for a wide range of procedures. For example, some embodiments described herein can be used with bare needles or catheterized needles. Thus, the embodiments described herein can be used to facilitate blood collection, sample collection (e.g., for biopsy), peripheral catheter insertion, central catheter insertion, and the like. For example, some embodiments allow the needle to be released to enable removal of the needle and / or insertion device components while the catheter remains in place in the patient.

[0327] Figure 1A1 shows an exemplary embodiment of the insertion device 100. The insertion device 100 may have a base 102. The stabilization channel (or stabilization hole or finger grip) 104 may be attached to the base 102 or may be part of the base 102. The stabilization hole 104 can be located in various positions, for example, in front, behind, or to the side of the insertion device 100, and can be located in any desired orientation, for example, horizontal or vertical. In some embodiments, the stabilization hole 104 may be designed to accommodate a user's finger (e.g., index finger). The stabilization hole 104 shown in Figure 1A1 is designed to accommodate a single finger, but in some embodiments, the stabilization hole 104 can accommodate multiple fingers. For example, the stabilization hole 104 may have an oval shape that can accommodate additional fingers, for example, two, three, four, or five fingers. The insertion device 100 may include an ultrasonic mount 106 for attaching an ultrasonic transducer to the insertion device 100. In some embodiments, the ultrasonic transducer may be fitted into the ultrasonic mount 106 and held in place by friction. In some embodiments, screws, clamps, etc., may be used to hold the ultrasonic transducer in place. In some embodiments, the ultrasonic mount 106 may be formed to accept a specific type of transducer (e.g., a specific model or group of models from a specific manufacturer). In some embodiments, the ultrasonic mount 106 may be formed to accommodate various different ultrasonic transducers of different shapes and / or sizes by using, for example, an adapter whose outer surface conforms to the shape of the ultrasonic mount 106 and whose inner surface conforms to the shape of the ultrasonic transducer. As will be described in more detail later, in some embodiments, the ultrasonic mount 106 may include components for self-centering the ultrasonic transducer, thereby enabling use in a wide range of ultrasonic devices. In some embodiments, the ultrasonic mount 106 may be modified to fit, for example, a smartphone to which an ultrasonic adapter is attached. It should be understood that the ultrasonic mount 106 may be positioned relative to other needle insertion components in a positional relationship different from that shown in Figure 1A1.For example, the ultrasonic mount 106 may have different orientations, such as being rotated by 90 degrees.

[0328] The insertion device 100 may have a tower 108 mounted on a base platform 102. In some embodiments, the tower 108 and the base 102 may be integrally formed or may be separate components. The insertion device 100 may have a rail 110 mounted on the top of the base 102. The insertion device 100 may also have an insertion guide 112 parallel to the rail 110. The insertion guide 112 may be printed on the base 102 of the insertion device 100 (for example, with ink or dye, or by 3D printing or molded raised areas) or embossed on the base 102. The insertion guide 112 may indicate the depth to which a needle can be inserted, as will be described in more detail later.

[0329] The insertion device 100 may include a movable angle fixture 114. The angle fixture 114 may be movably coupled to the rail 110. In some embodiments, a screw, lever, or similar mechanical mechanism may be used to restrict the movement of the angle fixture 114 along the track 110. The insertion device 100 may include a needle stopper 118 having a stopper tab 120. The stopper tab 120 can prevent further forward and / or downward movement of the needle when the stopper tab 120 abuts against the edge of the tower 108. In some embodiments, the needle stopper 118 may have markings indicating the needle length. In some embodiments, the insertion device 100 may include a needle support arm 122 which can be used to adapt the insertion device 100 to a wide range of needle lengths. For example, the bevel of the needle may push the needle support arm 122 downward. When the needle tip contacts the insertion point (which may be indicated by a removable block before the device is used on a patient), the needle support arm 122 is fixed in place against the needle stopper 118, allowing the device to be calibrated for the specific needle being used. Alternatively, the user can push the needle support arm 122 down to a set position on the needle stopper 118 (e.g., a position pre-measured for a specific needle length), and then fix the needle support arm 122 to the needle stopper 118. The needle support arm 122 can be held in place by a thumbscrew 124 or other fastener that holds the needle stopper 118 and the needle support arm 122 together. In some embodiments, only a specific single needle length exists, and the user does not need to perform calibration. In this case, 122 can be permanently fixed to 118, and a thumbscrew is not required. In this embodiment, the needle support arm 122 and stopper tab 120 are shown in front of the ultrasound probe, but in some embodiments, the needle support arm 122 and stopper tab 120 can be located on the narrow side of the ultrasound probe to save space. In some embodiments, the needle support arm 122 may have an alignment hole 126 (which may be aligned with the needle guide portion 138 of the angle fixture 114, as shown in Figures 3A and 3B in some embodiments).In some embodiments, the needle may be held by a clamp or other fastener, and alignment holes are not required. In some embodiments, a movable lever / pull 130 may be attached to the needle support arm 122 and used to allow or prevent free movement of the needle.

[0330] During insertion, the needle support arm 122 slides downward along the angle fixture 114. In the device 100 shown in Figure 1A1, the maximum needle depth is approximately 3 inches. This may cover most cases, but some procedures require deeper depths. For example, liver needle biopsies require a depth of at least 6 inches (and even deeper depths in larger patients). To accommodate these depths, the base 102 of the device may be extended to accommodate a taller tower 108 and a longer angle fixture 114. Alternatively, a depth extension device 115 may be attached to the device 100, which includes an extension tower 115B extending from the base extension 115A. The angle fixture extension 115C is supported by the extension tower 115B. This allows the needle support arm 122 to accommodate longer needles, resulting in a deeper insertion depth.

[0331] As shown in Figures 2A, 2B, and 2C, in some embodiments the insertion device may have a base 102 and a tower 108. In some embodiments, the tower 108 may be removable. For example, as shown in Figure 2B, in some embodiments the base 102 may include a post 134, and the tower 108 may be slidable on and supported by the post 134. Such a configuration may have several advantages. For example, different posts can be used depending on different situations, more compact packaging may be available, and the risk of damage during transport or handling may be reduced. In some embodiments, the tower 108 may be straight. In some embodiments, the tower 108 may be curved. The base 102 includes a channel or opening 132, which facilitates the removal of the insertion device 102 while the needle remains in place in the patient or after the catheter or line has been inserted into the patient. The channel 132 may have sufficient width to accommodate a wide range of gauges, catheter diameters, etc.

[0332] Figures 3A and 3B show exemplary embodiments of the angle fixture 114. The angle fixture 114 may have a coupling (or track, rail, gear) 146 that can connect the angle fixture 114 to the rail 110 of the base 102. The shape of the coupling 146 can be adapted to the shape of the rail 110 so that the angle fixture 114 can slide along the rail, track, gear 110 in one direction (e.g., one direction or substantially one direction). The angle fixture 114 may have a rail 136. The rail, track, gear 136 may function as a guide for the needle stopper 118. The angle fixture 114 may have a needle guide portion 138 that can receive a needle and assist in controlling the movement and positioning of the needle. As shown in Figure 3A, in some embodiments the needle guide portion 138 may have an open bottom. This configuration may be desirable, for example, when a healthcare professional wants to manipulate the needle to a lower angle during a procedure, such as during catheter insertion. In some embodiments, the opening position allows the insertion device 100 to be lifted and removed from the patient while the needle (or, for example, a catheter) remains in place within the patient. Alternatively, as shown in Figure 3B, the angle fixture 114 may have a needle guide section 138 configured with an upward opening. While such a configuration may be desirable in some cases as it can improve stability, it may reduce the range of motion of the needle and may be undesirable in certain procedures. In some embodiments, where the needle is firmly held in place by a clamp, lever, or tie on the needle support arm 122, these guides 138 are unnecessary.

[0333] Figure 4 shows exemplary embodiments of a needle stopper 118 according to several embodiments. The needle stopper 118 includes a coupling 140 that movably connects to a rail 136 of an angle fixture 114. The needle stopper 118 may have a rail 142 for connecting to a needle support arm 122. The needle stopper 118 may have markings 144 indicating the length of needles to be used in the insertion device 100. As previously mentioned, the user can calibrate the device by setting a predetermined needle size or by measuring the needles and fixing the components. Alternatively, the user may have no choice, and the needle stopper may have only a single number for a specific single needle size. In this case, the needle stopper 118 is permanently bonded to the needle support arm 122. This reduces confusion and user error.

[0334] Figures 5A and 5B show examples of needle support arms 122 according to several embodiments. The needle support arm has a coupling portion 146 for coupling to the rail 136 of the needle stopper 118. The needle support arm 122 has a thumbscrew hole 148 for receiving a thumbscrew 124 for immobilizing the needle support arm 122 and the needle stopper 118 (for example, after the needle support arm 122 has been properly positioned relative to the needle stopper 118 for a particular needle length). In some embodiments, the user of the insertion device 100 can position the needle support arm using a marking 144 on the needle stopper 118 and a position indicator 150 on the needle support arm 122. The needle support arm 122 may have a needle receiving portion 152. However, if the needle is firmly held in place by the needle support arm 122 using a screw, clamp, pin, lever or other arbitrary fastener, 152 is unnecessary. In some embodiments, the needle may be placed on a support platform 154, which can help maintain the needle in a properly oriented state during the procedure. A clip or stopper 158 can be used to prevent the needle from coming out of the opening of the support platform 154. If the stopper 158 is removed, it may release the catheter from the device.

[0335] In some embodiments, the insertion device 100 may be designed to operate at a fixed angle defined by an angle fixture 114. For example, as shown in Figure 6, the angle fixture 114 may be configured to facilitate insertion at an angle θ. In some embodiments, the angle fixture 114 may be interchangeable by the user with another angle fixture 114 of a different angle. In some embodiments, the insertion device 100 may be provided as a kit and may include one or more angle fixtures 114 to enable the healthcare provider to insert the needle at a desired angle. For example, in some cases, it may be desirable to insert the needle at a relatively shallow angle. For example, in a typical venous puncture procedure, a relatively shallow insertion angle can reduce the likelihood of the needle penetrating the vein. However, when inserting the needle relatively deeply into the patient, a steeper angle may be advantageous.

[0336] Figures 7A and 7B show exemplary steps 700 for configuring and using the insertion device 100. Depending on the embodiment, the steps in Figures 7A and 7B may include fewer or additional steps and / or may be performed in a different order than shown. In 702, the insertion device 100 is in its initial state, with the angle fixture 114 pushed in to its maximum forward position (i.e., the position closest to the ultrasound mount 106). The needle stopper 118 is positioned so that the stopper tab 120 contacts the tower 108. The needle support arm 122 may be positioned for the largest needle size. In 704, the user can measure the needle by inserting the needle into the needle support arm 122 and pushing it forward and downward until the needle tip contacts the stopper 158. The stopper 158 may be part of the packaging but is generally not present when the insertion device 100 is placed on the patient. The user can fix the needle support arm 122 to the needle stopper 118 in a position suitable for the length of the needle by tightening the thumb screw 124.

[0337] In 706, the user can set the insertion depth by sliding the angle fixture 114 backward from the ultrasonic mount 106 and tower 108 and positioning it at the appropriate depth indicated by the insertion guide 112. After positioning the angle fixture 114 at the desired insertion depth, the user can secure the angle fixture 114 using the thumbscrew 156. In 708, the user can slide the needle stopper 118 forward and downward along the angle fixture 114 until the needle stopper tab 120 contacts and stops against the tower 108, at which point the needle is centered on the target. To insert the needle into the patient to the desired depth, the needle is inserted below the ultrasonic mount 106 (and the ultrasonic probe positioned therein, which can be used to measure the depth to a vein or other target). In 710, the user can release the latch 130 from the needle support arm 122, thereby allowing the user to manipulate the angle. For example, to facilitate catheter insertion, the user can reduce the angle of the needle relative to the patient surface. In 712, the user can remove the insertion device 100 and, if desired, leave a catheter, needle, etc., inside the patient.

[0338] In some embodiments, the user may know the needle length (for example, if the user typically uses only needles of a specific length, or if the length is indicated on the needle packaging), and therefore the user may omit measuring the needle in step 704. Instead, the needle length can be set by adjusting the needle support arm 122 so that the position indicator 150 points to the appropriate needle length on the marking 144 of the needle stopper 118. In some embodiments described above, there is only one needle size, and therefore adjustment of the needle support arm is not necessary. In some embodiments, the user can measure the needle. As described above, a block included in the packaging may be positioned so that the needle contacts the block during the measurement process. In some embodiments, the block may be coplanar with the lower surface of the base 102. In other embodiments, the block may be positioned below the lower surface of the base 102. For example, the insertion device 100 may have a minimum insertion depth, which may be indicated on the insertion ruler 112. Therefore, it may be desirable to position the block below the base 102 to take this minimum insertion depth into consideration. In some embodiments, the insertion guide 112 and / or markings 144 may be adjusted as appropriate to accommodate any insertion depth offset. If the target (e.g., a vein) is very shallow, the needle support arm 122 may be moved upward (e.g., towards the operator or away from the patient) while the positions of the other components are fixed, thereby accommodating shallow insertion.

[0339] Figure 8 shows another exemplary procedure for using the insertion device according to several embodiments. Depending on the embodiment, the procedure in Figure 8 may include fewer or additional steps and / or may be performed in a different order than shown. As shown in Figure 8, in procedure (block) 802, the user can begin by setting the device 100 to its initial state. For example, the initial state may include moving the angle fixture 114 forward to the shallowest insertion depth indicated by the insertion guide 112, sliding the needle stopper 118 upward along the rail so that the stopper tab 120 is away from the tower 108, and moving the needle support arm 122 to its maximum length position (however, if the user knows that the needle is quite short, the user may choose not to start from the maximum extended position), etc. In procedure 804, the user can place the ultrasonic probe in a sterile bag 162 (which can be attached to the insertion device) and secure the probe to the ultrasonic mount 106. In procedure 806, the user can put on sterile gloves. In procedure 808, the user can measure the needle length. For example, the user can insert the needle into the needle receiving portion 152 of the needle support arm 122 until the hub of the needle (e.g., the larger portion of the needle at the proximal end) contacts the support platform 154. The user can slide the needle support arm 122 along the rail 142 of the needle stopper 118 by continuing to push the needle forward and downward until the distal end of the needle (e.g., the tip) encounters an obstacle and can no longer move. Once the needle can no longer move, the user can fix the needle length by tightening the thumbscrew 124 in step 810. In step 812, the user can position the insertion device 100 on the patient, and in step 814, the user can locate a target inside the patient using an ultrasound probe. The ultrasound probe can be used to indicate the depth of the target. After locating the depth of the target, the user can set the insertion depth in step 816 by adjusting the angle fixture 114 so that the insertion depth indicated by the insertion ruler 112 is the desired insertion depth.Next, the user can fix the position of the angle fixture 114 using the thumbscrew 156. In some embodiments, the insertion depth may range from about 0.5 cm to about 4 cm, for example, from about 0.7 cm to about 2 cm.

