Catheter apparatus including a catheter assembly having a catheter hub, a high pressure clamp, and a needle shield device, and a method of assembling the catheter apparatus

Abstract

A catheter instrument extending in a proximal-distal direction along a central axis (A). The catheter instrument (1000) comprises a catheter assembly (500) having a catheter hub (501) with a distal end (514), the catheter assembly (500) comprising a high pressure clamp (600) provided with an engagement receiving interface (630), and a needle shielding device (100) having a proximal end (112) comprising a needle protection clamp (200) having a proximal end engagement portion (235). When the catheter assembly (500) and the needle shielding device (100) are connected to each other, the proximal end engagement portion (235) engages the receiving interface (630). Furthermore, the invention relates to a method for assembling such a catheter instrument, high pressure clamp and catheter hub.

Description

TECHNICAL FIELD

[0001] The present invention relates to a catheter instrument comprising a high pressure clamp and a needle clamp. Furthermore, the present invention relates to a method for manufacturing the catheter instrument, the high pressure clamp and the catheter hub. BACKGROUND

[0002] Intravenous catheters are often used to administer fluids and / or medication to a patient. The fluids are supplied through an extension tube connected to the catheter via a presence of an extension tube connector and extending from the catheter hub body. When, for example, a caregiver wants to apply the catheter instrument to a patient, the catheter is inserted intravenously using a needle extending through the catheter tube. Once the catheter tube is in place, the needle is withdrawn and the catheter tube is left in the vein.

[0003] In order to protect the caregiver and the patient from infection caused by potential injuries from the needle, many catheter instruments comprise some type of needle shield during the process of withdrawing the needle after the catheter tube is in place. The needle shield protects the needle tip and sometimes also covers the needle to avoid spillage of bodily fluids such as blood.

[0004] A common problem with needle shields known in the art is that the needle shield device is too long in the axial direction, which causes difficulties for the user since the device is often handled with only one hand. Furthermore, many needle protectors rely on an automatic mechanism, such as a snipping mechanism, to activate the needle tip protection cover. The automatic mechanism relies on a tension within the device to trigger the automatic response of the protection cover. The tension within many devices is poorly regulated, which causes discomfort for the patient during use. Furthermore, the manufacturing process of some devices is complex.

[0005] Thus, there is a clear need for an improved catheter instrument with a needle shield that is easier to use, comfortable for the patient and simpler to manufacture. SUMMARY

[0006] In view of the above-mentioned drawbacks, it is an object of the present invention to provide a catheter instrument extending in a proximodistal direction along a central axis A. The catheter instrument comprises a catheter assembly comprising a catheter hub having a distal end and a high pressure clamp provided with an engagement socket, and a needle shield device having a proximal end comprising a needle protector having a proximal engagement portion. When the catheter assembly and the needle shield device are connected to each other, the proximal engagement portion engages the engagement socket. The advantage of this catheter instrument is that it is shorter in the longitudinal direction compared to when the high pressure clamp does not belong to the catheter instrument. The catheter instrument also makes it possible to tighten the needle protection clamp more controllably to the catheter hub, which results in a controlled tension within the needle protection clamp. Furthermore, it is easy to use and assemble.

[0007] In a second aspect, there is provided a method for manufacturing a catheter instrument extending in a proximodistal direction along a central axis A. The method comprises the steps of providing a catheter assembly comprising a catheter hub having a distal end; and providing a needle shield device having a proximal end and comprising a needle and a needle guard clip having a proximal end engagement portion. The method further comprises connecting the catheter assembly and the needle shield device by mating said proximal end with said distal end together; and inserting a high pressure clip provided with an engagement socket into the catheter hub through a cut-out provided in the catheter hub. When the high pressure clip is inserted, the proximal end engagement portion engages the socket, whereby the catheter assembly and the needle shield device are connected to each other. This method is advantageous in that it provides a catheter instrument having the above-mentioned advantages, and the assembly of the device can be conveniently made using this method.

[0008] In a third aspect, there is provided a high pressure clip comprising a pressure clip base provided with a socket, and a leg extending from said pressure clip base. This high pressure clip is advantageous in that it provides a dual function. It not only provides a socket that can engage with a needle guard clip of a needle shield device, but the leg extending from the base can also hold a needle septum in place in a catheter hub of a catheter instrument.

[0009] In a fourth aspect, there is provided a catheter hub extending along a proximodistal axis A, comprising a distal end provided with a cut-out connected to a lumen. This catheter hub is advantageous in that the lumen can accommodate a high pressure clip as described above, which can be securely fixed through the cut-out connected to said lumen.

