Systems and methods for deploying a cardiac anchor

A heart implant alignment and delivery device includes an elongate body having an opening that is disposed near a distal end of the elongate body. The opening is configured so that a heart implant is positionable within the opening with the heart implant exposed to a surrounding environment and so that the heart implant is substantially aligned with the distal end of the elongate body. The device also includes an implant reposition member, such as a cable, that is releasably coupleable with the heart implant and that is operationally coupled with the elongate body so that a first operation of the implant reposition member causes the heart implant to be retractably deployed from the opening of the elongate body. The first operation of the implant reposition member may be effected via a handle mechanism that is attached to a proximal end of the elongate body.

BACKGROUND

Heart implants are currently used to resize or alter the geometry of a ventricle in a failing heart, such as by reducing its radius of curvature through the process of excluding a portion of the circumference from contact with blood, and thereby reduce wall stress on the heart and improve the heart's pumping performance. Congestive heart failure may, for example, be treated using one or more implants which are selectively positioned relative to a first wall of the heart (typically an interventricular septum), and another wall of the heart so as to exclude scar tissue and limit a cross sectional area, or distance across a ventricle. Functional deterioration of the heart tissues may be inhibited by decreasing a size of the heart chamber and/or approximating tissues so that stress on the tissues is limited.

Congestive heart failure (sometimes referred to as “CHF” or “heart failure”) is a condition in which the heart does not pump enough blood to the body's other organs. Congestive heart failure may in some cases result from narrowing of the arteries that supply blood to the heart muscle, high blood pressure, heart valve dysfunction due to degenerative processes or other causes, cardiomyopathy (a primary disease of the heart muscle itself), congenital heart defects, infections of the heart tissues, and the like. However, in many cases congestive heart failure may be triggered by a heart attack or myocardial infarction. Heart attacks can cause scar tissue that interferes with the heart muscle's healthy function, and that scar tissue can progressively replace more and more of the contractile heart tissue. More specifically, the presence of the scar may lead to a compensatory neuro-hormonal response by the remaining, non-infarcted myocardium leading to progressive dysfunction and worsening failure.

People with heart failure may have difficulty exerting themselves, often becoming short of breath, tired, and the like. As blood flow out of the heart decreases, pressure within the heart increases. Not only does overall body fluid volume increase, but higher intracardiac pressure inhibits blood return to the heart through the vascular system. The increased overall volume and higher intracardiac pressures result in congestion in the tissues. Edema or swelling may occur in the legs and ankles, as well as other parts of the body. Fluid may also collect in the lungs, interfering with breathing (especially when lying down). Congestive heart failure may also be associated with a decrease in the ability of the kidneys to remove sodium and water, and the fluid buildup may be sufficient to cause substantial weight gain. With progression of the disease, this destructive sequence of events can cause the progressive deterioration and eventual failure of the remaining functional heart muscle.

Treatments for congestive heart failure may involve rest, dietary changes, and modified daily activities. Various drugs may also be used to alleviate detrimental effects of congestive heart failure, such as by dilating expanding blood vessels, improving and/or increasing pumping of the remaining healthy heart tissue, increasing the elimination of waste fluids, and the like.

Surgical interventions have also been applied for treatment of congestive heart failure. If the heart failure is related to an abnormal heart valve, the valve may be surgically replaced or repaired. Techniques also exist for exclusion of the scar and volume reduction of the ventricle. These techniques may involve (for example) surgical left ventricular reconstruction, ventricular restoration, the Dor procedure, and the like. If the heart becomes sufficiently damaged, even more drastic surgery may be considered. For example, a heart transplant may be the most viable option for some patients. These surgical therapies can be at least partially effective, but typically involve substantial patient risk. While people with mild or moderate congestive heart failure may benefit from these known techniques to alleviate the symptoms and/or slow the progression of the disease, less traumatic, and therefore, less risky therapies which significantly improve the heart function and extend life of congestive heart failure patients has remained a goal.

It has been proposed that an insert or implant be used to reduce ventricular volume of patients with congestive heart failure. With congestive heart failure, the left ventricle often dilates or increases in size. This can result in a significant increase in wall tension and stress. With disease progression, the volume within the left ventricle gradually increases and blood flow gradually decreases, with scar tissue often taking up a greater and greater portion of the ventricle wall. By implanting a device which brings opposed walls of the ventricle into contact with one another, a portion of the ventricle may be excluded or closed off. By reducing the overall size of the ventricle, particularly by reducing the portion of the functioning ventricle chamber defined by scar tissue, the heart function may be significantly increased and the effects of disease progression at least temporarily reversed, halted, and/or slowed.

