Midline catheter placement device

Abstract

A catheter insertion device (10) is provided for positioning and inserting a catheter (14), particularly a midline catheter, into a patient. The insertion device (10) includes an introducer needle (18) extending from a distal end of the catheter during insertion. A manually operated actuator assembly (20) is movable relative to a housing for deploying the catheter (14) over the distal end of the introducer needle (18). Stepwise movement of the actuator (20) advances the catheter (14) over the introducer needle (18) in stages. A shuttling or indexing mechanism (60, 76) advances the catheter and prevents retraction of the catheter after deployment.

Description

[0001] This application is a divisional application of the Chinese patent application with international application number PCT / US2018 / 022780, Chinese application number 201880018669.X, application date March 16, 2018, and name “Midline Catheter Placement Device”.

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application claims priority to U.S. Provisional Patent Application Serial No. 62 / 472,984, filed on March 17, 2017, which is incorporated herein by reference in its entirety. Technical Field

[0004] The present invention is in the field of catheter devices for delivering drugs or medicines to patients. In particular, the present invention relates to a catheter insertion device that can be operated in a manner that improves the efficiency of catheter insertion into a patient's body. In particular, the present invention relates to a catheter insertion device that can be operated with one hand. Background Art

[0005] Midline catheters are commonly used for parenteral nutrition, IV fluid replacement, and administration of analgesics and antibiotics. Midline catheters are inserted at the bedside using aseptic technique and can remain in place for several weeks. Insertion (venipuncture) is performed in the cephalic, basilic, or brachial veins above and below the antecubital fossa. The catheter tip is advanced 3 inches to 8 inches, where the tip terminates below the axilla and proximal central vein.

[0006] Potential advantages of midline catheters are reduced frequency of repeat venipunctures for labs / restarts, reduced incidence of catheter-related infections, extended implant / indwelling duration, improved clinical outcomes, patient satisfaction, and associated cost savings. Improved drug delivery therapy and hemodilution are provided by placing the catheter tip in a larger diameter vein in the upper arm compared to a smaller vein. Midline catheters can be used to infuse infectious agents at higher flow rates, which is typically accomplished through a CV catheter such as a PICC application.

[0007] Existing midline catheter devices typically include an integral guidewire. After the needle enters the vein, the guidewire is advanced through the lumen of the needle and into the vein. Typically, an ultrasound probe or imaging device is used to position the needle in the desired location. The catheter is then advanced over the guidewire into the vein. The needle and guidewire are then disengaged and separated from the catheter, which remains in place in the vein.

[0008] Existing devices typically require the guidewire to be fully deployed by moving the sliding member to a locked / braked position. To advance the catheter, the clinician must put down the ultrasound probe and use both hands to advance the catheter and complete the final steps of the procedure. This results in compromised visualization of the vein and positioning of the catheter relative to the vein.

[0009] Catheter placement and advancement depends on holding the device in a static position with one hand while the other hand manipulates the catheter advancement mechanism without the use of ultrasound imaging to aid in proper catheter placement. Once the catheter is fully advanced, the clinician must reposition the ultrasound probe to reestablish the image and confirm proper placement of the catheter. This maneuver requires a series of sequential steps with specialized training. The additional change of hand position from ultrasound probe to device and back to probe adds complexity to the procedure and can compromise proper catheter placement.

[0010] Early methods for placing midline catheters were similar to PICC placement. The Seldinger technique uses a needle, dilator, guidewire, and sheath or catheter to access the vessel and ultimately place the catheter into the vessel. The modified Seldinger technique couples the dilator and sheath components together. While providing some benefits, potential risks remain, such as penetration of the posterior vessel wall, air embolism during component replacement, component contamination, bloodstream infection, excessive bleeding, blood splatter contamination, needlestick injury, and loss of cannulation access or guidewire loss.

[0011] The accelerated Seldinger technique is a more recent method that combines four components into a single unit. This results in a reduction in the number of component changes and exposure to air events, thereby reducing potential contamination and shortening the time required to complete the procedure.

[0012] While existing devices are generally suitable for their intended use, there remains a need for improved devices for controlling penetration of a cannula to deliver a drug or medication. Summary of the invention

[0013] The present invention relates to a catheter insertion device for placing an IV catheter at a selected location in a patient's body, wherein the risk of the device moving relative to the selected location on the patient during insertion is reduced. In one embodiment, a midline catheter and a catheter insertion device are provided for inserting and placing the catheter in a vein or artery of a patient. The catheter insertion device is capable of placing the catheter in the selected location and enables the removal of the introducer needle with a reduced risk of catheter movement during the procedure. The catheter of the catheter insertion device of the present invention does not require a guide wire to be inserted into the patient's body prior to inserting the catheter.

[0014] A midline catheter insertion device provides improved ergonomics and one-handed functionality. The catheter insertion device of the present invention provides one-handed advancement of a catheter while enabling the clinician to operate an ultrasound probe to obtain an image of a target vessel. One-handed operation of the catheter insertion device enables the ultrasound probe to be held in one hand to provide visualization of catheter advancement while the insertion device is held in the other hand.