[0340] In step 818, the user can insert the needle by pushing the needle support arm 122 and the needle stopper 118 downward along the rail 136 of the angle fixture 114 until the stopper tab 120 of the needle stopper 118 collides with the tower 108. Thus, the user can prevent inserting the needle deeper than the depth selected by the user when setting the insertion depth in step 816. In step 820, the user can release the movable lever / pull 130, which allows the user to lift and remove the insertion device 100 in step 822, leaving the needle in place. The user can then perform any remaining procedure steps in step 824. For example, the user can tilt the needle downward, advance the catheter over the needle, then withdraw the needle and connect the catheter to the venous line.

[0341] As briefly mentioned in step 804 of Figure 8, the ultrasound probe can be placed in a sterile bag to prevent contamination. An example is shown in Figure 9. As shown in Figures 9 to 11, the insertion device 100 may be inside the packaging 160. The bag 162 may be open at both ends or open at one end and may be pre-positioned on the ultrasound mount 106 so that the insertion device 100 can receive the ultrasound probe into the ultrasound mount 106 without contamination. In some embodiments, one end of the bag 162 may be fixed (e.g., glued) to the ultrasound mount 106 and the other end may be fixed (e.g., glued) to a handle 164, the handle having an access hole 165. The handle 164 may include a sterile section and a non-sterile section that can be operated by the user to facilitate the positioning of the bag. In some embodiments, the user may use the handle 164 to pull the bag 162 over the ultrasound probe and cord (through the access hole 165) and ligate the bag 162 before performing a procedure on a patient using the insertion device 100. This allows the probe to remain sterile, minimizing the time required for the procedure. Sterilizing an ultrasound probe can take more than 3 minutes.

[0342] The exemplary embodiment shown in Figure 1A1 has many advantages, including mechanical simplicity that can reduce manufacturing costs and potential defects. However, the exemplary embodiment shown in Figure 1A1 may also have some disadvantages, such as the difficulty in precisely setting the insertion depth by sliding the angle fixture 114 along the rail 110. In some embodiments, a gear system may be used to facilitate setting the insertion parameters with greater accuracy and / or precision. This is shown in Figure 39A with a gear system.

[0343] Geared devices can offer several advantages. For example, in a fixed-angle configuration, the needle can be pulled back away from the probe to insert the needle deeper into the patient (e.g., to reach a deeper target). This is shown in Figure 38, where the needle punctures the skin at a first distance L1 from the ultrasound probe to reach a first target at subcutaneous distance D1, and also punctures the skin at a distance L2 from the ultrasound probe to reach a second target at subcutaneous distance D2. The geared mechanism can ensure that proper geometric relationships are maintained (e.g., two sides remain of equal length in an isosceles triangle). For example, as the needle is moved closer to or further away from the ultrasound probe, it can also be moved vertically at the same time. Such a configuration can be easier to use and less prone to errors compared to devices where the user manually sets the horizontal and vertical positions of the needle separately.

[0344] The embodiments described above offer simplicity and ease of use, which can be important in some situations, such as when the patient is uncooperative or time is critical. However, the embodiments described above have limited flexibility. For example, the insertion angle is generally fixed, but in some embodiments, the user can replace the angle fixture 114 with another angle fixture configured to insert the needle at a different angle. In some embodiments, the insertion angle may be adjustable by the user. For example, the insertion angle may be continuously adjustable over a range of insertion angles, or it may be selected from a set of delimited insertion angles.

[0345] Figures 12 and 13 show exemplary embodiments of a device capable of continuously adjusting the insertion angle. The device 300 may include a base 302, a swing arm 310, a main needle carriage 312, and a needle support carriage 314. Some embodiments may include additional functions such as an insertion stopper for limiting the needle insertion depth.

[0346] As shown in Figures 12 and 14, the base 302 may include various features similar to or identical to those of the base 102 of the insertion device 100. For example, the base 302 may include stabilization holes 304 and ultrasonic mounts 306 similar to or identical to those of the stabilization holes 104 and ultrasonic mounts 106 in Figure 1A1, respectively. The base 302 may include an arm receiver 308 for coupling to the swing arm 310.

[0347] As shown in Figure 12, the swing arm assembly may include a swing arm 310, a main needle carriage 312, and a needle support carriage 314. The swing arm 310 may include a pivot mounting portion 316 for coupling with the arm receiver 308. A thumb screw 318 (Figure 15) may be passed through the arm receiver 308 and screwed into the swing arm 310. The user can loosen the thumb screw 318 to adjust the angle of the swing arm 310 and tighten the thumb screw 318 to fix the swing arm 310 at a desired angle (in some embodiments, this may correspond to the insertion depth).

[0348] The main needle carriage 312 may be movably coupled to the swing arm 310. For example, the user may slide the main needle carriage 312 along a track on the swing arm 310. The main needle carriage 312 may include a lever 320 for fixing the position of the main needle carriage 312 along the swing arm 310. In some embodiments, the lever 320 may instead be a thumbscrew or other means for immovably fixing the main needle carriage 312 to the swing arm 310. In some embodiments, the lever 320 may be omitted if there is sufficient friction between the main needle carriage 312 and the swing arm 310 to prevent undesirable movement of the main needle carriage 312 during use of the device 300. In some embodiments, the main needle carriage 312 may include a marker, allowing the user to adjust the position of the main needle carriage 312 relative to the swing arm 310 to limit the insertion depth. In some embodiments, a needle support carriage 314 may be slid along the main needle carriage 312 toward the patient to assist in guiding and / or stabilizing the needle.

[0349] In some embodiments, the main needle carriage 312 can be used to set the needle length, and the needle support carriage 314 can be fixed to the main needle carriage 312 by a lever 322. In some embodiments, the main needle carriage 312 may include markings indicating the maximum insertion length of the needle, which can help prevent the needle from being inserted too deeply into the patient.

[0350] In some embodiments, the insertion angle may depend on the insertion depth. For example, when inserting the needle relatively deeply into a patient, the insertion angle may be steeper than in scenarios where the needle is inserted to a relatively shallow depth. In some embodiments, the user may initiate the insertion process by measuring the depth of a blood vessel, tumor, or other target area. In some embodiments, the arm receiver 308 may be labeled with the insertion depth (without or in addition to the angle). The user can rotate the swing arm 310 until the correct insertion depth is indicated on the arm receiver 308. The user can then fix the position of the swing arm 310. After fixing the position of the swing arm 310, the user can measure and set the needle length using the main needle carriage 312. The user can set the needle support carriage 314 so that the needle is inserted to its maximum depth and cannot move further after being inserted to the desired depth. An advantage of this configuration is that it can prevent the needle from being inserted too deeply, thus preventing it from puncturing the opposite side of the blood vessel (for example, during catheter insertion) or from penetrating the tumor and entering healthy tissue (for example, during biopsy).

[0351] Figures 16 to 18 show exploded views of the swing arm 310, the main needle carriage 312, and the needle support carriage 314.

[0352] Figures 36A to 36K illustrate exemplary procedures for using the device 300. In Figure 36A, the user can open the lever to allow movement of the main needle carriage 312 and the needle support carriage 314. The user can set the main needle carriage 312 to the correct depth indicated by the marker on the swing arm 310. For example, Figure 36A shows an insertion depth of 5 mm. As shown in Figure 36B, the user can lift the lever after setting the depth to fix the position of the main needle carriage 312. In Figure 36C, the user can loosen the thumb screw 318 and raise or lower the swing arm 310 to the correct depth indicated by the pivot mounting portion 316. For example, as shown in Figure 36D, the swing arm 310 is positioned at marker "5" on the pivot mounting portion 316, which indicates an insertion depth of 5 mm. As shown in Figure 36E, the user can add a needle so that the needle hub rests on the needle support carriage 314 and the needle passes through the hole in the main needle carriage 312. In Figure 36E, the main needle carriage 312 is fixed, and the one-way support carriage 314 is movable. Figure 36F shows the needle within the main needle carriage 312. As shown in Figures 36G and 36H, the user can carefully move the needle support carriage 314 forward until the needle tip aligns with the metal bar in the base of the device. The user can then fix the position of the needle support carriage 314. As shown in Figure 36I, the user can release the lever on the main needle carriage 312, allowing the main needle carriage 312 to slide along the swing arm 310. Thus, the user can advance the needle until the main needle carriage 312 abuts against the end stopper of the base, as shown in Figure 36J. Figure 36K shows a side view of the device when the main needle carriage 312 is fully advanced.

[0353] While the device 300 allows for easy adjustment of the needle angle to accommodate a range of insertion depths, configuring the device can be cumbersome. For example, as described above, the user can set the insertion depth twice: once using the pivot mounting section 316 and thumbscrew 318, and again using the swing arm 310 and main needle carriage 312. This increases complexity and can introduce potential errors. Therefore, in some embodiments, alternative systems for fixing and adjusting the swing arm may be used.

[0354] For example, in some embodiments, the insertion device may use a pinion system to change the angle of the swing arm 310. For example, as shown in Figure 19, the arm receiver 308 may include a rack or grooved surface 324, and the thumbscrew 318 may be replaced by an adjustment knob 326 having a pinion 328, as shown in Figure 20.

[0355] In some embodiments, the angle of the swing arm 310, the position of the main needle carriage 312, and / or the position of the needle support carriage 314 may be coupled so that a user can set one or more related parameters by making a single adjustment on the device. For example, the user may change the angle of the swing arm 310, and the main needle carriage 312 may move in response.

[0356] Figures 21 to 24 illustrate exemplary embodiments of an insertion device that can automatically adjust the position of the main needle carriage 312 in response to changes in the angle of the swing arm 310. Figures 21 and 22 illustrate embodiments in which a belt 330 is coupled to an adjustment knob 332 for changing the angle of the swing arm 310. The belt 330 may be mechanically coupled to the main needle carriage 312 so that when the adjustment knob 332 is rotated, the belt 330 can move the main needle carriage 312. In some embodiments, the belt 330 may include a stopper 334 which can help prevent the main needle carriage 312 from moving along the swing arm 310.

[0357] Figures 21 and 22 show the use of a belt 330 to connect the adjustment knob 332 and the main needle carriage 312, but other configurations are possible. For example, as shown in Figures 23 and 24, inserting devices of some embodiments may include a worm drive 336 such that when the user turns the adjustment knob 332, the worm drive 336 connected to the adjustment knob 332 and the main needle carriage 312 moves the main needle carriage 312 linearly along the swing arm 310.

[0358] By combining angle adjustment with the positioning of the main needle carriage 312, the user can more easily configure the device to insert the needle to the desired depth, thereby reducing the risk of the user misconfiguring the device, for example, by setting the maximum insertion depth too high (resulting in the needle penetrating the target inside the patient) or too low, preventing the needle from reaching the target.

[0359] In some embodiments, the user can adjust the insertion angle by linearly moving the member rather than, for example, turning a knob or manually tilting a swing arm. Figures 25 and 26 show exemplary embodiments of a structure or device 400 that may be used to adjust needle insertion parameters (e.g., insertion angle, insertion depth). The structure or device 400 may be mounted on a base (not shown), for example, the same or similar base as the base 102 or base 302 in the embodiments described above.

[0360] The structure or device 400 may include a vertical post 402 having a vertical groove through which the adjustment control 404 can pass. The user can raise or push down the adjustment control 404 and cylinder 406 to change the angle of the arm 408 and thereby control the needle insertion depth. The user can fix the adjustment control 404 to prevent further movement of the arm 408. The structure may include a movable needle carriage 410 slidably coupled to the arm 408. The arm 408 may include a coupled stopper 412 that can stop further movement of the movable needle carriage 410.

[0361] In some embodiments, the insertion procedure may include measuring the needle length by inserting the needle into the needle holder and pushing it down until the needle stops moving. The user can then secure the needle holder 414 to the needle carriage 410 using, for example, a thumbscrew or lever. The user can then locate the depth of the target (e.g., a blood vessel, tumor, etc.). The user can adjust the adjustment control 404 to set the insertion depth indicated on the vertical post 402. The user can release the needle carriage 410 from the arm 408 so that the needle transport structure (needle carriage) 410 can slide along the arm 408. When the user pushes the needle carriage 410, it is prevented from moving further when it comes into contact with the stopper 412.

[0362] While the adjustable embodiments described above offer flexibility to physicians and other healthcare professionals, in some situations, healthcare professionals may find the setup of some embodiments cumbersome, difficult, or time-consuming. Therefore, there may be a need for a device that offers some degree of adjustability while being easy and quick to configure. In some embodiments, the insertion device may be configured to allow the user to quickly select various insertion angles and / or insertion depths.