BRIEF DESCRIPTION

The embodiments described herein are particularly useful for positioning anchors or heart implants against heart walls. According to one aspect, a catheter for delivering and aligning a heart implant about a wall of a heart is provided. The catheter includes an elongate catheter body having a lumen disposed there through and a handle mechanism that is disposed at a proximal end of the elongate catheter body. The elongate catheter body includes a cavity that is positioned near a distal end of the elongate catheter body. The cavity is configured to deliver a heart implant adjacent the wall and is configured to receive the heart implant in a manner such that at least a portion of the heart implant is exposed to an interior region of the heart. A cable is positioned within the lumen of the elongate catheter body. The cable is releasably coupled with the heart implant that is positioned within the cavity and is operationally coupled with the handle mechanism so that a first operation of the handle mechanism causes the cable to flex outward from the cavity, which causes at least part of the heart implant to move outward from the cavity.

The catheter may be further configured so that a second operation of the handle mechanism causes the cable to retract within the lumen of the elongate catheter body, thereby enabling the heart implant to be repositioned within the cavity. The catheter may be even further configured so that a third operation of the handle mechanism causes the cable to retract within the lumen of the elongate catheter body thereby enabling the heart implant to be released from the cavity. The heart implant may be pivotably coupled with a tension member.

A distal tip of the elongate catheter body may be plugged, capped, solid, or otherwise closed so that the lumen does not extend through the distal tip. A distal end of the cable may contact the distal tip of the elongate catheter body so that distal sliding of the cable within the lumen causes the cable to flex outward from the cavity. The cavity may be formed in the distal end of the elongate catheter body by removing more with more than ½ of the material of the elongate catheter body. A strip of material may connect a proximal portion and a distal portion of the elongate catheter body on opposite sides of the cavity. The cable may be slidably disposed through a lumen of the heart implant in order to couple the heart implant with the cavity and elongate catheter body. The distal end of the elongate catheter body may flex or bend in response to the first operation of the handle mechanism and the heart implant may pivot outward from the cavity in response to the first operation of the handle mechanism.

According to another aspect, a heart implant alignment and delivery device is provided. The device includes an elongate body and an opening in the elongate body that is disposed near a distal end of the elongate body. The opening is configured so that a heart implant is positionable within the opening with the heart implant exposed to a surrounding environment, and so that the heart implant is substantially aligned with the distal end of the elongate body. The device also includes an implant reposition member that is releasably coupleable with the heart implant and that is operationally coupled with the elongate body so that a first operation of the implant reposition member causes the heart implant to be retractably deployed from the opening of the elongate body. Retractably deploying the heart implant may involve pivoting the heart implant out of the opening of the elongate body.

The implant reposition member may be also configured so that a second operation of the implant reposition member causes the heart implant to be retracted into the opening with the heart implant substantially aligned or realigned with the distal end of the elongate body. The implant reposition member may be further configured so that a third operation of the implant reposition member causes the heart implant to be permanently deployed from the opening of the elongate body. The device may include a handle mechanism that is disposed at a proximal end of the elongate body. The handle mechanism may be operably coupled with the implant reposition member to effect the first operation, the second operation, and/or the third operation of the implant reposition member. The implant reposition member may be a cable that is slidably disposed within a lumen of the elongate body and the elongate body may be configured so that the distal sliding of the cable within the lumen of the elongate body causes a portion of the cable to protrude outwardly from the opening.

According to another aspect, a method of deploying a heart implant from a catheter is provided. The catheter includes an elongate body having a lumen and a cavity, a cable disposed within the lumen, and a handle mechanism disposed at a proximal end of the elongate body. The heart implant is positioned within the cavity of the elongate body. The method includes positioning a distal end of the elongate body within a chamber of a heart so that the cavity and heart implant are adjacent a wall of the heart and performing a first operation via the handle mechanism to cause the cable to flex outward from the cavity of the elongate body and thereby cause the heart implant to pivot out of the cavity of the elongate body and into contact with the wall. The catheter is configured so that the heart implant is retractable within the cavity to enable repositioning of the elongate body within the heart and thereby ensure a proper alignment of the heart implant relative to the wall of the heart.

