CN119894565A

CN119894565A - Puncture instrument, guide wire assembly for puncture instrument, medical complete equipment consisting of puncture instrument and guide wire assembly, and drainage unit

Info

Publication number: CN119894565A
Application number: CN202380064315.XA
Authority: CN
Inventors: 哈尼·阿尔-卡赞
Original assignee: Individual
Current assignee: Individual
Priority date: 2022-07-07
Filing date: 2023-07-07
Publication date: 2025-04-25
Also published as: WO2024008915A3; DE102022116995A1; WO2024008915A2

Abstract

The invention relates to a puncture device (10, 200) for introducing the guide wire tip (60) of a guide wire into an anatomical space point. The puncture device (10) comprises a needle (12), which comprises: a distal needle tip (20, 202) with a suction port (24), a proximal end (26) and a needle suction channel (36) extending along a longitudinal axis (35). In addition, 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 port (30) for a guide wire (58). In addition, the housing (30) has a housing suction channel (40) that leads into the syringe connection end (32a, 32b, 204) and a housing guide wire channel (42) that is formed separately from the housing suction channel (40) and is connected to the introduction port (30).

Description

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

Technical Field

The present invention relates to a piercing instrument for introducing a guide wire tip of a guide wire to an anatomical space point, in particular a guide wire assembly for use with a piercing instrument, and a kit having a piercing instrument and a guide wire assembly. The invention also relates to a drainage unit.

Background

In the medical field, penetration is the targeted placement of a needle into the body. Puncturing allows blood, tissue and fluid samples to be collected, followed by laboratory examination, and injection of fluids into the body, such as vaccines. Puncture is also used to place catheters into blood vessels or organs.

The Seldinger (Seldinger) technique is a method for puncturing blood vessels to place catheters and for puncturing arterial and central venous access.

First, puncturing is performed with a puncture needle disposed on a syringe. The needle penetrates the skin of the patient to penetrate the area to be penetrated. Aspiration is then performed, i.e. the syringe is first withdrawn, thereby creating a negative pressure in the needle passage. Success of penetration may be confirmed by blood or other bodily fluids flowing through the needle into the syringe during aspiration. The liquid is visible 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 through the puncture needle into the point of the anatomical space being punctured. The needle is then withdrawn over the guidewire and removed. The catheter or drainage tube may then be advanced over the guidewire until reaching the anatomical point at the tip of the guidewire. The diameter of the catheter and the drainage tube is typically small, only slightly exceeding the diameter of the guide wire. After pushing in the catheter or the drainage tube, the guide wire is withdrawn from the catheter or the drainage tube, wherein the distal end of the catheter or the drainage tube is kept at the anatomical space point. The proximal end of the catheter or drain tube may be secured to the patient's skin.

One difficulty with puncturing the blood vessel is that after puncturing and prior to pushing the guidewire, blood flows through the puncture needle and out under high vascular pressure. The gushing blood pollutes the environment and may also pose a risk of infection. In case of low vascular pressure, there is a risk of air embolism for the patient.

Other complications may result from puncture errors. In this case, the tip of the puncture needle is not located at the desired anatomical point, for example in a blood vessel, but for example in subcutaneous adipose tissue, connective tissue or another blood vessel. In the event of a puncture failure, the nerve or organ may also be damaged, resulting in further damage.

The needle may also damage the target vessel at anatomical points in space, and bleeding may occur, particularly during arterial puncture. Bleeding may not initially be found, but rather is manifested by hemodynamic instability after hours. When the needle or guidewire is advanced, the vessel wall may fracture and the catheter may be advanced within the vessel wall.

Furthermore, the needle may slip, especially when the syringe is pulled off the connection or the guide wire is introduced into the needle. Because of needle slippage, it is often necessary to re-attempt the penetration, which can introduce additional penetration ports and new hazards. Previously created puncture ports are also at risk of bleeding and infection.

As previously described, a drainage tube for draining fluid from the body can be introduced through the introduced guide wire. Drainage tubes with smaller inside diameters may become clogged, even if there is still liquid to be drained, wherein the blockage tends to be unable to clear. The blocked drainage tube must then be removed and replaced, in which case there is a risk of infection, among other things. Drainage tubes with larger inner diameters may be used for aspiration to clear the blockage. When pushing in a larger diameter drainage tube, it is often necessary to dilate the tissue surrounding the guide wire into the body passageway in advance. This expansion is accomplished with the aid of a dilator and/or a scalpel. This procedure and the resulting tissue damage in turn present additional risks to the patient. In creating and expanding a body passage for a drainage tube, the guidewire may accidentally pull out or slip off, thereby failing to bring the drainage tube to the desired anatomical point. Furthermore, there are problems in introducing a large diameter drainage tube along an implanted guidewire without forming a body passageway. When the drainage tube is introduced, the drainage tube body itself may bend, whereby the subsequent discharge of liquid cannot be ensured.

