WO2025184357A1

WO2025184357A1 - Using a stylet for securing the position of a pacemaker and spinal cord stimulator lead

Info

Publication number: WO2025184357A1
Application number: PCT/US2025/017608
Authority: WO
Inventors: Vinayak Nilkanth BAPAT; Michael Mcdonald
Original assignee: Individual
Current assignee: Individual
Priority date: 2024-02-27
Filing date: 2025-02-27
Publication date: 2025-09-04
Anticipated expiration: 2026-08-27

Abstract

A guide includes a shaped, lead securing stylet. The stylet is used for implant in an organism. The stylet is adapted for securing a position of a stimulator lead having a lumen within. An end portion of the stylet is intended to remain within the central lumen of the lead. In order to assure that the end portion of the stylet that has been implanted remains properly positioned within the lumen of the lead after implant, the end portion of the stylet includes a mechanism for anchoring the lead securing stylet inside the lumen.

Description

USING A STYLET FOR SECURING THE POSITION OF A PACEMAKER AND SPINAL CORD STIMULATOR LEAD

BACKGROUND

[0001] The disclosure relates to medical devices and methods of surgery. More particularly, the disclosure relates to the directed placement and securing of pacemaker and/or spinal cord stimulator leads using a guide including a stylet.

[0002] Over one million pacemakers are implanted worldwide every year.

[0003] A common complication of cardiac implantable electronic devices (CIEDs) with leads in the right ventricle is tricuspid regurgitation. Tricuspid regurgitation induced by CIEDs is a very significant problem that results in morbidity and mortality for thousands of patients.

[0004] Indeed, during the pacemaker procedure, wires (referred to as leads) are placed into the right ventricle and right atrium. The right ventricular lead lays across the tricuspid valve. This lead can interfere with the valve leaflet function and can, in some cases, damage the valve. The tricuspid regurgitation occurs when this lead interferes with the complete closure of the valve. This lead can also create an inflammatory and fibrotic process that damages the valve leaflet. The result of this tissue change is tricuspid regurgitation. The lead-induced tricuspid regurgitation can be from the direct mechanical effect of the lead on the valve leaflet as well as the tissue changes inflicted on the leaflet.

[0005] Positioning the pacemaker lead at the base of a valve commissure will prevent or help to minimize lead-induced tricuspid regurgitation. The pacemaker lead can also be positioned in one of the other commissures. However, studies have shown that tricuspid regurgitation to still be present in 4% to 73% of patients with pacemaker leads. Primary tricuspid regurgitation accounts for over 7% tricuspid regurgitation. Over 66% of primary tricuspid regurgitation is pacemaker lead related.

[0006] Moreover, coronary sinus (CS) lead (or left ventricular (LV) lead) pacing is one of the more recent innovations in cardiac pacing. Early lead displacement is the most common cause of reintervention in these procedures.

[0007] Indeed, this form of pacing is the basis of resynchronization therapy. Resynchronization therapy is a mainstay in the treatment of some forms of congestive heart failure. In this form of pacing, the CS vein of the heart is used for pacemaker lead placement. The use of this cardiac lead enables pacing stimulation to the left side of the heart. The pacemaker lead in this position is also referred to as the CS lead or the LV lead.

[0008] After proper placement of the lead to the desired point in the CS vein, the lead is attached to the pacemaker generator. However, the lead can then be displaced. CS lead displacement can be challenging to prevent. The frequency of CS lead displacement is estimated to be in the 6% range. With CS lead displacement, the patient’s first symptom may be the return of congestive heart failure. Thus, there is a need to help prevent displacement of the CS lead.

[0009] Furthermore, spinal cord or nervous stimulators are used in patient’ s pain control or other purposes.

[0010] The spinal cord or nervous stimulator leads are subject to displacement from the original position. This event is often referred to as lead migration. The displacement of the distal end of the lead will often render the lead ineffective in the pain control of the patient. This lead displacement is a common occurrence for the spinal cord stimulator leads with estimates in the 10- 20% range or more. As such, there is a need the prevent the displacement of the distal end of the spinal cord or nervous stimulator lead from the desired position.

[0011] The guides described herein after, which control, change, and/or maintain the trajectory of the pacemaker lead, are key to solving these serious and ongoing patient afflictions.

