Catheter device including a lever member

Abstract

The present disclosure relates to a catheter device (1), which includes a catheter (2) and a subcutaneous puncture needle (3), and also includes a lever member (23), which is suitable for being removably attached to the catheter (2) and is also suitable for moving the catheter from a retracted proximal position to an advanced distal position in an axial direction relative to the puncture needle (3), and also includes an indicator to indicate at least the following advancement positions: the catheter (2) is advanced a distance d, the distance d corresponds to the length of the beveled tip (18) of the needle (3), and the catheter (2) is advanced a distance D, the distance D corresponds to the length of the beveled tip (18) of the needle (3).

Description

Technical Field

[0001] The present invention relates to a catheter device comprising a catheter and a hypodermic puncture needle. More particularly, the present disclosure relates to a catheter device as defined in the introductory part of claim 1, comprising a catheter and a hypodermic puncture needle. Background Art

[0002] Intravascular catheter devices are known in the art and are generally used to provide access to subcutaneous blood vessels such as veins to introduce drugs, medicines, chemotherapy, nutrients and / or any other fluids into the subject. SE 355946 discloses a basic type of infusion cannula assembly that is still widely used. The catheter is usually flexible or semi-flexible so as to be assembled in the blood vessel. Since the flexible or semi-flexible catheter cannot pierce the skin of the subject, the puncture needle is inserted into the lumen of the catheter so that the beveled tip of the needle is exposed outside the distal tip end of the catheter. By passing the beveled tip of the needle through the skin and inserting it into the target blood vessel, the patient's vascular system can be entered. The insertion of the needle into the blood vessel is indicated by the presence of blood in the chamber of the needle. Once the beveled tip of the needle is inserted into the blood vessel so that blood appears in the chamber, the catheter and the needle are advanced distally into the blood vessel until the desired position of the catheter is reached. Once the catheter is correctly positioned, the needle is removed by pulling the needle proximally from the catheter and then the needle is discarded.

[0003] A common problem when inserting a catheter is that after blood appears in the chamber, and the needle and catheter are advanced further distally, there is a risk of further puncturing the vessel and thereby exiting the vessel through the opposing vessel wall. This would result in the catheter not being properly positioned. However, this can be difficult to detect and often causes patient discomfort before it is discovered. Once detected, the incorrectly positioned catheter must be discarded and the entire procedure must be repeated with a new catheter device, causing great discomfort and additional pain to the patient, as well as negative economic impact due to the waste of medical materials.

[0004] A common practice to avoid the above problems is to "cap" the needle after the blood vessel has been entered. "Capping" involves maintaining the static position of the needle while moving the partially inserted catheter distally so that the beveled needle tip is withdrawn into the inner lumen of the catheter. Once the beveled needle tip is capped, the catheter device is advanced distally into the vein to the desired position.

[0005] One problem with this technique is when the beveled needle tip punctures the vessel just enough for blood to appear in the needle lumen, but does not fully enter the vessel. The cover can then cause the catheter to slide along the outside of the vessel. Thus, the catheter is not properly placed in the vessel. This will result in the need to repeat the procedure, with the same consequences as above.

[0006] In addition, because the user cannot see the subcutaneous position of the needle or catheter in the blood vessel, the cover is performed blindly. The beveled needle tip can therefore be over-covered or under-covered. Under-covering means that a part of the beveled needle tip is still exposed outside the catheter tip, such as mentioned above, with the risk of further puncturing the blood vessel. Over-covering means that the beveled needle tip penetrates too far into the lumen of the catheter to the proximal side, making the most distal end of the flexible or semi-flexible tip of the catheter unsupported by the needle. Then, the unsupported portion of the catheter may be bent, cut or otherwise obstructed when being advanced into the blood vessel. This may result in insufficient fluid and / or drug administration through the lumen.

[0007] Once the beveled needle tip is capped and in the desired subcutaneous position, the beveled needle tip cannot be pushed distally back to the exposed position where the beveled needle tip protrudes distally from the catheter tip end, as this may cause the beveled needle tip to cut off or tear off a portion of the catheter tip end. Therefore, when it is discovered that the catheter is not properly positioned after the beveled needle tip has been capped, the incorrectly positioned catheter must be discarded and the entire procedure must be repeated with a new catheter device, causing great discomfort and additional pain to the patient, as well as negative economic impact due to the waste of medical materials. Summary of the invention

[0008] The object of the present invention is to alleviate, mitigate or eliminate one or more of the above-mentioned defects and shortcomings in the prior art, and at least solve the above-mentioned problems. The inventor has noticed all the problems listed above that may occur when inserting an intravenous catheter. Specifically, inexperienced users may more frequently incorrectly position the catheter. Therefore, the inventor has determined the purpose of developing a kind of intravenous catheter device, which can guide the user and control the insertion process of the catheter, thereby avoiding the above problems. Another object of the inventor is to develop an intravenous catheter device that is easy to use and will not significantly change the practice compared to today. In addition, an object of the inventor is to develop an intravenous catheter device that can be operated with one hand, so that using one hand, for example, to hold the patient's limbs, while inserting the catheter with the other hand becomes possible.

[0009] According to a first aspect, there is provided a catheter device having an axis AA, a lower side adapted to face toward a patient and an upper side opposite to the lower side adapted to face away from the patient, the catheter device comprising a catheter and a subcutaneous puncture needle;

[0010] The catheter comprises an axially elongated housing having a proximal open end adapted to receive a coupling mechanism or a plug, the housing further comprising an internal passageway, a connection port with an internal aperture disposed on an upper side of the catheter, a protruding member on an outer surface of the proximal open endway, and the catheter further comprising a flexible catheter tubing connected to the elongated housing, the flexible catheter tubing comprising a distal tip end and a lumen in fluid communication with the internal passageway of the housing;

[0011] The puncture needle comprises a proximal head, a hollow needle having a distal beveled tip, an extension portion connecting the needle to the head and adapted to engage with the proximal end of the catheter when the needle is inserted into the catheter, the head comprising an axial channel in fluid communication with the interior of the hollow needle, a gripping plate arranged on the head and extending in a direction perpendicular to the axial direction, and an engagement member arranged on the gripping plate and protruding distally from the gripping plate,

[0012] the catheter and the needle being arranged such that when the needle is inserted into the catheter, the gripping plate is directed toward the upper side of the catheter and aligned with the connection port, and wherein the protruding member on the proximal end of the catheter is adapted to engage with the engagement member on the gripping plate to prevent the needle from rotating relative to the catheter about the axis AA;

[0013] The catheter device also includes a lever member adapted to be removably attached to the catheter and further adapted to move the catheter in an axial direction relative to the puncture needle from a retracted proximal position to an advanced distal position, wherein in the retracted proximal position the beveled tip of the puncture needle protrudes from the distal end of the catheter tube, and wherein in the advanced distal position the beveled tip of the puncture needle is covered by the catheter tube, the catheter device also including a visual and / or tactile indicator on the gripping plate and / or on the extension portion to indicate at least the following advancement positions: a) the catheter is advanced a distance d corresponding to the length of the beveled tip of the needle, and optionally b) the catheter is advanced a distance D corresponding to >the length of the beveled tip of the needle, such as 2x the length of the beveled tip, or more.

