Vascular access

Abstract

To provide a hemostasis valve capable of introducing or removing a large device or instrument fitted to an end of an engaged device such as a vascular graft.SOLUTION: A hemostasis valve 610 includes a housing 616 having a slit membrane 611 in which a medical device can be inserted. Moreover, the hemostasis valve 610 is provided with an introducer sheath 615 configured to be insertable into a distal end of a graft tubular body. The slit membrane 611 has a membrane slit 612 and a central hole 613. A part or the whole of the housing 616 is made of flexible polymer.SELECTED DRAWING: Figure 8

Description

[Technical Field]

[0001] Long-term vascular access (vascular access) is a common medical procedure used in several situations, including dialysis for patients requiring frequent dialysis treatments, chemotherapy treatments, and the use of ventricular assist devices. The devices and methods used vary depending on the patient's condition. Long-term vascular access in patients requiring ventricular assist devices is common through open-heart surgery and direct cardiac vascular access. [Background technology]

[0002] Recently, there has been a trend toward peripheral vascular access to the cardiovascular system, aiming to avoid the traumatic open-heart surgery. This shift from central cardiac vasculature to peripheral vasculature has been accompanied by the development of numerous individual devices and instruments specifically designed for peripheral use. Among the devices developed to enable peripheral vascular access, vascular introducers are the most common. Vascular access introducers typically have a tapered tip and are inserted directly into the vessel, often with the assistance of a dilator. These introducers have been limited to small diameters, ranging from 1 to 3 mm, and were used for a maximum of a few hours. Use of introducers for longer than 24 hours faces the problem of prolonged hemodynamic response to foreign material present in the bloodstream.

[0003] In the field of long-term large-bore vascular access, many of the devices and instruments used to access the large vessels of the cardiovascular system during open-heart surgery are the same as those used in peripheral vascular access. The use of inappropriate devices, instruments, and procedures in peripheral vascular access has undermined the viability of peripheral vascular access and resulted in less than optimal outcomes.

[0004] Dacron® grafts are widely used for long-term vascular access. These same Dacron® grafts are also widely used for peripheral access, where large-diameter access is required and the grafts are intended to remain in the patient's body for extended periods of several days or more. These grafts are typically sutured to the vessel at one end and closed at the other end using various hemostatic techniques. When blood enters the graft, the porous Dacron® mesh becomes clogged due to the blood seeping into it. Standard medical silicone plugs secured with standard medical sutures are often used to ensure hemostasis. However, grafts made from other materials, such as silicone, can also be used. The introduction of devices into these grafts requires physicians to master and master various techniques and instruments, leading to unpredictable results and a high complication rate. Given that these procedures involve major blood vessels, bleeding is a major concern. Therefore, hemostasis is a critical aspect of these procedures. Any failure of hemostasis at any time, whether during or after device insertion, can lead to significant blood loss and even patient death. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] U.S. Patent No. 3,953,566 Summary of the Invention [Problem to be solved by the invention]

[0006] It is an object of the present invention to provide a device that provides access to large vessels or cavities, and in particular access through which large diameter devices, tissue or fluids can be introduced and / or removed in a safe, controlled manner and through a simple procedure.

[0007] Another object of the present invention is to provide a vascular graft that is easily secured to a vessel or cavity, aids in hemostasis, and allows for the introduction or removal of large devices or tools.

[0008] Another object of the present invention is to provide a vascular graft with a hemostatic valve at its tip that allows for the introduction or removal of large devices or tools.

[0009] Another object of the present invention is to provide a separate hemostatic valve that can be integrated into a graft to provide rapid and effective hemostasis during and after medical procedures requiring access to a vessel or cavity within the body.

[0010] Another object of the present invention is to provide a device that interfaces with a vascular graft to achieve hemostasis during introduction or removal of a device or tool from the body, and to allow for the placement of a plug within the graft that provides long-term hemostasis and a bacterial barrier during and after the medical procedure.

[0011] Another object of the present invention is to provide a device that can work in conjunction with an implanted vascular graft to achieve hemostasis, as well as a means for easily handling and securing the graft during introduction or removal of the device or tool from the body, and after the medical procedure is completed.

[0012] Another object of the present invention is to achieve easy interfacing with standard vascular grafts using widely available or dedicated vascular introducers to achieve hemostasis and bacterial barriers during or after medical procedures involving the use of vascular or medical grafts.

[0013] Another object of the present invention is to provide a device that allows for the rapid and safe introduction or removal of devices or tools from vessels or body cavities having diameters in the range of 1 mm to 12 mm.

[0014] Another object of the present invention is to provide a continuous introducer sheath that is implemented with separate hemostatic valves of the same size or size range and that can be used in series and / or in combination with an integrated hemostatic valve that is integrated into a graft.

[0015] Another object of the present invention is to provide a continuous introducer sheath that is implemented with separate hemostatic valves of the same size or size range and that can be used in series and / or in combination with individual hemostatic valves integrated into the graft.

[0016] Another object of the present invention is to provide a "quick connect" connector designed to allow rapid connection to a graft and / or hemostatic valve.

[0017] Another object of the present invention is to provide a "quick connect" connector designed to quickly connect to the graft and any catheters or devices that may be passed through the graft.

[0018] Another object of the present invention is to provide a clamp that clamps a hemostatic valve to a graft as well as any devices that pass through the graft.

[0019] Another object of the present invention is to provide a removable hemostatic valve that allows for proper sizing of the graft length. [Means for solving the problem]

[0020] The invention is set out in the separate independent claims and preferred embodiments are specified in the dependent claims.

[0021] One embodiment of the present invention provides a system for providing vascular access within a patient's body. The system includes a vascular graft having a tubular body with a proximal and distal end, the proximal end configured for attachment to a vessel within the patient's body. The system further includes a valve configured for attachment to the distal end of the graft's tubular body, specifically at least one valve having a housing with a flexible membrane, the flexible membrane having at least one of a passageway through the membrane and a weakened area for allowing insertion of a medical device through the membrane into the vascular graft. The valve further includes an introducer sheath configured for insertion into the distal end of the graft's tubular body.

[0022] As will be understood, the term "base" refers to a direction toward the heart, and the term "distal" refers to a direction away from the heart. Hereinafter, the valve will also be referred to as a "hemostatic valve" when emphasizing its function of achieving hemostasis, i.e., sealing the distal end of a vascular graft to prevent blood from flowing through the valve during insertion of a medical device, such as a catheter. According to the present invention, a hemostatic valve is provided having an introducer sheath that is particularly suitable for insertion into a vascular graft. In other words, in contrast to a typical introducer, the introducer sheath of the hemostatic valve of the present invention is not configured for direct insertion into a vessel, but is introduced into the vascular graft. The valve introduced into the distal end of the vascular graft achieves more efficient hemostasis than common techniques such as simply clamping the graft or tying the graft with sutures. The membrane can be configured as a flexible disk or in other configurations that provide the functionality of a check valve, e.g., a flutter valve.

[0023] The system preferably further includes at least one clamp configured to be positioned around the graft tubular body, the clamp having a first configuration for inserting a valve introducer sheath into the distal end of the graft tubular body and a second configuration for clamping the graft against the valve introducer sheath, particularly when inserted into the graft tubular body. The clamp may provide a simple method of valve fixation in a vascular graft and may also be used to compress the valve membrane.

