|Publication number||US20050080472 A1|
|Application number||US 10/736,863|
|Publication date||14 Apr 2005|
|Filing date||16 Dec 2003|
|Priority date||10 Oct 2003|
|Also published as||EP1722847A2, EP1722847A4, US7797053, US20060009830, WO2005053784A2, WO2005053784A3|
|Publication number||10736863, 736863, US 2005/0080472 A1, US 2005/080472 A1, US 20050080472 A1, US 20050080472A1, US 2005080472 A1, US 2005080472A1, US-A1-20050080472, US-A1-2005080472, US2005/0080472A1, US2005/080472A1, US20050080472 A1, US20050080472A1, US2005080472 A1, US2005080472A1|
|Inventors||Robert Atkinson, Peter Keith, Michael Berman|
|Original Assignee||Atkinson Robert Emmett, Keith Peter Trexler, Michael Berman|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (57), Referenced by (51), Classifications (11), Legal Events (1)|
|External Links: USPTO, USPTO Assignment, Espacenet|
This application claims the benefit of U.S. Provisional Patent Application No. 60/510,663, filed Oct. 10, 2003, entitled LEAD STABILIZATION DEVICES AND METHODS to Atkinson et al., the entire disclosure of which is incorporated herein by reference.
The present invention generally relates to medical devices and methods. More specifically, the present invention relates to medical devices and methods for stabilizing leads in cardiac vasculature.
Heart failure is an increasingly common condition worldwide. Cardiac resynchronization therapy (CRT) has shown great promise as a treatment for a large percentage of patients in various stages of heart failure. CRT involves cardiac pacing of both the left and right ventricles of the heart (biventricular pacing), which causes both ventricles to beat simultaneously, greatly improving the pumping efficiency of the heart. Typically, the lead that stimulates the left ventricle is positioned via the coronary sinus into a cardiac vein along the free wall of the left ventricle.
There are numerous challenges in successfully positioning the left ventricular lead, including accessing the coronary sinus and veins, advancing the leads to a position which yields proper stimulation, and preventing subsequent lead dislodgement during removal of delivery devices. Post procedural challenges related to the left ventricular lead include lead dislodgement prior to fibrosis, loss of stimulation capture, and lead removal necessitated by infection.
Currently available left ventricular leads have generally been designed to facilitate effective delivery and provide fatigue resistance, and are particularly susceptible to dislodgement both intra-procedurally and post-procedurally. Efforts to incorporate more aggressive anchoring into the lead body have generally been insufficient for preventing dislodgment, and/or have compromised effective delivery, fatigue resistance and subsequent lead removal.
Therefore, a need exists to enable effective lead stabilization without compromising lead delivery, resistance to lead fatigue, or lead removal. To address this need, various exemplary non-limiting embodiments are described herein which provide devices and methods for acute and/or chronic lead stabilization. By way of example, not limitation, the lead stabilization mechanisms described herein may be separate from but cooperative with the lead, thus allowing independent delivery and function. To this end, the lead may be designed for effective delivery and fatigue resistance, and the stabilization mechanism may be designed for effective acute and/or chronic anchoring to prevent lead dislodgement. In addition, the stabilization mechanisms described herein may be separable from the lead to permit subsequent lead removal.
The following detailed description should be read with reference to the drawings in which similar elements in different drawings are numbered the same. The drawings, which are not necessarily to scale, depict illustrative embodiments and are not intended to limit the scope of the invention.
With reference to
Left ventricular leads are typically implanted with the proximal end connected to a pulse generator in a subcutaneous or submuscular pocket, and the distal end (electrode(s)) disposed in one of the cardiac veins to stimulate the left ventricle. The lead body typically extends from the pulse generator in the subcutaneous or submuscular pocket, through the vein wall and into the left subclavian vein (LSV), through the left brachio-cephalic vein (LBV), down the superior vena cava (SVC) and into the right atrium (RA), into the CS and into the target cardiac vein. The venous circulation is usually accessed by introducing delivery catheters (called guide catheters or guide sheaths) from a venous arteriotomy in the LSV to the CS ostium, following the dashed line shown in
There are generally two categories of LV leads, over-the-wire (OTW) leads and stylet-delivered leads. OTW leads incorporate a guide wire lumen which extends through the entire lead body, emerging at the tip of the lead. Navigation within the CS and cardiac veins is performed by advancing a steerable guide wire to a desired location in a cardiac vein, and the lead is then advanced over the guide wire. Stylet delivered leads have a stylet lumen which extends through the lead body, but typically terminates proximal of the distal tip. A shaped styled is positioned in the stylet lumen and the lead and stylet are advanced together to navigate the lead to a desired location in a cardiac vein.
