Patent Description:
Mild vein-related abnormalities are common and affect most adults. More severe disease with visible varicose veins occurs in up to forty percent (<NUM>%) of men and women. Chronic venous insufficiency occurs in about two percent (<NUM>%) of the U. population and can cause swelling, stasis pigmentation, scarring of the skin and underlying tissues, and skin ulceration in advanced cases. The incidence of all venous disease increases with advancing age.

The causes of varicose vein disease are varied. A family history is common and a genetic predisposition may play a factor. Obstruction of the main draining veins of the leg due to blood clots, called deep venous thrombosis or DVT, and loss of valve function or "valvular incompetence" are the main causes of varicose veins and most forms of venous insufficiency.

Patients with advanced disease are often unable to continue their customary employment, and they may become temporarily or permanently disabled from lack of mobility. The economic and psychological effects can be profound for these patients.

Patients who have varicose veins or more serious forms of venous insufficiency caused by valvular incompetence of the saphenous vein can be managed in a variety of ways. The first line of therapy in most cases is compression therapy and leg elevation. These noninvasive measures can help alleviate symptoms and heal ulcers in some instances. Oftentimes, patients are unable to tolerate tight compression garments and they may not be able to elevate the extremity for an adequate time to relieve symptoms and promote ulcer healing because of work requirements and/or other lifestyle issues.

Invasive treatment methods for disease stemming from valvular incompetence of the saphenous vein include: <NUM>) vein stripping, <NUM>) high-ligation, <NUM>) foam sclerotherapy, and <NUM>) endo-venous 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 had widespread adoption and is known to cause visual disturbance (scotoma), migraine-like headache, cough, and neurologic deficit (usually transient) in less than two percent (<NUM>%) of cases.

In recent years, endo-venous ablation using radiofrequency energy or laser energy has become the preferred treatment for patients who suffer from venous disease due to axial reflux in the long and short saphenous veins and in some cases involving reflux in the perforating veins. However, endo-venous ablation requires tumescent anesthesia and is typically done in an ambulatory surgery setting. Even though the procedure is minimally invasive, some patients experience significant bruising and post-procedural pain, which may last for more than a week. Endo-venous ablation involves destruction of the vein from the inside out along the full length of the treatment segment. The tissue destruction causes pain in the soft tissues after the anesthetic wears off. Some patients require prescription pain medications and often several days off work until the pain has resolved.

<CIT> describes an apparatus and methods for closing a tubular structure within a patient's body. The apparatus includes a needle including a proximal end including a hub, a distal end including a sharpened 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 within a patient's body, and a stressed state in which the tines are compressed to allow the clip to be loaded into the. The apparatus may also include a pusher member for deploying the clip from the distal tip of the needle such that the tines engage and close a tubular structure through which the tubular member is directed. This document discloses as well an instrument that includes a hollow cylindrical trocar introduced through the wall of the eye. The clip comprises two leading arms of a jaw-like member and two trailing legs that each have an eyelet. A suture is attached to each eyelet and the sutures extend substantially parallel to one another through the trocar and out of the proximal end of the trocar outside the eye. The clip comprises two arms hinged at their common base, and with an eyelet through the base to which a suture is to be attached.

Therefore, there is a need for improved systems for treating venous insufficiency caused by valvular incompetence of the saphenous vein.

The present invention is directed to an apparatus for closing a tubular structure, e.g., a blood vessel, such as a saphenous or other vein, to eliminate flow of fluid through the lumen of the tubular structure. In addition, the present invention is directed to an apparatus for delivering one or more clips into a patient's body, e.g., percutaneously, to close tubular structures.

According to the present invention there is described an apparatus for closing a tubular structure within a patient's body according to the appended claims.

The description herein focuses on using various apparatus and methods to close a saphenous vein, e.g., for treatment of valvular incompetence. It will be appreciated that other tubular structures may also be closed using the apparatus and methods described herein. For example, other structures that may be treated include arteries, biliary tubes, bronchial or other airway tubes, or other anatomical structures, including prosthetic tubular grafts, e.g., as are used in vascular bypass operations.

In accordance with an exemplary embodiment, an apparatus is provided for closing a tubular structure within a patient's body that includes a tubular member comprising a proximal end including a hub, a distal end including a sharpened distal tip to allow insertion into tissue through a tubular structure, and a lumen extending proximally from the distal end; a clip loaded in the lumen, the clip 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's body, 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 first and second ends positioned adjacent the hub and an intermediate region passing through the lumen and the eyelet; an actuator on the hub; and a pusher member comprising a proximal end and a distal end sized for advancement within the lumen for at least partially deploying the clip from the distal tip of the needle such that the tines engage and close a tubular structure through which the tubular member is directed. One or both ends of the release wire are coupled to the actuator to allow manipulation and release of the release wire.

