Introducer sheath

Abstract

It is an object of the present invention to provide an introducer sheath that can be split along its length.SOLUTION: The introducer sheath 10 includes a tubular body 11 with a distal portion 12 and a proximal portion 13, wherein the proximal portion 13 is configured to be inserted into a patient's body. The introducer sheath can be split longitudinally along its length. The introducer sheath 10 further comprises at least a first handle 15 which is pivotable about a fulcrum 21. The first handle 15 has a first end portion 151 and a free second end portion 152 so as to form a lever, such that pivoting of the handle 15 about the fulcrum 21 causes a contact portion 23 of the handle to affect a respective counter portion 24 operatively coupled to the distal portion 12 of the tubular body 11. It creates a breaking force that causes the distal portion 12 of the tubular body 11 to break.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present invention relates to an introducer sheath for providing access in a patient's body. [Background technology]

[0002] Long-term vascular access is a common medical procedure used in several medical settings, including dialysis for patients requiring frequent dialysis treatments, chemotherapy treatments, or the use of ventricular assist devices. Various devices and methods are used depending on the patient's needs. Long-term vascular access in patients requiring ventricular assist devices is common through open-chest procedures or direct cardiovascular access.

[0003] Recently, there has been a movement toward the use of peripheral vessels to access the cardiovascular system with the goal of avoiding traumatic open-heart surgery. The movement toward the use of peripheral vessels instead of central cardiovascular vessels has been accompanied by the development of a number of specific devices and tools designed specifically for peripheral use. Vascular introducers are the most common devices that have been developed to enable peripheral vascular access. To provide access to a vessel, an introducer sheath is usually inserted directly into the vessel, particularly with the aid of a dilator.

[0004] Once a medical device, such as a catheter, has been inserted through the introducer sheath into a patient's duct, the introducer sheath is typically obsolete and it is desirable to remove it. However, because the medical device may be coupled to a device external to the patient's body, such as a power source, the introducer sheath cannot simply be retracted but must be peeled away from the medical device. Typically, the introducer sheath is longitudinally separated along its length, allowing the resulting pieces to be removed from the patient. To assist in tearing the introducer sheath, a handle may be provided that a user, e.g., a surgeon, can grasp and apply the tearing force. Typically, a hemostatic valve in the distal portion of the introducer sheath must be broken, requiring a large initial force. This cumbersome procedure can cause complications and potentially injure the patient, for example, if the medical device is inadvertently retracted when manipulating the handle to apply the tearing force. Summary of the Invention [Problem to be solved by the invention]

[0005] It is an object of the present invention to provide an introducer sheath that can be separated along its length to provide access to a patient's body, improving operation and, in particular, reducing the breaking force that must be applied by the user to split the introducer sheath. [Means for solving the problem]

[0006] The invention is set out in the accompanying independent claims, with preferred embodiments specified in the dependent claims.

[0007] According to one embodiment of the present invention, an introducer sheath for providing access, particularly percutaneous access, and more particularly vascular access, within a patient's body is provided. The introducer sheath includes a tubular body with a distal portion and a proximal portion. The proximal portion is configured to be inserted into a patient's body, such as a vessel or other body cavity, so that a medical device can be inserted therethrough. For example, the medical device may be a catheter that can be inserted into a patient's vessel and connected to an axial blood pump. In other cases, the introducer sheath may be a cannula of a trocar. The introducer sheath is constructed to facilitate longitudinal detachment along its length. For example, at least a distal portion of the tubular body may include a structure such as a longitudinal notch that defines a predetermined break line. It should be understood that the term "proximal" refers to a direction toward the heart, while the term "distal" refers to a direction away from the heart.

[0008] The introducer sheath further includes at least one handle pivotable about a fulcrum, the handle having a first end portion and a free second end portion forming a lever. By pivoting the handle about the fulcrum, a contact portion of the handle impacts a respective counter portion operably coupled to the distal portion of the tubular body, thereby generating a breaking force that breaks, tears, or splits the distal portion of the tubular body. By using the principle of leverage, the pivotable handle can reduce the force a user must apply to break the introducer sheath. Not only is force reduced, but general operation during separation of the introducer sheath is also improved, particularly with regard to ergonomic aspects, such as the movement and position of the user's hand and arm. This is due to the fact that the pivotable handle indirectly transfers user-applied force to the introducer sheath, as opposed to a handle that is fixedly attached directly to the tubular body of the introducer sheath.

