• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
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  • 优先权
    • 专利摘要:
    the embodiments of the present invention are directed to the advancement of guidewire and reverse blood squirt systems. in particular, the insertion tool includes a frangible guide wire lever configured to break and prevent further movement of the guide wire if the guide wire becomes stuck. such a feature can prevent the breaking of a distal portion of the guidewire that would otherwise undesirably lead to embolism. the insertion tool may also include a blood squirt indicator that has a simplified needle coupling. the insertion tool can also include a guide wire feed set configured to allow the clinician to hold the insertion tool close to a distal end and operate the guide wire feed with one hand, while providing greater control over the tool insertion. the insertion tool may also include a safety clip attached to the catheter hub and configured to close around the needle tip when the catheter is detached from the device.
    公开号:BR112020017215A2
    申请号:R112020017215-4
    申请日:2019-03-07
    公开日:2020-12-22
    发明作者:Huy Ngoc Tran；Daniel B. Blanchard；Jason R. Stats
    申请人:Bard Access Systems, Inc.；
    IPC主号:
    专利说明:

    [001] [001] This application claims priority under 35 USC § l19 (e) of US Provisional Application No. 62 / 639,790, filed on March 7, 2018 and entitled "Blood Flashback and Guide Wire Advance Systems for a insertion of medical device ", which is hereby incorporated by reference in its entirety into this order. SUMMARY
    [002] [002] Briefly, the modalities disclosed here are directed to catheter insertion tools and methods.
    [003] [003] An insertion tool for inserting a medical device into a patient's body, the insertion tool including, in some embodiments, a housing, a needle, a feed set and a wire feed set, is disclosed in this document guide. The advance set is configured to selectively advance the medical device for placement on the patient's body. The guide wire advance set is configured to selectively advance a guide wire before advancing the medical device. The guide wire feed assembly includes a first portion, a second portion and a frangible portion that physically interconnects the first portion to the second portion. The guidewire is operationally attached to one of the first or second portion. The frangible portion is configured to break when a force of a predetermined magnitude is imposed on it.
    [004] [004] In some modalities, the proximal retraction of the guidewire is substantially avoided after breaking the frangible portion.
    [005] [005] In some modalities, the force imposed on the frangible portion is a tension force.
    [006] [006] In some embodiments, the predetermined magnitude of the force is less than a second predetermined magnitude of a force that is needed to break the guidewire.
    [007] [007] In some embodiments, the first and second portions are interconnected by the frangible portion and a hinge portion.
    [008] [008] In some embodiments, the first and second portions articulate in relation to each other around the hinge portion when the frangible portion breaks. The pivoting movement of the first and second portions inhibits the additional movement of the guide wire.
    [009] [009] In some embodiments, the first and second portions separate from each other when the force of the predetermined magnitude is imposed on them, causing the frangible portion to break.
    [0010] [0010] An insertion tool is also disclosed to place a medical device within a patient's vasculature including, in some modalities, a housing, an indicator tube and a needle. The indicator tube includes a lumen from the indicator tube. The needle includes a needle lumen and an opening arranged in a side wall of the needle. The opening fluidly connects the lumen of the needle with the lumen of the indicator tube.
    [0011] [0011] In some embodiments, the indicator tube extends through a translucent portion of the housing.
    [0012] [0012] In some embodiments, the translucent portion is a portion of the wing used to advance a medical device through the patient's vasculature.
    [0013] [0013] In some embodiments, the indicator tube extends over a surface of the housing.
    [0014] [0014] In some embodiments, the needle includes a second needle opening through the side wall of the needle disposed opposite the (first) needle opening.
    [0015] [0015] In some embodiments, a flow of blood from the needle enters the lumen of the indicator tube and flows in opposite directions along the lumen of the indicator tube away from the needle.
    [0016] [0016] A catheter placement tool for placing a catheter within a patient's vasculature is also disclosed, the catheter placement tool including, in some embodiments, a housing, a catheter, a needle, a safety clip from needle, a guide wire and a guide wire feed assembly. The housing extends along a longitudinal axis and includes a proximal end and a distal end of the housing. The catheter includes a catheter hub. The needle safety clip includes a base plate and one or more support arms configured to releasably secure the needle safety clip to the catheter hub. The guide wire feed assembly is coupled to the guide wire. The guide wire feed assembly is disposed within the insulation. A portion of the guidewire advance assembly is accessible through an opening near the distal end of the housing.
    [0017] [0017] In some embodiments, the guide wire advance set includes a guide wire advance and a flexible track. The flexible track is operable through the housing opening to advance the guide wire on a flexible track when the flexible track is advanced on a flexible track.
    [0018] [0018] In some embodiments, the flexible track includes a slit that extends along a longitudinal axis configured to allow at least one of the guide wire, the catheter or the needle to pass through it.
    [0019] [0019] In some embodiments, a distal end of the flexible track travels through an arc of substantially 180 ° as the guide wire feed assembly is advanced in a distal direction.
    [0020] [0020] In some embodiments, the guide wire feed assembly is hermetically insulated from an internal portion of the housing.
    [0021] [0021] In some embodiments, the housing includes a translucent portion and the inner portion of the housing that fills with blood when a distal tip of the needle accesses the patient's vasculature.
    [0022] [0022] In some embodiments, each arm of the one or more support arms includes, each, a retainer disposed at a distal end thereof. The retainer for each support arm is configured to engage a corresponding notch in the catheter hub.
