Medical access system

Abstract

The invention relates to a medical access system for providing access to a hollow body of a patient, the access system having at least one catheter with a tubular catheter intermediate tube, the catheter being configured to, after a puncture of a sheath of the hollow body to be punctured, provide access to the hollow body to be punctured. Through an opening through the sheath of the hollow body by means of a puncture needle or otherwise implemented, the catheter is pushed over at least a portion of the length of the catheter intermediate tube and is retained there for a period of time. Such a hollow body of a patient may be, for example, a tubular tube, in particular a blood vessel, such as a vein or artery or lymphatic vessel, or other hollow organ.

Description

Technical Field

[0001] The invention relates to a medical access system for providing access to a hollow body of a patient, wherein the access system has at least one catheter with a tubular catheter intermediate tube, wherein the catheter is configured to be pushed through an opening in the casing of the hollow body, which is achieved by means of a puncture needle or in some other way, over at least a portion of the length of the catheter intermediate tube and to remain there for a certain period of time after the casing of the hollow body to be punctured has been punctured. Such a hollow body of the patient can be, for example, a tubular tube, in particular a blood vessel, such as a vein or an artery or a lymphatic vessel, or another hollow organ. Background Art

[0002] Medical access systems are known in different configurations, for example as indwelling cannulas or intravenous catheters, for example for dialysis. Such indwelling cannulas can be designed, for example, as intravenous cannulas. Medical access systems can be designed, for example, as puncture systems / catheter systems.

[0003] The terms "puncture" and "perforation" are to be understood in the medical sense. "Puncture" means inserting a puncture needle into a hollow body, so that the puncture needle penetrates the sheath of the hollow body to be punctured.

[0004] The portion of the indwelling cannula that is located at the distal (distal) end and thus near the punctured hollow body from the user's perspective is considered to be a section of the portion of the indwelling cannula that is close to the hollow body. Correspondingly, the section that is far from the hollow body is arranged at the proximal end of the indwelling cannula from the user's perspective, i.e., further away from the punctured hollow body. In conjunction with the medical application of the indwelling cannula, the terms "close to the vein" or "close to the patient" or "far from the user" are also used synonymously with the term "close to the hollow body", and for the term "far from the hollow body", "far from the vein" and "far from the patient" as well as "close to the user" are also used.

[0005] Parts close to the vein tend to be inside the patient, parts remote from the vein tend to be outside the patient. This does not always apply mandatorily, but the terminology should be further clarified. Supplementary content is self-evident according to the regulations, and the context is decisive.

[0006] A puncture-resistant intravenous cannula is known from PCT / EP2019 / 057097.

[0007] An improved medical access system in the sense of a general puncture system / catheter system should be produced. In principle, it is also possible with the improved medical access system to advantageously puncture all body cavities and body spaces and all anatomical and pathological structures that are to be punctured and to insert a catheter therein. It is also possible to only puncture without inserting a catheter.

[0008] In principle, the components of the improved medical access system can also be used in combination with all known puncture and catheter systems or also as a stand-alone product.

[0009] Although the term "indwelling cannula" is to be retained in part below, it has a broad meaning in the sense of a medical access system or puncture system in general, with which not only veins can be punctured. That is, below, the terms "a vein" and "veins" include in principle all blood vessels that are to be punctured and that are to be provided with a catheter and more generally all body cavities and body spaces as well as all anatomical and pathological structures.

[0010] Thus, by means of an indwelling cannula, the trachea, the pleural cavity, the abdominal cavity, the stomach, the intestines, the renal pelvis, the bladder, structures of the central and peripheral nervous systems, the subarachnoid space and bones can additionally be punctured, for example. In addition, pathological structures such as abscesses can be punctured in and on the patient. Advantageously, arterial vessels can also be punctured.

[0011] In the following, the term "patient" includes all living beings of all age groups and sexes. Application in the technical field and in and at all objects and structures is also clearly possible, for example in and at reservoirs, containers, cavities, expandable materials and in and at pump systems, hose systems, tube systems and port systems.

[0012] If the word “or” is used below, this indicates possible alternatives, but a combination of features or expressions separated by “or” is in principle also explicitly possible.

[0013] All components described can be used once or several times at an indwelling cannula or also independently of such an indwelling cannula at / in other products or completely independently. Different features of different components can also be combined freely, and features of specific components can also be used at other components without this having to be explicitly mentioned. In principle, all components and features can be used both inside and outside the patient.

[0014] Indwelling cannulas and in particular venous indwelling cannulas are special medical devices in the sense that they must have specific diameter and length dimensions in order to be able to be applied to a vein at a common access site in a human or animal patient. For this purpose, a certain flexibility or elasticity of the catheter intermediate tube is also required. Therefore, such indwelling cannulas cannot be compared to catheter systems for other applications, such as bladder catheters, because completely different requirements apply there. Summary of the invention

[0015] The invention is based on the object of providing a medical access system which can be used more simply and more safely.

[0016] This object is achieved by a medical access system according to claim 1. Advantageous developments are specified in the dependent claims.

[0017] According to the present invention, at least the part of the catheter intermediate tube that is configured to be retained in the hollow body has at least one spiral support structure over its entire length or a major part of its length, in particular in the form of at least one spirally wound internal hollow guide wire. Due to the spiral shape of the support structure, an internal cavity is formed therein, and the puncture needle can be guided through the internal cavity. The catheter intermediate tube can be supported and the sharp bending of the catheter intermediate tube can be avoided in particular by the spiral support structure arranged in the catheter intermediate tube. By the spiral support structure, the internal tube lumen of the catheter intermediate tube remains permanently open, so it does not cause blockage. The bending resistance torque and / or radial resistance torque of the catheter intermediate tube are improved by the spiral support structure.

[0018] Due to the spiral support structure, the catheter intermediate tube can adapt to the direction of, for example, blood vessels or other anatomical structures and also branches without sharp bends. In addition to the application in / at the indwelling sleeve, when the catheter intermediate tube according to the present invention is longer, for example, up to 200 cm, and must be pushed into the body on a longer path section, for example, in the application in the field of interventional cardiology or (neuro) radiology or in the scope of minimally invasive surgery, this can also be particularly advantageous.

[0019] Any conventional / commercially available single lumen catheter intermediate tube or multi-lumen catheter intermediate tube or other tube of all diameter sizes and length sizes may be used.