[0015] In one embodiment, the catheter insertion device includes a housing for supporting a catheter and an introducer needle for positioning the catheter at a selected location in a patient's body. The insertion device enables the catheter to slide forward on the fixed introducer needle to position the catheter in a vein or artery, and then the introducer needle is retracted from the catheter. The insertion device avoids the need for a guide wire as in existing devices.

[0016] In one embodiment, the catheter insertion device includes a housing that accommodates a catheter adapter, the catheter adapter having a catheter extending from one end of the catheter adapter and extending from the distal end of the housing. An introducer needle is fixed in the housing and extends through the catheter and extends from the distal end of the catheter to help insert the catheter into the patient. An actuator is operably connected to the housing for moving the catheter forward to slide on the end of the introducer needle. The catheter and the catheter adapter can be released from the housing, and the introducer needle is retracted from the proximal end of the catheter and the catheter adapter to separate the insertion device from the catheter after insertion.

[0017] In one embodiment, the insertion device includes a housing having a sliding actuator that can be operated by a user to slide the actuator in a longitudinal direction relative to the longitudinal dimension of the housing. A movable catheter and a fixed guide needle are disposed within the housing. The actuator is operably connected to the catheter, whereby sliding movement of the actuator in a longitudinal direction toward the distal end of the housing causes the catheter to slide forward on the guide needle. The actuator is configured to move the catheter forward in incremental steps by sliding the actuator back to its original position and then sliding forward again. The actuator can be comfortably and conveniently used by an operator using a single hand.

[0018] The catheter insertion device of the present invention is configured to be held and operated with one hand and to advance the catheter over the introducer needle by single-handed operation. The catheter insertion device is suitable for use while the user holds the ultrasound probe in one hand to position the catheter at a selected position and the other hand can hold and operate the catheter insertion device.

[0019] According to one embodiment, the catheter insertion device includes a housing for housing a catheter, an introducer needle for the catheter, and a shuttle or indexing assembly and mechanism for deploying the catheter relative to the introducer needle. The shuttle mechanism is manually operated using one hand while the insertion device is held in a stable position relative to the patient. The shuttle mechanism is capable of deploying the catheter from a retracted position to an extended position in a stepwise manner. Once the catheter is deployed, the catheter and catheter adapter can be released from the distal end of the housing so that the introducer needle can be withdrawn from the catheter. A needle shield or cover can be deployed on the end of the withdrawn introducer needle to prevent accidental needle sticks.

[0020] The various aspects and features of the present invention are achieved by providing a catheter insertion device, which includes a housing, a catheter and a catheter seat, an introducer needle and an actuator. The housing has a longitudinal axis with a distal end and a proximal end. The catheter seat and the catheter are contained in the housing, wherein the catheter extends from the distal end of the housing. The introducer needle is fixed relative to the housing and is contained in the catheter and protrudes from the distal end of the catheter. The actuator is coupled to the housing for advancing the catheter relative to the housing and the introducer needle by movement of the actuator.

[0021] The features of the present invention are further realized by providing a catheter insertion device, which includes: a housing having a longitudinal axis including a distal end and a proximal end; a catheter and a catheter seat; an introducer needle; and an actuator assembly. The catheter has a proximal end connected to the catheter seat and a distal end for insertion into a patient's body. The catheter and the catheter seat are positioned in the longitudinal passage of the housing and can be moved from a retracted position relative to the proximal end of the housing to a second position toward the distal end of the housing. The introducer needle is fixed in the housing and extends through the lumen of the catheter, wherein when the catheter is in the first position, the introducer needle protrudes from the distal end of the catheter. In one embodiment, the actuator assembly includes a movable actuator that is coupled to the housing and can be moved in a longitudinal direction relative to the housing and is operably connected to the needle seat. The movable actuator is capable of gradually deploying the catheter relative to the introducer needle.

[0022] Features of the present invention are also provided by an actuator for a catheter insertion device, wherein the actuator includes a shuttling or indexing mechanism to advance the catheter from the distal end of the housing. The catheter and catheter adapter can be released from the housing, and the introducer needle can be removed and discarded.

[0023] The various features of the present invention are further achieved by providing a method for inserting a catheter into a patient using a catheter insertion device. A catheter having an introducer needle protruding from a distal end of the catheter is inserted into a desired location in the patient. An actuator on the insertion device is manually manipulated to slide the catheter in a distal direction relative to the device and the introducer needle to position the distal end of the catheter in the patient, wherein the distal end of the introducer needle is positioned within the catheter. The catheter and the catheter hub are separated from the housing of the device, and the introducer needle is retracted from the catheter.

[0024] It will be understood that each preferred or optional feature of the various embodiments may be combined with other features, and features described in conjunction with one or more specific features may also be combined with one or more other features of other embodiments.

