Intubation assistance system

Abstract

An assisted cannulation system for cannulating an artery or vein in a patient includes an adjustable stent comprising a base and a tray. The base and the tray are hinged together. The system further includes a needle actuator connected to the tray, a needle connected to the needle actuator, an dilator actuator connected to the tray, an dilator connected to the dilator actuator and surrounding the needle, a cannula actuator connected to the tray, and a cannula connected to the cannula actuator and surrounding the dilator and the needle. The needle actuator is configured to advance and retract the needle. The dilator actuator is configured to advance and retract the dilator. The cannula actuator is configured to advance the cannula. The adjustable stent is adjustable to change the angles of the needle, the dilator, and the cannula.

Description

Technical Field

[0001] This disclosure relates to extracorporeal life support (ECLS) systems. More specifically, this disclosure relates to intubating a patient to connect to an extracorporeal membrane oxygenation (ECMO) system. Background Technology

[0002] ECLS is a treatment option for patients who are critically ill, severely injured, and / or undergoing certain surgical procedures (such as heart surgery). ECLS can be administered when patients require cardiac or lung support by connecting them to an ECMO machine. ECMO machines can provide functional support to the heart and lungs, such as partial or full support. Intubation is used to connect a patient to an ECMO machine. Depending on the type of ECLS being implemented, intubation is performed at a specific site on the patient's body. For example, intubation may be performed in the groin region (e.g., the femoral artery and / or femoral vein) and / or in the neck / shoulder region (e.g., the subclavian artery and / or subclavian vein). While intubation is traditionally performed in a clinical setting, it is beneficial to initiate ECLS in a field setting (e.g., at the scene of an accident or medical emergency). However, intubating patients in the field carries risks such as blood loss and infection. Summary of the Invention

[0003] In Example 1, an auxiliary cannulation system for cannulating a patient's artery or vein includes: an adjustable stent comprising: a base and a tray; wherein the base and the tray are hinged together; a needle actuator connected to the tray; a needle connected to the needle actuator; a dilator actuator connected to the tray; a dilator connected to the dilator actuator and surrounding the needle; a cannula actuator connected to the tray; and a cannula connected to the cannula actuator and surrounding the dilator and the needle; wherein the needle actuator is configured to advance and retract the needle; wherein the dilator actuator is configured to advance and retract the dilator; wherein the cannula actuator is configured to advance the cannula; and wherein the adjustable stent is adjustable to change the angles of the needle, the dilator, and the cannula.

[0004] In Example 2, the assisted cannulation system according to Example 1 includes an electric actuator for the needle actuator, the dilator actuator, and the cannulation actuator.

[0005] In Example 3, the assisted cannulation system according to Example 1 includes a pneumatic actuator as part of the needle actuator, dilator actuator, and cannulation actuator.

[0006] In Example 4, according to the assisted intubation system of Example 1, the adjustable support also includes a strut connected to the tray; the base includes a plurality of recesses configured to engage with the strut to set the angle of the tray.

[0007] In Example 5, according to the assisted cannulation system of Example 1, the adjustable support also includes a support with a slot configured to receive fasteners to set the angle of the tray.

[0008] In Example 6, according to the assisted cannulation system of Example 1, the tray includes an array of channels, and each of the needle actuator, dilator actuator and cannulation actuator is positioned in a different channel.

[0009] In Example 7, the assisted intubation system according to Example 1 further includes: a needle link connecting a needle to a needle actuator; an expander link connecting an expander to an expander actuator; and an intubation link connecting an intubation cannula to an intubation actuator.

[0010] In Example 8, the assisted cannulation system according to Example 1 is further included in a control system configured to receive input from a user to control the power supplied to the actuator.

[0011] In Example 9, according to the auxiliary cannulation system of Example 1, the needle comprises a metallic material, the dilator comprises a polymeric material, and the cannula comprises a polymeric material.

[0012] In Example 10, the assisted cannulation system according to Example 1 includes at least one of the needle, dilator, and cannula, which includes a hydrophilic coating to reduce friction with tissue or an antithrombotic surface treatment.

[0013] In Example 11, an auxiliary cannulation system for cannulating a patient's artery or vein includes: a stent adjustable for different angles; an actuation system connected to the adjustable stent; a cannulation assembly connected to the adjustable stent; a power source connected to the actuation system; and a control system connected to the actuation system and the power source, wherein the control system is configured to receive input from a user to advance and retract components of the cannulation assembly to cannulate the patient.

[0014] In Example 12, according to the assisted cannulation system of Example 11, the cannulation assembly includes: a needle; an expander surrounding the needle; and a cannula surrounding the expander and the needle; and an actuation system includes: a needle actuator connected to the needle; an expander actuator connected to the expander; and a cannula actuator connected to the cannula.

[0015] In Example 13, the assisted cannulation system of claim 12, wherein the power source includes an electrical power source; and the needle actuator, dilator actuator, and cannulation actuator are electric actuators.

[0016] In Example 14, according to the auxiliary cannulation system of Example 12, the power source includes a pneumatic power source; and the actuation system further includes a plurality of solenoid valves fluidly connected between the power source and the needle actuator, the dilator actuator and the cannulation actuator.

[0017] In Example 15, according to the auxiliary cannulation system of Example 14, the control system is configured to selectively command pressurized airflow to the advance side and retraction side of the actuator.

[0018] In Example 16, according to the assisted cannulation system of Example 11, the adjustable support further includes a strut connected to the tray; the base includes a plurality of recesses configured to engage with the strut to set the angle of the tray.

