阅读说明：本技术 用于密封到血管的通路的护套 (Sheath for sealing a passageway to a blood vessel ) 是由 索斯藤·西斯 克里斯托夫·尼克斯 弗兰克·基尔霍夫 帕特里克·亨齐克 于 2015-07-06 设计创作，主要内容包括：一种用于产生对动物或人体的血管内部的完全密封通路的护套(10)包括具有管状主体的基部护套(20),管状主体限定通过通道(22)。基部护套(20)适于通过血管孔眼插入到血管中。基部护套的管状主体的壁具有直通通道(27)。这一通道在壁中从远端(20a)朝向近端(20b)延伸。通道(27)能够设置为独立于基部护套的通过通道(22),或者能够形成通过通道(22)的侧向延伸部,至少是在远端处形成。这种直通通道(27)适于在已将护套插入血管中时,将来自血管的血液导向护套的近端。(A sheath (10) for creating a completely sealed passageway to the interior of a blood vessel of an animal or human body includes a base sheath (20) having a tubular body defining a through passage (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 passage (27). This channel extends in the wall from the distal end (20a) towards the proximal end (20 b). The channel (27) can be provided as a through channel (22) independent of the base sheath, or can form a lateral extension of the through channel (22), at least at the distal end. Such a through-passage (27) is adapted to guide blood from the vessel towards the proximal end of the sheath when the sheath has been inserted into the vessel.)

1. A sheath (10) for creating a completely sealed access to the interior of a blood vessel of an animal or human body, comprising:

a base sheath (20) having a tubular body defining a through passage (22), wherein the base sheath (20) is adapted to be inserted into a blood vessel through a blood vessel aperture,

it is characterized in that the preparation method 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 a distal end (20a) towards a proximal end (20 b).

2. The sheath (10) according to claim 1, wherein the through channel (27) is provided independently of the through channel (22) of the base sheath (20).

3. The sheath (10) according to claim 1, wherein the through channel (27) is a lateral extension of the through channel (22) at least at the distal end (20 a).

4. The sheath (10) according to any of claims 1 to 3, wherein the through-passage (27) is adapted to conduct blood from a blood vessel to the proximal end (20b) of the sheath (10).

5. The sheath (10) according to claim 4, comprising a blood pressure measuring device (30) connected to the through channel (27).

6. The sheath (10) according to claim 4 or 5, comprising a temperature measuring element connected to the through channel (27) or inserted through the through channel (27).

7. The sheath (10) according to any of claims 4 to 6, wherein the through-passage (27) is configured such that blood of a patient can be accessed through the through-passage (27).

8. The sheath (10) according to any one of claims 1 to 7, comprising a guide wire (50) that can be introduced from the proximal end (20b) of the sheath into a blood vessel through the through-passage (27).

9. The sheath (10) according to any one of claims 1 to 8, comprising an expansion means (26), the expansion means (26) being adapted to cooperate with the base sheath (20) such that an outer diameter (D; D) of the sheath (10) increases in the region of the vessel aperture with the sheath (10) in a rest position in the vessel and when the expansion means (26) is actuated.

10. The sheath (10) according to claim 9, wherein the expansion means (26) is configured as an expansion sheath (26) displaceable on the base sheath (20) in the direction (R) of the vessel aperture.

11. The sheath (10) according to claim 9 or 10, comprising a sleeve (28), the sleeve (28) surrounding the base sheath (20) and the expansion means (26) such that in a rest position of the sheath (10) in a vessel, the sleeve (28) is in contact with the vessel aperture.

12. The sheath (10) according to claim 10, comprising a sleeve (28), the sleeve (28) surrounding the base sheath (20) and the expansion sheath such that in the rest position of the sheath (10) in the vessel, the sleeve (28) is in contact with the vessel aperture and such that the expansion sheath is displaceable on the base sheath (20) between the base sheath (20) and the sleeve (28).

13. The sheath (10) according to any of claims 9 to 12, wherein the expansion means (26) is adapted to increase the outer diameter (d) of the sheath (10) in the region of the vessel aperture by 0.33mm to 1.0mm, preferably 0.33mm to 1.33mm, particularly preferably 0.33mm to 1.66 mm.