[0025] These and other features of the present invention will become apparent from the following detailed description of the invention, which, taken in conjunction with the annexed drawings, discloses various embodiments of the invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] The following is a brief description of the accompanying drawings, in which:

[0027] Figure 1 is a perspective view of a catheter insertion device showing an actuator in a starting position;

[0028] Figure 2 The actuator is shown in the forward actuated position. Figure 1 A perspective view of a catheter insertion device;

[0029] Figure 3 yes Figure 1 A side view of a housing half of a catheter insertion device of FIG. 1 , showing a catheter and a catheter hub in an initial starting position, wherein an introducer needle extends from a distal end of the catheter;

[0030] Figure 4 yes Figure 3 A side view of a housing half of a catheter insertion device showing the actuator moved to an actuated position and the catheter advanced within the housing;

[0031] Figure 5 yes Figure 3 A side view of a catheter insertion device showing the actuator moving back to an original position while the catheter remains in an advanced position;

[0032] Figure 6 is a perspective exploded view showing the catheter and needle shield separated from the housing;

[0033] Figure 7 is a cross-sectional side view of a safety component of a needle insertion device in one embodiment;

[0034] Figure 8 is a perspective view of a fixture for a safety assembly;

[0035] Fig. 9 is a cross-sectional side view showing a partially withdrawn introducer needle;

[0036] Fig.10 is a cross-sectional side view showing the introducer needle withdrawn from the blood control valve;

[0037] Fig.11 is a cross-sectional perspective view showing the introducer needle being withdrawn to actuate the resilient clamp; and

[0038] Fig.12 is a cross-sectional perspective view showing the catheter adapter separated from the safety assembly. DETAILED DESCRIPTION

[0039] A catheter insertion device is provided for positioning a catheter in a patient's body in order to deliver a drug or other substance to the patient. The terms "needle" and "cannula" are used interchangeably herein to refer to a member having a sharp or angled end that is used to be inserted into an injection site of a subject. In one embodiment, the needle can be a thin hollow tubular member. The distal end refers to the end of the device facing the patient, and the proximal end refers to the opposite end away from the patient. As used herein, the "distal" direction is the direction toward the patient and the injection site, and the "proximal" direction is the opposite direction. "Axial" means along or parallel to the longitudinal axis of the needle, and the "radial" direction is the direction perpendicular to the axial direction. The forward direction is the direction toward the distal end of the device.

[0040] Unless expressly indicated to the contrary, the present invention may adopt various alternative variations. It should also be understood that the specific devices shown in the drawings and described in the following specification are exemplary embodiments of the present invention. The specific dimensions and other physical characteristics related to the embodiments disclosed herein should not be considered as limitations. These embodiments are not intended to be mutually exclusive, so that the features of one embodiment can be combined with other embodiments as long as they do not contradict each other.

[0041] The present embodiment relates to a catheter insertion device for inserting and positioning a catheter in a patient. These embodiments are particularly suitable for use with a midline catheter, which can be used in conjunction with an ultrasonic imaging device to help position the device at a selected position and selected depth in the patient. The catheter can be a conventional length and a conventional diameter. The catheter insertion device 10 of the present invention basically includes a body or housing 12, a catheter 14 with a catheter seat 16, an introducer needle 18, and an actuator assembly 20. The actuator assembly 20 forms a shuttle or indexing assembly and mechanism to index and advance on the end of the needle 18.

[0042] See also Figure 1 and 2 The housing 12 of the insertion device 10 has a longitudinal dimension including a distal end 22 and a proximal end 24. In the illustrated embodiment, the housing 12 is formed of two housing halves that are connected together by a suitable attachment mechanism. Figure 3As shown, the half bodies are aligned with the pin protruding from the first half body and the corresponding recess 13 on the other half body. The housing 12 has a size for supporting the guide needle 18 and the catheter 14 during use and enables the user to manipulate the device for positioning the catheter. The housing has a cavity 50 forming a longitudinal passage. In the embodiment shown, the housing 12 has a curved side wall 26, a flat top wall 28, and a flat bottom wall 30. The flat bottom wall is usually provided to allow the device to be placed in a stable position on a flat surface, and the stable position has a reduced risk of falling from the surface. The shape of the device can be changed according to the specific use to provide the operator with comfortable and convenient use.

[0043] In the illustrated embodiment, an elongated opening 32 is formed in the top wall 28 for receiving the actuator assembly 20. A tip 34 having converging sides defines the distal end 22 of the housing. Figure 6 As shown, two hinged walls 36 of the tip 34 are pivotally connected to the wall 26 by corresponding hinges 38 to access the interior of the housing and allow the catheter to be removed from the housing, as discussed in further detail below. An exit opening 40 in the tip 34 allows the catheter and the introducer needle to extend from the distal end of the housing during use. The converging surfaces of the tip 34 allow the device to be positioned at a small angle relative to the patient's skin to assist in inserting the catheter 14 and the introducer needle 18 into the patient's body while reducing the risk of kinking or folding of the catheter 14.

[0044] See also Figure 3 , 7 8-12, the catheter 14 is shown extending from the catheter hub 16, which is assembled in the housing 12 and slides in the housing 12. The catheter hub 16 has a distal end 42 connected to the catheter 14 and a proximal end 44 having a collar 45. The proximal end 44 is connected to the body 47 of the needle safety assembly 46. The body 47 is a movable body or a body that can slide in the housing 12, and is interchangeably referred to as the body 47 herein. Figure 6 In the illustrated embodiment, catheter hub 16 has a radially extending collar 45 at the proximal end for coupling with a Luer connector during use. Figure 7 A flexible seal 48 forming a valve as shown in FIG is provided at the distal end of the catheter adapter 16 for closing the end and preventing leakage when the introducer needle is removed from the catheter adapter. The flexible seal 48 may be a rubber member or septum with a slit for allowing the introducer needle 18 to pass therethrough and close when the introducer needle is removed. A standard Luer connector may be coupled to the proximal end of the catheter adapter 16 so that an actuator opens the valve to allow delivery of a substance or withdrawal of a fluid from the patient.

