Indwelling cannula
By designing a gripping area and a manually operable propulsion mechanism on the indwelling cannula, the problems of complex operation and insufficient safety of indwelling cannula are solved, achieving the effects of simplified operation and reduced pollution.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- ABNET MEDICAL LLC
- Filing Date
- 2024-11-05
- Publication Date
- 2026-05-26
AI Technical Summary
Existing indwelling cannulas are complex to operate and not safe enough, which can easily lead to unnecessary contamination and operational errors.
An indwelling cannula with a gripping area and a manually operated advance mechanism was designed. The gripping area provides easy gripping for the user and avoids contamination, while the advance mechanism ensures controlled relative movement between the catheter's intermediate tube and the puncture needle, preventing erroneous operation.
It enables simple and safe operation of indwelling cannulas, reduces the risk of contamination and operational errors, and is suitable for single-handed operation and robot-assisted use.
Smart Images

Figure CN122094733A_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to an indwelling cannula for puncturing a hollow body with a puncture needle, wherein the indwelling cannula has at least one catheter with a tubular intermediate tube in which the puncture needle is longitudinally movable and guided, wherein the catheter is configured to, after puncturing the wall of the hollow body to be punctured, be pushed along at least a portion of the length of the intermediate tube by means of the puncture needle through an opening in the wall of the hollow body to be punctured and remain there for a certain duration. Background Technology
[0002] This type of indwelling cannula can be configured as a venous indwelling cannula, for example. The hollow body to be punctured can be a hollow biological body or a hollow body of an object. As long as the indwelling cannula is involved in the medical field, the hollow body can be, for example, a blood vessel, such as a vein or artery.
[0003] The terms “puncture” and “perforation” should be understood in a medical sense here. “Puncture” means inserting a puncture needle into a hollow body, so that the puncture needle penetrates the wall of the hollow body to be punctured.
[0004] From the user's perspective, the portion of the indwelling cannula located at its distal end, near the punctured hollow body, is considered the portion of the indwelling cannula closer to the hollow body. Conversely, the portion further away from the hollow body is located at the proximal end of the indwelling cannula from the user's perspective, i.e., further away from the punctured hollow body. In the context of the medical application of indwelling cannulas, the terms "closer to the vein," "closer to the patient," or "farther from the user" are used synonymously with the term "closer to the hollow body," and for the term "farther from the hollow body," "farther from the vein," "farther from the patient," and "closer to the user" are also used.
[0005] Components closer to veins tend to be located inside the patient, while components farther from veins tend to be located outside the patient. This is not always mandatory, but the terminology should be further clarified. Additional information is self-evident as prescribed, and the context is crucial.
[0006] A type of indwelling sleeve is known from WO 2022 / 263550 A1.
[0007] An improved puncture system should be developed in the sense of a general puncture system. In principle, it is equally feasible, with the aid of an improved indwelling cannula, to advantageously puncture all body cavities and interstitial spaces and all anatomical and pathological structures that should be punctured, and to insert the catheter therein. The improved puncture system can also be used to achieve access to anatomical structures so that, upon reaching these structures, another longer catheter / catheter intermediary can be guided toward these anatomical structures via a puncture needle and / or via the catheter / catheter intermediary of the improved puncture system. In particular, if the other longer catheter / catheter intermediary is to remain in the body for a longer period than the improved puncture system, this can therefore be applied in regional anesthesia and all other interventional methods. In this case, the improved puncture system can also be used solely as an improved access system and can be removed directly again after achieving access to the desired anatomical structure.
[0008] In principle, the components of the improved indwelling cannula can also be used in combination with all known puncture and catheter systems, or as a standalone product.
[0009] Although the term “indwelling cannula” should be retained below, it has a broad meaning in the sense of a general puncture system, which can be used not only for puncturing veins. That is, in the following text, the terms “one vein” and “multiple veins” generally include all vessels that should be punctured and that should have catheters, and more generally all body cavities and internal spaces, as well as all anatomical and pathological structures.
[0010] Therefore, with the aid of an indwelling cannula, it is possible to additionally and exemplaryly puncture the trachea, pleural cavity, abdominal cavity, stomach, intestine, renal pelvis, bladder, structures of the central and peripheral nervous systems, subarachnoid space, and bones. Additionally, it is possible to puncture pathological structures in or on the patient, such as abscesses. Advantageously, it is also possible to puncture arterial vessels.
[0011] In the following text, the term "patient" includes all organisms of all ages and sexes. Its application in the technical field, as well as in all objects and structures, is equally clearly feasible, for example, in reservoirs, containers, cavities, expandable materials, and in pump systems, hose systems, pipe systems, and port systems.
[0012] If the word "or" is used below, it indicates a feasible alternative, but combinations of features or expressions separated by "or" are also generally clearly feasible.
[0013] All described components can be used once or multiple times at an indwelling cannula, or applied independently or in other products, unrelated to this indwelling cannula. Different features of different components can also be freely combined, and features of specific components can also be used with other components, without explicit mention. In principle, all components and features can be used both in and out of the patient's body.
[0014] Indwelling cannulas, and especially venous indwelling cannulas, are specialized medical devices that must have specific diameter and length dimensions to allow for intravenous administration at commonly used access sites in human or animal patients. This also necessitates a certain degree of flexibility or elasticity in the intermediate tubing. Therefore, such indwelling cannulas cannot be similar to catheter systems used for other applications, such as bladder catheters, where entirely different requirements apply. Summary of the Invention
[0015] The purpose of this invention is to provide an indwelling cannula that can be used more simply and safely.
[0016] The objective is achieved by the indwelling cannula according to claim 1. Advantageous improvements are described in the dependent claims.
[0017] According to an advantageous design of the invention, the indwelling cannula has a gripping area provided for the user to grip the cannula during operation. Here, the gripping area of the indwelling cannula can be an area where no other functions or functional elements of the indwelling cannula exist, but rather the area is solely for manually gripping the indwelling cannula. This has the advantage that the user intuitively grips the indwelling cannula at the correct location, thereby avoiding unnecessary contact at other locations, such as at areas of the indwelling cannula that should be kept strictly sterile. In this manner, unnecessary contamination of specific parts of the indwelling cannula can be avoided. For example, the gripping area can be formed in the cannula housing, for example, integrally molded with the housing. For example, the gripping area can be implemented by correspondingly designing a region of the outer surface of the housing.
[0018] For example, grooves, bumps, or other surface structures may be present in the gripping area. The gripping area may also be at least partially constructed of a material that increases frictional resistance or coated with at least one such material. This prevents unintended slippage of the user's fingers. The gripping area may also be made of, for example, an elastomer, such as rubber or silicone, or any other material that is softer than the rest of the indwelling sleeve's housing.
[0019] The gripping area can also be made of at least one antibacterial material or coated with at least one such material. The gripping area can also have particularly hydrophobic properties. Properties related to or similar to the lotus effect are also possible.
[0020] The gripping area can also be designed, at least partially, in a color different from the other parts of the indwelling venous cannula, such as green. Areas of the indwelling venous cannula that must never be touched can be designed, at least partially, in red. A yellow color is also conceivable, at least partially, in areas that should not be touched but where touching is still permissible in special circumstances. This should remind the user of the colors of traffic lights. However, strongly luminous or fluorescent colors could also be considered.
[0021] In another advantageous configuration, the entire indwelling cannula is made transparent, thereby allowing direct identification of fluid / blood flow. The puncture needle can also be made transparent, provided the material properties permit.
[0022] Special patterns, such as cross or arrow shapes, are also possible in the gripping area. The area can also be numbered or generally identified. It is also conceivable that the gripping area is initially covered by an adhesive structure, such as a film, which can be removed after the puncture procedure.
[0023] The features described for the gripping area can also be implemented individually or in combination at one or more gripping surfaces described below.
[0024] According to an advantageous design of the invention, the indwelling cannula comprises: a needle assembly, to which a puncture needle is secured; and a catheter assembly separate from the needle assembly, to which an intermediate catheter tube is secured, wherein the needle assembly is provided for removal from the catheter assembly after the puncture procedure has been performed. Correspondingly, the indwelling cannula can consist of only two separate and separable components, namely the needle assembly and the catheter assembly. It is also possible for the indwelling cannula to have one or more additional components. The components allow for simple operation by the user. In particular, the user can perform puncture of the hollow body using the indwelling cannula in the initial state. If the puncture procedure is completed, i.e., the intermediate catheter tube is advanced through the opening created by the puncture needle through the wall of the hollow body to be punctured and positioned as desired, then the needle assembly can be removed from the catheter assembly. Here, the puncture needle is also removed together. Only the catheter assembly is retained in the patient's presence, which, in an advantageous design, does not have sharp-edged or injury-threatening elements.
[0025] According to an advantageous design of the invention, the indwelling cannula has a manually operable advance mechanism with a manual operating element that, through manual operation, automatically generates relative movement between the intermediate cannula and the puncture needle, allowing the puncture tip of the puncture needle, protruding from the intermediate cannula near the patient, to be received within the intermediate cannula. This achieves several advantages when using the indwelling cannula. In conventional indwelling cannulas, the cannula is placed against the patient, for example, at a vein, so that the vein is first punctured using the puncture tip of the puncture needle protruding from the intermediate cannula. After puncturing the vein, the intermediate cannula is manually advanced beyond the puncture needle, which can then be at least partially pulled back into the intermediate cannula. This process depends on the user's judgment and skill. Errors may occur, for example, by advancing the intermediate cannula too far or too short, leaving a portion of the puncture tip still protruding from the intermediate cannula.
[0026] The manually operable advance mechanism present in the indwelling cannula according to the invention ensures user-defined operation and correspondingly ensures a defined relative movement between the catheter intermediate tube and the puncture needle, which is preset by the structure of the indwelling cannula. In particular, the structure of the advance mechanism ensures that the puncture tip is fully accommodated in the catheter intermediate tube, thereby preventing damage when the indwelling cannula is further introduced into the hollow body.
[0027] In addition, the catheter intermediate tube is supported by a puncture needle located inside the catheter intermediate tube, thus maintaining a relatively elastic or flexible intermediate tube.
[0028] The material used for the puncture needle can be a metallic material, especially stainless steel, or in principle a metal alloy. However, the puncture needle can also be made of plastic. The puncture needle can also be constructed in a lightweight manner, or made of at least one reabsorbable / easily soluble material in blood and infusion solutions, such as sugar or salt, for example, in the region of the puncture tip. Magnesium can also be used. The puncture needle can also be advantageously improved by means of at least one sensor and / or at least one optics, for example, in the region of the puncture tip. The sensor and / or the optics can be configured to display the specific orientation of the puncture tip.
[0029] Here, the structure of the propulsion mechanism ensures that the puncture needle is not pulled back too far into the catheter's intermediate tube, allowing the intermediate tube to be maintained essentially along its entire length. This is not possible in traditional indwelling cannulas, where the user must determine the extent of needle retraction.
[0030] According to an advantageous design of the invention, a propulsion mechanism enables the intermediate catheter to be pushed beyond the puncture tip of the puncture needle, and / or enables the puncture tip of the puncture needle to be pulled into the intermediate catheter. This allows for great flexibility in the configuration of a manually operable propulsion mechanism. Thus, selectively, the intermediate catheter can be advanced relative to the puncture needle, or the puncture needle can be pulled into the intermediate catheter, or a combination thereof.
[0031] According to an advantageous design of the invention, one, several, or all of the operating elements of a manually operable advance mechanism are disposed within and / or form part of the gripping area. This has the advantage that the indwelling cannula can be operated by the user particularly simply and hygienically, and is especially suitable for single-handed operation throughout the entire process of placing the indwelling cannula against the patient. Another advantage is that the improved indwelling cannula can be grasped by technical equipment / operating instruments such as robots. That is, the improved indwelling cannula can be part of a system for robot-assisted venipuncture, which can be configured to simplify both vein identification and correct puncture itself, or simply have the latter functionality. For this purpose, it is advantageous that the improved indwelling cannula or individual components thereof, such as components of the needle assembly, can be introduced and / or inserted into at least one component of an operating instrument such as a robotic arm.
