JP2010512803A - Intravenous catheter insertion device and method of use - Google Patents

Abstract

The catheter insertion device has a housing and an internal space. The access needle and the guide wire are supported by the access needle and are movable with respect to the access needle. A restraining member is attached to the handle to limit movement of the guidewire relative to the access needle. The catheter insertion device has a housing and an internal space. The access needle and guidewire channel are attached to the access needle. The guide wire is supported by a guide wire channel. A handle is attached to the guidewire to move the guidewire relative to the guidewire support channel. A method for introducing a catheter into a blood vessel is by substantially inserting a guide wire housed in the blood vessel within the housing. The catheter is then advanced over the guidewire and into the blood vessel. Next, the guide wire is completely drawn from the blood vessel into the housing.

Description

  The present invention relates to an apparatus and method for inserting and placing a venous catheter in a patient's vein or artery.

The following patent documents describe conventional venous catheter insertion devices and / or safety devices for syringes and needles.
Haining-EP0051571OA1 Intravenous catheter and insertion device
Haining-EP0051571OB1 Intravenous catheter and insertion device
Haining-US05019049 Intravenous catheter and insertion device
Haining-US05176650 Intravenous catheter and insertion device
Chang-EP00567321A2 Venous catheter with needle guard
Mahukar-EP00652020B1 Retractable hypodermic needle assembly
Mahukar-EP00910988A1 Blood specimen collection assembly
Mahukar-US05891105 hypodermic needle assembly
DeWitt-US03572334 IV catheter placement unit
van Heugten-EP00750916A2 Protection needle storage
Botich-EP00942761B1 Medical device with retractable needle
Botich-EP01075850B1 Device for venous catheter insertion
Botich et al-US05800395 Medical device with retractable needle
Botich et al-US06436070 Catheter insertion device with retractable needle
Botich et al-US23060760A1 Catheter insertion device with retractable needle
Botich et al-WO OOOl 2160Al Fluid injection device with retractable needle
Botich-WO09632981 Al Safety probe for venous catheter insertion
Botich-WO09824494A1 Medical device with retractable needle
Shue-EP01457229A1 Intravenous catheter insertion device
Shue-US24106903A1 Intravenous catheter insertion device
Harautuneian-US03592192 Intravenous catheter device using a catheter fitted outside the puncture cannula
Harautuneian-US03610240 Intravenous catheter device with a catheter fitted inside the puncture cannula
Poncy et al-US04037600 Catheter placement system
Hession-US04292970 Intravenous catheter starter
McDonald-US04834718 Safety needle device
McDonald-US04944725 Safety needle device
Vining et al-US04909793 Intravenous catheter device with retractable probe
Carrell et al-US04944728 Intravenous catheter placement device
Kaufman-US04966589 Intravenous catheter placement device
Shields-US05007901 Intravenous catheter insertion device
Haughton et al-US05562629 Catheter placement system utilizing a handle, needle and a releasable locking mechanism that allows the needle to be retracted when releasing the catheter from the handle
Flumene et al-US05562634 Intravenous catheter with self retracting needle guide
Isaacson-US05573510 Safe venous catheter assembly with automatic retractable needle
Isaacson-US06056726 Self-contained safety venous catheter insertion device
Isaacson-WO09523003A1 Self-contained safety venous catheter insertion device
Huang-US05891098 Safety venous catheter
Bhitiyakul-US05941854 venous catheter
Dysarz-US05997507 Energizing spring hardening needle retractable IV tetel
Dysarz-US06193690 Inclined Hasp Device for IV Catheter
Greene et al-US06221047 Safety venous catheter assembly and method for use with a needle
Greene et al-US06689102 Safety venous catheter assembly
Greene et al-US06695814 Safety venous catheter assembly and method for use with a needle
Greene et al-US21014786A1 Safe venous catheter assembly and method for use with a needle
Greene et al-US22165497A1 Safe venous catheter assembly
Greene et al-WO00006226A1 Safe venous catheter assembly and method for use with a needle
Chang-US06322537 Safety venous catheter
Pressly, Sr. et al-US06620136 Retractable IV catheter placement device
Pressly, Sr. et al-WO00047256A1 Retractable IV catheter placement device
Hoffman et al-US06730062 Safety catheter with non-removable retractable needle
Hoffman et al-US23073956A1 Safety catheter with a non-removable retractable needle
Brustowicz-US24267204A1 On-demand needle retention and fixation mechanism for use in venous catheter assemblies
Garcia Andreo-WO03043686A1 Flow-regulating / automatic valve venous catheter
Sircom-WO09222344A1 Needle guard for placement of venous catheters
Ogle-WO09519193 Al Needle and container for retractable venipuncture catheter
Rohrbough et al-WO09705912A2 Needle and container for retractable venipuncture catheter
Hwang-WO09721458A1 Intravenous catheter with flexible dilator and needle tip protector

  The device and method of the present invention facilitates the safe placement of a catheter in a patient's vein or artery, which is small, intricate, fragile, vulnerable and / or difficult to position the tube. Of particular importance. The device and method also provide protection against accidental puncture and contamination with a needle after placement of a venous catheter.

  In one embodiment of the present invention, a housing having an internal space, an access needle that is slidable relative to the internal space, a guide wire that is supported by the access needle and is slidable relative to the access needle, A handle attached to the guide wire movable relative to the housing to move the guide wire relative to the interior space, and a restraint attached to the handle to restrict movement of the guide wire relative to the access needle A catheter insertion device comprising a member is provided.

  In one form, the restraining member attached to the handle limits the proximal movement of the guidewire relative to the access needle. In another form, the access needle comprises a blood reflux indicator in the portion of the access needle that extends beyond the housing. In another form, the access needle includes a blood reflux indicator that is visualized at the distal end of the catheter when the access needle is placed into the catheter. In a further form, the blood reflux indicator comprises an opening in the distal sidewall of the access needle.

  In another form, the catheter insertion device is also designed to automatically retract one or both of the guidewire and access needle and also includes an applied biasing element and a release button. In a further form, the biasing element and the release button are designed and applied to retract the guidewire and access needle into the interior space simultaneously. In other forms, the biasing element and release button are designed and applied to retract the guidewire and access needle in turn. In one embodiment, the catheter insertion device also includes a restraining member in the interior space that limits distal movement of the access needle or guidewire in the interior space. In an alternative form, the restraining member limits the distal movement of the access needle or guide wire after the access needle or guide wire is retracted into the interior space after use to insert the catheter. In other alternative forms, the restraining member limits the distal movement of the access needle or guidewire so that the access needle or guidewire remains fully retracted into the interior space.

  In one embodiment of the catheter insertion device, the interior space is designed with dimensions that accommodate all of the guidewire and access needle after insertion of the catheter. In another form, the guidewire comprises a first portion having a first diameter, a reduced portion, and a second portion having a second diameter that is smaller than the first diameter. In yet a further form, the first diameter and the second diameter are smaller than the inner diameter of the access needle. In yet other embodiments, the distal end of the second portion has one or more full radius distal ends, a hemispherical portion having the same radius as the guidewire, a hemispherical portion different from the guidewire or distal end, or the same as the first diameter. And a distal end having a diameter. In an alternative form, the guidewire has a braided structure. In another alternative form, the catheter insertion device comprises a guide channel in the housing for restricting movement of the handle and a retention channel adjacent to the guide channel, the retention channel being when the handle is in the retention channel. , Provided to prevent movement of the handle. In one form, the restraining member prevents movement of the guide wire to the proximal side, and the retention channel prevents movement of the guide wire to the distal side. In another form, there is a pulley fixed in the interior space and the guide wire is provided so that it can be easily moved into the interior space.

  In another embodiment, a catheter insertion device comprising a housing having an internal space, an access needle having a distal end, a proximal end, and an inner wall forming a lumen extending from the distal end to the proximal end; An access needle that is slidable with respect to the space, an opening in the side wall of the access needle that communicates with the access needle lumen, and a guide wire supported by the access needle are provided. In another form, the catheter insertion device also includes a restraining member attached to the guide wire and provided to prevent the guide wire from moving into the opening. In one form, if there is a restraining member attached to the guide wire and the guide wire is positioned in the access needle distal to the opening, the restraining member causes the guide wire to move proximally toward the opening. Is limited. In another alternative, the access needle lumen has a guidewire cross-sectional shape that maintains the orientation of the guidewire relative to the access needle lumen. In one form, the access needle lumen has a non-circular cross-sectional shape. In other forms, the access needle lumen has an elliptical cross-sectional shape. In another form, a mechanism formed in the access needle sidewall is also provided to maintain the orientation of the guidewire relative to the access needle lumen. In an alternative form, the mechanism is a groove. In one form, the opening in the access needle sidewall is positioned proximal to the distal end of the access needle. In another alternative, the access needle side wall opening is positioned distal to the housing. In other alternative forms, the access needle includes a guide wire that becomes non-coiled within the access needle. In another alternative form, the guidewire is coiled within the access needle. In one form, the guidewire is coiled such that it rotates at least half a turn within the access needle lumen. In another form, the guidewire is coiled such that it makes one or more revolutions within the access needle lumen. In yet another form, the guidewire is in the access needle. In other forms, the guidewire is parallel to the access needle. In one embodiment, a guidewire channel supported by the access needle is also provided.

  In another embodiment of the catheter insertion device of the present invention, a housing having an internal space and a long axis, and a mechanism at the end of the housing for offsetting the housing long axis to the long axis of the catheter when engaged with the catheter, An access needle that passes through the mechanism and is attached to the needle holder, the needle holder is slidable relative to the internal space, and the access needle is slidable relative to the mechanism. In an alternative form, when the housing end feature engages the catheter, the housing major axis forms the major axis of the catheter so as to form an angle of less than 180 degrees. In an alternative form, when the housing end feature engages the catheter, the housing long axis is offset from the long axis of the catheter to form an angle of less than 60 degrees. In another alternative, when the housing end feature engages the catheter, the housing long axis is offset from the long axis of the catheter to form an angle of less than 45 degrees. In another alternative, a guide wire supported by the access needle and movable relative to the access needle is also provided. In another alternative form, a handle attached to the guide wire movable relative to the housing is also provided for moving the guide wire relative to the interior space. In another alternative form, a restraining member attached to the handle is included to limit the movement of the guide wire relative to the access needle. In one form, when the access needle and guide wire are retracted into the interior space, the guide wire and access needle are retracted substantially parallel to the housing major axis. In other forms, the guidewire is placed in the access needle. In other forms, the guidewire is parallel to the access needle.