EP 603,245 b1 discloses a puncture needle device with two connections for introducing a catheter into a blood vessel.

From EP 0 641 571 B1 a venipuncture cannula having the features of the preamble of claim 1 is known. The venipuncture cannula is for catheter placement and has a puncture needle with a Y-shaped connector 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 such a venipuncture cannula, the guide wire tip may be introduced to the anatomical space point according to the procedure described above. Advantageously, based on these two sockets, it is not necessary to remove the syringe before pushing in the guide wire. This reduces the risk, because on the one hand the needle will not slide when the syringe is removed, and on the other hand there is no open connection where blood can escape from the needle or air can be sucked into the blood vessel. The time required to introduce the tip of the guide wire may also be somewhat reduced, and the risk of injury due to the intracorporeal indwelling needle may also be reduced. The disadvantage is that the guide wire can only be pierced when the puncture needle is introduced. When holding the provided guide wire and subsequently introducing the insertion opening, the puncture needle is still slid or pulled out by the unavoidable grip variation just as with the simple needle described above. This in turn carries the above-mentioned risks.

Disclosure of Invention

The object of the invention is to improve the safety of the patient during the penetration to introduce the guide wire and during the pushing in of the drainage tube.

This object is achieved in particular by a puncture instrument for introducing a guide wire tip of a guide wire into an anatomical space point according to claim 1. To this end, the lancing apparatus includes a needle having a distal tip with a aspiration port, a proximal end and a needle aspiration channel extending along a longitudinal axis. In addition, a housing is provided on which the proximal end of the needle is disposed. The housing has a syringe connection end for a syringe and an introduction port for a guide wire separately formed from the syringe connection end. The housing further has a housing part suction channel which opens into the syringe connection and a housing part guide wire channel which is formed separately from the housing part suction channel and is connected to the introduction opening. It is further provided that the needle suction channel opens directly into the housing suction channel, and that the needle has a second needle thread guide channel formed separately from the needle suction channel, which connects the housing thread guide channel with a thread guide opening provided at the needle tip separately from the suction opening.

Thus, two channels, namely, a suction channel and a guide wire channel, are formed in the lancing device, which are continuously separated from each other in the housing and the needle without crossing points, so that no liquid or gas exchange occurs between the channels in the lancing device. Whereby the lancing device can be prepared prior to lancing (i.e., prior to the needle piercing the patient's skin). In this case, the guide wire may be introduced into the guide wire channel through the introduction channel of the housing, and the guide wire tip may be pushed at or immediately before the guide wire port of the needle without the guide wire tip protruding from the guide wire port. In addition, the syringe may be connected to the syringe connection end and remain disposed on the lancing device throughout the lancing process.

To introduce the guide wire tip, a needle is inserted through the skin of the patient into the area to be penetrated. At the same time, suction is applied through the suction channel using a syringe. Once suction is determined to be successful, the guidewire may be advanced with the guidewire tip extending from the guidewire port. The penetrating instrument may then be withdrawn from the body through the guidewire, with the guidewire tip held at the anatomical point. The puncture device prepared in this way can be introduced into the tip of the guide wire in a few seconds by a few simple operations. Compared with the prior art, some steps can be omitted. In particular, when the needle remains in the body, there is no need to switch the grip to grasp and introduce the guide wire. Since the guide wire tip of the guide wire can already be positioned in the region of the guide wire orifice during preparation, only a small amount of guide wire advancement is required to push the guide wire tip out of the guide wire orifice and introduce it into the desired anatomical site. According to the prior art, the guide wire must always be pushed through the entire needle and cannot be introduced into the needle before puncturing. In contrast, with the lancing device of the present invention, the total time required to puncture with the lancing device can be reduced to several seconds. By reducing the time the needle stays in the body, the risk of injury can be reduced and the safety of the patient during penetration can be improved.

Another advantage of the present invention is that aspiration can be safely and reliably performed at any time during the penetration through an aspiration channel formed separately from the wire channel, despite the presence of a syringe at the syringe connection end and despite the presence of a guidewire in the wire channel. Therefore, the position of the needle tip can be controlled continuously, and also can be controlled in the wire feeding process so as to avoid puncture errors. In particular, the sliding of the needle can be detected immediately and corrected if necessary.