[0032] The manually operated advance mechanism can be wholly or partially, at least with most of its components, such as the manually operated element, part of the needle assembly for the indwelling cannula. This has the advantage that after successful venous puncture (usually identifiable by blood return to the puncture needle), the needle assembly, and thus the puncture needle, can be held by the user in a stable, ideally stationary position, and the distal end of the catheter intermediate tube can be precisely advanced into the vein before the intermediate tube, held by the puncture needle, is further advanced into the vein. In this case, the puncture needle, together with the aforementioned components of the manually operated advance mechanism, constitutes an assembly that can be generally removed from the assembly, particularly the housing, connected to the catheter intermediate tube after the intermediate tube has been properly positioned at the patient's location, i.e., within the hollow body to be punctured.
[0033] The intermediate cannula of the catheter can be inserted precisely through a puncture needle held in a stable position. Here, the puncture needle can be pulled back out of the intermediate cannula at any time.
[0034] Advantageously, the user can always hold the puncture needle / needle assembly in place with their fingers.
[0035] In the indwelling venous cannula according to the invention, the puncture needle can be individually and controlledly pulled back by the user at any time, depending on the structural type. This has the advantage that the user always retains control over the withdrawal of the puncture needle, which enables an optimal combination of technical control and user-side control.
[0036] According to an advantageous design of the invention, the relative movement between the catheter intermediate tube and the puncture needle, generated by manually operated advance mechanism, can be limited to a maximum value. This has the advantages of being particularly simple to operate for the user, and the structure of the advance mechanism ensures that errors are avoided during the advancement of the catheter intermediate tube relative to the puncture needle. Limiting the relative movement to a maximum value can be achieved, for example, by force transmission from the operating element of the advance mechanism to the component connected to the catheter intermediate tube. For example, the advance mechanism can have at least one mechanical stop, by which the relative movement between the catheter intermediate tube and the puncture needle, generated by manual operation, is limited to a maximum value. However, limiting to a maximum value can also be achieved without such a mechanical stop.
[0037] According to an advantageous design of the invention, the maximum value of the relative motion is at least as large as the length of the puncture tip. This ensures, through the propulsion mechanism, sufficient relative motion to fully accommodate the sharp puncture tip within the intermediate tube of the catheter.
[0038] According to an advantageous design according to the invention, the maximum relative motion is less than twice the length of the puncture tip. This ensures that the puncture needle is not unnecessarily pulled back into the catheter midline and that sufficient support is maintained in the sense of keeping the catheter midline intact through the puncture needle. According to another advantageous design according to the invention, the maximum relative motion is less than three times the length of the puncture tip. According to yet another advantageous design according to the invention, the maximum relative motion is less than four times the length of the puncture tip.
[0039] Here, the puncture tip is understood as the sharpened portion of the puncture needle, for example, sharpened by a slanted edge or a tapered shape, near the patient. Therefore, the length of the puncture tip is the extension of the puncture tip in the longitudinal direction of the puncture needle.
[0040] The puncture tip can be configured such that it can penetrate intact patient skin without substantial advance by the user. In another configuration, the puncture tip, due to its shape, cannot penetrate the patient skin without significant advance or even bends before penetration. Therefore, the puncture tip is configured to be less pointed / more blunt. Thus, the invention can be advantageously applied directly to highly vulnerable / soft anatomical areas, such as areas already surgically accessed through the skin. Exemplarily, the invention can be applied to areas of the central nervous system, particularly areas of the brain. Exemplarily, the invention can also be applied substantially to areas of the nervous system, for example, during methods of regional anesthesia.
[0041] If the puncture tip has the aforementioned beveled edge, different puncture techniques are feasible. In the Bevel-Up Technique, the puncture tip is introduced through the skin such that the beveled edge, along with the internal opening of the puncture needle therein, points upward, i.e., away from the patient's skin. In the Bevel-Down Technique, the puncture tip is rotated 180° relative to the middle tube of the catheter, such that the beveled edge, along with the internal opening of the puncture needle therein, points downward, i.e., towards the patient's skin.
[0042] The indwelling cannula can be designed, for example, such that the puncture needle or at least the puncture tip can rotate about the longitudinal axis relative to the intermediate tube of the catheter at any time. The user can then selectively apply an upward bevel technique or a downward bevel technique, or a combination of both techniques within the scope of the puncture procedure. The indwelling cannula can also be designed such that the puncture needle or at least the puncture tip, in at least one specific longitudinal position, such as when the puncture tip extends from the intermediate tube near the patient's end, cannot or can only rotate relative to the intermediate tube with increased force. For example, the assembly with the puncture needle can be shape-fitted with the assembly with the intermediate tube in said longitudinal position, and in such a way that rotational capability of the puncture needle relative to the intermediate tube is prohibited. Here, the indwelling cannula can, for example, be designed such that the beveled edge, along with the internal opening of the puncture needle therein, points downward from the outset, i.e., toward the patient's skin or the underside of the indwelling cannula, where at least one retaining wing of the indwelling cannula is provided.
[0043] Another advantageous design according to the invention proposes that the puncture tip rotates / revolves about its own longitudinal axis and / or the longitudinal axis of the puncture needle, and is preferably adjustable to a circumferential amount of 45°, 90°, 135°, 180°, 225°, 270°, 315°, or 360° (the angle is described in degrees for a circumferential amount of 360°), wherein all intermediate levels of circumferential amount are conceivable. In this case, prior to using the indwelling cannula according to the invention, the inclined edge of the puncture tip is no longer forcibly pointed upwards, i.e., no longer forcibly away from the patient's skin, as determined by the structure. This advantageously enables a gentler puncture technique because the puncture / insertion angle can be varied in particular. The puncture needle or assembly having a puncture needle can here have a retaining / path limiting element (hereinafter simply referred to as a "retaining element") that restricts or eliminates the rotatability / rotatability of the puncture tip / needle, at least in a specific longitudinal position of the puncture tip and / or puncture needle and / or needle assembly relative to the intermediate catheter. In an advantageous embodiment of the invention, the rotatability / rotatability of the puncture tip / needle described above is completely eliminated if the puncture tip extends at least partially distally (towards the patient) into the intermediate catheter. For example, the retaining element can here be configured as a locking element, an incision, a groove, or a protrusion. The retaining element can interact with retaining elements located at the intermediate catheter or other parts of the indwelling cannula according to the invention, for example by locking, wedging, or twisting. All retaining elements can be at least partially constructed of a material that increases frictional resistance or coated with at least one such material. The angles mentioned above are identifiable to the user on the components of the indwelling cannula, making it easy to read the current circumference of the puncture tip and / or puncture needle. For example, circular or semi-circular markers of different line widths could be envisioned, as could colored markers representing traffic light colors such as "green," "yellow," and "red." It could also be envisioned that the initial puncture and further advancement of the puncture tip and / or needle into the tissue to be punctured would involve the puncture tip and / or needle being sequentially positioned at different circumferences, i.e., rotating / revolving around the longitudinal axis of the puncture tip / needle in a time sequence of the puncture process.
[0044] According to an advantageous design of the invention, the propulsion mechanism can be secured by means of a locking portion to a manually operated position in which the puncture tip is received within the intermediate tube of the catheter. The propulsion mechanism can, for example, have a first locking mechanism by which at least a portion of the propulsion mechanism can be locked in the manually operated position, in which the puncture tip is received within the intermediate tube of the catheter. This has the advantage that the construction of the propulsion mechanism prevents the puncture tip from unintentionally protruding again from the intermediate tube of the catheter. If the propulsion mechanism is manually operated once and the puncture tip is received within the intermediate tube of the catheter, then locking or locking prevents the puncture tip from undesirably moving out of the intermediate tube of the catheter again.
[0045] According to an advantageous design of the invention, in the manually operated position of the advance mechanism, where the puncture tip is received within the intermediate tube of the catheter, at least one operating element of the advance mechanism can be secured by means of a locking portion, and / or at least a portion of the catheter housing can be secured to the needle assembly. This allows for simple implementation of the locking portion of the advance mechanism in the manually operated position. For example, the operating element of the advance mechanism can be secured by means of a locking portion to another operating element associated as a mating element, or to another portion of the needle assembly.
[0046] According to an advantageous design of the invention, in the manually operated position of the advance mechanism (in which the puncture tip is received in the intermediate tube of the catheter), at least one operating element of the advance mechanism can be secured by locking via a first locking mechanism and / or at least a portion of the catheter housing can be secured by locking at the needle device. This allows for easy locking of the advance mechanism in the manually operated position.
[0047] According to an advantageous design of the invention, a first locking mechanism is provided to generate a signal sound when the operating element is locked. Thus, for example, a clicking sound can be produced. This acoustically provides the user with information that the operating element is fully manipulated. The advantage of this is that the user does not need to visually control the operation of the operating element; that is, they do not need to look away from the puncture site to know when the operating element is fully manipulated.
[0048] According to an advantageous design of the invention, the manual operating element is positioned substantially centrally at the indwelling cannula in the longitudinal direction. This allows for simple and particularly ergonomic operation of the propulsion mechanism by the user, as well as balanced operation of the indwelling cannula.
[0049] According to an advantageous design of the invention, at least one operating element of the propulsion mechanism is configured as a pivotally supported operating lever with at least one lever arm. In this manner, a reliable and robust propulsion mechanism that can be easily and intuitively operated by a user is achieved. For example, the operating lever can have a lever arm and a load arm, wherein the operating lever is pivotally supported by means of a support element at a position between the lever arm and the load arm. The load arm is the lever arm that applies force to a component connected to the intermediate tube of the conduit, such as the housing of an indwelling cannula. The lever arm is the lever arm where the user applies the operating force, for example at the gripping surface of the lever arm. The lengths of the lever arm and the load arm can be the same or different. For example, the load arm can be longer than the lever arm.
[0050] As an actuating element for advancing the catheter intermediate tube relative to the puncture needle, a rotatably supported wheel can also exist, which, upon rotation, transmits the advancing force to the catheter intermediate tube or the component connected thereto through force-coupled coupling and / or friction. Force-coupled coupling between the rotatably supported wheel and the catheter intermediate tube or the component connected thereto can be provided, for example, by a groove / pin guide or teeth. This rotatably supported wheel will be considered a special case of a lever below.
[0051] The necessary relative movement between the catheter intermediate tube and the puncture needle, through which the puncture tip is ultimately accommodated in the catheter intermediate tube, can be generated solely by a manually applied actuating force. The relative movement can also be additionally supported by a spring force, i.e., by the force of a pre-tensioned spring, through which the user-triggered relative movement continues to be guided fully or partially by the spring force. For example, an indwelling cannula serving as a manual operating element can have only a trigger element for initiating the relative movement, where the relative movement is then further performed by the spring force.
[0052] According to an advantageous design of the invention, the propulsion mechanism, as an actuating element, has at least two gripping surfaces, each capable of abutting at least one of the user's fingers, wherein the at least two gripping surfaces are arranged opposite to each other. This has the advantage that the user can easily grasp the indwelling cannula and can hold and manipulate the cannula at the same gripping surface throughout the entire administration process at the patient's site. In this manner, single-handed operation is feasible, and the user does not need to change the gripping position (no need to surround) during contact with the patient. By arranging the at least two gripping surfaces opposite to each other, the user can surround the gripping surfaces from both sides to securely grasp the indwelling cannula. This advantageous design of the invention also achieves hygienic operability of the indwelling cannula, which is not only derived from safety and single-handed operability. The at least two opposite-to-each-other gripping surfaces can be considered as components of a protective box, which, during the puncture process, particularly surrounds the portion of the indwelling cannula at which, after puncture and removal of the puncture needle, for example, the infusion line is aseptically connected to the indwelling cannula. It has been repeatedly observed that in conventional indwelling cannulas, due to the lack of a suitable gripping surface, the cannula is grasped and pushed into the body at the infusion line connection point far from the patient. This creates a risk of contamination of the connection point, such as bacterial contamination, which could lead to bloodstream infection. This can be avoided by the advantageous design of the present invention, as it features a contamination-protective housing.