In accordance with an example useful for understanding the invention, an apparatus is provided for closing a tubular structure within a patient's body that includes a) a clip comprising i) a central region including a proximal end and a distal end, the distal end including a hole for receiving a loading wire; ii) a pair of distal tines extending from the distal end, the distal tines biased to extend away from one another in a relaxed state; and iii) a pair of proximal tines extending from the proximal end, the proximal tines having a length greater than a length of the distal tines, the proximal tines defining loops in a relaxed state that at least partially surround respective distal tines within a plane, one of the 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 sharpened distal tip such that the tubular member may be directed into tissue through a tubular structure within a patient's body, and a lumen extending proximally from an outlet in the tubular member distal end, the clip loaded within the lumen in a stressed state wherein the proximal tines 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 deploy the distal tines initially from the outlet, the distal tines resiliently returning towards the relaxed state; and iii) a release wire including first and second ends and an intermediate region received through the eyelet, the release wire actuatable to direct the clip proximally relative to the tubular member distal end to engage the distal tines with the tubular structure, the release wire is removable from the eyelet to allow the proximal tines to be deployed from the lumen, whereupon the proximal tines resiliently return towards the relaxed state to at least partially surround and close the tubular structure.

In accordance with an example useful for understanding the invention, a clip is provided for closing a tubular structure within a patient's body that includes 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 one another in a relaxed state; and a pair of proximal tines extending from the proximal end, the proximal tines having a length greater than a length of the distal tines, the proximal tines defining loops in a relaxed state that at least partially surround respective distal tines within a plane, one of the proximal tines including an eyelet adjacent a tip thereof, the clip configured to be loaded within a delivery device in a stressed state wherein the proximal tines and distal tines are substantially straightened and axially aligned with the central region, the proximal tines and distal tines biased to the relaxed state.

In accordance with an example useful for understanding the invention, a method is provided for closing a tubular structure within a patient's body, e.g., a vein, that includes inserting a distal tip of a delivery device into the patient's body into-and-through the tubular structure, the delivery device carrying a clip including a set of distal tines and a set of proximal tines in a stressed state and a release wire coupled to one of the proximal tines; partially deploying the clip such that the distal tines of the clip extend from the distal tip beyond the tubular structure and elastically deform towards a relaxed state; actuating the release wire to direct the distal tines proximally into engagement with the tubular structure; disengaging the release wire from the one of the proximal tines; and fully deploying the clip from the lumen such that the proximal tines are released from the distal tip and elastically deform to at least partially surround and close the tubular structure.

In accordance with still another example useful for understanding the invention, a method is provided for closing a blood vessel within a patient's body that includes inserting a distal tip of a delivery device into the patient's body into-and-through the blood vessel, the delivery device carrying a clip including a set of distal tines and a set of proximal tines in a stressed state and a release wire coupled to one of the proximal tines; partially deploying the clip such that the distal tines of the clip extend from the distal tip beyond the tubular structure and elastically extend away from one another to a deployed configuration; directing the distal tines in the deployed configuration proximally into engagement with a distal side of the blood vessel; disengaging the release wire from the one of the proximal tines; and fully deploying the clip from the lumen such that the proximal tines are released from the distal tip and elastically deform to at least partially surround and close the blood vessel.

In accordance with yet another an example useful for understanding the invention, a method is provided for loading a clip into a delivery device that includes providing a delivery device including a tubular member comprising 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 comprising 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 one another in the relaxed state, and a pair of proximal tines extending from the proximal end, the proximal tines having a length greater than a length of the distal tines, the proximal tines defining loops in the relaxed state that at least partially surround respective distal tines within a plane. The clip is mounted to a loader in the relaxed state such that a pair of prongs are positioned within the loops, and a loading wire is directed through the hole and into the lumen. The loader is mounted to the proximal end of the tubular member such that the clip is disposed adjacent the opening, and the loading wire is manipulated to pull the clip through the opening into the lumen, thereby directing the proximal tines and distal tines to a stressed state where the proximal tines and distal tines are at least partially straightened and aligned with the central region. Thereafter, the loader may be removed from the proximal end of the tubular member, and the loading wire may be removed from the hole and lumen optionally, a pusher member may be coupled to the proximal end of the tubular member such that the pusher member is disposed within the lumen adjacent the clip such that subsequent advancement of the pusher member deploys the clip at least partially from the outlet.

Other aspects and features of the present invention will become apparent from consideration of the following description taken in conjunction with the accompanying drawings.

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 where:.

In the following description, numerous details are set forth in order to provide a more thorough description of the system. It will be apparent, however, to one skilled in the art, that the disclosed system may be practiced without these specific details. In the other instances, well known features have not been described in detail so as not to unnecessarily obscure the system.

