Surgical Devices

Abstract

To provide a device for controlling a fluid flow in a vessel defining a lumen in which fluid can flow.SOLUTION: A surgical device 40 controls a fluid flow in a vessel by using a C-shaped operation member 43 which has first and second slender and flexible members 42, 42' being formed so as to form first and second loops, the loops crossing so as to define an eye opening part 60 surrounding the vessel, the operation member capable of being compressed, and suppressing the vessel so as to be freely released. The operation member 43 comprises: first and second arms 44, 46 separated by a gap 47, the first arm can be fitted to the first slender flexible member so as to apply tension force to the first or second slender flexible member. The second arm can be fitted to the second slender flexible member 42', and the eye opening part is positioned in the gap, therefore compression of the operation member can relax the tension of the slender flexible member for opening the eye opening part, or for allowing the fluid flow in the vessel to flow.SELECTED DRAWING: Figure 4

Description

[Technical field]

[0001] The present invention relates to a surgical device for controlling fluid flow within a vessel defining a lumen. Natural vessels, which define lumens that allow fluid flow within the nervous system and organs, are referred to as vasculature, lymph nodes, and the like. The pulmonary, renal, respiratory, and other systems have tubular connective tissues. Synthetic or prosthetic devices The surgical instrument further includes a tubular part in which fluid flow control is desired during at least a portion of the surgical procedure. The present disclosure provides natural and synthetic biaxially endothelial cells having a length and lateral dimensions that define a lumen or passage therethrough. The vessel can be closed to flow, for example by clamping. The catheter may be a flexible walled vessel. [Background technology]

[0002] Commercially available valves that produce hemostasis within an intravascular delivery system are prohibitively expensive and overly expensive for many people. Over time, these valves are believed to be prone to overspec. This has been shown to result in a loss of efficacy and, for example, a loss of ability to produce hemostasis.

[0003] Surgical sutures, loops or ligatures are used to arrest or ligate natural vessels during surgery. A device comprising a wire-like surgical loop having a retention member is currently used in However, a time-efficient method is disclosed in WO 01 / 76487. When proper use is important, these surgical loops should not be loosened or tightened during the surgical procedure. It has proven to be tedious and time-consuming to [Prior art documents] [Patent documents]

[0004] [Patent Document 1] International Publication No. 01 / 76487 Brochure Summary of the Invention [Problem to be solved by the invention]

[0005] It is an object of the present invention to reduce or eliminate at least one problem in conventional devices, The goal is to obtain a device that is simple and easy to use. [Means for solving the problem]

[0006] According to a first aspect of the invention, a vessel (1; 101) defining a lumen through which a fluid can flow is provided. A device for controlling fluid flow within a fluid passageway, the device comprising: a first attachment configured to form an eyelet surrounding the vessel defining a lumen; at least one elongated flexible member having a first attachment point and a second attachment point; and an operating member for mounting the at least one elongated flexible member, the operating member comprising a handle or a joint. and in a preferred embodiment has a generally C-shaped, V-shaped, U-shaped, etc. and the operating member may be configured as a first arm. a first attachment point of the at least one elongated flexible member; The second arm of the motion member is attached to the second attachment point of the at least one elongated flexible member. The motion member includes the at least one elongated flexible member. The size of the device allows the user to handle and operate the operating member with one hand, forming a handheld device for It is.

[0007] In an embodiment, the motion member comprises at least one elongated flexible section when required. and tensioning the at least one elongated flexible member when required. A flexible material having sufficient elasticity to allow the user to handle and manipulate the operating member to reduce The common point of the motion member may be formed from the first and second motion members. The second arm may be a flexure or spring-loaded hinge portion relative to the second arm. The materials selected for the workpieces, especially the bends, should be able to withstand recoverable strain without permanent deformation. This produces a problem.

[0008] Each elongate member is made of a material known to be relatively flexible, such as silicone rubber. In an embodiment selected from the group consisting of cellulose, the tensile modulus (in GPa) and Understand the material parameters of the elongated flexible member, including the strain and recoverable tensile strain (%), and Both of these properties are measured using uniaxial tensile stress-strain tests (e.g., ASTM D412, Measured on elongated flexible members using ASTM D638, or optionally ASTM D1708 where the elongated member is loaded and unloaded in tension to a predetermined maximum deflection. In this case, a typical range of suitable modulus for a "flexible" slender member is 0.01 to 0.1 GPa. Typical suitable restorable strains are 5% to 300%. However, these are merely illustrative ranges. Other embodiments are contemplated in which the elongated flexible member has properties outside of this range (e.g., For example, a material having a higher elastic modulus and lower recoverable strain but with a different cross-sectional / length geometry may be used. In this case, the elongated flexible member is a polymer or a metal / alloy. Embodiments consisting of wires or braids made of metal are also contemplated.

