Introducer sheath and introducer set

Abstract

SUMMARY OF THE INVENTION It is an object of the present invention to provide an introducer set for providing access to a patient's vessels. An introducer set (1) for providing vascular access in a patient's body includes an introducer sheath (10) and a dilator (20). The introducer sheath (10) has a tubular body (11) made of a flexible material with a distal portion (12), a proximal portion (13), and an inner surface, the proximal portion (13) configured to be inserted into a patient's vessel so that a medical device (100) can be inserted into the patient's vessel through the introducer sheath (10). At least one of the dilator (20) and the introducer sheath (10) includes a stiffening structure (25) that imparts stiffening to the tubular body (11) of the introducer sheath (10), the stiffening structure (25) being capable of being released, removed, or otherwise deactivated.

Description

[Technical field]

[0001] The present invention relates to a patient Blood To tube Insertion of the introducer sheath of conduct This relates to an introducer set for [Background technology]

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

[0003] Recently, there has been a movement towards the use of peripheral vessels to access the cardiovascular system with the goal of avoiding traumatic open-heart surgery. The movement towards the use of peripheral vessels instead of central cardiovascular vessels has been accompanied by the development of a number of specific devices and tools that are specifically designed for peripheral use. Vascular introducers are the most common devices that have been developed to enable peripheral vascular access. blood To provide access to the duct, an introducer sheath is usually used, especially with the aid of a dilator. blood These introducer sheaths have been limited to small diameters in the range of 1 to 3 mm.

[0004] The diameter of the introducer sheath is a limiting factor in providing vascular access. On the one hand, the outer diameter is determined by the patient and the intended access area. blood The introducer sheath is limited depending on the tube. blood On the other hand, introducer sheaths are used to introduce medical devices such as catheters and catheters with axial flow blood pumps through them to the patient's vascular system. bloodThe introducer sheath must have a minimum inner diameter that allows it to enter the canal. For example, a medical device with a 14 French size would require a conventional introducer sheath with a 16 or 17 French size. Summary of the Invention [Problem to be solved by the invention]

[0005] The object of the present invention is to blood Access to the tube (aisle) The object of the present invention is to provide an introducer set for providing access which allows for the introduction and / or removal of large diameter devices in a safe and controlled manner and with a simple procedure, and the diameter of the device to be introduced can be maximized while minimizing the size of the access in the patient's body. [Means for solving the problem]

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

[0007] According to one embodiment of the present invention, a patient Blood tube Insertion of the introducer sheath into the of conductAn introducer set for a blood vessel is provided. The introducer set includes an introducer sheath and a dilator. The introducer sheath has a tubular body made of a flexible material such as polytetrafluoroethylene (PTFE) and includes a distal portion, a proximal portion, and an inner surface, the proximal portion being configured to be inserted into a blood vessel of a patient, such that a medical device can be inserted into the blood vessel of a patient through the introducer sheath. For example, the medical device may be a catheter and may be coupled to an axial blood pump. The dilator has a body with a proximal portion, a distal portion, and an outer surface. The dilator is insertable into the introducer sheath such that its proximal portion extends proximally of the introducer sheath when the dilator is inserted into the introducer sheath. 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 tubular body of the introducer sheath has a wall thickness of 0.3 mm or less, preferably less than 0.2 mm, more preferably less than 0.15 mm, and even more preferably less than 0.1 mm. Thus, the introducer sheath may be designated a "thin-walled introducer sheath." At least one of the dilator and the introducer sheath includes a stiffening structure that imparts stiffening to the tubular body of the introducer sheath, whereby the stiffening structure is released. Ruka , removed Deactivated by , or in any manner other than by release and removal. It can be deactivated.

[0009] A thin-walled introducer sheath allows the outer dimensions of the access to be minimized while maximizing its inner dimensions. For example, introduction of a 14 French device typically requires a 14.5 French or 15 French introducer sheath. However, such a thin-walled introducer sheath is too large for the patient. bloodThe stiffening structure prevents the thin-walled introducer sheath from buckling during insertion into the canal and during retraction of the dilator. blood However, particularly during retraction of the dilator, the stiffening structure may prevent the introducer sheath from buckling and taking the dilator with it to the patient's graft. blood To prevent retraction from the tube, Ruka , removed Deactivated by , or in any manner other than by release and removal. Releasing the stiffening structure facilitates retraction of the dilator without affecting the introducer sheath. The fact that a flexible, thin-walled introducer sheath is supported by a dilator that is stiffer than the introducer sheath can be a significant advantage for patients. blood During insertion into the canal, it is advantageous to remove the dilator so that the introducer sheath does not contact the patient's blood It is desirable for the introducer sheath to be released from the dilator so that it is left in place in the canal. Even slight retraction of the introducer sheath allows the patient to enter the canal without the dilator. blood This would cause problems since it would be impossible to push it back into the tube.

[0010] Preferably, the stiffening structure creates surface friction between at least a portion of the outer surface of the dilator and at least a portion of the inner surface of the tubular body of the introducer sheath when activated, and creates little or no friction when deactivated. Increasing and decreasing the surface friction between the outer surface of the dilator and the inner surface of the introducer sheath is a simple way to couple and decouple the dilator and the introducer sheath. For example, when the stiffening structure is deactivated, the body of the dilator has a first outer diameter that is smaller than the inner diameter of the tubular body of the introducer sheath, and when the stiffening structure is activated, at least a portion of the dilator, preferably at least a proximal portion, may have a second outer diameter that is larger than the first outer diameter, so that the outer surface of the dilator contacts the inner surface of the tubular body of the introducer sheath.

