Puncture instrument, guide wire assembly for puncture instrument, medical complete equipment composed of puncture instrument and guide wire assembly, and drainage unit

Abstract

The invention relates to a puncture instrument (10, 200) for introducing a guidewire tip (60) of a guidewire into an anatomical spatial point. A puncture instrument (10) includes a needle (12) including a distal needle tip (20, 202) having a suction port (24), a proximal end (26), and a needle suction channel (36) extending along a longitudinal axis (35). Furthermore, a housing (14) is provided on which the proximal end (26) of the needle (12) is arranged. The housing (14) has a syringe connection end (32a, 32b, 204) for a syringe and a separately formed introduction opening (30) for a guide wire (58). Furthermore, the housing (30) has a housing-part suction channel (40), which opens into the syringe connection end (32a, 32b, 204), and a housing-part thread guide channel (42), which is formed separately from the housing-part suction channel (40) and which is connected to the introduction opening (30).

Description

Technical Field

[0001] The present invention relates to a puncture instrument for introducing the guide wire tip of a guide wire into an anatomical space point, in particular to a guide wire assembly used with the puncture instrument and a complete set of equipment having the puncture instrument and the guide wire assembly. The present invention also relates to a drainage unit. Background Art

[0002] In medicine, a puncture is the targeted insertion of a needle into the body. It allows for the collection of blood, tissue, and fluid samples for subsequent examination in a laboratory, as well as for the injection of fluids into the body, such as vaccines. A puncture is also used to place catheters into blood vessels or organs.

[0003] The Seldinger technique is a method used to access blood vessels for catheter placement and for arterial and central venous access.

[0004] First, a puncture is performed with a puncture needle arranged on a syringe. The needle penetrates the patient's skin into the area to be punctured. At this time, suction is performed, that is, the syringe is first pulled back to generate negative pressure in the needle channel. The success of the puncture can be confirmed as follows: during the suction process, blood or other body fluids flow into the syringe through the puncture needle. The liquid can be seen through the transparent wall of the syringe barrel. Subsequently, the syringe is removed from the connection of the puncture needle, and the guide wire tip of the guide wire is introduced into the anatomical space point of the puncture through the puncture needle. The puncture needle is then withdrawn and removed on the guide wire. Subsequently, the catheter or drainage tube can be pushed forward through the guide wire until it reaches the anatomical space point at the top of the guide wire. The diameter of the catheter and drainage tube is usually very small, only slightly exceeding the diameter of the guide wire. After the catheter or drainage tube is pushed in, the guide wire is withdrawn from the catheter or drainage tube, wherein the distal end of the catheter or drainage tube remains at the anatomical space point. The proximal end of the catheter or drainage tube can be fixed on the patient's skin.

[0005] One difficulty with puncturing a blood vessel is that after puncture and before the guidewire is pushed in, blood flows through the puncture needle under high vascular pressure and gushes out. The gusher of blood contaminates the environment and may also pose a risk of infection. In the case of low vascular pressure, there is a risk of air embolism for the patient.

[0006] Other complications may result from puncture errors. In this case, the tip of the puncture needle is not located at the desired anatomical spatial point, such as in a blood vessel, but instead is located, for example, in subcutaneous fat tissue, connective tissue or another blood vessel. In the case of puncture errors, nerves or organs may also be damaged, leading to further damage.

[0007] The needle can also damage the target vessel at the point in the anatomical space, and bleeding may occur, especially during arterial puncture. Bleeding may not be detected initially, but may only become apparent hours later through hemodynamic instability. When the needle or guidewire is advanced, the vessel wall can be disrupted and the catheter can be pushed forward within the vessel wall.

[0008] In addition, the needle may slip, especially when the syringe is pulled from the connection or the guide wire is introduced into the needle. Needle slippage often requires re-attempting the puncture, which introduces additional punctures and new hazards. Previously created punctures also carry the risk of bleeding and infection.

[0009] As mentioned above, a drainage tube for draining fluid from the body can be introduced via an introduced guide wire. Drains with a smaller inner diameter may become blocked, even if there is still fluid to be drained, wherein the blockage often cannot be removed. The blocked drainage tube must then be removed and re-placed, with a particular risk of infection. Drains with a larger inner diameter can be used for suction to clear the blockage. When inserting a drainage tube with a larger diameter, it is usually necessary to expand the tissue around the guide wire into a body channel beforehand. This expansion is done with the help of a dilator and / or a scalpel. This procedure and the resulting tissue damage in turn pose additional risks to the patient. When creating and expanding a body channel for the drainage tube, the guide wire may be accidentally pulled out or slipped off, so that the drainage tube cannot be brought to the desired anatomical spatial point. In addition, there are problems when introducing a drainage tube with a larger diameter along the inserted guide wire without forming a body channel. When the drainage tube is introduced, the drainage tube body itself may be bent, whereby the subsequent drainage of the fluid cannot be ensured.

[0010] A puncture needle device having two connections for introducing a catheter into a blood vessel is known from EP 603 325 B1.