BRIEF DESCRIPTION OF THE DRAWINGS

[0012] For a more detailed description of the embodiments of the present disclosure, reference will now be made to the accompanying drawings, wherein:

[0013] FIG. 1 illustrates a device or guide that includes a shaped, lead securing stylet;

[0014] FIG. 2A-2D illustrates different views of the shape of the distal end of the lead securing stylet for directing the pacemaker lead into one of the commissures of the tricuspid valve;

[0015] FIG. 3 illustrates an alternative construction of the device or guide shown in FIG. 1 ;

[0016] FIGS. 4 and 5 illustrate different views where the guide is used for positioning the pacemaker lead in the CS vein of the heart; and [0017] FIGS. 6 and 7 illustrate different views of the shape of the distal end of the lead securing stylet for stabilizing the CS lead.

[0018] As is customary, the drawings may not be drawn to scale for the sake of clarity.

DETAILED DESCRIPTION

[0019] It is to be understood that the following disclosure describes several exemplary embodiments for implementing different features, structures, or functions of the invention. 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 invention.

[0020] Some pacemaker leads have a central lumen. The leads are closed on the distal end and open on the proximal end. Stylets (e.g., wires) are inserted into this central lumen. The function of the stylet is to help position the pacemaker lead.

[0021] In the prior art, these standard stylets are removed after proper positioning of the lead. In contrast, the disclosure describes a guide (or sometimes referred to as the device), including a shaped, lead securing stylet, which refers herein to an elongated rod-like or tube-like part of the guide or equivalent that is bent at rest. The shaped, lead securing stylet is used for the placement of a pacemaker lead, where at least an end portion of the lead securing stylet is intended to remain within the central lumen of the lead that has been implanted. Unlike the traditional lead placement stylets which are removed from the lead after the initial lead placement, the stylet described in the disclosure remains entirely or partially in the lead.

[0022] The guide (or device) includes a specifically shaped stylet. The stylet is composed of metals and/or other materials; for example, the stylet may include a combination of a metal, preferably nitinol, and a polymer. For example, with the guide described in the disclosure, a segment of the stylet may be left remaining in the pacemaker lead after suitable placement for securing the placement of the lead, and a segment of stylet may be removed from the patient’s body.

[0023] DEVICE:

[0024] The general design of the guide includes a specifically shaped, semi-stiff stylet made of nitinol or other materials, at least an end portion of which remains implanted within the central lumen of the lead. During implantation, the proximal end of the stylet, which may or may not remain implanted within the central lumen of the lead, will exit at the connector pin on the proximal end of the lead.

[0025] Generally, it may be important to assure the at least end portion of the stylet remains properly positioned within the lumen of the lead after implant. In some embodiments, an anchoring mechanism may be deployed to hold the at least end portion of the stylet that remains in the patient’s body in position after the at least end portion of the stylet is placed. Such an anchoring mechanism for the stylet within the lead may have multiple configurations. For example, it could be a ring, crimped (e.g., compressed into small folds or ridges) onto the end portion of the stylet that sticks out of connector pin on the lead. The crimped ring is short enough so that it fits in the space between the end of the connector pin on the lead and the end of the connector hole in the pacemaker header that engages the connector pin. The crimped ring is also no larger in diameter than the connector hole in the pacemaker header. Thus, the crimped ring may be encased into the connection between the pin on the lead and the hole in the pacemaker so that the crimped ring keeps the at least end portion stylet from moving farther into the lead. In other embodiments, the anchoring mechanism may alternatively be a simple tapered device that is intended to expand a part of the stylet into the space between the stylet and the inside of the lumen withing the lead when it is pushed or compressed into the lead. This tapered device could be made of any material such as metal or polymer. For example, the part of the stylet that is pushed into the space between the stylet and the inside of the connector pin of the lead may include a rod or tubular end made of soft polymer attached at the distal tip of a nitinol pointed end. This polymer end will anchor at the distal end of the lead when the nitinol pointed end is pressed into it. In some cases, the stylet anchoring mechanism may be omitted.