[0011] According to another embodiment of the invention, there is provided a dilator configured for use with an introducer sheath, preferably in an introducer set as described above. The dilator includes a body with an outer surface, the dilator being collapsible to facilitate reducing the cross-section of the body for the purpose of reducing surface friction between the outer surface and an inner surface of the introducer sheath. The dilator may be advantageously used with a thin-walled introducer sheath and is adapted to reduce the patient's blood During insertion into the vessel, increased surface friction between the dilator and the introducer sheath is preferred, whereas during retraction of the dilator, decreased surface friction is preferred to prevent buckling of the introducer sheath.

[0012] In accordance with another embodiment of the present invention, an introducer sheath is provided and includes a tubular body made of a flexible material having a distal portion and a proximal portion, the proximal portion being adapted to be inserted into the patient's anterior graft. blood The introducer sheath is configured to be inserted into the patient's duct, whereby the medical device is introduced through the introducer sheath into the patient's duct. bloodThe tubular body of the introducer sheath can be inserted into a tube. The tubular body of the introducer sheath has a wall thickness of 0.3 mm or less, preferably less than 0.2 mm, more preferably less than 0.15 mm, and even more preferably less than 0.1 mm.

[0013] A method for providing vascular access in a patient's body is disclosed, in which an introducer set is provided in a first step. The introducer set includes an introducer sheath and a dilator. The introducer sheath includes a tubular body with a distal portion, a proximal portion, and an inner surface, the proximal portion being disposed adjacent the patient's body. blood The introducer sheath is configured to be inserted into the patient's duct, whereby the medical device is introduced through the introducer sheath into the patient's duct. blood The dilator can be inserted into the tube. The tubular body of the introducer sheath has a wall thickness of 0.3 mm or less. The dilator includes a body with a proximal portion, a distal portion, and an outer surface. The dilator is inserted into the introducer sheath such that the proximal portion extends proximally out of the introducer sheath, and the dilator includes a deflatable balloon for reducing surface friction between at least a portion of the outer surface of the dilator and at least a portion of the inner surface of the tubular body of the introducer sheath.

[0014] Patient blood After insertion of the introducer sheath and dilator into the vessel, the balloon is deflated and the dilator is retracted from the introducer sheath, so that the introducer sheath remains in contact with the patient's blood Deflating the balloon before retracting the dilator prevents the introducer sheath from being retracted from the patient along with the dilator and prevents it from buckling. According to an embodiment, the introducer sheath and dilator are removed from the patient's bloodPrior to insertion into the canal, it may be necessary to insert a dilator into the introducer sheath and inflate the balloon of the dilator. Inflating the balloon causes the dilator to contact the inner surface of the introducer sheath, providing sufficient rigidity and comfort to the patient. blood To prevent the introducer sheath from buckling during insertion into the vessel.

[0015] In a preferred embodiment, the stiffening structure comprises a collapsible balloon. The balloon may be disposed preferably along substantially the entire length of the dilator body and at least on the proximal portion of the dilator body. It may be sufficient to provide a balloon at least on the proximal portion of the dilator body. However, for the purpose of increasing stability and stiffness, the balloon may be provided substantially along the entire length of the dilator body, in particular along the major portion of the dilator body, except for one or both of the distal tip, which may be tapered, and the proximal portion, which may have a handle or a connection port. The balloon may comprise a non-compliant material, preferably a polyamide, such as nylon.

[0016] To allow for the deflation and / or inflation of the balloon, the dilator may include an inflation port in a distal portion of the dilator body in fluid communication with the balloon. The inflation port may be filled with a fluid and may be coupled to a reservoir including a pressure device, preferably a syringe-type pressure device, so that the fluid received in the reservoir may be pressurized to inflate the balloon. The pressure device may include a plunger sealed against the inner wall of the reservoir and having a first thread. The pressure device may further include an actuation screw having a second thread that meshes with the first thread, so that the plunger can move inside the reservoir, and rotation of the actuation screw pressurizes the fluid received in the reservoir. The pressure device provides a simple mechanical device to control the pressure of the balloon and, therefore, the outer diameter of the dilator.

[0017] In another embodiment, the stiffening structure comprises first and second elements that are translatable relative to one another and at least one of the first and second elements is movable relative to the other of the dilator. Long and an actuation mechanism for translating the actuation mechanism in a direction. The longitudinal direction to Preferably, the second element has a tubular body and the first element extends through the tubular body of the second element beyond a proximal end of the second element.

[0018] The stiffening structure may include at least one deformable member that engages the first and second elements, thus Long direction to Translation is the dilator The longitudinal The deformable member forms part of the dilator and preferably has substantially the same diameter as the body of the dilator in an uncompressed state.

[0019] The deformable member may be ring-shaped or tube-shaped and may comprise a soft polymer, preferably silicone. In other embodiments, the deformable member is a Long The slits may extend in a direction such that Long In another embodiment, the deformable member may be attached to a first element and engage a second element, the deformable member being configured to allow the second element to radially collapse upon decompression in the radial direction. The longitudinal The stiffening structure may include a plurality of tabs slidable over the beveled end portion of the second element for radial deformation when translated in the radial direction. The deformable member may be formed separately or integrally with at least one of the first and second elements of the stiffening structure.