[0011] A venous puncture cannula having the features of the preamble of claim 1 is known from EP 0 641 571 B1. The venous puncture cannula is used for catheter placement and has a puncture needle with a Y-shaped connection and two sockets. In this case, one socket is used to push in the guide wire and the other socket is used to connect the syringe. With this venous puncture cannula, puncture can be carried out according to the above-mentioned process so that the tip of the guide wire is introduced into the anatomical space point. Advantageously, due to the two sockets, the syringe does not have to be removed before the guide wire is pushed in. The risks are thus reduced because, on the one hand, the needle cannot slip when the syringe is removed and, on the other hand, no blood can escape from the needle or air can be sucked into the open connection of the blood vessel. The time required for the introduction of the guide wire tip can also be slightly reduced and the risk of injury due to the indwelling needle in the body is also reduced. The disadvantage is that the guide wire can only be inserted when the puncture needle is introduced. When the provided guide wire is grasped and then introduced into the socket, the puncture needle can still slip or be pulled out due to the inevitable change of the grip just like when using a simple needle as described above. This in turn brings about the above-mentioned risks. Summary of the invention

[0012] The object of the present invention is to improve the safety of the patient during the puncture for the introduction of the guide wire and during the advancement of the drainage tube.

[0013] This purpose is achieved in particular by a puncture instrument for introducing the guide wire tip of the guide wire into the anatomical space point according to claim 1. To this end, the puncture instrument comprises a needle having a distal needle tip with a suction port, a proximal end and a needle suction channel extending along the longitudinal axis. In addition, a housing is provided, and the proximal end of the needle is arranged on the housing. The housing has a syringe connection end for a syringe and an introduction port for the guide wire formed separately from the syringe connection end. In addition, the housing has a housing suction channel that leads into the syringe connection end and a housing guide wire channel that is formed separately from the housing suction channel and connected to the introduction port. It is further provided that the needle suction channel directly leads into the housing suction channel, and the needle has a second needle guide wire channel formed separately from the needle suction channel, and the second needle guide wire channel connects the housing guide wire channel with the guide wire port, and the guide wire port is formed separately from the suction port and is arranged at the needle tip.

[0014] Therefore, two passages are formed in the puncture apparatus, that is, the suction passage and the guide wire passage, which are continuously separated from each other in the housing and the needle without a cross point, so that liquid or gas exchange does not occur between the passages in the puncture apparatus. Thus the puncture apparatus can be prepared before puncturing (that is, before the needle pierces the patient's skin). In this case, the guide wire can be introduced into the guide wire passage by the introduction passage of the housing, and the guide wire top can be pushed to the guide wire port of the needle or before being close to the guide wire port, and the guide wire top can not stretch out from the guide wire port. In addition, the syringe can be connected to the syringe connection end, and remains arranged on the puncture apparatus during the whole puncture process.

[0015] In order to introduce the guide wire tip, the needle is inserted through the patient's skin into the area to be punctured. At the same time, a syringe is used to aspirate through the suction channel. Once it is determined that the aspiration is successful, the guide wire can be pushed forward so that the guide wire tip extends from the guide wire port. Subsequently, the puncture instrument can be pulled out of the body through the guide wire, so that the guide wire tip remains at the anatomical space point. The puncture instrument prepared in this way can introduce the guide wire tip through a few simple operations in a few seconds. Compared with the prior art, some steps can be omitted. In particular, when the needle remains in the body, it is not necessary to switch the grip to grasp and introduce the guide wire. Since the guide wire tip of the guide wire can be positioned in the area of ​​the guide wire port during the preparation process, only a small amount of guide wire is required to push the guide wire tip out of the guide wire port and introduce it into the desired anatomical space point. According to the prior art, the guide wire must always be pushed through the entire needle and cannot be introduced into the needle before puncture. In contrast, using the puncture instrument of the present invention, the total time required for puncturing with the puncture instrument can be reduced to a few seconds. By reducing the time the needle remains in the body, the risk of injury can be reduced and patient safety during the puncture procedure can be improved.

[0016] Another advantage of the present invention is that during puncture through the suction channel formed separately from the wire channel, suction can be performed safely and reliably at any time, despite the presence of a syringe at the syringe connection end and despite the presence of a guide wire in the wire channel. Thus, the position of the needle tip can be controlled continuously and also during the wire feeding process to avoid puncture errors. In particular, needle slippage can be detected immediately and corrected if necessary.

[0017] It is conceivable that the needle comprises a cylindrical needle bar, in which the needle suction channel and the needle guide wire channel are arranged parallel to each other. A favorable suturing channel passing through the tissue is formed by the cylindrical needle bar.

[0018] Furthermore, it is conceivable that the channels in the needles have the same diameter, which can facilitate the production of the needles.

[0019] However, it is advantageous if the channels in the needle have different diameters. The diameter of the needle suction channel can be smaller than the diameter of the needle guidewire channel. By adapting the diameter of the channel to the purpose, in particular adapting the diameter of the needle guidewire channel to the guidewire diameter, the outer diameter of the needle shaft can be optimized to provide a needle that is as thin as possible and can be positioned particularly precisely at a point in the anatomical space.

[0020] It is conceivable that the needle tip is formed into a sharp cone. In this case, the suction port and the guide wire port can be located on the side surface of the cone, and in particular, each port can be arranged relatively. This realizes that each port is arranged to have the same distance as the far end of the needle tip.

[0021] It has been shown that it is advantageous that the needle tip is formed so that the suction port and the guide wire port are located in a common plane that is inclined relative to the longitudinal axis of the needle. The angle between the longitudinal axis and the inclined plane is an acute angle. This makes it possible to arrange the ports as close as possible.

