JPWO2021078535A5 - - Google Patents

Description

The present invention relates to catheter devices including catheters and hypodermic injection introducer needles. More specifically, the present disclosure relates to a catheter device comprising a catheter and a hypodermic injection introducer needle as defined in the introduction of claim 1.

Intravascular catheter devices are known in the art and provide access into subcutaneous blood vessels, such as veins, to deliver drugs, drugs, chemotherapy, nutrients, and/or any other fluids. Commonly used for introduction into a subject. SE355946 discloses a basic type of injection cannula assembly that is still widely used. Catheters are typically flexible or semi-flexible so that they can be fitted into blood vessels. Since flexible or semi-flexible catheters are unable to pierce the subject's skin, an introducer needle is inserted into the lumen of the catheter and the beveled tip of the needle is inserted into the lumen of the catheter. It is adapted to be exposed beyond the distal tip end. The patient's vasculature is accessed by inserting the beveled tip of the needle through the skin and into the targeted blood vessel. Insertion into a blood vessel by a needle is indicated by the appearance of blood in a chamber within the needle head. Once the beveled tip of the needle is inserted into the blood vessel and blood appears in said chamber, the catheter and needle are moved distally into the blood vessel until the desired position of the catheter is achieved. be moved forward. Once the catheter is properly positioned, the needle is removed by pulling the needle proximally from the catheter, after which the needle is discarded.

One common problem when inserting a catheter is that blood emerges into the chamber and as the needle and catheter are advanced further distally, it punctures the blood vessel further, thereby causing damage to the opposite blood vessel wall. This means that there is a risk of exiting the blood vessels through the blood vessels. This will result in the catheter not being properly placed. However, this can be difficult to detect and often causes discomfort to the patient before it is discovered. Once detected, the improperly positioned catheter must be discarded and the entire procedure must be repeated with a new catheter device, which results in significant discomfort and additional pain to the patient. , as well as negative economic consequences due to waste of medical materials.

One common practice to avoid the problems described above is to "hood" the needle when the blood vessel is accessed. "Hooding" involves maintaining the stationary position of the needle while simultaneously moving a partially inserted catheter distally so that the beveled needle tip enters the inner lumen of the catheter. It's like you're being drawn into it. Once the beveled needle tip is hooded, the catheter device is advanced distally into the vein to the desired location.

One problem with this technique is when the beveled needle tip punctures a blood vessel far enough, but not completely, for blood to appear within the needle chamber. The hooding can then cause the catheter to slide along the exterior of the blood vessel. As a result, the catheter is not properly placed within the blood vessel. This would result in the need to repeat the procedure, with the same result as stated above.

Moreover, hooding is performed blindly since the user cannot see the subcutaneous location of the needle or the catheter within the blood vessel. Thus, the beveled needle tip may be overhooded or underhooded. Underhooding means that a portion of the beveled needle tip is still exposed beyond the tip of the catheter, with the risk of further puncturing the blood vessel, as discussed above. Overhooding means that the beveled needle tip is pulled too proximally into the lumen of the catheter, and the most distal end of the catheter's flexible or semi-flexible tip. Leave the end unsupported by the needle. The unsupported portion of the catheter may then be at risk of being bent, nicked, or otherwise obstructed while being advanced into the blood vessel. This can result in insufficient administration of fluid and/or medication through the lumen.

Once the beveled needle tip is hooded to the desired subcutaneous location, the beveled needle tip is pushed distally back to an exposed position where the beveled needle tip projects distally of the catheter tip end. I can't. This is because this can cause the beveled needle tip to tear or tear a portion of the catheter tip end. Therefore, when it is discovered that the catheter is not properly positioned after hooding the beveled needle tip, the improperly positioned catheter must be discarded and a new catheter device used to complete the procedure. must be repeated, which causes great discomfort and additional pain to the patient, as well as negative economic consequences due to wastage of medical materials.

WO2017/074682 discloses an IV catheter having a catheter component with a catheter hub, a cannula extending distally from the hub, and a pusher mechanism projecting outwardly from the hub. The IV catheter also includes a needle component having a needle hub, a needle extending distally from the hub along an axis, and a grip extending from the hub generally parallel to the axis with a tensioning mechanism. It is possible to have In the insertion configuration, the needle can be positioned within the cannula and the distal end of the needle hub can be seated within the needle port of the catheter hub. In the fluid delivery configuration, the needle can be positioned outside the catheter hub. The push and pull mechanisms can be positioned to facilitate one-handed operation to move the IV catheter from the insertion configuration to the fluid delivery configuration.

US2011/224617 discloses an intravenous catheter device having features to assist the user in covering the bevel of the introducer needle during catheterization. The intravenous catheter device has been modified to include a biasing arm that allows a portion of the catheter device to be advanced so that the bevel of the introducer needle is coated within the inner lumen of the catheter tube. The dimensions of the biasing arm and various other interacting surfaces of the catheter device are configured to achieve effective coverage of the needle tip while avoiding over- or under-covering errors.

WO2017/074683 discloses a catheter adapter that can include a catheter adapter body formed from a compliant material. The catheter adapter body can have a generally elongated shape and an internal chamber. The catheter adapter body can include a compression resistant septum disposed toward the proximal end of the catheter adapter body. The compression resistant septum can have a lumen configured to receive an elongated object. The compression resistant septum can also be coupled to a compression cap that applies a compression force to the compression resistant septum such that the lumen narrows and seals when the elongate object is removed from the lumen.

It is an object of the present invention to alleviate, alleviate or eliminate one or more of the above-identified deficiencies and disadvantages in the prior art and to solve at least the problems mentioned above. The inventor has noticed all the problems listed above that can occur when inserting an intravenous catheter. In particular, inexperienced users are likely to frequently use improperly positioned catheters. The inventors have therefore identified the objective of developing an intravenous catheter device capable of guiding the user and controlling the catheter insertion process, such that the above-mentioned problems are avoided. Another objective of the inventors is to develop an intravenous catheter device that is easy to use and does not substantially change practice compared to what is available today. Additionally, the inventor has developed an intravenous catheter device that can be operated with one hand, e.g., using one hand to hold the patient's limb while inserting the catheter with the other hand. The purpose is to make it possible.