[0020] According to another preferred embodiment, the introducer sheath may include a hydraulic port in fluid communication with the space defined by the inner surface of the introducer sheath and the outer surface of the dilator. In order to stiffen and support the thin-walled introducer sheath, hydraulic fluid is pressed into the space, which is preferably substantially fluid-tight, at the proximal end, in particular where the proximal end of the introducer sheath contacts the dilator. A tight connection can be maintained until a certain pressure in the space between the dilator and the introducer sheath is exceeded. In order to release the introducer sheath from the dilator, the pressure of the hydraulic fluid is further increased, so that the fluid leaks out at the proximal end of the introducer sheath, creating a gap with a fluid film between the dilator and the introducer sheath. The dilator can then be easily retracted without buckling the introducer sheath. The hydraulic fluid is then forced into the space, which is preferably substantially fluid-tight, at the proximal end, in particular where the proximal end of the introducer sheath contacts the dilator. The tight connection can be maintained until a certain pressure in the space between the dilator and the introducer sheath is exceeded. In order to release the introducer sheath from the dilator, the pressure of the hydraulic fluid is further increased, so that the fluid leaks out at the proximal end of the introducer sheath, creating a gap with a fluid film between the dilator and the introducer sheath. The dilator can then be easily retracted without buckling the introducer sheath. The hydraulic fluid is then forced into the patient's cavity, which is then filled with the hydraulic fluid. blood It can be a saline solution that will not cause harm to the patient when it enters the tubing.

[0021] According to another embodiment, the tubular body of the introducer sheath has a tubular body. Long The support strut may include at least one cavity extending in a direction to accommodate a detachable support strut. At least one, and preferably a plurality, such as two, three, four, five, or six, such support struts may include: The longitudinal The support struts may be inserted into elongated cavities disposed in the wall of the introducer sheath along the length direction. The support struts may be wires or the like. When the support struts are no longer needed, they may simply be retracted from the cavities. Removing the struts may increase the inner diameter of the introducer sheath. The support struts preferably have a cross-section that differs in shape from the cross-section of the cavity, e.g., a polygonal or star-like cross-sectional shape, to provide low friction between the cavity and the support struts.

[0022] In an embodiment, the introducer sheath includes a hemostatic valve at its distal portion. 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. The introducer sheath is inserted into the patient's anterior graft through the introducer sheath. blood The introducer sheath may be detachable along its length to allow it to be peeled away from the medical device inserted into the vessel.

[0023] 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 description of the drawings]

[0024] [Figure 1] 1A and 1B are diagrams illustrating an introducer set including a dilator and an introducer sheath according to an embodiment of the present invention. [Diagram 2] FIG. 2 shows the dilator and introducer sheath of FIG. 1 separately. [Diagram 3] FIG. 2 is a cross-sectional view of the dilator of FIG. 1. [Figure 4] FIG. 2 is a cross-sectional view of the introducer sheath of FIG. [Figure 5a] 1A and 1B are side and cross-sectional views, respectively, of an introducer set assembled with a pressure device. [Figure 5b] 1A and 1B are side and cross-sectional views, respectively, of an introducer set assembled with a pressure device. [Figure 6a] 13A-13C show another embodiment of an introducer set in the process of being inserted into a patient's blood vessel. [Figure 6b]13A-13C show another embodiment of an introducer set in the process of being inserted into a patient's blood vessel. [Figure 7a] FIG. 6c shows the introducer set of FIGS. 6a and 6b with the dilator in a retracting position. [Figure 7b] FIG. 6c shows the introducer set of FIGS. 6a and 6b with the dilator in a retracting position. [Figure 7c] FIG. 6c shows the introducer set of FIGS. 6a and 6b with the dilator in a retracting position. [Figure 8a] 13A-13C show another embodiment of an introducer set in the process of being inserted into a patient's blood vessel. [Figure 8b] 13A-13C show another embodiment of an introducer set in the process of being inserted into a patient's blood vessel. [Figure 9a] FIG. 8c shows the introducer set of FIGS. 8a and 8b with the dilator in a retracting position. [Figure 9b] FIG. 8c shows the introducer set of FIGS. 8a and 8b with the dilator in a retracting position. [Figure 9c] FIG. 8c shows the introducer set of FIGS. 8a and 8b with the dilator in a retracting position. [Figure 10a] 13A-13C show another embodiment of an introducer set in the process of being inserted into a patient's blood vessel. [Figure 10b] 13A-13C show another embodiment of an introducer set in the process of being inserted into a patient's blood vessel. [Figure 11a] FIG. 10C shows the introducer set of FIGS. 10a and 10b with the dilator in a retracting position. [Figure 11b] FIG. 10C shows the introducer set of FIGS. 10a and 10b with the dilator in a retracting position. [Figure 11c] FIG. 10C shows the introducer set of FIGS. 10a and 10b with the dilator in a retracting position. [Figure 12a]13A-13C show another embodiment of an introducer set in the process of being inserted into a patient's blood vessel. [Figure 12b] 13A-13C show another embodiment of an introducer set in the process of being inserted into a patient's blood vessel. [Figure 13a] FIG. 12c shows the introducer set of FIGS. 12a and 12b with the dilator in a retracting position. [Figure 13b] FIG. 12c shows the introducer set of FIGS. 12a and 12b with the dilator in a retracting position. [Figure 13c] FIG. 12c shows the introducer set of FIGS. 12a and 12b with the dilator in a retracting position. [Figure 14a] 13A-13C show another embodiment of an introducer set in the process of being inserted into a patient's blood vessel. [Figure 14b] 13A-13C show another embodiment of an introducer set in the process of being inserted into a patient's blood vessel. [Figure 15a] FIG. 14C shows the introducer set of FIGS. 14a and 14b with the dilator in a retracting position. [Figure 15b] FIG. 14C shows the introducer set of FIGS. 14a and 14b with the dilator in a retracting position. [Figure 15c] FIG. 14C shows the introducer set of FIGS. 14a and 14b with the dilator in a retracting position. [Figure 16] FIG. 1 illustrates an application of the present invention. [Figure 17] FIG. 1 illustrates another application of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0025] 1-4, various views of an introducer set 1 according to an embodiment of the present invention are shown. The introducer set 1 includes an introducer sheath 10 and a dilator 20, shown assembled in FIG. 1 and separately in FIG. 2. The introducer sheath 10 includes a tubular body 11 having a distal portion 12 and a proximal portion 13. A hemostatic valve 14 having a flexible membrane 18 is provided in the distal portion 13. Two handles 15 and 16 are provided for manipulating the introducer sheath 10 and for separating the introducer sheath 10, in particular for splitting the hemostatic valve 14. Longitudinal A notch 17 is provided in the hemostasis valve 14 to define a predetermined break line. The tubular body 11 of the introducer sheath 10 has a wall 19 with a wall thickness d less than 0.3 mm. Thus, the introducer sheath 10 is a thin-walled introducer sheath.

