Catheter placement device

Abstract

The present invention provides a catheter placement device that offers improved safety during use and allows for a simpler design. [Solution] The catheter comprises a hollow housing body 4, a tubular element 5 attached to the distal end of the housing body 4, a valve element 6 disposed within the housing body 4 and having a fluid passage, and a fluid transmission path made to extend in the longitudinal direction, and a hollow needle made to extend in the longitudinal direction through the fluid passage when the catheter placement device 1 is ready, and to be withdrawn proximal to the fluid passage when the catheter placement device 1 is in use. The valve element 6 has an elastic wall portion, through which the fluid passage extends, and the wall portion is elastically deformable by the action of fluid pressure, and when the catheter placement device is in use, the fluid passage can transition between an open state where the fluid passage is open and a closed state where the fluid passage is closed due to the elastic deformation caused by the fluid pressure of the wall portion.

Description

Technical Field

[0001] The present invention relates to a catheter placement device, the catheter placement device comprising a catheter having a hollow housing body, a tubular element attached to the distal end of the housing body, a valve element disposed in the housing body and having a fluid passage, and a fluid transfer path made to extend longitudinally through the housing body, the fluid passage between the proximal inlet side and the distal outlet side, and the tubular element; and a hollow needle made to extend longitudinally through the fluid transfer path in a ready state of the catheter placement device and withdrawn proximally from the fluid transfer path in a use state of the catheter placement device.

Background Art

[0002] This type of catheter placement device is known from European Patent No. 1911485 and is provided for use in infusion therapy. According to conventional medical terminology, the known catheter placement device may also be called an indwelling intravenous catheter. The known catheter placement device has a hollow housing body in the form of a hollow cylindrical catheter bush, to which a tubular element called a catheter is attached at its distal end. A valve element having a fluid passage is located within the hollow cylindrical catheter bush. The fluid passage is constructed to extend longitudinally through the hollow cylindrical catheter bush and the fluid passage and tubular element between the proximal inlet and distal outlet sides. Furthermore, the known catheter placement device has a hollow needle attached to a needle bush. In the ready state of the catheter placement device, the aforementioned hollow needle extends longitudinally distally and is constructed to extend from the proximal inlet side to the distal outlet side through the catheter bush, the fluid passage of the valve element, and the tubular element. When the catheter placement device is used, the hollow needle is drawn out proximal to the fluid passage. In known catheter placement devices, the valve element is configured in a flat plate shape. To actuate the valve element, a valve actuating element is positioned within the catheter bush and can be moved axially relative to the valve element. The valve actuating element interacts with a fluid transfer component that can be connected proximal to the catheter bush. When the fluid transfer component is connected, the valve actuating element is moved distally by the mechanical contact connection of the valve element, thereby opening the fluid passage. When the fluid transfer component is removed, the valve actuating element is moved proximal, losing contact with the valve element, thereby closing the fluid passage. [Overview of the project] [Problems that the invention aims to solve]

[0003] The objective of the present invention is to provide a catheter placement device of the type described above, which has a simple design and offers improved safety in use compared to the prior art. [Means for solving the problem]

[0004] This objective is achieved in such a way that the valve element is provided with an elastic wall, the fluid passage is constructed to extend through the elastic wall, the wall is elastically deformable under the action of fluid pressure, and in the use of the catheter placement device, the fluid passage can transition between an open state and a closed state due to the elastic deformation caused by the fluid pressure in the wall. The solution according to the present invention makes it possible to omit, in particular, the valve actuation element located in the housing body for moving the fluid passage between the open and closed positions. This is because, according to the present invention, instead of the normal operation of the valve element brought about by mechanical contact, in short, operation is provided by fluid pressure. This allows the fluid passage to transition between a closed state and an open state in accordance with the fluid pressure difference present in the fluid path between the inlet and outlet sides. In contrast to conventional catheter placement devices, the opening and closing of the fluid transmission path by the valve element is possible to this extent, in some cases independently of fluid transmission components connected proximal to the housing body. This allows the fluid passage to be opened and / or closed depending solely on the existing fluid differential pressure, regardless of the presence or absence of such fluid passage components. This, firstly, improves safety in use and allows for a particularly simple design of the catheter placement device. The fluid passage is created to extend through the elastic wall of the valve element. The fluid passage is preferably formed by at least one opening that can be opened and closed in a manner caused by deformation, and consequently by fluid pressure, particularly by an opening in the form of a slot and / or a slot arrangement having multiple slots. The elastic wall is elastically deformable in different ways depending on the indication and value of the existing fluid differential pressure. In the open position, the fluid passage is open through an open fluid passage between the inlet and outlet sides. With the catheter applied to the patient, depending on the direction of flow through the fluid passage, medication can be administered to the patient or blood can be drawn from the patient. In the closed position, the fluid passage is liquid-tightly sealed by the closed fluid passage.The solution according to the present invention allows for the aforementioned fluid-tight sealing even when the assumed fluid transmission component is connected to the proximal inlet side of the fluid transmission path, more precisely to the hollow housing body, unlike in conventional catheter placement devices with valve operating elements. In a fluid-tight sealed state, the return of blood, particularly in the proximal direction, is suppressed. This suppresses unintended blood flow out, particularly through the proximal inlet side. To ensure that the valve element operates to meet the requirements, preferably, at least the elastic wall portion is made from an elastomer material. Alternatively, the entire valve element can be manufactured from an elastomer material. Suitable materials include, in particular, silicone and rubber. The tubular element may also be called the catheter attachment portion. The hollow housing body may also be called the catheter hub. The hollow needle may also be called a cannula. According to conventional medical terminology, the catheter placement device may also be called a peripheral indwelling venous catheter or peripheral indwelling venous cannula. The tubular element is preferably configured to be bendable and flexible. The tubular element is preferably attached directly to the hollow housing body. For this purpose, preferably, pressure-fit, shape-fit and / or materially bonded joint connections are provided between the housing body and the tubular element. For pressure-fit connections between the housing body and the tubular element, a metal sleeve may be positioned to be pressed proximal to the tubular element. Preferred materially bonded joint connections may be adhesive connections in particular. The tubular element and / or housing body are preferably made of plastic. The housing body may be formed as a single or multiple parts. The housing body preferably has a connector portion at its proximal end facing away from the tubular element for connecting to a medical fluid transmission component, such as a complementary connector portion of a medical syringe. The connector portion is preferably configured as a Luer connector. The hollow needle functions in a manner known to those skilled in the art for venipuncture and for introducing the tubular element into the patient's punctured vein. Once the catheter is applied in this manner, the catheter placement device is ready.Subsequently, the hollow needle is withdrawn proximal to the catheter and discarded in the conventional manner, thereby transitioning the catheter placement device to the ready state. In the ready state, the hollow needle and the valve element preferably interact as follows: the hollow needle is constructed to extend through the fluid passage so as to support the fluid tightly in a manner that elastically prestresses the outer circumference of the hollow needle by the elastic deformation of the wall causing the valve element to expand radially. When the hollow needle is withdrawn proximal to the catheter, the elastic wall springs back radially inward, thereby closing the fluid passage.

