Systems, methods, and devices for needle positioning

Abstract

Several needle injection devices are disclosed, including devices that implement a fixed or variable insertion angle. The fixed insertion angle devices may include a channel guide with a stop to limit the injection to the desired depth. The fixed insertion angle devices may also include rack and pinions to maintain the injection geometry to arrive at the desired depth. The variable insertion angle designs may include a channel guide with a stop to limit the injection to the desired depth. The variable insertion angle devices may also implement a depth cam that is constructed to correlate the injection angle to the injection depth. Improvements upon these designs are also disclosed.

Description

SYSTEMS, METHODS, AND DEVICES FOR NEEDLE POSITIONINGCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to US Provisional Application 63 / 534081, titled Systems, Methods, And Devices for Needle Positioning filed on August 22, 2023.

[0002] This application is also related to PCT Application PCT / US2022 / 036009, titled Systems, Methods, and Devices Directed to Ultrasonic Needle Positioning Apparatus, filed on July 1, 2022, and to U.S. Provisional Application 63 / 218191, titled Systems, Methods, And Devices Directed to Ultrasonic Needle Positioning Apparatus, filed on July 2, 2021. The entire contents of these applications are incorporated herein by reference in their entireties.FIELD OF THE INVENTION

[0003] This application relates to systems, methods, and devices for needle positioning in medical procedures.BACKGROUND

[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 indicated, 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 can require the use of needles, catheters, and so forth that are inserted into a patient’s body (e.g., into a vein). However, proper insertion can be difficult, especially for patients who are obese, use intravenous drugs, and so forth. Failed insertions can lead to frustration and discomfort. Ultrasound imaging can be used to locate features (e g., veins) for insertion, which can increase the likelihood of successful placement. However, failed attempts may still commonly occur, and some ultrasound-assisted methods can be cumbersome to use or offer only partial solutions. For example, for a needle insertion, it is important to keep the patient, ultrasound imaging probe, and needle steady during the insertion procedure. Additionally, it can be important to insert the needle at an appropriate angle and at an appropriate depth.BRIEF DESCRIPTION OF THE DRAWINGS

[0006] The invention can be better understood with reference to the following figures. The components within the figures are not necessarily to scale, emphasis instead being placed onclearly illustrating example aspects of the invention. In the figures, like reference numerals designate corresponding parts throughout the different views and / or embodiments. Furthermore, various features of different disclosed embodiments can be combined to form additional embodiments, which are part of this disclosure. It will be understood that certain components and details may not appear in the figures to assist in more clearly describing the invention.

[0007] FIG. 1A1 is a perspective view of an embodiment of a needle insertion device.

[0008] FIG. 1A2 illustrates an extension that may be added to the embodiment of FIG. 1A1 to extend the insertion depth of the needle.

[0009] FIG. 2A is a perspective view of the base of the embodiment of FIG. 1A1.

[0010] FIG. 2B is a perspective view of the base of the embodiment of FIG. 1A1.

[0011] FIG. 2C is a side view of the base of the embodiment of FIG. 1A1.

[0012] FIG. 3 A shows an angle fixture of the embodiment of FIG. 1A1.

[0013] FIG. 3B is an angle fixture of the embodiment of FIG. 1A1.

[0014] FIG. 4 shows a needle stop with a rail and a stop tab used in the embodiment of FIG. 1A1

[0015] FIG. 5A is a perspective view of the needle support arm of embodiment of FIG. 1A1

[0016] FIG. 5B is a side view of the needle support arm of embodiment of FIG. 1A1

[0017] FIG. 6 is a side view of the angle fixture of the embodiment of FIG. 1A1.

[0018] FIG. 7A illustrates an example process for configuring and using the insertion device of FIG. 1A1.

[0019] FIG. 7B illustrates an example process for configuring and using the insertion device of FIG. 1A1.

[0020] FIG. 8 is a flow chart for use of the insertion device.

[0021] FIG. 9 illustrates a packaging of the insertion device of FIG. 1A1.

[0022] FIG. 10 illustrates the probe inserted in a bag to maintain the probe sterile.

[0023] FIG. 11 illustrates the probe inserted in a bag to maintain the probe sterile from a lower perspective.

[0024] FIG. 12 is perspective view of another embodiment of a needle insertion device.

[0025] FIG. 13 is another perspective view of the embodiment of FIG. 12.

[0026] FIG. 14 is a perspective view of the base of the embodiment of FIG. 12.

[0027] FIG. 15 illustrates various components of the embodiment of FIG. 12.

[0028] FIG. 16 illustrates one of the components shown in FIG. 15 individually.

[0029] FIG. 17 illustrates one of the components shown in FIG. 15 individually.

[0030] FIG. 18 illustrates one of the components shown in FIG. 15 individually.

[0031] FIG. 19 is a side view of the embodiment of FIG. 12.

[0032] FIG. 20 shows the adjustment knob of the embodiment of FIG. 12.

[0033] FIG. 21 is a rear view of another embodiment of a needle insertion device that automatically adjusts the position of the main needle carriage.

[0034] FIG. 22 is a perspective view of the embodiment of FIG. 21.

[0035] FIG. 23 is a rear view of another embodiment of a needle insertion device that automatically adjusts the position of the main needle carriage.

[0036] FIG. 24 is a side view of the embodiment of FIG. 23.

[0037] FIG. 25 illustrates an example embodiment of a structure that can be used for adjusting needle insert parameters (e g., insertion angle, insertion depth).

[0038] FIG. 26 illustrates an example embodiment of a structure that can be used for adjusting needle insert parameters (e.g., insertion angle, insertion depth).

[0039] FIG. 27A is a side view of an insertion device that facilitates easy adjustment of the insertion depth of the needle.

[0040] FIG. 27B illustrates components of the embodiment of FIG. 27A.

[0041] FIG. 28 A illustrates a first step for using the embodiment of FIG. 27A.

[0042] FIG. 28B illustrates a second step for using the embodiment of FIG. 27A.

[0043] FIG. 28C illustrates a third step for using the embodiment of FIG. 27A.

[0044] FIG. 28D illustrates a fourth step for using the embodiment of FIG. 27A.

[0045] FIG. 28E illustrates a fifth step for using the embodiment of FIG. 27A.

[0046] FIG. 28F illustrates a sixth step for using the embodiment of FIG. 27A.

[0047] FIG. 29 illustrates another embodiment of a needle insertion device that include a selfcentering apparatus.

[0048] FIG. 30 is another view of the embodiment of FIG. 29.

[0049] FIG. 31 is another view of the embodiment of FIG. 29.

[0050] FIG. 32 is another view of the embodiment of FIG. 29.

[0051] FIG. 33 depicts a self-centering apparatus having slots of three different lengths to accommodate different needle sizes.

[0052] FIG. 34 shows an example embodiment of a motorized needle insertion device.

[0053] FIG. 35A illustrates the coupling of the motor to the worm drive.

[0054] FIG. 35B shows example needles and carriages that can be used with the embodiment of FIG. 34.

[0055] FIGS. 36A-36K illustrate an example procedure for using the embodiment of FIG. 12.

[0056] FIG. 37 shows another example of a motorized needle insertion device.

[0057] FIG. 38 illustrates the geometry of various angles and depths for needle insertion.

[0058] FIG. 39A is a perspective view of another embodiment of a needle insertion device.

[0059] FIG. 39B1 is a perspective view of the embodiment of FIG. 39A.

[0060] FIG. 39B2 is a plan view of the embodiment of FIG. 39A.FIG. 39C shows the base of the embodiment of FIG. 39A in greater detail.

[0061] FIG. 39D illustrates in exploded view various components of the embodiment of FIG. 39A.

[0062] FIG. 39E illustrates in exploded view various components of the embodiment of FIG. 39A.

[0063] FIG. 39F illustrates the relative movements of the components of the embodiment of FIG. 39A.

[0064] FIG. 39G is an enlarged rear perspective view of the embodiment of FIG. 39A.

[0065] FIG. 40A is a perspective view of another embodiment of a needle insertion device.

[0066] FIG. 40B is a perspective view of the embodiment of FIG. 40A.

[0067] FIG. 40C is an enlarged rear perspective view of the embodiment of FIG. 40A.

[0068] FIG. 40D illustrates in exploded view various components of the embodiment of FIG.40A.

[0069] FIG. 40E illustrates in exploded view various components of the embodiment of FIG. 40A.

[0070] FIG. 40F is a rear perspective view of the embodiment of FIG. 40A.

[0071] FIG. 40G is a side perspective view of the embodiment of FIG. 40A.

[0072] FIG. 40H is an enlarged view of the angle-down multi-channel guide of the embodiment of FIG. 40A.

[0073] FIG. 401 is an enlarged view of the angle-down multi-channel guide used in the embodiment of FIG. 40A.

[0074] FIG. 40J consists of various views of the angle-down multi-channel guide used in the embodiment of FIG. 40A.

[0075] FIG. 40K is an enlarged view of the angle-down multi-channel guide and its associated gears used in the embodiment of FIG. 40 A.

[0076] FIG. 40L consists of various views of the angle-down multi-channel guide and its associated gears used in the embodiment of FIG. 40 A.

[0077] FIG. 40M is a top perspective view of the internal components of the embodiment of FIG. 40A.

[0078] FIG. 40N is a side view of the internal components of the embodiment of FIG. 40A.

[0079] FIG. 400 is a bottom perspective view of the internal components of the embodiment of FIG. 40A.

[0080] FIG. 41 A is a perspective view of another embodiment of a needle insertion device.

[0081] FIG. 41B is a side view of the embodiment of FIG. 41A.

[0082] FIG. 41C is a side view of the embodiment of FIG. 41 A, set at an insertion depth of 10- 12mm.

[0083] FIG. 41D is a side view of the embodiment of FIG. 41A for an insertion depth of 10- 12mm as the needle angles down.

[0084] FIG. 41E is a side view of the embodiment of FIG. 41A, set at an insertion depth of 1- 3 mm.

[0085] FIG. 41F is a side view of the embodiment of FIG. 41 A for an insertion depth of l-3mm as the needle angles down.

[0086] FIG. 42A is a side view of another embodiment of a needle insertion device.

[0087] FIG. 42B is a perspective view of the embodiment of FIG. 42A.

[0088] FIG. 42C is a bottom perspective view of the embodiment of FIG. 42A.

[0089] FIG. 42D is a front perspective view of the embodiment of FIG. 42A.

[0090] FIG. 42E1 is a top perspective view of the base of the embodiment of FIG. 42A.

[0091] FIG. 42E2 is a bottom perspective view of the base of the embodiment of FIG. 42A.

[0092] FIG. 42F is a top perspective view of an alternate base of the embodiment of FIG. 42A.

[0093] FIG. 42G1 illustrates a needle carriage guide pin used in the embodiment of FIG. 42A.

[0094] FIG. 42G2 illustrates a needle carriage guide pin with a wraparound clip to increase stability.

[0095] FIG. 42G3 illustrates a needle carriage guide pin with a wraparound clip to increase stability.

[0096] FIG. 42H illustrates a needle carriage guide pin used in the embodiment of FIG. 42A.

[0097] FIG. 421 illustrates a needle anchor point used in the embodiment of FIG. 42A.

[0098] FIG. 42J illustrates a guide card where the channels only have a needle insertion portion.

[0099] FIG. 42K1 illustrates a guide card where the channels are extended with an angle-down portion.

[0100] FIG. 42K2 illustrates that a single channel may have its own angle-down / move forward portions.

[0101] FIG. 42L illustrates a guide card where the channels are extended with an angle-down portion and a move-forward portion.

[0102] FIG. 43 Al illustrates another embodiment of a needle insertion device.

[0103] 43A2 illustrates the various interchangeable probe mount inserts that accommodate several different types of ultrasound probes.

[0104] FIG. 43B1 is the depth cam used in the embodiment of FIG. 43 Al.

[0105] FIG. 43B2 is an enlarged view of the anti-slip feature used in the embodiment of FIG. 43A1.

[0106] FIG. 43B3 illustrates how the perimeter of the depth cam is calculated.

[0107] FIG. 43C1 are various views of the depth cam used in the embodiment of FIG. 43 Al.

[0108] 43 C2 illustrates the track used in the arm receiver.

[0109] 43 C3 illustrates the track used in the arm receiver.

[0110] FIG 43D1 illustrates a process for needle calibration for an adjustable carriage in the embodiment of FIG. 43 Al.

[0111] FIG. 43D2 illustrates the depth and needle calibration for an adjustable plunger carriage.

[0112] FIG. 43E1 illustrates a fixed needle assembly carriage used in the embodiment of FIG. 43A1.

[0113] FIG. 43E2 illustrates a hole and channel needle stabilization structure.

[0114] FIG. 43F1 illustrates a fixed needle assembly carriage used in the embodiment of FIG. 43A1.

[0115] FIG. 43F2 illustrates the various interchangeable needle / catheter mounts that can be used with the insertion device.

[0116] FIG. 43F3 illustrates the needle mount for a plunger.

[0117] 43F4 illustrate the needle / catheter mount for a catheter.

[0118] FIG. 43G is a plan view of the embodiment of FIG. 43 Al.

[0119] FIG. 43H is a perspective view of the embodiment of FIG. 43A1 without the base.

[0120] FIG. 431 is a side view of the embodiment of FIG. 43A1 without the base.

[0121] FIG. 43J is a bottom perspective view of the embodiment of FIG. 43A1 without the base.

[0122] FIG. 43K illustrates a variety of finger grip positions and shapes.

[0123] FIG. 44A is another embodiment of a motorized needle insertion device.

[0124] FIG. 44B is a partially exploded view of the embodiment of FIG. 44A.

[0125] FIG. 44C illustrates the removable motor assembly of the embodiment of FIG. 44A.

[0126] FIG. 44D is a side view of the needle assembly carriage of the embodiment of FIG. 44A.

[0127] FIG. 44E is a schematic showing the processor control of the electric motors of the embodiment of FIG. 44A.

[0128] FIG. 45 A is a top perspective view of another embodiment of a needle insertion device.

[0129] FIG. 45B is a bottom perspective view of the embodiment of FIG. 45A.

[0130] FIG. 45C comprises various views of the embodiment of FIG. 45A.

[0131] FIG. 46A illustrates a segmented robotic snake with an ultrasound segment and a needle insertion segment.

[0132] FIG. 46B illustrates a side view the robot of FIG. 46A when the needle insertion device is puncturing the patient.

[0133] FIG. 46C illustrates a top perspective view the robot of FIG. 46A when the needle insertion device is puncturing the patient.

[0134] FIG. 46D illustrates an enlarged side perspective view the robot of FIG. 46A when the needle insertion device is puncturing the patient.

[0135] FIG. 46E illustrates an enlarged top perspective view the robot of FIG. 46A when the needle insertion device is puncturing the patient.

[0136] FIG. 46F illustrates an enlarged top perspective view the robot of FIG. 46A when the needle insertion device is puncturing the patient.

[0137] FIG. 47A is another embodiment of a needle insertion device with an angle down structure.

[0138] FIG. 47B1 illustrates the angle down arch of the embodiment of FIG. 47A.

[0139] FIG. 47B2 is a side view of the embodiment of FIG. 47A.

[0140] FIG. 47C is an enlarged view illustrating the needle mount unlocking from the needle carriage.

[0141] FIG. 47D is a side view of the embodiment of FIG. 47A showing the needle insertion angle and the catheter insertion angle.

[0142] FIG. 47E is an isometric view of the embodiment of FIG. 47A showing the needle insertion angle and the catheter insertion angle.

[0143] FIG. 48A is another embodiment of a needle insertion device with an angle down structure and an automatic needle mount.

[0144] FIG. 48B is an enlarged view illustrating the needle mount unlocking from the needle carriage.

[0145] FIG. 48C is a side view of the embodiment of FIG. 48A showing the needle insertion angle and the catheter insertion angle.

[0146] FIG. 48D illustrates another embodiment of a needle insertion device with an arch spring.

[0147] FIG. 49 A is a cross-section view of the automatic needle mount.

[0148] FIG. 49B illustrates the spring trigger component of the automatic needle mount of FIG. 49A.

[0149] FIG. 49C illustrates the spring trigger component of the automatic needle mount of FIG. 49A.

[0150] FIG. 49D illustrates the internal components of the automatic needle mount of FIG. 49A in the non-trigger configuration.

[0151] FIG. 49E illustrates the internal components of the automatic needle mount of FIG. 49A just as the triggered configuration begins.

[0152] FIG. 49F illustrates the internal components of the automatic needle mount of FIG. 49A in the triggered configuration.

[0153] FIG. 49G illustrates the needle insertion device of FIG. 48A in the triggered configuration.DETAILED DESCRIPTION

[0154] Reference is made herein to some specific examples of the present invention, including any best modes contemplated by the inventor for carrying out the invention. Examples of these specific embodiments are illustrated in the accompanying figures. While the invention isdescribed in conjunction with these specific embodiments, it will be understood that it is not intended to limit the invention to the described or illustrated embodiments. To the contrary, it is intended to cover alternatives, modifications, and equivalents, as may be included within the spirit and scope of the invention as defined by the appended claims.

[0155] In the following description, numerous specific details are set forth to provide a thorough understanding of the present invention. Example embodiments of the present invention may be implemented without some or all these specific details. In other instances, process operations well known to persons of skill in the art have not been described in detail in order not to obscure unnecessarily the present invention. Various techniques and mechanisms of the present invention will sometimes be described in singular form for clarity. However, it should be noted that some embodiments include multiple iterations of a technique or multiple mechanisms, unless noted otherwise. Similarly, various steps of the methods shown and described herein are not necessarily performed in the order indicated, or performed at all, in certain embodiments. Accordingly, some implementations of the methods discussed herein may include more or fewer steps than those shown or described. Further, the techniques and mechanisms of the present invention will sometimes describe a connection, relationship or communication between two or more entities. It should be noted that a connection or relationship between entities does not necessarily mean a direct, unimpeded connection, as a variety of other entities or processes may reside or occur between any two entities. Consequently, an indicated connection does not necessarily mean a direct, unimpeded connection, unless otherwise noted.