[0026] The dilator 20 has a body 21 with a distal portion 22 and a proximal portion 23. The proximal portion 23 is blood The dilator 20 includes a tapered tip 24 to facilitate insertion into the vessel. Ports 26 and 28 are provided in the distal portion. Port 28 is coupled to an inner lumen 29 that is configured to receive a guidewire (not shown) therein. In other words, the dilator 20 is inserted into the patient's duct, for example, by the Seldinger technique. blood The balloon 25 may be positioned over a guidewire that has been inserted into the canal. The balloon 25 is disposed on the body 21 of the dilator 20 and extends over most of the body 21 except for the tapered tip 24 and the most distal portion of the body 21. The balloon 25 may be inflated and deflated through a port 26 that is connected to the balloon 25 through a lumen 27 in the distal portion 22 of the body 21. The balloon is made of a non-compliant material, such as nylon.

[0027] The balloon 25 of the dilator 20 is utilized as a stiffening structure to support the thin-walled introducer sheath 10. The dilator 20 is inserted into the introducer sheath 10 with the balloon 25 deflated. In other words, the balloon is pre-loaded before operation. A fluid such as air is filled into the balloon 25 via the port 26 to inflate the balloon 25, so that the balloon 25 contacts the inner surface of the introducer sheath 10. The surface friction between the dilator 20 and the introducer sheath 10 is thereby increased, which increases the patient's blood It provides stability to the introducer sheath 10 during insertion into the canal and prevents the introducer sheath 10 from buckling. blood When the dilator 20 is retracted after insertion into the vessel, the balloon 25 is deflated to reduce surface friction between the dilator 20 and the introducer sheath 10. The dilator 20 can then be retracted from the introducer sheath 10 substantially without any interference. The dilator 20 and introducer sheath 10 are free to move.

[0028] 5a and 5b show an embodiment of an introducer set including an introducer sheath 10 and a dilator 20 attached to a pressure device 30. The pressure device 30 is coupled to the balloon 25 for inflating and deflating the balloon 25. The syringe-type pressure device 30 has a body 31 forming a reservoir that can be filled with a fluid, such as air, via an aperture 35. A plunger 33 is disposed in the body 31 and sealed against the inner surface of the body 31 with a diaphragm seal 34. The plunger 33 is actuated with an actuation screw 32. The threads 38 of the screw 32 engage with the threads 39 of the plunger 33, translating the plunger 33 without rotating it upon rotation of the screw 32. A luer connector 36 may be provided at the end of the plunger 33 in communication with a guide tube 37 that can receive a guidewire. The pressure device 30 allows adjustment of the pressure within the balloon 25 and therefore the outer diameter of the dilator 20 by actuation of the screw 32 .

[0029] 6a and 6b, an introducer set is shown with a dilator 20 preloaded into the introducer sheath 10. This embodiment is similar to the embodiment described above and includes an inflatable balloon 25. As can be seen in FIG. 6b, the balloon 25 is inflated to form part of the transition between the proximal end of the body 11 of the introducer sheath 10 and the tapered tip 24 of the dilator 20, and to extend beyond the patient's anterior wall. blood The balloon 25 extends only within the proximal portion 23 of the body 21 of the dilator 20, or may extend along substantially the entire length of the body 21. During removal of the dilator 20, the balloon 25 expands as shown in Figures 7a-7c. The clearance between the introducer sheath 10 and the dilator 20 allows the dilator 20 to move freely within the introducer sheath 10 and to be retracted substantially without any interference. The balloon 25 may extend only within the proximal portion 23 of the body 21 of the dilator 20, or may extend along substantially the entire length of the body 21.

[0030] Another embodiment is shown in Figures 8a, 8b and 9a-9c. In this embodiment, the expansion of the diameter of the dilator 120 is not achieved by an inflatable balloon, but by Long The dilators 120 are configured with a deformable insert 125 that expands radially upon compression in the axial direction. The insert 125 may be made of a soft polymer such as silicone. Long The dilator 120 comprises two elements 121 and 122 which are translatable in the axial direction. The element 121, which forms the tip of the dilator 120, is inserted through the other element 122, which is tubular. A screw mechanism 123 is used to effect the translation of the elements 121 and 122. In particular, the tubular element 122 is advanced proximally. Between the two shoulders are arranged a ring 124 and a deformable insert 125. As can be seen from FIG. 8b, the insert 125 causes the elements 121 and 122 to translate relative to each other. Long1. The introducer sheath 10 is then compressed in the axial direction and therefore expands radially to contact the inner surface of the introducer sheath 10. The introducer sheath 10 is therefore blood The dilator 120 is clamped and stabilized for insertion into the canal. To remove the dilator 120, the screw mechanism 123 is actuated to release the insert 125, thus Long 2, the dilator 120 relaxes in the axial direction and collapses radially. The dilator 120 can then be removed from the introducer sheath 10 without any interference.

