Cuff electrode with integrated tendril

Information

  • Patent Grant
  • 9320889
  • Patent Number
    9,320,889
  • Date Filed
    Monday, February 10, 2014
    11 years ago
  • Date Issued
    Tuesday, April 26, 2016
    9 years ago
Abstract
A neurostimulation lead includes a lead body having a proximal portion and a distal portion and a first conductor extending through the lead body. An electrode cuff can be secured relative to the distal portion of the lead body. The electrode cuff includes a cuff body, a first tendril extending from a first region of the cuff body, a second tendril extending from a second region of the cuff body and a first electrode disposed on the cuff body and electrically connected to the first conductor.
Description
TECHNICAL FIELD

The present invention relates generally to implantable medical devices. More specifically, the present invention relates to medical device leads including helical neurostimulation electrodes


BACKGROUND

A significant amount of research has been directed both to the direct and indirect stimulation and sensing of the left and right vagus nerves, the phrenic nerve, the sacral nerve, the cavernous nerve, and portions of the anatomy with baroreceptors (e.g., the carotid artery) to treat a wide variety of medical, psychiatric, and neurological disorders or conditions. For example, stimulation of the vagus nerve has been proposed as a method for treating various heart conditions, including heart failure. The nerves stimulated and/or sensed may be sympathetic or parasympathetic in character.


In a nerve stimulation and sensing system, one or more electrodes are formed on a lead that are electrically connected to an implanted electronic package, such as a pulse generator. Electrical energy is delivered to the electrodes by conductors that extend from the pulse generator at a proximal end of the lead to the electrodes at a distal end of the lead. For direct stimulation of a nerve, the electrodes may be configured to be secured directly to, wrapped around, or laid next to the nerve.


SUMMARY

Example 1 is a neurostimulation lead including a lead body and a first conductor extending through the lead body. An electrode cuff is secured relative to a distal portion of the lead body. The electrode cuff includes a cuff body, a first tendril extending from a first region of the cuff body, a second tendril extending from a second region of the cuff body and a first electrode disposed on the cuff body and electrically connected to the first conductor.


Example 2 includes Example 1 and specifies that the first tendril extends from the first region of the cuff body at an acute angle and is biased to a curved configuration in which the first tendril curves in a first direction.


Example 3 includes either of Examples 1 and 2 and specifies that the second tendril extends from the second region of the cuff body at an acute angle and is biased to a curved configuration in which the second tendril curves in a second direction opposite the first direction.


Example 4 includes Example 1 and specifies that the first tendril extends substantially perpendicularly from the first region of the cuff body.


Example 5 includes Examples 1 and 4 and specifies that the second tendril extends substantially perpendicularly from the second region of the cuff body.


Example 6 includes Example 5 and specifies that the first tendril and the second tendril both extend in a same direction from the cuff body.


Example 7 includes Example 5 and specifies that the first tendril and the second tendril extend in opposite directions from the cuff body.


Example 8 includes any of Examples 1 through Example 7 and specifies inclusion of a second conductor extending through the lead body and a second electrode disposed on the cuff body and electrically connected to the second conductor.


Example 9 includes any of Examples 1 through Example 8 and specifies inclusion of a first suture molded into and extending through the first tendril and a second suture molded into and extending through the second tendril.


Example 10 includes any of Examples 1 through Example 9 and specifies that the cuff body is configured to extend less than about 360 degrees about the nerve.


Example 11 includes any of Examples 1 through Example 10 and specifies that the first and second tendrils are each configured to extend more than about 360 degrees about the nerve.


Example 12 includes any of Examples 1 through 9 and specifies that the cuff body is configured to be wrapped around the nerve, thereby extending more than about 360 degrees about the nerve.


Example 13 includes any of Examples 1 through 12 and specifies that the first tendril and the second tendril are portions of a unitary tendril, the unitary tendril biased to a wrapping direction that reverses direction near a midpoint of the unitary tendril.