[0019] In Example 17, according to the assisted cannulation system of Example 11, the adjustable support also includes a support with a slot configured to receive fasteners to set the angle of the tray.

[0020] In Example 18, according to the assisted cannulation system of Example 11, the stent is adjustable between a first angle configuration of greater than or equal to 30 degrees and a second angle configuration of less than 30 degrees.

[0021] In Example 19, a method of operating an auxiliary cannulation system includes an adjustable stent, an actuation system connected to the adjustable stent, a cannulation assembly (including a needle, a dilator surrounding the needle, and a cannula surrounding the dilator and needle) connected to the actuation system, a power source connected to the actuation system, and a control system connected to the actuation system and the power source. The method includes: placing the auxiliary cannulation system on a patient with the distal tip of the needle positioned above the skin and aligned with a blood vessel; advancing the needle to puncture the blood vessel; advancing the dilator along the needle and positioning it below the cannula to allow the dilator to enter the blood vessel; retracting the dilator and adjusting the angle of the adjustable stent to a lower angle; advancing the dilator along the needle and positioning it below the cannula to allow the dilator to re-enter the blood vessel; advancing the cannula along the dilator until the cannula is inserted into the blood vessel; retracting the needle and dilator from the patient while leaving the cannula in place; and removing the auxiliary cannulation system from the patient.

[0022] In Example 20, according to the method of Example 19, the propulsion and retraction operations include selectively commanding the pressurized airflow to drive each actuator to perform the propulsion and retraction actions respectively.

[0023] While several embodiments have been disclosed, other embodiments of this disclosure will become apparent to those skilled in the art from the following detailed description, which illustrates and describes illustrative embodiments of this disclosure. Therefore, the accompanying drawings and detailed description should be considered illustrative in nature and not restrictive. Attached Figure Description

[0024] Figure 1 is a schematic diagram of an exemplary clinical application scenario, illustrating an implementation scheme for extracorporeal membrane oxygenation (ECMO) system using an integrated assisted intubation system (ACS) to provide extracorporeal life support (ECLS) to a patient, which is consistent with various aspects of this disclosure.

[0025] Figure 2A This is a schematic diagram of the ACS cannulation assembly in a retracted configuration, consistent with various aspects of this disclosure.

[0026] Figure 2B This is a schematic diagram of the ACS cannulation assembly in an advance configuration, consistent with various aspects of this disclosure.

[0027] Figure 3A This is a side view of the cannulation assembly, consistent with various aspects of this disclosure.

[0028] Figure 3B This is an exploded side view of the cannulation assembly, consistent with various aspects of this disclosure.

[0029] Figure 4 This is a perspective view of the ACS cannula in a high-angle configuration, consistent with all aspects of this disclosure.

[0030] Figure 5A This is a perspective view of the base of the cannula stent, consistent with various aspects of this disclosure.

[0031] Figure 5B It is an exploded view of the base, consistent with various aspects of this disclosure.

[0032] Figure 6A This is a perspective view of the tray of the cannula stent, consistent with various aspects of this disclosure.

[0033] Figure 6B This is an exploded view of the pallet, consistent with various aspects of this disclosure.

[0034] Figure 7A This is a perspective view of the needle linkage, consistent with various aspects of this disclosure.

[0035] Figure 7B This is a perspective view of the cannulation linkage, consistent with various aspects of this disclosure.

[0036] Figure 7C This is a perspective view of the expander linkage, consistent with various aspects of this disclosure.

[0037] Figure 8 This is a method of operating ACS that conforms to all aspects of this disclosure.

[0038] Figures 9A-9E yes Figure 8A series of views of the results of the method operation, consistent with various aspects of this disclosure.

[0039] Figure 10 This is a perspective view of an alternative cannula for ACS in a mid-angle configuration, consistent with various aspects of this disclosure.

[0040] Figure 11A It is a perspective view of an alternative base for an alternative catheter stent, consistent with various aspects of this disclosure.

[0041] Figure 11B It is an exploded view of the alternative base, conforming to various aspects of this disclosure.

[0042] Figure 12A It is a perspective view of an alternative tray for an alternative catheter stent, consistent with various aspects of this disclosure.

[0043] Figure 12B It is an exploded view of the alternative tray, consistent with all aspects of this disclosure.

[0044] Figure 13 It is a perspective view of an alternative cannula stent, wherein an alternative actuator is connected to an alternative tray, consistent with various aspects of this disclosure.

[0045] Figure 14 This is a perspective view of the U-shaped clamp for the actuator, conforming to various aspects of this disclosure.

[0046] Figure 15A This is a perspective view of an alternative needle linkage, conforming to various aspects of this disclosure.

[0047] Figure 15B It is a perspective view of an alternative cannulation link, consistent with various aspects of this disclosure.

[0048] Figure 15C It is a perspective view of the alternative expander link, conforming to various aspects of this disclosure.

[0049] Figure 16A This is a perspective view of the connecting rod extension, consistent with various aspects of this disclosure.

[0050] Figure 16B It is a perspective view of an alternative link extension, conforming to various aspects of this disclosure.

[0051] Figure 17 This is a schematic diagram of the pneumatic system of the ACS, consistent with all aspects of this disclosure.

[0052] Figure 18 It is an alternative method for operating ACS, and is consistent with all aspects of this disclosure.

[0053] Figure 19AA-19EB yes Figure 18A series of views of the results of alternative method operations, consistent with various aspects of this disclosure.

