TISSUE ANCHOR AND RELATED METHODS

An apparatus for an image guided medical device, in at least one embodiment, provides uniform and continuous positioning of anchoring members to minimize or eliminate undesired tissue cutting or tearing. The apparatus includes a housing (40), a needle casing at least partially disposed in the housing and an anchor casing disposed at least partially disposed within the housing. A wheel (60) is disposed within the housing and is operatively engaged with and positioned between the needle casing and the anchor casing. An anchor assembly includes a tube with a proximal end coupled to the anchor casing and a distal end having an anchoring device (27). As the wheel (60) is rotated, the needle casing is drawn towards the wheel thereby retracting the needle and, simultaneously, the anchor casing is drawn toward the wheel thereby pushing the anchor assembly through the needle. The relative movement of the needle and the anchor assembly exposes an anchor member (27) in a uniform and continuous fashion.

TECHNICAL FIELD

The present invention relates to tissue anchors and related methods. More particularly, the present invention relates to tissue anchors and related methods for anchoring catheters or other access ports within tissue.

BACKGROUND ART

The current methods for diagnosing and/or treating tumors and lesions frequently employ image guided devices, e.g., needles. Currently such devices require an external stabilization apparatus to maintain the desired target location, e.g., lesion or tumor, and continued re-imaging to confirm the target location has not changed which sometimes happens due to breathing or other anatomical movement.

Various devices are known in the art that include tissue anchoring mechanisms. For example, U.S. Pat. No. 8,888,798 discloses a tissue repair device including an anchor disposed within the lumen of a needle. An actuator is disposed within the needle that includes a distal end engaged with the anchor and a proximal end coupled to a pusher shaft. A knob is provided for advancing the pusher shaft to deploy the anchor.

U.S. Pat. No. 8,956,318 discloses a gastrointestinal bypass device having a tissue anchor. The tissue anchor includes a proximal retention element, a distal retention element, and a tension element. The proximal retention element is configured to be deployed on a proximal side of a tissue wall and may take the form of a button or a bar. The distal retention element is configured to be deployed on a distal side of a tissue wall. The distal retention element includes a hub and a plurality of petals. An anchor delivery device is provided that includes a handle, a catheter, a side port, a sled, a delivery needle, a pushrod and a holder. The pushrod may be configured to push out a tissue anchor loaded in the delivery needle.

U.S. Patent Publication No. 2015/0366556 A1 discloses a system and method for anchoring an implant. An anchor, which may comprise a shape-set shape memory material, is deliverable from an inner lumen of a needle or introducer. The needle can be advanced distally below a tissue surface. A pusher can be used to expose the anchor. The pusher and needle can then be retracted once the anchor is retained within the tissue.

International Patent Publication No. WO 2019102484 A1 discloses a multiple anchor delivery system including an anchor loaded in a hollow needle and a driving assembly for deploying the anchor. The driving assembly includes a pusher which may be advanced and retracted by an actuator such as a trigger or a roller.

International Patent Publication No. WO 2020051147 A1 is directed to tissue anchors and needles for tissue anchor deployment. A tissue anchor is disclosed disposed within a delivery system. The delivery system includes a shaft and a needle disposed within a lumen of the shaft. The anchor is disposed within a lumen of the needle. A pusher/ejector is slidably disposed in the needle lumen and may be configured to push the tissue anchor out of a distal end of the needle.

Further improvements are still needed, however, for a more efficient anchored catheter or access port that results in a uniform and continuous deployment which will achieve precise positioning thus minimize or eliminate tissue cutting or tearing.

SUMMARY OF THE INVENTION

The apparatus of the current invention may be deployed in or around a tumor or lesion in a patient and provide a pathway for subsequent therapeutic or diagnostic minimally invasive surgical procedures or a fluid delivery pathway within the central lumen, i.e. access port.