It is conceivable that the needle comprises a cylindrical needle shaft in which the needle suction channel and the needle guide wire channel are arranged parallel to each other. An advantageous suture channel is formed through the tissue by a cylindrical waste human needle shaft.

Furthermore, it is conceivable that the channels in the needle have the same diameter, which may facilitate the manufacture of the needle.

Advantageously, however, the passages in the needle have different diameters. The diameter of the needle aspiration channel may be smaller than the diameter of the needle guidewire channel. By adapting the diameter of the channel according to the purpose, in particular adapting the diameter of the needle guide wire channel to the guide wire diameter, the outer diameter of the needle shaft can be optimized to provide a needle which can be positioned as thin as possible to the anatomical point with particular precision.

It is conceivable that the needle tip is formed in a pointed cone shape. In this case, the suction opening and the guide wire opening may be located on the side surface of the cone, and in particular, the openings may be arranged oppositely. This achieves that the ports are arranged at the same distance from the distal end of the needle tip.

It has proven advantageous if the needle tip is formed such that the suction opening and the guide wire opening lie in a common plane which is inclined with respect to the longitudinal axis of the needle. The included 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.

Advantageously, the syringe connection is formed as a double connection with two connection branches, wherein the connection branches are arranged transversely to the longitudinal axis and opposite to each other. This configuration provides aspiration convenience for right-handed and left-handed operators using lancing devices. Furthermore, the lancing apparatus can be adapted to the condition or site of the body that must be lanced, for example, if the lancing must be performed at an acute angle to the body. Furthermore, a valve is preferably provided in each connection branch for closing the other connection to which the syringe is not connected. Thus, air can be prevented from entering the lancing device or vessel, and fluid can be expelled from the aspiration channel.

It is conceivable to provide only one syringe connection with a connection branch. The single connector branch may be arranged parallel to the longitudinal axis of the distal end of the housing, thereby simplifying the arrangement of channels within the housing compared to a double connector.

Furthermore, it is conceivable for the introduction opening to have a sheath connection for a guide wire sheath surrounding the guide wire. In this way, the puncturing device can advantageously be prepared as a unit with the guide wire, so that the handling is improved.

Furthermore, it is conceivable that the sheath connection end is conical for accommodating a sheath head arranged at the distal end of the guide wire sheath. By the conical design of the sheath connection for the sheath head, the arrangement of the guide wire on the puncturing device, in particular when wearing gloves, is simplified.

Furthermore, it is conceivable to provide a detent at or in the sheath connection end for locking a corresponding detent provided on the guide wire sheath. For example, the positioning portion may be designed as a circumferential groove in the jacket connection end. Furthermore, it is conceivable to provide a positioning portion on the housing separate from the sheath connection end. This advantageously prevents the sheath head from sliding out of the housing of the lancing device during lancing.

It may be advantageous to provide a seal at the inlet. This prevents air from being sucked into the blood vessel or fluid from escaping from the lancing device during lancing.

Advantageously, a second fastening part is provided on the housing for the guide wire sheath, which part is different from the sheath connection end. The second fixation portion is preferably arranged at the proximal end of the housing. Further improvements in the operation of the lancing apparatus can be achieved by further securing the guidewire sheath. Furthermore, it is conceivable for the second fastening part to be arranged transversely to the longitudinal axis.

The above object is also achieved by a guidewire assembly for use with a lancing device, in particular for use with a lancing device according to the present invention. The guidewire assembly includes a guidewire having a guidewire tip, a guidewire sheath surrounding the guidewire, wherein the guidewire sheath has a sheath head at a distal end for connection to a penetration instrument.

Advantageously, the guide wire tip of the guide wire can be designed in a non-invasive manner.

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

It is also conceivable that the guide wire is wound in a spiral together with the guide wire sheath and that the guide wire windings on the sheath head overlap each other. The winding in this way may improve the ergonomics by passing the grip extensions through the guide wires overlapping each other, especially when the guide wire sheath is arranged on the puncturing device according to the invention.

Advantageously, the sheath head is at least partially conically shaped so as to co-act with a sheath attachment end provided on the lancing device.

It is also conceivable that the sheath head has a corresponding positioning portion for co-acting with a positioning portion provided on the piercing instrument. The corresponding positioning portion may be designed as an annular flange or a projection.

Advantageously, the guide wire assembly has a different fixation than the corresponding positioning portion, which fixation can co-act with a second fixation on the lancing device according to the present invention.