[0022] Advantageously, the syringe connection is formed as a double connection with two connection branch pipes, wherein the connection branch pipes are arranged transversely to the longitudinal axis and opposite to each other. This structure provides convenience for suction for right-handed and left-handed operators using the puncture device. In addition, the puncture device can be adapted to the body situation or part that must be punctured, for example, if the puncture must be performed at an acute angle to the body. In addition, a valve is preferably provided in each connection branch pipe, which valve is used to close the other connection end to which the syringe is not connected. Thus, it is possible to prevent air from entering the puncture device or the blood vessel and liquid from being discharged from the suction channel.

[0023] It is conceivable that only one syringe connection with a connection branch is provided. The only connection branch can be arranged parallel to the longitudinal axis of the housing distal end, thereby simplifying the channel arrangement in the housing compared to a double connection.

[0024] In addition, it is conceivable that the introduction port has a sheath connection end for the guide wire sheath surrounding the guide wire. Advantageously, the puncture instrument and the guide wire can be prepared together as a unit, thereby improving operation.

[0025] In addition, it is conceivable that the sheath connection end is conical to accommodate the sheath head at the distal end of the guide wire sheath. By the tapered design of the sheath connection end for the sheath head, the arrangement of the guide wire on the puncture instrument is simplified, particularly when wearing gloves.

[0026] In addition, it is conceivable that a positioning portion is provided at or in the sheath connection end, which is used to lock a corresponding positioning portion provided on the guide wire sheath. For example, the positioning portion can be designed as a circumferential groove in the sheath connection end. In addition, it is conceivable that a positioning portion is provided on the housing that is separate from the sheath connection end. This advantageously prevents the sheath head from slipping out of the housing of the puncture device during the puncture process.

[0027] It may be advantageous to provide a seal at the introduction port to prevent air from being sucked into the blood vessel or liquid from escaping from the puncture instrument during the puncture process.

[0028] Advantageously, a second fixing portion different from the sheath connection end is provided on the housing for the guide wire sheath. The second fixing portion is preferably arranged at the proximal end of the housing. By further fixing the guide wire sheath, further improvement in the operation of the puncture instrument can be achieved. In addition, it is conceivable that the second fixing portion is arranged transversely to the longitudinal axis.

[0029] The above object is also achieved by a guide wire assembly, which is used for use with a puncture instrument, in particular for use with the puncture instrument according to the present invention. The guide wire assembly comprises: a guide wire with a guide wire tip, a guide wire sheath surrounding the guide wire, wherein the guide wire sheath has a sheath head at the distal end for connecting to the puncture instrument.

[0030] Advantageously, the guidewire tip of the guidewire may be designed in an atraumatic manner.

[0031] It is advantageous if the sheath head is at least partially formed complementary to the sheath connection end. This facilitates arrangement at the sheath connection end and the sheath head can be arranged sealingly in the sheath connection end so that no liquid can escape from the line channel.

[0032] It is also conceivable that the guide wire is wound in a spiral shape together with the guide wire sheath, and the guide wire windings on the sheath head overlap each other. This winding can improve ergonomics by passing the grip extension through the overlapping guide wires, particularly when the guide wire sheath is arranged on the puncture instrument according to the present invention.

[0033] Advantageously, the sheath head is at least partially conically shaped in order to cooperate with a sheath connection end provided on the puncture instrument.

[0034] It is also conceivable that the sheath head has a corresponding positioning portion for cooperating with a positioning portion arranged on the puncture instrument. The corresponding positioning portion can be designed as an annular flange or a protrusion.

[0035] Advantageously, the guide wire assembly has a fixing portion which is different from the corresponding positioning portion and can cooperate with a second fixing portion on the puncture instrument according to the present invention.

[0036] It has been shown that advantageously, the sheath head has a moving device for moving the guide wire along the longitudinal axis. The moving device can be manually operated by a thumb or another finger, wherein the guide wire is exposed in an area of ​​the sheath head, and can be moved by pressing a finger on the sheath head. Movement can be carried out in the direction of the guide wire mouth, or the guide wire can also be withdrawn. Therefore, the usual advancement by clamping the guide wire between two fingers when moving the guide wire can be omitted. Preferably, the fingers of a hand holding the puncture instrument can be used to advance, so the syringe can be operated with the other hand to aspirate.

[0037] Advantageously, the sheath head has an advancement indicator for displaying the position of the guidewire tip. In the process of preparing the puncture instrument, it is very important to be able to accurately adjust the position of the guidewire tip in the wire channel. The guidewire tip is not visible or otherwise undetectable in the guidewire channel. During insertion, the guidewire tip must not extend from the guidewire port, otherwise it may cause injury. Advantageously, the guidewire tip is accurately positioned in front of the guidewire port to introduce the guidewire tip as quickly as possible by advancing the guidewire a small amount to the anatomical space point. In particular, the design can make two obvious marks overlap when the position of the guidewire tip is exactly at the guidewire port. In order to detect the position of the guidewire tip in the wire channel, a guidewire mark can be set on the guidewire and a corresponding line scale can be set on the sheath head. According to the position of the guidewire tip, the guidewire mark will move on the line scale, allowing the user to quickly detect the position.

[0038] The above object is also achieved by a puncture set, which comprises a puncture instrument according to the present invention, and in particular comprises a guide wire assembly according to the present invention. Advantageously, the puncture set also comprises a dilator, a syringe and a scalpel.

