Device and method for sealing a blood vessel

Abstract

An apparatus and method for closing a tubular structure in a patient are provided. The apparatus includes a needle including a proximal end including a hub, a distal end including a sharp distal tip, a lumen having an oblong cross-section extending proximally from the distal end and defining a longitudinal axis between the proximal and distal ends, and a clip deliverable from the lumen. The clip is compressible between a relaxed state, in which a plurality of tines of the clip are shaped to engage and close a tubular structure in a patient, and a stressed state, in which the tines are compressed to allow the clip to be loaded. The apparatus may also include a pusher member for deploying the clip from the distal tip of the needle so that the tines engage and close the tubular structure through which the tubular member is guided.

Description

[0001] Related application data

[0002] This application claims the benefit of co-pending provisional application serial number 62 / 772,045, filed on November 27, 2018, the entire disclosure of which is expressly incorporated herein by reference. Technical Field

[0003] The present invention relates to devices, systems and methods for closing blood vessels or other tubular structures in a patient's body. More specifically, the present invention relates to devices and methods for closing veins or other tubular structures in a patient's body, for example, by delivering one or more clips to, through and / or around the tubular structure. Background Art

[0004] Mild vein-related abnormalities are common and affect most adults. More severe visible varicose vein disease occurs in up to forty percent (40%) of men and women. Chronic venous insufficiency occurs in approximately two percent (2%) of the U.S. population and can lead to swelling, hyperpigmentation, scarring of the skin and underlying tissues, and advanced skin ulcers. The incidence of all venous diseases increases with age.

[0005] The causes of varicose vein disease vary. Family history is common, and genetic predisposition may play a role. Blockage of the main draining veins of the legs due to blood clots - called deep vein thrombosis or DVT, and loss of valve function or "valvular insufficiency" are the main causes of varicose veins and most forms of venous insufficiency.

[0006] Patients with advanced disease are often unable to continue their usual work, and they may become temporarily or permanently disabled due to reduced mobility. The economic and psychological impact on these patients can be profound.

[0007] Patients with varicose veins or more severe forms of venous insufficiency caused by valvular insufficiency of the saphenous vein can be treated in a variety of ways. The first line of therapy in most cases is compression therapy and leg elevation. In some cases, these non-invasive measures can help relieve symptoms and heal ulcers. Often, patients cannot tolerate tight compression garments due to work demands and / or other lifestyle issues, and they may not be able to elevate their limbs long enough to relieve symptoms and promote healing of ulcers.

[0008] Invasive treatments for disease caused by valvular insufficiency of the saphenous vein include: 1) vein stripping, 2) high ligation, 3) foam sclerotherapy, and 4) endovenous ablation. Vein stripping and high ligation have fallen out of favor because stripping is traumatic and high ligation is associated with a high recurrence rate. Foam sclerotherapy has not been widely adopted and is known to cause visual disturbances (scotomas), migraine-like headaches, cough, and neurologic deficits (usually transient) in less than two percent (2%) of cases.

[0009] In recent years, endovenous ablation using radiofrequency energy or laser energy has become the preferred treatment for patients with venous disease due to axial reflux in the long and short saphenous veins and in some cases involving reflux in the perforating veins. However, endovenous ablation requires tumescent anesthesia and is usually performed in an ambulatory surgical setting. Although the procedure is minimally invasive, some patients experience significant bruising and postoperative pain, which may last for more than a week. Endovenous ablation involves destroying the vein from the inside out along the entire length of the treatment segment. After the anesthetic wears off, tissue destruction results in soft tissue pain. Some patients require prescription pain medications and usually need to rest for a few days until the pain subsides.

[0010] Therefore, there is a need for improved systems for treating venous insufficiency caused by saphenous vein valvular insufficiency. Summary of the invention

[0011] The present invention relates to devices, systems and methods for closing a tubular structure (e.g., a blood vessel, such as a saphenous vein or other vein) to eliminate the flow of fluid through the lumen of the tubular structure. In addition, the present invention relates to devices, systems and methods for delivering one or more clips, e.g., percutaneously, into a patient to close a tubular structure.

[0012] The description herein focuses on the use of various devices and methods to close the saphenous vein, for example, for the treatment of valvular insufficiency. It will be appreciated that other tubular structures may also be closed using the devices and methods described herein. For example, other structures that may be treated include arteries, bile ducts, bronchial or other airway tubes, or other anatomical structures, including prosthetic tubular grafts, for example, as used in vascular bypass surgery.

[0013] According to an exemplary embodiment, a device for closing a tubular structure in a patient's body is provided, the device comprising a tubular member comprising a proximal end including a hub, a distal end including a sharp distal tip to allow insertion through the tubular structure into tissue, and a lumen extending proximally from the distal end; a clip loaded in the lumen, the clip being compressible between a relaxed state and a stressed state, in the relaxed state a plurality of tines of the clip being shaped to engage and close the tubular structure in the patient's body, in the stressed state the tines are compressed to allow the clip to be loaded into the lumen, at least one of the tines comprising an eyelet; a release line comprising a first end and a second end positioned adjacent the hub and an intermediate region passing through the lumen and the eyelet; and a pusher member comprising a proximal end and a distal end sized to be pushed within the lumen for at least partially deploying the clip from the distal tip of a needle so that the tines engage and close the tubular structure through which the tubular member is guided.