[0363] Figures 27A and 27B illustrate exemplary embodiments of an insertion device that facilitates easy adjustment of the needle insertion depth. As shown in Figure 27A, the insertion device may have a base 500. The insertion device may have movably coupled components of a post 502, a needle pusher 504, and a needle holder 506, which can be used to set the needle insertion depth and hold the needle in place. Components 502, 504, and 506 can be held in place relative to each other by lever locks 508 and 510. In some embodiments, other locking or fixing mechanisms, such as thumbscrews, may be used. These components may rotate around an insertion depth selector wheel 512. The insertion depth selector wheel 512 may have multiple grooves corresponding to multiple insertion depths. A pin 516 (shown in Figure 27B) may protrude from the side of component 502 (or another component) and engage with a groove cut into the selector wheel 512. For example, the pin may be attached to the component 502 using a spring so that the pin can move along the long axis of the component 502, thereby allowing the pin 516 to move in and out of the groove of the insertion depth selector wheel 512. An advantage is that the groove, pin, and / or spring may be configured so that the pin 516 does not come out of the groove unless the user of the insertion device wishes to change the insertion depth or angle. In some embodiments, the insertion device may include a mechanism, such as a lever, that the user can operate to release the pin 516 from the groove of the insertion depth selector wheel 512. For example, as shown in Figure 27B, the insertion device may include a slider 514 for operating the pin 516. The slider 514 may be coupled to the pin 516 by, for example, a rubber band, a spring, or other suitable mechanism. In some embodiments, the slider 514 and the pin 516 may be coupled by a rigid body. The slider 514 may be configured to return to a position near the distal end (e.g., the side closer to the needle tip) when not being operated by the user, so that the pin 516 slides into the groove of the insertion depth selector wheel 512, thereby maintaining the insertion device in a stable state unless the user chooses to manipulate the insertion depth.

[0364] The insertion device shown in Figures 27A and 27B allows for rapid adjustment of the insertion depth without the complexity associated with several implementations that enable arbitrary operations. The insertion depth selector wheel 512 can accommodate a wide range of pre-selected angles that may be suitable for various insertions. For example, the insertion depth selector wheel 512 may be configured to accommodate insertion depths and / or angles suitable for narrow and / or deep insertions.

[0365] In some embodiments, component 506 may be a needle holder and component 504 may be a needle pusher. The needle pusher may have a needle length marking thereon. The user can set the needle length using the needle length marking. In some embodiments, the user can set the insertion depth by adjusting the position of the needle holder. After setting the needle length and insertion depth, the user can lock the lever locks 508 and 510. The user can then insert the needle into the patient. Insertion may be limited by a needle stopper 518, which can prevent the needle from being inserted too deeply into the patient.

[0366] Figures 28A to 28F illustrate the steps for using the apparatus shown in Figures 27A and 27B. In Figure 28A, the needle holder 506 and needle pusher 504 can be positioned in a fully retracted position (e.g., fully rearward on the post 502). As shown in Figure 28B, the user can open the lever on the pusher 504 to allow the pusher 504 to move. As shown in Figure 28C, the user can adjust the position of the needle holder 506 to set the needle length. In some embodiments, there is only one needle length option. In this case, the needle holder 506 and pusher may be a single unit, thereby preventing user confusion and additional work. As shown in Figure 28C, the length can be set between 48 mm and 65 mm, but other ranges are possible and this range should not be interpreted restrictively. As shown in Figure 28D, after setting the needle length, the user can open the latch 520 and insert the needle. The user can close the latch 520 to fix the needle in place. In some embodiments, the needle can be firmly secured to the needle holder 506 using a clamp / tie / latch, so the latch 520 may not be necessary. As shown in Figure 28E, the user can position the pin 516 relative to the insertion depth selector wheel 512 (e.g., using a slider 514) to set the insertion angle. Figure 28F shows the device when the needle is in the inserted state. The needle holder 506 and needle pusher 504 can be pushed forward (e.g., towards the patient) until the needle stopper 518 contacts the needle pusher 504, thereby preventing further forward movement of the needle.

[0367] The insertion device may include various additional features that make the device easier to use and more suitable for a wider range of applications. For example, the insertion device may be configured to accept a range of needle diameters or gauges that may be used in different procedures. In some embodiments, the insertion device may be configured to accommodate a range of needle lengths, including, for example, short pediatric needles. Pediatric needles may be, for example, about 5 / 8 inch, about 1 inch, about 1 and 1 / 4 inches, etc. Therefore, for operation with the insertion device, it is preferable that the device does not require long needle lengths. For example, it is advantageous if the needle can puncture the patient's skin in very close proximity to the ultrasound probe.

[0368] Needles of different gauges may be used to perform different procedures. In some cases, healthcare professionals may use various ultrasound probes that may have a range of shapes and sizes. Therefore, it may be beneficial for an insertion device to have the ability to accommodate various needle gauges and / or ultrasound probes, as shown in Figure 43F2. Such an adaptable device may have many advantages. For example, hospitals and other healthcare facilities can simplify their supply inventory, manufacturers only need to produce fewer types of devices, healthcare providers can more easily select the appropriate device, waste due to careless selection of the wrong insertion device may be reduced, and / or time may be saved by having fewer insertion devices to choose from.

[0369] Figures 29 to 33 show exemplary embodiments of an insertion device having a self-centering needle function. As will be discussed in more detail below, the embodiments shown in Figures 29 to 33 may also include an ultrasonically transparent material, but other embodiments are also possible. For example, the insertion device may have an opening to allow ultrasound to propagate into the patient and be received by an ultrasonic transducer. In some embodiments, as described above, a sterile bag may be attached to the insertion device to ensure that only sterile components come into contact with the patient.

[0370] As shown in Figure 29, the insertion device may include a self-centering device 600 located between two towers and fixed to them. The self-centering device 600 may include a spring-lock latch 606 capable of clamping various needle types / gauges (as shown in Figure 30). In some embodiments, the ultrasonic cavity 604 may also include a self-centering function. For example, a spring load may be applied to one or more sides of the ultrasonic cavity 604 so that the force exerted by the ultrasonic cavity 604 on the ultrasonic probe is equalized (e.g., in one direction) when the ultrasonic probe is centered within the ultrasonic cavity 604.

[0371] In some embodiments, as shown in Figure 33, the self-centering device 600 may include one or more slots configured to receive needles of a specific size or size range. For example, Figure 33 shows a self-centering device 600 having three slots of different lengths to accommodate different needle sizes. The slots may function as a key system to ensure that only the correct needles are used in the device.

[0372] As briefly mentioned above, in some embodiments, the bottom of the ultrasonic cavity 604 may be an open structure, while in other embodiments, the bottom of the ultrasonic cavity 604 may be a solid structure. If the bottom is a solid structure, the material should preferably be such that distortion or absorption of ultrasound is minimized so that the degradation of image quality is acceptable. In some embodiments, the bottom of the ultrasonic cavity 604 may include polyvinyl chloride polymer, polystyrene, poly(methyl methacrylate), glass, or other suitable material. In some embodiments, a groove or "V" shape may be cut into the base of the ultrasonic cavity 604, which may allow the needle to be inserted closer to the center of the ultrasound probe (for example, closer to the center of the ultrasonic cavity 604), which may be particularly important for shallower insertion. Such a configuration may facilitate the use of very short needles, such as pediatric needles.

[0373] In some embodiments, one or more components may be motor-driven. For example, an insertion device may be configured to include one or more motors that can be used to set the insertion angle, advance the needle, retract the needle, etc. Any embodiment described herein may be motor-driven or otherwise automated to improve ease of use, accuracy, precision, etc.

[0374] In some embodiments, the insertion device may be designed to be used primarily, or exclusively, in a motor-driven or automated manner.

[0375] Figure 34 shows an exemplary embodiment of the motor-driven insertion device 900. The motor-driven insertion device 900 may include a base 902 similar to or identical to the bases shown in other insertion device embodiments described herein. The motor-driven insertion device 900 may include a motor-driven tower 904 including a shaft 906, an end cap 908, and a coupling mechanism 910. The coupling mechanism 910 may be configured to movably couple the motor-driven tower 904 to the base 902, and to allow the angle of the motor-driven tower 904 to be changed automatically or semi-automatically by a motor-driven mechanism inside the motor-driven tower 904. Electronic components (e.g., battery, motor, communication interface (e.g., Bluetooth), etc.) may be housed in the end cap 908. In some embodiments, the end cap 908 may be removed from the device after the procedure and reused in subsequent procedures. In some embodiments, the end cap 908 may be designed to withstand sterilization. The motor within the end cap 908 may be mechanically coupled to a screw drive mechanism 911 (which may be analogous to, for example, the lead screw of a 3D printer), as shown in Figure 35A, which may be used to advance the needle using a carriage 910. In some embodiments, the needle may be automatically retracted after insertion. In some embodiments, a spring load mechanism may release the catheter, thereby leaving the catheter in the body while the needle retracts. Figure 35B shows examples of needles and carriages that may be used in some implementations.

[0376] Figure 37 shows another example of a motor-driven insertion device. The example shown in Figure 37 may be broadly similar to the embodiment shown in Figure 34. As shown in Figure 37, the needle holder 920 may be configured to hold a needle assembly including a needle 914, a catheter sheath 916 surrounding the needle, and a receiver 918 for receiving the used needle. After insertion, the device may be configured to automatically retract the needle from the patient into the receiver 918, leaving the catheter sheath 916 in place (e.g., partially within the patient). The physician or other healthcare provider may then remove the insertion device, secure the catheter, and perform other steps as required by the specific procedure.

[0377] Figures 39A to 39G show a needle insertion device 1000 including a base 1010 having a patient contact surface 1011 on its underside. A finger grip 1014 may be used by a healthcare professional to stabilize the device 1000 on the patient's skin. The base 1010 has an ultrasound probe mount 1012 used to locate the vein and determine its depth. The base 1010 defines an insertion area 1007 in which the needle 1005 punctures the patient's skin. An upper assembly 1030 that holds the needle 1005 is mounted to the base 1010 at a fixed angle. The base 1010 may include a needle depth gauge 1015, and the upper assembly 1030 may have a depth indicator 1020. The healthcare professional operates the device 1000 by turning an actuation mechanism 1025 (shown as a wheel). It is obvious that other structures, such as levers or knobs, may be used, but are not limited to these. The upper assembly 1030 includes three main structures: (1) an upper assembly main support 1060 that can be slid into a base groove 1062 (a rail may be used instead of a groove) on the base 1010; (2) a needle rack support 1045 that slides relative to the upper assembly main support 1060; and (3) a needle carriage 1040 that slides relative to the needle rack support 1045, which can be fixed to the support 1045 by tightening a lock thumb screw 1055. The needle rack support 1045 and the needle carriage 1040 form a needle carriage assembly 1046.

[0378] During use, the healthcare professional first identifies the vein and its depth, and then rotates the actuation mechanism 1025 until the depth indicator 1020 matches the appropriate depth on the needle depth gauge 1015. This is the depth setting state. To calibrate for an unknown needle length, the healthcare professional then inserts the needle 1005 into the needle carriage 1040 and slides the carriage 1040 against the needle rack support 1045 until the needle tip is just touching the patient's skin or block (see sliding path 1050). Alternatively, the healthcare professional may move the needle carriage 1040 along the needle rack support 1045 to a fixed pre-measured needle length printed on the needle rack support 1045, and then lock these two structures together with the thumbscrew 1055. By tightening the locking thumbscrew 1055, the movement of the carriage 1040 against the rack support 1045 may be substantially fixed. If there is only one needle size option, the needle carriage 1040 and rack support 1045 may be a single integrated unit. By rotating the actuation wheel 1025 counterclockwise (viewed from the perspective of Figure 39A), the needle rack pinion 1048 engages with the needle rack 1047, and the needle carriage 1040 moves in the direction of arrow 1070 (towards the insertion area 1007), thereby inserting the needle tip into the patient's skin. Simultaneously with this insertion, the base rack pinion 1067 engages with the base rack 1065, moving the entire upper assembly 1030 laterally in the direction of arrow 1075 (away from the insertion area 1007). These two movements (1070, 1075) continue until the upper assembly 1030 moves along the base rack 1065 and stops, at which point the needle tip is at the previously set depth. This is the inserted state. It should be understood that during the depth setting state, the upper assembly 1030 and needle carriage 1040 move in the opposite direction compared to the insertion state.

[0379] When inserting a syringe using the apparatus disclosed above, the needle tip puncturing the vein is sufficient to allow the healthcare professional to then inject the solution into that vein. However, if the needle is to be used as a catheter after puncturing the vein, the needle must "advance at a reduced angle" to prevent the catheter from simply penetrating the vein completely as it advances along the needle. Furthermore, this reduced-angle technique allows the healthcare professional to tape the catheter to the patient's skin to prevent unintended movement. As in the previous embodiment, if the needle is secured to the needle carriage assembly 1046 using a clamp, latch, or any other fastener, a needle guide may not be necessary.

[0380] Embodiments shown in Figures 40A to 40O implement this angle-downward forward motion. The needle insertion device 1100 is similar to the insertion device 1000 but includes an angle-down multi-channel guide 1170. Similar to device 1000, the actuation structure 1125 is used to insert the needle 1105 into the patient. Instead of having the needle depth gauge 1115 on the base 1110, the needle depth gauge 1115 is located on the actuation structure 1125. The operation of device 1100 is similar to that of device 1000. The medical professional first uses the ultrasound probe 1112 to locate the vein and its depth, and then rotates the actuation structure 1125 until the depth indicator 1120 matches the appropriate depth on the needle depth gauge 1115. The medical professional then inserts the needle 1105 into the needle carriage 1140 so that the needle tip is just touching the patient's skin, and then secures the needle 1105 in the carriage 1140. By rotating the actuation structure 1125 counterclockwise (viewed from the perspective of Figure 40A), the needle rack and pinion 1148 engages with the needle rack 1147, causing the needle carriage 1140 to move relative to the upper assembly main support 1160 in the direction of arrow 1070, and the needle tip is inserted into the patient's skin. Simultaneously with this insertion, the base rack and pinion 1167 engages with the base rack 1165, causing the entire upper assembly 1130 to move in the direction of arrow 1075. These two movements (1070, 1075) continue until the upper assembly 1130 moves along the base rack 1165 and stops, at which point the needle tip is at the previously set depth.

[0381] Once the needle tip reaches the set depth, it has punctured the vein. The medical professional may now angle the needle down and advance it. First, the release button 1142 is pressed, causing the release latch 1144 to rotate outward from the latch receiver 1150 located on the angle-down needle carriage 1149 (arrow 1145) (see Figure 40H). Once the latch 1144 is released from the carriage 1149, the carriage 1149 is free to move along the center channel of the center channel guide 1175, and then forward to the channel on the angle-down multi-channel guide 1170. The complete movement is indicated by the path 1180 consisting of the center channel section 1176A and the multi-channel guide section 1170A. This is called the angle-down state.