[0014] According to some embodiments, the lever member includes a lever arm and a connector for connecting to a catheter.

[0015] According to some embodiments, the lever member interacts with a gripping plate of the introducer needle to move the catheter for distal advancement.

[0016] According to some embodiments, the connector further comprises an engagement recess adapted to engage with a protrusion on the proximal end of the catheter to removably connect the lever member to the catheter.

[0017] According to some embodiments, the lever member is adapted to be removably attached to a connection port of the catheter.

[0018] According to some embodiments, the length of the extended portion of the needle is at least equal to or greater than the total length that the lever member will advance the catheter when fully advanced.

[0019] According to some embodiments, the indicator comprises a stop surface disposed on the grip plate such that the lever member will engage the stop surface, thereby providing a tactile indication to the user.

[0020] According to some embodiments, the stop surface comprises a groove, a protrusion or an edge arranged on the grip plate.

[0021] According to some embodiments, the lever arm comprises an interaction member adapted to interact with a stop surface of the grip plate.

[0022] According to some embodiments, the lever arm has an L-shape or a curved shape and is arranged on the catheter such that the interaction member comprises an angle of the L-shape, or a convex surface of the curved shape, or a ridge on the convex surface adapted to engage with a stop surface of the gripping plate.

[0023] According to some embodiments, the indicator is arranged on an extended portion of the needle.

[0024] According to some embodiments, the extension portion of the needle is provided with ribs radially surrounding the extension portion from the axis AA, and the connector of the proximal end of the catheter or the lever member is provided with a locking flange, which is suitable for engaging with the ribs on the extension portion of the needle when the catheter moves distally relative to the needle, and 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.

[0025] According to some embodiments, the extension portion of the needle includes a chamfered surface along one side of the entire extension portion, resulting in a U-shape in cross-section of the extension portion.

[0026] According to some embodiments, the indicator includes markings on the ribs that will correspond to the catheter being advanced a specified distance, providing a visual indication to the user in addition to the tactile indication provided by each rib being pulled over and engaged with the locking flange.

[0027] According to some embodiments, the lever arm includes a lug and the proximal end of the elongated housing of the catheter or optionally the connector of the lever member includes a retaining element adapted to engage with the lug so that the lever member reversibly locks the catheter device in the fully advanced position.

[0028] According to a second aspect, there is provided a lever member adapted to be connected to a catheter, the lever member comprising a lever arm adapted to engage a gripping plate of an introducer needle inserted into the catheter, and a connector adapted to be removably attached to the catheter.

[0029] According to some embodiments, the connector further comprises an engagement recess adapted to engage with a protrusion on the proximal end of the catheter to removably connect the lever member to the catheter.

[0030] According to some embodiments, the connector is adapted to engage with a connection port of a catheter to removably connect the lever member to the catheter.

[0031] According to some embodiments, the lever arm comprises a protruding lug adapted to engage with a retaining element arranged on a connector of the lever member or on the proximal end of the catheter.

[0032] According to a third aspect, there is provided a catheter device according to the first aspect for placing a catheter in a blood vessel in a patient, comprising the following steps:

[0033] 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 by distal movement toward a subcutaneous blood vessel,

[0034] ii. When blood appears in the tip of the puncture needle, distal movement is stopped, indicating that the blood vessel has been entered,

[0035] iii. moving the lever member toward the gripping plate while keeping the puncture needle stationary,

[0036] iv. pressing the lever member against the grip plate, thereby sliding the lever member against the grip plate toward the elongated housing, further moving the catheter distally relative to the stationary introducer needle until a first indicator is reached indicating that the beveled tip of the introducer needle is covered,

[0037] v. Further move the catheter device into the blood vessel,

[0038] vi. further moving the lever member while keeping the introducer needle stationary to further advance the catheter distally into the blood vessel in one or optionally more than one step,

[0039] vii. attaching the catheter against the patient's skin by the attachment member when the catheter is fully advanced relative to the introducer needle by using the lever member,

[0040] viii. Removing the introducer needle and lever member from the catheter device and sealing the proximal open end of the catheter by using a removable plug or by connecting to an infusion set or the like.

[0041] The present invention also provides a method for placing a catheter in a blood vessel in a patient's body, comprising the steps of:

[0042] i. positioning a catheter device including a catheter and a puncture needle against the patient's skin at the location where the catheter is to be placed, and advancing the catheter device by distal movement toward a subcutaneous blood vessel,

[0043] ii. When blood appears in the tip of the puncture needle, distal movement is stopped, indicating that the blood vessel has been entered,

[0044] iii. moving the lever member toward the grip plate on the puncture needle while keeping the puncture needle stationary relative to the patient,

[0045] iv. pressing the lever member against the grip plate, thereby sliding the lever member against the grip plate toward the elongated housing, further moving the catheter distally relative to the stationary introducer needle until a first indicator is reached indicating that the beveled tip of the introducer needle is covered,

[0046] v. Further move the catheter device into the blood vessel,

[0047] vi. further moving the lever member while keeping the introducer needle stationary to further advance the catheter distally into the blood vessel in one or optionally more than one step,

[0048] vii. attaching the catheter against the patient's skin by the attachment member when the catheter is fully advanced relative to the introducer needle by using the lever member,

[0049] viii. Removing the introducer needle and lever member from the catheter device and sealing the proximal open end of the catheter by using a removable plug or by connecting to an infusion set or the like.

[0050] The present invention will become apparent from the detailed description given below. The detailed description and specific examples disclose preferred embodiments of the present invention only by way of illustration. Those skilled in the art will appreciate from the guidance in the detailed description that changes and modifications may be made within the scope of the present invention.