Example 14 is a neurostimulation lead including a lead body, a first conductor extending through the lead body and a second conductor extending through the lead body. A first cuff is secured relative to a distal portion of the lead body. A second cuff is secured relative to a distal portion of the lead body. A first electrode is disposed on the first cuff body and is electrically connected to the first conductor. A second electrode is disposed on the second cuff body and is electrically connected to the second conductor. The first cuff includes a first cuff body, a first tendril extending from the first cuff body and biased to a curved configuration in which the first tendril curves in a first direction. A second tendril extends from the first cuff body and is biased to a curved configuration in which the second tendril curves in a second direction opposite the first direction. The second cuff includes a second cuff body, a third tendril extending from the second cuff body and biased to a curved configuration in which the third tendril curves in a third direction. A fourth tendril extends from the second cuff body and is biased to a curved configuration in which the second tendril curves in a fourth direction opposite the third direction.


Example 15 includes Example 14 and specifies that the first cuff is secured relative to the distal portion of the lead body via a first lead extension. The first lead extension is secured to the lead body and the first cuff is attached to the first lead extension.


Example 16 includes Examples 14 and 15 and specifies that the second cuff is secured relative to the distal portion of the lead body via a second lead extension. The second lead is extension secured to the lead body and the second cuff is attached to the second lead extension.


Example 17 includes any of Examples 14 to 16 and specifies inclusion of a strain relief secured to the distal portion of the lead body.


Example 18 includes Example 14 and specifies that the first direction is the same as the third direction, and the second direction is the same as the fourth direction.


Example 19 is a method of securing a neurostimulation cuff to a surgically exposed nerve. The neurostimulation cuff is disposed proximate the nerve, the neurostimulation cuff including a cuff body and first and second tendrils extending from the cuff body. The neurostimulation cuff is positioned in position on the nerve. The first tendril is secured in position by wrapping the first tendril around the nerve in a rotational direction. The second tendril is secured in position by wrapping the second tendril around the nerve in the same rotational direction.


Example 20 includes Example 19 and specifies that the first tendril is biased to extend from the cuff body in a first rotational direction and the second tendril is biased to extend from the cuff in a second rotational direction opposite the first rotational direction in order to permit securement of the first and second tendrils by wrapping the first and second tendrils in the same rotational direction.


While multiple embodiments are disclosed, still other embodiments of the present invention will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments of the invention. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive.





BRIEF DESCRIPTION OF THE DRAWINGS


FIG. 1 shows an embodiment of a neurostimulation system according to the present invention and portions of an environment in which the neurostimulation system is used.



FIG. 1A is a cross-sectional view of the neurostimulation lead shown in FIG. 1.



FIG. 2 is a schematic illustration of a portion of a neurostimulation lead in accordance with embodiments of the invention.



FIG. 3 is a schematic illustration of a portion of a neurostimulation lead in accordance with embodiments of the invention.



FIG. 4 is a schematic illustration of a cuff suitable for use with the neurostimulation leads of FIGS. 1 to 3.



FIG. 5 is a schematic illustration of a cuff suitable for use with the neurostimulation leads of FIGS. 1 to 3.



FIG. 6 is a schematic illustration of a cuff suitable for use with the neurostimulation leads of FIGS. 1 to 3.



FIGS. 6A and 6B are cross-sectional views of a portion of the cuff shown in FIG. 6.



FIG. 7 is a schematic illustration of a cuff suitable for use with the neurostimulation leads of FIGS. 1 to 3.



FIG. 8 is a schematic illustration of a unitary tendril suitable for use with the neurostimulation leads of FIGS. 1 to 3.



FIG. 9 is a schematic illustration of a cuff suitable for use with the neurostimulation leads of FIGS. 1 to 3.



FIG. 10 is a schematic illustration of a cuff suitable for use with the neurostimulation leads of FIGS. 1 to 3.



FIG. 11 is a flow diagram illustrating a method that may be carried out using the neurostimulation leads of FIGS. 1 to 3.