    [0023] [0023] In some embodiments, the base plate of the needle safety clip includes an opening configured to slide the needle into engagement.
    [0024] [0024] A method of placing a medical device is also disclosed including, in some modalities, the provision of an insertion tool in a first step between a series of steps. The insertion tool includes a housing, a needle, a guidewire, a guidewire advance set, a medical device and a blood squirt indicator. The housing includes a translucent portion and a housing opening on an upper surface thereof close to a distal end of the housing. The needle extends from the distal end of the housing and includes a lumen extending proximally from a distal end of the needle. The guidewire advance assembly is disposed within the housing operationally attached to the guidewire and accessible through the housing opening. The blood squirt indicator is fluidly connected to the needle lumen and extends through the translucent portion of the housing. In addition to the first step, the number of steps includes gripping the insertion tool with one hand near its distal end; advance the distal end of the needle through a patient's vasculature; allow blood to flow proximally through the needle lumen to the blood squirt indicator; observe the presence of blood in the blood squirt indicator through the translucent portion of the housing; advancing the guide wire in a distal direction by accessing the guide wire advance assembly through the housing opening using a finger of one hand and advancing the guide wire advance assembly in a distal direction; and advance a medical device along the guidewire.
    [0025] [0025] A method of removing a catheter placement tool subsequent to the placement of a catheter is also disclosed including, in some embodiments, the provision of a medical device placement tool in a first step between a series of steps. The medical device placement tool includes a catheter, a needle, a needle safety clip, a guidewire and a guidewire advance set. The catheter includes a catheter hub. The needle safety clip is slidably attached to the needle and releasably attached to the catheter hub. The guidewire is configured to break at a first magnitude of predetermined force. The guide wire feed assembly includes a frangible connection portion configured to break with a second magnitude of predetermined force. In addition to the first step, the number of steps includes retracting the guide wire in a proximal direction using the guide wire advance assembly; retract the needle proximally from the catheter so that the needle safety clip slides to a distal end of the needle; and disengaging the catheter from the needle safety clip when the needle safety clip reaches a distal end of the needle.
    [0026] [0026] In some embodiments, the first magnitude of predetermined force is greater than the second magnitude of predetermined force.
    [0027] [0027] In some embodiments, the needle safety clip includes three support arms configured to release the needle safety clip reliably to the catheter hub. Each arm of the three support arms each includes a retainer arranged at a distal end thereof. The retainer is configured to engage a corresponding notch in the catheter hub.
    [0028] [0028] In some embodiments, the three support arms close around the needle tip when the catheter hub is released from the needle safety clip. DRAWINGS
    [0029] [0029] A more particular description of the present disclosure will be processed by reference to specific modalities of the same that are illustrated in the attached drawings.
    [0030] [0030] Reference will now be made to figures in which similar structures will be provided with similar reference designations. It is understood that the drawings are diagrammatic and schematic representations of exemplary modalities of the present invention and are not limiting or necessarily drawn to scale.
    [0031] [0031] For clarity, it should be understood that the word "proximal" refers to a direction relatively closer to a doctor using the device to be described in this document, while the word "distal" refers to a relatively more distant direction from the doctor. For example, the end of a catheter placed inside a patient's body is considered a distal end of the catheter, while the end of the catheter that remains outside the body is a proximal end of the catheter. In addition, the words "including", "has" and "having" as used in this document, including the claims, must have the same meaning as the word "comprising".
    [0032] [0032] Briefly, the modalities here are generally directed to an insertion tool to insert a catheter or other tubular medical device into a patient's body. The one-way insertion tool unifies needle insertion, guidewire advancement and catheter insertion in a single device to provide a simple catheter placement procedure.
    [0033] [0033] In one embodiment, the insertion tool comprises a housing in which at least a portion of the catheter is initially arranged, a hollow needle extending distally from the housing with at least a portion of the catheter pre-arranged over the needle and a thread-
    [0034] [0034] In one embodiment, the catheter advance assembly also includes a handle that is initially and removably attached to a catheter hub within the housing. The distal movement of the handle by a doctor, in turn, moves the catheter distally from the housing. The handle may include a needle safety component to isolate a distal tip from the needle when the needle is removed from the catheter and the distal tip is received into the handle. In addition, several guide wire and catheter advance sets are disclosed herein.
    [0035] [0035] In yet another modality, several features are included with the insertion tool, including: actuation of the guidewire and catheter advancement sets without moving the doctor's hand that grips the insertion tool during the catheter insertion procedure ; selective advance of one of the guidewires or catheter based on the previous advance of the other; and guide wire blunt features.
    [0036] [0036] In another embodiment, the catheter advancement and guide wire sets each include user engagement components that are configured in such a way that the user can start advancing the second user component after advancing the first user engagement component. user without substantially repositioning the thumb or finger used by the user for advancement.
    [0037] [0037] In yet another embodiment, the catheter advance set includes a handle set with first and second wings. A cover portion extends between the first and second wings and is positioned so that the advancement of the guidewire advance set and the catheter advance set can be accomplished by a single doctor's thumb or finger.