  In another embodiment of the catheter insertion device of the present invention, a housing having an internal space, an access needle that is slidable relative to the internal space, supported by the access needle, and relatively movable to the access needle And a handle attached to the guide wire with limited movement of the handle so that at least a portion of the guide wire remains in the interior space. In another alternative form, a biasing element is also provided that is designed and applied to move the needle holder proximally within the interior space upon release. In one form, the biasing element is designed and applied to move the guidewire proximally within the interior space upon release. In one form, the biasing element is applied with a design that moves the needle upon release, so that the needle is completely within the interior space. In another form, the biasing element is applied by moving the guidewire and designing it so that the entire length of the guidewire is completely within the interior space. In another alternative form, the restraining member in the interior space that restricts the access needle or guidewire from moving distally in the interior space when the access needle or guidewire moves to the proximal side of the restraining device. Is also provided. In one form, the one end part of a guide wire is fixed to a housing | casing. In one form, one end of the guidewire is constrained within the interior space when the guidewire extends beyond the distal end of the access needle. In one form, the guidewire is placed in the access needle. In other forms, the guidewire is disposed parallel to the access needle.

  In another embodiment of the catheter insertion device of the present invention, a housing having an internal space, an access needle that is slidable relative to the internal space, a guide wire channel attached to the access needle, and a guide wire channel A guide wire that is supported and movable relative to the guide wire channel, and a handle attached to the guide wire, the guide wire moves relative to the support channel as the handle moves. In one form, the movement of the handle is limited so that at least a portion of the guidewire always remains in the interior space. In another form, biasing elements and release buttons are provided that are designed and applied to automatically retract one or more guidewires and access needles. In another form, a restraining member in the interior space that limits the distal movement of the access needle or guidewire in the interior space is also provided. In one form, the distal end of the guidewire channel is adjacent to the distal end of the access needle. In other forms, the guidewire channel is at the top of the access needle. In another form, the guidewire channel is at the bottom of the access needle. In other forms, the guidewire is expelled from the distal end of the guidewire channel without passing through the access needle lumen. In yet another form, the guidewire is discharged from the distal end of the guidewire channel through a portion of the access needle lumen. In another form, the guidewire channel is attached to the access needle within the access needle lumen.

  In other embodiments of the present invention, various methods for introducing a catheter into a blood vessel, the step of inserting a guide wire substantially contained within a housing into the blood vessel, and advancement into the blood vessel beyond the guide wire And drawing the guide wire completely from the blood vessel into the housing. In an alternative form, the step of advancing the guide wire along the needle inserted into the blood vessel is performed prior to the insertion step. In an alternative form, the step of advancing the guide wire along the needle inserted into the blood vessel is performed prior to the insertion step. In another alternative form, the step of coiling the guide wire in the blood vessel is performed after the insertion step.

  In one form, the step of retracting is performed manually. In other forms, the step of retracting is performed automatically. In another alternative, the step of retracting is performed by releasing the biasing member to fully retract the guide wire into the housing. In another alternative, the needle supporting the guide wire is fully retracted into the housing by releasing the biasing member. In another alternative, the retracting step is initialized by pressing a button. In another alternative, inserting a needle attached to the housing into the blood vessel is performed prior to inserting the guide wire. In another alternative, the method includes using a backflow indicator near the needle distal end to determine that the needle has entered the blood vessel after the needle insertion step. In other alternative forms, the method also includes moving a handle attached to the proximal side of the guidewire prior to the insertion step.

  Although the present invention will be described with respect to insertion of a venous catheter, the devices and methods described herein are applicable for inserting any catheter or similar device into a vein, artery or other body structure.

FIG. 1 shows an exploded view of a venous catheter insertion device according to the present invention. FIG. 2 shows an assembled view of the venous catheter insertion device ready for use and undeployed. FIG. 3 shows a hypothetical view of the venous catheter insertion device with the safety guidewire advanced. FIG. 4A is a detailed view of a safety guidewire for use with a venous catheter insertion device. FIG. 4B is a detailed view of a safety guidewire for use with a venous catheter insertion device. FIG. 5A is a detailed view of another safety guidewire for use with a venous catheter insertion device. FIG. 5B is a detailed view of another safety guidewire for use with a venous catheter insertion device. FIG. 5C is a detailed view of another safety guidewire for use with a venous catheter insertion device. FIG. 6 shows a venous catheter insertion device according to another embodiment of the present invention. FIG. 7 illustrates a method for inserting a venous catheter according to the present invention. FIG. 8 shows a method for inserting a venous catheter according to the present invention. FIG. 9 shows a method for inserting a venous catheter according to the present invention. FIG. 10A is a cross-sectional view of one embodiment of a catheter insertion device. FIG. 10B is a cross-sectional view of one embodiment of a catheter insertion device. FIG. 10C is a cross-sectional view of a catheter hub with an angled base. FIG. 10D shows a cross-sectional view of a conventional catheter. FIG. 10E is a plan view of an access needle with one blood backflow display. FIG. 10F is a plan view of an access needle with two blood backflow displays. FIG. 10G is a plan view of the catheter insertion device inserted into the catheter. 11A-14B show a catheter insertion device for inserting a catheter into a blood vessel in use, and an access needle and guide wire that are automatically retracted into the housing. FIG. 15 is a cross-sectional view of an alternative catheter insertion device provided with a restraining portion to prevent unintentional distal movement inside the housing. FIG. 16A shows a perspective view of an access needle applied to maintain guidewire orientation. FIG. 16B shows an end view of an access needle applied to maintain guidewire orientation. FIG. 17A shows a perspective view of an access needle applied to maintain guidewire orientation. FIG. 17B shows an end view of an access needle applied to maintain guidewire orientation. 18A-18H are cross-sectional and perspective views of a catheter insertion layer comprising a guide channel and a restraining mechanism. FIG. 19A is a side view of the catheter of FIG. 10C. 19B is a cross-sectional view of the catheter of FIG. 10C. It is a side view of the catheter insertion apparatus which has the angle which offsets a housing | casing. It is sectional drawing of the catheter insertion apparatus which has an offset long axis. FIG. 22 shows a guidewire alternative. FIG. 23 shows a guidewire alternative. FIG. 24 shows a guidewire alternative. FIG. 25A shows a side view of the coil portion of the guidewire. FIG. 25B shows an end view of the coil portion of the guidewire. FIG. 26A shows a cross-sectional view of a catheter insertion device having an extended guidewire. FIG. 26B shows a cross-sectional view of the catheter insertion device, where a pulley has been used to pull the guidewire completely into the housing. 27A-27E show cross-sectional views of an access needle of a catheter insertion device having an attached guidewire channel.

  FIG. 1 shows an exploded view of one embodiment of a venous catheter insertion device 20 according to the present invention. FIG. 2 shows an assembled view of the venous catheter insertion device 20 ready for use and undeployed. FIG. 3 shows a hypothetical view of the venous catheter insertion device with the safety guidewire advanced.

  The venous catheter insertion device 20 includes an outer housing 1. In the example, the outer housing 1 has an elongated hollow cylindrical shape. Other shapes are possible including ergonomic handle shapes. The outer housing 1 may be made using any material suitable for use in the medical field. In one embodiment, the outer housing 1 is preferably molded using a rigid, transparent medical grade plastic. Alternatively, the outer housing 1 may be machined from an extruded plastic tube.

  An elongated slot 14 is in the outer housing 1 substantially parallel to the axis of the outer housing 1. The slot 14 is sized to fit the dwell pin 10 or provide a connection point for the slider 4 to move the slider along the interior of the outer housing 1. The end of the slot 14 extends into the triangular notch 15 as seen in FIGS. The notch 15 of other shapes may be used.

  The front plug 2 is sized to fit the end portion of the external housing 1. The front plug 2 may preferably be molded or alternatively machined using a rigid, transparent medical grade plastic. The front plug 2 is bonded, pinned, welded, or otherwise fixed to the distal end of the outer housing 1. The distal end portion of the front plug 2 includes a luer slip connection portion 16 and the like. The shoulder portion or flange 17 is coupled to the end portion of the outer casing 1. The proximal end portion of the front plug 2 has a connecting member 18, and the connecting member 18 has a needle holder 6 and is connected to a matching connecting member 19. In the illustrated example, the connecting member 18 is a tab that the needle holder 6 has and is connected with a corresponding helical claw or quarter-turn screw connecting member 19. The connecting members 18 and 19 may have other shapes.

  In the illustrated embodiment of FIGS. 1-3, the shape of the slot 14 and the triangular notch 15 is selected to operate in cooperation with the rotary connecting members 18, 19. The slot 14 allows the actuator handle 9 to move longitudinally relative to the outer housing 1 so that the safety guidewire 11 can be advanced distally while at the same time restricting lateral movement. Thus, the access needle 8 and the safety guide wire 11 are prevented from being pulled in early. By expanding the slot 14 at the distal end into the triangular notch 15, the actuator handle 9 is selectively rotated laterally so that the access needle 8 and the safety guide after the safety guidewire 11 is fully advanced. Until the wire 11 is pulled, the rotary connecting members 18 and 19 are released to release the biasing member 12. If different shapes or different release mechanisms are used in place of the rotary connecting members 18, 19, the shape of the slot 14 and the triangular notch 15 needs to be modified to accommodate the release mechanism.

  The needle holder 6 has a shape and a size that fit into the outer casing 1. In the embodiment shown in FIGS. 1 to 3, the needle holder 6 has a cylindrical shape having a size that fits in the cylindrical outer housing 1 so as to be slidable. Other shapes may be used, and the needle holder 6 is generally a shape that matches the internal shape of the outer casing 1. The needle holder 6 is preferably molded or alternatively machined using materials suitable for use in a medical environment. In one embodiment, the needle holder 6 is made of a rigid, medical grade plastic. A tubular access needle 8 having a sharply sloped distal end is attached to the needle holder protrusion 5, thereby in turn attached to the needle holder 6. The access needle 8 is preferably made using a stainless steel hypodermic tube. The small lumen or blood reflux chamber communicates with the lumen of the access needle 8 and is positioned in the needle holder 6 between the needle holder protrusion 5 and the needle holder 6. As described above, the distal end portion of the needle holder 6 has the connecting member 19 provided so as to be fitted to the compatible connecting member 18 at the proximal end portion of the front plug 2. In one embodiment, the connecting members 18 and 19 are provided to be fixed and released as the needle holder 6 rotates relative to the front plug 2. The connecting members 18 and 19 may be fixed and released using a bayonet connection tool. As shown in the figure, the connecting member is a helical pawl connecting member 19 that fits into a corresponding tab connecting member 18 of the front plug 2. In one embodiment, the connecting member is fixed and / or released using less than one rotation of the needle holder 6. In another embodiment, the connecting member is fixed and / or released using a member smaller than a half rotation of the needle holder 6. In yet another alternative, the connecting member is fixed and / or released using less than a quarter turn of the needle holder 6. The connecting member may have another shape.