According to a first aspect, there is provided a catheter device, the catheter device having an axis AA, a lower side adapted to face the patient, and a lower side adapted to face away from the patient. an upper side opposite a lower side, the catheter device including a catheter and a hypodermic introducer needle;
The catheter includes an axially elongated housing having a proximal open end adapted to receive a coupling mechanism or plug, the housing having an internal passageway and an upper side of the catheter. and a protruding member on the outer surface of the proximal open end, the catheter further comprising a flexible catheter tube connected to the elongated housing. a flexible catheter tube including a distal tip end and a lumen in fluid communication with an internal passageway of the housing;
The introducer needle includes a proximal head, a hollow needle having a distal beveled tip, and an extension connecting the needle with the head and the needle being inserted into the catheter. When the head is adapted to engage the proximal end of the catheter, the head includes an axial channel in fluid communication with an interior of the hollow needle, a grip plate, and an engagement member; The plate is disposed on the head and extends in a direction perpendicular to the axial direction, and the engagement member is disposed on the grip plate and projects distally from the grip plate. Ori,
The catheter and needle are positioned such that when the needle is inserted into the catheter, the grip plate is oriented toward the top of the catheter and aligned with the connection port, and the proximal end of the catheter a protruding member on the grip plate is adapted to engage an engagement member on the grip plate to prevent rotation of the needle about axis A-A with respect to the catheter;
The catheter device further includes a lever member adapted to be removably attached to the catheter with respect to the introducer needle from a retracted proximal position to an advanced distal position. further adapted to move the catheter axially, such that in the retracted proximal position, the beveled tip of the introducer needle protrudes from the distal end of the catheter tube and is advanced. In the distal position, the beveled tip of the introducer needle is hooded by the catheter tube, and the catheter device is mounted on the grip plate and/or on the extension, with a visual and/or tactile further comprising an indicator indicating an advanced position of at least: a) the catheter has been advanced a distance d, the distance d being the length of the beveled tip of the needle; correspondingly, and optionally, b) the catheter is advanced a distance D, the distance D corresponding to a length greater than the length of the beveled tip of the needle, e.g. A catheter device is provided that accommodates twice or more the length of the beveled tip.

According to some embodiments, the lever member includes a lever arm and a connector for connecting with a catheter.

According to some embodiments, the lever member interacts with the grip plate of the introducer needle and moves the catheter to advance distally.

According to some embodiments, the connector further includes an engagement recess that engages a protrusion on the proximal end of the catheter to removably connect the lever member to the catheter. adapted to do so.

According to some embodiments, the lever member is adapted to be removably attached to a connection port of a catheter.

According to some embodiments, the length of the needle extension is at least equal to or greater than the total length that the lever member will advance the catheter when fully advanced. .

According to some embodiments, the indicator includes a stop surface disposed on the grip plate such that the lever member engages the stop surface; Provide tactile indications to the user.

According to some embodiments, the stop surface includes a groove, protrusion, or edge disposed on the grip plate.

According to some embodiments, the lever arm includes an interaction member adapted to interact with a stop surface of the grip plate.

According to some embodiments, the lever arm has an L-shaped or curved shape and is located on the catheter, and the interaction member engages the stop surface of the grip plate. an L-shaped angular or curved shaped convex surface adapted to do so, or a ridge above said convex surface.

According to some embodiments, the indicator is located on the needle extension.

According to some embodiments, the needle extension is provided with ribs, the ribs surrounding the extension radially from axis AA, and the ribs surround the extension at the proximal end of the catheter or at the lever. The connector of the member is provided with a locking flange, the locking flange being adapted to engage a rib on the extension of the needle when the catheter is moved distally relative to the needle. , the ribs are optionally marked to indicate the position of the beveled tip of the needle relative to the distal end of the catheter tube.

According to some embodiments, the needle extension includes a beveled surface along one side of the entire extension, resulting in a U-shaped cross-section of the extension.

According to some embodiments, the indicator includes markings on the ribs, the markings corresponding to the catheter being advanced a certain distance, each rib pulling over the locking flange. In addition to the tactile indication provided by the locking flange being engaged with the locking flange, a visual indication is provided to the user.

According to some embodiments, the lever arm includes a protrusion, and the elongated housing of the catheter or, optionally, the proximal end of the connector of the lever member includes a retention element, the retention element including the protrusion. The lever member is adapted to engage with the catheter device such that the lever member reversibly locks the catheter device in the fully advanced position.

According to a second aspect, a lever member adapted to be connected to a catheter, the lever member being adapted to engage a grip plate of an introducer needle inserted into the catheter. A lever member is provided that includes a lever arm that is attached to the catheter and a connector that is adapted to be removably attached to the catheter.

According to some embodiments, the connector further includes an engagement recess that engages a protrusion on the proximal end of the catheter to removably connect the lever member to the catheter. It is adapted as follows.

According to some embodiments, the connector is adapted to engage a connection port of a catheter and removably connect the lever member to the catheter.

According to some embodiments, the lever arm includes a protruding protrusion, the protrusion being adapted to engage a retaining element, the retaining element being disposed over the connector of the lever member. or located on the proximal end of the catheter.

According to a third aspect, a catheter device according to the first aspect for use in placing a catheter in a blood vessel in a patient, the placing comprising:
i. positioning the catheter device against the patient's skin at the location where the catheter is to be placed; and advancing the catheter device with a distal motion toward the subcutaneous blood vessel;
ii. ceasing the distal movement when blood appears in the head of the introducer needle, indicating that the blood vessel has been entered;
iii. moving the lever member toward the grip plate while maintaining the introducer needle stationary;
iv. pressing the lever member against the grip plate, thereby causing the lever member to slide against the grip plate towards the elongate housing, the first indicator being reached and the beveled tip of the introducer needle being hooded; further causing the catheter to move distally relative to the introducer needle, which remains stationary until the catheter is
v. further moving the catheter device into the blood vessel;
vi. further moving the lever member while maintaining the introducer needle stationary to advance the catheter further distally into the blood vessel in one or optionally more than one steps;
vii. attaching the catheter to the patient's skin with the attachment member when the catheter is fully advanced relative to the introducer needle by use of the lever member;
viii. removing the introducer needle and lever member from the catheter device and sealing the proximal open end of the catheter by use of a removable plug or by connection to an injection device or the like. be done.

The invention will become apparent from the detailed description given below. The detailed description and specific examples disclose the preferred embodiments of the invention for purposes of illustration only. Those skilled in the art will appreciate from the guidance provided in the detailed description that changes and modifications may be made within the scope of the invention.