[0054] Figure 20 This is a perspective view of an alternative cannula for ACS in a low-angle configuration, consistent with all aspects of this disclosure.

[0055] While this disclosure is open to various modifications and alternatives, specific embodiments have been shown by way of example in the accompanying drawings and are described in detail below. However, this disclosure is not intended to limit it to the particular embodiments described. Rather, it is intended to cover all modifications, equivalents, and alternatives that fall within the scope of this disclosure as defined by the appended claims. Detailed Implementation

[0056] To facilitate understanding of the principles of the invention, reference is now made to the examples shown in the accompanying drawings described below. The illustrative examples disclosed herein are not intended to be exhaustive or to limit this disclosure to the precise forms disclosed in the following detailed description. Rather, these exemplary embodiments have been selected and described so that others skilled in the art can utilize their teachings. All features in a given example are applicable to all examples, which does not exceed the scope of this disclosure. Therefore, no figure should be construed as having any dependency requirement on any single component or combination of components shown therein. Furthermore, the various components depicted in a given figure may be integrated in the example with various other components (and / or components not shown) depicted therein, all of which are considered to be within the scope of this disclosure.

[0057] Figure 1 This illustration, representing an exemplary clinical application scenario 100, shows an implementation scheme for extracorporeal membrane oxygenation (ECMO) system 104 employing an integrated assisted intubation system (ACS) to provide extracorporeal life support (ECLS) to patient 102. In the illustrated embodiment, ECMO system 104 includes a fluid loop having a drainage tube 106, a pump 108, an oxygenator 110, and a return tube 112, which are fluidly connected together. ECMO system 104 also includes a control system comprising a computer 114.

[0058] In the illustrated embodiment, clinician 116 is using ACS 118 to intubate patient 102. ACS 118 assists clinician 116 in placing the cannula in patient 102, after which clinician 116 can connect these cannulas to drainage tube 106 and reflux tube 112. While clinician 116 is currently using ACS 118 in the groin region of patient 102, ACS 118 can also be used in other areas of patient 102 (e.g., the neck / shoulder region).

[0059] Figure 2AThis is a schematic diagram of ACS 118. In the illustrated embodiment, ACS 118 includes an adjustable support 150 with an actuation system 152 at its top. The proximal end of the cannulation assembly 154 is connected to the actuation system 152, which is also connected to a control system 156 and a power source 158. In some embodiments, the control system 156 is a computer, and the power source 158 is an electric, pneumatic, or hydraulic power source, depending on the type of power used by the actuation system 152. The control system 156 is also connected to the power source 158 and includes components configured to receive signals from a clinician 116 (e.g., ...). Figure 1 The user interface (shown) is used to control the supply of power to the actuation system 152.

[0060] In the illustrated embodiment, the cannula assembly 154 is in a retracted configuration such that it does not extend beyond the bottom of the adjustable support 150. The adjustable support 150 is configured at an angle of 160 degrees, for example, between 30 and 45 degrees.

[0061] Figure 2B This is a schematic diagram of ACS 118, where the cannulation assembly 154 is in the advancement configuration. In this configuration, the clinician 116 (e.g., Figure 1 As shown, the control system 156 has been used to advance the cannulation assembly 154 using the actuation system 152. Thus, the distal tip of the cannulation assembly 154 has been punctured into a blood vessel 162 (e.g., femoral artery, femoral vein, subclavian artery, or subclavian vein) of the patient 102.

[0062] As will be further explained in the accompanying diagram below, the ACS 118 allows clinicians to quickly and safely intubate patient 102, minimizing blood loss and trauma to surrounding tissues. Therefore, patient 102 can be connected to the ECMO system 104 (such as...). Figure 1 As shown), so that patient 102 can be in clinical application scenario 100 (such as... Figure 1 ECLS is accepted in (as shown).

[0063] Figure 3A This is a side view of the cannulation assembly 154. In the illustrated embodiment, the cannulation assembly 154 has an elongated shape and includes a needle 200, a dilator 202, and a cannula 204. When assembled, the dilator 202 surrounds the needle 200, and the cannula 204 surrounds the needle 200 and the dilator 202. The needle 200 extends beyond the dilator 202 at both its proximal and distal ends, while the dilator 202 extends beyond the cannula 204 at both its proximal and distal ends.

[0064] In some embodiments, needle 200 comprises a metallic material (e.g., stainless steel). In some embodiments, dilator 202 comprises a polymeric material (e.g., polypropylene (PP), high-density polyethylene (HDPE), low-density polyethylene (LDPE), fluorinated ethylene propylene (FEP), ethylene tetrafluoroethylene (ETFE), or ETEC®'s E-RigidForm® 3D-printable polymer). In some embodiments, cannula 204 comprises a polymeric material (e.g., PP, HDPE, LDPE, FEP, ETFE, or polyurethane (PU)) with one or more reinforcing metal coils embedded within it. In some embodiments, needle 200, dilator 202, and / or cannula 204 include a hydrophilic coating to reduce friction with tissue and / or an antithrombotic surface treatment (e.g., heparin bonding) to reduce the risk of thrombosis. In some embodiments, needle 200, dilator 202, and / or cannula 204 contain radiopaque markings (not shown) for fluorescence fluoroscopic visualization.