Turning to the drawings, <FIG> shows an exemplary embodiment of an apparatus <NUM> for delivering a clip <NUM> into a patient's body, e.g., to close a tubular structure, such as a saphenous vein or other blood vessel. Generally, the apparatus <NUM> includes a needle or other tubular member <NUM>, one or more clips <NUM> (one shown), a pusher member <NUM>, and a release wire <NUM>. Optionally, the apparatus <NUM> may be part of a system, e.g., including one or more other components to facilitate delivering the clip, such as a source of fluid, an ultrasound transducer and/or other imaging device, a needle guide, and the like (not shown).

The needle <NUM> may be a substantially rigid tubular member, e.g., a section of hypo-tube, including a proximal end <NUM> with a hub <NUM>, a distal end <NUM>, and a lumen or slot <NUM> extending at least partially between the proximal and distal ends <NUM>, <NUM>, thereby defining a longitudinal axis <NUM> between the proximal and distal ends <NUM>, <NUM>. The hub <NUM> may have a size and/or shape to allow the apparatus <NUM> to be held and/or manipulated during use. The hub <NUM> may be substantially permanently attached to the proximal end <NUM> of the tubular body <NUM>, e.g., by one or more of bonding with adhesive, sonic welding, interference fit, cooperating connectors (not shown), and the like. As shown, a clip <NUM> may be loaded within the lumen <NUM> adjacent the distal end <NUM>, and the pusher member <NUM> may be disposed at least partially within the lumen <NUM>. The distal end <NUM> of the needle <NUM> may terminate in a beveled, pointed, or other sharpened distal tip <NUM>, e.g., to facilitate percutaneous introduction of the needle <NUM> directly through tissue to a target location within a patient's body and includes an outlet <NUM> communicating with the lumen <NUM> from which the clip <NUM> may be deployed, as described further below. Alternatively, the distal end <NUM> may have a blunt shape (not shown) and the needle <NUM> may be directed into tissue through another needle, trocar, or other device (also not shown).

In one embodiment, as shown in <FIG>, the lumen <NUM> may have a rectangular shape, an oval shape, or other oblong shape, e.g., including a major axis "M" and a smaller minor axis "m," e.g., such that the clip <NUM> may be loaded into the lumen <NUM> in a predetermined orientation about the longitudinal axis <NUM> of the needle <NUM>. As used herein, "oblong" refers to any cross-sectional shape that includes a major axis that is larger than a minor axis and is configured to slidably receive one or more clips <NUM> therein while constraining the clip(s) <NUM> in a stressed state, as described further below.

In the embodiment shown in <FIG>, a single clip <NUM> is provided within the lumen <NUM>. Alternatively, a needle may be provided that includes a plurality of clips within the lumen, e.g., spaced apart axially from one another (not shown), such that multiple clips may be deployed sequentially from the needle. Exemplary embodiments of such needles are disclosed in <CIT>.

Generally, each clip <NUM> includes one or more pairs of tines or extensions thereon for engaging tissue, e.g., a wall of a vein or other tubular structure within a patient's body, as described further elsewhere herein. The clip <NUM> may be compressible between a relaxed state in which the tines are shaped to engage and/or close a tubular structure within a patient's body, and a stressed state in which the tines are compressed to allow the clip <NUM> to be loaded into the lumen <NUM> of the needle <NUM>. Tips of the tines may have rounded, blunt, bulbous, or other atraumatic shapes, e.g., to allow engagement without penetrating or tearing tissue. Alternatively, the tips of the tines may be sharpened, beveled, barbed, or otherwise configured to facilitate introduction through tissue and/or engagement with the wall of the tubular structure being closed.

Turning to <FIG>, an exemplary embodiment of a clip <NUM> is shown in a relaxed state that includes two pairs of tines or extensions <NUM>, <NUM> on opposite ends of an elongate central region <NUM>, all lying within a common plane. As shown, the clip <NUM> includes a distal set of tines <NUM> extending from a distal or first end 26a of the central region <NUM> and a proximal set of tines <NUM> extending from proximal or second end 26b of the central region <NUM>. In the relaxed state, the distal tines <NUM> are biased to extend away from one another, e.g., proximally and outwardly from the central region <NUM>, for example, having a curved shape within the plane.

In the relaxed state, the proximal tines <NUM> define loops that at least partially surround respective distal tines <NUM> within the plane. As shown, the proximal tines <NUM> have a length greater than a length of the distal tines <NUM> such that the proximal tines <NUM> extend around the distal tines <NUM> and tips <NUM> of the proximal tines <NUM> are disposed adjacent the distal end 26a of the central region <NUM>, e.g., on opposite sides of the distal end 26a. Consequently, tips <NUM> of the distal tines <NUM> are disposed within an open region defined within the proximal tines <NUM>. As shown, one of the proximal tines 24a including an eyelet <NUM> adjacent a tip 25a thereof. The eyelet <NUM> may be sized to slidably receive a release wire (not shown in <FIG>) to facilitate manipulation of the clip <NUM> during delivery, as described elsewhere herein.