Therefore, it is to be understood that the invention disclosed herein is not limited to the particular component parts of the devices described or steps of the methods described. This is because such devices and methods can vary. It should also be understood that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting. As used in this specification and the appended claims, the articles "a," "an," "the," and "said" are used unless the context clearly dictates otherwise. It should be noted that unless otherwise specified, it is intended to mean that one or more of the elements are present. Thus, for example, reference to "a unit" or "the unit" may include a number of devices and the like. Moreover, the words "comprising," "including," "containing," and similar phrases do not exclude other elements or steps.

DEFINITIONS The term "user" shall be construed as a caregiver who will perform catheter placement or perform other medical treatment, preparation, surgery, etc. on the patient. It is.

The term "distal" should be construed as referring to a location or location away from the user. The term "distally" should be interpreted as referring to movement directed away from the user.

The term "proximal" should be construed as referring to a location or location near the user. The term "proximally" should be interpreted as referring to movement directed towards the user.

The term "vessel" or "blood vessel" is to be construed as any blood vessel within a patient. It can involve arteries or veins.

The term "oblique angle" is discussed herein as an angle. However, a beveled needle tip can include more than one angled surface (eg, a heel of a bevel and a secondary bevel, etc.). It is important for the understanding of this disclosure that the term "bevel length" encompasses the entire bevel length (including all beveled surfaces of the needle tip).

1 is a perspective view of parts included within a catheter device according to an embodiment of the present disclosure; FIG. Figure Ia is a cross-sectional view of the catheter device as shown in Figure Ia when assembled; FIG. 3 is a cross-sectional view of a catheter device illustrating the functionality of a lever member, according to an embodiment of the present disclosure. FIG. 3 is a cross-sectional view of a catheter device illustrating the functionality of a lever member, according to an embodiment of the present disclosure. FIG. 3 is a cross-sectional view of a catheter device illustrating the functionality of a lever member, according to an embodiment of the present disclosure. FIG. 2 is a top view of a catheter device according to an embodiment of the present disclosure. FIG. 3 illustrates a catheter with a lever member. FIG. 2 is a top view of a catheter device according to an embodiment of the present disclosure. FIG. 3 illustrates a catheter with a lever member and an introducer needle inserted into the catheter. FIG. 3 is a cross-sectional view of a retention structure between a catheter and a lever member, according to an embodiment of the present disclosure. FIG. 3 is a cross-sectional view of a retention structure between a catheter and a lever member, according to an embodiment of the present disclosure. FIG. 4 is a cross-sectional view of another embodiment of the present disclosure. FIG. 4 is a cross-sectional view of another embodiment of the present disclosure. FIG. 4 is a cross-sectional view of another embodiment of the present disclosure. FIG. 4 is a cross-sectional view of another embodiment of the present disclosure. FIG. 4 is a cross-sectional view of another embodiment of the present disclosure. FIG. 4 is a cross-sectional view of another embodiment of the present disclosure. 1 is a perspective view of parts included within a catheter device according to an embodiment of the present disclosure; FIG. 7 is a perspective view of the embodiment of FIG. 6 illustrating the functionality of the extension portion according to an embodiment of the present disclosure. FIG. 7 is a perspective view of the embodiment of FIG. 6 illustrating the functionality of the extension portion according to an embodiment of the present disclosure. FIG.

The above objects, as well as additional objects, features, and advantages of the invention, will be apparent from the following illustrative and non-limiting example of exemplary embodiments of the invention when taken in conjunction with the accompanying drawings. A more complete appreciation may be obtained by reference to the detailed description.

A catheter device according to the present disclosure has an axis A-A, a lower side adapted to face the patient, and an upper side opposite the lower side adapted to face away from the patient. have. Catheter devices include catheters and hypodermic injection introducer needles.

The catheter includes an axially elongated housing having a proximal open end adapted to receive a coupling mechanism or plug. The proximal end may be provided with a female LUER LOK® fitting as a coupling mechanism, for easy fitting with, for example, a syringe or the like. Through the coupling mechanism, the catheter can be coupled to a common infusion device or any other medical equipment to connect with the catheter. The housing further includes an internal passageway and a connection port with an internal orifice located over the upper side of the catheter. The connection port may be used, for example, to inject drugs or pharmaceuticals into an infusion fluid that is being perfused into the patient through the catheter. The housing further includes a protruding member on the outer surface of the proximal open end for engaging and locking the plug or coupling mechanism disclosed above. The catheter further includes a flexible catheter tube connected to the elongate housing, the flexible catheter tube including a distal tip end and a lumen, the lumen communicating fluid to the internal passageway of the housing. It's communicating. The flexible catheter tube is the part of the catheter that is placed in the blood vessel and must be flexible so as not to damage or puncture the blood vessel into which it is inserted.

The introducer needle includes a proximal head, a hollow needle having a distal beveled tip, and an extension connecting the needle to the head. The extension portion is adapted to engage the proximal end of the catheter when the needle is inserted into the catheter. The head includes an axial channel in fluid communication with the interior of the hollow needle, a grip plate, and an engagement member, the grip plate being disposed on the head and extending in a direction perpendicular to the axial direction. The engagement member is disposed on and projects distally from the grip plate.

Catheters and introducer needles, apart from hypodermic hollow needles, are typically manufactured from synthetic polymeric materials, which are transparent or translucent. Typically, the material for manufacture can be polyurethane or polytetrafluoroethylene (eg, FEP, etc.). Hypodermic hollow needles are typically manufactured from stainless steel, which is optionally plated.

The catheter and needle are positioned such that the grip plate is oriented toward the top of the catheter and aligned with the connection port when the needle is inserted into the catheter. Additionally, a protruding member on the proximal end of the catheter is adapted to engage an engagement member on the grip plate and prevent rotation of the needle relative to the catheter about axis A-A. has been done.

The catheter device further includes a lever member adapted to be removably attached to the catheter from a retracted proximal position to an advanced distal position relative to the introducer needle. The catheter is further adapted to axially move the catheter into position. In the retracted proximal position, the beveled tip of the introducer needle projects from the distal end of the catheter tube. In the advanced distal position, the beveled tip of the introducer needle is hooded by the catheter tube. The catheter device further includes an indicator to indicate an advanced position of at least: a) the catheter has been advanced a distance d, the distance d being the length of the beveled tip of the needle; and, optionally, b) the catheter is advanced a distance D, the distance D corresponding to a length greater than the length of the beveled tip of the needle; For example, the length can be twice or more than the length of the beveled tip. The device can include additional distance-related indicators that are advantageous to indicate during use of a catheter device according to the present disclosure.