[0024] Another embodiment of the present invention provides a valve configured for use in such a system. The valve includes a housing having a flexible membrane with at least one of a passageway through the membrane and a weakened area to allow insertion of a medical device therethrough. The valve further includes an introducer sheath configured for insertion into the open end of a mating device, preferably a vascular graft. The valve may also be formed integrally with the vascular graft. As noted above, the introducer sheath is preferably particularly adapted for insertion into a vascular graft. It is not configured for direct insertion into a vessel.

[0025] Preferably, the introducer sheath has at least one retention structure on its outer surface to inhibit removal of the valve from the mating device into which it is inserted. The retention structure may be formed as an inclined surface, preferably including at least one barb tapering away from the introducer sheath's outer surface in a direction toward the housing. A surface with a retention structure is particularly useful when the valve is used in conjunction with a vascular graft, for improving fixation of the valve in the vascular graft. When the retention structure is comprised of one or more barbs, the barb is preferably located on the introducer sheath's outer surface so that the clamp can be positioned forward of the barb when the valve is clamped to the vascular graft. In contrast, typical introducers for direct intravascular insertion have a smooth surface without a retention structure, which can potentially damage the vessel.

[0026] Preferably, at least a portion of the housing, in addition to the membrane, is formed from a flexible, preferably elastic, material. Examples of flexible materials include soft rubber or other soft plastic materials, such as silicone, polyurethane, or polyvinyl chloride. The introducer sheath is preferably stiffer in terms of radial compression force than the portion of the housing where the membrane is located. In this configuration, compressing a clamp around the valve housing at the site of the valve can compress and seal the membrane against the inserted medical device. The stiffer distal end of the introducer sheath, and potentially the valve housing, provides stability to the valve.

[0027] Preferably, the housing is cylindrical. For example, by using a cylindrical housing instead of a conical one, a low-profile valve can be implanted in a patient's body for extended periods, e.g., several months. This cylindrical low-profile valve allows a clamp to be placed around the valve to tighten the membrane against an inserted medical device, e.g., a catheter, preventing blood flow and securing the device to prevent longitudinal movement. Preferably, the inner diameter of the introducer sheath does not decrease at its proximal end, but remains constant throughout its entire length. For example, the diameter may be within the range of 5-10 mm. This is in contrast to typical introducers, which have a tapered tip to allow for insertion into the vessel using a dilator.

[0028] In a preferred embodiment, the at least one passageway extends along at least a portion of the membrane's diameter, preferably the entire diameter. The at least one passageway in the membrane may include at least two slits extending diametrically through the membrane and intersecting each other. Additionally or alternatively, the membrane may include a hole extending through the membrane, preferably a central hole that can connect to the slits. The diameter of the hole may correspond to the diameter of the medical device to be inserted, such as a catheter. To allow for the insertion of larger components, such as a catheter pump located at the tip of the catheter, the slits may be provided to temporarily widen the membrane opening during insertion. However, for example, if a hemostatic valve is already pre-installed on the catheter and the catheter is intended to be implanted for a long period of time, the slits may be omitted because they are unnecessary and may lead to a risk of blood leakage.

[0029] It is desirable for the valve to have at least one seam, preferably two diametrically opposed seams, extending along the length of the valve and defining a predetermined tear line so that the valve can be torn into two halves along its length, facilitating removal ("peeling") of the valve when a medical device, such as a catheter, is inserted through the valve.

[0030] To facilitate easy handling of the valve, the housing preferably has at least one handle, preferably two diametrically opposed handles, extending radially outward from the housing. The handles can also be used to break the valve into two halves. A seam can extend through the handles, or the seam can be offset from the handles. Having the handles also breakable into two halves allows for less space to be required for handling and removal of the valve.

[0031] Another embodiment of the present invention provides a clamp configured for placement around a vascular graft, having a first configuration for inserting a valve introducer sheath into the vascular graft and a second configuration for clamping the vascular graft against the valve introducer sheath, particularly when inserted into the vascular graft. The clamp includes at least one annular body having first and second circumferential ends, particularly the first and second circumferential ends overlapping to allow for a change in the inner diameter of the annular body between the first and second configurations.

[0032] Preferably, the first and second circumferential ends of the annular body have mating toothed structures that together form a ratchet mechanism. The clamp preferably includes first and second handles for actuating the clamp between the first and second configurations, specifically a first handle extending radially outward from the annular body near the first circumferential end and a second handle extending radially outward from the annular body near the second circumferential end, such that movement of the first and second handles toward one another causes a reduction in the inner diameter of the annular body. The clamp preferably further includes a third handle extending radially outward from the annular body adjacent the first circumferential end and spaced from the first handle, such that movement of the first and third handles toward one another causes the first circumferential end to flex radially outward, thereby disengaging the ratchet mechanism.

[0033] To facilitate clamp removal, the annular body may have longitudinal notches defining predetermined break lines that allow the clamp to be broken longitudinally at the medial lobes of the first and second circumferential ends. This is particularly useful for clamp removal during insertion of a medical device, such as a catheter, into a vascular graft. Preferably, the notches are located on the opposite side of the annular body from the ratchet mechanism.

[0034] The clamp may comprise at least two of the above-described tubular bodies, magnetically, mechanically, physically, or chemically interconnected to form a single, integrated unit. This is particularly useful when using stacks of multiple valves, as described in more detail below. A circumferential notch may be circumferentially disposed between the at least two annular bodies to allow a predetermined break line to be formed, thereby separating the annular bodies.

[0035] Another embodiment of the present invention provides a kit for use with a vascular graft. The kit includes at least one valve having a housing with a flexible membrane, the flexible membrane having at least one of a passageway through the membrane and a weakened area to allow insertion of a medical device therethrough. The valve further includes an introducer sheath configured for insertion into the open end of the tubular body of the vascular graft. The kit also includes at least one clamp configured for placement around the tubular body of the graft, the clamp having a first configuration for inserting the valve introducer sheath into the distal end of the tubular body of the graft and a second configuration for clamping the graft against the valve introducer sheath, particularly when inserted into the tubular body of the graft. Preferably, the at least one valve and / or the at least one clamp are configured as described above.

[0036] Another embodiment of the present invention provides a system including at least two of the above-described valves, wherein the introducer sheath of one of the at least two valves is connectable to another of the at least two valves, preferably connectable to the distal end of the other of the at least two valves so as to be tandemly mounted to the distal end of a vascular graft. Preferably, the introducer sheath of one of the at least two valves is configured to be insertable into the housing of the other of the at least two valves. The system may further include a vascular graft. A stack of multiple valves provides double or multiple safety mechanisms against blood leaks, further improving hemostasis.

[0037] In a preferred embodiment, each of the at least two valves has a membrane with a central hole, the diameter of the central hole and / or the size of the at least one passageway increasing from one valve to the next in a direction approaching the graft, the different sizes being responsive to the different medical devices to be inserted, such as guidewires (K-wires) and catheters.

[0038] A system can be provided in which the introducer sheath for at least one of the at least two valves has a length at least 10 times its diameter, which is particularly useful for placing, e.g., pre-mounting, a medical device, such as a catheter pump, within the introducer sheath.

[0039] The system, which includes at least two valves, may further include at least two clamps configured as described above, at least one of which may be configured and disposed around the housing of one of the valves. The at least one clamp may be used to radially compress the valve membrane, thereby closing the valve. The at least two clamps may be coupled to each other by magnetic, mechanical, or physical forces. An additional clamp may be required to clamp the system to the graft, or one of the two clamps may be designed to clamp around the graft and around at least one of the valves, either simultaneously or individually.

