Stabilizer sleeve for a pacemaker lead

Abstract

A stabilizer sleeve is disclosed for use with cardiac implantable electronic device leads. The sleeve comprises a tubular body sized to receive the lead and shaped to bias the lead toward a desired anatomical location, thereby reducing migration, dislodgement, and interference with cardiac structures. The sleeve may be introduced with the lead as a unitary assembly or added after lead placement. Various embodiments include a slitted body for expansion, radiopaque markers for visualization, detachable nose-cone tips for guidewire tracking, and antimicrobial coatings. The sleeve may be formed of polymers, alloys, or composite materials, and may include features such as texturing or anchoring projections for tissue engagement. Applications include positioning within a tricuspid valve commissure to minimize regurgitation and stabilizing left ventricular leads within branches of the coronary sinus. The device and methods described provide improved long-term stability and performance of implanted cardiac leads.

Description

STABILIZER SLEEVE FOR A PACEMAKER LEADBACKGROUND

[0001] The present disclosure relates to medical devices and surgical techniques. More specifically, it concerns systems and methods for stabilizing the leads of cardiac implantable electronic devices (CIEDs).

[0002] A common complication associated with right ventricular pacing leads is tricuspid regurgitation. This occurs when the lead interferes with normal valve closure, either by mechanical displacement or by inducing inflammatory and fibrotic changes that compromise leaflet function. The combined effects of mechanical obstruction and progressive tissue alteration often result in clinically significant regurgitation. Published reports describe a wide incidence range, from about 4% to over 70% of patients with implanted pacemaker leads.

[0003] Advances in structural heart therapies have made transcatheter tricuspid valve replacement (TTVR) a viable treatment option. However, a substantial number of patients eligible for TTVR already have transvenous pacing or defibrillator leads traversing the tricuspid valve. During TTVR, these leads may become “jailed” between the native valve and the prosthetic valve, exposing them to compressive forces and altered angulation. Such stress can cause lead fracture, insulation breach, or functional failure. Clinical data show that patients with pre-existing leads undergoing TTVR may face heightened risk, with lead extraction, revision, or replacement sometimes required.

[0004] Coronary sinus (CS) and left ventricular (LV) pacing leads, essential components of cardiac resynchronization therapy, also present placement and stability challenges. While these leads enable stimulation of the left-sided chambers and provide therapeutic benefit in heart failure, they are prone to dislodgement. Once positioned in a target branch of the coronary venous system, displacement remains the most common cause of reintervention. The recurrence of heart failure symptoms may be the first clinical sign of lead migration. Published experience places the rate of LV lead dislodgement near 6%, representing a significant limitation in long-term therapy effectiveness.015403-0902 1

[0005] In view of these challenges, there remains a pressing need for medical devices and surgical methods that provide secure positioning and stabilization of CIED leads, both to reduce complications and to enhance the safety of emerging structural heart interventions.SUMMARY

[0006] The disclosure provides a stabilizer sleeve and associated surgical methods for positioning and supporting CIED leads within the cardiovascular system.

[0007] In general, the device consists of a shaped sleeve, fabricated for example from polyimide tubing or other suitable materials, configured to surround and stabilize a CIED lead. The design is particularly adapted for catheter-delivered leads that lack a central lumen.

[0008] In one application, the sleeve functions to direct a pacing or defibrillator lead into a commissure of the tricuspid valve, thereby minimizing leaflet interference and reducing the incidence of lead-induced tricuspid regurgitation. The sleeve may also shield a previously implanted lead from compressive forces during placement of a transcatheter tricuspid valve prosthesis.

[0009] In another application, the sleeve secures the position of a coronary sinus or left ventricular lead, reducing the likelihood of dislodgement and simplifying both initial placement and long-term stability.