FIG. 12 is a schematic illustration of a portion of a neurostimulation lead in accordance with embodiments of the invention.





While the invention is amenable to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and are described in detail below. The intention, however, is not to limit the invention to the particular embodiments described. On the contrary, the invention is intended to cover all modifications, equivalents, and alternatives falling within the scope of the invention as defined by the appended claims.


DETAILED DESCRIPTION


FIG. 1 shows an embodiment of a neurostimulation system 10 according to the present invention implanted in a patient P. The neurostimulation system 10 includes an implantable medical device (IMD) 12 with a lead 14 having a proximal end 16 and a distal end 18. In one embodiment, the IMD 12 includes a pulse generator. The IMD 12 can be implanted subcutaneously within the body, typically at a location such as in a patient's chest or abdomen, although other implantation locations are possible. The proximal end 16 of the lead 14 can be coupled to the IMD 12 via one or more connectors 19. Alternatively, the lead 14 may be formed integrally with the IMD 12. The distal end 18 of the lead 14, in turn, can be implanted at a desired location in the patient's body to stimulate excitable tissue.


The distal end 18 of the lead 14 includes one or more electrode cuffs 20. While a single electrode cuff 20 is shown in FIG. 1, it will be appreciated that in some embodiments the lead 14 may include one, two, three or more electrode cuffs 20. Further details regarding the construction and implantation of the electrode cuffs 20 will be described with respect to subsequent FIGS. In some embodiments, a single electrode cuff 20 may include two electrodes (not shown in FIG. 1). In some embodiments, the lead 14 may include several electrode cuffs 20, each with a single electrode. One electrode may, for example, function as a cathode electrode while another electrode may function as an anode electrode. The electrode(s) is(are) electrically connected to the IMD 12 via one or more conductors 11, 13, 15 (shown in FIG. 1A) extending through the lead 14.


During operation, the lead 14 delivers electrical signals between the IMD 12 and the electrode cuffs 20. The electrode cuffs 20 may be separately controlled by IMD 12, such that energy having different magnitude, phase, and/or timing characteristics may be delivered to or from each of the electrode cuffs 20. In some embodiments, one or more of the electrode cuffs 20 can alternatively be configured as a strain relief cuff that does not carry electrical signals, but secures the distal end 18 relative to the nerve N to minimize movement of the electrode cuffs 20 relative to the excitable tissue due to voluntary or involuntary movements of the patient. Furthermore, the IMD 12 shown is merely by way of illustration, and the IMD 12 may have any configuration suitable for use in conjunction with the lead 14 and may be implanted in any suitable location in the patient's body.


The electrode cuffs 20 include electrodes that are configured for stimulation or sensing of a nerve or nerve bundle. In the embodiment shown, the distal end 18 is secured to the vagus nerve N. The electrode cuffs 20 may be arranged around the nerve, with the IMD 12 configured to deliver energy to the electrode cuffs 20 to stimulate the nerve. Stimulating the sympathetic and parasympathetic nervous systems can have effects on physiological parameters associated with the heart H, such as heart rate and blood pressure. In addition, stimulating the sympathetic nervous system dilates the pupil, reduces saliva and mucus production, relaxes the bronchial muscle, reduces the successive waves of involuntary contraction (peristalsis) of the stomach and the motility of the stomach, increases the conversion of glycogen to glucose by the liver, decreases urine secretion by the kidneys, and relaxes the wall and closes the sphincter of the bladder. Stimulating the parasympathetic nervous system (inhibiting the sympathetic nervous system) constricts the pupil, increases saliva and mucus production, contracts the bronchial muscle, increases secretions and motility in the stomach and large intestine, and increases digestion in the small intestine, increases urine secretion, and contracts the wall and relaxes the sphincter of the bladder. The functions associated with the sympathetic and parasympathetic nervous systems are many and can be complexly integrated with each other.


