Sheath for sealing access to blood vessel

Abstract

A sheath (10) for creating a fully sealed access to the interior of a blood vessel of an animal or human body includes a base sheath (20) having a tubular body defining a passage channel (22). The base sheath (20) is adapted to be inserted into a blood vessel through a blood vessel aperture. The wall of the tubular body of the base sheath has a through channel (27). This channel extends in the wall from the distal end (20a) towards the proximal end (20b). The channel (27) can be provided independently of the passage channel (22) of the base sheath, or can form a lateral extension of the passage channel (22), at least at the distal end. The through channel (27) is adapted to direct blood from a blood vessel to the proximal end of the sheath when the sheath has been inserted into the blood vessel.

Description

[0001] Divisional application

[0002] This application is a divisional application of a patent application with application number 201580036594.4, international application date July 6, 2015, entry into the Chinese national phase date January 4, 2017, and invention name “Sheath for sealing an access to a blood vessel”. Technical Field

[0003] The present invention relates to a sheath for producing a completely sealed access to the interior of a blood vessel, such as an artery, of an animal or human body. Background Art

[0004] During percutaneous interventions on the human body, for example when a cardiac catheter is introduced through an artery or vein (eg the femoral artery), sheaths are used in different forms. The different steps of this intervention will be described below in a brief and simplified form to achieve the purpose of the present invention.

[0005] In a first stage, the blood vessel is punctured with a puncture needle for this purpose. Then, a first guide wire is inserted into the blood vessel through the needle. The needle is removed and a first sheath is inserted into the blood vessel along the guide wire. The above steps are performed according to the well-known "Seldinger technique". The sheath generally comprises a base sheath, a removable dilator and a hemostatic valve on the proximal end of the sheath, i.e. on the end of the sheath facing the doctor's body. With regard to the present invention, the anatomical direction terminology will be selected with reference to the practitioner. The sheath has an outer diameter of about 2 mm. The dilator and the guide wire are removed successively so that only the base sheath of the first sheath remains partially in the blood vessel.

[0006] In the second stage, the rigid guide wire is now inserted into the blood vessel through the remaining base sheath, for example to a depth of 40 cm. Thereafter, the base sheath is removed. The guide wire remains partially in the blood vessel.

[0007] Optionally, this may be followed by further pre-dilation, which is not described here. Optionally or alternatively, instead of applying a small intermediate sheath, the perforation into the vessel may be dilated upwardly by applying dilators of various sizes over the initially deployed guidewire.

[0008] Along the guide wire that remains in the blood vessel, the sheath is now inserted into the blood vessel that will introduce the heart pump. In the context of the present application, an "introducer" or "introducing sheath" is a sheath with a hemostatic valve. The introducing sheath typically has an inner diameter of about 4.5mm to 5mm and an outer diameter of about 5mm to 6mm. The basic structure of the introducing sheath is identical to that of the first sheath described above, i.e., it consists of an outer base sheath, a dilator, and a hemostatic valve. The dilator and guide wire are removed again, with the base sheath of the introducing sheath remaining in the blood vessel. A passage for the heart pump has now been formed.

[0009] Through the base sheath, now usually along the artery, the guide catheter is placed in the left ventricle. For this purpose, for example, a so-called pigtail catheter can be adopted, which is composed of a thin tube and a soft distal pre-bent guide tip. The support guide wire can be inserted into the guide catheter extending therein, which supports the catheter. Then the soft support wire is removed, and the harder guide wire is inserted into the heart through the catheter. Along the hard guide wire, after removing the pigtail catheter, the heart pump is inserted into the heart. Thus, the inlet of the heart pump is located in the left ventricle, the outlet in the aorta, and the guide wire is taken out. The pump is connected to a supply catheter, which extends along the artery for placing the pump and leaves at the vascular eyelet (puncture side). Alternatively, the pump can be directly inserted into the base sheath, and when the pump has been designed with the appropriate features necessary for retrograde passage through the aortic valve in an atraumatic manner, it can be delivered to the heart without the need for an additional guide catheter and guide wire.