[0031] The embodiment shown in Figures 10a, 10b and 11a-11c is similar to the embodiment described in relation to Figures 8a, 8b and 9a-9c. The dilator 220 includes two elements 221 and 222, which are moved by actuating a screw mechanism 223. Long It can be translated in the direction. Longitudinal The structure including the slits 225 and legs 226 is provided to allow radial expansion in the same manner as the silicone insert described above. As can be seen from FIG. 10b, the slits 225 Long The introducer sheath 10 allows the legs 226 to expand radially upon axial compression, thereby providing a blood The screw mechanism 223 is actuated to translate the element 222 distally, thereby radially collapsing the legs 226, in order to allow the dilator 220 to be retracted from the introducer sheath 10. The dilator 220 is then free to move within the introducer sheath 10, thus allowing the introducer sheath 10 to be inserted into the patient's canal. blood It is left inside the tube and will not buckle.

[0032] Another embodiment in which the dilator 320 has two elements 321 and 322 is shown in Figures 12a, 12b and 13a-13c. The radially expandable structure is formed by a tab 325 that is connected to or integrally formed with element 321 of the dilator 320. As can be seen from Figure 12b, element 322 has a beveled proximal end portion 326 such that tab 325 expands radially when element 322 is advanced proximally by movement of screw mechanism 323. Tab 325 then extends radially when the introducer sheath 10 is inserted into the patient's anterior graft. blood 13a-13c, the beveled end portion 326 is retracted distally such that the tabs 325 radially collapse, allowing the dilator 320 to move freely within the introducer sheath 10 during retraction of the dilator 320.

[0033] Another embodiment of an introducer set including a thin-walled introducer sheath 10 and a dilator 420 is shown in Figures 14a, 14b and 15a-15c. A space or recess 424 is formed between the dilator 420 and the introducer sheath 10 and can be filled with a fluid, such as saline, via a port 423. An enlarged diameter portion 425 of the dilator 420 is provided in the region of the distal end of the introducer sheath 10 to create a tight coupling between the dilator 420 and the introducer sheath 10. The patient's blood During insertion into the tube, the space 424 fills with fluid to stabilize the introducer sheath 10. Referring specifically to Fig. 15b, during removal of the dilator 420, the pressure of the fluid increases, forcing leakage of the fluid at the proximal end of the introducer sheath 10, thereby creating a film layer and creating a friction reduction between the dilator 420 and the introducer sheath 10, allowing the dilator 420 to be removed without buckling the introducer sheath 10.

[0034] 16 and 17, an application of the introducer set is shown. The introducer set can be according to any one of the embodiments disclosed above. It is used to introduce an axial blood pump 101 into the patient's ventricle using a catheter 100 to provide a ventricular assist device. blood It is used to insert the tube into the patient's heart. Vascular access can be placed in the patient's thorax (Figure 16) or in a peripheral blood vessel in the patient's groin (Figure 17).

[0035] Preferred Embodiments of the Invention In the following paragraphs, preferred embodiments of the present invention are disclosed.

[0036] [Embodiment 1] The introducer sheath 10 has a tubular body 11 made of a flexible material with a distal portion 12, a proximal portion 13, and an inner surface, the proximal portion 13 being adapted to be inserted into the patient's anterior graft. blood The introducer sheath 10 is configured to be inserted into the duct of a patient, whereby the medical device 100 is introduced through the introducer sheath 10 into the duct of the patient. blood an introducer sheath 10 that can be inserted into the vessel; a dilator 20 having a body 21 with a proximal portion 23, a distal portion 22, and an outer surface, the dilator 20 being insertable into the introducer sheath 10 such that the proximal portion 23 extends proximally of the introducer sheath 10 when the dilator 20 is inserted into the introducer sheath 10; An introducer set 1 for providing vascular access in a patient's body, comprising: The tubular body 11 of the introducer sheath has a wall thickness d of 0.3 mm or less; At least one of the dilator 20 and the introducer sheath 10 includes a stiffening structure 25 that imparts stiffening to the tubular body 11 of the introducer sheath 10, the stiffening structure 25 being released. Ruka , removed Ruka , or in any manner other than by release and removal. Introducer set 1 can be deactivated.

[0037] [Embodiment 2] The introducer set according to embodiment 1, wherein the tubular body 11 of the introducer sheath 10 has a wall thickness smaller than 0.2 mm, preferably smaller than 0.15 mm, more preferably smaller than 0.1 mm.

[0038] [Embodiment 3] An introducer set as described in embodiment 1 or 2, wherein the stiffening structure 25, when activated, creates surface friction between at least a portion of the outer surface of the dilator 20 and at least a portion of the inner surface of the tubular body 11 of the introducer sheath 10, and, when deactivated, creates little or no friction.

[0039] [Embodiment 4] An introducer set as described in embodiment 3, wherein when the stiffening structure 25 is deactivated, the body 21 of the dilator 20 has a first outer diameter smaller than the inner diameter of the tubular body 11 of the introducer sheath 10, and when the stiffening structure 25 is activated, at least a portion of the dilator 20, preferably at least the proximal portion 23, has a second outer diameter larger than the first outer diameter, such that the outer surface of the dilator 20 contacts the inner surface of the tubular body 11 of the introducer sheath 10.