The vagus nerve N has afferent properties, such that the neural stimulation is transmitted to the central nervous system (CNS). Vagal stimulation simultaneously increases parasympathetic and decreases sympathetic activity, and is believed to prevent further remodeling or predisposition to fatal arrhythmias in post-myocardial infarction (MI) patients, to help restore autonomic balance and increase heart rate variability (HRV), to increase parasympathetic and reduce sympathetic tone in hypertrophic cardiac myopathy (HCM), neurogenic hypertension, and arrhythmia protection, to reduce anginal symptoms, to increase coronary blood flow (CBF), and to prevent development or worsening of congestive heart failure (CHF) following MI. The electrode cuffs 20 may be configured and arranged to stimulate the vagus nerve N to provide any of the physiological responses described. While the electrode cuffs 20 are shown arranged around the right vagus nerve N in FIG. 1, the electrode cuffs 20 can be configured and arranged to stimulate the left vagus nerve to treat other physiological and psychological conditions, such as epilepsy and depression.



FIG. 2 provides a side view of a portion of the lead 14 that includes a lead body 30 and three (as illustrated) electrode cuffs 20. In some embodiments, the lead 14 also includes one or more of a first lead extension 32 and a second lead extension 34. The first and second lead extensions 32, 34 can, if included, each include electrical conductors that provide electrical connections between the IMD 12 and one or more of the electrode cuffs 20. In some embodiments, the electrode cuffs 20 include a strain relief 36, a first electrode cuff 38 and a second electrode cuff 40. In some embodiments, the strain relief 36 is secured to the lead body 30 in order to help mitigate movement of the first and second electrode cuffs 38, 40. The first electrode cuff 38 can be secured to the first lead extension 32 while the second electrode cuff 40 can be secured to the second lead extension 34. In some embodiments, as illustrated, the strain relief 36 can be secured to the lead body 30 by a connector 48. In some embodiments, the connector 48 can also secure at least one of the first lead extension 32 and/or the second lead extension 34, if present, to the lead body 30.



FIG. 3 is similar to FIG. 2 but shows a portion of a lead 14 having a strain relief 42 that is configured as a helical winding that is biased to a coiled configuration as shown. In some embodiments, the strain relief 42 includes a first end 44 and a second end 46, and the strain relief 42 can be wrapped around the nerve N by pulling each of the first end 44 and the second end 46 and wrapping each of the first end 44 and the second end 46 around the nerve N. In some embodiments, as illustrated, the strain relief 42 can be secured to the lead body 30 by a connector 48. In some embodiments, the connector 48 can also secure at least one of the first lead extension 32 and/or the second lead extension 34, if present, to the lead body 30.



FIGS. 4 and 5 provide an illustration of an electrode cuff 50 and an exemplary method of securing the electrode cuff 50 to the nerve N. The electrode cuff 50 is an example of an electrode cuff 20 that can be used in combination with the lead 14. In the illustrated embodiment, the electrode cuff 50 has a first region 52 and a second region 54. A first tendril 56 extends from the first region 52 of the electrode cuff 50 and a second tendril 58 extends from the second region 54 of the electrode cuff 50. In some embodiments, the first tendril 56 and the second tendril 58 curve in opposite directions (with respect to an observer viewing the Figure).


To secure the electrode cuff 50 to the nerve N, the electrode cuff 50 is disposed proximate the nerve N. The electrode cuff 50 can be rotated in a direction indicated by an arrow 60, thereby bringing the first tendril 56 and the second tendril 58 into contact with the nerve N. In some embodiments, the first tendril 56 and the second tendril 58 are sufficiently stiff to permit adequate securement of the electrode cuff 50 to the nerve N without requiring that either of the first tendril 56 or the second tendril 58 extend much beyond a half circle. In some embodiments, the first tendril 56 and/or the second tendril 58 may be sufficiently flexible to permit uncoiling and recoiling the first tendril 56 and/or the second tendril 58 around the nerve N.



