• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
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    • 专利摘要:
    Adhesive based treatment of varicose veins. The present invention relates to an intraluminal limb that can be used to deliver an adhesive to a vein which causes the vein to spasm, thereby controlling migration of the adhesive and ameliorating the effectiveness of the procedure.
    公开号:BR112014014122B1
    申请号:R112014014122-3
    申请日:2012-12-13
    公开日:2021-08-24
    发明作者:John P. Marano Jr.；Michael Tal
    申请人:Merit Medical Systems, Inc；
    IPC主号:
    专利说明:

    RELATED ORDER
    [0001] This application claims benefit under 35 U.S.C 119(e) of United States Utility Patent Application Serial Number 13/324,621, filed December 13, 2011. SUMMARY
    [0002] Conventional adhesive-based varicose vein treatment systems require the application of external pressure to the skin overlying the injection site to compress the vein, reduce the vein diameter and thereby control adhesive migration as well as provide approximation of the opposite walls of the vein to allow for effective bonding and occlusion of the vein lumen. Because external pressure can be difficult to apply consistently, and because the consequences of adhesive migration in the deep venous system are potentially so severe, adhesive-based treatment of varicose veins can be improved with techniques that achieve reduction circumferential vein diameter reliably and consistently. The present invention is a device that disturbs the inner wall of the vein to induce a circumferential vasospasm at or near the site of adhesive injection. Causing spasm at the time of adhesive delivery would provide such a thinner, more reliable vein diameter reduction, and thus would improve control of adhesive migration as well as improve the effectiveness of the procedure. BRIEF DESCRIPTION OF THE DRAWINGS
    [0003] FIGURE 1 shows an embodiment of a set of a vascular treatment device.
    [0004] FIGURE 2 illustrates a longitudinal cross-sectional view of the embodiment illustrated in FIGURE 1.
    [0005] FIGURE 3 shows a longitudinal cross-sectional view of a handle.
    [0006] FIGURE 4 illustrates a longitudinal cross-sectional view of a cartridge.
    [0007] FIGURE 5 shows the cartridge illustrated in FIGURE 4, with a syringe and an attached stopcock.
    [0008] FIGURE 6 shows a perspective view of an embodiment of a vascular treatment device having a single syringe holder.
    [0009] FIGURE 7 illustrates an exemplary set of the embodiment handle depicted in FIGURE 5.
    [00010] FIGURE 8 shows a top plan view of a portion of the handle illustrated in FIGURE 7.
    [00011] FIGURES 9 and 10 depict various embodiments of wire distal ends.
    [00012] FIGURES 11 to 13 illustrate cross-sectional views of various embodiments of the distal ends of wires over which the springs are wrapped.
    FIGURES 14 - 14A, 15 - 15A, 16 - 16A, 17 - 17A, 18 - 18A, 19 - 19A, 20 - 20A, 21 - 21A, 22 - 22A, 23, and 24 describe various embodiments of the distal ends of wire. DETAILED DESCRIPTION
    [00014] Ablation of superficial veins that have lost their ability to pump blood to the heart has known beneficial therapeutic effects. The use of adhesives to stop flow in the veins by forming a permanent hardened occlusion mass is limited because of concerns about allowing the adhesive to enter the deep system. Adhesive migration into the undesirable section, rather than the healthy sections, can have devastating effects. For example, the use of the adhesive to occlude a great saphenous vein, a common vein closure procedure, could result in migration of the adhesive into the deep system, eg, into the common femoral vein. If the adhesive migrates into the deep system it will harden and obstruct the deep vein; clots will form proximal and distal to the adhesive mass and an immobile uncorrectable deep vein thrombosis (DVT) will result. The affected extremity will be painful, swollen, and the veins will be engorged. The clot could travel and travel to the lungs, causing a pulmonary embolism (PE), associated with a substantial mortality rate. A medical emergency of acute deep vein thrombosis is usually treated by breaking the clot using thrombolytic agents and anticoagulants (blood thinners). In this case, however, the hardened adhesive mass is not removable. There is no apparent way to fix the condition. Efforts can be made to surgically bypass the hardened mass, but such procedures are known to be risky and have a limited success rate. Current procedures to limit the adhesive to the treatment zone and to prevent involuntary migration involve adjusting the viscosity of the adhesives to prevent movement, as well as applying external compression by the ultrasound transducer or by hand to block the passage of the adhesive block into undesirable locations. The viscosity approach is quite limiting and complicates both the adhesive delivery system and agent placement. External compression of the vein is unreliable.