The catheter device is initially used in the same manner as conventional catheter devices. Thus, the catheter device is positioned against the patient's skin, keeping the axis A-A almost parallel to the skin surface, which is slightly inclined, and the proximal end of the catheter and the introducer needle The distal beveled tip of the introducer needle is brought into contact with the skin while the head of the introducer needle is maintained at a small height above the skin surface. Thereafter, the catheter device is advanced distally such that the distal beveled tip pierces the skin and, ultimately, the target blood vessel. The user will know that a blood vessel has been punctured by the distal beveled tip. The reason is that blood will enter the introducer needle and will emerge within the axial channel of the needle head. Thus, the user will visually observe the blood appearing in the needle head through the transparent or translucent material.

When blood enters the axial channel, the lever member is moved to the first indicator, thereby moving the catheter from a retracted proximal position to an advanced distal position relative to the needle. I am made to exercise. Movement of the lever member to the first indicator position means that the catheter has been advanced a distance d relative to the needle, where distance d is the distal beveled tip of the needle. equal to the length of Thus, the distal beveled tip of the needle is hooded by the catheter tip end. At this point in the procedure, the beveled tip of the needle cannot be moved distally to protrude from the distal tip end of the catheter. This is because this can cause the beveled tip to cut or tear small pieces of catheter tubing. Therefore, reaching the first indicator by the lever member is also a point of no return for the catheter device. If it is discovered that something is wrong with the placement of the catheter, the entire catheter device must be discarded. In some cases, the lever member can be removed from the catheter device and reused with a new catheter device, provided that the lever member is not in contact with blood or any other body fluid.

After the hooding described above has been performed, the catheter device is moved further distally into the blood vessel. Thereafter, the lever member is further moved to a second indicator, thereby causing the catheter to move relative to the needle from the first advanced distal position to the second advanced distal position. I am made to exercise. Movement of the lever member to the second indicator position means that the catheter has been advanced a distance D relative to the needle. Distance D is equal to a length greater than the length of the distal beveled tip of the needle, such as equal to twice (2x) or more the length of the distal beveled tip. This action will therefore ensure that the catheter tube is fully inserted into the blood vessel beyond the distal beveled tip of the introducer needle.

In the first step, if the beveled tip partially (but not completely) enters the blood vessel, the hooding allows the catheter to be advanced to the same point as the beveled tip in the blood vessel. further advancement of the catheter device into the blood vessel, with the beveled tip protruding from the catheter tip, positions the catheter tip further into the blood vessel without risking perforation of the opposite blood vessel. That will happen.

The length of the beveled tip (and thus the distances d and D) depends on the gauge of the needle being used. A higher gauge corresponds to a needle with a smaller diameter, while a lower gauge corresponds to a needle with a larger diameter. The larger the diameter of the needle, the longer the beveled tip will be. Also, the length of the beveled tip will depend on the bevel of the needle tip. The indicator is therefore adapted to the gauge and bevel of the needle for which it is intended to be used. Those skilled in the art will be able to determine the lengths and distances with respect to the respective gauges and bevels, and subsequently install indicators to indicate said lengths and distances in accordance with the present disclosure. This means that you can do it.

All handling during catheter installation, from puncturing the skin to hooding the beveled tip of the needle, can be performed with one hand using the device of the present disclosure. While holding the catheter device with one hand, pulling the lever member involves an intuitive action by the user and can be performed with one finger of the same hand.

Thus, the user can use the other hand to hold the patient's limb, stretch the skin, etc. before piercing said skin.

The catheter devices disclosed herein provide clear indications when the beveled tip is hooded and overhooded, respectively. Indications can be visual and/or tactile. Therefore, the process of placing a catheter is no longer performed blindly by using the currently disclosed devices. The user will always be assured that the beveled tip of the needle will be hooded when the first indicator is reached by the lever member, thus reducing the risk of further perforating any tissue.

The lever member can include a lever arm and a connector for connecting to a catheter. The lever arm must be adapted to be actuated such that the catheter is moved distally relative to the introducer needle, where actuation of the lever arm causes the introducer needle to move in any direction. It will not cause it to be moved (neither distally nor proximally). Providing a lever arm on the lever member allows for intuitive actuation by the user in pulling the lever arm proximally to advance the catheter distally. The lever arm preferably includes an L-shaped or curved shape.

The lever member interacts with the grip plate of the introducer needle and is capable of moving and advancing the catheter distally. Accordingly, the lever member (or, optionally, the lever arm) is preferably moved proximally and interacts with the grip plate, which is positioned over the introducer needle and over the lever member and the catheter. positioned in a proximal position relative to both. The grip plate thus provides a resistance against which input forces applied to the lever member are directed. This causes the output force of the lever member to be exerted against the catheter at the point where the lever member is attached to or connected to the catheter, causing the catheter to move away from the grip plate (i.e. distally). exercise. As a result, the lever function of the lever member is strengthened.

As mentioned above, the lever member can include a connector. The connector can further include an engagement recess adapted to engage a protrusion on the proximal end of the catheter to removably connect the lever member to the catheter. ing. Engagement of the engagement recess with said proximal projection further prevents rotation of the lever member about axis AA. Thereby it is ensured that the lever member and optionally the lever arm are aligned with the connecting sleeve of the catheter and also with the grip plate of the needle. The lever member is therefore capable of interacting with the grip plate as disclosed above.

The lever member may alternatively be adapted to be removably attached to a connection port of a catheter. Accordingly, the connector is directly adjacent to the elongated housing and is adapted to at least partially surround or surround the outer periphery of the connection port, and the plug is fitted over the connection port. It is designed so that it does not prevent you from becoming able to do it. Preferably, the connector does not completely surround or surround the connection port, making it more easily removable from the connection port, whether or not the connection port is fitted by a plug. . Once the lever member is removably attached to the connection port, a plug fitted over the connection port can help maintain the lever member in place. However, this is not essential to the function of the lever member.

The lever member can be easily removed along with the needle once the catheter is properly positioned. During catheter installation, as the lever member is moved toward the grip plate of the introducer needle, simply grip the lever member and grip plate at the same time and hold them proximally until both items exit the catheter. It is easy to remove both from the catheter by pulling on it. Therefore, there is no extra step required to remove the lever member from the catheter. Both the lever member removably attached to the proximal end of the catheter and the lever member removably attached to the connection port may be removed accordingly.