[0005] In an improved embodiment of the present invention, the elastic wall is configured such that the fluid passage, when used with the catheter placement device, starts in a closed state, maintains the closed state at neutral fluid pressure, and can transition to an open state by inlet-side fluid positive pressure and / or inlet-side fluid negative pressure, wherein the inlet-side fluid negative pressure required to open the fluid passage is greater in value than the inlet-side fluid positive pressure required to open it. In other words, the wall is elastically deformable to various degrees depending on the direction of pressurization. Therefore, the behavior of the valve element depends on the direction of pressurization. In this improved embodiment of the present invention, the inlet-side fluid negative pressure required to open the fluid passage is greater in value than the inlet-side fluid positive pressure required to open it. The inlet-side fluid negative pressure corresponds to the outlet-side fluid positive pressure. This improvement of the present invention ensures that the flow can pass through the fluid transport path distally at a relatively lower fluid pressure than in the proximal direction. Preferably, the elastic wall is configured such that the inlet-side fluid positive pressure required to open the fluid passage is achieved during conventional gravity-driven injection. With the appropriate configuration of the elastic wall, the inlet-side negative fluid pressure or outlet-side positive fluid pressure required to open the fluid passage in the proximal direction is higher than the inlet-side positive fluid pressure required to open the fluid passage in the distal direction. This suppresses unintended blood flow back in the proximal direction, particularly blood leakage in the proximal direction, in a simple and particularly effective manner. To achieve the aforementioned direction-dependent behavior, the elastic wall can be configured in particular in the shape of a small cap, cup, funnel, dome, cupola, or spherical cap.

[0006] In a further improvement of the present invention, the inlet-side fluid negative pressure required to open the fluid passage is 15 to 25 times, preferably 20 times, higher than the inlet-side fluid positive pressure required to open the fluid passage. In other words, in this embodiment of the invention, the elastic wall is configured to open the fluid passage toward the patient in the case of relatively small positive pressure. In contrast, the fluid passage can be opened when the inlet-side fluid negative pressure is relatively high, and therefore equivalently, when the venous-side fluid positive pressure is relatively high. This brings about many advantages in the use of catheter placement devices.

[0007] In a further improvement of the present invention, the inlet-side fluid positive pressure required to open the fluid passage is 0.2 PSI to 0.4 PSI, preferably 0.3 PSI, and the inlet-side fluid negative pressure required to open the fluid passage is 5.0 PSI to 7.0 PSI, preferably 6.0 PSI. The aforementioned ranges have proven particularly beneficial in practice and are achieved by the corresponding configuration of the elastic wall. The aforementioned ranges ensure that the fluid passage is reliably opened, particularly during conventional gravity-assisted injection. Furthermore, the fluid passage is prevented from unintentionally opening due to patient-side influences, such as patient movement, sneezing, coughing, vomiting, and associated physiologically increased outlet-side (venous) fluid positive pressure.

[0008] In a further improvement of the present invention, the elastic wall portion has a dome-shaped curve, and the fluid passage is located in the region of the apex of the curve. The behavior of the valve element, which depends on the direction of the fluid pressure, can be achieved in a structurally simple manner by the arrangement of the fluid passage in the range of the dome-shaped curve and the apex. The shape of the elastic wall portion resulting in this improvement of the present invention may be specifically called a cupola or dome. More preferably, the apex of the curve is located on the longitudinal axis of the virtual center of the fluid transmission path.

[0009] In a further improvement of the present invention, the dome-shaped curve of the elastic wall is concave in the direction toward the proximal inlet and convex in the direction toward the distal outlet. This orientation of the dome-shaped curve ensures, in particular, that the fluid transmission path can be opened relatively "more easily" in the distal direction than in the proximal direction.

[0010] In a further improvement of the present invention, the dome-shaped curve of the elastic wall is concave in the direction toward the proximal inlet and convex in the direction toward the distal outlet. This orientation of the dome-shaped curve ensures, in particular, that the fluid transmission path can be opened relatively "more easily" in the distal direction than in the proximal direction.

[0011] In a further improvement of the present invention, the dome-shaped curve of the elastic wall is convex in the direction toward the proximal inlet and concave in the direction toward the distal outlet. The inventors have found that in this way, turbulence in the direction toward the proximal inlet through the fluid passage can be reduced, or laminar flow can also be achieved. In other words, the curve of the elastic wall that is convex in the proximal direction and concave in the distal direction allows for the aspiration of fluid with little or no turbulence. When the catheter placement device is used for blood collection, this allows for the avoidance of hematopoietic breakdown in a simple but particularly effective manner. Hematopoietic breakdown is understood to mean the lysis of red blood cells as a result of mechanical breakdown of the cell membrane. Such mechanical breakdown can occur, for example, as a result of turbulence and forces generated during operation. In addition, the improved form of the present invention allows for relatively turbulent flow in the distal direction. This allows for the avoidance of the accumulation of harmful bacteria at the site of the valve element, for example, when injecting distally.

[0012] In a further improvement of the present invention, the valve element has a radially outward elastic connecting wall, which is adjacent to the dome-shaped curve, and allows for rapid alternation between a first stable state in which the dome-shaped curve is arched distally and a second stable state in which the dome-shaped curve is arched proximal, due to the action of fluid pressure caused by injection and / or suction. This improvement of the present invention can reduce turbulence through the fluid passage in both distal and proximal directions, or even allow laminar flow. This achieves advantages in both injection and suction. In particular, it can avoid the hematopoietic breakdown already described. The connecting wall can alternately invert, push out, and / or buckle the elastic wall together with the dome-shaped curve, depending on the direction of the fluid flow. Depending on the direction of the fluid flow, the valve element "jumps" between the first and second states. In simplified terms, the valve element in this improvement has a flip-flop characteristic. The connecting wall is preferably annular. More preferably, the dome-shaped curved portion is circumferentially bounded by an annular connecting wall portion. The connecting wall portion preferably has a smaller wall thickness than the dome-shaped curved portion.

[0013] In a further improvement of the present invention, the axial height of the dome-shaped curve is smaller than the radial diameter of the elastic wall. In other words, the dome-shaped curve is relatively flat. The inventors have found that this improvement of the present invention can achieve advantageous flow properties. In particular, the accumulation of stagnant fluid is avoided at the outer edge of the convex, arched dome-shaped curve. In connection with this, the accumulation of health-threatening bacteria and / or biofilms in the aforementioned area is avoided. As a result, this improvement of the present invention can improve patient safety. The axial height is preferably up to 50%, preferably up to 40%, and particularly preferably up to 30% of the radial diameter.

[0014] The fluid passage is formed by a slot arrangement having at least one first slot and a second slot, these slots preferably arranged in a cross shape, particularly preferably in a "+" shape, forming at least one common intersection. The first and second slots are oriented across each other, preferably perpendicularly. The elastic wall is divided into various subsections by the slot arrangement. The aforementioned subsections are bounded and / or separated from each other by the first and / or second slots. Depending on the dominant fluid pressure, the aforementioned subsections may move relative to each other by elastic deformation. When the subsections move away from each other, the fluid passage transitions to an open state. When the subsections are in a liquid-tight position relative to each other, the fluid passage is in a closed state. This improvement of the present invention is structurally simple and robust.