[0045] The catheter 14 can be a common catheter and has a size commonly used in the art. For example, the catheter can be 18 or smaller, 20, 22, 24 or 26. In one embodiment, the catheter can have a length of about 3 inches, but other lengths can also be used.

[0046] Figures 3 to 6 The introducer needle 18 in the embodiment shown in FIG. 1 is hollow and has a proximal end 52 secured within a cavity 50 of the housing 12 by a post 54 or other support member and a proximal end 52 secured within a cavity 50 of the housing 12 by a post 54 or other support member. Figure 3 and 7 The distal end 56 shown in FIG. 4 extends from the distal end of the housing through the opening 40. Figure 1 As shown, the guide needle 18 extends a distance from the distal end of the housing so that it can be properly inserted into the patient's body. The distal end of the catheter 14 is spaced apart from the distal end of the guide needle 18 toward the proximal end in the initial position, so that the guide needle 18 extends beyond the distal end of the catheter 14, as shown in FIG. Figure 7 In the illustrated embodiment, the distal end 56 of the introducer needle 18 has an angled and sharpened tip as is known in the art for piercing the skin and inserting into a patient's body.

[0047] The body 47 of the safety assembly 46 in the illustrated embodiment is housed within the longitudinal passage of the cavity 50 of the housing 12 and is coupled to the catheter adapter 16 during use and is detached after the catheter 14 is inserted into the patient. Figures 3 to 5 In the illustrated embodiment, the safety assembly 46 defines a shield to cover the distal end of the introducer needle after use. During deployment of the catheter 14 relative to the introducer needle 18, the safety assembly 46 and the body 47 are able to move or slide within the housing 12.

[0048] In the illustrated embodiment, the wall 30 of the housing 12 includes at least one tab 60 that allows the safety assembly 46 and the catheter to move or slide toward the distal end 22 of the housing 12 and prevents the safety assembly 46 from moving or sliding back toward the proximal end 24 of the housing 12. In one embodiment, a tab 60 is provided as Figures 3 to 5The plurality of tabs 60 shown, each tab is formed in an inclined manner and protrudes into the center of the opening of the housing and toward the distal end 22 of the housing 12. In one embodiment, the tab 60 is formed integrally with the wall 30. In the embodiment shown, the tab 60 is biased inwardly toward the central axis of the housing 12 and can be bent or deformed and returned to the original position due to the forward movement of the main body 47 of the safety component 46 on the tab to help slide toward the distal end of the housing 12 and resist moving back toward the proximal end of the housing 12. In one embodiment, the flexible tab 60 allows the main body 47 of the safety component 46 to slide on the main body 47 of the safety component 46. In other embodiments, the tab 60 can be rigid. The housing 12 can be made of a molded plastic material to provide the tab 60 with resilience for bending and returning to the original position.

[0049] In one embodiment of the present invention, a series or plurality of tabs 60 are provided on the wall 30 and are angled toward the distal end of the housing, such as Figure 3 -5. Tabs 60 are spaced substantially uniformly along the length of the housing to limit the travel length of the body 47 of the safety assembly 46 and the catheter 14 within the housing 12. The spaced tabs 60 form part of a ratchet, shuttle or indexing assembly or mechanism for moving the catheter 14 from Figure 3 The first starting position shown is advanced toward the distal end of the housing 12. Figure 5 The second extended position is shown. The tab 60 has a distal end 62 that engages a surface 64 on the safety component 46, which prevents the body 47 of the safety component 46 from moving or sliding back toward the proximal end of the housing. The body 47 can slide on the tab 60 by the forward movement of the body, wherein the tab rebounds to the original position to prevent the body from moving toward the proximal end of the housing.

[0050] The actuation assembly 20 is disposed in the housing 12 to engage the body 47 of the safety assembly 46 to advance the body 47 and the catheter 14 toward the distal end 22 of the housing 12 after positioning the introducer needle 18 and the catheter 14 in a selected position of the patient. The actuation assembly 20 forms a ratchet, shuttle or indexing assembly for advancing or indexing the catheter relative to the needle 18. In the illustrated embodiment, the actuation assembly 20 includes an actuator body 66 located within the housing 12 and between the wall 28 and the body 47 of the safety assembly 46. A finger-operated button 68 is connected to the actuator body 66 by a connecting member 70 that extends through the elongated opening 32 in the wall 28 and slides therein. The button 68 is oriented on the outer surface of the top wall 28 for being accessed by an operator.

[0051] As shown, the actuator body 66 has a longitudinal length complementary to the longitudinal length of the housing 12 to slide and reciprocate within the cavity of the housing 12. In the illustrated embodiment, the actuator body 66 has a substantially flat planar configuration having a proximal end 72 and a distal end 74. The distal end 74 has a guide pin 75 that slides in a slot 77 in the wall 26. In the illustrated embodiment, a button 68 is connected to the distal end 74 of the actuator body 66 for ease of use by the operator. In other embodiments, the button 68 may be located at other suitable locations on the length of the actuator body 66 and the housing 12.