    [00015] The present inventors have found that the use of an intraluminal limb, such as a rotating wire catheter (scatter tip), is an effective, safe approach to delivering an adhesive to veins and arteries while controlling adhesive migration. . The rotating dispersion tip in combination with a sclerosant and an adhesive or an adhesive alone causes vasospasm. The vein consistently and reliably demonstrates circumferential narrowing and a marked reduction in diameter, causing complete occlusion of the treated vein at the treatment site. With the spasm, the vein is occluded distal to and at the adhesive injection point, thus preventing adhesive migration and collateral damage. The spasm blocks the flow of adhesive into the deep system and also reduces the volume of adhesive required. It provides more effective and reliable vein occlusion. There is no need to block the flow into the deep system using external compression or any other methods such as a mechanical plug or balloon. Obstruction of the flow through the spasm caused by the device makes a safer system.
    [00016] The use of adhesive with sclerosant makes the sclerosing procedure safer. An operator can inject the sclerosant and adhesive simultaneously, or in series. Either the sclerosant or the adhesive, or both, can be injected while the rotating wire is disturbing the vein to promote vasospasm. Also, an operator could serially activate the rotating wire device to spasm the target vein, withdraw the wire, and then inject the adhesive and/or sclerosant into the treatment zone.
    [00017] Combining the use of adhesive with a rotating wire has the advantage that the rotating tip of the wire will evenly distribute the adhesive radially, making the adhesive more effective.
    [00018] The tip can be configured to cause backflow proximal to the injection point, or the tip configuration can be arranged to provide backflow distal to the injection point, to further limit adhesive migration into unwanted vein segments. The tip of the device can be positioned at the end of the treatment zone and pulled back or down through the treatment zone. For example, in the great saphenous vein, the tip can be positioned close to the saphenous-femoral junction and be pulled out of the junction and through the treatment zone. Because it is highly undesirable (dangerous) to allow the adhesive to enter the deep system (in the example for the femoral vein), reflux is stimulated in a direction away from the deep system.
    [00019] Another alternative is to use rotation in a small segment of the vein and injection without rotation through the remainder of the treatment zone.
    [00020] A variety of known adhesives can be used. Usable adhesives can cure in different ways, for example chemically or by UV activation. A rotating wire catheter can be configured to provide UV light at the tip to activate the adhesive. In this way, the adhesive can be delivered through the catheter in a low-viscosity state, which helps to minimize the required diameter of the catheter lumen and then activated when applied or about to be applied. Alternatively, chemically activated adhesives can be used, with the activator added when the adhesive is applied or about to be applied.
    [00021] A wide variety of adhesives are suitable for use, mainly among them, acrylic-based adhesives, mainly cyanoacrylates, such as 2-octylcyanoacrylate (DERMABOND, ™ Ethicon) and n-butyl-2-cyanoacrylate (HISTOACRYL, ™ B. Braun, Germany; GLUBRAN, ™ GEM Srl, Italy; TRUFILL N-BCA, ™ Cordis Neurovascular, Inc., USA). Other adhesives include the BIOGLUE™ surgical adhesive (Cryolife), which is composed of purified bovine serum albumin (BSA) and glutaraldehyde; KRYPTONITA™ Adhesive (Doctors Research Group, Inc. of Connecticut.); and fibrin adhesive. Certain non-adhesive materials such as the ONYX liquid embolic system (ev3) may also be suitable.
    [00022] Once the adhesive is delivered to the target part of the vein, the adhesive hardens or cures, leaving the vein permanently clogged.
    [00023] A method of permanent occlusion of a vein by vein spasm combined with injection of an adhesive can be done as follows.
    [00024] An operator can advance an elongated intraluminal limb from an access site and into the vein. The intraluminal limb will include a disturbing part configured to disturb an inner vessel wall of the vein under the user's control when performing a defined movement. For example, the disturbing part can be a tip of a spinning wire and the defined movement can include rotation of the tip, an embodiment explained in more detail below. Defined movement can also include movement of the tip longitudinally (eg, proximally or distally in the vein); the longitudinal movement can be carried out simultaneously or in series with the rotary. The movement set can have other effects as well; for example, one end of the wire may have a helix-like blade configuration that generates a backflow of blood into the vein when the tip is rotated.
    [00025] The operator disturbs the vessel wall, performing the defined movement of the disturbing part of the intraluminal limb, thus inducing a region of the vein to undergo spasm and reduce its diameter.
    [00026] The operator also injects enough adhesive in or near the reduced diameter region of the vein to permanently occlude the vein. The occlusion can be formed proximal to, distal to, and/or coincident with the region of reduced diameter of the vein. Adhesive can be injected while the defined movement is being executed, or after the defined movement is executed. Sclerosant can also be injected. The sclerosant can be injected simultaneously with the adhesive or in series with the adhesive, at any time in relation to the defined movement performance.