[0015] In a further improved embodiment of the present invention, the slot arrangement has a third slot, and the first, second, and third slots are arranged in a particular H-shape, forming two common intersections. Such an arrangement, particularly an H-shape, allows the fluid passage to have a relatively large opening cross-section, especially in the open state.

[0016] In a further improved embodiment of the present invention, the slot arrangement has a third slot, and the first, second, and third slots are arranged particularly in a star shape, forming exactly one common intersection. Preferably, the first, second, and third slots are offset by 120° from each other so as to produce a star configuration of the slot arrangement having a centrally located intersection. The inventors have found that this provides certain advantages. In a further improved embodiment of the present invention, the valve element has an annular radial collar fixed in an annular radial groove of the housing body, and the housing body is constructed as a single piece. The annular radial collar may be manufactured separately from the elastic wall and then joined together. Alternatively, and preferably, the valve element is constructed as a single piece such that the radial collar and the elastic wall are connected as a single piece. Preferably, the radial groove is formed inside the housing body and is accessible from the proximal inlet side for installation of the valve element. The single-component construction of the housing body allows for a particularly simple design and, consequently, cost-effective manufacturing.

[0017] In a further improvement of the present invention, the elastic wall portion has at least one first pair of rib elements and one second pair of rib elements, each paired opposite each other with respect to at least one common intersection, wherein the first pair of rib elements is positioned radially outward with respect to the intersection than the second pair of rib elements. The first pair of rib elements is preferably assigned to a first hollow needle having a first diameter. The second pair of rib elements is preferably assigned to a second hollow needle having a second diameter, where the first diameter is relatively larger than the second diameter. The first pair of rib elements may also be called the first rib element. The second pair of rib elements may also be called the second rib element. Both the first and second rib elements serve to reinforce a region of the elastic wall portion. The rib elements are preferably each connected to the elastic wall portion as a single component. In one embodiment, the rib elements are manufactured as separate components and then attached to the elastic wall portion. The rib elements and the varying spacing of the rib elements from the intersection of the slot arrangement result in favorable deformation behavior of the elastic wall. The first rib element and / or the first pair of rib elements result in favorable deformation behavior during the use of the first hollow needle. The second rib element and / or the second pair of rib elements result in favorable deformation behavior during the use of the second hollow needle. It is preferable that each rib element be positioned proximal to the elastic wall. The rib elements preferably have a triangular shape, with one point of each triangle pointing towards the intersection. In further improvement, each rib element may have a different shape.

[0018] In a further improvement of the present invention, at least one additional fluid passage is created to extend through the elastic wall, and the additional fluid passage is formed by at least two circumferential slots created to extend longitudinally in the circumferential direction of the elastic wall, the at least two circumferential slots being positioned radially outward relative to the fluid passage. The inventors have found that this improvement of the present invention enables better fluid administration (injection) and fluid withdrawal (suction) through the valve element. The additional fluid passage, formed by at least two circumferential slots, which essentially correspond to the fluid passage, can transition between an open and closed state depending on the dominant fluid pressure. The properties of the fluid passage and the additional fluid passage are preferably coordinated with each other so that opening and closing, caused by fluid pressure, occurs alternately. For example, the fluid passage may be closed during suction and the additional fluid passage may be opened. Conversely, during injection, the additional fluid passage is preferably closed and the fluid passage is opened. Of course, the reverse improvement is also possible. The opening and closing characteristics caused by the corresponding fluid pressure in the fluid passages and further fluid passages are preferably achieved by the appropriate shape, thickness, and / or selection of the material within the region of the fluid passages and further fluid passages. At least two circumferential slots are preferably arranged offset from each other by 180° in the circumferential direction.

[0019] In a further improvement of the present invention, each circumferential slot has at least one slot that is longer on the distal side of the elastic wall than on the proximal side of the elastic wall, and / or the fluid passage has at least one slot that is longer on the proximal side of the elastic wall than on the distal side of the elastic wall. Thus, at least two circumferential slots are designed to be inclined relative to each other in the longitudinally opposing end regions, rather than being designed substantially linearly. This inclination results in the aforementioned difference in the length of the circumferential slots between the distal and proximal sides. Due to the aforementioned difference in length and / or inclination of the end regions, the circumferential slots can be opened relatively easily, i.e., at lower pressure, during suction of liquid (proximal direction) than during injection (proximal direction). The corresponding description applies similarly with respect to at least one slot of the fluid passage. In a further improvement of the present invention, the ratio of the lengths of the circumferential slots and at least one slot is designed inversely to the improvement described above.

[0020] In a further improvement of the present invention, the elastic wall portion has at least one concave or convex profile in the region of the fluid passage, and / or the elastic wall portion has at least one further concave or convex profile in the region of the further fluid passage. The profile and / or further profile make it possible to improve the directional dependence of the opening and closing behavior of the fluid passage and / or further fluid passage. When the profile and / or further profile is convex, this achieves a local increase in the region of wall thickness of the elastic wall portion. As a result, the elastic wall portion is locally strengthened and / or reinforced. When the profile and / or further profile is concave, this achieves a local decrease in the region of wall thickness of the elastic wall portion. The wall thickness thus reduced results in local weakening.

[0021] In a further improvement of the present invention, the valve element has a radial collar fixed between two joined housing portions of the housing body. The configuration, consisting of at least two parts of the housing body, allows the valve element to be installed relatively easily. For this purpose, the radial collar of the valve element is fixed axially between the two housing portions. The housing portions are then fixedly joined to each other by means known to those skilled in the art, for example, by adhesive bonding or welding.

[0022] Furthermore, the present invention relates to a valve element for a catheter placement device, wherein the valve element comprises an elastic wall, and a fluid passage is constructed to extend through the elastic wall, the wall being elastically deformable under the action of fluid pressure, and the fluid passage is transitionable between an open state, where the fluid passage is open, and a closed state, where the fluid passage is closed, due to the elastic deformation caused by the fluid pressure in the wall. Regarding the advantages relating to the configuration of the valve element according to this invention, we will note and explicitly refer to what has been stated with respect to the catheter placement device according to the present invention. The extent disclosed to this extent with respect to the catheter placement device according to the present invention also applies to the valve element according to the present invention with necessary modifications. Improvements to the valve element according to the present invention are evident from the features of the valve element of the improved catheter placement device according to the present invention.