[0052] The actuator body 66 of the actuator assembly 20 includes at least one tab and typically a plurality of tabs 76 for engaging the body 47 to advance the body 47 and the catheter 14 in a stepwise manner toward the distal end of the housing by the reciprocating motion of the body 47. The tabs 76 form a ratchet mechanism for advancing and indexing the body 47 toward the distal end of the housing. The actuator body can be made of a suitable plastic material. In the illustrated embodiment, the tab is formed with a base plate 79 that is attached to the face of the actuator body 66. In one embodiment, the base plate 79 and the tabs 76 can be made of metal or plastic. In other embodiments, the tabs 76 can be integrally formed with the actuator body 66. In one embodiment, the actuator body 66 can be made of plastic.

[0053] In the illustrated embodiment, the tab 76 is obliquely formed in a manner complementary to the tab 60. The tab 76 extends from the actuator body 66 and protrudes toward the central axis of the housing 12 and toward the distal end 22 of the housing 12. The tab 76 in the illustrated embodiment is generally flexible so as to be able to slide on the body 47 of the safety assembly 46. The distal end 78 of the tab 76 is biased inwardly toward the central axis of the housing and elastically returns to the original orientation after sliding on the body 47 of the safety assembly 46. The plurality of tabs 76 form a ratchet, shuttle and indexing mechanism and are oriented to move the catheter 14 and the safety assembly 46 toward the distal end of the housing. In other embodiments, the tab 60 can be manufactured as one or more components. The button 68 and the actuator 66 can also be manufactured as one or more components.

[0054] In use, the distal end 56 of the introducer needle 18 extends from the catheter 14, and the catheter 14 is positioned in a starting position toward the proximal end of the housing, such as Figure 3 As shown. The introducer needle 18 and catheter 14 are inserted into a selected location within the patient's body for the intended use. The insertion device 10 is configured to be easily used with one hand to pierce the skin and position the catheter and introducer needle within the patient's body, while freeing the user's other hand to hold other devices (such as an ultrasound imaging device that is typically used to ensure that the catheter is properly placed within the patient's body). The button 68 of the actuator assembly 20 is initially in the Figure 3By using one finger or thumb, the user can slide the button 68 forward to Figure 4 1. The second position shown. Tabs 76 engage body 47 toward the proximal end of actuator body 66 and slide body 47 and catheter 14 forward a distance corresponding to the travel distance of the actuator button. Tabs 60 on bottom wall 30 of housing 12 are positioned to complement the spacing and position of tabs 76 so that forward movement of body 47 toward the distal end of the housing engages corresponding tabs 60 to maintain body 47 in the advanced position and prevent body 47 from sliding back toward the proximal end of the housing. The forward movement of body 47 advances the catheter over fixed introducer needle 18.

[0055] The button 68 can then be slid back toward the proximal end of the housing 12, with the tab 76 sliding over the body 47 to engage a contact point on the body 47, such as Figure 5 As shown. The button 68 can slide by manual manipulation of the user or can slide between the housing and the main body by a spring member in the housing. Then the button 68 can slide forward again to slide the main body 47 and the catheter 14 forward so that the distal end of the catheter slides over the distal end of the guide needle. The sliding motion of the button can be repeated in a step-by-step manner so that the catheter is advanced to the extended position relative to the guide needle 18 and the housing 12. In one embodiment of the present invention, the button 68 slides back and forth in a manner of repeated sliding motion by manual manipulation of the user to push the catheter, the catheter seat and the safety assembly toward the patient in the distal direction through each forward stroke of the button and the actuator body. When each forward stroke is completed, the button is pulled back and the next tab of the actuator body is ready for the next forward stroke. For each forward stroke, the tab on the housing engages with the main body 47 to prevent movement to the proximal end of the housing.

[0056] Once body 47 and catheter hub 16 are advanced to the forward position at distal end 22 of housing 12, hinged wall 36 is pivoted to Figure 5 , to release the catheter adapter 16 and the body 47 and the safety assembly 46 from the housing 12. The catheter adapter 16 advances to contact the cam surface 81 on the inner surface of the hinge wall 36 to push the hinge wall 36 away. The housing 12 can be pulled away from the catheter adapter 16 to withdraw the guide needle 18 from the catheter 14. The body 47 slides over the distal end 56 of the guide needle 18 to close the sharp end and prevent accidental needle sticks. When the body 47 of the safety assembly 46 is actuated by the withdrawal of the guide needle 18, the catheter adapter 16 is released and separated from the safety assembly 46. The housing 12 is discarded in a sharps container together with the attached guide needle 18 and the body 47. The seal 48 forms a valve that closes to control blood backflow and allow the attachment of an extension assembly or other device.

[0057] The actuator assembly 20 shown in the figure is an example of a mechanism that can be used to advance the catheter on the guide needle. In other embodiments, various mechanisms that can advance the catheter relative to the needle can be used. In an exemplary embodiment, a wheel or rotatable member can be mounted in the housing to engage the body and advance the catheter seat. The wheel can be manually rotated by the user's thumb or finger to slide the body and catheter on the end of the guide needle toward the distal end of the housing.