[0020] The support structure can be, for example, a spiral structure extending over a certain longitudinal section of the catheter intermediate tube. There can also be a plurality of coaxial such support structures. The spiral support structure can also have spring-like properties. The spiral structure can be formed from round material or flat material, in particular from metal material. The catheter intermediate tube can be formed in a single layer or multiple layers in the radial direction, and in each radial layer it can be formed not only from the same material but also from different materials.

[0021] The support structure can be formed in a wave shape or have a wave surface. The wave surface is represented by the alternating diameter of the support structure at least in the cross section along the longitudinal axis of the support structure. Here, the wave shape can be formed by sinusoidal oscillation, square oscillation, triangular oscillation and / or sawtooth oscillation, for example. The support structure can also be formed by at least one braided structure or improved by means of at least one such structure. The support structure can also be formed by at least one structure extending longitudinally, transversely or diagonally relative to the longitudinal axis of the catheter intermediate tube, or can be improved by means of at least one such structure. At least one such structure can also include or overlap a certain distance of the support structure, so as to offset the length change in the case of a spiral support structure of a spiral, for example. Other configuration schemes and shapes of the support structure and its surface are also conceivable. Therefore, the support structure can not only have a smooth surface but also a convex surface. The surface of the support structure can be formed by at least one material or coated with at least one material, and the material is characterized by an improved or high sliding ability.

[0022] As materials for the catheter intermediate tube, polyurethane (PU) or FEP are considered, for example. The material for the support structure can be a metal material, in particular stainless steel and / or a metal alloy, in particular Nitinol. Nitinol has the advantage that the desired resistance of the catheter intermediate tube to being pressed together or bent is further increased by the memory effect.

[0023] Other materials for the support structure may be plastic materials, in particular fiber-reinforced plastics, such as carbon fibers or aramid fiber-reinforced plastics. The material for the support structure may be a polymer. The material for the support structure may be a polycondensate. The material for the support structure may be an addition polymer. The material for the support structure may be a thermosetting plastic or a thermoplastic. Plastic materials characterized by high mechanical strength, such as polyimides, may also be used. Plastic materials with rubber-elastic properties, such as silicone elastomers, may also be used. Resins, such as unsaturated polyester resins, may also be used. Polyethylene may also be used. Polytetrafluoroethylene (PTFE) may also be used. Polyvinyl chloride (PVC) may also be used. Thus, the support structure may be configured, for example, as a rigid PVC spiral.

[0024] Advantageously, as material for the support structure, a material can be used which has sufficient or good suitability for magnetic resonance tomography (MRT). Advantageously, as material for the support structure, a material can be used which has sufficient or good insulation properties with respect to heat and / or electric current. Such a material can also be embedded in the spiral support structure by means of interruptions through other materials. It is also possible to form only certain areas of the spiral support structure as areas with sufficient or good insulation properties. It is also conceivable to use a specific adhesive for this purpose.

[0025] The catheter intermediate tube may be made of one or more of the materials mentioned. The support structure may be made of one or more of the materials mentioned.

[0026] Composite materials and materials which expand or become stronger when heated by body temperature can also be used advantageously. The helical support structure can be completely or partially bimetallic.

[0027] The support structure may also be partially, mainly or completely composed of at least one resorbable / blood-soluble material or coated with such a material. The resorbable material may be a carbohydrate, but may also be other biomolecules or salts. The material may also be magnesium or contain magnesium. Resorbable polymers, composite materials, bioceramic materials or biodegradable metals may also be used. The material may also be a combination of multiple resorbable materials and may also contain at least one antibacterial or anticoagulant or other effective or biologically active substance or be coated with at least one such substance.

[0028] The support structure can also be used as a sensor and / or detector or as part of a sensor and / or detector in order to detect specific characteristics or state changes of the catheter intermediate tube, such as the pressing together or bending of the catheter intermediate tube. Advantageously, by means of such a sensor and / or detector, characteristics or state changes in the region of the catheter intermediate tube can also be detected, such as characteristics or state changes of the following parameters / measured values ​​of the blood: temperature, oxygen content, electrolytes, pH value, blood sugar, renal function and liver function. In the case of pulse-synchronous and / or blood pressure-dependent shape / state changes of the support structure, such as expansion in the radial direction or in the longitudinal direction, it is also conceivable to measure the following parameters in the arterial position of the catheter intermediate tube according to the invention: the parameters are used to determine the arterial blood pressure and the values ​​associated therewith, so as to be able to evaluate the patient's circulatory function. In the venous position of the catheter intermediate tube according to the invention, it is conceivable to determine the venous pressure. It is also conceivable to measure the width of the blood vessel by means of the support structure, in particular also to measure changes in the tension (tension state) of the blood vessel.

[0029] In the spiral shape of the support structure, there can be one spiral or multiple spirals placed in each other. In such a spiral, at least one spiral can also be configured as a sensor and / or detector. When there are multiple spirals, the spirals can be composed of different materials. Advantageously, at least one spiral can be electrically conductive and at least one other spiral can be electrically insulating. The coils of the spiral can have the same spacing from each other or a changing spacing over the entire length of the support structure. In an advantageous embodiment of the present invention, in an area away from the hollow body, the spiral support structure can have a smaller spacing between the coils than in an area close to the hollow body.

[0030] When using materials that are visible in medical imaging methods, in particular metallic materials, such a support structure can improve the visibility of the catheter in the patient by means of medical imaging methods, for example by ultrasound examination.

[0031] According to an advantageous embodiment of the invention, it is proposed that the spiral support structure is loosely arranged in the catheter middle tube over a large part of its longitudinal extension or over its entire longitudinal extension. In this way, the supporting effect of the spiral support structure can be further optimized. When the catheter middle tube is bent, the spiral support structure can loosely follow the shape change without excessive stresses occurring in the material of the spiral support structure. In this way, an improvement in the bending resistance can be achieved, in particular, compared to the following implementation: in the described implementation, the spiral support structure is embedded in the material of the catheter middle tube or in another material, and the individual spiral coils cannot move freely relative to the catheter middle tube accordingly.