[0382] The angle-down multichannel guide 1170 includes multiple discrete channels 1185, each linked to a specific needle depth. Shorter channels are for deeper insertion depths, and longer channels are for shallower insertion depths. The angle-down multichannel guide 1170 is mounted on an angle-down gear 1172, which rotates the guide 1170 so that the needle is positioned in the correct discrete channel 1185 at the time of vein puncture. The center channel guide 1175 is separate from the angle-down multichannel guide 1170 and does not rotate.

[0383] Embodiments shown in Figures 41A to 41F also implement angle-down operation. The needle insertion device 1200 includes a base 1203 having a lower surface 1011 that contacts the patient's skin. The base 1203 is connected to an ultrasound probe mount 1012 and a finger grip 1014. A needle assembly 1205 having a needle 1210 is connected to a needle carriage 1207. A needle carriage guide 1207.2 extending from the carriage 1207 slides into an insertion needle carriage channel 1230.4 and an angle-down needle carriage channel 1230.5. These channels (1230.4, 1230.5) are located on a needle carriage multi-channel guide 1230. The insertion needle carriage channel 1230.4 defines an insertion angle 1245 (Figure 41C) relative to the base 1203. This is the same angle that the needles (1205, 1210) define relative to the base 1203 during insertion. Each angle-down needle carriage channel 1230.5 is connected to and continuous with the insertion needle carriage channel (1230.4).

[0384] During use, the healthcare professional first identifies the location and depth of vein 1235, and then sets the adjustable venous depth stopper 1230.2 to the appropriate depth by aligning the depth indicator 1230.3 with the venous depth gauge 1230.1 on the multi-channel guide 1230. The needle (1205, 1210) is loaded into the needle carriage 1207 and slid in the direction of arrow 1207.1 until the needle carriage guide 1207.2 contacts the adjustable stopper 1230.2. This is the insertion position. The needle tip is inserted into vein 1235 at needle insertion point 1240. Then, during the angle-down position, the needle carriage 1207 is angled down in the direction of arrow 1207.3 (Figure 41D) to reduce the needle insertion angle (see 1245 and 1250). For deeper insertions of 10–12 mm (Figures 41C and 41D), the angle-down channel 1230.5 is shorter, while for shallower insertion depths of 1–3 mm (Figures 41E and 41F), a longer angle-down channel is used. After the needle is angled down, the healthcare professional can remove the cap from the needle assembly 1205 and insert the catheter.

[0385] The embodiments shown in Figures 42A to 42L also implement angle-down movement, but unlike devices 1000, 1100, and 1200, the insertion angle of device 1300 is not fixed. Rather, a multi-channel guide card 1310 is used, which has multiple channels, one channel for each venous depth, and each channel forms a different insertion angle relative to the base 1305. Also, similar to device 1200, the needle carriage has a guide pin 1344 that moves within the selected channel. Specifically, device 1300 has a base 1305 which has a finger grip 1014 and an ultrasound probe mount 1012. The base 1305 includes a guide card support 1330, a needle window 1320, and a needle anchor point 1345. The base 1305 also has a pin receiver 1340 which fits into a mounting pin 1335 on the underside of the ultrasound probe mount 1012. The configuration of the pin receiver 1340 allows the ultrasonic probe mount 1012 to connect to the base 1305 in a first orientation 1325A or a second orientation 1325B. The guide pin 1344 connects to the ultrasonic mount. Therefore, to change the orientation, the user simply lifts the ultrasonic mount and detaches it from the current set of mount pins, slides the guide pin 1344 along the channel 1342, and places the ultrasonic mount on top of the new set of mount pins 1335 (see Figures 42E and 42EE). The base 1305 may also have a pin receiver 1340A oriented in a different plane, as well as the mount pin 1335A on the ultrasonic probe mount 1012 (see Figure 42F). Figure 42F also shows a mount magnet 1338 that can be used instead of, or in addition to, the mount pins (1340, 1340A). Other fasteners, such as clips and clamps, may also be used in addition to, or in place of, the pins and magnets. The needle 1302 is attached to the needle carriage 1315, and the needle carriage 1315 is fitted with a needle carriage guide (pin) 1350 that moves within the channels of the multi-channel guide card 1310.

[0386] During use, the medical professional first identifies the location and depth of the vein, and then selects a channel on the guide card 1310 corresponding to that depth. The needle carriage 1315 is located within the channel and remains attached to the guide card 1310. The needle 1302 is loaded into the needle carriage 1315, and the needle carriage guide (pin) 1350 is inserted into the selected channel on the guide card 1310. The needle carriage 1315, along with its guide pin 1350, can move vertically within the channel, enter a horizontal orthogonal channel corresponding to the desired depth, and then move along the slope to enter the vein. The tip of the needle 1302 is positioned below the needle anchor point 1345. The needle carriage 1315 can now be moved along the channel, and when it reaches the end of the channel, it indicates that the needle has reached the selected depth. Figure 42G2 shows the needle carriage 1315 with a wrap-around clip 1316. This stabilizes the needle carriage 1315 against the guide card 1310, as shown in Figure 42G3. Figure 42A shows the carriage and needle path for the first channel (1317A, 1317AA), which results in a final needle depth of 1318A. A shallower insertion angle results in a shallower insertion depth, as shown in the carriage and needle path for the second channel (1317B, 1317BB) which results in a final needle depth of 1318B.

[0387] The advantages of the 1300 device are that it has no moving parts that can get stuck or slip, and does not require alignment. This simplifies operation and manufacturing. It also results in a robust device that can be easily sterilized without sacrificing performance and accuracy.

[0388] The guide card 1310 may be simplified to include only the needle loading section 1352 (the part in which a medical professional can load the needle 1302 into the needle carriage 1315) and the needle insertion section 1355, as shown in Figure 42J. Alternatively, the guide card 1310 may be modified to include an angle-down section. As shown in Figure 42K1, the channel includes the needle loading section 1352 (the part in which a medical professional can load the needle 1302 into the needle carriage 1315), the needle insertion section 1355, followed by an angle-down section 1360. Figure 42K2 shows that a single channel may have its own angle-down section 1360 / forward section 1365. In fact, all channels may each have their own angle-down section 1360 / forward section 1365.

[0389] Figure 42L shows a guide card 1310 having multiple angle-down sections and further including a forward section. The guide pin path is shown by a dashed line and includes a needle loading section 1352, a needle insertion section 1355, an angle-down section 1360, and a forward section 1365. Figure 42L shows the paths of four possible angle-down sections 1360 / forward sections 1365, each corresponding to multiple insertion angles.

[0390] Embodiments shown in Figures 43A1 to 43K also implement variable insertion angle, but unlike device 1300, a guide channel is not used. Specifically, device 1400 uses a depth cam 1410 fixed to the base 1405 to achieve the desired depth and angle. The swing arm assembly 1427 includes needles (1422, 1437) attached to a needle holder 1432 connected to a needle carriage (1435, 1465) that slides along the slide arm 1480. The needle holder 1432 may use a self-centering polymer or a drill chuck or a tapered key such as a deformable Toohey-Boast adapter, thereby enabling the acceptance of various needle types. For needles that do not have a catheter around them, such as central venous lines or biopsy needles, a hole / channel stabilizer 1467 may be used. The needle is stabilized by inserting it into the channel and passing it through the hole.

[0391] The swingarm assembly 1427 has an angular position pinion 1430 that engages with an angular position rack 1425 to change the angle of the swingarm assembly 1427 relative to the base 1405, thereby changing the needle insertion angle. The movement of the swingarm assembly 1427 relative to the base 1405 is indicated by arrow 1428. The needle carriage, which is part of the swingarm assembly 1427, has needle insertion stoppers (1440, 1475) which may be formed in a spear shape and contact the depth cam 1410 at a stopping point 1436.1 to prevent further insertion. The edge of the depth cam 1410 may have an anti-slip structure 1415 to prevent the carriage from sliding beyond the stopping point, especially at steep insertion angles. The structure may be teeth, ridges, notches, or slits (see Figure 43B2).

[0392] As shown in Figure 43A2, the base 1405 may have a base insert receiver 1407.1 that holds interchangeable probe mount inserts 1408.1-1408.4. These inserts are compatible with various types of ultrasound probes 1112. The materials used for these mounts 1408.1-1408.4 may vary. For example, the mount may be made of a flexible material to allow the user to press the ultrasound probe down into the patient's skin to confirm whether it is a vein or not. Alternatively, the material of the insert may be rigid, which may be advantageous when performing a biopsy. The mount may have a wedge / slit at the bottom to allow the needle to penetrate the patient's skin without encountering a foreign object (see Figures 45A-45C). An acoustic pad may be placed beneath the probe mount insert, and the insert may also have a needle insertion slit formed within the acoustic pad. The mount may also be fitted with a bag to maintain sterility (see Figures 9-11).

[0393] The outer circumference of the depth cam 1410 has a unique shape that ensures the needle tip reaches the required depth. Figure 43B3 shows how the periphery of the depth cam 1410 is calculated. All chords 1410A are the same length and all intersect at the needle insertion point 1407. The periphery shape of the depth cam 1410 is calculated by selecting a depth along the insertion dot line 1420, placing the end of a fixed-length chord at that depth, and intersecting it at the needle insertion point 1407 (repeating this for multiple depths). Thus, the depth cam 1410 correlates the needle insertion depth 1424 (Figures 43B1 and 43C1) with the insertion angle. Steeper insertion angles correspond to deeper insertions, and shallower angles correspond to shallower depths. As shown in Figure 43B1, carriage paths 1436 for three insertion angles are shown. Each path 1436 has a different stopping point 1436.1, resulting in a different needle depth 1436.2 along the insertion dotted line 1420.

[0394] Figures 43C1 to 43C3 show details of the interchangeable arm receiver 1426.1, which includes a track 1426.2 on which the swingarm interface 1426.3 sits. A track tab 1426.4 extends from the swingarm interface 1426.3 and is located within the track 1426.2. A depth-selection pinion 1430 may be used to change the position of the swingarm interface 1426.3 relative to the interchangeable arm receiver 1426.1. The depth-selection pinion 1430 is shown as a gear with corresponding teeth on the arm receiver 1426.1, although the arm receiver 1426.1 does not need to have teeth, and the depth-selection pinion may be a wheel that rolls across the peripheral surface of the arm receiver 1426.1. Interface 1426.3 may have a swingarm post 1426.5 on which the swingarm 1426.6 can be mounted. If a swingarm of a different size is required, the swingarm may be removed from post 1426.5 and replaced with a new one. Figure 43C3 shows the track horizontal displacement 1426.7 and track vertical displacement 1426.8. These displacements may differ from each other, which may result in an oval or elliptical movement of the interface 1426.3 relative to the base. The track may also have a straight section indicated as track horizontal displacement 1426.9. Since the arm receiver 1426.1 is interchangeable, another arm receiver 1426.1 with a different track layout may be used in the same insertion device.

[0395] During use, the healthcare professional first loads the required needle and inserts the non-adjustable needle carriage 1465 for the specific needle into the slide 1480 of the swing arm assembly 1427. The needle carriage 1465 has a small clip that allows it to remain in place at the distal end of the slide 1480. The healthcare professional then identifies the venous depth and rotates the depth selection pinion 1430 to the appropriate depth (see 1424). By rotating the depth selection pinion 1430, the swing arm assembly 1427, including the slide arm 1480, moves upward, increasing the insertion angle. The healthcare professional then applies a small downward force to the needle carriage 1465, which causes the needle carriage 1465 to slide along the slide 1480 toward the patient's skin, and the needle (1422, 1437) is inserted into the patient. The needle is pushed until the needle insertion stopper 1475 contacts the carriage stop point 1436.1, at which point the needle reaches the selected depth and the vein is punctured. If, for example, the patient requires another procedure such as a central venous line, this needle carriage 1465 can be easily removed from the swing arm assembly 1427 and replaced with a needle carriage that supports a central venous line. This replacement of the needle carriage takes only a few seconds. Another type of needle carriage 1470 may be used to accommodate a catheter-free needle, such as a central venous line needle or a biopsy needle.

[0396] The device 1400 may also be adjustable to accommodate various needle lengths. Instead of using a carriage with a non-adjustable needle insertion stopper 1475, an adjustable needle insertion stopper 1440 may be used. Again, the adjustable needle insertion stopper 1440 may be spear-shaped. Specifically, the needle and depth calibration method is shown in Figure 43D1. First, the carriage 1435 is placed in a horizontal position (step 1460.1). Next, the needle is inserted into the needle holder in step 1460.2. Then, the carriage 1435 is pushed along the slide arm 1480 until the needle tip contacts the needle calibration structure 1456 (step 1460.3). The needle carriage lever lock 1438 is locked in step 1460.4. Now, temporarily returning to Figure 43B2, the horizontal chord 1410B shows the horizontal position of the needle in steps 1460.1 to 1460.4. This configuration calibrates the fixed chord length of the depth cam 1410 to a needle of unknown length. Returning to Figure 43D1, the needle insertion stopper 1440 is inserted until it contacts the edge of the depth cam 1410 (step 1460.5). The needle insertion stopper 1440 is then secured to the carriage by locking the needle insertion stopper lever lock 1442 in step 1460.6. Finally, the needle carriage lever lock 1438 is released, allowing the carriage to move backward (step 1460.7). The needle length is now calibrated, and the device 1400 can be used as detailed above. Furthermore, after insertion is complete, the medical professional can release the stopper lever lock to push the needle deeper at the same angle.