[0065] Figure 3B This is an exploded side view of the cannulation assembly 154. In the illustrated embodiment, the needle 200 has a length 206 of approximately 304 mm, an outer diameter 208 of approximately 1.829 mm (approximately size 15) (except for the point where the needle 200 is pointed at its distal end of approximately 12.0 mm), and an inner diameter of approximately 1.372 mm. The dilator 202 has a length 210 of approximately 270 mm, an outer diameter 212 of approximately 4.40 mm, and an inner diameter of approximately 2.30 mm. The cannulation 204 has a length 214 of approximately 220 mm, an outer diameter 216 of approximately 6.30 mm, and an inner diameter of approximately 5.00 mm.

[0066] In other embodiments, the needle 200 has a length 206 of approximately 304 mm and an outer diameter 208 of approximately 13.7 mm (except that the needle 200 is pointed at its distal end of approximately 12.0 mm). The dilator 202 has a length 210 of approximately 584 mm and an outer diameter 212 of approximately 14.6 mm. The cannula 204 has a length 214 of approximately 499 mm and an outer diameter 216 of approximately 16.3 mm.

[0067] In other embodiments, the outer diameter 212 is approximately 6.67 mm (20 Fr) to approximately 7.00 mm (21 Fr), and the outer diameter 216 is approximately 7.33 mm (22 Fr). Thus, the size of the outer diameter 216 is between that of a cannula typically used for venous cannulation (23 Fr) and a cannula used for arterial cannulation (21 Fr).

[0068] In the illustrated embodiment, the proximal end of the needle 200 is provided with a blocking end 218, the width and / or height of which is greater than the inner diameter of the dilator 202, so that the needle 200 cannot pass completely distally through the dilator 202. The proximal end of the dilator 202 is provided with a blocking end 220, the width and / or height of which is greater than the inner diameter of the cannula 204 (e.g., about 15.0 mm to about 18.0 mm), so that the dilator 202 cannot pass completely distally through the cannula 204.

[0069] In the illustrated embodiment, the cannula 204 includes a port array 222 at its distal end. The ports 222 extend vertically through the wall of the cannula 204 into the central cavity of the cannula 204.

[0070] Although Figure 3A and 3B The cannulation assembly 154 is shown to include three separate components, but in other embodiments, the cannulation assembly includes only two components. In such embodiments, the needle and external dilator are a single integrated puncture assembly.

[0071] Figure 4 This is a perspective view of the adjustable support 150. In the illustrated embodiment, the adjustable support 150 includes a base 250, a tray 252, and a support column 254. The base 250 is connected to the tray 252 via a hinge 256, and the tray 252 is connected to the support column 254 via a hinge 258. The free end of the support column 254 is configured to engage with a series of notches 260 in the base 250 to set the angular configuration of the adjustable support 150. Figure 4 As shown, the support column 254 is located in the nearest notch 260, thus the adjustable bracket 150 is in a high-angle configuration. Each notch 260 further away from the hinge 256 will further reduce the angle of the tray 252.

[0072] Figure 5A This is a perspective view of base 250. Figure 5B This is an exploded view of base 250. In the illustrated embodiment, base 250 includes a portion of hinge 256 and consists of three parts held together by pins 262 and / or adhesive.

[0073] Figure 6A This is a perspective view of tray 252. Figure 6B This is an exploded view of tray 252. In the illustrated embodiment, tray 252 includes four longitudinally extending walls 264A-264D (collectively referred to as “walls 264”) that define three longitudinally extending channels 266A-266C (collectively referred to as “channels 266”). All walls 264 extend to the distal end of tray 252, while walls 264A and 264D extend to the proximal end of tray 252. Walls 264B and 264C are shorter to leave an open mounting space 268 at the proximal end of tray 252.

[0074] In the illustrated embodiment, tray 252 comprises two parts secured together by pin 270 and / or adhesive. Tray 252 includes a portion of hinge 256 at its distal end and a portion of hinge 258 at its proximal end. At the distal end, walls 264B and 264C are connected by guide 272. Guide 272 defines the end of channel 266B, extends upward, and defines a configuration for guiding cannula assembly 154 (e.g., Figure 2B Hole 274 (as shown).

[0075] In the illustrated embodiment, tray 252 is configured to accommodate one electric actuator (e.g., in each channel 266) Figure 9A (As shown), for example, a motor-driven linear actuator. Each actuator is connected to a tray 252 at mounting space 268 and extends distally.

[0076] Figure 7A This is a perspective view of the needle link 300. In the illustrated embodiment, the needle link 300 includes a foot 302 extending downward at its distal end, a hand 304 extending laterally at its proximal end, and a lug 306 extending downward in the middle (although the downward extension is not as far as that of the foot 302). The foot 302 and the lug 306 are configured to be slidably positioned in a channel 266A. The needle link 300 is configured to have its respective electric actuator (such as...) Figure 9A It is connected at the foot 302 (as shown) and configured to be at the blocking end 218 of the needle 200 (as shown). Figure 3B The lug 306 is connected at the hand part 304 (as shown). The lug 306 is configured to slidably contact the top side of its corresponding electric actuator.

[0077] Figure 7B This is a perspective view of the cannulation link 310. In the illustrated embodiment, the cannulation link 310 includes a distally downward extending foot 312, a distally upward extending front guide 314 defining an orifice 316, a proximal upward extending fork 318, and a middle guide 320 extending upward between the front guide 314 and the fork 318 defining an orifice 322. The foot 312 is configured to be slidably positioned in the channel 266B. In some embodiments, the orifices 316, 322 are large enough to allow insertion of the cannula 204 (e.g., Figure 3B As shown, the fork 318 is large enough to allow the expander 202 (as shown) to slide through, while the fork portion 318 is large enough to allow the expander 202 (as shown) to slide through. Figure 3B (As shown) it slides through, but is small enough to prevent the cannula 204 from sliding through. Therefore, the fork 318 is configured to push the proximal end of the cannula 204. The cannula link 310 applies such a force to the cannula 204 because the cannula link 310 is configured to connect its corresponding electric actuator (such as...) at the foot 312. Figure 9A (As shown).