[0010] Other features of the present invention and its embodiments are set forth in the appended claims.

[0011] BRIEF DESCRIPTION OF THE DRAWINGS

[0012] These and other aspects, features and advantages of the present invention will become apparent to those of ordinary skill in the art from the following description of non-limiting embodiments thereof, taken in conjunction with the accompanying drawings in which:

[0013] Figure 1 is an isometric side view of a catheter instrument comprising a needle shield device and a catheter assembly;

[0014] Figure 2A is a cross-section of a part of the catheter instrument disclosed in Figure 1

[0015] Figure 2B is an isometric side view of a high pressure clip connected to a needle guard clip;

[0016] Figure 3A ​is a cross-section of a catheter assembly and needle shield device separated from each other;

[0017] Figure 3B is an isometric side view of a high pressure clip separated from the needle protection clip shown in Figure 2B

[0018] Figures 3C and 3D show alternative forms of the needle protection clip;

[0019] Figure 4 shows a distal end perspective view of the catheter assembly;

[0020] Figure 5 shows a distal end perspective view of the high pressure clip;

[0021] Figure 6A and 6B shows isometric side views of two embodiments of the catheter hub; and

[0022] Figure 7 shows a flow chart of a method for assembling the catheter instrument. DETAILED DESCRIPTION

[0023] Embodiments of the present application will be described below in greater detail in conjunction with the accompanying drawings, so as to allow persons skilled in the art to carry out the present application. However, the present application can be embodied in many different forms and should not be construed as being limited to the embodiments set forth herein. Rather, these embodiments are provided so that the disclosure will be thorough and complete, and will fully convey the scope of the application to those skilled in the art. These embodiments are not limiting of the application, but merely the best mode presently contemplated for carrying out the application. Furthermore, the terminology used in the detailed description of the particular embodiments illustrated in the accompanying drawings is not intended to be limiting of the application.

[0024] Embodiments of the present application will be described below in greater detail in conjunction with the accompanying drawings, so as to allow persons skilled in the art to carry out the present application. However, the present application can be embodied in many different forms and should not be construed as being limited to the embodiments set forth herein. Rather, these embodiments are provided so that the disclosure will be thorough and complete, and will fully convey the scope of the application to those skilled in the art. These embodiments are not limiting of the application, but merely the best mode presently contemplated for carrying out the application. Furthermore, the terminology used in the detailed description of the particular embodiments illustrated in the accompanying drawings is not intended to be limiting of the application. Figures 1 to 7 Embodiments of the present application will be described below in greater detail in conjunction with the accompanying drawings, so as to allow persons skilled in the art to carry out the present application. However, the present application can be embodied in many different forms and should not be construed as being limited to the embodiments set forth herein. Rather, these embodiments are provided so that the disclosure will be thorough and complete, and will fully convey the scope of the application to those skilled in the art. These embodiments are not limiting of the application, but merely the best mode presently contemplated for carrying out the application. Furthermore, the terminology used in the detailed description of the particular embodiments illustrated in the accompanying drawings is not intended to be limiting of the application.

[0025] Reference will now be made to Figure 1 , a catheter instrument 1000 is provided that includes a needle shield device 100 and a catheter assembly 500. Figure 1 The needle shield device 100 shown is part of a retractable needle shield device. The catheter instrument 1000 and its components extend in a proximal-distal direction along a longitudinal central axis A.

[0026] The catheter assembly 500 includes a catheter hub 501, a coupler 502 for an extension tube, a pair of wings 504, and an opening 505 configured to receive a hollow catheter. A portion of the needle shield device 100 includes an encapsulation tube 110, a proximal push tab 120, and has a proximal end 112 and a distal end 114. When a needle 150 (as shown in Figure 2A , 3A and 3B) is withdrawn from the catheter assembly 500, the encapsulation tube 110 encloses the needle 150.​

[0027] Figure 2A A longitudinal cross-section of a part of the assembled catheter instrument 1000 is shown. Figure 1 A longitudinal cross-section of a part of the assembled catheter instrument 1000 is shown. Figure 2A The shown cross-section is the interface between the catheter assembly 500 and the needle shield device 100, wherein the catheter assembly 500 and the needle shield device 100 are connected to each other. The interior of the catheter assembly 500 comprises the needle septum 510 and the high pressure clamp 600. The interior of the proximal end 112 of the needle shield device 100 comprises the needle protection clamp 200 which is connected in engagement with the high pressure clamp 600. The high pressure clamp 600 can also be referred to as a U-lock or septum U-lock herein.