[0040] In a preferred embodiment, the medical device is a catheter, which may include an axial blood pump disposed at the end of the catheter to provide a ventricular assist device.

[0041] Yet another embodiment of the present invention provides a system for providing vascular access within a patient's body. The system includes a vascular graft having a tubular body having a proximal end and a distal end, the proximal end configured for attachment to a vessel within the patient's body. The system further includes at least one clamp configured for placement around the graft tubular body, specifically a clamp having a first configuration for inserting a valve introducer sheath into the distal end of the graft tubular body and a second configuration for clamping the graft against the valve introducer sheath when inserted into the graft tubular body. The at least one clamp may be configured as described above. The system may further include at least one valve, which may be configured as described above.

[0042] The foregoing summary, as well as the following detailed description of the preferred embodiments, will be better understood when read in conjunction with the accompanying drawings, to which reference is made for purposes of illustrating the present disclosure, although the scope of the present disclosure is not limited to the specific embodiments illustrated in the drawings. [Brief explanation of the drawings]

[0043] [Figure 1] 1 is an overall view of the graft system described herein. [Figure 2] FIG. 1 shows a conventional vascular graft anastomosed to a vessel. [Figure 3] FIG. 10 is a detailed view of the hemostasis valve. [Figure 4] FIG. 10 is a cross-sectional view of the hemostatic valve along a seam. [Figure 5] FIG. [Figure 6] FIG. [Figure 7] FIG. [Figure 8] FIG. 10 is a detailed view of a low-profile hemostatic valve. [Figure 9] FIG. 1 is a cross-sectional view of multiple hemostatic valves attached to a graft. [Figure 10]FIG. 1 is an exploded view of a graft system with multiple hemostasis valves. [Figure 11] FIG. 1 is an assembled view of a graft system with multiple hemostasis valves. [Figure 12] FIG. 1 shows a low-profile hemostatic valve and dual clamp implemented on a catheter. [Figure 13] This is an assembled diagram of the dual clamp, low-profile hemostatic valve, catheter, and graft. [Figure 14] This is an assembled diagram showing the dual clamp, low-profile hemostatic valve, catheter, and graft anastomosed to the vessel. [Figure 15] FIG. 10 is an exploded view of an elongate introducer sleeve for use with an elongate device. [Figure 16] FIG. 10 is a cross-sectional view of an elongate introducer sleeve for use with an elongate device. [Figure 17] 13 is a cross-sectional view of an assembled elongate introducer sleeve for use with an elongate device. FIG. [Figure 18] FIG. 1 shows a low-profile hemostatic valve with a membrane without a slit. [Figure 19] FIG. 1 shows a low-profile hemostatic valve pre-mounted on a catheter. [Figure 20] FIG. 10 shows a branched hemostatic valve. [Figure 21] FIG. 1 illustrates an application of the system of the present invention. [Figure 22] FIG. 10 illustrates another application of the system of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0044] FIG. 1 shows a graft system 10 according to the present invention. The graft system 10 includes a graft 110 having a proximal end 110A and a distal end 110B, a clamp 210, and a hemostatic valve 310. The graft 110 is typically a porous soft medical fabric as described in Patent Document 1 and is intended for use as a conduit for contact with blood and biological tissue. The graft 110 is a widely used medical product and is available in a variety of shapes, sizes, and materials. The graft 110 is typically sutured to a vessel, as shown in FIG. 2, where the graft 110 is secured to a vessel 112 using a surgical suture tool 111. The suture tool 111 is a common medical product and is available in a variety of shapes, sizes, and materials.

[0045] Typically, the graft 110 is used in medical procedures requiring vascular access, particularly for inserting and / or removing medical products and / or devices or for enabling circulation of blood or bodily fluids through the graft 110 to other parts of the vasculature or to the exterior. When the graft 110 is used to deliver a medical device 114, the proximal end 110B of the graft is typically occluded by wrapping and tying a medical thread 115 around the graft 110, as shown in Figure 2. However, securing the medical device 114 with the medical thread 115 is not very reproducible and can result in blood loss during this procedure.

[0046] 1, the hemostatic valve 310 and clamp 210 allow the introduction of a medical device without the risk of blood loss. The clamp 210 essentially eliminates the need for the medical suture 115 and eliminates subject dependency of the procedure, which can result in faster hemostasis and more reproducible results.

[0047] Figure 3 shows a hemostatic valve 310 according to one embodiment of the present invention. The hemostatic valve 310 includes a slit membrane 314, an introducer sheath 315, and a housing 311. The housing 311 includes two separate halves 311A and 311B that are joined by two seams 312A and 312B that run the entire length of the hemostatic valve 310. The seams 312A and 312B are designed to thin the wall of the hemostatic valve 310 and thus provide a preferential tear line that will result in the two separate halves 311A and 312B when the hemostatic valve 310 is split into two halves. The handle 313 is designed to assist the user in handling the hemostatic valve 310 and to provide a handle to aid in splitting the hemostatic valve 310 into the two separate halves. In this embodiment, seams 312A, 312B run through the middle of handle 313, allowing handle 313 to break into two halves.

[0048] The slit membrane 314 is typically a soft rubber disk having membrane slits 316 and a central hole 317 that facilitate the introduction and removal of various devices into and from the hemostatic valve 310. Some or all of the slits 316 and central hole 317 extend through the entire thickness of the slit membrane 314 or partially through the slit membrane 314 for the entire length or a portion of the slit 316, facilitating the introduction of various devices through the slit membrane 314 or the slit membrane 314 being easily severable into multiple segments. Depending on the intended use of the valve, a minimum of one slit or multiple slits may be provided. Similarly, the length of the slit 316 may vary depending on the intended use. For example, a hemostatic valve intended for use with larger diameter devices will typically have a longer membrane slit 316 and a larger diameter central hole 317.

[0049] The introducer sheath 315 is typically a thin-walled tubular member that is inserted into the graft 110 and secured in place by a clamp 210 .

[0050] FIG. 4 is a cross-sectional view of hemostatic valve 310, showing introducer sheath 315, hemostatic valve half 311A and slit membrane 314 separated from their mating halves.

[0051] 5 includes an annular body having overlapping first and second circumferential edges 216, 218 and a toothed structure 211, e.g., a ratchet mechanism, that allows the inner surface 212 to be clamped against any circular structure within the clamp 210 and in contact with the inner surface 212. Compression handle 213 and release handle 214 allow the diameter of the inner surface 212 to be reduced, thereby moving the toothed structure 211, particularly in a direction that locks the toothed structure 211 and maintains a tighter compression against any circular structure passing through the clamp 210. Conversely, compression of unlock handle 215 and release handle 214 causes the toothed structure 211 to disengage, thereby releasing any compression force acting on any circular structure in contact with the inner surface 212. Preferably, a release band 216 located at the first circumferential end between the unlocking handle 215 and the release handle 214 is formed of a flexible, pliable material to allow engagement and disengagement of the toothed structure 212. Additionally, a softer release band 216 may provide a softer grip on any circular structure positioned within the clamp 210. A notch 217 is provided as a thinned portion along the length of the wall of the clamp 210. The notch 217 creates a weakened area, preferably along the entire length of the clamp 210, allowing the clamp 210 to be broken into two pieces and easily removed when no longer needed. If the clamp 210 is not intended to be removed during use, the notch 217 may be omitted from the clamp 210.