[0051] Therefore, it should be understood that the invention disclosed herein is not limited to the specific components of the described device or the steps of the described method, because such devices and methods can change. It should also be understood that the terms used herein are only used for the purpose of describing specific embodiments and are not intended to be restrictive. It should be noted that, as used in the specification and the appended claims, the articles "a / kind (a)", "an / kind (an)", "the" and "said" are intended to mean that there are one or more elements, unless the context clearly stipulates otherwise. Therefore, for example, mentioning "a unit" or "said unit" can include several devices and similar elements. In addition, the words "include", "comprise", "contain", and similar expressions do not exclude other elements or steps.

[0052] definition

[0053] The term "user" is to be interpreted as a caregiver who places a catheter or performs other medical treatment, preparation, procedure, etc. on a patient.

[0054] The term "distal" is to be interpreted as referring to a position or location away from a user. The term "distally" is to be interpreted as referring to movement away from a user.

[0055] The term "proximal" is to be interpreted as referring to a position or location close to a user. The term "proximally" is to be interpreted as referring to a movement toward a user.

[0056] The term "vessel" or "blood vessel" is to be interpreted as any blood vessel in a patient's body. It may relate to an artery or a vein.

[0057] The term "bevel angle" is discussed herein as one angle. However, a beveled tip may include more than one angled surface, such as a heel and a secondary bevel of the bevel. Important for understanding the present disclosure is that the term "bevel length" encompasses the entire bevel length, including all beveled surfaces of the tip. BRIEF DESCRIPTION OF THE DRAWINGS

[0058] Figure 1a A perspective view of components included in a catheter device according to an embodiment of the present disclosure is shown. Figure 1b Shown as Figure 1a A cross-sectional view of the catheter device when assembled is shown.

[0059] Figure 2a -c shows a cross-sectional view of a catheter device according to an embodiment of the present disclosure, illustrating the function of the lever member.

[0060] Figure 3a and 3b 3a illustrates a catheter with a lever member, and 3b illustrates a catheter with a lever member and a puncture needle inserted into the catheter.

[0061] Figure 4a and 4b Shown is a cross-sectional view of a retention arrangement between a catheter and a lever member according to an embodiment of the present disclosure.

[0062] Figure 5a -f shows cross-sectional views of other embodiments of the present disclosure.

[0063] Figure 6 A perspective view of components included in a catheter device according to an embodiment of the present disclosure is shown.

[0064] Figure 7a and 7b The embodiment according to the present disclosure is shown Figure 6 A perspective view of an embodiment of the invention illustrating the function of the extension portion. DETAILED DESCRIPTION

[0065] The above objects as well as additional objects, features and advantages of the present invention will be more fully understood by referring to the following illustrative and non-limiting detailed description of example embodiments of the present invention when taken in conjunction with the accompanying drawings.

[0066] The catheter device according to the present disclosure has an axis AA, a lower side adapted to face the patient, and an upper side opposite to the lower side adapted to face away from the patient. The catheter device comprises a catheter and a hypodermic puncture needle.

[0067] The catheter comprises an axially elongated shell having a proximal open end adapted to receive a coupling mechanism or a plug. For example, the proximal end may be provided with a female Luer lock, which is assembled as a coupling mechanism for easy assembly with a syringe, etc. Through the coupling mechanism, the catheter can be connected to an infusion device or any other medical device generally connected to the catheter. The shell also includes an internal passage, a connection port with an internal orifice arranged on the upper side of the catheter. The connection port can be used, for example, to inject medicine or liquid medicine into an infusion perfused into a patient via a catheter. The shell also includes a protruding member on the outer surface of the proximal open end, so as to engage and lock the plug or coupling mechanism disclosed above. The catheter also includes a flexible catheter tubing connected to the elongated shell, the flexible catheter tubing including a distal tip end and a lumen, and the lumen is in fluid communication with the internal passage of the shell. The flexible catheter tubing is a part of the catheter placed in the blood vessel, and must be flexible so as not to damage or puncture the blood vessel into which it is inserted.

[0068] The puncture needle comprises a proximal head, a hollow needle having a distal beveled tip, and an extension portion connecting the needle to the head. The extension portion is adapted to engage with the proximal end of the catheter when the needle is inserted into the catheter. The head comprises an axial channel in fluid communication with the interior of the hollow needle, a gripping plate arranged on the head and extending in a direction perpendicular to the axial direction, and an engagement member arranged on the gripping plate and protruding distally from the gripping plate.

[0069] Except hypodermic hollow needle, catheter and puncture needle are typically made of transparent or translucent synthetic polymer material. Typically, the material used for manufacturing can be polyurethane or polytetrafluoroethylene, such as FEP. Hypodermic hollow needle is usually made of stainless steel, and the steel is optionally electroplated.

[0070] Catheter and needle are arranged so that when needle is inserted into catheter, grip plate points to the upper side of catheter and aligns with connection port.In addition, the protruding member on the proximal end of catheter is adapted to engage with the engagement member on grip plate to prevent needle from rotating around axis AA relative to catheter.

[0071] The catheter device also includes a lever member adapted to be removably attached to the catheter and further adapted to move the catheter in an axial direction from a retracted proximal position to an advanced distal position relative to the puncture needle. In the retracted proximal position, the beveled tip of the puncture needle protrudes from the distal end of the catheter tube. In the advanced distal position, the beveled tip of the puncture needle is covered by the catheter tube. The catheter device also includes an indicator to indicate at least the following advancement positions: a) the catheter is advanced a distance d, the distance d corresponds to the length of the beveled tip of the needle, and optionally b) the catheter is advanced a distance D, the distance D corresponds to the length of the beveled tip of the needle, such as 2x the length of the beveled tip, or more. The device may include additional indicators related to other distances that are useful for indication during use of the catheter device according to the present disclosure.

[0072] The catheter device is initially used in the same manner as a conventional catheter device. Thus, the catheter device is positioned against the patient's skin, keeping the axis AA almost parallel to the skin surface, slightly tilted so that the distal beveled tip of the puncture needle is in contact with the skin, while the proximal end of the catheter and the head of the puncture needle are maintained at a small height from the skin surface. Thereafter, the catheter device is advanced distally so that the distal beveled tip passes through the skin and eventually also through the target blood vessel. The user will know that the blood vessel has been pierced by the distal beveled tip because blood will enter the puncture needle and appear in the axial channel of the head of the needle. Thus, the user will visually observe the blood appearing in the head of the needle through the transparent or translucent material.