It has proven advantageous if the sheath head has a displacement device for displacing the guide wire along the longitudinal axis. The movement means may be operated manually by a thumb or another finger, wherein the guide wire is exposed in an area of the sheath head and may be moved by pressing only one finger against the sheath head. The movement may be in the direction of the guidewire port or the guidewire may be withdrawn. Therefore, the usual advance by sandwiching the guide wire between two fingers when moving the guide wire can be omitted. Preferably, the pushing may be performed with a finger of one hand holding the lancing device, and thus the aspiration may be performed by operating the syringe with the other hand.

Advantageously, the sheath head has an advance indication for displaying the position of the tip of the guide wire. In preparing the penetrating instrument, it is important that the position of the tip of the guidewire in the wire channel can be precisely adjusted. The guide wire tip is not visible or otherwise detectable in the guide wire channel. The tip of the guidewire must not protrude from the guidewire port during penetration, which could otherwise cause injury. Advantageously, the guide wire tip is positioned precisely in front of the guide wire orifice to introduce the guide wire tip as soon as possible by advancing the guide wire a small amount to the anatomical site. In particular, the design may be such that when the position of the tip of the guide wire is located exactly at the guide wire orifice, the two distinct markings overlap. In order to detect the position of the tip of the guide wire in the wire channel, a guide wire mark can be provided on the guide wire and a corresponding line scale can be provided on the sheath head. According to the position of the top end of the guide wire, the guide wire mark can move on the online graduated scale, so that a user can quickly detect the position.

The above object is also achieved by a lancing kit comprising a lancing device according to the present invention and in particular comprising a guide wire assembly according to the present invention. Advantageously, such a penetration kit further comprises a dilator, a syringe and a scalpel.

The above object is also achieved by a drainage unit for draining liquid or gas from a body, having an introduction device with a hollow tip and a continuous guide wire channel, wherein the guide wire can be passed through the wire channel and the tip, and a flexible drainage tube arranged around the wire channel. The drainage unit is designed for introduction into the body along an introduced guide wire. In particular, it is advantageous if a guide wire is introduced into the body using a puncturing device according to the invention. The guide wire channel of the introduction device differs from the guide wire channel of the puncturing device according to the invention. The flexible drainage tube can be introduced by the introduction device without widening or creating a body passage by the scalpel and/or the dilator. When the drainage unit is introduced, the tip of the introduction device expands/dilates the tissue surrounding the guide wire to the diameter of the drainage tube, thereby forming a body passageway. The introduction device also internally supports the flexible drain tube to protect it from flexing. After introduction, the guidewire and the introduction device are withdrawn so that only the drainage tube remains in the body. Thus, it is advantageous that the tip is designed to be stable so that the drainage unit can be guided through the tissue, while at the same time it is designed 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 large inner diameter to be reliably introduced into anatomical points of space. The larger inner diameter draft tube allows cleaning in case of clogging, for example by aspiration.

It has proven advantageous when the tip protrudes over the distal end of the drainage tube and is designed to prevent the extraction of the introduction device from the drainage tube as long as a guide wire is present in the tip. Foreign bodies, such as guide wires, left or lost in the body are at risk of infection and may cause later complications. Some of the firmly grown foreign matter is difficult to remove. The tip formed in this manner may prevent the guidewire from being forgotten and/or lost within the patient. Thus, the use of such a drainage unit may improve patient safety.

It is also conceivable that the tip of the introduction device is compressible and/or spherical in the radial direction, the diameter of the tip increasing from the diameter of the guide wire channel at the tip protruding from the channel in the longitudinal axis from the distal end to the maximum diameter in the proximal direction. The diameter of the tip then reduces until the transition portion reduces to the diameter of the shaft portion surrounding the guidewire channel. The maximum diameter of the top end is larger than the inner diameter of the drainage tube. Due to the spherical shape of the tip, 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 tip is larger than the inner diameter of the drainage tube, the introduction device cannot be pulled out of the drainage tube as long as a guide wire is present in the passage in the tip region. Because the guide wire may interfere with the compressibility of the tip. Preferably, once the guidewire is removed, the tip may be compressed to the diameter of the wire channel. Advantageously, the tip is at least compressible by the difference between the maximum diameter and the inner diameter to ensure that the tip and the introduction device pass through the drain tube.