[0010] The introduction sheath that has been used to insert the heart pump is now removed from the blood vessel and completely pulled out, and then, for example, by separation along a predetermined separation line ("stripping" technique) to perform final removal. Now, in order to close the blood vessel again at the blood vessel eyelet, i.e., in order to close the gap between the periphery of the hole in the blood vessel and the outer diameter of the supply catheter of the pump, another sheath is inserted into the blood vessel along the part of the heart pump supply catheter located outside the body. The last-mentioned sheath is the subject of the present invention. Since the heart pump can also be displaced or repositioned through this sheath, for example via the supply catheter, this sheath is also called a repositioning sheath (or "reflux sheath").

[0011] To avoid blood flow disturbances in the artery and potential low-flow or outer surface related thrombosis, the sheath should be inserted only as deeply into the vessel as necessary and have an outer diameter just sufficient to close the vessel in a completely sealed manner, i.e., to stop bleeding or extravasation that would otherwise occur.

[0012] It is therefore desirable to be able to reliably identify whether and when the sheath has been inserted sufficiently deep into the blood vessel. This can vary depending on the thickness of the subcutaneous fat tissue to be penetrated and / or the angle of the passage, and is therefore difficult to determine. Summary of the invention

[0013] Therefore, the object of the present invention is to propose a sheath capable of identifying a sufficient puncture depth.

[0014] This object is achieved by a sheath and a method having the features of the independent claims. Advantageous embodiments and developments are stated in the dependent claims.

[0015] To this end, the sheath comprises a base sheath having a tubular body defining a through passage. Typically, the sheath comprises a conventional hemostatic valve at the proximal end. The base sheath is adapted to be inserted into a blood vessel through a vessel eyelet, ie, to be installed in the blood vessel through the vessel eyelet.

[0016] To allow identification of penetration depth, the wall of the tubular body of the base sheath can have a through channel. The through channel extends in the wall from the distal end toward the proximal end. The through channel can leave the wall of the tubular body at the proximal end of the sheath or earlier, i.e. between the distal end and the proximal end of the sheath to reach the outside of the sheath. The through channel can exist separately from the through channel of the base sheath. According to an alternative embodiment, the through channel can be formed as a lateral extension of the through channel at least at the distal end, i.e., it does not have to be separated from the through channel over its entire length. When the sheath has been inserted into the blood vessel, this through channel is suitable for guiding blood from the blood vessel to the proximal end of the sheath. In this way, once the sheath has been inserted into the blood vessel through the tissue to a sufficient depth, it can be reliably seen. In other words, the channel makes it possible to obtain a kind of insertion depth indicator, which is simply obtained by the following fact: once blood from the blood vessel can be identified at the proximal end of the channel, it can be inferred that the sheath is inserted into the blood vessel deeply enough. In particular, there is no risk that the sheath is inserted further into the blood vessel than necessary, which could otherwise cause blood flow disturbances again.

[0017] Advantageously, blood can also be collected in a suitable manner through the channel for diagnostic purposes. Important diagnostic methods here are in particular measuring the patient's blood pressure and determining the cardiac output. To measure the blood pressure, the sheath can also include a blood pressure measuring device connected to the channel. The cardiac output can be determined, for example, by thermodilution. For this purpose, the sheath can include a temperature measuring element, such as a thermistor, which is inserted through the channel.

[0018] The sheath may also include a guide wire, which is preferably installable through the channel. In other words, the channel is thus adapted to insert the guide wire into the blood vessel from the proximal end of the sheath via the channel. Via such a guide wire, even after the pump is withdrawn, the blood vessel access is maintained.

[0019] According to a preferred embodiment, the sheath comprises expansion means. The latter are adapted to cooperate with the base sheath such that when the sheath is in a rest position in the blood vessel and when the expansion means are actuated, the sheath outer diameter increases in the region of the blood vessel eyelet.

[0020] To produce a completely sealed access to the blood vessel by the sheath of this embodiment, the sheath is therefore inserted into the blood vessel through the blood vessel eyelet. Thereafter, the sheath outer diameter is increased in the region of the blood vessel eyelet by actuating the expansion device of the sheath as required.