[0014] According to another embodiment, a device for closing a tubular structure in a patient's body is provided, the device comprising a) a clamp, the clamp comprising i) a central region including a proximal end and a distal end, the distal end including a hole for receiving a load line; ii) a pair of distal tines extending from the distal end, the distal tines being biased to extend away from each other in a relaxed state; and iii) a pair of proximal tines extending from the proximal end, the proximal tines having a length greater than the length of the distal tines, the proximal tines defining a ring in a relaxed state that at least partially surrounds the respective distal tines in a plane, one of the proximal tines including an eyelet adjacent to its tip; and b) a delivery device, the delivery device comprising i) a tubular member including a proximal end including a hub, a distal end including a sharp distal tip so that the tubular member can be passed through A tubular structure within a patient's body is guided into tissue, and a lumen extending proximally from an outlet in the distal end of the tubular member, the clamp being loaded within the lumen in a stress state in which the proximal tines and the distal tines are substantially straightened and axially aligned with a central region; ii) a pusher member movable from a first position to a second position within the lumen relative to the tubular member to initially deploy the distal tines from the outlet, the distal tines elastically returning toward a relaxed state; and iii) a release line comprising a first and second end and an intermediate region received through an eyelet, the release line being actuatable to guide the clamp proximally relative to the distal end of the tubular member to engage the distal tines with the tubular structure, the release line being removable from the eyelet to allow the proximal tines to deploy from the lumen, whereupon the proximal tines elastically return toward a relaxed state to at least partially surround and close the tubular structure.

[0015] According to still another embodiment, a clip for closing a tubular structure within a patient's body is provided, the clip comprising a central region including a proximal end and a distal end, the distal end comprising a hole for receiving a loading line; a pair of distal tines extending from the distal end, the distal tines being biased to extend away from each other in a relaxed state; and a pair of proximal tines extending from the proximal end, the length of the proximal tines being greater than the length of the distal tines, the proximal tines defining a ring in a relaxed state that at least partially surrounds the respective distal tines in a plane, one of the proximal tines comprising an eyelet adjacent to its tip, the clip being configured to be loaded within a delivery device in a stress state in which the proximal tines and the distal tines are substantially straightened and axially aligned with the central region, the proximal tines and the distal tines being biased to a relaxed state.

[0016] According to another embodiment, a method for closing a tubular structure (e.g., a vein) in a patient is provided, comprising inserting a distal tip of a delivery device with a clamp comprising a set of distal tines and a set of proximal tines in a stressed state into the patient's body, into and through the tubular structure; partially deploying the clamp so that the distal tines of the clamp extend from the distal tip beyond the tubular structure and elastically deform toward a relaxed state; actuating the release line to guide the distal tines proximally into engagement with the tubular structure; disengaging the release line from one of the proximal tines; and fully deploying the clamp from the lumen so that the proximal tines are released from the distal tip and elastically deform to at least partially surround and close the tubular structure.

[0017] According to still another embodiment, a method for closing a blood vessel in a patient is provided, comprising inserting a distal tip of a delivery device with a clamp including a set of distal tines and a set of proximal tines in a stressed state into the patient's body, into and through the blood vessel, and a release line coupled to one of the proximal tines; partially deploying the clamp so that the distal tines of the clamp extend from the distal tip beyond a tubular structure and elastically extend away from each other to an deployed configuration; guiding the distal tines in the deployed configuration proximally into engagement with the distal side of the blood vessel; disengaging the release line from one of the proximal tines; and fully deploying the clamp from the lumen so that the proximal tines are released from the distal tip and elastically deformed to at least partially surround and close the blood vessel.

[0018] According to yet another embodiment, a method for loading a clip to a delivery device is provided, comprising providing a delivery device including a tubular member including a proximal end, a distal end, and a lumen extending between an opening in the proximal end and an outlet in the distal end, and providing a clip in a relaxed state, the clip including a central region including a proximal end and a distal end, the distal end including a hole for receiving a loading wire, a pair of distal tines extending from the distal end, the distal tines biased to extend away from each other in a relaxed state, and a pair of proximal tines extending from the proximal end, the proximal tines having a length greater than the length of the distal tines, the proximal tines defining a loop in the relaxed state that at least partially surrounds the respective distal tines in a plane. The clip is mounted to the loader in the relaxed state such that the pair of tines are positioned within the loop and the loading wire is directed through the hole and into the lumen. A loader is mounted to the proximal end of the tubular member such that the clip is disposed adjacent the opening, and a loading wire is manipulated to pull the clip through the opening into the lumen, thereby directing the proximal and distal tines to a stress state in which the proximal and distal tines are at least partially straightened and aligned with the central region. Thereafter, the loader can be removed from the proximal end of the tubular member, and the loading wire can be removed from the hole and lumen. Optionally, a pusher member can be coupled to the proximal end of the tubular member such that the pusher member is disposed adjacent the clip within the lumen, such that subsequent advancement of the pusher member at least partially deploys the clip from the outlet.

[0019] Other aspects and features of the present invention will become apparent by consideration of the following description taken in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] These and other features, aspects and advantages of the present disclosure will become better understood with regard to the following description, appended claims and accompanying drawings, in which:

[0021] Figure 1 is a partial cross-sectional side view of an exemplary embodiment of a device including a needle, a plunger, and an occlusion clip deployable from the needle.

[0022] Figure 1A It is taken along line 1A-1A Figure 1 An exemplary cross-sectional view of a needle of a device.

[0023] Figure 2A-2C They can be used Figure 1 1 and 2 are perspective, side, and end views, respectively, of an exemplary embodiment of an occlusion clip delivered by a device of the type described herein.

[0024] Figures 3A-3D The occlusion clamp is shown as Figure 2A-2C The clip is loaded into a delivery device such as Figure 1 An exemplary method for a device.