[0039] The above-mentioned purpose is also achieved by a drainage unit for discharging liquid or gas from the body, the drainage unit having an introduction device and a flexible drainage tube, the introduction device having a hollow top and a continuous guide wire channel, wherein the guide wire can pass through the wire channel and the top, and the flexible drainage tube is arranged around the wire channel. The drainage unit is designed to be introduced into the body along the introduced guide wire. In particular, it is advantageous if the guide wire is introduced into the body using a puncture device according to the present invention. The guide wire channel of the introduction device is different from the guide wire channel of the puncture device according to the present invention. The flexible drainage tube can be introduced by the introduction device without widening or forming a body channel by a scalpel and / or a dilator. When the drainage unit is introduced, the top of the introduction device expands / expands the tissue around the guide wire to the diameter of the drainage tube, thereby forming a body channel. The introduction device also supports the flexible drainage tube from the inside to protect it from bending. After introduction, the guide wire and the introduction device are pulled out, so that only the drainage tube remains in the body. Advantageously, the tip is therefore designed to be stable so that the drainage unit can be guided through the tissue, and at the same time to be flexible so that the introduction device can be pushed into the drainage tube and pulled out again. This arrangement allows a flexible drainage tube with a larger inner diameter to be reliably introduced into the anatomical space point. Drainage tubes with a larger inner diameter enable cleaning, for example by suction, in the event of a blockage.

[0040] It has been shown to be advantageous when the tip protrudes over the distal end of the drainage tube and is designed to prevent the introduction device from being withdrawn from the drainage conduit as long as the guide wire is present in the tip. Foreign bodies such as guide wires that are forgotten or lost in the body pose a risk of infection and may cause complications later. Some firmly ingrown foreign bodies are difficult to remove. A tip formed in this way can prevent the guide wire from being forgotten and / or lost in the patient's body. Therefore, the use of such a drainage unit can improve the safety of the patient.

[0041] It is also conceivable that the top of the introduction device is compressible and / or spherical in the radial direction, and the diameter of the top end is increased from the distal end to the proximal direction by the diameter of the guide wire channel along the longitudinal axis at the top end protruding from the channel to the maximum diameter. The diameter of the top end is then reduced to the diameter of the rod portion around the guide wire channel until the transition portion. The maximum diameter of the top end is greater than the inner diameter of the drainage tube. Due to the spherical shape of the top end, the tissue can be stretched as gently as possible during the introduction process, and the introduction device can be introduced through the tissue. Since the diameter of the top end is greater than the inner diameter of the drainage tube, as long as there is a guide wire in the channel of the top end area, the introduction device cannot be pulled out from the drainage tube. Because the guide wire can hinder the compressibility of the top end. Preferably, once the guide wire is removed, the top end can be compressed to the diameter of the wire channel. Advantageously, the top end can at least compress the difference between the maximum diameter and the inner diameter to ensure that the top end and the introduction device pass through the drainage tube. BRIEF DESCRIPTION OF THE DRAWINGS

[0042] Further details and advantageous designs of the present invention can be found in the following description, on the basis of which embodiments of the present invention are described and explained in more detail. Among them:

[0043] Figure 1 A top view of a puncture device having a needle and a housing is shown;

[0044] Figure 2 Show according to Figure 1 A side view of the puncture instrument;

[0045] Figure 3 Show according to Figure 2 A detailed cross-sectional view of the puncture instrument;

[0046] Figure 4 Show Figures 1 to 3 The tip of the needle in

[0047] Figure 5 A side view of a guidewire assembly having a guidewire sheath and a sheath head surrounding the guidewire is shown;

[0048] Figure 6 Show according to Figure 5 A top view of a guide wire assembly;

[0049] Figure 7 Show Figure 5 and Figure 6 The sheath head and Figure 4 A longitudinal cross-sectional view of a needle tip, wherein the guide wire tip of the guide wire is located inside the needle;

[0050] Figure 8 Show according to Figure 7 A view of the tip of the guidewire protruding from the needle tip;

[0051] Fig. 9 Shown arranged according to Figure 1 and Figure 2 The basis of the puncture instrument Figure 5 Guide wire assembly;

[0052] Fig.10 The drainage unit is shown;

[0053] Fig.11 Show according to Fig.10 A drainage unit with a guide wire;

[0054] Figures 12 to 15 Show according to Fig.10 and Fig.11 a distal tip of the drainage unit in different positions;

[0055] Fig.16 A top view showing another embodiment of a puncture instrument having a needle and a housing;

[0056] Fig.17 Show according to Fig.16 A side view of the puncture instrument;

[0057] Fig.18 Show according to Fig.16 and Fig.17 The needle tip;

[0058] Fig.19 Another embodiment of a guide wire assembly is shown;

[0059] Fig. 20 Shown arranged according to Fig.16 and Fig.17 The basis of the puncture instrument Fig.19 A guidewire assembly; and

[0060] Fig.21 Show according to Fig.19 The guide wire assembly and arrangement are based on Fig.16 and Fig.17 The syringe on the puncture instrument. DETAILED DESCRIPTION

[0061] Figure 1 and Figure 2 FIG. 1 shows a puncture device 10 having a needle 12 and a housing 14. The needle 12 includes a cylindrical needle shaft 16 and has a needle tip 20 at its distal end region 18. The needle tip 20 is provided with two ports, namely, a guide wire port 22 and a suction port 24. Figure 3 and Figure 4 The needle 12 also has a relatively blunt proximal end 26 at which the housing 14 is fixedly arranged.