[0028] The needle protection clamp 200 comprises a lower base 210 having a lateral distal wall 220a and a lateral proximal wall 220b, each wall comprising a distal through hole 225a and a proximal through hole 225b, respectively. Furthermore, the clamp 200 has a proximally extending arm 230 comprising a proximal engagement portion 235. The proximal engagement portion 235 is also referred to as proximal hook 235 herein. Furthermore, the proximal hook 235 extends radially in a lateral direction away from the central axis A (substantially perpendicular to the axis A). Furthermore, the needle shield device 100 is provided with an internal latch 122 which is connected in engagement with a distal wall latch 222 on the protection clamp 200. The distal wall latch 222 is provided on an upper edge of the distal wall 220a.

[0029] The high pressure clamp 600 has a pressure clamp base 610 from which a distal receiving mouth 630 extends centrally towards the central axis A. As Figure 2A The proximal hook 235 of the proximal arm 230 engages the distal receiving mouth 630 of the high pressure clamp 600 as shown. The high pressure clamp 600 is fitted into the catheter hub 501 and inserted into the catheter assembly 500 from below at the catheter assembly distal end 514 through a lower cutout 506 and two upper cutouts 508 in the catheter hub 501. The assembly of the catheter instrument 1000 will be explained in more detail below with reference to Figure 5 、 6A and 6B.

[0030] In Figure 2A (and Figure 2B ), the through holes 225a, 225b of the distal wall 220a and the proximal wall 220b are laterally aligned. The needle 150 extends along the axis A through the aligned through holes 225a, 225b of the needle protection clamp 200, the high pressure clamp 600 and the septum 510.

[0031] Figure 2BAn isometric side view of the high pressure clamp 600 and the needle clamp 200 engaged with each other is shown. The high pressure clamp 600 is arranged in contact with the septum 510 and matches the lower cutout 506 and the upper cutout 508 of the catheter assembly 500. The through holes 225a, 225b of the respective lateral walls 220a, 220b of the clamp 200 are aligned and the proximal hook 235 of the proximal extension arm 230 engages the high pressure clamp 600. The needle septum 510 is held in place by the high pressure clamp 600, which will be referred to with reference to Figure 5 Further details are explained.

[0032] More specifically, the high pressure clamp 600 has a protruding receiving mouth 630 extending centrally from the high pressure clamp base 610. When the high pressure clamp 600 and the needle clamp 200 are connected to each other, the hook 235 of the proximal arm 230 engages the receiving mouth 630.

[0033] In addition, the needle protection clamp 200 is provided with a needle recess 237 configured to accommodate the needle (as shown in Figure 2A ) when the needle extends through the catheter instrument 1000. This needle recess 237 reduces the friction of the needle 150 when moving in the axial direction and facilitates the sliding of the needle 150. The high pressure clamp 600 further comprises two laterally extending legs 615a, 615b. Each of the legs 615a, 615b is provided with an upper protrusion 618a, 618b, respectively.

[0034] Figure 2A and 2B The engagement configuration of the needle protection clamp 200 in

[0035] As shown in Figure 2A and 2B , the needle 150 extending through the through holes 225a, 225b forces the through holes 225a, 225b to align along the central axis A. This is possible due to the flexibility of the needle protection clamp 200. The distal wall 220a is connected to the needle shield device 100 by the distal wall latch 222, so when the needle 150 is inserted through the distal and proximal through holes 225a, 225b, the lower base 210 is forced downwards.

[0036] With reference to Figure 3A , the catheter assembly 500 and the needle shield device 100 have been separated from each other. As shown in Figure 3AAs shown, the needle 150 has been retracted from within the catheter assembly 500 and has been further retracted distally through the proximal through hole 225b of the needle protection clip 200.

[0037] Since the needle protection clip 200 is formed from a flexible material, and since the through holes 225a, 225b are not aligned when it is in the standby state, the removal of the needle 150 from the proximal through hole 225b causes the lower base 210 to bend towards the central axis A. This causes the through holes 225a, 225b to be misaligned, which in turn prevents the needle 150 from possibly being pushed back outside the needle shield device 100. When the base 210 is moved towards the axis A, if the needle 150 is then pushed in the proximal direction towards the catheter assembly 500, the proximal wall 220b will abut the tip of the needle 150.