[0052] FIG. 6 illustrates another embodiment of a dual clamp 410 of the present invention. The dual clamp 410 includes a dual clamping mechanism, i.e., a base clamp 411 and a tip clamp 412, which can be operated individually or as a single clamp. The base clamp 411 and the tip clamp 412 can be configured as a single member, or as separate members that can be user-attached to each other. The dual clamp 410 can be configured with multiple individual clamps, preferably 2-6 clamps in total. The multiple clamps can be configured as a single member, or as multiple individual clamps that can be user-attached to each other. The mechanism for connecting the multiple individual clamps (not shown) can be magnetic, mechanical, chemical, or physical (e.g., adhesive) in nature, resulting in the clamps being secured together. Proximal clamp 411 and distal clamp 412 can have similar or different features (e.g., different clamp bore diameters to allow for soft or hard clamping of devices passing through the bore, different maximum clamping forces, different materials) and can have similar or different constructions compared to clamp 210, aiming to allow versatility for use with a variety of devices while maintaining hemostasis. Radial notch 415 is provided to weaken the bond between proximal clamp 411 and distal clamp 412, allowing them to be broken apart when desired. Longitudinal notch 413 is provided to weaken distal clamp 412, allowing for longitudinal fracture and removal of distal clamp 412. Proximal clamp 411 may have a similar notch (not shown) for the same purpose.

[0053] FIG. 7 shows a clamping mechanism according to another embodiment of the present invention, a multi-clamp 510 including a triple-clamp mechanism base clamp 511, a triple-clamp mechanism front middle lobe clamp 513, and a triple-clamp mechanism front clamp 512, which can be operated individually or as a single clamp. The triple-clamp mechanism base clamp 511, the triple-clamp mechanism front middle lobe clamp 513, and the triple-clamp mechanism front clamp 512 may be configured as a single member, or may be configured as separate members that can be connected together by the user. The multi-clamp 510 can be configured with multiple individual clamps, preferably 2 to 6 clamps in total. The multiple clamps may be configured as a single member, or may be configured as multiple individual clamps that can be connected together by the user. The mechanism for connecting the multiple individual clamps (not shown) can be magnetic, mechanical, chemical, or physical (e.g., adhesive) in nature, which secures the multiple clamps together. The triple clamp mechanism proximal clamp 511, triple clamp mechanism distal middle lobe clamp 513, and triple clamp mechanism distal clamp 512 may have similar or different characteristics (e.g., different clamp inner diameters to allow for soft or hard clamping of devices passing through the inner diameter, different maximum clamping forces, different materials) and similar or different structures compared to clamp 210 in order to allow for versatility in the use of various devices while maintaining hemostasis.

[0054] 8 illustrates a cross-section of a low-profile hemostatic valve 610 according to another embodiment of the present invention, comprising a slit membrane 611, an introducer sheath 615, and a housing 616. The housing 616 preferably comprises two separate halves joined by two seams 617A, 617B that extend the entire length of the low-profile hemostatic valve 610, one of which is shown and designated here as 614A (the other half, 614B, is not shown). The seams 617A, 617B are intended to thin the wall of the low-profile hemostatic valve 610 and thus provide a preferential tear line that will result in the two separate halves 614A, 614B when the low-profile hemostatic valve 610 is split into two halves. Preferably, the housing 616 is partially or entirely formed from a soft polymer so that the slit membrane 611 can be clamped by clamping, such as with clamp 210. The slit membrane 611 is typically a soft rubber disk having membrane slits 612 and a central hole 613 that facilitate the introduction or removal of various solid devices into or from the low-profile hemostatic valve 610. Depending on the intended use of the valve, there may be as few as one slit or multiple slits. Similarly, the length of the slit 612 may vary depending on the intended use. For example, a hemostatic valve intended for use with larger diameter devices will typically have a longer membrane slit 612 and a larger diameter central hole 613. One or more of the slits 612 may extend along the entire diameter of the slit membrane 611, allowing the membrane to be torn into several sections and removed from any device or catheter that passes through the central hole 613.

[0055] 9, 10, and 11 show a graft system 710 having multiple hemostatic valves according to another embodiment of the present invention, with Fig. 9 being a cross-sectional view, Fig. 10 being an exploded view, and Fig. 11 being an assembled view. This graft system 710 with multiple hemostatic valves includes a graft 110, a proximal hemostatic valve 711, a distal hemostatic valve 712, a proximal clamp 713, and a distal clamp 714. The proximal hemostatic valve 711 is somewhat similar in structure and function to the low-profile hemostatic valve 610, and includes a proximal hemostatic valve slit membrane 715, a proximal hemostatic valve introducer sheath 716, and a proximal hemostatic valve housing 717. Proximal hemostatic valve housing 717 preferably comprises two separate halves joined by proximal hemostatic valve seam 719A and proximal hemostatic valve seam 719B that extend the entire length of proximal hemostatic valve 711 (one of the halves is shown and designated here as 718A; the other half, 718B, is not shown in FIG. 9 ). The purpose of proximal hemostatic valve seams 719A and 719B is to thin the wall of proximal hemostatic valve 711 and thus provide a preferential tear line that will result in the two separate halves 719A and 719B when proximal hemostatic valve 711 is split into two halves. Preferably, part or all of proximal hemostatic valve housing 717 is formed from a flexible polymer so that proximal hemostatic valve slit membrane 715 can be clamped by clamping with a clamp, such as proximal clamp 713. The proximal hemostatic valve slit membrane 715 is typically a soft rubber disk having a proximal hemostatic valve membrane slit 719 and a proximal hemostatic valve central hole 720 that facilitate the introduction and removal of various solid devices into and from the proximal hemostatic valve 711. Depending on the intended use of the valve, there may be as few as one slit or multiple slits. Similarly, the length of the proximal hemostatic valve slit 719 may vary depending on the intended use. For example, a hemostatic valve intended for use with larger diameter devices will typically have a longer proximal hemostatic valve membrane slit 719 and a larger diameter proximal hemostatic valve central hole 720.The barbs 740 are provided as raised surfaces on the proximal hemostatic valve introducer sheath 716 that engage the inner surface of the graft 110 to provide a firm grip when the graft 110 is captured between the barbs 740 and the proximal clamp 710. The barbs 740 may cover a portion of the proximal hemostatic valve introducer sheath 716 or the entire circumference. The barbs 740 may be a single raised surface, or multiple raised surfaces that are radially aligned or offset from one another to provide a greater grip on the graft 110. The barbs 740 allow a user to tie down the proximal hemostatic valve introducer sheath 716 to the graft 110 using sutures, umbilical tape, medical tape, or other means. Tie-down of the proximal hemostatic valve introducer sheath 716 to the graft 110 provides a secure connection that is less likely to disengage or slip during insertion or removal of the device.