14. The sheath (10) according to any one of claims 1 to 13, wherein the sheath (10) comprises an externally readable marking region (29a,29b) in the region of the sheath located, in operation, within the region of the vascular puncture site.

15. The sheath (10) according to any one of claims 1 to 14, comprising a fixing element (60) for fixing the sheath (10) to a patient, wherein the fixing element (60) has a region (62) for applying a sterile cover across the base sheath (20), the region (62) being inclined downwards in a ramp shape on both sides of the base sheath (20) transverse to a main direction of the base sheath.

16. Sheath (10) according to claim 15, wherein the fixation element (60) comprises a stop (64) for applying the sterile cover, said stop extending transversely to the main direction of the base sheath on a proximal end of the region (62).

17. The sheath (10) according to any one of claims 1 to 16, comprising a heart pump (70) having a supply catheter (40), wherein the sheath (10) is adapted to be displaceably arranged on the supply catheter (40).

18. A method for determining a sufficient penetration depth of a sheath (10) according to any of claims 1 to 17 into a vessel of an animal or human body, comprising the steps of:

the sheath (10) is inserted into a blood vessel through animal or human tissue to a depth identifiable at a proximal end of the through-channel (27) by guiding blood or blood pressure signals from the blood vessel via the through-channel (27).

Technical Field

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

During percutaneous interventions in the human body, such as when introducing a cardiac catheter through an artery or vein (e.g. the femoral artery), sheaths are used in different forms. The different steps of such intervention will be set forth below in a simplified and simplified form in order to achieve the object of the invention.

In a first phase, the blood vessel is punctured with a puncture needle for this purpose. A first guidewire is then inserted through the needle and into the blood vessel. The needle is removed and the first sheath is inserted into the vessel along the guidewire. The above steps are performed according to the well-known "Seldinger technique". The sheath typically includes a base sheath, a removable dilator, and a hemostasis valve on the proximal end of the sheath, i.e., the end of the sheath facing the physician's body. With respect to the present invention, anatomical directional terms will be selected with reference to the practitioner. The jacket has an outer diameter of about 2 mm. The dilator and the guidewire are successively removed such that only the base sheath of the first sheath remains partially in the vessel.

In the second stage, the rigid guidewire is now inserted into the vessel through the remaining base sheath, for example up to a depth of 40 cm. Thereafter, the base sheath is removed. The guidewire is partially retained in the vessel.

Optionally, this may be followed by a further pre-expansion, which will not be described here. Optionally or alternatively, instead of applying a small intermediate sheath, the puncture into the vessel may be dilated upward by applying dilators of various sizes over the initially deployed guidewire.

Along the guide wire held in the vessel, the sheath is now inserted into the vessel into which the heart pump is to be introduced. In the context of the present application, an "introducer" or "introducer sheath" is a sheath with a hemostatic valve. The introducer sheath typically has an inner diameter of about 4.5mm to 5mm and an outer diameter of about 5mm to 6 mm. The basic structure of the introducer sheath is the same as 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 guidewire are again removed, with the base sheath of the introducer sheath remaining in the vessel. A pathway for a heart pump has now been formed.

With the base sheath, the guide catheter is now placed into the left ventricle, usually along the artery. For this purpose, a so-called pigtail catheter, for example, can be used, which consists of a thin tube and a soft distal pre-bent guide tip. The support guidewire may already be inserted into the guide catheter extending therein, which supports the catheter. The soft support wire is then removed and a stiffer guide wire is inserted through the catheter into the heart. Following removal of the pigtail catheter along the hard guide wire, a heart pump was inserted into the heart. Thus, the inlet of the heart pump is located in the left ventricle, the outlet in the aorta, and the guidewire is withdrawn. The pump is connected to a supply conduit that runs along the artery for placement of the pump and exits at the vascular aperture (puncture side). Alternatively, the pump can be inserted directly into the base sheath and delivered into the heart without the need for additional guide catheters and guidewires, in cases where the pump has been designed with the appropriate features necessary to pass retrograde through the aortic valve in an atraumatic manner.