[0009] In this case, such flexible fibers have relatively low tensile stiffness and high recoverable strain properties. The use of elongated members allows for the elongated member material to be stretched with relatively low forces (e.g. For example, by inserting a large catheter over a guidewire into a blood vessel while maintaining hemostasis. This means that the "eye" can be enlarged, and this expansion does not result in permanent deformation of the elongated member. This means that the results will not be

[0010] For cases in which the elongated members are selected to have a relatively high tensile stiffness (e.g. Monofilament or multifilament sutures, nylon or polyethylene In this case, the important material parameter is the tensile stiffness. This stiffness is such that there is negligible stretch of the elongated member under the forces involved in obtaining a hemostatic seal. In view of the materials used in this example, they should be The polymer may have a Young's modulus in the range of 10 GPa. Other materials with different Young's moduli may also be selected to provide a slender member design with sufficient tensile stiffness. It is possible.

[0011] In this instance, the relatively high tensile stiffness of the elongate member means that the size of the "eye" is This means that the force is controlled primarily by the position of a compressible moving member (i.e., the articulation Compression against the arm allows the user to expand the eyepiece and release the arm. and restoring the elongated flexible member, thereby allowing the eye diameter to be reduced. (I).

[0012] In some embodiments, the compressible motion member is at least one elongated flexible member. a compressible movable member that can be attached to a first attachment point and a second attachment point that can be attached to a At least one arm of the actuation member is compressible upon application of pressure to the compressible actuation member. and operable to act on the at least one elongated flexible member, the action being the at least one elongated flexible portion such that the eye portion inhibits fluid flow within the lumen. a first position in which the material is under tension and the eye is positioned so as not to restrict fluid flow within the lumen. the at least one elongated flexible member being movable from a relaxed second position. This is what we do.

[0013] The pressure applied to the compressible motion member may be finger pressure from a device user. The device is conveniently held in the user's hand and the pressure is applied by the user. by compressing a compressible motion member of the device between the thumb and one or more fingers of the It is possible to apply the voltage.

[0014] The compressible motion members each extend from a common point such as a hinge, joint, or flexible portion. The compressible motion member may have first and second arms extending therefrom, such that They are configured as roughly C-, V- or U-shaped members that connect together when compressed by a user. The first and second arms have separate free ends that are movable toward each other. The first and second arms may have straight or curved lengths. The device may be made of a material that retains the first and second elastic bands, allowing the user to compress the device from the first and second positions. When the second arm is released, the first and second arms are allowed to return to their original configuration. The compressed state may be considered a first configuration in which the elongated flexible member is in a first position. may be considered a second configuration in which the elongated flexible member is in a second position.

[0015] The device is adapted to compress and release the first and second compressible motion members after a user compresses and releases the compressible motion members. The arm may include a configuration biasing member that ensures the arm is returned to the uncompressed first configuration. The configuration biasing member is configured to avoid interference with the at least one elongated flexible member. A hinge, joint, or the like, of the compressible motion member is optionally provided between the first and second arms within a space of sufficient width. Coil springs, leaf springs, torsion springs for placement on or near the hand or flexible part; and the like, and urging the first and second arms into the uncompressed first configuration. Such a configuration biasing member may include at least one fine It may also be beneficial to maintain or oppose tension in the elongate flexible member.

[0016] The operating member is less flexible or more rigid, and is less susceptible to pressure from the user's hand or fingers. In embodiments where the material is more resistant to shrinkage, at least one of the elongated flexible members is The elastic member may be an elongated elastic member that retains elastic properties under tension. , they exhibit limited elongation under tensile load, but recover to their original length when the load is removed. While underneath the elastic strip, the elastic member resists further stretching or "creep."

[0017] Natural fibers such as silk or cotton may be used alone or in combination to modify their natural properties. The flexible silicone material may be at least one elongated strip. At least one of the elongated flexible members may be made of synthetic filaments. The filaments can be optionally silicone coated or partially PTFE coated. The filament can be coated with nylon, polyester, polypropylene, Polyvinylidene fluoride (PVDF), or easy to handle and shape, but compressible When attached to the operating member, it shall not be permanently stretched under the tension anticipated for the disclosed use. The material may be based on other flexible materials with similar physical properties.

[0018] At least one elongated flexible member is adapted to shift from a lumen-occluded condition to an lumen-open condition. The present invention is intended to provide an easy to use mechanism that is user activated, but has a first position and a second position. It is understood that the user can grasp and manipulate the elongated flexible member at an intermediate position between the two positions. It will be understood.

[0019] A "vessel" may be a natural vessel, such as a blood vessel. Alternatively, a "vessel" may be a vascular group. The "elongated flexible member" may be a synthetic vessel such as a branch in a raft. At least one loop can be easily formed, and the loop is referred to herein as the "eye mouth part." It should be understood that the flexible member is an elongated flexible member capable of defining an interior space within the flexible member. The flexible member may be, for example, a yarn, thread, filament, ribbon, fiber, or cord. The loop may be a cord or piece of string, with the space within the loop being able to accommodate the width of the vessel. The elongated flexible member is easy to handle and shape, and is elastic but compressible. The material from which the elongated flexible member is made for the disclosed use when attached to the movable member. It may be one that does not stretch under tension beyond its elastic limit.

