Patent ID: 12208260

DETAILED DESCRIPTION

Implantable medical devices such as cardiac pacemakers or implantable cardioverter defibrillators (ICDs) may provide therapeutic electrical stimulation to the heart of a patient. The electrical stimulation may be delivered in the form of electrical pulses or shocks for pacing, cardioversion or defibrillation. This electrical stimulation is typically delivered via electrodes on one or more implantable leads that are positioned in, on or near the heart.

In one particular implementation discussed herein, a lead may be inserted in the region of the cardiac notch of a patient so that the distal end of the lead is positioned within the mediastinum, adjacent to the heart. For example, the distal end of the lead may be positioned in the anterior mediastinum, beneath the patient's sternum. The distal end of the lead can also be positioned so to be aligned with an intercostal space in the region of the cardiac notch. Other similar placements in the region of the cardiac notch, adjacent the heart, are also contemplated for this particular application of cardiac pacing.

In one exemplary procedure, as shown inFIG.1, a cardiac pacing lead100may be inserted within the ribcage101of a patient104through an intercostal space108in the region of the cardiac notch. Lead100may be inserted through an incision106, for example. The incision106may be made in proximity to the sternal margin to increase the effectiveness in finding the appropriate intercostal space108and avoiding certain anatomical features, for example the lung109. The incision may be made lateral to the sternal margin, adjacent the sternal margin or any other direction that facilitates access to an appropriate intercostal space108. A distal end of lead100can be positioned to terminate within the mediastinum of the thoracic cavity of the patient, proximate the heart118. Lead100may then be connected to a pulse generator or controller102, which may be placed above the patient's sternum110. In alternative procedures, for temporary pacing, a separate controller may be used that is not implanted in the patient.

In some implementations, the pericardium is not invaded by the lead during or after implantation. In other implementations, incidental contact with the pericardium may occur, but heart118(contained within the pericardium) may remain untouched. In still further procedures, epicardial leads, or leads that reside within the pericardium, which do invade the pericardium, may be inserted.

FIG.2Ais an illustration of an exemplary lead delivery system200facilitating delivery of a lead in the region of a cardiac notch.FIG.2Aillustrates delivery system200and a cross section201(including left chest203and right chest207) of a patient104.FIG.2Aillustrates sternum110, lung109, intercostal muscle108, heart118, mediastinum202, pericardium204, and other anatomical features. As shown inFIG.2A, lead delivery system200may be configured to allow for a distal end206of delivery system200to be pressed against the sternum110of patient104.

In one implementation, a physician identifies an insertion point above or adjacent to a patient's sternum110and makes an incision. The distal end206of delivery system200can then be inserted through the incision, until making contact with sternum110. The physician can then slide distal end206of delivery system200across sternum110toward the sternal margin until it drops through the intercostal muscle108in the region of the cardiac notch under pressure applied to the delivery system200by the physician.FIG.2Billustrates the distal end206having dropped through the intercostal muscle in the region of the cardiac notch toward the pericardium.

In certain implementations, delivery system200may include an orientation or level guide316to aid the physician with obtaining the proper orientation and/or angle of delivery system200to the patient. Tilting delivery system200to the improper angle may negatively affect the deployment angle of lead100into the patient. For example, a horizontal level guide316on delivery system200helps to ensure that the physician keeps delivery system200level with the patient's sternum thereby ensuring lead100is delivered at the desired angle.

Following this placement of delivery system200, the system may be actuated to insert an electrical lead100into the patient.FIG.2Cillustrates an exemplary electrical lead100exiting delivery system200with two electrodes210,212positioned on one side of lead100, within the mediastinum202and facing heart118.FIG.2Cillustrates the lead100advancing in a direction away from sternum110. This example is not intended to be limiting. For example, the lead100may also be advanced in a direction parallel to the sternum110. In some implementations, delivery system200may be configured such that lead100advances in the opposite direction, under sternum110, advances away from sternum110at an angle that corresponds to an angle of one or more ribs of patient104, and/or advances in other orientations. Similarly, an exemplary device as shown inFIG.2may be flipped around so that the handle would be on the left side ofFIG.2, or held in other positions by the physician, prior to system actuation and insertion of lead100.

Distal end206of delivery system200may be configured to move or puncture tissue during insertion, for example, with a relatively blunt tip (e.g., as described herein), to facilitate entry into the mediastinum without requiring a surgical incision to penetrate through intercostal muscles and other tissues. A blunt access tip, while providing the ability to push through tissue, can be configured to limit the potential for damage to the pericardium or other critical tissues or vessels that the tip may contact.

In an exemplary implementation, the original incision made by the physician above or adjacent to the sternum may also be used to insert a controller, pulse generator or additional electrode to which the implanted lead may be connected.

The delivery system and lead technologies described herein may be especially well suited for the cardiac pacing lead delivery example described above. While this particular application has been described in detail, and may be utilized throughout the descriptions below, it is contemplated that the delivery system(s)200and lead(s)100herein may be utilized in other procedures as well, such as the insertion of a defibrillation lead.

FIG.3illustrates an exemplary delivery system200. Delivery system200can include a handle300, a component advancer302, a first insertion tip304, a second insertion tip306, a lock308, and/or other components. Handle300may be configured to be actuated by an operator. In some implementations, handle300may be coupled to a body310and/or other components of delivery system200. Body310may include an orifice312, finger depressions314, a knurled surface, a lever arm, and/or other components configured to facilitate gripping of handle300by an operator. In some implementations, handle300and the body of the delivery system200may be coated with a material or their surfaces covered with a texture to prevent slippage of the physician's grasp when using delivery system200.

Component advancer302may be coupled to handle300and configured to advance a component such as an electrical lead (as one example) into the patient by applying a force to the portion of the component in response to actuation of handle300by the operator.

First insertion tip304and second insertion tip306may be configured to close around a distal tip and/or segment of the component when the component is placed within component advancer302. In some implementations, closing around a distal segment of the component may include blocking a path between the component and the environment outside delivery system200. Closing around the distal segment of the component may also prevent the component from being unintentionally deployed and contacting biological tissue while delivery system200is being manipulated by the operator.

