Patent Publication Number: US-2022212005-A9

Title: Transvenous Phrenic Nerve Stimulation System

Description:
CROSS REFERENCE TO RELATED CASES 
     The present case claims the benefit of and incorporates by reference U.S. Provisional Application 60/926,910 filed Apr. 30, 2007 entitled “Leads for Transvenous Phrenic Stimulation”. The present case also claims the benefit of and incorporates by reference and is a continuation-in-part of U.S. Utility application Ser. No. 11/601,150 filed Nov. 17, 2006 entitled “System and Method to Modulate Phrenic Nerve to Prevent Sleep Apnea”. 
    
    
     FIELD OF THE INVENTION 
     The present invention relates generally to a method of implanting a phrenic nerve stimulation lead system and a related phrenic nerve stimulation lead for use with an implanted pulse generator (IPG) for treating a breathing disorder. 
     BACKGROUND OF THE INVENTION 
     Many patients with breathing disorders such as central sleep apnea (CSA) display periods of rapid respiration followed by a relatively long compensatory pause in respiration. The clinical manifestation of the disorder is a period of shallow rapid breathing followed by frank apnea or hypopnea. This pattern repeats episodically and is called Cheyne Stokes Respiration (CSR). Several treatment regimes have been proposed to alleviate CSR, including a technique presented in detail in the utility application incorporated by reference. 
     Historically, the ability to control respiration via phrenic nerve stimulation is widely known and well reported in the literature. Early work shows the use of phrenic nerve stimulation to treat paralyzed patients to initiate and support respiration. A substantial body of animal research discloses the basic mechanisms for respiration control though stimulation of the phrenic nerve. 
     Although phrenic nerve stimulation is known in the art there is a continuing need to improve the “leads” devices for accessing and electrically stimulating the phrenic nerve. And there is a continuing need to improve the stimulation methodology. 
     SUMMARY OF THE INVENTION 
     The phrenic nerve stimulation lead device has a flexible elongate lead body with a proximal connector and a distal tip. In use the lead is permanently implanted in a vein near one portion of the phrenic nerve. The lead has physical features and properties important for successful transvenous deployment and stimulation of the phrenic nerve from the left pericardiophrenic vein. 
     The stimulation lead has a distal tip tapered into a “rats tail”. The presence of this extended tapered section will serve to orient and stabilize the lead and the electrodes in the vessel by restricting movement of the lead with respect to the vessel. The additional surface area of the lead provides additional friction and ensures that the vessel and lead do not move relative to each other. One or more and preferably two electrode sites are placed proximal of this distal tip. Each electrode is typically formed as a ring and individually electrically coupled to the proximal connector by internal conductors within the lead. 
     In one embodiment a guidewire lumen is carried entirely through the lead body and the lumen is concentric with the distal tip at the distal tip. In an alternate embodiment the lead is stiffened by a removable stylet that is inserted into the lead into a stylet lumen. 
     An optional mechanical stop feature may be included within the lead body to intercept and interact with a finishing guide wire to stabilize the lead during placement. 
     The lead is acutely repositionable but anticipated foreign-body response will render it permanent in the vessel. The lead may have steroid eluting features to regulate this physiologic process. 
     The shape of the lead body includes two or more curves, bends or loops near the distal end of the lead. These curves in the lead body lie in two planes and direct the tip at an angle. These features stabilize the lead in a large companion vessel while biasing the distal “rats tail” into a stable position in the smaller target vessel. 