[0156] The following list of example features corresponds with the attached figures and is provided for ease of reference, where like reference numerals designate corresponding features throughout the specification and figures:

[0157] 100 Insertion Device

[0158] 102 Base

[0159] 104 Stabilization Hole

[0160] 106 Ultrasound Mount

[0161] 108 Tower

[0162] 110 Rail / Track

[0163] 112 Insertion Ruler

[0164] 114 Angle Fixture

[0165] 115 Depth Extension Device

[0166] 115A Base Extension

[0167] 115B Extension Tower

[0168] 115C Angle Fixture Extension

[0169] 115D Extension Rail

[0170] 118 Needle Stop

[0171] 120 Stop Tab

[0172] 122 Needle Support Arm

[0173] 124 Thumb Screw

[0174] 126 Alignment Hole

[0175] 130 Movable Lever / Pull

[0176] 132 Channel

[0177] 134 Post

[0178] 136 Rail

[0179] 138 Needle Guide Portion

[0180] 140 Coupling Portion

[0181] 142 Rail

[0182] 144 Markings

[0183] 146 Coupling Portion

[0184] 148 Thumbscrew Hole

[0185] 150 Position Indicator

[0186] 152 Needle Receiving Portion

[0187] 154 Support Platform

[0188] 156 Thumbscrew

[0189] 158 Stop

[0190] 160 Packaging

[0191] 162 Bag

[0192] 164 Handle

[0193] 165 Access Hole

[0194] 300 Insertion Device

[0195] 302 Base

[0196] 304 Stabilization Hole

[0197] 306 Ultrasound Mount

[0198] 308 Arm Receiver

[0199] 310 Swing Arm

[0200] 312 Main Needle Carriage

[0201] 314 Needle Support Carriage

[0202] 316 Pivot Attachment

[0203] 318 Thumbscrew

[0204] 320 Lever

[0205] 322 Lever

[0206] 324 Rack

[0207] 326 Adjustment Knob

[0208] 328 Pinion

[0209] 330 Belt

[0210] 332 Adjustment Knob

[0211] 334 Stop

[0212] 336 Worm Drive

[0213] 400 Insertion Device

[0214] 402 Post

[0215] 404 Adjustment Control Structure

[0216] 406 Cylinder

[0217] 408 Arm

[0218] 410 Needle Carriage

[0219] 412 Stop

[0220] 414 Needle Holder

[0221] 500 Base

[0222] 502 Post

[0223] 504 Needle Pusher

[0224] 506 Needle Holder

[0225] 508 Lever Lock

[0226] 510 Lever Lock

[0227] 512 Insertion Depth Selector Wheel

[0228] 514 Slider

[0229] 516 Pin

[0230] 518 Needle Stop

[0231] 520 Latch

[0232] 600 Self-Centering Apparatus

[0233] 602 Needle Insertion Slit / Wedge

[0234] 604 Ultrasound Cavity

[0235] 606 Latch

[0236] 700-712 Process Steps

[0237] 802-824 Process Steps

[0238] 900 Motorized Insertion Device

[0239] 902 Base

[0240] 904 Motorized Tower

[0241] 906 Shaft Portion

[0242] 908 End Cap

[0243] 910 Coupling Mechanism

[0244] 914 Needle

[0245] 916 Catheter Sheath

[0246] 918 Receiver

[0247] 920 Needle Holder

[0248] 1000 Insertion Device

[0249] 1005 Needle

[0250] 1007 Insertion Area

[0251] 1010 Base

[0252] 1011 Patient Contact Surface

[0253] 1012 Ultrasound Probe Mount

[0254] 1014 Finger Grip

[0255] 1015 Needle Depth Gauge

[0256] 1020 Depth Indicator

[0257] 1025 Actuation Structure

[0258] 1030 Upper Assembly

[0259] 1040 Needle Carriage

[0260] 1045 Needle Rack Support

[0261] 1046 Needle Carriage Assembly

[0262] 1047 Needle Rack

[0263] 1048 Needle Rack Pinion

[0264] 1050 Adjustment Slide Path

[0265] 1055 Lock Thumbscrew

[0266] 1060 Upper Assembly Main Support

[0267] 1062 Base Groove

[0268] 1065 Base Rack

[0269] 1067 Base Rack Pinion

[0270] 1070 Needle Carriage Insertion Lateral Movement

[0271] 1075 Upper Assembly Lateral Movement

[0272] 1100 Insertion Device

[0273] 1105 Needle

[0274] 1110 Base

[0275] 1112 Ultrasound Probe

[0276] 1115 Needle Depth Gauge

[0277] 1120 Depth Indicator

[0278] 1125 Actuation Structure

[0279] 1130 Upper Assembly

[0280] 1140 Needle Carriage

[0281] 1142 Release Button

[0282] 1144 Release Latch

[0283] 1145 Latch Swing Path / Directi on

[0284] 1147 Needle Rack

[0285] 1148 Needle Rack Pinion

[0286] 1149 Angle-Down Needle Carriage

[0287] 1150 Latch Receiver

[0288] 1160 Upper Assembly Main Support

[0289] 1165 Base Rack

[0290] 1167 Base Rack Pinion

[0291] 1170 Angle-Down Multi-Channel Guide (Sand dollar)

[0292] 1170A Multi-Channel Guide Portion

[0293] 1172 Angle-Down Gears

[0294] 1175 Center Channel Guide

[0295] 1176 Center Channel

[0296] 1176A Center Channel Portion

[0297] 1180 Angle-Down Needle Carriage Path

[0298] 1185 Discrete Channels for Selected Needle Depths

[0299] 1200 Insertion Device

[0300] 1203 Base

[0301] 1205 Needle Assembly

[0302] 1207 Needle Carriage

[0303] 1207.1 Needle Carriage Insertion Slide Direction

[0304] 1207.2 Needle Carriage Guide

[0305] 1207.3 Needle Carriage Angle-Down Direction

[0306] 1210 Needle

[0307] 1230 Needle Carriage Multi-Channel Guide

[0308] 1230.1 Vein Depth Gauge

[0309] 1230.2 Adjustable Vein Depth Stop

[0310] 1230.3 Depth Indicator

[0311] 1230.4 Insertion Needle Carriage Channel

[0312] 1230.5 Angle-Down Needle Carriage Channel

[0313] 1235 Vein

[0314] 1240 Needle Insertion

[0315] 1245 Needle Insertion Angle

[0316] 1250 Needle Reduced Angle

[0317] 1300 Insertion Device

[0318] 1302 Needle

[0319] 1305 Base

[0320] 1310 Multi-Channel Guide Card

[0321] 1315 Needle Carriage

[0322] 1316 Wrap-Around Clip

[0323] 1317A Carriage Path for First Channel

[0324] 1317AA Needle Path for First Channel

[0325] 1317B Carriage Path for Second Channel

[0326] 1317BB Needle Path for Second Channel

[0327] 1318A Ultimate Needle Depth for First Channel

[0328] 1318B Ultimate Needle Depth for Second Channel

[0329] 1320 Needle Window

[0330] 1325A Ultrasound Window (Orientation 1)

[0331] 1325B Ultrasound Window (Orientation 2)

[0332] 1330 Guide Card Support

[0333] 1335 Mount Pins

[0334] 1335 A Mount Pins

[0335] 1338 Mount Magnets

[0336] 1340 Pin Receivers

[0337] 1340A Pin Receivers

[0338] 1342 Slide Channel

[0339] 1344 Guide Pin

[0340] 1345 Needle Anchor Point

[0341] 1350 Needle Carriage Guide (Pin)

[0342] 1352 Needle Loading Portion of Path

[0343] 1355 Needle Insertion Portion of Path

[0344] 1360 Angle-Down Portion of Path

[0345] 1365 Move Forward Portion of Path

[0346] 1400 Needle Insertion Device

[0347] 1405 Base

[0348] 1407.1 Base Insert Receiver

[0349] 1408.1 - 1408.4 Interchangeable Probe Mount Inserts

[0350] 1410 Depth Cam

[0351] 1415 Anti-slip Feature

[0352] 1420 Insertion Point Line

[0353] 1422 Needle

[0354] 1424 Needle Insertion Depth

[0355] 1425 Angle Position Rack

[0356] 1426.1 Interchangeable Arm Receiver

[0357] 1426.2 Tracks

[0358] 1426.3 Swing Arm Interface

[0359] 1426.4 Track Tab

[0360] 1426.5 Swing Arm Post

[0361] 1426.6 Swing Arm

[0362] 1426.7 Track Horizontal Displacement

[0363] 1426.8 Track Vertical Displacement

[0364] 1426.9 Track Horizontal Extension

[0365] 1427 Swing Arm Assembly

[0366] 1428 Swing Arm Movement

[0367] 1430 Depth Selection Pinion

[0368] 1432 Needle Holder

[0369] 1435 Needle Carriage (Adjustable)

[0370] 1436 Needle Carriage Path

[0371] 1436.1 Needle Carriage Stop Point

[0372] 1436.2 Needle Depth

[0373] 1437 Needle

[0374] 1438 Needle Carriage Lever Lock

[0375] 1440 Needle Insertion Stop (Adjustable)

[0376] 1442 Needle Insertion Stop Lever Lock

[0377] 1456 Needle Calibration Structure

[0378] 1460.1 Needle Calibration Step 1

[0379] 1460.2 Needle Calibration Step 2

[0380] 1460.3 Needle Calibration Step 3

[0381] 1460.4 Needle Calibration Step 4

[0382] 1460.5 Needle Calibration Step 5

[0383] 1460.6 Needle Calibration Step 6

[0384] 1460.7 Needle Calibration Step 7

[0385] 1465 Needle Carriage (Nonadjustable)

[0386] 1467 Hole and Channel Stabilizer

[0387] 1470 Needle Carriage (Nonadjustable, Non-catheter)

[0388] 1475 Needle Insertion Stop (Nonadjustable)

[0389] 1476 Plunger

[0390] 1477 Plunger Holder

[0391] 1477.1 Hole and Channel Stabilizer

[0392] 1477.2 Plunger Carriage

[0393] 1480 Slide Arm

[0394] 1500 Insertion Device

[0395] 1503 Base

[0396] 1505 Needle Carriage

[0397] 1510 Catheter Carriage

[0398] 1515 Needle

[0399] 1517 Gear Housing

[0400] 1520 Needle Carriage Worm Drive

[0401] 1525 Catheter Carriage Worm Drive

[0402] 1530 Removable Motor Assembly

[0403] 1535 Needle Carriage Motor

[0404] 1540 Catheter Carriage Motor

[0405] 1545 Insertion Angle Motor

[0406] 1550 Motor Assembly Lock

[0407] 1555 Processor

[0408] 1560 Linear Position Sensors

[0409] 1565 Angular Position Sensor

[0410] 1570 Vein Depth Input Device

[0411] 1600 Insertion Device

[0412] 1605 Elevated Ultrasound Probe Mount

[0413] 1610 Sound-Conductive Material (Pad)

[0414] 1615 Needle Insertion Slit / Wedge

[0415] 1620 Needle

[0416] 1700 Robotic Snake

[0417] 1705 Robotic Snake Segments

[0418] 1710 Ultrasound Probe Segment

[0419] 1715 Needle Insertion Segment

[0420] 1720 Head Segment with Sensors

[0421] 1725 Patient

[0422] 1730 Antiseptic Spray Nozzle

[0423] 1730 Peg and Hole Connection Structures

[0424] 1800 Insertion Device

[0425] 1802 Base

[0426] 1804 Ultrasound Mount

[0427] 1806 Ultrasound Probe

[0428] 1808 Swing Arm

[0429] 1808.1 Swing Arm Movement

[0430] 1809 Needle Insertion Stop

[0431] 1810 Arm Receiver

[0432] 1812 Need Carriage

[0433] 1812.1 Needle Carriage Movement

[0434] 1813 Needle / Catheter Mount

[0435] 1813.1 Negative Impression

[0436] 1814 Depth Cam

[0437] 1816 Angle-Down Arch

[0438] 1816.1 Arch Movement

[0439] 1818 Angle-Down Arch Slot

[0440] 1820 Arch Lock

[0441] 1820.1 Carriage Lock

[0442] 1822 Lock Receiver

[0443] 1825 Needle

[0444] 1826 Catheter

[0445] 1826 Catheter Mount

[0446] 1830 Arch Manipulation Structure

[0447] 1832 Needle Insertion Angle

[0448] 1834 Catheter Insertion Angle

[0449] 1900 Insertion Device

[0450] 1902 Base

[0451] 1913 Automatic Needle / Catheter Mount

[0452] 1918 Teeth

[0453] 1930 Release Spear

[0454] 1931 Pinion Latch

[0455] 1932 Pre-Tensioned Pinion

[0456] 1932.1 Pinion Movement

[0457] 1933 Arch Spring

[0458] 1934 Spring

[0459] 1940 Catheter Spring

[0460] 1940.1 Catheter Spring Movement

[0461] 1941 Catheter Spring Window

[0462] 1942 Needle Spring

[0463] 1942.1 Needle Spring Movement

[0464] 1943 Needle Spring Window

[0465] 1944 Spring Trigger

[0466] 1944.1 Spring Trigger Movement

[0467] 1946 Needle Slot

[0468] 1948 Spring Support

[0469] As discussed briefly above, difficulties can be encountered when attempting to insert a needle into a patient’s vein or otherwise when needing to place a needle with accuracy inside a patient’s body. Failed attempts can result in frustration on the part of the healthcare provider and the patient, patient discomfort, and an overall negative experience for both the patient and the healthcare provider. Mistakes or failures can lead to bruising, bleeding, discomfort, and so forth.

[0470] In some cases, it can be difficult to locate a vein and to successfully insert a needle into the vein (or similarly into another desired location in the body, such as a tumor site when collecting a biopsy sample). Thus, there is a need for methods and apparatuses that can improve the likelihood of success when inserting a needle into a patient. Such methods and apparatuses can offer many advantages. For example, they may help a provider locate a vein (or another target), help to ensure that the needle is not inserted too deeply nor too shallowly, help to ensure that the needle is inserted at an appropriate angle, and so forth. In some embodiments, an insertion device can be relatively simple and low-cost, for example consisting entirely or substantially entirely of mechanical components. In some embodiments, an insertion device can include one or more electronic components, for example for measuring needles (which may be done using 1) mechanical means, such as a mechanical sliding mechanism, 2) optically, for example using a laser, or 3) via ultrasound, using a printed circuit board with sensors thereon), or for setting needle insertion angles. In some embodiments, the apparatuses and methods herein can be manual, mostly manual, partially automated, mostly automated, or fully automated (for example, the actual insertion of the needle may be automated). And may have WIFI connection with the ultrasound probe.

[0471] The apparatuses and methods described herein can be used in a wide variety of circumstances, but they may be especially useful for difficult patients, such as patients who receive chemotherapy, suffer from atherosclerosis, or who are intravenous drug users who have veins that are easy to find, but difficult to insert into due to scarring. Some patients may be difficult due to swelling or obesity. In some cases, intensive care patients and / or trauma patients can present difficulties for needle insertion. While the description herein primarily discusses inserting needles into veins, such descriptions are for illustrative purposes only and should not be interpreted in a limiting manner. The apparatuses and methods described herein can be used for a variety of procedures such as, for example, thoracentesis, paracentesis, placing a central line, placing an arterial line, or other procedures that require or benefit from accurate needle placement. The methods and apparatuses herein can be used by physicians, nurses, phlebotomists, veterinarians, and so forth. Moreover, the systems, methods, and devices herein are not limited to human usage and may be used for accurately placing needles or catheters in pets, livestock, and other animals.

[0472] The systems, methods, and devices described herein can have many advantages and can be used in a wide variety of procedures. For example, some embodiments described herein can be used with bare needles or with needles with catheters. Thus, embodiments herein can be used to facilitate blood draws, sample collection (e.g., for biopsies), peripheral catheter insertion, central catheter insertion, and so forth. For example, some embodiments can release the needle to allow the needle and / or insertion device components to be removed while a catheter stays in place in the patient.

[0473] FIG. 1A1 shows an example embodiment of an insertion device 100. The insertion device 100 can have a base 102. A stabilization channel (or stabilization hole or finger grip) 104 can be attached to or can be a part of the base 102. The stabilization hole 104 can be placed in a variety of locations, for example in the front, in the rear, or at the side of the insertion device 100, and can be placed in any desired orientation, for example horizontal or vertical. In some embodiments, the stabilization hole 104 can be designed to receive a finger (e.g., an index finger) of a user. While the stabilization hole 104 shown in FIG. 1A1 is designed to accommodate a single finger, in some embodiments the stabilization hole 104 can accommodate multiple fingers. For example, the stabilization hole 104 can have an ovoid shape to allow additional fingers to fit in the stabilization hole 104, for example two fingers, three fingers, four fingers, or five fingers. The insertion device 100 can include an ultrasound mount 106 for mounting an ultrasound transducer to the insertion device 100. In some embodiments, an ultrasound transducer can fit into the ultrasound mount 106 and can be held in place by friction. In some embodiments, screws, clamps, and so forth can be used to hold the ultrasound transducer in place. In some embodiments, the ultrasound mount 106 can be formed to receive a particular type of transducer (e.g., a particular model or range of models from a particular manufacturer). In some embodiments, the ultrasound mount 106 can be shaped to accommodate a variety of different ultrasound transducers having different shapes and / or sizes, for example using adapters having an outer surface that conforms to the shape of the ultrasound mount 106 and an inner surface that conforms to the shape of the ultrasound transducer. As discussed in more detail below, in some embodiments an ultrasound mount 106 can include components for selfcentering an ultrasound transducer, which can enable the use of a wide range of ultrasound devices. In some embodiments, the ultrasound mount 106 can be modified, for example to accommodate a smartphone with an ultrasound adapter affixed thereto. It will be appreciated thatthe placement of the ultrasound mount 106 with respect to the other needle insertion components can be different from what is shown in FIG. 1A1. For example, the ultrasound mount 106 can have a different orientation, such as rotated by 90 degrees.