First insertion tip304and second insertion tip306may also be configured to fully enclose the distal segment of the component when the component is placed within component advancer302. Fully enclosing the distal segment of the component may include covering, surrounding, enveloping, and/or otherwise preventing contact between the distal segment of the component and an environment around first insertion tip304and second insertion tip306.

In still other implementations, first insertion tip304and second insertion tip306may be configured to only partially enclose the distal segment of the component when the component is placed within component advancer302. For example, first insertion tip304and/or second insertion tip306may cover, surround, envelop, and/or otherwise prevent contact between one or more portions (e.g., surfaces, ends, edges, etc.) of the distal segment of the component and the environment around tips304and306, but the tips304and306may also still block the path between the component and the environment outside the delivery system200during insertion.

In some implementations, first insertion tip304and second insertion tip306may be configured such that the component is held within component advancer302rather than within first insertion tip304and second insertion tip306, prior to the component being advanced into the patient.

First insertion tip304and second insertion tip306may be further configured to push through biological tissue when in a closed position and to open (see, e.g.,320inFIG.3) to enable the component to exit from the component advancer302into the patient. In some implementations, opening may comprise second insertion tip306moving away from first insertion tip304, and/or other opening operations. In some implementations, first and second insertion tips304,306may be configured to open responsive to actuation of handle300.

In some implementations, first insertion tip304and/or second insertion tip306may be configured to close (or re-close) after the component exits from the component advancer302, to facilitate withdrawal of delivery system200from the patient. Thus, first insertion tip304and second insertion tip306may be configured to move, after the component exits from component advancer302into the patient, to a withdrawal position to facilitate withdrawal of first insertion tip304and second insertion tip306from the biological tissue. In some implementations, the withdrawal position may be similar to and/or the same as an original closed position. In some implementations, the withdrawal position may be a different position. In some implementations, the withdrawal position may be wider than the closed position, but narrower than an open position. For example, first insertion tip304and/or second insertion tip306may move to the open position to release the component, but then move to a different position with a narrower profile (e.g., the withdrawal position) so that when the tips304,306are removed they are not met with resistance pulling through a narrow rib space, and/or other biological tissue.

In some implementations, first and second insertion tips304,306may have blunt edges. Blunt edges may include rounded and/or otherwise dull edges, corners, surfaces, and/or other components of first and second insertion tips304,306. The blunt edges may be configured to prevent insertion tips304and306from rupturing any veins or arteries, the pericardial sac, the pleura of the lungs, and/or causing any other unintentional damage to biological tissue. The blunt edges may prevent, for example, rupturing veins and/or arteries by pushing these vascular items to the side during insertion. The blunt edges may also prevent, for example, the rupturing of the pericardium or pleura because they are not sharp.

FIG.4illustrates first and second insertion tips304,306with exemplary implementations of such blunt edges. As shown inFIG.4, first and second insertion tips304,306may have rounded corners400,402and/or end surfaces401,403at their respective ends404,406. First and second insertion tips304,306may have rounded edges408,410that run along a longitudinal axis of tips304,306. However, this description is not intended to be limiting. In some implementations, first and second insertion tips304,306may also have sharp edges, ends, and/or other features.

In some implementations, first and second insertion tips304,306may each include a channel at least partially complimentary to a shape of the component and configured to guide the component into the patient.FIG.5illustrates an example of such a channel. As shown inFIG.5, first insertion tip304may include a channel500at least partially complimentary to a shape of the component and configured to guide the component into the patient. Second insertion tip306may also include a channel similar to and/or the same as channel500(although the channel in insertion tip306is not visible inFIG.5). Channel500may extend along a longitudinal axis of insertion tip304from an end502of insertion tip304configured to couple with component advancer302toward end404.

In some implementations, channel500may be formed by a hollow area of insertion tip304that forms a trench, for example. The hollow area and/or trench may have one or more shapes and/or dimensions that are at least partially complimentary to a shape and/or dimension(s) of the component, and are configured to guide the component into the patient. In some implementations, the hollow area and/or trench may be configured such that the component may only slide within channel500inside the insertion tips304,306, and therefore prevent the component from advancing out one of the sides of the insertion tips304,306when pushed by component advancer302.

In some implementations, channel500may include a second channel and/or groove configured to engage alignment features included on a component. The second channel or groove may be located within channel500, but be deeper and/or narrower than channel500. The component may then include a rib and/or other alignment features configured to engage such a groove. The rib may be on an opposite side of the component relative to electrodes, for example. These features may enhance the guidance of a component through channel500, facilitate alignment of a component in channel500(e.g., such that the electrodes are oriented in a specific direction in tips304,306, preventing the component from exiting tips304,306to one side or the other (as opposed to exiting out ends404,406), and/or have other functionalities.

In some implementations, the second channel and/or groove may be sized to be just large enough to fit an alignment feature of the component within the second channel and/or groove. This may prevent an operator from pulling a component too far up into delivery system200(FIG.3) when loading delivery system200with a component (e.g., as described below).

The channels and/or grooves may also provide a clinical benefit. For example, the channel and/or groove may allow for narrower insertion tips304and306that need not be configured to surround or envelop all sides of the component (e.g., they may not need sidewalls to keep the component in position during implantation). If surrounding or enveloping all sides of a component is necessary, the insertion tips would need to be larger, and would meet with greater resistance when separating tissue planes within intercostal spaces, for example. However, in other implementations (e.g., as described herein), insertion tips304,306may completely surround and/or envelop the component.

In some implementations, as shown inFIG.6, a first insertion tip304may be longer than a second insertion tip306and the end404of first insertion tip304will extend beyond the end406of insertion tip306. Such a configuration may assist with spreading of tissue planes and help to avoid pinching tissue, veins, arteries or the like while delivery system200is being manipulated through biological tissue.

In some implementations, both the first and second insertion tips304,306may be moveable. In other implementations, the first insertion tip304may be fixed, and second insertion tip306may be moveable.

In one particular implementation, a fixed insertion tip304may be longer than a movable insertion tip306. This configuration may allow more pressure to be exerted on the outermost edge (e.g., end404of tip304) of delivery system200without (or with reduced) concern that tips304and306will open when pushing through biological tissue. Additionally, the distal ends404and406may form an underbite600that allows distal end406of movable insertion tip306(in this example) to seat behind fixed insertion tip304, and thus prevent tip406from experiencing forces that may inadvertently open movable insertion tip306during advancement. However, this description is not intended to be limiting. In some implementations, a movable insertion tip306may be longer than a fixed insertion tip304.