The method may also include performing a second operation via the handle mechanism to cause the cable to retract within the lumen of the elongate body and thereby cause the heart implant to retract into the cavity. The cavity and heart implant may then be repositioned within the cavity of the heart after retraction of the cable and heart implant. The method may additionally include repositioning the cavity and heart implant within the chamber of the heart so that the heart implant is repositioned relative to the wall. The first operation of the handle mechanism may then be performed again to cause the cable to flex outward from the cavity and thereby cause the heart implant to pivot out of the cavity and into contact with the wall. The method may additionally include performing a third operation with the handle mechanism to permanently deploy the heart implant from the cavity of the elongate body. The heart implant may be pivotably coupled with a tension member that extend distally from heart implant and through the wall of the heart. The cable may be slidably disposed through a lumen of the heart implant.

DETAILED DESCRIPTION

The embodiments herein generally provide improved medical devices, systems, and methods. Exemplary embodiments of the devices are described for use in reducing the distance between a region along the septum and a region of an external wall of the left and/or right ventricle of a heart in a less or minimally invasive manner. Hence, embodiments of the tools and methods described herein may find specific use in the treatment of congestive heart failure and other progressive heart diseases by reconfiguring abnormal heart geometry that may be contributing to heart dysfunction.

The embodiments of the tools and methods described herein are particularly useful for positioning anchors or heart implants that are deployed against the heart walls and that are used to urge opposing heart walls together. The tools and methods allow a physician to have improved control over the position and deployment of the anchor against the heart wall. The improved control enables the physician to ensure that Chordae, Papillary Leaflets, the Tricuspid Valve, and other heart tissue or material are not contacted, entangled, or otherwise detrimentally affected by the heart anchor. The tools and methods also allow the physician to easily reposition the heart anchor if such repositioning is needed. The embodiments herein enable more precise positioning of heart anchors within a chamber of the heart, which may greatly simplify the heart anchor delivery procedure and/or reduce operation and recovery time associated with the procedure.

The controlled placement of the heart anchor is achieved via a catheter or heart implant alignment and delivery device that is configured to deliver the heart anchor within the chamber in a manner that enables the heart anchor to be retractably pivoted or deployed from the catheter. Stated differently, the catheter is designed so that the heart anchor may be deployed from the catheter, but the deployment is controlled so that the heart anchor is not permanently or non-reversibly deployed from the catheter. Rather, the heart anchor remains coupled with the catheter even after an initial deployment, which enables the heart anchor to be retracted against or relative to the catheter if desired.

The retractable deployment of the heart anchor allows a physician to check or inspect a placement, position, or other deployment related characteristic of the heart anchor prior to permanently deploying the heart anchor. For example, the physician may inspect that the heart anchor is properly aligned about the heart, and/or in relation to another heart anchor, to ensure that a desired closure or other treatment of the heart will be achieved via the heart anchor. In other instances, the physician may ensure that the heart anchor is not entangled with or in contact with sensitive heart tissue, such as the Chordae, Papillary Leaflets, Tricuspid Valve, etc. If the physician determines that the heart anchor is not properly aligned about the heart, and/or with another heart anchor, the physician may retract the heart anchor, reposition the heart anchor, and retractably deploy the heart anchor to ensure that a desired and proper alignment and/or placement of the heart anchor is achieved.

After a desired placement or alignment of the heart anchor is achieved, the physician may then permanently deploy the heart anchor from the catheter. The heart anchor may then be used to partially or fully close a portion of the heart as desired. In some instances, retractable deployment of the heart anchor may involve positioning of the heart anchor against one of the walls of the heart, such as adjacent the septum. In other embodiments, the heart anchor may be deployed elsewhere relative to the heart. The physician may inspect the placement or position of the heart anchor via fluoroscopy, echocardiography (e.g., 3D echocardiography, Transesophageal Echocardiography (TEE)), and the like.

The catheter may include an elongate body that includes an opening body that is disposed near a distal end of the elongate body. The elongate body is typically a cylindrical body or tubing. The opening is configured so that a heart implant may be positioned within the opening. The opening is typically formed in a portion of the elongate body by removing some of the tubing's material, which may expose an interior portion of the tubing or elongate body. With the material removed, a small strip or section of the elongate body or tubing may connect a distal and proximal portion of the elongate body.