[0073] Once blood enters the axial passage, the lever member moves to the first indicator, whereby the catheter moves to the distal position of advancement from the proximal position of the retraction relative to the needle. The position of the lever member moving to the first indicator means that the catheter has been advanced a distance d relative to the needle, wherein the distance d is equal to the length of the distal beveled tip of the needle. Therefore, the distal beveled tip of the needle has been covered by the catheter tip end. At this point in the procedure, the beveled tip of the needle cannot move distally to protrude from the distal tip end of the catheter, because this can cause the beveled tip to cut off or tear off a small piece of catheter tubing. Therefore, using the lever member to reach the first indicator is also the point of no return of the catheter device. If anything related to the catheter placement is found to be incorrect, the entire catheter device must be discarded. When the lever member does not have any contact with blood or any other body fluid, the lever member can be removed from the catheter device and reused with a new catheter device.

[0074] After performing the above-mentioned cover, the catheter device is further moved distally into the blood vessel. Thereafter, the lever member is further moved to the second indicator, whereby the catheter moves from the first advanced distal position to the second advanced distal position relative to the needle. Moving the lever member to the position of the second indicator means that the catheter has been advanced a distance D relative to the needle. The distance D is equal to a length exceeding the length of the distal beveled tip of the needle, such as twice (2x) or more of the length of the distal beveled tip. Therefore, this action will ensure that the catheter tube is well inserted into the blood vessel, exceeding the distal beveled tip of the puncture needle.

[0075] In the event that the beveled tip is partially but not fully entered into the vessel in the first step, the cover will advance the catheter to the same position as the beveled tip point within the vessel, and further advancement of the catheter device into the vessel will position the catheter tip further into the vessel without the risk of the beveled tip protruding from the catheter tip puncturing the vessel on the opposite side.

[0076] The length of the bevel tip, and therefore the distances d and D, depends on the gauge of the needle being used. A high gauge corresponds to a needle with a smaller diameter, while a low gauge corresponds to a needle with a larger diameter. The larger the diameter of the needle, the longer the length of the bevel tip. The length of the bevel tip will also depend on the bevel angle of the needle tip. Therefore, the indicator is adapted to the gauge and bevel angle of the needle to be used. A person skilled in the art will be able to determine the length and distance for each gauge and bevel angle, and will therefore be able to place the indicator so that the length and distance are indicated according to the present disclosure.

[0077] All operations during the placement of the catheter can be accomplished with one hand using the device of the present disclosure, from piercing the skin to covering the beveled tip of the needle. Pulling the lever member while holding the catheter device with one hand requires an intuitive action by the user and can be accomplished with one finger on the same hand. Thus, the user can hold the patient's limb with the other hand to stretch the skin, etc. before piercing the skin.

[0078] The catheter device disclosed herein provides a clear indication of when the beveled tip is covered and over-covered, respectively. The indication can be visual and / or tactile. Therefore, the process of placing a catheter is no longer blindly performed using the currently disclosed device. The user will always be assured that once the first indicator is reached using the lever member, the beveled tip of the needle is covered and the risk of further piercing any tissue is therefore reduced.

[0079] The lever member may include a lever arm and a connector for connecting to the catheter. The lever arm must be adapted to be actuated so that the catheter moves distally relative to the puncture needle, wherein actuation of the lever arm will not cause the puncture needle to move in any direction, neither distally nor proximally. Providing a lever member with a lever arm enables an intuitive action by a user to pull the lever arm proximally to advance the catheter distally. The lever arm preferably includes an L-shaped or curved shape.

[0080] The lever member can interact with the gripping plate of the puncture needle to move the catheter to advance distally. Therefore, the lever member or optionally the lever arm preferably moves proximally to interact with the gripping plate, which is positioned on the puncture needle and is in a proximal position relative to both the lever member and the catheter. Therefore, the gripping plate provides a resistance to the input force applied by the lever member. This causes the lever member to output a force applied to the catheter at the point where the lever member is attached or connected to the catheter, thereby moving the catheter in a direction away from the gripping plate, i.e., distally. Therefore, the lever function of the lever member is enhanced.

[0081] As mentioned above, the lever member may include a connector. The connector may include an engagement recess adapted to engage with a protrusion on the proximal end of the catheter to removably connect the lever member to the catheter. The engagement of the engagement recess with the proximal protrusion further prevents the lever member from rotating about the axis AA. Thereby ensuring that the lever member and optionally the lever arm are aligned with the gripping plate of the connecting sleeve and needle of the catheter. Thus, the lever member may interact with the gripping plate as disclosed above.

[0082] The lever member may alternatively be adapted to be removably attached to the connection port of the catheter. Thus, the connector is adapted to at least partially surround or encircle the outer circumference of the connection port, directly adjacent to the elongated housing, so as not to prevent the plug from being able to be fitted on the connection port. Preferably, the connector does not completely surround or encircle the connection port so that it can be more easily removed from the connection port, regardless of whether the connection port is equipped with a plug. Once the lever member has been removably attached to the connection port, the plug fitted on the connection port can help keep the lever member in place. However, this is not necessary for the function of the lever member.

[0083] Once the catheter has been correctly positioned, the lever member can be easily removed together with the needle. Since the lever member moves toward the gripping plate of the puncture needle during placement of the catheter, it is easy to grasp the lever member and the gripping plate at the same time and remove both items from the catheter by pulling them proximally until they exit the catheter. Therefore, no additional steps are required to remove the lever member from the catheter. The lever member removably attached to the proximal end of the catheter and the lever member removably attached to the connection port can be removed accordingly.

[0084] The length of the extended portion of the needle may preferably be at least equal to or greater than the total length of the catheter that the lever member can advance. This will provide stability during operation of the catheter device, in particular during removal of the puncture needle after the catheter has been correctly positioned in the blood vessel. Thus, when the catheter tubing is advanced distally beyond the needle, and when the needle is further proximally pulled back and removed from the catheter, there will be no risk of the needle shaking or moving in a direction perpendicular to the axis AA. Thus, the risk of damaging the catheter tubing during removal of the needle is minimized. In addition, the manipulation of the needle by the user placing the catheter becomes stable and safe.