     The preferred implantation process requires a percutaneous puncture to access the subclavian vein. The implanted pulse generator (IPG) will be implanted in a subcutaneous pocket nearby. A guide catheter having a shaped tip is navigated along the subclavian vein using a guidewire. The catheter and wire pass through the brachiocephalic vein in to the ostium of the left pericardiophrenic vein. Normal contrast venography techniques are used to illuminate and access this location. The guidewire is inserted several centimeters into the left pericardiophrenic vein and the mouth of the guide catheter is passed into the ostium of the left pericardiophrenic vein. Next the stimulation lead is delivered to a target location through the guide catheter over the guidewire alone or with the use of a stylet. When the electrodes are well positioned near the phrenic nerve target location the stylet or guidewire is removed and the optional stabilizing or finishing guidewire wire is exchanged and inserted into the lead body. Relative traction between the finishing guide wire and the guide sheath allows for the smooth removal of the guide catheter without dislodging the lead. In essence the “rats tail” remains biased and stationary in the left pericardiophrenic vein as the lead “relaxes” and assumes its natural low mechanical energy state while the guide catheter is removed. Withdrawal of the finishing wire if used or the guidewire or stylet activates the complementary shaped curves of the lead. As the curves bend and unfurl into contact with the larger brachiocephalic vein the most distal tip of the of the lead in the smaller vessel becomes stabilized. Next the proximal connector of the lead is coupled to the IPG. The IPG provides stimulation that completes the implantation method and the method of therapy. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Identical reference numerals indicate identical features throughout the figures of the drawing, wherein: 
         FIG. 1  depicts the implanted system; 
         FIG. 2  depicts the lead device; 
         FIG. 3  depicts a step in method used to implant the device; 
         FIG. 4  depicts the lead in position in the target vessel with the electrodes positioned at the target location. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     Stimulation Regime 
     The applicant has incorporated a utility patent reference that discloses in detail a medical device (IPG) that can detect and treat CSR and other forms of breathing disorders by the transvenous electrical stimulation of the phrenic nerve. 
     For purposes of this disclosure it is sufficient to understand that the disclosed technique uses electrical stimulation of one phrenic nerve to arrest or still the motion of one hemidiaphragm of the patient. This process lowers the observed breathing rate post therapy and over time drives the blood gases to an improved state of oxygen saturation and carbon dioxide elimination. 
     The implanted pulse generator (IPG)  12  has the ability to detect the respiration process in real time. Preferably impedance plesthysmography is used to detect both the rate of respiration and the turning points within a single breath. It is anticipated that the companion IPG  12  includes an impedance plethysmograph that emits minute electrical pulses between electrodes on a measurement lead system (not shown in the present figures). These impedance signals are used to measure the volume of the lung and rate of change of volume of the lung. 
     The phrenic nerve stimulation therapy is provided after the start of a breath but before the natural end of the breath. The magnitude of the stimulation is sufficient to arrest the motion of the diaphragm. By essentially stopping the breathing for a moment the overall duration of the breath is extended. This breath hold process lowers the observed rate of breathing of at least one lung. 
     This stimulation therapy may be supplied to each breath for a series of breaths or on a less frequent basis. The stimulation may be supplied in response to a detected episode of CSR or it may be provided to prevent progression to CSR. For example, stimulation may be initiated upon the detected occurrence of CSR. Alternatively an activity sensor may report that the patient is supine and at rest and this set of criteria may be necessary and sufficient to invoke therapeutic stimulation. Regardless of the specific intervention criteria, the IPG will delivery the appropriate amount of energy to still the breath, via the transvenous stimulation lead. 
     System Architecture 
       FIG. 1  depicts the overall architecture and context of the therapy where the lead  10  coupled to an implanted pulse generator  12 . The lead is inserted through the brachiocephalic vein  14  into the ostium  16  of the left pericardiophrenic vein  18 . In this chronic condition the two electrodes  20  and  22  can deliver electrical stimulation to the phrenic nerve  24 , which courses parallel to the vein  18  in this target vessel at this target location. This half of the branching phrenic nerve  24  terminates in the hemidiaphragm  26  as indicated by the innervations depicted at location  28 . The nerve innervations excite the muscles of the hemidiaphragm which move downward as indicated by motion arrows  32  to produce inspiration followed by upward motion as indicated by motion arrow  30  to produce expiration. Together the motion arrows represent rhythmic respiration. For purposes of orientation other familiar anatomic structures are seen but not labeled in the figure. 
     In summary after implantation the lead  10  system delivers electrical stimulation to the phrenic nerve to arrest diaphragm  26  motion by the delivery of electrical energy after the onset of inspiration indicated by motion arrow  32  in the figure and the electrical energy delivered is sufficient to pause that diaphragm motion. In this fashion the lead  10  system and the IPG  12  are used for stimulating the phrenic nerve  24  of a patient to treat defects in respiration. 
     Stimulation Lead 
       FIG. 2  depicts the lead system  10  in isolation. The lead is best considered by dividing it up into various segments. The most distal segment  50  takes the form of a narrow taper. This “rats tail” is coupled to a stimulation segment  58  that includes a first electrode  22  and a second electrode  20 . Although the preferred exemplary embodiment shows two electrodes, other numbers of electrodes are operable and desirable in some situations. The electrode placement on the leads seen in the figures is desirable because to the extent possible it is desired to have the stimulation current path transect the longitudinal fibers of the phrenic nerve  24  at the target location. It has been determined experimentally that this orientation reduces thresholds for stimulation of the nerve. 