[0010] It is to be understood that the following disclosure describes several exemplary embodiments for implementing different features, structures, or functions of the device, system, and method. Exemplary embodiments of components, arrangements, and configurations are described below to simplify the disclosure; however, these exemplary embodiments are provided merely as examples and are not intended to limit the scope of the disclosure.BRIEF DESCRIPTION OF THE DRAWINGS

[0011] For a more complete understanding of the embodiments described herein, reference is made to the accompanying figures, in which:015403-0902 2

[0012] Figure 1 is a perspective view of a stabilizer sleeve 100 in accordance with the present disclosure.

[0013] Figure 2 is a schematic representation of a CIED lead 202 in combination with a stabilizer sleeve 204.

[0014] The figures are schematic and not necessarily drawn to scale, being simplified for clarity of explanation.DETAILED DESCRIPTION

[0015] The following detailed description sets forth representative embodiments of the stabilizer sleeve for a pacemaker lead, together with associated methods of use. These embodiments are provided as illustrative examples to aid in understanding the device, its features, and clinical applications. It will be appreciated that modifications and variations in materials, geometry, and procedural technique may be made without departing from the scope of the disclosure.

[0016] As seen in Figure 1, the stabilizer sleeve 100 is configured as a tubular body extending from a proximal end 102 to a distal end 104. The sleeve extends from a proximal end 102 to a distal end 104 and includes a central slit 108 configured to receive a CIED lead. Markers 106 may be disposed along the sleeve to facilitate radiographic visualization and orientation during implantation.

[0017] The sleeve 100 is dimensioned to surround at least a portion of a cardiac implantable electronic device (CIED) lead, thereby influencing its trajectory and stabilizing its position within the heart or coronary venous system. Radiopaque markers 106 facilitate fluoroscopic visualization and alignment during implantation. A longitudinal slit 108 extends along the sleeve, enabling it to be opened and fed onto a lead body, particularly advantageous when stabilizing a lead that is already in place. In some embodiments, the slit may include interlocking features or elastic memory so that it closes securely once deployed.

[0018] In certain embodiments, the geometry of the stabilizer sleeve 100 may be tailored to the intended application. Sleeve 100 may be straight for ease of advancement or preformed with bends or curves to bias the lead into a desired anatomical recess. For example, a curve near the distal end 104 can direct the lead body toward a commissural pocket of the tricuspid valve, thereby015403-0902 3minimizing interference with valve leaflet coaptation. In coronary sinus applications, the sleeve may have a longer tubular section that provides additional stiffness and secures a left ventricular lead within a venous branch, reducing the likelihood of displacement.

[0019] Figure 2 illustrates the stabilizer sleeve 204 in combination with a representative CIED lead 202. The lead 202 includes a proximal lead pin 206 for connection to a generator, a lead collar 208, and a distal screw tip 210 for active myocardial fixation. The stabilizer sleeve 204 is positioned along a portion of the lead body 212 and includes a slit 214 that permits feeding of the sleeve onto the lead. In use, the sleeve cooperates with the lead to enhance stability and maintain secure placement within the heart.

[0020] The stabilizer sleeve 204 provides distinct clinical benefits in two principal contexts. In the right heart, when a pacing lead 202 crosses the tricuspid valve, the sleeve 204 may bias the lead into a commissural recess. This positioning reduces the risk of leaflet impingement, thereby mitigating the development of tricuspid regurgitation. Because tricuspid regurgitation associated with pacing leads has been identified as a significant contributor to morbidity, the ability of the sleeve to maintain commissural anchoring represents an important advance. In the left heart, the sleeve 204 can be deployed along a left ventricular lead 202 positioned in the coronary sinus or one of its tributaries. By increasing stiffness and reinforcement, the sleeve prevents proximal retraction and helps preserve resynchronization therapy efficacy.