[0062] Housing 14 has an elongated matrix 28, on which an introduction port 30 for guide wire and two syringe connection ends 32a, 32b for connecting syringes are provided. The two syringe connection ends 32a, 32b are surrounded by connection end branches 34a, 34b respectively to improve the stability of the connected syringe (not shown). Syringe connection ends 32a, 32b and connection end branches 34a, 34b are transverse to the longitudinal axis 35 and arranged relative to each other. Thus, the syringe for suction can be arranged in a variable manner on the puncture device 10 according to the situation, and the operation for right-handed people and left-handed people is improved. The elongated matrix 28 is also used as a grip for operating the puncture device 10, wherein the elongated matrix 28 can be made into a circular cross section, for example. However, other shapes or arrangements (not shown) of the gripping recess are also preferred to improve ergonomic design.

[0063] Figure 3A cross-sectional view of the puncture device 10 is shown with a detailed view of the needle tip 20 and the housing 14. A needle suction channel 36 and a needle guide wire channel 38 are arranged inside the needle 12 along the longitudinal axis 35, and the needle suction channel 36 and the needle guide wire channel 38 are also shown in FIG. Figure 4 As shown. A housing part suction channel 40 and a housing part guide wire channel 42 are provided inside the housing 14. The needle part suction channel 36 directly passes into the housing part suction channel 40, and the suction port 24 is connected to the syringe connection end 32a, 32b, so that the connected syringe (not shown) is used for suction during the puncture process. The needle part guide wire channel 38 directly passes into the housing part guide wire channel 42, and the guide wire port 22 at the needle tip 20 is connected to the introduction port 30 in the housing 14. The needle part suction channel 36 and the housing part suction channel 40 jointly form a continuous suction channel 44. The needle part guide wire channel 38 and the housing part guide wire channel 42 jointly form a continuous guide wire channel 46. The entire wire channel 46 and the entire suction channel 44 are formed in the puncture instrument 10, do not cross each other and are independent of each other, so that liquid or gas exchange does not occur between the channel 44 and the channel 46.

[0064] like Figure 3 As shown, the introduction port 30 is formed into a conical shape, so it is convenient to introduce the guide wire. The introduction port 30 is also configured as a sheath connection end 48, so that it can be introduced and fixed. Figure 5 The sheath head 50 of the guide wire assembly 52 shown. In the sheath connection end 48, a positioning portion 54, for example as a circumferential groove, is provided, which cooperates with a corresponding positioning portion 56 on the sheath head 50 to lock. Thus, the guide wire assembly 52 can be securely arranged and fastened to the puncture instrument 10.

[0065] The introduction port 30 and the sheath connection end 48 are arranged in a sleeve 57, and the sleeve 57 is arranged at an angle α to the longitudinal axis 35 on the housing 14. The range of angle α can be 10° to 45°, in particular 20° to 30°. The sleeve 57 is arranged in the connection area between the proximal end 26 of the needle 12 and the housing 14. Therefore, the sleeve 57 is arranged between the needle tip 20 and the connection end branches 34a, 34b. This achieves a compact and ergonomic design of the puncture instrument 10. The guide wire channel 42 of the housing part extends partially in the sleeve 57, and therefore forms an angle α with the longitudinal axis 35. In the sleeve 57, the sleeve connection end 48 expands conically until it at least reaches the width b (b) of the elongated base 28 as much as possible. Figure 1 ).

[0066] The housing part suction channel 40 extends in the housing 14 parallel to the longitudinal axis 35 until it branches into two channels (not shown) in each case towards the respective syringe connection 32 a , 32 b .

[0067] Figure 4The distal region 16 of the needle 12 with the needle tip 20 is shown in detail in a cross-sectional view. It can be clearly seen here that the suction port 24 and the guide wire port 22 are located in a plane 59 extending obliquely relative to the longitudinal axis 35. The ports 22, 24 are open in the distal direction toward the needle tip 20 so that they are as close to each other as possible. It is more obvious that the channels 36, 38 in the needle have different diameters A, D, respectively. The corresponding diameters A, D are respectively suitable for the corresponding channels 36, 38 and their purposes. For example, the diameter A of the suction channel 36 can be smaller than the diameter D of the wire channel 38. The diameter D must be large enough so that the guide wire with a diameter d can be freely pushed through the wire channel 38 ( Figure 7 ).

[0068] Figure 5 A guidewire assembly 52 is shown. The guidewire assembly 52 comprises a helically wound guidewire 58 surrounded by a guidewire sheath 62. The guidewire has a guidewire diameter d and a guidewire tip 60 of a non-invasive design and a guidewire sheath 62 surrounding the guidewire 58. At the distal end 64 of the guidewire sheath 62, a sheath head 50 is arranged, which is configured to be connected to the sheath connection end 48 of the puncture instrument 10. To this end, the sheath head 50 has a tapered portion 66 at its distal end, which has a circumferential protrusion as a corresponding positioning portion 56 opposite to the positioning portion 54. Therefore, when the sheath head 50 is introduced into the sheath connection end 48 of the puncture instrument 10, the circumferential protrusion snaps into the circumferential groove of the positioning portion 54.