[0032] For example, the spiral support structure can be loosely attached to the inner side of the catheter intermediate tube. The spiral support structure can perform a slight relative movement relative to the catheter intermediate tube when the catheter intermediate tube is bent. Therefore, even if the spiral support structure is fastened to the catheter intermediate tube or another component of the indwelling sleeve, the spiral support structure can at least slightly move relative to the catheter intermediate tube in a loose area. The spiral support structure can have a certain clearance relative to the inner side of the catheter intermediate tube in the radial direction.

[0033] It is also conceivable that the catheter center tube also contains a section in which the helical support structure is present over its length, but the helical support structure is not loosely arranged but fixedly arranged in the catheter center tube. It is also conceivable that the degree of relative movement of the helical support structure relative to the catheter center tube is different in different sections of the catheter center tube.

[0034] For example, the helical support structure can be designed, for example, like a section of a Seldinger wire. However, unlike the Seldinger wire, the helical support structure is fixed to the catheter intermediate tube so that the helical support structure cannot fall out of the catheter intermediate tube or escape from the catheter intermediate tube due to improper use. If the catheter intermediate tube is placed against the patient, the helical support structure remains in the catheter intermediate tube during the entire placement time.

[0035] According to an advantageous design of the present invention, the spiral support structure is permanently fixed to the catheter intermediate tube or a component of the medical access system connected to the catheter intermediate tube via at least one fastening element. This fastening element ensures that the spiral support structure will not fall off from the catheter intermediate tube or change its position to a large extent undesirably. However, here, the individual coils of the spiral support structure are mainly loosely arranged in the catheter intermediate tube. Therefore, unlike the known application with the aid of the Sedinger wire, the difference of the spiral support structure is that it is permanently arranged in the catheter intermediate tube, and cannot extend from the catheter intermediate tube and cannot be removed from the catheter intermediate tube.

[0036] According to an advantageous design of the present invention, the spiral support structure is fixed at one or both ends via at least one fastening element to the catheter middle tube or a component of the medical access system connected to the catheter middle tube, and is otherwise loosely arranged in the catheter middle tube. Correspondingly, the spiral support structure is only fixed at the end side, so that the region between the ends of the spiral support structure is loosely arranged in the catheter middle tube, or in the case of only one-sided fastening, the end side facing away from it is also loosely arranged in the catheter middle tube.

[0037] For example, the helical support structure can be fixed only at one end, so that the helical support structure cannot move in one axial direction or in the opposite axial direction at the fixed end. If the helical support structure is fixed at both ends, the helical support structure can be inserted, for example, between two fastening elements, which bring about the fixation in mutually opposite axial directions. The helical support structure can then have a certain axial play between the two fastening elements, i.e. can be slightly movable in the axial direction.

[0038] According to an advantageous design of the present invention, a tubular inner body is arranged in the spiral support structure. In this way, the spiral support structure is shielded inwardly by the tubular inner body, for example, with respect to a puncture needle guided therethrough or with respect to a puncturing liquid. The spiral support structure can be arranged on the tubular inner body with a certain radial gap. The tubular inner body extends through the spiral structure in the longitudinal direction. The tubular inner body can extend over the entire length of the spiral support structure or only over a part of the length. The tubular inner body can also be longer than the spiral support structure and extend from the spiral support structure at one or both end sides.

[0039] Therefore, the catheter intermediate tube can, for example, have a tubular outer body and a tubular inner body, the tubular inner body being arranged in the tubular outer body at a certain radial spacing, wherein an annular gap is formed between the tubular outer body and the tubular inner body, and the spiral support structure is arranged in the annular gap. The spiral support structure can be arranged in the annular gap with a certain radial gap. In the annular gap, a substance can be additionally present, such as an oily or grease-containing substance or other substance or liquid, which reduces the friction resistance between the spiral support structure and its surroundings. Therefore, the mobility of the spiral support structure according to the present invention relative to its surroundings is further improved. Such a substance or liquid can, for example, also have other properties, such as keeping the spiral support structure and its surroundings in a specific temperature range or protecting the used material from change, wear or damage, such as fracture or corrosion or from pathogenic bacteria.

[0040] The tubular inner body can also be associated in and / or at a component of the medical access system that is different from the catheter central tube, such as a support component explained further below. The tubular inner body can be designed, for example, as a tube or hose.

[0041] In an alternative design, the spiral support structure is not covered by the inner layer inwardly, that is, it is exposed and can, for example, contact with the fluid passing through the catheter middle tube. If the puncture needle is guided through the catheter middle tube, the puncture needle can, for example, directly abut against the inner side of the spiral support structure.

[0042] According to an advantageous design of the present invention, a spiral support structure is detachably fixed to a catheter intermediate tube or a component of a medical access system connected to the catheter intermediate tube, and can be removed from the catheter intermediate tube when necessary. This has the following advantages: even when the catheter is already against the patient, the spiral support structure can be removed or replaced. This is meaningful, for example, when a blockage occurs in the catheter intermediate tube. It is also feasible to use another spiral support structure with the same or different length there, for example a spiral support structure that is longer than the spiral support structure originally arranged there, after removing the spiral support structure from the catheter intermediate tube. There can also be multiple removable or replaceable spiral support structures.

[0043] According to an advantageous design of the present invention, the medical access system has a support assembly as an additional component, which is additionally present relative to the catheter and is detachably coupled to the catheter, for example, coupled to the housing of the catheter, wherein the support assembly has a spiral support structure. This has the following advantages: the spiral support structure can be removed from the catheter intermediate tube by the user in a simple manner by removing the entire support assembly. For example, the user can grab the housing of the support assembly in order to remove the support assembly. In the manufacturing and delivery state of the medical access system, the system can then be delivered together with all components, that is, at least with the catheter and the support assembly fastened to the catheter. According to the design of the medical access system, a needle device can be additionally provided at the medical access system.

[0044] According to an advantageous design of the present invention, the spiral support structure is permanently fixed to a part of the support assembly, for example, to a housing of the support assembly. For example, the spiral support structure can be formed into the material of a part of the support assembly, or can be permanently fastened to the material of a part of the support assembly by form fit or in other ways, for example, by adhesive, welding and / or plug-in.

[0045] In an advantageous embodiment of the invention, the housing of the support assembly can have a fastening element which is associated with a corresponding fastening element of the housing of the catheter which is configured as a counterpart to it. The support assembly can then be fastened to the catheter via the fastening element by coupling the housing of the support assembly to the housing of the catheter. For example, the fastening element can be configured as a bayonet connection and / or as a locking element. A plurality of support assemblies can also be present.

