String-like elements, particularly sheath assemblies for inserting catheters into a patient's body.

Abstract

The present invention provides a sheath assembly for inserting a cord-like element into a patient's body, at least partially. [Solution] A sheath assembly for inserting string-shaped elements (32, 105), comprising an introduction sheath (101) and an auxiliary sheath (104) for insertion into the introduction sheath (101) together with the string-shaped elements (32, 105), comprising a first fastening means (106) for detachably fastening the auxiliary sheath to the introduction sheath and a second fastening means (107) for detachably fastening the string-shaped elements to the auxiliary sheath, wherein the introduction sheath (101) has a first sheath housing (13, 114), a distal tubular section (11, 41a) ending at the first sheath housing, and a first cleaning device (108), and the auxiliary sheath (104) has a second sheath chamber (111), a distal tubular section (112), and a second cleaning device (109).

Description

[Technical Field]

[0001] The present invention relates to the field of structure and can be particularly advantageously used in the field of medical technology. More specifically, it relates to a sheath assembly for inserting a cord-like element, in particular a catheter, at least partially into a patient's body. [Background technology]

[0002] It is a known principle to use an introduction sheath for the purpose of inserting a catheter into a patient's body, for example, into a blood vessel, with the proximal end of the sheath protruding from the patient's body and the distal end remaining inside the patient's body. Such an introduction sheath may be designed as, for example, an integral part, or it may be easily inserted sterilely through the skin or through an orifice in the patient's body. Such a sheath is advantageous, for example, when the catheter is inserted into and removed from the patient's blood vessel. One specific application of such a catheter is with a functional catheter, for example, a hollow catheter with a blood pump installed at one end, which is transported intravascularly to the ventricle or a large blood vessel, where it is optionally expanded. Suitable blood pumps capable of expansion and subsequent recompression are known in many forms in the literature.

[0003] However, other devices, such as surgical excision devices for removing deposits from blood vessels or other areas, can also be attached to the catheter as functional elements.

[0004] In Patent Document 1, the catheter introduction system comprises a catheter sheath having a valve for providing a friction fit to the catheter.

[0005] Patent Document 2 discloses a vascular introduction device comprising a proximal hub portion having an internal bore, an elongated sheath extending distally from the hub portion and having a lumen communicating with the internal bore of the hub portion, and a hemostatic valve installed within the bore of the hub portion. The hemostatic valve has a passage extending therein and includes a sealing flap that is movable between an open position relative to the passage and a closed position relative to the passage.

[0006] Patent Document 3 relates to a catheter system comprising an introducer having a main body, an introduction sheath protruding from the main body, and a first seal supported within the introducer, and a catheter having a main body, an outer sheath protruding from the main body, a second seal supported within the catheter, and an inner core configured to advance the main body, the second seal, and the outer sheath axially. The introducer may be configured to be selectively matable with the catheter so that the catheter can be selectively and detachably connected to the introducer axially. The catheter system may also be configured so that the catheter is rotatable relative to the introducer when the introducer and catheter are connected. The introducer may be configured to radially restrain the intracavitary prosthesis.

[0007] Regarding the insertion of catheter pumps, it has already been proposed in Patent Document 4 and other documents that an auxiliary sheath is used in addition to the introduction sheath, and that a catheter with a compression pump is inserted into the auxiliary sheath, and the auxiliary sheath temporarily holds the end portion of the catheter and the compression pump, and is then inserted into the introduction sheath together with the pump.

[0008] It is known that a sheath cleaning device may be provided in the sheath chamber where the article is inserted into the sheath, and this device may be used to clean the element to be inserted and / or the sheath opening before or during insertion to prevent bacteria and / or air from entering the patient's body. It is also known that a sealing device may be provided in this type of sheath to prevent blood or other bodily fluids from flowing out of the sheath before insertion of the element through the sheath, and to seal the opening into which the element is inserted into the sheath to the greatest extent possible from the area outside the opening during insertion of the element into the sheath. [Prior art documents] [Patent Documents]

[0009] [Patent Document 1] U.S. Patent Application No. 2004 / 0147877A1 [Patent Document 2] U.S. Patent Application No. 2008 / 0097386A1 [Patent Document 3] U.S. Patent Application No. 2010 / 0004730A1 [Patent Document 4] European Patent No. 2399639A1 [Overview of the Initiative] [Problems that the invention aims to solve]

[0010] Considering the prior art described above, the object of the present invention is to devise a sheath assembly that encompasses an introduction sheath and an auxiliary sheath, enabling the insertion of a cord-like element, particularly a catheter, into the introduction sheath via the auxiliary sheath in the most comfortable manner possible, thereby preventing bacteria or other unwanted objects and substances from entering the patient's body to the greatest extent possible. The sheath assembly is also protected to the greatest extent possible from the leakage of bodily fluids. Furthermore, trauma to the patient is minimized as much as possible, so that the outer diameter of the introduction sheath is made as slightly as possible larger than the outer diameter of the (optionally compressed) functional element and / or catheter. [Means for solving the problem]

[0011] This problem is resolved by the features specified in this application.

[0012] This solution requires a sheath assembly for inserting a string element, particularly a catheter, into a patient's body, comprising: an introduction sheath having a distal end provided for insertion into the patient's body and a proximal end that protrudes from the patient's body when the distal end is inserted into the patient's body; an auxiliary sheath for insertion into the introduction sheath together with a string element / catheter; a first fastening means for particularly detachably fastening the auxiliary sheath to the introduction sheath; and a second fastening means for particularly detachably fastening the string element to the auxiliary sheath, wherein the introduction sheath has a first chamber having a first accommodation passage for the string element and a first cleaning device for cleaning the sheath chamber; and the auxiliary sheath has a second sheath chamber having a second accommodation passage for the string element and a second cleaning device for the second sheath chamber. For example, this solution requires a sheath assembly for inserting a string-like element, particularly a catheter, into a patient's body, comprising: an introduction sheath including a distal end provided for insertion into the patient's body and a proximal end that protrudes from the patient's body when the distal end is inserted into the patient's body; an auxiliary sheath for insertion into the introduction sheath together with the string-like element / catheter; a first fastening means for particularly detachably fastening the auxiliary sheath to the introduction sheath; and a second fastening means for particularly detachably fastening the string-like element to the auxiliary sheath. The first sheath has a first sheath housing, which includes a first sheath chamber having a first accommodation passage for a string-shaped element, a distal tubular section ending at the first sheath housing, and a first cleaning device installed in the housing for cleaning the sheath chamber. The auxiliary sheath has a second sheath chamber having a second accommodation passage for a string-shaped element, a distal tubular section, and a second cleaning device for the second sheath chamber. The first sheath housing has means for positioning the distal end of the tubular section of the auxiliary sheath in the first sheath housing and proximal forward of the proximal end of the tubular section.

[0013] The sheath assembly according to the present invention ensures that the auxiliary sheath can be permanently and securely attached to the introduction sheath, and that the introduction sheath and auxiliary sheath are thus washable and kept in a clean, sterile state. Inside the introduction sheath, the chambers between the auxiliary sheath and the introduction sheath, and / or between the distal portion of the auxiliary sheath and the introduction sheath, are kept sterile by washing. Inside the auxiliary sheath, the cord-like elements placed in or protruding from this region, particularly the inner region of the auxiliary sheath along the catheter, are kept sterile by washing. As a result, an overall assembly is obtained that is permanently and mechanically held together at least until the connection between the introduction sheath and the auxiliary sheath is deliberately released, and that allows for easy cleaning of the transition from the introduction sheath to the auxiliary sheath and the transition from the auxiliary sheath to the cord-like elements placed thereon. In this way, it can be ensured that, on the one hand, the number of pathogenic bacteria and / or other contaminants entering the introduction sheath from the outside is minimized, while at the same time, blood leakage from the introduction sheath and auxiliary sheath can be prevented.

[0014] It is advantageous for the means for positioning the tubular portion of the auxiliary sheath inside the introduction sheath to encompass the cylindrical passage inside the introduction sheath, the diameter of which corresponds to the diameter of the tubular portion of the auxiliary sheath, or shows no substantial deviation from this diameter, i.e., 30% or less, particularly 15% or less. An annular land portion projecting radially inward in the form of a reduced diameter portion of the passage for the tubular portion of the auxiliary sheath may also be provided, forming an axial stop or an axial stop of a different configuration. The corresponding land portion leaves a round opening, the diameter of which corresponds to the inner diameter of the tubular portion of the auxiliary sheath, or shows no substantial deviation from this diameter, i.e., 30% or less, particularly 15% or less. Such an axial stop may be offset and thus can be positioned within the tubular section of the introduction sheath. It is possible to design the system so that the auxiliary sheath is inserted into the tubular section of the introduction sheath only by a distance sufficient to keep the auxiliary sheath itself proximal to the opening in the patient's skin. In this way, the diameter of the introduction sheath exceeds the diameter of the functional elements of the compressed catheter by only a minimum amount, thereby minimizing the risk of trauma and bleeding to the patient.