[0023] Further advantages and features of the present invention will become apparent from the claims and from the following description of preferred exemplary embodiments of the invention illustrated with reference to the drawings. [Brief explanation of the drawing]

[0024] [Figure 1] An embodiment of the catheter placement device according to the present invention, equipped with a catheter and a hollow needle, is shown in a schematic perspective view, with the catheter placement device in a ready state. [Figure 2] Figure 1 shows the catheter placement device, where the hollow needle is drawn out from the catheter in the proximal direction and placed separately. [Figure 3]Figure 3 shows a schematic and highly simplified, partially cut-away longitudinal cross-sectional view of the hollow housing body of the catheter and the valve element disposed therein. [Figure 4] An alternative improvement of the hollow housing body is shown in a figure corresponding to Figure 3. [Figure 5] A detailed enlarged view of the valve element in the cross-sectional views corresponding to Figures 3 and 4 is shown. [Figure 6] The valve element according to Figure 5 is shown in the direction of looking axially at the fluid passage. [Figure 7] An embodiment of the valve element according to the invention having an alternatively configured fluid passage is shown in a figure corresponding to Figure 6. [Figure 8] A further embodiment of the valve element according to the invention having an alternatively configured fluid passage is shown in figures corresponding to Figures 6 and 7. [Figure 9] A further embodiment of the valve element according to the invention having a dome shape with a flat design is shown in a schematic longitudinal cross-sectional view. [Figure 10] A further embodiment of the valve element according to the invention comprising a further fluid passage formed from two circumferential slots is shown in a schematic perspective view. [Figure 11] A very simplified schematic cross-sectional view is shown to clarify further features of the valve element according to Figure 10. [Figure 12] A further embodiment of the valve element according to the invention is shown in a schematic cross-sectional view. [Figure 13] A further embodiment of the valve element according to the invention is shown in a schematic cross-sectional view. [Figure 14] A further embodiment of the valve element according to the invention that can transition between a first stable state (Figure 16) and a second stable state (Figure 17) by fluid pressure is shown in a schematic perspective view. [Figure 15] The valve element according to Figure 14 is shown in a schematic longitudinal cross-sectional view. [Figure 16] The valve element according to Figures 14 and 15 in the first state is shown. [Figure 17]The valve elements in the second state are shown in Figures 14 and 15. [Figure 18] Further embodiments of the valve element according to the present invention are shown in a schematic perspective view. [Figure 19] The valve element shown in Figure 18 is further shown in a perspective view from the direction of viewing the proximal wall side of the elastic wall member. [Figure 20] Further embodiments are shown in schematic side views. [Modes for carrying out the invention]

[0025] As shown in Figures 1 and 2, a catheter placement device 1 for use in infusion therapy is provided, comprising a catheter 2 and a hollow needle 3. The catheter placement device 1 may also be called a peripheral indwelling venous cannula or peripheral indwelling venous catheter. As is known to those skilled in the art, the catheter placement device 1 is applied to the back of the patient's hand or the curved part of the arm and is particularly useful for parenteral liquid therapy, intravenous administration of drugs, and / or blood collection.

[0026] Catheter 2 comprises a hollow housing body 4, a tubular element 5, and a valve element 6 (Figure 3). In Figure 3, the housing body 4 and the tubular element 5 are depicted with continuous hatching. This does not necessarily mean that the housing body 4 and the tubular element 5 are connected as a single component.

[0027] The housing body 4, sometimes called a catheter hub, has a generally known basic shape, consisting of two laterally protruding fixed wings 7 and a connecting portion 8.

[0028] In embodiments not shown, the housing body does not have fixed wings.

[0029] The connecting portion 8 is located at the proximal end 9 of the housing body 4 and, in this example, is configured as a female Luer lock connecting portion. The tubular element 5 is located at the distal end 10 of the housing body 4 and is fixed and joined to the housing body 4 by a method known to those skilled in the art. For example, the tubular element 5 can be joined to the housing body 4 for this purpose by press connection, welding connection, or adhesive connection. A metal sleeve can be provided for press connection and can be pushed into its proximal end by the expansion of the tubular element 5. Furthermore, a housing body configuration in which the tubular element is integrally connected to the housing body is also conceivable.

[0030] The catheter 2 has a fluid transport path F (Figures 2 and 3) which is constructed to extend axially through the catheter 2 between the proximal inlet side E and the distal outlet side A. The fluid transport path F here extends from the distal end 9 into the housing body 4, more specifically into the cavity 11 of the housing body 4, from there distally through the fluid passage 12 of the valve element 6, and from there through the tubular element 5 and its tip 13 to the outlet side A.

[0031] The fluid passage 12 can transition between a closed state and an open state in a more detailed manner. In the closed state, the fluid passage 12 is closed, and the fluid transmission path F between the inlet side E and the outlet side A is tightly sealed. In the open state, the fluid passage 12 is opened, thereby opening the fluid transmission path F between the inlet side E and the outlet side A.

[0032] The hollow needle 3 is constructed to extend longitudinally between a proximal end 14 and a distal needle tip 15, the needle tip of which is clearly covered in relation to Figure 2 by a safety element 16 in a manner known to those skilled in the art. The hollow needle 3 is coupled together with a needle attachment portion 17 at its proximal end. The needle attachment portion 17 is constructed in a manner known to those skilled in the art, similar to the hollow needle 3. In this regard, further description of the configuration of the needle attachment portion 17 can be omitted here.

[0033] The state shown in Figure 1 represents the ready state of the catheter placement device 1, with the hollow needle 3 inserted distally into the catheter 2 from the inlet side E. The hollow needle 3 is constructed to extend distally through the housing body 4, the fluid passage 12 of the valve element 6, and the tubular element 5, with the needle tip 15 protruding distally beyond the tip 13.

[0034] To apply catheter 2, the catheter placement device 1 is brought close to a suitable vein in the patient in a ready state, and the vein is punctured by the needle tip 15. The hollow needle 3 is pushed into the punctured vein together with the tubular element 5. The hollow needle 3 is then withdrawn proximal to catheter 2 and disposed of conventionally, thereby transitioning the catheter placement device 1 to a ready state. In the ready state described above, catheter 2 is applied to the patient and is generally usable for several days. In the ready state, the fluid transport path F is either tightly sealed or open by the sealing element 6, depending on the ready state of catheter 2.

[0035] The valve element 6 has an elastic wall 18. The fluid passage 12 is formed to extend in the thickness direction through the elastic wall 18, in a form described in more detail. The elastic wall 18 is elastically deformable due to the action of the fluid pressure acting thereon. This elastic deformation caused by the fluid pressure allows the fluid passage 12 to transition between an open state and a closed state at any stage in the operation of the catheter placement device 1. In the open state, the fluid passage 12 is open so that the fluid transmission path F between the inlet side E and the outlet side A is open. In the closed state, the fluid passage 12 is closed, thereby sealing the fluid transmission path F liquid-tightly by the closed fluid passage 12. Thus, in contrast to solutions known from the prior art, the valve element 6 can be opened and closed only by the fluid pressure state that prevails in the fluid transmission path F.

[0036] In the illustrated embodiment, the elastic wall 18 is configured such that various fluid pressures are required to open the fluid passage 12, depending on the orientation of the passage through the fluid transport channel F. For further explanation, it is assumed that a fluid pressure pE is applied to the fluid transport channel F on the inlet side, and a fluid pressure pA is applied on the outlet side. The inlet-side fluid pressure pE acts on the proximal wall portion 24 of the elastic wall 18, which faces the inlet side E. The outlet-side fluid pressure pA acts on the distal wall portion 25 of the elastic wall 18, which faces the outlet side A. In the case of neutral fluid pressure, i.e., when pE = pA, the fluid passage 12 starts in a closed state and remains closed. If the inlet-side fluid pressure pE exceeds the outlet-side fluid pressure pA, there exists an inlet-side positive fluid pressure ΔpE. The inlet-side positive fluid pressure Δp1 is required to open the fluid passage 12. This pressure may also be referred to as the required inlet-side fluid positive pressure or inlet-side open positive pressure Δp1.