[0085] The indicator may include a stop surface. The stop surface may be arranged on the grip plate so that the lever member will engage with the stop surface, thereby providing a tactile indication to the user. The stop surfaces arranged on the grip plate are placed at different distances from the center AA axis on the distal surface of the grip plate. The first indicator stop surface will be placed at a longer distance from the center AA axis than the second indicator stop surface. Therefore, the lever member will first engage with the first indicator stop surface when moving toward the grip plate. Further proximal movement of the lever member will cause the lever member to slide along the grip plate toward the center AA axis of the catheter device and engage with the second indicator stop surface.

[0086] The stop surface may include a groove, a protrusion or an edge arranged on the gripping plate. The specific shape of the stop surface is not important. The stop surface is arranged at a predetermined position on the gripping plate, wherein the position will correspond to the catheter being advanced by at least a distance d and optionally D during operation of the catheter device as described in the present disclosure.

[0087] The lever arm may include an interaction member adapted to interact with the stop surface of the gripping plate. As disclosed above, the lever arm preferably has an L-shaped or curved shape. The interaction member may preferably include an outer corner of the L-shaped shape, or a convex surface of the curved shape, or a ridge on the convex surface adapted to engage with the stop surface of the gripping plate. However, a person skilled in the art will recognize that other shapes are possible that will provide the lever member with the functionality disclosed herein.

[0088] The extension of the needle may be provided with ribs that radially surround the extension from the 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 that is adapted to engage with the ribs on the extension of the needle when the catheter moves distally relative to the needle. For each rib that engages with the locking flange, a tactile indication is provided to the user. In addition, the ribs that engage with the locking flange will prevent the needle from moving back into the catheter. This embodiment of the extension may be combined with any lever member disclosed herein.

[0089] Once the beveled tip of the needle is covered by the catheter tip end, as disclosed above, the rib on the extension part is engaged with the locking flange, thereby preventing any distal movement of the needle relative to the catheter. Therefore, at this stage, the entire catheter device can be further advanced by only pushing the needle distally. Due to the engagement of the rib with the locking flange, there is no risk of the needle protruding the catheter tip end by pushing the needle. Therefore, the risk of the beveled tip cutting off a part of the catheter tip end is very small or there is no such risk. The indicator can be arranged on the extension part of the needle alternatively or additionally. Therefore, the extension part of the needle can be provided with a rib radially surrounding the extension part from the axis AA, as disclosed above, and the rib can be marked so as to indicate the position of the beveled tip of the needle relative to the distal end of the catheter pipe. Therefore, the indicator includes the mark of the rib corresponding to the catheter being pushed into the specified distance, in addition to the tactile indication provided by each rib that is pulled through and engaged with the locking flange, a visual indication is also provided for the user. The mark of the rib can include the symbol, letter, number or color of the specific rib. Thus, a rib that will cause the catheter to move distally a distance d when engaged with the locking flange can be marked, as well as a rib that will cause the catheter to move distally a distance D when engaged with the locking flange. The markings can be the same or different. The first marking located proximally on the introducer needle and closest to the gripping plate will indicate the distance d, while any other marking located more distally and farther from the gripping plate will indicate one or more distances D.

[0090] The extension of the needle provided with ribs according to any of the above embodiments may also include a chamfered surface along one side of the entire extension, resulting in a U-shaped cross section of the extension. Therefore, rotation of the needle will enable the needle to re-enter the catheter because the flat chamfered surface of the extension will not engage with the locking flange. Therefore, the needle can be re-advanced into the catheter. If the puncture needle accidentally moves out of the catheter, this may be useful. However, more importantly, this is crucial for being able to introduce the puncture needle into the catheter during assembly of the catheter device. However, if the catheter device has been inserted into the patient's body, the needle must not be rotated to reinsert the needle into the catheter, as the above in this disclosure has been given.

[0091] The lever arm may include a lug and the elongated housing of the catheter or optionally the proximal end of the connector of the lever member may include a retaining element. The retaining element is adapted to engage with the lug so that the lever member reversibly locks the catheter device in the fully advanced position. It is feasible to design this locking arrangement to have other features in addition to the lug and retaining element disclosed herein while maintaining the same functionality.

[0092] Therefore, the present invention discloses a lever member suitable for being connected to a catheter, the lever member comprising a lever arm suitable for engaging with a gripping plate of a puncture needle inserted into the catheter, and a connector suitable for being removably attached to the catheter. The lever member may display all or some of the features disclosed above for the lever member. Therefore, the connector may also include an engagement recess, which is suitable for engaging with a protrusion on the proximal end of the catheter so as to removably connect the lever member to the catheter, as disclosed above. Alternatively, the connector may be suitable for engaging with a connection port of the catheter so as to removably connect the lever member to the catheter, as disclosed above. The lever arm may include a protruding lug suitable for engaging with a retaining element, which is arranged on the connector of the lever member or on the proximal end of the catheter.

[0093] The lever member may be provided separately for the user to connect to the catheter device, or the catheter device may be provided with the lever member when it is manufactured.

[0094] The manufacture and packaging of the lever member and / or catheter device according to the present disclosure should comply with regulatory rules and guidelines for use in healthcare systems. Any device intended for use in healthcare and in contact with patients and / or bodily fluids must comply with such regulatory rules and guidelines.

[0095] According to the present disclosure, there is provided a catheter device according to the above, for placing a catheter in a blood vessel in a patient's body, comprising the following steps:

[0096] 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 by distal movement toward a subcutaneous blood vessel,

[0097] ii. When blood appears in the tip of the puncture needle, distal movement is stopped, indicating that the blood vessel has been entered,

[0098] iii. moving the lever member toward the grip plate while keeping the introducer needle stationary relative to the patient,

[0099] iv. pressing the lever member against the grip plate, thereby sliding the lever member downward against the grip plate, moving the catheter further distally relative to the introducer needle, which remains stationary, until a first indicator is reached, indicating that the beveled tip of the introducer needle is covered,

[0100] v. Further move the catheter device into the blood vessel,

[0101] vi. further moving the lever member while keeping the introducer needle stationary to further advance the catheter distally into the blood vessel in one or optionally more than one step,

[0102] vii. attaching the catheter against the patient's skin when the catheter is fully advanced relative to the introducer needle by using the lever member,

[0103] viii. Removing the introducer needle and lever member from the catheter device and sealing the proximal open end of the catheter by using a removable plug or by connecting to an infusion set or the like.