    [0038] [0038] The modalities in this document further describe additional aspects of the insertion tool, including several sets of guide wire advancement and blood splatter indicators. INSERTION TOOLS
    [0039] [0039] Figures 1A-2 represent various details of the insertion tool 10 according to an embodiment. As shown in Figures 1A and 2, the insertion tool 10 includes the top and bottom housing portions 12A, 12B of housing 12, from which catheter 42 disposed over needle 16. extends. finger 1218 of the guide wire feed assembly 20 slidably arranged in a slot 1236 defined in the top housing part 12A, and a portion of a handle assembly 1220 of catheter feed assembly 40. More details are given below of the present insertion tool 10 and its various details according to the present modality. Additional details of which can also be found in US 2016/0256667, filed on May 13, 2016, which is incorporated herein by reference in its entirety.
    [0040] [0040] Figures 1A-1F show that the finger pad 1218 as part of the guide wire advance assembly 20 can be slid by a physician's finger (s) distally along the slot 1236, to allow advancement selection of the guide wire 22 (initially disposed within the lumen of the needle 16) out of the distal end 16B of the needle 16. A proximal end of the guide wire 22 is attached to an inner portion of the top housing portion 12A so that a single distal slide advance unit of the 1218 finger pad results in two distal guide wire advance units. This is possible by winding the guide wire 22 from its attachment point to the top housing portion 12A and across the guide surfaces 980 included in the guide wire lever 24 (Figures 6A and 6B) before extending into the lumen of needle 16. Note that in the present embodiment, the guide wire lever 24 and the finger pad 1218 of the guide wire advance assembly 20 are integrally formed with each other, although they may be formed separately in other embodiments. Also note that the guide wire 22 can be attached to other external or internal portions of the insertion tool 10, including the bottom housing portion 12B, the needle hub 1214, etc.
    [0041] [0041] Figures 1A-1F also show that the catheter advance set 40 to selectively advance the catheter
    [0042] [0042] The top and bottom housing portions 12A, 12B are mated by engaging the four flaps 1230 (Figures 1D, 2) of the top housing portion with four corresponding recesses 1232 located in the bottom housing portion. Obviously, other mating mechanisms and schemes can be employed to join the top and bottom housing portions.
    [0043] [0043] The exploded view of the insertion tool 10 in Figure 2 shows that the handle assembly 1220 includes a head portion 1222 from which the wings 1280 extend and a tail portion 1224. Both the head portion 1222 and the tail portion 1224 are removably attached to the catheter hub 46. Internal components of the insertion tool 10 which are arranged within the housing 12, each of which is passed through the needle 16 include the valve 52, the safety housing 54 in which the carriage 1008 and the needle safety component 56 are arranged, and the cover 58 of the safety housing. The sealing ring 1002 that is included with the needle safety component 56 is also shown, as well as a needle hub 1214, which is attached to a proximal end of the needle 16 and is mounted in the housing 12 to secure the needle
    [0044] [0044] Figures 3A and 3B represent various details in relation to the stability structure 70 to support and stabilize the needle 16 at its exit point from the housing 12, according to the present modality. As shown, the proximal portions of the top and bottom housing 12A, 12B interengage to provide the stability structure 70 for the needle 16. The bottom housing portion 12B includes two distally disposed arms 1248 separated by a slot 1246 that allows the arms , when unrestricted, separate from each other. The top housing portion 12A defines a distal slot 1240 and a horseshoe feature 1242 distal to the slot. Given the downward curvature of the top housing portion 12A (see Figure 1C), slot 1240 allows the arms 1248 of the bottom housing portion 12B to project upwardly through the slot to wrap and support needle 16 in order to stabilize it. The horseshoe feature 1242 is arranged around the needle 16 at the distal end of the bottom housing arms 1248 and acts as a collar to stabilize the needle.
    [0045] [0045] The arms 1248 of the bottom housing portion 12B are configured to be able to move back and forth in the x direction, according to the xy axis shown in Figures 3A and 3B, while remaining substantially rigid in the y direction . On the other hand, the distal portion of the top housing portion 12A which includes the slot 1240 and the horseshoe feature 1242 is configured to flex in the y direction according to the xy axis shown in Figures 3A and 3B, while remaining substantially in the x direction. Thus, when superimposed or interengaged as shown in Figures 3A and 3B, the above-referenced components of the stability structure 70 cooperate to support the needle 16 and prevent its substantial movement when the housing 12 is in the configuration shown in Figures 3A, 3B, i.e. , before removing catheter 42 from the housing 12. This, in turn, helps the doctor to accurately pierce the skin and access a patient's vessel. It is appreciated that the stability structure can include other components to stabilize the needle in addition to those explicitly described in this document.
    [0046] [0046] Figures 4-7 represent various details in relation to the catheter advance set 40 and the guide wire advance set 20, according to the present modality. As discussed, catheter advance assembly 40 includes handle assembly 1220, which in turn includes head portion 1222 with corresponding wings 1280, and tail portion 1224 arranged around a portion of catheter hub 46 and the safety housing 54. As will be discussed below, the handle assembly 1220 is employed in advancing and distal removal of catheter 42 from the insertion tool 10.
    [0047] [0047] Figures 4-7 further show the finger pad 1218 and the guide wire lever 24 of the guide wire advance assembly 20 for the present embodiment. As shown, the guide wire lever 24 extends proximally from the finger pad 1218 and includes at its proximal end the previously discussed guide surfaces 980 to guide the guide wire loop 22. An actuation block 1258 is also included near the proximal end of the guide wire lever 24 for use in enabling catheter advance. Note that the size, shape and other particular configuration of the actuation block may vary from what is shown and described in this document while maintaining the desired functionality.