[0037] When the inlet fluid pressure pE is lower than the outlet fluid pressure pA, an inlet fluid negative pressure -ΔpE exists. This corresponds to the outlet fluid positive pressure ΔpA. To open the fluid passage 12, an inlet fluid negative pressure -Δp2 is required. Regarding the outlet side A, it can also be mentioned that an outlet fluid positive pressure Δp3 is required to open the fluid passage 12. This is sometimes called the outlet opening positive pressure Δp3.

[0038] The fluid differential pressures Δp1, -Δp2, and Δp3 required to open the fluid passage 12 differ depending on the direction of fluid pressurization in the elastic wall portion 18. In the illustrated embodiment, the required outlet-side fluid positive pressure Δp3 is greater than the required inlet-side fluid positive pressure Δp1. In other words, the required inlet-side fluid negative pressure -Δp2 is greater than the required inlet-side fluid positive pressure Δp1.

[0039] Furthermore, it is understood that when using this catheter placement device clinically, a neutral fluid pressure, i.e., a state where pE = pA, cannot occur. This is due to the venous pressure that is always present and acts on the outlet side of the elastic wall portion 18.

[0040] In the illustrated embodiment, the elastic wall 18 is configured such that the inlet-side opening positive pressure Δp1 is 0.3 PSI. This allows the fluid passage to open in a manner that satisfies the requirements, especially during conventional gravity-assisted injection. The elastic wall 18 is also configured such that the inlet-side opening negative pressure -Δp2 is 6 PSI. Such a negative pressure can be easily applied by a medical syringe connected to the coupling 8, thereby ensuring blood aspiration that satisfies the requirements. At the same time, the fluid passage 12 is prevented from opening unintentionally due to physiological phenomena at the patient's site.

[0041] The direction-dependent opening and closing operation of the fluid passage 12, as described above, is achieved by the configuration of the elastic wall portion 18 and the fluid passage 12 located within it, which will be described in more detail later.

[0042] For this purpose, it is provided that the elastic wall portion 18 has a dome-shaped curved portion W (Figure 5). The fluid passage 12 is located in the region of the apex S of the curved portion W. The dome-shaped curved portion W is curved outward in the direction of the outlet side A and inward in the direction of the inlet side E. In other words, the dome-shaped curved portion W is configured to be concave in the direction of the proximal inlet side E and convex in the direction of the distal outlet side A. In the illustrated embodiment, the elastic wall portion 18 has a constant wall thickness, and therefore the wall surfaces of the elastic wall portion 18 that face each other in the thickness direction are configured to extend in parallel.

[0043] In further embodiments, the elastic wall portion does not have a constant wall thickness.

[0044] The dome-shaped curved portion W gives the valve element 6 a configuration that is visually sometimes called a cupola shape, dome shape, or nearly hemispherical shape. Here, the valve element E is rotationally symmetric, and is rotationally symmetric with respect to the line of symmetry that coincides with the fluid transmission path F schematically shown in Figure 3.

[0045] The valve element 6 has a radial collar 19 on its outer circumference, which surrounds the elastic wall portion 18 in the circumferential direction and protrudes from the elastic wall portion 18 in the radial direction R. The radial collar 19 is fixed to the radial groove 20 of the hollow housing body 4 (Figure 3). The housing body 4 is configured here as a single component.

[0046] In the illustrated embodiment, the entire valve element 6 is manufactured from an elastomer material, such as silicon. This is not necessarily required. In an embodiment not shown, only the elastic wall portion 18 is manufactured from an elastomer material.

[0047] For installation, the valve element 6 is introduced into the cavity 11 distally from the inlet side E. During this process, the valve element 6 is slightly elastically compressed in the radial direction R. As soon as the radial collar 19 enters the range of the radial groove 20, the valve element 6 springs outward in the radial direction R. This causes the radial collar 19 to conform and engage with the radial groove 20, thereby securing the valve element 6 within the housing body 4.

[0048] In the alternative embodiment shown in Figure 4, the housing body 4a has a configuration consisting of two parts: a first housing portion 41a and a second housing portion 42a. The valve element 6 is fixed between the two housing portions 41a and 42a. At this time, the valve element 6 is pushed axially into the first housing portion 41a from the inlet side E. Here, elastic deformation of the valve element 6 is not necessarily required. After the valve element 6 is introduced, the second housing portion 42a is pushed axially and tipwise into the first housing portion 41a, thereby fixing the valve element 6 between the axially opposing end faces of the first housing portion 41a and the second housing portion 42a. The two housing portions 41a and 42a are then joined to each other by methods known to those skilled in the art, for example, adhesive bonding or welding.

[0049] Instead of a catheter housing, 42a could also be an example of a tubular valve (e.g., a silicone valve found in ported IVCs) or an integrated IVC.

[0050] In particular, the fluid passages may have different configurations. In the simplest case, the fluid passages are formed by individual slots.

[0051] In the configuration shown in Figure 6, the fluid passage 12 is formed by slot arrangements 21 and 22 having a first slot 21 and a second slot 22. The first slot 21 and the second slot 22 extend as radial slots in the radial direction R, forming a common intersection P. In the illustrated embodiment, the intersection coincides with the apex S of the dome-shaped curved portion W. Here, the first slot 21 and the second slot 22 are arranged in a cross shape with respect to each other and oriented toward each other. Thus, the slot arrangements 21 and 22 have a "+" shape configuration. The slot arrangements 21 and 22 extend axially through the wall thickness of the elastic wall portion 18. The fluid passage 12 is shown in its closed state with respect to Figure 6. In the aforementioned closed state, the subsections 181, 182, 183, and 184 of the elastic wall portion 18 are separated from each other by the slot arrangements 21 and 22 and are liquid-tight with respect to each other. Subsections 181-184 are generally triangular in all cases, and are intended to be schematically illustrated by the dashed lines shown in Figure 6. While the elastic wall 18 is subjected to corresponding fluid pressurization, subsections 181-184 expand axially into an arch shape relative to the rest of the elastic wall, thereby opening the fluid passage 12. This arching or expansion of subsections 181-184 occurs either in the direction of the outlet side A or the inlet side E, depending on the conditions of the fluid pressure present.

[0052] Figures 7 to 20 show further embodiments of valve elements 6a to 6i according to the present invention. Valve elements 6a to 6i are substantially identical to valve element 6 in terms of their design and operation. Therefore, to avoid repetition, mainly the substantial differences between valve elements 6a to 6i are described below. Otherwise, it should be noted that something has already been disclosed with respect to valve element 6 and will be explicitly referred to. Valve elements 6a to 6i can be used in place of valve element 6 in the catheter placement device 1.

[0053] The valve element 6a shown in Figure 7 provides a slot arrangement 21a, 22a, 23a having a first slot 21a, a second slot 22a, and a third slot 23a. The aforementioned slots are arranged to form two common intersections P, P', forming an H shape in the illustrated embodiment. The slot arrangements 21a, 22a, 23a separate subsections 181a, 182a of the elastic wall portion 18a. The aforementioned subsections have a substantially rectangular configuration, which is clarified by dashed lines. In Figure 7, the fluid passage 12a formed by the slot arrangements 21a, 22a, 23a is shown in a closed state. When transitioning to an open state, the subsections 181a, 182a elastically unfold in the axial direction.