The heart anchor may be positioned within the opening so that one side of the heart anchor faces the interior of the elongate body. The heart implant is typically exposed to a surrounding environment when positioned within the opening. The heart implant is also typically aligned with the distal end of the elongate body or tubing. The catheter also includes an implant reposition member that is releasably coupled with the heart implant when the heart implant is positioned within the opening. In one embodiment, the implant reposition member is a cable, wire, or cord that is positioned through a lumen of the elongate body and through a lumen of the heart implant. In other embodiments, the implant reposition member may be any component or member that is able to attach to the heart implant in a manner that allows the heart implant to be retractably deployed from the catheter.

The implant reposition member is operationally coupled with the elongate body so that a first operation of the implant reposition member causes the heart implant to be retractably deployed from the opening of the elongate body. The implant reposition member may be attached to a handle mechanism that is disposed at a proximal end of the elongate body and that is operable to effect the first operation of the implant reposition member. Retractable deployment of the heart implant may including pivoting of the heart implant out of the opening of the elongate body.

The implant reposition member is also configured so that a second operation of the implant reposition member causes the heart implant to be retracted into the opening of the elongate body. Upon retraction of the heart implant within the opening, the heart implant is once again substantially aligned with the distal end of the elongate body. The handle mechanism may be designed to effect the second operation of the implant reposition member. The implant reposition member is further configured so that a third operation of the implant reposition member causes the heart implant to be permanently deployed from the opening of the elongate body. The handle mechanism may be designed to effect the third operation of the implant reposition member. In instances where the implant reposition member is a cable, the cable may be slidably disposed within a lumen of the elongate body and the elongate body may be configured so that distal sliding of the cable within the lumen of the elongate body causes a portion of the cable to protrude outwardly from the opening.

Having generally described aspects of a heart implant deliver device or catheter, additional features of such devices will be more apparent in reference to the description of the various figures that is provided below.

Referring now to theFIGS. 1A-1C, illustrated are various view of a heart implant alignment and delivery device or catheter (hereinafter catheter100) that may be used to deliver, align, and deploy a heart implant or anchor120(hereinafter heart implant120) within the heart. The catheter100has a proximal end102and a distal end104. A handle mechanism106(hereinafter handle106) is attached to the proximal end102of the catheter100. The handle106may be used by a physician to control and navigate the distal end104of the catheter100within the vasculature of a patient's body. Specifically, the distal end104may be directed or navigated to a desired location within or adjacent a chamber of the heart for deployment of one or more heart implants120. The handle106is also used in aligning and/or deploying the heart implant120within the heart as described in greater detail herein.

The distal end104includes an elongate or catheter body108(hereinafter elongate body108) having a lumen110(seeFIG. 3A) that extends substantially through the elongate body108. The elongate body108is typically a cylindrical body or section of flexible tubing. In some embodiments, the elongate body108may be made of a braid material, catheter, or tubing, such as braid reinforced tubing. The elongate body108is sufficiently flexible to allow the tubing to be inserted through the vasculature of the patient and within a chamber of the heart. The tubing should be sufficiently flexible and strong to enable insertion within the vasculature while minimizing trauma to the patient. A cable, wire, flexible rod, or other component112(hereinafter cable112) is slidably positioned within the lumen110of the elongate body108. As illustrated in greater detail inFIGS. 2A-C, the cable112is operationally coupled with the handle106so that an operation of the handle106causes the cable112to slide proximally and distally within the lumen110of the elongate body108, which effects deployment or retraction of the heart implant120. Specifically, as described in greater detail below, a grip member202of the handle106may be slid proximally and distally about the handle106to initially deploy and retract the heart implant120. A release member208may be employed to permanently deploy the heart implant120after a proper alignment or positioning of the implant is determined.

An opening or cavity114(hereinafter cavity114) is formed in the distal end104of the elongate body108. The cavity114is configured so that the heart implant120may be positioned within the cavity114. The cavity114is formed in the distal end104of the elongate body108by removing some of the tubing's material (typically more than ½ of the material), which exposes an interior portion of the tubing and lumen110. In some embodiments, the cavity114may be formed via laser cutting or machining. Laser cutting may be particularly useful when the elongate body108is formed of a braid material, since the laser may prevent or minimize fraying of the braid material As illustrated inFIG. 1C, a small strip or material section115of the elongate body108connects a distal and proximal portion of the elongate body108adjacent the cavity114. The heart implant120is positionable within the cavity114of the elongate body108. When positioned within the cavity114, an exterior surface of the heart implant120is positioned against the elongate body108, although the heart implant120generally remains exposed to a surrounding environment as illustrated. The heart implant120is also substantially aligned within the distal end104of the elongate body108when positioned within the cavity114.