[0015] In another further development, the inner diameter of the tubular section of the auxiliary sheath is also larger than the inner diameter of the tubular section of the introduction sheath, resulting in a two-stage compression of the functional element. First, in the first step, as the catheter advances into the auxiliary sheath, the functional element is compressed to the inner diameter of the auxiliary sheath. Once transported to the introduction sheath, the diameter of the functional element is further compressed to correspond to the inner diameter of the introduction sheath. This two-stage compression ensures that the force used to compress the functional element does not exceed a critical value at which the connection of the functional element to the catheter would, for example, break. The same applies equally to sheaths with non-circular cross-sections, such as sheaths with oval or elliptical cross-sections.

[0016] In one advantageous embodiment of the present invention, the auxiliary sheath is provided to have a tubular distal portion and a proximal sheath housing, wherein only the tubular portion is particularly detachably connected to the introduction sheath.

[0017] In this case, the tubular portion of the auxiliary sheath is clamped inside the introduction sheath in a simple manner, thus being detachably fastened, and the assembly is configured such that the difference in concentricity between the tubular sections of the sheath relative to each other in the clamping area is 30% or less of the larger inner sheath diameter, and particularly advantageously, does not exceed the difference in sheath diameter. This helps to avoid the need for the string element / catheter to cross edges that could be damaged by the difference in diameter during transfer from the auxiliary sheath to the introduction sheath. Inside the auxiliary sheath, the outside of the tubular portion of the auxiliary sheath is kept sterile by a cleaning device, and the inside of the introduction sheath is kept sterile by a cleaning device. For example, a string element / catheter equipped with a compressed blood pump may be housed inside the tubular portion of the auxiliary sheath while the tubular portion is inserted into the introduction sheath. Once the tubular portion of the auxiliary sheath is inserted into the introduction sheath, the blood pump may be transferred from the auxiliary sheath to the introduction sheath, for example, to the tubular portion of the introduction sheath. In this process, the sterility of the surrounding area is simultaneously ensured during the transfer process by cleaning the inside of the introduction sheath.

[0018] The sterile tube in which the tubular part of the auxiliary sheath is disposed can be attached in a liquid-tight state to the end face of the introduction sheath. The sterile tube terminates the auxiliary sheath, particularly its housing, in a liquid-tight state. The sterile tube is axially compressed so that the auxiliary sheath, particularly its tubular part, is pressed against the introduction sheath and the string-like element is placed where it will be inserted into the introduction sheath. The sterile tube can be embodied, for example, as a corrugated tube.

[0019] In a further advantageous embodiment of the invention, it is provided that the auxiliary sheath has a tubular distal part and a sheath housing, and that the sheath housing of the auxiliary sheath is connected, particularly detachably, to the introduction sheath, particularly the sheath housing of the introduction sheath.

[0020] When the sheath housing of the auxiliary sheath is fixedly connected to the sheath housing of the introduction sheath, a solid and non-deformable unit is obtained as a whole, which is particularly easy to handle on the patient's body. And it is also particularly easy to insert the string-like element from the auxiliary sheath into the introduction sheath. When the auxiliary sheath is connected to the introduction sheath, the sheath assembly acts as a single multi-stage sheath.

[0021] The invention can be further advantageously embodied by connecting the auxiliary sheath to the introduction sheath in the form of a clamping connection by a detachable force coating or friction coating, a double-cone connection, a screw connection, a bayonet connection, a press-fit connection, or other detachable engagement connections. This type of detachable connection is easily manufactured and is released again under surgical conditions. Due to the simple mechanical function, no chemical bonding agent is required, so there is no risk of contamination when used on live patients. The relevant connection can be easily released in exactly the same way as during production.

[0022] Individual examples of corresponding detachable connections are specified in more detail below with regard to the exemplary embodiments.

[0023] The present invention can be implemented more advantageously by connecting a second cleaning device to a first cleaning device. In this example, the same fluid may be used in both cleaning devices, particularly since the fluid is exchanged between the first and second cleaning devices. This reduces costs and increases the certainty of sterility. For example, the same pump may be used in both the first and second cleaning devices to move the cleaning fluid.

[0024] In this example, it is advantageous that the inner chamber of the auxiliary sheath housing is directly connected to the first cleaning device by an auxiliary cleaning passage. In one implementation, for example, the auxiliary cleaning passage may extend from a conduit in the form of a hose or tube attached to the outer circumference of the auxiliary sheath housing. In this example, the cleaning device for the auxiliary sheath and the cleaning device for the introduction sheath have the same design, and only the two cleaning passages are interconnected.

[0025] However, it is also possible and advantageous for the auxiliary cleaning passage to extend directly from the sheath housing of the introduction sheath to the interior of the tubular section of the auxiliary sheath, particularly through an opening on the outer surface of the tubular section of the auxiliary sheath. Therefore, if the tubular section of the auxiliary sheath has an opening on its outer surface through which cleaning fluid flows in, the interior of the auxiliary sheath, especially the interior of the tubular section of the auxiliary sheath, can be cleaned in the inner chamber of the sheath housing of the introduction sheath, together with the outer region of the auxiliary sheath installed inside the introduction sheath. At this time, it is advantageous if the cleaning fluid flows axially along the tubular section of the auxiliary sheath, so that the auxiliary sheath is cleaned as a whole unit.

[0026] In this case, the irrigation fluid can move from the introduction sheath to the sheath housing of the auxiliary sheath, and in principle can move between the auxiliary sheath and the cord-like element / catheter installed therein, so that such a catheter / cord-like element is also kept sterile. This catheter / cord-like element is inserted into the patient's body, and therefore the cord-like element / catheter itself must be kept sterile.

[0027] In a more advantageous embodiment of the present invention, in a case of a direct connection between the sheath housing of an auxiliary sheath and the sheath housing of an introduction sheath, the auxiliary cleaning passage extends into the connection area, particularly through the wall region of the sheath housing of the auxiliary sheath installed within the introduction sheath, or through a portion of the wall of the introduction sheath housing surrounded by a portion of the auxiliary sheath. In this embodiment, a fixed passage-like connection is formed between the inner chamber of the introduction sheath and the inner chamber of the housing of the auxiliary sheath, thus ensuring the transfer of cleaning fluid between the inner chambers of the two sheath housings. In addition, at least one opening is provided on the outer surface of the housing of the auxiliary sheath, which may function for either the discharge of cleaning fluid or ventilation.

[0028] Alternatively or additionally, a subcutaneous injection needle is attached to the distal end of the auxiliary sheath and, for example, when the auxiliary sheath is inserted into the introduction sheath, penetrates the rubber gasket of the introduction sheath, such as a dome gasket or plate gasket, and protrudes into the interior of the cleaning chamber of the introduction sheath. As a result, a communication passage is formed between the inner chamber of the introduction sheath housing and the housing of the auxiliary sheath by the hollow chamber of the injection needle.

[0029] In one advantageous embodiment of the present invention, the introduction sheath and the auxiliary sheath abut each other as connecting partners in an annular region, an annular or arc-shaped circumferential groove extending in the circumferential direction is provided in at least one of the two connecting partners in the annular region, and both the sheath housing of the introduction sheath and the sheath housing of the auxiliary sheath are provided with a passage-like recess that connects the inside of the sheath to the circumferential groove in a connected state. In this example, the housing portion of the introduction sheath surrounds the housing portion of the auxiliary sheath in the connecting region, or conversely, the housing portion of the auxiliary sheath surrounds the housing portion of the introduction sheath in this region.

[0030] The passage-like recesses in the housing of the introduction sheath, particularly the housing wall, and the housing of the auxiliary sheath, particularly the housing wall, are interconnected by annular or arcuate passages, so that rotation of the auxiliary sheath relative to the introduction sheath will not hinder the establishment of the connection between the passage-like recesses. As a result, regardless of the rotation of the parts, high reliability is obtained when establishing a connection between the cleaning chambers of the introduction sheath and the auxiliary sheath as soon as the two housings are connected to each other. In this regard, the passage-like recesses and / or circumferential passages may be configured such that at least the passages provided in the housing of the introduction sheath, particularly both passages, are closed by sliding elements as soon as the two sheath housings are separated from each other.