The length of the needle extension can preferably be at least equal to or greater than the total length over which the lever member can advance the catheter. This will provide stability during handling of the catheter device and especially during removal of the introducer needle once the catheter is properly positioned within the blood vessel. Thus, as the catheter tube is advanced distally over the needle and as the needle is pulled back further proximally to be removed from the catheter, the needle is aligned perpendicular to axis A-A. There will be no risk of wobbling or shifting. The risk of damaging the catheter tube during needle removal is thereby minimized. Furthermore, handling of the needle by the user installing the catheter is made stable and reliable.

The indicator can include a stop surface. A stop surface may be disposed on the grip plate such that the lever member engages the stop surface to provide a tactile indication to the user. The stop surfaces located on the grip plate are located at different distances from the central AA axis on the distal surface of the grip plate. The first indicator stop surface will be located at a greater distance from the center AA axis than the second indicator stop surface. Thereby, the lever member will initially engage the first indicator stop surface when being moved towards the grip plate. Further proximal movement of the lever member causes the lever member to slide along the grip plate towards the central AA axis of the catheter device and engage the second indicator stop surface. becomes.

The stop surface can include a groove, protrusion, or edge located on the grip plate. The particular shape of the stop surface is not critical. A stop surface is provided at a predetermined location on the grip plate, wherein said location during handling of a catheter device as described in this disclosure is such that the catheter is at least a distance d and optionally This corresponds to being moved forward by a distance D.

The lever arm can include an interaction member adapted to interact with a stop surface of the grip plate. As disclosed above, the lever arm preferably has an L-shaped or curved shape. The interaction member preferably has an L-shaped outer angle or a curved shaped convex surface adapted to engage a stop surface of the grip plate or a convex surface of said convex surface. It is possible to include a ridge on the top. However, those skilled in the art will recognize that additional shapes are possible that would provide the functionality as disclosed herein for the lever member.

The extension of the needle may be provided with a rib, which surrounds the extension radially from axis AA. In this embodiment, the proximal end of the catheter, or optionally the connector of the lever member, is provided with a locking flange, which locks when the catheter is moved distally relative to the needle. , adapted to engage a rib on the needle extension. A tactile indication is provided to the user regarding each rib that engages the locking flange. Additionally, the rib engaging the locking flange will prevent the needle from being moved back into the catheter. This embodiment of the extension portion may be combined with any of the lever members disclosed herein.

When the beveled tip of the needle is hooded by the catheter tip end, as disclosed above, a rib on the extension engages the locking flange, thereby locking the needle against the catheter. Prevent distal movement of. Therefore, at this stage it is possible to further advance the entire catheter device simply by pushing the needle distally. Due to the engagement of the ribs and the locking flange, there is no risk of the needle protruding from the catheter tip end by pushing on the needle. Thereby, there is little or no risk of the beveled tip severing a portion of the catheter tip end. Alternatively or additionally, the indicator may be placed on the needle extension. The extension portion of the needle may thus be provided with a rib, the ribs surrounding the extension portion radially from the axis AA, as disclosed above, the ribs distal to the catheter tube. It may be marked to indicate the position of the beveled tip of the needle relative to the end. The indicator thus includes markings on the ribs, the markings corresponding to that the catheter is being advanced a certain distance, each rib being pulled over and engaged with the locking flange. Provide visual indications to the user in addition to the tactile indications provided by what you are doing. Rib markings can include specific rib symbols, letters, numbers, or colors. Thus, a rib that, when engaged with the locking flange, results in the catheter being moved distally by a distance d; The ribs that result in being removed can be marked. The markings may be the same or different. The first marking located most proximally on the introducer needle and closest to the grip plate will indicate the distance d, and the first marking located more distally and located furthest from the grip plate Any further markings made will indicate one or more distances D.

The needle extension is provided with ribs according to any of the embodiments described above and may further include a chamfered surface along one side of the entire extension, such that the extension has a U-shaped cross-section. bring about shape. Rotation of the needle thereby allows re-entry of the needle into the catheter. This is because the flat chamfered surface of the extension will not engage the locking flange. The needle can then be re-advanced into the catheter. This may be useful if the introducer needle is accidentally removed from the catheter. But more importantly, this is critical to being able to introduce the introducer needle into the catheter during assembly of the catheter device. However, for the reasons given above in this disclosure, rotation of the needle to reinsert it into the catheter is never performed if the catheter device has already been inserted into the patient. must not.

The lever arm may include a protrusion and the elongated housing of the catheter or, optionally, the proximal end of the connector of the lever member may include a retention element. The retaining element is adapted to engage the protrusion so that the lever member reversibly locks the catheter device in the fully advanced position. It is feasible to design this locking arrangement with features other than projections and retention elements as disclosed herein while retaining the same functionality. Accordingly, disclosed herein is a lever member adapted to be connected to a catheter, said lever member being adapted to engage a grip plate of an introducer needle inserted into the catheter. A lever member is provided that includes a lever arm adapted and a connector adapted to be removably attached to a catheter. The lever member may exhibit all or some of the features disclosed above with respect to lever members. Accordingly, the connector can further include an engagement recess adapted to engage a protrusion on the proximal end of the catheter and as disclosed above. The lever member is adapted to removably connect to the catheter. Alternatively, the connector may be adapted to engage a connection port of a catheter to removably connect the lever member to the catheter as disclosed above. The lever arm may include a projecting protrusion, the protrusion being adapted to engage a retaining element, said retaining element being disposed over a connector of the lever member; or , located on the proximal end of the catheter.

The lever member may be provided separately for a user to connect the lever member to the catheter device, or the catheter device may be provided with the lever member during its manufacture.

Manufacturing and packaging of lever members and/or catheter devices according to the present disclosure should comply with regulatory rules and guidelines for use within healthcare systems. Any device intended for use in health care and intended to come into contact with patients and/or bodily fluids must comply with such regulatory rules and guidelines.

According to the present disclosure, a catheter device according to the above for use in placing a catheter within a blood vessel in a patient, wherein placing comprises:
i. positioning the catheter device against the patient's skin at the location where the catheter is to be placed; and advancing the catheter device with a distal motion toward the subcutaneous blood vessel;
ii. ceasing the distal movement when blood appears in the head of the introducer needle, indicating that the blood vessel has been entered;
iii. moving the lever member toward the grip plate while maintaining the introducer needle stationary relative to the patient;
iv. pressing the lever member against the grip plate, thereby causing the lever member to slide downwardly against the grip plate to indicate that the first indicator is reached and the beveled tip of the introducer needle is hooded; causing the catheter to move further distally relative to the introducer needle which remains stationary until indicated;
v. further moving the catheter device into the blood vessel;
vi. further moving the lever member while maintaining the introducer needle stationary to advance the catheter further distally into the blood vessel in one or optionally more than one steps;
vii. attaching the catheter to the patient's skin when the catheter is fully advanced relative to the introducer needle by use of the lever member;
viii. removing the introducer needle and lever member from the catheter device and sealing the proximal open end of the catheter by use of a removable plug or by connection to an injection device or the like. be done.