Once the lead is positioned in a location that yields acceptable stimulation (capture), the delivery catheter is removed. Depending on the particular lead, and the type of electrical connector utilized, removal is accomplished either by withdrawing the delivery catheter over the proximal end of the lead, or by splitting the delivery catheter as it is removed over the proximal end of the lead. In some situations, removal of the delivery catheter may dislodge the lead, as the stability of the lead position is often quite tenuous. Even if the lead is not dislodged during removal of the delivery catheter, the beating of the heart and other patient activities can cause lead movement or dislodgement, leading to potential loss of capture (effective pacing of the LV).
With reference to
Lead 10 may comprises a conventional pacing lead having an elongate body or shaft 12 and one or more electrodes 14 connected to a pulse generator (not shown) by corresponding wires or traces inside the lead body 12. Lead 10 is generally designed to be very flexible and fatigue resistant to permit free cardiac movement, to minimize tissue trauma, and to withstand repeated flexure primarily caused by the beating heart. The electrodes 14 are typically positioned on or near the wall of the vein facing the heart to establish effective conduction into the heart wall.
Stent 20 may be self-expandable or balloon expandable, for example, and may be formed of a biocompatible metal material such as stainless steel, Nitinol, Elgiloy, or MP35N. Alternatively, stent 20 may be formed of a biodegradable polymeric material such as poly-L-lactic acid, polyglycolic acid, or polycaprolactone, or other biodegradable materials such as those used for biodegradable sutures. In the case of polymeric materials used for stent 20, the polymer may be loaded with a radiopaque agent such as barium, bismuth subcarbonate, etc. to facilitate x-ray visualization. Generally speaking, all of the anchors of the anchor devices described herein may be formed of the aforementioned materials and may be radiopaque.
Stent 20 may be connected to lead 10 by an elongate connector 30. Elongate connector 30 may comprise a tether that is flexible and fatigue resistant such as a braided cord of a high strength biocompatible polymer such as polyester, polypropylene, or polyethylene (e.g., Spectra brand), and may be partially or fully covered or coated with a material that promotes tissue in-growth such as ePTFE. The tissue in-growth promoting material may serve to secure the elongate member 30 to the lead 10 and/or prevent bacteria migration along the elongate member 30.
In the embodiment illustrated in
In this embodiment, the stent 20 and tether 30 may be deployed before the lead 10 is delivered. The stent 20 may be deployed in a distal portion of the target CV with a delivery device as described in more detail with reference to
If it is necessary or desired to remove or reposition the lead 10, the lead 10 may be removed from the CV by disconnecting the tether 30 from the lead 10 (e.g., by cutting the knot in the tether 30 at the proximal end of the lead 10), the tether 30 may be removed from the CV by disconnecting the tether 30 from the stent 20 (e.g., by using a cutting device as described in more detail with reference to
With reference to
The tether 30 may be connected to the lead 10 by a fastener such as collar 40. Collar 40 may comprise a short dual lumen tube including a relatively large lumen to accommodate the lead 10 therethrough and a relatively small lumen to accommodate the tether 30 therethrough. Collar 40 may be fixedly connected to the lead 10 if the anchor device is delivered prior to the lead 10 by swaging, adhesive, etc. To facilitate delivery of the lead after placement of the lead 10, the collar 40 may be slidable over the lead 10 and lock in place adjacent the distal potion of the lead 10 using a mating geometry such as a detent on the outer surface of the lead 10 that receives a protrusion extending from the inside surface of the collar 40. Alternatively, the outer surface of the lead 10 may include a protrusion such as a stepped ridge 45 that abuts the distal end of the collar 40 as the collar 40 is advanced over the lead 10 in order to prevent proximal movement of the lead 10 relative to the collar 40. With this alternative, the stepped ridge 45 may be an integral extension of the outer surface of the lead 10 or a separate component fixedly connected to the lead 10.