  The biasing member 12 is formed to fit between the needle holder 6 and the front plug 2, thereby facilitating their separation. When the needle holder 6 and the front plug 2 are fixed to each other, the force of the biasing member 12 is suppressed by the connecting members 18 and 19. In one embodiment, the biasing member 12 is a spring. In FIG. 1, the biasing member or compression spring 12 is shown in a compressed state and is in the assembled venous catheter insertion device 20 in an undeployed state.

  In another embodiment, the connecting members 18, 19 are replaced by two members connected to each other using a frangible bond or one member having a frangible link. The member is provided to restrain the biasing member 12 until it is necessary to retract the access needle 8 and safety guidewire 11, at which time the actuator breaks the bond or link and releases the biasing member 12 To do. This configuration allows the device 20 to be more resistant to remanufacturing or reuse.

  A tubular venous catheter 13 such as ANGIOCATH® fits coaxially around the access needle 8. Preferably, the venous catheter 13 closely fits the access needle 8 and the tapered end, thereby minimizing the step between the access needle 8 and the catheter 13 when inserted through the vein wall. To. There is a luer connection 27 etc. at the proximal end of the venous catheter 13, which fits the luer slip connection 16 at the distal end of the front plug 2 using a weak interference fit that holds the venous catheter 13 in place. . An alternative form of device uses a locking mechanism such as a luer lock that attaches the venous catheter 13 to the front plug 2.

  The slider 4 has a generally cylindrical shape, and has a dimension that fits in the cylindrical outer casing 1 so as to be slidable. Depending on the internal shape of the external housing 1, the slider 4 may have other shapes. The slider 4 is preferably molded or alternatively machined using a suitable medical grade material. For example, the slider may be formed using a hard medical grade plastic. The handle 9 or the operation member is attached to the slider 4 using an attachment member such as a dowel pin 10 that extends through the slot 14 in the external housing 1. The slider 4 is adapted to the external housing 1 on the proximal end side of the needle holder 6. The pin 25 extends from the distal surface of the slider 4 and is provided to reversibly engage with a hole, step, boss or similar connecting mechanism 26 at the proximal end of the needle holder 6. During the appropriate steps of the venous catheter insertion and placement procedure, the pin 25 engages the connection mechanism 26. When the pin 25 engages the connection mechanism 26 during the appropriate steps of the venous catheter insertion and placement procedure, the rotation of the slider 4 is transmitted to the needle holder 6, thereby engaging the connecting members 18, 19. And / or release is facilitated. Pin 25 and mechanism 26 are merely exemplary. The pin 25 may be replaced with a female mechanism, and a matching female mechanism is disposed on the proximal end surface of the needle holder 6. Further, the connection mechanisms 25 and 26 are aligned with respect to the sliding movement of the elongated slot and the slider 4, and as a result, the connection mechanisms 25 and 26 are connected by the movement of the slider 4 toward the distal end side. When the device 20 operates, the device 20 may be formed so that the connection between the slider 4 and the needle holder 6 occurs irreversibly as appropriate.

  As shown in FIG. 3, the safety guidewire 11 is directly or indirectly attached to the slider 4 so that it advances and retracts with the handle 9 attached to the slider 4. In a preferred embodiment, the safety guidewire 11 is constructed using a very flexible nickel-titanium alloy (Nitinol) wire. Since this type of wire is very flexible, preferably the safety guidewire 11 is encapsulated along most of its length so that it bends while the safety guidewire 11 is advanced, It can prevent kinking. For this reason, the illustrated example includes a support tube 7 attached to the proximal end portion of the needle holder 6. The safety guide wire 11 extends through the inner lumen of the sheath tube 3, and the proximal end portion of the safety guide wire 11 is attached to the proximal end portion of the sheath tube 3. The end portion of the sheath tube 3 is attached to the slider in order, and as a result, the safety guide wire 11 is indirectly attached to the slider 4. The support tube 7 fits slidably into the sheath tube 3, so that when the slider 4 is advanced in the distal direction, the two parts fit in sequence with each other. The fitting operation of the support tube 7 and the sheath tube 3 includes a support having a variable length for the proximal end portion of the safety guide wire 11, so that the safety guide wire 11 is bent or twisted during advancement. Can be prevented. The support tube 7 and the sheath tube 3 are preferably made using stainless steel hypodermic tubes, although any suitable medical grade material may be used. In other embodiments, such as using a large diameter or rigid guidewire, a mating support tube is not required and the proximal end of the safety guidewire 11 may be attached directly to the slider 4.

  4A and 4B are detailed views of the safety guidewire 11 for use with the venous catheter insertion device 20. The safety guidewire 11 is preferably constructed using a very flexible nickel-titanium alloy wire with a diameter of about 0.004 to 0.012 inches, most preferably about 0.008 inches in diameter. As shown in FIG. 4B, the distal end portion of the safety guide wire 11 is preformed by being tightly wound in a spiral shape having an outer diameter smaller than the inner diameter of the target blood vessel to be inserted. The helical tip acts as a safety bumper for the guide wire and can prevent puncture or damage to the interior of the target vessel. The tip of the coiled guide wire is particularly useful for protecting fragile or vulnerable blood vessels. Due to the extreme flexibility of the nickel-titanium alloy wire when the safety guidewire 11 is retracted into the access needle 8 and the safety guidewire 11 is fully restored to the helical shape when it is plastically deformed by advancement from the access needle 8, The helical end curve can be straight. As shown, the distal end of the safety guidewire 11 has a first small diameter coil of about 0.167 inch diameter that rotates about 0.75 and a second large diameter of about 0.175 inch diameter that rotates about 1 turn. A coil. The first and second coils are preferably substantially coplanar with each other, and preferably are coplanar with the linear proximal portion of the guidewire 11. Other shapes for the safety guidewire 11 include multiple planes, a single coil, a full radius end, and / or an end that is rounded with a diameter smaller than the diameter of the needle.

  5A, 5B and 5C are detailed views of another safety guidewire 11 for use with the venous catheter insertion device 20. In this embodiment, the end portion of the approximately 0.008 inch diameter nickel-titanium alloy wire is tapered by approximately 0.004 inch diameter by polishing, stretching, etc., thereby increasing flexibility. Thus, it can be formed into a smaller diameter spiral for use with smaller diameter vessels. The helical curvature of the guidewire tip preferably has an outer diameter that is smaller than the inner diameter of the target vessel. In the illustration, the helical shape comprises a first small diameter coil having a diameter of about 0.034 inches at about 0.75 revolutions and a second large diameter coil having a diameter of 0.059 inches at about one revolution. The first and second coils are preferably substantially coplanar with each other, and are preferably substantially coplanar with the linear proximal end of the guidewire 11.

  The safety guidewire 11 may have other dimensions and shapes.

  As shown in FIGS. 1 to 3, in order to assemble the venous catheter insertion device 20, the access needle 8 is adhered on the same plane as the proximal end surface of the needle holder protrusion 5, which in turn is attached to the needle holder 6. The The support tube 3 is disposed in the distal hole of the needle holder 6 and is adhered in the same plane as the proximal end surface of the blood reflux chamber. The formed safety guidewire 11 is advanced through the lumen of the access needle 8 and the support tube 7 until the coiled portion of the safety guidewire 11 fits the tip chamfer of the access needle 8. The sheath tube 3 slides through the slider 4 and adheres in the same plane as the end surface. The assembly of the sheath tube 3 and the slider 4 advances over the safety guide wire 11. If the safety guidewire 11 is in the same plane as the proximal end of the sheath tube 3, the two are bonded. The spring 12 is compressed by the needle holder protrusion 5 and advances to the front plug 2, and the connecting members 18 and 19 of the front plug 2 and the needle holder 6 are connected. This assembly of parts is arranged in the outer casing 1 and moves forward until the front plug 2 is flush with the outer casing 1, and the front plug 2 rotates at an appropriate angle. Next, the front plug 2 is bonded to the external housing 1. The dwell pin 10 and the handle 9 are compressed together with the slider 4. The handle 9 slides proximally to retract the safety guidewire 11 into the access needle 8, thereby straightening the helical distal curve. The venous catheter 13 is then provided concentrically around the access needle 8. Optionally, the venous catheter 13 insertion device may be provided with a needle cover or other protective package. The assembled venous catheter insertion device 20 includes the venous catheter 13, which is then packaged, labeled and sterilized.

  The above description of the assembly is presented to show an example of a process for manufacturing an embodiment of the venous catheter insertion device 20, whereby the internal relationships of the various components will also be understood. . The improvements and derivations described herein are believed to be due to the particular selected assembly or manufacturing technique. For example, the bonded parts may be redesigned to be formed using a single integrated piece or the like. The manufacturing process may be modified and applied to combine other embodiments of the venous catheter insertion device 20.

  FIG. 6 shows an internal view of another embodiment of the venous catheter insertion device 20 according to the present invention. This embodiment is similar in many respects to the venous catheter insertion device 20 of FIGS. The venous catheter insertion device 20 includes an external housing 1, a front plug 2 that is appropriately formed integrally with the external housing 1, a needle 8 that is attached to the needle holder 6, a safety guide wire 11, and a spring 12. A venous catheter 13. However, the functions of the handle 9 and the slider 4 have been replaced by a thumb wheel 21 that connects a set of friction wheels 22, 23. The friction wheels 22 and 23 are in contact with the safety guide wire 11. Similarly, the functions of the sheath tube 3 and the support tube 7 have been replaced by a guide wire spool 24. By these mechanisms, the venous catheter insertion device 20 is configured in a more compact shape. The safety guide wire 11 is advanced by rotating the thumb wheel 21 in use. By moving the thumb wheel 21 in the lateral direction, the needle holder 6 is released from the front plug 2, thereby extending the biasing member 12, and as a result, the needle 8 and the safety guide wire 11 are connected to the outer casing 1. Store in. Alternatively, a separation button, lever or other operating member may be provided to activate the retraction of the needle 8 and safety guidewire 11. The guide wire spool 24 includes a rotation spring or a similar mechanism (not shown) as appropriate to assist in retracting the safety guide wire 11 to the external housing 1.

  In one embodiment, the length of the guide wire 11 at the spool 24 is longer than twice the length of the housing. In other forms, the length of the guide wire in the spool 24 is sufficient to access the blood vessel in which the guide wire is located. In one embodiment, the guidewire spool includes a guidewire having a length between 10 and 60 centimeters. In order to reduce the force required to rotate the thumb wheel 21 or the wheels 22, 23, the guide wire spool 24 may be a clutch, cam, or other openable that releases the spool 24 during advancement of the guide wire 11. It may be provided so as to include various connecting members. After completion of the advancement, the releasable connecting member then connects the retracting mechanism associated with the spool 24. When the guide wire needs to be retracted, the retract mechanism is activated. By using the guide wire spool 24, it is possible to use a guide wire insertion length that is much longer than the length of the housing containing the guide wire spool.