[0046] When replacing the spiral support structure, another spiral support structure can be used after removing the spiral support structure, for example a spiral support structure with the previously mentioned tubular inner body. In this case, the tubular inner body can extend beyond the spiral support structure at the end close to the patient, so that when the spiral support structure is completely introduced into the catheter middle tube, the tubular inner body extends from the end close to the patient of the catheter middle tube, and is thus introduced, for example, into the patient's vein or another hollow body. With this tubular section extending from the catheter middle tube at the end close to the patient, for example, a venous valve can be overlapped.

[0047] Alternatively, such a tubular section extending from the catheter intermediate tube at the end close to the patient can also be provided by an additional component, which is placed at the end close to the patient of the spiral support structure, for example by welding, plugging and / or bonding. In this case, the spiral support structure can also be formed without a tubular inner body. The mentioned tubular section formed as an additional component is then placed at the end close to the patient of the spiral support structure.

[0048] According to an advantageous design of the present invention, the spiral support structure has a plurality of spiral coils, which are directly adjacent to each other. This results in a good supporting effect of the spiral support structure. The spiral support structure can have such a spiral coil only in one or more individual regions, wherein the spiral windings are directly adjacent to each other, and the spiral windings can also be constructed in the manner described over their entire length. In the regions, the spiral support structure is therefore tightly wound, for example, similar to the Sedinger wire winding. There is no intermediate space between the individual coils. The region of the spiral coils that are directly adjacent to each other can extend over a large part of the longitudinal extension of the spiral support structure or over the entire longitudinal extension. The spiral support structure can also have one or more regions, in which the spiral coils are spaced apart from each other, wherein in the regions, the spiral coils can have a constant or variable pitch in length.

[0049] According to an advantageous embodiment of the invention, the spiral support structure has a plurality of spiral coils which are loosely adjacent to one another but are not fastened to one another, for example, not bonded or the like, and in particular not embedded in a connecting material. In this way, the spiral coils can move relative to one another when the catheter intermediate tube is bent. As a result, the stresses in the spiral support structure are optimally dissipated, so that the supporting effect is further improved.

[0050] According to an advantageous embodiment of the present invention, the spiral support structure or its spiral coil is provided with a friction-reducing coating, in particular a PTFE coating. This makes it easier to pull the puncture needle out of the spiral support structure, for example. Alternatively or additionally, the inner side of the catheter intermediate tube can also be provided with such a friction-reducing coating, in particular a PTFE coating.

[0051] According to an advantageous embodiment of the invention, the helical support structure extends only over a portion of the longitudinal extension of the catheter central tube. The helical support structure is therefore shorter than the catheter central tube and cannot protrude from the catheter central tube, in particular from the end close to the patient, in any operating state of the access system. The length specification here relates to the length of the helical support structure in the wound state, not to the length in the stretched state of the material of the helical support structure.

[0052] The diameter of the helical support structure can remain constant over its entire length. Advantageously, the inner diameter of the helical support structure can be selected such that the puncture needle can be guided through the helical support structure with little clearance.

[0053] According to an advantageous design of the present invention, the catheter intermediate tube ends at the end close to the patient with an axial opening, the inner diameter of which is smaller than the outer diameter of the spiral support structure or at least smaller than the outer diameter of the end region of the spiral support structure close to the patient. The axial opening is used, for example, as an outlet opening of the catheter intermediate tube for administering drugs to the patient. If a puncture needle is guided through the catheter intermediate tube, the axial opening is used to lead the puncture tip of the puncture needle out of the end of the catheter intermediate tube close to the patient, for example, for performing a puncture.

[0054] According to an advantageous embodiment of the invention, the medical access system is designed as an indwelling cannula for puncturing a hollow body of a patient by means of a puncture needle, wherein the indwelling cannula has at least a catheter with a tubular catheter intermediate tube, in which the puncture needle can be guided longitudinally displaceably, wherein the catheter is configured to be pushed through the opening of the casing of the hollow body to be punctured by means of the puncture needle over at least a portion of the length of the catheter intermediate tube after puncturing the casing of the hollow body to be punctured and to be indwelled there for a certain period of time. In this way, it is ensured that the spiral support structure does not protrude from the end of the catheter intermediate tube close to the patient in any case, even in the event of malfunction of the access system.

[0055] Such an indwelling cannula can be designed, for example, as an indwelling venous cannula, also called a peripheral venous catheter.

[0056] Such an indwelling cannula can also be designed as an arterial catheter.

[0057] Such an indwelling cannula can also be designed as a catheter for puncturing the pleural cavity.

[0058] The catheter intermediate tube with a spiral support structure according to the present invention can also be used at / with a medical access system, which is used to puncture a central vein. Therefore, the catheter intermediate tube with a spiral support structure can be a part of a central venous catheter system. In an advantageous design of a central venous catheter system, a plurality of or all of the hoses (tube cavities, edges) that are directed into the vein and that branch off from the main hose are configured as the catheter intermediate tube with a spiral support structure mentioned above according to the present invention. But it is also conceivable that only the selected tube cavity is configured according to the present invention, such as the tube cavity that must be particularly protected from bending. Here, the selected tube cavity can also be configured as the catheter intermediate tube with a spiral support structure according to the present invention only in sections at least in part of the length or the main length. Only the tube cavity where the tube cavity enters through the patient's skin and / or enters the region in the vein can also be configured as the catheter intermediate tube according to the present invention, because the risk of bending of the catheter intermediate tube in the region is particularly large.

[0059] The catheter intermediate tube according to the invention having a helical support structure can also be used at / with a pulmonary artery catheter.

[0060] The catheter intermediate tube with a helical support structure according to the invention can also be used at / with a medical puncture / catheter system (access system) in the fields of interventional cardiology and interventional radiology as well as neuroradiology.