[0020] In the case of an application as a prosthetic device having a soft textile tubular portion, The closure of the eye around the soft woven tubular portion of the prosthetic device is achieved by the soft woven fabric of the prosthetic device. It will be appreciated that the present invention provides a conformable seal around any object present within the tubular portion. Thus, a hemostatic seal can be created and catheters, wires, etc. or other exemplary delivery system components, if desired. This allows the prosthetic device to pass through the soft woven tubular portion. The disclosed devices act as hemostatic valves that are easily applied and removable. The device is tethered to the graft to keep it in place during the surgical procedure. (The Ring) is possible.

[0021] The actuation member is adapted to bias the at least one elongated flexible member toward the first position. , may be operable to act on at least one elongated flexible member. .

[0022] The movement members may be "C" shaped, or V or U shaped, or separated by a gap. The device may be a bifurcated device of similar configuration having first and second arms. The first arm of the motion member is attached to a first attachment point of the at least one elongated flexible member. and the second arm of the motion member is attached to the second attachment of the at least one elongated flexible member. At least one elongated flexible member is attached to the motion member. The eyepiece may be manipulated to form at least one loop that defines an eye mouth prior to insertion. The eye can be positioned in a gap between the first and second arms of the motion member. At least one of the first and second arms of the motion member may include at least one elongated a first arm of the motion member and a second arm of the motion member for moving the flexible member from the first position to the second position; Each of the first and second arms may be movable inwardly relative to the other. In an assembly step prior to use, the at least one elongated flexible member is passed through a corresponding adapter. Each of the first and second arms may have an aperture through which the first and second arms can be attached. The corresponding apertures in the are accessible from above and below the arms, i.e. The openings may be circular or elliptical, or may additionally be accessible through a side slot. For example, the opening can be substantially J-shaped or L-shaped when viewed from above. The aperture forms part of the mounting structure, e.g., for receiving at least one elongated flexible member. It serves as a threading structure for attaching the

[0023] In some embodiments, at least one flexible member may be passed through the at least one flexible member. The aperture may be a pinhole aperture in at least one of the first and second arms of the motion member. The pinhole aperture may be a hole. The pinhole aperture may be a hole formed in at least one of the elongated flexible members. At least a portion of the surface may be defined by a surface configured to interact upon contact. The interaction is achieved by applying a force to the surface and the contact portion of the at least one elongated flexible member. and act to sufficiently position said at least one elongated flexible member without additional fastening means. The surface defining the pinhole aperture is in friction contact with the at least one elongated flexible member. Can be roughened, ribbed, grooved, or serrated to enhance interaction This ensures that the at least one elongated flexible member is properly positioned for use. and configuration, and avoid undesirable loosening or sagging during use. Preferably, each of the first and second arms is provided with such a pinhole aperture. The user can selectively change the shape, for example by changing at least one Overcoming friction between the contacting portion of the elongated flexible member and the surface defining the pinhole aperture. By applying a sufficient force to a portion of at least one of the elongated flexible members, The mouth can be enlarged.

[0024] In one embodiment, the motion member and the at least one elongated flexible member are "Ready for use" to control fluid flow within a vessel that defines a lumen through which the body can flow. The device may be preassembled for delivery to a user. In such an embodiment, at least At least one elongated flexible member is sufficient to form a loop defining an eye of a desired size. Insert it through the hole for a sufficient length and then pull it back in.

[0025] The at least one elongated flexible member includes a contact portion of the at least one elongated flexible member. The user applies a force sufficient to overcome the friction between the surface defining the pinhole aperture and the It may be made from a material that reduces the tendency for the material to slip through the aperture in the absence of additional tension. A flexible silicone material is preferred for the at least one elongated flexible member. At least a portion of the flexible silicone material may include at least one elongated The flexible member is covered with a removable low friction material to facilitate assembly when inserted through the aperture. Polytetrafluoroethylene (PTFE) tape is a removable, low-friction adhesive. It can act as a friction material. A composite material may be used as the at least one elongated flexible member.

[0026] The at least one elongated flexible member is a single elongated flexible member having first and second ends. The first arm of the motion member may have a first threading formation; and The second arm of the motion member may have a second threading configuration. the second end may be inserted through the second insertion structure and the second end may be inserted through the second insertion structure.

[0027] Each of the first and second threading arrangements provides a plurality of wraparound points for the threading. It may have a zigzag shaped aperture.

[0028] At least one of the first and second threading arrangements, and optionally both, are a laterally disposed J-slot accessible from a side of said arm in said member; can be done.

[0029] The at least one elongated flexible member includes a first elongated flexible member configured to form a first loop. and a second elongated flexible member configured to form a second loop. The first and second elongated flexible members define an eye portion surrounding the lumen. The first and second loops may be arranged in parallel so as to The first and second loops may be linked together. The first elongated flexible member may be a the second elongated flexible member having a first attachment point and the second elongated flexible member having a second attachment point. This can be done.

[0030] The first arm of the motion member has a first threading configuration and the second arm of the motion member has a first threading configuration. The arm can have a second threading configuration. The first elongated flexible member can have the first threading configuration. and the second elongated flexible member can be threaded through the second threading arrangement.