The heart implant120is pivotally coupled or attached to a tether or tension member122(hereinafter tether122). Exemplary heart implants120and tethers122are further described in the following U.S. applications, the disclosures of which are incorporated by reference herein: U.S. application Ser. No. 13/632,108, filed Sep. 30, 2012, entitled “Over-the-Wire Cardiac Implant Delivery System for Treatment of CHF and Other Condition”; U.S. application Ser. No. 13/632,106, filed Sep. 30, 2012, entitled “Cardiac Implant Migration Inhibiting Systems”; U.S. application Ser. No. 13/632,104, filed Sep. 30, 2012, entitled “Trans-Catheter Ventricular Reconstruction Structures, Methods, and Systems for Treatment of Congestive Heart Failure and Other Conditions”; U.S. application Ser. No. 13/632,103, filed Sep. 30, 2012, entitled “Remote Pericardial Hemostasis for Ventricular Access and Reconstruction or Other Organ Therapies”. As described in said applications, the tether122may be used to apply tension to the heart walls and/or fix the heart walls in engaged state to close off a portion of a heart chamber. The tether122may also be used to guide the heart implant120to a desired location within the heart chamber. In such instances, the tether122may extend distally of the distal end104of the elongate body108as illustrated.

The heart implant120is coupleable with the elongate body108so that the heart anchor120may be removed or uncoupled therefrom. For example,FIGS. 1A and 1Billustrate the heart implant120positioned within the cavity114of the elongate body108whileFIG. 1Cillustrated the heart implant120removed therefrom. The heart implant120is removably coupled with the cavity114by inserting the cable112through a lumen124of the heart implant120as illustrated in greater detail inFIGS. 3A and 3B.

The distal tip of the elongate body108is plugged, capped, or otherwise closed so that the cable112is not able to extend entirely through the elongate body108and beyond the distal tip of the elongate body108. To plug, cap, or close the distal tip, a cap or plug130(hereinafter plug130) is coupled or attached to the distal tip. Because the distal tip is plugged, capped, or otherwise closed, distal sliding of the cable112causes the cable112to flex and deploy outward from the cavity114, which is used in initially deploying the heart implant120within the heart chamber.

FIGS. 2A-Cillustrate cross sectional views of the handle106of the catheter100in greater detail. The handle106is configured to be grasped and manipulated by a physician to align and deploy the heart implant120within the heart.FIG. 2Aillustrates a cross section of the entire handle106, whileFIGS. 2B and 2Cillustrate distal and proximal ends of the handle106, respectively. As illustrated, the cable112is positioned through the lumen110of the elongate body108and through the interior of the handle106. The cable112is fixedly attached to a plunger206that is axially movable or slidable within a main body200of the handle106. The plunger206is attached to the grip member or lever202(hereinafter grip member202) so that axial sliding of the grip member202causes the plunger206to move axially within the main body200. In turn, axial movement of the plunger206causes the cable112to similarly move or slide axially within the elongate body108. The grip member202may be mechanically attached to the plunger206via set screws210or other mechanical fasteners as illustrated. In other embodiments, the grip member202may be adhesively bonded, ultrasonically welded, RF welded, and the like to the plunger206.

The grip member202is slidably disposed within a elongate slot or opening212of the main body200. The elongate slot212limits the amount of sliding of the grip member202relative to the main body200, which correspondingly limits the amount of axial sliding of the plunger206within the main body200and thereby limits the amount of axial sliding of the cable112within the lumen110of the elongate body108. The catheter100may be arranged so that the distal end of the cable112is adjacent to, or contacts, the plug130when the grip member202is positioned at a proximal most point within the elongate slot212. In such instances, distal sliding of the grip member202within the elongate slot212causes the cable112to flex or deploy outwardly from the cavity114since the plug130prevents the cable's distal tip from extending or protruding beyond the distal tip of the elongate body108. In this manner, distal sliding of the grip member202may be employed to initially deploy the heart implant120from the cavity114of the elongate body108. The grip member202may be slid proximally to retract the cable112within the cavity114of the elongate body108. In this manner, proximal sliding of the grip member202may be employed to retract the heart implant120within the cavity of the elongate body108.