With additional reference to <FIG>, the clip <NUM> is configured to be loaded within the lumen <NUM> of the needle <NUM> in a stressed state wherein the proximal tines and distal tines are compressed towards one another. For example, as shown in <FIG>, the tines <NUM>, <NUM> may be substantially straightened and axially aligned with the central region <NUM> within the plane, e.g., oriented towards proximally within the lumen <NUM> towards the hub <NUM> of the needle <NUM> when the clip <NUM> is loaded within the needle <NUM>. However, once released from the lumen <NUM>, the tines <NUM>, <NUM> are biased to return automatically back towards the relaxed state.

The thickness of the clip <NUM> may be slightly less than the minor dimension "m" of the lumen <NUM>, and the width of the tines <NUM>, <NUM> and central region <NUM> within the plane may be slightly less than the major axis "M. " Given the relative dimensions, the clip <NUM> may be slidably received in the lumen <NUM> with the tines <NUM>, <NUM> maintained in the stressed state within the plane by the walls of the lumen <NUM>. Optionally, the lumen <NUM> may provide sufficient clearance around the clip <NUM> to allow fluid to be delivered through the lumen <NUM> with the clip <NUM>, or the lumen <NUM> include a longitudinal groove (not shown), e.g., in a wall of the major dimension to provide a path for fluid to travel through the lumen <NUM>.

In an exemplary embodiment, the central region <NUM> may have a length between about one and four millimeters (<NUM>-<NUM>), the distal tines <NUM> may have a length between about two and eight millimeters (<NUM>-<NUM>), and the proximal tines <NUM> may have a length between about four and twelve millimeters (<NUM>-<NUM>) (but longer than the distal tines <NUM>). For example, the proximal tines <NUM> may have sufficient length to at least partially or entirely surround the outer wall of a vessel being occluded, e.g., a vein having a diameter between about four and fifteen millimeters (<NUM>-<NUM>).

The clip <NUM> may be formed from an elastic or superelastic material, e.g., metal such as Nitinol or plastic, such that the tines <NUM>, <NUM> may be compressed to facilitate loading the clip <NUM> into the needle <NUM> and resiliently biased towards the relaxed state to surround, penetrate, and/or otherwise engage a wall of a tubular structure and/or surrounding tissue to close the tubular structure. Alternatively, the clip <NUM> may be formed from shape memory material, e.g., that may be loaded into the needle <NUM> in a first state, e.g., a martensitic state at a first temperature below body temperature, and may be deployable from the needle <NUM> in a second state, e.g., an austenitic state at body temperature in which the clip <NUM> may remember an engagement shape for closing the tubular structure. For example, the clip <NUM> may be cut or otherwise formed from a sheet of Nitinol or other superelastic metal, e.g., by laser cutting, stamping, machining, and the like, and heat treated and/or otherwise processed to set the shape of the relaxed state.

Turning to <FIG>, an exemplary method is shown for loading the clip <NUM> into a delivery device, such as the lumen <NUM> of the needle <NUM> shown in <FIG>. Initially, the clip <NUM> may be formed and provided in the relaxed state, e.g., as shown in <FIG>. A release wire <NUM>, e.g., an elongate flexible filament formed from suture material, metal wire, and the like, may be directed through the eyelet <NUM> such that the clip <NUM> is positioned at an intermediate location between opposite ends (not shown) of the release wire <NUM>.

In addition, as shown in <FIG>, a pull or loading wire <NUM> and a loader structure <NUM> may be provided that may be used during the loading process and removed before final assembly, packaging, sterilization, and/or other manufacturing procedures. The loading wire <NUM> may be a flexible filament formed from suture material, metal wire, and the like sized to be received through the hole <NUM> in the clip <NUM> as well as the lumen <NUM> of the needle <NUM>. During loading, one end of the loading wire <NUM> may be directed through the hole <NUM> in the clip <NUM>, e.g., to position the clip <NUM> at an intermediate location between the ends (not shown) of the loading wire <NUM>.

The clip <NUM> may be mounted to the loader <NUM> before or after directing the loading wire <NUM> through the hole <NUM>. For example, as shown in <FIG>, the loader <NUM> may include a recess <NUM> defining a planar surface <NUM> from which a pair of prongs <NUM> extend. The prongs <NUM> may be spaced apart such that the central region <NUM> of the clip <NUM> may be positioned between the prongs <NUM> and the proximal tines <NUM> at least partially surround respective prongs <NUM>. In addition, the loader <NUM> includes a slot or passage <NUM> that extends distally from the recess <NUM> towards a distal end <NUM> of the loader <NUM>, the slot <NUM> having a cross-sectional shape, e.g., an oblong shape, corresponding to the shape of the lumen <NUM> of the needle <NUM>. The loader <NUM> may be formed from substantially rigid material, e.g., metal, plastic, or composite material, for example, by molding, casting, machining, and the like.