[0061] The catheter intermediate tube with a spiral support structure according to the present invention can also be used independently, rather than being part of a medical puncture / catheter system. Therefore, the catheter intermediate tube can be used at / with an infusion / infusion hose, or the catheter intermediate tube itself is an infusion / infusion hose. This hose can also be configured so that the hose is suitable for, for example, a high flow rate that allows dialysis to be performed. The catheter intermediate tube according to the present invention can have a length of up to 10 meters, preferably a length of 1 meter to 2 meters. The spiral support structure is then also extended accordingly. It is also conceivable that the spiral support structure only surrounds the area of ​​the catheter intermediate tube that must be specially protected to avoid bending, that is, the spiral support structure is not arranged in the entire catheter intermediate tube. In this case, the spiral support structure can also be connected to the catheter intermediate tube at multiple locations, or the catheter intermediate tube contains multiple spiral support structures that are bounded by each other. If the external mechanical deformation of the catheter intermediate tube is desired, for example, the external mechanical deformation of the catheter intermediate tube is desired when using a hose pump or a hose extrusion pump, then there can be no spiral support structure or a spiral support structure with special characteristics at the corresponding location. It is also conceivable that the catheter central tube also contains a section over whose length the helical supporting structure is present, but that the helical supporting structure is not arranged loosely but fixedly in the catheter central tube.

[0062] The catheter intermediate tube with the spiral support structure according to the present invention can also be a component of an infusion system.

[0063] The catheter intermediate tube with a helical support structure according to the invention can also be a component of a puncture / catheter system for performing regional anesthesia and interventional pain therapy methods. This includes not only peripheral but also close to the spinal cord and close to the joints.

[0064] The catheter central tube according to the invention with the helical support structure can also be a component of a puncture / catheter system for draining cerebrospinal fluid (cerebral-spinal fluid).

[0065] The catheter intermediate tube with the spiral support structure according to the invention can also be a component of a puncture / catheter system for draining urine.

[0066] The catheter central tube according to the invention with the helical supporting structure can also be a component of a drainage system which removes fluids from the body, for example wound secretions.

[0067] The catheter intermediate tube with a spiral support structure according to the present invention can also be used independently, so as to be introduced into a blood vessel and keep the blood vessel open and / or also cover defects such as the blood vessel wall for a longer period of time. Therefore, the catheter intermediate tube with a spiral support structure according to the present invention can be used as a stent, such as a stent in the coronary vessels of the heart. The catheter intermediate tube can also be used as a stent or vascular prosthesis in larger blood vessels, such as in arm vessels and leg vessels and in the aorta (Aorta) or vena cava (Vena cava inferior / superior (inferior vena cava / superior vena cava)). For this reason, it is conceivable that the diameter size and length size are significantly deviated from the diameter size and length size of the indwelling sleeve, such as a diameter of up to 4 cm and a length of up to 120 cm.

[0068] The catheter central tube according to the invention having a helical support structure can also be used as a dialysis shunt or as a component thereof.

[0069] The catheter intermediate tube according to the invention with the spiral support structure can also be used as a hose which is not necessarily intended for medical use. Thus, the catheter intermediate tube can also be used as a hose in the sanitary sector with the diameter and length dimensions customary there, for example as a shower hose. An application as a garden hose is also conceivable, as is an application as a fuel hose or a fire hose.

[0070] In principle, it is conceivable to use the catheter intermediate tube with a spiral support structure according to the invention as a hose in all fields of application in which the hose should / must be protected from sharp bends. Therefore, the catheter intermediate tube with a spiral support structure according to the invention can also be used as an independent hose, which can be used in a variety of fields of application.

[0071] The conduit intermediate tube with a helical support structure according to the invention can also be at least one component of a plurality of devices, machines, pump systems, installations and, for example, also at least one component of a motor and a transport / vehicle.

[0072] In principle, in all the other above-mentioned designs of the catheter intermediate tube according to the present invention, significant deviations downward or upward compared to the indwelling sleeve with respect to the diameter and length dimensions and also the wall thickness are conceivable and partly necessary. Downward, this can also include the nanometer range (nanostructure).

[0073] The catheter intermediate tube with a spiral support structure according to the present invention can be bent and / or folded at least one bending or bending position in the transition area away from the vein in other components of the medical access system, such as the venous indwelling sleeve. The bending or bending position of the catheter intermediate tube with a spiral support structure according to the present invention is in the venous indwelling sleeve located in the patient, such as in the area at the skin level. There, the catheter intermediate tube can withstand special mechanical loads determined by use. Contrary to the catheter intermediate tube that extends straight toward the vein from the venous indwelling sleeve, the catheter intermediate tube with a spiral support structure according to the present invention can be bent and / or folded at least 1° relative to a straight line at the bending or bending position, but preferably bends and / or folds at an angle of 2° to 5°, 6° to 10°, 11° to 25°, 26° to 45° or greater than 45°. Therefore, the catheter intermediate tube with a spiral support structure according to the present invention constitutes a bend that can point upward or downward. The puncture needle guided through the catheter intermediate tube with a spiral support structure according to the present invention can also be configured as curved and / or bent as just described. This can facilitate the puncture process, because, for example, it can be punctured more flatly or more individually in the area of ​​bony protrusions or joints in coordination with anatomical conditions.

[0074] The catheter intermediate tube with a spiral support structure according to the present invention can be improved in the area of ​​skin level or in other areas subjected to strong mechanical loads by means of at least one other mesh, braid or grid-like structure. It is conceivable that the combination with the structure extending laterally, longitudinally or diagonally can also ensure the desired / improved stability of the wall of the catheter intermediate tube at least in sections, without the need for a spiral support structure at least in sections. The catheter intermediate tube can also be improved in other critical areas, for example in the area of ​​the entry site into the vein or in the area of ​​its distal end in the manner just described or in another manner.

[0075] If the puncture needle guided through the catheter central tube with a spiral support structure according to the invention has a tip with an inclined grinding edge, different puncture techniques are possible. In the bevel-up technique, the puncture needle tip is introduced through the skin so that the inclined grinding edge with the inner opening of the puncture needle located therein points upward, i.e. away from the patient's skin. In the bevel-down technique, the puncture needle tip is rotated 180° relative to the catheter central tube so that the inclined grinding edge with the inner opening of the puncture needle located therein points downward, i.e. towards the patient's skin.

[0076] The medical access system according to the present invention, such as a venous indwelling cannula, can be designed, for example, so that the puncture needle or at least the puncture needle tip can be rotated around the longitudinal axis relative to the catheter intermediate tube with a spiral support structure according to the present invention at any time. Then, the user can selectively apply the bevel-up technique or the bevel-down technique. Here, the catheter intermediate tube with a spiral support structure according to the present invention can make the rotation around the longitudinal axis easier, because the design of the catheter intermediate tube with a spiral support structure according to the present invention prevents sharp bending of the catheter intermediate tube, which may make the rotation of the puncture needle around the longitudinal direction difficult.