  7 to 9 show a venous catheter insertion method using the venous catheter insertion device 20 as described in FIGS. The venous catheter insertion device 20 is a disposable, non-reusable device that is sterilized and ready for use and supplied to a physician or medical practitioner and is shown in an undeployed state in FIG. In use, the doctor operates the venous catheter insertion device 20 using the outer casing 1 as a handle. As shown in FIG. 7, in the case of a non-arranged device, the access needle 8 is punctured into a vein. When venous blood is observed in the blood reflux chamber, the distal end of the access needle 8 is in the venous lumen. The physician can then advance the handle 9 distally to extend the safety guidewire 11 from the access needle 8 to the venous lumen. The distal portion of the safety guidewire 11 is assumed to have a helical shape so that it acts as a safety bumper to prevent vein damage such as accidental piercing of the far wall of the vein. When the safety guidewire 11 is placed in this manner, the physician can continue to advance the venous catheter insertion device 20 safely until the distal end of the venous catheter 13 is located within the lumen of the vein. Once the venous catheter 13 is inserted into a sufficiently far vein, the physician rotates the handle 9 and rotates the slider 4. Thereby, the needle holder 6 sequentially rotates, and the connecting member 18 of the needle holder 6 is released from the compatible connecting member 19 of the front plug 2. (In the above-described embodiment, the handle moves in the clockwise direction enabled by the triangular notch 15 at the end of the slot 14 of the outer casing 1. Further, structural features regarding the mechanism of the actuator are as follows. 1 to 3 in detail.) When the handle 9 is released, the biasing member 23 (in this embodiment, the compression spring 12) biases the needle holder 6 and the slider 4 in the proximal direction, and at the same time, the access needle 8 and the safety The guide wire 11 is pulled into the outer housing 1 and only the venous catheter 13 is left in the venous lumen. FIG. 8 shows the access needle 8 and the safety guide wire 11 that are pulled into the external housing 1. Depending on the shape of the triangular notch 15, the handle 9 moves to the proximal end side under the action of the biasing member 12, so that it can move smoothly to the elongated slot 14. Finally, the venous catheter 13 is released from the luer slip 16 connected at the end of the front plug 2 as shown in FIG. 9, and the venous flow source, syringe and other devices are connected to the luer connection 27 of the venous catheter 13. It is attached.

  Intravenous catheter insertion device 20 preferably retracts access needle 8 and safety guidewire 11 simultaneously, but the actuation mechanism may be modified to retract access needle 8 and safety guidewire 11 in turn. For example, the actuating mechanism first retracts the access needle 8 and then retracts the safety guidewire 11 with a slight delay.

  Instead, the actuation mechanism requires two actuations of one actuation member or selective movement of two separate actuation members to selectively retract the access needle 8 and safety guidewire 11. It may be improved as follows.

  In an alternative embodiment of the venous catheter insertion device 20, the compression spring 12 is removed from the actuation mechanism, thereby allowing the access needle 8 and safety guidewire 11 to be manually retracted using the handle 9. When the venous catheter 13 is inserted into the patient's vein, the handle 9 rotates laterally to release the needle holder 6 from the front plug 2. Next, the handle 9 moves proximally along the slot 14 in order to retract the access needle 8 and the safety guidewire 11 into the outer housing 1.

  Parts of a catheter insertion device 20 according to another embodiment are shown in FIGS. 10A and 10B. FIG. 10A shows the housing 1 having an internal space 34. The housing 1 represents a generally cylindrical container having sufficient strength to hold the various components of the catheter insertion device 20. The attachment mechanism 40 can also be seen in the interior space 34. As shown in subsequent figures, the attachment mechanism 40 may be used to secure the restraining member 36 to the handle 1 or in the interior space 34. The access needle 8 is positioned at the end of the housing 1 and exits from the internal space 34. The access needle has a distal end 45 and a lumen 46. The access needle 8 can slide relative to the internal space 34. The release bar 32 is used to hold the needle 8 in the housing 1. In the present embodiment, the urging member 12 is compressed between the housing 1 and the needle support portion 29. The release button 30 is used to tilt the release bar 32, allowing the biasing member 12 to extend and move the access needle 8 in the interior space proximally.

  The catheter insertion device described herein is designed and applied so that at the time of release, at least a part of the needle moves the insertion needle from a predetermined position outside the housing to a predetermined position in the internal space 23. A biasing member. Further, the same or different biasing members are designed and applied to move the guide wire 11 from a predetermined position outside the housing to a predetermined position in the housing 1 when released. In the configurations described in many of the embodiments described herein, movement of the needle 8 or guide wire 11 to the distal side indicates insertion into the target vessel and movement to the proximal side is indicative of the target vessel. Shows retraction from. The biasing member will be described using a conventional one for consideration. Other movements may be used to advance in or retract from within. The description regarding the movement and design of the biasing member will be adjusted accordingly. In one form, the biasing member is designed and applied to move the needle 8 upon release from the constrained state, so that the needle 8 is completely contained within the interior space 34. In another form, the biasing member moves the guide wire 11 when released from the restrained state, so that the entire length of the guide wire 11 is completely contained within the interior space 34. In the embodiment shown in FIG. 11A, the biasing member 12 is a spring.

  FIG. 10B shows the parts associated with the guidewire 11. In the illustrated embodiment, the proximal end portion of the guide wire 11 is attached to the guide wire support portion 38. The distal end of the guide wire extends along the access needle in use and exceeds the distal end of the housing 1. Prior to use, one end of the guide wire 11 is always attached to the handle 1 and / or into the interior space. After use, the guide wire 11 is completely contained in the handle 1 or in the interior space 34. The handle 9 is attached to the guide wire either directly or indirectly. The handle 9 is movable with respect to the housing 1 in order to move the guide wire 11 with respect to the internal space 34.

  The guide wire support 38 and the guide wire 11 are connected using an appropriate technique. Since the guide wire 11 is a small diameter, flexible wire, coiled, fragile, or well-known wire in the medical arts as described herein, the guide wire support 38 is a guide wire. 11 is used to provide mechanical strength. The guide wire support portion 38 has a shape different from that of the illustrated embodiment, and further satisfies the functional requirement of supporting one end portion of the guide wire 11. The handle 9 is attached to the guide wire 11 directly or indirectly, and as a result, the guide wire 11 moves relative to the internal space 34 or the housing 1 by the movement of the handle 9. In the illustrated embodiment, the handle 9 is attached to the guide wire 11 using a guide wire support 38. FIG. 10B also shows the suppression member 36. The restraining member 36 is used to prevent the guide wire 11 from moving. In one form, the restraining member 36 attached to the handle 9 limits the movement of the guide wire 11 with respect to the access needle 8. In the illustrated embodiment, one end of the restraining member 36 is attached to the guide wire support 38. The other end or other part of the restraining member 36 is attached to the handle 1. In one embodiment, the restraining member extends between the guidewire support 38 or handle 9 and the handle 1 or interior space 34. The restraining member 36 may be attached to the attachment mechanism 40, to the handle 1 by suitable means, or into the interior space 34.

  10C and 10D show side views of an embodiment of a catheter hub. FIG. 10D shows a conventional catheter hub assembly 13. FIG. 10C is a catheter hub 13A having a sloped base 61 that allows for easy insertion of the catheter into the blood vessel, as will be further described with reference to FIGS. 19A and 19B.

  FIGS. 10E and 10F show various devices 43 in the access needle 8 to allow early indications regarding punctures to blood vessels. FIG. 10E shows a single display opening 43 and FIG. 11F shows an embodiment of two display parts 43. The display 43 has an appropriate size and shape to provide an indication that blood is present in the needle lumen 46. The shape shown is the rectangle of FIG. 10E and the egg shape of FIG. 10F. A circular shape may be used.

  FIG. 10G shows a plan view of the needle 6, the guide wire 11, and the distal end of the handle 1 attached to the catheter hub 13. The length of the needle 8 is selected to extend beyond the distal end of the catheter as shown. The needle end 45 extends far enough to pierce the blood vessel beyond the catheter end. The guide wire 11 is supported by the access needle 8 and is movable relative to the access needle 8. The guide wire 11 is shown extending from the needle end 45.

  In the illustrated form, the guide wire 11 is coiled on the paper surface. The guide wire coil may be formed in the needle lumen 46 and advance from the needle 8 in a coiled manner, or the guide wire 11 may be constrained in a straight shape within the access needle lumen 46. Once extended from the access needle lumen 46, the guidewire 11 is assumed to have a predetermined coil shape. In other forms, the guidewire 11 is not coiled, but instead remains straight during use. Various coil types are shown and described in FIGS. 1, 4A, 4B, 5B, 5A, 16A-17B, 22, 23 and 24.

  Access needle 8 includes a visible blood reflux indicator 42 at the distal end of catheter 13 when access needle 8 is positioned within catheter 13. In the illustrated embodiment, the blood reflux display unit 43 includes an opening 43 on the side wall of the distal end of the needle 8. The blood regurgitation port 42 is visualized through the catheter assembly 13, thereby allowing a display that is substantially simultaneous with the puncture of the blood vessel. The blood backflow display 42 is in a portion that extends beyond the housing 1 of the access needle 8. As shown in the figure, the blood reflux display portion 42 is an opening 43 formed in the needle 8 and formed in the portion of the needle closer to the distal side than the distal end portion of the housing 1.

  FIG. 10G also shows the relationship between the guidewire and the blood reflux opening. One of the considerations when operating the guide wire is the careless movement of the handle 9. When the handle 9 moves to the proximal end side, for example, the distal end portion of the guide wire jumps out from the needle lumen 46 through the backflow channel 43. In this example, the guidewire 11 needs to be passed again through the access needle lumen 46. FIGS. 11A and 11B illustrate one technique for preventing such undesirable proximal movement using a restraining member 36. The restraining member 36 is used for restricting the movement of the guide wire 11. As best shown in FIG. 11A, the restraining member 36 is attached to the handle 9 and restricts the proximal movement of the guidewire 11 relative to the access needle 8. The restraining member 36 is pulled strongly and restricts the handle 9 from further moving to the proximal end side. As shown, the guide wire 11 remains in the access needle 8 when it is located proximally before the release button 30 is actuated. In one embodiment, the restraining member 36 is an elongated piece of Kevlar fiber that is cut to fit within the interior space 36. The restraining member 36 can be any of a wide variety of materials that limit or prohibit movement of the guidewire. The restraining member 36 may be a flexible member that increases resistance as the handle moves, thereby allowing the user to feel tactile feedback that it is undesirable to move further in that direction.