In some implementations, a fixed (e.g., and/or longer) insertion tip304may include a ramped portion configured to facilitate advancement of the component into the patient in a particular direction.FIG.7illustrates an example of a ramped portion700of insertion tip304. Ramped portion700may be located on an interior surface702of insertion tip304, between channel500and distal end404of insertion tip304. Ramped portion700may be configured to facilitate advancement of the component into the patient in a particular direction. The particular direction may be a lateral direction relative to a position of insertion tip304, for example. The lateral deployment of a component (e.g., an electrical lead) when it exits insertion tip304and moves into the anterior mediastinum of the patient may facilitate deployment without contacting the heart (e.g., as described relative toFIGS.2A-2Cabove). Ramped portion700may also encourage the component to follow a preformed bias (described below) and help prevent the lead from deploying in an unintentional direction.

In some implementations, insertion tips304,306may have open side walls.FIG.8illustrates an example of insertion tips304,306with open side walls800,802.FIG.8illustrates a cross sectional view of insertion tips304,306, looking at insertion tips304,306from distal ends404,406(as shown inFIG.7). Open side walls800,802may be formed by spaces between insertion tip304and insertion tip306. In the example ofFIG.8, insertion tips304and306are substantially “U” shaped, with the ends804,806,808,810extending toward each other, but not touching, such that open side walls800and802may be formed. Open side walls800,802may facilitate the use of a larger component (e.g., a component that does not fit within channel(s)500), without having to increase a size (e.g., a width, etc.) of insertion tips304,306. This may avoid effects larger insertion tips may have on biological tissue. For example, larger insertion tips are more invasive than smaller insertion tips. As such, larger insertion tips may meet with greater resistance when separating tissue planes within intercostal spaces during deployment and may cause increased trauma than insertion tips having a reduced cross sectional size.

In some implementations, delivery system200(FIG.3) may include a handle300(FIG.3), a component advancer302(FIG.3), and a unitary insertion tip (e.g., instead of first and second insertion tips304and306).FIG.9Aillustrates one possible example of a delivery system200having a unitary insertion tip900. Insertion tip900may be coupled to a component advancer302similar to and/or in the same manner that insertion tips304and306(FIG.7) may be coupled to component advancer302.

Unitary insertion tip900may have a circular, rectangular, wedge, square, and/or other cross sectional shape(s). In some implementations, insertion tip900may form a (circular or rectangular, etc.) tube extending along a longitudinal axis902(FIG.9B) of insertion tip900. Referring toFIG.9B, in some implementations, insertion tip900may be configured to hold the component (labeled as904) when the component is placed within component advancer302. In some implementations, insertion tip900may be configured to hold a distal end (labeled as906) and/or tip of component904when component904is placed within component advancer302.

Insertion tip900may be configured to push through biological tissue and may include a distal orifice908configured to enable component904to exit from component advancer302into the patient.

FIG.9Cillustrates an alternative insertion tip900design having a wedge shape. A wedge-shaped insertion tip900reduces and/or eliminates the exposure of distal orifice908to the surrounding tissue during insertion. This design prevents tissue coring since only the leading edge of insertion tip900is exposed and thereby separates tissues rather than coring or cutting tissue during insertion. Accordingly, the present disclosure contemplates an insertion tip that may be configured to reduce the exposure of the distal orifice during insertion.

Referring toFIG.9D, distal tip912may be rounded into an arc so the deployment force exerted by the physician during insertion concentrates in a smaller area (the distalmost portion of distal tip912). Additionally, the distalmost portion of distal tip912may be blunted to minimize trauma and damage to surrounding tissue during insertion. Notch914provides additional room for the proximal end of lead100having a rigid electrical connector to more easily be inserted when loading lead100in delivery system200. Rails916overlap lead100and hold lead100flat when the lead is retracted and held within delivery system200. In some implementations, the inner edge of rails916gradually widen as rails916advance toward distal tip912.

FIG.9Dillustrates certain features applicable to a unitary insertion tip design.

In some implementations, insertion tip900may include a movable cover918configured to prevent the biological tissue from entering distal orifice908when insertion tip900pushes through the biological tissue. The moveable cover may move to facilitate advancement of component904into the patient.

It is contemplated that many of the other technologies disclosed herein can also be used with the unitary tip design. For example, insertion tip900may include a ramped portion910configured to facilitate advancement of the component into the patient in a particular direction and to allow the protruding electrodes210,212to pass easier through the channel created within insertion tip900.

In some implementations, delivery system200(FIG.3) may include a dilator. In some implementations, insertion tips304,306, and/or insertion tip900may operate in conjunction with such a dilator. Use of a dilator may allow an initial incision to be smaller than it may otherwise be. The dilator may be directionally oriented to facilitate insertion of a component (e.g., an electrical lead) through the positioned dilator manually, and/or by other means. The dilator may comprise a mechanism that separates first and second insertion tips304,306. For example, relatively thin first and second insertion tips304,306may be advanced through biological tissue. An actuator (e.g., a handle, and/or a device couple to the handle operated by the user) may insert a hollow, dilating wedge that separates first and second insertion tips304,306. The actuator (operated by the user) may advance a lead through the hollow dilator into the biological tissue. The dilator may also be used to separate the first and second insertion tips304,306such that they lock into an open position. The dilator can then be removed and the lead advanced into the biological tissue.

FIGS.10and11illustrate an exemplary lock1000that may be included in delivery system200. A lock1000may be similar to and/or the same as lock308shown inFIG.3. In some implementations, lock1000may be configured to be moved between an unlocked position that allows actuation of handle300(and in turn component advancer302) by the operator and a locked position that prevents actuation, and prevents first insertion tip304(FIG.7) and second insertion306tip (FIG.7) from opening.