Drawings

Further details and advantageous embodiments of the invention can be taken from the following description, on the basis of which embodiments of the invention are described and explained in more detail. Wherein:

FIG. 1 shows a top view of a lancing device having a needle and a housing;

FIG. 2 shows a side view of the lancing apparatus according to FIG. 1;

FIG. 3 shows a detailed cross-sectional view of the lancing apparatus according to FIG. 2;

fig. 4 shows the tip of the needle of fig. 1 to 3;

fig. 5 shows a side view of a guidewire assembly having a guidewire sheath surrounding a guidewire and a sheath head;

fig. 6 shows a top view of the guide wire assembly according to fig. 5;

fig. 7 shows a longitudinal cross-sectional view of the sheath head of fig. 5 and 6 and the needle tip of fig. 4, with the guidewire tip of the guidewire positioned within the needle;

FIG. 8 shows a view of the guide wire tip according to FIG. 7 extending from the needle tip;

FIG. 9 shows the guidewire assembly according to FIG. 5 disposed on the lancing apparatus according to FIGS. 1 and 2;

Fig. 10 shows a drainage unit;

fig. 11 shows the drainage unit according to fig. 10 with a guide wire;

fig. 12 to 15 show the distal tip of the drainage unit in different positions according to fig. 10 and 11;

FIG. 16 illustrates a top view of another embodiment of a lancing apparatus having a needle and a housing;

FIG. 17 shows a side view of the lancing apparatus according to FIG. 16;

fig. 18 shows a needle tip according to fig. 16 and 17;

fig. 19 shows another embodiment of a guidewire assembly;

FIG. 20 shows the guide wire assembly according to FIG. 19 arranged on the lancing apparatus according to FIGS. 16 and 17, and

Fig. 21 shows the guide wire assembly according to fig. 19 and a syringe arranged on the puncturing device according to fig. 16 and 17.

Detailed Description

A lancing device 10 having a needle 12 and a housing 14 is shown in FIGS. 1 and 2. The needle 12 includes a cylindrical shaft 16 having a needle tip 20 at a distal end region 18 thereof. The needle tip 20 is provided with two ports, namely a guidewire port 22 and a aspiration port 24, as shown in detail in figures 3 and 4. The needle 12 also has a blunt proximal end 26, with the housing 14 fixedly disposed at the proximal end 26.

The housing 14 has an elongate base body 28, on which base body 28 an introduction opening 30 for a guide wire and two syringe connection ends 32a, 32b for connecting a syringe are provided. The two syringe connecting ends 32a, 32b are surrounded by connecting end branches 34a, 34b, respectively, to improve the stability of the connected syringe (not shown). The syringe connection ends 32a, 32b and the connection end branches 34a, 34b are arranged transversely to the longitudinal axis 35 and opposite each other. The syringe for aspiration can thus be arranged on the puncturing device 10 in a variable manner, as the case may be, and the handling by right-handed and left-handed persons is improved. The elongate base 28 also serves as a grip for operating the puncturing device 10, wherein the elongate base 28 can be made of circular cross-section, for example. However, other shapes or arrangements (not shown) of gripping recesses are also preferred to improve the ergonomic design.

Fig. 3 shows a cross-sectional view of lancing device 10 in a detailed view of needle tip 20 and housing 14. Disposed within the needle 12 along the longitudinal axis 35 are a needle aspiration channel 36 and a needle guidewire channel 38, the needle aspiration channel 36 and the needle guidewire channel 38 also being shown in fig. 4, respectively. A housing suction channel 40 and a housing guide wire channel 42 are arranged inside the housing 14. The needle aspiration channel 36 opens directly into the housing aspiration channel 40 and connects the aspiration port 24 to the syringe connection ends 32a, 32b for aspiration with a connected syringe (not shown) during lancing. The needle guide wire channel 38 opens directly into the housing guide wire channel 42 and connects the guide wire port 22 at the needle tip 20 with the introduction port 30 in the housing 14. The needle portion suction channel 36 and the housing portion suction channel 40 together form a continuous suction channel 44. The needle portion guidewire channel 38 and the housing portion guidewire channel 42 together form a continuous guidewire channel 46. The entire wire channel 46 and the entire aspiration channel 44 are formed in the lancing device 10 so as not to intersect and be independent of each other, so that no fluid or gas exchange occurs between the channel 44 and the channel 46.

As shown in fig. 3, the introduction port 30 is formed in a conical shape, thereby facilitating the introduction of the guide wire. The introduction port 30 is also configured as a sheath attachment end 48 so that a sheath head 50 of a guidewire assembly 52, as shown in fig. 5, can be introduced and secured. In the sheath connection end 48, a positioning portion 54 is provided, for example as a circumferential groove, which positioning portion 54 cooperates with a corresponding positioning portion 56 on the sheath head 50 for locking. Thus, guidewire assembly 52 may be securely disposed and secured to lancing device 10.