  Similar to FIGS. 7-9 described above, FIGS. 11A-14B are used to illustrate an exemplary catheter insertion procedure. The insertion of the catheter 13 and the operation of the embodiment of the catheter insertion device 20 is described using a series of views including a cross-sectional view of the interior of the housing 1, and the illustrated device is used to access a blood vessel. The

  FIG. 11A shows the housing 1 in a preparation position when using a needle for puncturing a blood vessel. It should be noted that the proximal movement of the handle 9 is limited by the restraining device 35 so that the guide wire 11 remains in place in the interior space 34 and the needle lumen 46. FIG. 11B shows the device 20 inserted into the catheter 13 before the blood vessel attaches. FIG. 11C shows the needle 8 piercing into the blood vessel through the blood vessel wall (VW). The blood (B) appears on the blood backflow display unit 42. The blood backflow display unit 42 can display the puncture of the blood vessel at an early stage. The guide wire 11 remains in the access needle lumen 46 between the distal end of the needle 45 and the blood reflux opening 43.

  FIG. 12A shows the position of the internal parts after the guidewire has been advanced. As shown in the figure, the handle 9 moves to the distal side relative to the housing 1. By this movement, the guide wire 11 advances beyond the needle end portion 45 and reduces the tension of the suppressing member 36. FIG. 12B shows the guide wire 11 assuming a coil shape after coming out of the needle 8. As the handle 9 continues to move, the guide wire 11 advances to the further blood vessel (V).

  FIG. 13A shows the catheter 13 being advanced along the guidewire 11 beyond the needle distal end 45. When the catheter is inserted into the blood vessel V, the guide wire 11 and the access needle 8 can be retracted. There are various methods for retracting the guide wire 11 and the needle 8. Retraction may be done simultaneously or sequentially. In sequential cases, either the guide wire or the needle is withdrawn first. Retraction is accomplished by manual manipulation of a guide wire 11, needle 8, or a knob, handle, slider or other component attached directly or indirectly to both guide wire 11 and needle 8. Retraction can also be done by using an automatic mechanism provided to retract one or both of the guide wire 11 and the needle 8. Retracting the element automatically may be combined with manually retracting the element. Regardless of the retracting technique or procedure performed, the fully retracting procedure ends with both the needle and guidewire proximal to the housing distal end 1 and / or within the interior space 34. In one form, as a result of the retraction operation, the guide wire 11 and the needle 8 are completely in the interior space 38 so that the sharp, blood-exposed parts are contained in the housing 1 ( For example, see FIGS. 14A, 15 13C, 18G and 31).

  The automatic retraction procedure is described starting from FIG. 12A. When the release button 30 is pressed, the release bar 32 is released from the proximal end portion of the needle support portion 29. The urging member 12 is constrained in the proximal direction and extends in that direction. When the urging member 12 moves to the proximal end side, the needle support portion 29 also moves along the needle 8 to the proximal end side. By moving the needle support portion 29 toward the proximal end side, the guide wire support portion 38 and the handle 9 also move along the guide wire 11 toward the proximal end side. FIG. 13B shows the guide wire 11 shown near the distal end of the catheter 13 moving proximally, rather than going further down the blood vessel as shown in FIG. 13A. FIG. 13C shows the continuous proximal movement indicated by the arrows. Here, both the guide wire 11 and the needle 8 are retracted from the catheter 13 and are closer to the proximal end than the distal end of the housing 1. FIG. 13D is a cross-sectional view of the housing 1 at the end of the retracting procedure. At the end of the retracting procedure, the catheter 13 is inserted into the blood vessel v, but the housing 1 is still attached to the catheter 13 as shown. The needle 8 and the guide wire 11 are both on the proximal side from the housing distal end 1 and in the internal space 34. Furthermore, FIG. 13D shows both the guide wire 11 and the needle 8 completely in the housing 1 and the interior space 34.

  FIG. 14A shows the housing 1 separated from the catheter assembly 13. At this time, the housing 1 is ready for disposal and the catheter 13 is in the blood vessel shown in FIG. 14B. As shown in FIGS. 14A and 15, the needle end 45 is retracted from the housing end 35 at a distance d. Needle 8 and guide wire 11 are completely within housing interior 34. The distance d is adjusted based on a number of design factors such as the length of the housing, the length of the needle, the amount of energy stored in the biasing member, and the travel length required to retract. Also good. The distance d is 1 mm to about 20 mm, and is closer to the base end side than the housing distal end portion 35 as shown in FIG. 18G.

  Referring to FIG. 14A, when the needle 8 and guide wire 11 are pulled into the housing 11, the sharp, device 20 parts exposed to blood are typically the needle 8 and guide wire 11; It is in the handle inner space 34. This additional mechanism can further increase safety and ensure that the needle and guidewire remain within the housing or interior space. In one form of the invention, the restraining member is positioned in the interior space 34 thereby restricting movement of one or both of the access needle 8 or guidewire 11. The restraining device is positioned in the interior space based on the required travel length during the retracting procedure. The restraining member, in one embodiment, is positioned in the interior space 36 near the end where the needle and / or guidewire moves. The moving end of the needle and guidewire may vary depending on the application. When properly positioned, the guide wire 11, needle 8 or guide wire or part engaged with the needle is restricted from moving distally, so that both the guide wire and needle are removed from the housing end 1. Elongate. Instead, when properly positioned, the guidewire 11, needle 8 or guidewire or part engaged with the needle is restricted from moving distally so that the guidewire and needle are in the interior space 34. Stay on. The internal space 34 may be a cavity in the housing 1 or may be a hollow space in the housing 1.

  In one embodiment, the restraining device regulates movement to both the proximal side and the distal side. In another embodiment, the suppression device allows movement to the proximal end side but restricts movement to the proximal end side. FIG. 15 shows an embodiment of the suppression device 64 in the interior space 34. The restraining device 64 has a chamfered cone shape with a base released towards the housing end 1. The restraining device is made of a flexible material and allows sufficient access for the guidewire 11, needle 8 and associated sub-parts to move in one direction proximally. In the illustrated embodiment, the restraining device is designed and applied to be secured at the proximal end of the needle support 29. A restraining device 29 may be provided to hold, limit, or regulate and connect any part to keep the guidewire and needle in the desired position. The restraining device 64 may be confined in the interior space 34 that creates a friction fit between the housing inner wall and the guidewire and / or needle component. Further, the guide wire and the needle component may be provided so as to be connected and fixed when the needle or the guide wire is moved to the proximal side of either one of the needles or the guide wire. In one embodiment, proximal movement secures both the guidewire and the needle so that they may move proximally through the housing 1 as a single unit. The restraining device 64 may then be designed and applied to couple with one of the guidewire or needle, or the mechanism of a single guidewire / needle unit.

  In other embodiments, the restraining device 64 includes one or more angle phi toward the proximal end of the interior space 34. Virtually any shape is possible as long as the needle / guidewire can be passed in one direction (from here to the proximal end) and prevented from moving in the opposite direction (from here to the distal end). Can also be used. In the figure, the movement of the needle guide is shown to be limited, but this is for illustrative purposes only. The restraining device is designed and applied to connect in any part of the needle or guide wire assembly to the extent that it can be pulled into the housing by engagement and prevent advancement from inside the housing. Is done. Other restraining mechanisms and configurations include, for example, one or more rings, wedges or other friction locking designs.

  The guidewire 11 is conventional in the field of curved, coiled or linear, or guidewire for medical applications as shown and described in FIGS. 3, 4a, 4b, 5a-5c, 8, 22, 23 and 24. It can be any of a number of different designs including certain other shapes. In the illustration of the embodiment of FIGS. 16A-17B, the guidewire 11 is coiled within the access needle lumen 46. 16A-17B are an end view (FIGS. 16A and 17A) and an isometric view (FIGS. 16B and 17B) of the distal portion of an embodiment of an access needle 8 used in the catheter insertion device 20. The illustrated access needles 8a and 8b have a distal end 45 and an inner wall that forms a lumen 46 extending from the distal end to the proximal end. As described with reference to the access needle 8, the access needles 8 a and 8 b are slidable with respect to the internal space 46 and extend beyond the housing end 1. The openings 43 of the access needle side walls 8 a and 8 b communicate with the access needle lumen 46. The opening 43 on the side wall of the access needle is located closer to the proximal end than the distal end 45 of the access needle. The guide wire 11 is supported by an access needle.

  The lumens of the access needles 8 a and 8 b have a cross-sectional shape that maintains the directionality of the guide wire 11 relative to the access needle lumen 46. Access needles 8a and 8b indicate access needle lumens having a non-circular cross-sectional shape. In one form, the shape of the access needle lumen is used to maintain the orientation of the guide wire, thereby allowing the guide wire to be expelled from the access needle through the blood reflux indicator or opening 43. Stop. 16A-17B, when the guide wire 11 is drawn proximally into the region of the blood reflux opening 43, either by the mechanism (FIGS. 16A and 16B) or the internal shape of the needle (FIGS. 17A and 17B) The guidewire 11 is maintained in a direction that prevents it from being discharged from the access needle lumen 46 through the opening 43. The orientations maintaining the mechanism shown in FIGS. 16A-17B may be used alone or in combination with each other. In other variations, the orientation to maintain the mechanism may be used instead of or in combination with the restraining device 36 described with reference to FIGS. 10B and 11A.

  In certain embodiments, a mechanism formed in the access needle sidewall maintains the orientation of the guidewire 11 relative to the access needle lumen 46. The mechanism may be formed on the side wall or a separate part connected to the side wall. FIGS. 16A and 16B show a mechanism 52 formed in the access needle sidewall to maintain the orientation of the guidewire 11 relative to the access needle lumen. In the illustrated embodiment, the mechanism 52 is a groove formed along the sidewall. The depth of the groove is sufficient to limit the guide wire 11 and maintain orientation within the needle lumen 46.

  In the embodiment shown in FIGS. 17A and 17B, the cross-sectional shape of the access needle lumen 46 is such that the guide in the needle lumen 46 prevents the guidewire 11 from exiting the lumen 46 through the blood reflux opening. Used to limit the wire. 17A and 17B show an access needle lumen 46 having an elliptical cross-sectional shape. Other cross-sectional shapes may be used to restrict the guidewire 11 into the access needle lumen 46.

  In one embodiment, the access needle lumen 46 restricts the coiled guidewire 11 to form at least a half turn within the access needle lumen 46. In an alternative embodiment, the access needle lumen constrains the coiled guidewire 11 to form one or more rotations within the access needle lumen 46.

  Another challenge with the use of guidewires to assist vascular access devices is that the guidewire is advanced rapidly distally during or before puncture. 18A-18H show an embodiment of a catheter insertion device 20 having a main channel 14 and a guide channel 70. FIG. The main channel 14 in the housing 1 restricts the movement of the handle 9 along the housing 1. The guide channel 70 is adjacent to the main channel 14 and is accessible from the main channel 14. The guide channel 70 is provided to prevent or restrict movement of the handle 9 when the handle 9 is in the guide channel 70.