[0025] Figures 4A-4F is a cross-sectional view of a patient showing the Figure 1 An exemplary method of closing a blood vessel using a device. DETAILED DESCRIPTION

[0026] In the following description, many details are set forth in order to provide a more comprehensive description of the system. However, it is apparent to those skilled in the art that the disclosed system can be practiced without these specific details. In other cases, well-known features are not described in detail to avoid unnecessarily obscuring the system.

[0027] Go to the attached picture, Figure 1 An exemplary embodiment of an apparatus 8 for delivering a clip 20 into a patient's body, for example, to close a tubular structure, such as a saphenous vein or other blood vessel, is shown. Generally, the apparatus 8 includes a needle or other tubular member 10, one or more clips 20 (one is shown), a pusher member 30, and a release line 40. Optionally, the apparatus 8 can be part of a system that includes, for example, one or more other components to facilitate delivery of the clip, such as a fluid source, an ultrasound transducer and / or other imaging device, a needle guide, etc. (not shown).

[0028] Needle 10 can be a substantially rigid tubular member, for example, a section of hypotube, comprising a proximal end 12 having a hub 50, a distal end 14, and a lumen or slot 16 extending at least partially between the proximal end 12 and the distal end 14 to define a longitudinal axis 18 between the proximal end 12 and the distal end 14. Hub 50 can be sized and / or shaped to allow device 8 to be held and / or manipulated during use. Hub 50 can be substantially permanently attached to proximal end 12 of tubular body 10, for example, by one or more of bonding with an adhesive, sonic welding, interference fit, cooperating connectors (not shown), etc. As shown, clip 20 can be loaded within lumen 16 adjacent distal end 14, and pusher member 30 can be at least partially disposed within lumen 16. The distal end 14 of the needle 10 can terminate in a beveled, pointed or other sharp distal tip 15, for example, to facilitate percutaneous introduction of the needle 10 directly through tissue to a target location in a patient's body, and include an outlet 17 in communication with a lumen 16 from which a clip 20 can be deployed, as further described below. Alternatively, the distal end 14 can have a blunt shape (not shown), and the needle 10 can be introduced through another needle, trocar or other device (also not shown) into the tissue.

[0029] In one embodiment, if Figure 1AAs shown in , the lumen 16 can have a rectangular shape, an elliptical shape, or other oblong shapes, for example, including a major axis "M" and a smaller minor axis "m", for example, so that the clip 20 can be loaded into the lumen 16 in a predetermined orientation around the longitudinal axis 18 of the needle 10. As used herein, "oblong" refers to any cross-sectional shape that includes a major axis that is greater than the minor axis and is configured to slidably receive one or more clips 20 therein while constraining the clip (s) 20 in a stressed state, as further described below.

[0030] exist Figure 1 In the embodiment shown in , a single clip 20 is provided in the lumen 16. Alternatively, a needle may be provided that includes, for example, a plurality of clips axially spaced apart from each other (not shown) in the lumen so that the plurality of clips may be deployed sequentially from the needle. An exemplary embodiment of such a needle is disclosed in U.S. Publication No. 2015 / 0201947.

[0031] Typically, each clip 20 includes one or more pairs of tines or extensions thereon to engage tissue, e.g., a vein wall or other tubular structure in a patient, as further described elsewhere herein. The clip 20 can be compressible between a relaxed state in which the tines are shaped to engage and / or close a tubular structure in a patient and a stress state in which the tines are compressed to allow the clip 20 to be loaded into the lumen 16 of the needle 10. The tips of the tines can have a rounded, blunt, bulbous, or other non-traumatic shape, e.g., to allow engagement without penetrating or tearing tissue. Optionally, the tips of the tines can be sharp, beveled, barbed, or otherwise configured to facilitate introduction through tissue and / or engagement with the wall of the closed tubular structure.

[0032] Go to Figure 2A-2C , an exemplary embodiment of a clip 20 is shown in a relaxed state, which includes two pairs of tines or extensions 22, 24 on opposite ends of an elongated central region 26, all located in a common plane. As shown, the clip 20 includes a distal tines set 22 extending from a distal or first end 26a of the central region 26 and a proximal tines set 24 extending from a proximal or second end 26b of the central region 26. In the relaxed state, the distal tines 22 are biased to extend away from each other, e.g., proximally and outwardly from the central region 26, e.g., having a curved shape in a plane.

[0033] In the relaxed state, the proximal tines 24 define a loop that at least partially surrounds the respective distal tines 22 in a plane. As shown, the length of the proximal tines 24 is greater than the length of the distal tines 22, such that the proximal tines 24 extend around the distal tines 22, and the tips 25 of the proximal tines 24 are disposed adjacent to the distal end 26a of the central region 26, e.g., on opposite sides of the distal end 26a. Thus, the tips 23 of the distal tines 22 are disposed within an open area defined within the proximal tines 24. As shown, one of the proximal tines 24a includes an eyelet 27 adjacent to its tip 25a. The eyelet 27 may be sized to slidably receive a release line ( Figure 2A-2C ), to facilitate manipulation of the clip 20 during delivery, as described elsewhere herein.

[0034] Additional references Figure 1 , the clip 20 is configured to be loaded within the lumen 16 of the needle 10 in a stress state in which the proximal tines and the distal tines are compressed toward each other. Figure 1 , the tines 22, 24 can be substantially straightened and axially aligned with the in-plane center region 26, such as when the clip 20 is loaded within the needle 10, the tines 22, 24 are oriented proximally within the lumen 16, toward the hub 50 of the needle 10. However, once released from the lumen 16, the tines 22, 24 are biased to automatically return toward the relaxed state.