[0031] The present invention is described below with reference to an example embodiment illustrated in a set of drawings, and will be described in more detail below. First, possible methods for securing the auxiliary sheath to the introduction sheath, or the catheter to the auxiliary sheath, will be described, and then the combination of the cleaning device and the mutual fastening of the two sheaths will be described in more detail. [Brief explanation of the drawing]

[0032] [Figure 1] This is a schematic diagram of the cardiovascular system with a sheath inserted. [Figure 2] This is a detailed view of one section of Figure 1. [Figure 3] This figure shows an embodiment of the present invention having a first sheath (introductory sheath) and a second sheath (auxiliary sheath). [Figure 4] This is a diagram showing an embodiment of the pump. [Figure 5] This diagram shows the second sheath (auxiliary sheath) with the pump removed. [Figure 6] This diagram shows the pump being stored in the second sheath (auxiliary sheath). [Figure 7] This diagram shows the pump being stored in the second sheath (auxiliary sheath). [Figure 8] This diagram shows the pump transfer from the second sheath to the first sheath (inlet sheath). [Figure 9]This diagram shows the pump transfer from the second sheath to the first sheath (inlet sheath). [Figure 10] This is a longitudinal section showing a sheath housing with tubular divisions. [Figure 11] This is a longitudinal section showing a part of the sheath housing containing a cutting device. [Figure 12] This is a longitudinal section showing a sheath housing having a clamping device for pipe-shaped division and an additional clamping device. [Figure 13a] This is a longitudinal section showing an alternative clamping ring with a conical clamping pad. [Figure 13b] This is a longitudinal section showing a clamping connection portion, each having longitudinal grooves and beads on its outer surface. [Figure 13c] This is a longitudinal cross-section showing a clamping connector having a clamping connector in the shape of a threaded connector. [Figure 13d] This is a longitudinal section showing a clamping connection part in the shape of a conical connector, including the bayonet sheath. [Figure 13e] This is a diagram of the cone from Figure 13d rotated by 90°. [Figure 13f] This is a longitudinal cross-section showing a lure cone connector with a threaded connector. [Figure 13g] This is a longitudinal section showing a clamping connection portion having a spring clip that is guided within the sheath housing, displaced laterally, and expandable radially. [Figure 13h] This figure shows possible embodiments of the elements that are clamped in the region of the clamping point. [Figure 13i] This figure shows a side view of the spring clip in Figure 13g, rotated 90° relative to Figure 13g. [Figure 14] This is a longitudinal section showing a sheath housing with a clamping device for a cord-shaped element inserted on the proximal side. [Figure 15] This diagram shows an introduction sheath and an auxiliary sheath coupled to it, illustrating that a cleaning device for the two sheaths is connected. [Figure 16]This diagram shows the introduction sheath and the auxiliary sheath connected to it, with the connection part located inside the auxiliary sheath being positioned inside the introduction sheath. [Figure 17] This figure shows a sheath assembly with the auxiliary sheath and introduction sheath sheath housings fixedly connected. [Figure 18] This diagram shows an introduction sheath, including an auxiliary sheath, that can be housed in a sterile tube. [Figure 19a] This figure shows an axial cross-sectional view of the introduction sheath, including the auxiliary sheath and the cord-shaped element / catheter inside the auxiliary sheath, with the auxiliary sheath extending inside the introduction sheath. [Figure 19b] This is an axial cross-sectional view showing an auxiliary sheath containing a cord-shaped element / catheter inside the auxiliary sheath. [Figure 19c] This is an axial cross-sectional view showing the introduction sheath containing the string-shaped element / catheter inside the introduction sheath. [Modes for carrying out the invention]

[0033] Figure 1 shows a schematic diagram of the human cardiovascular system 1. A single femoral artery 2 is located in the groin area, which connects to the aortic arch 3 via the main artery and then leads to the heart chambers 4. For example, using the Seldinger technique, an introduction sheath 10 is first inserted into the femoral artery 2. In this process, the femoral artery or some other vessel is first perforated using, for example, a steel cannula equipped with a cutting edge. A guidewire 12 is then pushed through the perforated opening into the inserted steel cannula and retrogradely inserted into the left ventricle 4 via the aortic arch 3. Once the perforated cannula is removed, the first sheath 10, which embodies the introduction sheath and includes a tubular section 11 and an optional but not illustrated dilator, is screw-connected to the guidewire and inserted into the cardiovascular system through the perforation site. The sheath is inserted only a short distance into the lumen of the cardiovascular system, or to the site where the elements to be inserted are located. Then, a fluid pump is inserted into the cardiovascular system from the introduction sheath 10.

[0034] The tubular section 11 of the first sheath 10 is inserted into the artery such that the proximal end of the first sheath 10 is located lateral to the femoral artery and protrudes from the patient's body, and can therefore be used, for example, to insert a blood pump. The pump is screw-connected to a guidewire 12, and the pump is guided to the left ventricle with the assistance of the guidewire.

[0035] It is also possible to guide the tubular section / section 11 of the first sheath / introduction sheath 10, guided by the guidewire, to the left ventricle, and then withdraw the guidewire 12 from the first sheath. This allows the pump unit to be guided through the lumen of the first sheath to the vicinity of or inside the left ventricle 4.

[0036] The above describes only the method of inserting a pump into the left ventricle to support cardiac function. However, it will be readily apparent to those skilled in the art that pumps or any other functional elements can be positioned and inserted into other parts of the body's cardiovascular system.

[0037] Needless to say, other functional elements, particularly compressible and expandable elements, rather than blood pumps / cardiac support pumps, may be inserted via a catheter and sheath.

[0038] Figure 2 shows the first sheath 10 passing through the body's tissues from the outside into the lumen L of the femoral artery 2. G The area shown in Figure 1 is where the guide is located. In this example, the first sheath includes a tubular section 11 connected to the proximal side of the sheath housing 13. The tubular section 11 has an inner diameter d 11 A lumen L1 having the following characteristics is defined. In region 14, this lumen expands in a trumpet shape toward the proximal end of the tubular section 11.

[0039] The sheath housing 13 includes a hemostatic valve, which is well known in this art. This valve has a lumen L G This prevents the fluid held inside from flowing out through the lumen L1 to the outside.

[0040] In the example shown in Figure 3, the first sheath 10 from Figure 2 is connected to the second sheath 20. Only the tubular section 21 of the second sheath 20 (auxiliary sheath) is shown, which has an inner diameter d 21 The lumen L2 having is defined. The distal end of the second sheath 20 has an outer diameter such that the end can be inserted into the sheath housing 13. However, the inner diameter d 21 The inner diameter is d 11 Larger.

[0041] A pump, located inside lumen L2 and not shown in the figure, is transferred from the second sheath lumen L2 to the first sheath lumen L1 by applying pressure. The pump is then transported through the first sheath lumen L1 to a site within the cardiovascular system where it is positioned. In this step, the pump may be guided along a guidewire or inserted into the first sheath lumen without a guidewire. To protect the shaft catheter along with the pump and the vascular wall, the first sheath is advanced distally and anteriorly to the pump position before the pump is pushed out.

[0042] One possible embodiment of the pump 30 is described in more detail with reference to Figure 4. The pump 30 comprises a distal pump unit 31 and a shaft catheter 32 attached to the proximal end of the distal pump unit 31. The shaft catheter 32 has a coupling at its proximal end (not shown) for connecting the shaft catheter 32 to a drive unit. The drive unit is located outside the patient's body and rotates a flexible shaft extending inside the shaft catheter 32, so that the flexible shaft drives the distal pump unit 31. However, the present invention is also suitable for inserting pumps that are operated in a different way (by an electric motor located on the pump or by an air turbine disposed on the pump).

[0043] The distal pump unit encloses a pump housing 33 manufactured from crossed nitinol braces. A portion of the nitinol housing is provided with a coating 34 that extends distally and proximal to a rotor 35 located inside the housing 33. The rotor extends to a shaft catheter 32 and connects to a shaft 36 on which it rests during rotation. The housing and rotor are compressible; that is, the pump is an automatic decompression pump. The pump expands when the distal pump unit is pushed out from the distal end of the sheath. To compress the pump during preparation for a demonstration, the distal pump unit is housed in the distal end of the lumen of a second sheath (auxiliary sheath). This lumen has an inner diameter larger than the outer diameter of the shaft catheter.

[0044] In particular, the rotor may be axially displaced relative to the pump housing due to the axial displacement of the drive shaft. Conversely, the rotor may be fixed axially relative to the pump housing.

[0045] The pump optionally has a discharge pipe 37 that defines a flow path for the supplied fluid, located proximal to the rotor 35. Located at the proximal end of the discharge pipe 37 is an outlet opening, which will not be described in detail.

[0046] Naturally, since the pump can switch from supplying to suctioning, it does not conduct fluid from the distal end to the proximal end, or vice versa.

[0047] Further details regarding suitable pumps can be found, for example, in reference EP 2 047 872 A1.

[0048] Now, the system's functions are described in more detail with reference to Figures 5 through 9.