[0069] In addition, the guide wire sheath 62 has a second fixing portion 68, which can be fixed to the proximal end 69 of the housing 14 (see Figure 1 ). For this purpose, matching threads can be provided at the proximal end 69 and the fixing portion 68 of the housing 14. Alternatively, the fixing portion 68 can be attached to the proximal end 69 and snapped into place for fixing. By fixing the guide wire assembly 52 in the second position on the puncture device 10 during puncture, a particularly safe operation can be ensured, in particular during the puncture process. The guide wire assembly 52 arranged on the puncture device 10 can now be used as a grip extension. For this purpose, the guide wire windings are stacked on top of each other in the region of the distal end 64.

[0070] like Figure 5 and Figure 6 As shown, a moving device 70 for moving the guide wire 58 is provided on the sheath head 50 , and the moving device 70 has an integrated advancement indicator 72 .

[0071] Figure 7 and Figure 8The functions of the moving device 70 and the advancing indicator 72 for displaying the position of the guide wire tip 60 are shown. For this purpose, the sheath head 50 and the needle tip 20 are shown in a cross-sectional view with the guide wire 58 and the guide wire tip 60. The sheath head 50 is arranged in the sheath connection end 48, and the guide wire 58 is introduced into the introduction port. For the sake of clarity, the illustration of the housing 14 is omitted.

[0072] In the embodiment shown in the drawings, the guide wire is freely guided on the advancement indicator 72, wherein a plurality of spacing marks 74 are provided on the advancement indicator 72. One spacing mark 76 of the plurality of spacing marks is particularly highlighted, which can be achieved, for example, by color or by a ridge of the spacing mark 76. The guide wire 58 located on the advancement indicator 72 also has a guide wire mark 78. When the guide wire tip 60 located in the needle guide wire channel 38 is positioned just before the guide wire opening 22, the position of the guide wire mark 78 on the guide wire 58 is selected to coincide with the highlighted spacing mark 76. The guide wire tip 60 positioned just before the guide wire opening 22 is as shown in FIG. Figure 7 shown.

[0073] In order to push the guide wire tip 60 out of the guide wire channel, as shown in FIG. Figure 8 As shown, the guide wire 58 in the moving device 70 is pushed toward the distal end of the sheath head 50 with a finger (particularly with a thumb). This also causes the position of the guide wire marker 78 to move in the distal direction, wherein the guide wire tip 60 is pushed out along a path away from the needle guide wire channel 38, and the guide wire marker 78 moves away from the spacing mark 76 along the path. The position of the guide wire marker 78 can be adjusted according to the length and purpose of the needle 12 of the puncture instrument 10. It is also conceivable to adjust the position of the spacing mark 76 highlighted on the sheath head 50.

[0074] By using the moving device 70, the guide wire tip 60 can be introduced into the anatomical space point in a controlled manner. Due to the advancement indicator 72 having the spacing mark 76 and the guide wire mark 78, the distance that the guide wire tip 60 is actually introduced into the puncture space can also be estimated. On the one hand, the advancement of the guide wire 58 is simplified, and on the other hand, it is safer.

[0075] Fig. 9 A complete set 80 consisting of a guide wire assembly 52 arranged on a puncture device 10 is shown. The puncture device 10 is prepared for puncture together with the guide wire assembly 52; only the syringe still needs to be placed on one of the syringe connection ends 32a, 32b. Therefore, the puncture device 10 and the guide wire assembly 52 form a complete set 80, which allows the guide wire tip 60 to be reliably introduced into the anatomical space point by puncture. The complete set 80 can also be expanded by a scalpel, a syringe and a dilator (not shown).

[0076] exist Fig.10 and Fig.11 in and Figures 12 to 15 In the detailed view of FIG. 1 , a drainage unit 100 is shown having a drainage tube 102 and an introduction device 104. The drainage tube 102 has an inner diameter i and is partially arranged around the introduction device 104. The drainage unit 100 is particularly configured to be introduced into an anatomical space point along a guide wire 58 introduced through the puncture instrument 10.

[0077] The introduction device 104 includes a hollow top 106, a continuous guide wire channel 108 for the guide wire 58, and a grip 110. The diameter d' of the guide wire channel 108 is greater than the guide wire diameter d to achieve the degree of freedom of the introduced guide wire 58. The top 106 is spherical and compressible, and has a maximum outer diameter s greater than the inner diameter i in the uncompressed normal state. The top is squeezed to a normal state with a diameter of s after being compressed. When the introduction device 104 is introduced into or pulled out of the drainage tube 102, the top 106 is always compressed.

[0078] Fig.10 The drainage unit 100 is shown without the guide wire 58. Fig.11 Shown is a drainage unit 100 with a guide wire 58 introduced into a channel 108. The drainage tube 102 has a distal end 112 and a proximal end 114. The distal end 112 is formed to be blunt to avoid damage and also facilitate introduction into the body. In the introduced state, the top 106 protrudes beyond the distal end 112.