[0078] Figure 7CThis is a perspective view of the expander link 326. In the illustrated embodiment, the expander link 326 includes a foot 328 extending downward at its distal end, a hand 330 extending laterally at its proximal end, and a lug 332 extending downward in the middle (although not as far downward as the foot 328). The foot 328 and lug 332 are configured to be slidably positioned in a channel 266C. The expander link 326 is configured to have its respective electric actuator (e.g., Figure 9A It is connected at the foot 328 (as shown) and configured to be at the blocking end 220 of the expander 202 (as shown). Figure 3B The lug 332 is connected at the hand part 330 (as shown). The lug 332 is configured to slidably contact the top side of its corresponding electric actuator.

[0079] Figure 8 This is method 350 for operating ACS 118. Figures 9A-9E This is a series of views of the results of method 350. Therefore, it will be combined with... Figure 8 and Figures 9A-9E Let's discuss this. Method 350 begins with operation 352, in which ACS 118 is placed in patient 102 (e.g., ...). Figure 1 As shown, the distal tip of needle 200 is positioned above the skin and aligned with blood vessel 162 (as shown). Figure 2B (As shown). Based on the patient's anatomy, the angle between ACS 118 and patient 102 is approximately between thirty and forty-five degrees.

[0080] exist Figure 9A In the illustrated embodiment, the ACS 118 includes a needle actuator 400 connected to a needle 200 via a needle link 300, a cannula actuator 402 connected to a cannula 204 via a cannula link 310, and an expander actuator 404 connected to the expander 202 via an expander link 326. In the illustrated embodiment, the distal end of the needle 200 extends 30 mm beyond the distal end of the expander 202, and the distal end of the expander 202 extends 30 mm beyond the distal end of the cannula 204.

[0081] exist Figure 9BA and 9BB In the illustrated embodiment, during operation 354, actuators 400-404 advance needle 200, dilator 202, and cannula 204 by 30 mm each. Thus, needle 200 punctures blood vessel 162, even though dilator 202 and cannula 204 have not yet been punctured.

[0082] exist Figure 9C In the illustrated embodiment, during operation 356, the dilator actuator 404 advances the dilator 202 to also puncture the blood vessel 162, for example, by 30 mm. The needle actuator 400 and the cannula actuator 402 remain stationary, so the dilator 202 is advanced over the needle 200 and positioned below the cannula 204.

[0083] In operation 358, dilator 202 is retracted. In operation 360, the angle of adjustable stent 150 is lowered from a high configuration (e.g., about thirty to about forty-five degrees) to a low configuration (e.g., about twenty-five degrees). In operation 362, dilator 202 is advanced past needle 200 and positioned below cannula 204 for re-entry into vessel 162. In operation 364, needle actuator 400 retracts needle 200 from patient 102.

[0084] exist Figure 9D In the illustrated embodiment, during operation 366, the cannulation actuator 402 advances the cannula 204 past the dilator 202 until the cannula 204 is positioned inside the blood vessel 162, for example, 30 mm.

[0085] exist Figure 9E In the illustrated embodiment, during operation 368, the dilator actuator 404 retracts the dilator 202, positioning it below the cannula 204 and removing it from the patient 102.

[0086] In procedure 370, the ACS 118 is removed from the patient 102, leaving the cannula 204 in place. The ACS 118 and method 350 make it easy and safe to intubate the patient 102. The ACS 118 and method 350 also eliminate the need for a guidewire, which simplifies the intubation procedure and reduces the total number of components involved.

[0087] Figure 10 This is a perspective view of an alternative adjustable bracket 450. In the illustrated embodiment, the adjustable bracket 450 includes a base 452, a tray 454, and two supports 456 located on either side of the base 452 and the tray 454. The base 452 is connected to the tray 454 via a hinge 458, and the tray 454 is connected to each support 456 via fasteners (e.g., wing nuts 460). The wing nuts 460 extend through a slot 462 in the support 456, so that when the wing nuts 460 are tightened, the tray 454 is secured. Thus, an angular configuration of the adjustable bracket 450 is established. This is in contrast to a stepped adjustable bracket 150 (e.g., Figure 4 Compared to (as shown), the adjustable bracket 450 can be steplessly adjusted within the range of the slot 462. For example... Figure 10 As shown, the tray 454 is positioned near the midpoint of the slot 462, thus the adjustable bracket 450 is in a mid-angle configuration.

[0088] Figure 11A This is a perspective view of base 452. Figure 11B This is an exploded view of base 452. In the illustrated embodiment, base 452 includes a portion of hinge 458 and consists of two parts held together by pin 464 and / or adhesive.

[0089] Figure 12AThis is a perspective view of tray 454. Figure 12B This is an exploded view of tray 454. In the illustrated embodiment, tray 454 includes four longitudinally extending walls 466A-466D (collectively referred to as “walls 466”) that define three longitudinally extending channels 468A-468C (collectively referred to as “channels 468”). All walls 466 extend from the distal end of tray 454 to the proximal end of tray 454.