The tether 30 may be effectively connected to the collar 40 to prevent proximal movement of the collar 40 relative to the tether 30 by utilizing a knot or stop 35 that is slid down the length of the tether 30. A knot may be made in the tether at its proximal end and advanced distally to the collar 40 using a conventional knot pusher. A stop 35 may be used and configured to readily advance distally over the tether 30 and resist retraction proximally. For example, stop 35 may comprise a short tubular segment having proximal facing flanges extending from the inside surface that selectively engage the tether 30 only when the stop 35 is advanced in the proximal direction relative to the tether 30. To facilitate removal of the lead 10, the stop 35 may be cut or the tether 30 may be cut between the stop 35 and the collar 40 using the cutting device described with reference to
To facilitate advancement of the collar 40 over the lead 10 and to facilitate advancement of the stop 35 over the tether 35, a dual lumen advancement sheath 50 may be slid (pushed) over the lead 10 and tether 30. Sheath 50 may comprise an elongate dual lumen tube having a length sufficient to extend over the lead 10, through the venous vasculature, and out the venous access site, with one lumen to accommodate the lead 10 and another lumen to accommodate the tether 30. Sheath 50 may include a slit (not shown) along the length thereof to facilitate peeling over the lead 10. Sheath 50 may be removed over the lead 10 and tether 30 after advancement of the collar 40 and stop 35, or it may be left implanted to contain the tether 30 relative to the lead 10.
With reference to
With reference to
To facilitate delivery, a guide wire 130 may be used to initially navigate the CV. Once the guide wire 130 is in the desired position, the delivery catheter 100 with the pre-loaded stent 20 therein may then be advanced over the proximal end of the guide wire 130 and advanced thereover to the desired deployment position. The inner tube 110 may be advanced in the distal direction with respect to the outer tube 120 as indicated by arrow 115 to deploy the stent 20 in the CV. Once the stent 20 is deployed, the delivery catheter 100 may be removed.
With reference to
To accommodate delivery through the lumen extending through the lead 10, the coil 70 may have a delivery configuration wherein the coil 70 is elongated to have a reduced profile sufficiently small to fit into the lumen, and a deployed configuration wherein the coil 70 is radially expanded to have an expanded profile sufficiently large to frictionally engage the wall of the CV. The coil 70 may be highly elastic such that it assumes the deployed configuration automatically upon advancement out of the distal end of the lead 10, or the coil may be actuated (e.g., thermally) upon advancement out of the distal end of the lead 10 to assume the deployed configuration.
With reference to
With reference to
With reference to
With specific reference to
With specific reference to
With reference to
In this exemplary embodiment, cutting device 160 includes an outer tube 162 and an inner tube 164 coaxially disposed and movable therein. The outer and inner tubes 162 and 164 may have a length sufficient to extend from outside the vascular access site to the anchor device, and may be configured for intravascular navigation and advancement over tether 30. The distal end of the inner tube 164 may have a sharpened edge and may be formed of a material that retains a cutting edge (e.g., metal). A cutting hole 168 is provided adjacent the distal end of the outer tube 162 through which the tether 30 may be threaded. The distal circumference of the cutting hole 168 may be sharpened and may be formed of a material that retains a cutting edge (e.g., metal) After the cutting device is advanced over the tether 30 to the desired cutting site, the inner tube 164 may be advanced distally as indicated by arrow 166, with the sharpened distal end of the inner tube 164 and the sharpened cutting hole 168 acting as shears to cut the tether 30 at the cutting hole 168.
With reference to
Coil stent 200 may be formed of a resilient material such as Nitinol, Elgiloy, MP35N, or stainless steel. Coiled stent 200 could also be formed of degradable materials such as those described in reference to stent 20 above. Coiled stent 200 may be releasably attached to the lead 10 utilizing collar 210, and collar 210 may frictionally engage the body 12 of lead 10, thus facilitating anchoring of the lead within the coronary sinus or cardiac vein.
With reference to
To facilitate subsequent removal of the lead 10, the coiled stent 200 may be connected to the collar 210 in a detachable manner. For example, the coiled stent 200 may be connected to the collar 210 utilizing a biodegradable adhesive connecting adjacent portions of the coil 200 to the collar 210. Such an adhesive may degrade after the lead 10 has chronically anchored to the wall of the CS by normal tissue encapsulation. After the adhesive has degraded, the lead 10 (along with collar 210) may be removed utilizing standard techniques, with the coiled stent 200 remaining in the CS.