[0053] According to an advantageous design of the invention, at least one of the grip surfaces is located at the lever arm of the pivotally supported operating lever of the propulsion mechanism. This ensures safe operation of the propulsion mechanism. The user can intuitively place the fingers required for operation in the correct position.
[0054] According to an advantageous design of the invention, the control lever is rotatable about a rotation axis, wherein, at least in the unoperated state of the advance mechanism, the gripping surface disposed at the control lever extends from a position further away from the puncture needle than the rotation axis to a position closer to the puncture needle than the rotation axis. This has the advantage of avoiding unintended misoperation of the advance mechanism during the introduction of the puncture tip of the puncture needle into the hollow body. Due to the corresponding placement of the gripping surface relative to the rotation axis, insufficient torque is still transmitted to the lever during the puncture process, preventing unintended premature activation of the advance mechanism. Generally speaking, the rotation axis should not be positioned too close to the puncture needle, so as to provide sufficient control path for the advancement of the catheter intermediate tube relative to the puncture needle. For example, the gripping surface disposed at the control lever can be located mostly at the lever arm, and the gripping surface can also extend at least over a portion of the load arm.
[0055] According to an advantageous design of the invention, the propulsive force for advancing the intermediate catheter relative to the puncture needle is transmitted from the operating lever to the intermediate catheter or a component connected thereto at a location located closer to the distal end of the intermediate catheter than the axis of rotation, where the operating lever is pivotally supported about the axis of rotation.
[0056] According to an advantageous design of the invention, the puncture needle and a manually operable advance mechanism are configured as a single assembly, the components of which are securely connected to each other, for example, such that the components cannot be detached from each other without tools. In particular, a pivotally supported operating lever can be configured as a fixed component of the assembly, including the advance mechanism and the puncture needle. If the puncture needle is to be removed after puncture of the blood vessel, then the entire assembly, i.e., the puncture needle along with the advance mechanism including the operating lever, is always removed in this manner.
[0057] According to an advantageous design of the invention, the lever can be infinitely pivoted from an initial position in which the tip of the puncture needle extends completely out of the intermediate tube of the catheter to a final position in which the puncture needle is fully received in the intermediate tube of the catheter. This allows for very sensitive manipulation of the indwelling venous cannula during administration to the patient.
[0058] According to an advantageous design of the invention, the advancement mechanism has at least one locking element that prevents operation of the advancement mechanism until the locking element is released. For example, the locking element can be designed such that the pivotable operating lever cannot pivot initially, i.e., in the locked state. The locking is released only by targeted manipulation of the unlocking element or unlocking mechanism, allowing the operating lever to pivot. This provides a locking mechanism to prevent unintentional advancement of the catheter intermediate tube relative to the puncture needle. For example, unlocking the locking element can be performed such that a specific part of the advancement mechanism must first be manipulated in a particular direction, especially in a direction different from the direction in which the operating lever is used for pivoting. For example, to unlock the locking element, it may be necessary to first press the operating lever downward toward the puncture needle, for example, in a direction substantially orthogonal to the longitudinal direction of the puncture needle, and / or to first press portions of the operating lever together laterally to release the lock.
[0059] According to an advantageous design of the invention, the operating lever is rotatable about a rotation axis, wherein the rotation axis is movably positioned. This movability of the rotation axis enables further functionality of the indwelling cannula, such as a locking function of the operating lever in the unoperated state, as previously described. For example, the operating lever can be prevented from pivoting in the unoperated state when the rotation axis is in a first position. This preventance can only be removed and the pivotability of the operating lever realized when the operating lever is moved to a second position different from the first position. This provides additional locking against unintentional advancement of the catheter intermediate tube. The rotation axis can be movable relative to the puncture needle, for example, in a direction perpendicular to the longitudinal extension of the puncture needle or at an angle of inclination relative to the longitudinal extension of the puncture needle, for example, within a range of + / -45°.
[0060] According to an advantageous design of the invention, the axis of rotation is movably configured relative to the base. In this way, for example, to unlock the locking element, the operating lever can first be brought into the unlocked position by a movement. In the unlocked position, the operating lever can then pivot. In the locked position, pivoting is prevented by the locking element.
[0061] Because of the gaps at the lateral gripping surfaces (the lateral expansion of these gaps is smaller than the longitudinal expansion (elongated holes)), the lever can only make precise movements toward the puncture needle in order to unlock, usually downward movements, without any other lateral deflections.
[0062] When the operating lever is pressed down, the tab located on the lower side of the indwelling sleeve can also be pressed down. As a result, the lower edge of the operating lever can be pressed down further than is allowed by the rigid limit portion on the lower side of the indwelling sleeve.
[0063] Thus, in the upper region of the curved portion of the control lever, the control lever can slide proximally (i.e., away from the patient) below the curved surface of the base of the propulsion mechanism, thereby pivoting.
[0064] The operation of the pivotable lever, especially during the unlocking process, can also be associated with an acoustic signal, such as a clicking sound. The lever can also be locked into a specific position upon acoustic signal input.
[0065] In an advantageous design, all gripping surfaces have grooves, bumps, or other surface structures, thereby enabling the indwelling sleeve to be gripped particularly securely. The gripping surfaces can also be partially or completely magnetically magnetized or magnetizable, thereby creating further possibilities for operation via components of instruments such as robots through corresponding interactions.
[0066] The pivotable lever can also include or be combined with a spring mechanism. This spring mechanism can be configured such that the force of the spring must first be overcome in order to bring the pivotable lever to the actuated position of the propulsion mechanism, or to move it to the unlocked position. Alternatively, the spring can be configured such that a larger force must first be applied to the spring on one segment of the path of actuating the lever, and then a smaller force must be applied to the spring on another segment of the path to actuate the lever's function. This can also be done in reverse order; that is, a smaller force must first be applied to the spring, and then a larger force. In an advantageous design, the aforementioned tab can implement this spring functionality.
[0067] The pivotable control lever can also contain or be combined with a bimetal, which warms up upon successful venipuncture by the blood flowing back into the indwelling cannula and automatically unlocks and / or triggers the control lever by a change in shape.
[0068] Alternatively, the pivotable lever can be operated via an instrument, such as a robot. The lever and / or other components, or the entire indwelling venous cannula, can be grasped and manipulated by a robot, for example, by a gripper on a robotic arm. The operation of the aforementioned locking element is also possible in this manner.
[0069] Alternatively, the circuit can be closed by operating the aforementioned locking element and / or pivotable lever, thereby causing, for example, a diode to illuminate. The diode can be located within the area of the lever and / or surrounded by the lever's gripping and covering surfaces. These surfaces can be configured to be fully or partially translucent. Therefore, even under difficult conditions, the user can identify whether the lever has been properly unlocked and / or operated, i.e., whether the diode is illuminating.
[0070] According to an advantageous design of the invention, the indwelling cannula, particularly its intermediate cannula, has one or more markings that indicate the relative movement between the intermediate cannula and the puncture needle caused by manual manipulation of the advancement mechanism. In this manner, the user can easily and optically check whether sufficient relative movement has been performed between the intermediate cannula and the puncture needle. In particular, the current position generated by the advancement mechanism can be read optically.
[0071] According to an advantageous design of the invention, the advancement mechanism has at least one intermediate position detectable by the user's touch between its final positions, for example, in the form of a locked position. In this manner, one or more intermediate positions of the relative movement of the puncture needle with respect to the intermediate tube of the catheter can be structurally preset and can be actively set by the user. Through tactile inspection, the user can easily identify which intermediate position the advancement mechanism has reached, for example, by the presence of increased resistance when manipulating the advancement mechanism at the corresponding intermediate position. In this manner, the stiffness of the intermediate tube of the catheter can be varied and can be matched to individualized anatomical situations. Therefore, it is advantageous in fragile blood vessels that the intermediate tube of the catheter is already configured to be more flexible, especially in the area close to the patient, to ensure gentler insertion into the blood vessel.
[0072] A characteristic of conventional indwelling venous cannulas is the unrestricted longitudinal mobility of the internal puncture needle relative to the external catheter midline, determined by its structure. This allows the puncture needle to be pulled back / out of the midline after successful puncture, depending on its function towards the user, for removal. However, the relatively flexible midline typically needs to be held in place after successful puncture and during advancement into the vein, thereby ensuring stable advancement. This holding is achieved by the internal puncture needle. However, in conventional indwelling venous cannulas, the degree of needle retraction is uncertain. With insufficient retraction, the needle tip may still protrude near the vein end of the midline, undesirably damaging the anatomy. With excessive retraction, the midline may not be adequately held during advancement into the vein. However, the needle may also undesirably advance again towards the vein after retraction. This can cause damage to the midline via the needle tip, potentially resulting in, for example, a portion of the midline being sheared into the vein.
[0073] In the indwelling cannula according to the invention, after successful venous puncture, the puncture needle is pulled back along a defined path segment in the longitudinal direction into the intermediate cannula of the catheter. This has the advantage that the user can ensure that the tip of the puncture needle no longer protrudes into the intermediate cannula of the catheter in the longitudinal direction. In this state, the tip is completely surrounded by the external intermediate cannula of the catheter, thus avoiding undesirable damage to anatomical structures.
[0074] However, in the indwelling cannula according to the invention, it is also avoided that the puncture needle be pulled back into the intermediate tube of the catheter too far from the vein during the puncture process, thus failing to adequately hold the intermediate tube. Therefore, the puncture needle holds the intermediate tube of the catheter along a precisely defined path segment and precisely stabilizes the intermediate tube of the catheter as it is advanced into the vein. Furthermore, the path segment can be indicated by markings at the indwelling cannula. The path segment can also be precisely modified by the user by providing corresponding grooves / recesses at the indwelling cannula, for example, by locking a grip into the grooves / recesses.
[0075] Advantageously, a maximum relative movement between the catheter intermediate tube and the puncture needle can be preset, which the user can overcome with special effort to remove the puncture needle. This prevents the puncture needle from unintentionally slipping completely out of the indwelling cannula. This is particularly important if the catheter intermediate tube is very flexible and / or also has a helical or wavy structure, as may be the case in the indwelling cannula according to the invention. The catheter intermediate tube may also include a helical or wavy support structure loosely disposed within the catheter intermediate tube on a portion or main portion of its longitudinal extension or its entire longitudinal extension. This support structure can, for example, loosely abut against the inner and / or outer sides of the catheter intermediate tube and / or loosely fit into the gaps / slots of the catheter intermediate tube. This improves the bending resistance of the catheter intermediate tube.
[0076] It can also be particularly important if the indwelling cannula is constructed very flexibly only at the transition between intermediate catheter tubes and / or only in the portion away from the vein, such as at the skin level, as just described. The intermediate catheter tubes can also have a helical or corrugated structure only at the sites that are particularly subjected to mechanical loads and / or only at those sites include the loosely arranged support structure described above.
[0077] In particular, if the intermediate tube of the catheter is additionally constructed to prevent puncture, then there is maximum safety relative to the anatomical structure and the undesirable injury from the tip of the puncture needle.
[0078] The significant thermoplasticity of the catheter intermediate tube is no longer mandatory, as the catheter intermediate tube can be constructed very flexibly, and the rigidity usually required for advancement into the vein is mainly ensured by the puncture needle.