  The insertion device shown is used by an insertion procedure similar to that described above with reference to FIGS. 7-9 and 11A-14B. The parts and operation of the catheter device 20 of FIGS. 18A-18H are similar to those of the above-described embodiment, and the same reference numerals are used for the same elements. The guide channel is an example of an additional mechanism for restricting or preventing the movement of the guide wire 11 toward the distal side. The housing 1 has a guide channel 70 in addition to the main channel 14. Guide channel 70 is best shown in the isometric view of FIG. 18B.

  18A and 18B show a side view and an isometric view, respectively, of one embodiment of a catheter insertion device 20 having a handle 9 in place on the proximal side of the main channel 14. This embodiment of the catheter insertion device 20 includes a housing 1 having an internal space 34. The access needle 8 is slidable with respect to the internal space 34 and extends from the housing end 1. The guide wire 11 is supported by the access needle 8 and is movable relative to the access needle 8. The handle 9 is attached to the guide wire. The movement of the handle is limited so that at least a part of the guide wire 11 always remains in the interior space 34. In the illustrated embodiment, the handle 9 is attached to the guide wire 11 using a guide wire support 38. The handle 9 and the guide wire support 38 may be an integral part. As shown at the beginning of the procedure (FIG. 18A) and at the end of the procedure (FIG. 18G), the movement of the handle 9 is limited, so that the proximal end portion 11A of the guidewire always remains in the interior space 34.

  As shown in FIG. 18A, the movement of the handle 9 toward the proximal end side is restricted or stopped by the suppressing device 36. As shown in FIG. 18B, even when the handle 9 and the guide wire 11 are pulled to the proximal end side, the guide wire 11 has a needle lumen 46 that is distal to the opening 43 and proximal to the distal end 45. Stay inside. In the embodiment shown in FIGS. 18A-18D, the restraining member 36 prevents movement of the guide wire to the proximal side, and the retention channel 70 prevents movement of the guide wire to the distal side in use. One end of the guide wire 11 is fixed to the housing 1 using an attachment point 40. As shown in FIGS. 18A and 18B, the guide wire 11 is placed in the access needle 8.

  The guide channel 70 may include a friction or interference fit or regulate the handle 9 once the handle 9 moves into the guide channel. For example, the guide channel is provided with a mechanism such as a fixing portion, a tab, or the like with a uniform width at the end of the channel 70 in order to releasably fix the handle in the channel 70. Alternatively, the movement of the handle relative to the guide channel 70 may be used to secure and unlock the handle 9 from the guide channel 70. For example, the handle 9 may move to a J-shaped guide channel to secure and move from the J-shaped guide channel to return from the channel 14. In another alternative, the width of the guide channel 70 is smaller on the distal side to cause friction on the distally advanced handle 9.

  18C and 18D show the handle 9 advanced distally in the guide channel 70. Comparing FIGS. 18A and 18B, the movement of the handle 9 to the distal side causes a corresponding movement of the guide wire 11 to the distal side. As shown in FIG. 18D, the guide wire 11 is still in the access needle 8 and is proximal to the distal end 45. The guide channel 70 is designed so that the guide wire 11 remains in the needle 8 when the handle 9 moves into the channel 70. For those embodiments where the needle includes an opening 43, the channel 70 limits the movement of the guide wire 11 between the opening 43 and the distal end of the needle 45.

  18E and 18F show the advancement of the guide wire as described with reference to FIGS. 8, 12A and 13. FIG. 18E and 18F also show an embodiment of the catheter insertion device. In the catheter insertion device, when the guide wire 11 extends beyond the access needle distal end 45, one end of the guide wire 11 is constrained in the internal space 34.

  18G and 18H show the component placement at the end of the pull-in procedure described with reference to FIGS. 9, 13A, 13B, 13C, 13D, 14 and 15. FIG. 18G shows the retraction of the needle distal end 45 to a predetermined position just proximal to the housing distal end 35. FIG. 14A and 15, the final position is a position where the needle end portion 45 is retracted from the housing end portion 35 by the distance d. The spatial relationship of the parts used in this form may be modified so that the needle end is retracted by a distance d. In each of the embodiments described herein, the guide wire is at the same location or distance to the proximal side of the needle distal end 45, ie, at least from the housing distal end 35 to at least the proximal end or as described above. Only d is drawn.

  18A-18D show the restriction of the movement of the handle 9 provided by the restraining device 36 and the guide wire channel 70. FIG. The catheter insertion device 20 may be provided to the user in the “ready for use” state shown in FIGS. 18C and 18D. In this configuration, the inadvertent advancement of the guide wire 11 toward the distal side is reduced by the arrangement of the handle 9 of the guide channel 70. In order to advance the guide wire 11 distally or beyond the needle distal end 45, the handle 9 and the guide wire 11 move proximally when the handle 9 needs to be freed from the guide channel 70. . This proximal movement is limited by the restraining device 36 as shown in FIG. 18A to maintain the guidewire 11 in the needle 8. Thus, the handle 9 and guidewire 11 are advanced distally as described herein by catheter insertion according to a needle / guidewire withdrawal procedure.

  Another challenge associated with vascular puncture or general entry is to provide catheter orientation for patient comfort after insertion. One potential problem with directionality is best shown in FIG. 14B. FIG. 4B shows a conventional catheter hub assembly 13 in which the catheter lumen bends down to fit a flat base and a generally grid array of hubs. In contrast, FIGS. 19A and 19B show a tilted catheter lumen. The catheter lumen angle θ is selected so as to visualize the approach angle of the needle 8 entering the blood vessel V. As shown in FIG. 19A, the housing 1 is aligned with the catheter lumen. As a result, the needle 8 is also aligned with the catheter lumen angle θ. FIG. 19 is a cross-sectional view of the catheter hub 13A and shows the catheter lumen angle θ formed between the base 61 and the catheter lumen. In one embodiment, the catheter lumen angle θ varies from about 0 degrees to about 90 degrees. In other embodiments, the catheter lumen angle θ varies from about 0 degrees to less than about 25 degrees. The catheter 13A is used differently from the catheter hub 13 shown in FIGS. 7 and 11C. As shown in FIGS. 7 and 11C, the housing and catheter are not supported above the blood vessel where the catheter base does not contact the skin. On the other hand, when the catheter 13A is used, the base 61 is in contact with the skin, and when the catheter 61A is properly disposed on the skin, the catheter lumen angle .theta. It may be used to guide into the blood vessel V. The tilted catheter hub improves patient comfort and reduces the possibility of inadvertent disconnection of the catheter. Such advantages are provided by the hub and lumen, which will make better contact with the skin as the catheter lumen is angled for insertion into the blood vessel.

  FIG. 20 shows an embodiment of a catheter insertion device having a housing 1 with an internal space 34 and a long axis. The mechanism 80 is positioned at or formed from the housing end 35. When the mechanism 80 engages the catheter 13, the housing long axis is offset from the long axis of the catheter 13. The offset is indicated by the housing offset angle β. As illustrated, the housing offset angle β is about 10 degrees to about 15 degrees. In other embodiments, the housing offset angle β ranges from about 5 degrees to less than about 50 degrees. The access needle 8 passes through the mechanism 80 and is attached to a needle holder or other part in the housing. The needle and / or needle holder is slidable with respect to the interior space 34, and the access needle 8 is slidable with respect to the mechanism 80. In one embodiment, when the mechanism 80 engages the catheter 13, the housing long axis is offset from the long axis of the catheter, thereby forming a housing offset angle β less than 180 degrees. In other configurations, when the mechanism 80 engages the catheter 13, the housing long axis is offset from the long axis of the catheter, thereby forming a housing offset angle β less than 60 degrees. In other forms, when the mechanism 80 engages the catheter 13, the housing long axis is offset from the long axis of the catheter, thereby forming a housing offset angle β less than 45 degrees. As a result of the offset angle β, in the retraction procedure, the needle and guide wire initially move according to the offset angle β at a predetermined angle with respect to the long axis of the housing. After passing through the mechanism 80, the retracting movement changes to a parallel movement, and in one embodiment, the movement in the same direction as the major axis of the housing 1. As such, as the guidewire and / or needle is withdrawn through mechanism 80, the access needle and guidewire are withdrawn into an interior space 34 that is substantially parallel to the long axis of housing 1.

  Other techniques for adjusting the angle of entry into the blood vessel and facilitating use of the catheter insertion device include changing the location where the needle exits the housing. By moving the needle, it is assumed that the central access point of the housing as shown in the previous embodiment and as in the conventional general safe syringe is retracted, and the different access angles are different from the housing 1 and the target. Formed between blood vessels.

  FIG. 21 shows an embodiment of a catheter insertion device having a housing 1 with an internal space 34 and a long axis. The interior space 34 is designed to be dimensioned to include all of the guidewire 11 and access needle 8 after catheter insertion is complete. The access needle 8 is slidable with respect to the internal space 34. The axis of the needle is offset from the long axis of the housing. The offset needle is near one wall of the housing and exits from the housing end which is not central. Here, the withdrawal of the needle extends in parallel below the long axis of the housing.

  The biasing member 12 is in the same direction as the housing axis. The release bar 32 is provided so as to connect the end support portion 21 positioned toward one wall portion of the housing. The part acts for insertion and retraction of the needle and guide wire as described above.

  In the illustrated embodiment, the long axis of the housing extends through the axis of the Fus western seat 12. The guide wire 11 is in the same direction as the needle 8. The needle axis is parallel, but is not offset to the housing major axis. The biasing member 12 is above the needle 8 in contrast to the previous embodiment where the needle and biasing member were in the same direction. Here, the needle and the guide wire may move so as to approach one wall portion of the housing. As a result, the needle exits from the housing close to one wall, and as a result, the housing is held closer to the skin than the previous embodiment before the needle exits from the approximate center of the housing. Is possible. In other forms, the restraining member 36 and the attachment location 40 may move above the needle to assist in moving the needle to one wall of the housing.

  For example, as illustrated and described in FIGS. 1, 3, 4A, 4B, 5A, 5B, 5C, 8, 10B, 10G, and 16A-17B, the design area of the various guidewires may be varied. Furthermore, the guidewire design is also used in the catheter insertion device described herein. As illustrated and described herein, the guidewire 11 may be used in a coiled, non-coiled or curved shape. Further, the distal end of the second portion may be made of one or more full radius distal ends, a hemispherical portion of the same material as the guidewire, and a different material from the guidewire or the distal end having a diameter substantially similar to the first diameter. A hemisphere.