[0021] In order to increase the outer diameter of the sheath when necessary, it is not necessary to insert the sheath deeper into the blood vessel, since it is possible to increase the outer diameter of the sheath in the region of the blood vessel eyelet when the sheath is in the rest position. Since the sheath has a relatively small outer diameter in its initial state, i.e. without actuation of the expansion device, unnecessary widening of the blood vessel eyelet and disturbances of the blood flow in the blood vessel due to a large outer diameter or a long puncture depth can be avoided.

[0022] It is intended to design the repositioning sheath so that it is initially undersized, for example. The initial outer diameter of the sheath can reach a smaller diameter of 4F (=T.33mm) compared to the initial perforation diameter created by the introduction sheath for the pump. The reason for this undersized outer diameter is that if the initial larger sheath is only placed for a short period of time (<60min), the blood vessel itself may have the ability to elastically rebound to the smaller hole. It should be understood that the smallest obstruction to achieve hemostasis is the most preferred embodiment, where there is a minimum amount of foreign material in the vessel and the possibility of complete vessel occlusion and discontinuous distal perfusion is minimized. Only in the absence of or limited vessel recoil, the expansion portion of the repositioning sheath will gradually expand to obtain hemostasis. In a preferred embodiment, the expansion device is constructed so that the expansion portion of the sheath is confined to the target area surrounding the vessel perforation, allowing the proximity sheath recess extending through the skin to the outside of the body. In this way, bleeding is still visible at the level of the skin, thereby requiring further expansion of the expansion portion. Thereafter, it is unlikely that the perforation will be plugged at the skin level, and there may be continuous bleeding at the site of the vessel perforation into adjacent tissues, which then appears as a circular hematoma.

[0023] According to a further preferred embodiment, the expansion device is configured as an expansion sheath displaceable on the sheath in the direction of the vessel eyelet. Such an expansion sheath can, for example, surround the base sheath in a tubular manner. By displacing the expansion sheath on the base sheath in the direction of the vessel eyelet, the outer diameter of the sheath can be increased in the region of the location of entry into the vessel without inserting the entire cannula deeper into the vessel.

[0024] A number of embodiments of the expansion device different from those described above are also possible. For example, the expansion device can be arranged not to be displaced on the base sheath in the direction of the vessel eyelet, but to be arranged in a straight-through channel of the base sheath or to be arranged around the base sheath. Such an expansion device can be constructed essentially like a dilator and, for example, widen the base sheath from the inside like a balloon dilator or a sleeve arranged on the base sheath (described in more detail below). The balloon dilator can also be arranged on the outside of the sheath. According to a preferred embodiment, an expansion device in the form of a spiral inflation tube is provided, which is preferably arranged between the base sheath and the sleeve. The inflation tube is spirally wound around the base sheath. During inflation of the tube, the sheath expands while still being flexible, i.e. bendable, in the expansion area.

[0025] Instead of a balloon dilator or the like, a mechanical expansion element, such as a wire mesh stent, can also be provided. Such an expansion element can be brought from a contracted position to an expanded position, for example by rotation or displacement of an actuating element arranged at the proximal end of the sheath and connected to the expansion element, thereby increasing the outer diameter of the sheath in the region of the expansion element. According to a preferred embodiment, the sheath comprises a flexible portion in the region to be expanded. The flexible portion forms part of the base sheath and is arranged between the proximal end and the distal end. The flexible portion can be expanded by operating a pulling device connected to the base sheath at the distal end.

[0026] According to another preferred embodiment, the sheath comprises a stretchable portion in the area to be expanded as an expansion means. The stretchable portion forms part of the base sheath and is arranged between the proximal end and the distal end. The stretchable portion is configured to reach a first thickness in a stretched state and a second thickness greater than the first thickness in an unstretched state so as to increase the outer diameter of the sheath when the proximal end of the base sheath is released from the stretched state to the unstretched state in the direction of the vessel eyelet. In other words, the sheath with the stretchable portion provides a minimum outer diameter in the stretched state. By releasing the stretch from the proximal end of the sheath in the direction of the vessel eyelet, the stretchable portion reaches the unstretched state, which results in the sheath having a larger outer diameter in the area of ​​the vessel eyelet. This embodiment is advantageous in the case where the sheath has a minimum wall thickness, which hinders uniform compression by axial displacement.