[0009] In an embodiment, the fulcrum is eccentrically disposed on the first end portion of the handle, and the contact portion is disposed on an edge of the first end portion, with the distance between the contact portion and the fulcrum being shorter than the distance between the second end portion of the handle and the fulcrum, thereby utilizing the principle of leverage. The distance between the fulcrum and the contact portion is preferably longer than the distance between the fulcrum and a portion of the edge of the first end portion adjacent to the contact portion. The edge of the first end portion of the handle may be specifically shaped, e.g., curved. In other words, pivoting the handle moves the contact portion of the handle toward the counter portion, which then displaces the counter portion as the pivoting of the handle, i.e., particularly pushing or pulling, continues. The contact portion may already be in contact with the counter portion in a neutral, i.e., unstressed, position, or may only come into contact as the handle is pivoted. Depending on the shape of the contact portion, the counter portion is displaced until the distal portion of the introducer sheath fractures.

[0010] In an alternative embodiment, the fulcrum is disposed between the first and second end portions and the contact portion is disposed at an edge of the first end portion. In another alternative embodiment, the contact portion is disposed between the first and second end portions and the fulcrum is disposed at the first end portion.

[0011] Generally, a single handle is sufficient to create the breaking force. However, additional handles may improve operation. As such, the introducer sheath can include at least one additional handle; if two handles are provided, the two handles are preferably diametrically opposed relative to the tubular body. The additional handle may be fixedly attached to the distal portion of the tubular body, or both handles may be pivotally attached to the distal portion of the tubular body. In some cases, more than two handles, e.g., three or four handles, may be provided and may be symmetrically arranged relative to the tubular body of the introducer sheath. It will be understood that asymmetric arrangements are also possible. It will be understood that all of the features described with respect to a single handle or one of the handles may equally apply to another or all of the handles in embodiments in which two or more handles are provided.

[0012] The counter portion may be disposed on, and in particular be part of, the distal portion of the introducer sheath. Alternatively, in embodiments having two handles, the counter portion associated with one of the handles may be a contact portion of the other handle, preferably vice versa. In other words, the contact portions of the two handles may influence each other, and thus a breaking force may be applied to the distal portion of the introducer sheath.

[0013] The handle may be pivotally attached to the distal portion of the tubular body via a hinge, which preferably includes at least one pin disposed along a fulcrum and at least one cavity for receiving the pin. It will be appreciated that the handle may be pivotally attached to the tubular body of the introducer sheath in other manners.

[0014] The handles may extend at different angles from the distal end of the introducer sheath tubular body in an unstressed state, i.e., in a neutral state without the application of external forces. In cases where two handles are provided, the handles may extend symmetrically, i.e., at the same angle, from the introducer sheath. However, the two handles may extend at different angles. The handles may extend from the introducer sheath at an angle between 45 and 90 degrees, or at an angle less than 45 degrees. The angle preferably ranges between 60 and 80 degrees, or between 10 and 30 degrees. In cases where the angle is not equal to 90 degrees, the handle may point toward either the distal or proximal end of the introducer sheath body.

[0015] The handle can be either pushed or pulled by the user. In other words, the handle can be pivotally attached to the distal portion of the tubular body, such that pivoting it toward or away from the proximal portion of the tubular body causes the distal portion to break. Pushing the handle, i.e., pivoting it toward the proximal end portion, can be advantageous because pulling the handle can cause the introducer sheath to be inadvertently retracted from the patient's vessel, which can cause problems because the introducer sheath cannot be pushed back into the vessel.

[0016] In a preferred embodiment, the handle may be secured to prevent inadvertent actuation. To this end, the handle may include an engagement portion configured to engage the securing member, thereby preventing the handle from pivoting. The securing member may be provided separately or may be included in the introducer sheath, and the securing member may be manipulated to engage or disengage with the engagement portion of the handle. The securing member may be engageable with the engagement portion of the handle using a screw, hook, clip, or other suitable engagement means. The securing member may be a securing cap. For example, the securing member may be rotated to secure or release the handle. It will be appreciated that the securing member may be part of a dilator that is inserted into the introducer sheath.