[0397] The ability to accept various needle lengths provides healthcare professionals with ultimate flexibility. For example, in trauma patients, IV lines, central venous lines, and arterial lines may all be required for a single patient. The device 1400 accommodates all of these insertions by accepting carriers with pre-set needle lengths and accommodating variable needle lengths. Thus, healthcare professionals may start insertions with small needles and change the device when using larger needles. Thus, a single device 1400 can be quickly converted to accommodate many needle procedures by simply removing one needle carriage and loading a different needle carriage. Figure 43D2 shows the needle calibration of an adjustable plunger holder 1477 that holds a plunger 1476. In step 1, the carriage 1477.2 is placed in a horizontal position and pushed along the slide arm 1480 until the needle tip contacts the needle calibration structure 1456. Here, it is optional to fix the carriage 1477.2 to the slide arm 1480 by locking the needle carriage lever lock 1438. In step 2, the needle insertion stopper 1440 is inserted until it contacts the edge of the depth cam 1410, and then the needle insertion stopper 1440 is fixed to the carriage by locking the needle insertion stopper lever lock 1442. In step 3, the carriage 1477.2 slides along the slide arm 1480, allowing the needle to be pulled away from the calibration structure 1456, and the carriage 1477.2 can be fixed to the slide arm 1480 by locking the needle carriage lever lock 1438. The medical professional can then rotate the depth selection pinion 1430 to select the appropriate depth, and in step 4, the carriage lever lock 1438 is released, allowing the carriage 1477.2 to slide along the slide arm 1480 to puncture the skin and reach the vein. After insertion is complete, the medical professional can angle down by releasing the needle insertion stopper lever lock 1442.

[0398] Figure 43F2 shows various needle / catheter carriages that can be used with the same insertion device 1400. For example, a needle carriage 1470 with a fixed needle insertion stopper 1475 may be used. A plunger 1476 and plunger carriage 1477, including a hole / channel stabilizer 1477.1 (Figure 43F3), may be used with an adjustable needle insertion stopper 1440. An automatic needle / catheter mount 1913 with an angled down arch 1816 may be used (these features are described in more detail in Figures 49A to 49G). Also, as shown in Figure 43F4, a catheter 1826 on a catheter / needle mount 1813 connected to the angled arch 1816 may be used (these features are described in more detail in Figures 47A to 47E).

[0399] The device 1400 may also have various positions and shapes of finger grips 1014, as shown in Figure 43K. These positions and shapes may also be used in other devices disclosed herein.

[0400] The embodiments shown in Figures 44A to 44D illustrate a motor-driven insertion device 1500 having a base 1503. A needle 1515 can be mounted on a needle carriage 1505. A needle carriage worm drive 1520 connected to the needle carriage 1505 moves the carriage along a gear housing 1517 (Figure 44B). Similarly, a catheter carriage 1510 is also connected to a catheter carriage worm drive 1525, which allows it to move along the gear housing 1517. A removable motor assembly 1530 includes three motors: a needle carriage motor 1535, a catheter carriage motor 1540, and an insertion angle motor 1545. The motor assembly 1530 can be fixed in place by a motor assembly lock 1550. The motor assembly 1530 can be removed to allow sterilization of the device 1500 without damaging the electronic components. Preferably, the motors are stepper motors.

[0401] The device 1500 may also have a linear position sensor 1560 for determining the position of the carriages (1505, 1510) and an angular position sensor 1565 for determining the angular position of the carriages (1505, 1510). As shown in Figure 44E, the sensors (1560 and 1565) may supply information to the processor 1555. A venous depth input device 1570 also provides the venous depth as input to the processor 1555. This input device 1570 may be a keyboard into which a medical professional manually inputs the venous depth. Alternatively, as another non-limiting example, the input device may be the ultrasound probe itself that directly reports the venous depth to the processor 1555. Other input devices may include, but are not limited to, a touchscreen, a mobile phone, or a microphone. The processor 1555 can then calculate the optimal insertion angle and insertion depth and provide appropriate instructions to the insertion angle motor 1545 and the needle carriage motor 1535. The processor may also angle down and advance the needle 1515 by instructing the insertion angle motor 1545 and the needle carriage motor 1535 after reaching the insertion depth. The catheter carriage motor 1540 can then be activated to insert the catheter into the needle.

[0402] Figures 45A to 45C illustrate in detail the improvements that may be used with the insertion device described above. The device 1600 has an elevated ultrasound probe mount 1605 that allows the ultrasound probe to be positioned away from the patient's skin. The sound-conducting material 1610 may be positioned below the elevated probe mount 1605, and a needle slit / wedge 1615 may be cut into the material 1610. The slit / wedge 1615 allows the needle 1620 to get closer to the ultrasound probe, which may make the width of the device 1600 smaller and potentially more stable.

[0403] The use of sound-conducting material 1610 eliminates the need for topical gels, which are common in ultrasound practice. While commonly used gels provide good sound conduction for reliable ultrasound readings, they can enter the patient's body and cause irritation as the needle passes through them during insertion. The sound-conducting pad of material 1610 fulfills the function of improving sound conduction, and the slit / wedge 1615 allows the needle to penetrate the patient's skin without encountering a foreign object. The sound-conducting pad 1610 may or may not have the slit / wedge 1615. The sound-conducting pad and elevated ultrasound probe mount 1605 of material 1610 can be used in all insertion devices described herein.

[0404] Figures 46A–46F show a segmented robotic snake 1700 having an ultrasound probe segment 1710 and a needle insertion segment 1715. The snake consists of multiple segments 1705, each segment being able to move relative to the segment 1705 to which it is attached. The movement is driven by an electronic motor within the segment 1705. As shown in Figure 46A, the robotic snake 1700 wraps around the injection target area of ​​the patient 1725. The head segment 1720 includes multiple sensors such as a thermometer, projector, video camera, infrared sensor, and vein scanner. The head segment 1720 may also include a scalpel and other cutting instruments. The needle insertion segment 1715 may be part of the head segment 1720 or may be a separate segment. The robotic snake 1700 maneuvers itself so that the ultrasound probe segment 1710 makes contact with the patient's skin to identify a target (such as a vein). Once a target is found, the robotic snake 1700 maneuvers its head segment 1720 toward the ultrasound probe segment 1710 (Figures 46B and 46C). A motor-driven version of the insertion device discussed above may be attached to the head segment 1520 or provided on another needle insertion segment 1715. The head segment 1720 connects to the ultrasound probe segment 1710 to stabilize the position of the robotic snake 1700 on the patient 1725 (see Figures 46D–46F). This connection is shown as a peg and hole 1735. At this stage, the ultrasound probe segment 1710 may guide the needle insertion segment 1715 to enter the target accurately and precisely. The needle insertion segment 1715 may have a disinfectant spray nozzle 1730 for spraying disinfectant onto the injection area to keep the procedure sterile.

[0405] Figures 47A–47E show another embodiment of the needle insertion device 1800 having an angled down arch 1816. Similar to the previous embodiment, the device 1800 has a base 1802 with a depth cam 1814 having a periphery constructed to correlate the needle insertion angle 1832 with the insertion depth, the periphery stopping the needle carriage at a desired depth. The base 1802 further includes an arm receiver 1810. A swing arm 1808 is attached to the arm receiver 1810 and moves relative to the arm receiver along a track 1426.2 (see Figures 43C1–43C3) to form a needle insertion angle 1832 between the swing arm 1808 and the base 1802. The swing arm 1808 is movable as indicated by arrow 1808.1, thereby changing the needle insertion angle 1832. It should be noted that, because a track system is used, the movement of the swing arm 1808 can be oval, elliptical, or linear relative to the base 1802.

[0406] The needle carriage 1812 is slidably mounted on the swing arm 1808 and is movable as indicated by arrow 1812.1. The needle carriage 1812 includes a needle insertion stopper 1809 that abuts against the periphery of the depth cam 1814 to limit the sliding movement 1812.1 of the needle carriage 1812 on the swing arm 1808. The needle carriage 1812 also has an angled down arch slot 1818. The arch 1816 also has a needle mount 1813 that holds the needle 1825 and catheter 1826. The needle mount 1813 may have a negative shape 1813.1 for the needle / catheter for a secure connection. Other mounting structures may be used, but may include, clamps, ties, and adhesives. The arch 1816 slides through the angle-down arch slot 1818 and is movable as indicated by arrow 1816.1, thereby forming a catheter insertion angle 1834 between the needle mount 1813 and the base 1802 that is smaller than the needle insertion angle 1832. The radius of this arch 1816 is equal to the distance from the needle tip to the point where the needle is held in the needle holder. In other words, the angle-down arch 1816 is constructed such that the tip of the needle 1825 remains in the same position as the angle-down arch 1816 slides through the angle-down arch slot 1818. Therefore, the needle tip is always at the center of the radius and does not move, so the needle tip does not slip out of the vein when the needle is angled down.

[0407] As described above, when inserting a syringe using the apparatus of this disclosure, the needle tip puncturing the vein is sufficient to allow a healthcare professional to then inject a solution into that vein. However, when the needle is used as a catheter after puncturing the vein, the needle must be “angled down and advanced” to prevent the catheter from completely penetrating the vein as it advances along the needle. Furthermore, this angle-down technique allows a healthcare professional to tape the catheter to the patient's skin to prevent unintended movement. The angle-down arch 1816 moves relative to the swing arm 1808 in the direction indicated by arrow 1816.1. This movement reduces the catheter insertion angle 1834, allowing the catheter 1826 to be inserted into the vein without puncturing the opposite side of the vein. The arch 1816 guides the needle completely from the start (needle puncture to the center of the vein) to the end (catheter advancement along the needle). The arch 1816 prevents the needle from dislodging due to excessive / insufficient angle-down or lateral displacement by the user. This arch is specific to a particular needle length. The arch radius is the same as the distance from the needle tip to the needle attachment point on the needle holder, and it maintains the needle tip at the center of the arch even when the arch rotates and is angled down. Therefore, regardless of the insertion depth, the needle tip is always centered on the vein when the needle is angled down.

[0408] The needle carriage 1812 may have an arch lock 1820 that engages with a lock receiver hole 1822 on the angle-down arch 1816. Other locking structures may be used, but are not limited to, clips, levers, latches, and clamps. The lock 1820 prevents movement of the arch 1816, thereby preventing the arch 1816 from changing the insertion angle 1832 while the needle 1825 is being inserted. Once needle insertion is complete, the lock 1820 is released, and the insertion angle can be angled down for catheter insertion. An arch operating structure 1830, such as a hole, an orthogonal ring attachment, or a handle, may be used to slide the arch 1816 along the slit 1818.

[0409] Figures 48A to 48D show another embodiment of the needle insertion device 1900 having an angle-down arch 1816 similar to the embodiment shown in Figure 47A. However, this embodiment 1900 has several improvements that automate it. The angle-down arch 1816 has teeth 1918 that engage with a pre-tension pinion 1932 on the needle carriage 1812. When the lock is released, a spring 1934 contracts, pulling the needle carriage 1812 along the swing arm 1808 until the needle insertion stopper 1809 contacts the depth cam 1814. Then, a release spear 1930 retracts and contacts the latch 1931, releasing the latch 1931 from the pre-tension pinion 1932. The pinion 1932 rotates in the direction of arrow 1932.1, automatically driving the angle-down arch 1816 along the angle-down arch slot 1818 until it reaches the catheter insertion angle 1834. The device may have, instead of, or in addition to, the pre-tension pinion 1932, an arch spring 1933 that automatically drives the arch 1816 along the angle-down arch slot 1818 until it contracts and reaches a catheter insertion angle 1834, as shown in Figure 48D.

[0410] The device 1900 also has an automatic needle / catheter mount 1913, which is shown in detail in Figures 49A to 49F. Figure 49A shows a cross-section of the automatic needle / catheter mount 1913, which has a catheter spring 1940 connected to a catheter 1826 and a needle spring 1942 connected to a needle 1825. A spring trigger 1944 maintains both springs in a compressed state in the non-triggered state shown in Figures 49A and 49D. The spring trigger 1944 has a catheter spring window 1941 and a needle spring window 1943, which are shown in Figures 49B and 49C. Above the catheter spring window 1941 is a needle slot 1946, which allows the needle 1825 to move during the transition to the triggered state. Figure 49D shows the connection of the automatic needle / catheter mount 1913 to an angled down arch 1816. Figure 49E shows the movement of the spring trigger 1944, indicated by arrow 1944.1. Both springs also move and slide along the spring support 1948. When the spring trigger 1944 aligns the catheter spring 1940 with the catheter spring window 1941, the catheter spring 1940 is released (arrow 1940.1) and applies an insertion force to the catheter 1826. The movement of the spring trigger 1944 also aligns the needle spring 1942 with the needle spring window 1943, and the needle spring 1942 is released (arrow 1942.1) and applies an extraction force to the needle 1825. It is preferable to configure the window so that the catheter spring 1940 is triggered before the needle spring 1942. Also, setting the tension of the needle spring 1942 lower than that of the catheter spring 1940 may allow the catheter 1826 to slide over the needle 1825 and be placed in the vein before the needle 1825 retracts. Adding friction to the needle spring 1942 by a track, or adding a damper to delay the release of the compression of the needle spring 1942, may assist in this ordered insertion and retraction.

[0411] Figure 49G shows how the pre-tension pinion 1932 works with the automatic needle / catheter mount 1913 to insert the catheter 1826 and withdraw the needle 1825. Once the healthcare professional identifies the target depth using ultrasound, they rotate the depth selection pinion 1430 to the appropriate depth. The needle carriage lock 1820, which may be a pin, clip, lever, switch, etc., is released, and the spring 1934 contracts, pulling the needle carriage 1812 along the swing arm 1808 until the needle insertion stopper 1809 strikes the depth cam 1814. At this point, the release spear 1930 retracts and strikes the latch 1931, releasing the pre-tension pinion 1932. The pre-tension pinion 1932 then rotates in the direction of arrow 1932.1, propelling the angle-down arch 1816 along the angle-down arch slot 1818. The spring trigger 1944 is activated by contact with the base 1802, pushing the spring trigger 1944 in the direction of arrow 1944.1. This movement aligns the catheter spring 1940 and the needle spring 1942 to their respective windows, allowing the compression of both springs to be released, thereby applying an insertion force to the catheter 1826 and an extraction force to the needle 1825, respectively. Thus, all the medical professional has to do is dial in the target depth and release the pin, while the insertion device 1900 does everything else.