During loading, the clip <NUM> may be placed in the relaxed state against the planar surface <NUM> with the central region <NUM> between the prongs <NUM> and the prongs <NUM> extending through the open region defined by the proximal tines <NUM> adjacent the distal tines <NUM>. The prongs <NUM> may include flanges, hooks, or other features that engage the proximal tines <NUM> to prevent the tines from moving out of plane, i.e., away from the planar surface <NUM> during subsequent loading and/or other manipulation, while allowing the tines <NUM>, <NUM> to slide around the prongs <NUM> within the plane.

In one example, the ends of the loading wire <NUM> (not shown in <FIG>) may be directed through the slot <NUM> of the loader <NUM> before and/or during mounting of the clip <NUM> to the loader <NUM>. Alternatively, after mounting the clip <NUM> to the loader <NUM>, one end of the loading wire <NUM> may be directed through the slot <NUM> from the distal end <NUM>, through the hole <NUM> and back into the slot <NUM> such that both ends of the loading wire <NUM> are located outside and distal to the distal end <NUM> of the loader <NUM>. Similarly, the release wire <NUM> may be directed through the eyelet <NUM> in one of the proximal tines <NUM> before or after mounting the clip <NUM> to the loader <NUM>.

The ends of the loading wire <NUM> may be introduced into the lumen <NUM> of the needle <NUM>, e.g., through the hub <NUM> into the proximal end <NUM> until the ends exit the outlet <NUM> at the distal end <NUM> (not shown). The distal end <NUM> of the loader <NUM> may then be mounted to the hub <NUM> on the proximal end <NUM> of the needle <NUM>, thereby aligning the slot <NUM> through the loader <NUM> with the lumen <NUM> of the needle <NUM>. In an exemplary embodiment, the distal end <NUM> of the loader <NUM> may have a predetermined cross-sectional shape that ensures that the loader <NUM> is mounted to the hub <NUM> in the necessary orientation to align the major axes of the slot <NUM> and lumen <NUM>. In addition or alternatively, the distal end <NUM> and/or hub <NUM> may include one or more cooperating elements that secure the loader <NUM> to the hub <NUM> in the desired orientation. Thus, with the loader <NUM> mounted to the hub <NUM>, the central region <NUM> of the clip <NUM> and the slot <NUM> may be axially aligned with the longitudinal axis <NUM> of the needle and lumen <NUM>.

The loading wire <NUM> may then be manipulated, e.g., by pulling both ends of the loading wire <NUM>, to direct the clip <NUM> into and through the slot <NUM> in the loader <NUM> and into the lumen <NUM> of the needle <NUM>. During this manipulation, the proximal and distal tines <NUM>, <NUM> may be directed to the stressed state, e.g., where the proximal and distal tines <NUM>, <NUM> are at least partially straightened and aligned with the central region <NUM>, as shown in <FIG>. For example, the prongs <NUM> of the loader <NUM> may allow first the distal tines <NUM> and then the proximal tines <NUM> to slide along the prongs <NUM> to compress them inwardly as they enter the slot <NUM>. The loading wire <NUM> may continue to be pulled until the clip <NUM> is positioned at a desired location within the lumen <NUM>, e.g., within the distal end <NUM> adjacent the outlet <NUM>. As the clip <NUM> is pulled along the lumen <NUM>, the release wire <NUM> may be pulled through the slot <NUM> into the lumen <NUM> following the proximal tine 24a having the eyelet <NUM>.

Once the clip <NUM> is positioned within the lumen <NUM>, the loader <NUM> may be disengaged and/or removed from the hub <NUM>. For example, any connectors may be disengaged and the loader <NUM> withdrawn over the ends of the release wire <NUM> until fully removed. In addition, once the clip <NUM> is positioned at the desired location, the loading wire <NUM> may also be removed, e.g., by pulling one end to cause the other end to pass into the outlet <NUM> of the lumen <NUM>, through the hole <NUM> and back out the outlet <NUM>, thereby releasing the clip <NUM> constrained within the needle <NUM>.

Once the clip <NUM> is loaded into the needle <NUM>, any final assembly of the apparatus <NUM> may then be completed. For example, returning to <FIG>, a pusher member <NUM> and valve member <NUM> may be coupled to the hub <NUM> after loading the clip <NUM> within the lumen <NUM>. The valve member <NUM> may include a valve housing containing on or more seals therein, e.g., a hemostatic valve (not shown), which may provide a substantially fluid-tight seal, while accommodating axial movement of the pusher member <NUM> through the valve member <NUM> and hub <NUM>.

The valve member <NUM> may be permanently or removably coupled to the proximal end 50a of the hub <NUM>, e.g., using one or more of an interference fit, mating connectors, bonding with adhesive, sonic welding and the like. Alternatively, the valve member <NUM> may be integrated into the hub <NUM>, e.g., by providing one or more valves within the proximal end 50a.