    [0048] [0048] A spring arm 1260 extends downwards from the guide wire lever 24 and is configured to be slidably retained between two guide posts 1264 of needle hub 1214, as best seen in Figures 6A and 6B . The spring arm 1260 is used to lock additional movement of the guide wire advance assembly 20, once the guide wire 22 has been fully extended distally from the insertion tool 10 and the catheter 42 advanced in an incremental amount . In particular, the physician's distal sliding of the finger pad 1218 causes the guide wire lever 24 to also move distally, which in turn advances the guide wire 22 distally (which passes internally through the guide surfaces 980 of the lever guide wire 24 and into the needle lumen) through the needle lumen 16 and through the distal end 16B of the needle, as seen in Figure 7.
    [0049] [0049] After the total distal advance of the finger pad 1218 and the guide wire lever 24, as seen in Figure 7, the free end of the spring arm 1260 is arranged just above a pocket 1266 defined between the guide posts 1264 needle hub 1214, as seen in Figure 6B. Because of the location of the safety housing 54 proximal and adjacent to the needle hub 1214 at this stage (catheter 42 - and also the safety housing attached - in its initial seated position because it has not yet been advanced distally by advancing distal end of catheter advancement set 40), the free end of the spring arm 1260 cannot yet rest in pocket 1266. Since catheter 42 is advanced distally incrementally, however, the attached safety housing 54 does not prevent plus the downward movement of the spring arm 1260 and its free end rests in the needle hub pocket 1266
    [0050] [0050] Note that the finger pad 1218 includes on its lower side close to its distal end a protrusion 1254 which engages with a depression 1252 defined in the top housing portion 12A when the finger pad is completely distally advanced. This helps to keep the 1218 finger pad seated in its distal position and provides a tactile indication that the finger pad has been fully advanced distally.
    [0051] [0051] Also note that if catheter advance set 40 is moved proximally back to its initial position (as seen in Figure 5), the safety housing 54 will once again touch against needle hub 1214 and push the free end of the spring arm 1260 upward and out of pocket 1266. This, in turn, allows the guide wire advance assembly 20 to move again proximally and distally, causing the corresponding proximal and distal advance of itself guide wire 22. Thus, the locking of the guide wire feed is reversible in the present mode.
    [0052] [0052] In another embodiment, it is appreciated that a push button can be included with the guide wire advance assembly 20 to allow the guide wire to be extended or retracted after the guide wire lock has occurred initially, such as by pressing the button to disengage the spring arm 1260 from the pocket 1266 of the needle hub, for example. These and other variations are therefore contemplated. FRANGIBLE GUIDE WIRE MECHANISMS
    [0053] [0053] Figures 8A-9C show various details of a guide wire lever 24 that is part of the guide wire feed assembly 20 and is used to selectively extend the guide wire from the housing 12 of the insertion tool . In accordance with the present embodiment and as shown in Figures 8B and 8C, the guide wire lever 24 includes a frangible portion 1400, which is configured to prevent excessive force being applied to the guide wire when it is retracted proximally to the housing 12 of the insertion tool 10. Figures 8B and 8C show that the frangible portion 1400 in the present embodiment includes a connecting portion 1406 that joins a first, relatively proximal portion, 1408 of the guide wire lever 24 to a second portion , relatively distal, 1410 thereof through a gap 1412 defined between the relatively proximal and distal portions 1408, 1410. The connecting portion 1406 is configured to break when a predetermined tension force is applied to it. This tension force can be applied when the guide wire lever 24 is moved with excessive force by the doctor to retract the guide wire 22 to the housing 12. In an exemplary scenario where such excessive force is applied includes, when the wire guide attaches to the distal end 16B of needle 16 during retraction of the guide wire. The breaking of the connection portion 1406 when the tension force is imposed on it prevents an additional retraction of the guide wire 22. This, in turn, prevents possible breakage of the guide wire itself, which otherwise could lead to undesirably embolism of a portion of the guidewire in the patient's body.
    [0054] [0054] It will be appreciated that a variety of sizes, shapes, positions, configurations and numbers of the frangible portion (s) 1400 and its connecting portion (s) 1406 are possible and within the scope of the present invention. In one embodiment, as shown in Figures 8B-8C, the gap 1412 between the proximal and distal portions 1408, 1412 only partially cuts the guide wire lever 24 in order to define a hinge portion 1414. Although hinge 1414 is shown as a living hinge, it will be appreciated that other hinge joints can be used and are within the scope of the present invention. Consequently, when connector 1406 breaks, as described herein, the proximal portion 1408 pivots with respect to the distal portion 1410 around hinge 1414. The pivoting motion can absorb any continuous movement of the guide wire lever 24 to prevent any further movement of the guide wire 22. The pivoting movement of the proximal portion 1408 may also intentionally misalign and obstruct any additional proximal movement of the guide wire lever 24 and / or movement of the guide wire 22 through the guide surfaces 980, further preventing any movement of the wire -guide 22. Obstruction of the movement of the guidewire lever 24 and associated structures may also indicate to the physician that excessive force has been incurred.