    [00027] The treatment site can be observed during treatment, such as by an ultrasound administration, by means of an ultrasound probe placed on the skin overlying the treatment site. Adhesive administration can be delayed until a vein spasm is observed, to help ensure that the adhesive is not introduced into the vasculature until the vein has been primed to limit adhesive migration.
    [00028] An example of a rotating wire catheter is described below.
    [00029] A vascular treatment device can be used for the ablation of blood vessels, such as varicose veins, and for the treatment of thrombosis by maceration of a clot and injection of a thrombolytic drug, among other uses. A vascular treatment device may include a swivel wire, suitably sized and shaped for blood vessel ablation, coupled to a cartridge that is capable of engaging a loop. The wire can, in this way, be indirectly wrapped with a motor in the handle such that the wire rotates when the motor is started. When the device is used to treat a varicose vein, the rotating wire can disturb the vessel to cause vasospasm, a condition in which blood vessels spasm, and can damage the vessel wall to promote sclerosis.
    [00030] FIGURE 1 shows an embodiment of an assembly of a vascular treatment device 10 having a handle 12 and a cartridge 14. The cartridge 14 can be suitably sized and molded that engages with the handle 12 by fitting a component to the another as shown. One embodiment of the handle 12 is shown in greater detail in FIGURE 3. The handle may define a receptacle 29 in which the male coupling 30 is positioned to receive the female coupling 40 of the cartridge 14 when the cartridge 14 and the handle 12 engage. The handle 12 can include a motor 22, a trigger 26, and a male coupling 30. The male coupling 30 can be connected to the motor 22 in such a way that the motor pivotally drives the male coupling after activation. A potentiometer 24 can be electrically coupled to motor 22 to control motor speed. Trigger 26 may be handle mounted and be capable of transitioning between a first state, which does not electrically couple the motor to a power source, and a second state, which couples the motor to the power source.
    [00031] The handle 12 may also include a power source 20 and a microswitch 28 connected to the motor 22 by a wire 32. The microswitch 28 may be interposed in an electrical circuit, connecting the trigger 26 and the motor 22. micro switch can be tilted to an open position such that the circuit between trigger and motor is open. When the cartridge 14 is involved in the handle 12, the cartridge can press against the microswitch, causing it to transition to a closed state, thus completing the electrical circuit connecting the trigger 26 and the motor 22. For example, the microswitch may include two contacts with a conductor that is attached to one contact and disconnected from the second contact when the microswitch is in an open state. In one embodiment, the conductor may include a metal strip that hangs in the channel into which the cartridge is slid during engagement with the handle. As the cartridge is wrapped in the handle, it pushes the metal strip out of the channel and into connection with the second microswitch contact. An advantage resulting from such a configuration may be that a user will not be able to activate the device inadvertently by pressing the trigger before he/she is ready to use the device, that is, before the cartridge 14 is fully engaged with the handle 12.
    [00032] The handle 12 may also include a switch 16 as shown in FIGURE 3. The switch 16 allows the cartridge 14 to be received by, and secured to, the handle 12. The switch may include a grip 15 to allow a user to can operate the switch with one finger. The switch may also include a gate 17 that alternately occludes or blocks the cartridge, depending on the gate's position. For example, a user may place a thumb on grip 15 and push switch 16 away from grip grip 25 to cause switch 16 to transition from a first position in which gate 17 is positioned in the channel and therefore avoids coupling the cartridge 14 with the handle 12 to a second position in which the gate 17 is moved out of the channel and thereby allows engagement of the cartridge with the handle. Upon release of tilt switch 16, gate 17 can fit into a complementary detent on the cartridge and, in this way, help keep the cartridge engaged with the handle.
    [00033] The gate 17 can be tilted to the first position by means of a spring 23 that contacts the handle. As the user pushes the switch 16 away from the grip grip 25, the switch 16 will push the spring, thereby creating a restoring force that urges the switch to its original position once the user releases the button.
    [00034] As noted above, gate 17 may still be able to perform a transition to a third position that prevents removal of cartridge 14 from handle 12. For example, gate 17 may be forced into a retainer 35 (shown in FIGURE 4), defined by cartridge 14, when tilt switch 16 returns to its original position from the second position to lock the cartridge into the handle.