[0027] Any other form of similar expansion mechanism, dilation mechanism or widening mechanism may be provided as the expansion device. In another embodiment, the expansion may be automated by swelling the material (e.g., hydrophilic gel) with surrounding blood, which, by appropriate choice of swelling modulus, only slightly expands to the "correct size" with minimal stress on the vessel.

[0028] According to another preferred embodiment, the sheath comprises a sleeve as already indicated. The sleeve encases the base sheath and the expansion device so that when the sheath has been inserted into the vessel, i.e. when the sheath is in a rest position in the vessel, the sleeve is in contact with the vessel eyelet. This makes it possible to prevent a traumatic effect of the expansion device on the vessel when the expansion device is actuated, in particular advanced, to increase the outer diameter of the sheath. This sleeve also serves as a sterile barrier and allows the insertion of a non-sterile dilator from the proximal end of the repositioning sheath.

[0029] In case the expansion device is configured in the form of the above-mentioned expansion sheath displaceable on the base sheath, the sleeve encases the base sheath and the expansion sheath so that the expansion sheath is displaceable on the base sheath between the base sheath and the sleeve.

[0030] Preferably, the base sheath has a through passage, the inner diameter of which allows a catheter, preferably a supply catheter of a heart pump, to be guided through the through passage. For this purpose, an inner diameter of about 3 mm is sufficient. It should be understood that the inner diameter of the sheath can be adjusted according to the intended application and can also be paired and operated with any other indwelling device.

[0031] Preferably, the outer diameter of the sheath is selected to be large enough so that the vessel perforation created when the heart pump is inserted into the vessel is closed in a completely sealed manner, ideally without the need to activate an optional actuating expansion device. Considering currently used heart pumps and introduction sheaths for introducing the pumps, an outer diameter of about 3.33 to 5 mm is sufficient for this purpose. It should be understood that the outer diameter of the sheath can also be adjusted, i.e. reduced or increased, depending on the application. However, it should be mentioned that above 5 mm, the incidence of vascular complications increases exponentially, which is why the preferred target size should be the smallest possible diameter to achieve hemostasis.

[0032] The expansion device of the sheath is preferably suitable for increasing the outer diameter of the sheath in the region of the vessel eyelet by about 1F to 3F (0.33mm to 1.00mm), preferably about 1F to 4F (0.33mm to 1.33mm), particularly preferably about 1F to 5F (0.33mm to 1.66mm). In this way, it is possible to ensure that completely sealed access to the interior of the vessel is produced in different situations, in particular taking into account the different vascular recoil potentials and vessel sizes of different patients.

[0033] In addition to having the correct sealing diameter, it is also important that the expansion portion of the sheath is "radially soft". In this context, radially soft means that this portion does not have to act like a rigid portion, which can deform and / or traumatize the vessel, but that this portion can still limit the curvature / radius of the repositioning sheath where it enters the vessel. This requires low durometer polymer materials and / or special designs of the expansion device, such as a helically wound inflation tube (already mentioned above). The latter can expand radially, but will not exceed any tangential forces that cause longitudinal stretching or extension of the pre-curved portion.

[0034] The degree of expansion of the sheath outer diameter is guided by the inflation pressure of the balloon or any other force feedback device that can be used to limit the expansion to a diameter sufficient to provide hemostasis. An expansion force slightly above the maximum blood pressure is considered sufficient. If the balloon material is highly flexible, the expansion force can be considered equal to the inflation pressure of the balloon.

[0035] According to another preferred embodiment, the sheath comprises a fixing element at the proximal end. The fixing element is used to fix the sheath to the patient after the sheath is inserted into the patient's blood vessel. For example, the fixing element can thereby be sutured to the patient's skin. The fixing element comprises an area spanning the base sheath for applying a sterile cover. The area is inclined downward in a ramp shape on both sides of the base sheath transverse to the main direction of the base sheath.