FIG.10illustrates lock1000in a locked position1002.FIG.11illustrates lock1000in an unlocked position1004. Lock1000may be coupled to handle300and/or component advancer302via a hinge1003and/or other coupling mechanisms. In some implementations, lock1000may be moved from locked position1002to unlocked position1004, and vice versa, by rotating and/or otherwise moving an end1006of lock1000away from handle300(see, e.g.,1005inFIG.11). Lock1000may be moved from locked position1002to unlocked position1004, and vice versa, by the operator with thumb pressure, trigger activation (button/lever, etc.) for example, and/or other movements. Additionally, the mechanism may also include a safety switch such that a trigger mechanism must be deployed prior to unlocking the lock with the operator's thumb.

When lock1000is engaged or in locked position1002, lock1000may prevent an operator from inadvertently squeezing handle300to deploy the component. Lock1000may prevent the (1) spreading of the distal tips304,306, and/or (2) deployment of a component while delivery system200is being inserted through the intercostal muscles.

Lock1000may be configured such that deployment of the component may occur only when lock1000is disengaged (e.g., in the unlocked position1004shown inFIG.11). Deployment may be prevented, for example, while an operator is using insertion tips304,306of delivery system200to slide between planes of tissue in the intercostal space as pressure is applied to delivery system200. Lock1000may be configured such that, only once system200is fully inserted into the patient can lock1000be moved so that handle300may be actuated to deliver the component through the spread (e.g., open) insertion tips304,306. It should be noted that the specific design of lock1000shown inFIGS.10and11is not intended to be limiting. Other locking mechanism designs are contemplated. For example, the lock1000may be designed so that lock1000must be fully unlocked to allow the handle300to be deployed. A partial unlocking of lock1000maintains the handle in the locked position as a safety mechanism. Furthermore, the lock1000may be configured such that any movement from its fully unlocked position will relock the handle300.

Returning toFIG.3, component advancer302may be configured to advance a component into a patient. The component may be an electrical lead (e.g., as described herein), and/or other components.

The component advancer302may be configured to removably engage a portion of the component, and/or to deliver the component into the patient through insertion tips304and306. In some implementations, component advancer302and/or other components of system200may include leveraging components configured to provide a mechanical advantage or a mechanical disadvantage to an operator such that actuation of handle300by the operator makes advancing the component into the patient easier or more difficult. For example, the leveraging components may be configured such that a small and/or relatively light actuation pressure on handle300causes a large movement of a component (e.g., full deployment) from component advancer302. Or, in contrast, the leveraging components may be configured such that a strong and/or relatively intense actuation pressure is required to deliver the component. In some implementations, the leveraging components may include levers, hinges, wedges, gears, and/or other leveraging components (e.g., as described herein). In some implementations, handle300may be advanced in order to build up torque onto component advancer302, without moving the component. Once sufficient torque has built up within the component advancer, the mechanism triggers the release of the stored torque onto the component advancer, deploying the component.

In some implementations, component advancer302may include a rack and pinion system coupled to handle300and configured to grip the component such that actuation of handle300by the operator causes movement of the component via the rack and pinion system to advance the component into the patient. In some implementations, the rack and pinion system may be configured such that movement of handle300moves a single or dual rack including gears configured to engage and rotate a single pinion or multiple pinions that engage the component, so that when the single pinion or multiple pinions rotate, force is exerted on the component to advance the component into the patient.

FIG.12Aillustrates an exemplary rack and pinion system1200. Rack and pinion system may include rack(s)1202with gears1204. Example system1200includes two pinions1206,1208. Pinions1206and1208may be configured to couple with a component1210(e.g., an electrical lead), at or near a distal end1212of component1210, as shown inFIG.12A. Rack and pinion system1200may be configured such that movement of handle300moves rack1202comprising gears1204configured to engage and rotate pinions1206,1208that engage component1210, so that when pinions1206,1208rotate1214, force is exerted1216on component1210to advance component1210into the patient.

In some implementations, responsive to handle300being actuated, a component (e.g., component1210) may be gripped around a length of a body of the component, as shown inFIG.12B. The body of the component may be gripped by two opposing portions1250,1252of component advancer302that engage either side of the component, by two opposing portions that engage around an entire circumferential length of a portion of the body, and/or by other gripping mechanisms.

Once gripped, further actuation of handle300may force the two opposing portions within component advancer302to traverse toward a patient through delivery system200. Because the component may be secured by these two opposing portions, the component may be pushed out of delivery system200and into the (e.g., anterior mediastinum) of the patient. By way of a non-limiting example, component advancer302may comprise a clamp1248having a first side1250and a second side1252configured to engage a portion of the component. Clamp1248may be coupled to handle300such that actuation of handle300by the operator may cause movement of the first side1250and second side1252of clamp1248to push on the portion of the component to advance the component into the patient. Upon advancing the component a fixed distance (e.g., distance1254) into the patient, clamp1248may release the component. Other gripping mechanisms are also contemplated.

Returning toFIG.3, in some implementations, component advancer302may include a pusher tube coupled with handle300such that actuation of handle300by the operator causes movement of the pusher tube to push on the portion of the component to advance the component into the patient. In some implementations, the pusher tube may be a hypo tube, and/or other tubes. In some implementations, the hypo tube may be stainless steel and/or be formed from other materials. However, these examples are not intended to be limiting. The pusher tube may be any tube that allows system200to function as described herein.

FIGS.13and14illustrate different views of an exemplary implementation of a component advancer302including a pusher tube1300coupled with handle300. As shown inFIG.13, in some implementations, pusher tube1300may include a notch1302having a shape complementary to a portion of a component and configured to maintain the component in a particular orientation so as to avoid rotation of the component within system200.FIG.13shows notch1302formed in a distal end1304of pusher tube1300configured to mate and/or otherwise engage with an end of a distal portion of a component (not shown inFIG.13) to be implanted. Pusher tube1300may be configured to push, advance, and/or otherwise propel a component toward and/or into a patient via notch1302responsive to actuation of handle300.

In some implementations, the proximal end1308of pusher tube1300may be coupled to handle300via a joint1310. Joint1310may be configured to translate articulation of handle300by an operator into movement of pusher tube1300toward a patient. Joint1310may include one or more of a pin, an orifice, a hinge, and/or other components. In some implementations, component advancer302may include one or more guide components1314configured to guide pusher tube1300toward the patient responsive to the motion translation by joint1310. In some implementations, guide components1314may include sleeves, clamps, clips, elbow shaped guide components, and/or other guide components. Guide components1314may also add a tensioning feature to ensure the proper tactile feedback to the physician during deployment. For example, if there is too much resistance through guide components1314, then the handle300will be too difficult to move. Additionally, if there is too little resistance through the guide components1314, then the handle300will have little tension and may depress freely to some degree when delivery system200is inverted.