The pusher member <NUM> is an elongate member including a proximal end <NUM> disposed proximal to the hub <NUM> and valve member <NUM> and a distal end <NUM> that is sized to be slidably received within the lumen <NUM>. For example, the pusher member <NUM> may have a length corresponding to the length of the needle <NUM> such that the distal end <NUM> is disposed immediately proximal and adjacent to the proximal tines <NUM> of the clip <NUM>. The proximal end <NUM> may extend a sufficient distance proximally out of the valve member <NUM> such that the pusher member <NUM> may be directed distally from an initial or first position to one or more distal positions during deployment of the clip <NUM>, as described further elsewhere herein.

The pusher member <NUM> and/or lumen <NUM> may be sized to accommodate the release wire <NUM> passing alongside the pusher member <NUM> within the lumen <NUM>. For example, the pusher member <NUM> may be sized smaller than the lumen <NUM> such that the ends of the release wire <NUM> may be simply be disposed adjacent the pusher member <NUM> within the lumen <NUM>. Alternatively, one or both of the pusher member <NUM> and lumen wall may include an axial groove to receive the release wire <NUM>. In a further alternative, the pusher member <NUM> may include a passage (not shown) extending between the proximal and distal ends <NUM>, <NUM> that may receive the release wire <NUM> therethrough.

During assembly, one or both ends of the release wire <NUM> may be directed through the valve member <NUM>, e.g., through a valve passage and the one or more valves (not shown), such that the valve member <NUM> may be coupled to a proximal end 50a of the hub <NUM>, as shown in <FIG>. For example, a first end 40a of the release wire <NUM> may be engaged between the hub <NUM> and valve member <NUM> to prevent subsequent movement of the first end 40a, while a second end 40b of the release wire may be directed through the valve member <NUM> such that the second end 40b extends proximally from the valve member <NUM> and is free to move. In this example, the valve member <NUM> may be removably coupled to the hub <NUM> such that the valve member <NUM> may be removed to release the first end 40a of the release wire <NUM>.

Alternatively, both ends of the release wire <NUM> may pass through the valve member <NUM> and be free to move. In this example, the valve member <NUM> may be substantially permanently or removably attached to the proximal end 50a of the hub, as desired. According to an embodiment of the invention, one or both ends of the release wire <NUM> are coupled to an actuator (not shown) on the hub <NUM> to allow manipulation and release of the release wire <NUM>, as described further below.

Optionally, as shown in <FIG>, the hub <NUM> may include a side port <NUM> communicating with the lumen <NUM>. The side port <NUM> may include one or more connectors, e.g., a Luer fitting (not shown), that may be used to couple a source of fluid to the side port <NUM>. For example, a section of tubing <NUM> may be coupled to the side port <NUM> that communicates with a syringe (not shown) containing saline or other biocompatible liquid, which may be delivered from the syringe through the tubing <NUM> and side port <NUM> into the lumen <NUM> during use, as desired. The tubing <NUM> may be coupled to the side port <NUM> by cooperating connectors or, alternatively, may be substantially permanently attached to the side port <NUM>, e.g., by one or more of an interference fit, mating connectors, bonding with adhesive, sonic welding, and the like.

In addition or alternatively, the hub <NUM> and/or valve member <NUM> may include one or more additional features to facilitate use of the apparatus <NUM>. For example, if desired, one or more visual markers and/or other features (not shown) may be provided at desired locations around the periphery of the hub <NUM> and/or valve member <NUM>, e.g., to provide a visual indication of the orientation of the clip <NUM> within the lumen <NUM> of the needle <NUM>. For example, in one embodiment, the hub <NUM> may have an oblong shape, e.g., such that a major axis of the hub <NUM> is ninety degrees offset from the major dimension of the lumen <NUM>. In addition or alternatively, one or more colored or other markers or elements (not shown) may be provided on the hub <NUM>, e.g., on opposite sides of the hub <NUM> aligned with the minor dimension of the lumen <NUM> to define the plane of the clip <NUM> relative to the needle <NUM>.

Optionally, the apparatus <NUM> may include a removable stop, e.g., disposed around the proximal end <NUM> of the pusher member <NUM>, e.g., adjacent the valve member <NUM>. For example, in one embodiment, the stop may be a "C" shaped collar or other element (not shown) that extends at least partially around the pusher member <NUM> and has a predetermined length to limit advancement of the pusher member <NUM>. In the proximal or first position shown in <FIG>, the clip <NUM> may be disposed entirely within the lumen <NUM>, e.g., such that distal tines <NUM> of the clip <NUM> are disposed within and/or adjacent the distal tip <NUM> of the needle <NUM>.

The pusher member <NUM> may be advanceable to a second or distal position, e.g., to deploy the distal tines <NUM> of the clip <NUM> from the lumen <NUM> beyond the distal tip <NUM> while the proximal tines <NUM> remain within the lumen <NUM>. For example, the pusher member <NUM> may be advanced until the plunger stem <NUM> on the pusher member <NUM> abuts the stop, thereby preventing further advancement of the pusher member <NUM>. The length of the stop may correspond to deploying a distal portion of the clip <NUM>, e.g., the distal tines <NUM> beyond the distal tip <NUM>, such that the distal tines <NUM> resiliently return at least partially towards the relaxed state.