[0026] Generally, the stylet and/or guide as described herein may require proper positioning during implantation. There are two aspects to the positioning. First, the guide is placed correctly with respect to the length of the lead. Toward this end, a marker may be provided on the end of the stylet that gives an indication of the position of the tip of the stylet with respect to the end of the lead (e.g., a distance therebetween). The marker should be radio opaque to be adequately visualized in the lead. For example, the nitinol stylet may have a gentle taper at the distal end, such as by having a ball at the very distal tip. The tapered portion may be radiopaque. Alternatively, the end of the stylet may comprise a polymer extension that is intended to abut against the end of the lumen within the lead. The polymer extension may be cut to a size suitable for the proper placement of the stylet and/or guide within the lead. Second, the bend on the guide may be oriented radially with respect to the tricuspid valve. For this purpose, the proximal portion of the stylet may contain a collar on the removable end. The collar for stylet rotation may be an independent accessory (e.g., may be detachable). This collar will serve to twist the entire stylet. The twisting can be used to help properly position the pacemaker lead in a commissure. An example of achieving this radial orientation may involve inserting the guide into the lead by an appropriate amount based on the distal marker, and then using an arrow provided on the proximal end of the guide (the arrow is pointed in the same direction as the bend at the distal end of the guide) to point the bend in a specific direction with respect to the patient’s body (or a clock-like reference). Alternatively, another potential procedure for proper positioning may be to orient an xray beam in a specific direction and then rotate the guide until either the bend is maximally visible (perpendicular to the beam) or becomes a line (the bend is in the plane of the xray beam). Thus, the arrow provided on the proximal end of the guide may be omitted.

[0027] In some embodiments, the stylet is a single-piece construction. For example, the stylet can be a single metal wire (or guidewire), or two metal wire, construction. The guide system includes some mechanism for cutting the stylet to length. Any cutting device, part of a system, could be used for cutting the stylet to length, and the cutting device could be as simple as a pair of scissors. This mechanism could also be a scoring device that creates a defect in the stylet that can then be broken using a back-and-forth motion. Alternatively, the stylet may comprise one section substantially made nitinol, and one or more other sections substantially made of a polymer on one or both sides of the nitinol section. The polymer may contain braided metal wires (e g., in a proximal section), and the distal end of the stylet may have a soft polymer tip. The sections may be permanently connected (e.g., glued, or fused together). A portion or the entire stylet may have an outer coating.

[0028 J In other embodiments, the stylet may be a two-piece construction. The stylet can be of a two-piece construction that will allow separation of the distal and proximal stylet segments. In the two-piece construction, the distal segment of the stylet is one piece; the very proximal segment of the stylet is another piece; and the two pieces are connected. The very proximal segment of the stylet is released and retracted from the patient, and the distal part of the stylet is left retained in the desired area of the pacemaker lead. The proximal portion serves to deliver the distal shaped segment into the proper position within the pacemaker lead. The proximal portion of the stylet may be hollow (e.g., it includes an essentially empty tube), or it may comprise a wire at least rotatable inside an essentially empty tube. The distal shaped segment can be released from the proximal portion of the stylet using various mechanisms. The release may be by unscrewing the proximal portion of the stylet. The release of the shaped segment of the stylet may be done by unscrewing a proximal knob on the stylet. For example, this knob is attached to an inner wire forming the proximal portion of the stylet. The connection between proximal and distal segments can also be magnetic or another coupling mechanism known to facilitate recoupling and removal, and/or adjustments. When a proximal inner wire which connects to the distal segment of the stylet is unscrewed, the proximal part of the stylet can be removed. This action leaves the distal shaped segment within the pacemaker lead.

Positioning the pacemaker lead at the base of a commissure of the tricuspid valve

[0029] In some embodiments, when the guide is used for securing the position of the pacemaker lead at the base of a commissure of the tricuspid valve, the at least end portion of the stylet may be retained in approximately the proximal two thirds of the lead. The securing stylet may be shaped such that the distal one third to one half of the stylet braces off the medial wall of the superior vena cava and then off the lateral wall right atrium. The securing stylet then partially loops at the base of the right atrium and courses posteriorly to the tricuspid valve. The distal end of the securing stylet may remain in the right atrium or may just pass up to the tricuspid valve and extend slightly beyond it into the right ventricle. As such, the pacemaker lead conforms to this shape and resultant lead position will be into the commissure of the tricuspid valve. And a segment of the securing stylet retained with the pacemaker lead is used to position the pacemaker lead across the tricuspid valve to minimize tricuspid regurgitation and/or damage to the valve. Figures 1, 2, and 3 illustrate different views of shaping of the distal end of the stylet for directing the lead of the cardiac implantable electronic device (CIED) into one of the commissures of the tricuspid valve.