Attachment of the catheter to the patient's skin is preferably accomplished by attaching an attachment member to the skin. The attachment member can be, for example, a wing-like structure located on the underside of the catheter.

The invention will now be described with reference to the accompanying drawings, in which preferred exemplary embodiments of the invention are shown. However, this invention may be embodied in other forms and should not be construed as limited to the embodiments disclosed herein. The disclosed embodiments are provided to fully convey the scope of the invention to those skilled in the art.

Although the arrangement and design for the stop surface and interaction member are mostly illustrated with respect to embodiments in which the connector of the lever member is attached to the proximal end of the elongate housing, it is not limited to those figures. It is also possible to combine embodiments in which the connector is attached to the connection port.

Figures 1a and 1b show one embodiment of a catheter device 1, which has a central axis AA, a lower side (L) adapted to face the patient, and a side facing away from the patient. The catheter device 1 includes a catheter 2 and a hypodermic injection introducer needle 3 , having a lower side (L) and an opposite upper side (U) adapted to face. Catheter 2 includes an axially elongated housing 4 having a proximal open end 5 adapted to receive a coupling mechanism or plug. The housing 4 further comprises an internal passage 6 and a connecting port 7 with an internal orifice 8 arranged on the upper side of the catheter, said orifice 8 being connected to the internal passage 6 by a check valve 9. There is. A plug 10 can be fitted over the connection port 7. A protruding member 15 is disposed on the outer surface of the proximal open end 5. Catheter 2 further includes a flexible catheter tube 12 connected to an elongate housing 4, flexible catheter tube 12 including a distal tip end 13 and a lumen 14, the lumen 14 being connected to the housing 4. is in fluid communication with an internal passageway 6 of the. In this embodiment, the catheter 2 further includes an attachment member 11 for attaching the catheter 2 to the patient's skin. The introducer needle 3 includes a proximal head 16, a hollow needle 17 having a distal beveled tip 18, and an extension 19 connecting the needle 17 with the head 16 and 3 is adapted to engage the proximal end 5 of the catheter 2 and the elongate housing 4 when inserted into the catheter 2. The head 16 has an axial channel 20 in fluid communication with the interior of the hollow needle 17 and a grip disposed on the head 16 extending in a direction perpendicular to the axial direction of the catheter device 1. It includes a plate 21 and an engagement member 22 disposed on and projecting distally from the grip plate 21. Catheter 2 and needle 3 are arranged such that when needle 3 is inserted into catheter 2, grip plate 21 is oriented towards the upper side of catheter 2 and aligned with connection port 7. . A protruding member 15 on the proximal end 5 of the catheter 2 typically engages an engagement member 22 on the grip plate 21 so that the needle 3 is aligned relative to the catheter 2 about the axis AA. Adapted to prevent rotation.

Catheter device 1 further includes a lever member 23 that is adapted to be removably attached to catheter 2 and that is advanced from a retracted proximal position relative to introducer needle 3. The catheter 2 is further adapted to move the catheter 2 axially to the distal position. Lever member 23 includes a lever arm 24 and a connector 25 for connecting to catheter 2 . As shown in Figure Ib, the lever member 23 interacts with the grip plate 21 of the introducer needle 3 and moves the catheter 2 to advance distally. Connector 25 further includes an engagement recess 26 for engaging projection 15 on proximal end 5 of catheter 2 to removably connect lever member 23 to catheter 2. It is adapted to. Additionally, the connector 25 includes a locking protrusion 28 disposed proximally on the connector and adapted to engage the engagement member 22 on the introducer needle. ing. The projecting member 15 on the catheter 2 thus engages the engagement recess 26 of the connector 25 and the locking projecting member 28 of the connector 25 engages the engagement member 22 on the grip plate 21 of the needle 3. . This arrangement ensures that all the main units contained within catheter device 1 (i.e. catheter 2, introducer needle 3, and lever member 23) are aligned around the A-A axis with respect to each other. This will ensure that it will be locked against rotation.

Figures 2a-2c further illustrate the function of the lever member. In FIG. 2a, the catheter 2 is in a retracted proximal position, where the beveled tip 18 of the introducer needle 3 projects a length d from the distal end 13 of the catheter tube 12. . In FIG. 2b, the lever member 23 has been moved to the first indicator stop surface 35 on the grip plate 21, as indicated by arrow B in FIG. A first advanced distal position corresponding to the hooding of the tip 18 is provided. Thus, catheter tube 12 has been advanced a distance d relative to the introducer needle. In FIG. 2c, the lever member 23 has been fully moved along the grip plate 21 resulting in a fully advanced distal position in which the catheter tube 14 is positioned relative to the introducer needle 3. It is moved forward by a distance D.

Figure 2c further illustrates an embodiment in which the length of the extension 19 of the needle 3 is the total length that the lever member 23 will advance the catheter 2 when fully advanced. is at least equal to or greater than D.

FIG. 3a illustrates an embodiment in which the lever member 23 is removably attached to a connection port 7 located on the elongate housing 4 of the catheter 2. FIG. 3b illustrates the same embodiment including an introducer needle 3, in which the plug 10 is positioned over the connection port 7 and the lever member 23 is directed towards the grip plate 21 of the needle 3. and is fully exercised. Thus, the head 16 of the introducer needle 3 is visible proximal to the catheter 2 as the catheter 2 is fully advanced relative to the needle 3, and the beveled tip (not shown) It is designed to be overhooded by a tube 12.

FIG. 4a illustrates an embodiment in which the lever arm 24 of the lever member 23 includes a protrusion 33 and the proximal end of the connector 25 of the lever member 23 includes a retaining element 34. The retaining element 34 is adapted to engage the projection 33, as shown in Figure 4b, so that the lever member 23 can be reversibly locked in the fully advanced position of the catheter. It has become. The retaining element may be arranged on the elongate housing 4 of the catheter 2. This is suitable when the lever member 23 is connected to the connection port. 5a to 5f illustrate different non-limiting embodiments of the lever member 23, including different versions for the lever arm 24, the interaction member 27, the grip plate 21 and the stop surface 35.