[0054] The valve element 6b shown in Figure 8 provides slot arrangements 21b, 22b, 23b having a first slot 21b, a second slot 22b, and a third slot 23b. These slots are arranged to form exactly one common intersection P'', forming a star shape in the illustrated embodiment. The slot arrangements 21b, 22b, 23b separate subsections 181b, 182b, 183b of the elastic wall portion 18b. The aforementioned subsections have a substantially triangular configuration, which is clarified by dashed lines. In Figure 8, the fluid passage 12b formed by the slot arrangements 21b, 22b, 23b is shown in a closed state. When transitioning to an open state, the subsections 181b, 182b, 183b elastically unfold in the axial direction.

[0055] In contrast to valve element 6, valve element 6c according to Figure 9 has a relatively flat dome-shaped curved portion Wc. This is achieved by the fact that the maximum height H of the dome-shaped curved portion Wc is smaller than the radial diameter D of the elastic wall portion 18c. In the illustrated embodiment, the ratio of the axial height H to the radial diameter D is approximately 1:5. Valve element 6c has improved flow characteristics compared to valve element 6. For this purpose, a direct comparison between Figure 3 and Figure 9 is referred to. In the fitted state shown in Figure 3, what is called dead space is identified by the symbol T. Dead space T extends annularly in the radially outer region of the distal wall side portion 25 of valve element 6. Even when valve element 6 is open, liquid flows slowly or, in the worst case, no liquid flow occurs in dead space T. Dead space T is relatively narrow due to the relatively prominent dome-shaped curved portion W, and therefore, flow passes through weakly or, in the worst case, not at all. In contrast, in the fitted state of the valve element 6c shown in Figure 9, the dead space Tc is relatively wide, and flow can pass through relatively easily. This is because the dome-shaped curved portion Wc is relatively flat. The flat dome-shaped curved portion Wc improves the flow in the radially outer region of the distal wall side portion 25c. In the simplest case, the fluid passage 12c can be formed by a single longitudinal slot. Alternatively, configurations of the fluid passage 12c such as the slot arrangements described above and / or below are also possible.

[0056] In further embodiments, the dead space T may also be reduced by molding the catheter hub to conform to the shape of the valve. For example, the catheter hub may have a curved profile that conforms to the dome or cupola shape of the valve. This helps to minimize the dead space T and improve the alignment of the valve and catheter hub during the assembly process. To minimize the dead space, the valve may be molded to conform to the shape of the inner profile of the catheter hub. The catheter hub may also be molded to conform to the shape of the valve.

[0057] In contrast to the embodiments described above, the valve element 6d according to Figure 10 has a further fluid passage 26d. The further fluid passage 26d is constructed to extend through the elastic wall 18d and can transition between open and closed states in a manner caused by fluid pressure. This essentially corresponds to the fluid passage 12d formed by a single first slot 21d in the illustrated embodiment. The further fluid passage 26d has at least two circumferential slots 27d, 28d, which may also be referred to as a first circumferential slot 27d and a second circumferential slot 28d. The circumferential slots 27d, 28d are formed to extend circumferentially through the cupola-shaped curved elastic wall 18d. The circumferential slots 27d, 28d are offset from each other by 180° in the circumferential direction. The circumferential slots 27d, 28d are arranged mirror-symmetrically to each other and / or opposite with respect to the fluid passage 12d, more precisely its slot 21d. The circumferential slots 27d and 28d are positioned radially outward relative to the fluid passage 12d. The first slot 21d is located at the apex of the dome-shaped curve (not specifically shown).

[0058] In further embodiments, the slots may be linear cuts instead of circumferential ones, and may be arranged radially.

[0059] With respect to Figure 11, it is shown that the slot 21d of the fluid passage 12d has a proximal slot length L1 at the proximal wall side portion 24d. Slot 21d has a different distal slot length L2 at its distal wall side portion 25d. In the illustrated embodiment, the proximal slot length L1 is greater than the distal slot length L2. This assists in the opening of the fluid passage 12d caused by injection pressure. Conversely, if the ratio between the proximal slot length L1 and the distal slot length L2 were reversed, it would assist in the opening of the fluid passage 12d caused by suction pressure. Because the slot lengths L1 and L2 are different, the end regions of slot 21d that are opposite each other in the longitudinal direction are inclined relative to each other.

[0060] The circumferential slots 27d and 28d of the further fluid passage 26d have the opposite slot length ratio compared to slot 21d. In other words, both circumferential slots 27d and 28d are longer at the distal wall portion 25d than at the proximal wall portion 24d. This simplifies the suction of liquid through the further fluid passage 26d.

[0061] In one use of valve element 6d, its operation is as follows: When liquid is injected (fluid flows distally) and the injection pressure is dominant, fluid passage 12d is opened. At this time, it is preferable that the further fluid passage 26d remains closed. As the injection pressure increases, the further fluid passage 26d may also be opened. When liquid is drawn in (fluid flows proximal) and the suction pressure is dominant, the further fluid passage 26d is opened. Fluid passage 21d is kept closed here. The opening and closing behavior of fluid passage 12d and the further fluid passage 26d, which depend on the aforementioned direction, is aided by the ratio of the lengths of the aforementioned slots.

[0062] Furthermore, it should be understood that the fluid passage 12d can alternatively be formed by the slot arrangement described above or below. In addition, further fluid passages 26d may be formed by fewer or more circumferential slots than the two circumferential slots 27d, 28d shown herein. For example, three, four, five, six, or more than six circumferential slots are possible.

[0063] The valve element 6e shown in Figure 12 is differentiated by a profile 30e present in the region of the fluid passage 12e. The profile 30e is formed in the elastic wall 18e. The profile 30e can be designed as either a convex or concave profile. In this example, the profile 30e is concave within the elastic wall 18e. The profile 30e is concave within the elastic wall 18e from the proximal wall side 24e. Alternatively, if the profile is designed as a convex profile, the profile preferably starts from the distal wall side 25e and protrudes from the elastic wall 18e. The profile 30e leads to a reduction in the wall thickness of the elastic wall 18e in the region of the fluid passage 12e. The profile 30e is sometimes called a recess, cavity, groove, or channel. The profile 30e assists in the opening of the fluid passage 21e caused by the injection pressure.

[0064] Furthermore, the fluid passage 12e has only one first slot 21e. It is understood that an improved fluid passage 12e may be formed by the slot arrangement described above or below. In this case, the profile is adapted to the specific improvement of the fluid passage.

[0065] In addition, the valve element 6e formed by the valve element 6d in Figures 10 and 11 has a further fluid passage 26e, although this is not essential.