[0056] Leading hemostatic valve 712 is similar in structure and function to low-profile hemostatic valve 610 and includes a leading hemostatic valve slit membrane 721, a leading hemostatic valve introducer sheath 722, and a leading hemostatic valve housing 723. Leading hemostatic valve housing 723 preferably includes two separate halves joined by leading hemostatic valve seam 725A and leading hemostatic valve seam 725B that extend the entire length of leading hemostatic valve 712 (one of the halves is shown and designated here as 724A; the other half, 724B, is not shown in FIG. 9 ). The purpose of leading hemostatic valve seams 725A, 725B is to thin the wall of leading hemostatic valve 712 and thus provide a preferential break line that will result in the two separate halves 725A, 725B when leading hemostatic valve 711 is split into two halves. Preferably, the distal hemostatic valve housing 723 is formed partially or entirely from a soft polymer so that the distal hemostatic valve slit membrane 721 can be clamped by clamping with a clamp, such as the distal clamp 713. The distal hemostatic valve slit membrane 721 is typically a soft rubber disk having a distal hemostatic valve membrane slit 725 and a distal hemostatic valve central hole 726 that facilitate the introduction and removal of various solid devices into and from the distal hemostatic valve 711. Depending on the intended use of the valve, there may be as few as one slit or multiple slits. Similarly, the length of the distal hemostatic valve slit 725 may vary depending on the intended use. For example, a hemostatic valve intended for use with larger diameter devices will typically have a longer distal hemostatic valve membrane slit 725 and a larger diameter distal hemostatic valve central hole 720.

[0057] 10 and 11 is a graft system having multiple hemostatic valves according to another embodiment of the present invention, comprising a proximal hemostatic valve 711, a distal hemostatic valve 712, and a middle leaflet hemostatic valve 750. Middle leaflet hemostatic valve 750 is somewhat similar in structure and function to low-profile hemostatic valve 610, and comprises a middle leaflet hemostatic valve slit membrane 729, a middle leaflet hemostatic valve introducer sheath 730, and a middle leaflet hemostatic valve housing 731. Middle leaflet hemostatic valve housing 731 preferably comprises two separate halves (not shown in FIGS. 10 and 11 ) joined by middle leaflet hemostatic valve seam 732A and middle leaflet hemostatic valve seam 732B that extend the entire length of middle leaflet hemostatic valve 750. The middle leaflet hemostatic valve seams 732A, 732B are intended to thin the wall of the middle leaflet hemostatic valve 750 and thus provide a preferential tear line that will result in the two separate halves 732A, 732B when the middle leaflet hemostatic valve 750 splits into two halves. Preferably, the middle leaflet hemostatic valve housing 731 is partially or entirely formed from a soft polymer so that the middle leaflet hemostatic valve slit membrane 729 can be clamped by clamping with a clamp, such as the proximal clamp 713. The middle leaflet hemostatic valve slit membrane 729 is typically a soft rubber disk with middle leaflet hemostatic valve membrane slits 732 and a central middle leaflet hemostatic valve hole 734 that facilitate the introduction and removal of various solid devices into and from the middle leaflet hemostatic valve 750. Depending on the intended use of the valve, there may be as few as one slit or multiple slits. Similarly, the length of the middle leaflet hemostatic valve slit 732 may vary depending on the intended use. For example, a hemostatic valve intended for use with larger diameter devices will typically have longer middle leaflet hemostatic valve membrane slits 732 and a larger diameter middle leaflet hemostatic valve central hole 734. As will be appreciated, slits 719, 732, 725 can be of the same length, e.g., maximum length, to allow medical devices of any diameter to penetrate membranes 715, 729, 721 while still providing a blood-tight connection.

[0058] 12 shows a low-profile hemostatic valve 610 and a double clamp 410 mounted on a catheter 810 according to the present invention. The catheter 810 is a typical medical catheter intended for insertion into a vessel or cavity in the human body. The catheter functional end 811 is the functional portion of the catheter, i.e., the portion that performs a specific function inside the human body, and is delivered into the human body by delivering the catheter shaft 812 into the body or vessel. When the catheter 810 is delivered into the low-profile hemostatic valve 610, the double clamp 410 is released and does not exert any radial force on the low-profile hemostatic valve 610. The functional end 811 can be made larger or smaller in diameter than the shaft 812, and the double clamp 410 can be mounted on the catheter 810 from the tip of the catheter 810 or pre-mounted on the catheter 810 during the manufacturing of the catheter 810.

[0059] 13 and 14, the dual clamp 410, low-profile hemostatic valve 610, and catheter 810 can be inserted into the graft 110 to couple the catheter 810 and introducer sheath 615 to the graft 110 and secured in place by clamping the proximal clamp 411, thereby firmly securing the graft 110 to the proximal clamp 411 and creating a hemostatic seal between the graft 110 and the introducer sheath 615. The catheter 810 can be advanced into the graft 110 by sliding the catheter shaft 812 through the low-profile hemostatic valve 610. Clamping the distal clamp 412 will secure the catheter 810 in place and create a hemostatic seal around the catheter shaft 812. The graft 110 can then be anastomosed to a body cavity or vessel 112 (as shown in FIG. 14) using a surgical suture tool 111 or any other anastomosis instrument used in medical procedures intended to anastomosing a graft to a body cavity or vessel.

[0060] 15, 16, and 17 show a graft system 910 with a long introducer according to another embodiment of the present invention, with FIG. 15 being an exploded view, FIG. 16 being a cross-sectional view, and FIG. 17 being an assembled cross-sectional view. This graft system 910 with a long introducer includes a graft 110, a proximal hemostatic valve 711, a distal hemostatic valve 911 with a long introducer sheath, two proximal clamps 713, and a distal clamp 714. The proximal hemostatic valve 711 is somewhat similar in structure and function to the low-profile hemostatic valve 610, and includes a proximal hemostatic valve slit membrane 715, a proximal hemostatic valve introducer sheath 716, and a proximal hemostatic valve housing 717. Proximal hemostatic valve housing 717 preferably comprises two separate halves joined by proximal hemostatic valve seam 719A and proximal hemostatic valve seam 719B that extend the entire length of proximal hemostatic valve 711 (one of the halves is shown and designated here as 718A; the other half, 718B, is not shown in FIG. 16 ). The purpose of proximal hemostatic valve seams 719A and 719B is to thin the wall of proximal hemostatic valve 711 and thus provide a preferential tear line that will result in the two separate halves 719A and 719B when proximal hemostatic valve 711 is split into two halves. Preferably, part or all of proximal hemostatic valve housing 717 is formed from a flexible polymer so that proximal hemostatic valve slit membrane 715 can be clamped by clamping with a clamp, such as proximal clamp 713. The proximal hemostatic valve slit membrane 715 is typically a soft rubber disk having a proximal hemostatic valve membrane slit 719 and a proximal hemostatic valve central hole 720 that facilitate the introduction and removal of various solid devices into and from the proximal hemostatic valve 711. Depending on the intended use of the valve, there may be as few as one slit or multiple slits. Similarly, the length of the proximal hemostatic valve slit 719 may vary depending on the intended use. For example, a hemostatic valve intended for use with larger diameter devices will typically have a longer proximal hemostatic valve membrane slit 719 and a larger diameter proximal hemostatic valve central hole 720.

[0061] The barbs 740 are provided as raised surfaces on the proximal hemostatic valve introducer sheath 716 that engage the inner surface of the graft 110 to provide a firm grip when the graft 110 is captured between the barbs 740 and the proximal clamp 713. The barbs 740 may cover a portion of the proximal hemostatic valve introducer sheath 716 or the entire circumference. The barbs 740 may be a single raised surface or multiple raised surfaces that are radially aligned or offset from one another to provide greater gripping force on the graft 110. The barbs 740 allow a user to fasten the graft 110 to the proximal hemostatic valve introducer sheath 716 using sutures, umbilical tape, medical tape, or other means. Such a connection between the graft 110 and the proximal hemostatic valve introducer sheath 716 allows the proximal hemostatic valve introducer sheath 716 to be tied to the graft 110, thereby providing a more stable access point for device insertion or removal.