[0474] The insertion device 100 can have a tower 108 affixed to the base platform 102. In some embodiments, the tower 108 and the base 102 can be formed from a single piece, or they can be different pieces. The insertion device 100 can have a rail 110 affixed to a top portion of the base 102. The insertion device 100 can also have an insertion ruler 112 parallel to the rail 110. The insertion ruler 112 can be printed onto (e.g., with an ink or dye, or a raised portion that is 3D printed or molded) or embossed into the base 102 of the insertion device 100. The insertion ruler 112 can indicate a depth to which a needle can be inserted, as explained more fully below.

[0475] The insertion device 100 can include a movable angle fixture 114. The angle fixture 114 can be movably coupled to the rail 110. In some embodiments, a screw, lever, or similar mechanical mechanism can be used to limit the movement of the angle fixture 114 along the track 110. The insertion device 100 can include a needle stop 118 having stop tabs 120. The stop tabs 120 can prevent further forward and / or downward movement of a needle when the stop tabs 120 hit the edge of the tower 108. In some embodiments, the needle stop 118 can have markings that indicate a needle length. In some embodiments, the insertion device 100 can include a needle support arm 122 that can be used to allow the insertion device 100 to accommodate a wide range of needle lengths. For example, the bevel of the needle can push the needle support arm 122 down. Once the needle tip hits the point of insertion (which may be indicated by a block that can be removed prior to using the device on the patient), the needle support arm 122 can be locked in place relative to the needle stop 118, thereby calibrating the device for the part icular needle being used. Alternatively, a user can push the needle support arm 122 down to a set (e.g., premeasured for a particular needle length) point on the needle stop 118 and then lock the needle support arm 122 to the needle stop 118. The needle support arm 122 can be held in place with a thumb screw 124 or another fastener) that holds the needle stop 118 and the needle support arm 122 together. In some embodiment there is only one specific needle length and the user does not have to calibrate. In this case, 122 can be permanently fixed to 118 . there won’t be a need for a thumb screw. While the needle support arm 122 and stop tabs 120 are shown in front of the ultrasound probe in this embodiment, in some embodiments, the needle support arm 122 and stop tabs 120 can be placed on a narrow side of the ultrasound probe, which may save space. In someembodiments, the needle support arm 122 can have an alignment hole 126 (which can, in some embodiments, align with a needle guide portion 138 of the angle fixture 114, as shown in FIGS. 3A and 3B). In some embodiment, the needle can be held with a clamp or another fastener and alignment holes are not necessary. In some embodiments, a movable lever or pull 130 can be affixed to the needle support arm 122 and can be used to allow or to prevent the free movement of the needle.

[0476] During insertion, the needle support arm 122 slides down along the angle fixture 114. For the device 100 shown in FIG. 1A1, the maximum needle depth is about 3 inches. This can cover most cases; however, some procedures require deeper depths. For example, a needle biopsy of the liver requires at least a 6-inch depth (larger patient would require even deeper depths). To accommodate these depths, the device base 102 may be elongated to accommodate a taller tower 108 and a longer angle fixture 114. Alternatively, a depth extension device 115 may be attached to device 100, and it includes an extension tower 115B extending from a base extension 115A. An elongated angle fixture extension 115C is supported by the extension tower 115B. The needle support 122 can now accommodate a much longer needle and, consequently, a much deeper insertion depth.

[0477] As shown in FIGS. 2A, 2B, and 2C, in some embodiments the insertion device can have a base 102 and a tower 108. In some embodiments, the tower 108 can be removable. For example, as shown in FIG. 2B, in some embodiments the base 102 can include a post 134, and the tower 108 can slide over and be supported by the post 134. Such an arrangement can have several advantages. For example, different posts can be used for different situations, more compact packaging can be used, and the risk of damage during shipping or handling can be reduced. In some embodiments, the tower 108 can be straight. In some embodiments, the tower 108 can be curved. The base 102 includes a channel or opening 132 that facilitates removing of the insertion device 102 while the needle is still in the patient or after a catheter or line has been inserted into the patient. The channel 132 can be wide enough to accommodate a range of gauges, catheter diameters, etc.

[0478] FIGS. 3A and 3B show example embodiments of an angle fixture 114. The angle fixture 114 can have a coupling portion ( or track, rails, gears) 146 that can couple the angle fixture 114 to the rail 110 of the base 102. The shape of the coupling portion 146 can conform to the shape of the rail 110 such that the angle fixture 114 can slide in one dimension along the rail, trackgears 1 10 (e.g., in one dimension or substantially in one dimension). The angle fixture 114 can have a rail 136. The rail, track, gears 136 can operate as a guide for the needle stop 118. The angle fixture 114 can have a needle guide portion 138 that can receive a needle and helps to control the movement and positioning of the needle. As shown in FIG. 3A, in some embodiments, the needle guide portion 138 can be open at the bottom. Such a configuration may be desirable if, for example, a practitioner would like to manipulate the needle to a lower angle during a procedure, for example when inserting a catheter. In some embodiments, the opening location can allow the insertion device 100 to be lifted away from the patient while the needle (or, for example, a catheter) is still in the patient. Alternatively, the angle fixture 114 can have a needle guide portion 138 configured with an upward opening, as shown in FIG. 3B. Such a configuration can be desirable in some cases because it can offer improved stability, although such a configuration may reduce the range of motion of the needle, which can be undesirable for certain procedures. In some embodiment where the needle is held tightly to the needle support arm 122 with clamps, levers, or ties rendering these guides 138 unnecessary.

[0479] FIG. 4 depicts an example needle stop 118 according to some embodiments. The needle stop 118 includes a coupling portion 140 that can movably couple to the rail 136 of the angle fixture 114. The needle stop 118 can have a rail 142 for coupling to a needle support arm 122. The needle stop 118 can have markings 144 that indicate the length of a needle being used with the insertion device 100. As discussed above, a user can set a pre-determined needle size or can calibrate the device by measuring the needle to locking components in place. Or the user has no option, and the needle stop will only have one number for one specific needle size. In this case, needle stop 118 will be permanently glued to needle support arm 122. This will cause less confusion and user error.

[0480]

[0016] FIGS. 5 A and 5B depict an example needle support arm 122 according to some embodiments. The needle support arm has a coupling portion 146 for coupling to the rail 136 of the needle stop 118. The needle support arm 122 has a thumbscrew hole 148 for receiving thumbscrew 124 for immovably coupling the needle support arm 122 and the needle stop 118 (for example, after the needle support 122 has been positioned relative to the needle stop 118 appropriately for a particular needle length). In some embodiments, a user of the insertion device 100 can position the needle support arm using the markings 144 on the needle stop 118 and the position indicator 150 on the needle support arm 122. The needle support arm 122 can have aneedle receiving portion 152. However, if the needle is held tightly to the needle support arm 122, using screws, clamps, pins, levers or any other fastener, 152 will not be necessary. In some embodiments, a needle can rest on a support platform 154, which can help to keep the needle properly aligned during a procedure. A clip or stop 158 can be used to prevent the needle from coming out of the opening in the support platform 154. The stop 158, when removed, can free a catheter from the device.

[0481] In some embodiments, the insertion device 100 can be designed to operate at a fixed angle, which can be defined by the angle fixture 114. For example, as shown in FIG. 6, an angle fixture 114 can be configured to facilitate insertion at an angle 9. In some embodiments, the angle fixture 114 can be replaced by a user with another angle fixture 114 at a different angle. In some embodiments, an insertion device 100 can be provided as a kit and can include one or more angle fixtures 114 to enable a provider to insert a needle at a desired angle. For example, in some cases, it may be desirable to insert a needle at a relatively shallow angle. For example, for a typical venipuncture procedure, a relatively shallow insertion angle can reduce the likelihood of the needle going through the vein. However, a steeper angle may be advantageous when inserting the needle relatively deeply into the patient.

[0482] FIGS. 7A and 7B illustrate an example process 700 for configuring and using the insertion device 100. Depending on the embodiment, the process of FIGS. 7A and 7B can include fewer or additional steps, and / or steps may be performed in an order different than is illustrated. At 702, the insertion device 100 is in an initial state with the angle fixture 114 pushed to its maximum extent forward (i.e., closest to the ultrasound mount 106). The needle stop 118 is positioned such that the stop tabs 120 are in contact with the tower 108. The needle support arm 122 can be positioned at its maximum needle size. At 704, a user can measure a needle by inserting the needle into the needle support arm 122 and then pushing forward and down until the tip of the needle hits the stop 158. The stop 158 can be part of the packaging but generally will not be present when the insertion device 100 is placed on the patient. The user can tighten the thumbscrew 124 to secure the needle support arm 122 to the needle stop 118 at the appropriate location for the length of the needle.

[0483] At 706, the user can set the insertion depth by sliding the angle fixture 114 back away from the ultrasound mount 106 and away from the tower 108 to an appropriate depth as indicated by the insertion ruler 112. Once the angle fixture 114 is positioned to give the desired insertiondepth, the user can lock the angle fixture 114 in place using the thumbscrew 156. At 708, the user can slide the needle stop 118 forward and downward along the angle fixture 114 until it is stopped by the needle stop tab 120 contacting the tower 108, at this point the needle is at the center of the target, to insert the needle at the desired depth into the patient, the needle being inserted below the ultrasound mount 106 (and the ultrasound probe that can be placed therein and used to measure a depth to a vein or other target). At 710, the user can release the latch 130 from the needle support arm 122, thereby enabling the angle to be manipulated by the user. For example, a user may reduce the angle of the needle with respect to the surface of the patient, for example to facilitate insertion of a catheter. At 712, the user can remove the insertion device 100, and can leave the catheter, needle, etc. in place in the patient, as desired.

[0484] In some embodiments, the user may know the needle length (for example, the user may typically use only particular lengths of needle, or the length may be indicated on the packaging of the needle), and thus the user may skip the needle measurement at step 704 and can instead set the needle length by adjusting the needle support arm 122 until the position indicator 150 points to the appropriate needle length on the markings 144 of the needle stop 118. In some embodiments discussed above, there is only one needle size and therefore there is no need to adjust the needle support arm. In some embodiments, a user can measure the needle. As discussed above, a block included in the packaging can be placed so that the needle hits the block during a measurement process. In some embodiments, the block can be level with the bottom surface of the base 102, while in other embodiments the block can be at a distance below the bottom surface of the base 102. For example, an insertion device 100 can have a minimum insertion depth that can be indicated on the insertion ruler 112. Thus, it may be desirable for the block to be positioned below the base 102 to account for said minimum insertion depth. In some embodiments, the insertion ruler 112 and / or markings 144 can be adjusted as appropriate to account for any insertion depth offset. When a target (e.g., vein) is extremely shallow, the needle support arm 122 can be moved up (e.g., closer to the practitioner or farther from the patient), while other components are locked into position, thereby accommodating a shallower insertion.

[0485] FIG. 8 depicts another example process for using an insertion device according to some embodiments. Depending on the embodiment, the process of FIG. 8 can include fewer or additional steps, and / or steps may be performed in an order different than is illustrated. As shown in FIG. 8, at block 802 the user can begin by placing the device 100 into an initial state.For example, an initial state can include moving the angle fixture 114 forward to the shallowest insertion depth as indicated by the insertion ruler 112, sliding the needle stop 118 up the rail so that the stop tabs 120 are away from the tower 108, moving the needle support arm 122 to the maximum length position (although if a user knows that the needle is fairly short, the user may choose not to start in a maximally extended position), and so forth. At block 804, the user can place an ultrasound probe in a sterile bag 162 (which can be attached to the insertion device) and can secure the probe in the ultrasound mount 106. The user can, at block 806, don sterile gloves. At block 808, the user can measure the needle length. For example, the user can insert the needle through the needle receiving portion 152 of the needle support arm 122 until the hub of the needle (e.g., the larger part of the needle at the proximal end) hits against the support platform 154. The user can continue pushing the needle forward and downward, causing the needle support arm 122 to slide along the rail 142 of the needle stop 118 until the distal end (e.g., tip) of the needle encounters an obstacle and can no longer move. Once the needle can no longer move, the user can tighten the thumbscrew 124 to fix the needle length at step 810. At step 812, the user can place the insertion device 100 on the patient and, at block 814, the user can identify a target inside the patient using the ultrasound probe. The ultrasound probe can be used to provide an indication of the depth of the target. After determining the depth of the target, the user can, at block 816, set the insertion depth by adjusting the angle fixture 114 to the desired insertion depth as indicated by the insertion ruler 112. The user can then lock the angle fixture 114 in place using the thumbscrew 156. In some embodiments, the insertion depth can be from about 0.5 cm to about 4 cm, for example from about 0.7 cm to about 2 cm.

[0486] At block 818, the user can insert the needle, pushing the needle support arm 122 and the needle stop 118 down the rail 136 of the angle fixture 114 until the stop tabs 120 of the needle stop 118 collide with the tower 108. Thus, the user can be prevented from inserting the needle to a depth greater than what the user selected when setting the insertion depth at block 816. At block 820, the user can release the movable lever / pull 130 such that, at block 822, the user can lift away the insertion device 100 while leaving the needle in place. The user can then, at block 824, perform any remaining procedure steps. For example, a user can angle the needle down and advance a catheter over the needle and then retract the needle and connect the catheter to an intravenous line.

[0487] As mentioned briefly at block 804 of FIG. 8, an ultrasound probe can be placed into a sterile bag to prevent contamination. An example is depicted in FIG. 9. As shown in FIGS. 9 -11, an insertion device 100 can be inside packaging 160. A bag 162, which may be open at both ends or open at one end, can be placed in the ultrasound mount 106 beforehand so that the insertion device 100 can receive an ultrasound probe in the ultrasound mount 106 without contamination. In some embodiments, one of end of the bag 162 can be affixed (e.g., glued) to the ultrasound mount 106, and the other end can have a handle 164 affixed (e.g., glued) thereto, the handle having an access hole 165. The handle 164 can include a sterile portion and a dirty portion that can be handled by a user to facilitate placement of the bag. In some embodiments, a user can use the handle 164 to pull the bag 162 over the ultrasound probe and cord (via the access hole 165) and can tie off the bag 162 prior to using the insertion device 100 to perform a procedure on a patient. This allows the probe to remain sterile and minimizes the time necessary to perform procedures - it can take three minutes or more to sterilize an ultrasound probe.

[0488] The example embodiment illustrated in FIG. 1A1 has many advantages, such as mechanical simplicity, which can reduce manufacturing costs and potential defects. However, the example embodiment shown in FIG. 1A1 can also have some drawbacks, such as difficulty in precisely setting the insertion depth by sliding the angle fixture 114 along the rail 110. In some embodiments, a gear system can be used to facilitate setting insertion parameters with greater accuracy and / or precision. This is demonstrated in FIG. 39A with a gear system.

[0489] A geared device can offer several advantages. For example, for a fixed angle configuration, the needle can be pulled back away from the probe in order to insert a needle more deeply into the patient (e.g., to hit a deeper target), as illustrated in FIG. 38, where a needle pierces the skin are at a first distance LI from the ultrasound probe to hit a first target a distance DI below the skin, and pierces the skin at a distance L2 from the ultrasound probe in order to hit a second target a distance D2 below the skin. A geared mechanism can ensure that the proper geometry is maintained (e.g., for an isosceles triangle, that two sides remain of equal length). For example, as a needle is moved closer or farther from the ultrasound probe, it can simultaneously be moved vertically. Such a configuration can be easier to use and can result in fewer errors as compared to a device in which a user manually and separately sets horizontal and vertical positions of a needle.

[0490] The embodiments described above provide simplicity and ease of use, which can be important in some situations, such as when patients are uncooperative or when time is of the essence. However, the embodiments described above offer limited flexibility. For example, the angle of insertion is generally fixed, although in some embodiments a user could swap out the angle fixture 114 for a different angle fixture that is configured to insert a needle at a different angle. In some embodiments, the insertion angle can be adjustable by the user. For example, the insertion angle can be continuously adjustable over a range of insertion angles, or an insertion angle can be selected from a discrete set of insertion angles.

[0491] FIGS. 12-13 show an example embodiment of a device with a continuously adjustable insertion angle. The device 300 can include a base 302, a swing arm 310, a main needle carriage 312, and a needle support carriage 314. Some embodiments can include additional features, such as an insertion stop to limit the insertion depth of the needle.

[0492] As shown in FIGS. 12 and 14, the base 302 can include various features that are similar to or the same as those of the base 102 of the insertion device 100. For example, the base 302 can include a stabilization hole 304 and an ultrasound mount 306 that are similar to or are the same as the stabilization hole 104 and the ultrasound mount 106, respectively, in FIG. 1A1. The base 302 can include an arm receiver 308 for coupling to a swing arm 310.

[0493] As shown in FIG. 12, a swing arm assembly can include a swing arm 310, a main needle carriage 312, and a needle support carriage 314. The swing arm 310 can include a pivot attachment 316 for coupling to the arm receiver 308. A thumbscrew 318 (FIG. 15) can be fed through the arm receiver 308 and screwed into the swing arm 310. A user can loosen the thumbscrew 318 to adjust the angle of the swing arm 310, and the user can tighten the thumbscrew 318 to secure the swing arm 310 at a desired angle (which can, in some embodiments, correspond to an insertion depth).