5a and 5b illustrate an embodiment of a catheter device in which the lever arm 24 has a curved shape and the convex surface of the lever arm 24 is located above the grip plate 21. It engages a stop surface 35 in the form of an edge.

FIG. 5c illustrates an embodiment in which the lever arm 24 has an L-shaped shape and the outer angle of the L-shaped shape acts as an interaction member 27 and grips the lever arm 24. It engages a stop surface 35 in the form of a groove in the plate 21 .

Figure 5d illustrates an embodiment in which the lever arm 24 has a curved shape and a convex surface is provided with an interaction member 27 in the form of a ridge. Said ridge engages a stop surface 35 in the form of a groove in the grip plate 21.

FIG. 5e illustrates an embodiment in which the lever arm 24 has an L-shaped shape and the outer angle of the L-shaped shape acts as an interaction member 27. In this embodiment, grip plate 21 does not include a stop surface. Such embodiments may be provided with a visual indicator (not shown) on the grip plate 21 and/or alternatively a visual and/or tactile indicator on the extension portion 19. indicators (not shown) may be provided.

FIG. 5f illustrates an embodiment in which the lever arm 24 has an L-shaped configuration, and the outer angle of the L-shaped configuration acts as an interaction member 27. FIG. In this embodiment, the grip plate 21 is provided with a stop surface 35 in the form of an edge that is arranged in the opposite direction compared to the embodiment shown in FIGS. 5a-5b.

FIG. 6 illustrates another embodiment of a catheter device 1 according to the present disclosure. Many features are the same as in FIG. 1a, and references to those features are the same in FIG. 6. The extension 29 of the needle 3 is provided with a rib 30 which surrounds the extension 29 radially from the axis AA (not shown) and proximal to the connector 25 of the lever member 23. The end is provided with a locking flange 32 that engages a rib 30 on the extension 29 of the needle 3 when the catheter 2 is moved distally relative to the needle 3. It is adapted as follows.

Figures 7a and 7b further illustrate the function of the extension portion 29. The extension 29 of the needle 3 includes a chamfered surface 31 along one side of the entire extension 29, giving the extension 29 a U-shaped cross-section. By lowering the lever arm 24 as indicated by arrow B in FIG. 7a, the catheter 2 is moved distally in direction C relative to the introducer needle 3. Ribs 30 (not shown) are adapted to engage locking flanges 32 to prevent needle 3 from being reinserted distally into catheter 2. By rotating the needle 3 as shown by arrow D in Figure 7b, the chamfered surface 31 is aligned with the locking flange 32, thereby causing the needle to rotate as shown by arrow F. 3 into the catheter, or it is possible to reposition the catheter 2 by pulling it proximally, as indicated by arrow E. The correct positioning of the locking flange 32 and the chamfered surface 31 is ensured when the grip plate is facing upward and aligned with the connection port on said upper side (i.e. for insertion of the catheter into the patient). The catheter device needle placement (for catheter device needle placement) is not critical unless they are aligned.

Those skilled in the art will recognize that the invention is not limited to the preferred embodiments described above. Those skilled in the art will further appreciate that modifications and variations are possible within the scope of the appended claims. For example, the precise shape of the lever arm, stop surface, or interaction member may vary without departing from the scope of the following claims. Additionally, modifications to the disclosed embodiments can be understood and realized by those skilled in the art who practice the claimed invention from a study of the drawings, this disclosure, and the appended claims.

Claims (21)