[0412] The angled down arch 1816, pre-tension pinion 1932, and spring 1934, along with other automation features described above, can be used in conjunction with the previous embodiments to automate the process and facilitate accurate and repeatable catheter insertion.

[0413] Examples of Embodiments The following are non-limiting examples relating to specific embodiments of this technology.

[0414] A1. Needle insertion device (1000, 1100), A base (1010, 1110) having a base rack (1065, 1165) and defining an insertion area (1007), Upper assembly (1030, 1130), The upper assembly main support (1060, 1160) is slidably connected to the base (1010, 1110), A needle carriage assembly (1046) configured to hold needles (1005, 1105), slidably connected to the upper assembly main support (1060, 1160), and including needle racks (1047, 1147), An upper assembly (1030, 1130) comprising, Operating structure (1025, 1125), Base rack pinions (1067, 1167) that engage with the base rack (1065, 1165), Needle rack and pinion (1048, 1148) that mesh with the aforementioned needle rack (1047, 1147), Mechanically connected to both are the operating structure (1025, 1125) and In the inserted state, by operating the aforementioned operating structures (1025, 1125), (1) The needle rack and pinion (1048, 1148) rotates and moves the needle carriage assembly (1046) toward the insertion area (1007), (2) The base rack and pinion (1067, 1167) rotates, moving the upper assembly main support (1060, 1160) away from the insertion area (1007). Needle insertion device (1000, 1100).

[0415] A2. The needle insertion device of Embodiment A1, further comprising a depth setting state, wherein the operating structure (1025, 1125) is activated by rotating the following: (1) The needle rack and pinion (1048, 1148) rotates, moving the needle carriage assembly (1046) away from the insertion area (1007), (2) The base rack and pinion (1067, 1167) rotates, moving the upper assembly main support (1060, 1160) toward the insertion region (1007). Needle insertion device.

[0416] A3. A needle insertion device according to Embodiment A1, further comprising needle depth gauges (1015, 1115) and depth indicators (1020, 1120), wherein the depth setting state is maintained until the depth indicators (1020, 1120) are aligned to a desired depth on the needle depth gauges (1015, 1115).

[0417] A4. A needle insertion device according to Embodiment A3, wherein the needle depth gauges (1015, 1115) and the depth indicators (1020, 1120) are part of the upper assembly (1030, 1130).

[0418] A5. A needle insertion device according to Embodiment A3, wherein the needle depth gauges (1015, 1115) are part of the base (1010, 1110).

[0419] A6. A needle insertion device according to any one of embodiments A1 to A5, wherein the base (1010, 1110, 1203, 1305) includes an ultrasonic mount (1012).

[0420] A7. A needle insertion device according to Embodiment A6, wherein the ultrasonic mount (1012) is connected to the base (1010, 1110, 1203, 1305) via a pin (1335), a magnet (1338), a clamp, or a clip.

[0421] A8. A needle insertion device according to any one of embodiments A1 to A6, wherein the base (1010, 1110, 1203, 1305) includes at least one finger grip (1014).

[0422] A9. A needle insertion device according to any one of embodiments A1 to A8, wherein the operating structure (1025, 1125), the base rack and pinion (1067, 1167), and the needle rack and pinion (1048, 1148) are part of the upper assembly (1030, 1130).

[0423] A10. A needle insertion device according to any one of embodiments A1 to A9, wherein the needle carriage assembly (1046) includes a needle carriage (1040) slidably connected to a needle rack support (1045).

[0424] A11. A needle insertion device according to embodiment A10, further comprising a lock screw (1055) for fixing the needle carriage (1040) to the needle rack support (1045).

[0425] A12. A needle insertion device according to any one of embodiments A1 to A11, wherein the base includes (1) a groove (1062) on which the upper assembly (1030, 1130) slides, or (2) a rail on which the upper assembly (1030, 1130) slides.

[0426] A13. A needle insertion device in any one of embodiments A1 to A12, wherein the upper assembly (1130) further comprises An angled down needle carriage (1149) configured to hold the needles (1005, 1105), An angle-down multi-channel guide (1170) including multiple channels (1185), Equipped with, A needle insertion device wherein the angle-down needle carriage (1149) is configured to travel along one of the plurality of channels (1185) that define a portion (1170A) of the angle-down needle carriage path (1180).

[0427] A14. A needle insertion device according to embodiment A13, wherein each of the plurality of channels (1185) is associated with a needle depth.

[0428] A15. A needle insertion device according to embodiment A13, comprising a central channel guide (1175) having a central channel that forms part of the angle-down needle carriage path (1180).

[0429] A16. A needle insertion device according to Embodiment A15, comprising a central channel guide (1175) that holds the angle-down needle carriage (1149) relative to the needle carriage assembly (1046) while in the insertion state.

[0430] A17. A needle insertion device according to Embodiment A15, wherein the central channel guide (1175) includes a latch receiver (1150) and a release latch (1144), the release latch (1144) preventing the angle-down needle carriage (1149) from traveling along the angle-down needle carriage path (1180) when the release latch (1144) is engaged with the latch receiver (1150).

[0431] A18. A needle insertion device according to embodiment A17, comprising a release button (1142) configured to disengage the release latch (1144) from the latch receiver (1150) when activated.

[0432] A19. A needle insertion device according to embodiment A13, comprising an angle-down gear (1172) configured to rotate the angle-down multi-channel guide (1170) while the needle is inserted.

[0433] A20. A needle insertion device according to Embodiment A13, wherein during the insertion state, the needles (1005, 1105) are at an angle with respect to the base (1010, 1110), and the device includes an angle-down state after the insertion state, wherein in the angle-down state, the angle-down needle carriage (1149) is pushed along the angle-down needle carriage path (1180), and the angle it makes with respect to the base (1010, 1110) is reduced.

[0434] A21. A needle insertion device according to Embodiment A6, comprising a sound conduction pad (1610) positioned below the ultrasonic mount (1012).

[0435] A22. A needle insertion device according to embodiment A21, comprising a needle insertion slit (1615) formed in the sound conduction pad (1610).

[0436] A23. A needle insertion device according to Embodiment A6, wherein the base (1010, 1110) includes a first ultrasonic window (1325A) having a first orientation and a second ultrasonic window (1325B) having a second orientation, and the ultrasonic mount (1012) can be connected to the base to conform to the first and second orientations.

[0437] A24. A needle insertion device according to any one of embodiments A1 to A23, wherein the main support (1060, 1160) forms a fixed angle with respect to the base (1010, 1110).

[0438] A25. A needle insertion device according to any one of embodiments A1 to A23, comprising a sterile bag (162) attached to the base (1010, 1110) and configured to enclose an ultrasonic probe.

[0439] A26. A needle insertion device according to Embodiment A24, comprising a handle (164) connected to the sterile bag (162), wherein the handle (164) includes an access hole (165) providing access to the inside of the sterile bag (162), and the access hole (165) is configured to allow an ultrasonic probe to pass through.

[0440] B1. Needle insertion device (1200), Base (1203) and, A needle carriage multichannel guide (1230) extending away from the base (1203), An insertion needle carriage channel (1230.4) having a venous depth stopper (1230.2), wherein the position of the venous depth stopper (1230.2) within the insertion needle carriage channel (1230.4) is adjustable, and the insertion needle carriage channel (1230) defines an insertion angle (1245) with respect to the base (1203), A plurality of angle-down needle carriage channels (1230.5), each of which is connected to and continuous with the insertion needle carriage channel (1230.4), A needle carriage multichannel guide (1230) equipped with, A needle carriage (1207) includes a needle carriage guide (1207.2) configured to hold needles (1205, 1210) and to allow the needle carriage (1207) to slide along the insertion needle carriage channel (1230.4) and the plurality of angle-down needle carriage channels (1230.5), Equipped with, Needle insertion device (1200).

[0441] B2. A needle insertion device according to Embodiment B1, further comprising an insertion state in which the needle carriage (1207) slides along the insertion needle carriage channel (1230.4) until the needle carriage guide (1207.2) contacts the venous depth stopper (1230.2).

[0442] B3. A needle insertion device according to Embodiment B2, wherein, after the insertion state, (1) the needle carriage (1207) slides along one of the plurality of angle-down needle carriage channels (1230.5), and (2) the needles (1205, 1210) further comprises an angle-down state in which a reduction angle (1250) is defined with respect to the base (1203), and the reduction angle (1250) is smaller than the insertion angle (1245).

[0443] B4. One of the needle insertion devices of Embodiments B1 to B3, The needle carriage multichannel guide (1230) includes a venous depth gauge (1230.1), A needle insertion device in which the venous depth stopper (1230.2) includes depth indicators (1020, 1120).

[0444] B5. A needle insertion device according to any one of embodiments B1 to B4, wherein the base includes an ultrasonic mount (1012).

[0445] B6. A needle insertion device according to Embodiment B5, wherein the ultrasonic mount (1012) is connected to the base via a pin (1335) or a magnet (1338).

[0446] B7. A needle insertion device according to Embodiment B5, comprising a sound conduction pad (1610) positioned below the ultrasonic mount (1012).

[0447] B8. A needle insertion device according to Embodiment B7, comprising a needle insertion slit (1615) formed in the sound conduction pad (1610).

[0448] B9. The needle insertion device of Embodiment B5, The base includes a first ultrasonic window (1325A) having a first orientation and a second ultrasonic window (1325B) having a second orientation. A needle insertion device in which the ultrasonic mount (1012) can be connected to the base to conform to the first orientation and the second orientation.

[0449] B10. A needle insertion device according to any one of embodiments B1 to B9, wherein the base includes at least one finger grip (1014).

[0450] B11. A needle insertion device according to any one of embodiments B1 to B10, wherein the plurality of angle-down needle carriage channels (1230.5) include at least three channels.

[0451] B12. A needle insertion device according to any one of embodiments B1 to B11, comprising a sterile bag (162) attached to a base (1405) and configured to enclose an ultrasonic probe.

[0452] B13. A needle insertion device according to Embodiment B12, comprising a handle (164) connected to the sterile bag (162), wherein the handle (164) includes an access hole (165) providing access to the inside of the sterile bag (162), and the access hole (165) is configured to allow an ultrasonic probe to pass through.

[0453] C1. Needle insertion device (1300), Base (1305) including needle anchor point (1345), A multi-channel guide card (1310) extending away from the base (1305), comprising a plurality of channels, each of which defines an insertion angle relative to the base (1305) and has a needle insertion portion that conforms to the needle insertion depth, wherein the insertion angle and insertion depth are different from those of the other channels among the plurality of channels, A needle carriage (1315) configured to hold a needle (1302), and including a needle carriage guide (1350.2) configured to allow the needle carriage to slide along any of the multiple channels on the multi-channel guide card (1310), Equipped with, A needle insertion device in which the needle anchor point (1345) is configured to contact the needle (1302) during insertion to stabilize the needle (1302).

[0454] C2. A needle insertion device according to Embodiment C1, wherein each of the plurality of channels includes a needle loading section (1352) and a needle insertion section (1355).

[0455] C3. A needle insertion device according to Embodiment C1, wherein each of the plurality of channels includes a needle loading section (1352), a needle insertion section (1355), and an angle-down section (1360).

[0456] C4. A needle insertion device according to Embodiment C1, wherein each of the plurality of channels includes a needle loading section (1352), a needle insertion section (1355), an angle-down section (1360), and a forward section (1365).

[0457] C5. A needle insertion device according to any one of embodiments C1 to C4, wherein the base includes an ultrasonic mount (1012).

[0458] C6. A needle insertion device according to Embodiment C5, wherein the ultrasonic mount (1012) is connected to the base via a pin (1335) or a magnet (1338).

[0459] C7. A needle insertion device according to embodiment C5, further comprising a sound conduction pad (1610) disposed below the ultrasonic mount (1012).

[0460] C8. A needle insertion device according to embodiment C7, further comprising a needle insertion slit (1615) formed in the sound conduction pad (1610).

[0461] C9. A needle insertion device according to Embodiment C5, wherein the base includes a first ultrasonic window (1325A) having a first orientation and a second ultrasonic window (1325B) having a second orientation, and the ultrasonic mount (1012) can be connected to the base to conform to the first and second orientations.

[0462] C10. A needle insertion device according to any one of embodiments C1 to C9, wherein the base includes at least one finger grip (1014).

[0463] C11. A needle insertion device according to any one of embodiments C1 to C10, wherein the plurality of channels includes at least three channels.

[0464] C12. A needle insertion device according to any one of embodiments C1 to C11, comprising a sterile bag (162) attached to the base (1305) and configured to enclose an ultrasonic probe.

[0465] C13. A needle insertion device according to Embodiment C12, comprising a handle (164) connected to the sterile bag (162), wherein the handle (164) includes an access hole (165) providing access to the interior of the sterile bag (162), and the access hole (165) is configured to allow an ultrasonic probe to pass through.

[0466] D1. Needle insertion device (1400), The base (1405) A depth cam (1410) having a periphery configured to correlate the insertion angle with the insertion depth, Arm receiver (1426.1) including track (1426.2), It is equipped with a base (1405) and Swingarm assembly (1427), A swing arm interface (1426.3) is slidably connected to the track (1426.2) and configured to move along the track (1426.2), A needle carriage (1435, 1465) configured to hold a needle (1437), the needle carriage (1435, 1465) being slidably mounted on a slide arm (1480), A depth-selection pinion (1430) configured to move along the arm receiver (1426.1) to change the insertion angle, A needle insertion stopper (1440, 1475) is configured to contact the periphery of the depth cam (1410) and restrict the sliding movement of the needle carriage (1435, 1465) on the slide arm (1480), A swingarm assembly (1427) equipped with, A needle insertion device equipped with the following features.

[0467] D2. A needle insertion device according to Embodiment D1, wherein the needle carriage (1435, 1465) includes a needle holder (1432).

[0468] D3. A needle insertion device according to Embodiment D2, wherein the needle holder (1432) is selected from the group consisting of a self-centering polymer, a drill chuck, or a tapered key.

[0469] D4. A needle insertion device according to any one of embodiments D1 to D3, wherein the depth cam (1410) includes a plurality of anti-slip structures (1415).