[0079] Fig.12 Shows Fig.10 Detailed view of the top 106 in FIG. The top 106 has a guide wire opening with a diameter of d' at the distal end 115. In addition, the top 106 has a transition portion 116 to a shaft 118 surrounding the guide wire channel 108 and an intermediate region 119. In the intermediate region 119, the top 106 has a maximum diameter s. For the compressibility of the top 106, a solid joint not shown can be provided at the transition portion 116 from the top 106 to the shaft 118 of the introduction device 104. The top 106 is compressible only in the radial direction, and at the same time it is very stable, so that when introduced into the body, it can expand the tissue around the guide wire into a body channel, so that the entire drainage unit 100 can be introduced.

[0080] After the drainage unit 100 is introduced into the body along the guide wire, in order to drain the liquid or gas from the body, the introduction device 104 must be pulled out from the drainage tube 102. However, the introduction device 104 can only be pulled out if at least the guide wire 58 is removed from the top 106. Since the diameter s of the top 106 is greater than the inner diameter i of the drainage tube 102, the top 106 must be compressed accordingly, and the top can only be compressed to the size d' of the guide wire channel 108.

[0081] like Fig.13 and Fig.14 As shown, with the guidewire 58 introduced, the tip 106 can be compressed to below dimension i. Fig.14 In the embodiment of the present invention, the introduction device 104 is attempted to be pulled out from the drainage tube 102. Therefore, the top end 106 is compressed to a dimension s', which is still greater than the dimension i, thereby preventing the introduction device 104 from being pulled out.

[0082] exist Fig.15 In the embodiment, there is no guide wire 58 in the guide wire channel 108. Therefore, while the top 106 is compressed to the size s", the introduction device 104 can be pulled out of the drainage tube 102. It can be seen that to pull out the top 106, it must be compressed to at least the size d' of the guide wire channel.

[0083] The following relationships should apply to the dimensions of the introduction device 104 and the drainage tube 102:

[0084] s"=s-d' <i,

[0085] Where s>i and s'>i.

[0086] In order to compress the top end 106 when the drainage tube 102 is introduced or pulled out, preferably, the top end 106 is grooved (not shown) in addition or in place of the solid joint. The groove can be designed so that the top end 106 is halved, one-third or one-quartered in the top view from the distal direction. The length of the groove can be from the distal end 115 to the transition portion 116. Alternatively, the top end 106 at the distal end 115 can be formed continuously to ensure better guidance along the guide wire 58 when the drainage unit 100 is introduced. The groove can be formed in the intermediate area 119 between the distal end 115 and the transition portion 116. The length and depth of the groove should be designed to meet the compression characteristics of the top end 106. This design of the drainage unit 100 with the introduction device 104 including the top end 106 ultimately prevents the unintentional and undesirable stay or loss of the guide wire 58 in the patient's body.

[0087] Fig.16 and 17 Another embodiment of a puncture device 200 is shown. The above-mentioned parts are marked with corresponding reference numbers. The puncture device 200 is similar to the puncture device 10 and has a needle 12 and a housing 14, wherein the needle 12 is connected to the housing at its distal end 26. Similarly, the introduction port 30 for the guide wire 58 with the sheath connection end 48 is shown. The difference between the puncture device 200 and the puncture device 10 can be seen in that the needle tip 202 (such as the puncture device 10) is designed in a different way. Fig.18), a single syringe connection end 204 and a different second fixing part 206. The single syringe connection end 204 is connected to the suction channel (not shown here) and is surrounded by a connection end branch 208. The syringe connection end 204 and the connection end branch 208 are arranged at the proximal end 69 of the housing 14 and parallel to the longitudinal axis 35. The housing part suction channel 40 extends in the housing 4 parallel to the longitudinal axis 35 until the syringe connection end 204.

[0088] The second fixing part 206 is arranged beside the housing 14 and transversely to the longitudinal axis 35. The second fixing part 206 has a ball 210 as a fixing means for a complementary fixing part 212 of a guide wire assembly 216, such as Fig.19 In addition to the second fixing portion 206, another fixing portion (not shown) may be provided on the opposite side of the housing, or the fixing portion 206 may be arranged on the left side of the housing ( Fig. 20 ), so that the guide wire assembly 216 can be arranged on the right or left side of the housing and fixed to allow maximum flexibility in puncture.

[0089] Fig.18 The needle tip 202 designed as a pointed cone is shown in detail. It can be seen here that the guide wire port 22 and the suction port 24 are arranged on the side 214 of the pointed cone-shaped needle tip 202.

[0090] Fig.19 Another embodiment of a guide wire assembly 216 is shown, which is particularly designed for use with the puncture device 200. The guide wire assembly 216 includes: a guide wire 58 having a guide wire tip 60 surrounded by a guide wire sheath 62 and a sheath head 50. As in the embodiment of the guide wire assembly 52 described previously, a moving device 70 and an advancement indicator 72 having the same functions and operations are arranged on the sheath head 50. The fixing portion 212 is arranged at the proximal end of the sheath head 50 to cooperate with the second fixing portion 206 arranged on the side of the puncture device 200.

[0091] Fig. 20 The complete set 218 consisting of the guide wire assembly 216 and the puncture instrument 200 is shown. As can be seen here, the guide wire assembly 216 is arranged beside the housing 14 and fixed at the second fixing part 206.

[0092] Fig.21 The puncture instrument 200 is shown ready for puncture, along with a guidewire assembly 216 and a syringe 220 disposed at the syringe connection end 204 .