[0035] The thickness of the clip 20 can be slightly less than the minor dimension "m" of the lumen 16, and the width of the tines 22, 24 and the in-plane center region 26 can be slightly less than the major axis "M". Given the relative sizes, the clip 20 can be slidably received in the lumen 16 with the tines 22, 24 held in a stressed state in-plane by the wall of the lumen 16. Optionally, the lumen 16 can provide sufficient clearance around the clip 20 to allow fluid to be delivered through the lumen 16 with the clip 20, or the lumen 16 includes a longitudinal groove (not shown), for example, in the wall of the major dimension, to provide a path for fluid to travel through the lumen 16.

[0036] In an exemplary embodiment, the central region 26 can have a length of between about one and four millimeters (1-4 mm), the distal tines 22 can have a length of between about two and eight millimeters (2-8 mm), and the proximal tines 24 can have a length of between about four and twelve millimeters (4-12 mm) (but longer than the distal tines 22). For example, the proximal tines 24 can have a sufficient length to at least partially or completely surround the outer wall of an occluded blood vessel (e.g., a vein having a diameter of between about four and fifteen millimeters (4-15 mm)).

[0037] The clip 20 can be formed of an elastic or superelastic material, e.g., a metal such as nitinol or a plastic, such that the tines 22, 24 can be compressed to facilitate loading the clip 20 into the needle 10 and elastically biased toward a relaxed state to surround, penetrate, and / or otherwise engage the wall of the tubular structure and / or surrounding tissue to close the tubular structure. Alternatively, the clip 20 can be formed of a shape memory material, e.g., which can be loaded into the needle 10 in a first state (e.g., a martensitic state at a first temperature below body temperature) and can be deployed from the needle 10 in a second state, e.g., an austenitic state at body temperature, wherein the clip 20 can memorize an engaged shape for closing the tubular structure. For example, the clip 20 can be cut from a nitinol or other superelastic metal sheet or otherwise formed from a nitinol or other superelastic metal sheet, e.g., by laser cutting, stamping, machining, etc., and heat treated and / or otherwise processed to set the shape of the relaxed state.

[0038] Go to Figures 3A-3D , showing a method for loading a clip 20 into a delivery device—e.g. Figure 1 10. Initially, the clip 20 may be formed and provided in a relaxed state, e.g., as Figure 2A-2C A release line 40 , such as an elongated flexible filament formed of suture material, wire, etc., may be guided through eyelet 27 such that clip 20 is positioned midway between opposite ends (not shown) of release line 40 .

[0039] In addition, if Figure 3B As shown in the drawings, a pull wire or loading wire 60 and a loader structure 70 may be provided that may be used during the loading process and removed prior to final assembly, packaging, sterilization, and / or other manufacturing procedures. The loading wire 60 may be a flexible filament formed of suture material, wire, or the like, sized to be received through the hole 28 in the clip 20 and the lumen 16 of the needle 10. During loading, one end of the loading wire 60 may be guided through the hole 28 in the clip 20, for example, to position the clip 20 at an intermediate position between the ends (not shown) of the loading wire 60.

[0040] The clip 20 may be mounted to the loader 70 before or after guiding the loading wire 60 through the hole 28. For example, Figure 3CAs described in the fork 74, the loader 70 may include a recess 71 defining a planar surface 72 from which a pair of prongs 74 extend. The prongs 74 may be spaced apart so that the central region 26 of the clip 20 may be positioned between the prongs 74 and the proximal tines 24 at least partially surround the respective prongs 74. In addition, the loader 70 includes a slot or channel 76 extending distally from the recess 71 toward the distal end 78 of the loader 70, the slot 76 having a cross-sectional shape corresponding to the shape of the lumen 16 of the needle 10, for example, an oblong. The loader 70 may be formed of a substantially rigid material, such as a metal, plastic, or a composite material, by, for example, molding, casting, machining, etc.

[0041] During loading, the clip 20 can be placed against the planar surface 72 in a relaxed state with the central region 26 between the tines 74 and the tines 74 extending through the open area defined by the proximal tines 24 adjacent the distal tines 22. The tines 74 may include flanges, hooks, or other features that engage the proximal tines 24 to prevent the tines from moving out of plane, i.e., away from the planar surface 72, during subsequent loading and / or other manipulations, while allowing the tines 22, 24 to slide in-plane about the tines 74.

[0042] In one embodiment, before and / or during installation of the clip 20 onto the loader 70, the end of the loading wire 60 (at Figure 3C 76 of the loader 70. Alternatively, after the clip 20 is installed in the loader 70, one end of the loading wire 60 can be guided from the distal end 78 through the slot 76, through the hole 28 and back into the slot 76 so that both ends of the loading wire 60 are located outside the loader 70 and distal to the distal end 78 of the loader 70. Similarly, the release wire 40 can be guided through the eyelet 27 in one of the proximal tines 24 before or after the clip 20 is installed in the loader 70.

[0043] The end of the loading wire 60 can be introduced into the lumen 16 of the needle 10, for example, through the hub 50 into the proximal end 12, until the end exits the outlet 17 at the distal end 14 (not shown). The distal end 78 of the loader 70 can then be mounted to the hub 50 on the proximal end 12 of the needle 10, thereby aligning the slot 76 through the loader 70 with the lumen 16 of the needle 10. In an exemplary embodiment, the distal end 78 of the loader 70 can have a predetermined cross-sectional shape that ensures that the loader 70 is mounted to the hub 50 in the necessary orientation to align the major axis of the slot 76 with the lumen 16. Additionally or alternatively, the distal end 78 and / or the hub 50 can include one or more cooperating elements that secure the loader 70 to the hub 50 in a desired orientation. Thus, with the loader 70 mounted to the hub 50, the central region 26 of the clip 20 and the slot 76 can be axially aligned with the longitudinal axis 18 of the needle and the lumen 16.