[0470] D5. A needle insertion device according to any one of embodiments D1 to D4, wherein the needle carriage (1435, 1465) includes a needle hole stabilizer and / or a channel stabilizer (1467).

[0471] D6. A needle insertion device according to any one of embodiments D1 to D5, wherein the needle carriage (1470) is suitable for a needle without a catheter.

[0472] D7. A needle insertion device according to any one of embodiments D1 to D5, wherein the needle carriage (1470) is fitted to a needle having a catheter.

[0473] D8. A needle insertion device according to any one of embodiments D1 to D7, wherein the needle carriage (1465) is adapted to a specific needle length.

[0474] D9. A needle insertion device according to any one of embodiments D1 to D7, wherein the needle insertion stopper (1440) is adjustable and the needle carriage (1435) is compatible with a plurality of needle lengths.

[0475] D10. A needle insertion device according to any one of embodiments D1 to D9, wherein the base includes an ultrasonic mount (1012).

[0476] D11. A needle insertion device according to embodiment D10, wherein the ultrasonic mount (1012) is connected to the base via a pin (1335) or a magnet (1338).

[0477] D12. A needle insertion device according to embodiment D11, further comprising a sound conduction pad (1610) disposed below the ultrasonic mount (1012).

[0478] D13. A needle insertion device according to embodiment D12, further comprising a needle insertion slit (1615) formed in the sound conduction pad (1610).

[0479] D14. A needle insertion device according to Embodiment D10, wherein the base includes a first ultrasonic window (1325A) having a first orientation and a second ultrasonic window (1325B) having a second orientation, and the ultrasonic mount (1012) can be connected to the base to conform to the first and second orientations.

[0480] D15. A needle insertion device according to any one of embodiments D1 to D14, comprising a sterile bag (162) attached to the base (1405) and configured to enclose an ultrasonic probe.

[0481] D16. A needle insertion device according to Embodiment D15, comprising a handle (164) connected to the sterile bag (162), wherein the handle (164) includes an access hole (165) providing access to the inside of the sterile bag (162), and the access hole (165) is configured to allow an ultrasonic probe to pass through.

[0482] E1. Needle insertion device (1500), Base (1503), A gear housing (1517) pivotably mounted on the base (1503), the gear housing (1517) including a needle carriage worm drive (1520) and a catheter carriage worm drive (1525), A needle carriage (1505) configured to hold a needle (1515) and connected to the needle carriage worm drive (1520), A catheter carriage (1510) configured to hold a catheter and connected to the catheter carriage worm drive (1525), A detachable motor assembly (1530), A needle carriage motor (1535) is configured to rotate the needle carriage worm drive (1520), thereby moving the needle carriage (1505) along the gear housing (1517), A catheter motor (1540) is configured to rotate the catheter carriage worm drive (1525), thereby moving the catheter carriage (1510) along the gear housing (1517), An insertion angle motor (1545) configured to rotate the gear housing (1517) relative to the base (1503), A detachable motor assembly (1530) equipped with, A needle insertion device equipped with the following features.

[0483] E2. A needle insertion device according to Embodiment E1, The system comprises a processor (1555) connected to the needle carriage motor (1535), the catheter motor (1540), and the insertion angle motor (1545), wherein the processor (1555) a. A step of calculating the insertion angle and insertion depth for the assigned venous depth or assigned target depth, b. A step of operating the insertion angle motor (1545) based on the calculation in step (a), c. A step of operating the needle carriage motor (1535) based on the calculations of step (a), A needle insertion device programmed to perform the following action.

[0484] E3. A needle insertion device according to Embodiment E2, wherein the processor (1555) is additionally d. A step of determining that the venous depth or target depth has been reached, e. A step of operating the insertion angle motor (1545) in order to reduce the insertion angle, A needle insertion device programmed to perform the following action.

[0485] E4. A needle insertion device according to Embodiment E2, wherein the assigned venous depth or target depth is transmitted to the processor (1555) via a depth input device (1570).

[0486] E5. A needle insertion device according to Embodiment E3, wherein the depth input device (1570) is an ultrasonic probe, a keyboard, a touchscreen, a mobile phone, or a microphone.

[0487] E6. A needle insertion device according to Embodiment E1, A linear position sensor (1560) configured to detect the positions of the needle carriage (1505) and the catheter carriage (1510), An angular position sensor (1565) configured to detect the position of the gear housing (1517) relative to the base (1503), A needle insertion device that also includes the following features.

[0488] E7. A needle insertion device according to Embodiment E5, The system comprises a needle carriage motor (1535), a catheter motor (1540), an insertion angle motor (1545), a linear position sensor (1560), and a processor (1555) connected to the angular position sensor (1565). The aforementioned processor (1555) a. A step of calculating the insertion angle and insertion depth for the assigned venous depth or assigned target depth, b. A step of determining the position of the gear housing (1517) relative to the base (1503) using the angle position sensor (1565), c. A step of determining the positions of the needle carriage (1505) and the catheter carriage (1510) using the linear position sensor (1560), d. A step of operating the insertion angle motor (1545) based on the calculation of step (a) and the identification of step (b), e. A step of operating the needle carriage motor (1535) based on the calculation of step (a) and the identification of step (c), A needle insertion device programmed to perform the following action.

[0489] E8. A needle insertion device according to embodiment E5, wherein the processor (1555) is f. A step of determining that the vein depth or the target depth has been reached, g. A step of operating the insertion angle motor (1545) in order to reduce the insertion angle, A needle insertion device programmed to perform the following action.

[0490] E9. A needle insertion device according to Embodiment E7, wherein the assigned venous depth or target depth is transmitted to the processor (1555) via a depth input device (1570).

[0491] E10. A needle insertion device according to Embodiment E9, wherein the depth input device (1570) is an ultrasonic probe, a keyboard, a touchscreen, a mobile phone, or a microphone.

[0492] E11. A needle insertion device according to any one of embodiments E1 to E10, wherein the base includes an ultrasonic mount (1012).

[0493] E12. A needle insertion device according to Embodiment E11, wherein the ultrasonic mount (1012) is connected to the base via a pin (1335) or a magnet (1338).

[0494] E13. A needle insertion device according to embodiment E12, further comprising a sound conduction pad (1610) disposed below the ultrasonic mount (1012).

[0495] E14. A needle insertion device according to embodiment E13, further comprising a needle insertion slit (1615) formed in the sound conduction pad (1610).

[0496] E15. A needle insertion device according to Embodiment E11, wherein the base includes a first ultrasonic window (1325A) having a first orientation and a second ultrasonic window (1325B) having a second orientation, and the ultrasonic mount (1012) can be connected to the base to conform to the first and second orientations.

[0497] E16. A needle insertion device according to any one of embodiments E1 to E15, wherein the needle carriage motor (1540) is oriented in a direction perpendicular to the needle carriage motor (1540).

[0498] E17. A needle insertion device according to any one of embodiments E1 to E16, comprising a sterile bag (162) attached to the base (1503) and configured to enclose an ultrasonic probe.

[0499] E18. A needle insertion device according to Embodiment E17, comprising a handle (164) connected to the sterile bag (162), wherein the handle (164) includes an access hole (165) providing access to the interior of the sterile bag (162), and the access hole (165) is configured to allow an ultrasonic probe to pass through.

[0500] F1. Needle insertion device (1400), The base (1405) A depth cam (1410) having a periphery configured to correlate the insertion angle with the insertion depth, Arm receiver (1426.1) including track (1426.2), It is equipped with a base (1405) and Swingarm assembly (1427), A swing arm interface (1426.3) is slidably connected to the track (1426.2) and configured to move along the track (1426.2), A needle carriage (1435, 1465) configured to hold a needle (1437), the needle carriage (1435, 1465) being slidably mounted on a slide arm (1480), A depth-selection pinion (1430) is configured to mesh with an angular position rack (1425) and change the insertion angle, Needle insertion stoppers (1440, 1475) are configured to contact the periphery of the depth cam (1410) and to restrict the sliding movement of the needle carriage (1435, 1465) on the slide arm (1480), A swingarm assembly (1427) is provided, A needle insertion device (1400) equipped with the following.

[0501] F2. A needle insertion device according to embodiment F1, wherein the depth cam (1410) includes a plurality of anti-slip structures (1415).

[0502] F3. A needle insertion device according to Embodiment F1, wherein the needle carriage (1435, 1465) includes a needle holder (1432).

[0503] F4. A needle insertion device according to embodiment F3, wherein the needle holder (1432) is selected from the group consisting of a self-centering polymer, a drill chuck, or a tapered key.

[0504] F5. A needle insertion device according to Embodiment F1, wherein the needle carriage (1435, 1465) includes a needle hole stabilizer and / or a channel stabilizer (1467).

[0505] F6. A needle insertion device according to Embodiment F1, wherein the needle carriage (1470) is suitable for a needle without a catheter.

[0506] F7. A needle insertion device according to Embodiment F1, wherein the needle carriage (1813) is compatible with a needle having a catheter.

[0507] F8. A needle insertion device according to Embodiment F7, wherein the needle carriage (1813) includes a negative shape (1813.1) of a needle having a catheter.

[0508] F9. A needle insertion device according to Embodiment F1, wherein the needle carriage (1465) is adapted to a specific needle length.

[0509] F10. A needle insertion device according to Embodiment F1, wherein the needle insertion stopper (1440) is adjustable and the needle carriage (1435) is accommodating multiple needle lengths.

[0510] F11. A needle insertion device according to Embodiment F1, wherein the base includes an ultrasonic mount (1012).

[0511] F12. A needle insertion device according to embodiment F11, wherein the ultrasonic mount (1012) is connected to the base via a pin (1335), a magnet (1338), a clip or a clamp.

[0512] F13. A needle insertion device according to embodiment F11, further comprising a sound conduction pad (1610) disposed below the ultrasonic mount (1012).

[0513] F14. A needle insertion device according to embodiment F11, further comprising a needle insertion slit / wedge (1615) formed in the sound conduction pad (1610).

[0514] F15. A needle insertion device according to Embodiment F11, wherein the base includes a first ultrasonic window (1325A) having a first orientation and a second ultrasonic window (1325B) having a second orientation, and the ultrasonic mount (1012) can be connected to the base to conform to the first and second orientations.

[0515] F16. A needle insertion device according to Embodiment F1, comprising a sterile bag (162) attached to the base (1405) and configured to enclose an ultrasonic probe.

[0516] F17. A needle insertion device according to Embodiment F16, comprising a handle (164) connected to the sterile bag (162), wherein the handle (164) includes an access hole (165) providing access to the inside of the sterile bag (162), and the access hole (165) is configured to allow an ultrasonic probe to pass through.

[0517] G1. Needle insertion device (1800, 1900), Base (1802), A depth cam (1814) having a periphery configured to correlate the needle insertion angle (1832) with the insertion depth, Arm receiver (1810), A base (1802) equipped with, A swing arm (1808) is pivotably or slidably mounted to the arm receiver (1810), and the swing arm (1808) and the base (1802) form the needle insertion angle (1832), A needle carriage (1812) is slidably mounted on the swing arm (1808), A needle insertion stopper (1809) is configured to contact the periphery of the depth cam (1814) and to restrict the sliding movement of the needle carriage (1812) on the swing arm (1808), Angle-down arch slot (1818), Including the needle carriage (1812), An angle-down arch (1816) slidably disposed within the angle-down arch slot (1818), comprising needle mounts (1813, 1913) for holding a needle (1825) and a catheter (1826), and sliding through the angle-down arch slot (1818) to form a catheter insertion angle (1834) between the needle mount (1813) and the base (1802) that is smaller than the needle insertion angle (1832), and A needle insertion device equipped with the following features.

[0518] G2. A needle insertion device according to Embodiment G1, wherein the angle-down arch (1816) is configured such that the tip of the needle (1825) remains in the same position when the angle-down arch (1816) slides through the angle-down arch slot (1818).

[0519] G3. A needle insertion device according to Embodiment G1, wherein the base (1802) includes an ultrasonic mount (1804).

[0520] G4. A needle insertion device according to Embodiment G3, wherein the ultrasonic mount (1804) is connected to the base (1802) via a pin (1335) or a magnet (1338).

[0521] G5. A needle insertion device according to embodiment G3, further comprising a sound conduction pad (1610) disposed below the ultrasonic mount (1012).

[0522] G6. A needle insertion device according to embodiment G5, further comprising a needle insertion slit (1615) formed in the sound conduction pad (1610).

[0523] G7. A needle insertion device according to Embodiment G1, comprising a sterile bag (162) attached to the base (1802) and configured to enclose an ultrasonic probe.

[0524] G8. A needle insertion device according to Embodiment G7, comprising a handle (164) connected to the sterile bag (162), wherein the handle (164) includes an access hole (165) providing access to the inside of the sterile bag (162), and the access hole (165) is configured to allow an ultrasonic probe to pass through.

[0525] G9. A needle insertion device according to Embodiment G1, wherein the needle carriage (1812) includes an arch lock (1820) configured to prevent the angle-down arch (1816) from sliding relative to the needle carriage (1812).

[0526] G10. A needle insertion device according to Embodiment G1, wherein the angle-down arch (1816) includes an arch operating structure (1830).

[0527] G11. A needle insertion device according to Embodiment G1, wherein the needle carriage (1812) includes a pre-tension pinion (1932) configured to propel the angle-down arch (1816) through the angle-down arch slot (1818).

[0528] G12. A needle insertion device according to Embodiment G1, further comprising an arch spring (1933) configured to connect the angle-down arch (1816) to the needle carriage (1812) and to propel the angle-down arch (1816) through the angle-down arch slot (1818).

[0529] G13. A needle insertion device according to Embodiment G1, wherein the needle mount (1913) is A catheter spring (1940) connected to the catheter (1826), The needle spring (1942) connected to the aforementioned needle (1825), Spring trigger (1944), Includes, The aforementioned needle mount (1913) In a non-triggered state, the spring trigger (1944) holds both the catheter spring (1940) and the needle spring (1942) in a compressed state. The spring trigger (1944) is activated, releasing both the catheter spring (1940) and the needle spring (1942) from their compressed state, thereby creating a triggered state in which (1) the catheter spring (1940) applies an insertion force to the catheter (1826), and (2) the needle spring (1942) applies an extraction force to the needle (1925). It has two states, Needle insertion device.