[0049] Figure 5 shows pump 30' which substantially corresponds to pump 30 in Figure 4. For the sake of simplification, the details of the pump are not shown. A bulbous housing and a "pigtail" located distal to the bulbous housing to prevent the cardiac pump from being drawn into the heart wall are shown. The shaft catheter 32' extends proximal to the distal pump unit 31'. The second sheath 20' is positioned to surround the region 38' of the shaft catheter 32', and this sheath has a lumen L2 and an inner diameter d 21 In its expanded state, it is smaller than the diameter of the distal pump unit 31'.

[0050] The pump 30′ shown in Figure 5 is a compressible pump; in other words, the distal pump unit 31′, which includes the pump housing and the rotor mounted thereon, is designed to be compressible, that is, to have its diameter reduced. Once a quality assurance inspector, such as a physician, confirms the proper functioning of the pump 30′ by observing the rotational movement of the rotor unit mounted on the distal pump unit 31′ during a test operation, the distal pump unit 31′ is retracted into the lumen L2 of the second sheath 20′ by pulling the shaft catheter 32′ proximal. Retracting the pump into the second sheath 20′ prevents bending and / or breakage of the shaft catheter and / or the shaft mounted therein. The pump 30' and the second sheath 20', which surrounds the region 38' of the shaft catheter 32' shown in Figure 5, form a system 200, which allows for timely functional testing of the pump 30' before operation and prevents damage to the shaft by compressing the pump by pulling the distal pump unit 31' toward the distal end of the second sheath 20'.

[0051] The system may be equipped with both active and automatic depressurizing pumps, but it is particularly suited to automatic depressurizing pumps, that is, pumps in which the distal pump unit automatically returns to the first dimension outside the sheath.

[0052] Figure 6 shows an intermediate step in the hoisting of the distal pump unit 30' into the lumen of the second sheath 20'. Since the distal pump unit 30' is compressible and can be small in diameter, it is clear that the distal pump unit 30' can be housed in the lumen of the second sheath 30'.

[0053] As shown in Figure 6, the connector 39' is attached to the shaft catheter 32', and this connector allows the shaft extending within the shaft catheter to be connected to the drive unit. The outer diameter of the connector 39' is often larger than the inner diameter of the lumen L2, and in most cases, the second sheath 20' is pressed distally from the proximal end of the shaft catheter 32' prior to the attachment of the connector 39', so that the pump is delivered in the system 200, that is, the pump is delivered together with the second sheath 20' placed proximal to the distal pump unit 31' and the pre-attached connector 39'. Figure 6 also shows a slight widening of the distal end of the second sheath 20'. The trumpet-shaped extension 24' facilitates the insertion of the distal pump unit 31' into the lumen L2 of the second sheath 20'.

[0054] Finally, in Figure 7, the entire distal pump unit 31' is installed inside the lumen L2 of the second sheath 20″. The second sheath 20″ has two pre-attached grip units 22″ that allow for good retention and / or removal of the second sheath 20″ and / or good subsequent detachment when the pump unit 31' is housed in the lumen L2. However, according to the present invention, it is also advantageous to use an auxiliary sheath that remains permanently connected to or held in the introduction sheath. If a “pigtail” is provided, it is also housed in the lumen L2, so that the distal pump unit 31' is housed inside the lumen L2 together with the pump components that are installed distal to the distal pump unit 31'.

[0055] Figure 8 illustrates how the system 200, consisting of the pump 30' and the second sheath 20'', is combined with the first sheath 10 in an actively connected state to form system 100. First, the second sheath 20'' (auxiliary sheath) is inserted at its distal end into the sheath housing of the first sheath 10 (introduction sheath). As soon as the distal tip of the second sheath 20'' reaches the opening of the tubular section of the first sheath 10, the pump is transferred from the second sheath 20' to the first sheath 10' by pressing the pump distally, and the pressure is achieved by applying pressure to the shaft catheter 32'. In this process, the diameter of the distal pump unit 31' is equal to the inner diameter d of the lumen L1. 11 It will be further reduced to this size.

[0056] Figure 9 shows the next step in which the entire distal pump unit 31' is positioned inside the lumen L1 of the first sheath 10. The fact that the entire distal pump unit 31' is positioned inside the lumen L1 of the first sheath 10 can be indicated, for example, by a color marking 50 applied to the outside of the shaft catheter 32'.

[0057] Assuming that the second sheath 20″ is embodied as a "detachment" sheath, the second sheath can be optionally removed from the shaft catheter 32′ by peeling the detachment sheath from the proximal end to the distal end. Detachment in a fixed direction from the proximal end to the distal end may be assisted by notch A, but is mainly based on the orientation of the molecular chains of the plastic used in the proximal-to-distal direction.

[0058] Once the sheath is removed, the pump 30' is guided further to the desired location inside the lumen L1 of the first sheath 10.

[0059] Optionally, the first sheath may be pressed forward along with the distal sheath opening immediately adjacent to the placement site before and after the pump is inserted. The length of the first sheath is sufficient for this purpose.

[0060] Since the risk of shaft breakage during the pulling motion is substantially reduced, reinforcement of the second sheath 20″ is not necessary, especially when the distal pump unit 31′ is housed in the distal end of the lumen L2 of the second sheath.

[0061] As shown in Figures 7 to 9, since the pump is transferred from the second sheath to the first sheath, the second sheath may contain a reinforcing structure in the form of an insertion wire, or the tubular section 21" of the sheath 20" may be made of rigid plastic or metal instead of flexible plastic.

[0062] Further options for stabilizing the pump and the second sheath involve holding the second sheath 20″ in the form of a stable outer sleeve and / or by a support device 40 as a receiving passage for the introduction sheath, when the pump 30′ is pressed distally forward, that is, particularly when the pump 30′ is transferred from the second sheath to the first sheath.

[0063] The following describes another possible variation of the method for inserting the pump into the left ventricle of the heart. As a preparatory step, the pump is first filled with sterile saline solution, thus completely removing air. Then, an auxiliary sheath, positioned adjacent to the distal pump unit, is pushed forward towards the discharge tube, if provided. The auxiliary sheath has a diameter of, for example, 10 Fr. Once the auxiliary sheath has advanced to the discharge tube, it is enclosed in a sleeve-shaped support device. Then, by applying a pulling motion proximal to the shaft catheter, and optionally with a slight rotational motion, the distal pump unit is retracted into the auxiliary sheath. The pump is further pushed into the auxiliary sheath so that any existing pigtail is also concealed inside the auxiliary sheath. These steps allow for testing the proper function of the pump before surgery, and also allow for insertion into the sheath immediately after testing, without the need to perform such actions under time constraints. For example, the vascular system is perforated to insert the first sheath immediately after testing. However, to save time, the assistant can prepare the pump while the surgeon performs the perforation in parallel.

[0064] Once the 9Fr insertion sheath is inserted into the left ventricle of the heart, the dilator, if present, can be optionally withdrawn from the insertion sheath and removed.

[0065] Next, the pump, held inside the auxiliary sheath and initially surrounded by, for example, a sleeve, is pushed into the sheath housing of the introduction sheath until the tip of the auxiliary sheath hits a mechanical stop. Then, by applying pressure to the shaft catheter, the pump is transferred from the auxiliary sheath to the tubular section of the introduction sheath. Once the entire distal pump unit has been transferred into the introduction sheath, as can be confirmed, for example, based on any markings on the shaft catheter shaft, the auxiliary sheath is left inside the introduction sheath, or optionally the detachment sheath is peeled off and removed from the shaft catheter. The pump is then pushed forward inside the first sheath (introduction sheath) to the left ventricle. Then, the first sheath is pulled back from the left ventricle to the starting point of the descending aorta.

[0066] The positioning of the distal pump unit in the left ventricle can be confirmed, for example, by radiographic imaging. For this purpose, radiographically detectable markings are placed on or near the pump housing, for example, on the catheter, or the pump housing itself is radiographically detectable. The pump outlet region, i.e., the outflow opening of the discharge tube, should also be located in the region of the ascending aorta. This can also be confirmed by radiographically detectable markings. If a pigtail catheter tip is present, it should be in contact with the tip of the left ventricle.

[0067] To remove the pump from the ventricle, a traction force is applied to the shaft catheter, pulling the pump back into the introduction sheath, removing it from the arterial vascular system and compressing it. If the first sheath is already shortened, the pump is first pulled back a short distance into the shaft catheter to compress it. For this purpose, the shaft catheter may have a storage funnel on the drive shaft into which the pump is retracted by tension. The first sheath and the other remaining components are then removed from the cardiovascular system.

[0068] The present invention offers particular advantages when a long sheath is used, especially as an introduction sheath, for pump implantation and external implantation. The long sheath is useful not only for inserting the pump into the internal lumen of the body, as is common in the prior art, but also for guiding the pump through the lumen of the sheath to the area of ​​the implantation site. In this regard, in the medical field, it is advantageous for the sheath to have a length between 40 and 120 cm. This length is determined by the site of the pump implantation to be performed later and the patient's physique.