FIG.14provides an enlarged view of distal end1304of pusher tube1300. As shown inFIG.14, notch1302is configured with a rectangular shape. This rectangular shape is configured to mate with and/or otherwise engage a corresponding rectangular portion of a component (e.g., as described below). The rectangular shape is configured to maintain the component in a specific orientation. For example, responsive to a component engaging pusher tube1300via notch1302, opposing (e.g., parallel in this example) surfaces, and/or the perpendicular (in this example) end surface of the rectangular shape of notch1302may be configured to prevent rotation of the component. This notch shape is not intended to be limiting. Notch1302may have any shape that allows it to engage a corresponding portion of a component and prevent rotation of the component as described herein. For example, in some implementations, pusher tube1300may include one or more coupling features (e.g., in addition to or instead of the notch) configured to engage the portion of the component and configured to maintain the component in a particular orientation so as to avoid rotation of the component within system200. These coupling features may include, for example, mechanical pins on either side of the pusher tube1300configured to mate with and/or otherwise engage receptacle features on a corresponding portion of a component.

FIG.15illustrates insertion tips304and306in an open position1502.FIG.15also illustrates pusher tube1300in an advanced position1500, caused by actuation of handle300(not shown). Advanced position1500of pusher tube1300may be a position that is closer to insertion tips304,306relative to the position of pusher tube1300shown inFIG.14.

In some implementations, the component advancer302may include a wedge1506configured to move insertion tip304and/or306to the open position1502. In some implementations, wedge1506may be configured to cause movement of the moveable insertion tip306and may or may not cause movement of insertion tip304.

Wedge1506may be coupled to handle300, for example, via a joint1510and/or other components. Joint1510may be configured to translate articulation of handle300by an operator into movement of the wedge1506. Joint1510may include one or more of a pin, an orifice, a hinge, and/or other components. Wedge1506may be designed to include an elongated portion1507configured to extend from joint1510toward insertion tip306. In some implementations, wedge1506may include a protrusion1509and/or other components configured to interact with corresponding parts1511of component advancer302to limit a travel distance of wedge1506toward insertion tip306and/or handle300.

Wedge1506may also be slidably engaged with a portion1512of moveable insertion tip306such that actuation of handle300causes wedge1506to slide across portion1512of moveable insertion tip306in order to move moveable insertion tip306away from fixed insertion tip304. For example, insertion tip306may be coupled to component advancer302via a hinge1520. Wedge1506sliding across portion1512of moveable insertion tip306may cause moveable insertion tip to rotate about hinge1520to move moveable insertion tip306away from fixed insertion tip304and into open position1502. In some implementations, moveable insertion tip306may be biased to a closed position. For example, a spring mechanism1350(also labeled inFIGS.13and14) and/or other mechanisms may perform such biasing for insertion tip306. Spring mechanism1350may force insertion tip306into the closed position until wedge1506is advanced across portion1512, thereby separating insertion tip306from insertion tip304.

In some implementations, as described above, first insertion tip304and second insertion tip306may be moveable. In some implementations, first insertion tip304and/or second insertion tip306may be biased to a closed position. For example, a spring mechanism similar to and/or the same as spring mechanism1350and/or other mechanisms may perform such biasing for first insertion tip304and/or second insertion tip306. In such implementations, system200may comprise one or more wedges similar to and/or the same as wedge1506configured to cause movement of first and second insertion tips304,306. The one or more wedges may be coupled to handle300and slidably engaged with first and second insertion tips304,306such that actuation of handle300may cause the one or more wedges to slide across one or more portions of first and second insertion tips304,306to move first and second insertion tips304,306away from each other.

In some implementations, system200may comprise a spring/lock mechanism or a rack and pinion system configured to engage and cause movement of moveable insertion tip306. The spring/lock mechanism or the rack and pinion system may be configured to move moveable insertion tip306away from fixed insertion tip304, for example. A spring lock design may include design elements that force the separation of insertion tips304and306. One such example may include spring forces that remain locked in a compressed state until the component advancer or separating wedge activate a release trigger, thereby releasing the compressed spring force onto insertion tip306, creating a separating force. These spring forces must be of sufficient magnitude to create the desired separation of tips304and306in the biological tissue. Alternatively, the spring compression may forceable close the insertion tips until the closing force is released by the actuator. Once released, the tips are then driven to a separating position by the advancement wedge mechanism, as described herein.

In some implementations, the component delivered by delivery system200(e.g., described above) may be an electrical lead for implantation in the patient. The lead may comprise a distal portion, one or more electrodes, a proximal portion, and/or other components. The distal portion may be configured to engage component advancer302of delivery system200(e.g., via notch1302shown inFIGS.13and14). The distal portion may comprise the one or more electrodes. For example, the one or more electrodes may be coupled to the distal portion. The one or more electrodes may be configured to generate therapeutic energy for biological tissue of the patient. The therapeutic energy may be, for example, electrical pulses and/or other therapeutic energy. The biological tissue may be the heart (e.g., heart118shown inFIG.1-FIG.2C) and/or other biological tissue. The proximal portion may be coupled to the distal portion. The proximal portion may be configured to engage a controller when the lead is implanted in the patient. The controller may be configured to cause the one or more electrodes to generate the therapeutic energy, and/or perform other operations.

FIG.16illustrates an example implementation of an electrical lead1600. Lead1600may comprise a distal portion1602, one or more electrodes1604, a proximal portion1606, and/or other components. Distal portion1602may be configured to engage component advancer302of delivery system200(e.g., via notch1302shown inFIGS.13and14). In some implementations, distal portion1602may comprise a proximal shoulder1608. Proximal shoulder may be configured to engage component advancer302(e.g., via notch1302shown inFIGS.13and14) such that lead1600is maintained in a particular orientation when lead1600is advanced into the patient. For example, in some implementations, proximal shoulder1608may comprise a flat surface1610(e.g., at a proximal end of distal portion1602). In some implementations, proximal shoulder1608may comprise a rectangular shape1612. Flat surface1610and/or rectangular shape1612may be configured to correspond to a (e.g., rectangular) shape of notch1302shown inFIGS.13and14. In some implementations, transition surfaces between flat surface1610and other portions of distal portion1602may be chamfered, rounded, tapered, and/or have other shapes.