The introducer sheath, which has been used to insert the heart pump, is now removed from the vessel and pulled completely out, and then finally removed, for example by separation along a predetermined separation line ("peel-off" technique), to perform final removal. Now, to close the blood vessel again at the vessel aperture, i.e. to close the gap between the circumference of the hole in the blood vessel and the outer diameter of the supply catheter of the pump, a further sheath is inserted into the blood vessel along the portion of the heart pump supply catheter which is located outside the body. The last mentioned jacket is the subject of the present invention. Because the heart pump may also be displaced or repositioned through the sheath, e.g., via a supply catheter, the sheath is also referred to as a repositioning sheath (or "reflux sheath").

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 prevent bleeding or oozing that would otherwise occur.

It is therefore desirable to be able to reliably identify if and when the sheath has been inserted sufficiently deep into the vessel. This may vary depending on the thickness of the subcutaneous adipose tissue to be penetrated and/or the angle of the passage, and is therefore difficult to determine.

Disclosure of Invention

The object of the invention is therefore to propose a sheath which allows sufficient penetration depth to be identified.

This object is achieved by a sheath and a method having the features of the independent claims. Advantageous embodiments and improvements are set out in the dependent claims.

To this end, the sheath comprises a base sheath having a tubular body defining a through passage. Typically, the sheath includes a conventional hemostatic valve at the proximal end. The base sheath is adapted to be inserted into a blood vessel through a vessel aperture, i.e. to be mounted in a blood vessel through a vessel aperture.

To allow identification of the penetration depth, the wall of the tubular body of the base sheath can have a through passage. The through passage extends proximally in the wall from the distal end. This through passage may exit the wall of the tubular body to the outside of the sheath at the proximal end of the sheath or earlier, i.e. between the distal and proximal ends of the sheath. The through channel can be present 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. Such a through-passage is adapted to guide blood from the vessel to the proximal end of the sheath when the sheath has been inserted into the vessel. In this way, the sheath can be reliably seen once it has been inserted through the tissue and into the vessel to a sufficient depth. In other words, the channel enables to obtain an insertion depth indicator, simply by the fact that: once blood from the vessel can be identified at the proximal end of the channel, it can be concluded that the sheath is inserted deep enough into the vessel. In particular, there is no risk of the sheath being inserted further into the vessel than is necessary, which would otherwise again cause a disturbance in the blood flow.

Advantageously, blood can also be collected in a suitable manner through the channel for diagnostic purposes. Important diagnostic methods here are, in particular, the measurement of the blood pressure of the patient and the determination of the cardiac output. For measuring the blood pressure, the sheath may further comprise a blood pressure measuring device connected to the channel. Cardiac output can be determined, for example, by thermodilution. To this end, the sheath can comprise a temperature measuring element, such as a thermistor, inserted through the channel.

The sheath may also include a guide wire, which is preferably mountable through the channel. In other words, the channel is thereby adapted for inserting the guidewire into the vessel from the proximal end of the sheath via the channel. Via such a guidewire, vascular access is maintained even after the pump is withdrawn.

According to a preferred embodiment, the sheath comprises an expansion means. The latter is adapted to cooperate with the base sheath such that the sheath outer diameter increases in the region of the vessel aperture in case of a rest position of the sheath in the vessel and when the expansion means is actuated.

To produce a completely sealed access to the vessel by the sheath of this embodiment, the sheath is thus inserted into the vessel through the vessel aperture. Thereafter, the sheath outer diameter is increased in the region of the vessel aperture by actuating the expansion means of the sheath as required.