     Next, an intermediate shaped segment is shown at numeral  60 . The shaped segment includes two or more bends or loops or curves. The bend curve  48  lies in the XZ plane in the figure. The bend curve  46  rises out of the XZ plane in the Y direction. Preferably the axis of the distal segment  50  makes an included angle of about 15 degrees with respect to the XZ plane. 
     The most proximal segment includes a connector pin assembly  52  that allows conductors within the lead to communicate with the two electrodes. For clarity the conductors are not shown. The construction of the conductors is well known in this art and need not be shown in detail. Preferably and overall the elongate portion  54  of the shaped segment  60  and the distal segment  50  are not coplanar and the major axis of the elongate portion  54  and major axis of the distal segment  50  are not coaxial. These geometric constraints place the elongate segment  54  and the distal segment  50  in separate planes and the major axes of these sections of the lead are not collinear. 
       FIG. 2  shows the lead  10  in isolation in its low stress state. The lead has a natural neutral bias in the figure and the lead structure and shape gives rise to a friction zone caused by a in-plane deflection of the lead around first primary radius of bend curve  48  and a secondary radius of bend curve  46 . In use the curvilinear structures will permit the stable positioning of the lead body in the brachiocephalic vein and permit entry of the stimulation segment into the ostium of the left pericardiophrenic vein and stabilize the electrodes at the target location. 
     The lead may also have a through lumen to accept a guide wire  56  as depicted in the figure passing into the connector  52  pin and traveling beyond the distal tip and emerging at reference numeral  56 . As an alternative, a stylet lumen may be located within the lead to permit the use of a stylet to stiffen the lead. It may also be desirable to have a mechanical stop in the stylet or guide wire lumen to accept a “finishing wire”. This optional finishing wire can be used to supply a force to the lead to keep it in position as the guide catheter is removed. In general the finishing wire is of slightly larger diameter and it bottoms out at a location near but still proximal of the electrode and shaped segments of the lead. Pulling on the guide catheter while pushing on the finishing wire at the same time prevents the lead to guide catheter friction from dislodging or moving the electrodes from their preferred location. 
     Method of Implantation 
       FIG. 3  is an enlarged portion of part of  FIG. 1  designated by numeral  34  on  FIG. 1 . The brachiocephalic vein  14  and the branching left pericardiophrenic vein  18  are shown in isolation. The figure illustrates a method of implanting a lead in a small vein  18  that branches off from a large vein  14 . The process begins with a “percutaneous stick” to access a large vein connecting to the brachiocephalic vein. A sharp hollow needle trocar enters the vein and a guidewire is advanced through the trocar into the vessel. The trocar is withdrawn over the wire and replaced with a sheath which is passed into the vessel. Next a guide wire and guide catheter of the type having a distal curve are navigated to the ostium  16  of the left pericardiophrenic vein. The curved tip for the guiding catheter is introduced in to this small vein. Venographic imaging technologies such as contrast injection and biplane fluoroscopy are used to locate the ostium  16 . With both the guide wire and guide catheter in the small vein the lead  10  may be passed over the wire into the vein. Under contrast imaging and temporary stimulation the best spot for activating the phrenic nerve is located. This defines the target location. Next the guidewire and guiding catheter are carefully removed while holding the lead in position with the optional finishing wire if present. The finishing wire if used compensates for the friction between the guide catheter  60  and the lead  10  which would otherwise causes the guide catheter to tend to drag the lead out of position as the guide catheter is removed. 
     Lead Interactions 
     Turning to  FIG. 4  once again there is a shown an enlarged section of  FIG. 1  indentified in that figure by reference numeral  34 .  FIG. 4  shows the lead  10  delivered through a guide sheath  40 . A stylet or guidewire (GW) may be inserted into the lead  10  to straighten and stiffen the structure. Once the lead enters the target vessel the stylet may be removed and the lead adopts its low stress state in the vessel. In this figure the biasing mechanism  46  is shown in contact with the walls of the vessel  18 . The bend  48  lies in a single plane in contact with the wall of vessel  14 . The bend or shape  46  exerts a force against the ostium  16  to help anchor the electrodes and stimulation segment in the smaller target vessel  18 . 
     Steroid eluting features may be provided on portions of the lead system to reduce inflammation associated with the placement of the leads. Other coatings maybe used to enhance or reduce friction to help stabilize the lead.