    [0055] [0055] In one embodiment, as shown in Figures 9A-9C, the gap 1412 can cut the guide wire lever 24 entirely. The proximal portion 1408 and the distal portion 1410 of the guide wire lever 24 can be coupled by means of of one or more connectors 1406, for example, 1406A, 1406B. Connectors 1406A, 1406B may break, as described in this document, and the proximal portion 1408 of the guide wire lever 24 then separates from the distal portion 1410, thereby preventing any further movement of the guide wire 22, regardless of any movement subsequent use of the guide wire lever 24. Connectors 1406A, 1406B may be spaced apart and it will be appreciated that any number and configuration of connectors 1406 falls within the scope of the present invention.
    [0056] [0056] In one embodiment, connectors 1406 may be formed from the same material as that of the guide wire lever 24 or from a different material that may exhibit different physical characteristics. Connectors 1406 can be formed as a single monolithic piece with that of the guide wire lever 24. In one embodiment, connectors 1406 can be formed separately from the guide wire lever 24 and attached to it using adhesives, gluing, welding or similar suitable techniques for coupling connector 1406 to the guide wire lever 24. BLOOD SQUEEZE MECHANISMS
    [0057] [0057] Figures 10-13 represent various modalities of a blood splatter indicator ("indicator") 1500 that cooperates with needle 16 of the insertion tool 10. Indicator 1500 confirms, through a blood flow through the indicator, that the distal tip of the needle is desirably located in the vein or other blood vessel of the patient's body. In one embodiment, as shown in Figure 10, indicator 1500 includes an indicator tube 1510, which includes a lumen 1512 disposed therethrough. The needle 16 includes an opening 1520 defined in a wall of the needle 16 that fluidly connects the lumen of the needle 1522 with the indicator tube lumen 1512.
    [0058] [0058] In one embodiment, the indicator tube 1510 includes an opening 1514 formed therein extending from a first side wall 1516 to a second side wall 1518 of the indicator tube 1510 and passes through the lumen 1512. The needle 16 extends through the opening of indicator tube 1514 until needle opening 1520 aligns with the lumen
    [0059] [0059] In one embodiment, the needle 16 penetrates and is advanced through the indicator tube 1510 during the manufacture and assembly of the insertion tool. In another embodiment, the needle 16 is movable in relation to the insertion tool 10 during use. Therefore, as needle 16 is implanted, needle 16 passes through indicator tube 1510, creating the opening of indicator tube 1514, until needle opening 1520 aligns with indicator lumen 1512.
    [0060] [0060] When the distal tip of needle 16 is disposed in the vein, blood will flow proximally through the needle, through opening 1520, and into the lumen of indicator tube 1512, as indicated by arrow 1530. Visual inspection by the doctor of the indicator tubing 1510 will confirm by the presence of blood in it that the distal tip of the needle is properly positioned. It will be appreciated that the size, shape, position and configuration of the indicator tubing 1510, openings 1520, 1514 and the like, may vary from what is shown without departing from the spirit of the invention. For example, needle 16 can include two openings 1520a, 1520b (not shown) that pass through opposite walls of needle 16 and each communicates fluidly with lumen 1512. Consequently, blood flow 1530 can advance along indicator lumen 1512 in both directions away from needle 16 providing additional indicators that the needle is desirably located in a patient's vasculature. In addition, indicator tube 1510 is formed of a material at least partially translucent so that the presence of blood in it can be observed.
    [0061] [0061] Advantageously, the design of indicator 1500 requires fewer components by connecting needle 16 to indicator tube 1510. For example, there is no need for a "saddle" or similar component fluidly connecting the needle to the indicator tube. Consequently, manufacturing efficiency is improved and reducing the complexity and associated costs.
    [0062] [0062] In one embodiment, Figures 11-13 show more details of the blood splatter indicator ("indicator") 1500 that cooperates with needle 16 of the insertion tool 10. Indicator tubing 1510 includes a first end 1540 that is arranged close to needle 16 and needle opening 1522. The first end 1540 of the tube can be arranged inside valve 52. Indicator tubing 1510 then extends from a proximal end of valve 52. Valve 52 is removably received at cube 46 of catheter 42 during catheter insertion in the patient. More details can be found at US 2016/0256667, filed on May 13, 2016, which is incorporated herein by reference in its entirety. The tube 1510 extends from a proximal end of the valve 52 and extends along a tortuous path within the handle assembly 1220, including the wings 1280 thereof. Portions of the handle assembly, such as the 1280 wings, are made of translucent material so that the tube 1510 can be seen. When the distal tip of needle 16 is disposed in the vein, blood will flow proximally through needle 16, out of opening 1520, and to indicator tube 1510 through valve 52 disposed in catheter hub 42. Blood continues to flow along along the length of the 1510 pipe on its tortuous path through the wings
    [0063] [0063] Figure 12C shows an example of the appearance of the insertion tool 10 to the doctor while blood is present in the tubing 1510 arranged inside the wings 1280 according to the present modality. It will be appreciated that the size, shape, position and configuration of the 1510 indicator tubing may vary from what is shown without departing from the spirit of the invention. For example, as shown in Figure 13, tubing 1510 can extend to other portions of the insertion tool, where it can be seen by the physician. Piping 1510 can extend across a surface of tool 10 or be arranged within the various structures of tool 10, such as housing 12. In one embodiment, various components of tool 10, such as housing 12 or the like, can be formed translucent material so that the tube 1510 disposed therein can be observed. GUIDELINE ADVANCE MECHANISMS
    [0064] [0064] Figures 14A-18B show an exemplary embodiment of an insertion tool 1600. Insertion tool 1600 includes a guide wire feed assembly 1610 for selectively advancing guide wire 22 distally from the tool housing. insertion, using the movements of the doctor's fingers. The guide wire feed assembly 1610 includes a housing 1612, a guide wire 22 and a guide wire feeder 1624, which is coupled to the guide wire 22. Housing 1612 includes a left portion 1614, a right portion 1616 and a cap portion 1618 which cooperate to form the housing 1612 and enclose the guidewire advance 1624. Optionally, at least a portion of the housing 1612 is formed of a translucent material.