[0077] The medical access system according to the invention, for example, an intravenous cannula, can also be designed such that the puncture needle or at least the puncture needle tip cannot be rotated relative to the catheter intermediate tube with a helical support structure according to the invention or can only be rotated with increased force in at least one specific longitudinal displacement position, for example when the puncture needle tip protrudes from the catheter intermediate tube with a helical support structure according to the invention at the end close to the patient. For example, the component with the puncture needle can be coupled in a form-fitting manner to the component with the catheter intermediate tube with a helical support structure according to the invention in the longitudinal displacement position and the rotatability of the puncture needle relative to the catheter intermediate tube with a helical support structure according to the invention is prohibited in the described manner.

[0078] Here, the medical access system according to the present invention, such as an intravenous cannula, can be designed, for example, so that the inclined grinding edge together with the inner opening of the puncture needle present therein points downward from the beginning, that is, towards the patient's skin or the underside of the cannula, on which at least one fixing wing of the cannula is arranged.

[0079] According to another advantageous embodiment of the medical access system according to the invention, for example, an intravenous cannula, it is provided that the puncture needle tip is rotated / rotated about its own longitudinal axis and / or the longitudinal axis of the puncture needle and can be preferably adjusted to a circumferential amount of 45°, 90°, 135°, 180°, 225°, 270°, 315° or 360° (angle specification in degrees about a circumferential amount of 360 degrees (360°)), wherein all intermediate levels about the circumferential amount are conceivable. In this case, before the use of the medical access system according to the invention, for example, an intravenous cannula, the inclined grinding edge of the puncture needle tip is already determined by the structure so that it no longer points upwards, i.e., no longer points away from the patient's skin. This can advantageously enable a gentler puncture technique, since in particular the puncture / insertion angle can be changed. The puncture needle or a component having a puncture needle can here have a retaining / path limiting element (hereinafter referred to as "retaining element" only), by which the rotatability / rotatability of the puncture needle tip / puncture needle relative to the catheter intermediate tube with a spiral support structure according to the present invention is limited or cancelled, at least in a specific longitudinal displacement position of the puncture needle tip and / or the puncture needle and / or the needle device.

[0080] In an advantageous embodiment of a medical access system according to the invention, such as an intravenous cannula, if the puncture needle tip at least partially extends distally (towards the patient) beyond the catheter intermediate tube with a spiral support structure according to the invention, the just described rotatability / rotatability of the puncture needle tip / puncture needle is completely eliminated. For example, the retaining element can be configured as a locking element, a notch, a groove or a protrusion. The retaining element can interact with the retaining element at the catheter intermediate tube with a spiral support structure according to the invention or at other components of the medical access system according to the invention, such as an intravenous cannula, for example by locking, wedging or twisting. All retaining elements can be at least partially composed of a material that increases friction resistance or coated with at least one such material. The angle descriptions mentioned above can be recognizable to the user on a component of a medical access system, such as an intravenous cannula, so that the current circumference of the puncture needle tip and / or the puncture needle can be simply read. For example, circular or semicircular markings of different line widths can also be conceivable here, and color markings of the traffic light colors "green", "yellow" and "red" can also be conceivable, for example. It is also conceivable that the initial puncture is performed and the puncture needle tip and / or puncture needle is further advanced into the tissue to be punctured so that the puncture needle tip and / or puncture needle are sequentially placed on different circumferences, i.e. rotated / rotated around the longitudinal axis of the puncture tip / puncture needle in a time sequence of the puncture process.

[0081] In another advantageous embodiment, the present invention relates to a medical access system for providing an access port to a patient's hollow body, wherein the access system has at least one catheter with a tubular catheter intermediate tube, wherein the catheter is configured to, after the sheath of the hollow body to be punctured is punctured, by means of a puncture needle or in other ways through the opening of the sheath of the hollow body, push and retain there for a certain duration on at least a portion of the length of the catheter intermediate tube, wherein at least the configuration of the catheter intermediate tube for a portion retained in the hollow body has at least one supporting structure over its entire length or a large portion of its length. The supporting structure does not have to be spirally constructed, but can be cylindrically, tubularly or hose-shaped, for example. This supporting structure can be advantageously improved by means of the features described above and below for the spiral supporting structure. By this supporting structure, for example, a component of the catheter intermediate tube can be supported. There can also be a plurality of supporting structures configured in this way, which can be movably arranged relative to the puncture needle, the catheter intermediate tube and / or relative to each other, and in particular can also be longitudinally movably arranged, for example also in the sense of a telescopic arrangement. BRIEF DESCRIPTION OF THE DRAWINGS

[0082] The present invention will be explained in detail below based on embodiments using the accompanying drawings.

[0083] The accompanying drawings show:

[0084] Figure 1 A medical access system in the form of an indwelling cannula is shown in a stereoscopic view,

[0085] Figure 2 The area of ​​the central tube of the catheter close to the patient is shown in a side view.

[0086] Figures 3 to 5 The area of ​​the central tube of the catheter close to the patient is shown in a side sectional view in different embodiments.

[0087] Figure 6 Show according to Figure 5 A cross-sectional view of the intermediate tube of the catheter,

[0088] Figure 7 Another embodiment of the medical access system is shown in a stereoscopic view.

[0089] Figure 8 The exploded view shows Figure 7 system,

[0090] Fig. 9 Show according to Figure 7 part of the system,

[0091] Fig.10 The support assembly is shown,

[0092] Fig.11 Show according to Fig.10 The support assembly is provided together with the conduit. DETAILED DESCRIPTION

[0093] exist Figure 1 The medical access system shown in FIG. 1 has a catheter 29 and a needle device 39. The needle device 39 forms a structural unit separate from the catheter 29, which can be separated from the catheter 29 after the puncture is performed. Only the catheter 29 remains while the patient is in the patient's position.

[0094] The catheter 29 has a housing 20, on which there is an intermediate tube exit region 21 on the side facing the patient, at which the catheter intermediate tube 1 exits from the housing 20 and extends from it. The catheter intermediate tube 1 is designed to be relatively flexible and is used as an administration option for intravenous introduction of liquids, especially infusion solutions, blood products and drugs. The catheter intermediate tube 1 is then located with its distal end in a hollow body, for example a vein of the patient.