FIG. 6 is a schematic illustration of an electrode cuff 70 disposed about the nerve N. The electrode cuff 70 is an example of an electrode cuff 20 that can be used in combination with the lead 14. The electrode cuff 70 includes a cuff body 72 and an electrode 74 that is disposed on or otherwise secured to the cuff body 72. In some embodiments, the electrode 74 may be a foil electrode. While a single electrode 74 is shown, in some embodiments the cuff body 72 may include two or more electrodes 74.


The cuff body 72 includes a first region 76 and a second region 78. A first tendril 80 extends from the first region 76 of the cuff body 72 and a second tendril 82 extends from the second region 78 of the cuff body 72. In some embodiments, the first tendril 80 is biased to a curved configuration as shown. In some embodiments, the second tendril 82 is biased to a curved configuration as shown. In some embodiments, as illustrated, the first tendril 80 extends at an acute angle with respect to the cuff body 72 and the second tendril 82 extends at an acute angle with respect to the cuff body 72. For illustrative purposes, this acute angle is indicated as angle alpha (α), which can be in a range greater than zero degrees and less than 90 degrees.


The first tendril 80, the second tendril 82 and the cuff body 72 can be formed of any suitable material. In some embodiments, the first tendril 80, the second tendril 82 and the cuff body 72 are each formed of a polymeric material such as silicone. FIGS. 6A and 6B are cross-sectional views of the first tendril 80 and the second tendril 82, respectively.


In some embodiments, as illustrated, the first tendril 80 can include a first suture 86 that is molded within the first tendril 80 and that extends through the first tendril 80. In some embodiments, as illustrated, the second tendril 82 can include a second suture 88 that is molded within the second tendril 82 and that extends through the second tendril 82. The first suture 86 and the second suture 88 can, if present, aid in deployment of the electrode cuff 70 by providing the surgeon with something that can be grasped and pulled on in order to appropriately wrap the first tendril 80 and/or the second tendril 82 around the nerve N. In some embodiments, as illustrated, the first suture 86 can extend out of the end of the first tendril 80 so that the surgeon can grasp it. In some embodiments, as illustrated, the second suture 86 can extend out of the end of the second tendril 82 so that the surgeon can grasp it.



FIG. 7 is an illustration of a unitary tendril 90 that can form part of the electrode cuffs 20 described herein. The unitary tendril 90 includes a first portion 92 and a second portion 94. The unitary tendril 90 also includes a midpoint 96 where the unitary tendril 90 switches wrapping direction. In some embodiments, as illustrated, the first portion 92 of the unitary tendril 90 can be considered as having a first coil direction indicated by arrow 98 while the second portion 94 of the unitary tendril 90 can be considered as having a second coil direction indicated by arrow 100.


By having either end biased to opposite coil directions, it will be appreciated that the surgeon installing an electrode cuff with such a unitary tendril 90 can wrap or unwrap either end in the same direction, i.e., both ends can be wrapped or unwrapped in a clockwise direction or in a counter-clockwise direction by virtue of the two ends of the unitary tendril 90 extending from opposite ends of the electrode cuff 20. In some situations, this can simplify and speed up the deployment of the electrode cuff 20.



FIG. 8 illustrates an electrode cuff 110. The electrode cuff 110 is an example of an electrode cuff 20 that can be used in combination with the lead 14. The electrode cuff 110 includes a cuff body 112 and one or more electrodes (not shown). The cuff body 112 includes a first region 114 and a second region 116. A first tendril 118 extends from the first region 114 of the cuff body 112 and a second tendril 120 extends from the second region 116 of the cuff body 112. In some embodiments, the first tendril 118 is biased to a curved configuration as shown. In some embodiments, the second tendril 120 is biased to a curved configuration as shown. While in some respects the electrode cuff 110 is similar to the electrode cuff 70 (FIG. 6), in this instance the first tendril 118 and the second tendril 120 are long enough to wrap several times around the nerve N. In some embodiments, the first tendril 118 and the second tendril 120 are biased to a coiled configuration in which the first and second tendrils 118, 120 have an overall diameter that is greater than a diameter of the cuff body 112.