    [0065] [0065] The left and right portions 1614, 1616 of housing 1612 further include dividing structures 1634 which cooperate to hermetically insulate the guidewire advance 1624 from an internal portion of housing 1612. It will be appreciated that the dividing structures 1634 can be formed monolithically with housing 1612, or portions thereof, or be separate structures that fit within housing 1612, or combinations thereof. The housing 1612 includes an opening 1620 arranged on an upper surface thereof formed by recesses 1621, 1622 in the left and right portions 1614, 1616, respectively. Opening 1620 provides access to a portion of the guidewire advance 1624 arranged within housing 1612. Housing 1612 further includes a needle connection pocket 1642, which aligns longitudinally with a distal opening 1619 of housing 1612 and supports one end proximal needle
    [0066] [0066] In use, a physician can advance the insertion tool 1600 until a distal tip 16B of needle 16 accesses a vasculature of the patient. The blood will flow proximally along the needle 16, creating a splash of blood as described here, and will fill an internal portion of the housing 1612. Since the guidewire advance 1624, including the opening 1620, is hermetically insulated from the inside of the housing 1612, the blood remains contained within housing 1612. In addition, since housing 1612 may be formed of a translucent material, the splash of blood can be observed by the physician. Housing 1612 further includes a vent 1636 located, for example, on housing cover 1618. Housing cover 1618 includes a valve to allow air to escape from the interior of housing 1612 as the interior of the housing fills with blood . The valve can also prevent any blood from escaping from the insulation. Therefore, the housing 1612 of the insertion tool 1600 is a reverse blood squirt indicator. With the distal tip 16B of needle 16 confirmed as located in the patient's vasculature, the doctor can advance the guidewire
    [0067] [0067] Figures 15A-E show various views of the guidewire advance 1624. The guidewire advance 1624 includes a flexible track 1626 that includes an upper surface and a lower surface and extends from an end proximal to a distal end of the guidewire lead 1624. The flexible track 1626 includes a centrally defined slot 1630 configured to allow track 1626 to slide past and on either side of needle 16, catheter 42, guide wire 22 or combinations thereof, extending from the insertion tool housing. Slit 1630 extends from an upper surface to a lower surface of flexible track 1626 and extends from a distal end to a distal point of the proximal end.
    [0068] [0068] The flexible track 1626 includes a plurality of ridges 1628 arranged on the top surface, bottom surface or combinations thereof. The ridges 1628 extend perpendicular to a longitudinal axis of the insertion tool 10 and are positioned in a spaced relation to each other. In addition, when viewed from a side profile, and as shown in Figures 15B-15C, the ridges 1628 arranged on the upper surface are spaced in a displacement relation to the ridges 1628 arranged on the lower surface. Advantageously, the ridges 1628 provide improved friction and allow a physician to grasp the flexible track 1624 through the opening 1620 in the housing 1612 and allow the sliding movement of the guide wire advance 1624. In addition, the spaced and displaced relationships of the ridges 1628 allow flexible track 1626 to flex along a vertical plane, defined by the longitudinal and transverse axes.
    [0069] [0069] The guide wire feeder 1624 also includes a proximal block 1632 disposed at a proximal end thereof, which is coupled to the guide wire 22. The proximal block 1632 is configured to push the guide wire 22 distally through the opening 1619 of housing 1612, through needle 16 and catheter 42 removably disposed on needle 16, when the doctor's finger slides the flexible track 1626 distally.
    [0070] [0070] Figure 16A shows a sectional view of the guide wire feed assembly 1610 showing the guide wire feeder 1624 disposed thereon. The flexible track 1626 extends distally and a portion of it is exposed to the doctor through opening 1620. Figure 16B shows a predetermined path 1640 of the guidewire advance 1624 which is defined by the left and right housing portions 1614, 1616, partition structure 1634 or combinations thereof. As the physician advances the 1624 guide wire advance distally, a distal portion of it is guided downward through a 180 ° arc. Slit 1630 allows flexible track 1626 to pass either side of needle 16, catheter 42 and / or guidewire 22. Advantageously, guidewire advance set 1610 provides enhanced control over needle 16 and guidewire 22, allowing the physician to hold the insertion tool 1600 close to a distal end thereof. This gives the doctor greater control over the placement of the 1600 insertion tool, while allowing one-handed control over the guidewire advance.