[0058] In various embodiments of the present invention, the actuator assembly 20 may have other suitable configurations and mechanisms that enable the catheter to be advanced on the end of the needle by a single operation of the user or by a series of repeated operations of the user. In the illustrated embodiment, the tab is flexible and formed on the inner surface of the opposite wall of the housing, and the tab engages the main body of the safety assembly, but other parts and components can be effectively used. In an alternative embodiment, a tab, a pawl or other member may be formed on the main body of the safety mechanism or attached to the main body of the safety mechanism, which engages a complementary tab, pawl or member on the actuator body and / or the housing so that the catheter is advanced to the needle on the end. The inner surface of the housing may be formed with one or more pawls, ridges, recesses or other structures that engage with the pawls or members on the safety assembly. For example, a pawl may be formed on one or more surfaces of the main body of the safety assembly, which engages with a complementary pawl or recess in the housing so that the safety assembly and the catheter can travel in a direction toward the distal end of the housing so that the catheter slides on the end of the needle. A detent or other feature may also be formed on the body of the safety assembly to engage a complementary feature on a movable actuator that can slide or move the safety assembly toward the distal end of the housing in a manner that will slide the catheter over the end of the needle.

[0059] The body 47 defines a safety needle assembly 46 which is a passive needle shield that can be deployed to cover the tip of the introducer needle 18. The safety needle assembly 46 is similar to the devices disclosed in WO2015 / 161296 and WO2015 / 161294, which are incorporated herein by reference in their entirety.

[0060] Figure 7 -12 shows an embodiment in which the safety assembly 46 includes a body 47 having a proximal end 82 and a distal end 84. In the illustrated embodiment, the distal end 84 has an inner protrusion 86 and an outer ring 88 that forms an annular ring for coupling with the proximal end 44 of the catheter hub 16, such as Figure 7 The proximal end 52 of the introducer needle 18 is fixed to the proximal end 24 of the housing 12 and extends through the longitudinal passage in the body 47 and through the seal 48 and the catheter 14 .

[0061] The proximal end of the catheter adapter has an outer diameter that is greater than the diameter of a portion of the catheter adapter adjacent to collar 45. The collar extends around a portion of the catheter adapter and is formed with an opening.

[0062] The safety assembly 46 includes a resilient clamp 100 and a washer 102. The body 47 of the assembly has an opening to receive the introducer needle 18. The distal end of the body 47 is configured to be coupled to the proximal end of the catheter hub 16. Figure 8 The resilient clamp 100 shown has a substantially V-shaped shape having a first leg 104 and a second leg 106 connected by a hinge portion 110. In the illustrated embodiment, the first leg 104 includes a scoop 112 having an inclined portion for coupling to the body 47. A first mark 114 extends from the second leg 106 toward the first leg 104, and a second mark 116 extends from the first leg 104 toward the second leg 106. A foot 118 extends outwardly from the first mark 114 away from the first and second legs 104, 106. A latch 120 extends upwardly from the foot 118 and is positioned between the legs 104, 106.

[0063] During operation of the device, the body 47 of the safety assembly 46 is connected to the catheter adapter 16, wherein the introducer needle 18 passes through the catheter adapter 16 and the body 47. The introducer needle 18 is engaged with the clamp 100 by pressing the legs 104, 106 of the clamp toward each other to bias the clamp into a locked position. The introducer needle 18 contacts the outer surface of the leg 106 to maintain the leg 106 in a compressed state relative to the first leg, as shown in FIG. Figure 7 In the locked position, latch 120 engages collar 45 on catheter adapter 16 to prevent removal of catheter adapter 16 from safety assembly 46. Clamp 100 is in a position to allow introducer needle 18 to slide within the device.

[0064] When the needle is withdrawn from the catheter adapter and enters the safety assembly, the tip of the needle 18 does not contact the clamp 100 and the legs 106 of the clamp 100 are allowed to expand outwardly, with the second leg 106 moving away from the first leg 106. When the clamp 100 is expanded, the first and second markers 114, 116 block the opening in the body 47 and prevent the tip of the introducer needle 18 from exiting the distal end of the body 47.

[0065] The movement of the second leg 106 moves the latch 120 from engaging the collar 45 of the catheter adapter 16 to a position aligned with the opening in the collar. This allows the catheter adapter 16 to be disengaged from the body 47. As the needle 18 is pulled further in the proximal direction, the needle 18 slides through the body 47 until the crimp or deformed portion 122 formed near the distal end of the needle 18 engages the gasket 102. The gasket 102 has an opening to allow the needle shaft to pass through instead of the crimp or deformed portion 122. The inner dimensions of the opening are smaller than the outer dimensions of the crimp or deformed portion 122. The gasket prevents the distal tip of the needle 18 and the crimp or deformed portion 122 from leaving the assembly when the needle is retracted. The combination of the clamp 100 and the gasket 102 acts as a needle tip protection mechanism to cover the needle tip and prevent needle stick injuries. In other embodiments, other types of safety mechanisms with different shapes and features used on other peripheral IV catheters can be used.