[0038] Furthermore, the movement of the base 210 towards the central axis A causes the hooks 235 on the arms 230 to disengage from the receiving interfaces 630 provided on the pressure clip base 610 inside the catheter assembly 500. Thus, the needle shield device 100 is separated from the catheter assembly 500, while the needle 150 is protected and cannot harm the patient or the caregiver.

[0039] Furthermore, under the pusher tab 120, the proximal end 112 of the needle shield device 100 is provided with an arm-encapsulation portion 130 that circumvents the arms 230 of the needle protection clip 200. The pusher tab 120 is also equipped with side walls, each having an inner recess 125 that is configured to engage a longitudinal protrusion 525 provided on the housing 520 at the distal end 514 of the catheter assembly 500 (as shown in Figure 4 ).

[0040] One leg 615b of the pressure clip 600 is shown in Figure 3A . The legs 615a, 615b provide a means for connecting the pressure clip 600 to the catheter assembly 500. Furthermore, the pressure clip 600 holds the needle septum 510 in place. These features of the pressure clip 600 will be explained in more detail with reference to Figure 5 .

[0041] Figure 3B The pressure clip 600 and the protection clip 200 are shown separated from each other. The needle 150 has been retracted distally through the septum 510, the pressure clip 600, and through the proximal through hole 225b. The removal of the needle 150 causes the arms 230 to bend upwards so that the proximal hooks 235 no longer engage the receiving interfaces 630 on the pressure clip base 610.

[0042] Furthermore, if the needle 150 is pushed forward in the proximal direction towards the proximal wall 220b, the area of the wall 220b under the through hole 225b will block the needle 150 since the distal through hole 225a is no longer aligned with the proximal through hole 225b.

[0043] Thus, the needle guard clip 200 in the present disclosure has a dual function, it protects the potential user from being injured by the needle 150 when the needle 150 is withdrawn from the catheter assembly 500, and it also provides an engagement feature (the proximal hook 235) for connecting the needle shield device 100 to the catheter assembly 500.

[0044] The septum 510 can be devoid of pre-formed perforations and can instead be formed of a malleable material that the needle 150 can penetrate and that will automatically seal when the needle 150 is removed from the septum 510. However, any septum known in the art can be used in the catheter instrument 1000 according to the present disclosure. The needle recess 237 configured to cooperate with the needle 150 facilitates smooth retraction of the needle 150. The needle recess 237 has a concave shape to accommodate and cooperate with the needle 150 and to reduce friction between the needle 150 and the proximal extension arm 230.

[0045] Alternatively, as shown in FIG. 3C, the needle guard clip 200 can be an alternative needle guard clip 200’ provided with a lower base 210’ and an upper base 210”. Further, another needle guard clip 200” is also shown in FIG. 3D. The needle guard clips 200’, 200” in FIGS. 3C and 3D each have a lower base 210’, 210”, a distal end wall 220a’, 220a”, a proximal end wall 220b’, 220b”, a distal end through hole 225a’, 225a”, a proximal end through hole 225b’, 225b”, an arm 230’, 230”, and a proximal hook 235”.

[0046] Further, the needle guard clip 200 can include a side wall connected with the base 210 and can be connected to the catheter assembly 500 using other connection mechanisms or adhesives. The needle guard clip 200’ can also be provided with a distal end wall latch (not shown) as the needle guard clip 200.

[0047] The needle guard clips 200, 200’, 200” disclosed herein can be connected to the needle shield device 100 using adhesives and the latch 122 and the distal end wall latch 222 can be disposed on opposite sides of the distal end wall 220a. Further, the needle guard clips 200, 200’, 200” disclosed herein can be connected using any other connection mechanism suitable in the art.

[0048] Figure 4 The catheter assembly 500 is shown as viewed from the distal end 514. The distal end 514 of the catheter hub 501 is provided with a housing 520 having two longitudinal protrusions 525 extending along the exterior of the housing 520. The protrusions 525 mate with the recesses 125 provided on the inner surface of the side wall below the button 129 (as shown in FIG. 2A) to secure the needle shield device 100 to the catheter assembly 500. Figure 3Ashown). Moreover, when the catheter assembly 500 and the needle shield device 200 are connected to each other, the housing 520 encloses the arm encapsulation portion 130 (also shown in Figure 3A

[0049] Disposed proximal of the housing 520 is the high pressure clamp 600, of which the base 610, the receiving mouth 630 and the legs 615a, 615b can be seen. The needle spacer 510 is further disposed within the catheter hub 501, proximal of the high pressure clamp 600.