[0494] The main needle carriage 312 can be movably coupled to the swing arm 310. For example, a user can slide the main needle carriage 312 along a track of the swing arm 310. The main needle carriage 312 can include a lever 320 for securing the main needle carriage 312 in place along the swing arm 310. In some embodiments, the lever 320 can instead be a thumbscrew or other means for immovably affixing the main needle carriage 312 to the swing arm 310. In some embodiments, the lever 320 can be omitted, for example if there is sufficient friction between the main needle carriage 312 and swing arm 310 to prevent undesirable motionof the main needle carriage 312 during use of the device 300. In some embodiments, the main needle carriage 312 can include a marker, and the user can adjust the position of the main needle carriage 312 relative to the swing arm 310 to limit the insertion depth. In some embodiments, the needle support carriage 314 can slide along the main needle carriage 312 toward the patient to help guide and / or stabilize the needle.

[0495] 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 in place relative to the main needle carriage 312 with a lever 322. In some embodiments, the main needle carriage 312 can include markings that indicate a maximum insertion length of the needle, which may help to prevent inserting a needle too deeply into a patient.

[0496] In some embodiments, the insertion angle can depend on the insertion depth. For example, if a needle is to be inserted relatively deeply into a patient, then the insertion angle can be steeper than it would be in a scenario in which the needle is to be inserted to a relatively shallow depth. In some embodiments, a user can begin an insertion process by measuring a depth of a vessel, tumor, or other target area. The arm receiver 308 can, in some embodiments, be labeled with insertion depths (as opposed to, or in addition to, angles). A user can rotate the swing arm 310 until the correct insertion depth is indicated on the arm receiver 308. The user can then lock the swing arm 310 into place. After locking the swing arm 310 in place, the user can then 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 a maximum depth and cannot continue moving after inserted to the desired depth. Advantageously, such a configuration can prevent a needle from being inserted too deeply and potentially piercing through the other side of a blood vessel (e.g., when inserting a catheter) or exiting a tumor and entering healthy tissue (e g., when performing a biopsy).

[0497] FIGS. 16-18 shows an exploded view of the swing arm 310, the main needle carriage 312, and the needle support carriage 314.

[0498] FIGS. 36A-36K illustrate an example procedure for using the device 300. In FIG. 36A, the user can open the levers to allow for 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 as indicated by the markers on the swing arm 310. For example, FIG. 36A shows an insertion depth of 5mm. As shown in FIG. 36B, the user can lift the lever to lock the main needle carriage 312 inplace after setting the depth. In FIG. 36C, the user can loosen the thumbscrew 318 and can lift or lower the swing arm 310 to the correct depth indicated on the pivot attachment 316. For example, as shown in FIG. 36D, the swing arm 310 is positioned at the “5” marker on the pivot attachment 316, indicating a 5mm insertion depth. As shown in FIG. 36E, the user can add the needle so that the needle hub rests on the needle support carriage 314 and goes through the hole in the main needle carriage 312. In FIG. 36E, the main needle carriage 312 is locked while the needle support carriage 314 is moveable. FIG. 36F shows the needle in the main needle carriage 312. As shown in FIGS. 36G and 36H, the user can carefully move the needle support carriage 314 forward until the needle tip is aligned with a metal bar in the base of the device. The user can then lock the needle support carriage 314 in place. As shown in FIG. 361, the user can release the level for the main needle carriage 312 to allow it to slide along the swing arm 310. The user can thus advance the needle forward until the main needle carriage 312 encounters the end stop of the base, as shown in FIG. 36J. FIG. 36K shows a side view of the device when the main needle carriage 312 has been fully advanced.

[0499] While the device 300 allows the angle of the needle to be easily modified to accommodate a range of insertion depths, configuring the device can potentially be cumbersome. For example, as explained above, a user can set the insertion depth twice, once using the pivot attachment 316 and thumbscrew 318, and once using the swing arm 310 and main needle carriage 312, which can add complexity and introduce potential room for error. Accordingly, some embodiments can use an alternative system for affixing and adjusting a swing arm.

[0500] For example, in some embodiments, an insertion device can use a pinion system for altering the angle of the swing arm 310. For example, as shown in FIG. 19, the arm receiver 308 can comprise a rack or a grooved surface 324, and the thumbscrew 318 can be replaced by an adjustment knob 326 having a pinion 328, as shown in FIG. 20.

[0501] 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 can be coupled such that a user can set more than one relevant parameter by performing only one adjustment on the device. For example, a user may alter the angle of the swing arm 310, and the main needle carriage 312 may move in response.

[0502] FIGS. 21-24 illustrate example embodiments of an insertion device that can automatically adjust the position of the main needle carriage 312 in response to a change in angle of the swingarm 310. FIGS. 21 and 22 illustrate views of an embodiment in which a belt 330 is coupled to an adjustment knob 332 for changing the angle of the swing arm 310. The belt 330 can be mechanically coupled to the main needle carriage 312 such that as the adjustment knob 332 is rotated, the belt 330 can move the main needle carriage 312. In some embodiments, the belt 330 can include a stop 334 that can help to prevent movement of the main needle carriage 312 along the swing arm 310.

[0503] While FIGS. 21 and 22 illustrate the use of a belt 330 to couple the adjustment knob 332 and main needle carriage 312, other configurations are possible. For example, as shown in FIGS. 23 and 24, some embodiments of an insertion device can include a worm drive 336 such that when a user turns the adjustment knob 332, the worm drive 336, which is coupled to the adjustment knob 332 and the main needle carriage 312, and causes the main needle carriage 312 to move linearly along the swing arm 310.

[0504] By coupling the angle adjustment and the positioning of the main needle carriage 312, a user can more easily configure the device for insertion of a needle to a desired depth, which can reduce the risk that the user configures the device incorrectly and, for example, sets the maximum insertion depth too great (such that the needle passes through the target inside the patient) or too short, such that the needle fails to reach the target.

[0505] In some embodiments, a user can adjust an insertion angle by moving a piece linearly instead of, for example, rotating a knob or manually tilting a swing arm. FIGS. 25 and 26 illustrate an example embodiment of a structure or device 400 that can be used for adjusting needle insert parameters (e.g., insertion angle, insertion depth). The structure or device 400 can be attached to a base (not shown), such as a base that is similar to or the same as the base 102 or base 302 of previously discussed embodiments.

[0506] The structure or device 400 can include a vertical post 402 having a vertical groove through which an adjustment control 404 can pass. A user can lift or push down the adjustment control 404 and cylinder 406 to change the angle of an arm 408 and thereby to control the insertion depth of the needle. The user can lock the adjustment control 404 to prevent further movement of the arm 408. The structure can include a moveable needle carriage 410 slidably coupled to the arm 408. The arm 408 can have a stop 412 coupled thereto that can stop further movement of the moveable needle carriage 410.

[0507] In some embodiments, an insertion procedure can include measuring the needle length by inserting the needle into the needle holder and pushing down until the needle stops moving. The user can then lock the needle holder 414 to the needle carriage 410, for example using a thumbscrew or lever. Next, the user can find the depth of a target (e.g., vessel, tumor, and so forth). 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 410 can slide along the arm 408. When the user pushes the needle carriage 410, The needle carriage 410 will be stopped from moving further once the needle carriage 410 hits the stop 412.

[0508] While the adjustable embodiments described above offer flexibility to physicians and other health practitioners, in some circumstances health professionals may find setting up some embodiments to be cumbersome, difficult, time-consuming, etc. Thus, there can be a need for a device that offers a degree of adjustability while also being easy and fast to configure. In some embodiments, an insertion device can be configured to allow a user to select between a variety of insertion angles and / or insertion depths quickly.

[0509] FIGS. 27A and 27B show an example embodiment of an insertion device that facilitates easy adjustment of the insertion depth of the needle. As shown in FIG. 27A, an insertion device can have a base 500. The insertion device can have movably coupled components of a post 502, needle pusher 504, and needle holder 506 that can be used to set the insertion depth of a needle and to hold a needle in place. The components 502, 504, and 506 can be held in place with respect to each other using lever locks 508 and 510. In some embodiments, other locking or securing mechanisms can be used such as, for example, thumbscrews. The components can rotate around an insertion depth selector wheel 512. The insertion depth selector wheel 512 can have a plurality of grooves cut therein that correspond to a plurality of insertion depths. A pin 516 (shown in FIG. 27B) can protrude from a side of the component 502 (or another component) and can fit into the grooves cut into the selector wheel 512. For example, the pin can be mounted in the component 502 using a spring such that the pin can move along the long axis of the component 502, thus enabling the pin 516 to slide in and out of the grooves in the insertion depth selector wheel 512. Advantageously, the grooves, the pin, and / or the spring can be configured so that the pin 516 does not come out of a groove unless the user of the insertion device wishes to change the insertion depth or angle. In some embodiments, an insertion device may include amechanism such as, for example, a lever, that the user can manipulate to free the pin 516 from a groove in the insertion depth selector wheel 512. For example, as shown in FIG. 27B, the insertion device can include a slider 514 for manipulating a pin 516. The slider 514 can be coupled to the pin 516, for example by a rubber band, spring, or other suitable mechanism. In some embodiments, the slider 514 and pin 516 can be joined by a rigid body. The slider 514 can be configured such that, when it is not being manipulated by the user, it returns to a position near the distal end (e.g., closer to the needle tip) such that the pin 516 slides into a 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.

[0510] An insertion device as depicted in FIGS. 27A and 27B allows for rapid adjustment of insertion depth without the complexity involved in some implementations that enable arbitrary manipulations. The insertion depth selector wheel 512 can accommodate a wide range of preselected angles as may be appropriate for a variety of insertions. For example, the insertion depth selector wheel 512 can be configured to accommodate insertion depths and / or angles appropriate for narrow and / or deep insertions.

[0511] In some embodiments, the component 506 can be a needle holder and the component 504 can be a needle pusher. The needle pusher can have needle length markings thereon. A user can set the needle length using the needle length markings. The user can, in some embodiments, set the insertion depth by adjust the position of the needle holder. Once the user has set the needle length and insertion depth, the user can lock lever locks 508 and 510. The user can then insert the needle into the patient. The insertion can be limited by the needle stop 518, which can prevent the needle from being inserted too deeply into the patient.

[0512] FIGS. 28A-28F illustrate a process for using the apparatus shown in FIGS. 27A and 27B. In FIG. 28A, the needle holder 506 and needle pusher 504 can be positioned in a fully retracted position (e.g., all the way back on post 502). As shown in FIG. 28B, the user can open the lever on the pusher 504 to allow for movement of the pusher 504. As shown in FIG. 28C, the user can adjust the position of the needle holder 506 to set the needle length. In some embodiments, there will only be an option for one needle length. In this case the needle holder 506 and the pusher may be a unitary structure., preventing confusion and extra work for the user. As shown in FIG. 28C, the length can be set between 48mm and 65mm, although other ranges are possible, and this range should not be interpreted in a limiting manner. As shown in FIG. 28D, after setting theneedle length, the user can open the latch 520 and insert the needle. The user can close the latch 520 to secure the position of the needle. In some embodiments, the needle can be tightly secured to the needle holder 506 using clamps / ties / latchesand so latch 520 may not be necessary. As shown in FIG. 28E, the user can position the pin 516 with respect to the insertion depth selector wheel 512 (e.g., using the slider 514) so set an insertion angle of the needle. FIG. 28F shows the device when the needle is in an inserted state. The needle holder 506 and needle pusher 504 can be pushed forward (e.g., toward the patient) until the needle stop 518 contacts the needle pusher 504, thereby preventing further forward movement of the needle.

[0513] An insertion device can include a variety of additional features that can make the device easier to use, suitable for a wider range of applications, and so forth. For example, an insertion device may be configured to accept a range of needle diameters or gauges as may be used for different procedures. In some embodiments, an insertion device can be configured to accommodate a range of needle lengths, including, for example, short pediatric needles. Pediatric needles can be, for example, about 5 / 8”, about 1”, about 1 ’A”, and so forth. Thus, to work in an insertion device, the device should preferably be configured so that a long needle length is not needed. For example, the needle can advantageously pierce the patient’s skin very near to the ultrasound probe.

[0514] Different gauges of needles may be used for performing different procedures. In some cases, healthcare professionals may use a variety of ultrasound probes, which may have a range of shapes and sizes. Thus, it may be beneficial for an insertion device to have the capability to accommodate a variety of needle gauges and / or ultrasound probes as seen in FIG. 43F2. Such an adaptable device can have many advantages. For example, hospitals and other medical facilities can simplify their supply stock, manufacturers can produce fewer types of devices, and healthcare providers can more easily select an appropriate device, which may reduce waste due to inadvertently selecting an incorrect insertion device and / or may save time as there can be fewer insertion devices to select from.

[0515] FIGS. 29-33 show example embodiments of an insertion device with self-centering needle functionality. As will be discussed in more detail below, the embodiments depicted in FIGS. 29-33 can also include an ultrasound-transparent material, although other embodiments are possible. For example, an insertion device may have an opening to allow ultrasound waves to propagate into the patient and be received by an ultrasound transducer. In some embodiments, asdescribed above, a sterile bag can be fitted to the insertion device to ensure that only sterile components contact the patient.

[0516] As shown in FIG. 29, an insertion device can include a self-centering apparatus 600 positioned between and affixed to two towers. The self-centering apparatus 600 can include a spring locked latch 606 (as shown in FIG. 30) that can clamp down on a variety of needle types / gauges. In some embodiments, the ultrasound cavity 604 can also include self-centering functionality. For example, one or more sides of the ultrasound cavity 604 can be spring-loaded such that the forces of the ultrasound cavity 604 on the ultrasound probe are equalized (e.g., equalized in one direction) when the ultrasound probe is centered in the ultrasound cavity 604.

[0517] In some embodiments, as shown in FIG. 33, the self-centering apparatus 600 can include one or more slots configured to accept a matching needle of a particular size or range of sizes. For example, FIG. 33 depicts a self-centering apparatus 600 having slots of three different lengths to accommodate different needle sizes. The slots can act as a keying system to ensure that only the correct needles are used with the device.

[0518] As mentioned briefly above, in some embodiments, the bottom of the ultrasound cavity 604 can be open, while in others, the bottom of the ultrasound cavity 604 can be solid. If the bottom is solid, then the material should preferably allow ultrasound waves to penetrate with minimal distortion or absorption so that the image quality is acceptably reduced. In some embodiments, the bottom of the ultrasound cavity 604 can comprise a polyvinyl chloride polymer, polystyrene, poly (methyl methacrylate), glass, or other suitable material. In some embodiments, a groove or “V” shape can be cut into the base of the ultrasound cavity 604, which may allow a needle to be inserted closer to the center of an ultrasound probe (e.g., closer to the center of the ultrasound cavity 604), which can be especially important for shallower insertions. Such a configuration can facilitate the use of very short needles such as pediatric needles.

[0519] In some embodiments, one or more components can be motorized. For example, an insertion device can be configured with one or more motors that can be used to set insert angles, to advance the needle, to retract the needle, and so forth. Any of the embodiments described herein can be motorized or otherwise automated to improve ease of use, precision, accuracy, and so forth.

[0520] In some embodiments, an insertion device can be designed primarily or solely to be used in a motorized or automated manner.

[0521] FIG. 34 shows an example embodiment of a motorized insertion device 900. The motorized insertion device 900 can include a base 902, which can be similar to or the same as the bases shown in other insertion device embodiments described herein. The motorized insertion device 900 can include a motorized tower 904 that includes a shaft portion 906, an end cap 908, and a coupling mechanism 910. The coupling mechanism 910 can movably couple the motorized tower 904 to the base 902 and can be configured to allow the angle of the motorized tower 904 to be changed in an automated or semi-automated manner by a motorized mechanism inside the motorized tower 904. Electronic components (e.g., batteries, motors, communications interfaces (e.g., Bluetooth), etc.) can be housed inside the end cap 908. In some embodiments, the end cap 908 can be removed from the device after a procedure and can be reused in subsequent procedures. In some embodiments, the end cap 908 can be designed to withstand sterilization procedures. A motor inside the end cap 908 can have a screw-drive mechanism 911(which can be similar to, for example, lead screws in a 3D printer) mechanically coupled thereto as shown in FIG. 35 A, which may be used to advance the needle using the carriage 910. In some embodiments, the needle can be automatically retracted after insertion. In some embodiments, a spring-loaded mechanism can release the catheter, thereby leaving it inside the body, while the needle is retracted. FIG. 35B shows example needles and carriages that can be used in some implementations.

[0522] FIG. 37 shows another example of a motorized insertion device. The example shown in FIG. 37 can be broadly similar to the embodiment shown in FIG. 34. As shown in FIG. 37, a needle holder 920 can be configured to carry a needle assembly comprising a needle 914, a catheter sheath 916 surrounding the needle, and a receiver 918 for receiving the needle after use. After insertion, the device can be configured to automatically retract the needle from the patient into the receiver 918, leaving the catheter sheath 916 in place (e.g., partially inside the patient). A physician or other healthcare provider can then remove the insertion device and can secure the catheter and performs other steps as warranted for a particular procedure.

[0523] FIGS. 39A-39G illustrate a needle insertion device 1000 that includes a base 1010 with a patient contact surface 1011 on the underside. A finger grip 1014 may be used by the medical professional to stabilize the device 1000 onto the patient’s skin. The base 1010 has an ultrasound probe mount 1012 that is used to locate the vein and the vein depth. The base 1010 defines an insertion area 1007, where the needle 1005 will puncture the patient’s skin. An upperassembly 1030, which holds the needle 1005, is attached to the base 1010 at a fixed angle. The base 1010 may include a needle depth gauge 1015, with the upper assembly 1030 having a depth indicator 1020. The medical professional actuates the device 1000 by turning the actuation structure 1025 (shown as a wheel). It would be apparent that other structures may be used such as, but not limited to, a lever or a knob. The upper assembly 1030 comprises three main structures: (1) an upper assembly main support 1060 that can slide into a base groove 1062 located on the base 1010 (instead of a groove, a rail may be used); (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, and may be fixed to the support 1045 by tightening a lock thumbscrew 1055. The needle rack support 1045 and the needle carriage 1040 form the needle carriage assembly 1046.