[0017] In embodiments, the introducer sheath includes a hemostatic valve in the distal portion of the tubular body. The hemostatic valve provides hemostasis. In other words, it seals the distal end of the introducer sheath to prevent blood from flowing through the valve during insertion of a medical device, such as a catheter. The valve may include a membrane that may be constructed as a flexible disk or in other configurations that provide the function of a check valve. At least one handle is preferably attached to the hemostatic valve so that a breaking force can be applied directly to the valve to tear it. Tearing the valve typically requires the greatest force during separation of the introducer sheath.

[0018] The foregoing summary, as well as the following detailed description of the preferred embodiments, will be better understood when read in conjunction with the appended drawings. For purposes of illustrating the present disclosure, reference is made to the drawings. However, the scope of the present disclosure is not limited to the specific embodiments disclosed in the drawings. [Brief explanation of the drawings]

[0019] [Figure 1] 10A-10C illustrate an embodiment of an introducer sheath assembled onto a dilator. [Figure 2a] 2 is a side view of the distal portion of the introducer sheath of FIG. 1 in an initial position. [Figure 2b] 2 is a side view of the distal portion of the introducer sheath of FIG. 1 in the activated position. [Figure 3a] 3a and 4b are side views of an alternative embodiment of an introducer sheath in the initial position (FIGS. 3a and 4a) and the activated position (FIGS. 3b and 4b), respectively. [Figure 3b] 3a and 4b are side views of an alternative embodiment of an introducer sheath in the initial position (FIGS. 3a and 4a) and the activated position (FIGS. 3b and 4b), respectively. [Figure 4a] 3a and 4b are side views of an alternative embodiment of an introducer sheath in the initial position (FIGS. 3a and 4a) and the activated position (FIGS. 3b and 4b), respectively. [Figure 4b] 3a and 4b are side views of an alternative embodiment of an introducer sheath in the initial position (FIGS. 3a and 4a) and the activated position (FIGS. 3b and 4b), respectively. [Figure 5] 10A-10C show another embodiment of an introducer sheath. [Figure 6a] FIG. 6 shows a detail of the embodiment of FIG. 5. [Figure 6b] FIG. 6 shows a detail of the embodiment of FIG. 5. [Figure 6c] FIG. 6 shows a detail of the embodiment of FIG. 5. [Figure 7] 10A-10C show another embodiment of an introducer sheath. [Figure 8] 10A-10C show another embodiment of an introducer sheath. [Figure 9a] 9A-9C are cross-sectional views of the introducer sheath of FIG. 8 in the initial and actuated positions, respectively. [Figure 9b] 9A-9C are cross-sectional views of the introducer sheath of FIG. 8 in the initial and actuated positions, respectively. [Figure 10a] FIG. 10 is a different view of another example of an introducer sheath. [Figure 10b] FIG. 10 is a different view of another example of an introducer sheath. [Figure 10c]FIG. 10 is a different view of another example of an introducer sheath. [Figure 11a] FIG. 10 is a different view of another example of an introducer sheath. [Figure 11b] FIG. 10 is a different view of another example of an introducer sheath. [Figure 12] FIG. 1 illustrates an application of the present invention. [Figure 13] FIG. 10 illustrates another application of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0020] Referring to FIG. 1 , an embodiment of an introducer sheath 10 is shown assembled on a dilator 20. The tapered tip 201 of the dilator 20 extends proximally from the introducer sheath 10. The distal end portion 202 of the dilator can be grasped to manipulate the assembly and may include a port 203 for, for example, a guidewire. The dilator and introducer sheath assembly can be inserted into a patient's vessel, for example, accessed via a Seldinger technique. In other embodiments, the assembly may be a trocar with a cannula and obturator to provide access to other body cavities. The introducer sheath 10 has a tubular body 11 with a distal portion 12 and a proximal portion 13. A hemostatic valve 14 is disposed in the distal portion 12 of the tubular body 11 to provide hemostasis, i.e., prevent blood from flowing out of the introducer sheath 10 during insertion into a patient's vessel. In one embodiment, the hemostatic valve may be made of two or more separate pieces that, when assembled within the hemostatic shell, will create a fluid-tight seal to prevent backflow of blood. The hemostatic valve may be "silicone gland."