[0069] Once the pump is removed from the body's lumen along with the long sheath, a compression bandage is used to stop bleeding from the femoral artery. Alternatively, the pump may be removed from the lumen of the long sheath. An additional guidewire is then positioned through the lumen of the sheath, and once the sheath is removed, a device for closing the hole may be guided through this wire. This results in improved hemostasis.

[0070] Figures 10 to 13 illustrate modified examples of the first sheath according to the present invention, which has one or more clamping devices for fixing the tubular section 41 to the sheath housing 43.

[0071] Figure 10 also shows a longitudinal section of the sheath housing 43, which substantially has the shape of a cylindrical sleeve, closed at least at the distal end 44 facing away from the patient's body by a pressure screw 45. The sheath housing 43 has a continuous housing passage 46 for a tubular section 41 of the sheath. In the diagram of Figure 10, the tubular section 41 is shown with a solid line up to the irrigation chamber 47 of the housing passage 46, and then with a dotted line proximal to that point. This indicates that the tubular section 41 is axially displaced relative to the sheath housing 43 within the housing passage 46, or in other words, the sheath housing 43 is displaceable in the tubular section 41.

[0072] The sheath shown here can be used, for example, as an introduction sheath (first sheath).

[0073] To insert a functional element, such as a pump, into the first sheath, the tubular section 41 is either fully extended distally from the sheath housing 43, or positioned during the manufacturing of the first sheath, and then clamped in place by, for example, operating a pressure screw 45, such that the tubular section 41 terminates at approximately the height of the first stop member 48. Then, in order to move the pump from the second sheath to the first sheath, the second sheath, which includes the aforementioned housing pump, is pushed forward to this point.

[0074] The first clamping device includes a first pressure screw 45, a first clamping ring 50 made of elastomer material, and a first stop member 48 as a fastening means. A sliding layer or a rotating seal ring 69 may be provided between the clamping ring 50 and the pressure screw 45.

[0075] The pressure screw is screwed to the distal end 44 of the sheath housing 43 by an external thread in the overlapping region. Therefore, manual rotation of the pressure screw 45 causes the pressure screw to move axially, resulting in axial compression or expansion of the clamping ring 50. In the case of axial compression, the clamping ring 50 receives resistance from the first stop member 48 on the proximal side, so the clamping ring 50 tends to clamp the tubular section 41 by maintaining its volume radially inward and expanding outward.

[0076] In this way, the tubular section 41 is fixed axially to the sheath housing 43. This fixation can be easily released by releasing the pressure screw 45, so that the tubular section 41 can be displaced a short distance axially inside the sheath housing 43. For this reason, in the relaxed state, the clamping ring may have an inner diameter equal to or greater than the diameter of the first sheath.

[0077] Therefore, if the tubular section 41 initially advances as deep as possible into the patient's body so that the pump is inserted into its intended location, for example, the ventricle of the heart, while protected by the sheath, once the pump is delivered, the tubular section 41 is withdrawn, and the entire sheath protrudes a relatively long distance from the patient's body. The clamping devices 48, 45, 50 are then released, and the sheath housing 43 can advance closer to the patient's body in the tubular section 41. In this step, the tubular section 41 extends all the way to the sheath housing 43 and optionally protrudes proximally from the housing. The tubular section 41 may be partially removed to remove the excess length using means described in more detail below.

[0078] To generate a good seal, a so-called composite hemostatic valve, consisting of a dome valve 51 and a valve plate 52, is provided inside the sheath housing 43. When neither the tubular section 41 nor the shaft catheter extends into the housing passage 46 at any point in the sheath housing 43, the valve plate closes the sheath housing 43, while the dome valve 51 is optimized to create a tight seal around the cord-shaped element, such as the tubular section or catheter.

[0079] An additional pressure screw 54 is provided at the proximal end 53 of the sheath housing 43, which in principle functions in the same way as the first pressure screw 45, and also influences the compression of the second clamping ring 56 against the second mechanical stop 57 via the clamping pad 55. In this way, the catheter, or the inserted auxiliary sheath, can be clamped into the introduction sheath. It should be noted here that a unique feature is that the second clamping ring 56 extends in a conical shape at its distal end, which is advantageous for radial inward deformation when axial pressure is applied by the pressure screw 54. The second stop 57 is appropriately designed as an opposite cone shape. However, a non-conical clamping ring 56, or one with a rectangular or round cross-section instead, can also be used at this location.

[0080] Figure 10 schematically shows a cleaning device 58 for cleaning a cleaning chamber 47 inside the sheath housing with a fluid that prevents bacteria from entering the patient's body from the first sheath. This cleaning is particularly effective when the tubular section 41 terminates at the cleaning chamber 47 or its distal end, so that the cleaning fluid reaches both the outside and inside of the tubular section 41.

[0081] Figure 11 illustrates the configuration and functional modes of a cutting device according to the present invention as an example.

[0082] If predetermined fracture points are not provided, pre-cut, or provided by other means, for example, by a predetermined molecular structure or local weakening of the wall thickness of the tubular section 21, these can be appropriately introduced by a cutting device during use of the first sheath. In Figure 11, a cutting device equipped with blades 59, 60 is provided in the area of ​​the cleaning chamber 47 of the sheath housing 43, and these blades cut the housing circumferentially, for example, when the sheath housing is rotated relative to the tubular section. Cutting may also be performed axially.

[0083] For this purpose, blades 59 and 60 may be arranged to cut longitudinally when the tubular section 41 is moved axially, as indicated by arrow 61. It is also possible to provide a blade for cutting circumferentially and a single blade for cutting longitudinally.

[0084] Figure 11 further shows that the blades 59 and 60 are moved radially into the tubular section 41 by manipulating the blades from outside the sheath housing 43. At this location, radially extending guides, corresponding seals, and spring mounts are provided for one or more blade holders, preventing bacteria from entering the blade displacement device, and in the non-operational state, the blades are positioned at a radial distance from the tubular section 41. Once the first sheath is used, pressure can be applied to the blades by hand, potentially cutting off a portion of the tubular section 41 that is no longer needed. A stopper (not shown) prevents damage to a catheter that may be placed inside the sheath by exceeding a critical cutting depth.

[0085] The illustrated blade also forms a cutting device for the second sheath.

[0086] Figure 12 illustrates the advantageous use of the second clamping device at the proximal end of the sheath housing 43 when the tubular section 41 is shortened and the shaft catheter 61 protrudes from the proximal end of the tubular section 41 and the sheath housing 43 and is connected to a coupling device (not shown) for the drive shaft of the pump. The shaft catheter is sealed in the dome seal 51 described above, and the clamping device, which includes elements of the second pressure screw 54, and the second clamping ring 56, which is axially compressed against the second stop 57 by the clamping pad 55, expand radially inward enough to clamp the shaft catheter 61, which has an outer diameter substantially smaller than the tubular section 41, or in particular the second sheath which also seals the catheter. However, this clamping does not prevent rotation of the shaft, which is rotatable inside. In this way, both the tubular section 41 and the shaft catheter 61 protruding from it can be fixed inside the sheath housing 43.

[0087] Just as the second sheath is properly secured to the sheath housing 43, particularly to the tubular section 41, so that the shaft catheter 61 is pushed in, the second clamping device is also suitable for securing the second sheath with the second clamping ring 56 during insertion of the second sheath into the sheath housing 43.

[0088] The first and second clamping rings 50 and 56 are made of elastomer, such as rubber or silicone elastomer, and are therefore fully flexible, but deformable while remaining incompressible in volume. However, a flexible foam that is partially compressible in volume may also be used in this location. Instead of the clamping rings 56, radially displaceable spring clips are provided to create a clamping connection, as illustrated in Figures 13g, 13h, and 13i, and will be further described below. Corresponding spring clips may be provided in addition to or instead of the clamping rings. The spring clips may be provided in the area of ​​the dotted line 70 in Figure 12. However, since the area of ​​the dotted line 70' is proximal to the seal 51, it is advantageous for the spring clips to also be provided in the area of ​​the dotted line 70', and therefore it is not necessary to apply particularly high stress to the seal of the sliding mechanism of the spring clips.

[0089] Figures 13a to 13i show sheath clamping and / or fixing devices, which can be used on the introduction sheath and / or auxiliary sheath, individually or in combination.

[0090] Figure 13a shows a schematic diagram of a clamping ring 62 of a type that is made of, for example, plastic or metal, and is particularly slotted so that it can be compressed radially. The slotted clamping ring 62 has a conical outer contour, and as soon as an axial compressive force is applied to the clamping pad 63 in the direction of arrow 65, for example by the pressure screw described above, the clamping ring is compressed radially so that the conical contour of the clamping pad 63 is pressed against this outer contour. The slotted clamping ring 62 is fixed axially by a stopper member 64.