An access member204is coupled with the distal end of the main body200. The access member204may couple with the elongate body108and reinforce the elongate body108. The access member204may include a port111that provides fluid access to the elongate body108and/or vasculature. An O-ring220, or other fluid inhibitor, may be disposed within a distal end of the main body200at a proximal end of the elongate body108. The O-ring220may be used to fluidly seal the elongate body108in order to prevent blood or other bodily fluid from passing through the elongate body108and into the main body200of the handle106. In some instances, the cable112may be reinforced within the interior of the main body200, such as by including a rigid covering or tubing that prevents or minimizes buckling of the cable112.

A release member or cable deployment mechanism208(hereinafter cable deployment mechanism208) is removably attached to the proximal end of the plunger206. The cable deployment mechanism208is also fixedly attached to the cable112. The cable deployment mechanism208is designed to be removed or detached from the plunger206and pulled proximally relative thereto. Detachment of the cable deployment mechanism208from the plunger206, and proximal movement of the cable deployment mechanism208relative thereto, causes the cable112to be slid proximally within the lumen110of the elongate body108and out of engagement with the heart implant120. This allows the heart implant120to be permanently deployed or detached from the cavity114of the elongate body. The cable deployment mechanism208may include a luer type connector, or any other connector, to enable the cable deployment mechanism208to be detached from the proximal end of the plunger206.

In operation, the handle106is used to both initially deploy the heart implant120and to permanently deploy the heart implant120once a desired alignment or orientation of the heart implant is achieved. For example, the heart implant120may be inserted within the patient's vasculature and into a chamber of the heart (e.g., left ventricle). The heart implant120is typically positioned within the cavity114of the elongate body108during insertion of the heart implant120through the vasculature. Insertion of the heart implant120within the vasculature and heart chamber is further described in the various U.S. applications incorporated by reference herein.

The grip member202may then be slid distally within the elongate slot212to flex the cable112outward from the cavity114, which correspondingly causes the heart implant120to pivot or deploy outward from the cavity114due to the coupling of the cable112and the heart implant120. A physician may determine if the heart implant120is properly aligned or oriented within the heart chamber, or if the heart implant is in contact with any sensitive tissue. If the heart implant120is not properly aligned, or if the heart implant120contacts sensitive tissue, the grip member202may be slid proximally within the elongate slot212to retract the heart implant120within the cavity of the elongate body108. The heart implant may then be realigned or repositioned within the heart chamber via proximal or distal movement of the elongate body108, rotation of the handle106and elongate body108, etc., and the heart implant120may then be redeployed within the heart chamber via the grip member202to determine if the new alignment or orientation of the heart implant120is proper.

Upon a determination of a proper alignment or orientation of the heart implant120, the cable deployment mechanism208may be detached from the plunger to disengage the cable112from the heart implant120, which enables the heart implant120to be permanently deployed or detached from the elongate body108. The heart implant120may then be used to apply tension to the heart walls so as to bring opposing heart walls into engagement. The heart implant120and tether may then be used to permanently affix the engaged heart walls. Tensioning and affixing of the heart walls is further described in the various U.S. applications incorporated by reference herein.

Referring now toFIGS. 3A-C, illustrated are cross sectional views of the distal end102of the elongate body108.FIGS. 3A-Cprovide greater detail of the functional relationship or operation of the cavity114, heart implant120, and plug130.FIG. 3Ashows the heart implant120removed from the cavity114and detached from the elongate body108. The cable112is retracted within the lumen110of the elongate body108so as to be positioned proximally of a proximal end of the cavity114. The cable112is typically moved to this position via detachment of the cable deployment mechanism208from the plunger206.FIG. 3Billustrates the heart implant120positioned within the cavity114with the heart implant's lumen124substantially axially aligned within an axis of the cavity114and the elongate body108. The cable112is inserted through the lumen124of the heart implant120, which temporarily couples the heart implant120with the elongate body108. The distal tip of the elongate body108is capped, plugged, or otherwise closed via the plug130to prevent the cable112from extending distally beyond the elongate body108. The distal tip of the cable112is directly adjacent, or in contact with, the plug130as illustrated.

Since the cable112is positioned internally within the elongate body108, both proximally and distally of the heart implant120and cavity114, the heart implant120is essentially locked or restrained within the cavity114, which prevents accidental or undesired uncoupling or detachment of these components. An inner surface of the heart implant120is in direct contact with the interior of the elongate body108while the heart implant120remains exposed to the surrounding environment, which in use is typically the interior of the heart chamber.