FIGS. 9 and 10 provide illustrations of electrode cuffs that are configured to minimize the overall length of the electrode cuff and thus minimize the overall cut-down length required for deployment of the electrode cuff. FIG. 9 illustrates an electrode cuff 130 deployed on the nerve N. The electrode cuff 130 is an example of an electrode cuff 20 that can be used in combination with the lead 14. The electrode cuff 130 includes a cuff body 132 and an electrode 134. The cuff body 132 includes a first region 136 and a second region 138. A first tendril 140 extends from the first region 136 of the cuff body 132 and a second tendril 142 extends from the second region 138 of the cuff body 132.


In the illustrated embodiment, the first tendril 140 extends perpendicularly or at least substantially perpendicular to the cuff body 132. The second tendril 142 extends perpendicularly or at least substantially perpendicularly to the cuff body 132. In some embodiments, the first tendril 140 and/or the second tendril 142 extend more than 360 degrees around the nerve N and thus overlap on the cuff body 132. In some embodiments, the first tendril 140 and/or the second tendril 142 may extend less than 360 degrees around the nerve N. The first tendril 140 and the second tendril 142 extend from a common side 144 of the cuff body 132.



FIG. 10 illustrates an electrode cuff 150 deployed on the nerve N. The electrode cuff 150 is an example of an electrode cuff 20 that can be used in combination with the lead 14. The electrode cuff 150 includes a cuff body 152 and an electrode 154. The cuff body 152 includes a first region 156 and a second region 158. A first tendril 160 extends from the first region 156 of the cuff body 152 and a second tendril 162 extends from the second region 158 of the cuff body 152.


In the illustrated embodiment, the first tendril 160 extends perpendicularly or at least substantially perpendicular to the cuff body 152. The second tendril 162 extends perpendicularly or at least substantially perpendicularly to the cuff body 152. In some embodiments, the first tendril 160 and/or the second tendril 162 extend more than 360 degrees around the nerve N and thus overlap on the cuff body 152. In some embodiments, the first tendril 160 and/or the second tendril 162 may extend less than 360 degrees around the nerve N. In the illustrated embodiment, the first tendril 160 extends from a first side 164 of the cuff body 152 and the second tendril 162 extends from a second side 166 of the cuff body 152.


As noted, each of the electrode cuffs described herein, such as the electrode cuff 50, the electrode cuff 70, the electrode cuff 110, the electrode cuff 130 or the electrode cuff 150 can be used in combination with the lead 14 as one or more of the electrode cuffs 20. Each of the electrode cuffs described herein can be formed of any suitable material including a polymeric material such as silicone. In some embodiments, the tendrils can be biased to a particular curved or coiled configuration. In some embodiments, the tendrils can be formed of a shape memory material such as a shape memory polymer.



FIG. 11 illustrates a method that can be carried out using the lead 14 and the electrode cuffs described herein. An electrode cuff having a first tendril and a second tendril can be disposed proximate the nerve N as generally indicated at block 170. At block 172, the electrode cuff can be positioned on the nerve N. The first tendril can be secured in position on the nerve N as generally indicated at block 174. In some embodiments, the first tendril can be secured by wrapping the first tendril around the nerve in a rotational direction. The second tendril can be secured in position on the nerve N as generally indicated at block 176. In some embodiments, the second tendril can be secured by wrapping the second tendril around the nerve N in the same rotational direction.



FIG. 12 illustrates a lead 214 that includes a first electrode cuff 220 secured to a lead body extension 221 and a second electrode cuff 222 secured to a lead body extension 223. The first electrode cuff 220 includes a first cuff body 224 and a first tendril 226 extending from the first cuff body 224. The first tendril 226 is biased to a curved configuration in which the first tendril 226 curves in a first direction 228. A second tendril 230 extends from the first cuff body 224 and is biased to a curved configuration in which the second tendril 230 curves in a second direction 232.