[0091] Figure 13b shows an adapter member 71 inside a sheath housing 43 having a through passage 72, the cylindrical outer surface of which is provided with a continuous longitudinal groove and bead 73, which engages with the longitudinal groove and bead 74 on the engaging adapter member 75 of the element 76 to be clamped. The engaging adapter member 75 is inserted into the adapter member 71 and snapped in place by its flexibility, holding it in place and advantageously forming a seal. A stopper member 77 prevents the element 76 from being inserted too deeply, so that the snap connection can be detected by touch.

[0092] Figure 13c shows a configuration similar to that of Figure 13b, where each of the adapter member 71' and the engaging adapter member 75' is equipped with a screw rather than concentric continuous longitudinal grooves and beads. The engaging adapter member 75' is moved toward the adapter member 71' by rotating it, but it is also conceivable to insert the adapter axially beyond the screw. A visual marking 78 is provided on the clamped element 76 to enable identification of the target position. However, a mechanism may be provided to activate electrical contacts to emit a signal when the target position is detected by touch or sound by shape marking, or when the target position is reached or left.

[0093] Figure 13d shows a cone 79 on the clamped element 76, which fits into a conical recess 80 of an adapter member 71' that forms a seal. The cone 79 has one or more circumferential pins 81 which are guided within a gate 82 on the inner circumferential surface of the recess 80, helping to form a bayonet-type sheath. Conversely, the pins may be provided on the outer cone and the gate on the inner cone. A so-called Luer sheath may be formed while maintaining a corresponding standard in the connection between the sealed cone and the sheath. Instead of a bayonet sheath, a threaded connection may also be provided with the cone system.

[0094] Figure 13e shows a rotational side view of the cone 79 containing the two pins 81.

[0095] Figure 13f shows a cone system having a cone 79' and a threaded nut 83 surrounding this cone. The threaded nut 83 can be screw-connected to the threads of a pipe socket 84 connected to an adapter member 85. The adapter member 85 is fixedly incorporated into the sheath housing 43 of the introduction sheath and has an inner cone. The threaded nut 83 can also be embodied as a cap nut that is freely rotatable relative to the cone 79'.

[0096] Figure 13g shows a sheath housing having a radially displaceable spring clip that can be operated by a push button 87. A stopper 88 is provided to stop the push button 87 at a target position. In addition, a photodetectable marking may also be provided on the spring clip. When the spring clip 86 is moved into the sheath housing, it enters the opposite guide 89. Before that, the spring clip elastically expands upon impact with the element to be clamped 76. For this purpose, the spring clip has an entrance opening 90 as shown in Figure 13i. As insertion continues, a retaining area 91 is supported around the element to be clamped. As is evident from Figure 13h, this element may have a continuous groove or longitudinal groove 92, or a collar 93 having such a longitudinal groove 92. In this modification, the functions of clamping and sealing the element to be clamped are separate.

[0097] Contrary to the described method of function, clamping may also be performed by advancing the spring clip all the way to the sheath housing 43 and then inserting the element to be clamped, for example, a catheter or a second sheath, axially. In this example, the conical guide bevel 94 clamps the collar 93, which is inserted together with the element, to the spring clip 86, where it is held in place.

[0098] In principle, the clamped element / second sheath is also held to the first sheath by flexible, self-covering vanes, fins, or teeth that cover the element or make it significantly difficult to pull it out of the sheath. Such vanes are schematically illustrated on the left side of Figure 13d and are identified by reference numeral 95.

[0099] Figure 14 shows the sheath housing 43' of an introduction sheath, which has an internal receiving passage 46 for a sheath and / or catheter. At the distal end 44, the sheath housing 43' has a tubular section 41 fastened to the end, which may be joined, cast, or otherwise fastened to the opening of the sheath housing, for example. The tubular section 41 is inserted into the opening of the sheath housing 43' up to a mechanical stop 63.

[0100] The second sheath 20″ (auxiliary sheath) is inserted into the housing passage 46 from the proximal end 53 of the sheath housing 43′ to a sufficient extent to terminate the mechanical stop 63 distally. In one embodiment, the system may be designed so that the second sheath 20″ terminates just at the tubular section 41. Functional elements in the form of a pump with a hollow catheter are housed, for example, in the second sheath 20″′, but these will not be described further.

[0101] To transfer the catheter, including the pump, from the second sheath 20'' to the tubular section 41 of the first sheath 43'',41, the two sheaths are coaxially aligned with each other within the housing passage 46, and the second sheath 20'' is fixed in place by a clamping device. The clamping device has a flexible clamping ring 56'' which is embodied as a cone shape at its distal end and pressed against a mechanical stop 57''. For this purpose, axial pressure is applied to the clamping ring 56'' by a pressure screw 54'' having an external thread 64. For this purpose, the pressure screw 54'' is screw-connected to the opening of the tubular section of the sheath housing 43'' and moves axially in the direction of arrow 65.

[0102] To reduce friction between the rotating pressure screw 54' and the clamping ring 56', it is advantageous to provide a rotating seal ring 69 made of, for example, PTFE or another plastic with good sliding properties.

[0103] The clamping ring 56′ is made of, for example, elastomer and clamps the cord-shaped element installed in the housing passage 46 by expanding radially under axial pressure. In the clamping area, the element to be clamped may have one or more continuous beads, lands, grooves or longitudinal grooves, or edges, for example, to improve the clamping action. For this purpose, the element may be provided with a collar. The second sheath 20″′ has a wall thickness between 0.3 and 0.7 mm and is made of a material stable enough to withstand radial pressure, and the second sheath can clamp the catheter extending inside without simultaneously clamping it. Thus, the catheter is easily pushed out from the proximal end of the second sheath 20″′ into the tubular section 41. The second sheath 20″′ is sealed in the washing chamber 47 by a combination of plate and dome seals 51, 52.

[0104] When functional elements, such as a pump, are transferred together with the catheter from the second sheath 20'' to the tubular section 41, the second sheath is detached and removed using manual tabs 67, 68. For this purpose, the second sheath has axially weak areas or notches, or corresponding predetermined molecular structures, so that it can be appropriately removed by longitudinally rupturing it to its distal end. To rupture the sheath, it would be convenient to release the clamping devices 54′, 56′, 57′.

[0105] When the second sheath is removed or partially removed, the clamping devices 54', 56', and 57' are held in close contact with each other, as a result of additional radial compression of the clamping ring 56', a small-diameter catheter is clamped in the housing space 46. The catheter, and therefore the implanted pump, is thus fixed axially to the first sheath, and therefore to the patient's body, at the distal end of the catheter.

[0106] However, a second sheath (auxiliary sheath) may be implemented so that it remains attached to the initial sheath. In this case, proper sealing and cleaning performance should also be guaranteed, as will be described in more detail below.

[0107] For each of the different end positions of the pressure screw corresponding to the different diameters being clamped, a stop is provided that is recognizable by an unillustrated form of the sheath housing, so that when the screw reaches each clamping position, the user can detect a clear increase in rotational resistance to the operation of the screw.

[0108] Following an initial stage in which the assembly is mechanically stable and warmed to the patient's body temperature, the clamping device is released, the catheter is readjusted, and then re-fastened. At any point in the described structure in which one of two cylindrical elements is inserted into the other to form a seal, a conical seal having a conical angle of several degrees is advantageous, as is well known, when used in the medical field as a rule.

[0109] In the described sheath embodiment, for example, an implantable heart pump can be transferred from a second sheath, which is ready after initial examination, to a first sheath, which is connected to the patient's body, without problems, with low complexity and high reliability.

[0110] Figure 15 shows the introduction sheath 101 on the right side of the figure and the auxiliary sheath 104 on the left side, with the tubular portion 112 of the auxiliary sheath being inserted into the introduction sheath 101 and held in place.

[0111] The introduction sheath 101, like the auxiliary sheath 104, substantially corresponds to the sheath shown in Figure 14 and described in the text.

[0112] The entire sheath assembly shown in Figure 15 includes an introduction sheath and an auxiliary sheath, and is suitable for inserting the cord-like element / catheter 105 from the auxiliary sheath 104 to the introduction sheath 101, and then from the introduction sheath into the patient's body.