[0021] Once a medical device, such as a catheter, has been inserted through the introducer sheath 10 after retracting the dilator 20, it is desirable to remove the introducer sheath 10 from the patient. However, due to the presence of the medical device, the introducer sheath 10 cannot be retracted and must be severed and peeled away from the medical device. While the tubular body 11 of the introducer sheath 10 can be torn along its length with a relatively small force, the hemostatic valve 14 must be split with a relatively large force. To enable the hemostatic valve 14 to be torn, the valve 14 includes longitudinal notches 17 (only one visible in FIG. 1; a single notch is also possible) on opposite sides of the hemostatic valve 14 to define a predetermined fracture line. Handles 15 and 16 are provided for applying a rupture force to the hemostatic valve 14 to initiate tearing of the valve 14. A locking or safety cap 18 is provided to prevent inadvertent actuation of the handles 15 and 16, as described in more detail below. In this embodiment, both handles 15, 16 are preferably swivelable, although one of the handles may be fixed, or alternatively only one handle may be provided.

[0022] 2a and 2b show side views of the distal portion 12 of the introducer sheath 10 of FIG. 1, including the hemostatic valve 14, handles 15 and 16, and a locking cap 18. The handles 15 and 16 have first end portions 151 and 161 and free second end portions 152 and 162, respectively. They extend from the hemostatic valve 14 at an angle of approximately 70 degrees and point away from the proximal portion 13 of the body 11 of the introducer sheath 10. The handles 15 and 16 are pivotally attached to the hemostatic valve 14, for example, using hinges, as described in more detail below with reference to FIGS. 6a-6c. The handles 15 and 16 each form a lever and are pivotable about fulcrums 21 and 22, respectively, particularly toward the proximal portion 13 of the body 11 of the introducer sheath 10, as indicated by the arrows in FIG. 2a.

[0023] Handles 15 and 16 have engaging portions 19, such as hooks, that are engageable with locking cap 18. For example, locking cap 18 may have internal threads that engage with hooks 19, or may engage with hooks such as a bayonet coupling. Locking cap 18 prevents handles 15 and 16 from being inadvertently actuated during insertion of introducer sheath 10, particularly during assembly onto dilator 20 as shown in FIG. 1. During this stage in the procedure, handles 15 and 16 may be used to aid in insertion of the assembly, which is undesirable and would be harmful to tearing hemostatic valve 14 at this point.

[0024] When the surgeon decides to remove the introducer sheath 10 from the patient, the introducer sheath 10 must be separated into two pieces and stripped away from the medical device inserted therethrough. The surgeon can then release the locking cap 18 to allow the handles 15 and 16 to become operable. In this embodiment, the handles 15 and 16 can be depressed toward the proximal portion 13 of the tubular body 11 of the introducer sheath 10. The actuated position is shown in FIG. 2. The handles 15 and 16 pivot about fulcrums 21 and 22, respectively, causing the contact portions 23 and 24 to interact with each other, resulting in a breaking force that cracks the hemostatic valve 14. The location where the contact portions 23 and 24 interact with each other is indicated in FIG. 2b by reference numeral 25. In this embodiment, the contact portions 23 and 24 each function as a counter portion. Contact portion 23 of handle 15 functions as a counter portion for contact portion 24 of handle 16, while contact portion 24 of handle 16 functions as a counter portion for contact portion 23 of handle 15. Due to the eccentric locations of fulcrums 21 and 22 at end portions 151 and 161 of handles 15 and 16 and the uniquely shaped edges of end portions 151 and 161, contact portions 23 and 24 are forced away from each other when handles 15 and 16 are pivoted, creating a breaking force that splits hemostatic valve 14 along notch 17. The leverage principle reduces the force that the surgeon must apply to create the breaking force. Pivotable handles facilitate operation compared to fixedly attached handles.