[0079] Alternatively, it may be necessary to first advance the puncture needle to a position where the tip of the puncture needle is facing the vein and extending into the middle of the catheter for puncture.
[0080] The indwelling cannula can also be secured to the skin with a suture at the concave ridge (see attached figure), especially when the ridge has grooves / concave / protrusions, lateral openings and / or other fastening elements.
[0081] Furthermore, the indwelling cannula according to the present invention is better suited for single-handed operation than conventional indwelling cannulas. Therefore, the user's other hand can be used, for example, to stabilize the body site to be punctured and to tension the skin. This increases the probability of successful puncture.
[0082] Unlike conventional indwelling cannulas, the indwelling cannulas according to the invention also features a defined and intuitively operable gripping surface for the user's fingers. Therefore, the indwelling cannulas is no longer unintentionally soiled / contaminated, especially in the area of entry into the skin and / or the area of support surface into the skin. Furthermore, the structure specifically protects the entry area into the skin from soiling / contamination. The gripping surface itself is adapted to the user's anatomy and can also be kneaded / deformable.
[0083] The fixation of the indwelling cannula according to the invention is further simplified because the fixing wings are connected to other parts of the indwelling cannula only via narrow tabs, thereby simplifying, for example, the placement of adhesive bandages. In particular, the wings and / or strips of adhesive bandages can be easily passed under the indwelling cannula. It is also conceivable that the wings can be pivotally positioned at the indwelling cannula. It is also conceivable that the wings can be kneaded and / or deformable, thereby also being able to optimally match the unevenness of the patient's skin area. It is also possible that the tab is made of at least one kneadable and / or deformable and / or elastic material. Advantageously, the tab can also be improved by means of at least one helical and / or spring-like structure. Thus, if the tab, as just described, is positioned between the load-bearing parts and other parts, the effects of forces / movements acting on the load-bearing parts of the indwelling venous cannula on the other parts of the indwelling venous cannula can be reduced, for example, buffered.
[0084] Any conventional / commercially available single-lumen or multi-lumen catheter intermediate tube can be used. However, according to an advantageous design of the invention, the catheter intermediate tube has at least one support structure that increases the flexural and / or radial resistance torque of the catheter intermediate tube. The support structure can be configured in the form of one or more reinforcing elements.
[0085] For example, as described above, a support structure that can be loosely and partially disposed within / at the intermediate tube of the catheter can be a spiral structure extending along a certain longitudinal section of the intermediate tube. This spiral structure can be integrated into the inner and / or outer sides of the intermediate tube, and / or partially or completely integrated into the intermediate tube wall. Multiple coaxial support structures are also possible. The spiral structure can also possess spring-like properties. Alternatively, spaced-apart support rings can exist, integrated not only into the inner and outer sides of the intermediate tube wall, but also / or completely or partially integrated into the intermediate tube wall. The spiral structure and / or rings can be formed from circular or flat materials, particularly metals. At least one support structure can also be formed by a thin-walled support sleeve or a support braid composed of interwoven fibers or fibers combined into a textile or woven fabric. The intermediate tube of the catheter can be constructed in a single layer or multiple layers in the radial direction, with each radial layer composed not only of the same material but also of different materials. For example, the support structure can be embedded in the inner radial layer covered by the outer radial layer of the conduit intermediate tube.
[0086] Materials used for the catheter intermediate tube include, for example, polyurethane (PU) or femtosecond EP. Materials used for the support structure can be metallic, particularly stainless steel and / or metal alloys, especially nitinol. Nitinol offers the advantage of further enhancing the catheter intermediate tube's resistance to compression or bending through its memory effect.
[0087] Other materials used for supporting structures can be plastic materials, especially fiber-reinforced plastics, such as carbon fiber or aramid fiber-reinforced plastics.
[0088] In the helical design of the support structure, there can be one helix or multiple helices placed among each other. The coils of the helix can have the same or varying spacing between each other along the entire length of the support structure. In an advantageous embodiment of the invention, the helical support structure can have a smaller coil spacing in the region away from the hollow body than in the region closer to the hollow body.
[0089] Other structures that allow for stable support between the coils. In an advantageous configuration, the structure becomes tensile, i.e., more rigid, as the coils move away from each other. The structure between the coils also ensures that the coils can only be spaced apart from each other in a limited manner. When the coils move toward each other, the structure between the coils becomes less rigid. In this configuration, the support structure has an accordion-like structure.
[0090] In an advantageous configuration, the structure between the coils enables the support structure to be at least partially fluid-impermeable, provided the corresponding material selection is chosen.
[0091] When using materials visible in imaging medical methods, especially metallic materials, this support structure allows for improved catheter visibility in the patient using imaging medical methods, such as ultrasound. In an advantageous embodiment of the invention, the support structure, or a series of multiple support structures existing in the longitudinal direction, is designed non-uniformly along its longitudinal extension. This non-uniform design allows for more precise location identification of specific regions of the catheter in the patient using imaging medical methods.
[0092] According to an advantageous design of the invention, the intermediate conduit has a plurality of lateral through-holes extending from the inside to the outside. The through-holes (side holes) can be present along the entire length of the intermediate conduit, or only in one or more longitudinal sections, for example, in sections closer to the hollow body. The through-holes can be arranged in a manner distributed around the circumference of the intermediate conduit. The through-holes in the wall of the intermediate conduit improve the flow of liquid through the intermediate conduit.
[0093] According to an advantageous design of the invention, one, several, or all of the through openings are located in an area of the intermediate tube of the conduit that is not covered by the support structure. For example, if the support structure has a helical shape, through holes can be provided between the coils of the helix. In this manner, flow through the through openings is not obstructed by the support structure.
[0094] Alternatively, the helical support structure may not be surrounded and / or covered by a fluid-impermeable material, at least for a portion of the intermediate tube of the conduit. Thus, even without a through-hole, the indwelling sleeve can be permeable to the liquid in this region. In an advantageous design, the coils of the helical support structure have a greater spacing between them in this region than in other regions of the intermediate tube. This region can preferably be located close to the hollow body, as described above.
[0095] Alternatively, the fluid-impermeable material surrounding the spiral support structure and / or its covering may have gaps and / or interruptions at least along a portion of its length, thereby ensuring fluid permeability of the indwelling sleeve in the regions of these gaps / interruptions. In this case, side holes are no longer mandatory.
[0096] The indwelling cannula according to the invention has the following advantages: the aforementioned fluid-permeable sites, such as the side holes, are only located in the following area of the catheter's central tube: this area is maintained by the puncture needle during the puncture procedure, thereby also sealing it from the inside. Therefore, during the puncture procedure, foreign bodies and / or, for example, protruding skin components, will not obstruct the side holes and / or will not be undesirably introduced into deeper anatomical structures through said side holes.
[0097] However, it is also advantageously feasible in the indwelling cannula according to the invention to precisely and selectively release the fluid-permeable portion, such as the side hole, at different locations in the longitudinal direction of the catheter's central tube, or at different locations within the central tube. This allows for precisely controlled dilution, for example, to more gently inject intravenous irritants.
[0098] In another advantageous configuration, the aforementioned material can also partially surround the helical support structure in a continuous manner along the longitudinal direction of the indwelling sleeve. Therefore, a tab can be formed that counteracts the unwinding of the support structure. With very tight winding, the support structure can be configured to be fluid-impermeable, but with less tight winding, it can also be fluid-permeable. The density of the winding can also determine whether the support structure is fluid-impermeable, but still permeable to gases / vapors. It is also conceivable that the support structure is permeable only to a specific fluid. Similarly, it is conceivable that the support structure has thermoplastic properties and / or expands with body heat.
[0099] According to an advantageous design of the invention, the catheter has a housing in which a catheter intermediate tube is disposed. The catheter intermediate tube extends from the side of the housing pointing towards the hollow body. According to an advantageous design of the invention, the catheter has a bend protection structure in the region where the catheter intermediate tube extends from the housing, i.e., in the region where the intermediate tube leaves the housing, a bend protection structure that completely or at least partially surrounds the catheter intermediate tube on the circumferential side, thereby reducing the risk of bending of the catheter intermediate tube in the region of departure from the housing. This avoids unwanted bending of the catheter intermediate tube during manipulation of the indwelling cannula, especially in the region of departure from the housing. This region is particularly susceptible to bending damage because, in known indwelling venous cannulas, there is an abrupt transition from a relatively robust, inflexible housing to a relatively thin-walled and correspondingly sensitive catheter intermediate tube. With the bend protection structure according to the invention, the previously abrupt transition in this region is designed to be smoother. For example, the bend protection structure can include a flared, rounded surface surrounding the catheter intermediate tube on the circumferential side.
[0100] In an advantageous embodiment of the invention, the gripping area is designed to have two gripping surfaces disposed on opposite sides of the member in which the gripping area is located. This has the advantage of allowing the indwelling cannula to be gripped well in the gripping area in a simple and safe manner using the thumb and another finger, such as the middle or index finger. In particular, the gripping surfaces can be mostly flat, or have at least a mostly flat portion. In the flat areas of the gripping surfaces, the gripping surfaces can be arranged parallel to each other. The gripping surfaces can also be configured as cavities with at least partially curved (concave) surfaces. The gripping surfaces can be structured, which further improves the gripping of the indwelling cannula and prevents finger slippage.
[0101] For example, grooves, bumps, or other surface structures can be present on the gripping surface. In particular, the gripping surface can be designed such that its dimension in the longitudinal direction of the indwelling cannula is larger than its dimension in the transverse direction, for example, at least twice the size in the transverse direction. Here, the corresponding gripping surface can be made of the material of the indwelling cannula shell, or of another material, especially of a material with greater elasticity or flexibility. For example, the gripping surface can be configured as an insertion component, for example, made of an elastomer, such as rubber or silicone, or of any other material softer than the material of the indwelling cannula shell. This insertion component can then be fastened in a corresponding recess in the shell of the indwelling cannula.
[0102] According to an advantageous design of the invention, the indwelling cannula has at least one finger-stopping device at the housing, which is disposed at or near the exit region of the intermediate tube. Thus, the finger-stopping device is clearly spaced from the proximal end of the housing. The finger-stopping device serves to prevent the user's finger, which is holding the indwelling cannula, from unintentionally slipping from the housing in the longitudinal direction of the indwelling cannula, i.e., slipping towards the patient, during application to the patient. In this way, the finger-stopping device forms an obstacle to the finger slipping from the housing relative to the patient. Contamination of the insertion site at the patient and components of the indwelling cannula in the insertion site area is avoided in this manner. For example, the finger-stopping device can be configured as a circumferential enlargement relative to the adjacent circumferential region of the housing, for example, in the form of a rim, bulge, or other thickening. The finger-stopping device can completely surround the housing on the circumferential side, or can only surround the housing in a portion, for example, only laterally on the left and right sides of the intermediate tube of the catheter.
[0103] According to an advantageous design of the invention, the indwelling cannula has a needle-protection device that minimizes the risk of injury at the puncture needle after the puncture procedure. This needle-protection device has a housing configured to completely contain the puncture needle withdrawn from the catheter's intermediate tube and shield it from the surrounding environment. The needle-protection device protects the user of the indwelling cannula, especially medical personnel, from injury to the puncture needle, particularly its sharp tip. This is especially necessary when the needle assembly is separated from the catheter assembly after the puncture procedure and needs to be disposed of separately. The needle-protection device according to the invention advantageously contains the entire puncture needle within the housing, thus protecting the user not only from the sharp puncture tip but also additionally preventing unintended contact with other parts of the puncture needle. In this way, protection against unintended infection due to accidental contact with the puncture needle can be further improved. The containment of the puncture needle within the housing is automatically performed when the puncture needle is withdrawn from the catheter's intermediate tube, i.e., after the puncture procedure. This allows for simple operations by the user.