[0030] In these embodiments, the purpose of the securing stylet is to maintain the position of the CIED lead into an area of the valve where it produces no or minimal effect on the valve. More specifically, the purpose of the lead securing device is to direct the lead to the annulus of the tricuspid valve within one of the commissures of the valve. In other words, the purpose of this shaped and implanted segment of securing stylet is for controlling the positioning of the pacemaker or defibrillator lead into the commissure of the tricuspid valve. However, it may be adequate to simply direct the lead away from the septal leaflet. This controlled positioning will result in less interference of the lead with the valve. This lead positioning may eliminate or substantially reduce lead induced tricuspid regurgitation.

[0031] PROCEDURE:

[0032] The RV lead is positioned into the RV in the usual manner. The standard lead stylet that comes with the pacemaker lead is withdrawn after the tip of the lead is positioned in the desired area of the right ventricle. The shaped, lead securing stylet is then inserted into the pacemaker lead. The shaped stylet is advanced into the pacemaker lead to the desired level. This area is where the various bends of the stylet and pacemaker lead make contact to the earlier described areas within the heart. E.g., the tip of the shaped, lead securing stylet may be guided to the atrium, tricuspid valve or the ventricle during the implant. The collar on the proximal portion of shaped, lead securing stylet can be used to rotate the lead to help to obtain proper position. A ring may optionally be crimped on the shaped, lead securing stylet, next to or close to the connector pin on the proximal end of the lead. In some cases, once the desired position of the shaped, lead securing stylet is achieved, the proximal lead knob can be rotated to unscrew and release the proximal portion of the shaped, lead securing stylet, leaving the distal portion of the shaped, lead securing stylet in the pacemaker lead. In other cases, once the desired position of the shaped, lead securing stylet is achieved, the shaped, lead securing stylet is cut near its exit at the connector pin on the proximal end of the lead, leaving only a small segment extending out of the connector pin (e.g., below the crimped ring). The proximal segment of the shaped, lead securing is removed from the pacer lead and the pacer procedure may be finished in the usual manner.

[0033] The implanted segment of the shaped, lead securing stylet is left at the level going from the superior vena cave, into the right atrium, and to (or past) the tricuspid valve. The distal tip of the retained segment of the shaped, lead securing is either at or just through the commissure of the tricuspid valve.

[0034] Another method of use for the guide described in herein is to have multiple guides each with a different stiffnesses. A use of multiple guides with different stiffnesses would be in patients in whom the CIED has already been implanted and the patient is suffering from significant tricuspid regurgitation. In this scenario, a stiffer guide could be delivered first to move the lead away from the current position and into a more favorable position with respect to tricuspid regurgitation. Then the stiffer guide could be removed and a softer guide could be left in place to assure the lead remains in the more favorable position.

Positioning the pacemaker lead in the coronary sinus vein of the heart

[0035] In other embodiments, when the guide is used for positioning the pacemaker lead in the coronary sinus vein of the heart, the shape of the shaped, lead securing stylet will anchor or help retain the lead in its position in the coronary sinus vein. The shaped, lead securing stylet extends into the main body of the coronary sinus vein but may also extend further into the secondary vein branches. The proximal end of the shaped, lead securing stylet is located at the proximal end of the CS lead. The shaped, lead securing stylet may be shaped to avoid the lead from being extracted from the CS vein either acutely or chronically. If the shaped, lead securing stylet is a two-piece construction, the separation will be at the level (estimated) of where the stylet will exit from the proximal end of the CS lead, near the connector pin to the pacemaker. Otherwise, the shaped, lead securing stylet may be cut at this level. As such, the shaped, lead securing stylet will stabilize the CS lead to help prevent dislodgement and patient compromise. The device will also help to prevent the need for a second procedure (reintervention for repositioning of the CS lead). Figures 7 and 8 illustrate different views where the guide is used for positioning the pacemaker lead in the coronary sinus vein of the heart. Figures 9 and 10 illustrate different views of shaping of the distal end of the shaped, lead securing stylet for stabilizing the CS lead.

[0036] In these embodiments, the guide may be used in left bundle pacing and coronary vein left sided pacing. The purpose of the stylet is to stabilize the position of the CS lead to prevent dislodgment from the obtained proper position. This device may also be used to aid in the initial placement of the CS lead.