[0530] G14. A needle insertion device according to embodiment G13, wherein the spring trigger (1944) is activated when it comes into contact with the base (1802).

[0531] G15. A needle insertion device according to embodiment G13, wherein the spring trigger (1944) is activated when the needle mount (1913) reaches the catheter insertion angle (1834).

[0532] H1. Needle insertion device (1800, 1900), A base (1802) including a base insert receiver (1407.1), Multiple probe mount inserts (1408.1~1408.4), Each includes a slot configured to hold an ultrasound probe, The dimensions of each of the aforementioned slots are different from each other. Each is configured to fit into the base insert receiver (1407.1), Multiple probe mount inserts (1408.1~1408.4), The swing arm (1808) is attached to the base (1802) and forms a needle insertion angle (1832) between the swing arm (1808) and the base (1802), A needle carriage (1812) is slidably mounted on the swing arm (1808), A needle insertion device equipped with the following features.

[0533] H2. A needle insertion device according to Embodiment H1, wherein each of the plurality of probe mount inserts (1408.1 to 1408.4) is made of a rigid material.

[0534] H3. A needle insertion device according to Embodiment H1, wherein each of the plurality of probe mount inserts (1408.1 to 1408.4) is made of a flexible material.

[0535] H4. A needle insertion device according to Embodiment H1, The base includes a depth cam (1814) having a periphery configured to correlate the needle insertion angle (1832) with the insertion depth, A needle insertion device, comprising a needle insertion stopper (1809) configured to contact the periphery of the needle carriage (1812) with the depth cam (1814) to restrict the sliding movement of the needle carriage (1812) on the swing arm (1808).

[0536] H5. A needle insertion device according to Embodiment H4, wherein the needle carriage (1812) is adapted to a specific needle length.

[0537] H6. A needle insertion device according to Embodiment H4, wherein the needle insertion stopper (1809) is adjustable and the needle carriage (1812) is compatible with a plurality of needle lengths.

[0538] H7. A needle insertion device according to Embodiment H4, wherein the depth cam (1814) includes a plurality of anti-slip structures (1415).

[0539] H8. A needle insertion device according to Embodiment H4, wherein the needle carriage (1812) includes an angle-down arch slot (1818), the device comprises an angle-down arch (1816) slidably disposed within the angle-down arch slot (1818), the angle-down arch (1816) includes needle mounts (1813, 1913) for holding a needle (1825) and a catheter (1826), and the angle-down arch (1816) slides through the angle-down arch slot (1818) to form a catheter insertion angle (1834) between the needle mount (1813) and the base (1802) that is smaller than the needle insertion angle (1832).

[0540] H9. A needle insertion device according to Embodiment H1, The base (1802) includes an arm receiver (1426.1) having a track (1426.2), A needle insertion device comprising a swing arm interface (1426.3) configured to be slidably connected to the track (1426.2) and to move along the track (1426.2), wherein the swing arm (1808) is a swing arm interface (1426.3).

[0541] H10. A needle insertion device according to Embodiment H1, comprising a sterile bag (162) attached to the base (1802) and configured to enclose the ultrasonic probe.

[0542] H11. A needle insertion device according to Embodiment H10, comprising a handle (164) connected to the sterile bag (162), wherein the handle (164) includes an access hole (165) that provides access to the inside of the sterile bag (162), and the access hole (165) is configured to allow an ultrasonic probe to pass through.

[0543] H12. A needle insertion device according to Embodiment H1, wherein the probe mount insert includes a needle insertion slit (1615) formed in a sound conduction pad (1610).

[0544] H13. A needle insertion device according to Embodiment H1, comprising a sound conduction pad (1610) positioned below the plurality of probe mount inserts (1408.1 to 1408.4).

[0545] H14. A needle insertion device according to Embodiment H13, comprising a needle insertion slit (1615) formed in the sound conduction pad (1610).

[0546] The above-disclosed descriptions of the embodiments are provided to enable those skilled in the art to manufacture or use the invention. Various modifications to these embodiments are readily apparent to those skilled in the art, and the general principles described herein can be applied to other embodiments without departing from the spirit or scope of the invention. Accordingly, the descriptions and drawings presented herein should be understood to represent preferred embodiments of the invention at present and thus representative of the subject matter broadly intended by the invention. Furthermore, the scope of the invention fully encompasses other embodiments that may become apparent to those skilled in the art, and it should be understood that the scope of the invention is not limited by anything other than the appended claims.

Claims

1. The base (1405) A depth cam (1410) having a periphery configured to correlate the insertion angle with the insertion depth, An arm receiver (1426.1) including a track (1426.2), A base (1405) equipped with, A swingarm assembly (1427), A swing arm interface (1426.3) is slidably connected to the track (1426.2) and configured to move along the track (1426.2), A needle carriage (1435, 1465) configured to hold a needle (1437), the needle carriage (1435, 1465) being slidably mounted on a slide arm (1480), A depth-selection pinion (1430) is configured to mesh with an angular position rack (1425) and change the insertion angle, Needle insertion stoppers (1440, 1475) are configured to contact the periphery of the depth cam (1410) and to restrict the sliding movement of the needle carriages (1435, 1465) on the slide arm (1480), A swingarm assembly (1427) comprising, A needle insertion device (1400) equipped with the following.

2. The depth cam (1410) includes a plurality of anti-slip structures (1415), A needle insertion device according to claim 1.

3. The needle carriage (1435, 1465) includes a needle holder (1432). A needle insertion device according to claim 1.

4. The needle holder (1432) is selected from the group consisting of a self-centering polymer, a drill chuck, or a tapered key. The needle insertion device according to claim 3.

5. The needle carriage (1435, 1465) includes a needle hole stabilizer and / or a channel stabilizer (1467), A needle insertion device according to claim 1.

6. The needle carriage (1470) is suitable for a needle that does not have a catheter. A needle insertion device according to claim 1.

7. The needle carriage (1813) is compatible with a needle having a catheter. A needle insertion device according to claim 1.

8. The needle carriage (1813) includes the negative shape (1813.1) of a needle having a catheter. Needle insertion device according to claim 7.

9. The needle carriage (1465) is adapted to a specific needle length. A needle insertion device according to claim 1.

10. The needle insertion stopper (1440) is adjustable, and the needle carriage (1435) is compatible with multiple needle lengths. A needle insertion device according to claim 1.

11. The base includes an ultrasonic mount (1012), A needle insertion device according to claim 1.

12. The ultrasonic mount (1012) is connected to the base via a pin (1335), a magnet (1338), a clip, or a clamp. The needle insertion device according to claim 11.

13. The ultrasonic mount (1012) is further provided with a sound-conducting pad (1610) positioned below it. The needle insertion device according to claim 12.

14. The sound conduction pad (1610) further comprises a needle insertion slit / wedge (1615) formed therein. Needle insertion device according to claim 13.

15. The base includes a first ultrasonic window (1325A) having a first orientation and a second ultrasonic window (1325B) having a second orientation, and the ultrasonic mount (1012) can be connected to the base to conform to the first and second orientations. The needle insertion device according to claim 11.

16. The base (1405) is attached to a sterile bag (162) configured to enclose the ultrasonic probe, A needle insertion device according to claim 1.

17. The sterile bag (162) is connected to a handle (164), the handle (164) includes an access hole (165) that provides access to the inside of the sterile bag (164), and the access hole (165) is configured to allow the ultrasonic probe to pass through. Needle insertion device according to claim 16.

18. Base (1802), A depth cam (1814) having a periphery configured to correlate the needle insertion angle (1832) with the insertion depth, Arm receiver (1810), A base (1802) equipped with, A swing arm (1808) is pivotably or slidably mounted to the arm receiver (1810), and the swing arm (1808) and the base (1802) form the needle insertion angle (1832), A needle carriage (1812) is slidably mounted on the swing arm (1808), A needle insertion stopper (1809) is configured to contact the periphery of the depth cam (1814) and to restrict the sliding movement of the needle carriage (1812) on the swing arm (1808), Angle-down arch slot (1818), Including the needle carriage (1812), An angle-down arch (1816) slidably disposed within the angle-down arch slot (1818), comprising needle mounts (1813, 1913) for holding a needle (1825) and a catheter (1826), and sliding through the angle-down arch slot (1818) to form a catheter insertion angle (1834) between the needle mount (1813) and the base (1802) that is smaller than the needle insertion angle (1832), and A needle insertion device (1800, 1900) equipped with the following.

19. The angle-down arch (1816) is configured such that the tip of the needle (1825) remains in the same position when the angle-down arch (1816) slides through the angle-down arch slot (1818). Needle insertion device according to claim 18.

20. The base (1802) includes an ultrasonic mount (1804), Needle insertion device according to claim 18.

21. The ultrasonic mount (1804) is connected to the base (1802) via a pin (1335) or a magnet (1338). Needle insertion device according to claim 20.

22. The ultrasonic mount (1012) is further provided with a sound-conducting pad (1610) positioned below it. Needle insertion device according to claim 20.

23. The sound conduction pad (1610) further comprises a needle insertion slit (1615) formed therein. Needle insertion device according to claim 22.

24. The base (1802) is attached to a sterile bag (162) configured to enclose the ultrasonic probe, Needle insertion device according to claim 18.

25. The sterile bag (162) is connected to a handle (164), the handle (164) includes an access hole (165) that provides access to the inside of the sterile bag (164), and the access hole (165) is configured to allow the ultrasonic probe to pass through. Needle insertion device according to claim 24.

26. The needle carriage (1812) includes an arch lock (1820) configured to prevent the angle-down arch (1816) from sliding relative to the needle carriage (1812), Needle insertion device according to claim 18.

27. The angle-down arch (1816) includes an arch operating structure (1830). Needle insertion device according to claim 18.

28. The needle carriage (1812) includes a pre-tension pinion (1932) configured to propel the angle-down arch (1816) through the angle-down arch slot (1818), Needle insertion device according to claim 18.

29. The angle-down arch (1816) is connected to the needle carriage (1812), and the arch spring (1933) is configured to propel the angle-down arch (1816) through the angle-down arch slot (1818), further comprising Needle insertion device according to claim 18.

30. The aforementioned needle mount (1913) A catheter spring (1940) connected to the catheter (1826), The needle spring (1942) connected to the needle (1825), Spring trigger (1944), Includes, The aforementioned needle mount (1913) In a non-triggered state, the spring trigger (1944) holds both the catheter spring (1940) and the needle spring (1942) in a compressed state. The spring trigger (1944) is activated, releasing both the catheter spring (1940) and the needle spring (1942) from their compressed state, thereby creating a triggered state in which (1) the catheter spring (1940) applies an insertion force to the catheter (1936), and (2) the needle spring (1942) applies an extraction force to the needle (1925). It has two states, Needle insertion device according to claim 18.

31. The spring trigger (1944) is activated when it comes into contact with the base (1802). Needle insertion device according to claim 30.

32. The spring trigger (1944) is activated when the needle mount (1913) reaches the catheter insertion angle (1834). Needle insertion device according to claim 30.

33. A base (1802) including a base insert receiver (1407.1), Multiple probe mount inserts (1408.1 to 1408.4), Each includes a slot configured to hold an ultrasound probe, The dimensions of each of the aforementioned slots are different from each other. Each is configured to fit into the base insert receiver, Multiple probe mount inserts (1408.1 to 1408.4), The swing arm (1808) is attached to the base (1802) and forms a needle insertion angle (1832) between the swing arm (1808) and the base (1802), A needle carriage (1812) is slidably mounted on the swing arm (1808), A needle insertion device (1800, 1900) equipped with the following.

34. Each of the plurality of probe mount inserts (1408.1 to 1408.4) is made of a rigid material. Needle insertion device according to claim 33.

35. Each of the plurality of probe mount inserts (1408.1 to 1408.4) is made of a flexible material. Needle insertion device according to claim 33.

36. The base includes a depth cam (1814) having a periphery configured to correlate the needle insertion angle (1832) with the insertion depth, The needle carriage (1812) includes a needle insertion stopper (1809) configured to contact the periphery of the depth cam (1814) and restrict the sliding movement of the needle carriage (1812) on the swing arm (18080), Needle insertion device according to claim 33.

37. The needle carriage is adapted to a specific needle length. Needle insertion device according to claim 36.

38. The needle insertion stopper is adjustable, and the needle carriage is compatible with multiple needle lengths. Needle insertion device according to claim 36.

39. The depth cam (1814) includes a plurality of anti-slip structures (1415), Needle insertion device according to claim 36.

40. The needle carriage (1812) includes an angle-down arch slot (1818), and the device comprises an angle-down arch (1816) slidably disposed within the angle-down arch slot (1818), the angle-down arch (1816) includes needle mounts (1813, 1913) for holding a needle (1825) and a catheter (1826), and the angle-down arch (1816) slides through the angle-down arch slot (1818) to form a catheter insertion angle (1834) between the needle mount (1813) and the base (1802) that is smaller than the needle insertion angle (1832). Needle insertion device according to claim 36.

41. The base (1802) includes an arm receiver (1426.1) having a track (1426.2), The swing arm (1808) includes a swing arm interface (1426.3) configured to be slidably connected to the track (1426.2) and to move along the track (1426.2), Needle insertion device according to claim 33.

42. The base (1802) is attached to a sterile bag (162) configured to enclose the ultrasonic probe, Needle insertion device according to claim 33.

43. The sterile bag (162) is connected to a handle (164), the handle (164) includes an access hole (165) that provides access to the inside of the sterile bag (164), and the access hole (165) is configured to allow the ultrasonic probe to pass through. Needle insertion device according to claim 42.

44. The probe mount insert includes a needle insertion slit (1615) formed in the sound conduction pad (1610). Needle insertion device according to claim 33.

45. The system includes a sound conduction pad (1610) positioned below the plurality of probe mount inserts, Needle insertion device according to claim 33.

46. The sound conduction pad (1610) is provided with a needle insertion slit (1615) formed therein. Needle insertion device according to claim 45.

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