[0524] In operation, the medical professional first locates the vein and its depth, then rotates the actuation structure 1025 until the depth indicator 1020 lines up with the proper depth on the needle depth gauge 1015; this is the depth setting configuration. To calibrate for an unknown needle length, the professional then inserts a needle 1005 into the needle carriage 1040 and slides the carriage 1040 relative to the needle rack support 1045 (see slide path 1050) until the needle tip is just touching the patient’s skin or a block. Or the professional may move the needle carriage 1040 along the needle rack support 1045 to a fixed premeasured needle length, imprinted on the needle rack support 1045, then locking these two structures to each other with the thumb screw 1055. The lock thumbscrew 1055 may be tightened, effectively fixing the movement of the carriage 1040 to the needle rack support 1045. Where there is only one needle size option, then needle carriage 1040 and rack support 1045 may be a unitary structure. By turning the actuator wheel 1025 counterclockwise (as viewed from the perspective of FIG. 39A), the needle rack pinion 1048 will engage the needle rack 1047, causing the needle carriage 1040 to move in the direction of arrow 1070 (towards the insertion area 1007), thereby inserting the needle tip into the patient’s skin. Simultaneous to this insertion, the base rack pinion 1067 engages the base rack 1065 causing the entire upper assembly 1030 to move in the lateral direction of arrow 1075 (away from the insertion area 1007). These two movements (1070, 1075) continue until the upper assembly 1030 travels across the base rack 1065 and stops, at which point the needle tip is at the depth previously set. This is the insertion configuration. Itshould be appreciated that during the depth setting configuration, the upper assembly 1030 and the needle carriage 1040 move in the opposite direction compared to the insertion configuration.

[0525] When inserting a syringe using the devices disclosed above, having the needle tip puncture the vein is sufficient to then allow the medical professional to inject the solution into that vein. If, however, the needle is to be used as a catheter once the needle punctures the vein it must “angle-down and move forward” to prevent the catheter from simply going through the vein entirely when the catheter is advanced over its needle. Moreover, this angling-down technique allows the medical professional to tape the catheter to the patient’s skin to prevent unintended movement. Like the previous embodiment, if the needle if fixed to 1046 using clamps, latches or any other fasteners, then the needle guide may not be necessary.

[0526] The embodiment shown in FIGS. 40A-400 implements this angle-down-moving forward motion. Needle insertion device 1100 is similar to insertion device 1000 but includes an angledown multi-channel guide 1170. Like device 1000, an 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, it is located on the actuation structure 1125. The operation of the device 1100 is similar to that of device 1000. The medical professional first locates the vein and its depth using the ultrasound probe 1112, then rotates the actuation structure 1125 until the depth indicator 1120 lines up with the proper depth on the needle depth gauge 1115. The professional then inserts a needle 1105 into the needle carriage 1140 such that the needle tip is just touching the patient’s skin, then fixes the needle 1105 to the carriage 1140. By turning the actuator structure 1125 counterclockwise (as viewed from the perspective of FIG. 40A), the needle rack pinion 1148 will engage 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 inserting the needle tip into the patient’s skin. Simultaneous to this insertion, the base rack pinion 1167 engages 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 travels across the base rack 1165 and stops, at which point the needle tip is at the depth previously set.

[0527] Once the needle tip is at the set depth, it has punctured the vein. Now the medical profession may angle-down and move forward the needle. First, the release button 1142 is depressed, which causes the release latch 1144 to swing (arrow 1145) out of the latch receiver 1150 located on the angle-down needle carriage 1149 (see FIG. 40H). Once the latch 1144 isdisengage from the carriage 1149, the carriage 1 149 is free to travel along the center channel in the center channel guide 1175, which then feeds into a channel on the angle-down multi-channel guide 1170. The complete movement is shown by path 1180, comprised of a center channel portion 1176A and a multi-channel guide portion 1170A. This is called the angle-down configuration.

[0528] The angle-down multi-channel guide 1170 contains several discrete channels 1185, each of which is linked to a particular needle depth. The shorter channels are for the deeper insertion depths and the longer channels for the more swallow insertion depths. The angle-down multichannel guide 1170 is attached to angle-down gears 1172 that rotates the guide 1170 so that it is at the precise discrete channel 1185 at the point where the needle punctures the vein. The center channel guide 1175 is separate from the angle-down multi-channel guide 1170 and does not rotate.

[0529] The embodiment shown in FIGS. 41A-41F also implements the angle-down motion. Needle insertion device 1200 includes a base 1203 with an underside 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 assemblyl205 with a needle 1210 is connected to a needle carriage 1207. Extending from the carriage 1207 is a needle carriage guide 1207.2 that slides into an insertion needle carriage channel 1230.4 and angle-down needle carriage channels 1230.5. These channels (1230.4, 1230.5) are located on the needle carriage multi-channel guide 1230. The insertion needle carriage channel 1230.4 defines an insertion angle 1245 (FIG. 41C) with the base 1203. This is the same angle that the needle (1205, 1210) defines with the base 1203 during the insertion configuration. Each of the angle-down needle carriage channels 1230.5 is connected to and contiguous with the insertion needle carriage channel (1230.4).

[0530] In operation, the medical professional first locates the vein 1235 and its depth, then sets the adjustable vein depth stop 1230.2 to the appropriate depth by aligning the depth indicator 1230.3 to the vein depth gauge 1230.1 on the multi-channel guide 1230. A needle (1205, 1210) is loaded onto the needle carriage 1207 and is slid in the direction of arrow 1207.1 until the needle carriage guide 1207.2 contacts the adjustable stop 1230.2. This is the insertion configuration. The needle tip is inserted into the vein 1235 at the needle insertion point 1240. Then, during the angle-down configuration the needle carriage 1207 is angled-down in the direction of arrow 1207.3 (FIG. 41D), reducing the needle insertion angle (see 1245 and 1250).For a deep insertion of 10-12mm (FIGS. 41 C and 41D), the angle-down channel 1230.5 is short, while for shallower insertion depth of l-3mm (FIGS. 41E and 41F), the angle-down channel used is longer. Once the needle is angled down, the medical professional can remove the cap on the needle assembly 1205 and insert the catheter.

[0531] The embodiment shown in FIGS. 42A-42L also implements an angle-down motion, but unlike the devices 1000, 1100, 1200, the insertion angle of device 1300 is not fixed. Rather, a multi-channel guide card 1310 is used that has several channels, one for each vein depth, each channel forming a different insertion angle with the base 1305. And like the device 1200, the needle carriage has a guide pin 1344 that travels in the selected channel. Specifically, the device 1300 has a base 1305 with a finger grip 1014 and ultrasound probe mount 1012. The base 1305 contains a guide card support 1330, a needle window 1320 and a needle anchor point 1345. The base 1305 also has a configuration of pin receivers 1340 that mate with mount pins 1335 on the underside of the ultrasound probe mount 1012. The configuration of pin receivers 1340 allows the ultrasound probe mount 1012 to be connected to the base 1305 in a first orientation 1325A or a second orientation 1325B. Guide pin 1344 is connected to the ultrasound mount. Therefore, to change the orientation, the user need only lift the ultrasound mount, dislodging it from the current set of mount pins, slide the guide pin 1344 along the channel 1342, and set the ultrasound mount onto the new set of mount pins 1335. (see FIGS. 42E and 42EE). The base 1305 may also have the pin receivers 1340A oriented in a different plane, as are the mount pins 1335 A on the ultrasound probe mount 1012 (see FIG. 42F). FIG. 42F also illustrates mount magnets 1338 that may be used instead of the mount pins (1340, 1340A), or in addition to the mount pins (1340, 1340A). Other fasteners such as clips or clamps may also be used in addition to, or instead of the pins and magnets. A needle 1302 is mounted to a needle carriage 1315, which has a needle carriage guide (pin) 1350 attached thereto, which travels within a channel in the multi-channel guide card 1310.

[0532] In operation, the medical professional first locates the vein and its depth, then selects a channel on the guide card 1310 that corresponds to that depth. The needle carriage 1315 is inside the channel and does not leave the guide card 1310. A needle 1302 is loaded onto 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 with its guide pin 1350 may move vertically in a channel, enter a horizontal perpendicular channel which correlates to the depthdesired, and then travel a slope and into the vein. The needle 1302 tip is positioned under the needle anchor point 1345. The needle carriage 1315 can now be moved along the channel, until the channel ends, indicating that the needle has reached the selected depth. In FIG. 42G2 illustrates the needle carriage 1315 with a wrap-around clip 1316. This stabilizes the needle carriage 1315 against the guide card 1310 as shown in FIG. 42G3. FIG. 42A illustrates the carriage and needle path (1317A, 1317AA) for a first channel that results in an ultimate needle depth 1318A. A shallower insertion angle results in a swallow insertion depth, as shown in the carriage and needle path (1317B, 1317BB) for a second channel that results in an ultimate needle depth 1318B.

[0533] An advantage of device 1300 is that it has no moving parts that may become jammed or slip and does not required alignment. This simplifies operation and manufacturing. It also results in a robust device that can be easily sterilized without sacrificing performance and accuracy.

[0534] The guide card 1310 may be simplified as shown in FIG. 42J to only include channels with a needle loading portion 1352 (where the medical professional can load the needle 1302 onto the needle carriage 1315) and a needle insertion portion 1355. The guide card 1310 may also be modified to include an angle-down portion. As shown in FIG. 42K1, the channels include needle loading portion 1352 (where the medical professional can load the needle 1302 onto the needle carriage 1315) a needle insertion portion 1355 followed by an angle-down portion 1360. FIG. 42K2 illustrates that a single channel may have its own angle-down 1360 / move forward 1365 portions; indeed, every channel may have its own angle-down 1360 / move forward 1365 portions.

[0535] FIG. 42L illustrates a guide card 1310 with several angle-down portions, and further includes a move forward portion. A guide pin path is dashed, and comprises a needle loading portion 1352, a needle insertion portion 1355, an angle-down portion 1360, and a move forward portion 1365. FIG. 42L illustrates four possible angle-down 1360 / move forward 1365 paths that each accommodates multiple insertion angles.

[0536] The embodiment shown in FIGS. 43A1-43K also implements a variable insertion angle, but unlike device 1300, a guide channel is not used. Specifically, device 1400 uses a depth cam 1410 fixed to a base 1405 to achieve the desired depth and angle. A swing arm assembly 1427 includes a needle (1422, 1437) mounted in the needle holder 1432 connected to a needle carriage(1435, 1465) that slides along slide arm 1480. The needle holder 1432 may use a self-centering polymer or drill chuck, or tapered key such as a modified tuohy borst adapter allowing a diversity of accepted needle types. For needles that do not have a catheter around them, including for example a central line or a biopsy needle, a hole and channel stabilizer 1467 may be used. Inserting the needle into the channel and through the hole will stabilize it.

[0537] The swing arm assembly 1427 has an angle position pinion 1430 that engages an angle position rack 1425 to change the angle of the swing arm assembly 1427 to the base 1405, which consequently changes the needle insertion angle. The movement of the swing arm assembly 1427 relative to the base 1405 is shown by arrow 1428. The needle carriage, which is part of the swing arm assembly 1427, has a needle insertion stop (1440, 1475) that may be shaped like a spear, that contacts the depth cam 1410 at a stop point 1436.1, preventing further insertion. The edge of the depth cam 1410 may have an anti-slip feature 1415 to prevent the carriage from slipping past the stop point, particularly on steep insertion angles. The feature may be teeth, ridges, a notch or slit (see FIG. 43B2).

[0538] As shown in FIG. 43 A2, the base 1405 may have a base insert receiver 1407.1 that hold interchangeable probe mount inserts 1408.1-1408.4. These inserts accommodate various type of ultrasound probes 1112. The material for 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 push the ultrasound probe down onto the patient skin to confirm if this is a vein or not. Or, the insert material may be rigid which may be advantageous when performing a biopsy. The mount may have a wedge / slit on the bottom that allows the needle to penetrate the patient’s skin without encountering a foreign substance (see FIGS. 45A-45C). A sound-conductive pad may be positioned underneath the probe mount inserts, and this insert may also have a needle insertion slit formed into the sound-conductive pad. The mounts may also have a bag attached to them to maintain sterility (See FIGS. 9 -11).

[0539] The outside perimeter of the depth cam 1410 has a unique shape that will ensure that a needle tip achieves the required depth. FIG. 43B3 illustrates how the perimeter of the depth cam 1410 is calculated. Chords 1410A are all the same length and all intersect at the needle insertion point 1407. By selecting a depth along the insertion point line 1420, placing the end of the fixed- length chord at that depth, and intersecting the needle insertion point 1407 (repeating this for several depths) the perimeter shape of the depth cam 1410 is calculated. Therefore, the depthcam 1410 correlates the needle insertion depth 1424 (FIGS. 43B1 and 43C1) to the insertion angle - steep insertion angles accommodate deep insertion, and shallow angles accommodate shallow depths. As illustrated in FIG. 43B1, the carriage paths 1436 for three insertion angles are shown. Each path 1436 has a different stop point 1436.1, resulting in different needle depths 1436.2 along the insertion point line 1420.

[0540] FIGS. 43C1-43C3 illustrate the details of the interchangeable arm receiver 1426.1, which include tracks 1426.2 on which a swing arm interface 1426.3 rides. A track tab 1426.4 extends from the swing arm interface 1426.3 and is disposed in the tracks 1426.2. A depth selection pinion 1430 may be uses to change the position of the swing arm 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, but the arm receiver 1426.1 need not have teeth and the depth selection pinion may be a wheel that rides across the perimeter surface of the arm receiver 1426.1. The interface 1426.3 may have a swing arm post 1426.5 onto which a swing arm 1426.6 may mount. If a different size swing arm is needed, the swing arm may be detached from the post 1426.5 and replaced with a new one. FIG. 43C3 illustrates the track horizontal displacement 1426.7 and the track vertical displacement 1426.8. These displacements may be different from each other, resulting in an oval or elliptical movement of the interface 1426.3 relative to the base. The track may also have a straight section, shown as a track horizontal displacement 1426.9. Because the arm receiver 1426.1 are interchangeable, a different track layout on a different arm receiver 1426. Imay be used with the same insertion device.

[0541] In operation the medical professional first loads the required needle inserting a nonadjustable needle carriage 1465 for the specific needle onto slide 1480 of the swing arm assembly 1427. This needle carriage 1465 has a small clip which allows it to remain at the distal end of the slide 1480. The medical professional then locates the vein depth and turns the depth selection pinion 1430 to the appropriate depth (see 1424). Turning the depth selection pinion 1430, moves the swing arm assembly 1427, including the slide arm 1480, up and increases the angle of insertion. The medical professional then applies a small downward force on the needle carriage 1465, which allows the needle carriage 1465 to slide down slide 1480 towards the patient’s skin, inserting the needle (1422, 1437) into the patient. The needle is pushed until the needle insertion stop 1475 hits the carriage stop point 1436.1, at which point the needle has achieved the selected depth, and the vein is punctured. If for example, the patient requiresanother procedure such as a central line, this needle carriage 1465 can be easily removed from the swing arm assembly 1427 and a replaced with a needle carriage supporting a central line. This interchanging of the needle carriage will only take seconds. Another type of needle carriage 1470 that accommodates a needle without a catheter, e.g. central line needles, biopsy needle, may be used.

[0542] Device 1400 can also be adjustable to accommodate a variety of needle lengths. Instead of using a carriage with a needle insertion stop 1475 that is nonadjustable, a adjustable needle insertion stop 1410 may be used. Again, the adjustable needle insertion stop 1410 may be shaped like a spear. Specifically, a method for needle and depth calibration is shown in FIG. 43D1. First, the carriage 1435 is placed in the horizontal position (step 1460.1). Then, a needle is inserted in the needle holder at step 1460.2. Then, the carriage 1435 is pushed along the slide arm 1480 until the tip of the needle contacts the needle calibration structure 1456 (step 1460.3). The needle carriage lever lock 1438 is locked at step 1460.4. Turning to FIG. 43B2 for a moment, the horizontal chord 1410B illustrates the horizontal placement of the needle in steps 1460.1-1460.4. This placement calibrates the fixed chord length of the depth cam 1410 to the needle of an unknown length. Returning to FIG. 43D1, the needle insertion stop 1440 is then inserted until it hits the edge of the depth cam 1410 (step 1460.5). The needle insertion stop 1440 is then fixed to the carriage by locking the needle insertion stop lever lock 1442 in step 1460.6. Finally, the needle carriage lever lock 1438 is unlocked allowing the carriage to be moved back (step 1460.7). Now, the needle length has been calibrated, and the device 1400 can be used as detailed above. Further, after insertion is complete, the medical profession can push the needle deeper while still at the same angle by releasing the stop lever lock.

[0543] The ability to accept a variety of needle lengths gives the medical professional ultimate flexibility. For example, in a trauma patient an IV line, a central line and an arterial line may all be needed for a single patient. Device 1400 accommodates all these insertions by accepting the carrier with a pre-set needle length and permitting a variable needle length. Thus, a professional may begin an insertion using a small needle, but may change the equipment when using a larger needle. Thus, one device 1400 can quickly convert to accommodate many needle procedures by simply removing one needle carriage and loading a different needle carriage. FIG. 43D2 illustrate the needle calibration for an adjustable plunger holder 1477 holding a plunger 1476. At Step 1, the carriage 1477.2 is placed in the horizontal position, and the carriage 1477.2 ispushed along the slide arm 1480 until the tip of the needle contacts the needle calibration structure 1456. It is optional at this point to lock the carriage 1477.2 to the slide arm 1480 by locking the needle carriage lever lock 1438. At Step 2, the needle insertion stop 1440 is inserted until it hits the edge of the depth cam 1410, and the needle insertion stop 1440 is then fixed to the carriage by locking the needle insertion stop lever lock 1442. At Step 3, the carriage 1477.2 may slide along the slide arm 1480 pulling the needle away from the calibration structure 1456, and the carriage 1477.2 may be locked to the slide arm 1480 by locking the needle carriage lever lock 1438. Now the professional can select the appropriate depth by turning the depth selection pinion 1430, and at Step 4 release the carriage lever lock 1438, allowing the carriage 1477.2 to slide along the slide arm 1480 puncturing the skin and reaching the vein. After insertion is complete, the medical profession can angle-down by releasing the needle insertion stop lever lock 1442.