[0050] Reference is made to Figure 5 , showing a detail view of the high pressure clamp 600 in a ready-to-use state. The high pressure clamp 600 is essentially U-shaped and made of a slightly flexible material, such that the legs 615a, 615b can be bent inwardly towards the center of the U-shaped clamp 600. As previously mentioned with reference to Figures 1 to 4 , the high pressure clamp 600 comprises a base 610, a receiving mouth 630, a pair of legs 615a, 615b, and an upper protrusion 618a, 618b, one for each of the legs 615a, 615b, respectively. The pressure clamp legs 615a, 615b each have a proximal flange 616a, 616b, which together lock the spacer 510 and hold the spacer 510 in a proximal position of the high pressure clamp 600.

[0051] Arranging the high pressure clamp 600 in the catheter hub 501 thus has several functions. First, it provides the receiving mouth 630 to engage with the needle protection clamp 200 of the needle shield device 100, and it locks the needle spacer 510 within the catheter hub 501. Furthermore, disposing the high pressure clamp 600 in the lumen 515 of the catheter hub 501 (as shown in Figure 6A ) improves the assembly process of the catheter instrument 1000, making it simpler.

[0052] Each of the upper protrusions 618a, 618b has an upper side 619a, 619b, which is inclined downwardly in opposite directions, so as to conform and align with the concave upper surface of the catheter hub 501 when the high pressure clamp 600 is fitted in the catheter hub 501. Furthermore, the slightly curved upper sides 619a, 619b formed when the high pressure clamp 600 is pressed against the upper cutout 508 help to direct the bending of the legs 615a, 615b centrally. Alternatively, the upper protrusions 618a, 618b engage on the inner wall of the catheter hub 501. This will be described in further detail with reference to Figure 6B .

[0053] Furthermore, the high pressure clamp 600 comprises two lower protrusions 612a, 612b, which extend from the base 610 in a direction perpendicular to the axis A. Each of the lower protrusions 612a, 612b of the base 610 has a center-facing upper side 617a, 617b. ​

[0054] Preferably, the high-pressure clamp 600 is made of a polymeric material, such as plastic, or a metallic material.

[0055] In Figure 6A In Fig. 5, an isometric side view of the catheter hub 501 is shown. The catheter hub 501 comprises a distal end 514 and has a width W C The outer portion of the catheter hub 501 is provided with two longitudinal protrusions 525 and a lower cut-out 506. The lower cut-out 506 has a lower cut-out upper edge 507, the upper cut-outs 508 are spaced apart from each other and aligned laterally in a direction perpendicular to the axis A.

[0056] The upper cut-outs 508 are configured to match and engage with the upper protrusions 618a, 618b of the high-pressure clamp 600. The width W B corresponds to the width W C of the catheter hub distal end 514. Furthermore, the area between the lower cut-out 506 and the upper cut-outs 508 forms a lumen 515 in which the high-pressure clamp 600 is arranged in the assembled state of the catheter instrument 1000. Furthermore, when the high-pressure clamp 600 is inserted into the lower cut-out 506 and forced laterally upwards, the lower protrusions 612a, 612b of the base 610 will prevent the high-pressure clamp 600 from being pushed too far into the lumen 515. The centrally facing upper flanks 617a, 617b will engage the lower cut-out upper edge 507, thereby preventing the high-pressure clamp 600 from being pressed further into the lumen 515.

[0057] Figure 6B A catheter hub 501'according to another embodiment disclosed herein is shown. The catheter hub 501'comprises a distal end 514', outer protrusions 525' and a lower cut-out 506'. However, the catheter hub 501'does not comprise upper cut-outs as the catheter hub 501. Instead, when the high-pressure clamp 600 is present in the lumen 515, the high-pressure clamp 600 is connected to the catheter hub 501'by other means, such as the upper protrusions 618a, 618b each engaging in an inner recess within the catheter hub 501'and being clamped securely in the lumen 515.

[0058] When arranged in the catheter hub 501, the pressure clamp base 610 extends laterally at the bottom of the catheter hub 501 and fits in the lower cut-out 506. The legs 615a, 615b extend from the base 610 towards the centre and further laterally through the central axis A along the inner side wall of the catheter hub 501. The upper leg protrusions 618a, 618b secure the high-pressure clamp 600 in the catheter hub 501, preventing the high-pressure clamp 600 from being withdrawn from the upper cut-outs 508, the lumen 515 and the lower cut-out 506.