In some implementations, proximal shoulder1608may include one or more coupling features configured to engage component advancer302to maintain the lead in a particular orientation so as to avoid rotation of the lead when the lead is advanced into the patient. In some implementations, these coupling features may include receptacles for pins included in pusher tube1300, clips, clamps, sockets, and/or other coupling features.

In some implementations, proximal shoulder1608may comprise the same material used for other portions of distal portion1602. In some implementations, proximal shoulder may comprise a more rigid material, and the material may become less rigid across proximal shoulder1608toward distal end1620of distal portion1602.

In some implementations, proximal shoulder1608may function as a fixation feature configured to make removal of lead1600from a patient (and/or notch1302) more difficult. For example, when lead1600is deployed into the patient, lead1600may enter the patient led by a distal end1620of the distal portion1602. However, retracting lead1600from the patient may require the retraction to overcome the flat and/or rectangular profile of flat surface1610and/or rectangular shape1612, which should be met with more resistance. In some implementations, delivery system200(FIG.3) may include a removal device comprising a sheath with a tapered proximal end that can be inserted over lead1600so that when it is desirable to intentionally remove lead1600, the flat and/or rectangular profile of shoulder1608does not interact with the tissue on the way out.

FIG.17illustrates another example implementation1700of electrical lead1600. In some implementations, as shown inFIG.17, distal portion1602may include one or more alignment features1702configured to engage delivery system200(FIG.3) in a specific orientation. For example, alignment features1702of lead1600may include a rib1704and/or other alignment features configured to engage a groove in a channel (e.g., channel500shown inFIG.5) of insertion tip304and/or306(FIG.5). Rib1704may be on an opposite side1706of the lead1600relative to a side1708with electrodes1604, for example. These features may enhance the guidance of lead1600through channel500, facilitate alignment of lead1600in channel500(e.g., such that electrodes1604are oriented in a specific direction in tips304,306), prevent lead1600from exiting tips304,306to one side or the other (as opposed to exiting out ends404,406shown inFIG.4), and/or have other functionality.

In some implementations, rib1704may be sized to be just large enough to fit within the groove in the channel500. This may prevent the lead from moving within the closed insertion tips304,306while the insertion tips are pushed through the intercostal muscle tissue. Additionally, rib1704may prevent an operator from pulling lead1600too far up into delivery system200(FIG.3) when loading delivery system200with a lead (e.g., as described below). This may provide a clinical benefit, as described above, and/or have other advantages.

FIG.18illustrates distal portion1602of lead1600bent1800in a predetermined direction1804. In some implementations, distal portion1602may be preformed to bend in predetermined direction1804. The pre-forming may shape set distal portion1602with a specific shape, for example. In the example, shown inFIG.18, the specific shape may form an acute angle1802between ends1620,1608of distal portion1602. The pre-forming may occur before lead1600is loaded into delivery system200(FIG.3), for example. In some implementations, distal portion1602may comprise a shape memory material configured to bend in predetermined direction1804when lead1600exits delivery system200. The shape memory material may comprise nitinol, a shape memory polymer, and/or other shape memory materials, for example. The preforming may include shape setting the shape memory material in the specific shape before lead1600is loaded into delivery system200.

Distal portion1602may be configured to move in an opposite direction1806, from a first position1808to a second position1810when lead1600enters the patient. In some implementations, first position1808may comprise an acute angle1802shape. In some implementations, the first position may comprise a ninety degree angle1802shape, or an obtuse angle1802shape. In some implementations, the second position may comprise a ninety degree angle1802shape, or an obtuse angle1802shape. Distal portion1602may be configured to move from first position1808to second position1810responsive to the shape memory material being heated to body temperature or by removal of an internal wire stylet, for example. In some implementations, this movement may cause an electrode side of distal portion1602to push electrodes1604into tissues toward a patient's heart, rather than retract away from such tissue and the heart. This may enhance electrical connectivity and/or accurately delivering therapeutic energy toward the patient's heart, for example.

FIG.19illustrates distal portion1602bending1800in the predetermined direction1804when lead1600exits delivery system200. In some implementations, as shown inFIG.19, the predetermined direction may comprise a lateral and/or transverse direction1900relative to an orientation1902of insertion tips304and/or306, a sternum of the patient, and/or other reference points in delivery system200and/or in the patient.

FIGS.20and21illustrate implementations2000and2100of distal portion1602of lead1600. In some implementations, distal portion1602may include distal end1620and distal end1620may include a flexible portion2002so as to allow distal end1620to change course when encountering sufficient resistance traveling through the biological tissue of the patient. In some implementations, distal end1620may be at least partially paddle shaped, and/or have other shapes. The paddle shape may allow more surface area of distal end1620to contact tissue so the tissue is then exerting more force back on distal end1620, making distal end1620bend and flex via flexible portion2002. In some implementations, flexible portion2002may comprise a material that flexes more easily relative to a material of another area of distal portion1602. For example, flexible portion2002may comprise a different polymer relative to other areas of distal portion1602, a metal, and/or other materials.

In some implementations, flexible portion2002may comprise one or more cutouts2004. The one or more cutouts2004may comprise one or more areas having a reduced cross section compared to other areas of distal portion1602. The one or more cutouts2004may be formed by tapering portions of distal portion1602, removing material from distal portion1602, and/or forming cutouts2004in other ways. The cutouts may increase the flexibility of distal end1620, increase a surface area of distal end1620to drive distal end1620in a desired direction, and/or have other purposes. Cutouts2004may reduce a cross-sectional area of distal end1620, making distal end1620more flexible, and making distal end1620easier to deflect. Without such cutouts, for example, distal end1620may be too rigid or strong, and drive lead1600in a direction that causes undesirable damage to organs and/or tissues within the anterior mediastinum (e.g., the pericardium or heart).

In some implementations, the one or more areas having the reduced cross section (e.g., the cutouts) include a first area (e.g., cutout)2006on a first side2008of distal end1620. The one or more areas having the reduced cross section (e.g., cutouts) may include first area2006on first side2008of distal end1620and a second area2010on a second, opposite side2012of distal end1620. This may appear to form a neck and/or other features in distal portion1602, for example.