[0036] This embodiment of the fixation element allows for simple and safe application of the sterile cover, thereby minimizing entry sites for bacteria and pathogens at the vessel eyelet.

[0037] The fixing element can additionally comprise a fixing area which abuts against the patient's skin in the fixed state.Thus, this fixing area is located opposite to the above-mentioned area for applying the sterile cover.

[0038] Preferably, the fixing element further comprises a guide element. The guide element serves as a stop for applying the sterile cover. Preferably, the guide element extends transversely to the main direction of the base sheath on the proximal end of the region and substantially perpendicularly to the region, but at least protrudes from the region so as to provide the function of a stop. By applying the sterile cover on the guide element and by the configuration of a smooth region for wrinkle-free application of the sterile cover, a particularly safe and sterile covering of the wound can be obtained. The guide element also helps to prevent unintentional fixation of any element in the repositioning sheath close to the fixing element, such as an anti-contamination sleeve for protecting the proximal part of the catheter from contamination.

[0039] According to another preferred embodiment, the sheath comprises a heart pump with a supply catheter. The sheath is here adapted to be movably arranged on the supply catheter. In other words, the heart pump, the supply catheter and the sheath form a cohesive system according to this embodiment. BRIEF DESCRIPTION OF THE DRAWINGS

[0040] In the following, the present invention will be described by way of example with reference to the accompanying drawings, in which:

[0041] Figure 1 is a plan view of a preferred embodiment of a sheath according to the present invention;

[0042] Figure 2 yes Figure 1 A transverse cross-sectional view of the sheath,

[0043] Figure 3 yes Figure 1 A stereoscopic view of a sheath and additional optional sheath elements. DETAILED DESCRIPTION

[0044] Figures 1 to 3The illustration of the sheath 10 in the figure is not to scale, but is merely schematic. In order to better illustrate some elements of the sheath 10, the actual size relationship is therefore sometimes incorrect. For example, the tapered portion is exaggerated and looks more like an inclined step rather than a gentle and smooth transition from a small diameter to a large diameter.

[0045] like Figure 1 and Figure 2 As shown, a sheath 10 for creating a completely sealed access to the interior of a blood vessel of an animal or human comprises a base sheath 20 having a tubular body defining a through passage 22. A hemostatic valve 24 (see Figure 3 ) terminates the proximal end 20b of the sheath.

[0046] The through passage 22 has an inner diameter d' and an outer diameter d. The inner diameter d' is sized so that the sheath 10 is suitable for being pushed through the supply conduit 40 of the heart pump 70 (compare Figure 3 ), and is preferably about 3 mm. The outer diameter d is preferably about 3.33 mm to 5 mm, so that the sheath 10 is suitable for closing the blood vessel hole created when the introducer of the heart pump 70 is inserted into the blood vessel in a completely sealed manner. Based on, for example, the minimum wall thickness of the sheath 10, the straight channel 27 in the wall of the tubular body (see Figure 2 ) or the size of the supply conduit 40 (see Figure 3 ) size, the outer diameter d may need to be larger than 3.33mm.

[0047] The sheath 10 comprises an expansion device in the form of an expansion sheath 26 which is displaceable on the base sleeve 20 in the direction R of the vessel eyelet. In the present example, the expansion sheath 26 is configured as an expansion sheath 26 which tubularly surrounds the base sheath 20. The expansion sheath 26 is adapted to be displaced on the base sheath 20 in the direction R so as to increase the sheath outer diameter d in the region of the entry position G of the vessel when the sheath 10 has been inserted into the vessel. Thereafter, the outer diameter D present in the region of the vessel eyelet exceeds the initial outer diameter d by an amount 2x, wherein 2x may be as large as 0.75*d.

[0048] The sheath 10 comprises a sleeve 28. The latter is preferably fastened at its distal end to the base sheath 20 and can moreover be fastened at its proximal end to a fixing element 60. The sleeve 28 surrounds the base sheath 20 and the expansion sheath 26 so that the expansion sheath 26 can be displaced on the base sheath 20 between the base sheath 20 and the sleeve 28. In this way, a traumatic effect of the expansion sheath 26 on the vessel can be prevented and sterility is maintained when the expansion sheath 26 is moved along the base sheath 20 into the vessel eyelet to increase the outer diameter of the sheath 10 in the vessel eyelet.