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

It is intended that the repositioning sheath be designed such that its initial dimensions are too small, for example. The initial outer diameter of the sheath can reach a smaller diameter of 4F (═ t.33mm) than the initial perforation diameter produced by the introducer sheath for the pump. The reason for this undersized outer diameter is that if the initially larger sheath is placed for only a short time (<60min), the vessel itself may have the ability to resiliently spring back to the smaller hole. It will be appreciated that the smallest obstruction to achieve hemostasis is the most preferred embodiment, with the least amount of foreign material in the vessel and the least likelihood of complete vessel occlusion and discontinuous distal perfusion. Only in the absence or limited vessel recoil will the expanded portion of the repositioning sheath gradually expand to achieve hemostasis. In a preferred embodiment, the expansion means is configured such that the expanded portion of the sheath is confined to the target area surrounded by the vessel puncture, allowing an access sheath recess extending through the skin to the exterior of the body. In this way, bleeding is still visible at the skin level, requiring further expansion of the expanded portion. Thereafter, it is unlikely that the perforation will be plugged at the skin level, and there may be continuous bleeding at the vascular perforation into the adjacent tissue, which then appears as a circular hematoma.

According to a further preferred embodiment, the expansion device is configured as an expansion sheath which is displaceable on the sheath in the direction of the vessel aperture. Such an expansion sheath may, for example, surround the base sheath in a tubular manner. By displacing the expanding sheath over the base sheath in the direction of the vessel aperture, it is possible to increase the sheath outer diameter in the region of the site of entry into the vessel without inserting the entire cannula deeper into the vessel.

A number of embodiments of the expansion device other than those described above are also possible. For example, the expansion device can be provided not to be displaced on the base sheath in the direction of the vessel aperture, but to be arranged in a through-channel of the base sheath or around the base sheath. Such an expansion device can be configured substantially similar to 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 may also be disposed outside of the sheath. According to a preferred embodiment, an expansion device in the form of a helical inflation tube is provided, preferably arranged between the base sheath and the sleeve. The inflation tube is helically wrapped around the base sheath. During inflation of the tube, the sheath expands while still being flexible, i.e., bendable, in the expanded region.

Instead of balloon dilators or the like, it is also possible to provide mechanical expansion elements, such as wire mesh stents. Such a stent 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 coupled with the stent element, thereby increasing the sheath outer diameter in the region of the stent element. According to a preferred embodiment, the sheath comprises a flexible portion in the area to be expanded. The flexible portion forms a portion of the base sheath and is disposed between the proximal end and the distal end. The flexible portion is expandable by operation of a pulling device connected at a distal end to the base sheath.

According to another preferred embodiment, the sheath comprises a stretchable portion in the area to be expanded as the expansion means. The stretchable portion forms a portion of the base sheath and is disposed 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 to increase the sheath outer diameter when the proximal end portion of the base sheath is released from the stretched state to the unstretched state in a direction of the vessel aperture. In other words, the sheath with the stretchable portion provides the smallest outer diameter in the stretched state. By releasing the stretch from the proximal end of the sheath in the direction of the vessel aperture, the stretchable portion reaches an unstretched state, which results in a sheath having a larger outer diameter in the region of the vessel aperture. This embodiment is advantageous in case the sheath has a minimum wall thickness which hinders an even compression by axial displacement.

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

According to another preferred embodiment, the sheath comprises a sleeve as already indicated. The sleeve encases the base sheath and the expansion means such that the sleeve is in contact with the vessel aperture when the sheath has been inserted into the vessel, i.e. when the sheath is in a resting position in the vessel. This can prevent traumatic effects 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.

In the case of an expansion device configured in the form of an expansion sheath displaceable over the base sheath as described above, the sleeve encases the base sheath and the expansion sheath, so that the expansion sheath is displaceable over the base sheath between the base sheath and the sleeve.

Preferably, the base sheath has a through-passage with an inner diameter allowing 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 3mm is sufficient. It will be appreciated that the inner diameter of the sheath may be adjusted depending on the intended application, and may also be paired and operated with any other indwelling device.

Preferably, the outer diameter of the sheath is selected to be large enough so that the vessel aperture created when the heart pump is inserted into the vessel is closed in a completely sealed manner, ideally without the need to actuate an optional dynamic expansion device. An outer diameter of about 3.33 to 5mm is sufficient for this purpose, taking into account the heart pumps currently used and the introducer sheaths used for introducing the pumps. It should be understood that the outer diameter of the sheath may also be adjusted, i.e., decreased or increased, depending on the application. It should be mentioned, however, that above 5mm the incidence of vascular complications increases exponentially, which is why the preferred target size should be in order to achieve the smallest possible diameter of hemostasis.