Alternatively, the coiled stent 200 may be secured to the collar 210 utilizing a retractable pin 220. In this alternative embodiment, collar 210 may include two angled flanges 214 collectively defining a recess 216 in which stent coil 200 may reside. Pin 220 may span the length of the recess 216 between the flanges 214, extending over the coiled stent 200 to retain the coil stent 200 in the recess 216, thus providing a connection between the stent coil 200 and the collar 214. Subsequent release of the stent coil 200 from the lead 10 may be accomplished by removing pin 220 using tether 30 which extends from the proximal end of the lead 10 to the pin 220. The proximal end of the pin 220 is connected to the distal end of the tether 30, and the pin 220 may be removed by pulling the tether 30 proximally. After the pin 220 is removed, the lead 10 and collar 210 are free from the stent coil 200 and may be removed with standard techniques, leaving stent coil 200 in the CS.
Delivery and deployment of the stent coil 200 and collar 210 may be facilitated by deployment sheath 230. The deployment sheath 230 may comprise a tubular catheter, having a lumen extending therethrough to accommodate the lead 10 and the stent coil 200. Alternatively, the lumen in the deployment sheath 230 may extend from a distal opening to a mid-shaft opening as used in conventional monorail style balloon catheters. After lead 10 has been positioned by standard techniques to a desired position, the stent coil 200 and collar 210 may be loaded on the proximal end of the lead 10. Coil 200 may be initially in a compressed condition, and loaded in the inside of the deployment sheath 230. If the lead 10 has a large diameter proximal connector, an optional slit 215 may be provided in the collar 220 to facilitate loading over the large diameter connector. In this case, the collar 210 and coil 200 may be positioned on the lead body 12 before the coil 200 is loaded into the deployment sheath 230. The deployment sheath 230 may be advanced distally down the body 12 of the lead 10 until the stent coil 200 and collar 210 are in the desirable location. The deployment sheath 230 may then be withdrawn proximally, with the collar 210 and stent coil 200 remaining in position on the lead 10 due to grips 218 on collar 210. As the stent coil 200 emerges from the deployment sheath 230, it expands to engage the wall of the CS. The deployment sheath 230 can then be removed from the lead 10.
In use, the anchoring catheter 300 is positioned next to the lead 10 after lead 10 has been positioned in a desired location. Anchoring catheter 300 may be advanced within the guide sheath (not shown), generally parallel to the lead body 12, or may be advanced outside the guide sheath. An expandable member such as a balloon 314 is inflated to frictionally secure lead 10 against the wall of the blood vessel. The guide sheath can then be removed without inadvertent dislodgement of the lead 10. The anchoring catheter 300 can then be removed. Since anchoring catheter 300 is next to and not surrounding the lead body 12, removal of the anchoring catheter 300 does not pose a risk of dislodging lead 10.
With particular reference to
Proximal shaft portion 312A may be relatively stiff and may be formed of a metallic tube such as a stainless steel hypotube. Distal shaft portion 312B may be relatively flexible and may be formed of a polymeric tube, for example. To facilitate advancement of the flexible distal shaft portion 312B and the balloon 314, a core wire may be connected to and extend from the distal end of the proximal shaft portion 312A. The core wire 320 may comprise a metal wire such as a tapered stainless steel mandrel.
Core wire 320 extends to the distal end of the balloon 314, and may extend beyond with an atraumatic spring tip, for example. The distal end of the balloon 314 may be bonded to the core wire 320, and the proximal end of the balloon 314 may be bonded to the distal end of the distal shaft portion 312B. Within the shaft 312 is a lumen through which inflation medium is infused to inflate balloon 314.
Those skilled in the art will recognize that the present invention may be manifested in a variety of forms other than the specific embodiments described and contemplated herein. Accordingly, departures in form and detail may be made without departing from the scope and spirit of the present invention as described in the appended claims.
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|International Classification||A61F2/86, A61N1/05|
|Cooperative Classification||A61F2230/0076, A61F2230/005, A61F2220/0008, A61F2/86, A61F2/95, A61N1/057|
|European Classification||A61N1/05N4, A61F2/86|
|16 Dec 2003||AS||Assignment|
Owner name: AETHERWORKS I, INC., MINNESOTA
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:ATKINSON, ROBERT E.;KEITH, PETER T.;BERMAN, MICHAEL;REEL/FRAME:014804/0692
Effective date: 20031212