    [00035] One or more parts of the handle 12 may define a trigger ring 18 in which the trigger is positioned at least in part, and on which the handle is arranged to be balanced when supported from only one or more parts of the handle that define the trigger ring. In this way, a user can balance the handle simply by supporting it with a single finger, such as with an index finger, against a portion of the handle that defines trigger ring 18. As motor 22 it may well be the most important component heavy on the handle, it can be positioned below the trigger 26 as indicated in FIGURE 3 to reduce the torque applied by the motor 22 on a finger that supports the handle via the trigger ring, thereby reducing the fatigue experienced by the user.
    [00036] The handle 12 can be formed by joining two pieces of outer casing.
    [00037] An embodiment of the cartridge 14 shown in FIGURE 1 is illustrated in greater detail in FIGURE 4. The cartridge 14 may include a female coupling 40, a wire 33 (shown as a broken line) and a sheath 32 attached and extending to from cartridge 14. Wire can be attached to female coupling 40; for example, the proximal end of the wire can be bent approximately 90 degrees to fit through a channel that is of a defined size and shape to receive the bent end of the wire. A set screw can be received in female coupling 40 and/or a suitable adhesive can be used to secure the wire and prevent it from rotating relative to the female coupling.
    [00038] Sheath 32 can define a lumen through which wire 33 runs. Sheath 32 can have a wide range of inside and outside diameters. In some embodiments, the sheath may have an inside diameter in the range of 0.022 inches to 0.048 inches. In some embodiments, sheath 32 may have an outside diameter in the range of 0.025 inches to 0.051 inches. The outer diameter of the sheath may also be in the range that is consistent with standard needles having corresponding inner diameters. For example, the sheath can be so sized and shaped that it can be insertable into a standard needle or vascular sheath, having an inside diameter in the range of from 0.0035 inches to 0.1060 inches, or from from 0.0160 inches to 0.0420 inches, or from 0.0420 inches to 0.0630 inches, or from 0.0115 inches to 0.0630 inches. The maximum outer diameter of the sheath can be less than 0.035 inches to allow the sheath to be inserted through an intravenous needle or catheter with an inside diameter of less than 0.0039 inches to allow a wider range of professionals to perform the procedure . Needles, catheters, or vascular sheaths with an outer diameter greater than 0.079 inches (6 French, Fr) or 0.092 inches (7 Fr) typically require insertion to be performed by a vascular surgeon or interventional radiologist.
    [00039] Sheath 32 can also include external marks at regular intervals that can guide the user to monitor the speed of insertion or removal of device 10.
    [00040] An exemplary embodiment depicting a reservoir connectable to the cartridge may include a syringe 44, a stopcock 46, and a plunger 48 as shown in FIGURE 5. The syringe 44 may be in fluid communication with the bore of the sheath 32 to release a substance to the distal end of the wire, such as a sclerosant (examples of which include polidocanol, sodium tetradecyl sulfate, and hypertonic saline) and/or adhesive. In this way, the physical disturbance of the wire can be synergistically combined with the drug or adhesive treatment to improve the effectiveness of the device.
    [00041] Handle 12 may include a bracket 19 (shown in FIGURE 3) specifically positioned to receive syringe 44. Bracket 19 may then be sized and molded to be compatible with standard syringes and may prevent the syringe from falling out. during injection, especially if the material to be injected has a viscosity and/or high volume and requires significant pressure from the user's thumb on the syringe. When the cartridge 14, with an attached syringe 44, is engaged with the handle, the syringe 44 can engage the holder 19. As shown in FIGURE 1, the holder can be formed from two loops that accommodate the syringe. An alternative embodiment shown in FIGURES 6 and 7 includes a holder formed from a single hook that partially surrounds the syringe. These embodiments allow for right-handed as well as left-handed use of the device, depending on the user's preference and/or the patient's position on the treatment table.
    [00042] The handle 12 and the syringe 44 can be sized, formatted and positioned in such a way as to allow a user to actuate the trigger 26 with the index finger of one hand and simultaneously press a plunger 48 inside the syringe with the thumb of the same hand, allowing a treatment drug to be implanted from the syringe through the sheath while rotating wire 33. For example, a user can grasp the strap by positioning the gripper of the strap 25 in the center of the palm of the hand and wrapping the third, fourth and fifth fingers around the gripper of the handle and placing the index finger through the trigger ring 18 and, if necessary, positioning the thumb to depress the plunger in order to release the treatment drugs inside the syringe. The handle can be designed in such a way that it allows either right-handed or left-handed users to operate.