The cavity114is sized slightly larger than the heart implant120. For example, the cavity114has a longitudinal dimension X which is slightly greater than the longitudinal length Y of the heart implant120. The cavity114should be dimensioned so that the heart implant may be easily aligned and coupled with the cavity114and so that the cable112is able to flex or deploy outward from the cavity114in response to distal sliding of the cable112within the lumen110of the elongate body108. Stated differently, the cavity114should not be dimensioned so that it prevents or greatly restricts the cable112from flexing or deploying outward from the cavity114, which may occur if the cavity114is similar in size to the longitudinal length of the heart implant120.

The tether122is shown extending distally from the heart implant120and elongate body108. The tether122may be inserted within the vasculature and heart chamber distally of the heart implant120and elongate body108and may be used to guide or direct the heart implant120and elongate body108through the vasculature and within the heart chamber. The tether122is pivotally attached or coupled with the heart implant120so that the implant is able to pivot about the end of the tether122.

FIG. 3Cillustrates the cable112being used to initially deploy or pivot the heart implant120from the cavity114of the elongate body108. The cable112is designed to flex, buckle, or bend in response to an operation of the handle106and specifically, the distal movement of the grip member202within the elongate slot212of the main body200. Distal movement of the grip member202causes the plunger206to slide distally within the main body200, which causes a corresponding distal sliding of the cable112within the lumen110of the elongate body108. The plug130prevents the cable from extending or sliding distally of the distal tip of the elongate body108, which causes the cable112to buckle and bend or flex outward from the cavity114as illustrated. Because the cable112is disposed within the lumen124of the heart implant120, outward flexing or bending of the cable112causes the heart implant to pivot, move, or deploy outward from the cavity114. The buckling of the cable112may also cause the distal end of the elongate body108to flex or bend in an opposite direction as illustrated inFIG. 3C. This flexing or bending of the elongate body108may be controlled by increasing or decreasing the thickness of the elongate body's material strip that extends across the cavity114.

Proximal movement of the grip member202causes the plunger206to slide proximally within the main body200, which causes a corresponding proximal sliding of the cable112within the lumen110of the elongate body108. This retracts the cable112within the lumen110of the elongate body, which causes the heart implant120to pivot or move back into the cavity114. When the heart implant120is retracted within the cavity114, the lumen124is typically realigned with the axis of the cavity114and elongate body108. In this manner, the heart implant120may be initially deployed from and retracted within the cavity114. The heart implant120may also be permanently deployed form the cavity114by detaching the cable deployment mechanism208from the plunger206.

WhileFIGS. 3A-Cillustrate the elongate body108including the plug130, in other embodiments the elongate body108may be configured so that the lumen110terminates or stops short of the distal end of the elongate body108and therefore, does not extend fully through the distal end of the elongate body108. In yet other embodiments, the distal tip of the elongate body108may be pinched or formed together to plug, cap, or otherwise close the lumen110and thereby prevent the cable112from extending distally of the elongate body's distal tip.

FIGS. 4A-Billustrate the deployment of the heart implant120from the cavity114of the elongate body108. As described herein, the heart implant120is deployed via operation of the cable112. Prior to deployment of the heart implant120, the heart implant120may be aligned with the cable112and elongate body108as illustrated inFIG. 4A. The heart implant120may be deployed from the cavity114in a pivot-like manner or fashion. Since the tether122is connected to the heart implant120via a pivot joint121, the sliding of the cable112causes the heart implant120to pivot or flex about the pivot joint121. The bowing or flexing of the cable112may also cause the distal portion or end of the elongate body108to bow or flex in an opposite direction as shown. The heart implant120may be deployed or pivoted relative to the elongate body108so that the heart implant120is roughly orthogonal to an axis of proximal portion of the elongate body108as illustrated.

FIGS. 5A-Cillustrates a method of deploying the heart implant120from the catheter100and within a chamber302(e.g., left ventricle) of a heart300. InFIG. 5A, the distal end of the elongate body108is positioned within the chamber302of the heart100so that the cavity114and heart implant120are positioned near or adjacent a septum304of the heart300. The tether122extends from the heart implant120and through the septum304and an exterior wall306of the heart. The tether122may extend distally therefrom and through an incision within the patient's body, such as through an incision between the patient's ribs.