[0062] The distal hemostatic valve with elongated introducer sheath 911 is similar in structure and function to the low-profile hemostatic valve 610, except that the distal hemostatic valve 911 includes a distal hemostatic valve slit membrane 921, a distal hemostatic valve sleeve 922, and a distal hemostatic valve housing 923. The distal hemostatic valve housing 923 preferably includes two separate halves joined by distal hemostatic valve seam 925A and distal hemostatic valve seam 925B that extend the entire length of the distal hemostatic valve 911 (one of the halves is shown and designated here as 924A; the other half 924B is not shown in Figures 16 and 17). The distal hemostatic valve seams 925A, 925B are intended to thin the wall of the distal hemostatic valve 911 and thus provide a preferential tear line that will result in the two separate halves 925A, 925B when the distal hemostatic valve 911 is split into two halves. Preferably, the distal hemostatic valve housing 923 is partially or entirely formed from a soft polymer so that the distal hemostatic valve slit membrane 921 can be clamped by clamping with a clamp, such as distal clamp 714. The distal hemostatic valve slit membrane 921 is typically a soft rubber disk that has a distal hemostatic valve membrane slit 925 and a distal hemostatic valve central hole 926 that facilitate the introduction or removal of various solid devices into or from the distal hemostatic valve 911 with an elongated introducer sheath. Depending on the intended use of the valve, there may be as few as one slit or multiple slits. Similarly, the length of the distal hemostatic valve sheath slit 925 may vary depending on the intended use. For example, a hemostatic valve intended for use in conjunction with a large diameter device will typically have a longer distal hemostatic valve sheath slit 925 and a distal hemostatic valve central hole 920 with a larger diameter.

[0063] An example of an elongated device 930 is a catheter intended for insertion into the human body, which includes a dilating tip 931 and a thin catheter 932 that is typically smaller in diameter than the dilating tip 931. It is common practice in the medical field to insert the elongated device 930 into the graft 110 without the aid of any hemostatic valve, introducer sheath, or clamp, which has led to significant blood loss that jeopardizes patient safety. The intent of this graft system 910 with a long introducer is to reduce the risks associated with introducing a medical device through the graft 110. This is one example of a graft system 910 with a long introducer, and is not the only way a graft system with a long introducer may be useful in the medical field. The distal hemostatic valve sleeve 922 can be any length, preferably between 1 cm and 200 cm, to accommodate the dilator tip 931 while leaving some excess length at the proximal and distal ends of the distal hemostatic valve 911. As shown in FIGS. 16 and 17 , the elongate device 930 is positioned within the distal hemostatic valve 911 with the elongate introducer sheath, the thin catheter 932 passes through the distal hemostatic valve central bore 926, and the dilator tip 931 is positioned entirely within the distal hemostatic valve sleeve 922. In certain embodiments, the graft 110, proximal clamp 713, and proximal hemostatic valve sheath 716 are provided in a kit. The kit may also include a ruler with length scale and graft angle inclination markings to assist the user in graft preparation and accurate cutting. The ruler with length and angle markings allows the user to tailor the graft 100 to fit the patient and situation.

[0064] After the graft is anastomosed to a vessel or body cavity using standard medical procedures, the proximal hemostatic valve 711 can be inserted into the graft 110 and secured in place using the proximal clamp 713. The distal hemostatic valve sleeve 922 can then be inserted through the proximal hemostatic valve slit membrane 715 and advanced to the desired depth within the graft 110, as shown in FIG. 17 . No blood loss should occur up to this point. The elongated device 930 can then be advanced further into the graft 110 and into the anastomosed vessel (not shown in FIGS. 15, 16, and 17, but shown in FIG. 2 for reference only) by pushing the thin catheter 932 through the hemostatic valve with the elongated introducer sheath 911. Once the dilating tip 931 reaches the desired location within the vessel or body cavity, the thin catheter 932 can be locked in the desired position by clamping it with the distal clamp 714.

[0065] 18 and 19 show a hemostatic valve 610A according to another embodiment of the present invention. This hemostatic valve 610A is somewhat similar in structure and function to the low-profile hemostatic valve 610, but differs in that the membrane 611A does not have any slits and the hemostatic valve 610A cannot be separated into two halves. The hemostatic valve 610A includes a hemostatic valve membrane 611A, a hemostatic valve introducer sheath 615A, and a hemostatic valve housing 616A. Preferably, the hemostatic valve housing 616A is formed in part or entirely from a soft polymer so that the hemostatic valve membrane 611A can be clamped with a clamp, such as clamp 210. The hemostatic valve membrane 611A is typically a soft rubber disk and has a central hemostatic valve hole 613A that facilitates the introduction and removal of various solid devices into and from the middle leaflet hemostatic valve 610A. The absence of slits in the membrane 611A improves hemostasis and prevents blood leakage, especially in long-term use. If a medical device, such as a catheter 810, is pre-mounted within the hemostasis valve 610A (as shown in FIG. 19), a slit in the membrane is not necessary. The size of the central hole 613A may vary depending on the intended use of the valve. For example, a hemostasis valve intended for use with a large-diameter device will typically have a larger-diameter hemostasis valve central hole 613A.

[0066] Figure 20 shows a branched hemostatic valve 1110 according to one embodiment of the present invention. This hemostatic valve 1110 is somewhat similar in structure and function to the low-profile hemostatic valve 610. However, in contrast to the stack of multiple hemostatic valves arranged in tandem as shown in Figures 9 to 17, this branched hemostatic valve 1110 includes two hemostatic valves 1111, 1112 arranged side-by-side in a branched or Y-shaped configuration. For their structure and function, please refer to the above descriptions, particularly those related to the low-profile hemostatic valve. The hemostatic valve 1111 includes a housing 1116 with a slit membrane 1117. The membrane 1117 has a slit 1118 and a central hole 1119. Similarly, the hemostatic valve 1112 includes a housing 1120 with a slit membrane 1121. The membrane 1121 has a slit 1122 and a central hole 1123. The bifurcated hemostatic valve 1110 includes an introducer sheath 1115 having barbs 1140 that function as described above in connection with barbs 740. The bifurcated hemostatic valve 1110 allows for the parallel and independent insertion and manipulation of two medical devices, such as a catheter and a guidewire. To this end, the central holes 1119 and 1123 are sized differently to provide a tight connection to the corresponding medical devices. In particular, as described in connection with the above embodiments, the housings 1116 and 1120 can be provided with portions made of a soft material to allow the corresponding one of the membranes 1117 and 1121 to be clamped thereto, for example, by clamp 210.

[0067] As will be appreciated, the features of the described hemostatic valves and clamps can be combined in combinations other than those described. In particular, any of the described hemostatic valves can include a retention structure, such as one or more barbs, on the exterior surface of the introducer sheath. Furthermore, any of the described hemostatic valves can have a seam so that they can be separated into two halves, or they can be formed as a single piece without a seam.