[0025] 3a and 3b show another embodiment of handles 15' and 16', which are similar to the embodiment described above, except that handles 15' and 16' are pivotable away from proximal portion 13 of body 11 of introducer sheath 10 to create a breaking force. As shown in FIG. 3a, the initial position is substantially the same as the embodiment of FIG. 2a. However, FIG. 3b illustrates that handles 15' and 16' pivot in opposite directions about fulcrums 21' and 22' compared to the embodiment of FIG. 2b, and interact at point 25' to create a breaking force that splits hemostatic valve 14 along notch 17.

[0026] Another embodiment is shown in Figures 4a and 4b and is similar to the embodiment described above. As in the embodiment of Figures 2a and 2b, handles 15" and 16" can pivot about fulcrums 21" and 22", respectively, toward the proximal portion 13 of the body 11 of the introducer sheath 10 to generate a breaking force that cracks the hemostatic valve 14. However, in an unstressed state, handles 15" and 16" extend from the hemostatic valve 14 at a different angle compared to other embodiments, i.e., a smaller angle that brings the handles 15" and 16" closer to the tubular body 11. In this "low-profile configuration," only handles 15" and 16" must be pressed against each other to crack the hemostatic valve 14. In this embodiment, handles 15" and 16" move only a shorter distance compared to other embodiments. However, this can be advantageous because it is sufficient to at least initially crack the hemostatic valve 14 and reduces the risk of retracting the introducer sheath 10. The surgeon can complete the disconnection of the introducer sheath 10 by manually tearing the introducer sheath 10 apart and peeling it away from the inserted medical device.

[0027] FIG. 5 shows another embodiment of an introducer sheath 10′ that is similar to the embodiment of FIGS. 1, 2a, and 2b. The only difference is the shape of an engagement portion 19′ that can be engaged by a locking cap 18 (not shown) to lock the handles 15 and 16 and prevent them from pivoting. In the embodiment of FIG. 5, the engagement portion 19′ has a semicircular shape and is formed as a separate piece, e.g., an injection molded piece, from the handles 15 and 16. In the embodiment of an introducer sheath 10″ shown in FIG. 7, the engagement portion 19″ is integrally formed with the handles 15 and 16.

[0028] 6a-6c show details of the hinge connection between the handles 15 and 16 and the hemostasis valve 14. Generally, the hinge includes a pin 81 rotatably received in a cavity 84 to allow the handles 15 and 16 to pivot about fulcrums 21 and 22, respectively. The hinge further includes a base portion 82 having an elongated shape and supporting the pin 81. As shown in FIG. 6c, the base portion 82 prevents the handles 15 and 16 from falling off the hemostasis valve 14. A slot 83 is provided for accessing the cavity 84. The slot 83 has a width corresponding to the width of the base portion 82 and allows the base portion 82 to be inserted into the slot 83 only in certain orientations where the elongated base portion 82 is aligned with the slot 83.

[0029] Another embodiment of an introducer sheath 30 is shown in Figures 8, 9a, and 9b. The introducer sheath 30 includes a tubular body 31 and a hemostatic valve 34 disposed in a distal portion 32 of the body 31. Handles 35 and 36 are pivotally attached to the hemostatic valve 34 and aid in tearing the hemostatic valve 34. In contrast to the previously described embodiment, the handles 35 and 36 do not contact or influence each other to create the tearing force. Instead, the handles 35 and 36 are pivotally attached to a fixed frame portion 37 using hinges that form fulcrums 41 and 42, respectively. In this embodiment, the fulcrums 41 and 42 are disposed between the first end portions 351 and 361 and the second end portions 352 and 362 of the handles 35 and 36, respectively. First end portions 351 and 361 are bent so that contact portions 43 and 44 contact counter portions 45 and 46, respectively, disposed on hemostasis valve 34. Pulling handles 35 and 36 in a direction away from proximal portion 33 of body 31 of introducer sheath 30 creates a force that pushes counter portions 45 and 46, respectively, away from frame portion 37, cracking hemostasis valve 34. In this embodiment, both handles 35 and 36 function independently.