[0095] The needle device 39 has a puncture needle 30 which, in the basic state of the medical access system, is largely located in the housing 20 and the catheter intermediate tube 1, wherein the tip 31 of the puncture needle 30 protrudes from the distal end of the catheter intermediate tube 1. The needle device 39 can be moved in the longitudinal direction L relative to the catheter 29.

[0096] The housing 20 is provided with fixing wings 23, which are used for manual operation and for securing the catheter 29 on the patient. On the side facing away from the intermediate tube exit area 21, the housing 20 has a needle opening 25, through which the puncture needle 30 can be placed in the housing 20 and the catheter intermediate tube 1. After the medical access system is placed against the patient, the needle device 39 is removed. The needle opening 25 is then used as a connection option for, for example, an infusion line or an extraction element, such as a syringe.

[0097] An injection port may also be present at the housing 20, which protrudes from the housing 20, for example, on the side facing away from the fixing wing 23. The injection port is used to inject the drug. Otherwise, the injection port is closed by means of a closure cap.

[0098] Furthermore, the needle device 39 has a closure element 34 with a stopper and an operating element 32 at the proximal end of the puncture needle 30. In the basic state, the needle opening 25 is closed by the closure element 34. The operating element 32 serves for the user to operate the needle device 39, i.e., essentially for pulling back the puncture needle 30 after the puncture has been carried out. As mentioned, the needle device 39 is removed after the catheter 29 has been placed against the patient.

[0099] The needle device 39 can have a connection port at the proximal end, i.e. in the region of the operating element 32, for connecting a syringe or an infusion line, for example for drawing blood. The connection port is closed by a closure cap 40. For example, the closure cap 40 can be screwed on or plugged on.

[0100] exist Figure 2 As can be seen in the figure, the catheter intermediate tube 1 is hose-like on the outside, for example, with a cylindrical outer shape. At the end close to the patient, the catheter intermediate tube 1 ends with an expansion section 6, which tapers on the outside toward the free end. At the free end, the catheter intermediate tube 1 has an axial opening 7, which serves as an outlet opening of the catheter intermediate tube 1 for drug administration. In addition, in the case of an indwelling cannula, a puncture needle 30 extends from the opening 7.

[0101] Figure 3 A first embodiment of a medical access system with a catheter intermediate tube 1 is shown in a cross-sectional view, in which a spiral support structure 2 is arranged. In the described case, the catheter intermediate tube 1 has, in addition to the tubular outer body 15, a tubular inner body 3, which is arranged in the tubular outer body 15. An annular gap is formed between the tubular outer body 15 and the tubular inner body 3, in which the spiral support structure 2 is arranged with a certain radial gap. In another advantageous embodiment, the spiral support structure 2 can be connected to the tubular inner body 3. Here, the support structure 2 and the tubular inner body 3 form a connected unit, which can be axially moved relative to the tubular outer body 15.

[0102] Furthermore, it can be seen that the tubular outer body 15 tapers in cross-sectional dimensions towards the end also on the inside in the widened section 6. In this region, the spiral support structure 2 is no longer provided, and a free space 4 can be present there.

[0103] Figure 4 Another advantageous embodiment of a catheter central tube 1 is shown without a tubular inner body 3. It can be seen that the helical support structure 2 is arranged directly in the catheter central tube 1 and is not covered toward the inside. The puncture needle 30 is then guided directly in the helical support structure 2.

[0104] As another advantageous embodiment, Figure 5 The catheter intermediate tube 1 is shown, and the catheter intermediate tube is connected to the Figure 4 The embodiment is similar to that in FIG. 1 , but has a plurality of groove-like grooves 5 extending in the longitudinal direction distributed on the circumference. The arrangement of the grooves 5 can be Figure 6 The cross-sectional view of FIG. 5 shows clearly that the friction between the catheter intermediate tube 1 and the spiral support structure 2 is further reduced. In addition, this longitudinal groove contributes to the recognizability of the blood flow through the catheter intermediate tube 1.

[0105] Especially through Figure 6 As can be seen, the inner diameter of the opening 7 can be smaller than the outer diameter of the spiral support structure 2 . Correspondingly, the spiral support structure 2 cannot escape from the opening 7 .

[0106] The spiral support structure 2 can be formed of a metal wire or another suitable material, for example. For example, a round material or a flat material, for example a flat material with a rectangular or square cross section, can be used. The material of the spiral support structure 2 can be solid or hollow inside.

[0107] according to Figures 7 to 9 Another embodiment of the medical access system is described, in which the spiral support structure 2 can be removed from the catheter central tube 1. Figure 7 Here, the medical access system is shown in the delivery state, ie, all components are in the installed initial position. It can be seen that the medical access system has additional components, more precisely in the form of a support component 10, wherein Figure 7 Only the housing 11 of the support assembly 10 can be seen in FIG. The housing 11 is coupled to the housing 20 of the catheter 29 via a fastening element. The operating element 32 of the needle device 39 is then located at the end of the housing 11 of the support assembly 10 facing away from the patient.

[0108] Figure 8 In an exploded view, the Figure 7 2, so that the individual components can be seen. Thus, there are the components: catheter 29, support assembly 10 and needle device 39. It can be seen that the helical support structure 2 is fixed to the housing 11 or another part of the support assembly 10. If the housing 11 is disengaged from the housing 20, for example by a rotational movement, the housing 11 can be removed from the assembly catheter 29 together with the helical support structure 2. In a similar manner, the needle device 39 can be removed from the support assembly 10.

[0109] Fig. 9 The complete support assembly 10 with the helical support structure is shown again after the helical support structure 2 has been removed from the catheter 29. For example, a new support assembly 10 of identical shape can now be fastened to the catheter 29, ie a new helical support structure 2 is pushed into the catheter 1.

[0110] Alternatively, a differently designed support assembly can also be attached to the guide tube 29, for example according to Fig.10 implementation method. Fig.10In the embodiment of the present invention, an additional component in the form of a tubular section 12 is arranged at the end of the spiral support structure 2 close to the patient, for example, by injection, welding, plugging and / or bonding by means of an injection molding method. By means of the additional tubular section 12, the spiral support structure 2 is extended at the end close to the patient to such an extent that, when inserted into the catheter intermediate tube 1, at least a portion of the tubular section 12 protrudes therefrom, such as Fig.11 By means of such a tubular section 12 which projects out of the catheter central tube 1 at the end close to the patient, for example a venous valve can be bridged.