[0104] According to an advantageous design of the invention, in the initial state of the indwelling cannula (in which the indwelling cannula is provided by the manufacturer) or before puncture of the hollow body to be punctured, the puncture needle is positioned primarily or completely outside the receptacle. In this initial state, the puncture needle can therefore be positioned primarily or substantially completely within the intermediate tube of the catheter, wherein the puncture tip of the puncture needle can extend from the end of the intermediate tube closer to the patient.
[0105] According to an advantageous design of the invention, the needle puncture protection device is configured to automatically detach from the catheter assembly if the puncture needle reaches a predetermined minimum position when pulled out of the intermediate tube of the catheter. This allows for simple operation by the user.
[0106] According to an advantageous design of the invention, the needle insertion protection device has a locking mechanism that prevents the device from separating from the catheter assembly before the puncture needle reaches a predetermined minimum position. This automatically avoids erroneous operation of the indwelling cannula or the needle insertion protection device. The corresponding structural elements of the locking mechanism automatically ensure that the needle insertion protection device does not prematurely separate from the catheter assembly, especially before the puncture needle is fully contained within the receptacle. For example, the predetermined minimum position can be reached when the puncture needle is fully contained within the receptacle.
[0107] A needle protection device can be part of a needle assembly, that is, a component of the needle assembly that is fixedly connected to the puncture needle.
[0108] According to an advantageous design of the invention, the receptacle has an outer body and an inner body disposed within the outer body, the inner body being retractably movable out of the outer body. For example, the inner body can retract linearly out of the outer body. In this way, a needle puncture protection device can be constructed simply, at low cost, and reliably. The retractable mechanism also achieves a relatively short structural length of the locking device in the initial state of the indwelling cannula, i.e., before puncture. The structural length only increases when the puncture needle is received into the receptacle or the inner body, as the inner body subsequently retracts out of the outer body. For example, in the initial state of the indwelling cannula, the puncture needle can be completely positioned outside the outer body and / or the inner body. After puncture, i.e., when the puncture needle is pulled out from the intermediate tube of the catheter, the puncture needle can be completely positioned within the inner body.
[0109] According to an advantageous design of the invention, the puncture needle is positioned at a location where the indwelling cannula is fixed relative to the external body portion. For example, the puncture needle can be fixedly and inseparably connected to the external body portion.
[0110] In an advantageous design, the outer body can also serve as an auxiliary mechanism for holding and / or advancing the puncture needle during puncture of the hollow body.
[0111] According to an advantageous design of the invention, the needle protection device is configured to automatically remove the inner body from the outer body and house the needle therein when the puncture needle is pulled out of the intermediate tube of the catheter. This allows for simple and intuitive operation by the user. Although a new mechanism exists compared to the use of conventional indwelling cannulas, the user does not need to switch to other usage methods.
[0112] According to an advantageous design of the invention, the locking device has a first end stop that limits the removal path of the inner body from the outer body to a maximum value. This ensures that the inner body cannot unintentionally detach from the outer body, especially during the pull-out movement of the puncture needle from the intermediate tube of the catheter.
[0113] According to an advantageous design of the invention, the needle insertion protection device has a second locking mechanism by which the inner body can be automatically locked relative to the outer body when the puncture needle is received within the inner body. The advantage of the second locking mechanism is that the inner body cannot be pushed against the outer body again in the opposite direction, and correspondingly, there is no risk of the puncture needle becoming accessible from the outside again. The second locking mechanism further enhances user safety because the puncture needle received within the inner body remains securely inside.
[0114] According to an advantageous design of the invention, the needle protection device has a blocking mechanism that prevents the inner body from moving relative to the outer body as long as the operating lever is not in the operating position. In this way, the design of the indwelling cannula automatically guides the user to operate the cannula correctly. The user must first manually operate the manual operating element via a manually operable advance mechanism to induce the desired advancement of the catheter intermediate tube, pushing it past the puncture tip at the end near the patient. Then, the needle protection device or its blocking mechanism allows the needle assembly to be pulled back to withdraw the puncture needle from the catheter intermediate tube. The blocking mechanism can be implemented, for example, by preventing the operating lever from pivoting in the unoperated state and releasing it through different types of manipulation, such as traversing movements. The outer body can be securely connected to the puncture needle, the outer body, or another part of the needle assembly. Due to this secure connection, the outer body can only be moved together with the operating lever.
[0115] According to an advantageous design of the invention, the outer body is positioned closer to the end of the indwelling cannula away from the patient than the operating lever. Therefore, the outer body is positioned on the side of the operating lever or advancement mechanism opposite to the intermediate tube of the catheter.
[0116] According to an advantageous design of the invention, the indwelling cannula has at least one resiliently deformable pressing element at the catheter assembly, particularly in the region of the fixing wing of the catheter assembly. This pressing element has at least one manually operable surface, wherein the lumen of the intermediate catheter can be reduced or closed by applying manual pressure acting on at least one manually operable surface of the pressing element. The pressing element is a practical auxiliary mechanism for the user to prevent blood flow from the intermediate catheter after it has been placed on the patient and the needle assembly removed. The pressing element can be intuitively operated by the user, for example, by pressing two fingers against each other in the region of the pressing element on opposite sides of the indwelling cannula.
[0117] According to an advantageous design of the invention, the compression element and the fixation wing of the indwelling cannula are configured as an integral assembly. This has the advantage that the indwelling cannula can be manufactured with relatively few individual parts, which simplifies the manufacturing process and the assembly of individual parts. The fixation wing is used to secure the indwelling cannula to the patient, for example, by means of tape.
[0118] According to an advantageous design of the invention, the pressing element is made of a material with higher elasticity than the intermediate tube of the catheter, particularly a material with rubber elasticity. Correspondingly, the pressing element can be easily operated by the user with reasonable force. Due to its elasticity, the pressing element springs back when no longer operated by the user. This reliably re-establishes flow through the intermediate tube of the catheter, for example, for the delivery of infusion fluids.
[0119] According to an advantageous design of the invention, the pressing element is connected to the intermediate tube of the conduit via a material-fitting connection. For example, the pressing element can be bonded to the intermediate tube of the conduit. This has the advantage that when the pressing element springs back, i.e., when the user removes the operating force, the intermediate tube of the conduit simultaneously returns to its original shape under tension.
[0120] The pressing element can have a continuous receiving channel in the longitudinal direction of the indwelling cannula. The intermediate tube of the catheter can be guided through this receiving channel. Here, the intermediate tube can be guided through the receiving channel without interruption, i.e., continuously and in a closed manner. Alternatively, the intermediate tube can have an interruption in the region of the receiving channel, and at least in the outward-facing end section of the receiving channel, it is fluid-tightly connected to the receiving channel so that liquid does not undesirably leak out at that point.
[0121] According to an advantageous design of the invention, the indwelling cannula has a blood collection chamber configured to automatically provide a blood sample for analytical purposes after puncture of the hollow body to be punctured. This has the advantage that the indwelling cannula can be used aseptically for automatic blood sample provision. After the indwelling cannula is placed at the patient's site, blood automatically flows through the puncture needle and / or the intermediate tube of the catheter into the blood collection chamber. The user only needs to wait a short time before separating the needle assembly from the catheter assembly.
[0122] According to an advantageous design of the invention, the blood collection chamber is disposed within the needle prick protection device, particularly within the external body portion. This has the advantage that the needle prick protection device can simultaneously serve another function, namely, providing the blood collection chamber. Therefore, it is not necessary to provide a separate component for the blood collection chamber, nor is it necessary to provide additional structural space for it. In applications where blood reflux indicates possible malpuncture (since vascular puncture is undesirable), such as in the field of regional anesthesiology, the blood collection chamber can indicate malpuncture.
[0123] According to an advantageous design of the invention, the blood collection chamber has a window for optically inspecting the amount of blood contained within the chamber and / or for indicating that the chamber is fully filled. The window can be, for example, a transparent window. Alternatively, the entire blood collection chamber, or at least its outer portion, may be constructed as a transparent component. The window allows for simple optical inspection of the amount contained within the chamber, or determination that the chamber is adequately filled. The window can, for example, have a measuring scale through which the user can read the amount of blood contained in the chamber to date. The color of the blood can also indicate the puncture site: in the case of bright red blood, an arterial puncture may have been performed.
[0124] Alternatively, the blood collection chamber may be at least partially pre-filled with liquid, such as sterile water, and sealed towards the patient at least until the puncture begins to prevent fluid leakage. In this case, the puncture needle connected to the blood collection chamber can also be sealed towards the patient to prevent fluid leakage. If the indwelling cannula is now used for puncture, for example, in a space filled with air and / or steam, such as for decompression of pneumothorax in the thoracic region, the correct puncture site can be identified by air bubble formation in the area of the blood collection chamber after the seal near the patient is removed, for example, due to overpressure at the seal site (e.g., which may occur in the area of tension pneumothorax).
[0125] A measuring device for detecting and displaying the pressure in the blood collection chamber may be present in or at the blood collection chamber. Similarly, at least one display element may be present in the blood collection chamber to display the inflow of gas, vapor, and / or fluid into the blood collection chamber, said display element being, for example, at least one spherical element that moves with the inflow of gas, vapor, and / or fluid.
[0126] According to an advantageous design of the invention, the indwelling cannula has an absorbent element, which automatically cleans the needle at least on its outer side when the needle is pulled out of the catheter's central tube. This further improves infection protection of the indwelling cannula.
[0127] The indwelling cannula can, for example, have the described needlestick protection device, but may also not have the described advance mechanism. In this case, the indwelling cannula is administered to the patient in a known manner, i.e., by the user manually advancing the catheter assembly relative to the needle assembly, without the need for a dedicated manual operating element. For example, the user can hold the needle assembly with one hand while using the other hand to slightly advance the catheter assembly, pushing the intermediate tube of the catheter beyond the puncture tip. Then, the needle assembly can be removed from the catheter assembly with the aforementioned hand, i.e., the puncture needle is pulled out of the intermediate tube of the catheter. Here, the puncture needle is automatically received in the receiver of the needlestick protection device, as described above.
[0128] Indwelling cannulas can also be used without needle protection devices and / or manually operated advance mechanisms, but with the aforementioned pressing element. Thus, the advantageous effects achievable through the pressing element can also be achieved in indwelling cannulas conventionally constructed in other respects. This also applies to all other puncture systems. This is particularly applicable to puncture systems used in regional anesthesia. This is especially applicable to puncture systems capable of puncturing the trachea, the space between the lung and the pleural cavity (pneumothorax decompression), and the abdominal cavity (ascites paracentesis). The puncture systems used for this purpose are in part very similar to indwelling cannulas used for vascular puncture (venous, arterial).
[0129] The indwelling cannula can be configured as a peripheral venous indwelling cannula (peripheral venous catheter) or a central venous catheter (ZVK).
[0130] Other advantages:
[0131] - Intuitive operation
[0132] - Simple manufacturing, such as through two-component injection molding
[0133] - The cannula contains no valves or multiple components, thus preventing blood pooling or accumulation.
[0134] - Simple operation when changing IV tubing
[0135] The aforementioned compression element can also be used independently of the indwelling cannula. For example, the compression element can be combined with or placed therein with other catheter systems, or alternatively with other components of the indwelling cannula. Application at tubing is also possible, such as at a breathing tubing (endotracheal tube). Attached Figure Description
[0136] The invention is described in more detail below with reference to the accompanying drawings and embodiments. The drawings show:
[0137] Figure 1 The indwelling sleeve in the first embodiment is shown in the perspective view.
[0138] Figure 2 The base of the propulsion mechanism is shown in the perspective view.
[0139] Figure 3 The levers of the propulsion mechanism are shown in the perspective view.
[0140] Figures 4 to 6 The indwelling cannula is shown in the side view in the first sectional plane.