[0037] PROCEDURE:

[0038] Once the CS lead is properly positioned and the standard stylet is removed, the shaped, lead securing stylet of the guide is placed into the CS lead. A shaped, lead securing stylet with a shape that matches the shape of the just placed CS lead is chosen. The shaped, lead securing stylet is then advanced into the central lumen of the CS lead. The shaped, lead securing stylet may or may not extend to the distal tip of the CS lead. Depending on the anatomy, the shaped, lead securing stylet within the CS lead may extend in to the main coronary sinus vein or may extend out into one the secondary vein branches. When the shaped, lead securing stylet is properly in place, the proximal end of the stylet is cut nearly flush with the opening of the lead pin which is at the proximal end of the lead, or, if the shaped, lead securing stylet is a two-piece construction, the separation will be at the level (estimated) of where the shaped, lead securing stylet will exit from the proximal end of the CS lead. The pin is then ready to be placed into the pacemaker generator and secured with the set screw.

Positioning and securing a spinal cord and/or nervous stimulator lead

[0039] In yet other embodiments, the guide is used to prevent the displacement of the distal end of the lead from the desired position. Spinal cord stimulators are of the basic design as cardiac pacemakers. The stimulators include a pulse generator that is connected to one or more leads. These stimulator leads are of similar construction as the cardiac pacing leads. The leads include a long tube (usually polymer) that contains a metal pacing coil. The central lumen of the tube is used for the placement of a stylet that is inserted before positioning and removed after the lead is properly positioned. The central lumen of the lead is then left empty. The lead is then connected to the generator.

[0040] The shaped, lead securing stylet will be of the same construction as or a similar construction to the shaped, lead securing stylet stylets described herein for use in the cardiac pacemaker leads. The shaped, lead securing stylet retained in the lead will help prevent the displacement of the distal end of the lead from the desired position.

[0041] PROCEDURE:

[0042] Once the shaped, lead securing stylet is properly placed in the stimulator lead, it is left in place. The proximal end may be trimmed off to the desired length (if necessary). The lead can then be connected to the generator.

[0043] FIG. 1 illustrates a device or guide that includes a shaped, lead securing stylet used for shaping a lead. The lead is not shown in FIG. 1.

[0044] The guide 10 includes a shaped, lead securing stylet that is a two-piece construction comprising a distal segment 12, which is semi-stiff and permanently shaped, and a proximal segment 14, which may be flexible. The distal segment 12 includes a shaped stylet, for example, made of nitinol. The proximal segment 14 includes a release wire 16 at least rotatable inside an essentially empty tube 18. As illustrated in FIG. 1, the distal segment 12 is connected to the proximal segment 14 at the release junction 20. In this example, the distal segment 12 is screwed to the release wire 16. Furthermore, the distal segment 12 is partially inserted inside the essentially empty tube 18 and prevented to rotate inside the essentially empty tube 18, for example using matching ribs and grooves. However, the distal segment 12 is allowed to slide out of the essentially empty tube 18, unless it is retained partially inserted in the essentially empty tube 18. As illustrated in FIG. 1, the distal segment 12 is retained partially inserted in the essentially empty tube 18 by the release wire 16, and thus, is prevented to slide out of the essentially empty tube 18.

[0045] The distal segment 12 may have a ball or other tapered portion at the very distal end 26. The ball may be at least partially radiopaque in order to form a marker.

[0046] The distal segment 12 may include a mechanism for anchoring the distal segment 12 within the lumen of the lead after implant, such as a ring 34.

[0047] In use, an operator can insert at least a portion of the distal segment 12 of the guide 10 within the central lumen of a peacemaker lead that has been implanted in a patient. Then, the operator can rotate a collar 22 to twist the entire guide 10. The twisting can be used to help properly position the pacemaker lead into which the distal segment 12 is inserted in a commissure of the tricuspid valve of the patient. Then, the operator can rotate a knob 24 attached to the release wire 16. The release wire 16 rotates inside the essentially empty tube 18. The distal segment 12, being prevented to rotate inside the essentially empty tube 18, will not rotate, thus unscrewing the distal segment 12 from the release wire 16. Once the distal segment 12 is unscrewed from the release wire 16, it is no longer retained partially inserted in the essentially empty tube 18 and can slide out of the essentially empty tube 18. Thus, the proximal segment 14 and the collar 22 may be retrieved from the body of the patient, the distal segment 12 remaining within the central lumen of the peacemaker lead.