[0044] The loading wire 60 may then be manipulated, e.g., by pulling on both ends of the loading wire 60, to direct the clip 20 into and through the slot 76 in the loader 60 and into the lumen 16 of the needle 10. During this manipulation, the proximal and distal tines 24, 22 may be directed into a stressed state, e.g., wherein the proximal and distal tines 24, 22 are at least partially straightened and aligned with the central region 26, as shown. Figure 1 For example, the tines 74 of the loader 70 can allow first the distal tines 22 and then the proximal tines 24 to slide along the tines 74 to compress them inwardly as they enter the slots 76. The loading wire 60 can continue to be pulled until the clip 20 is positioned at a desired location within the lumen 16, for example, within the distal end 14 adjacent the outlet 17. As the clip 20 is pulled along the lumen 16, the release wire 40 can be pulled through the slot 76 into the lumen 16 behind the proximal tines 24a having the eyelets 27.

[0045] Once the clip 20 is positioned within the lumen 16, the loader 70 can be disengaged and / or removed from the hub 50. For example, any connector can be disengaged and the loader 70 withdrawn over the end of the release wire 40 until fully removed. Additionally, once the clip 20 is positioned at the desired location, the load wire 60 can also be removed, for example, by pulling one end so that the other end enters the exit 17 of the lumen 16, passes through the hole 28 and exits the exit 17, thereby releasing the clip 20 trapped within the needle 10.

[0046] Once the clip 20 is loaded into the needle 10, any final assembly of the device 8 can then be completed. For example, returning to Figure 1 , after the clip 20 is loaded within the lumen 16, the pusher member 30 and the valve member 54 can be coupled to the hub 50. The valve member 54 can include a valve housing containing one or more seals therein, such as a hemostatic valve (not shown), which can provide a substantially fluid-tight seal while accommodating axial movement of the pusher member 30 through the valve member 54 and the hub 50.

[0047] The valve member 54 may be permanently or removably coupled to the proximal end 50a of the hub 50, for example, using one or more of an interference fit, a mating connector, bonding with an adhesive, sonic welding, etc. Alternatively, the valve member 54 may be integrated into the hub 50, for example, by providing one or more valves within the proximal end 50a.

[0048] The pusher member 30 is an elongated member that includes a proximal end 32 disposed proximal to the hub 50 and the valve member 54 and a distal end 34 sized to be slidably received within the lumen 16. For example, the length of the pusher member 30 can correspond to the length of the needle 10 such that the distal end 34 is disposed proximally and adjacent to the proximal tines 24 of the clip 20. The proximal end 32 can extend proximally beyond the valve member 54 a sufficient distance such that during deployment of the clip 20, the pusher member 30 can be distally directed from an initial or first position to one or more distal positions, as further described elsewhere herein.

[0049] The pusher member 30 and / or lumen 16 can be sized to accommodate a release wire 60 that passes in parallel with the pusher member 30 within the lumen 16. For example, the pusher member 30 can be smaller than the lumen 16 so that the end of the release wire 60 can be simply disposed adjacent to the pusher member 30 within the lumen 16. Alternatively, one or both of the pusher member 30 and the lumen wall can include an axial groove to receive the release wire 60. In a further alternative, the pusher member 30 can include a channel (not shown) extending between the proximal and distal ends 32, 34 that can receive the release wire 60 therethrough.

[0050] During assembly, one or both ends of the release wire 40 may be guided through the valve member 54, e.g., through a valve passage and one or more valves (not shown), so that the valve member 54 may be coupled to the proximal end 50a of the hub 50, e.g., Figure 1 For example, in one embodiment, the first end 40a of the release line 40 can be engaged between the hub 50 and the valve member 54 to prevent subsequent movement of the first end 40a, while the second end 40 of the release line can be guided through the valve member 54 so that the second end 40b extends proximally from the valve member 54 and moves freely. In this embodiment, the valve member 54 can be removably coupled to the hub 50 so that the valve member 54 can be removed to release the first end 40a of the release line 40.

[0051] Optionally, both ends of the release line 40 can pass through the valve member 54 and move freely. In this embodiment, the valve member 54 can be substantially permanently or removably attached to the proximal end 50a of the hub, as desired. In a further alternative, one or both ends of the release line 40 can be coupled to an actuator (not shown) on the hub 50 to allow the release line 40 to be manipulated and released, as further described below.

[0052] Optionally, as Figure 1, the hub 50 may include a side port 52 in communication with the lumen 16. The side port 52 may include one or more connectors, such as a Luer connector (not shown), which may be used to couple a fluid source to the side port 52. For example, a length of tubing 58 may be coupled to the side port 52, which is in communication with a syringe (not shown) containing saline or other biocompatible liquid, and during use, as desired, saline or other biocompatible liquid may be delivered from the syringe through the tubing 58 and the side port 52 into the lumen 16. The tubing 58 may be coupled to the side port 52 by a cooperating connector, or alternatively, may be substantially permanently attached to the side port 58, such as by one or more of an interference fit, a mating connector, bonding with an adhesive, sonic welding, and the like.

[0053] Additionally or alternatively, the hub 50 and / or valve member 54 may include one or more additional features to facilitate use of the device 8. For example, if desired, one or more visual indicia and / or other features (not shown) may be provided at desired locations around the perimeter of the hub 50 and / or valve member 54, for example, to provide a visual indication of the orientation of the clip 20 within the lumen 16 of the needle 10. For example, in one embodiment, the hub 50 may have an oblong shape, for example, such that the major axis of the hub 50 is offset 90 degrees from the larger dimension of the lumen 16. Additionally or alternatively, one or more colored or other indicia or elements (not shown) may be provided on the hub 50, for example, on the opposite side of the hub 50 that is aligned with the smaller dimension of the lumen 16 to define a plane of the clip 20 relative to the needle 10.