[0544] FIG. 43F2 illustrates a variety of needle / catheter carriages that may be used with the same insertion device 1400. For example, the needle carriage 1470 with the fixed needle insertion stop 1475 may be used. The plunger 1476 and a plunger carriage 1477 containing a hole and channel stabilizer 1477.1 (FIG. 43F3), along with an adjustable needle insertion stop 1410 may be used. An automatic needle / catheter mount 1913 with an angle-down arch 1816 may be used (these features are described in more detail in FIGS. 49A-49G). And as shown in FIG. 43F4, a catheter 1826 on a catheter / needle mount 1813 connected to an angle-arch 1816 may be used (these features are described in more detail in FIGS. 47A-47E).

[0545] Device 1400 may also have a variety of finger grip 1014 locations and shapes, as shown in FIG. 43K. These locations and shapes may also be used with the other devices disclosed herein.

[0546] The embodiment shown in FIGS. 44A-44D illustrates a motorized insertion device 1500 with a base 1503. A needle 1515 may be mounted to a needle carriage 1505. A needle carriage worm drive 1520 connected to the needle carriage 1505 moves the carriage along the gear housing 1517 (FIG. 44B). A catheter carriage 1510 is likewise connected to a catheter carriage worm drive 1525, thus permitting movement along the gear housing 1517. A removable motor assembly 1530 contains three motors: a needle carriage motor 1535, a catheter carriage motor 1540 and an insertion angle motor 1545. The motor assembly 1530 may be fixed into place by a motor assembly lock 1550. The motor assembly 1530 may be removed to allow for sterilizationof the device 1500 without potentially damaging the electronic components. Preferably, the motors are step motors.

[0547] The device 1500 may also have linear position sensors 1560 to determine the position of the carriages (1505, 1510), and an angular position sensor 1565 to determine the angular position of the carriages (1505, 1510). As shown in FIG. 44E, the sensors (1560 and 1565) may feed information into the processor 1555. Also, the vein depth input device 1570 gives the vein depth as an input to the processor 1555. This input device 1570 may be a keyboard on which the medically professional manually enters the vein depth. Or, in another non-limiting example, the input device may be the ultrasound probe itself that reports the vein depth directly to the processor 1555. Other input devices may include, but are not limited to, a touch screen, a mobile phone, or a microphone. Next, the processor 1555 may calculate the optimal insertion angle and insertion depth and provide the appropriate instructions to the insertion angle motor 1545 and to the needle carriage motor 1535. The processor may also angle-down and move the needle 1515 forward after the insertion depth is achieved, also by instructing the insertion angle motor 1545 and the needle carriage motor 1535. Then, the catheter carriage motor 1540 may be actuated to insert the catheter into the needle.

[0548] FIGS. 45A-45C detail improvements that may be used with the insertion devices previously discussed. Device 1600 has an elevated ultrasound probe mount 1605 that allows the ultrasound probe to be placed at a distance from the patient’s skin. A sound-conductive material 1610 may be placed below the elevated probe mount 1605, and a needle slit / wedge 1615 may be cut out of the material 1610. The slit / wedge 1615 allows the needle 1620 to be closer to the ultrasound probe, which makes the device 1600 narrower and potentially more stable.

[0549] The use of the sound-conductive material 1610 negates the use of topical gels that are common in ultrasound practice. The commonly used gels provide good sound conduction for a reliable ultrasound reading. But as the needle travels through the gel during insertion, the gel enters the patient’s body and may cause irritation. The sound conducting pad of material 1610 satisfies the function of improving sound conduction, and the slit / wedge 1615 allows the needle to penetrate the patient’s skin without encountering a foreign substance. The sound conducting pad 1610 may or may not have the slit / wedge 1615. The sound conducting pad of material 1610 and the elevated ultrasound probe mount 1605 may be used on all the insertion devices discussed herein.

[0550] FIGS. 46A-46F illustrate a segmented robotic snake 1700 with an ultrasound probe segment 1710 and a needle insertion segment 1715. The snake is comprised of several segments 1705 each of which can move relative to the segments 1705 to which it is attached. The movement is driven by electronic motors in the segment 1705. As shown in FIG. 46 A, the robotic snake 1700 wraps around the injection target area of the patient 1725. The head segment 1720 includes several sensors such as a thermometer, projector, video camera, infrared sensor, venous scanner. The head segment 1720 can also have scalpels and other cutting implements. The needle insertion segment 1715 may be a part of the head segment 1720 or may be an independent segment. The robotic snake 1700 will maneuver itself in such a way that the ultrasound probe segment 1710 touches the patient’s skin to locate the target (such as a vein). Once the target is found, the robotic snake 1700 will maneuver its head segment 1720 toward the ultrasound probe segment 1710 (FIGS. 46B and 46C). A motorized version of the insertion devices discussed above may be attached to the head segment 1520, or may be in a separate needle insertion segment 1715. The head segment 1720 will connect with the ultrasound probe segment 1710 to stabilize the robotic snake 1700 position on the patient 1725 (see FIGS 46D- 46F). This connection is illustrated is a peg and hole 1735. The ultrasound probe segment 1710 may now guide the needle insertion segment 1715 to enter the target accurately and precisely. The needle insertion segment 1715 may have an antiseptic spray nozzle 1730 that sprays antiseptic in the injection area to keep the procedure sterile.

[0551] FIGS. 47A-47E illustrate another embodiment of a needle insertion device 1800 with an angle-down arch 1816. As in previous embodiments, device 1800 has a base 1802 with a depth cam 1814 having a perimeter that is constructed to correlate a needle insertion angle 1832 to an insertion depth, whereupon the perimeter stops 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 travels relative to the arm receiver along tracks 1426.2 (see FIGS. 43C1-43C3) and forms the needle insertion angle 1832 between the swing arm 1808 and the base 1802. The swing arm 1808 is capable of movement shown by arrow 1808.1, thus changing the needle insertion angle 1832. It should be noted that because a track system is used, the travel of the swing arm 1808 may be oval, elliptical or straight relative to the based 1802.

[0552] A needle carriage 1812 is slidably mounted on the swing arm 1808 and is capable of movement shown by arrow 1812.1. The needle carriage 1812 includes a needle insertion stop1809 that contacts the perimeter of the depth cam 1814 to restrict the slide movement 1812.1 of the needle carriage 1812 on the swing arm 1808. The needle carriage 1812 also has an angledown arch slot 1818. The arch 1816 also has a needle mount 1813 that holds a needle 1825 and catheter 1826. The needle mount 1813 may have a negative impression 1813.1 of the needle / catheter for a robust connection. Other mounting structure may be used, and may include, but are not limited to, clamps, ties and adhesives. This arch 1816 slides through the angle-down arch slot 1818 and is capable of movement shown 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 tip of the needle to the point where the needle is held onto 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 location when the angle-down arch 1816 slides through the angle-down arch slot 1818. Thus, the needle tip cannot slip out of the vein when the needle is angled down because its tip is always at the center of the radius and does not move.

[0553] As described above, when inserting a syringe using the devices disclosed herein, having the needle tip puncture the vein is sufficient to then allow the medical professional to inject the solution into that vein. If, however, the needle is to be used as a catheter once the needle punctures the vein it must “angle-down and move forward” to prevent the catheter from simply going through the vein entirely when the catheter is advanced over its needle. Moreover, this angling-down technique allows the medical 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 shown 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 other side of the vein. The arch 1816 completely guides the needle from start (the needle puncture to center of vein) to finish (advancing the catheter over its needle). The arch 1816 prevents the user from over / under angling down or going sideways which will dislodge the needle. This arch is specific for a specific needle length. The arch radius is the same length as the tip of the needle to the needle attachment point to the needle holder, maintaining the needle tip at the arch center when then arch rotates and angles down. Thus, no matter what depth the insertion point is, when the needle angles down, it will always will be at the center of the vein.

[0554] The needle carriage 1812 may have an arch lock 1820 that mates with lock receiver holes 1822 on the angle-down arch 1816. Other locking structures may be used, and may include, but are not limited to, clips, levers, latches and clamps. The lock 1820 prevents the movement of arch 1816, thereby preventing the arch 1816 from changing the insertion angle 1832 while the needle 1825 is being inserted. Once the needle insertion is complete, the lock 1820 is released and the insertion angle can be angled-down for catheter insertion. An arch manipulation structure 1830 such as a hole, a perpendicular ring attachment, or a handle may be used to slide the angle-down arch 1816 through slit 1818.

[0555] FIGS. 48A-48D illustrate another embodiment of a needle insertion device 1900 with an angle-down arch 1816, similar to the embodiment shown in FIG. 47A. However, this embodiment 1900 has a few improvements that make it automated. The angle-down arch 1816 has teeth 1918 that mate with a pre-tensioned pinion 1932 located on the needle carriage 1812. When the lock is released, the spring 1934 contracts pulling the needle carriage 1812 along the swing arm 1808 until the needle insertion stop 1809 hits the depth cam 1814. In turn, the release spear 1930 retracts contacting the latch 1931 and disengaging the latch 1931 from the pre-tension pinion 1932. The pinion 1932 rotates in the direction of arrow 1932.1 automatically driving the arch 1816 through the angle-down arch slot 1818 until the catheter insertion angle 1834 is achieved. Instead of a pre-tensioned pinion 1932, or in addition to a pre-tensioned pinion 1932, the device may have an arch spring 1933 as shown in FIG. 48D, which contracts automatically driving the arch 1816 through the angle-down arch slot 1818 until the catheter insertion angle 1834 is achieved.

[0556] The device 1900 also has an automatic needle / catheter mount 1913 that is illustrated in detail in FIGS. 49A-49F. In FIG. 49A, a cross section of the automatic needle / catheter mount 1913 is shown with a catheter spring 1940 connected to the catheter 1826 and a needle spring 1942 connected to the needle 1825. A spring trigger 1944 maintains both springs compressed when in the non-triggered configuration shown in FIGS. 49A and 49D. The spring trigger 1944 has a catheter spring window 1941 and a needle spring window 1943 shown in FIGS. 49B and 49C. Above the catheter spring window 1941 is a needle slot 1946 wherein the needle 1825 may travel during the transition to the triggered configuration. FIG. 49D illustrates the connection of the automatic needle / catheter mount 1913 to the angle-down arch 1816. FIG. 49E illustrates the movement of the spring trigger 1944 as shown by arrow 1944.1. Both springs also move, slidingalong spring support 1948. Once the spring trigger 1944 aligns the catheter spring 1940 with the catheter spring window 1941, the catheter spring 1940 decompresses (arrow 1940.1) applying an insertion force on the catheter 1826. The movement of the spring trigger 1944 also aligns the needle spring 1942 with the needle spring window 1943, the needle spring 1942 decompress (arrow 1942.1) applying an extraction force on the needle 1825. It is preferable to construct the windows such that the catheter spring 1940 triggers before the needle spring 1942. Also decreasing the tension of the needle spring 1942 as compared to the catheter spring 1940 may allow allowing the catheter 1826 to slide over the needle 1825 and lodge in the vein before the needle 1825 is retracted. Adding friction to the needle spring 1942 with a track, or a damper to the slow down the needle spring 1942 decompression may assist in this ordered insertion and retraction.

[0557] FIG. 49G illustrates the how the pre-tensioned pinon 1932 works in concert with the automatic needle / catheter mount 1913 to insert the catheter 1826 and extract the needle 1825. Once the medical professional determines the depth of the target using ultrasound, the professional turns the depth selection pinion 1430 to appropriate depth. The needle carriage lock 1820, this could be a pin, clip, lever, switch, is disengaged, causing the spring 1934 to contract pulling the needle carriage 1812 along the swing arm 1808 until the needle insertion stop 1809 hits the depth cam 1814. At this point, the release spear 1930 retracts and contacts the latch 1931, releasing the pre-tensioned pinion 1932. The pre-tensioned pinion 1932 then rotates in the direction of arrow 1932.1, propelling the angle-down arch 1816 through the angle-down arch slot 1818. The spring trigger 1944 is actuated by contacting 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 with their respective windows, allowing both springs to decompress, thus applying an insertion force on the catheter 1826 and an extraction force on the needle 1825. Thus the only thing the professional has to do is dial in the target depth and release the pin - the insertion device 1900 does everything else.

[0558] The angle down arch 1816, pre-tension pinions 1932 and spring 1934, along with the other automated features described above, can be used with the previous embodiments to automate the process, promoting accurate and repeatable catheter insertion.EXAMPLE OF EMBODIMENTS

[0559] Provided hereafter are non-limiting examples of certain embodiments of the technology.

[0560] Al . A needle insertion device (1000, 1 100), comprising: a base (1010, 1110) with a base rack (1065, 1165), the base (1010, 1110) defining an insertion area (1007); an upper assembly (1030, 1130), comprising: an upper assembly main support (1060, 1160) slidably connected to the base (1010, 1110); and a needle carriage assembly (1046) constructed to hold a needle (1005, 1105), wherein the needle carriage assembly (1046) is slidably connected to the upper assembly main support (1060, 1160), and comprises a needle rack (1047, 1147); an actuation structure (1025, 1125) mechanically connected to both: a base rack pinion (1067, 1167) that engages the base rack (1065, 1165); and a needle rack pinion (1048, 1148) that engages the needle rack (1047, 1147); and an insertion configuration, wherein actuating the actuation structure (1025, 1125) turns:(1) The needle rack pinion (1048, 1148), causing the needle carriage assembly (1046) to move towards the insertion area (1007); and(2) the base rack pinion (1067, 1167), causing the upper assembly main support (1060, 1160) to move away from the insertion area (1007).

[0561] A2. The needle insertion device of embodiment Al, further comprising a depth setting configuration, wherein actuating the actuation structure (1025, 1125) turns:(1) the needle rack pinion (1048, 1148), causing the needle carriage assembly (1046) to move away the insertion area (1007); and(2) the base rack pinion (1067, 1167), causing the upper assembly main support (1060, 1160) to move towards from the insertion area (1007).

[0562] A3. The needle insertion device of embodiment Al, further comprising a needle depth gauge (1015, 1115) and a depth indicator (1020, 1120), wherein the depth setting configuration continues until the depth indicator (1020, 1120) aligns with a desired depth on the needle depth gauge (1015, 1115).

[0563] A4. The needle insertion device of embodiment A3, wherein the needle depth gauge (1015, 1115) and the depth indicator (1020, 1120) are part of the upper assembly (1030, 1130).

[0564] A5. The needle insertion device of embodiment A3, wherein the needle depth gauge (1015, 1115) is part of the base (1010, 1110).

[0565] A6. The needle insertion device of any of embodiments A1-A5, wherein the base (1010, 1110, 1203, 1305) comprises an ultrasound mount (1012).

[0566] A7. The needle insertion device of embodiment A6, wherein the ultrasound mount (1012) is connected to the base (1010, 1110, 1203, 1305) via pins (1335) magnets (1338), clamps or clips.

[0567] A8. The needle insertion device of any of embodiments A1-A6, wherein the base (1010, 1110, 1203, 1305) comprises at least one finger grip (1014).

[0568] A9. The needle insertion device of any of embodiments A1-A8, wherein the actuation structure (1025, 1125), base rack pinion (1067, 1167), and needle rack pinion (1048, 1148) are part of the upper assembly (1030, 1130).

[0569] A10. The needle insertion device of any of embodiments A1-A9, wherein the needle carriage assembly (1046) comprises a needle carriage (1040) slidably connected to a needle rack support (1045).

[0570] Al l. The needle insertion device of embodiment A10, further comprising a lock screw (1055) that fixes the needle carriage (1040) to the needle rack support (1045).

[0571] A12. The needle insertion device of any of embodiments Al-Al l, wherein the base comprises (1) a groove (1062) in in which the upper assembly (1030, 1130) slides, or (2) a rail on which the upper assembly (1030, 1130) slides.

[0572] A13. The needle insertion device of any of embodiments A1-A12, wherein the upper assembly (1130) further comprises: an angle-down needle carriage (1149) constructed to hold a needle (1005, 1105); and an angle-down multi-channel guide (1170) comprising a plurality of channels (1185), wherein the angle-down needle carriage (1149) is constructed to ride along one of the plurality of channels (1185), defining a portion (1170A) of an angle-down needle carriage path ( 1180).

[0573] A14. The needle insertion device of embodiment A13, wherein each in the plurality of channels (1185) is associated with a needle depth.

[0574] A15. The needle insertion device of embodiment A13, comprising a center channel guide (1175) with a center channel that forms a portion of the angle-down needle carriage path (1180).

[0575] Al 6. The needle insertion device of embodiment Al 5, comprising a center channel guide (1175) that holds the angle-down needle carriage (1149) fixed relative to the needle carriage assembly (1046) during the insertion configuration.

[0576] A17. The needle insertion device of embodiment A15, wherein the center channel guide (1175) comprises a latch receiver (1150) and a release latch (1144), wherein the release latch (1144) prevents the angle-down needle carriage (1149) from riding along the angle-down needle carriage path (1180) when the release latch (1144) is engaged in the latch receiver (1150).