[0104] The present invention also provides a method for placing a catheter in a blood vessel in a patient's body, comprising the steps of:

[0105] i. positioning a catheter device according to the present disclosure against the patient's skin at the location where the catheter is to be placed, and advancing the catheter device by distal movement toward a subcutaneous blood vessel,

[0106] ii. When blood appears in the tip of the puncture needle, distal movement is stopped, indicating that the blood vessel has been entered,

[0107] iii. moving the lever member toward the gripping plate of the puncture needle while keeping the puncture needle stationary relative to the patient,

[0108] iv. pressing the lever member against the grip plate, thereby sliding the lever member downward against the grip plate, moving the catheter further distally relative to the introducer needle, which remains stationary, until a first indicator is reached, indicating that the beveled tip of the introducer needle is covered,

[0109] v. Further move the catheter device into the blood vessel,

[0110] vi. further moving the lever member while keeping the introducer needle stationary to further advance the catheter distally into the blood vessel in one or optionally more than one step,

[0111] vii. attaching the catheter against the patient's skin when the catheter is fully advanced relative to the introducer needle by using the lever member,

[0112] viii. Removing the introducer needle and lever member from the catheter device and sealing the proximal open end of the catheter by using a removable plug or by connecting to an infusion set or the like.

[0113] Attachment of the catheter to the patient's skin is preferably accomplished by attaching an attachment member to the skin.The attachment member may for example be a wing-like structure arranged on the underside of the catheter.

[0114] The present invention will now be described with reference to the accompanying drawings, in which preferred exemplary embodiments of the present invention are shown. However, the present invention may be embodied in other forms and should not be construed as being limited to the embodiments disclosed herein. The disclosed embodiments are provided to fully convey the scope of the present invention to the skilled person.

[0115] The arrangement and design of the stop surface and the interaction member are mainly shown for the embodiment where the connector of the lever member is attached to the proximal end of the elongated housing, but are not limited to these figures. They can also be combined with the embodiment where the connector is attached to the connection port.

[0116] Figure 1a and 1b An embodiment of a catheter device 1 is shown, which has a central axis AA, a lower side (L) adapted to face the patient and an upper side (U) adapted to face away from the patient opposite to the lower side (L), and the catheter device 1 includes a catheter 2 and a subcutaneous puncture needle 3. The catheter 2 includes an axially elongated housing 4 having a proximal open end 5 adapted to receive a coupling mechanism or a plug. The housing 4 also includes an internal passage 6, a connection port 7 with an internal orifice 8 arranged on the upper side of the catheter, and the orifice 8 is connected to the internal passage 6 through a check valve 9. The plug 10 can be assembled on the connection port 7. A protruding member 15 is arranged on the outer surface of the proximal open end 5. The catheter 2 also includes a flexible catheter tube 12 connected to the elongated housing 4, the flexible catheter tube 12 including a distal tip end 13 and a lumen 14, wherein the lumen 14 is in fluid communication with the internal passage 6 of the housing 4. In this embodiment, the catheter 2 also includes an attachment member 11 for attaching the catheter 2 to the skin of the patient. The puncture needle 3 includes a proximal head 16, a hollow needle 17 having a distal beveled tip 18, and an extension 19 that connects the needle 17 to the head 16 and is adapted to engage with the proximal end 5 of the catheter 2 and the elongated housing 4 when the needle 3 is inserted into the catheter 2. The head 16 includes an axial channel 20 in fluid communication with the interior of the hollow needle 17, a gripping plate 21 arranged on the head 16 extending in a direction perpendicular to the axial direction of the catheter device 1, and an engagement member 22 arranged on the gripping plate 21 and protruding distally from the gripping plate 21. The catheter 2 and the needle 3 are arranged so that when the needle 3 is inserted into the catheter 2, the gripping plate 21 points to the upper side of the catheter 2 and is aligned with the connection port 7. The protruding member 15 on the proximal end 5 of the catheter 2 is typically adapted to engage with the engagement member 22 on the gripping plate 21 to prevent the needle 3 from rotating relative to the catheter 2 about the axis AA.

[0117] The catheter device 1 further comprises a lever member 23 adapted to be removably attached to the catheter 2 and further adapted to move the catheter 2 in the axial direction from a retracted proximal position to an advanced distal position relative to the puncture needle 3. The lever member 23 comprises a lever arm 24 and a connector 25 for connecting to the catheter 2. Figure 1bAs shown, the lever member 23 interacts with the gripping plate 21 of the puncture needle 3 to move the catheter 2 to advance distally. The connector 25 also includes an engagement recess 26, which is adapted to engage with the protrusion 15 on the proximal end 5 of the catheter 2 to removably connect the lever member 23 to the catheter 2. The connector 25 also includes a locking protrusion member 28, which is arranged proximally on the connector and is adapted to engage with the engagement member 22 on the puncture needle. Therefore, the protrusion member 15 on the catheter 2 engages with the engagement recess 26 of the connector 25, and the locking protrusion member 28 of the connector 25 engages with the engagement member 22 on the gripping plate 21 of the needle 3. This arrangement will ensure that all the main units included in the catheter device 1, namely the catheter 2, the puncture needle 3 and the lever member 23, will be locked so that any of the units will not rotate relative to each other around the AA axis.

[0118] Figure 2a -c further illustrates the function of the lever member. Figure 2a In FIG. 1 , the catheter 2 is in a retracted proximal position, wherein the beveled tip 18 of the introducer needle 3 protrudes a length d from the distal end 13 of the catheter tube 12. Figure 2b In the embodiment, the lever member 23 is Figure 2a The catheter tube 12 is moved to the first indicator stop surface 35 on the grip plate 21 as shown by the arrow B in FIG. 1 , leading to the first advanced distal position corresponding to the beveled tip 18 of the catheter tube 12 cover. Thus, the catheter tube 12 has been advanced a distance d relative to the puncture needle. Figure 2c , lever member 23 has moved completely along grip plate 21 to a fully advanced distal position, wherein catheter tube 14 has been advanced a distance D relative to introducer needle 3.

[0119] Figure 2c An embodiment is further illustrated wherein the length of the extension 19 of the needle 3 is at least equal to or greater than the total length D that the lever member 23 will advance the catheter 2 when fully advanced.