[0054] Optionally, the device 8 can include a removable stopper, for example, disposed about the proximal end 32 of the pusher member 30, for example, adjacent the valve member 54. For example, in one embodiment, the stopper can be a "C" shaped ring or other element (not shown) that extends at least partially around the pusher member 30 and has a predetermined length to limit the advancement of the pusher member 30. Figure 1 In the illustrated proximal or first position, the clip 20 may be disposed completely within the lumen 16 , for example, such that the distal tines 22 of the clip 20 are disposed within and / or adjacent to the distal tip 15 of the needle 10 .

[0055] The pusher member 30 can be advanced to a second or distal position, for example, to deploy the distal tines 22 of the clip 20 from the lumen 16 beyond the distal tip 15 while the proximal tines 24 remain within the lumen 16. For example, the pusher member 30 can be advanced until the plunger rod 33 on the pusher member 30 abuts a stopper, thereby preventing further advancement of the pusher member 30. The length of the stopper can correspond to the distal portion of the deployed clip 20, for example, the distal tines 22 beyond the distal tip 15, so that the distal tines 22 at least partially elastically return toward a relaxed state.

[0056] The stopper may be removed from about the pusher member 30, whereupon the needle 10 may be retracted proximally, e.g., equivalent to advancing the pusher member 30, until the pusher member 30 is in a third position relative to the needle 10, e.g., wherein the entire clip 20 is deployed from the lumen 16 beyond the distal tip 15 of the needle 10. As the proximal tines 24 are deployed from the lumen 16, they may also resiliently return toward a relaxed state, thereby surrounding or otherwise engaging a tubular structure to be closed, as further described elsewhere herein.

[0057] Optionally, the hub 50 and / or the pusher member 30 may include a cooperating track (not shown) to control or limit the movement of the pusher member 30 relative to the needle 10. For example, the track may include a first axial portion that allows the pusher member 30 to be axially advanced from a first position to a second position, thereby partially deploying the clip 20, e.g., the distal tines 22. When it is desired to fully deploy the clip 20, the pusher member 30 may then be partially rotated, e.g., moved along a circumferential (non-axial) portion of the track, and then axially advanced along a third axial portion to guide the pusher member 30 and the needle 10 from the second position to the third position. Optionally, in this alternative, the hub 50 and / or the pusher member 30 may include one or more markings (not shown) that may provide visual confirmation when the pusher member 30 is properly aligned along the track, e.g., fully rotated to allow movement between the second and third positions.

[0058] Once assembled, the device 8 can be further processed as needed, for example, sterilized and packaged. The device 8 can then be sold and / or otherwise provided to a physician or other end user who can use the device 8 to deliver the clip 20 into a patient's body.

[0059] Go to Figures 4A-4F , showing the use of Figure 1 8. Initially, as Figure 4A As shown in , a location along a vein or other body lumen 90, e.g., an anterior side 92 of the vein 90 closest to the skin (not shown), can be identified as a target location for delivery of the clip 20, e.g., a saphenous vein that suffers from valvular insufficiency, etc. Optionally, a marking (not shown) can be applied to the patient's skin over the target location, e.g., to identify an entry point for the needle 10. As described elsewhere herein, optionally, using the needle 10, a local anesthetic can be injected or otherwise delivered to the skin and / or underlying tissue, e.g., between the skin and the vein and / or around the vein.

[0060] Go to Figure 4B, needle 10 may be inserted through the skin and access point and into and through vein 90 so that tip 15 is disposed on the back side 94 of vein 90, for example, using ultrasound visual control, such as Figure 4C The distal tip 15 of the needle 10 may be positioned beyond the back or inner wall 94 of the vein 90 , for example, about one or two millimeters (1-2 mm) deep beyond the back wall 92 of the vein 90 .

[0061] Optionally, as Figure 4B As shown in FIG. 1 , fluid can be supplied, for example, from a connection to a side port 52 (see FIG. Figure 1 ) is delivered through the needle 10 by a syringe or other source (not shown) of a needle 10, thereby delivering a fluid through the lumen 16 and out of the distal tip 15 into an area adjacent to the vein 90. For example, such a fluid can guide tissue surrounding the tubular structure away from the outer wall of the vein 90 and / or create a working space around the vein 90 to accommodate the deployment of the distal tines 22. In an exemplary embodiment, the fluid can simply be saline, or can include an anesthetic and a vasoactive agent, such as lidocaine and epinephrine, which can be injected around the vein 90 to induce small muscle contractions or spasms, for example, so that the vein 90 contracts around the needle 10 after the needle 10 pierces the vein 90. Optionally, such a fluid can be delivered to the area adjacent to the vein 90 one or more times during surgery, for example.

[0062] For example, the orientation of the clip 20 may be checked using one or more markings or other features on the hub 50 and / or valve member 54. For example, the needle 10 may be rotated about its longitudinal axis to ensure that the tines 22, 24 of the clip 20 may be oriented across the width of the vein 90, e.g., with the plane of the clip 20 substantially perpendicular to the longitudinal axis 96 of the vein 90.