[0577] A18. The needle insertion device of embodiment A17, comprising a release button (1142) constructed to disengage the release latch (1144) from the latch receiver (1150) when the release button (1142) is actuated.

[0578] A19. The needle insertion device of embodiment A13, comprising angles-down gears (1172) constructed to rotate the angle-down multi-channel guide (1170) during the insertion configuration.

[0579] A20. The needle insertion device of embodiment A13, wherein during the insertion configuration, the needle (1005, 1105) forms an angle with the base (1010, 1110), the device comprising: an angle-down configuration after the insertion configuration wherein the angledown needle carriage (1149) is pushed along the angle-down needle carriage path (1180), and the angle formed with the base (1010, 1110) is reduced.

[0580] A21. The needle insertion device of embodiment A6, comprising a sound-conductive pad (1610) positioned underneath the ultrasound mount (1012).

[0581] A22. The needle insertion device of embodiment A21, comprising a needle insertion slit (1615) formed into the sound-conductive pad (1610).

[0582] A23. The needle insertion device of embodiment A6, wherein the base (1010, 1110) comprises a first ultrasound window (1325A) with a first orientation and a second ultrasound window (1325B) with a second orientation, and wherein the ultrasound mount (1012) may be connected to the base to accommodate the first orientation and the second orientation.

[0583] A24. The needle insertion device of any of embodiments A1-A23, wherein the main support (1060, 1160) forms a fixed angle with the base (1010, 1110).

[0584] A25. The needle insertion device of any of the embodiments A1-A23, comprising a sterile bag (162) attached to the base (1010, 1110) and constructed to envelope an ultrasound probe.

[0585] A26. The needle insertion device of embodiment A24, comprising a handle (164) connected to the sterile bag (162), the handle (164) comprising an access hole (165) that provides access to the interior of the sterile bag (164), the access hole (165) is constructed to allow the ultrasound probe to pass there through.

[0586] Bl. A needle insertion device (1200), comprising: a base (1203); a needle carriage multi-channel guide (1230) extending away from the base (1203), the guide (1203) comprising: an insertion needle carriage channel (1230.4) with a vein depth stop (1230.2), wherein the position of vein depth stop (1230.2) within the insertion needle carriage channel (1230.4) is adjustable, and wherein the insertion needle carriage channel (1230) defines an insertion angle (1245) with the base (1203); a plurality of angle-down needle carriage channels (1230.5), wherein each channel in the plurality is connected to and is contiguous with the insertion needle carriage channel (1230.4); and a needle carriage (1207) constructed to hold a needle (1205, 1210) and comprising a needle carriage guide (1207.2) constructed 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).

[0587] B2. The needle insertion device of embodiment Bl, further comprising an insertion configuration where the needle carriage (1207) slides along the insertion needle carriage channel (1230.4) until the needle carriage guide (1207.2) contacts the vein depth stop (1230.2).

[0588] B3. The needle insertion device of embodiment B2, further comprising an angle-down configuration after the insertion configuration, where (1) the needle carriage (1207) slides along one of the plurality of angle-down needle carriage channels (1230.5), and (2) the needle (1205, 1210) defines a reduced angle (1250) with the base (1203), wherein the reduced angle (1250) is smaller than the insertion angle (1245).

[0589] B4. The needle insertion device of any of the embodiments B1-B3, wherein: a needle carriage multi-channel guide (1230) comprises a vein depth gauge (1230.1); and the vein depth stop (1230.2) comprises a depth indicator (1020, 1120).

[0590] B5. The needle insertion device of any of the embodiments B1-B4, wherein the base comprises an ultrasound mount (1012).

[0591] B6. The needle insertion device of embodiment B5, wherein the ultrasound mount (1012) is connected to the base via pins (1335) or magnets (1338).

[0592] B7. The needle insertion device of embodiment B5, comprising a sound-conductive pad (1610) positioned underneath the ultrasound mount (1012).

[0593] B8. The needle insertion device of embodiment B7, comprising a needle insertion slit (1615) formed into the sound-conductive pad (1610).

[0594] B9. The needle insertion device of embodiment B5, wherein: the base comprises a first ultrasound window (1325A) with a first orientation and second ultrasound window (1325B) with a second orientation; and the ultrasound mount (1012) may be connected to the base to accommodate the first orientation and the second orientation.

[0595] B10. The needle insertion device of any of embodiments B1-B9, wherein the base comprises at least one finger grip (1014).

[0596] Bl l. The needle insertion device of any of the embodiment B1-B10, wherein the plurality of angle-down needle carriage channels (1230.5) comprises at least three channels.

[0597] B12. The needle insertion device of any of the embodiments Bl-Bl l, comprising a sterile bag (162) attached to the base (1405) and constructed to envelope an ultrasound probe.

[0598] B13. The needle insertion device of embodiment 12, comprising a handle (164) connected to the sterile bag (162), the handle (164) comprising an access hole (165) that provides access to the interior of the sterile bag (164), the access hole (165) is constructed to allow the ultrasound probe to pass there through.

[0599] Cl. A needle insertion device (1300), comprising: a base (1305) comprising a needle anchor point (1345); a multi-channel guide card (1310) extending away from the base (1305), the guide card (1310) comprising a plurality of channels, each in the plurality having a needle insertion portion defining an insertion angle with the base (1305) and accommodating a needle insertion depth, wherein the insertion angle and insertion depth are different from the insertion angles and insertion depths for other channels in the plurality of channels; anda needle carriage (1315) constructed to hold a needle (1302) and comprising a needle carriage guide (1350.2) constructed to allow the needle carriage to slide along any of the plurality of channels on the multi-channel guide card (1310); wherein the needle anchor point (1345) is constructed to contact and to stabilize the needle (1302) during insertion.

[0600] C2. The needle insertion device of embodiment Cl, wherein each channel in the plurality of channels comprises a needle loading portion (1352) and a needle insertion portion (1355).

[0601] C3. The needle insertion device of embodiment Cl, wherein each channel in the plurality of channels comprises a needle loading portion (1352), a needle insertion portion (1355) and an angle-down portion (1360).

[0602] C4. The needle insertion device of embodiment Cl, wherein each channel in the plurality of channels comprises a needle loading portion (1352), a needle insertion portion (1355), and angle-down portion (1360) and a move-forward portion (1365).

[0603] C5. The needle insertion device of any of the embodiments C1-C4, wherein the base comprises an ultrasound mount (1012).

[0604] C6. The needle insertion device of embodiment C5, wherein the ultrasound mount (1012) is connected to the base via pins (1335) or magnets (1338).

[0605] C7. The needle insertion device of embodiment C5, further comprising a sound- conductive pad (1610) positioned underneath the ultrasound mount (1012).

[0606] C8. The needle insertion device of embodiment C7, further comprising a needle insertion slit (1615) formed into the sound-conductive pad (1610).

[0607] C9. The needle insertion device of embodiment 5, wherein the base comprises a first ultrasound window (1325A) with a first orientation and a second ultrasound window (1325B) with a second orientation, and wherein the ultrasound mount (1012) may be connected to the base to accommodate the first orientation and the second orientation.

[0608] CIO. The needle insertion device of any of embodiments C1-C9, wherein the base comprises at least one finger grip (1014).

[0609] Cl l. The needle insertion device of any of the embodiment Cl -CIO, wherein the plurality of channels comprises at least three channels.

[0610] Cl 2. The needle insertion device of any of the embodiments Cl -Cl 1, comprising a sterile bag (162) attached to the base (1305) and constructed to envelope an ultrasound probe.

[0611] C13. The needle insertion device of embodiment C12, comprising a handle (164) connected to the sterile bag (162), the handle (164) comprising an access hole (165) that provides access to the interior of the sterile bag (164), the access hole (165) is constructed to allow the ultrasound probe to pass there through.

[0612] D.1 A needle insertion device (1400), comprising: a base (1405), comprising: a depth cam (1410) with a perimeter that is constructed to correlate an insertion angle to an insertion depth; an arm receiver (1426.1) comprising a track (1426.2); a swing arm assembly (1427) comprising: a swing arm interface (1426.3) slidably connected to the track (1426.2) and constructed to travel along the track (1426.2); a needle carriage (1435, 1465) constructed to hold a needle (1437), the needle carriage (1435, 1465) slidably mounted on a slide arm (1480); a depth selection pinion (1430) constructed to travel along the arm receiver (1426.1) and change the insertion angle; a needle insertion stop (1440, 1475) constructed to contact the perimeter of the depth cam (1410) and restrict the slide movement of the needle carriage (1435, 1465) on the slide arm (1480).

[0613] D.2 The needle insertion device of embodiment DI, wherein the needle carriage (1435, 1465) comprising a needle holder (1432).

[0614] D3. The needle insertion device of embodiment D2, wherein the needle holder (1432) is selected from a group consisting of: a self-centering polymer, a drill chuck, or a tapered key.

[0615] D4. The needle insertion device of any of the embodiments D1-D3, wherein the depth cam (1410) comprises a plurality of anti-slip features (1415).

[0616] D5. The needle insertion device of any of the embodiments D1-D4, wherein the needle carriage (1435, 1465) comprises a needle hole stabilizer and / or a channel stabilizer (1467).

[0617] D6. The needle insertion device of any of the embodiments D1-D5, wherein the needle carriage (1470) accommodates a needle without a catheter.

[0618] D7. The needle insertion device of any of the embodiments D1-D5, wherein the needle carriage (1470) accommodates a needle with a catheter.

[0619] D8. The needle insertion device of any of the embodiments D1-D7, wherein the needle carriage (1465) accommodates a specific needle length.

[0620] D9. The needle insertion device of any of the embodiments D1-D7, wherein the needle insertion stop (1440) is adjustable and the needle carriage (1435) accommodates a several needle lengths.

[0621] DIO. The needle insertion device of any of embodiments D1-D9, wherein the base comprises an ultrasound mount (1012).

[0622] Dl l. The needle insertion device of embodiments D10, wherein the ultrasound mount (1012) is connected to the base via pins (1335) or magnets (1338).

[0623] D12. The needle insertion device of embodiment Dl l, further comprising a sound- conductive pad (1610) positioned underneath the ultrasound mount (1012).

[0624] D13. The needle insertion device of embodiment D12, further comprising a needle insertion slit (1615) formed into the sound-conductive pad (1610).

[0625] D14. The needle insertion device of embodiment D10, wherein the base comprises a first ultrasound window (1325A) with a first orientation and second ultrasound window (1325B) with a second orientation; wherein the ultrasound mount (1012) may be connected to the base to accommodate the first orientation and the second orientation.

[0626] D15. The needle insertion device of any of the embodiments D1-D14, comprising a sterile bag (162) attached to the base (1405) and constructed to envelope an ultrasound probe.

[0627] DI 6. The needle insertion device of embodiment DI 5, comprising a handle (164) connected to the sterile bag (162), the handle (164) comprising an access hole (165) that provides access to the interior of the sterile bag (164), the access hole (165) is constructed to allow the ultrasound probe to pass there through.

[0628] El. A needle insertion device (1500) comprising: a base (1503); a gear housing (1517) pivotally mounted to the base (1503), the gear housing comprising a needle carriage worm drive (1520), and a catheter carriage worm drive (1525);a needle carriage (1505) constructed to hold a needle (1515) and connected to the needle carriage worm drive (1520); a catheter carriage (1510) constructed to hold a catheter and connected to the catheter carriage worm drive (1525); and a removable motor assembly (1530), comprising: a needle carriage motor (1535) constructed to rotate the needle carriage worm drive (1520) and thereby move the needle carriage (1505) along the gear housing (1517); a catheter motor (1540) constructed to rotate the catheter carriage worm drive (1525) and thereby move the catheter carriage (1510) along the gear housing (1517); and an insertion angle motor (1540) constructed to rotate the gear housing (1517) relative to the base (1503).

[0629] E2. The needle insertion device of embodiment El, comprising: a processor (1555) connected to the needle carriage motor (1535), the catheter motor (1540) and the insertion angle motor (1540), wherein the processor (1555) is programmed to perform the following steps: a. calculate an insertion angle and an insertion depth for an assigned vein depth or an assigned target depth; b. actuate the insertion angle motor (1540) based on the calculation of step (a); and c. actuate the needle carriage motor (1540) based on the calculation of step (a).

[0630] E3. The needle insertion device of embodiment E2, wherein the processor (1555) is programmed to perform the following additional steps: d. determine that the vein depth or the target depth has been reached; and e. actuate the insertion angle motor (1540) to reduce the insertion angle.

[0631] E4. The needle insertion device of embodiment E2, wherein the assigned vein depth or target depth is communicated to the processor (1555) via a depth input device (1570).

[0632] E5. The needle insertion device of embodiment E3, wherein the depth input device (1570) is an ultrasound probe, a keyboard, a touchscreen, mobile phone or a microphone.

[0633] E6. The needle insertion device of embodiment El, further comprising: linear position sensors (1560) constructed to detect the positions of the needle carriage (1505) and the catheter carriage (1510); andan angular position sensor (1565) constructed to detect the position of the gear housing (1517) relative to the base (1503).

[0634] E7. The needle insertion device of embodiment E5, comprising: a processor (1555) connected to the needle carriage motor (1535), the catheter motor (1540), the insertion angle motor (1540), the linear position sensors (1560) and the angular position sensor (1565), wherein the processor (1555) is programmed to perform the following steps: a. calculate an insertion angle and an insertion depth for an assigned vein depth or an assigned target depth; b. determine the position of the gear housing (1517) relative to the base (1503) from the angular position sensor (1565); c. determine the positions for the needle carriage (1505) and the catheter carriage (1510) from the linear position sensors (1560); d. actuate the insertion angle motor (1540) based on the calculation of step (a) and the determination of step (b); and e. actuate the needle carriage motor (1540) based on the calculation of step (a), and the determination of step (c).

[0635] E8. The needle insertion device of embodiment E5, wherein the processor (1555) is programmed to perform the following additional steps: f. determine that the vein depth or target depth has been reached; and g. actuate the insertion angle motor (1540) to reduce the insertion angle.

[0636] E9. The needle insertion device of embodiment E7, wherein the assigned vein depth or target depth is communicated to the processor (1555) via a depth input device (1570).

[0637] E10. The needle insertion device of embodiment E9, wherein the depth input device (1570) is an ultrasound probe, a keyboard, a touchscreen, mobile phone or a microphone.

[0638] El l. The needle insertion device of any of embodiments E1-E10, wherein the base comprises an ultrasound mount (1012).

[0639] E12. The needle insertion device of embodiments El l, wherein the ultrasound mount (1012) is connected to the base via pins (1335) or magnets (1338).

[0640] E13. The needle insertion device of embodiment E12, further comprising a sound- conductive pad (1610) positioned underneath the ultrasound mount (1012).

[0641] E14. The needle insertion device of embodiment E13, further comprising a needle insertion slit (1615) formed into the sound-conductive pad (1610).

[0642] E15. The needle insertion device of embodiment El l, wherein the base comprises a first ultrasound window (1325A) with a first orientation and second ultrasound window (1325B) with a second orientation; wherein the ultrasound mount (1012) may be connected to the base to accommodate the first orientation and the second orientation.

[0643] E16. The needle insertion device of any of embodiments E1-E15, wherein the needle carriage motor (1540) is oriented perpendicularly to the needle carriage motor (1540).

[0644] E17. The needle insertion device of any of the embodiments E1-E16, comprising a sterile bag (162) attached to the base (1503) and constructed to envelope an ultrasound probe.

[0645] E18. The needle insertion device of embodiment E17, comprising a handle (164) connected to the sterile bag (162), the handle (164) comprising an access hole (165) that provides access to the interior of the sterile bag (164), the access hole (165) is constructed to allow the ultrasound probe to pass there through.

[0646] Fl. A needle insertion device (1400), comprising: a base (1405), comprising: a depth cam (1410) with a perimeter that is constructed to correlate an insertion angle to an insertion depth; an arm receiver (1426.1) comprising a track (1426.2); a swing arm assembly (1427) comprising: a swing arm interface (1426.3) slidably connected to the track (1426.2) and constructed to travel along the track (1426.2); a needle carriage (1435, 1465) constructed to hold a needle (1437), the needle carriage (1435, 1465) slidably mounted on a slide arm (1480); a depth selection pinion (1430) that engages the angle position rack (1425) and is constructed to change the insertion angle; a needle insertion stop (1440, 1475) constructed to contact the perimeter of the depth cam (1410) and restrict the slide movement of the needle carriage (1435, 1465) on the slide arm (1480).

[0647] F2. The needle insertion device of embodiment Fl, wherein the depth cam (1410) comprises a plurality of anti-slip features (1415).

[0648] F3. The needle insertion device of embodiment Fl , wherein the needle carriage (1435, 1465) comprising a needle holder (1432).

[0649] F4. The needle insertion device of embodiment F3, wherein the needle holder (1432) is selected from a group consisting of: a self-centering polymer, a drill chuck, or a tapered key.

[0650] F5. The needle insertion device of embodiment Fl, wherein the needle carriage (1435, 1465) comprises a needle hole stabilizer and / or a channel stabilizer (1467).

[0651] F6. The needle insertion device of embodiment Fl, wherein the needle carriage (1470) accommodates a needle without a catheter.

[0652] F7. The needle insertion device of embodiment Fl, wherein the needle carriage(1813) accommodates a needle with a catheter.

[0653] F8. The needle insertion device of embodiment F7, wherein the needle carriage(1813) comprises a negative impression (1813.1) of the needle with the catheter.

[0654] F9. The needle insertion device of embodiment Fl, wherein the needle carriage(1465) accommodates a specific needle length.

[0655] F10. The needle insertion device of embodiment Fl, wherein the needle insertion stop (1440) is adjustable and the needle carriage (1435) accommodates a several needle lengths.

[0656] Fl 1. The needle insertion device of embodiment Fl, wherein the base comprises an ultrasound mount (1012).