The introduction port 30 and the sheath connection end 48 are arranged in a sleeve 57, the sleeve 57 being arranged at an angle α to the longitudinal axis 35 on the housing 14. The angle α may range from 10 ° to 45 °, in particular from 20 ° to 30 °. A cannula 57 is disposed in the area of connection of the proximal end 26 of the needle 12 with the housing 14. Thus, the cannula 57 is disposed between the needle tip 20 and the connector branches 34a, 34 b. This achieves a compact and ergonomic design of the lancing device 10. The housing portion guidewire channel 42 extends partially within the cannula 57 and is therefore at an angle α to the longitudinal axis 35. Within the sleeve 57, the sheath connection 48 expands conically until it reaches at least as far as possible the width b of the elongate base body 28 (fig. 1).

The housing part suction channel 40 extends parallel to the longitudinal axis 35 within the housing 14 until it splits into two channels (not shown) towards the respective syringe connection ends 32a, 32 b.

Fig. 4 shows in detail the distal end region 16 of the needle 12 with the needle tip 20 in a cross-sectional view. It can be clearly seen here that the suction opening 24 and the guidewire opening 22 lie in a plane 59 extending obliquely with respect to the longitudinal axis 35. The ports 22, 24 are open toward the distal end of the needle tip 20 so that they are as close together as possible. It is further apparent that the passages 36, 38 in the needle have different diameters A, D, respectively. The respective diameters A, D are adapted to the respective channels 36, 38 and their purpose. For example, the diameter a of the suction channel 36 may be smaller than the diameter D of the wire channel 38. Diameter D must be large enough so that a guide wire of diameter D can be freely pushed through wire channel 38 (fig. 7).

Fig. 5 shows a guidewire assembly 52. Guidewire assembly 52 includes a helically wound guidewire 58 surrounded by a guidewire sheath 62. The guide wire has a guide wire diameter d and a guide wire tip 60 of non-invasive design and a guide wire sheath 62 surrounding the guide wire 58. At a distal end 64 of the guidewire sheath 62, a sheath head 50 is disposed that is configured for connection to the sheath connection end 48 of the lancing apparatus 10. To this end, the sheath head 50 has a taper 66 at its distal end, the taper 66 having a circumferential projection as a corresponding detent 56 opposite the detent 54. Thus, when the sheath head 50 is introduced into the sheath coupling end 48 of the lancing apparatus 10, the circumferential projection snaps into the circumferential groove of the positioning portion 54.

In addition, guidewire sheath 62 has a second securing portion 68 that may be secured to a proximal end 69 of housing 14 (see FIG. 1). For this purpose, mating threads may be provided at the proximal end 69 and the securing portion 68 of the housing 14. Alternatively, the securing portion 68 may be attached to the proximal end 69 and snapped into place for securing. By securing the guidewire assembly 52 in the second position on the lancing device 10 during lancing, particularly safe operation is ensured, particularly during lancing. Guidewire assembly 52 disposed on lancing device 10 can now be used as a grip extension. For this purpose, the guide wire windings are stacked on top of one another in the region of the distal end 64.

As shown in fig. 5 and 6, a displacement device 70 for displacing the guide wire 58 is provided on the sheath head 50, the displacement device 70 having an integrated advance indication 72.

Fig. 7 and 8 illustrate the function of the movement device 70 and the advance indication 72 for displaying the position of the guide wire tip 60. To this end, sheath head 50 and needle tip 20 are shown in cross-section with guidewire 58 and guidewire tip 60. The sheath head 50 is disposed in the sheath coupling end 48 and the guide wire 58 is introduced into the introduction port. The illustration of the housing 14 is omitted for clarity.

In the embodiment shown in the figures, the guide wire is guided freely over the advance indication 72, wherein a plurality of spacing marks 74 are provided on the advance indication 72. One of the plurality of spacing marks 76 is particularly prominently shown, which may be implemented, for example, in color or by a bulge of the spacing mark 76. Guidewire 58 on advance indication 72 also has guidewire markings 78. When the guidewire tip 60 located within the needle guidewire channel 38 is positioned immediately before the guidewire port 22, the position of the guidewire mark 78 on the guidewire 58 is selected to coincide with the spacing mark 76 as highlighted. The guidewire tip 60 positioned immediately prior to guidewire port 22 is shown in fig. 7.