In at least one embodiment, an apparatus according to the invention includes a housing and a wheel disposed in and protruding from the housing. A threaded rod is engaged with and is attached to the wheel, the rod includes a first threaded section and a second threaded section. The threaded rod may be extended through the center or off-of-the center of the wheel. A needle casing is disposed within the housing and is engaged with the first threaded section of said threaded rod at a first end. An anchor casing is disposed within the housing. The anchor casing is engaged with the second threaded section of said threaded rod at a first end. A needle is disposed and secured in the needle casing. An anchor assembly includes a tube having a proximal end and distal end including a plurality of anchor members extending therefrom. In yet at least one other embodiment, an apparatus according to the invention includes a housing and a wheel disposed in and protruding from the housing. A threaded rod engages with and extends through the wheel. The threaded rod includes a first threaded section and a second threaded section. A needle casing is disposed at least in part within the housing and the needle casing is engaged with the first threaded section of the threaded rod. An anchor casing is disposed at least in part within the housing. The anchor casing is engaged with the second threaded section of the threaded rod. A needle is disposed in the needle casing. The needle includes a proximal end and a beveled distal end having a bevel angle. An anchor assembly is provided and includes a tube having a proximal end and distal end and an anchoring device attached to the distal end of the tube. The anchor assembly extends through the needle, the needle housing, and the threaded rod and has a proximal end connected to the anchor casing.

In at least another embodiment of the current invention, an apparatus includes a housing and a wheel disposed in and protruding from the housing. A threaded rod is engaged with and is attached to the wheel, the rod includes a first threaded section and a second threaded section and an anchor lumen. The threaded rod may be extended through the center or off-of-the center of the wheel. A needle casing is disposed within the housing. The needle casing is engaged with the first threaded section of the threaded rod at a first end. An anchor casing is disposed within the housing. The anchor casing is engaged with the second threaded section of said threaded rod at a first end. A needle is disposed and secured in the needle casing. An anchor assembly extends through the anchor lumen of the needle, the needle housing, the threaded rod and is securely attached to the anchor casing. An anchor assembly includes a tube having a proximal end and distal end including a plurality of anchor members extending therefrom. A fluid delivery assembly is provided and includes a tubular shaft that extends distally through the needle and extends proximally through the anchor casing. The tubular shaft is configured to move axially relative to said needle.

In operation, the needle is advanced to a desired target via the use of any known image guided procedure. Once the desired position of the medical device disclosed herein has been achieved, the user rotates the wheel, the needle will be retracted as the tube is translated forward, resulting in a uniform and continuous positioning of the anchoring members.

The position of each anchoring member has been carefully aligned and positioned with respect to the needle bevel angled configuration, resulting in a uniform and continuous deployment. This uniform and continuous deployment will minimize or eliminate tissue cutting or tearing.

Many modifications and variations of the present disclosure may be made without departing from the spirit and scope thereof. Therefore, the exemplary embodiments described above should not be used to limit the scope of the invention.

DESCRIPTION OF EMBODIMENTS

In the following description, certain specific details are set forth in order to provide a thorough understanding of various embodiments of the invention. However, one skilled in the relevant art will recognize that the invention may be practiced without one or more of these specific details, or with other methods, components, materials, etc.

When introducing elements of the current invention or the preferred embodiment(s) thereof, the articles “a”, “an”, and “the” are intended to mean that there are one or more of the elements.

The term “plurality” when used herein refers to one or more.

As used herein, the term “proximal” shall mean close to the operator (further away from the target tissue) and “distal” shall mean away from the operator (closer to the target tissue).

The headings provided herein are for convenience only and do not interpret the scope or meaning of the claimed invention.

Referring toFIGS. 1 and 2, an apparatus10is shown in the ready to use state. The apparatus10comprises a housing40having a wheel60disposed therein. The housing40may have a clamshell design as shown in the figures, however, alternative configurations are possible. For illustrative purposes, in reference to the figures, a threaded rod65extends through and engages the center of wheel60. A first section of threaded rod65is threadably engaged with a needle casing50and a second section of threaded rod65is threadably engaged with anchor casing70. In some embodiments, the first and second sections of threaded rod65are configured as right-handed helix. In some embodiments the first and second sections of the threaded rod65are configured as a left-handed helix. In some embodiments, the first section of threaded rod65is configured as a right-handed helix and the second section of threaded rod65is configured as a left-hand helix, or vice versa. In some embodiments, the first section of threaded rod65has a pitch that is equal to or greater than the pitch of the second section of threaded rod65. In some embodiments, the first section of threaded rod65has a pitch that is less than or equal to the pitch of the second section of threaded rod65. In some embodiments, needle casing50and anchor casing70are all disposed within housing40. In other embodiments one or both of needle casing50and anchor casing70may be disposed either partially or fully external to housing40. In either configuration, the needle casing50and anchor casing70are slidable within the housing40and, due to relative geometries, are fixed against rotation about the longitudinal axis of housing40.