[0031] Each of the threading structures may have an aperture, and each of the elongated flexible members may pass through the aperture to the other. The elongated flexible member is inserted through the loop formed by the elongated flexible member, and then inserted back through the opening. The aperture of each threading arrangement may be formed through at least one of the at least one elongated flexible member. both portions may be defined by surfaces configured to interact upon contact; The interaction occurs when the contact portion of the surface and the at least one elongated flexible member and (c) providing a support member for supporting said at least one flexible elongated member in said housing and supporting said at least one flexible elongated member. The surfaces defining the aperture are operative to contact the at least one elongated flexible member. The surface may be roughened, ribbed, grooved, or serrated to enhance frictional interaction. This allows the at least one elongated flexible member to be properly configured for use. The invention provides a method for positioning and configuring the device, and for preventing undesirable loosening or sagging during use. can be avoided.

[0032] The at least one elongated flexible member is attached to the first and second arms of the motion member. Threading the at least one elongated flexible member for attachment to the movable member during use. The at least one fine hole is provided to prevent the working member from slipping through an aperture in the arm. The elongate flexible member may be secured by tying a knot in the elongate flexible member.

[0033] The at least one elongate flexible member may be formed from silicone. The at least one elongate flexible member may be an elastic cord. The motion member may be compressible upon application of finger pressure.

[0034] In use of the device, in particular, the at least one elongated flexible member is substantially a single In embodiments where the elongated flexible member is a flexible member, the device is abutted against or attached to the vessel. The maintenance of the eye in the expanded loop configuration during handling and removal is achieved by using a thin probe, Any manually operated elongated instrument such as a catheter end, scalpel handle, urethral dilator, etc. This can be facilitated by inserting an elongated retainer which may be

[0035] In a preferred embodiment, first and second eyelets operable with each other to define an eyelet of variable size. The use of two crossed loops of the second elongated flexible member allows the eye to be formed at any time. This results in the vascular graft remaining available to expand or close around the vessel.

[0036] According to a second aspect of the present invention, a prosthetic graft having a tubular branch defining a lumen, and The eye of the device is adapted to control fluid flow in the lumen of the tubular branch. and a device as described above surrounding the branch of the outlet.

[0037] Preferred embodiments of the present invention will now be described, by way of example only, with reference to the accompanying drawings, in which: [Brief description of the drawings]

[0038] [Figure 1] 1 shows a device according to a first embodiment of the invention. [Figure 2A] 3 shows a device according to a second embodiment of the invention. [Figure 2B] 3 shows a device according to a second embodiment of the invention. [Figure 2C] 3 shows a device according to a second embodiment of the invention. [Figure 3A] FIG. 2 shows a perspective view of a generally C-shaped compressible motion member forming part of a manually controlled fluid flow device in an embodiment of the present invention. [Figure 3B] FIG. 3B illustrates a longitudinal cross-sectional view of the compressible motion member shown in FIG. 3A, showing indentations in the upper and lower surfaces for a user's fingers to facilitate compression of the motion member in use. [Figure 3C] 3B illustrates a perspective view from above and one side of the longitudinal section of the compressible motion member shown in FIG. 3A, more clearly illustrating the ribbed inner surface of each threaded hole for receiving an elongated flexible member; FIG. [Figure 4] 1 shows an embodiment of the device of the present invention assembled for use, the device comprising a compressible motion member having two cross-threaded elongated flexible members defining an eye port that accommodates a blood vessel (not shown) to be arrested during a surgical procedure. [Diagram 5] 13 shows a device according to a second embodiment for use in a branch vessel of a tubular prosthetic implant. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0039] Reference is now made to FIG. 1, which illustrates a vascular endoscopic device defining a lumen, in accordance with a first embodiment of the present invention. 1 shows a device 10 for controlling a fluid passing through a fluid passage 1. The device 10 may be, in the illustrated example, It includes an elongated flexible member 12 which is a flexible cord.

[0040] The device 10 further comprises a compressible motion member 13, which in the illustrated example is C-shaped. The C-shaped member 13 has distal free ends separated by a gap 17 and First and second hinges extend from a common point in the form of a hinge portion 18 at the proximal end of the hinged member. The hinge portion 18 is connected to the C-shaped member 13. As shown in FIG. 1, the elongated flexible member 12 is a flexible U-shaped portion that extends through the vessel 1. The eye 20 is positioned in the gap 17. and in use is positioned generally transversely on the exterior of the vessel 1.

[0041] The terms "hinge" and "hinge portion" as used in this disclosure and in the claims are intended to In any embodiment, a flexible connection between the proximal ends of the first and second arms is provided. , a coupling, or a return portion, whereby one of the first and second arms is The second arm can move towards the other one of the arms.

[0042] The first arm 14 has a first threading arrangement 26 and the second arm 16 has a second threading arrangement 28. The elongated flexible member 12 has a first end 22 that is inserted into a first insertion configuration 26. 2, by passing the second end 24 of the elongated flexible member through the second passing arrangement 28. 4. In this way, it is attached to the C-shaped member 13.