[0090] In the illustrated embodiment, tray 454 comprises two parts secured together by pin 470 and / or adhesive. Tray 454 includes a portion of hinge 458 at its distal end and a threaded hole 472 at its proximal end for engagement with a wing nut 460 (e.g., Figure 10 (As shown) Joining.

[0091] Figure 13 This is a perspective view of an alternative adjustable support 450, wherein needle actuator 474, cannula actuator 476, and dilator actuator 478 are located in channel 468. In the illustrated embodiment, actuators 474-478 are pneumatic actuators, such as pneumatic cylinders. Each actuator 474-478 is connected to the proximal end of tray 454 and extends distally. Each actuator 474-478 includes a U-shaped clip 480 at its distal end. In some embodiments, the travel of needle actuator 474 is approximately 50 mm, the travel of dilator actuator 476 is approximately 75 mm, and the travel of cannula actuator 478 is approximately 100 mm.

[0092] Figure 14 This is a perspective view of the U-shaped clip 480 for each actuator 474-478. The U-shaped clip 480 allows the actuators 474-478 to be connected to the needle 200, the dilator 202, and the cannula 204, respectively.

[0093] Figure 15A This is a perspective view of an alternative needle link 500. In the illustrated embodiment, the needle link 500 includes a foot 502 extending downward at its distal end, a hand 504 extending laterally at its proximal end, and a lug 506 extending outward and downward in the middle (although the downward extension is not as far as that of the foot 502). The foot 502 and the lug 506 are configured to be slidably positioned in channel 468A and to contact the sides of walls 466A, 466B. The needle link 500 is configured to connect a needle actuator 474 (e.g., ...) at the foot 502. Figure 13 As shown), and configured to connect the blocking end 218 of the needle 200 at the hand 504 (as shown). Figure 3B As shown), lug 506 is configured to slidably contact the top side of needle actuator 474.

[0094] Figure 15BThis is a perspective view of an alternative cannulation link 510. In the illustrated embodiment, the cannulation link 510 includes a distally downward extending foot 512, a distally upward extending front guide 514 defining an orifice 516, a proximal upward extending rear guide 518 defining an orifice 520, and an outwardly and downward extending lug 522. The foot 512 is configured to be slidably positioned in channel 468B and contacting the sides of walls 466B, 466C. In some embodiments, the orifice 516 is large enough to allow insertion of the cannula 204 (e.g., Figure 3B As shown, the hole 520 is large enough to allow the expander 202 (as shown) to slide through, while the hole 520 is large enough to allow the expander 202 (as shown) to slide through. Figure 3B (As shown) It slides through, but is small enough to prevent the cannula 204 from sliding through. Therefore, the rear guide 518 is configured to push the proximal end of the cannula 204. The cannula linkage 510 applies such a force to the cannula 204 because the cannula linkage 310 is configured to connect the cannula actuator 476 (as shown) at the foot 512. Figure 13 (As shown). Lug 522 is configured to slidably contact the top side of cannulation actuator 476.

[0095] Figure 15C This is a perspective view of an alternative expander link 526. In the illustrated embodiment, the expander link 526 includes a foot 528 extending downward at its distal end, a hand 530 extending laterally at its proximal end, and a lug 532 extending outward and downward in the middle (although not as far downward as the foot 528). The foot 528 and lug 532 are configured to be slidably positioned in channel 468C and contacting the sides of walls 466C, 466D. The expander link 526 is configured to connect to expander actuator 478 (e.g., at foot 528) at foot 528. Figure 13 As shown), and configured to connect the blocking end 220 of the expander 202 at the hand 530 (as shown). Figure 3B (As shown). Lug 532 is configured to slidably contact the top side of expander actuator 478.

[0096] Figure 16A This is a perspective view of the connecting rod extension 536. Figure 16B This is a perspective view of the alternative link extension 538. Link extensions 536 and 538 are configured to connect to links 500, 510, and 526 (as shown below) as needed. Figures 15A-15C (as shown) and their respective U-shaped clips 480 (as shown) Figure 14 Between (as shown). Linkage extensions 536 and 538 are configured as adjusting pin 200, expander 202, and / or cannula 204 (as shown). Figure 3B (As shown) the initial position of the distal end. In some embodiments, the link extension 536 changes the initial position by about 30 mm, and the link extension 538 changes the initial position by about 60 mm.

[0097] Figure 17This is a schematic diagram of a pneumatic system 500 for use with an ACS 118. In the illustrated embodiment, the pneumatic system 500 includes a control system 156, a power source 158, actuators 474-478, and solenoid valves 552A-552C (collectively referred to as "solenoid valves 552"). Solenoid valves 552 are communicatively connected to and controlled by the control system 156. Solenoid valves 552 are fluidly connected to the power source 158 and actuators 474-478, respectively. Therefore, the clinician 116 (e.g., Figure 1 (As shown) The control system 156 can selectively and independently command pressurized air (e.g., about 140 kPa) to flow to the advance and retraction sides of actuators 474-478 to control needle 200, dilator 202, and cannula 204 (as shown). Figure 3B (as shown in the image) motion.

[0098] Figure 18 This is method 600 for operating ACS 118. Figure 19AA-19EB This is a series of views of the results of method 600. Therefore, it will be combined with... Figure 18 and Figure 19AA-19EB Let's discuss this. Method 600 begins with operation 602, in which the ACS 118 is placed in patient 102 (e.g., ...). Figure 1 As shown, the distal tip of needle 200 is positioned above the skin and aligned with blood vessel 162 (as shown). Figure 2B (As shown). Based on the patient's anatomy, the angle between ACS 118 and patient 102 is approximately between thirty and forty-five degrees.