    [00043] The faucet 46 shown in FIGURE 5 can allow the refilling of liquid (such as adhesives and/or sclerosants) and also changing the fluid concentration of the composition as well as mixing fluid with gas. For example, air can be mixed to generate foam as well as agitating an existing mix and also recreating the foam, because the foam has a limited duration (typically a minute or less) before the liquid and gas begin to separate. . Stopcock 46 can allow the fluid composition mixture to be stirred without disconnecting the syringe from the cartridge or without stopping the procedure.
    [00044] A Type 34 hemostasis connector as shown in FIGURE 4, or other hemostasis Y connector, can be used to aid fluid communication between syringe 44 and the lumen defined by sheath 32. A hemostasis Y connector 34 can be connected to female luer connector 31 and tube nut 36 to prevent liquid from leaking into the region containing motor 22. An O-ring can be used to prevent leakage around the wire shaft. Wire tubing 42 can be sized and shaped in such a way that it can receive wire 33 and be attached to female coupling 40. The combination of the aforementioned components can allow the motor to rotate the wire without increasing torque beyond the scale appropriate work schedule. The engine can rotate in the range from 500 to 3000 rpm - 4000 rpm for varicose vein destruction and thrombectomy procedures. The handle can also include a built-in RPM display for the user to read speed or it can include an electrical port through which speed can be measured by an external monitor.
    [00045] The male coupling 30 of the handle 12 can be slanted towards an expanded state and capable of performing a transition from an expanded state to a contracted state. The female coupling 40 can be sized and shaped in such a way as to allow the transition of the male coupling 30 from the expanded state to the contracted state during engagement of the loop 12 with the cartridge 14. As the male coupling 30 and coupling female 40 fully engage each other, male coupling displaces female coupling retainers 13 to allow female coupling to slide into cartridge.
    [00046] Attaching the female coupling 40 with the male coupling 30 thereby makes the sheath 32 slideable back in relation to the wire. This is because the sheath is attached to the cartridge, while the wire is attached to the female coupling. As the cartridge is fully inserted into the handle, the female coupling is pushed forward on the cartridge. Then, when female coupling 40 is not engaged with male coupling 30, sheath 32 can cover the distal end of wire 33, allowing it to be safely advanced into the patient's vasculature; and when female coupling 40 is engaged with male coupling 30, the sheath may reveal the distal end of the wire. Consequently, when the female and male couplings are engaged (1) the distal end of the wire is revealed, and (2) the wire is operably coupled to motor 22 via female and male couplings to enable the motor can rotate the wire 33. As noted above, the cartridge can also carry a lever arm, along with the microswitch 28 to complete a circuit between the trigger 26 and the motor 22. The male coupling 30 can be sized and shaped as such. so that it can return to the expanded state once the cartridge 14 and handle 12 are fully engaged as described above.
    [00047] The female coupling can be uncoupled from the male coupling to cover the distal end of the wire, when the wire is about to be removed to the place of use, or if a treatment is interrupted. The disengagement of the female coupling from the male coupling slides the wire 33 with respect to the sheath 32 (attached to the cartridge attached to the handle); as a result, the end of the wire is no longer exposed, allowing it to be safely removed. This mechanism can protect the wire tip 33 prior to use and also protect blood vessels and other body tissues during device removal or repositioning.
    [00048] The male coupling 30 can have at least two pins separated by slotted parts to facilitate the transition from the expanded state to the contracted state. The male coupling can be made with polycarbonate, plastic or other materials that allow the transition between an expanded and a contracted state.
    [00049] In some embodiments, the vascular treatment device 10 may be of a one-piece construction having a handle and a cartridge. The cartridge may be mounted with the handle during manufacture and be capable of transitioning within the handle between a first position, where the male and female couplings are not engaged, and a second position, where the male and female couplings are engaged. One embodiment of such a device may allow the cartridge to slide back and forth within a predetermined range, such as the first and second positions, in the groove defined by the loop, but the cartridge cannot disengage from the loop. A sheath can be attached and extend from the cartridge and define a lumen through which the wire runs. The cartridge may also include a syringe to be received by a holder mounted on the handle.
    [00050] In the present embodiment, the handle may include a motor, a motor coupling, a trigger and a power source. The wire that has a main shaft, a distal end and a proximal end, which is fixed to the motor coupling can be connected to the motor coupling. The motor coupling can be driven by the motor in a rotary mode. The trigger can be mounted on the handle and be capable of transitioning between a first state, which does not electrically couple the motor to the power source, and a second state, which couples the motor to the power source. The handle may also include a microswitch to allow the trigger and motor to be electrically coupled together.