[0043] In the illustrated example, each of the first and second threading structures 26, 28 has an open end with a comb-like portion. Each aperture thus forms a number of teeth 30 in the C-shaped member 13. In the illustrated example, each end of the elongated flexible member 12 has an associated threading feature 26, 28. The elongated flexible member 1 is positioned in one of the threading configurations 26, 28 and is threaded around the teeth 30. The two parts form a friction fit in a threaded configuration and are thereby positioned in the gap 17. A portion of the first elongated flexible member 12 can be tensioned and the eye portion can be moved toward a closed position. The elongated flexible member 12 is threaded through the threading features 26, 28, which The insertion of the flexible member 12 is performed by applying tension to the portion of the flexible member 12 that is located within the gap 17 in the rest position. 2 and 3, such that the eye port 20 is under pressure to restrict fluid flow through the lumen.

[0044] Either one of the arms 14, 16 is movable inwardly in response to pressure applied to the outer surface. This means that when pressure is applied to one of the arms 14, 16, it will be positioned within the gap 17. The portion of the elongated flexible member that is being held in place relaxes, and this relaxation has the effect of increasing the size of the eye portion 20. Each arm 14, 16 has a distal end that is responsive to finger pressure to permit fluid flow in the lumen. It is preferable that the movable member is movable in the same direction as the movable member.

[0045] 2A, 2B and 2C, which show a second embodiment of the present invention. Shown is a device 100 for controlling fluid flow within a vessel 101 that defines a cavity 102. In one embodiment, the device 100 comprises an elongated flexible cord, which in the illustrated example is a flexible cord. The first elongated flexible member 132 defines a first loop 136. and the second elongated flexible member 134 is configured to form a second loop 138. As shown, the first loop 13 is wound around the vessel 101 to define an eye opening 120. The first and second elongated flexible members 132, 136 are linked to the second loop 138. One part of the four passes through the loop in the other at least once to form a cross loop. The use of first and second elongated flexible members 132, 134 configured to 0, which provides stability so that objects such as vessels or catheters or surgical instruments can be inserted into the eye. The eye mouth morphology is maintained even if the eye mouth is not present in the oocyte. Used when the user wants to pass the eye over an object or insert an object into the eye. The use of cross loops allows the loop to be loosened and unwound if it does not form a loop around the object. This has an advantage over a single loop.

[0046] The device 100 further acts on the first and second elongated flexible members 132, 134 to The eye opening 120 is provided with an operable member 113 that can be operated to close it again. In an embodiment, the motion member 113 is a C-shaped member. 3 includes first and second apertures separated by a gap 117 in which an eye 120 is located. The first and second arms 114, 116 have a hinge portion 118. It extends upward from

[0047] Each arm 114, 116 includes a threading arrangement 126 for a respective elongated flexible member 132, 134. , 128. In the illustrated example, each threading arrangement 126, 128 has a single aperture. In the illustrated example, each elongated flexible member 132, 134 has a corresponding aperture 126, 138. 28 and into gap 117, and the other elongated flexible member is inserted through a loop in the other elongated flexible member. Each of the elongated flexible members 132, 134 is an elastic cord. Also, the corresponding apertures 11 are provided with corresponding arms 12 so as to form a friction fit with the corresponding arms 12 within the corresponding apertures. 26, 128. This allows the loop to be formed. The portions of each flexible elongate member 132, 134 that are tensioned can be adjusted by adjusting the size of the loop. This enables

[0048] In this embodiment, both loops 136, 138 are interconnected such that they operate in unison. This has the overall effect of stabilizing the eye and mouth parts and also the movement of the moving member 1. Under tension bias from 13, loops 136, 138 form eye-mouth portion 12 as shown in FIG. 2B. As shown in FIG. 2C, the arms 114, 116 are inwardly This means that sufficient compressive force is applied to the working part to move the arms inward. When applied to material 113, each loop 136, 138 relaxes, thereby opening eyelet 120. .

[0049] The use of the device disclosed herein will now be described with reference to the first embodiment described above with reference to FIG. In use, the device 10 of the first embodiment is configured to, for example, In the case of a branched vessel of the same vessel, the orifice 20 can be prepared to already surround the vessel 1. Alternatively, the device 10 can be assembled on-site by medical personnel as described below. When assembling the device 10, the medical practitioner may determine whether or not a vessel is present within the orifice 20. The elongated flexible member 12 is configured to define the eye mouth portion 20 when positioned. As part of the procedure, the medical practitioner may insert the first end 22 of the elongated flexible member 12 into the first threading configuration 26. 2 and 3. The medical practitioner then inserts the second end 24 through the second insertion feature 28. A portion of the elongated flexible member 12 positioned within the gap 17 to inhibit flow within the vessel 1. When the medical practitioner wishes to allow fluid to flow through vessel 1, the medical practitioner performs the action Gripping the member and simply manipulating it between the finger and thumb to apply finger pressure to the operating member 13 This changes the size of the eyelet 20, opening the eyelet 20 and allowing fluid flow in the vessel. This has the effect of changing the shape of the eye-mouth portion 20 to one that allows the medical staff to release the finger pressure. When the operating member 13 pushes and biases the eye opening portion 20 toward the closed position, the eye opening portion 20 closes the blood vessel 1. 1. The eye mouth 20 then reverts to a tighter shape around the vessel 1, thereby inhibiting the flow of blood within the vessel. Impedes fluid flow.