The expansion means of the sheath is preferably adapted to increase the sheath outer diameter 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 the region of the vessel aperture. In this way, it can be ensured that a completely sealed access to the interior of the blood vessel is produced under different circumstances, in particular taking into account different patients with different possibilities of recoil of the blood vessel and blood vessel sizes.

In addition to having the correct sealing diameter, it is also important that the expanded portion of the sheath is "radially soft". In this context, radially soft means that the portion does not have to function as a rigid portion, which may deform and/or traumatize the vessel, but which may still limit the curvature/radius at which the repositioning sheath enters the vessel. This requires a low durometer polymer material and/or a special design of the inflation device, such as a helically wound inflation tube (as already mentioned above). The latter can expand radially but not exceed any tangential force causing longitudinal stretching or extension of the pre-bent section.

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 inflation force may be considered to be equal to the inflation pressure of the balloon.

According to another preferred embodiment, the sheath comprises a fixation element at the proximal end. The fixation element is used to fix the sheath to the patient after insertion of the sheath into the patient's blood vessel. For example, the fixation element can thereby be sutured to the skin of the patient. The fixation element includes an area spanning the base sheath for application of the sterile cover. This region slopes downward in a ramp shape on both sides of the base sheath transverse to the main direction of the base sheath.

Such an embodiment of the fixation element allows for a simple and safe application of the sterile cover, thereby minimizing the entry site of bacteria and pathogens at the vascular aperture.

The fixation element may additionally comprise a fixation area which in the fixed state abuts against the skin of the patient. The fixing area is thus located opposite the area for applying the sterile cover.

Preferably, the fixing element further comprises a guiding element. The guide element serves as a stop for applying the sterile cap. Preferably, the guide element extends transversely to the main direction of the base sheath and substantially perpendicularly to the region on the proximal end of the region, but at least protrudes from the region such that a stop function can be provided. By applying the sterile cover on the guide element and by the configuration of the smooth area 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 prevent inadvertent fixation of any elements of the repositioning sheath that are proximal to the fixation element, such as a contamination-resistant sleeve for protecting the proximal portion of the catheter from contamination.

According to another preferred embodiment, the sheath comprises a heart pump with a supply conduit. The sheath is here adapted to be movably arranged on the supply conduit. In other words, the heart pump, the supply catheter and the sheath form a cohesive system according to this embodiment.

Drawings

In the following, the invention will be described by way of example with reference to the accompanying drawings. In which it is shown that:

FIG. 1 is a plan view of a preferred embodiment of a sheath according to the present invention;

figure 2 is a transverse cross-sectional view of the sheath of figure 1,

fig. 3 is a perspective view of the sheath of fig. 1 and additional optional sheath elements.

Detailed Description

The illustration of the sheath 10 in fig. 1 to 3 is not to scale, but merely schematic. The actual dimensional relationships are therefore sometimes incorrect in order to better illustrate some of the elements of the sheath 10. For example, the tapered portion is exaggerated and appears more like a sloped step rather than a flat and smooth transition from a small diameter to a large diameter.

As shown in fig. 1 and 2, a sheath 10 for creating a completely sealed passageway to the interior of a blood vessel of an animal or human body includes a base sheath 20 having a tubular body defining a through passage 22. A hemostasis valve 24 (see fig. 3) terminates the proximal end 20b of the sheath.

The through passage 22 has an inner diameter d' and an outer diameter d. The inner diameter d' is dimensioned such that the sheath 10 is adapted to be pushed through the supply conduit 40 of the heart pump 70 (compare fig. 3), and is preferably about 3 mm. The outer diameter d is preferably about 3.33mm to 5mm, so that the sheath 10 is suitable for closing in a completely sealed manner the vessel aperture created when the introducer of the heart pump 70 is inserted into a vessel. The outer diameter d may need to be greater than 3.33mm based on, for example, the minimum wall thickness of the sheath 10, the size of the through passage 27 (see fig. 2) in the wall of the tubular body, or the size of the supply conduit 40 (see fig. 3).