[0068] 21 and 22, an application of a graft system 1010 is shown. This graft system 1010 can be any of the systems described above. It is used to deliver an axial blood pump 1020 via a catheter 1030 through a patient's aorta into the patient's heart to provide a ventricular assistant device. Vascular access can be achieved through the patient's thorax (FIG. 21) or a peripheral vessel in the patient's groin (FIG. 22). In FIG. 21, the graft system 1010 can be completely implanted subcutaneously using one or more low-profile hemostatic valves as described above.

[0069] <Additional Notes> [1] 1. A system for providing vascular access within a patient's body, comprising: a vascular graft comprising a tubular body having a proximal end and a distal end, the proximal end being configured to be attached to a vessel within a patient's body; At least one valve configured to be attached to the distal end of the graft tubular body, the at least one valve comprising: a housing having a flexible membrane with at least one of a passageway through the membrane and a weakened area through which a medical device can be inserted into the vascular graft; and an introducer sheath configured to be inserted into the distal end of the graft tubular body. A system comprising: [2] The system according to [1] above, further comprising: A system comprising at least one clamp configured to be positioned around the graft tubular body, the clamp having a first configuration that allows the valve introducer sheath to be inserted into the distal end of the graft tubular body, and a second configuration that allows the clamp to clamp the graft against the valve introducer sheath, particularly when inserted into the graft tubular body. [3] A valve for use in the system described in [1] or [2] above, comprising: a housing having a flexible membrane with at least one of a passageway penetrating the membrane and a weakened area through which a medical device can be inserted; and an introducer sheath configured to be inserted into the open end of a mating device, preferably a vascular graft. [4] The valve according to [3] above, wherein the introducer sheath has at least one retention structure on its outer surface to inhibit removal of the valve from the mating device into which it is inserted. [5] A valve as described in [4] above, wherein the retention structure is formed as an inclined surface, and the inclined surface preferably has at least one hook tapered away from the outer surface of the introducer sheath along the direction approaching the housing. [6] The valve according to any one of [3] to [5] above, wherein the membrane and at least a portion of the housing are formed from a flexible material, preferably an elastic material. [7] The valve according to [6] above, wherein the introducer sheath is harder with respect to radial compressive force than the portion of the housing in which the membrane is located. [8] A valve according to any one of the above [3] to [7], wherein the housing is cylindrical. [9] A valve according to any one of [3] to [8] above, wherein the inner diameter of the introducer sheath does not decrease at the proximal end of the introducer sheath, and is preferably constant over the entire length of the introducer sheath.

[10] A valve as described in any one of [3] to [9] above, wherein the at least one passage extends along at least a portion of the diameter of the membrane, preferably along the entire diameter of the membrane, and further preferably the at least one passage in the membrane has at least two slits extending diametrically through the membrane and intersecting each other.

[11] A valve according to any one of [3] to

[10] above, wherein the membrane has a hole penetrating the membrane.

[12] A valve according to any one of [3] to

[11] above, having at least one seam, preferably two seams on opposite sides in a radial direction, which seams extend along the length of the valve and define a predetermined break line so that the valve can be broken into two halves along its length.

[13] A valve according to any one of [3] to

[12] above, wherein the housing has at least one handle, preferably two handles on opposite radial sides, extending radially outward from the housing.

[14] A valve according to any one of the above [3] to

[13] , which is integrally formed with the mating device.

[15] A clamp for use in the system described in [2] above, which is configured to be positioned around a vascular graft and has a first configuration that allows a valve introducer sheath to be inserted into the vascular graft, and a second configuration that allows the vascular graft to be clamped against the valve introducer sheath, particularly when inserted into the vascular graft, and which comprises at least one annular body having overlapping first and second circumferential ends that allow the inner diameter of the annular body to change between the first and second configurations.

[16]

[15] The clamp according to

[15] above, wherein the first and second circumferential ends of the annular body have matable toothed structures that together form a ratchet mechanism.

[17] A clamp according to

[15] or

[16] above, comprising a first handle and a second handle, the first handle extending radially outward from near a first circumferential end of the annular body, and the second handle extending radially outward from near a second circumferential end of the annular body, wherein movement of the first and second handles toward each other reduces the inner diameter of the annular body.

[18]

[17] The clamp described above, further comprising a third handle extending radially outward from a portion of the annular body adjacent to the first circumferential end and spaced apart from the first handle, wherein movement of the first and third handles toward each other causes the first circumferential end to bend radially outward, thereby releasing the ratchet mechanism.

[19] A clamp according to any one of

[15] to

[18] above, wherein the annular body has longitudinal notches at the middle of the first and second circumferential ends that form predetermined break lines along the longitudinal direction to enable the clamp to be broken.

[20] The clamp according to

[19] above, wherein the notch is disposed on the opposite side of the annular body from the ratchet mechanism. [twenty one] A clamp according to any one of

[15] to

[20] above, comprising at least two of the annular bodies, which are interconnected by magnetic, mechanical or physical force to form a single integrated body. [twenty two]

[21] A clamp according to

[21] above, wherein a circumferential notch is disposed around the circumference between the at least two annular bodies so as to form a predetermined break line and thereby separate the annular bodies. [twenty three] A kit to be used in combination with a vascular graft, at least one valve including a housing with a flexible membrane having at least one of a passageway through the membrane and a weakened area through which a medical device can be inserted, and an introducer sheath configured to be insertable into the open end of the tubular body of the vascular graft; at least one clamp configured to be positionable around the graft tubular body, the at least one clamp having a first configuration that allows insertion of the valve introducer sheath into the distal end of the graft tubular body, and a second configuration that allows clamping of the graft against the valve introducer sheath, particularly when inserted into the graft tubular body; A kit comprising: [twenty four] The kit according to

[23] above, wherein the at least one valve is a valve according to any one of [3] to

[14] above, and / or the at least one clamp is a clamp according to any one of

[15] to

[22] above. [twenty five] A system comprising at least two valves according to any one of [3] to

[14] above, wherein the introducer sheath of one of the at least two valves is connectable to another of the at least two valves.

[26] A system according to [1] or [2] above, comprising at least two valves according to any one of [3] to

[14] above, wherein the introducer sheath of one of the at least two valves can be connected to the tip of another of the at least two valves so that they can be tandemly attached to the tip of the vascular graft.

[27] The system according to

[25] or

[26] above, wherein the introducer sheath of one of the at least two valves is configured to be insertable into the housing of the other of the at least two valves.

[28] A system according to any one of

[25] to

[27] above, wherein each of the at least two valves has a membrane with a central hole, and the diameter of the central hole and / or the size of the at least one passage increases from one valve to the next in the direction approaching the graft.

[29] A system described in any one of

[25] to

[28] above, wherein the introducer sheath of at least one of the at least two valves has a length at least 10 times the diameter of the introducer sheath.

[30] A system according to any one of

[25] to

[29] above, comprising at least two clamps according to any one of

[15] to

[22] above, at least one of which is configured to be positionable around the housing of one of the valves.

[31]

[30] The system according to

[30] above, wherein the at least two clamps are connected to each other by magnetic, mechanical or physical force.

[32] The system according to any one of [1], [2] and

[25] to

[31] above, wherein the medical device is a catheter.

[33]

[32] The system according to

[32] above, wherein the medical device comprises an axial blood pump disposed at the end of the catheter.