[0050] The use of the second embodiment is described below with reference to Figures 2A, 2B and 2C. In two embodiments of the device, the vessel is a tubular portion of a prosthetic device, such as a vascular graft. If it is a bifurcation, the eye opening 120 can be prepared in advance to surround the vessel 101. Alternatively, device 100 may be assembled on-site by medical personnel as described below. When assembling the device 100, the medical personnel may assemble the first and second Each of the elongated flexible members 132, 134 forms a loop and is configured to define an eye portion 120. The flexible elongated members 132, 134 are configured to be linked together in such a manner that the flexible elongated members 132, 134 are The elongated flexible members 132, 134 are passed through corresponding apertures 126, 128 into the gap 117. and one of the elongated flexible members 132, 134 is looped into the other elongated flexible member. This is accomplished by inserting the wire through the corresponding openings 126, 128 and back through the corresponding holes. The medical professional then aligns each of the elongated flexible catheters so that the orifice portion inhibits flow through the vessel 1. Referring to FIG. 5, if a medical professional wishes to allow fluid to flow through a vessel, When performing the procedure, the medical professional grasps the motion member and simply manipulates it to apply finger pressure to the motion member 113. This can be done by moving the eye port to a position that allows fluid flow in the vessel 101. When the medical professional releases this pressure, the operating member 113 moves the eye opening to the closed position. When the eye is biased toward the eye, the eye obstructs the flow of fluid in the vessel 101. Return to position.

[0051] Commercially appealing and predictable in use due to its relative lack of complexity Another embodiment that provides the advantage of high reliability is described below with reference to FIGS. 3A, 3B, and 3C and FIG. 4 will now be described.

[0052] Referring first to FIG. 4, there is shown a vessel (not shown) defining a lumen, in accordance with another embodiment. 1 shows an assembled device 40 suitable for controlling a fluid in a In the illustrations and examples, the interdigitated holes are operable with each other to define an eyelet 60 of variable size. The flexible member 42 is formed of two adjacent flexible members 42, 42'. The elongated flexible members 42, 42' are made from flexible silicone cord. The material 42, 42' is a user compressible material shown separately in FIGS. 3A, 3B, and 3C. The arms of the operating member 43 are inserted through the respective arms.

[0053] 3A, 3B, and 3C, in this embodiment, the user compressible The motion member 43 is generally C-shaped and has a proximal hinge portion 48 and a proximal hinge portion 49. Extending from portion 48 are first and second arms 44, 46 having distal free ends. The first and second arms 44, 46 are separated by a gap 47. In the illustrated example, The hinge portion 48 is a V-shaped or U-shaped portion of the C-shaped member 43. Each of the two arms 44, 46 has a corresponding first and second arm 44, 46 near the distal end thereof. The inner surface 62 defining each pinhole aperture 61 is In this state, when the elongated flexible members 42, 42' are inserted through the corresponding pinhole openings 61, A rib is formed which frictionally interacts with a portion of the elongated flexible members 42, 42'.

[0054] As shown in FIG. 4, a compressible motion member 43 contains a pair of elongated flexible members 42, 42'. The elongated flexible members are each configured to define an eye 60 surrounding a vessel. Together they function to form an elongated flexible member.

[0055] The first arm 44 has a first threading arrangement 56 and the second arm 46 has a second threading arrangement 58. The elongated flexible members 42, 42' are inserted through the first end 52 of the elongated flexible member 42. 56 to form a first loop, and then pass first end 52 back through first threading structure 56. At this time, the second elongated flexible member 42' is attached to the C-shaped member 43 by being inserted through the second elongated flexible member 42'. has a free end defined as a second end 54, the second end 54 being connected to a second threading arrangement 58. and through the first loop to form a linked second loop, and then a second end 54 back through the second threading configuration 58. In the illustrated example, again referring to FIGS. 3C, each of the first and second threading structures 56, 58 includes a ribbed inner surface portion. 62. Thus, each pinhole aperture is configured as a pinhole aperture 61 having A plurality of ribs 63 are formed within the pinhole opening 61 of the C-shaped member 43. In the illustrated example, , each end of the elongated flexible member 42, 42' is connected to an associated threading feature 56, 58. The elongated flexible member 56, 58 is inserted through the rib 63. Each portion of the conductive member 42, 42' is guided through the pinhole opening 61 of the threading arrangement 56, 58. 4. The grooved surface portion 62 forms a friction fit with the grooved surface portion 62 located within the gap 47. 2. Tensioning a portion of the first elongated flexible member 42, 42' and orienting the eye 60 to a closed position. The elongated flexible members 42, 42' are provided with respective threading structures 56, 58. 4. The pinhole 61 in the pin hole 61 is inserted in the gap 47 in the rest position. The portion of the elongated flexible member 42 that is placed is under tension and the eye portion 60 is in contact with the vascular Fluid flow through the lumen can be inhibited.