The stop may be removable from around the pusher member <NUM>, whereupon the needle <NUM> may be retracted proximally, e.g., equivalent to advancing the pusher member <NUM>, until the pusher member <NUM> is in a third position relative to the needle <NUM>, e.g., in which the entire clip <NUM> is deployed from the lumen <NUM> beyond the distal tip <NUM> of the needle <NUM>. As the proximal tines <NUM> are deployed from the lumen <NUM>, they may also resiliently return towards the relaxed state, thereby surrounding or otherwise engaging the tubular structure to be closed, as described further elsewhere herein.

Alternatively, the hub <NUM> and/or pusher member <NUM> may include a cooperating track (not shown) to control or limit movement of the pusher member <NUM> relative to the needle <NUM>. For example, the track may include a first axial section allowing the pusher member <NUM> to be advanced axially from the first position to the second position, thereby partially deploying the clip <NUM>, e.g., the distal tines <NUM>. When desired to fully deploy the clip <NUM>, the pusher member <NUM> may then be partially rotated, e.g., to move the pusher member <NUM> along a circumference (non-axial) section of the track, and then advanced axially along a third axial section to direct the pusher member <NUM> and needle <NUM> from the second position to the third position. Optionally, in this alternative, the hub <NUM> and/or pusher member <NUM> may include one or more markers (not shown) that may provide visual confirmation when the pusher member <NUM> is properly aligned along the track, e.g., sufficiently rotated to allow movement between the second and third positions.

Once assembled, the apparatus <NUM> may be further processed as desired, e.g., sterilized and packaged. The apparatus <NUM> may then be sold and/or otherwise provided to a doctor or other end-user who may use the apparatus <NUM> to deliver the clip <NUM> into a patient's body.

Turning to <FIG>, an exemplary method is shown for using the apparatus <NUM> of <FIG>. Initially, as shown in <FIG>, a location along a vein or other body lumen <NUM>, e.g., an anterior side <NUM> of the vein <NUM> closest to the skin (not shown), may be identified as a target location for delivering a clip <NUM>, e.g., a saphenous vein experiencing valvular incompetence and the like. Optionally, a mark (not shown) may be applied to the patient's skin above the target location, e.g., to identify a point of entry for the needle <NUM>. A local anesthetic may be injected or otherwise delivered to the skin and/or underlying tissue, e.g., between the skin and vein and/or around the vein, optionally, using the needle <NUM>, as described elsewhere herein.

Turning to <FIG>, the needle <NUM> may be inserted through the skin and the point of entry and passed into-and-through the vein <NUM> such that the tip <NUM> is disposed on a posterior side <NUM> of the vein <NUM>, e.g., using ultrasound visual control, as shown in FIG. The distal tip <NUM> of the needle <NUM> may be positioned beyond the posterior or inner wall <NUM> of the vein <NUM>, e.g., about one or two millimeters (<NUM>-<NUM>) deep beyond the posterior wall <NUM> of the vein <NUM>.

Optionally, as shown in <FIG>, fluid may be delivered through the needle <NUM>, e.g., from a syringe or other source (not shown) coupled to the side port <NUM> (see <FIG>), thereby delivering the fluid through the lumen <NUM> and out the distal tip <NUM>, into the region adjacent the vein <NUM>. For example, such fluid may direct tissue surrounding the tubular structure away from the outer wall of the vein <NUM> and/or create a working space around the vein <NUM> to accommodate deployment of the distal tines <NUM>. In exemplary embodiments, the fluid may simply be saline, or may include an anesthetic with vasoactive agent, such as lidocaine with epinephrine, which may be injected around the vein <NUM> to induce small muscle contraction or vasospasm, e.g., causing the vein <NUM> to contract around the needle <NUM> after being pierced through the vein <NUM>. Optionally, such fluid may be delivered into the region adjacent to the vein <NUM>, e.g., at one or more times during the procedure.

The orientation of the clip <NUM> may be checked, e.g., using one or more markers or other features on the hub <NUM> and/or valve member <NUM>. For example, the needle <NUM> may be rotated about its longitudinal axis to ensure that the tines <NUM>, <NUM> of the clip <NUM> may be oriented across the width of the vein <NUM>, e.g., with the plane of the clip <NUM> substantially perpendicular to the longitudinal axis <NUM> of the vein <NUM>.

The pusher member <NUM> may be advanced until the distal tines <NUM> of the clip <NUM> exit the distal tip <NUM> of the needle <NUM>, whereupon the distal tines <NUM> may expand automatically towards their relaxed state, as shown in <FIG>. For example, the pusher member <NUM> may be advanced until the plunger stem <NUM> contacts a stop (not shown) or is otherwise limited to a second position where the central region <NUM> and proximal tines <NUM> remain within the lumen <NUM>. Optionally, anesthetic with vasoactive agent or other fluid may be delivered into the region adjacent to the vein <NUM>, e.g., just before deployment of the distal tines <NUM>, as shown in <FIG>.