[0120] Figure 3a An embodiment is illustrated in which the lever member 23 is removably attached to the connection port 7 arranged on the elongated housing 4 of the catheter 2 . Figure 3b The same embodiment is illustrated, comprising an introducer needle 3, wherein the plug 10 has been positioned on the connection port 7, and the lever member 23 has been fully moved toward the gripping plate 21 of the needle 3. Thus, the head 16 of the introducer needle 3 is visible on the proximal side of the catheter 2 when the catheter 2 has been fully advanced relative to the needle 3, such that the beveled tip (not shown) is over-covered by the catheter tube 12.

[0121] Figure 4aAn embodiment is shown in which the lever arm 24 of the lever member 23 includes a lug 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 with the lug 33, such as Figure 4b As shown, the lever member 23 can be reversibly locked in the position in which the catheter is fully advanced. The retaining element can be arranged on the elongated housing 4 of the catheter 2. This is preferred when the lever member 23 is connected to the connection port.

[0122] Figure 5a -f illustrates different non-limiting embodiments of the lever member 23 , including different versions of the lever arm 24 , the interaction member 27 , the gripping plate 21 and the stop surface 35 .

[0123] Figure 5a and 5b An embodiment of the catheter device is illustrated in which the lever arm 24 has a curved shape and the convex surface of the lever arm 24 engages with a stop surface 35 on the gripping plate 21 in the shape of an edge.

[0124] Figure 5c An embodiment is illustrated wherein the lever arm 24 has an L-like shape, and the outer corner of the L-like shape acts as the interaction member 27 and engages with a stop surface 35 in the grip plate 21 in the shape of a groove.

[0125] Figure 5d An embodiment is shown wherein the lever arm 24 has a curved shape and the convex surface is provided with an interaction member 27 in the shape of a ridge. The ridge engages with a stop surface 35 in the grip plate 21 in the shape of a groove.

[0126] Figure 5e An embodiment is illustrated in which the lever arm 24 has an L-like shape and the outer corner of the L-like shape serves as the interaction member 27. In this embodiment, the gripping plate 21 does not include any stop surface. Such an embodiment may provide a visual indicator (not shown) on the gripping plate 21 and / or alternatively provide a visual and / or tactile indicator (not shown) on the extension 19.

[0127] Figure 5f An embodiment is shown in which the lever arm 24 has an L-like shape and the outer corner of the L-like shape serves as the interaction member 27. In this embodiment, the gripping plate 21 is provided with a stop surface 35 in the shape of an edge, which is aligned with the outer corner of the L-like shape. Figure 5a -b is arranged in the opposite direction compared to the embodiment shown.

[0128] Figure 6 Another embodiment of a catheter device 1 according to the present disclosure is shown. Many features are similar to Figure 1a The same as those in Figure 6The extension 29 of the needle 3 is provided with a rib 30 (not indicated) radially surrounding the extension 29 from the axis AA, and the proximal end of the connector 25 of the lever member 23 is provided with a locking flange 32, which is adapted to engage with the rib 30 on the extension 29 of the needle 3 when the catheter 2 moves distally relative to the needle 3.

[0129] Figure 7a and b further illustrate the function of the extension 29. The extension 29 of the needle 3 includes a chamfered surface 31 along one side of the entire extension 29, resulting in a U-shaped cross section of the extension 29. By lowering the lever arm 24, as shown Figure 7a As shown by arrow B in FIG. 1 , the catheter 2 moves distally relative to the puncture needle 3 in direction C. The rib 30 (not shown) will engage with the locking flange 32 to prevent the needle 3 from being reinserted distally into the catheter 2. By rotating the needle 3, as shown in FIG. Figure 7b As shown by arrow D, chamfered surface 31 is aligned with locking flange 32 so that needle 3 can be reinserted into the catheter, as shown by arrow F, or catheter 2 can be repositioned by pulling catheter 2 proximally, as shown by arrow E. The exact positioning of locking flange 32 and chamfered surface 31 is not important, as long as they are not aligned when the gripping plate faces the upper side and is aligned with the connection port on the upper side, i.e., the arrangement of the catheter device needle for inserting the catheter into the patient's body.

[0130] Those skilled in the art recognize that the present invention is not limited to the preferred embodiments described above. Those skilled in the art also recognize that modifications and variations are possible within the scope of the appended claims. For example, the exact shape of the lever arm, stop surface, or interaction member may vary without departing from the scope of the appended claims. Furthermore, variations to the disclosed embodiments may be understood and effected by those skilled in the art in practicing the claimed invention by studying the drawings, the disclosure, and the appended claims.

Claims

1. A catheter device (1) having an axis AA, a lower side (L) adapted to face a patient and an upper side (U) opposite to the lower side (L) adapted to face away from the patient, The catheter device (1) comprises a catheter (2) and a subcutaneous puncture needle (3), wherein the catheter (2) comprises an axially elongated outer shell (4), the axially elongated outer shell (4) having a proximal open end (5) suitable for receiving a coupling mechanism or a plug, the axially elongated outer shell (4) also comprising an internal passage (6), a connection port (7) with an internal orifice (8) arranged on the upper side (U) of the catheter, a protruding member (15) on the outer surface of the proximal open end (5), and the catheter (2) also comprises a flexible catheter tube (12) connected to the axially elongated outer shell (4), the flexible catheter tube (12) comprising a distal tip end (13) and a lumen (14), the lumen (14) being in fluid communication with the internal passage (6) of the axially elongated outer shell (4); The subcutaneous puncture needle (3) comprises a proximal head (16), a hollow needle (17) having a distal beveled tip (18), an extension portion (19, 29), the extension portion (19, 29) connecting the hollow needle (17) to the head (16) and being adapted to engage with the proximal open end (5) of the catheter (2) when the subcutaneous puncture needle (3) is inserted into the catheter (2), the head (16) comprising an axial channel (20) communicating with the internal fluid of the hollow needle (17), a gripping plate (21) arranged on the head (16) and extending in a direction perpendicular to the axial direction, and an engaging member (22) arranged on the gripping plate (21) and protruding distally from the gripping plate (21), The catheter (2) and the subcutaneous puncture needle (3) are arranged so that when the subcutaneous puncture needle (3) is inserted into the catheter (2), the gripping plate (21) points to the upper side (U) of the catheter (2) and is aligned with the connecting port (7), and wherein the protruding member (15) on the proximal opening end (5) of the catheter (2) is suitable for engaging with the engaging member (22) on the gripping plate (21) to prevent the subcutaneous puncture needle (3) from rotating relative to the catheter (2) around the axis AA, Features The catheter device (1) further comprises a lever member (23) adapted to be removably attached to the catheter (2) and further adapted to move the catheter (2) in the axial direction relative to the subcutaneous puncture needle (3) from a retracted proximal position to an advanced distal position, wherein in the retracted proximal position, the distal beveled tip (18) of the subcutaneous puncture needle (3) protrudes from the distal tip end (13) of the flexible catheter tube (12), and wherein in the advanced distal position, the distal beveled tip (18) of the subcutaneous puncture needle (3) is covered by the flexible catheter tube (12), The catheter device (1) further comprises a visual and / or tactile indicator on the gripping plate (21) and / or on the extension (19, 29) to indicate at least the following advancement positions: a) the catheter (2) is advanced a distance d, the distance d corresponding to the length of the distal beveled tip (18) of the hypodermic puncture needle (3), and b) The catheter (2) is advanced a distance D corresponding to a distance greater than the length of the beveled tip of the subcutaneous puncture needle (3).