    [0071] [0071] The insertion tool 1600 may also include a needle safety clip 1650. Safety clip 1650 includes a base plate 1652, with an opening 1656 arranged therein and at least one support arm, for example, support arms support 1654A, 1654B, 1654C. The support arms 1654 can flex between an open state, Figures 17A, 17C, and a closed state, Figures 17B, 17D. The safety clip 1650 is arranged distal to a distal end of the housing 1612 and receives the catheter hub 46, retaining the hub 46 within the support arms 1654, as shown in Figure 17E. Each of the distal ends of the support arms 1654 includes a retainer 1662 that engages a notch 1658 on the catheter hub 46, as shown in Figures 18A-
    [0072] [0072] Once the catheter is placed correctly, as discussed in this document, the insertion tool 1600, together with needle 16, is retracted. Catheter 42, with safety clip 1650 attached to it, remains in position and slides distally to distal tip 16B of needle 16, Figure 17F. At that point, clip 1650 disengages catheter hub 46 and support arms 1654 close around needle tip 16B. The distal ends of the support arms 1654 engage with each other to lock around the needle tip 16B, securing the clamp thereon. This avoids accidental needle stick injuries as the 1610 guide wire advance assembly is removed from catheter 42. METHODS
    [0073] [0073] In an exemplary method of using a catheter insertion tool, including a guide wire lever 24 with a frangible portion 1400, a blood squirt indicator 1500, blood squirt indicator housing 1612, set of 1610 guide wire feed or combinations thereof are provided. The doctor, holding the insertion tool with one hand close to the distal end, advances the needle of the catheter insertion tool into a patient's vasculature.
    [0074] [0074] When the distal tip 16B of needle 16 accesses the vasculature, blood flows proximally through the lumen of the needle 1522. Blood can enter the indicator lumen 1512, through a needle opening 1520. Blood continues to flow through of the indicator lumen 1512 along a tortuous path within a portion of the insertion tool, such as handle assembly 1220, wings 1280, housing 12, combinations thereof or the like. Portions of the insertion tool 10 or indicator tubing 1510 are translucent and / or indicator tubing 1510 extends over a portion of the outer surface of the insertion tool. In addition, a plurality of tortuous paths can be employed to indicate to the physician that the needle tip is located correctly. In one embodiment, blood flows proximally through the lumen of needle 1522 and fills housing 1612, at least part of which is translucent. The doctor can then observe the presence of blood inside the indicator tube 1510 / housing 1612 to confirm that the needle tip is located correctly within the patient's vasculature.
    [0075] [0075] With the needle tip located correctly, the doctor advances the guidewire using the 1610 guidewire advance set. The doctor uses one hand to hold the insertion tool, close to its distal end, guides the needle to access the vasculature and advance the guide wire using the guide wire advance set
    [0076] [0076] A doctor can selectively retract the cord
    [0077] [0077] The modalities of the invention can be carried out in other specific ways without departing from the spirit of the present disclosure. The described modalities should be considered in all aspects only as illustrative, not restrictive. The scope of the modalities is therefore indicated by the appended claims instead of the previous description. All changes that come within the meaning and equivalence range of the claims must be covered within its scope.
    权利要求:
    Claims (26)
    [1]
    1. Insertion tool to insert a medical device into a patient's body, the insertion tool FEATURED by the fact that it comprises: a housing; a needle; an advance set configured to selectively advance the medical device for placement on the patient's body; a guide wire advance set configured to selectively advance a guide wire before advancing the medical device, the guide wire advance set comprising: a first portion; a second portion, the guide wire operatively attached to one of the first or second portion; and a frangible portion physically interconnecting the first portion to the second portion, the frangible portion configured to break when a force of a predetermined magnitude is imposed on it.
    [2]
    2. Insertion tool, according to claim 1, CHARACTERIZED by the fact that the proximal retraction of the guidewire is substantially avoided after breaking the frangible portion.
    [3]
    3. Insertion tool, according to claim 1 or 2, CHARACTERIZED by the fact that the force imposed on the breakable portion is a tension force.
    [4]
    4. Insertion tool according to any one of claims 1 to 3, CHARACTERIZED by the fact that the predetermined magnitude of the force is less than a second predetermined magnitude of the force that is necessary to break the guidewire.
    [5]
    5. Insertion tool, according to any of claims 1 to 4, CHARACTERIZED by the fact that the first and second portions are interconnected by the frangible portion and a hinge portion.
    [6]
    6. Insertion tool, according to claim 5, CHARACTERIZED by the fact that the first and second portions articulate in relation to each other around the hinge portion when the frangible portion breaks, the pivoting movement of the first and second second portions inhibiting further movement of the guide wire.
    [7]
    7. Insertion tool, according to claim 5, CHARACTERIZED by the fact that the first and second portions separate from each other when the force of the predetermined magnitude is imposed on them and causes the frangible portion to break.
    [8]
    8. Insertion tool to place a medical device within a patient's vasculature, CHARACTERIZED by the fact that it comprises: a housing; an indicator tube, including a lumen of the indicator tube; and a needle, the needle including a needle lumen and an opening, arranged in a side wall of the needle, the opening fluidly connecting the needle lumen with the lumen of the indicator tube.
    [9]
    9. Insertion tool, according to claim 8, CHARACTERIZED by the fact that the indicator tube extends through a translucent portion of the housing.
    [10]
    10. Insertion tool according to claim 9, CHARACTERIZED by the fact that the translucent portion is a wing portion used to advance a medical device through the patient's vasculature.
    [11]
    11. Insertion tool according to claim 8, CHARACTERIZED by the fact that the indicator tube extends along a surface of the housing.
    [12]
    12. Insertion tool according to any one of claims 8 to 11, CHARACTERIZED by the fact that the needle includes a second needle opening disposed opposite the needle opening, through the side wall of the needle.