[0059] The use of the high pressure clip 600 in the catheter instrument 1000 disclosed herein provides a catheter instrument 1000 with a more controlled locking mechanism between the needle protection clip 200 and the catheter hub 501 of the catheter assembly 500. This results in a controlled level of tension created within the needle protection clip 200, which in turn provides a comfortable experience for the patient and an easy to use device.

[0060] Furthermore, the effect of the design and arrangement of the high pressure clip 600 in the catheter instrument 1000 disclosed herein is that the needle protection clip 200 can be axially shortened compared to known protection clips. As the needle protection clip 200 is shorter in size, the length of the device along the axis A is reduced. A shorter device is easier to handle and thus easier to use, even with one hand.

[0061] A method for assembling the catheter instrument 1000 will now be described with reference to Figure 1 -6. In Figure 7 a flow chart indicating the steps of the method is shown in Fig. 8. First, the method comprises a step 830 of providing a needle shielding device 100, wherein the needle shielding device 100 comprises a needle protection clip 200 and a needle 150. (If the needle shielding device 100 is a retractable needle shielding assembly as disclosed in SE 2050266-2, the needle 150 is connected to a needle hub in a holding part, which is connected to a retractable intermediate part).

[0062] Secondly, the method 800 comprises a step 850 of providing a catheter assembly 500. The lumen 515 formed between the lower cut-out 506 and the upper cut-out 508 of the catheter assembly 500 is empty. The catheter assembly 500 can or can not comprise an internal needle spacer 510 inserted into the needle hub 501.

[0063] The step 850 of providing the catheter assembly 500 and the step 830 of providing the needle shielding device 100 can be performed simultaneously, or the step 830 of providing the needle shielding device 100 can be performed before or after the step 850 of providing the catheter assembly 500, as indicated by the arrows between the steps 830 and 850 in Figure 7 Fig. 8.

[0064] Optionally, the method comprises a step 810 of engaging the needle 150 with the needle protection clip 200 by passing the needle 150 through the distal and proximal through holes 225a, 225b in the distal and proximal walls 220a, 220b, before the step 820 of providing the needle shielding device 100.

[0065] In yet another optional step, the method 800 comprises connecting (from Figure 2Ato the step 820 of inserting the needle shield device 100 from below (under the needle protection clip 200) to engage the distal wall latch 222 with the inner latch 122 with a snip-fit function. (If the needle shield assembly 100 is a retractable needle shield assembly as disclosed in SE 2050266-2, the needle protection clip 200 is inserted into the packaging tube 110 and then the packaging tube 110 is moved distally to engage the middle part of the retractable needle shield device).

[0066] Furthermore, the method 800 can comprise an optional step 840 of mounting the needle septum 510. This step can be performed by inserting the needle septum 510 into the catheter hub 501 of the catheter assembly 500 or by threading the needle septum 510 onto the needle 150. If the needle septum 510 is threaded onto the needle 150, the step 840 is performed after the needle protection clip 200 is threaded onto the needle 150.

[0067] The step 840 of mounting the needle septum 510 can be performed before or after the step 830 of providing the needle shield device 100 and / or the step 840 of connecting the needle protection clip 200 into the packaging tube 110.

[0068] Subsequently, the method comprises a step 860 of connecting the needle shield device 100 and the catheter assembly 500 by pressing the proximal end 112 of the needle shield device 100 and the distal end 514 of the catheter assembly 500 together. The protrusions 525 on the catheter assembly 500 will each engage with the recesses 125 provided on the side walls of the pusher tab 120. Furthermore, the arm packaging parts 130 will be fitted into the housing 520.

[0069] The final step of the method 800 of assembling the catheter instrument 1000 comprises a step 870 of inserting the high pressure clip 600 into the lower cutout 506 of the catheter assembly. The high pressure clip 600 is forced to pass laterally upwards through the lower cutout 506 from below such that the leg upper protrusions 618a, 618b reach the upper cutouts 508. The distance between the upper cutouts 508 corresponds to the width W between the legs 615a, 615b of the high pressure clip 600 A .