[0056] Each arm 44, 46 is movable inwardly in response to pressure applied to its outer surface. This means that when pressure is applied to one of the arms 44, 46, it will be positioned within the gap 47. The portion of the elongated flexible member 42 that is being inserted relaxes, which increases the size of the eye portion 60. Each arm 44, 4 6 are preferably movable inwardly in response to finger pressure applied thereto. The recesses 344, 346 in the outer surface of 46 prevent bodily fluids during a surgical procedure from wetting the device surface. and use of device 40 that may interfere with the intended use of device 40. Finger pressure guides that support the user's fingers while reducing the risk of fingers slipping off the arm Serve as.

[0057] The at least one elongated flexible member is formed from a flexible silicone material or filament. The material or filament can be optionally silicone coated or at least Can be partially PTFE coated, filaments are nylon, polyester, poly Propylene, polyvinylidene fluoride (PVDF) or other materials that are easy to handle, manipulate and shape. , based on other flexible materials with similar physical properties that do not permanently stretch under tension. It is possible.

[0058] The operating members are made of acrylonitrile butadiene styrene (ABS), nylon, or molded It has a memory that can be compressed repeatedly by user manipulation. From a wide range of materials, including any other material that exhibits sufficient flexural / bending modulus with shape memory. They can be formed from a pair of wires that are joined or fused together at one end and have a free end at the other end. Optionally, the arm may be made of stainless steel with gripping holes milled into the outer surface of the arm. Optionally, steel sheets impermeably coated with lacquer or resin can be used. Molded plywood may also be used in some circumstances, but it is not recommended for use with materials such as ceramic or glass. Brittle materials are unsuitable and soft materials such as synthetic foam or rubber may cause excessive It is flexible and therefore unsuitable for use as a moving member.

[0059] The actuation members are movable toward one another under an applied pressure and are movable toward one another upon release of the pressure. and in particular, the movable member is capable of elastically restoring itself to a desired shape when the user selectively applies pressure to the movable member. The compressible motion member may have curved or angled arms that are compressible. The motion member moves the distal ends of the arms toward each other in response to finger pressure. The compressibility of the material may be sufficient.

[0060] The device may comprise a prosthetic graph having a device as described herein and a tubular branch defining a lumen. In such a kit, the device may be provided as part of a kit comprising: The chair is assembled with the motion member and the elongated flexible member such that the eye of the device surrounds the branch. The equipment can be provided as "ready for use" equipment. [Industrial Applicability]

[0061] The devices described herein can be used in surgical procedures. The devices described herein use the same materials as existing delivery systems and are naturally The new clip provides a "hassle-free" solution that can be used quickly and efficiently on both natural and synthetic vessels. In addition, it offers a user-friendly interface due to its relative simplicity compared to some commercially available devices. It is intuitive and easy to operate by the user.

[0062] The devices described herein provide hemostasis during placement of catheters of different sizes within a vessel. This can be advantageously used to generate a catheter when inserting the catheter into a vessel. There is no need to make any adjustments to the device, and the device controls intravascular flow.

[0063] The devices described herein are adapted to move fluid within a lumen by applying pressure to a working member. It provides medical personnel with a simple method for quickly and selectively controlling flow.

[0064] The devices described herein have smaller through holes or provides a loop that creates an "eye mouth." The loop and the vascular surface around which the loop is formed, For example, the interaction between the graft and the soft Zellweave fabric surface is Any device that is inserted into a lumen in a graft, such as a catheter or graft lumen. The catheter creates a conformal seal with the sheath around the device being delivered to the catheter.

[0065] Advantageously, the device can be disassembled and reassembled in the field by medical personnel as needed. Cut.

[0066] The devices described herein have lengths and lateral dimensions that define a lumen or passageway therethrough. Both natural and synthetic vessels can be used, and the vessels can be flexible walled vessels. The wall sections can be clamped or clamped together to reduce the transverse dimension of the lumen. The device can be used to pinch or clamp the vessel so that the catheter can be inserted into the vessel. 3. Close the catheter to form a conformal seal with the object, thereby holding the catheter in place. It can completely occlude flow within the lumen when it is inserted or during its removal.

[0067] The reference characters used in the above description of the accompanying drawings are also used in the claims, and are not intended to be limiting. The present invention is intended to assist in identifying technical features in the illustrated embodiments and to provide a more complete understanding of the invention as defined by the appended claims without limiting the scope thereof. This is intended to promote understanding of the

[0068] Changes and modifications may be made without departing from the scope of the invention as defined by the claims. can be incorporated.