A needle30includes a proximal end and a distal end wherein the proximal end is disposed in and securely coupled to needle casing50. As shown inFIGS. 3A and 3B, needle30includes a tip35having a bevel angle. An anchoring assembly is provided and comprises a tube20(seeFIG. 2) having an anchoring device25attached to the distal end of tube20as depicted inFIG. 2. The tube20extends through anchor lumens provided in needle30, needle casing50and threaded rod65, and is disposed in and securely coupled to anchor casing70.

As shown inFIGS. 3A-6A, the apparatus according to the invention may be deployed by rotating wheel60clockwise, which distally displaces anchor casing70as shown inFIG. 2, i.e., draws anchor casing70towards wheel60as depicted by the arrows inFIGS. 3A-6Aand which distally displaces tube20, i.e., pushes tube20distally away from wheel60. Simultaneously, needle casing50is proximally displaced, i.e., drawn toward wheel60, which pulls needle30toward wheel60. The relative movement of needle30and tube20allows anchor member25to deploy from within needle in a uniform and continuous manner and achieve precise positioning. Rotating wheel60in the opposite direction, e.g., counter-clockwise, retracts the anchor member25back into the tube20. In alternative embodiments, counter-clockwise rotation of wheel60can deploy the anchor member25, and clockwise rotation of wheel60can retract the anchor member25.

In some embodiments, anchoring device25includes a plurality of formed anchoring members27, e.g., tines or fingers preformed into the shape of a hook and attached to a distal end portion of tube20. The tines of anchoring member27include sharp tips to facilitate tissue penetration, for example into soft tissue. In some embodiments, as best illustrated inFIG. 3B, anchoring members27are formed at varying positions along and around a circumference of tube20to align with the bevel angle of needle tip35. By align it is meant that in the ready to use state, no portion of anchoring device25protrudes past needle tip35. In some embodiments, each anchoring member27includes a proximal end and a distal end wherein the distal end of each member is positioned substantially flush with a circumferential edge of needle tip35. Anchoring device25remains in flush position until wheel60is rotated to begin deployment.

In other embodiments, anchoring device25may include one or more anchoring members in the form of stacked helical coils, spiral umbrella coils, or the like. In all embodiments, anchoring device25may be made of a shape memory material, e.g., Nitinol, or other suitable material.

The anchoring device25and its associated tines or anchoring members27are constrained within needle30when the anchoring device25is recessed within needle30, for example, when located in the position shown inFIG. 3Bor positions more proximal thereto. The anchoring members27expand as the anchoring device25is deployed out of the needle30, for example, by operating wheel60.FIGS. 4A and 4Bshow anchoring device25in a first stage of deployment, where the tines of anchoring members27are disposed in a substantially constricted state but are beginning to emerge from needle30. In this first stage, anchoring members27begin to expand radially outward from their position in the constrained configuration and radially outward relative to a longitudinal axis of tube20and needle30and wherein the end portions of anchoring members27are disposed substantially perpendicular to the longitudinal axes of tube20and needle30.

FIGS. 5A and 5Bdepict anchoring device25in a second stage of deployment where anchoring members27have expanded through the first stage into a C-shape or J-shape configuration where respective end portions of anchoring members are generally parallel with the longitudinal axes of tube20and needle30.

FIGS. 6A and 6Billustrate anchoring device25fully deployed, for example in a spider leg configuration. By spider leg configuration, it is meant that each anchoring member27includes a first section that extends radially outward from the longitudinal axes of needle30and tube20, a second arcuate section, and a third section that extends radially inward towards the longitudinal axes of needle30and tube20.

In at least one embodiment, as illustrated inFIG. 7, the apparatus10may be configured to deliver a liquid therapeutic agent into a soft tissue such as a solid tumor. Apparatus10may include a fluid delivery assembly having an elongate tubular shaft80configured to penetrate into soft tissue. A sharp edge85at the distal end of tubular shaft80is configured to facilitate penetration into the soft tissue. The sharp edge85is beveled and defines a point in this illustrated embodiment, which may help tubular shaft80pierce into the soft tissue and be advanced in the soft tissue with a minimal amount of tissue trauma. In one embodiment, the tubular shaft80is a needle, such as a hypodermic needle.