[0040] [Embodiment 5] An introducer set according to any one of embodiments 1 to 4, wherein the stiffening structure comprises a collapsible balloon 25.

[0041] [Embodiment 6] An introducer set as described in embodiment 5, wherein the balloon 25 is disposed at least in the proximal portion 23 of the dilator body 21, preferably along substantially the entire length of the dilator body 21.

[0042] [Embodiment 7] An introducer set as described in embodiment 5 or 6, wherein the dilator 20 includes an inflation port 26 in fluid communication with the balloon 25 at the distal portion 22 of the dilator body 21.

[0043] [Embodiment 8] An introducer set as described in embodiment 7, wherein the inflation port 26 is fluid-fillable and connected to a reservoir 31 including a pressure device 30, preferably a syringe-type pressure device, such that the fluid received in the reservoir 31 can be pressurized to inflate the balloon 25.

[0044] [Embodiment 9] An introducer set as described in embodiment 8, wherein the pressure device 30 includes a plunger 33 sealed against the inner wall of the reservoir 31 and having a first thread 39, and the pressure device 30 further includes an actuation screw 32 having a second thread 38 that meshes with the first thread 39, such that the plunger 33 can move inside the reservoir 31 and rotation of the actuation screw 32 pressurizes the fluid received in the reservoir 31.

[0045] [Embodiment 10] The introducer set according to any one of embodiments 5 to 9, wherein the balloon 25 comprises a non-compliant material, preferably polyamide, preferably nylon.

[0046] [Embodiment 11] The stiffening structure comprises first and second elements 121, 122; 221, 222; 321, 322 that are translatable relative to each other and a dilator 120; 220; 320 that moves at least one of the first and second elements relative to the other. Long and an actuation mechanism 123; 223; 323 for translating in a direction, and rotation of the actuation mechanism 123; 223; 323 The longitudinal direction to 5. The introducer set according to any one of embodiments 1 to 4, which preferably causes translation.

[0047] [Embodiment 12] An introducer set as described in embodiment 11, wherein the second element 122;222;322 has a tubular body and the first element 121;221;321 extends through the tubular body of the second element 122;222;322 beyond the proximal end of the first element 121;221;321.

[0048] [Embodiment 13] The stiffening structure includes at least one deformable member 125; 225 that engages the first and second elements 121, 122; 221, 222, thus Long direction to Translation is dilator 120; 220 The longitudinal An introducer set as described in embodiment 11 or 12, wherein the deformable member 125;225;325 is decompressed in the axial direction, thereby causing a radial contraction of the deformable member 125;225, the deformable member preferably forming part of the dilator and having substantially the same diameter as the body of the dilator in an uncompressed state.

[0049] [Embodiment 14] 14. The introducer set according to embodiment 13, wherein the deformable member 125 is ring-shaped or tubular-shaped.

[0050] [Embodiment 15] 15. The introducer set according to embodiment 13 or 14, wherein the deformable member 125 comprises a soft polymer, preferably silicone.

[0051] [Embodiment 16] The deformable member is a member of the dilator 220. The longitudinal a plurality of slits 226 extending in the direction Long 14. An introducer set as described in embodiment 13, wherein the deformable member is capable of radially collapsing upon decompression in the radial direction.

[0052] [Embodiment 17] The stiffening structure includes at least one deformable member 325 attached to the first element 321 and engaging the second element 322, the deformable member 325 being configured to engage the second element 322 when the second element 322 is The longitudinal 13. The introducer set of embodiment 11 or 12, comprising a plurality of tabs 325 slidable on the beveled end portion 326 of the second element 322 to deform radially when translated in the radial direction.

[0053] [Embodiment 18] An introducer set according to any one of embodiments 13 to 17, wherein the deformable member 125; 225; 325 is formed separately or integrally with at least one of the first and second elements 121, 122; 221, 222; 321, 322.

[0054] [Embodiment 19] An introducer set as described in embodiment 1 or 2, wherein the introducer sheath includes a hydraulic port 426 in fluid communication with a space 424 defined by an inner surface of the introducer sheath and an outer surface of the dilator 420.

[0055] [Embodiment 20] The tubular body of the introducer sheath is Long 20. An introducer set according to any one of the preceding embodiments, comprising at least one cavity extending in the direction to accommodate a detachable support strut.

[0056] [Embodiment 21] 21. The introducer set of embodiment 20, wherein the support strut has a cross-section that is different in shape from the cross-section of the cavity, preferably a polygonal or star-like cross-sectional shape, to provide low friction between the cavity and the support strut.

[0057] [Embodiment 22] An introducer set according to any one of embodiments 1 to 21, wherein the flexible material of the introducer sheath 10 comprises PTFE.

[0058] [Embodiment 23] An introducer set according to any one of embodiments 1 to 22, wherein the introducer sheath 10 includes a hemostasis valve 14 in its distal portion 12.

[0059] [Embodiment 24] An introducer set according to any one of embodiments 1 to 23, wherein the introducer sheath 10 is detachable along its length.

[0060] [Embodiment 25] An introducer set according to any one of embodiments 1 to 24, wherein the medical device includes a catheter 100.

[0061] [Embodiment 26] An introducer set as described in embodiment 25, comprising an axial blood pump 101 disposed at the tip of the catheter 100.

[0062] [Embodiment 27] A dilator 20;120;220;320 configured for use in an introducer sheath and including a body with an outer surface, the dilator being collapsible to permit a cross-section of the body to be reduced for the purpose of reducing surface friction between the outer surface and an inner surface of the introducer sheath.

[0063] [Embodiment 28] 28. A dilator as described in embodiment 27, comprising a collapsible balloon 25.