Claims

1. A puncture instrument (10, 200) for introducing a guide wire tip (60) of a guide wire (58) into an anatomical space point, the puncture instrument (10, 200) comprising: A needle (12), the needle (12) comprising: a distal needle tip (20, 202) having an aspiration port (24), a proximal end (26), and a needle aspiration channel (36) extending along a longitudinal axis (35); and a housing (14) on which the proximal end (26) of the needle (12) is arranged, The housing (14) has a syringe connection end (32a, 32b, 204) for a syringe (220) and an introduction port (30) for the guide wire (58) formed separately from the syringe connection end (32a, 32b, 204). The housing (14) comprises a housing suction channel (40) which leads into the syringe connection end (32a, 32b, 204) and a housing guide wire channel (42) which is formed separately from the housing suction channel (40), and the housing guide wire channel (42) is connected to the introduction port (30). It is characterized in that The needle suction channel (36) directly leads into the housing suction channel (40). The needle (12) has a second needle guide wire channel (38) formed separately from the needle suction channel (36), the second needle guide wire channel (38) connects the housing guide wire channel (42) with the guide wire port (22), and the guide wire port (22) is formed separately from the suction port (24) and is arranged at the needle tip (20, 202).

2. The puncture instrument (10, 200) according to claim 1, characterized in that: The needle (12) comprises a cylindrical needle shaft (16), and the needle suction channel (36) and the needle guide wire channel (38) are arranged parallel to each other in the needle shaft (16).

3. The puncture instrument (10) according to any one of the preceding claims, characterized in that The needle tip (20) is formed such that the suction port (24) and the guide wire port (22) are located in a plane (59) that is inclined relative to the longitudinal axis (35) of the needle (12).

4. The puncture instrument (10) according to any one of the preceding claims, characterized in that The syringe connection (32a, 32b) is formed as a double connection with two connection branch pipes (34a, 34b), wherein the connection branch pipes (34a, 34b) are arranged transversely to the longitudinal axis (35) and opposite to each other.

5. The puncture instrument (10, 200) according to any one of the preceding claims, characterized in that The introduction port (30) has a sheath connection end (48) for a guide wire sheath (62) surrounding the guide wire (58).

6. The puncture instrument (10, 200) according to any one of the preceding claims, characterized in that The sheath connection end (48) is conical so as to accommodate a sheath head (50) disposed at the distal end (64) of the guide wire sheath (62).

7. The puncture instrument (10, 200) according to any one of the preceding claims, characterized in that A positioning portion (54) is provided at or in the sheath connection end (48), and the positioning portion (54) is used to lock a corresponding positioning portion (56) provided on the guide wire sheath (62).

8. The puncture instrument (10, 200) according to any one of the preceding claims, characterized in that On the housing (14), a second fixing portion (68, 206) different from the sheath connecting end (48) is provided for the guide wire sheath (62).

9. A guide wire assembly (52, 216) for use with a puncture device (10, 200), in particular for use with a puncture device (10, 200) according to any one of the preceding claims, the guide wire assembly (52, 216) comprising: A guidewire (58) having a guidewire tip (60), and a guidewire sheath (62) surrounding the guidewire (58), wherein the guidewire sheath (62) has a sheath head (50) at a distal end (64) for connecting to the puncture instrument (10).

10. The guide wire assembly (52, 216) according to claim 9, characterized in that: The sheath head (50) is at least partially formed into a conical shape so as to cooperate with a sheath connection end (48) provided on the puncture instrument (10, 200).

11. The guide wire assembly (52, 216) according to claim 9 or 10, characterized in that: The sheath head (50) has a corresponding positioning portion (56), and the corresponding positioning portion (56) is used to cooperate with a positioning portion (54) arranged on the puncture instrument (10, 200).

12. The guide wire assembly (52, 216) according to any one of claims 9 to 11, characterized in that: The sheath head (50) has a moving device (70) for moving the guide wire (58) along the longitudinal axis (35).

13. The guide wire assembly (52, 216) according to any one of claims 9 to 12, wherein: The sheath head (50) has an advancement indicator (72) for displaying the position of the guide wire tip (60).

14. A puncture set (80, 218), comprising the puncture instrument (10, 200) according to any one of claims 1 to 8, and in particular comprising a guide wire assembly (52, 216) according to any one of claims 9 to 13.

15. A drainage unit (100) for draining liquid or gas from a body, comprising an introduction device (104) and a flexible drainage tube (102), wherein the introduction device (104) has a hollow top end (106) and a continuous guide wire channel (108), wherein: The guide wire (58) can pass through the guide wire channel (108) and the top end (106), and the flexible drainage tube (102) is arranged around the guide wire channel (108).

16. The drainage unit (100) according to claim 15, characterized in that: The tip (106) protrudes from the distal end (112) of the drainage tube (102) and is designed to prevent the introduction device (102) from being withdrawn from the drainage tube (102) as long as the guide wire (58) is present in the tip (106).

17. The drainage unit (100) according to claim 15 or 16, characterized in that: The top end (106) of the introduction device (104) is compressible in the radial direction and is formed into a spherical shape, wherein the diameter of the top end (106) increases from the diameter (d') of the guide wire channel (108) along the longitudinal axis from the distal end (115) toward the proximal end to a maximum diameter (s), and until the transition portion (116) is reduced to the diameter of the rod portion (118) surrounding the guide wire channel (108), wherein the maximum diameter (s) of the top end (106) is greater than the inner diameter (i) of the drainage tube (102).

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