In some embodiments, fluid delivery assembly a handle90at a proximal end thereof. The handle90is configured to facilitate user manipulation of tubular shaft80. The tubular shaft80is configured to move longitudinally relative to needle30and tube20. The handle90is configured to be manipulated to cause the longitudinal movement of the tubular shaft80, e.g., moved in a proximal direction to cause proximal movement of the tubular shaft80and moved in a distal direction to cause distal movement of the tubular shaft80.

The tubular shaft80includes an inner lumen (not shown) extending longitudinally therethrough. A liquid therapeutic agent is configured to be passed through the inner lumen and out a distal opening thereof at the distal end of tubular shaft80to deliver the liquid therapeutic agent into the soft tissue in which tubular shaft80is penetrated.

In some embodiments, tubular shaft80has a textured outer surface along at least a partial longitudinal length thereof, e.g., at least along a distal portion of the tubular shaft80. The textured outer surface of tubular shaft80is configured to engage soft tissue when the tubular shaft80is penetrated into the soft tissue. The textured outer surface of tubular shaft80is configured to increase friction between tubular shaft80and the soft tissue to help prevent any movement of the soft tissue relative to tubular shaft80and any movement of tubular shaft80relative to the soft tissue, which may help ensure that the entire desired amount of the liquid therapeutic agent is delivered into the soft tissue and/or that any fluid gaps around the delivery device10(e.g., around the third tube16) are sealed.

In some embodiments, a locking collet80is coupled to anchor casing70to lock anchor member25in a desired position. Locking anchor member25as described may facilitate maintaining anchor member25in the optimum configuration. Suitable locking collets include a standard off-the-self torquer or guide wire handle.

A method of using the apparatus described herein is disclosed. The apparatus10is introduced into a body of a patient, either directly, e.g., through an incision, or indirectly, e.g., through an access device such as a trocar, cannula, or scoping device. The delivery device10is advanced to a target soft tissue in the body of the patient and positioned as desired relative to and outside of the soft tissue. Imaging equipment can be used to assist placement of the delivery device10in the desired position. In at least one embodiment, the soft tissue is a solid tumor, the apparatus10can be used to deliver a liquid therapeutic agent to other soft tissues. In an exemplary embodiment, the apparatus10is in an initial configuration illustrated inFIG. 3Bduring the introduction of the apparatus10into the patient's body and during the delivery device's advancement to and positioning relative to the soft tissue.

With the delivery device10in the first configuration and positioned as desired relative to and outside of the soft tissue, the operator rotates wheel60which simultaneously draws needle casing50and anchor casing70toward wheel60which distally pushes anchoring assembly25causing its sharp ends to expand as illustrated inFIGS. 4A, 5A and 6Aand penetrate the soft tissue.

The tubular shaft90is moved distally relative to the needle30and the tube20to penetrate the sharp edge95of the tubular shaft90into the soft tissue. When tubular shaft90is in place, a liquid therapeutic agent may be delivered e.g., through the inner lumen the tubular shaft90, and into the soft tissue.

After delivering the liquid therapeutic agent into the soft tissue, the apparatus10may be removed from the patient's body. In some embodiments, anchoring members27may be dislodged by rotating wheel60in a direction opposite to the direction of rotation from that employed to expand anchoring members27as described above. Wheel60may be rotated until anchoring members27are returned to their initial configuration as depicted inFIG. 3B. In some embodiments tubular member90may be removed before either before or after anchoring members27are dislodged.

While the foregoing disclosure references particular embodiments of the invention, it will be appreciated by those skilled in the art that changes in these embodiments may be made without departing from the principles and spirit of the invention, including embodiments that do not provide all the features and benefits described herein. It will be understood by those skilled in the art that the present disclosure extends beyond the specifically disclosed embodiments to other alternative or additional embodiments and/or uses and obvious modifications and equivalents thereof. In addition, while a number of variations have been shown and described in varying detail, other modifications, which are within the scope of the present disclosure, will be readily apparent to those of skill in the art based upon this disclosure. It is also contemplated that various combinations or subcombinations of the specific features and aspects of the embodiments may be made and still fall within the scope of the present disclosure. Accordingly, it should be understood that various features and aspects of the disclosed embodiments can be combined with or substituted for one another in order to form varying modes of the present disclosure. Thus, it is intended that the scope of the present disclosure herein disclosed should not be limited by the particular disclosed embodiments described above. For all of the embodiments described above, the steps of any methods need not be performed sequentially.