[0099] Figure 19 shows a pneumatic system angle adjustment mechanism with a curved groove plate (A), a connecting shaft (B), an adjustment knob (C), and a base plate (D). Figure 19AA and 19AB In the illustrated embodiment, the ACS 118 includes a needle actuator 474 connected to the needle 200 via a needle link 500, a cannula actuator 476 connected to the cannula 204 via a cannula link 510, and an expander link.

[0100] exist Figure 19BA and 19BB In the illustrated embodiment, during operation 604, the needle actuator 474 advances the needle 200 so that it is positioned below the dilator 202, for example, 50 mm (i.e., the entire stroke of the needle actuator 474). Thus, the needle 200 punctures the blood vessel 162.

[0101] exist Figure 19CA and 19CBIn the illustrated embodiment, during operation 606, the dilator actuator 478 advances the dilator 202 to also puncture the blood vessel 162, for example, by 75 mm (i.e., the entire stroke of the dilator actuator 478). The needle actuator 474 and the cannula actuator 476 remain stationary, so the dilator 202 is advanced past the needle 200 and positioned below the cannula 204.

[0102] exist Figure 19DA and 19DB In the illustrated embodiment, during operation 608, the cannula actuator 476 pushes the cannula 204 forward along the dilator 202 until the cannula 204 reaches the target position within the blood vessel 162, for example, with a depth of 100 mm.

[0103] exist Figure 19EA and 19EB In the illustrated embodiment, during operation 610, needle actuator 474 retracts needle 200, and dilator actuator 478 retracts dilator 202, positioning it below cannula 204 and removing it from patient 102.

[0104] In operation 612, the ACS 118 is removed from the patient 102, leaving the cannula 204 in place. The ACS 118 and method 600 enable easy and safe cannulation of the patient 102. The ACS 118 and method 600 also eliminate the need for a guidewire, simplifying the cannulation procedure and reducing the total number of components involved.

[0105] Figure 20 This is a perspective view of the ACS 118 alternative adjustable bracket 650 in a low-angle configuration. Figure 20 This is a disposable expander accessory for needle, cannula, and expander power systems. In the illustrated embodiment, the adjustable bracket 650 includes a base 652, a tray 654, and two supports 656 located on either side of the base 652 and tray 654. The base 652 is connected to the tray 654 via a hinge 658, and the tray 654 is connected to each support 656 via a wing nut (not shown). The wing nut extends through a slot 660 in the support 656, thus securing the tray 654 when the wing nut is tightened. Therefore, an angular configuration of the adjustable bracket 650 is established. Figure 20 As shown, the tray 654 is positioned at the bottom of the slot 660, so the adjustable bracket 650 is in a low-angle configuration.

[0106] In the illustrated embodiment, tray 654 has a slotted shape, so the needle actuator 662 and needle link 664, the cannulation actuator (not shown, but present below the cannulation assembly 666) and cannulation link 668, and the dilator actuator 670 and dilator link 672 are arranged in a semi-circular arrangement around the cannulation assembly 666. This arrangement contrasts with the previous adjustable supports 150, 450, which arrange their actuators 400-404, 474-478 in a planar manner with the cannulation assembly 154, which is located above the actuators 400-404, 474-478 (see, for example, Figure 9A and 19AA ).

[0107] As is well known, for methods comprising one or more steps, the order of the steps listed is not a limitation of the claims unless expressly or implied in the specification or the claims themselves. It is also understood that the methods shown are merely some of the many examples disclosed, and certain steps may be added or omitted without departing from the scope of this disclosure. Such steps may include combinations of apparatus, systems, or methods or components thereof that are known, conventional, and customary in the art.

[0108] The connecting lines shown in the various figures included herein are intended to illustrate exemplary functional relationships and / or physical couplings between various elements. It should be noted that many alternative or additional functional relationships or physical connections may exist in actual systems. However, any benefit, advantage, solution to a problem, and any element that may cause any benefit, advantage, or solution to occur or become more apparent should not be construed as a critical, essential, or necessary feature or element. Accordingly, the scope is defined only by the appended claims, wherein references to singular elements are not intended to mean "only one," but rather "one or more," unless explicitly stated otherwise. Furthermore, when phrases such as "at least one A, B, or C" are used in the claims, such phrases are intended to be interpreted as A alone may exist in one embodiment, B alone may exist in one embodiment, C alone may exist in one embodiment, or any combination of elements A, B, or C may exist in a single embodiment; for example, A and B, A and C, B and C, or A and B and C. The terms “coupled,” “connected,” “attached,” and their variations are used to describe arrangements that include two or more components in direct physical contact, as well as arrangements in which two or more components are not in direct contact with each other (e.g., components are “coupled” through at least a third component) but still cooperate or interact with each other.

[0109] In this detailed description, references to "an embodiment," "an embodiment," "an exemplary embodiment," etc., indicate that the described embodiments may include specific features, structures, or characteristics, but not every embodiment necessarily includes that specific feature, structure, or characteristic. Furthermore, such phrases do not necessarily refer to the same embodiment. Additionally, when a specific feature, structure, or characteristic is described in connection with an embodiment, it should be understood that those skilled in the art, based on the teachings of this disclosure, will be able to implement such features, structures, or characteristics in other embodiments, whether explicitly described or not. After reading this description, those skilled in the art will understand how to implement this disclosure in alternative embodiments.