[0030] An example of an introducer sheath 50 is disclosed in FIGS. 10a-10c, having a tubular body 51 and a hemostatic valve 54 that can be separated using handles 55 and 56. In this embodiment, handles 55 and 56 are used to split the hemostatic valve 54 by applying a twisting force, as shown by the arrows in FIG. 10c. Longitudinal notches 57 and 58 facilitate splitting the hemostatic valve into two pieces. As is apparent from FIGS. 10b and 10c, the handles extend at a 45-degree angle from the hemostatic valve and are designed asymmetrically in plan view for ease of manipulation, particularly to provide space between the patient's body and the handles 55 and 56 for grasping the handles 55 and 56.

[0031] 11a and 11b disclose another example introducer sheath 70 having a tubular body 71 and a hemostatic valve 74 that can be separated using handles 75 and 76. Handles 75 and 76 each have wings 75a, 75b and 76a, 76b, respectively. To apply a rupturing force to hemostatic valve 74, a user grasps handles 75 and 76 and twists them in opposite directions, as indicated by the arrows in FIG. 11b. Twisting of handles 75 and 76 is facilitated by the provision of two wings on each handle, and handles 75 and 76 are twisted about an axis of rotation that runs perpendicular to the longitudinal axis of tubular body 71 between wings 75a, 75b and 76a, 76b, respectively. 11a and 11b, wing 75a can move "down" and wing 75b can move "up," while simultaneously wing 76a moves "up" and wing 76b moves "down," creating a twisting motion. After the initial break-off force is applied, the user pulls further on handles 75 and 76 to completely separate introducer sheath 70 into two pieces.

[0032] 12 and 13, an application of introducer sheath 10 is shown. The introducer sheath can be according to any one of the embodiments disclosed above. It is used to insert an axial blood pump 101 into a patient's heart through the patient's vasculature using catheter 100 to provide a ventricular assist device. Vascular access can be located in a peripheral vessel in the patient's thorax (FIG. 12) or in the patient's groin (FIG. 13).

[0033] Preferred Embodiments of the Invention In the following paragraphs, preferred embodiments of the present invention are disclosed.

[0034] [Embodiment 1] an introducer sheath (10) for providing access in a patient's body, the introducer sheath (10) including a tubular body (11) with a distal portion (12) and a proximal portion (13), the proximal portion (13) configured to be inserted into the patient's body so that a medical device (100) can be inserted therethrough, the introducer sheath (10) being constructed to facilitate longitudinal separation along its length; The introducer sheath 10 further includes at least a first handle 15 that is rotatable around a fulcrum 21, the first handle 15 having a first end portion 151 and a free second end portion 152 that forms a lever, and thus, by pivoting the handle 15 around the fulcrum 21, the contact portions 23 of the handle affect respective counter portions 24 that are operably connected to the distal portion 12 of the tubular body 11, thereby creating a breaking force that breaks the distal portion 12 of the tubular body 11, introducer sheath 10.

[0035] [Embodiment 2] An introducer sheath as described in embodiment 1, wherein the fulcrum 21 is arranged eccentrically at the first end portion 151 of the first handle 15, the contact portion 23 is arranged at the edge of the first end portion 151, and the distance between the contact portion 23 and the fulcrum 21 is shorter than the distance between the second end portion 152 of the first handle 15 and the fulcrum 21.

[0036] [Embodiment 3] An introducer sheath as described in embodiment 2, wherein the distance between the fulcrum 21 and the contact portion 23 is longer than the distance between the fulcrum 21 and a portion of the edge of the first end portion 151 adjacent to the contact portion 23.

[0037] [Embodiment 4] An introducer sheath as described in embodiment 2 or 3, wherein the edge of the first end portion 151 of the first handle 15 is curved.

[0038] [Embodiment 5] An introducer sheath as described in embodiment 1, wherein the fulcrum 41 is disposed between the first and second end portions 351, 352, and the contact portion 43 is disposed at the edge of the first end portion 351.

[0039] [Embodiment 6] An introducer sheath as described in embodiment 1, wherein the contact portion is disposed between the first and second end portions and the fulcrum is disposed in the first end portion.

[0040] [Embodiment 7] An introducer sheath according to any one of embodiments 1 to 6, which includes a second handle 16, the two handles 15, 16 preferably being diametrically opposed with respect to the tubular body 11.