[0021] Sleeve 204 may be fabricated from a variety of biocompatible materials. Suitable polymers include polyimide, polyurethane, silicone, or polyethylene, each offering flexibility, strength, and long-term durability. Metallic elements, such as nitinol or stainless steel, may be incorporated to provide shape memory or structural reinforcement. Composite designs may balance flexibility and rigidity to suit the clinical context. Polyimide is particularly advantageous because of its tensile and flexural strength, favorable dielectric properties, and thermoset capability, which allows the sleeve to retain a preformed shape.

[0022] Several optional features may enhance sleeve performance. Radiopaque markers 106 facilitate visualization during placement and confirm final orientation. In some embodiments, a detachable nose-cone may be affixed to the distal end 104 to aid advancement through vascular structures or regions of fibrosis. The nose-cone may comprise two halves that snap together around015403-0902 4the lead and may include spiral ridges to provide auger-like rotational advancement. Once the sleeve is in position, the nose-cone can be detached and withdrawn.

[0023] The slit 108, 214 may be engineered with ridges, elastic memory, or interlocking edges to maintain closure once deployed. Placement may be facilitated by a splitter tool that temporarily separates the slit edges. One such tool may include a half-pipe channel aligned with the lead body and a guide bar that engages the slit edges, allowing the sleeve to advance smoothly over the lead. Delivery mechanisms may also be incorporated, such as a ribbon or wire that acts as both a pusher and rigidity backbone. The ribbon may be attached to the sleeve by a designed weak junction, which can be twisted or broken once the sleeve is correctly positioned.

[0024] The outer surface of the sleeve may be modified to improve safety and therapeutic performance. Surface coatings may include hydrophilic layers to aid navigation, antimicrobial or antibiotic agents to reduce infection risk, or antithrombotic compounds to limit clot formation. Microtexturing or ridges may be incorporated to enhance tissue integration and anchoring. The sleeve may also be impregnated with therapeutic agents, such as antibiotics or antiproliferative compounds, for extended local release.

[0025] Manufacturing techniques for the sleeve may include extrusion, molding, or laser cutting, depending on the chosen material. For polymeric designs, extrusion followed by precise slit formation produces uniform geometry. In composite designs, metallic reinforcement may be coextruded or bonded to the polymeric body. These manufacturing approaches allow the sleeve to be produced in various lengths, diameters, and stiffness profiles suited to different implantation scenarios.

[0026] Procedurally, the stabilizer sleeve may be employed in two ways. In one approach, the sleeve is preloaded onto the lead prior to insertion into the venous system. The combined assembly is advanced under fluoroscopic guidance to the desired position, where the sleeve provides directional bias and stability. In another approach, the sleeve is introduced after the lead has already been implanted. In this case, a slitted sleeve is advanced over the lead body and oriented using fluoroscopic or echocardiographic visualization. Once positioned, excess material may be trimmed proximally to ensure proper fit with the lead connector pin 206 and generator interface.015403-0902 5

[0027] Once implanted, the sleeve functions as a passive stabilizing structure, reducing flexion points, limiting mechanical stress on the lead body, and preventing displacement. It achieves these outcomes without active fixation mechanisms such as screws or tines, thereby reducing trauma to surrounding tissue. The sleeve may also be rigid enough in certain embodiments to be delivered without the use of a catheter. In other cases, two-piece constructions allow proximal and distal portions to be separated or removed selectively.

[0028] In application near the tricuspid valve, the sleeve stabilizes right ventricular leads by directing them into commissural recesses, reducing interference with leaflet closure. This function is critical for patients with native valves as well as those who have undergone transcatheter tricuspid valve replacement (TTVR). By minimizing flexion and compressive stress points, the sleeve also reduces abrasion of the lead against prosthetic valve surfaces. In coronary sinus applications, the sleeve anchors left ventricular leads within the sinus or its branches, preserving pacing site stability and reducing the likelihood of reintervention.

[0029] The stabilizer sleeve is therefore a versatile adjunct to conventional pacing leads. It is intuitive to use for physicians familiar with standard lead implantation techniques and addresses well-recognized complications without requiring substantial changes in procedural workflow. By reducing tricuspid regurgitation, minimizing lead migration, and enhancing the durability of resynchronization therapy, the sleeve provides both immediate procedural benefits and improved long-term outcomes.