The sheath 10 comprises expansion means in the form of an expansion sheath 26, the expansion sheath 26 being displaceable on the base sleeve 20 in the direction R of the vessel aperture. In the present example, the expansion sheath 26 is configured as an expansion sheath 26 that tubularly surrounds the base sheath 20. The expansion sheath 26 is adapted to be displaced over the base sheath 20 in the direction R in order to increase the sheath outer diameter d in the region of the entry location 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 aperture exceeds the initial outer diameter D by an amount 2x, wherein 2x may be as large as 0.75 x D.

The sheath 10 includes a sleeve 28. The latter is preferably fastened at its distal end to the base sheath 20 and can furthermore be fastened at its proximal end to the fixation element 60. The sleeve 28 surrounds the base sheath 20 and the expansion sheath 26 such that the expansion sheath 26 is displaceable on the base sheath 20 between the base sheath 20 and the sleeve 28. In this way, traumatic effects of the expanded sheath 26 on the vessel can be prevented and sterility is maintained as the expanded sheath 26 is moved along the base sheath 20 into the vessel aperture to increase the outer diameter of the sheath 10 in the vessel aperture.

The wall 25 of the tubular body of the base sheath 20 has a through passage 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 separated from the through passage 22 of the base sheath 20, and preferably extends parallel to the through passage 22. According to another embodiment (not shown), the through channel 27 is not separated from the through channel 22 over its entire length, but only at the proximal end, for example. On the distal end, the through channel 27 can form a lateral extension through the channel 22. The through-passage 27 is adapted to guide blood from the vessel (e.g. an artery) to the proximal end of the sheath 10 once the sheath 10 has been inserted sufficiently deep into the vessel. In this way, a sufficient penetration depth into the blood vessel can be determined in a simple manner by the channel 27.

Furthermore, the sheath 10 may comprise externally readable marking areas in the region of the sheath, which marking areas are intended in operation to be located in the region of the vessel puncture site. External readability can be achieved, for example, by providing radiopaque markers in the area. In addition, fluorescent or echogenic substances can be used to form the labels. According to a first embodiment, as shown in fig. 2 and 3, this area can be defined by two limit marks 29a and 29 b. These markings also guide the inflation and help locate the correct position of the sheath relative to the distal opening of the through passage 27 and its vascular puncture site. The respective markings can be provided, for example, on the sleeve 28 covering the base sheath 20 and on the base sheath 20. Alternatively, the entire region may be marked substantially uniformly by adding a suitable externally readable substance to the jacket material in that region. According to such embodiments, at least a portion of the expandable portion, such as the above-described flexible portion and/or stretchable portion of the sheath, can be marked.

Other components of the sheath 10 will now be described with reference to fig. 3, which fig. 3 shows the sheath 10 of fig. 1 in perspective view.

The channel 27 may be connected to different measuring devices, such as a blood pressure measuring device 30, by suitable connectors 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 cardiac output of the patient.

Via channel 27, guidewire 50 may be further inserted into the blood vessel. For example, access to channel 27 can be made via luer connector 55.

As mentioned above, the sheath 10 is adapted to be pushed through the supply conduit 40 of the heart pump 70. The heart pump 70 with the catheter 40 and the sheath 10 may be provided as a cohesive unit. The heart pump 70 is preferably introduced into the vascular system of the patient in the manner described above by introducing a sheath, which is removed with a peeling technique and replaced by advancing the sheath 10.

The above-described securing element 60 is used to secure (e.g., suture) the sheath 10 to the patient after insertion of the sheath into the patient's blood vessel. For this purpose, openings 66 may be provided. The fixation element 60 has a region 62 across the base sheath 20 for application of a sterile cover (not shown). The regions 62 of the fixing element 60 slope downwards in a ramp shape on both sides of the base sheath 20 transversely to the main direction of the base sheath. Furthermore, the fixing element 60 comprises a guide element 64, the guide element 64 serving as a stop for applying the sterile cover.

The fixation element 60 may also include circulation openings 67 and/or circulation open 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.