[0041] [Embodiment 8] An introducer sheath as described in embodiment 7, wherein the second handle is fixedly attached to the distal portion of the tubular body.

[0042] [Embodiment 9] An introducer sheath as described in embodiment 7, wherein the first and second handles (15, 16) are pivotally attached to the distal portion (12) of the tubular body (11).

[0043] [Embodiment 10] An introducer sheath according to any one of embodiments 1 to 9, wherein the counter portions (45, 46) are part of the distal portion (32) of the introducer sheath (30).

[0044] [Embodiment 11] An introducer sheath according to any one of embodiments 7 to 10, wherein the counter portion is a contact portion 24 of the second handle 16, and said contact portion 24 of the second handle 16 preferably influences the contact portion 23 of the first handle 15.

[0045] [Embodiment 12] An introducer sheath described in any one of embodiments 1 to 11, wherein the first handle 15 is pivotally attached to the distal portion 12 of the tubular body 11 via a hinge, and the hinge preferably includes at least one pin 81 arranged along the fulcrum 21 and at least one cavity 84 for receiving the pin 81.

[0046] [Embodiment 13] An introducer sheath according to any one of embodiments 1 to 12, wherein the first handle 15 extends from the distal portion 12 of the tubular body 11 at an angle between 45 degrees and 90 degrees, preferably between 60 degrees and 80 degrees, in an unstressed state.

[0047] [Embodiment 14] An introducer sheath according to any one of embodiments 1 to 12, wherein the first handle 15'' extends from the distal portion of the tubular body at an angle of less than 45 degrees, preferably between 10 and 30 degrees, in an unstressed state.

[0048] [Embodiment 15] An introducer sheath as described in any one of embodiments 1 to 14, wherein the first handle 15 is pivotally attached to the distal portion 12 of the tubular body 11, such that pivoting it in a direction toward the proximal portion 13 of the tubular body 11 causes the distal portion 12 to break.

[0049] [Embodiment 16] An introducer sheath as described in any one of embodiments 1 to 14, wherein the first handle 15' is pivotally attached to the distal portion of the tubular body, such that pivoting it away from the proximal portion of the tubular body causes the distal portion to break.

[0050] [Embodiment 17] An introducer sheath as described in any one of embodiments 1 to 16, wherein the first handle 15 includes an engagement portion 19 configured to engage with the fixation member 18, and thus the first handle 15 is prevented from pivoting.

[0051] [Embodiment 18] An introducer sheath as described in embodiment 17, further comprising a fixing member 18, which can be operated to engage or disengage with an engagement portion 19 of the first handle 15.

[0052] [Embodiment 19] An introducer sheath as described in embodiment 18, wherein the fixing member 18 is engageable with the engagement portion 19 of the first handle 15 using a screw, hook, or clip.

[0053] [Embodiment 20] An introducer sheath according to embodiment 18 or 19, wherein the fixing member is a fixing cap 18.

[0054] [Embodiment 21] An introducer sheath according to any one of embodiments 1 to 20, wherein at least the distal portion 12 of the tubular body 11 includes a longitudinal notch 17 forming a predetermined break line.

[0055] [Embodiment 22] An introducer sheath according to any one of embodiments 1 to 21, comprising a hemostatic valve 14 in the distal portion 12 of the tubular body 11.

[0056] [Embodiment 23] An introducer sheath as described in embodiment 22, wherein the first handle 15 is attached to the hemostatic valve 14.

[0057] [Embodiment 24] An introducer sheath according to any one of embodiments 1 to 23, wherein the medical device includes a catheter 100.

[0058] [Embodiment 25] An introducer sheath as described in embodiment 24, wherein the medical device includes an axial blood pump 101 disposed at the tip of the catheter 100.

Claims

1. an introducer sheath (10) for providing access in a patient's body, the introducer sheath including a tubular body (11) with a distal portion (12) and a proximal portion (13), the proximal portion (13) configured to be inserted into the patient's body so that a medical device (100) can be inserted therethrough, the introducer sheath (10) being constructed to facilitate longitudinal separation along its length; The introducer sheath (10) further comprises: The introducer sheath (10) comprises at least a first handle (15) pivotally attached to the distal portion (12) of the tubular body (11) via a hinge and pivotable about a fulcrum (21), the first handle (15) having a first end portion (151) and a free second end portion (152) forming a lever, such that pivoting of the first handle (15) about the fulcrum (21) causes a contact portion (23) of the first handle (15) to act on a counter portion (24) operably connected to the distal portion (12) of the tubular body (11), thereby generating a breaking force that breaks the distal portion (12) of the tubular body (11).