In some implementations, as shown inFIG.21, the one or more areas having the reduced cross section may include one or more cutouts2100that surround distal end1620. Referring back toFIG.18, in some implementations, distal portion1602may have a surface1820that includes one or more electrodes1604, and a cut out1822in a surface1824of distal end1620opposite surface1820with one or more electrodes1604. This positioning of cutout1822may promote a bias of distal end1620back toward proximal shoulder1608(FIG.16) of lead1600. In some implementations, cutout1822may create a bias (depending upon the location of cutout2100) acutely in direction1804or obtusely in direction1806. Similarly, alternative cutouts2100may be inserted to bias distal end1620in other directions.

Returning toFIGS.20and21, in some implementations, flexible portion2002may be configured to cause distal end1620to be biased to change course in a particular direction. Distal end1620may change course in a particular direction responsive to encountering resistance from biological tissue in a patient, for example. In some implementations, biasing distal end1620to change course in a particular direction may comprise biasing distal end1620to maintain electrodes1604on a side of distal portion1602that faces the heart of the patient. For example, distal end1620may be configured to flex or bend to push through a resistive portion of biological material without twisting or rotating to change an orientation of electrodes1604.

In some implementations, distal portion1602may include a distal tip2050located at a tip of distal end1620. Distal tip2050may be smaller than distal end1620. Distal tip2050may be more rigid compared to other portions of distal end2050. For example, distal tip2050may be formed from metal (e.g., that is harder than other metal/polymers used for other portions of distal end1620), hardened metal, a ceramic, a hard plastic, and/or other materials. In some implementations, distal tip2050may be blunt, but configured to push through biological tissue such as the endothoracic fascia, and/or other biological tissue. In some implementations, distal tip2050may have a hemispherical shape, and/or other blunt shapes that may still push through biological tissue.

In some implementations, distal tip2050may be configured to function as an electrode (e.g., as described herein). This may facilitate multiple sense/pace vectors being programmed and used without the need to reposition electrical lead1600. For example, once the electrical lead1600is positioned, electrical connections can be made to the electrodes1604and cardiac pacing and sensing evaluations performed. If unsatisfactory pacing and/or sensing performance is noted, an electrical connection may be switched from one of the electrodes1604to the distal electrode2050. Cardiac pacing and/or sensing parameter testing may then be retested between one of the electrodes1604and the distal electrode2050. Any combination of two electrodes can be envisioned for the delivery of electrical therapy and sensing of cardiac activity, including the combination of multiple electrodes to create one virtual electrode, then used in conjunction with a remaining electrode or electrode pairing. Additionally, electrode pairing may be selectively switched for electrical therapy delivery vs. physiological sensing.

Returning toFIG.16, in some implementations, at least a portion of distal portion1602of lead1600may comprise two parallel planar surfaces1650. One or more electrodes1604may be located on one of the parallel planar surfaces, for example. Parallel planar surfaces1650may comprise elongated, substantially flat surfaces, for example. (Only one parallel planar surface1650is shown inFIG.16. The other parallel planar surface1650may be located on a side of distal portion1602opposite electrodes1604, for example.) In some implementations, at least a portion1652of distal portion1602of lead1600may comprise a rectangular prism including the two parallel planar surfaces1650.

Because the proximal end of the distal portion1602may be positioned within the intercostal muscle tissue (while the distal end of the distal portion1602resides in the mediastinum), the elongated, substantially flat surfaces of proximal end of the distal portion1602may reduce and/or prevent rotation of distal portion1602within the muscle tissue and within the mediastinum. In contrast, a tubular element may be free to rotate. In some implementations, distal portion1602may include one or more elements configured to engage and/or catch tissue to prevent rotation, prevent egress and/or further ingress of distal portion1602, and/or prevent other movement. Examples of these elements may include tines, hooks, and/or other elements that are likely to catch and/or hold onto biological tissue. In some implementations, the bending of distal portion1602(e.g., as described above related toFIG.18) may also function to resist rotation and/or other unintended movement of distal portion1602in a patient. Distal portion1602may also be designed with multiple segments, with small separating gaps between each segment, designed to increase stability within the tissue, increase the force required for lead retraction or to promote tissue ingrowth within the distal portion1602.

FIG.22illustrates an example of an electrode1604. In some implementations, an electrode1604may be formed from a conductive metal and/or other materials. Electrodes1604may be configured to couple with distal portion1602of lead1600, proximal portion1606(e.g., wiring configured to conduct an electrical signal from a controller) of lead1600, and/or other portions of lead1600. In some implementations, distal portion1602may comprise a rigid material, with an area of distal portion1602around electrodes1604comprising a relatively softer material. One or more electrodes1604may protrude from distal portion1602of lead1600(e.g., as shown inFIG.16). Electrodes1604may be configured to provide electrical stimulation to the patient or to sense electrical or other physiologic activity from the patient (e.g., as described above). In some implementations, one or more electrodes1604may include one or both of corners2200and edges2202configured to enhance a current density in one or more electrodes1604. In some implementations, at least one of the electrodes1604may comprise one or more channels2204on a surface2206of the electrode1604. In some implementations, at least one of the one or more electrodes1604may comprise two intersecting channels2204on surface2206of the electrode1604. In some implementations, the channels2204may be configured to increase a surface area of an electrode1604that may come into contact with biological tissue of a patient. Other channel designs are contemplated.

FIG.23illustrates a cross section2300of example electrode1604. In some implementations, as shown inFIG.23, at least one of the one or more electrodes1604may be at least partially hollow2302. In such implementations, an electrode1604may include a hole2304configured to allow the ingress of fluid. In some implementations, an electrode1604may include a conductive mesh (not shown inFIG.23) within hollow area2302. The conductive mesh may be formed by conductive wiring, a porous sheet of conductive material, and/or other conductive meshes electrically coupled to electrode1604. In some implementations, an electrode1604may include electrically coupled scaffolding within hollow area2302. The scaffolding may be formed by one or more conductive beams and/or members placed in and/or across hollow area2302, and/or other scaffolding.