[0066] In the illustrated embodiment, a blood flashback feature is provided in the catheter device. Flashback is the visibility of blood that confirms that the needle tip has entered a vein. The first flashback can be seen through the catheter tubing 14 as blood enters the open distal end of the hollow needle 18 and then exits through the notch or opening 126 in the needle 18 near the needle tip, as shown in FIG. Figure 7 As shown. Blood travels upward through the interior tubular space between the needle 18 and the interior of the catheter 14. In one embodiment, a second flashback can be seen in the needle hub as blood flows out the back of the catheter 14 and enters the flashback chamber in the needle hub. Air can be vented through a plug in the back of the needle hub or through a porous membrane or microgrooves inside the housing. A third flashback can be seen in the catheter hub as blood from the first flashback flows into the catheter hub and stops at the blood control septum 48. Air is vented through the microgrooves around the blood control septum 48. The features described in this embodiment can be used in combination with the features described in the present invention.

[0067] The above description of the preferred embodiments should not be construed as limiting the present invention, which is defined by the appended claims. The disclosure is intended to enable a person of ordinary skill to implement the described variations of the present invention without departing from the scope of the present invention. Numerical limitations in this specification and claims should be understood to be limited by the modifier "about", so that minor deviations that produce equivalent results are within the scope of the present invention. Features or dependent claim limitations disclosed in conjunction with one embodiment or independent claim may be combined in another embodiment or with different independent claims without departing from the scope of the present invention.

Claims

1. A catheter insertion device, comprising: a housing having a longitudinal dimension, the housing having a proximal end and a distal end, the distal end having an opening and including a tip (34) having converging surfaces, the two hinged walls (36) of the tip being pivotably connected to the side walls (26) of the housing by respective hinges (38); a catheter having a distal end and a proximal end coupled to a catheter hub received in the lumen of the housing and movable relative to the housing from a first retracted position to a second extended position; and an actuator assembly movable in a longitudinal direction of the housing and operably connected to the catheter adapter to move the catheter adapter and the catheter from a first position to a second position toward the distal end of the housing, wherein the actuator assembly is configured to prevent the catheter adapter and the catheter from moving toward the proximal end of the housing when an actuator body (66) moves toward the proximal end of the housing; wherein the actuator assembly comprises a movable body (47) engaging the catheter seat to move the catheter seat and the catheter toward the distal end of the housing; wherein, once the movable body (47) and the catheter seat advance to a forward position at the distal end of the housing, the hinged wall (36) pivots to an open position to release the catheter seat from the housing; and wherein an inner surface of the hinged wall (36) comprises a cam surface (81), the catheter seat advances to contact the cam surface, thereby pushing the hinged wall (36) open.

2. The catheter insertion device according to claim 1, wherein: The actuator body is configured to sequentially move the catheter adapter and the catheter toward the distal end of the housing by sequentially moving the actuator body toward the distal end of the housing.

3. The catheter insertion device according to claim 2, wherein: The movable body of the actuator assembly is coupled to and detachable from the catheter adapter, and the actuator assembly includes the actuator body operably connected to the movable body of the actuator assembly for sliding the movable body of the actuator assembly within the housing.

4. The catheter insertion device according to claim 3, wherein: The actuator body includes at least one first flexible tab (76) for sliding on the movable body of the actuator assembly in a direction toward the proximal end of the shell, and wherein the at least one first flexible tab engages the movable body of the actuator assembly to cause the movable body of the actuator assembly to slide in a direction toward the distal end of the shell.

5. The catheter insertion device according to claim 3, wherein: The actuator body includes a first indexing assembly configured to move a movable body of the actuator assembly toward the distal end of the housing and prevent the movable body of the actuator assembly from sliding toward the proximal end of the housing.

6. The catheter insertion device according to claim 5, wherein: The housing includes a second indexing assembly configured to enable a movable body of the actuator assembly to move toward the distal end of the housing and to prevent the movable body of the actuator assembly from sliding toward the proximal end of the housing.

7. The catheter insertion device according to claim 3, wherein: The actuator body includes a plurality of spaced-apart first flexible tabs (76) for engaging complementary surfaces on the movable body of the actuator assembly and sliding the movable body of the actuator assembly toward the distal end of the housing by sliding movement of the actuator body toward the distal end of the housing.

8. The catheter insertion device according to claim 7, wherein: The housing includes a plurality of spaced-apart second flexible tabs (60) for engaging complementary surfaces on the movable body of the actuator assembly to allow the movable body of the actuator assembly to slide toward the distal end of the housing and prevent the movable body of the actuator assembly from sliding toward the proximal end of the housing.

9. The catheter insertion device according to claim 3, wherein: The movable body of the actuator assembly is a needle safety assembly having: a resilient clamp for blocking a distal opening in the movable body of the actuator assembly when the introducer needle is withdrawn from the catheter; and a gasket to prevent the introducer needle from separating from the movable body of the actuator assembly.