To push the guidewire tip 60 out of the guidewire channel, the guidewire 58 in the moving device 70 is pushed with a finger (particularly with a thumb) toward the distal end of the sheath head 50, as shown in fig. 8. This also moves the position of the guidewire mark 78 in a distal direction, wherein the guidewire tip 60 is pushed out along a path away from the needle guidewire channel 38 along which the guidewire mark 78 moves away from the spacing mark 76. The position of the guidewire markings 78 may be adjusted depending on the length and use of the needle 12 of the puncturing device 10. It is also conceivable to adjust the position of the spacing marks 76 shown on the sheath head 50.

With the described moving device 70, a controlled introduction of the guide wire tip 60 into the anatomical space point can be achieved. The distance that the guidewire tip 60 is actually introduced into the puncture space can also be estimated due to the advancement indicator 72 having the spacing mark 76 and the guidewire mark 78. On the one hand, the advancement of the guide wire 58 is simplified and on the other hand, it is safer.

Fig. 9 shows a kit 80 comprised of guidewire assembly 52 disposed on lancing device 10. The penetrating instrument 10 is ready for penetration with the guidewire assembly 52 except that a syringe still needs to be placed over one of the syringe attachment ends 32a, 32 b. Thus, the penetrating instrument 10 and the guidewire assembly 52 form a kit 80 that allows for reliable introduction of the guidewire tip 60 into the anatomical space point by penetration. The kit 80 may also be expandable by a scalpel, syringe and dilator (not shown).

In fig. 10 and 11 and in the detailed views of fig. 12 to 15, a drainage unit 100 with a drainage tube 102 and an introduction device 104 is shown. The draft tube 102 has an inner diameter i and is disposed partially around the introduction device 104. Drainage unit 100 is specifically configured to be introduced to a point of anatomical space along guide wire 58 introduced through lancing apparatus 10.

The introduction device 104 includes a hollow tip 106, a continuous guidewire channel 108 for the guidewire 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 tip 106 is spherical and compressible, having a maximum outer diameter s that is greater than the inner diameter i in an uncompressed normal state. The tip is extruded after compression to a normal state of diameter s. The tip 106 is always compressed when the introduction device 104 is introduced or withdrawn from the drain tube 102.

Fig. 10 shows a drainage unit 100 without a guide wire 58, and fig. 11 shows a drainage unit 100 with a guide wire 58 introduced into a channel 108. Drainage tube 102 has a distal end 112 and a proximal end 114. The distal end 112 is formed blunt to avoid trauma and also to facilitate introduction into the body. In the introduced state, the tip 106 protrudes beyond the distal end 112.

Fig. 12 shows a detailed view of the tip 106 of fig. 10. The tip 106 has a guidewire port with a diameter d' at the distal end 115. Furthermore, the tip 106 has a transition 116 to a stem 118 surrounding the guidewire channel 108 and an intermediate region 119. In the intermediate region 119, the tip 106 has a maximum diameter s. For compressibility of the tip 106, a solid state joint, not shown, may be provided at the transition 116 of the introduction device 104 from the tip 106 to the stem 118. The tip 106 is compressible only in the radial direction while it is very stable so that when introduced into the body it can expand the tissue around the guide wire into the body passage so that the entire drainage unit 100 can be introduced.

After the drainage unit 100 is introduced into the body along the guide wire, the introduction device 104 must be pulled out of the drainage tube 102 in order to drain the liquid or gas from the body. However, the introduction device 104 can only be withdrawn if the guide wire 58 has been previously removed from at least the tip 106. Since the diameter s of the tip 106 is greater than the inner diameter i of the draft tube 102, the tip 106 must be compressed accordingly, the tip being compressible only to the dimension d' of the guidewire channel 108.

As shown in fig. 13 and 14, with the introduction of guidewire 58, tip 106 may be compressed below dimension i. In fig. 14, an attempt is made to withdraw the introduction device 104 from the drainage tube 102. Thus, the tip 106 is compressed to a dimension s', which is still greater than the dimension i, thereby preventing the withdrawal of the introduction device 104.

In fig. 15, guide wire 58 is absent from guide wire channel 108. Thus, the introduction device 104 may be withdrawn from the draft tube 102 during compression of the tip 106 to the dimension s ". It follows that to withdraw the tip 106, it is necessary to compress at least to the dimension d' of the guide wire channel.

The following relationship should apply to the dimensions of the introduction device 104 and the draft tube 102:

s”=s-d’<i,

Where s > i and s' > i.