Turning to <FIG>, once the distal tines <NUM> are deployed and expanded, the release wire <NUM> may be manipulated to direct the clip <NUM> proximally, e.g., to engage the distal tines <NUM> with the posterior side <NUM> of the vein <NUM>. For example, the release wire <NUM> may be pulled at least partially proximally to engage the distal tines <NUM> with the posterior wall <NUM> of the vein <NUM>, e.g., to prevent migration of the clip <NUM> during subsequent deployment and/or may partially compress or close the vein <NUM>, as shown in <FIG>. Optionally, anesthetic with vasoactive agent or other fluid may be delivered into the region adjacent to the vein <NUM>, e.g., after deploying the distal tines <NUM> and pulling outwardly on the release wire <NUM>. Such fluid may create additional working space around the vein <NUM>, e.g., to accommodate deployment of the proximal tines <NUM>, e.g., as shown in <FIG>.

For example, if both ends of the release wire <NUM> are free, both ends may be pulled simultaneously to pull the intermediate region and consequently the clip <NUM> proximally. Alternatively, if one end of the release wire <NUM> is fixed, e.g., between the hub <NUM> and valve member <NUM>, the other end may be pulled. Further alternatively, if the release wire <NUM> is coupled to an actuator (not shown), the actuator may be manipulated to pull the release wire <NUM> to a desired extent.

Once the distal tines <NUM> are engaged as desired with the vein <NUM>, the release wire <NUM> may be removed from the eyelet <NUM> of the proximal tine 24a (not shown in <FIG>) to allow full deployment of the clip <NUM>. For example, if both ends of the release wire <NUM> are free, one end may be pulled to direct the other end distally into the lumen <NUM>, through the eyelet <NUM>, and proximally back out through the lumen <NUM>. Alternatively, if one end is fixed between the hub <NUM> and valve member <NUM>, the valve member <NUM> may be disengaged to release the fixed end, whereupon the other end may be pulled to remove the release wire <NUM>.

Turning to <FIG>, the entire needle <NUM> and pusher member <NUM> may then be removed through the vein <NUM> overlying tissue and skin, thereby deploying the clip <NUM> fully from the lumen <NUM>. For example, with the distal tines <NUM> engaged to the posterior side <NUM> of the vein <NUM>, removing the needle <NUM> may cause the proximal tines <NUM> to exit the outlet <NUM> and become exposed, whereupon the proximal tines <NUM> may automatically move towards the relaxed state, e.g., the loop shape shown in <FIG>, thereby at least partially surrounding, compressing, and/or closing the vein <NUM>.

In an alternative embodiment, if the apparatus <NUM> includes a stop, the stop may be removed as the needle <NUM> and pusher member <NUM> are held substantially steadily in place. The needle <NUM> may then be withdrawn as the pusher member <NUM> is held or otherwise remains substantially stationary, thereby moving between the second and third positions, to push the proximal tines <NUM> of the clip <NUM> out the outlet <NUM>.

Optionally, this procedure may be repeated one or more times, e.g., at the same location and/or different locations along the length of the vein <NUM>, to deliver multiple clips (not shown) to close the vein <NUM>.

Claim 1:
An apparatus (<NUM>) for closing a tubular structure (<NUM>) within a patient's body, comprising:
a tubular member (<NUM>) comprising a proximal end (<NUM>) including a hub (<NUM>), a distal end (<NUM>) including a sharpened distal tip (<NUM>) to allow insertion into tissue through a tubular structure, and a lumen (<NUM>) extending proximally from the distal end (<NUM>);
a clip (<NUM>) loaded in the lumen (<NUM>), the clip (<NUM>) compressible between a relaxed state in which a plurality of tines (<NUM>, <NUM>) of the clip (<NUM>) are shaped to engage and close a tubular structure within a patient's body, and a stressed state in which the tines (<NUM>, <NUM>) are compressed to allow the clip (<NUM>) to be loaded into the lumen (<NUM>), at least one of the tines (<NUM>) including an eyelet (27a) adjacent a tip (25a) thereof;
a release wire (<NUM>) including first and second ends (40a, 40b) positioned adjacent the hub (<NUM>) and an intermediate region passing through the lumen and the eyelet (27a);
an actuator on the hub (<NUM>);
and
a pusher member (<NUM>) comprising a proximal end (<NUM>) and a distal end (<NUM>) sized for advancement within the lumen (<NUM>) for at least partially deploying the clip (<NUM>) from the distal tip (<NUM>) of the tubular member (<NUM>) such that the tines (<NUM>, <NUM>) engage and close a tubular structure through which the tubular member is directed;
wherein one or both ends of the release wire are coupled to the actuator to allow manipulation and release of the release wire.