[0113] The introduction sheath 101 further has a tubular section 41a at its distal end 102 that is fixed to the proximal section 103 forming the sheath housing 114 to form a seal. The tubular section 112 at the distal end of the auxiliary sheath 104 is inserted into the introduction sheath 101 and pushed in up to a stop 63 in front of the tubular section of the introduction sheath. The stop 63 simultaneously forms an axial stop for the tubular section 112 of the auxiliary sheath and for the proximal end of the tubular section 41a of the introduction sheath, and the tubular sections 112,41a may have the same inner diameter as the flange-type stop 63. The stop 63 is formed in the housing wall of the sheath housing. The introduction sheath has a first fastening means 108 as a clamping device, which is described in detail with reference to Figure 14, and is similar in design to, for example, the second fastening means 107 of the auxiliary sheath 104. However, in principle, the first and second fastening means may encompass each of the types of fastening means shown as examples in Figures 13a to 13j.

[0114] To maintain a sterile transition area between the auxiliary sheath and the tubular portion of the introduction sheath located in the inner chamber 110 of the housing 114 of the introduction sheath, and to clean this area for this purpose, the cleaning device 108 comprises a corresponding cleaning tube and an opening provided in the wall of the housing 114. The cleaning device is connected to a cleaning medium supply source 120, which includes, for example, a pump 121 and a container 122. The auxiliary sheath 104 similarly has a cleaning device 109 comprising a cleaning tube and an opening in the wall of the housing 113. Through this cleaning device 109, the interior of the housing 111 of the auxiliary sheath, and thus the transition area from the catheter 105 to the tubular portion 112 of the auxiliary sheath, is cleaned and maintained in a sterile state.

[0115] The first cleaning device 108 is connected to, for example, the second cleaning device 109 via a cleaning medium supply source 120. Thus, the pump 121 may be configured to transport the cleaning medium to both the first cleaning device 108 and the second cleaning device 109, and to transport this medium into the inner chambers of the housings 113 and 114.

[0116] Figure 16 shows a modified example in which a cleaning medium source 120 supplies cleaning medium to the interior 110 of the housing 114 of the introduction sheath 101 via a first cleaning device 108. The tubular section 112 of the auxiliary sheath, fixed inside the introduction sheath, has at least one external opening 119 of the inner chamber 110, for example, an external perforation consisting of multiple openings, through which the cleaning medium flows into the tubular section 112 and axially into the interior 111 of the housing 113. Thus, the cleaning medium can be actively moved from the cleaning medium source 120 through the introduction sheath 101 to the auxiliary sheath 104. In this example, in order to collect the cleaning fluid in a collection tank 123, the structural device of the second cleaning device 109 may function to discharge from the auxiliary sheath, for example, to discharge the cleaning fluid inside. In this example, the interior of the tubular section 112 of the auxiliary sheath forms part of an auxiliary cleaning passage 115' for connecting the two sheaths. In the modified example shown in Figure 15, an auxiliary cleaning passage 115 is provided by the supply pipes and / or connections of the cleaning devices 108 and 109.

[0117] The outer opening / recess 119 of the tubular portion 112 of the auxiliary sheath can be introduced into portion 112 only after, for example, the catheter has been inserted into the patient's body. For example, the cutting assembly shown in Figure 11 can be used for this purpose.

[0118] Finally, Figure 17 shows a design in which the sheath housing 114 of the introduction sheath is securely connected to the sheath housing 113 of the auxiliary sheath 104. The two sheath housings are securely inserted into the inside of the other in a cylindrical or somewhat conical lower region. Screw connections or bayonet connections may also be provided.

[0119] For example, in the embodiment shown in the figure, a circumferential groove 116 is provided on one side, formed by a circumferential groove in the auxiliary sheath housing 113, and on the opposite side, by a circumferential groove in the introduction sheath housing 114. However, it is sufficient to provide a circumferential groove on only one of the housings. The circumferential grooves, or both circumferential grooves, are each connected via a passage-like recess 117, 118, which extends through the walls of the housings 114, 113 into the first cleaning device 108 and / or the interior of the sheath housings 114, 113. As a result, in the modified example shown in the figure, the interiors of housing 114 and housing 113 can be cleaned via the first cleaning device 108. In this example, the second cleaning device 109 is used for discharge and to discharge the cleaning fluid, as shown in Figure 16. However, conversely, both housings can also be cleaned by the second cleaning device. Due to the provided circumferential groove 116, it is not necessary to bond the two sheath housings at a precise angular position when connecting them; rather, it is only necessary that the axial positions of the two sheath housings 101 and 104 be maintained relative to each other. This can be ensured, for example, by the fixing stopper on one of the two sheath housings.

[0120] In addition, in each case, the spring-mounted sliding element on the inner circumference of housing 114 located in the circumferential groove region and a similar element on the outside of housing 113 can help ensure that the corresponding circumferential groove and / or passage-like recess is covered before connection of the two housings. The sliding element is spring-biased and retractable so that the circumferential groove or recess is not covered during the joining of the two housings.

[0121] In the example configuration shown in Figure 17, the passage-like recesses 117, 118 and / or circumferential groove 116 form an auxiliary cleaning passage 115″.

[0122] In the modified version described above, the auxiliary sheath 104 is permanently connected to the introduction sheath 101 and remains connected to it, and the two are cleaned together to ensure that bacteria do not enter the patient's body within the area of ​​the sheath.

[0123] FIG. 18 shows an embodiment of a sheath assembly in which a sterile tube 130 is connected to an introduction sheath 101 in a liquid-tight connection. In principle, this tube can be cleaned from the introduction sheath 101 or from an auxiliary sheath 104′ (only partially and schematically shown in FIG. 18).

[0124] The sterile tube 130 is itself in a liquid-tight state and is embodied as a corrugated tube. It is connected to the housing of the introduction sheath 114 and / or to the housing of the auxiliary sheath and / or to the catheter grip by a flange connection or adhesive connection 131, or generally by one of the connection types shown in FIGS. 13a to 13i, and at least partially surrounds an auxiliary sheath partially inserted into the introduction sheath. The sterile tube can also be clamped in the immediate vicinity of the catheter shaft.

[0125] When the catheter has been inserted into the patient's body, the entire auxiliary sheath can be accommodated inside the sterile tube 130. The proximal end member 132 has a through-passage for the catheter, which is sent from a passage forming a seal.

[0126] Following the insertion process, the sterile tube is axially compressed, and the end member 132 can be connected to, for example, the flange 131. The auxiliary sheath is peeled off as a peel sheath, pulled out from the introduction sheath into the sterile tube, and left there. Then the introduction sheath can be sealed against the sterile tube.

[0127] FIG. 19a shows an axial cross-sectional view of a sheath assembly, in which a string-shaped element / catheter 105 extends into the tubular part of an auxiliary sheath 21, and the auxiliary sheath 21 is installed inside the tubular part of an introduction sheath 41a. The string-shaped element / catheter 105, shown as a hollow catheter in this example, has an outer diameter d1. The tubular part of the auxiliary sheath 21 has an outer diameter d2 and an inner diameter corresponding to the outer diameter d1 of the string-shaped element / catheter 105. The tubular part of the introduction sheath 41a has an inner diameter corresponding to the outer diameter d2 of the tubular part of the auxiliary sheath and an outer diameter d 3a and. Generally, it is impossible for the wall thickness of the component to be randomly reduced based on material properties.

[0128] In this type of sheath assembly, the overall outer diameter d of the system 3a Due to the tubular configuration of the auxiliary sheath and introduction sheath, where one is surrounding the other, it is relatively large, and as it passes through the patient's skin, it clearly results in a correspondingly high risk of trauma and bleeding.

[0129] Figure 19b shows an axial cross-sectional view of the sheath assembly, which is not shown in the same figure, where the string-shaped element / catheter 105 extends to the tubular portion of the auxiliary sheath 21, and the auxiliary sheath is positioned axially proximal to the tubular section of the introduction sheath. It is clear that the outer diameter of the system in this region corresponds to the outer diameter d2 of the tubular portion of the auxiliary sheath.

[0130] Figure 19c shows another axial cross-sectional view of the sheath assembly in Figure 19b, where the string-shaped element / catheter 105 is located distal to the cross-sectional view in Figure 19b in the plane extending to the tubular portion of the introduction sheath 41a. The tubular portion of the auxiliary sheath is not located on this plane. The absence of the auxiliary sheath in this section reduces the outer diameter d of the tubular portion of the introduction sheath 41a. 3b It is designed to be substantially small; for example, it corresponds to or is even smaller than the outer diameter of the tubular section of the auxiliary sheath 21.