    [00051] In the first position, the cartridge can cover the distal end of the wire. In the second position, the cartridge (1) exposes the distal end of the wire from the sheath, and (2) completes a circuit between the trigger and the motor by carrying a lever arm coupled with the microswitch. For that reason, the one-piece construction vascular treatment device can allow a user to obtain similar functionality as the device explained above and shown in FIGURE 1.
    [00052] FIGURE 6 illustrates another embodiment of vascular treatment device 10. The loop may have a holder 19 for the syringe 46 in the form of a hook, as described above. This embodiment can be assembled by mating two capsules as shown in FIGURE 7. The syringe can engage the holder and remain in position during use of the device. Bracket 19 (and/or handle 12) may be made of SLA resin or other materials that allow the bracket to withstand the adjustment force applied by the syringe.
    [00053] FIGURE 8 shows a top end view of an alternative embodiment of handle 12 having a notch 80 for retaining cartridge 14 (not shown) to handle 12. In the aforementioned embodiments, the handle had a switch that could be coupled to a gate that held the cartridge to the handle. In this configuration, notch 80 may prevent the cartridge from disengaging from the handle. In use, a user can slide the cartridge into the handle and then "snap" the cartridge into the notch 80 to prevent the cartridge from slipping out of the handle.
    [00054] A wide variety of distal wire tips can be used; FIGURES 9 - 11, 14 - 14A, 15 - 15A, 16 - 16A, 17 - 17A, 18 - 18A, 19 - 19A, 20 - 20A, 21 - 21A, 22 - 22A, 23, and 24, show several examples .
    [00055] FIGURE 9 shows an embodiment of a wire 33 having a proximal end 50, a distal end 52, and in the order of proximal to distal, a first segment 54, a second segment 56, and a third segment 58. The first segment 54 can extend between main axis 51 and second segment 56 and can be slanted to a first inner angle α which is defined between main axis 51 and first segment 54 and is less than 180 degrees. The second segment 56 can extend between the first segment 54 and the third segment 58 and can be angled to a second inner angle β which is defined between the first segment 54 and the second segment 56 and is less than 180 degrees. The third segment 58 can extend from the second segment 56 to a free end and can be slanted to a third inner angle Y which is defined between the second segment 56 and the third segment 58 and is less than 180 degrees.
    [00056] The second interior angle can be greater than the first interior angle. The sum of the first inside angle and the third inside angle, minus the second inside angle, can range from about 70 degrees to about 110 degrees. The sum of the first inside angle and the third inside angle minus the second inside angle can be in the range of about 80 degrees to about 100 degrees. The sum of the first inside angle and the third inside angle minus the second inside angle can be about 90 degrees.
    [00057] The third segment 58 of wire 33 may have a length that is less than the inside diameter of sheath 32. For example, the third segment 58 may have a length of less than 0.028 inches or it may have a length that is equal at or less than two-thirds of the inner diameter of the sheath 32.
    [00058] The perpendicular distance, measured from a center axis of the mainshaft 51 to the free end, may be less than 0.3 inches. The first segment 54 and the second segment 56 each can have a length in the range of about 0.2 inches to about 0.3 inches, or in the range of about 0.24 inches to about 0.26 inches. . The length of the first segment 54 can be in the range of about 0.248 inches to about 0.25 inches, and the length of the second segment is in the range of about 0.25 inches to about 0.252 inches. In one embodiment, the length of the first segment 54 may be 0.249 inches, and the length of the second segment is 0.2504 inches.
    [00059] The distal end 52 of wire 33 may include at least two linear segments oriented at an angle other than zero relative to each other. Having at least two linear segments can allow the distal end of the wire to thread into a sheath without touching the sheath wall, and this can also allow the main axis of the wire to run along the vessel wall while the tip (eg, third segment) of wire burrows into vessel wall.
    [00060] The wire tip located at the distal end 52 can have a wide variety of configurations depending on the intended use. The shape of the wire can be "non-traumatic," meaning that it can be shaped such that its insertion causes little or no spasm or damage to the vessel. For example, FIGURE 10 shows a distal end 52 ending with a hemispherical free end. The hemispherical end can be textured either mechanically or chemically altered to create a rough surface. Other non-traumatic extremities can include an extremity having a full radius, or a curved J shape, or simply a curved shape.
    [00061] FIGURE 10 shows a non-traumatic tip having a sleeve that extends from the hemispherical shape, along wire 33, towards the proximal end of the wire. Sleeve 70 can add strength to the distal tip, thereby increasing the break-out force and increasing the contact surface area to prevent the hemispherical tip 72 from coming off.