[0070] Thus, when the upper protrusions 618a, 618b reach the upper cutouts 508 from below, the legs 615a, 615b will bend inwards towards the central axis A. When the upper protrusions 618a, 618b are forced through the upper cutouts 508, the legs 615a, 615b will spring back to their rest state. Thereby, the upper side faces 619a, 619b of the upper protrusions 618a, 618b are aligned with the upper surface of the catheter hub 501. Thus, the upper protrusions 618a, 618b engage the upper cutouts 508 with a snip-fit mechanism, thereby firmly connecting the high pressure clip 600 to the catheter hub 501.

[0071] The width of the lower cutout 506 corresponds to the width W between the base lower protrusions 612a, 612b B The upper cutout 506 corresponds to the width W between the leg portions 615a, 615b A Thus, when the high pressure clamp 600 is inserted into the lower cutout 506, and when the leg protrusions 618a, 618b reach the upper cutout 508, the leg portions 615a, 615b will bend inwardly towards the central axis A. When the leg protrusions 618a, 618b are forced further upwards through the upper cutout 508 of the catheter hub 501, the leg portions 615a, 615b will spring back out to their resting state, such that the leg protrusions 618a, 618b are fixedly matched with the side edges of the upper cutout 508.

[0072] Alternatively, the catheter hub 501’ is provided with other means for connecting the high pressure clamp 600 to the catheter assembly 500.

[0073] Optionally, the method further comprises the step 870 of inserting the needle 150 through the proximal and distal end through holes 225a, 225b of the lateral walls 220a, 220b, the needle guard 510 and the opening 505, and thus through the catheter instrument 1000 to a catheter (not shown), as Figure 2A illustrated.

[0074] As disclosed herein, the arrangement of the high pressure clamp 600 in the lumen 515 of the catheter hub 501 facilitates the manufacturing and assembly process. Furthermore, the length of the entire catheter instrument 1000 is reduced and the tension in the catheter instrument 1000 is relaxed.

[0075] For example, if the catheter instrument 1000 does not comprise the high pressure clamp 600, the catheter hub 501 would comprise a ledge / receptacle corresponding to the receptacle 630 of the high pressure clamp 600. This would result in the need to bend the proximally extending arms 230 centrally during the assembly process, which increases the risk of the arms 230 becoming fatigued. In order to avoid fatigue of the material of the arms 230, the arms 230 of the needle protection clamp 200 must be longer, resulting in a longer overall length of the catheter instrument 1000, which is disadvantageous. By using the high pressure clamp 600, the tension in the needle protection clamp 200 is transferred to the lower base 210, reducing the risk of causing fatigue of the proximally extending arms 230.

[0076] The disclosed catheter assembly 500 is a closed system, i.e. where the guard 510 (as Figures 2A-3B illustrated) is provided in the catheter hub 501 and fluid is withdrawn or introduced through an extension tube (not shown) connected to the extension tube coupler 502. However, the high pressure clamp 600 is equally applicable to an open catheter assembly, where fluid can be introduced or withdrawn longitudinally from the distal end of the catheter hub to form a catheter instrument 1000 as disclosed herein.

[0077] Figure 1 The needle shield device 100 disclosed in the background art is part of a retractable packaging shield assembly as disclosed in the applicant's patent application SE 2050266-2. However, the needle protection clip 200 and the high pressure clip 600 can be provided in other types of needle shield devices.

[0078] Furthermore, the high pressure clip 600 can be mounted from top to bottom instead of from bottom to top as explained with reference to the drawings. Alternatively, a cut-out is present in the side wall of the catheter hub 501 and the legs 615a, 615b extend from the base 610 such that the upper protrusions 618a, 618b are horizontally in line with the cut-out in the side wall and engage said cut-out with a snap-fit mechanism.

[0079] Alternatively, the high pressure clip 600 comprises only one laterally extending leg 615a, 615b. In this case, the single leg 615a, 615b will hold the spacer 510 in place. Furthermore, the protrusions 618a, 618b can be provided as lower protrusions that connect the high pressure clip to another location of the catheter hub 501 than the upper protrusion 508.

[0080] In the claims, the term "comprising" does not exclude other elements or steps. Furthermore, although individually listed, a plurality of means, elements or method steps can be implemented by one and the same item of software or hardware. Additionally, these features can be implemented by one or more units, for example, a single unit or processor. Furthermore, the features can be combined in different ways. Also, the division into different claims does not imply that the features of the different claims are necessarily mutually exclusive. Furthermore, the terms "a" or "an", as used herein do not exclude pluralities. The term "one" or "said one" does not exclude that a plurality of devices is meant. The terms "preferably", "preferred", "preferably comprises" and words of similar meaning do not place a restriction on the scope of a claim. The use of the term "an" or "one" including a singular noun does not exclude the plural. The indefinite articles "a" and "an" do not exclude a plurality. The mere fact that different features are recited in mutually different dependent claims does not indicate that the features cannot be used in combination.