[0063] The pusher member 30 can be advanced until the distal tines 22 of the clip 20 are clear of the distal tip 15 of the needle 10, whereupon the distal tines 22 can automatically expand toward their relaxed state, such as Figure 4C For example, the pusher member 30 can be advanced until the plunger rod 33 contacts a stop (not shown) or is otherwise constrained to a second position in which the central region 26 and the proximal tines 24 remain within the lumen 16. Optionally, an anesthetic agent and a vasoactive agent or other fluid can be delivered to an area adjacent to the vein 90, for example, just before the distal tines 22 are deployed, as shown in FIG. Figure 4B as shown in .

[0064] Go to Figure 4DOnce the distal tines 22 are deployed and expanded, the release wire 40 can be manipulated to guide the clip 20 proximally, for example, to engage the distal tines 22 with the posterior side 94 of the vein 90. For example, the release wire 40 can be at least partially pulled proximally to engage the distal tines 22 with the posterior wall 94 of the vein 90, for example, to prevent the clip 20 from migrating during subsequent deployment and / or can partially compress or close the vein 90, as shown. Figure 4C Optionally, for example, after deploying the distal tines 22 and pulling the release line 40 outward, an anesthetic and vasoactive agent or other fluid may be delivered to the area adjacent to the vein 90. Such fluid may create additional working space around the vein 90, for example, to accommodate the deployment of the proximal tines 24, for example, as Figure 4E as shown in .

[0065] For example, if both ends of the release wire 40 are free, both ends can be pulled simultaneously to pull the intermediate region proximally and thus the clip 20. Alternatively, if one end of the release wire 40 is fixed, for example, between the hub 50 and the valve member 54, the other end can be pulled. Further alternatively, if the release wire 40 is coupled to an actuator (not shown), the actuator can be manipulated to pull the release wire 40 to a desired degree.

[0066] Once the distal tine 22 is engaged with the vein 90 as desired, the release line 40 can be released from the eyelet 27 ( Figure 4C 40) to allow full deployment of the clip 20. For example, if both ends of the release wire 40 are free, one end can be pulled to guide the other end distally into the lumen 40, through the eyelet 27, and out proximally through the lumen 40. Alternatively, if one end is fixed between the hub 50 and the valve member 54, the valve member 54 can be disengaged to release the fixed end, whereupon the other end can be pulled to remove the release wire 40.

[0067] Go to Figure 4F , the entire needle 10 and pusher member 30 can then be removed through the vein 90 covered with tissue and skin, thereby fully deploying the clip 20 from the lumen 16. For example, with the distal tines 22 engaged to the back side 94 of the vein 90, removal of the needle 10 can cause the proximal tines 24 to exit the outlet 17 and become exposed, whereupon the proximal tines 24 can automatically move toward a relaxed state, e.g. Figure 2A-2C The annular shape shown in FIG. 1 at least partially surrounds, compresses and / or closes vein 90.

[0068] In an alternative embodiment, if the device 8 includes a stopper, the stopper can be removed while the needle 10 and the pusher member 30 are held substantially stably in position. The needle 10 can then be withdrawn, moving between the second and third positions to push the proximal tines 24 of the clip 20 out of the outlet 17 while the pusher member 30 is held or otherwise held substantially stationary.

[0069] Optionally, the process may be repeated one or more times, for example, at the same location and / or at different locations along the length of vein 90 to deliver multiple clips (not shown) to close vein 90 .

[0070] Although the invention is susceptible to various modifications and alternative forms, specific examples thereof have been shown in the drawings and described in detail herein. However, it should be understood that the invention is not limited to the specific forms or methods disclosed, but rather, the invention encompasses all modifications, equivalents and alternatives falling within the scope of the appended claims.

Claims

1. A device for closing a tubular structure in a patient, comprising: a tubular member comprising a proximal end including a hub, a distal end including a sharp distal tip to allow insertion through the tubular structure into tissue, and a lumen extending proximally from the distal end; a clip loaded into the lumen, the clip being compressible between a relaxed state in which a plurality of tines of the clip are shaped to engage and close a tubular structure within a patient, and a stressed state in which the tines are compressed to allow the clip to be loaded into the lumen, at least one of the tines including an eyelet adjacent a tip thereof; a release wire including a first end and a second end positioned adjacent the hub and an intermediate region passing through the lumen and the eyelet; an actuator on the hub to allow manipulation and release of the release line, and A pusher member includes a proximal end and a distal end, the pusher member being sized to be advanced within the lumen for at least partially deploying the clip from the distal tip of the tubular member such that the tines engage and close the tubular structure through which the tubular member is introduced.

2. The apparatus of claim 1, wherein only one of the tines comprises an eyelet.

3. The device of claim 1, wherein one or both ends of the release line are coupled to the actuator to allow manipulation and release of the release line.

4. The device according to claim 1, wherein the tines of the clip include a set of proximal tines and a set of distal tines, the tines arranged in the tubular cavity are compressed together in the stressed state, the pusher member can be moved relative to the tubular member from a first position to a second position in which the distal tines are deployed from the tubular cavity beyond the distal tip, the distal tines elastically return toward the relaxed state to at least partially engage the tubular structure through which the distal end of the tubular member is guided, and wherein one of the proximal tines includes the eyelet adjacent to its tip, the release line can be actuatable to guide the clip proximally after deploying the distal tines to enhance the engagement of the distal tines with the tubular structure.

5. The apparatus of claim 4, wherein the actuator is configured to remove the release line from the eyelet to allow the proximal tine to deploy from the lumen, whereupon the proximal tine elastically returns toward the relaxed state to further engage the tubular structure to close the tubular structure.

6. The device of claim 5, wherein the release wire is removable from the eyelet by pulling the first end of the release wire, the second end freely passing through the eyelet to release the proximal tine.

7. The apparatus of claim 5, wherein when the tubular member is removed to deploy the proximal tine from the lumen, the first end of the release wire is coupled to the actuator and the second end of the release wire is free to pass through the eyelet.