    [00062] In other embodiments, the distal tip 52 may be "aggressive" and be bent or curved so that it scrapes the vessel wall. FIGURE 9 shows the distal end 52, having a flat free end with a sharp edge around it. An aggressive distal tip 52 can also be created by chamfering an edge to create a sharp point. The distal tip, having a cutting blade like a shark's fin, can also be aggressive. Distal tip 52 can be roughened to make the distal tip cut more aggressively and/or spasm the blood vessel wall.
    [00063] The rough surface can be formed by subjecting an initially mild steel to abrasion, machining, sandblasting, chemical conditioning such as an acid etching (eg, nitric acid, hydrofluoric acid, hydrochloric acid, and/or sulfuric acid). The rough outer surface can also be created by winding a sheet of metal, such as a sheet forming sleeve 70, over an irregularly shaped guide to create surface irregularity.
    [00064] In addition, the outer surfaces of the first, second, and/or third segment can be smeared with an abrasive to roughen the surface. Other surface treatments may include a bastard-cut type file or a diamond grain. For example, 30 diamond grains can produce an aggressive surface and 200 diamond grains can produce a non-aggressive surface.
    [00065] During use, especially with a roughened tip, the wire can be periodically re-sheathed to help dislodge any debris from the wire tip and keep the device functioning normally.
    [00066] An aggressive surface can also be formed on the first segment 54 and/or on the second segment 56 of wire 33 by introducing a screw thread profile with a second wire along the length of wire 33, following floating threads of several shapes like a square, or a rhomboid, or a trapeze, or a parallelogram, or an ellipse, or a triangle, or a pentagon.
    [00067] FIGURE 10 shows an embodiment having a first segment 56 with a sleeve 70 having a rough outer surface using one of the several methods mentioned above. In addition to showing a rough surface treatment, FIGURE 10 further illustrates a yarn with added weight at the distal end, in which case the weight is added by a sleeve with a rough outer surface. The weight can be centered on the wire or eccentrically positioned. An eccentric weight can cause the wire to curl during rotation. Spasms can disturb the vessels more aggressively compared to a wire with added weight in a centered fashion.
    [00068] The distal end 52 of wire 33 may also include a curved segment. The curvature of the curved segment can be constant, or it can follow other curves, such as a sector of an ellipse or an oval. Distal end 52 of wire 33 may also have a straight segment distal to the curved segment. Similar to embodiments with a constant curvature, the curvature of the section curved with a straight line segment can be constant or can follow the forms mentioned above.
    [00069] A spring 90 can be attached from distal end 52 of wire 33 along first segment 54 and/or second segment 56 to create an aggressive cutting surface. Spring ends can be welded at various points. Spring 90 can follow the various profiles mentioned above. FIGURES 11 - 13 illustrate a cross-sectional view of a spring following floating threads of a square, a trapezoid, and a pentagon, respectively.
    [00070] The sharp corners of the various profiles (eg a square, a triangle, a parallelogram, a pentagon) can pierce the blood vessel wall and perform ablation of the vessel wall. Wire 33 may have a flat or hemispherical free end depending on the intended use. The hemispherical end or the flat free end can also be textured or roughened.
    [00071] FIGURES 14 - 14A show a wire similar to that shown in FIGURE 9 having a first, second and third linear segments distal to the main axis.
    [00072] FIGURES 15 - 15A show a wire similar to that shown in FIGURES 14 - 14A, in which the free end of the third segment is hemispherical.
    [00073] FIGURES 16 - 16A show a wire that has a curved segment distal to the main axis, and in which the free end of the curved segment is hemispherical.
    [00074] FIGURES 17 - 17A show a wire similar to that shown in FIGURE 10 having a first, second and third linear segments with added weight at the distal tip.
    [00075] FIGURES 18 - 18A show a wire with a single linear segment distal to the main axis, where the linear segment ends with a ball-shaped free end.
    [00076] FIGURES 19 - 19A show a wire with a single linear segment distal to the main axis, where the distal tip has added a weight and the free end is hemispherical.
    [00077] FIGURES 20 - 20A show a wire with two linear segments distal to the main axis, where the second linear segment ends with a free end in ball shape.
    [00078] FIGURES 21 - 21A show a wire with two linear segments distal to the main axis, where the second linear segment has added a weight and ends with a hemispherical free end.
    [00079] FIGURES 22 - 22A show a wire similar to that shown in FIGURES 14 - 14A, having three linear segments where the third segment ends with an aggressive free end.
    [00080] FIGURES 23 - 24 show wires having a spring wrapped around the distal part of the wire.