[34] 1. A system for providing vascular access within a patient's body, comprising: a vascular graft comprising a tubular body having a proximal end and a distal end, the proximal end being configured to be attached to a vessel within a patient's body; at least one clamp configured to be positionable around the graft tubular body, the at least one clamp having a first configuration that allows a valve introducer sheath to be inserted into the distal end of the graft tubular body, and a second configuration that allows the clamp to clamp the graft against the valve introducer sheath, particularly when inserted into the graft tubular body; A system comprising:

[35] The system according to

[34] above, wherein the at least one clamp is a clamp according to any one of

[15] to

[22] above.

[36] The system according to

[34] or

[35] above, further comprising at least one valve according to any one of [3] to

[14] above.

Claims

1. A valve for use in a system for providing vascular access within a patient's body, the valve comprising: a housing having a flexible membrane having at least one of a passageway through the membrane and a weakened area through which a medical device can be inserted; and an introducer sheath configured to be inserted into an open end of a vascular graft; the passage extends along at least a portion of the diameter of the membrane, or the membrane has a hole therethrough; The valve includes at least one retention structure on the exterior surface of the introducer sheath to inhibit removal of the valve from the vascular graft into which it is inserted.

2. 2. The valve of claim 1, wherein the retaining structure is formed as a sloped surface.

3. 3. The valve of claim 2, further comprising at least one barb tapered away from the outer surface of the introducer sheath in a direction toward the housing.

4. 4. A valve according to any one of claims 1 to 3, wherein the membrane and at least a portion of the housing are formed from a flexible material.

5. 5. The valve of claim 4, wherein said flexible material is an elastic material.

6. 6. The valve of claim 4, wherein the introducer sheath is stiffer with respect to radial compressive force than the portion of the housing in which the membrane is located.

7. A valve according to any one of claims 1 to 6, wherein the housing is cylindrical.

8. 8. The valve of any one of claims 1 to 7, wherein the inner diameter of the introducer sheath does not decrease at the proximal end of the introducer sheath.

9. 9. The valve of claim 8, wherein the inner diameter of the introducer sheath is constant along the entire length of the introducer sheath.

10. 10. A valve according to any preceding claim, wherein the passage extends along the entire diameter of the membrane.

11. 11. The valve of claim 10, wherein the passage in the membrane comprises at least two slits extending diametrically through the membrane and intersecting each other.

12. 12. A valve as claimed in any one of claims 1 to 11, having at least one seam extending along the length of the valve and forming a predetermined break line so that the valve can be broken into two halves along the length of the valve.

13. 13. The valve of claim 12, wherein the at least one seam comprises two diametrically opposed seams.

14. 14. A valve according to any one of claims 1 to 13, wherein the housing has at least one handle, the handle extending radially outward from the housing.

15. 15. The valve of claim 14, wherein the housing has two diametrically opposed handles, the handles extending radially outward from the housing.

16. 16. The valve of any one of claims 1 to 15, wherein the valve is integrally formed with the vascular graft.

17. A valve for use in a system for providing vascular access within a patient's body, the valve comprising: a housing having a flexible membrane having at least one of a passageway through the membrane and a weakened area through which a medical device can be inserted; and an introducer sheath configured to be inserted into an open end of a vascular graft; the valve has at least one seam extending along the length of the valve and defining a predetermined tear line such that the valve can be torn into two halves along the length of the valve; The valve includes at least one retention structure on the exterior surface of the introducer sheath to inhibit removal of the valve from the vascular graft into which it is inserted.

18. 18. The valve of claim 17, wherein the retention structure is formed as a sloped surface.

19. 20. The valve of claim 18, further comprising at least one barb tapered away from an outer surface of the introducer sheath in a direction toward the housing.

20. 20. A valve according to any one of claims 17 to 19, wherein the membrane as well as at least a portion of the housing are formed from a flexible material.

21. 21. The valve of claim 20, wherein the flexible material is an elastic material.

22. 22. The valve of claim 20 or 21, wherein the introducer sheath is stiffer with respect to radial compressive force than the portion of the housing in which the membrane resides.

23. 23. A valve according to any one of claims 17 to 22, wherein the housing is cylindrical.

24. 24. The valve of any one of claims 17 to 23, wherein the inner diameter of the introducer sheath does not decrease at the proximal end of the introducer sheath.

25. 25. The valve of claim 24, wherein the inner diameter of the introducer sheath is constant along the entire length of the introducer sheath.

26. 26. A valve according to any one of claims 17 to 25, wherein the passage extends along at least a portion of the diameter of the membrane.

27. 27. The valve of claim 26, wherein the passage extends along the entire diameter of the membrane.

28. 28. The valve of claim 27, wherein the passage in the membrane comprises at least two slits extending diametrically through the membrane and intersecting each other.

29. 29. A valve according to any one of claims 17 to 28, wherein the membrane has holes passing through it.

30. 30. A valve according to any one of claims 17 to 29, wherein the at least one seam comprises two diametrically opposed seams.

31. 31. The valve of any one of claims 17 to 30, wherein the housing includes at least one handle, the handle extending radially outward from the housing.

32. 32. The valve of claim 31, wherein the housing has two diametrically opposed handles, the handles extending radially outward from the housing.

33. 33. The valve of any one of claims 17 to 32, wherein the valve is integrally formed with the vascular graft.

34. A valve for use in a system for providing vascular access within a patient's body, the valve comprising: a housing having a flexible membrane having at least one of a passageway through the membrane and a weakened area through which a medical device can be inserted; and an introducer sheath configured to be inserted into an open end of a vascular graft; the housing having at least one handle extending radially outward from the housing; A valve having at least one retention structure on the exterior surface of the introducer sheath to inhibit removal of the valve from the vascular graft into which it is inserted.

35. 35. The valve of claim 34, wherein the retention structure is formed as a sloped surface.

36. 36. The valve of claim 35, further comprising at least one barb tapered away from an outer surface of the introducer sheath in a direction toward the housing.

37. 37. A valve according to any one of claims 34 to 36, wherein the membrane as well as at least a portion of the housing are formed from a flexible material.

38. 38. The valve of claim 37, wherein the flexible material is an elastic material.

39. 39. The valve of claim 37 or 38, wherein the introducer sheath is stiffer with respect to radial compressive force than the portion of the housing in which the membrane resides.

40. 40. A valve according to any one of claims 34 to 39, wherein the housing is cylindrical.

41. 41. The valve of any one of claims 34 to 40, wherein the inner diameter of the introducer sheath does not decrease at the proximal end of the introducer sheath.

42. 42. The valve of claim 41, wherein the inner diameter of the introducer sheath is constant along the entire length of the introducer sheath.

43. 43. A valve according to any one of claims 34 to 42, wherein the passage extends along at least a portion of the diameter of the membrane.

44. 44. The valve of claim 43, wherein the passageway extends along the entire diameter of the membrane.

45. 45. The valve of claim 44, wherein the passageway in the membrane comprises at least two slits extending diametrically through the membrane and intersecting each other.

46. 46. A valve according to any one of claims 34 to 45, wherein the membrane has holes extending therethrough.

47. 47. A valve as claimed in any one of claims 34 to 46, having at least one seam extending along the length of the valve and defining a predetermined break line so that the valve can be broken into two halves along the length of the valve.

48. 48. The valve of claim 47, wherein the at least one seam comprises two diametrically opposed seams.

49. 49. A valve according to any one of claims 34 to 48, wherein the housing has two diametrically opposed handles, the handles extending radially outward from the housing.

50. 50. The valve of any one of claims 34 to 49, wherein the valve is integrally formed with the vascular graft.

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