In order to be able to compress the tip 106 when introducing or extracting the drain tube 102, the tip 106 is preferably slotted (not shown) in addition to or instead of the solid state connector. The grooves may be designed such that the tip 106 is halved, third-wise or quarter-wise in top view from the distal direction. The length of the slot may be from the distal end 115 to the transition 116. Alternatively, the tip 106 at the distal end 115 may be continuously formed to ensure better guidance along the guidewire 58 when introducing the drainage unit 100. A slot may be formed in intermediate region 119 between distal end 115 and transition 116. The length and depth of the groove should be designed to meet the compression characteristics of the tip 106. This design of the drainage unit 100 with the introduction device 104 including the tip 106 ultimately prevents unintended and undesired retention or loss of the guidewire 58 within the patient.

Fig. 16 and 17 illustrate another embodiment of a lancing apparatus 200. The above-mentioned components bear corresponding reference numerals. Lancing device 200 is similar to lancing device 10 with needle 12 and housing 14, wherein needle 12 is connected to housing at distal end 26 thereof. Likewise, an introduction port 30 for a guide wire 58 is shown with a sheath connection end 48. The difference between lancing apparatus 200 and lancing apparatus 10 can be seen in the differently designed needle tip 202 (as shown in FIG. 18), the single syringe attachment end 204, and the different second securing portion 206. A single syringe connection 204 is connected to a suction channel (not shown here) and is surrounded by a connection manifold 208. The syringe connection end 204 and connection end leg 208 are disposed at the proximal end 69 of the housing 14 and parallel to the longitudinal axis 35. The housing portion suction channel 40 extends parallel to the longitudinal axis 35 within the housing 4 up to the syringe attachment end 204.

The second fixing portion 206 is arranged beside the housing 14 and transverse to the longitudinal axis 35. The second securing portion 206 has a ball 210 as a securing means for a complementarily formed securing portion 212 of a guidewire assembly 216, as shown in fig. 19. In addition to the second securing portion 206, another securing portion (not shown) may be provided opposite the housing, or the securing portion 206 may be disposed on the left side of the housing (in fig. 20) so that the guidewire assembly 216 may be disposed on the right or left side of the housing and secured to allow for maximum flexibility of penetration.

Fig. 18 shows in detail a needle tip 202 designed as a pointed cone. It can be seen here that the guidewire port 22 and the aspiration port 24 are arranged on the side 214 of the pointed cone-shaped needle tip 202.

Fig. 19 illustrates another embodiment of a guidewire assembly 216 that is specifically designed for use with the lancing apparatus 200. Guidewire assembly 216 includes guidewire 58 having guidewire tip 60 surrounded by guidewire sheath 62 and sheath head 50. As in the previously described embodiment of guidewire assembly 52, a movement device 70 and a advancement indicator 72 having the same function and operation are disposed on sheath head 50. A fixation portion 212 is disposed at the proximal end of sheath head 50 to cooperate with a second fixation site 206 disposed alongside lancing apparatus 200.

Fig. 20 shows a kit 218 comprised of a guidewire assembly 216 and a lancing instrument 200. It can be seen here that the guide wire assembly 216 is arranged beside the housing 14 and fixed at the second fixing portion 206.

Fig. 21 shows lancing apparatus 200 ready for lancing, as well as guidewire assembly 216 and syringe 220 disposed at 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) 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 is characterized in that the needle (12) includes a cylindrical needle rod (16), and the needle suction channel (36) and the needle guide wire channel (38) are arranged parallel to each other in the needle rod (16).

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

4. A puncture instrument (10) according to any one of the preceding claims, characterized in that the syringe connection end (32a, 32b) is formed as a double connection end having two connection end branches (34a, 34b), wherein the connection end branches (34a, 34b) are transverse to the longitudinal axis (35) and are arranged 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 to accommodate a sheath head (50) arranged 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 is characterized in that a positioning portion (54) is provided at the sheath connecting end (48) or in the sheath connecting 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 is characterized in that a second fixing portion (68, 206) different from the sheath connecting end (48) is provided on the housing (14) for the guide wire sheath (62).

9. A guide wire assembly (52, 216) for use with a puncture instrument (10, 200), in particular for use with a puncture instrument (10, 200) according to any one of the preceding claims, the guide wire assembly (52, 216) comprising: a guide wire (58) having a guide wire top end (60), a guide wire sheath (62) surrounding the guide wire (58), wherein the guide wire 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 is characterized in that the sheath head (50) is at least partially formed into a cone so as to cooperate with the sheath connecting end (48) provided on the puncture instrument (10, 200).

11. The guide wire assembly (52, 216) according to claim 9 or 10 is 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) provided 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 is characterized in that the top end (106) protrudes on 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 top end (106).

17. The drainage unit (100) according to claim 15 or 16 is 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 direction to a maximum diameter (s) at the top end protruding from the channel, 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).