These and/or other features of electrodes1604may be configured to increase a surface area and/or current density of an electrode1604. For example, channels in electrodes1604may expose more surface area of an electrode1604, and/or create edges and corners that increase current density, without increasing a size (e.g., the diameter) of an electrode1604. The corners, hollow areas, conductive mesh, and/or scaffolding may function in a similar way.

In some implementations, an anti-inflammatory agent may be incorporated by coating or other means to electrode1604. For example, a steroid material may be included in hollow area2302to reduce the patient's tissue inflammatory response.

As described above, in some implementations, system200(FIG.3) includes the electrical lead1600(FIG.16), handle300(FIG.3), component advancer302(FIG.3), first and second insertion tips304,306(FIG.3), and/or other components. First insertion tip304and second insertion tip306may be configured to close around a distal tip of the electrical lead when the electrical lead is placed within component advancer302. First insertion tip304and second insertion tip306may be configured to push through biological tissue when in a closed position and to open to enable the electrical lead to exit from component advancer302into the patient. Component advancer302, first insertion tip304, and second insertion tip306may be configured to maintain the electrical lead in a particular orientation during the exit of the component from component advancer302into the patient. Also as described above, first insertion tip304may include a ramped portion configured to facilitate advancement of the component into the patient in a particular direction, and/or the electrical lead may be configured to bend in a predetermined direction after the exit of the component from the component advancer (e.g., because of its shape memory properties, etc.).

FIG.24illustrates components of delivery system200configured to load (or reload) a component (e.g., an electrical lead1600shown inFIG.16) into delivery system200. In some implementations, to facilitate reloading delivery system200, an operator may thread proximal portion1606(FIG.16) of lead1600backwards through insertion tips304,306(FIG.3), through pusher tube1300(in an implementation shown inFIG.13) and out through an opening2430in handle300. In some implementations, component advancer302may be configured to reload a component (e.g., an electrical lead) into delivery system200. In such implementations, handle300may be configured to move from an advanced position2400to a retracted position2402to facilitate the reload of the component (e.g., the electrical lead).

In some implementations, handle300may include a dock2404configured to engage an alignment block coupled with the component (e.g., electrical lead) such that, responsive to handle300moving from advanced position2400to retracted position2402, the engagement between dock2404and the alignment block draws the component into delivery system200to reload delivery system200. As a non-limiting example using the implementation of component advancer302shown inFIG.13-14, once the alignment block and electrical lead are properly seated within dock2404, handle300may be re-cocked (e.g., moved from position2400to position2402), which draws distal portion1602of electrical lead1600into delivery system200and closes insertion tips304,306(FIG.3).

In some implementations, dock2404may comprise one or more alignment and/or locking protrusions2406(the example inFIG.24illustrates two protrusions2406) located on a portion2408of handle300toward component advancer302. Locking protrusions2406may have a “U” shaped channel configured to receive a wire portion (e.g., part of proximal portion1606) of an electrical lead1600(FIG.16). Locking protrusions2406may have a spacing2410that corresponds to a size of an alignment block on the wire portion of electrical lead1600and allows the alignment block to fit between locking protrusions2406(with the wire portions resting in the “U” shaped channels of locking protrusions2406).

FIG.25illustrates an example of an alignment block2500coupled to proximal portion1606of an electrical lead1600. Alignment block2500may have a cylindrical shape, for example, with a length matching spacing2410configured to fit between locking protrusions2406shown inFIG.24.

Returning toFIG.24, in some implementations, handle300may include an alignment surface2420configured to receive the proximal portion1606(FIG.25) of electrical lead1600(FIG.16) such that, responsive to handle300moving from the advanced position to the retracted position, the component is drawn into delivery system200to reload delivery system200. In some implementations, alignment surface2420may be the same as surface2408, but without locking protrusions2406. In some implementations, an operator may hold proximal portion1606against alignment surface2420, within a retention block2406, with finger pressure while handle300moves from advanced position2400to retracted position2402, for example. In some implementations, the alignment block2500may not be utilized.

In the descriptions above and in the claims, phrases such as “at least one of” or “one or more of” may occur followed by a conjunctive list of elements or features. The term “and/or” may also occur in a list of two or more elements or features. Unless otherwise implicitly or explicitly contradicted by the context in which it used, such a phrase is intended to mean any of the listed elements or features individually or any of the recited elements or features in combination with any of the other recited elements or features. For example, the phrases “at least one of A and B;” “one or more of A and B;” and “A and/or B” are each intended to mean “A alone, B alone, or A and B together.” A similar interpretation is also intended for lists including three or more items. For example, the phrases “at least one of A, B, and C;” “one or more of A, B, and C;” and “A, B, and/or C” are each intended to mean “A alone, B alone, C alone, A and B together, A and C together, B and C together, or A and B and C together.” Use of the term “based on,” above and in the claims is intended to mean, “based at least in part on,” such that an unrecited feature or element is also permissible.

The subject matter described herein can be embodied in systems, apparatus, methods, computer programs and/or articles depending on the desired configuration. Any methods or the logic flows depicted in the accompanying figures and/or described herein do not necessarily require the particular order shown, or sequential order, to achieve desirable results. The implementations set forth in the foregoing description do not represent all implementations consistent with the subject matter described herein. Instead, they are merely some examples consistent with aspects related to the described subject matter. Although a few variations have been described in detail above, other modifications or additions are possible. In particular, further features and/or variations can be provided in addition to those set forth herein. The implementations described above can be directed to various combinations and subcombinations of the disclosed features and/or combinations and subcombinations of further features noted above. Furthermore, above described advantages are not intended to limit the application of any issued claims to processes and structures accomplishing any or all of the advantages.

Additionally, section headings shall not limit or characterize the invention(s) set out in any claims that may issue from this disclosure. Further, the description of a technology in the “Background” is not to be construed as an admission that technology is prior art to any invention(s) in this disclosure. Neither is the “Summary” to be considered as a characterization of the invention(s) set forth in issued claims. Furthermore, any reference to this disclosure in general or use of the word “invention” in the singular is not intended to imply any limitation on the scope of the claims set forth below. Multiple inventions may be set forth according to the limitations of the multiple claims issuing from this disclosure, and such claims accordingly define the invention(s), and their equivalents, that are protected thereby.