[0111] In the case where the tubular inner body 3 is present in the spiral support structure 2, the tubular inner body can be designed to be extended to such an extent at the end close to the patient that the tubular inner body forms such a tubular section 12 that protrudes from the catheter central tube 1 at the end close to the patient. The tubular inner body 3 then protrudes a substantial distance from the spiral support structure 2 at the end close to the patient.

[0112] The tubular inner body 3 or at least the tubular section 12 can be made of plastic, for example, optionally with barium additives or introduced markers made of other materials in order to produce improved X-ray visibility.

[0113] Fig.11 The catheter 29 is shown together with the Fig.10 The support assembly 10 is arranged thereon. It can be seen that the tubular section 12 extends out from the central tube 1 of the catheter.

[0114] Reference numerals list

[0115] 1. Intermediate tube of catheter

[0116] 2 Spiral support structure

[0117] 3 Tubular endosomes

[0118] 4 Free Space

[0119] 5 slots

[0120] 6 Expansion section

[0121] 7 Axial opening

[0122] 10 Support components

[0123] 11 Housing supporting the assembly

[0124] 12 tubular sections

[0125] 15 Tubular outer body

[0126] 20 Shell

[0127] 21 Intermediate pipe exit area

[0128] 23 Fixed wing

[0129] 25-pin opening

[0130] 29 Catheter

[0131] 30 puncture needle

[0132] 31 Tip

[0133] 32 Operating elements

[0134] 34 Closure element

[0135] 39-pin device

[0136] 40 Closure cap

[0137] L Longitudinal direction

Claims

1. A medical access system for providing access to a hollow body of a patient, wherein the access system has at least one catheter (29) with a tubular catheter intermediate tube (1), wherein the catheter (29) is configured to, after puncturing the sheath of the hollow body to be punctured, be pushed over at least a portion of the length of the catheter intermediate tube (1) through an opening through the sheath of the hollow body by means of a puncture needle (30) or in some other way and remain there for a certain duration, characterized in that At least the portion of the catheter intermediate tube (1) configured to be retained in the hollow body has at least one helical support structure (2) over its entire length or over a large part of its length, in particular in the form of at least one helically wound internal hollow guide wire.

2. The medical access system according to claim 1, characterized in that: The helical support structure (2) is loosely arranged in the catheter central tube (1) over a large part of its longitudinal extension or over its entire longitudinal extension.

3. The medical access system according to any one of the above claims, characterized in that: The spiral support structure (2) is permanently fixed to the catheter intermediate tube (1) or a component of the medical access system connected to the catheter intermediate tube via at least one fastening element.

4. The medical access system according to claim 3, characterized in that: The spiral support structure (2) is fixed at one end or at both ends thereof to the catheter central tube (1) or a component of the medical access system connected to the catheter central tube via at least one fastening element and is otherwise loosely arranged in the catheter central tube (1).

5. The medical access system according to any one of the above claims, characterized in that: The helical support structure (2) increases the bending resistance moment and / or radial resistance moment of the catheter central tube (1).

6. The medical access system according to any one of the above claims, characterized in that: A tubular inner body (3) is arranged inside the spiral support structure (2).

7. The medical access system according to any one of the above claims, characterized in that: The spiral support structure (2) is detachably fixed to the catheter intermediate tube (1) or a component of the medical access system connected to the catheter intermediate tube, and can be removed from the catheter intermediate tube (1) when necessary.

8. The medical access system according to any one of the above claims, characterized in that: The medical access system has a support component (10) as a further component, which is additionally present relative to the catheter (29) and is detachably coupled to the catheter (1), for example, detachably coupled to the housing (20) of the catheter (1), wherein the support component (10) has the spiral support structure (2).

9. The medical access system according to claim 8, characterized in that: The spiral support structure (2) is permanently fixed to a part of the support assembly (10), for example, to a housing (11) of the support assembly (10).

10. The medical access system according to any one of the above claims, characterized in that: The helical support structure (2) has a plurality of helical coils which lie directly against one another.

11. The medical access system according to any one of the above claims, characterized in that: The helical support structure (2) has a plurality of helical coils which are loosely adjacent to one another but are not fastened to one another.

12. The medical access system according to any one of the above claims, characterized in that: The helical support structure (2) or its helical coils are provided with a friction-reducing coating, in particular a PTFE coating.

13. The medical access system according to any one of the above claims, characterized in that: The helical support structure (2) extends only over a portion of the longitudinal extension of the catheter intermediate tube (1).

14. The medical access system according to any one of the above claims, characterized in that: The catheter intermediate tube (1) terminates at the end close to the patient with an axial opening (7), the inner diameter of which is smaller than the outer diameter of the spiral support structure (2) or at least smaller than the outer diameter of the end region of the spiral support structure (2) close to the patient.

15. The medical access system according to any one of the above claims, characterized in that: The catheter central tube (1) has on its inner side a plurality of groove-like grooves (5) distributed over the circumference and extending linearly or helically in the longitudinal direction.

16. The medical access system according to any one of the above claims, characterized in that: A tubular section (12) extends from the spiral support structure (2) at the end close to the patient, and the tubular section extends from the catheter central tube (1) at the end close to the patient through an axial opening (7) formed at the free end of the catheter central tube (1).

17. The medical access system according to any one of the above claims, characterized in that: The medical access system is designed as an indwelling cannula for puncturing a patient's hollow body by means of a puncture needle (30), wherein the indwelling cannula has at least the catheter (29) with the tubular catheter intermediate tube (1), the puncture needle being able to be guided longitudinally displaceably in the indwelling cannula, wherein the catheter (29) is configured to, after puncturing the sheath of the hollow body to be punctured, be pushed through an opening through the sheath of the hollow body to be punctured by means of the puncture needle (30) over at least a portion of the length of the catheter intermediate tube (1) and to be retained there for a certain period of time.

18. The medical access system according to any one of the above claims, characterized in that: The spiral support structure (2) is mainly or completely composed of one or more plastic materials.

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