[0066] The valve element 6f shown in Figure 13 differs from the valve element 6e shown in Figure 12 in that an additional profile 31f exists in the region of the further fluid passage 26f. The additional profile 31f is located on the first circumferential slot 27f and the second circumferential slot 28f, respectively, and affects the opening and closing behavior of the aforementioned circumferential slots. The additional profile 31f corresponding to profile 30e can be basically convex or concave. In addition, the additional profile 31f may be located on the proximal wall side 24f and / or distal wall side 25f of the elastic wall portion 18f. In the illustrated embodiment, the additional profile 31f is located on the proximal wall side 24f and is concave within the proximal wall side 24f. In a further improved form, two additional profiles are convexly located and formed on the distal wall side 25f. In a further improved form, one of the additional profiles is located on the proximal wall side and the other is located on the distal wall side.

[0067] It is understood that the profiles 30e and 31f shown with reference to Figures 12 and 13, which affect the opening and closing behavior of the fluid passages and further fluid passages, can be combined and formed differently from each other. In addition, combinations with different slot lengths on the proximal and distal wall sides, as shown with reference to Figure 11, are possible.

[0068] The valve element 6g (Figures 14 and 15) enables the rapid alternation of the elastic wall portion 18g between the first state (Figure 16) and the second state (Figure 17). The rapid inversion occurs in response to the pressurization and / or direction of the fluid flow. The valve element 6g is represented in a simplified form and has abrupt inversion characteristics, inverting based on the direction of the fluid.

[0069] For this purpose, the valve element 6g has an elastic connecting wall 32g. The elastic connecting wall 32g is positioned radially outward, with one end in contact with the elastic wall 18g and the other end in contact with the radial collar 19g. The elastic connecting wall 32g has an annular design. In the region of the elastic connecting wall 32g, the valve element 6g has a thinner wall thickness compared to the adjacent wall. This reduction in wall thickness enables the aforementioned reversal and / or switching operation of the valve element 6g.

[0070] Furthermore, with respect to Figure 15, it can be seen that the elastic wall portion 18g thickens radially R from the outside to the inside, and has a wall thickness that is almost maximum in the region of the apex of the dome-shaped curved portion Wg. In both the first state (Figure 16) and the second state (Figure 17), the elastic wall portion 18g has improved stability due to the increase in wall thickness from the outside to the inside. The radially outer region where the wall thickness is minimum can also be called the annular wall portion 33g. Because the annular wall portion 33g has a relatively thin wall thickness, it assists in inversion that satisfies the necessary conditions. In addition, the valve element 6g has a substantially cylindrical cylinder wall portion 34g (Figure 15). At any point in the first state, the cylinder wall portion 34g is located radially inside the valve element 6g, and one end of it is in contact with the proximal wall portion 24g.

[0071] In the first state, the dome-shaped curved section Wg is arched in the distal direction. In other words, the elastic wall section 18g is concave in the direction of the proximal inlet side E and convex in the direction of the distal outlet side A in the first state.

[0072] In the second state, the elastic wall portion 18g is convex in the direction of the proximal inlet and concave in the direction of the distal outlet A. Therefore, there exists a dome-shaped curved portion Wg' which is the inverse of the dome-shaped curved portion Wg (Figure 17).

[0073] In the use of valve element 6g, its operation is as follows: Starting from a first state (Figure 16), injection pressure is applied to inject liquid. The injection pressure opens the fluid passage 12g. Valve element 6g is maintained in the first state here. The first state is stable at this point. As the injection pressure decreases, the fluid passage 12g transitions to a closed state. Suction pressure is applied to draw in liquid. This suction pressure causes the elastic wall 18g to rapidly invert to a second state (Figure 17), where the fluid passage 12g is initially maintained in a closed state. If the suction pressure is maintained and / or increased, the fluid passage 12g then transitions to an open state so that the liquid can flow from outlet side A to inlet side E. The second state, as discussed here, is again stable. As the suction pressure decreases, the fluid passage 12g transitions to a closed state. By applying new injection pressure, the valve element 6g can be reversed back to its first state, reopening the fluid passage 12g and allowing liquid to be injected.

[0074] The 6g valve element enables particularly favorable flow characteristics. Both fluid injection and aspiration can reduce turbulence, or in the best case, become completely layered. This is due to the aforementioned rapid alternation between the first and second states. When the 6g valve element is used within the scope of blood collection, particularly unfavorable blood cell destruction can be avoided.

[0075] The valve element 6h shown in Figures 18 and 19 differs from the valve elements shown previously by the first pair of rib elements P1 and the second pair of rib elements P2. The first pair of rib elements P1 has two rib elements 35h and 36h, which are sometimes referred to as the first rib element 35h and the second rib element 36h. The second pair of rib elements P2 has two rib elements 37h and 38h, which are sometimes referred to as the third rib element 37h and the fourth rib element 38h. The first rib element 35h and the second rib element 36h are positioned opposite each other in pairs with respect to the intersection P of the fluid passage 12h. The same applies to the third rib element 37h and the fourth rib element 38h. The first pair of rib elements P1 is positioned radially outward with respect to the intersection P compared to the second pair of rib elements P2.

[0076] The inventors have found that, in the ready state, the hollow needle 3, which is made to extend through the fluid passage 12h, can cause an undesirable memory effect, and thus can cause partial residual deformation of the elastic wall portion 18h to any degree. This memory effect is inherently undesirable. The second pair of rib elements P2 suppresses the aforementioned memory effect. For this purpose, the rib elements 37h and 38h are positioned relatively close to the intersection P of the fluid passage 12h. This provides mechanical reinforcement of the elastic wall portion 18h to counteract the aforementioned memory effect.

[0077] The first pair P1, positioned further outward in the radial direction, assists the elastic deformation of the elastic wall portion 18a by satisfying the requirements for elastic deformation during the suction and injection of liquid.

[0078] In the illustrated embodiment, the first pair P1 and the second pair P2, and therefore all of the rib elements 35h, 36h, 37h, and 38h, are positioned on the proximal wall portion 24h. In a further improved form, at least one of the rib elements may be positioned on the distal wall portion 25h. Furthermore, an improvement is conceivable in which only one pair of the two pairs P1 and P2 is present. Moreover, the shape of the rib elements shown with respect to Figure 19 should be understood as merely illustrative. Further improved forms may provide different shapes.

[0079] With respect to Figure 20, a further simplified embodiment is shown that provides inverse mounting of the valve element 6i to the housing body 4. The valve element 6i has an elastic wall portion 18i with a dome-shaped curved portion Wi. The dome-shaped curved portion Wi is arched in the direction of the proximal inlet side E. In other words, the elastic wall portion 18i is convex in the direction of the proximal inlet side E and concave in the direction of the distal outlet side A. The inventors have found that this embodiment can improve the flow characteristics during liquid aspiration. This is because the orientation of the aforementioned dome-shaped curved portion Wi reduces turbulence in the direction of proximal flow. In the best case, even laminar flow can be achieved. This suppresses undesirable blood cell destruction when the catheter placement device is used for blood collection. Conversely, distal turbulence is promoted. This prevents bacterial accumulation.

[0080] With regard to the above description, it is clear that the individual features of valve elements 6-6i are considered independent forms and can be combined with each other to form various combinations of features. For example, the flat dome shape of valve element 6c can be combined with the further fluid passage of valve element 6d, the profiles of valve elements 6e and 6f, the abrupt transition characteristics of valve element 6g, and / or the rib elements of valve element 6h.