InFIG. 3B, a first operation of the handle106is performed to cause the cable112to flex, buckle, or bend outward from the cavity114of the elongate body108and thereby cause the heart implant120to pivot out of the cavity114. In some instances, the heart implant120may pivot into contact with the septum304. As described herein, the first operation of the handle106may be a distal sliding of the grip member202within the elongate slot212of the handle's main body200. The heart implant120is retractable within the cavity114to enable repositioning of the elongate body108within the heart300and thereby ensure a proper alignment of the heart implant120relative to the wall304of the heart300. For example, with the heart implant120pivoted or deployed from the cavity114, a physician may assess if the heart implant120is properly aligned or oriented about the septum304to provide a desired therapeutic treatment, such as closing off a desired portion of the right ventricle.

The elongate body108and heart implant120may be repositioned within the chamber302of the heart300so that the heart implant120is repositioned relative to the septum304. The first operation of the handle106(i.e., distal sliding of the grip member202) may then be performed again to cause the cable112and heart implant120to flex or pivot outward from the cavity114so that the physician can assess the new position of the heart implant120relative to the septum304.

As illustrated inFIG. 5C, upon a determination that the alignment or orientation of the heart implant120is proper relative to the septum304, a third operation of the handle106may be performed to permanently deploy the heart implant120from the cavity114of the elongate body108. As described herein, the third operation of the handle106may involve detaching the cable deployment mechanism208from the plunger206of the handle106and/or pulling the cable deployment mechanism208proximally of the plunger206. Once the heart implant120is detached from the cavity114and elongate body108, the elongate body108may be removed from the chamber302of the heart300and from the patient's body. As further described in the various U.S. applications incorporated herein, the heart implant120and tether122may then be used to apply tension to the septum304and exterior wall306for various reasons including bringing the inner surfaces of the walls,304and306, into engagement. The heart implant120and tether122may also be used to permanently affix the septum304and exterior wall306in a desired orientation, such as by affixing an epicardial anchor (not shown) to the tether122.

Deployment of the heart implant120via the cable112allows the physician to have improved control over positioning of the heart implant120against the heart wall. For example, if the heart implant120needs to be rotated relative to the heart wall, the cable112may be retracted proximally to cause the heart implant120to be repositioned within the cavity114and the catheter100and elongate body108may be rotated to cause the heart implant120to be moved rotationally relative to the heart wall. The heart implant120may then be redeployed into contact with the heart wall via the process described herein. Similarly, if the heart implant120is contacting, entangling, or otherwise engaging with internal heart structures during deployment, the cable112may be retracted proximally to reposition the heart implant120within the cavity114. The heart implant120and/or elongate body108may then be rotated to reposition the heart implant120relative to the heart to a position where it is less likely that the heart implant120will contact, entangle, or engage with heart structures during deployment. The heart implant120may then be redeployed against the heart wall using the cable112and handle106.

The use of the cable112further prevents or minimizes unnecessary and potentially problematic movement of the heart implant120at the distal end of the tether122. For example, if the heart implant120is able to freely pivot or move at or about the distal end of the tether122, the heart implant120may be prone to contacting and engaging with the heart tissue (e.g., Chordae, Papillary Leaflets, Tricuspid Valve, etc.). The use of the cable112prevents or minimizes free pivoting or movement of the heart implant120about the distal end of the tether122.

FIG. 6illustrates an image of a heart implant or anchor being positioned within a right ventricle of an animal. The left hand image shows the heart implant or anchor in an un-deployed or insertion position where an axis of the heart implant or anchor is aligned with the axis of the elongate body. The right hand image shows the heart implant or anchor being deployed or pivoted from the elongate body's cavity or anchor window and into contact with the inner surface of the right ventricle via the cable. The heart implant or anchor rests against the septum of the heart subsequent to deployment of the anchor.

While several embodiments and arrangements of various components are described herein, it should be understood that the various components and/or combination of components described in the various embodiments may be modified, rearranged, changed, adjusted, and the like. For example, the arrangement of components in any of the described embodiments may be adjusted or rearranged and/or the various described components may be employed in any of the embodiments in which they are not currently described or employed. As such, it should be realized that the various embodiments are not limited to the specific arrangement and/or component structures described herein.

In addition, it is to be understood that any workable combination of the features and elements disclosed herein is also considered to be disclosed. Additionally, any time a feature is not discussed with regard in an embodiment in this disclosure, a person of skill in the art is hereby put on notice that some embodiments of the invention may implicitly and specifically exclude such features, thereby providing support for negative claim limitations.

As used herein and in the appended claims, the singular forms “a”, “an”, and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to “a process” includes a plurality of such processes and reference to “the device” includes reference to one or more devices and equivalents thereof known to those skilled in the art, and so forth.