[0064] [Embodiment 29] A dilator as described in embodiment 28, wherein the balloon 25 is disposed at least in the proximal portion 23 of the body 21, preferably along substantially the entire length of the body 21.

[0065] [Embodiment 30] A dilator as described in embodiment 28 or 29, comprising an inflation port 26 in fluid communication with the balloon 25 at the distal portion 22 of the dilator body 21.

[0066] [Embodiment 31] The dilator of embodiment 30, wherein the inflation port 26 is fluid-fillable and connected to a reservoir 31 including a pressure device 30, preferably a syringe-type pressure device, such that the fluid received in the reservoir 31 can be pressurized to inflate the balloon 25.

[0067] [Embodiment 32] A dilator as described in embodiment 31, wherein the pressure device 30 includes a plunger 33 sealed against the inner wall of the reservoir 31 and having a first thread 39, and the pressure device 30 further includes an actuation screw 32 having a second thread 38 that meshes with the first thread 39, such that the plunger 33 can move inside the reservoir 31 and rotation of the actuation screw 32 pressurizes the fluid received in the reservoir 31.

[0068] [Embodiment 33] 33. The dilator according to any one of embodiments 28 to 32, wherein the balloon 25 comprises a non-compliant material, preferably polyamide, preferably nylon.

[0069] [Embodiment 34] a first and second element 121, 122; 221, 222; 321, 322 that are translatable relative to each other, and a dilator 120; 220; 320 that moves at least one of the first and second elements relative to the other; Long and an actuation mechanism 123; 223; 323 for translating in a direction, and rotation of the actuation mechanism 123; 223; 323 The longitudinal direction to 28. A dilator as described in embodiment 27, which preferably produces translation.

[0070] [Embodiment 35] A dilator as described in embodiment 34, wherein the second element 122;222;322 has a tubular body and the first element 121;221;321 extends through the tubular body of the second element 122;222;322 beyond the proximal end of the first element 121;221;321.

[0071] [Embodiment 36] At least one deformable member 125; 225 that engages with the first and second elements 121, 122; 221, 222, thus Long direction to Translation is dilator 120; 220 The longitudinal A dilator as described in embodiment 34 or 35, which causes a reduction in pressure of the deformable member 125; 225; 325 in the direction, thereby causing a radial contraction of the deformable member 125; 225, the deformable member preferably forming part of the dilator and having, in an uncompressed state, substantially the same diameter as the body of the dilator.

[0072] [Embodiment 37] A dilator according to embodiment 36, wherein the deformable member 125 is ring-shaped or tube-shaped.

[0073] [Embodiment 38] 38. The dilator of embodiment 36 or 37, wherein the deformable member comprises a soft polymer, preferably silicone.

[0074] [Embodiment 39] The deformable member is a member of the dilator 220. The longitudinal a plurality of slits 226 extending in the direction Long 37. The dilator of embodiment 36, wherein the deformable member is capable of radial collapse upon decompression in the radial direction.

[0075] [Embodiment 40] At least one deformable member 325 attached to the first element 321 and engaging the second element 322, the deformable member 325 being configured to The longitudinal 36. The dilator of embodiment 34 or 35, comprising a plurality of tabs 325 slidable on the beveled end portion 326 of the second element 322 to deform radially when translated in the radial direction.

[0076] [Embodiment 41] A dilator according to any one of embodiments 36 to 40, wherein the deformable member 125; 225; 325 is formed separately or integrally with at least one of the first and second elements 121, 122; 221, 222; 321, 322.

[0077] [Embodiment 42] An introducer sheath including a tubular body made of a flexible material with a distal portion and a proximal portion, the proximal portion being adapted to be inserted into the patient's blood The introducer sheath is configured to be inserted into the patient's duct, whereby the medical device is introduced through the introducer sheath into the patient's duct. blood An introducer sheath capable of being inserted into a tube, the tubular body having a wall thickness of 0.3 mm or less, preferably less than 0.2 mm, more preferably less than 0.15 mm, even more preferably less than 0.1 mm.

[0078] [Embodiment 43] An introducer sheath as described in embodiment 42, comprising a hydraulic port 426 in fluid communication with a space 424 defined by an inner surface of the introducer sheath and an outer surface of the dilator 420.

[0079] [Embodiment 44] The tubular body is Long An introducer sheath as described in embodiment 42 or 43, comprising at least one cavity extending in the direction and accommodating a detachable support strut.

[0080] [Embodiment 45] 45. The introducer sheath of embodiment 44, wherein the support strut has a cross-section that is different in shape from a cross-section of the cavity, preferably a star-like cross-sectional shape, to provide low friction between the cavity and the support strut.

[0081] [Embodiment 46] 46. ​​An introducer sheath as described in any one of embodiments 42 to 45, wherein the flexible material comprises PTFE.

[0082] [Embodiment 47] An introducer sheath as described in any one of embodiments 42 to 46, comprising a hemostasis valve 14 in the distal portion 12.

[0083] [Embodiment 48] An introducer sheath according to any one of embodiments 42 to 47, wherein the introducer sheath 10 is detachable along its length.