Claims

1. Catheter placement device (1), Catheter (2), A hollow housing body (4, 4a) and A tubular element (5) attached to the distal end (10) of the housing body (4, 4a), The housing body (4, 4a) is arranged and includes valve elements (6, 6a to i) having fluid passages (12, 12a-i), The housing body (4, 4a), the fluid transmission path (F) is made to extend longitudinally through the fluid passage (12, 12a-i) between the proximal inlet side (E) and the distal outlet side (A), and the tubular element (5), The catheter (2) having, A hollow needle (3) is provided, which is manufactured to extend longitudinally through the fluid transmission path (F) when the catheter placement device (1) is ready, and is withdrawn proximal to the fluid transmission path (F) when the catheter placement device (1) is in use. The catheter placement device is characterized in that the valve elements (6, 6a to i) are provided with elastic wall portions (18, 18a to i), the fluid passage (12, 12a-i) is constructed to extend through the elastic wall portions, the wall portions (18, 18a to i) are elastically deformable under the action of fluid pressure (pE, pA), and in the usage state of the catheter placement device (1), the fluid passage (12, 12a-i) is transitionable between an open state in which the fluid passage (12, 12a-i) is open and a closed state in which the fluid passage (12, 12a-i) is closed due to elastic deformation caused by the fluid pressure of the wall portions (18, 18a to i).

2. The catheter placement device (1) according to claim 1, characterized in that the elastic wall portion (18, 18a-i) is configured such that the fluid passage (12, 12a-i) starts from the closed state in the usage state of the catheter placement device (1), maintains the closed state at neutral fluid pressure, and can transition to the open state by inlet-side fluid positive pressure (ΔpE) and / or inlet-side fluid negative pressure (-ΔpE), and the inlet-side fluid negative pressure (-Δp2) required to open the fluid passage (12, 12a-i) is greater in value than the inlet-side fluid positive pressure (Δp1) required to open it.

3. The catheter placement device (1) according to claim 2, characterized in that the inlet-side fluid negative pressure (-Δp2) required to open the fluid passage (12, 12a-i) is 15 to 25 times, preferably 20 times, the inlet-side fluid positive pressure (Δp1) required to open the fluid passage (12, 12a-i).

4. The catheter placement device (1) according to claim 2 or 3, characterized in that the inlet-side fluid positive pressure (Δp1) required to open the fluid passage (12, 12a-i) is 0.2 PSI to 0.4 PSI, preferably 0.3 PSI, and the inlet-side fluid negative pressure (-Δp2) required to open the fluid passage (12, 12a-i) is 5.0 PSI to 7.0 PSI, preferably 6.0 PSI.

5. The catheter placement device (1) according to any one of claims 1 to 4, characterized in that the elastic wall portion (18, 18a-i) has a dome-shaped curved portion (W, Wc, Wg, Wg', Wi), and the fluid passage (12, 12a-i) is arranged in the region of the apex (S) of the curved portion (W, Wc, Wg, Wg', Wi).

6. The catheter placement device (1) according to claim 5, characterized in that the dome-shaped curved portions (W, Wc, Wg') of the elastic wall portions (18, 18a, h) are concave in the direction of the proximal inlet (E) and convex in the direction of the distal outlet (A).

7. The catheter placement device (1) according to claim 5 or 6, characterized in that the dome-shaped curved portion (Wg', Wi) of the elastic wall portion (18g, 18i) is convex in the direction of the proximal inlet side (E) and concave in the direction of the distal outlet side (A).

8. The catheter placement device (1) according to any one of claims 5 to 7, wherein the valve element (6g) has a radially outward elastic connecting wall portion (32g), the elastic connecting wall portion (32g) is adjacent to the dome-shaped curved portion (Wg, Wg'), and is characterized in that it can be rapidly and alternately reversed between a first stable state in which the dome-shaped curved portion (Wg) is arched distally and a second stable state in which the dome-shaped curved portion (Wg') is arched proximal to the action of fluid pressure caused by injection and / or fluid pressure caused by suction.

9. The catheter placement device (1) according to any one of claims 5 to 8, characterized in that the axial height (H) of the dome-shaped curved portion (Wc) is smaller than the radial diameter (D) of the elastic wall portion (18c).

10. The catheter placement device (1) according to any one of claims 1 to 9, characterized in that the fluid passage (12, 12a-i) is formed by a slot arrangement (21, 21a, 21b, 21h) having at least one first slot (21, 21a, 21b, 21h) and a second slot (22, 22a, 22b, 22h), wherein the slots are preferably arranged in a cross shape, particularly in a "+" shape, and form at least one common intersection (P, P).

11. The catheter placement device (1) according to claim 10, characterized in that the slot arrangement (21a, 22a, 23a) has a third slot (23a), and the first slot (21a), the second slot (22a), and the third slot (23a) are arranged in an H shape in particular, forming two common intersections (P, P').

12. The catheter placement device (1) according to claim 10, characterized in that the slot arrangement (21b, 22b, 23b) has a third slot (23b), and the first slot (21b), the second slot (22b), and the third slot (23b) are arranged in a star shape to precisely form one common intersection (P'').

13. The catheter placement device (1) according to any one of claims 10 to 12, characterized in that the elastic wall portion (18h) has at least one first pair (P1) of rib elements (35h, 36h) and one second pair (P2) of rib elements (37h, 38h), each pair being arranged opposite to each other with respect to at least one common intersection (P), and the first pair (P1) of the rib elements (35h, 36h) is positioned radially outward with respect to the intersection (P) than the second pair (P2) of the rib elements (37h, 38h).

14. A catheter placement device (1) according to any one of claims 1 to 13, characterized in that at least one further fluid passage (26d-f) is created to extend through the elastic wall portion (18d-f), the further fluid passage (26d-f) is formed by at least two circumferential slots (27d-f, 28d-f) created to extend longitudinally in the circumferential direction of the elastic wall portion (18d-f), and the at least two circumferential slots (27d-f, 28d-f) are arranged radially outward with respect to the fluid passage (12, 12a-i).

15. The catheter placement device (1) according to claim 14, characterized in that the circumferential slots (27d-f, 28d-f) are each longer on the distal side (25d-f) of the elastic wall portion (18d-f) than on the proximal side (24d-f) of the elastic wall portion (18d-f), and / or the fluid passage (12d-f) has at least one slot (21d-f) which is longer on the proximal side (18d-f) of the elastic wall portion (18d-f) than on the distal side (25d-f) of the elastic wall portion (18d-f).

16. The catheter placement device (1) according to claim 14 or 15, characterized in that the elastic wall portion (18e) has at least one concave or convex profile (30e) in the region of the fluid passage (12e), and / or the elastic wall portion (18f) has at least one further concave or convex profile (31f) in the region of the further fluid passage (26f).

17. The catheter placement device (1) according to any one of claims 1 to 16, characterized in that the valve elements (6, 6a to i) have annular radial collars (19, 19g, 19h) fixed in an annular radial groove (20) of the housing body (4), and the housing body (4) is configured as a single component.

18. The catheter placement device (1) according to any one of claims 1 to 16, characterized in that the valve element (6, 6a-i) has radial collars (19, 19g, 19h) fixed between two mutually joined housing portions (41a, 42a) of the housing body (4a).

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