[0049] The wall 25 of the tubular body of the base sheath 20 has a through channel 27. The latter extends in the wall 25 from the proximal end 20b to the distal end 20a of the base sheath 20 and is separate from the through channel 22 of the base sheath 20 and preferably extends parallel to the through channel 22. According to another embodiment (not shown), the through channel 27 is not separate from the through channel 22 over its entire length, but for example only at the proximal end. At the distal end, the through channel 27 can form a lateral extension of the through channel 22. The through channel 27 is suitable for guiding blood from a blood vessel, such as an artery, to the proximal end of the sheath 10 once the sheath 10 has been inserted deep enough into the blood vessel. In this way, a sufficient puncture depth into the blood vessel can be determined in a simple manner by means of the channel 27.

[0050] In addition, the sheath 10 may include an externally readable marking area in an area of ​​the sheath that is intended to be located in the area of ​​the vascular puncture site during operation. External readability can be achieved, for example, by providing a radiopaque marking in this area. In addition, fluorescent or echogenic substances can be used to form the marking. According to Figure 2 and 3 In the first embodiment shown, the region can be defined by two limiting marks 29a and 29b. These marks also guide the expansion and help locate the correct position of the sheath relative to the distal opening of the through channel 27 and its vascular puncture site. Individual marks can be provided, for example, on the sleeve 28 covering the base sheath 20 and on the base sheath 20. Alternatively, the entire region can be substantially uniformly marked by adding a suitable externally readable substance to the sheath material in the region. According to such an embodiment, at least a portion of the expansion portion can be marked, such as the above-mentioned flexible portion and / or stretchable portion of the sheath.

[0051] The following will refer to Figure 3 Describing the other components of the sheath 10, Figure 3 Shown in stereogram Figure 1 The sheath 10.

[0052] The channel 27 can be connected to different measuring devices, such as a blood pressure measuring device 30, by suitable connections 32, 55. Alternatively or additionally, a temperature measuring device, such as a thermistor (not shown), can be connected to or inserted into the channel 27, for example to obtain information for measuring the patient's cardiac output.

[0053] The guide wire 50 can be further inserted into the blood vessel via the channel 27. For example, access to the channel 27 can be formed via a Luer connector 55.

[0054] As described above, the sheath 10 is adapted to be pushed through the supply catheter 40 of the heart pump 70. The heart pump 70 with the catheter 40 and the sheath 10 can be arranged as a cohesive unit. The heart pump 70 is preferably introduced into the patient's vascular system in the manner described above by means of an introduction sheath, which is removed with a stripping technique and replaced by the advancement sheath 10.

[0055] The fixing element 60 described above is used to fix (e.g. sew) the sheath 10 to the patient after the sheath has been inserted into the patient's blood vessel. For this purpose, an opening 66 can be provided. The fixing element 60 has an area 62 across the base sheath 20 for applying a sterile cover (not shown). The area 62 of the fixing element 60 is inclined downward in a ramp shape on both sides of the base sheath 20 transverse to the main direction of the base sheath. In addition, the fixing element 60 includes a guide element 64, which serves as a stop for applying a sterile cover.

[0056] The fixing element 60 may also include circulation openings 67 and / or circulation opening slots (not shown) to allow air to circulate under the sterile cover. These openings or slots preferably pass through the fixing element in the direction in which the sheath passes.

Claims

1. A sheath (10) for creating a completely sealed passage to the interior of a blood vessel of an animal or human body, comprising: a base sheath (20) having a tubular body and adapted to be inserted into a blood vessel through a blood vessel eyelet, It is characterized in that The wall (25) of the tubular body of the base sheath (20) has a through passage (27) extending in the wall (25) from the distal end (20a) towards the proximal end (20b).