Claims

1. A catheter instrument extending in a proximal-distal direction along a central axis (A), wherein the catheter instrument (1000) comprises: - a catheter assembly (500) comprising a catheter hub (501) having a distal end (514) and a high-pressure clamp (600) provided with an engagement socket (630); - a needle shielding device (100) having a proximal end (112) comprising a needle protection clamp (200) having a proximal engagement portion (235); and wherein, when the catheter assembly (500) and the needle shielding device (100) are connected to each other, the proximal engagement portion (235) engages with the socket (630), characterized in that: the high-pressure clamp (600) is U-shaped comprising a pressure clamp base (610) and a pair of flexible laterally extending legs (615a, 615b).

2. The catheter instrument according to claim 1, wherein the high-pressure clamp (600) is disposed in a lumen (515) of the catheter hub (501).

3. The catheter instrument according to claim 1, wherein the high-pressure clamp (600) is connected to the catheter hub (501) by a snap-fit mechanism.

4. The catheter instrument according to claim 1, wherein the catheter hub (501) has a lower cutout (506) relative to the central axis (A), and wherein the high-pressure clamp (600) is disposed in the lower cutout (506).

5. The catheter instrument according to claim 4, wherein the high-pressure clamp (600) is inserted into the catheter hub (501) from below through the lower cutout (506).

6. The catheter instrument according to claim 4, wherein the catheter hub further comprises an upper cutout (508) relative to the central axis (A), and wherein the high-pressure clamp (600) is disposed in the upper cutout (508).

7. The catheter instrument according to any one of claims 1 to 6, wherein each of the legs (615a, 615b) comprises an upper protrusion (618a, 618b), and wherein the upper protrusions (618a, 618b) each engage with an upper cutout (508) of the catheter hub (501).

8. The catheter instrument according to any one of claims 1 to 6, wherein each of the legs (615a, 615b) comprises an upper protrusion (618a, 618b), and wherein the upper protrusions (618a, 618b) each engage with an inner recess within the catheter hub (501).

9. Catheter instrument according to any one of claims 1 to 6, wherein the needle protection clip (200) comprises a distal through hole (225a) and a proximal through hole (225b), which accommodate a needle (150) in an assembled state of the catheter instrument (1000) and, when the needle (150) is withdrawn through the proximal through hole (225b), a base (210) of the needle protection clip (200) is moved towards the central axis (A), whereby the proximal engagement portion (235) is detached from the receiving interface (630).

10. Method for manufacturing a catheter instrument, which extends along a central axis (A) in a proximal-distal direction, the method (800) comprising the following: - a step (830) of providing a needle shield device (100) having a proximal end (112) and comprising a needle (150) and a needle protection clip (200) having a proximal engagement portion (235); - a step (850) of providing a catheter assembly (500) comprising a catheter hub (501) having a distal end (514); - a step (860) of connecting the catheter assembly (500) and the needle shield device (100) by mating the proximal end (112) and the distal end (514) together; and - a step (870) of inserting a high pressure clip (600) provided with an engagement receiving interface (630) into the catheter hub (501) through a lower cutout (506) provided in the catheter hub (501); wherein the high pressure clip (600) being U-shaped in shape comprising a pressure clip base (610) and a pair of flexible laterally extending legs (615a, 615b) and, when inserted, the proximal engagement portion (235) engages the receiving interface (630), whereby the catheter assembly (500) and the needle shield device (100) are connected to each other.

11. Method according to claim 10, wherein the method further comprises a step (810) of engaging the needle (150) comprised in the needle shield device (100) with the needle protection clip (200) by passing the needle (150) through distal and proximal through holes (225a, 225b) in distal and proximal walls (220a, 220b) of the needle protection clip (200).

12. Method according to claim 11, further comprising a step (820) of connecting the needle protection clip (200) accommodating the needle (150) to the needle shield device (100) such that a distal wall latch (222) of the needle protection clip (200) engages with an internal latch (122) in the needle shield device (100) with a snap-fit function.

13. The method according to any one of claims 10 to 12, further comprising the step (840) of mounting an inner needle spacer (510) either into the catheter hub (501) of the catheter assembly (500) or onto the needle (150) comprised in the needle shielding device (100).

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