  FIG. 22 is a cross-sectional view of the guidewire 11 having a first portion having a first diameter, a reduced portion 84, and a second portion having a second diameter smaller than the first diameter. The guide wire end portion 85 is formed on the rounded tip portion 87 or the ball-like tip portion 87 and attached to the end portion 85. The first diameter and the second diameter are smaller than the inner diameter of the access needle 8. In one embodiment, the first diameter is made using a 0.008 inch diameter wire and the second diameter is made using a 0.004 inch diameter wire with a full radius end 85. It is done. The transition or taper 84 is a linear change from the first diameter to the second diameter, as shown. In one embodiment, the tip 87 is a hemisphere having a diameter between 0.005 and 0.012 inches formed with the distal end 85 or with a separate part attached to the distal end 85. The hemispherical portion 87 may be formed using various metals, alloys, plastics, nitinol, and other materials suitable for use in the body.

  FIG. 23 is a cross-sectional view of a guidewire that includes a first portion having a first diameter, a reduced portion 84, and a second portion having a second diameter that is smaller than the first diameter. A guide wire distal end 85 is formed at the rounded end. The first diameter and the second diameter are smaller than the inner diameter of the access needle 8. In one embodiment, the first diameter is made using a 0.008 inch diameter wire and the second diameter is made using a 0.004 inch diameter wire with a full radius end 85. . The transition or taper 84 is a linear change from the first diameter to the second diameter, as shown. In an alternative embodiment, the transition 84 may be removed and the guidewire may have a single diameter from the proximal end to the distal end. In one particular form, the wire used for the guide wire has a diameter of 0.006 inches.

  FIG. 24 shows the guide wire 11 formed with a braided structure 89.

  In one embodiment, the braided structure 89 is made using nitinol fiber having a 0.002 inch diameter.

  FIGS. 25A and 25B show an embodiment of a guidewire 11 having a coiled portion 91. FIG. 25A is a side view of guidewire 11 having a first diameter region, a tapered or transition region 84, and a second diameter region formed in coil portion 91. FIG. The coil portion 91 will be described with respect to the coil width (cw) and the coil span (cp). The coil width (cw) is best shown in FIG. 25A. The coil span (cs) is best shown in FIG. 25B. In one embodiment, the distal end 85 moves through an angular change of at least 180 degrees when moving from a linear shape (FIG. 23) to a coil shape (FIG. 25A). In other embodiments, the distal end 85 moves through an angular change of less than 270 degrees when moving from a linear shape (FIG. 23) to a coil shape (FIG. 25A). In other embodiments, the coil portion 91 includes at least one fully formed coil. In other embodiments, the coil width is from about 0.04 to about 0.05 inches, and in other embodiments, the coil span is less than 0.015 inches.

  26A and 26B show cross-sectional views of a catheter insertion device that is similar in many respects to the device described with reference to FIGS. 10A and 11A. FIG. 6 shows a drum with built-in spring to provide a mechanism to ensure complete retraction of the guide wire 11 into the housing 1 when the length of the guide wire 11 used exceeds the length of the housing. 24 is used. FIG. 26 shows a catheter insertion device that also includes a mechanism for retracting the length of the guide wire 11 that is longer than the length of the housing 1 along the same line as FIG. 6, FIG. 26A and FIG. 26B.

  FIGS. 26A and 26B show one embodiment of a catheter insertion device that includes a pulley 98 secured in the interior space 34. The pulley 98 is provided so as to facilitate the movement of the guide wire 11 to the internal space 34. FIG. 26A illustrates another catheter insertion device embodiment in which one end of the guidewire is constrained to the interior space when the guidewire is advanced beyond the needle distal end 45.

  The housing interior 34 can store more guidewires, but the guidewire to be retrieved is longer than the housing and at the end of the pull-in procedure, all of the guidewire 11 is in the housing. Size. The guide wire 11 passes around the pulley 98 and is attached to the housing with the attachment 40a. The biasing member 12a is an alternative to the biasing member 12. As the guide wire 11 moves forward as shown in FIG. 26A, the biasing member 12a extends. At the time of release, the pulley 98 moves to the proximal side in the housing 1 as shown in FIG. 26B. The movement of the pulley to the proximal side is the driving force of the retraction procedure used to retract the needle 8 and guide wire 11 as described above. The reference numerals used according to the above-described parts exhibit the same function in the present embodiment.

  27A-27E show multiple cross-sectional views of the distal end of the access needle 8 provided for use with the guidewire channel 54. In these embodiments, guidewire channel 54 is supported by access needle 8. In one embodiment, guidewire 54 is a suitably sized needle that is attached to access needle 8 using a suitable connection or adhesive technique. The diameter of the guidewire channel is less than half the length of the access needle diameter in one embodiment. In other embodiments, the guidewire channel diameter ranges from 0.016 inches to 0.028 inches. In other embodiments, the access needle is a standard sized market available needle and the guidewire channel is a large gauge needle available on the standard sized market. For example, if the access needle is a standard 17 gauge needle (0.058 inch diameter), the gauge wire channel is a large gauge needle, such as 18 gauge to 27 gauge. In other embodiments, the gauge wire channel is a standard gauge needle selected to accommodate the guide wire 11. For example, a 27-20 gauge needle (diameter ranging from 0.016 to 0.035 inches) may be used for a 0.008 inch diameter guidewire depending on the desired spacing size. In other configurations, the inner diameter of the guidewire channel is about twice the diameter of the guidewire in channel 54.

  In the following embodiment, the side of the needle having the distal end 45 indicates the bottom of the needle, and the side faces the surface as the top of the needle. FIG. 27A shows an embodiment where the guidewire channel 54 is on top of the needle 8. Guidewire 11 remains in guidewire channel 54. In this embodiment, the guidewire may be advanced proximally and distally without passing through the access needle lumen 46 or within the access needle lumen 46.

  FIG. 27B shows an embodiment where the guidewire channel 54 is at the bottom of the needle 8. Guidewire 11 remains in guidewire channel 54. In this embodiment, the guidewire may be advanced proximally and distally without passing through the access needle lumen 46 or within the access needle lumen 46. FIG. 27B1 shows an alternative embodiment where the guide channel 54 is a needle with a distal end 57 positioned in the vicinity of the access needle distal end 45.

  FIG. 27C shows an embodiment where the guidewire channel 54 is on top of the needle 8 in the needle lumen 45. In the present embodiment, the length of the guidewire channel 54 is shorter than the access needle lumen. The access needle includes a port 58 on the side wall of the needle distal to the end of the guidewire channel and proximal to the distal end of the needle. The guide wire is discharged from the end of the guide wire channel through port 58 into the blood vessel. The guidewire 11 remains in the guidewire channel 54 for most of the length of the access needle lumen.

  FIG. 27D shows an embodiment where the guidewire channel 54 is on top of the needle 8. In the present embodiment, the length of the guidewire channel 54 is shorter than the length of the access needle lumen. The access needle includes a port 58 on the needle sidewall at the end of the guidewire channel and proximal to the distal end of the needle. The guide wire is discharged from the end of the guide wire channel through port 58 and into the access needle lumen 46. The guidewire 11 remains in the guidewire channel 54 for most of the length of the access needle lumen.

  FIG. 27E shows an embodiment where the guidewire channel 54 is on top of the needle 8 in the needle lumen 45. In contrast to FIG. 27C, the access needle does not include the needle sidewall port 58. Referring to FIG. 27C, the length of the guidewire channel 54 is shorter than the length of the access needle lumen. However, instead of discharging the needle lumen, the distal side of the end of the guidewire channel opens into the needle lumen proximal to the distal end of the access needle. The guide wire is discharged from the end of the guide wire channel through the needle lumen end to the blood vessel V. As in the previous embodiment, the guidewire 11 remains in the guidewire channel 54 for most of the length of the access needle lumen, but does not exit the guide channel, and the implementation of FIGS. 27A, 27B and 27B1. It enters the blood vessel directly like a form.

  Although described as using one button for automatically retracting both the guidewire and the needle in one action, one of the guidewire or the needle may be manually retracted from the blood vessel. In other alternative forms, both the guidewire and the needle are manually retracted. In one embodiment of the present embodiment, the biasing member 12 shown in FIG. 10A may be removed, and the needle support portion 29 may be attached to the second handle. In the present embodiment, the retraction of the needle is executed by moving the second slider attached to the proximal end side of the needle while the needle is in the housing interior 34. Furthermore, the device may be adapted so that the handle 9 can be used for manually pulling the guidewire separately or in a needle retraction procedure.

  The catheter insertion device described above may be used to perform many different methods of introducing a catheter into a blood vessel. An example of a basic method includes three steps. First, a guide wire substantially contained within the housing is inserted into the blood vessel. The catheter is then advanced along the guide wire into the blood vessel. Finally, the guide wire is drawn completely from the blood vessel into the housing.

  The basic method may include other steps. In an alternative form, the guidewire is advanced into the needle along the needle inserted into the blood vessel before performing the insertion step. In another alternative, the guidewire is advanced outside the needle along the needle inserted into the blood vessel prior to performing the insertion step. In yet another alternative, the guidewire is advanced in the hide wire channel before entering the blood vessel. In yet another form, after the insertion step, while in the access needle, or after exiting the guidewire channel, the guidewire is coiled in the blood vessel.

  Other different or improved method steps may be performed. In some forms, the retraction step is performed manually, and other forms of retraction are performed automatically. In an alternative form, the step of retracting is performed by releasing the biasing member to fully retract the guidewire into the housing. In another form, releasing the biasing member also retracts the needle that fully supports the guidewire to the housing. In an alternative form, the retraction step or retraction procedure is initialized by pressing a button. In a further form, the step of inserting a needle attached to the housing into the blood vessel is performed prior to the step of inserting the guide wire. One additional optional step also includes using a backflow indicator near the distal end of the needle to determine that the needle has entered the blood vessel after the needle insertion step. In other forms, the method may include moving the handle attached to the guide wire proximally prior to the insertion step.

  Each of the patent specifications, patents and references mentioned herein is hereby incorporated by reference in its entirety. In addition, U.S. Pat. No. 4,747,831, U.S. Pat. No. 4,509,945, U.S. Pat. No. 4,900,307 and U.S. Pat. No. 5,749,371 are hereby incorporated by reference in their entirety.

  Although the present invention has been described herein with reference to exemplary embodiments and best modes for carrying out the invention, many improvements, improvements and combinations of various embodiments, applications and derivatives have been described herein. What can be done without departing from the spirit and scope of the invention is naturally contemplated by those skilled in the art. For example, all dimensions and materials included in the specification or drawings are intended only as examples of presently preferred embodiments and are not intended to limit the scope of the invention.