8. The apparatus of claim 4, wherein the tubular member is axially movable relative to the pusher member from the second position to a third position to deploy the entire clip from the lumen beyond the distal tip and remove the release line from the eyelet, the proximal tines elastically returning toward the relaxed state to further engage the tubular structure to close the tubular structure.

9. The apparatus of claim 8, further comprising a stop coupled between the pusher member and the hub to limit movement of the pusher member relative to the tubular member between the first position and the second position.

10. The apparatus of claim 9, wherein the stop is removable from at least one of the pusher member and the hub to allow the tubular member to move from the second position to the third position relative to the pusher member.

11. The device of any one of claims 4-10, wherein the distal tines are shorter than the proximal tines.

12. The apparatus of claim 11, wherein each of the proximal tines defines, in the relaxed state, a ring in a plane at least partially surrounding a respective distal tine.

13. The apparatus of claim 1, wherein the plurality of tines comprises a pair of distal tines extending from a first end of a central region of the clip and a pair of proximal tines extending from a second end of the central region, one of the proximal tines comprising the eyelet.

14. The apparatus of claim 13, wherein the distal tines, proximal tines, and central region define a plane in the relaxed state.

15. The apparatus of claim 14, wherein said distal and proximal tines remain substantially within said plane when said tines are compressed to said stressed state.

16. The device of any one of claims 13-15, wherein the distal tines are shorter than the proximal tines.

17. A device according to any one of claims 13-15, wherein the distal tine extends from the central region to define a relative hook shape in the relaxed state, and wherein the proximal tine extends from the central region so that the tine at least partially surrounds the central region and the distal tine in the plane in the relaxed state.

18. The apparatus of claim 17, wherein when the clip is loaded within the lumen, the proximal tines and the distal tines are substantially straightened such that in the stressed state the proximal tines are axially aligned with the central region.

19. The apparatus of claim 16, wherein each of the proximal tines defines, in the relaxed state, a ring in a plane at least partially surrounding a respective distal tine.

20. The apparatus of any one of claims 13-15, further comprising a hole in the central region adjacent the distal tines for receiving a loading wire to load the clip into the lumen.

21. The apparatus of any one of claims 1-10 and 12-15, wherein the clip is biased to the relaxed state and is elastically deformable to the stressed state.

22. The apparatus of any of claims 1-10 and 12-15, further comprising one or more features on the hub to provide a visual indication of the orientation of the clip within the lumen.

23. A device for closing a tubular structure in a patient, comprising: a) A clamp comprising: i) a central region comprising a proximal end and a distal end, the distal end comprising a hole for receiving a load wire; ii) a pair of distal tines extending from said distal end, said distal tines being biased to extend away from each other in a relaxed state; and iii) a pair of proximal tines extending from said proximal end, said proximal tines having a length greater than a length of said distal tines, said proximal tines in a relaxed state defining a ring in a plane at least partially surrounding a respective distal tine, one of said proximal tines including an eyelet adjacent a tip thereof; and b) a delivery device comprising: i) a tubular member comprising a proximal end including a hub, a distal end including a sharp distal tip so that the tubular member can be guided through a tubular structure in a patient's body into tissue, and a lumen extending proximally from an exit port in the distal end of the tubular member, the clip being loaded within the lumen in a stressed state wherein the proximal and distal tines are substantially straightened and axially aligned with the central region; ii) a pusher member within the lumen movable relative to the tubular member from a first position to a second position to initially deploy the distal tines from the outlet, the distal tines resiliently returning toward the relaxed state; and iii) a release line comprising a first end and a second end and a middle region received through the eyelet; and iv) an actuator coupled to the release wire to direct the clip proximally relative to the distal end of the tubular member while the proximal tine remains within the lumen to engage the distal tine with the rear wall of the tubular structure, the actuator being configured to remove the release wire from the eyelet while the proximal tine remains within the lumen to allow the proximal tine to deploy from the lumen, The proximal tines then elastically return toward the relaxed state to at least partially surround and close the tubular structure.

24. The apparatus of claim 23, wherein the release wire is removable from the eyelet by pulling the first end of the release wire, the second end freely passing through the eyelet to release the proximal tine.

25. The apparatus of claim 23, wherein the first end of the release wire is coupled to the actuator and the second end of the release wire is free to pass through the eyelet when the tubular member is removed to deploy the proximal tine from the lumen.

26. A device according to claim 23, wherein the tubular member is axially movable relative to the pusher member from the second position to a third position to deploy the entire clip from the outlet beyond the distal tip and remove the release line from the eyelet, and the proximal tines elastically return toward the relaxed state to at least partially surround and close the tubular structure.

27. The apparatus of claim 23, further comprising a stop coupled between the pusher member and the hub to limit movement of the pusher member relative to the tubular member between the first position and the second position.

28. The apparatus of claim 26, further comprising a stopper coupled between the pusher member and the hub to limit movement of the pusher member relative to the tubular member between the first position and the second position, wherein the stopper is removable from at least one of the pusher member and the hub to allow the tubular member to move from the second position to the third position relative to the pusher member.

29. The apparatus of claim 23, wherein the distal tines, proximal tines, and central region define a plane in the relaxed state.

30. The apparatus of claim 29, wherein said distal and proximal tines remain substantially within said plane when said tines are compressed to said stressed state.

31. The apparatus of claim 23, wherein the tubular member is a needle.

32. The apparatus of claim 23, wherein the hub comprises a side port in communication with the lumen, the apparatus further comprising a fluid source coupled to the side port for delivering fluid through the lumen and out of the outlet.

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