[0048] The distal segment 12 may be configured such as the distal one third to one half of the distal segment 12 braces off the medial wall of the superior vena cava at area 36 and then off the lateral wall right atrium at area 38. The stylet then partially loops at the base of the right atrium at area 40, the medial of right atrium at area 42 and courses posteriorly to the tricuspid valve (e.g., posteriorly to the septal commissure) at the distal end 26. [0049] In alternative embodiments, the guide 10 includes a shaped, lead securing stylet that is a one-piece construction. The release wire 16, the tube 18, and the distal segment 12 may be permanently joint so that junction 20 is not releasable. However, the proximal segment 14, and optionally the tip of the distal segment 12, may be cuttable using scissors.

[0050] Figure 2A shows a shaped, lead securing stylet that is part of a guide. A collar for stylet rotation may be an independent accessory (e.g., detachable). In this example, a nitinol portion which is shaped (i.e., bent at rest) and semi-stiff includes an arc portion having a radius of 0.75 inch inducing a 20 deg bend between a relatively long, proximal end that is substantially straight at rest, and a tip end having a length of approximately 1 inch.

[0051] Figure 2B shows another shaped, lead securing stylet that is part of a guide. Again, a collar for stylet rotation may be an independent accessory (e.g., detachable). In this example, a nitinol portion which is shaped and semi-stiff includes an arc portion having a radius of 2 inches inducing a 20 deg bend between a relatively long, proximal end that is substantially straight at rest, and a tip end having a length of approximately 2 inches.

[0052] Figure 2C shows yet another shaped, lead securing stylet that is part of a guide. Again, a collar for stylet rotation may be an independent accessory (e.g., detachable). In this example, a nitinol portion which is shaped and semi-stiff includes an arc portion having a radius of 0.75 inch inducing a 45 deg bend between a relatively long, proximal end that is substantially straight at rest, and a tip end having a length of approximately 1 inch.

[0053] Figure 2D shows yet another shaped, lead securing stylet that is part of a guide. Again, a collar for stylet rotation may be an independent accessory (e.g., detachable). In this example, a nitinol portion which is permanently shaped and semi-stiff includes an arc portion having a radius of 2 inches inducing a 45 deg bend between a relatively long, proximal end that is substantially straight at rest, and a tip end having a length of approximately 2 inch.

[0054] Bends different from the ones illustrated in Figures 2A-2D are also possible.

[0055] FIG. 3 illustrates an alternative construction of the device or guide shown in FIG. 1.

[0056] The guide 100 includes a polymer embedded braid shaft 102. The shaft 102 can have a length of approximately 18 inches. The shaft 102 has preferably a diameter of approximately 0.014 inch to fit inside the connector pin of a pacemaker. The shaft may be double braid or braid with 4 strands of 0.001 inch round wire. Thus, the shaft 102 is made of a material that can be cut to length at the connector pin once in place inside the lumen of the pacemaker lead. However, the shaft 102 is able to transmit torque applied by an operator on a collar directly coupled to the shaft (e.g., similar collar 22 in FIG. 1) to wire 104.

[0057] The guide 100 includes a nitinol wire 104 that also has preferably a diameter of approximately 0.014 inch. Preferably, the nitinol wire 104 is finished for maximum fatigue resistance and has low inclusion. In this example, the nitinol wire 104 is approximately 22 inches in length end to end. It has a substantially straight portion of approximately 12 inches, followed by a 45 deg bent 108 with a 0.75 inch radius. A pointed end 110 of the nitinol wire 104 has a tapered cone having a length of approximately 0.75 inches. The cone may be tapered to a diameter of approximately 0.010 inches. The nitinol wire 104 forms a shaped, lead securing stylet that is bent at rest.

[0058] The guide 100 includes a soft polymer rod 106 that also has preferably a diameter of approximately 0.014 inch. The soft polymer rod 106 can be cut to length to place the tip of nitinol wire 104 at a desired location or distance from the closed end of the lead. The pointed end of the nitinol wire 104 and the soft polymer rod 106 cooperate to locks against the lumen inside the lead when compressed, thus anchoring the nitinol wire 104 and preventing or limiting further distal movement.