[0030] The scope of the present disclosure is defined by the claims. The detailed embodiments, examples, and figures described herein are intended to illustrate representative features and clinical advantages of the stabilizer sleeve for a pacemaker lead, but do not limit the breadth of the disclosure.015403-0902 6

Claims

What is claimed is:

1. A stabilizer sleeve for a cardiac implantable electronic device lead, comprising: a tubular body extending from a proximal end to a distal end, the tubular body being sized to fit over and stabilize the lead, wherein the tubular body has a size and shape configured to direct the lead into a desired anatomical position so as to reduce displacement or valve interference; and a longitudinal slit formed in, and extending along, at least a portion of the tubular body, wherein the longitudinal slit is configured to receive the lead.

2. The stabilizer sleeve of claim 1, wherein the tubular body is formed of a polymer selected from polyimide, polyethylene, polyurethane, or combinations thereof.

3. The stabilizer sleeve of claim 1, wherein the tubular body is formed of a metallic material, a composite of polymer and metal, or nitinol.

4. The stabilizer sleeve of claim 1, further comprising one or more radiopaque markers disposed on the tubular body.

5. The stabilizer sleeve of claim 1, further comprising an antibiotic, antimicrobial, or antithrombotic coating disposed on the tubular body.

6. The stabilizer sleeve of claim 1, wherein the tubular body is pre-shaped with a curvature configured to bias the lead into a commissure of the tricuspid valve or to conform to a coronary sinus vein or one of its tributary branches.

7. The stabilizer sleeve of claim 1, further comprising one or more interlocking features configured to maintain the longitudinal slit in a closed configuration.

8. A sy stem compri si ng : a cardiac implantable electronic device lead including a lead pin, collar, and distal screw tip; and015403-0902 7a tubular body extending from a proximal end to a distal end, the tubular body being sized to fit over and stabilize the lead, wherein the tubular body has a size and shape configured to direct the lead into a desired anatomical position so as to reduce displacement or valve interference; and a longitudinal slit formed in, and extending along, at least a portion of the tubular body, wherein the longitudinal slit is configured to receive the lead.

9. The system of claim 8, wherein the tubular body has a length selected so that the tubular body fits between the lead pin and the distal screw tip of the lead.

10. The system of claim 8, wherein the tubular body is formed of a polymer selected from polyimide, polyethylene, polyurethane, or combinations thereof.

11. The system of claim 8, wherein the tubular body is formed of a metallic material, a composite of polymer and metal, or nitinol.

12. The system of claim 8, further comprising one or more radiopaque markers disposed on the tubular body.

13. The system of claim 8, further comprising an antibiotic, antimicrobial, or antithrombotic coating disposed on the tubular body.

14. The system of claim 8, wherein the tubular body is pre-shaped with a curvature configured to bias the lead into a commissure of the tricuspid valve or to conform to a coronary sinus vein or one of its tributary branches.

15. The system of claim 8, further comprising one or more interlocking features configured to maintain the longitudinal slit in a closed configuration.

16. A method of stabilizing a cardiac implantable electronic device lead comprising:015403-0902 8opening a longitudinal slit formed in, and extending along, at least a portion of a tubular body; inserting the lead through the longitudinal slit so that a portion of the lead is disposed within the tubular body; closing the longitudinal slit; and directing the lead into a desired anatomical location using the tubular body as a guide.

17. The method of claim 16, wherein the lead is disposed within the tubular body prior to implantation.

18. The method of claim 16, wherein the lead is disposed within the tubular body after implantation.

19. The method of claim 16, wherein the desired anatomical location is a tricuspid valve.

20. The method of claim 16, wherein the desired anatomical location is a left ventricle, a coronary sinus vein or a tributary thereof.015403-0902 9

Images