[0141] Figures 7 to 9 Shown in side view according to Figure 1 The indwelling cannula,
[0142] Figures 10 to 12 The side view is shown in the second section plane according to Figure 1 The indwelling cannula,
[0143] Figure 13 The indwelling sleeve in the second embodiment is shown in the perspective view.
[0144] Figure 14 The sectional view shows the... Figure 13 The indwelling cannula,
[0145] Figures 15 to 18The side sectional view shows the operation in different maneuvering states. Figure 13 The indwelling cannula,
[0146] Figures 19 to 21 The sectional top view shows the different operating states according to... Figure 13 Part of the indwelling cannula,
[0147] Figure 22 A perspective view is shown in the first section plane according to Figure 13 The needle assembly of the indwelling cannula,
[0148] Figure 23 A perspective view is shown in the second section plane according to Figure 13 The needle assembly of the indwelling cannula,
[0149] Figure 24 The indwelling sleeve in the third embodiment is shown in the perspective view.
[0150] Figure 25 , 26 The sectional top view shows the different usage states according to Figure 24 The indwelling sleeve in the top view. Detailed Implementation
[0151] Figure 1 , Figure 4 , Figure 7 and Figure 10 The image shows the indwelling sleeve in its initial state, with a completely unoperated propulsion mechanism. Figure 5 , Figure 8 and Figure 11 In the process, the propulsion mechanism moves to the unlocked position, in which the locking element is in the unlocked position. Figure 6 , Figure 9 and Figure 12 In the middle, the propulsion mechanism is adjusted to a position where the pivotable lever is fully manipulated.
[0152] exist Figure 1 The indwelling cannula 1 shown has a catheter assembly 3 and a needle assembly 2. The catheter assembly 3 has a catheter 23 with a housing 24, on which a mid-tube exit region 7 is provided on the patient-facing side, and a mid-tube 9 exits from and extends from the housing 24 at the mid-tube exit region. The mid-tube 9 is configured to be relatively flexible and is intended as a feasible method for intravenous administration of fluids, particularly infusion solutions, blood products, and drugs. Thus, the mid-tube 9 is positioned with its distal portion in a hollow body, such as a patient's vein.
[0153] Needle assembly 2 has a puncture needle 30 (self- Figure 14As can be seen, in the initial state of the indwelling cannula 1, the puncture needle is largely contained within the housing 24 and the intermediate tube 9 of the catheter, with the puncture tip 10 of the puncture needle 30 extending from the distal end of the intermediate tube 9. The needle assembly 2 is movable relative to the catheter assembly 3 in the longitudinal direction L.
[0154] A retaining wing 8 is provided at the housing 24 for manual operation and securing the catheter 23 to the patient. On the side opposite to the intermediate tube exit area 7, the housing 24 has a needle opening through which the puncture needle 30 can be placed between the housing 24 and the intermediate tube 9. After the indwelling cannula 1 is placed against the patient, the needle assembly 2 is removed. The needle opening then serves as a possible connection for infusion tubing or aspiration elements, such as syringes.
[0155] An injection port may also be present at the housing 24, extending from the housing 24, for example, on the side opposite to the fixed wing 8. The injection port is used for injecting medication. Alternatively, the injection port may be closed by means of a sealing cap.
[0156] Furthermore, the needle assembly 2 has a closure element 6 with a plug at the proximal end of the puncture needle 30 and optionally has an operating element. In the basic state, the needle opening is closed by the closure element 6.
[0157] Figures 1 to 12 An indwelling cannula 1 is shown, which has a manually operable advance mechanism 5 for generating relative movement between the catheter intermediate tube 9 and the puncture needle 30. The advance mechanism 5 has a base 51, which is fastened to another part of the housing or needle assembly 3. A pivotally supported operating lever 53 is connected to the base 51 via a hinge, the operating lever forming the operating element 4 of the manually operable advance mechanism 5. The operating lever 53 is pivotally connected to the base 51 via a hinge. The hinge 52 here can form a rotation axis 18 about which the operating lever 53 is pivotally or rotatably supported.
[0158] A gripping surface 50 for the user's fingers to rest on is provided at the base 51. A gripping surface 54 is provided at the lever 53, for example, in the form of a downwardly curved surface with grooves. The gripping surfaces 50 and 54 are provided on opposite sides of the respective components, such that the gripping surfaces can be held, for example, between the user's thumb and forefinger. Here, the user's middle finger can rest supportively against the lower side 72 of the base 51, for example. For example, the gripping surfaces 50 and 54 can have grooves in the lateral direction.
[0159] Figure 2The base 51 is shown as a separate component. A rotation stop 13 can be seen inside the base 51. Furthermore, grooves 16 extending in the longitudinal direction L are present on the inner side of the corresponding sidewalls of the base 51, respectively, for introducing an operating lever 53, as will be explained below. At least one elastically deflectable tab 11 is also present on the lower side 72 of the base 51, i.e., on the side facing the fixed wing 8, as shown: such tabs 11 can be symmetrically present on the left and right sides respectively. The tab 11 can be integrally formed from the material of the base 51, and its elastic deflectability is obtained through lateral notches cut from the sidewalls of the base 51. Elongated holes 17 are also formed on these two sidewalls of the base 51. The base 51 also has a locking element 14.
[0160] Figure 3 A pivotable operating lever 53 as a separate component is shown. The manual grip surface 54 of the operating lever 53 can be seen. Furthermore, the operating lever 53 has one or more locking elements 15 on its back side facing the inner cavity of the base 51 (which points towards the enclosure 6). The operating lever 53 also has protruding pins on its lateral surfaces, on the left and right sides respectively, which form the axis of rotation 18 of the operating lever 53 when pivoting. A protruding cam 22 is formed on the side of the operating lever 53 facing the lower side 72 of the base 51, which is configured to interact with a resiliently deflectable tab 11. The operating lever 53 is introduced into the base 51 through a slot 16 via the laterally protruding pin 18 and subsequently locks into the elongated holes 17 upon reaching them.
[0161] The maximum possible rotational movement of the operating lever 53 is ensured by rotating the stop 13, for example, the rotational movement can include a pivot angle in the range of 30° to 60°.
[0162] exist Figure 1 , Figure 4 , Figure 7 , Figure 10 In the initial state, before the propulsion mechanism 5 is fully operated, the indwelling cannula 1 is shown. Correspondingly, the puncture tip 10 extends from the intermediate tube 9 of the catheter.
[0163] exist Figure 5 , Figure 8 , Figure 11The indwelling cannula shown has an unlocked locking element 14, meaning the protection preventing further manipulation of the advance mechanism 5 to perform relative movement between the catheter intermediate tube 9 and the puncture needle 30 is now removed. In the initial state, the operating lever 53 is still locked by the locking element 14 to prevent pivoting, meaning the advance mechanism 5 cannot be fully manipulated. This is achieved by the back side of the pointing closure plug 6 of the operating lever 53 being at the same height as the locking element 14, and correspondingly stopped there when an actuating force is applied for pivoting the operating lever 53. To unlock this lock, the operating lever 53 must first be manually pressed against the grip surface 54 and moved slightly downward toward the lower side 72 of the base 51, i.e., toward the tab 11. Therefore, pivoting of the operating lever 53 cannot be performed in this situation. In this case, the axis of rotation 18 shifts from the upper position to the lower position in the elongated hole 17. In this case, the cam 22 in the base 51 contacts the tabs 11 and causes these tabs to deflect slightly downward, i.e., the user must overcome a certain spring force. If the manual operation at the grip area 54 is removed again, the operating lever 53 will move upward again by the elastic force of the tab 11, that is, move into the safety position.
[0164] In the unlocked position, lever 53 is now pivotable, enabling relative movement between the intermediate catheter tube 9 and the puncture needle 30, in which the puncture tip 10 is ultimately covered by the intermediate catheter tube 9. In the final position of this pivoting movement of lever 53, the puncture tip 10 is thus located inside the intermediate catheter tube 9.
[0165] exist Figure 6 , 9 Figure 12 shows an indwelling cannula 1 with a fully maneuverable propulsion mechanism 5. Correspondingly, the puncture tip 10 is housed in the intermediate tube 9 of the catheter.
[0166] To lock the propulsion mechanism 5 in a fully manually operated position, one or more locking devices can be present. Exemplarily shown, at least one locking edge 12 is formed at the base 51, for example in the form of two fixed tabs 12 on the inner side of the base 51, which interact with a locking element 15 provided at the operating lever 53. The locking element 15 can be configured, for example, as one or more locking wings. Figure 6In the manually operated position shown, the locking element 15 locks behind the locking edge 12, preventing undesirable re-entry of the manually operated position to the point that the puncture tip 10 is no longer released, in which position the puncture tip 10 is contained within the catheter intermediate tube 9. This further prevents undesirable back movement of the catheter intermediate tube 9 relative to the puncture needle 30. The locking by the locking element 15 / locking edge 12 becomes particularly effective after the operating lever 53 has been rotated up to the rotation stop 13. In this rotated position, further rotation of the operating lever 53 is prevented by the back side of the operating lever 53 abutting against the rotation stop 13.
[0167] At least one locking element can be designed to generate an acoustic signal, such as a clicking sound, when the propulsion mechanism 5 is manually operated and the corresponding locking element 15 / locking edge 12 is locked. In this way, acoustic feedback can be provided to the user regarding the full operation of the propulsion mechanism 5.
[0168] Other grip surfaces 71 can also be formed laterally on the base 51. The grip surfaces can be arranged laterally so that the base 51 can no longer be "seen through" from the side. Intuitively, for example, the grip surfaces can be gripped with the right thumb (on the left) and the right middle finger (on the right), wherein the right index finger can then operate the lever 53.
[0169] exist Figure 1 , 4 In the initial state, the indwelling cannula 1 (points 7 and 10) has the puncture tip 10 protruding from the intermediate tube 9. In this state, puncture is performed on the hollow body to be punctured, as in a conventional indwelling cannula. If puncture has been performed, i.e., the puncture tip 10 is inside the hollow body along with the patient-proximity end of the intermediate tube 9, then manual manipulation for unlocking the advance mechanism 5 can be performed first. Subsequently, the intermediate tube 9 can be advanced by pivoting the lever 53. For this purpose, force is transmitted to the lever 53 via the grip surface 54, where the hand, for example, can be supported on the opposite grip surface 50 via the thumb. Figure 6 , 9 As can be seen in section 12, the puncture tip 10 is now housed in the intermediate tube 9 of the catheter. Here, the puncture needle 30 remains in a fixed position when the advancement mechanism 5 is manipulated.
[0170] Here, the indwelling cannula 1 can be advantageously held and operated with one hand, for example, by placing the user's thumb against the grip surface 50, the index finger against the grip surface 54, and optionally additionally, for support, placing another finger, such as the middle finger, against the underside 72 of the base 51.
[0171] After the relative movement generated by the propulsion mechanism 5 is performed, the intermediate tube 9 of the catheter, which is held at least substantially along its entire length by the internal puncture needle 30, can now be further pushed into the hollow body until the desired position is reached. Thereafter, as in a conventional indwelling cannula, the needle assembly 2 is removed from the catheter 2, wherein the propulsion mechanism 5 can also be removed at the same time.
[0172] A pivotable operating lever 53 is housed in a base 51 that is at least laterally and largely closed, and supported at the axis of rotation 18. The base 51 at least laterally and partially also surrounds the operating lever 53 at the rear, such that the lever 53 is largely covered relative to the surrounding environment, and the grip surface 54, primarily for manual operation, is on the outside. In particular, a locking mechanism with locking elements 15 and locking edges 12 can be provided within the area surrounded by the base 51. In this manner, the components of the advance mechanism 5 and the needle opening are also better protected from contamination. Furthermore, it prevents, for example, parts of a user's glove from obstructing the area of the locking elements 12, 15.