[0059] FIG. 4 shows a stimulator lead 120 in the CS 122 of the heart. A shaped, lead securing stylet 124 is placed within the lumen of the stimulator lead 120 to help stabilize the stimulator lead 120 and prevent its dislodgment. The stimulator lead 120 is shown connected to the generator 126 after a portion of a guide including the shaped, lead securing stylet 124 is removed from a patient’s body.

[0060] FIG. 5 shows a stimulator lead 130 placed in the left ventricular branch of the CS 132 of the heart with a shaped, lead securing stylet 134 in the lumen of the stimulator lead 130 to help stabilize the stimulator lead 130 and prevent its dislodgment. The stimulator lead 130 is shown connected to the generator 136.

[0061] FIG. 6 shows the side view (left) and the front view (right) of a shaped, lead securing stylet (vein of Marshall to lateral vein). [0062] FIG. 7 shows the side view (left) and the front view (right) of a shaped, lead securing stylet (vein of Marshall).

[0063] Shapes different from the ones illustrated in Figures 6 and 7 are also possible.

Claims

What is claimed is:

1. A device for implant in an organism and adapted for securing a position of a stimulator lead having a lumen therewithin, comprising: a lead securing stylet that is bent at rest; and a mechanism for anchoring the lead securing stylet inside the lumen.

2. The device of claim 1 further comprising: a twistable collar coupled to the lead securing stylet and adapted for rotating the lead securing stylet inside the stimulator lead.

3. The device of claim 2 wherein: the twistable collar is detachable from the lead securing stylet.

4. The device of any of claims 2, wherein: the lead securing stylet comprises a cuttable segment joined end-to-end to a metallic segment; the metallic segment is bent at rest; and the cuttable segment is adapted for being cut using scissors.

5. The device of claim 4, wherein: the twistable collar is directly coupled to the cuttable segment.

6. The device of claim 4, wherein: the cuttable segment comprises a polymer containing braided metal wires; and the metallic segment comprises nitinol.

7. The device of any of claims 1 to 6, wherein the mechanism for anchoring the lead securing stylet inside the lumen comprises: a ring that is adapted for being crimped on the lead securing stylet; or a tapered device that is configured to expand a part of the lead securing stylet into a space between the lead securing stylet and a wall of the lumen when lead securing stylet is pushed or compressed into the stimulator lead.

8. The device of claim 7 wherein the mechanism for anchoring the lead securing stylet inside the lumen comprises: an end having a pointed tip and made of rigid material; and a rod or tubular end made of soft material and coupled at the pointed tip, wherein the rigid material refers to a material that is less deformable than the soft material, and the soft material refers to a material that is more deformable than the soft material.

9. The device of claim 8 wherein: the rigid material comprises nitinol; and the soft material comprises a polymer.

10. The device of claim 8 wherein: the soft material is cuttable using scissors.

11. The device of claim 1 wherein: the lead securing stylet comprises a cuttable segment joined end-to-end to a metallic segment, wherein the metallic segment is bent at rest; and the cuttable segment is adapted for being cut using scissors.

12. The device of claim 11, wherein: the cuttable segment comprises a polymer containing braided metal wires; and the metallic segment comprises nitinol.

13. The device of claim 1 wherein the mechanism for anchoring the lead securing stylet inside the lumen comprises: a ring that is adapted for being crimped on the lead securing stylet; or a tapered device that is configured to expand a part of the lead securing stylet into a space between the lead securing stylet and a wall of the lumen when lead securing stylet is pushed or compressed into the stimulator lead.

14. The device of claim 13 wherein the mechanism for anchoring the lead securing stylet inside the lumen comprises: an end having a pointed tip and made of rigid material; and a rod or tubular end made of soft material and coupled at the pointed tip, wherein the rigid material refers to a material that is less deformable than the soft material, and the soft material refers to a material that is more deformable than the soft material.

15. The device of claim 14 wherein: the rigid material comprises nitinol; and the soft material comprises a polymer.

16. The device of any of claims 13 to 15, wherein: the lead securing stylet comprises a cuttable segment joined end-to-end to a metallic segment, wherein the metallic segment is bent at rest, and the cuttable segment is adapted for being cut using scissors.