2. The sheath (10) of claim 1, wherein the tubular body of the base sheath (20) defines a through passage (22).

3. A sheath (10) for creating a completely sealed passage to the interior of a blood vessel of an animal or human, comprising: a base sheath (20) having a tubular body defining a through passage (22), It is characterized in that The wall (25) of the tubular body of the base sheath (20) has a through passage (27) extending in the wall (25) from the distal end (20a) towards the proximal end (20b).

4. The sheath (10) according to claim 3, wherein the base sheath (20) is adapted to be inserted into a blood vessel through a vessel eyelet.

5. The sheath (10) according to any one of claims 2 to 4, wherein the through-channel (27) is provided as a through-channel (22) independent of the base sheath (20).

6. The sheath (10) according to any one of claims 2 to 4, wherein the through channel (27) is a lateral extension of the through channel (22) at least at the distal end (20a).

7. The sheath (10) according to any one of claims 1 to 4, wherein the through channel (27) is adapted to conduct blood from a blood vessel to the proximal end (20b) of the sheath (10).

8. The sheath (10) according to claim 7, comprising a blood pressure measuring device (30) connected to the through-channel (27).

9. The sheath (10) according to claim 7, comprising a temperature measuring element connected to or inserted through the through-channel (27).

10. The sheath (10) according to claim 7, wherein the through-channel (27) is configured such that the patient's blood can be accessed through the through-channel (27).

11. The sheath (10) according to any one of claims 1 to 4, comprising a guide wire (50) which can be introduced from the proximal end (20b) of the sheath through the through channel (27) into a blood vessel.

12. The sheath (10) according to any one of claims 1 to 4, comprises an expansion device (26), which is suitable for cooperating with the base sheath (20) so that when the sheath (10) is in a static position in a blood vessel and when the expansion device (26) is actuated, the outer diameter (d; D) of the sheath (10) increases in the area of ​​the blood vessel eyelet.

13. The sheath (10) according to claim 12 in accordance with claim 4, wherein the expansion device (26) is configured as an expansion sheath (26) displaceable on the base sheath (20) in the direction (R) of the vessel eyelet.

14. The sheath (10) according to claim 12 according to claim 4, comprises a sleeve (28) which surrounds the base sheath (20) and the expansion device (26) so that in the static position of the sheath (10) in the blood vessel, the sleeve (28) is in contact with the blood vessel eyelet.

15. The sheath (10) according to claim 13, comprises a sleeve (28), which surrounds the base sheath (20) and the expansion sheath (26), so that in the static position of the sheath (10) in the blood vessel, the sleeve (28) is in contact with the blood vessel hole and enables the expansion sheath (26) to be shifted on the base sheath (20) between the base sheath (20) and the sleeve (28).

16. The sheath (10) according to claim 12, wherein the expansion means (26) is adapted to increase the outer diameter (d) of the sheath (10) in the region of the vessel eyelet by 0.33 mm to 1.0 mm.

17. The sheath (10) according to claim 12, wherein the expansion means (26) is adapted to increase the outer diameter (d) of the sheath (10) in the region of the vessel eyelet by 0.33 mm to 1.33 mm.

18. The sheath (10) according to claim 12, wherein the expansion means (26) is adapted to increase the outer diameter (d) of the sheath (10) in the region of the vessel eyelet by 0.33 mm to 1.66 mm.

19. The sheath (10) of claim 4, wherein the sheath (10) comprises an externally readable marking area (29a, 29b) in an area of ​​the sheath that is located in the area of ​​the vascular puncture site during operation.

20. The sheath (10) according to any one of claims 1 to 4, comprising a fixing element (60) for fixing the sheath (10) to a patient, wherein the fixing element (60) has an area (62) across the base sheath (20) for applying a sterile cover, the area (62) being inclined downward in a ramp shape on both sides of the base sheath (20) transversely to the main direction of the base sheath.

21. The sheath (10) according to claim 20, wherein the fixing element (60) comprises a stop (64) for applying the sterile cover, the stop extending transversely to the main direction of the base sheath on the proximal end of the region (62).

22. The sheath (10) according to any one of claims 1 to 4, comprising a heart pump (70) having a supply conduit (40), wherein the sheath (10) is adapted to be displaceably arranged on the supply conduit (40).

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