2. 2. The introducer sheath according to claim 1, wherein the fulcrum (21) is disposed eccentrically on the first end portion (151) of the first handle (15), the contact portion (23) is disposed on an edge of the first end portion (151), and a distance between the contact portion (23) and the fulcrum (21) is shorter than a distance between the second end portion (152) of the first handle (15) and the fulcrum (21).

3. 3. The introducer sheath according to claim 2, wherein the distance between the fulcrum (21) and the contact portion (23) is longer than the distance between the fulcrum (21) and a portion of the edge of the first end portion (151) adjacent to the contact portion (23).

4. 4. The introducer sheath according to claim 2 or 3, wherein the edge of the first end portion (151) of the first handle (15) is curved.

5. An introducer sheath according to any one of claims 1 to 4, characterized in that it includes a second handle (16).

6. 6. An introducer sheath according to claim 5, characterized in that the two handles (15, 16) are diametrically opposed with respect to the tubular body (11).

7. 7. An introducer sheath according to claim 5 or 6, characterized in that the first and second handles (15, 16) are pivotally attached to the distal portion (12) of the tubular body (11).

8. 8. The introducer sheath according to any one of claims 5 to 7, characterized in that the counter portion is a contact portion (24) of the second handle (16).

9. 9. The introducer sheath of claim 8, wherein the contact portion (24) of the second handle (16) influences the contact portion (23) of the first handle (15).

10. 10. An introducer sheath according to any one of claims 1 to 9, wherein the hinge includes at least one pin (81) arranged along the fulcrum (21) and at least one cavity (84) for receiving the pin (81).

11. 11. The introducer sheath according to any one of claims 1 to 10, wherein the first handle (15) extends longitudinally of the introducer sheath (10) from the distal portion (12) of the tubular body (11) at an angle between 45 degrees and 90 degrees in an unstressed state.

12. 12. The introducer sheath of claim 11, wherein the first handle (15) extends longitudinally of the introducer sheath (10) from the distal portion (12) of the tubular body (11) at an angle between 60 and 80 degrees in an unstressed state.

13. 13. An introducer sheath according to any one of claims 1 to 12, wherein the first handle (15) is pivotally attached to the distal portion (12) of the tubular body (11), such that pivoting the first handle (15) in a direction towards the proximal portion (13) of the tubular body (11) causes the distal portion (12) to break.

14. 14. An introducer sheath according to any one of claims 1 to 13, characterized in that the first handle (15) includes an engagement portion (19) configured to engage with a fixation member (18), thereby preventing the first handle (15) from pivoting.

15. 15. The introducer sheath of claim 14, further comprising a fixing member (18), the fixing member (18) being operable to engage or disengage with the engagement portion (19) of the first handle (15).

16. 16. The introducer sheath of claim 15, wherein the fixation member (18) is a fixation cap.

17. 17. An introducer sheath as claimed in claim 15 or 16, characterized in that the fixing member (18) can be manipulated to engage or disengage with the engagement portion (19) of the first handle (15) using a screw, hook or clip.

18. 18. An introducer sheath according to any one of claims 1 to 17, characterized in that at least the distal portion (12) of the tubular body (11) includes a longitudinal notch (17) forming a predetermined break line.

19. 19. An introducer sheath according to any one of claims 1 to 18, characterized in that it comprises a hemostatic valve (14) in the distal portion (12) of the tubular body (11).

20. 20. The introducer sheath of claim 19, wherein the first handle (15) is attached to the hemostatic valve (14).

21. 21. The introducer sheath of any one of claims 1 to 20, wherein the medical device comprises a catheter (100).

22. 22. The introducer sheath of claim 21, wherein the medical device includes an axial blood pump (101) disposed at the tip of the catheter (100).

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