[0110] Various modifications and additions may be made to the exemplary embodiments discussed without departing from the scope of this disclosure. For example, while the above embodiments relate to specific features, the scope of this disclosure also includes embodiments with different combinations of features and embodiments that do not include all of the stated features. Therefore, the scope of this disclosure is intended to cover all such alternatives, modifications, and variations falling within the scope of the claims, and all their equivalents.

Claims

1. An assisted cannulation system for inserting cannulas into a patient's artery or vein, comprising: An adjustable bracket includes a base and a tray; wherein the base and the tray are connected by a hinge. A needle actuator connected to the tray; A needle connected to the needle actuator; An expander actuator connected to the tray; An expander connected to the expander actuator and surrounding the needle; The cannula actuator connected to the tray; and A cannula connected to the cannula actuator and surrounding the dilator and the needle; The needle actuator is configured to advance and retract the needle; The expander actuator is configured to advance and retract the expander; The cannulation actuator is configured to advance the cannulation; and The adjustable support is adjustable to change the angles of the needle, the dilator, and the cannula.

2. The auxiliary intubation system of claim 1, wherein, The needle actuator, the dilator actuator, and the cannula actuator include electric actuators.

3. The auxiliary intubation system of claim 1, wherein, The needle actuator, the dilator actuator, and the cannula actuator include pneumatic actuators.

4. The auxiliary cannulation system according to claim 1, characterized in that, The adjustable support also includes a support column connected to the tray; The base includes a plurality of recesses configured to engage with the support post to set the angle of the tray.

5. The auxiliary intubation system of claim 1, wherein, The adjustable bracket also includes a bracket with a slot configured to receive fasteners to set the angle of the tray.

6. The auxiliary intubation system of claim 1, wherein, The tray includes an array of channels, and each of the needle actuator, the dilator actuator, and the cannula actuator is positioned in a different channel.

7. The assisted intubation system according to claim 1, further comprising: Connect the needle to the needle linkage of the needle actuator; Connect the expander to the expander actuator's expander linkage; as well as Connect the cannula to the cannula linkage of the cannula actuator.

8. The auxiliary intubation system of claim 1, wherein, The system also includes a control system configured to receive input from a user to control the power supplied to the actuator.

9. The auxiliary cannulation system according to claim 1, characterized in that, The needle comprises a metallic material, the dilator comprises a polymeric material, and the cannula comprises a polymeric material.

10. The auxiliary cannulation system according to claim 1, characterized in that, At least one of the needle, the dilator, and the cannula includes either a hydrophilic coating or an antithrombotic surface treatment for reducing friction with tissue.

11. An assisted cannulation system for inserting cannulas into an artery or vein of a patient, comprising: Adjustable stand for different angles; An actuation system connected to the adjustable support; The cannulation assembly connected to the adjustable support; A power source connected to the actuation system; as well as A control system connected to the actuation system and the power source, wherein the control system is configured to receive input from the user to advance and retract components of the cannulation assembly for cannulation of the patient.

12. The auxiliary cannulation system according to claim 11, characterized in that, The cannulation assembly includes: Needle; An expander surrounding the needle; and The cannula surrounding the dilator and the needle; and The actuation system includes: A needle actuator connected to the needle; An expander actuator connected to the expander; and A cannula actuator connected to the cannula.

13. The auxiliary cannulation system according to claim 12, characterized in that, The power source includes an electrical power source; and The needle actuator, the dilator actuator, and the cannula actuator are electric actuators.

14. The auxiliary cannulation system according to claim 12, characterized in that, The power source includes a pneumatic power source; and the actuation system further includes a plurality of solenoid valves fluidly connected between the power source and the needle actuator, the dilator actuator, and the cannulation actuator.

15. The auxiliary cannulation system according to claim 14, characterized in that, The control system is configured to selectively command pressurized airflow to the propulsion and retraction sides of the actuator.

16. The auxiliary cannulation system according to claim 11, characterized in that, The adjustable support also includes a support column connected to the tray; The base includes a plurality of recesses configured to engage with the support post to set the angle of the tray.

17. The auxiliary cannulation system according to claim 11, characterized in that, The adjustable bracket also includes a bracket with a slot configured to receive fasteners to set the angle of the tray.

18. The auxiliary cannulation system according to claim 11, characterized in that, The bracket can be adjusted between a first angle configuration of 30 degrees or more and a second angle configuration of less than 30 degrees.

19. A method for operating an assisted intubation system, characterized in that, The system includes an adjustable support, an actuation system connected to the adjustable support, and a cannulation assembly connected to the actuation system. The cannulation assembly includes a needle, an expander surrounding the needle, and a cannulation surrounding the expander and the needle. A power source is connected to the actuation system, and a control system is connected to the actuation system and the power source. The method includes: Place the auxiliary cannulation system on the patient with the distal tip of the needle positioned above the skin and aligned with the blood vessel; Advance the needle to puncture the blood vessel; The dilator is advanced along the needle and positioned below the cannula, allowing the dilator to enter the blood vessel; Retract the expander and adjust the angle of the adjustable bracket to a lower angle; The dilator is advanced along the needle and positioned below the cannula, allowing the dilator to re-enter the blood vessel; The cannula is advanced along the dilator until it is inserted into the blood vessel. Retract the needle and the dilator from the patient's body while leaving the cannula in place; and Remove the assisted intubation system from the patient.

20. The method according to claim 19, characterized in that, The propulsion and retraction operations include selectively commanding the pressurized airflow to drive each of the actuators to perform the propulsion and retraction actions, respectively.

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