    权利要求:
    Claims (9)
    [0001]
    1. A vascular treatment device (10) for permanently occluding a vein, comprising: an elongated intraluminal member (32) wherein the elongated intraluminal member (32) comprises a disturbing portion (52) configured to disturb an inner wall of the vein. vein vessel under the control of a user when performing a defined motion, wherein the defined motion includes rotating the disturbing part (52), and wherein the disturbing part (52) is configured to be moved in the defined motion to induce a region of the vein to spasm and to reduce its diameter, in which the defined movement is still configured to generate a return of blood in the vein; and characterized in that it further comprises: a reservoir (44, 46) of adhesive in fluid communication with the intraluminal member (32), the delivery of an adhesive from the reservoir (44, 46) of adhesive to a distal end of the intraluminal member (32) being under the control of the user.
    [0002]
    2. Device (10) according to claim 1, characterized in that the adhesive is configured to be delivered while the disturbing part (52) is performing the defined movement.
    [0003]
    3. Device (10) according to claim 1, characterized in that the defined movement further comprises a longitudinal movement of the disturbing part (52).
    [0004]
    4. Device (10) according to claim 1, characterized in that the disturbing part (52) comprises a tip of a wire (33).
    [0005]
    5. Device (10) according to claim 4, characterized in that the tip of the wire (33) is configured to be simultaneously rotated and moved longitudinally.
    [0006]
    6. Device (10) according to claim 4, characterized in that the wire (33) has a blade configuration that generates a backflow of blood into the vessel when the wire (33) is rotated.
    [0007]
    7. Device (10) according to claim 1, characterized by the fact that the adhesive is curable with a UV light.
    [0008]
    8. Device (10) according to claim 1, characterized by the fact that it further comprises a motor that is configured to rotate the disturbing part (52).
    [0009]
    9. Device (10) according to claim 1, characterized in that the adhesive is a chemically activated adhesive.
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    AU2018203595B2|2020-02-06|Vascular treatment device
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    同族专利:
    公开号 | 公开日
    KR101995043B1|2019-07-01|
    US20150005742A1|2015-01-01|
    EP2790594A4|2015-12-09|
    EP2790594B1|2019-11-13|
    US20120109191A1|2012-05-03|
    IL232928D0|2014-07-31|
    BR112014014122A2|2017-06-13|
    CA2858580A1|2013-06-20|
    IL232928A|2019-08-29|
    US9480467B2|2016-11-01|
    WO2013090563A1|2013-06-20|
    AU2012352183A1|2014-07-24|
    CA2858580C|2020-02-25|
    KR20140133811A|2014-11-20|
    AU2012352183B2|2017-01-12|
    JP2015503951A|2015-02-05|
    ES2768247T3|2020-06-22|
    MX2014006951A|2014-10-17|
    EP2790594A1|2014-10-22|
    JP2018034006A|2018-03-08|
    IN2014DN05826A|2015-05-15|
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    法律状态:
    2018-12-04| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|
    2020-02-11| B25C| Requirement related to requested transfer of rights|Owner name: VASCULAR INSIGHTS, LLC (US) Free format text: A FIM DE ATENDER A TRANSFERENCIA, REQUERIDA ATRAVES DA PETICAO NO 870190097148 DE 27/09/2019, E NECESSARIO QUE O DOCUMENTO DE CESSAO CONTENHA O NUMERO DO PEDIDO A SER TRANSFERIDO, VISTO QUE O ANEXO A CITADO NO MESMO NAO FOI APRESENTADO NA PETICAO. |
    2020-03-17| B25A| Requested transfer of rights approved|Owner name: MERIT MEDICAL SYSTEMS, INC. (US) |
    2020-04-07| B25L| Entry of change of name and/or headquarter and transfer of application, patent and certificate of addition of invention: publication cancelled|Owner name: MERIT MEDICAL SYSTEMS, INC. (US) Free format text: ANULADA A PUBLICACAO CODIGO 25.3 NA RPI NO 2562 DE 11/02/2020 POR TER SIDO INDEVIDA. |
    2020-04-14| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|
    2020-12-08| B07A| Application suspended after technical examination (opinion) [chapter 7.1 patent gazette]|
    2021-04-13| B06A| Patent application procedure suspended [chapter 6.1 patent gazette]|
    2021-06-01| B350| Update of information on the portal [chapter 15.35 patent gazette]|
    2021-06-29| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2021-08-24| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 13/12/2012, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    US13/324,621|US20120109191A1|2011-12-13|2011-12-13|Adhesive-based varicose vein treatment|
    US13/324,621|2011-12-13|
    PCT/US2012/069495|WO2013090563A1|2011-12-13|2012-12-13|Adhesive-based varicose vein treatment|
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