A catheter device (1), said catheter device (1) having an axis AA, a lower side (L) adapted to face a patient, and a lower side (L) adapted to face away from said patient. an upper side (U) opposite said lower side (L), said catheter device (1) comprising a catheter (2) and a hypodermic introducer needle (3);
The catheter (2) includes an axially elongated housing (4) having a proximal open end (5) adapted to receive a coupling mechanism or plug. The housing (4) has an internal passageway (6) and a connection port (7) with an internal orifice (8) located on the upper side of the catheter, and the proximal open end ( a protruding member (15) on said outer surface of said catheter (2) further comprising a flexible catheter tube (12) connected to said elongated housing (4); The flexible catheter tube (12) includes a distal tip end (13) and a lumen (14) in fluid communication with the internal passageway (6) of the housing (4). and
Said introducer needle (3) comprises a proximal head (16), a hollow needle (17) with a distal beveled tip (18), and an extension (19, 29); , 29) connects said needle (17) with said head (16) and when said needle (3) is inserted into said catheter (2) said proximal part of said catheter (2) The head (16) is adapted to engage the distal end (5), the head (16) having an axial channel (20) in fluid communication with the interior of the hollow needle (17) and a grip plate ( 21) and an engaging member (22), the grip plate (21) is disposed on the head (16) and extends in a direction perpendicular to the axial direction. , the engagement member (22) is disposed on the grip plate (21) and projects distally from the grip plate (21);
The catheter (2) and needle (3) are arranged such that the grip plate (21) is attached to the upper side (U) of the catheter (2) when the needle (3) is inserted into the catheter (2). ) on the proximal end (5) of the catheter (2), the protruding member (15) on the proximal end (5) of the catheter (2) engaging the engagement member (22) on the grip plate (21) to prevent rotation of the needle (3) about the axis AA relative to the catheter (2); In a catheter device (1) adapted to
The catheter device (1) further comprises a lever member (23) adapted to be removably attached to the catheter (2) and the introducer needle (3). further adapted to move said catheter (2) axially from a retracted proximal position to an advanced distal position relative to said retracted proximal position. , the beveled tip (18) of the introducer needle (3) projects from the distal end (13) of the catheter tube (12), and in the advanced distal position: the beveled tip (18) of the introducer needle (13) is hooded by the catheter tube (12);
Said catheter device (1) further comprises visual and/or tactile indicators on said grip plate (21) and/or on said extensions (19, 29), at least for advancement of It is characterized by indicating the position where the person was forced to
a) said catheter (2) is advanced by a distance d, said distance d corresponding to the length of said beveled tip (18) of said needle (3); and
Optionally, b) said catheter (2) is advanced a distance D, said distance D corresponding to a length greater than the length of said beveled tip (18) of said needle (3); a catheter device (1), for example, corresponding to a length twice or more than said length of said beveled tip (18). Catheter device (1) according to claim 1, wherein the lever member (23) comprises a lever arm (24) and a connector (25) for connecting with the catheter (2). 3. The lever member (23) interacts with the grip plate (21) of the introducer needle (3) and moves the catheter (2) to advance distally. catheter device (1). The connector (25) further includes an engagement recess (26), which engages the protrusion (15) on the proximal end (5) of the catheter (2). Catheter device (1) according to claim 2 or 3, adapted to engage and removably connect the lever member (23) to the catheter (2). A catheter device (1) according to any one of claims 1 to 3, wherein the lever member (23) is adapted to be removably attached to the connection port (7) of the catheter (2). ). The length of the extension (19, 29) of the needle (3) is at least equal to the total length that the lever member (23) will advance the catheter (2) when fully advanced. Catheter device (1) according to any one of claims 1 to 5, wherein the catheter device (1) is larger than or equal to . The indicator includes a stop surface (35), the stop surface (35) being disposed on the grip plate (21) and the lever member (23) engaging the stop surface (35). Catheter device (1) according to any one of claims 1 to 6, adapted to provide a tactile indication to the user. Catheter device (1) according to claim 7, wherein the stop surface (35) comprises a groove, a protrusion or an edge located on the grip plate (21). said lever arm (24) comprises an interaction member (27), said interaction member (27) adapted to interact with said stop surface (35) of said grip plate (21); Catheter device (1) according to claim 7 or 8. Said lever arm (24) has an L-shaped or curved shape and is arranged on said catheter (2), and said interaction member engages said stop surface ( 35) an angle of said L-shaped shape, or a convex surface of said curved shape, or a ridge on said convex surface adapted to engage said L-shaped shape; Catheter device (1) according to any one of claims 7 to 9. Catheter device (1) according to any one of the preceding claims, wherein the indicator is arranged on the extension (19, 29) of the needle (3). The extension (29) of the needle (3) is provided with a rib (30), which surrounds the extension (29) radially from the axis AA. , the proximal end (5) of the catheter (2) or the connector (25) of the lever member (23) is provided with a locking flange (32), the locking flange (32) , so as to engage the rib (30) on the extension (29) of the needle (3) when the catheter (2) is moved distally relative to the needle (3). and the rib (30) is marked to indicate the position of the beveled tip (18) of the needle (3) relative to the distal end (13) of the catheter tube (12). Catheter device (1) according to claim 11. The catheter device (1) further comprises an extension (29) of the needle (3) provided with a rib (30) surrounding the extension radially from the axis AA, the catheter (2) The proximal end (5) of the or optionally the connector (25) of the lever member (23) is provided with a locking flange (32), the locking flange (32) The catheter (2) is adapted to engage the rib (30) on the extension (29) of the needle (3) when the catheter (2) is moved distally relative to the needle (3). and the rib (30) is optionally arranged to indicate the position of the beveled tip (18) of the needle (3) relative to the distal end (13) of the catheter tube (12). Catheter device (1) according to any one of claims 7 to 9, marked. The extension (29) of the needle comprises a chamfered surface (31) along one side of the entire extension (29), resulting in a U-shaped cross-section of the extension (29). The catheter device (1) according to item 12 or 13. Said indicator comprises markings of ribs (30), said markings corresponding to said catheter (2) being advanced a certain distance, each rib (30) being attached to said locking flange. 12. In addition to the tactile indication provided by being pulled over (32) and engaging the locking flange (32), a visual indication is provided to the user. Catheter device (1) according to any one of 14 to 14. Said lever arm (24) includes a protrusion (33), said elongated housing (4) of said catheter (2), or optionally said proximal of said connector (25) of said lever member (23). The end includes a retaining element (34), said retaining element (34) being adapted to engage said protrusion (33), said lever member (23) being fully advanced. Catheter device (1) according to any one of claims 2 to 15, adapted to allow reversible locking of the catheter device (1) in position. A lever member (23) adapted to be connected to a catheter (2) according to any one of claims 1 to 16, wherein said lever member (23) a lever arm (24) adapted to engage a grip plate (21) of an introducer needle (3) inserted therein; and a lever arm (24) adapted to be removably attached to said catheter (2); a lever member (23) including a connector (25) with a connector (25); The connector (25) further includes an engagement recess (26) and a locking protrusion (28), the engagement recess (26) being a protrusion on the proximal end (5) of the catheter (2). (15) and is adapted to removably connect said lever member (23) to said catheter (2), said locking projection member (28) being adapted to engage said lever member (23) with said introducer needle (3). 18. Lever member (23) according to claim 17, adapted to engage the engagement member (22) on the grip plate (21) of. 2. The connector (25) is adapted to engage the connection port (7) of the catheter (2) and removably connect the lever member (23) to the catheter (2). The lever member (23) according to item 17. Said lever arm (24) includes a projecting projection (33), said projection (33) adapted to engage a retaining element (34), said retaining element (34) 20. Any of claims 17 to 19, being arranged on the connector (25) of the lever member (23) or on the proximal end (5) of the catheter (2). The lever member (23) according to item 1. 17. Catheter device (1) according to any one of the preceding claims, for use in placing a catheter (2) in a blood vessel in a patient, said placing ,
i. positioning the catheter device (1) against the skin of the patient at the location where the catheter is to be placed and advancing the catheter device (1) by a distal movement towards a subcutaneous blood vessel; step and
ii. ceasing the distal movement when blood appears in the head (16) of the introducer needle (3), indicating that a blood vessel has been entered;
iii. moving a lever member (23) towards the grip plate (21) while maintaining the introducer needle (3) stationary;
iv. pressing said lever member (23) against said grip plate (21), thereby causing said lever member (23) to slide against said grip plate (21) towards said elongated housing (4); The introducer needle (3) remains stationary until a first indicator is reached and indicates that the beveled tip (18) of the introducer needle (3) is hooded. further causing said catheter (2) to move distally;
v. moving the catheter device (1) further into the blood vessel;
vi. While keeping the introducer needle (3) stationary, further movement of the lever member (23) moves the catheter (2) into the blood vessel in one or optionally more steps. further distally advancing the
vii. When the catheter (2) is fully advanced relative to the introducer needle (3) by use of the lever member (23), the attachment member (11) allows the catheter (2) to be inserted into the skin of the patient. installation steps,
viii. The introducer needle (3) and optionally the lever member (23) are removed from the catheter device (1) and the catheter (2) is removed by use of a removable plug or by connection to an injection device or the like. ) sealing said proximal open end (5) of a catheter device (1).