[0084] [Embodiment 49] Providing an introducer set 1 including an introducer sheath 10 and a dilator 20, the introducer sheath 10 including a tubular body 11 having a distal portion 12, a proximal portion 13, and an inner surface, the proximal portion 13 being adapted to be connected to the patient's blood The introducer sheath 10 is configured to be inserted into the duct of a patient, whereby the medical device 100 is introduced through the introducer sheath 10 into the duct of the patient. blood a dilator 20 including a body 21 having a proximal portion 23, a distal portion 22, and an outer surface, the dilator 20 being inserted into the introducer sheath 10 such that the proximal portion 23 extends proximally out of the introducer sheath 10, the dilator 20 including a collapsible balloon 25 for reducing surface friction between at least a portion of the outer surface of the dilator 20 and at least a portion of the inner surface of the tubular body 11 of the introducer sheath 10; The introducer sheath 10 and the dilator 20 are inserted into the patient's blood Inserting into a tube; Deflating the balloon 25; The introducer sheath 10 is inserted into the patient's blood retracting the dilator 20 from the introducer sheath 10 so that it remains in the vessel; 16. A method for providing vascular access in a patient's body, comprising:

[0085] [Embodiment 50] Providing an introducer set 1 including an introducer sheath 10 and a dilator 20, the introducer sheath 10 including a tubular body 11 having a distal portion 12, a proximal portion 13, and an inner surface, the proximal portion 13 being adapted to be connected to the patient's blood The introducer sheath 10 is configured to be inserted into the duct of a patient, whereby the medical device 100 is introduced through the introducer sheath 10 into the duct of the patient. blood a dilator 20 including a body 21 having a proximal portion 23, a distal portion 22, and an outer surface, the dilator 20 being insertable into the introducer sheath 10 such that the proximal portion 23 extends proximally out of the introducer sheath 10 when the dilator 20 is inserted into the introducer sheath 10, the dilator 20 including a collapsible balloon 25 for reducing surface friction between at least a portion of the outer surface of the dilator 20 and at least a portion of the inner surface of the tubular body 11 of the introducer sheath 10; Inserting a dilator 20 into the introducer sheath 10; Inflating the balloon 25 of the dilator 20; The introducer sheath 10 and the dilator 20 are inserted into the patient's blood Inserting into a tube; Deflating the balloon 25; The introducer sheath 10 is inserted into the patient's blood retracting the dilator 20 from the introducer sheath 10 so that it remains in the vessel; 16. A method for providing vascular access in a patient's body, comprising:

Claims

1. 1. An introducer sheath including a tubular body made of a flexible material with a distal portion and a proximal portion, the proximal portion configured to be inserted into a blood vessel of a patient such that a medical device can be inserted through the introducer sheath and into the blood vessel of the patient, the tubular body having a wall thickness of 0.3 mm or less; The introducer sheath, wherein the tubular body includes at least one cavity extending longitudinally of the tubular body that accommodates a detachable support strut.

2. 2. The introducer sheath of claim 1, wherein the support struts have a cross-section that is shaped differently than a cross-section of the cavity to provide low friction between the cavity and the support struts.

3. The introducer sheath of claim 2 , wherein the support struts have a polygonal cross-sectional shape that is different from a cross-sectional shape of the cavity.

4. 4. The introducer sheath according to claim 1, wherein the flexible material comprises polytetrafluoroethylene (PTFE).

5. 5. The introducer sheath of claim 1, further comprising a hemostasis valve in the distal portion.

6. 6. The introducer sheath according to any one of claims 1 to 5, characterized in that the introducer sheath is detachable along its length.

7. 7. The introducer sheath according to any one of claims 1 to 6, wherein the wall thickness is less than 0.2 mm.

8. 7. The introducer sheath according to any one of claims 1 to 6, wherein the wall thickness is less than 0.15 mm.

9. 7. The introducer sheath according to any one of claims 1 to 6, wherein the wall thickness is less than 0.1 mm.

10. 1. An introducer set for providing vascular access in a body of a patient, comprising: An introducer sheath according to any one of claims 1 to 9; a dilator having a body with a proximal portion, a distal portion, and an outer surface, the dilator being insertable into the introducer sheath such that the proximal portion extends proximally of the introducer sheath when the dilator is inserted into the introducer sheath; At least one of the dilator and the introducer sheath includes a stiffening structure that imparts stiffening to the tubular body of the introducer sheath, the stiffening structure being capable of being released, removed, or otherwise deactivated.

11. An introducer set for inserting an introducer sheath into a blood vessel of a patient, comprising: an introducer sheath including a tubular body made of a flexible material with a distal portion and a proximal portion, the proximal portion configured to be inserted into a blood vessel of a patient whereby a medical device can be inserted through the introducer sheath into the blood vessel of the patient, the tubular body having a wall thickness of 0.3 mm or less; a dilator having a body with a proximal portion, a distal portion, and an outer surface, the dilator being insertable into the introducer sheath such that the proximal portion extends proximally of the introducer sheath when the dilator is inserted into the introducer sheath; at least one of the dilator and the introducer sheath includes a stiffening structure that imparts stiffening to the tubular body of the introducer sheath, the stiffening structure being capable of being released, removed, or otherwise deactivated; the stiffening structure, when activated, creates a surface friction between at least a portion of the outer surface of the dilator and at least a portion of the inner surface of the tubular body of the introducer sheath, and, when deactivated, creates less surface friction or no surface friction compared to when activated; an introducer set, characterized in that when the stiffening structure is deactivated, the body of the dilator has a first outer diameter smaller than an inner diameter of the tubular body of the introducer sheath, and when the stiffening structure is activated, at least a portion of the dilator has a second outer diameter larger than the first outer diameter, such that the outer surface of the dilator contacts the inner surface of the tubular body of the introducer sheath.

12. The introducer set of claim 11, wherein the portion of the dilator is a proximal portion of the dilator.

13. The introducer set according to claim 11 or 12, characterized in that the medical device comprises a catheter.

14. 14. The introducer set according to claim 13, further comprising an axial blood pump disposed at the tip of the catheter.

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