    [13]
    13. Insertion tool according to claim 12, CHARACTERIZED by the fact that a flow of blood from the needle enters the lumen of the indicator tube and flows in opposite directions along the lumen of the indicator tube, away from the needle.
    [14]
    14. Catheter placement tool to place a catheter within a patient's vasculature, the catheter placement tool FEATURED by the fact that it comprises: a housing, extending along a longitudinal axis and including a proximal end and an end distal; a catheter, including a catheter hub; a needle; a needle safety clip, the needle safety clip including a base plate and one or more support arms configured to releasably secure the needle safety clip to the catheter hub; a guidewire; and a guide wire feed assembly coupled to the guide wire, the guide wire feed assembly disposed within the housing, a portion of the guide wire feed assembly accessible through an opening near the distal end of the housing .
    [15]
    15. Catheter placement tool according to claim 14, CHARACTERIZED by the fact that the guide wire feed assembly includes a guide wire feed and a flexible track, the flexible track being operable through the housing opening to advance the guidewire on a flexible track when the flexible track is advanced on a flexible track.
    [16]
    16. Catheter placement tool, according to claim 15, CHARACTERIZED by the fact that the flexible track includes a slot extending along a longitudinal axis configured to allow at least one of the guidewire, the catheter or the needle pass through it.
    [17]
    17. Catheter placement tool according to claim 15 or 16, CHARACTERIZED by the fact that a distal end of the flexible track travels through an arc of substantially 180 ° as the guidewire advance assembly is advanced in one flexible track.
    [18]
    18. Catheter placement tool, according to any of claims 14 to 17, CHARACTERIZED by the fact that the guide wire advance assembly is hermetically insulated from an internal portion of the housing.
    [19]
    19. Catheter placement tool, according to claim 18, CHARACTERIZED by the fact that the housing includes a translucent portion and the inner portion of the housing that fills with blood when a distal tip of the needle accesses the patient's vasculature.
    [20]
    20. Catheter placement tool, according to any of claims 14 to 19, CHARACTERIZED by the fact that one or more support arms each includes a retainer arranged at a distal end of it and configured to engage a corresponding notch in the catheter hub.
    [21]
    21. Catheter placement tool according to any one of claims 14 to 20, CHARACTERIZED by the fact that the base plate of the needle safety clip includes an opening configured to slide the needle into engagement.
    [22]
    22. Method of placing a medical device, CHARACTERIZED by the fact that it comprises: providing an insertion tool, the insertion tool including: a housing, including a distal end and a proximal end, the housing including a translucent portion, and including a housing opening on an upper surface, close to the distal end; a needle extending from the distal end of the housing, the needle including a lumen extending proximally from a distal end of the needle; a guidewire; a guide wire advance set disposed within the housing, operationally attached to the guide wire and accessible through the housing opening; a medical device; a blood squirt indicator, the blood squirt indicator fluidly connected to the needle lumen and extending through the translucent portion of the housing; grasp the insertion tool with one hand, close to its distal end; advance the distal end of the needle through a patient's vasculature; allow blood to flow proximally through the needle lumen to the blood squirt indicator; observe the presence of blood in the blood squirt indicator through the translucent portion of the housing; advance the guide wire on a flexible track by accessing the guide wire advance assembly through the housing opening using a finger of one hand and advancing the guide wire advance assembly on a flexible track; and advance a medical device along the guidewire.
    [23]
    23. Method for removing a catheter placement tool subsequent to the placement of a catheter, CHARACTERIZED by the fact that it comprises: providing a medical device placement tool comprising: a catheter, including a catheter hub; a needle; a needle safety clip, slidably attached to the needle and releasably attached to the catheter hub; a guidewire, configured to break at a first magnitude of predetermined force; and a guide wire feed assembly, including a frangible connection portion configured to break into a second predetermined magnitude of force; retract the guide wire in a proximal direction using the guide wire advance assembly; retract the needle proximally from the catheter so that the needle safety clip slides to a distal end of the needle; and disengaging the catheter from the needle safety clip when the needle safety clip reaches a distal end of the needle.
    [24]
    24. Method, according to claim 23, CHARACTERIZED by the fact that the first predetermined force magnitude is greater than the second predetermined force magnitude.
    [25]
    25. Method, according to claim 23 or 24, CHARACTERIZED by the fact that the needle safety clip includes three support arms configured to release the needle safety clip reliably to the catheter hub, the three support each including a retainer disposed at a distal end thereof, the retainer configured to engage a corresponding notch in the catheter hub.
    [26]
    26. Method, according to claim 25, CHARACTERIZED by the fact that the three support arms close around a needle tip when the catheter hub is released from the needle safety clip.
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    同族专利:
    公开号 | 公开日
    EP3762084A4|2021-09-29|
    WO2019173641A1|2019-09-12|
    CN111801133A|2020-10-20|
    EP3762084A1|2021-01-13|
    US20190275303A1|2019-09-12|
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    法律状态:
    2021-12-14| B350| Update of information on the portal [chapter 15.35 patent gazette]|
    优先权:
    申请号 | 申请日 | 专利标题
    US201862639790P| true| 2018-03-07|2018-03-07|
    US62/639,790|2018-03-07|
    PCT/US2019/021231|WO2019173641A1|2018-03-07|2019-03-07|Guidewire advancement and blood flashback systems for a medical device insertion system|
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