Claims

1. 1. A device for controlling fluid flow within a vessel defining a lumen through which liquid can flow, comprising: at least one elongated flexible member configured to form an eye surrounding the vessel defining a lumen, the eye including a first attachment point and a second attachment point; a compressible motion member attachable to the first and second attachment points of the at least one elongated flexible member, a compressible motion member having first and second arms separated by a gap, each of the first and second arms having a distal free end for receiving the at least one elongated flexible member to attach the at least one elongated flexible member to the first and second arms of the compressible motion member, the compressible motion member being compressible upon application of pressure to the compressible motion member and operable to act on the at least one elongated flexible member such that the at least one elongated flexible member is movable from a first position in which the at least one elongated flexible member is under tension such that the eye portion inhibits fluid flow within the lumen, and a second position in which the at least one elongated flexible member is relaxed such that the eye portion does not inhibit fluid flow within the lumen; Equipped with the at least one elongated flexible member comprises a first elongated flexible member configured to form a first loop and a second elongated flexible member configured to form a second loop, the first and second elongated flexible members being linked together such that the first and second loops define the eyeport surrounding the lumen; a portion of the first elongated flexible member having a first attachment point and a portion of the second elongated flexible member having a second attachment point, the first arm having a first piercing configuration and the second arm having a second piercing configuration; the first elongated flexible member extends through the first threading arrangement and the second elongated flexible member extends through the second threading arrangement; a device in which each of the first and second insertion configurations has an aperture, an end of the first elongated flexible member is inserted through the aperture of the first insertion configuration and back through the aperture of the first insertion configuration so that a length of the first elongated flexible member is sufficient to form a loop, and an end of the second elongated flexible member is inserted through the aperture of the second insertion configuration and back through the aperture of the second insertion configuration so that a length of the second elongated flexible member is sufficient to form a loop, each of the flexible members being inserted such that one of the first and second elongated flexible members passes through the loop formed by the other of the first and second flexible members.

2. 10. The device of claim 1, wherein the compressible motion member is compressible upon application of finger pressure, and wherein the compressible motion member has indentations on upper and lower surfaces to facilitate finger pressure.

3. 2. The device of claim 1, wherein the compressible motion member is a C-shaped member, the first arm is attachable to the first attachment point and the second arm is attachable to the second attachment point, and the eye is positioned within the gap.

4. 10. The device of claim 1, wherein the compressible motion member has a proximal V- or U-shaped hinge portion, the first and second arms extending from the proximal V- or U-shaped hinge portion.

5. 10. The device of claim 1, wherein the aperture has a roughened, ribbed, grooved, or serrated inner surface to enhance frictional interaction with the at least one elongated flexible member.

6. The device of claim 1 , wherein the at least one elongated flexible member is formed from a resilient silicone material.

7. The device of claim 1 , wherein the at least one elongated flexible member is an elastic cord or an elastic filament.

8. 13. A kit for use in a medical procedure comprising: a device as described in claim 1; and a prosthetic graft having a tubular branch defining an internal lumen, wherein (a) the device is provided ready for use with the compressible motion member and the first and second elongate flexible members assembled such that an eye portion of the device surrounds the tubular branch; or (b) the compressible motion member and the first and second elongate flexible members of the device are separate components to be assembled by a user.

9. The device of claim 1 , wherein the at least one elongated flexible member is formed from a resilient silicone material.

10. The device of claim 1 , wherein the at least one elongated flexible member is an elastic cord or an elastic filament.

11. 10. The device of claim 1, wherein the aperture has a roughened, ribbed, grooved, or serrated inner surface to enhance frictional interaction with the at least one elongated flexible member.

12. 10. The device of claim 1, wherein the first and second threading arrangements each have an aperture shaped to create a plurality of wrap points for threading the at least one elongated flexible member.

13. 1. A kit for use in a medical procedure comprising a device for controlling fluid flow in a vessel defining a lumen through which a liquid can flow, the device comprising: at least one elongated flexible member configured to form an eye surrounding the vessel defining a lumen, the eye including a first attachment point and a second attachment point; a compressible motion member attachable to the first and second attachment points of the at least one elongated flexible member, a compressible motion member having first and second arms separated by a gap, each of the first and second arms having a distal free end for receiving the at least one elongated flexible member to attach the at least one elongated flexible member to the first and second arms of the compressible motion member, the compressible motion member being compressible upon application of pressure to the compressible motion member and operable to act on the at least one elongated flexible member such that the at least one elongated flexible member is movable from a first position in which the at least one elongated flexible member is under tension such that the eye portion inhibits fluid flow within the lumen, and a second position in which the at least one elongated flexible member is relaxed such that the eye portion does not inhibit fluid flow within the lumen; Equipped with the at least one elongated flexible member comprises a first elongated flexible member configured to form a first loop and a second elongated flexible member configured to form a second loop, the first and second elongated flexible members being linked together such that the first and second loops define the eyeport surrounding the lumen; a portion of the first elongated flexible member having a first attachment point and a portion of the second elongated flexible member having a second attachment point, the first arm having a first piercing configuration and the second arm having a second piercing configuration; the first elongated flexible member extends through the first threading arrangement and the second elongated flexible member extends through the second threading arrangement; The kit further comprises a prosthetic graft having a tubular branch defining an internal lumen, wherein (a) the device is provided with the compressible motion member and the first and second elongate flexible members assembled such that an eye portion of the device surrounds the tubular branch, or (b) the compressible motion member and the first and second elongate flexible members of the device are separate components to be assembled by a user.

14. 14. The device of claim 13, wherein at least one of the first and second threading structures has an aperture configured to frictionally retain a portion of the at least one elongated flexible member within the aperture.

15. 14. The device of claim 13, wherein the first and second threading arrangements each have an aperture shaped to create a plurality of wrap points for threading the at least one elongated flexible member.

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