[0131] In such a sheath assembly, the overall outer diameter d of the system 3b This is substantially smaller for positioning the tubular sections of the auxiliary and introduction sheaths, which are axially forward of the other, resulting in a reduced risk of trauma and bleeding at the point of passage through the patient's skin. Furthermore, the embodiments described below are also included as specific examples of the present invention. <Aspect 1> A sheath assembly for inserting a catheter, which is a string-shaped element (32, 105), into a patient's body, comprising an introduction sheath (101) having a distal end (102) provided for insertion into the patient's body and a proximal end (103) that protrudes from the patient's body during insertion of the distal end of the assembly into the patient's body, and comprising an auxiliary sheath (104) for insertion into the introduction sheath (101) together with the string-shaped element / catheter (32, 105), comprising a first fastening means (106) for detachably fastening the auxiliary sheath to the introduction sheath, and a second fastening means (107) for detachably fastening the string-shaped element to the auxiliary sheath, wherein the introduction sheath (101) comprises a first sheath housing (13, 114) and a first receiving passage for the string-shaped element (32, 105) and a distal end ending at the first sheath housing The first sheath chamber (110) has a tubular section (11, 41a), and the auxiliary sheath (104) has a second sheath chamber (111) having a second housing passage for string-shaped elements (32, 105), a tubular distal section (112), and a second cleaning device (109) for the second sheath chamber (111), and the first sheath housing (13, 114) A sheath assembly having means (63) for positioning the distal end of the tubular distal portion (112) of the auxiliary sheath (104) in the first sheath housing (13, 114) proximal forward of the proximal end of the tubular section (11, 41a), the second cleaning device (109) being connected to the first cleaning device (108), and enabling the exchange of cleaning fluid between the first cleaning device (108) and the second cleaning device (109). <Aspect 2> The sheath assembly according to aspect 1, characterized in that the auxiliary sheath (104) has a tubular distal portion (112) and a sheath housing (113), the tubular distal portion (112) is inserted into the introduction sheath (101), and the auxiliary sheath (104) is detachably connected to the introduction sheath (101). <Aspect 3> The sheath assembly according to aspect 1, characterized in that the auxiliary sheath (104) has a tubular distal portion (112) and a sheath housing (113), and the sheath housing (113) of the auxiliary sheath is detachably connected to the sheath housing (114) of the introduction sheath (101). <Aspect 4> The sheath assembly according to any one of aspects 1 to 3, characterized in that the connection between the auxiliary sheath (104) and the introduction sheath (101) is embodied as a detachable clamping connection including a pressure-fit connection or a friction connection, such as a double-cone connection, a screw connection, a bayonet connection, a press-fit connection, or another detachable engaging connection. <Aspect 5> The sheath assembly according to aspect 2 or 3, characterized in that the inner chamber of the sheath housing (113) of the auxiliary sheath is directly connected to the first cleaning device (108) by an auxiliary cleaning passage (115, 115', 115''). <Aspect 6> The sheath assembly according to aspect 5, characterized in that the auxiliary cleaning passage (115, 115', 115") extends into a hose or tube-shaped conduit attached to the outer circumference of the housing of the auxiliary sheath (104). <Aspect 7> The sheath assembly according to aspect 5, characterized in that the auxiliary cleaning passage (115, 115', 115") extends directly from the sheath housing (114) of the introduction sheath (101) to the interior of the tubular distal portion (112) of the auxiliary sheath (14) through the outer opening (119) of the tubular distal portion (112) of the auxiliary sheath. <Aspect 8> The sheath assembly according to aspect 5, in an example of a direct connection between the sheath housing (113) of the auxiliary sheath and the sheath housing (114) of the introduction sheath, characterized in that the auxiliary cleaning passage (115, 115', 115'') extends inside the connection area through the wall region of the sheath housing (113) of the auxiliary sheath, which is located inside the introduction sheath (101). <Aspect 9> The sheath assembly according to aspect 8, characterized in that the introduction sheath (101) and the auxiliary sheath (104) abut each other as connecting partners in an annular region, an annular or arc-shaped circumferential groove (116) extending in the circumferential direction is provided in at least one of the two connecting partners in the annular region, and passage-shaped recesses (117, 118) are provided in both the sheath housing (114) of the introduction sheath and the sheath housing (113) of the auxiliary sheath that connect the inner chamber of the sheath to the circumferential groove (116) when connected. <Aspect 10> The sheath assembly according to any one of aspects 1 to 9, characterized in that a sterile tube (130) is connected to the introduction sheath (101) by a liquid-tight connection, the tube forms a proximal extension of the introduction sheath (101) and surrounds at least a part of the auxiliary sheath (104), and the sterile tube is connected to the auxiliary sheath (104) by a liquid-tight connection. <Aspect 11> The sheath assembly according to aspect 10, wherein the sterile tube (130) is attached to the end face of the introduction sheath (101). <Aspect 12> The sheath assembly according to aspect 10, wherein the sterile tube (130) has the housing of the auxiliary sheath (104) as its liquid-tight end. <Aspect 13> The sheath assembly according to aspect 10, wherein the sterile tube (130) is compressible in the axial direction, and when the string-shaped elements (32, 105) are inserted into the introduction sheath (101), the auxiliary sheath (104) and the tubular distal portion (112) of the auxiliary sheath are pressed into the introduction sheath and placed on the introduction sheath. <Aspect 14> The sheath assembly according to any one of aspects 1 to 13, characterized in that the inner diameter of the tubular distal portion (112) of the auxiliary sheath is larger than the inner diameter of the tubular section (11, 41a) of the introduction sheath, or that each of the tubular distal portion (112) and the tubular section (11, 41a) has the same diameter as the means (63) for positioning the distal end of the tubular distal portion (112) in the first sheath housing (114). <Aspect 15> The sheath assembly according to aspect 1, characterized in that the outer diameter of the tubular section (11, 41a) of the introduction sheath (101) is equal to or smaller than the outer diameter of the distal tubular section (112) of the auxiliary sheath. <Aspect 16> A system comprising a string-shaped element and a sheath assembly for inserting the string-shaped element into a patient's body, as described in at least one of aspects 1 to 15, wherein the string-shaped element is a pump.

Claims

1. A sheath assembly for inserting a catheter (32, 105) into a patient's body, comprising an introduction sheath (101) having a distal end (102) provided for insertion into the patient's body and a proximal end (103) that protrudes from the patient's body during insertion of the distal end of the assembly into the patient's body, and comprising an auxiliary sheath (104) for insertion into the introduction sheath (101) together with the catheter (32, 105), wherein the introduction sheath (101) comprises a first sheath housing (13, 114) and a first sheath chamber (110) having a first accommodating passage for the catheter (32, 105) and a distal tubular section (11, 41a) terminating at the first sheath housing, and the auxiliary sheath (104) comprises a second sheath chamber (111) having a second accommodating passage for the catheter (32, 105) and a tubular distal section (112), The tubular distal portion (112) is provided with at least one opening (119) that opens into the first sheath housing (13, 114). Sheath assembly.

2. A sheath assembly according to claim 1, The first sheath housing (13, 114) has a stopper (63) for positioning the distal end of the tubular distal portion (112) of the auxiliary sheath (104) within the first sheath housing (13, 114) to be more proximal to the proximal end of the distal tubular section (11, 41a), At least one of the openings (119) opens into the first sheath housing (13, 114) in an arrangement where the distal end of the tubular distal portion (112) abuts against and is positioned against the stop portion (63). Sheath assembly.

3. A sheath assembly according to claim 1, The auxiliary sheath (104) has the tubular distal portion (112) and the second sheath housing (113), The second sheath housing (113) of the auxiliary sheath (104) is detachably connected to the first sheath housing (13, 114) of the introduction sheath (101). Sheath assembly.

4. The sheath assembly according to claim 3, A sheath assembly in which the inner chamber of the second sheath housing (113) of the auxiliary sheath (104) is directly connected to the first cleaning device (108) by an auxiliary cleaning passage (115, 115', 115'').

5. The sheath assembly according to claim 4, The sheath assembly according to claim 3, characterized in that the auxiliary cleaning passage (115, 115', 115") extends into a hose or tube-shaped conduit attached to the outer circumference of the second sheath housing (113) of the auxiliary sheath (104).

6. The sheath assembly according to claim 5, A sheath assembly in which the auxiliary cleaning passage (115, 115', 115") extends directly from the first sheath housing (13, 114) of the introduction sheath (101) to the interior of the tubular distal portion (112) of the auxiliary sheath (14), through the outer opening (119) of the tubular distal portion (112) of the auxiliary sheath.

7. A sheath assembly according to claim 1, The first sheath housing (13, 114) is provided with blades (59, 60) that are radially movable and capable of opening the opening (119) to the tubular distal portion (112). Sheath assembly.

8. The sheath assembly according to claim 7, The blades (59, 60) can be operated from the outside of the first sheath housing (13, 114). Sheath assembly.

9. The sheath assembly according to claim 8, A guide that supports the blade so as to be movable in the radial direction, A seal provided on the aforementioned guide, A sheath assembly equipped with the following features.

10. A sheath assembly according to claim 9, A sheath assembly comprising a spring mount for biasing the blade so as to be radially separated from the tubular distal portion (112).

Images