2. The catheter device (1) according to claim 1, wherein the lever member (23) comprises a lever arm (24) and a connector (25) for connecting to the catheter (2).

3. The catheter device (1) according to claim 1, wherein the lever member (23) interacts with the gripping plate (21) of the subcutaneous puncture needle (3) to move the catheter (2) to advance distally.

4. The catheter device (1) according to claim 2, wherein the connector (25) further comprises an engagement recess (26), the engagement recess (26) being adapted to engage with the protruding member (15) on the proximal opening end (5) of the catheter (2) to removably connect the lever member (23) to the catheter (2).

5. The catheter device (1) according to claim 1, wherein the lever member (23) is adapted to be removably attached to the connection port (7) of the catheter (2).

6. The catheter device (1) according to claim 1, wherein the length of the extension portion (19, 29) of the subcutaneous puncture needle (3) is at least equal to or greater than the total length that the lever member (23) will advance the catheter (2) when fully advanced.

7. The catheter device (1) according to claim 2, wherein the indicator includes a stop surface (35) arranged on the gripping plate (21), so that the lever member (23) will engage with the stop surface (35) to provide a tactile indication to the user.

8. The catheter device (1) according to claim 7, wherein the stop surface (35) comprises a groove, a protrusion or an edge arranged on the gripping plate (21).

9. The catheter device (1) according to claim 7, wherein the lever arm (24) comprises an interaction member (27) adapted to interact with the stop surface (35) of the gripping plate (21).

10. The catheter device (1) according to claim 9, wherein the lever arm (24) has an L-shape or a curved shape, and is arranged on the catheter (2) so that the interaction member (27) includes an angle of the L-shape, or a convex surface of the curved shape, or a ridge on the convex surface suitable for engaging with the stop surface (35) of the gripping plate (21).

11. The catheter device (1) according to claim 2, wherein the indicator is arranged on the extension (19, 29) of the subcutaneous puncture needle (3).

12. The catheter device (1) according to claim 11, wherein the extension portion (29) of the subcutaneous puncture needle (3) is provided with a rib (30) radially surrounding the extension portion (29) from the axis AA, and the proximal opening 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) being suitable for engaging with the rib (30) on the extension portion (29) of the subcutaneous puncture needle (3) when the catheter (2) moves distally relative to the subcutaneous puncture needle (3), and the rib (30) is marked to indicate the position of the distal beveled tip (18) of the subcutaneous puncture needle (3) relative to the distal tip end (13) of the flexible catheter tube (12).

13. The catheter device (1) according to claim 7 further includes an extension portion (29) of the subcutaneous puncture needle (3), the extension portion (29) of the subcutaneous puncture needle (3) being provided with a rib (30) radially surrounding the extension portion from the axis AA, and the proximal opening end (5) of the catheter (2) or the connector (25) of the lever member (23) being provided with a locking flange (32), the locking flange (32) being suitable for engaging with the rib (30) on the extension portion (29) of the subcutaneous puncture needle (3) when the catheter (2) moves distally relative to the subcutaneous puncture needle (3), and the rib (30) being marked to indicate the position of the distal beveled tip (18) of the subcutaneous puncture needle (3) relative to the distal tip end (13) of the flexible catheter tube (12).

14. A catheter device (1) according to any one of claims 12 or 13, wherein the extension portion (29) of the subcutaneous puncture needle (3) includes a chamfered surface (31) along one side of the entire extension portion (29), resulting in a U-shaped cross-section of the extension portion (29).

15. A catheter device (1) according to any one of claims 12 or 13, wherein the indicator includes markings of ribs (30) corresponding to the catheter (2) being advanced a specified distance, providing a visual indication to the user in addition to the tactile indication provided by each rib (30) being pulled over and engaged with the locking flange (32).

16. A catheter device (1) according to claim 2, wherein the lever arm (24) includes a lug (33) and the proximal end of the axially elongated housing (4) of the catheter (2) or the connector (25) of the lever member (23) includes a retaining element (34), the retaining element (34) being suitable for engaging with the lug (33) so that the lever member (23) can reversibly lock the catheter device (1) in a fully advanced position.

17. The catheter device (1) according to claim 1, for placing a catheter (2) in a blood vessel in a patient, comprising the following steps: i. positioning the catheter device (1) against the patient's skin at the location where the catheter is to be placed and advancing the catheter device (1) by distal movement towards a subcutaneous blood vessel, ii. when blood appears in the head (16) of the hypodermic puncture needle (3), stopping the distal movement, indicating that the blood vessel has been entered, iii. moving the lever member (23) toward the gripping plate (21) while keeping the subcutaneous puncture needle (3) stationary, iv. pressing the lever member (23) against the gripping plate (21), thereby sliding the lever member (23) against the gripping plate (21) toward the axially elongated housing (4), further moving the catheter (2) distally relative to the subcutaneous puncture needle (3) which remains stationary, until reaching a first indicator indicating that the distal beveled tip (18) of the subcutaneous puncture needle (3) is covered, v. further moving the catheter device (1) into the blood vessel, vi. further moving the lever member (23) while keeping the subcutaneous puncture needle (3) stationary to further advance the catheter (2) distally into the blood vessel in one or more steps, vii. by using the lever member (23), when the catheter (2) is fully advanced relative to the subcutaneous puncture needle (3), attaching the catheter (2) against the patient's skin by the attachment member (11), viii. Removing the hypodermic puncture needle (3) and removing the lever member (23) from the catheter device (1), and sealing the proximal open end (5) of the catheter (2) by using a removable plug or by connecting to an infusion set or the like.

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