[0173] As in Figure 7 As can be seen from the puncture needle 30, the gripping surface 54 extends from a position below the rotation axis 18, that is, a position closer to the puncture needle 30 than the rotation axis 18, toward a position above the rotation axis 18.
[0174] The operation of the indwelling cannula 1 and its advancement mechanism 5 when applied to a patient can be further improved in the illustrated variant by providing lateral gripping surfaces 71 on both sides of the base component 51. Additionally, a lower gripping surface can also be present on the lower side 72 of the base 51, i.e., the side facing the patient. The lateral gripping surfaces 71 and / or the lower gripping surfaces 72 can also have the corresponding structure as already described for gripping surfaces 50 and 54.
[0175] The base 51, to which the operating lever 53 is fastened, can be configured with the housing of the needle assembly 2 as a one-piece structural unit, for example, as a plastic injection molded component.
[0176] For example, the base 51 can be configured as a largely closed housing to accommodate the operating lever 53. For example, the base 51 can have at least two opposing sidewalls, a lower wall, and a rear wall facing the proximal end. Then, the side of the base 51 that is open towards the distal end can be largely closed by the lever 53.
[0177] The operating lever 53 may have sidewalls that are arranged parallel to and at least partially overlap with the sidewalls of the base 51. In this manner, the arrangement formed by the base 51 and the operating lever 53 also provides good protection against contamination in the lateral direction.
[0178] Here, the operating lever 53 is rotatably supported on the base 51 via its axis of rotation 18. For example, to design a rotatable support, a protruding pin can be formed at one of the components, namely the operating lever 53 and the base 51, which engages in a recess at the corresponding other component.
[0179] Due to the various grip surfaces, there are multiple possibilities for the user to hold and operate the indwelling cannula 1. An advantageous variation of operating the indwelling cannula 1 with three fingers involves the user holding the indwelling cannula 1 with their thumb and middle finger at the opposing lateral grip surfaces 71, and placing their index finger on the grip surface 54 of the operating lever 53. In this manner, puncture of the hollow body can be performed first by means of the puncture tip 10, and then the propulsion mechanism 5 can be operated with the index finger via the grip surface 54 without changing the position of the hand 6.
[0180] In the initial position, the operating lever 53 cannot rotate, but can only move vertically downwards through the elongated hole 17 in the housing. The tab 11 prevents the operating lever 53 from moving downwards uncontrollably.
[0181] Figure 4 The diagram illustrates the indwelling cannula 1 in its initial position. In this configuration, uncontrolled rotation of the operating lever 53 is prohibited, thereby preventing unintentional advancement of the catheter 3, as the operating lever 53 is supported on its back side at the housing edge 14 of the base 51, which forms a locking element.
[0182] Figure 10 This illustrates how the catheter 23 is held in its initial position. This is achieved by manipulating the guide slots 19 at lever 53, which secure the catheter 23 at its guide pin 20, preventing movement of the catheter 23 relative to the needle assembly 2. The guide pin 20 can, for example, be secured to the housing 24.
[0183] By manipulating the lever 53 vertically downwards, the cam 22 is pressed against the tab 11 at the base 51. In this position, the lever 53 can rotate because it is no longer supported at the housing edge 14. The vertically movable path of the lever 53 is limited by the elongated hole 17.
[0184] The implementation of cam 22 ensures that the operating lever 53 is tensioned only when compressed and is no longer tensioned during subsequent rotational movements. This should ensure that the operating lever 53 can rotate smoothly within the base 51.
[0185] Figure 11 This illustrates how pressing down on the cam 22 deflects the tab 11 when the lever 53 is activated by pressing down in the vertical direction.
[0186] By rotating the lever 53, the guide pin 20 slides along the guide groove 19 at the lever 53, thereby advancing the conduit 23 in the longitudinal direction L.
[0187] Figure 12 The indwelling cannula 1 with the advanced catheter 23 is shown. The opening plane 21 allows the catheter 23 to disengage from the needle assembly 2. In this rotated position, the guide groove 19 no longer obstructs the movement of the catheter 23 relative to the needle assembly 2 in the longitudinal direction L.
[0188] The rotational movement of the operating lever 53 is limited by the rotation stop 13 to prevent the operating lever 53 from being over-rotated. This should prevent fingers or the tube 23 from being pinched.
[0189] Figures 13 to 23 A second embodiment of the indwelling cannula 1, in addition to the features described above, includes a needle puncture protection device 31 and a pressing element 28. The pressing element 28 is structurally integrated into the housing 24 of the catheter 23 and is also formed as an integral structural unit with the fixing wing 8. In this way, the fixing wing 8 is fastened to the housing 24. The pressing element 28 is made of a material that is softer and / or more elastic than the housing 24 and / or the intermediate tube 9 of the catheter. For example, in… Figures 19 to 21 As can be seen, the intermediate conduit 9 passes through the longitudinal channel formed inside the pressing element 28 and extends through the pressing element 28.
[0190] The housing 24 and / or the intermediate conduit 9 can be made of a relatively rigid plastic material, such as ABS or PC (polycarbonate). The pressing element 28 can be made of a soft material, such as silicone or thermoplastic polyurethane.
[0191] The needle protection device 31 is located on the side of the housing 24 opposite to the intermediate tube 9 of the catheter or the puncture tip 10. The needle protection device 31 is structurally connected to the advance mechanism 5 or other components of the needle assembly 2. In particular, the needle protection device 31 is located on the side of the indwelling cannula 1 opposite to the patient.
[0192] The needle puncture protection device 31 has receptacles 32 and 33, in which the entire puncture needle 30 can be accommodated after the puncture procedure. The receptacles 32 and 33 have an outer body portion 32 and an inner body portion 33 disposed within the outer body portion 32. The inner body portion 33 is movably disposed relative to the outer body portion 32 in the longitudinal direction L, and can be removed from the outer body portion 32 to accommodate the puncture needle 30, such as... Figure 17 and Figure 18 As indicated. Figure 22 The inner body 33, which has been completely removed from the outer body 32, is also shown.
[0193] If the indwelling cannula 1 according to the second embodiment is applied to the patient, the operation described above for the first embodiment is performed first. In the initial state, the operating lever 53 is locked by the locking element 14 to prevent pivoting, that is, the advancement mechanism 5 cannot be fully operated. In this state, the needle protection device 31 is still blocked, that is, the inner body 33 cannot be removed from the outer body 32. Only by unlocking the operating lever 53 from the locking element 14 can the desired advancement of the catheter intermediate tube 9 relative to the puncture needle 30 be achieved via the advancement mechanism 5 through the pivoting of the operating lever 53. Here, the needle protection device 31 is also automatically activated, that is, the inner body 33 can now be removed from the outer body 32.
[0194] Figures 13 to 15 The image shows the indwelling sleeve 1 in its initial state before the operation of the propulsion mechanism 5. According to... Figure 16 The propulsion mechanism 5 is now actuated so that the puncture tip 10 is located inside the intermediate tube 9 of the catheter. The actuation lever 53 pivots and rests its back against the rotation stop 13. In this manually actuated position, the locking element 15 is locked behind the locking edge 12 so that the actuation lever 53 will not move back accidentally.
[0195] A guide plate 46 is also provided at the operating lever 53, which is oriented horizontally in this manually operated position, i.e., parallel to the puncture needle 30. In this position, it is permissible to pull the puncture needle 30 back from the intermediate tube 9 of the catheter.
[0196] The user can now pull the puncture needle 30 out of the catheter intermediate tube 9 in a direction away from the end closest to the patient by pulling back the outer body 32, while the inner body 33 is simultaneously pulled out from the outer body 32. The inner body 33 has a retaining head 40, which extends through a retaining sleeve 41 located at the catheter assembly 3 or housing 24 with its widened end. This mechanism automatically pulls the inner body 33 out of the outer body 32 when the puncture needle 30 is pulled out. Thus, the inner body 33 is telescopically removed from the outer body 32, while the puncture needle 30 is simultaneously accommodated within the inner body 33. During this pull-out process, the advancing mechanism 5 is pulled back together with the operating lever 53. Here, the guide plate 46 is accommodated and guided in the guide groove 34 associated with the inner body 33. This ensures reliable telescopic guidance of the inner body 33 relative to the outer body 32 throughout the entire pull-out movement.
[0197] When the guide plate 46 reaches the end of the guide groove 34 furthest from the patient, the linear movement path of the inner body 33 relative to the outer body 32 is limited by the guide plate 46. An additional sliding plate 36 reduces sliding friction between the inner body 33 and the outer body 32 during pull-out. If the maximum pull-out path of the inner body 33 from the outer body 32 is reached, further relative movement between the inner body 33 and the outer body 32 is prevented by locking the locking protrusion 43 in the locking groove 37, as... Figure 17 As shown. Thus, the needle protection device 31 is locked, and the inner body 33 is prevented from sliding back into the outer body 32.
[0198] The puncture needle 30 is now positioned in the inner body 33 with its puncture tip 10 in such a manner that, from the patient's perspective, the puncture tip 10 is located behind the locking portion between the retaining head 40 and the fixing sleeve 41. If the needle assembly 2 is now pulled further back, i.e. away from the patient, as... Figure 21 As shown, the obstruction between the retaining head 40 and the retaining sleeve 41 can be overcome by slightly compressing the retaining head 40 at its free end (where the retaining head 40 is slit-like by means of the unlocking slot 39) by means of the retaining sleeve 41, thereby reducing its circumference and allowing the retaining head 40 to be pulled through the opening of the retaining sleeve 41. Now, the needle assembly 2 can be completely separated from the catheter assembly 3, as... Figure 21 As shown.
[0199] Upon arrival Figure 21 Prior to the state shown, disengagement of the retaining head 40 from the retaining sleeve 41 is prevented by the following: the puncture needle 30 remains inside the retaining head 40, thereby preventing the compression process required for disengagement of the retaining head 40 from the retaining sleeve 41, as described above. Figure 19 and Figure 20 As shown. Therefore, in this position, the needle assembly 2 cannot detach from the catheter assembly 3 because the puncture needle 30 prevents the retaining head 40 from bending inward into the unlocking suture 39 and exiting through the retaining sleeve 41.
[0200] Figure 20 A cross-sectional view is shown in which the puncture needle 30 is fully retracted in a linear direction. In this position, the needle assembly 2 can disengage from the catheter assembly 3 because the retaining head 40 can bend inward and slide through the retaining sleeve 41.
[0201] The indwelling cannula 1 also has a blood collection chamber 44 configured to automatically provide a blood sample for analytical purposes after puncture of the hollow body to be punctured. After the indwelling cannula is placed at the patient, blood automatically flows into the blood collection chamber 44 through the puncture needle 30 and / or the intermediate tube 9 of the catheter. Advantageously, the blood collection chamber 44 is located in the needle protection device 31, particularly in the outer body portion 32. The blood collection chamber 44 has a first viewing window 27 for optically checking the amount of blood contained in the blood collection chamber 44. The first viewing window 27 can be configured as an elongated window in the longitudinal direction L, for example, configured as a blood viewing slot, through which the blood flow entering the blood collection chamber 44 can be optically checked. The blood collection chamber 44 has a second viewing window 38 at the end of the blood collection chamber 44 away from the patient, which is used to signal that the blood collection chamber 44 is completely filled.
[0202] The indwelling cannula has an absorbent element 47, which automatically cleans the puncture needle at least on its outer side when the needle 30 is pulled out of the catheter intermediate tube 9. This further improves the infection protection of the indwelling cannula 1. The absorbent element 47 can be disposed, for example, in the form of a sleeve inside the retaining head 40 or inside another part of the inner body 33. When the needle 30 is pulled back, blood is absorbed by the absorbent element 47, thereby preventing uncontrolled blood droplets from spraying out and cleaning the needle 30. The absorbent element 47 can be made of a liquid-absorbing material, such as paper, plastic (sponge, fabric), etc. The needle unit 3 is removed after use.