Claims (78)

A housing having an internal space;
An access needle that can slide relative to the internal space;
A guide wire supported by the access needle and movable relative to the access needle;
A handle attached to the guide wire movable relative to the housing to move the guide wire relative to the internal space;
A catheter insertion device comprising: a restraining member attached to the handle to limit movement of the guide wire relative to the access needle. The catheter insertion device according to claim 1, wherein the restraining member attached to the handle restricts the guide wire from moving proximally relative to the access needle. The catheter insertion device according to claim 1, wherein the access needle includes a blood backflow display portion in a portion extending beyond the housing of the access needle. The catheter insertion device according to claim 1, wherein the access needle includes a blood backflow display unit that visualizes at the distal end of the access needle when the access needle is positioned in the catheter. The catheter backflow device according to claim 4, wherein the blood backflow display unit includes an opening in a side wall portion of an access needle end portion. The catheter insertion device according to claim 1, further comprising an urging member and a release button that are designed to automatically retract one or both of the guide wire and the access needle. The catheter insertion device according to claim 6, wherein the urging member and the release button are designed and applied so that the guide wire and the access needle are simultaneously drawn into the internal space. The catheter insertion device according to claim 6, wherein the urging member and the release button are designed and applied so as to sequentially retract the guide wire and the access needle. Furthermore, the restraining member in the internal space restricts the movement of the access needle or the guide wire toward the distal side in the internal space. The restraining member restricts movement of the access needle or guide wire to the distal side after the access needle or guide wire is retracted into the internal space after being used to insert the catheter. Such a catheter insertion device. The catheter insertion device according to claim 9, wherein the restraining member restricts movement of the access needle or the guide wire toward the distal side so that the access needle and the guide wire are completely drawn into the internal space. The catheter insertion device according to claim 1, wherein the internal space is designed with dimensions to include all of the guidewire and access needle after catheter insertion. The guide wire includes a first portion having a first diameter, a reduced portion,
A catheter insertion device according to claim 1, further comprising a second portion having a second diameter smaller than the first diameter. The catheter insertion device according to claim 13, wherein the first diameter and the second diameter are smaller than the inner diameter of the access needle. The distal portion of the second portion includes one or more full-radius distal portions, a hemispherical portion of the same material as the guidewire, and a hemispherical portion of a material different from the guidewire or distal end having approximately the same size as the first diameter. The catheter insertion device according to claim 13, comprising: The catheter insertion device according to claim 1, wherein the guide wire has a braided structure. A guide channel in the housing for restricting the movement of the handle, and a holding channel in the vicinity of the guide channel;
The catheter insertion device according to claim 1, wherein the holding channel is provided to prevent movement of the handle when the handle is in the holding channel. The catheter insertion device according to claim 17, wherein the restraining member prevents movement of the guide wire to the proximal end side, and the holding channel prevents movement of the guide wire to the distal side. The catheter insertion device according to claim 1, further comprising a pulley that is provided so as to easily move the guide wire into the internal space and is fixed in the internal space. A housing having an internal space;
An access needle having a distal end, a proximal end, and an inner wall forming a lumen extending from the distal end to the proximal end;
An access needle that is slidable with respect to the internal space;
An access needle sidewall opening communicating with the access needle lumen;
A catheter insertion device comprising a guide wire supported by an access needle. The catheter insertion device according to claim 20, further comprising a restraining member attached to the guide wire and provided to prevent the guide wire from moving to the opening. Further comprising a restraining member attached to the guide wire;
21. When the guide wire is disposed on the distal side of the opening in the access needle, the restraining member restricts movement toward the proximal end of the guide wire toward the opening. The catheter insertion apparatus which concerns on this. The catheter insertion device according to claim 20, wherein the access needle lumen has a cross-sectional shape that maintains the directionality of the guide wire relative to the access needle lumen. The catheter insertion device according to claim 20, wherein the access needle lumen has a non-circular cross-sectional shape. The catheter insertion device according to claim 20, wherein the access needle lumen has an elliptical cross-sectional shape. 21. A catheter insertion device according to claim 20, wherein a mechanism is formed in the access needle sidewall to maintain the guidewire orientation relative to the access needle lumen. 27. The catheter insertion device according to claim 26, wherein the mechanism is a groove. 21. The catheter insertion device according to claim 20, wherein the opening of the access needle side wall is positioned proximal to the distal end of the access needle. The catheter insertion device according to claim 20, wherein the opening of the side wall of the access needle is positioned more distally than the distal end of the housing. The catheter insertion device according to claim 20, wherein the access needle restrains the guide wire in a non-coiled shape within the access needle. The catheter insertion device according to claim 20, wherein the guide wire is coiled in the access needle. The catheter insertion device according to claim 31, wherein the guide wire has a coil shape that is at least half-rotated in the access needle lumen. The catheter insertion device according to claim 31, wherein the guide wire has a coil shape of one or more rotations in the access needle. The catheter insertion device according to claim 20, wherein the guide wire is in the access needle. The catheter insertion device according to claim 20, wherein the guide wire is parallel to the access needle. The catheter insertion device according to claim 20, further comprising a guide wire channel supported by the access needle. A housing having an internal space and a long axis;
A mechanism at the end of the housing that, when engaged with the catheter, offsets the housing long axis from the catheter long axis;
An access needle that passes through the mechanism and is attached to the needle holder,
The needle holder is slidable with respect to the internal space,
The catheter insertion device, wherein the access needle is slidable relative to the mechanism. 38. Catheter insertion according to claim 37, wherein when the mechanism at the end of the housing is engaged with the catheter, the housing long axis is offset from the catheter long axis so as to form an angle of less than 180 degrees. apparatus. The catheter insertion device according to claim 37, wherein when the mechanism at the end of the housing engages with the catheter, the housing long axis is offset from the catheter long axis so as to form an angle of less than 60 degrees. . The catheter insertion device according to claim 37, wherein when the mechanism at the end of the housing is engaged with the catheter, the housing long axis is offset from the catheter long axis so as to form an angle of less than 45 degrees. . The catheter insertion device according to claim 37, further comprising a guide wire supported by the access needle and movable relative to the access needle. The catheter insertion device according to claim 41, further comprising a handle attached to the guide wire movable relative to the housing in order to move the guide wire relatively to the internal space. 43. The catheter insertion device according to claim 42, further comprising a restraining member on the handle to limit movement of the guide wire relative to the access needle. The catheter insertion device according to claim 41, wherein when the access needle and the guide wire are drawn into the internal space, the guide wire and the access needle are drawn substantially parallel to the long axis of the housing. The catheter insertion device according to claim 41, wherein the guide wire is disposed in the access needle. The catheter insertion device according to claim 41, wherein the guide wire is parallel to the access needle. A housing having an internal space;
An access needle that can slide relative to the internal space;
A guide wire supported by the access needle and movable relative to the access needle;
A handle attached to the guide wire,
As a result of the limited movement of the handle, at least a portion of the guide wire always remains in the interior space. 48. The catheter insertion device according to claim 47, further comprising an applied biasing member designed to move the needle holder toward the proximal side in the internal space when released. 49. The catheter insertion device according to claim 48, wherein the urging member is designed and applied so as to move the guide wire to the proximal side in the internal space when released. 49. The catheter insertion device according to claim 48, wherein the biasing member is designed and applied such that it moves the needle upon release so that the needle is completely within the interior space. 50. The catheter insertion device according to claim 49, wherein the biasing member is designed and applied so that the guide wire is moved so that the entire length of the guide wire is completely within the internal space. . Furthermore, when the access needle or the guide wire moves to the proximal end side from the restraining device, the restraining member is provided in the inner space that restricts the movement of the access needle or the guide wire in the inner space to the distal end. 48. A catheter insertion device according to claim 47. The catheter insertion device according to claim 47, wherein one end of the guide wire is fixed to the housing. The catheter insertion device according to claim 47, wherein one end of the guide wire is constrained to the internal space when the guide wire exceeds the distal end portion of the access needle. The catheter insertion device according to claim 47, wherein the guide wire is disposed in the access needle. The catheter insertion device according to claim 47, wherein the guide wire is disposed in parallel with the access needle. Inserting a guide wire substantially contained within the housing into the blood vessel;
Advancing the catheter along the guide wire into the blood vessel;
A method of inserting a catheter into a blood vessel, comprising: drawing a guide wire from the blood vessel completely into the housing. 58. A method of inserting a catheter into a blood vessel according to claim 57, further comprising advancing a guide wire along a needle inserted into the blood vessel prior to performing the insertion step. 58. A method of inserting a catheter into a blood vessel according to claim 57, further comprising advancing a guide wire along a needle inserted into the blood vessel prior to performing the insertion step. 58. The method of inserting a catheter into a blood vessel according to claim 57, further comprising coiling a guide wire in the blood vessel after the insertion step. 58. The method of inserting a catheter into a blood vessel according to claim 57, wherein the retracting step is performed manually. 58. The method of inserting a catheter into a blood vessel according to claim 57, wherein the step of retracting is performed automatically. 63. A method of inserting a catheter into a blood vessel according to claim 62, wherein the step of retracting is performed by opening the biasing member to retract the guidewire completely into the housing. 64. A method of inserting a catheter into a blood vessel according to claim 63, wherein releasing the biasing member retracts the needle supporting the guide wire completely into the housing. 63. A method of inserting a catheter into a blood vessel according to claim 62, wherein the step of retracting is initiated by pressing a button. 58. The method of inserting a catheter into a blood vessel according to claim 57, wherein a needle attached to the housing is inserted into the blood vessel prior to the step of inserting the guide wire. 68. The blood vessel catheter according to claim 66, further comprising using a backflow indicator near the distal end of the needle to determine that the needle has inserted the blood vessel after the step of inserting the needle. How to insert. 58. The method of inserting a catheter into a blood vessel according to claim 57, further comprising moving a handle attached proximally of the guide wire prior to the insertion step. A housing having an internal space;
An access needle that is slidable with respect to the internal space;
A guidewire channel attached to the access needle;
A guide wire supported by the guide wire channel and movable relative to the guide wire channel;
A handle attached to the guide wire,
A catheter insertion device, wherein a guide wire moves relative to a support channel by moving a handle. 70. The catheter insertion device of claim 69, wherein the movement of the handle is limited so that at least a portion of the guidewire always remains in the interior space. 70. The catheter insertion device of claim 69, further comprising a biasing member and a release button designed and applied to automatically retract one or both of the guidewire and access needle. 70. The catheter insertion device according to claim 69, further comprising a restraining member in the inner space that restricts movement of the access needle or guide wire in the inner space toward the distal side. 70. The catheter insertion device of claim 69, wherein the distal end of the guidewire channel is adjacent to the distal end of the access needle. 70. The catheter insertion device of claim 69, wherein the guidewire channel is on top of the access needle. 70. The catheter insertion device of claim 69, wherein the guidewire channel is at the bottom of the access needle. 70. The catheter insertion device of claim 69, wherein the guidewire is discharged from the distal end of the guidewire channel without passing through the access needle lumen. 70. The catheter insertion device of claim 69, wherein the guidewire is expelled from the distal end of the guidewire channel through a portion of the access needle lumen. 70. The catheter insertion device of claim 69, wherein the guidewire channel is attached to an access needle in the access needle lumen.

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