[0657] F12. The needle insertion device embodiment Fl l, wherein the ultrasound mount (1012) is connected to the base via pins (1335) magnets (1338), clips or clamps.

[0658] F13. The needle insertion device of embodiment Fl l, further comprising a sound- conductive pad (1610) positioned underneath the ultrasound mount (1012).

[0659] F14. The needle insertion device of embodiment Fl l, further comprising a needle insertion slit / wedge (1615) formed into the sound-conductive pad (1610).

[0660] F15. The needle insertion device of embodiment Fl l, wherein: the base comprises a first ultrasound window (1325A) with a first orientation and second ultrasound window (1325B) with a second orientation; wherein the ultrasound mount (1012) may be connected to the base to accommodate the first orientation and the second orientation.

[0661] Fl 6. The needle insertion device of embodiment Fl, comprising a sterile bag (162) attached to the base (1405) and constructed to envelope an ultrasound probe.

[0662] Fl 7. The needle insertion device of embodiment Fl 6, comprising a handle (164) connected to the sterile bag (162), the handle (164) comprising an access hole (165) that provides access to the interior of the sterile bag (164), the access hole (165) is constructed to allow the ultrasound probe to pass there through.

[0663] Gl. A needle insertion device (1800, 1900), comprising: a base (1802), comprising: a depth cam (1814) with a perimeter that is constructed to correlate a needle insertion angle (1832) to an insertion depth; an arm receiver (1810); a swing arm (1808) pivotally or slidably attached to the arm receiver (1810) and forming the needle insertion angle (1832) between the swing arm (1808) and the base (1802); a needle carriage (1812) slidably mounted on the swing arm (1808), wherein the needle carriage comprises: a needle insertion stop (1809) constructed to contact the perimeter of the depth cam (1814) and restrict the slide movement of the needle carriage (1812) on the swing arm (1808); and an angle down arch slot (1818); an angle-down arch (1816) slidably disposed in the angle down arch slot (1818), the angledown arch (1816) comprising a needle mount (1813, 1913) holding a needle (1825) and catheter (1826), wherein the angle-down arch (1816) slides through the angle-down arch slot (1818), 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).

[0664] G2. The needle insertion device of embodiment Gl, wherein the angle-down arch (1816) is constructed such that the tip of the needle (1825) remains in the same location when the angle-down arch (1816) slides through the angle-down arch slot (1818).

[0665] G3. The needle insertion device of embodiment Gl, wherein the base (1802) comprises an ultrasound mount (1804).

[0666] G4. The needle insertion device of embodiment G3, wherein the ultrasound mount (1804) is connected to the base (1802) via pins (1335) or magnets (1338).

[0667] G5. The needle insertion device of embodiment G3, further comprising a sound- conductive pad (1610) positioned underneath the ultrasound mount (1012).

[0668] G6. The needle insertion device of embodiment G5, further comprising a needle insertion slit (1615) formed into the sound-conductive pad (1610).

[0669] G7. The needle insertion device of embodiment Gl, comprising a sterile bag (162) attached to the base (1802) and constructed to envelope an ultrasound probe.

[0670] G8. The needle insertion device of embodiment G7, comprising a handle (164) connected to the sterile bag (162), the handle (164) comprising an access hole (165) that provides access to the interior of the sterile bag (164), the access hole (165) is constructed to allow the ultrasound probe to pass there through.

[0671] G9. The need insertion device of embodiment Gl, wherein the needle carriage (1812) comprises an arch lock (1820) constructed to disable the slide movement of the angle down arch (1816) relative to the needle carriage (1812).

[0672] GIO. The need insertion device of embodiment Gl, wherein the angle-down arch (1816) comprises an arch manipulation structure (1830).

[0673] Gi l. The need insertion device of embodiment Gl, wherein the needle carriage (1812) comprises a pre-tensioned pinion (1932) constructed to propel the angle-down arch (1816) through the angle-down arch slot (1818).

[0674] G12. The need insertion device of embodiment Gl, further comprising an arch spring (1933) connecting the angle-down arch (1816) to the needle carriage (1812), and constructed to propel the angle-down arch (1816) through the angle-down arch slot (1818).

[0675] G13. The needle insertion device of embodiment Gl, wherein the needle mount (1913) comprises: a catheter spring (1940) connected to the catheter (1826); a needle spring (1942) connected to the needle (1825); a spring trigger (1944); wherein the needle mount (1913) has two configurations: non-triggered configuration wherein the spring trigger (1944) holds both the catheter spring (1940) and the needle spring (1942) in compression; a trigger configuration wherein the spring trigger (1944) is actuated releasing both the catheter spring (1940) and the needle spring (1942) from compression such that:(1) the catheter spring (1940) applies an insertion force on the catheter (1936) and(2) the needle spring (1942) applies an extraction force on the needle (1925).

[0676] G14. The needle insertion device of embodiment G13, wherein the spring trigger (1944) is actuated when it contacts the base (1802).

[0677] G15. The needle insertion device of embodiment G13, wherein the spring trigger (1944) is actuated when the needle mount (1913) reaches the catheter insertion angle (1834).

[0678] Hl. A needle insertion device (1800, 1900), comprising: a base (1802) comprising a base insert receiver (1407.1); a plurality probe mount inserts (1408.1-1408.4), wherein each in the plurality comprises a slot constructed to hold an ultrasound probe; the size of the slot is different for each in the plurality; each in the plurality is constructed to fit into the base insert receiver; a swing arm (1808) attached to the base (1802) and forming a needle insertion angle (1832) between the swing arm (1808) and the base (1802); a needle carriage (1812) slidably mounted on the swing arm (1808).

[0679] H2. The needle insertion device of embodiment Hl, wherein each in the plurality probe mount inserts (1408.1-1408.4) is comprised of a rigid material.

[0680] H3. The needle insertion device of embodiment Hl, wherein each in the plurality probe mount inserts (1408.1-1408.4) is comprised of a flexible material.

[0681] H4. The needle insertion device of embodiment Hl, wherein the base comprises a depth cam (1814) with a perimeter that is constructed to correlate the needle insertion angle (1832) to an insertion depth; the needle carriage (1812) comprises a needle insertion stop (1809) constructed to contact the perimeter of the depth cam (1814) and restrict the slide movement of the needle carriage (1812) on the swing arm (18080.

[0682] H5. The needle insertion device of embodiment H4, wherein the needle carriage accommodates a specific needle length.

[0683] H6. The needle insertion device of the embodiment H4, wherein the needle insertion stop is adjustable and the needle carriage accommodates a several needle lengths.

[0684] H7. The needle insertion device of embodiment H4, wherein the depth cam (1814) comprises a plurality of anti-slip features (1415).

[0685] H8. The needle insertion device of embodiment H4, wherein the needle carriage (1812) comprises an angle down arch slot (1818), and the device comprises: an angle-down arch(1816) slidably disposed in the angle down arch slot (1818), the angle-down arch (1816) comprising a needle mount (1813, 1913) holding a needle (1825) and catheter (1826), wherein the angle-down arch (1816) slides through the angle-down arch slot (1818), 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).

[0686] H9. The needle insertion device of embodiment Hl, wherein: the base (1802) comprises an arm receiver (1426.1) with a track (1426.2); and the swing arm (1808) comprises a swing arm interface (1426.3) slidably connected to the track (1426.2) and constructed to travel along the track (1426.2).

[0687] H10. The needle insertion device of embodiment Hl, comprising a sterile bag (162) attached to the base (1802) and constructed to envelope the ultrasound probe.

[0688] Hl l. The needle insertion device of embodiment H10, comprising a handle (164) connected to the sterile bag (162), the handle (164) comprising an access hole (165) that provides access to the interior of the sterile bag (164), the access hole (165) is constructed to allow the ultrasound probe to pass there through.

[0689] H12. The needle insertion device of embodiment Hl, wherein the probe mount insert comprising a needle insertion slit (1615) formed into the sound-conductive pad (1610).

[0690] Hl 3. The needle insertion device of embodiment Hl, comprising a sound-conductive pad (1610) positioned underneath the probe mount inserts.

[0691] H14. The needle insertion device of embodiment H13, comprising a needle insertion slit (1615) formed into the sound-conductive pad (1610).

[0692] The above description of the disclosed embodiments is provided to enable any person skilled in the art to make or use the invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the generic principles described herein can be applied to other embodiments without departing from the spirit or scope of the invention. Thus, it is to be understood that the description and drawings presented herein represent a presently preferred embodiment of the invention and are therefore representative of the subject matter that is broadly contemplated by the present invention. It is further understood that the scope of the present invention fully encompasses other embodiments that may become obvious to those skilled in the art, and that nothing accordingly limits the scope of the present invention other than the appended claims.

Claims

CLAIMS1. A needle insertion device (1400), comprising: a base (1405), comprising: a depth cam (1410) with a perimeter that is constructed to correlate an insertion angle to an insertion depth; an arm receiver (1426.1) comprising a track (1426.2); a swing arm assembly (1427) comprising: a swing arm interface (1426.3) slidably connected to the track (1426.2) and constructed to travel along the track (1426.2); a needle carriage (1435, 1465) constructed to hold a needle (1437), the needle carriage (1435, 1465) slidably mounted on a slide arm (1480); a depth selection pinion (1430) that engages the angle position rack (1425) and is constructed to change the insertion angle; a needle insertion stop (1440, 1475) constructed to contact the perimeter of the depth cam (1410) and restrict the slide movement of the needle carriage (1435, 1465) on the slide arm (1480).

2. The needle insertion device of claim 1, wherein the depth cam (1410) comprises a plurality of anti-slip features (1415).

3. The needle insertion device of claim 1, wherein the needle carriage (1435, 1465) comprising a needle holder (1432).

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

5. The needle insertion device of claim 1, wherein the needle carriage (1435, 1465) comprises a needle hole stabilizer and / or a channel stabilizer (1467).

6. The needle insertion device of claim 1, wherein the needle carriage (1470) accommodates a needle without a catheter.

7. The needle insertion device of claim 1, wherein the needle carriage (1813) accommodates a needle with a catheter.

8. The needle insertion device of claim 7, wherein the needle carriage (1813) comprises a negative impression (1813.1) of the needle with the catheter.

9. The needle insertion device of claim 1, wherein the needle carriage (1465) accommodates a specific needle length.

10. The needle insertion device of claim 1, wherein the needle insertion stop (1440) is adjustable and the needle carriage (1435) accommodates a several needle lengths.

11. The needle insertion device of claim 1, wherein the base comprises an ultrasound mount (1012).

12. The needle insertion device of claim 11, wherein the ultrasound mount (1012) is connected to the base via pins (1335) magnets (1338), clips or clamps.

13. The needle insertion device of claim 12, further comprising a sound-conductive pad (1610) positioned underneath the ultrasound mount (1012).

14. The needle insertion device of claim 13, further comprising a needle insertion slit / wedge (1615) formed into the sound-conductive pad (1610).

15. The needle insertion device of claim 11, wherein: the base comprises a first ultrasound window (1325A) with a first orientation and second ultrasound window (1325B) with a second orientation; wherein the ultrasound mount (1012) may be connected to the base to accommodate the first orientation and the second orientation.

16. The needle insertion device of claim 1 , comprising a sterile bag (162) attached to the base (1405) and constructed to envelope an ultrasound probe.

17. The needle insertion device of claim 16, comprising a handle (164) connected to the sterile bag (162), the handle (164) comprising an access hole (165) that provides access to the interior of the sterile bag (164), the access hole (165) is constructed to allow the ultrasound probe to pass there through.

18. A needle insertion device (1800, 1900), comprising: a base (1802), comprising: a depth cam (1814) with a perimeter that is constructed to correlate a needle insertion angle (1832) to an insertion depth; an arm receiver (1810); a swing arm (1808) pivotally or slidably attached to the arm receiver (1810) and forming the needle insertion angle (1832) between the swing arm (1808) and the base (1802); a needle carriage (1812) slidably mounted on the swing arm (1808), wherein the needle carriage comprises: a needle insertion stop (1809) constructed to contact the perimeter of the depth cam (1814) and restrict the slide movement of the needle carriage (1812) on the swing arm (1808); and an angle down arch slot (1818); an angle-down arch (1816) slidably disposed in the angle down arch slot (1818), the angle-down arch (1816) comprising a needle mount (1813, 1913) holding a needle (1825) and catheter (1826), wherein the angle-down arch (1816) slides through the angle-down arch slot (1818), 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).

19. The needle insertion device of claim 18, wherein the angle-down arch (1816) is constructed such that the tip of the needle (1825) remains in the same location when the angle-down arch (1816) slides through the angle-down arch slot (1818).

20. The needle insertion device of claim 18, wherein the base (1802) comprises an ultrasound mount (1804).

21. The needle insertion device of claim 20, wherein the ultrasound mount (1804) is connected to the base (1802) via pins (1335) or magnets (1338).

22. The needle insertion device of claim 20, further comprising a sound-conductive pad (1610) positioned underneath the ultrasound mount (1012).

23. The needle insertion device of claim 22, further comprising a needle insertion slit (1615) formed into the sound-conductive pad (1610).

24. The needle insertion device of claim 18, comprising a sterile bag (162) attached to the base (1802) and constructed to envelope an ultrasound probe.

25. The needle insertion device of claim 24, comprising a handle (164) connected to the sterile bag (162), the handle (164) comprising an access hole (165) that provides access to the interior of the sterile bag (164), the access hole (165) is constructed to allow the ultrasound probe to pass there through.

26. The need insertion device of claim 18, wherein the needle carriage (1812) comprises an arch lock (1820) constructed to disable the slide movement of the angle down arch (1816) relative to the needle carriage (1812).

27. The need insertion device of claim 18, wherein the angle-down arch (1816) comprises an arch manipulation structure (1830).

28. The need insertion device of claim 18, wherein the needle carriage (1812) comprises a pre-tensioned pinion (1932) constructed to propel the angle-down arch (1816) through the angle-down arch slot (1818).

29. The need insertion device of claim 18, further comprising an arch spring (1933) connecting the angle-down arch (1816) to the needle carriage (1812), and constructed to propel the angle-down arch (1816) through the angle-down arch slot (1818).

30. The needle insertion device of claim 18, wherein the needle mount (1913) comprises: a catheter spring (1940) connected to the catheter (1826); a needle spring (1942) connected to the needle (1825); a spring trigger (1944); wherein the needle mount (1913) has two configurations: non-triggered configuration wherein the spring trigger (1944) holds both the catheter spring (1940) and the needle spring (1942) in compression; a trigger configuration wherein the spring trigger (1944) is actuated releasing both the catheter spring (1940) and the needle spring (1942) from compression such that: (1) the catheter spring (1940) applies an insertion force on the catheter (1936) and (2) the needle spring (1942) applies an extraction force on the needle (1925).

31. The needle insertion device of claim 30, wherein the spring trigger (1944) is actuated when it contacts the base (1802).

32. The needle insertion device of claim 30, wherein the spring trigger (1944) is actuated when the needle mount (1913) reaches the catheter insertion angle (1834).

33. A needle insertion device (1800, 1900), comprising: a base (1802) comprising a base insert receiver (1407.1); a plurality probe mount inserts (1408.1-1408.4), wherein each in the plurality comprises a slot constructed to hold an ultrasound probe;the size of the slot is different for each in the plurality; each in the plurality is constructed to fit into the base insert receiver; a swing arm (1808) attached to the base (1802) and forming a needle insertion angle (1832) between the swing arm (1808) and the base (1802); a needle carriage (1812) slidably mounted on the swing arm (1808).

34. The needle insertion device of claim 33, wherein each in the plurality probe mount inserts (1408.1-1408.4) is comprised of a rigid material.

35. The needle insertion device of claim 33, wherein each in the plurality probe mount inserts (1408.1-1408.4) is comprised of a flexible material.

36. The needle insertion device of claim 33, wherein the base comprises a depth cam (1814) with a perimeter that is constructed to correlate the needle insertion angle (1832) to an insertion depth; the needle carriage (1812) comprises a needle insertion stop (1809) constructed to contact the perimeter of the depth cam (1814) and restrict the slide movement of the needle carriage (1812) on the swing arm (18080.

37. The needle insertion device of claim 36, wherein the needle carriage accommodates a specific needle length.

38. The needle insertion device of claim 36, wherein the needle insertion stop is adjustable and the needle carriage accommodates a several needle lengths.

39. The needle insertion device of claim 36, wherein the depth cam (1814) comprises a plurality of anti-slip features (1415).

40. The needle insertion device of claim 36, wherein the needle carriage (1812) comprises an angle down arch slot (1818), and the device comprises: an angle-down arch (1816) slidably disposed in the angle down arch slot (1818), the angle-down arch (1816)comprising a needle mount (1813, 1913) holding a needle (1825) and catheter (1826), wherein the angle-down arch (1816) slides through the angle-down arch slot (1818), 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).

41. The needle insertion device of claim 33, wherein: the base (1802) comprises an arm receiver (1426.1) with a track (1426.2); and the swing arm (1808) comprises a swing arm interface (1426.3) slidably connected to the track (1426.2) and constructed to travel along the track (1426.2).

42. The needle insertion device of claim 33, comprising a sterile bag (162) attached to the base (1802) and constructed to envelope the ultrasound probe.

43. The needle insertion device of claim 42, comprising a handle (164) connected to the sterile bag (162), the handle (164) comprising an access hole (165) that provides access to the interior of the sterile bag (164), the access hole (165) is constructed to allow the ultrasound probe to pass there through.

44. The needle insertion device of claim 33, wherein the probe mount insert comprising a needle insertion slit (1615) formed into the sound-conductive pad (1610).

45. The needle insertion device of claim 33, comprising a sound-conductive pad (1610) positioned underneath the probe mount inserts.

46. The needle insertion device of claim 45, comprising a needle insertion slit (1615) formed into the sound-conductive pad (1610).

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