10. A catheter insertion device comprising: a housing having a proximal end and a distal end, the distal end including a tip (34) having converging surfaces, the two hinged walls (36) of the tip being pivotably connected to the side walls (26) of the housing by respective hinges (38); a catheter having a catheter hub received in the housing and movable relative to the housing from a first retracted position to a second extended position; a movable body (47) having a proximal end and a distal end engaged with the catheter hub, the movable body being movable toward the distal end of the housing along the longitudinal direction of the housing and being configured to prevent the movable body from moving toward the proximal end of the housing; and an actuator body (66) located in the housing and engaged with the movable body of the catheter insertion device, the actuator body being movable from a first position to a second position to move the movable body of the catheter insertion device and the catheter adapter toward the distal end of the housing and movable from the second position toward the proximal end of the housing, wherein, once the movable body (47) and the catheter seat advance to a forward position at the distal end of the shell, the hinged wall (36) pivots to an open position to release the catheter seat from the shell; and wherein the inner surface of the hinged wall (36) includes a cam surface (81), and the catheter seat advances to contact the cam surface, thereby pushing the hinged wall (36) open.

11. The catheter insertion device according to claim 10, wherein: The actuator body includes a first indexing mechanism configured to allow sequential movement of the movable body of the catheter insertion device toward the distal end of the housing and to prevent movement of the movable body of the catheter insertion device toward the proximal end of the housing.

12. The catheter insertion device according to claim 11, wherein: The housing includes a second indexing mechanism configured to allow the movable body of the catheter insertion device to slide toward the distal end of the housing and to prevent the movable body of the catheter insertion device from moving toward the proximal end of the housing.

13. The catheter insertion device of claim 10, wherein: The movable body of the catheter insertion device is separable from the catheter adapter and the catheter.

14. The catheter insertion device of claim 10, wherein: The actuator body includes at least one first flexible tab for sliding on the movable body of the catheter insertion device in a direction toward the proximal end of the shell, and wherein the at least one first flexible tab engages the movable body of the catheter insertion device to cause the movable body of the catheter insertion device to slide in a direction toward the distal end of the shell when the actuator body slides toward the distal end of the shell.

15. The catheter insertion device of claim 14, further comprising at least one second flexible tab for engaging the movable body of the catheter insertion device and preventing the movable body of the catheter insertion device from sliding toward the proximal end of the housing.

16. The catheter insertion device of claim 15, wherein: The at least one second flexible tab is coupled to the housing.

17. The catheter insertion device of claim 15, wherein: The actuator body includes a plurality of the first flexible tabs for engaging complementary surfaces on the movable body of the catheter insertion device to slide the movable body of the catheter insertion device in a stepwise manner toward the distal end of the housing by sliding the actuator body toward the distal end of the housing.

18. The catheter insertion device according to claim 17 further includes a plurality of second flexible tabs, which extend from the shell and are used to engage the movable body of the catheter insertion device and allow the movable body of the catheter insertion device to slide toward the distal end of the shell and prevent the movable body of the catheter insertion device from sliding toward the proximal end of the shell.

19. The catheter insertion device of claim 10, wherein: The movable body of the catheter insertion device includes: a resilient clamp for blocking an opening in the movable body of the catheter insertion device when the introducer needle is withdrawn from the catheter; and a gasket to prevent the introducer needle from being separated from the movable body of the catheter insertion device.

20. A catheter insertion device comprising: a housing having a proximal end and a distal end, the distal end including a tip (34) having converging surfaces, the two hinged walls (36) of the tip being pivotably connected to the side walls (26) of the housing by respective hinges (38); a catheter having a catheter hub received in the housing and movable relative to the housing from a first retracted position to a second extended position; a movable body (47) having a proximal end and a distal end engaged with the catheter hub, the movable body being movable along the longitudinal direction of the housing toward the distal end of the housing and being prevented from moving toward the proximal end of the housing; an actuator body (66) disposed in the housing and movable from a first position to a second position within the housing, the actuator body having a first ratchet mechanism for engaging the movable body of the catheter insertion device to move the movable body of the catheter insertion device and the catheter hub toward the distal end of the housing; and the housing having a second ratchet mechanism for engaging the movable body of the catheter insertion device, thereby allowing the movable body of the catheter insertion device to move toward the distal end of the housing and preventing the movable body of the catheter insertion device from moving toward the proximal end of the housing when the actuator body moves toward the proximal end of the housing, wherein, once the movable body (47) and the catheter seat advance to a forward position at the distal end of the shell, the hinged wall (36) pivots to an open position to release the catheter seat from the shell; and wherein the inner surface of the hinged wall (36) includes a cam surface (81), and the catheter seat advances to contact the cam surface, thereby pushing the hinged wall (36) open.

21. The catheter insertion device of claim 20, wherein: The first ratchet mechanism of the actuator body includes a plurality of first flexible tabs located on the actuator body, and the plurality of first flexible tabs protrude obliquely toward the distal end of the shell, for engaging the movable body of the catheter insertion device to move the movable body of the catheter insertion device toward the distal end of the shell when the actuator body slides toward the distal end of the shell.

22. The catheter insertion device of claim 21, wherein: The second ratchet mechanism of the shell includes a plurality of second flexible tabs located on the shell, the plurality of second flexible tabs protruding obliquely toward the distal end of the shell, the plurality of second flexible tabs enabling the movable body of the catheter insertion device to move toward the distal end of the shell and preventing the movable body of the catheter insertion device from moving toward the proximal end of the shell.

23. The catheter insertion device of claim 20, further comprising an insertion needle positioned in the catheter and extending through the movable body of the catheter insertion device when the catheter and the movable body of the catheter insertion device move toward the distal end of the housing relative to the introducer needle.

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