[0203] Figures 24 to 26 A third embodiment of the indwelling cannula 1 is shown, which, by way of example, does not have the advancing mechanism 5 and the needle protection device 31. A pressing element 28 is present, which can be configured as described above.
[0204] according to Figure 25 and Figure 26 The function of the pressing element 28 is described, which applies to both the second and third embodiments of the indwelling sleeve 1. In normal conditions, such as... Figure 25 As shown, the pressing element 28 is not actuated. This provides free passage of the intermediate conduit 9 along its entire length (and through the pressing element 28). Correspondingly, fluid can flow through the intermediate conduit 9, as indicated by the dashed arrow. For example, if unwanted blood flow through the intermediate conduit 9 should be prevented, pressure can be applied at the opposing outer actuating surfaces of the pressing element 28, such as... Figure 26As indicated by the arrows pointing towards each other, the pressing element 28 or its internal channels are thus pressed together to such an extent that the lumen of the intermediate tube 9 is similarly reduced, possibly even blocked, thereby prohibiting unwanted blood flow through the intermediate tube 9. If removed according to... Figure 26 When the force is applied as shown, the pressing element 28 and a portion of the intermediate tube 9 located therein spring back together, so that the force is again applied. Figure 25 The state shown in the figure.
[0205] The indwelling sleeve 1 may additionally have an anti-torsion protection element 26, which, for example, in Figure 24 As shown in the diagram. However, the anti-torsion protection 26 can be implemented in every embodiment of the indwelling cannula 1. The anti-torsion protection 26 prevents the catheter assembly 3 from accidentally twisting or rotating about the longitudinal axis L in the needle assembly 2. Rotation of the catheter assembly may cause functional failure during advancement, which is avoided by the anti-torsion protection 26.
[0206] List of reference numerals
[0207] 1. Indwelling cannula
[0208] 2-pin assembly
[0209] 3-catheter assembly
[0210] 4 operating elements
[0211] 5. Propulsion mechanism
[0212] 6 Enclosed Elements
[0213] 7 Intermediate pipe outlet area
[0214] 8 fixed-wing
[0215] 9. Intermediate tube of the conduit
[0216] 10 puncture tips
[0217] 11 stitches
[0218] 12 Locking edges (e.g., retaining plates)
[0219] 13 Rotation stop
[0220] 14. The edge of the dorsal side
[0221] 15 Locking Elements
[0222] 16 slots
[0223] 17 long holes
[0224] 18 Rotation Axis
[0225] 19 guide slots
[0226] 20 lead-in sales
[0227] 21 Opening Plane
[0228] 22 Cam
[0229] 23 catheters
[0230] 24 shell
[0231] 26 Anti-torsion protection components
[0232] 27 First Window
[0233] 28 pressing elements
[0234] 30 puncture needles
[0235] 31 Needle Puncture Protection Equipment
[0236] 32 External body parts
[0237] 33 Internal Body Parts
[0238] 34 guide slots
[0239] 35 key slots
[0240] 36 sliding pieces
[0241] 37 locking slots
[0242] 38 Second Window
[0243] 39 Unlock seams
[0244] 40 Keep your head
[0245] 41 Fixed Sleeve
[0246] 43 Locking Protrusion
[0247] 44 Blood collection chamber
[0248] 46 guiding films
[0249] 47 Absorption Elements
[0250] 50 grip surface
[0251] 51 matrix
[0252] 53 Leverage
[0253] 54 grip surfaces
[0254] 71 Side grip surface
[0255] 72 Lower grip surface
[0256] L longitudinal direction
Claims
1. An indwelling cannula (1) having a puncture needle (30) for puncturing a hollow body, wherein the indwelling cannula (1) has at least one catheter (23) having a tubular intermediate tube (9) in which the puncture needle (30) is longitudinally movable and guided, wherein the catheter (23) is configured to, after puncturing the wall of the hollow body to be punctured, push through the wall of the hollow body to be punctured through an opening made by means of the puncture needle (30) over at least a portion of the length of the intermediate tube (9) and remain there for a certain duration.
2. The indwelling cannula according to claim 1, Its features are, The indwelling cannula (1) has a needle assembly (2) and a catheter assembly (3) separate from the needle assembly (2), the puncture needle (30) is secured to the needle assembly, and the intermediate tube (9) of the catheter is secured to the catheter assembly, wherein the needle assembly (2) is configured to be removed from the catheter assembly (3) after the puncture procedure is performed.
3. The indwelling cannula according to any one of the preceding claims, Its features are, The indwelling cannula (1) has a manually operable advance mechanism (5) with a manual operating element (4) that can automatically generate relative movement between the intermediate tube of the catheter (9) and the puncture needle (30) by manual operation of the operating element, wherein the puncture tip (10) of the puncture needle (30) extending from the intermediate tube of the catheter (9) at the end near the patient can be accommodated in the intermediate tube of the catheter (9).
4. The indwelling cannula according to claim 3, Its features are, The propulsion mechanism (5) can push the intermediate tube (9) of the catheter beyond the puncture tip (10) of the puncture needle (30) and / or pull the puncture tip (10) of the puncture needle (30) into the intermediate tube (9).
5. The indwelling sleeve according to any one of claims 3 to 4, Its features are, The propulsion mechanism (5) has a first locking mechanism, through which at least a portion of the propulsion mechanism (5) can be locked in a manually operated position, in which the puncture tip (10) is accommodated in the intermediate tube (9) of the catheter.
6. The indwelling cannula according to any one of claims 3 to 5, Its features are, In the manually operated position of the propulsion mechanism (5), the puncture tip (10) is housed in the intermediate tube (9) of the catheter, in which at least one operating element (4) of the propulsion mechanism (5) can be locked by means of the first locking mechanism, and / or at least a portion of the housing (24) of the catheter (23) can be locked at the needle device.
7. The indwelling sleeve according to claim 5, Its features are, The first locking mechanism is configured to generate a signal sound when the operating element is locked.
8. The indwelling cannula according to any one of claims 3 to 7, Its features are, The manual operating element (4) is positioned substantially centrally in the longitudinal direction (L) of the indwelling sleeve (1) at the indwelling sleeve (1).
9. The indwelling sleeve according to any one of claims 3 to 8, Its features are, At least one operating element (4) of the propulsion mechanism (5) is configured as a pivotally supported operating lever having at least one lever arm.
10. The indwelling cannula according to claim 9, Its features are, The control lever is rotatable about a rotation axis (18), wherein the rotation axis (18) is movably positioned.
11. The indwelling cannula according to any one of claims 3 to 10, Its features are, The propulsion mechanism (5) is configured to generate relative movement between the intermediate tube (9) of the catheter and the puncture needle (30) by manually applied manipulation force and / or by elasticity.
12. The indwelling sleeve according to any one of claims 3 to 11, Its features are, The propulsion mechanism (5) as an operating element (4) has at least two grip surfaces (50, 54, 71, 72), and at least one of the user's fingers can rest on the grip surfaces respectively, wherein the at least two grip surfaces (50, 54, 71, 72) are arranged opposite to each other.
13. The indwelling sleeve according to claim 12, Its features are, At least one of the gripping surfaces (50, 54, 71, 72) is disposed at the lever arm of the pivotally supported operating lever of the propulsion mechanism (5).
14. The indwelling cannula according to any one of the preceding claims, Its features are, The indwelling cannula (1) has a needle protection device (31) for reducing the risk of injury at the puncture needle (30), wherein the needle protection device (31) has a receptacle configured to completely accommodate the puncture needle (30) pulled out from the intermediate tube (9) of the catheter and to shield it relative to the surrounding environment.
15. The indwelling sleeve according to claim 14, Its features are, In the initial state of the indwelling cannula (1), which is provided by the manufacturer, the puncture needle (30) is mostly or completely outside the receptacle in the initial state or before puncturing the hollow body to be punctured.
16. The indwelling sleeve according to any one of claims 14 to 15, Its features are, The needle protection device (31) is configured to automatically separate the needle protection device (31) from the catheter assembly (3) when the puncture needle (30) reaches a predetermined minimum position after being pulled out of the intermediate tube (9) of the catheter.
17. The indwelling sleeve according to any one of claims 14 to 16, Its features are, The needle protection device (31) has a locking device that prevents the needle protection device (31) from separating from the catheter assembly (3) before the puncture needle (30) reaches the predetermined minimum position.
18. The indwelling sleeve according to any one of claims 14 to 17, Its features are, The container has an outer body (32) and an inner body (33) disposed in the outer body (32), the inner body being retractable from the outer body (32).
19. The indwelling sleeve according to claim 18, Its features are, The puncture needle (30) is positioned at a fixed position on the indwelling cannula (1) relative to the outer body portion (32).
20. The indwelling sleeve according to any one of claims 18 to 19, Its features are, The needle protection device (31) is configured to automatically remove the inner body portion (33) from the outer body portion (32) when the puncture needle (30) is pulled out from the intermediate tube (9) of the catheter, and the puncture needle (30) is accommodated in the inner body portion (33).
21. The indwelling sleeve according to any one of claims 18 to 20, Its features are, The locking device has a first end stop, which limits the movement path of the inner body (33) away from the outer body (32) to a maximum value.
22. The indwelling sleeve according to any one of claims 18 to 21, Its features are, The needle protection device (31) has a locking mechanism, through which the inner body (33) can be automatically locked relative to the outer body (32) when the puncture needle (30) is housed in the inner body (33).
23. The indwelling sleeve according to any one of claims 18 to 22, Its features are, The needle protection device (31) has a blocking mechanism that prevents the inner body (33) from moving out relative to the outer body (32) as long as the operating lever is not moved to the operating position.
24. The indwelling sleeve according to any one of claims 18 to 23, Its features are, The external body portion (32) is positioned closer to the end of the indwelling cannula (1) that is furthest from the patient than the operating lever.
25. The indwelling sleeve according to any one of claims 2 to 24, Its features are, The indwelling cannula (1) has at least one elastically deformable pressing element (28) at the catheter assembly (3), particularly in the region of the fixed wing of the catheter assembly (3), the pressing element having at least one manually operated surface, wherein the lumen of the catheter intermediate tube (9) can be reduced or closed by applying manual pressure to the at least one manually operated surface of the pressing element (28).
26. The indwelling sleeve according to claim 25, Its features are, The pressing element (28) and the fixed wing of the indwelling sleeve (1) are integrated into a single component.
27. The indwelling sleeve according to any one of claims 25 to 26, Its features are, The pressing element (28) is made of a material with higher elasticity than the conduit intermediate tube (9), especially a material with rubber elasticity.
28. The indwelling sleeve according to any one of claims 25 to 27, Its features are, The pressing element (28) is connected to the intermediate tube (9) of the conduit via a material-fitted connection.
29. The indwelling cannula according to any one of the preceding claims, Its features are, The indwelling cannula (1) has a blood collection chamber (44) configured to automatically provide a blood sample for analytical purposes after puncture of the hollow body to be punctured.
30. The indwelling sleeve according to claim 29, Its features are, The blood collection chamber (44) is disposed in the needle protection device (31), and particularly in the outer body part (32).
31. The indwelling sleeve according to any one of claims 29 to 30, Its features are, The blood collection chamber (44) has windows (27, 38) for optical inspection of the amount of blood contained in the blood collection chamber (44) and / or for displaying that the blood collection chamber (44) is completely filled.
32. The indwelling cannula according to any one of the preceding claims, Its features are, The indwelling cannula (1) has an absorbent element (47) at which the puncture needle (30) is automatically cleaned, at least on its outer side, when pulled out of the intermediate tube (9) of the catheter.