The second electrode cuff 222 includes a second cuff body 234 and a third tendril 236 extending from the second cuff body 234. The third tendril 236 is biased to a curved configuration in which the third tendril 226 curves in a third direction 238. A fourth tendril 240 extends from the second cuff body 234 and is biased to a curved configuration in which the fourth tendril 240 curves in a fourth direction 242. In some embodiments, the first direction 228 and the third direction 238 can be the same. In some embodiments, the second direction 230 and the fourth direction 240 can be the same.


By having opposing ends of each electrode cuff 220 and 222 biased to opposite coil directions, it will be appreciated that the surgeon installing the electrode cuffs can wrap or unwrap either end in the same direction, i.e., both ends of each electrode cuff 230, 232 can be wrapped or unwrapped in a clockwise direction or in a counter-clockwise direction. In some situations, this can simplify and speed up the deployment.


Various modifications and additions can be made to the exemplary embodiments discussed without departing from the scope of the present invention. For example, while the embodiments described above refer to particular features, the scope of this invention also includes embodiments having different combinations of features and embodiments that do not include all of the described features. Accordingly, the scope of the present invention is intended to embrace all such alternatives, modifications, and variations as fall within the scope of the claims, together with all equivalents thereof.

Claims
  • 1. A neurostimulation lead comprising: a lead body having a proximal portion and a distal portion;a first conductor extending through the lead body; andan electrode cuff secured relative to the distal portion of the lead body, the electrode cuff including: a cuff body having a first region and a second region;a first tendril extending from the first region of the cuff body, the first tendril biased to a curved configuration;a second tendril extending from the second region of the cuff body, the second tendril biased to a curved configuration; anda first electrode disposed on the cuff body and electrically connected to the first conductor.
  • 2. The neurostimulation lead of claim 1, wherein the first tendril extends from the first region of the cuff body at an acute angle and is biased to curve in a first direction.
  • 3. The neurostimulation lead of claim 2, wherein the second tendril extends from the second region of the cuff body at an acute angle and is biased to curve in a second direction opposite the first direction.
  • 4. The neurostimulation lead of claim 1, wherein the first tendril extends substantially perpendicularly from the first region of the cuff body.
  • 5. The neurostimulation lead of claim 4, wherein the second tendril extends substantially perpendicularly from the second region of the cuff body.
  • 6. The neurostimulation lead of claim 5, wherein the first tendril and the second tendril both extend in a same direction from the cuff body.
  • 7. The neurostimulation lead of claim 5, wherein the first tendril and the second tendril extend in opposite directions from the cuff body.
  • 8. The neurostimulation lead of claim 1, further comprising: a second conductor extending through the lead body; anda second electrode disposed on the cuff body and electrically connected to the second conductor.
  • 9. The neurostimulation lead of claim 1, further comprising: a first suture molded into and extending through the first tendril; anda second suture molded into and extending through the second tendril.
  • 10. The neurostimulation lead of claim 1, wherein the cuff body is configured to extend less than about 360 degrees about the nerve.
  • 11. The neurostimulation lead of claim 1, wherein the first and second tendrils are each configured to extend more than about 360 degrees about the nerve.
  • 12. The neurostimulation lead of claim 1, wherein the cuff body is configured to be wrapped around the nerve, thereby extending more than about 360 degrees about the nerve.
  • 13. The neurostimulation lead of claim 1, wherein the first tendril and the second tendril are portions of a unitary tendril, the unitary tendril biased to a wrapping direction that reverses direction near a midpoint of the unitary tendril.
  • 14. A neurostimulation lead comprising: a lead body having a proximal portion and a distal portion;a first conductor extending through the lead body;a second conductor extending through the lead body; anda first cuff secured relative to the distal portion of the lead body, the first cuff including: a first cuff body;a first tendril extending from the first cuff body, the first tendril biased to a curved configuration in which the first tendril curves in a first direction;a second tendril extending from the first cuff body, the second tendril biased to a curved configuration in which the second tendril curves in a second direction opposite the first direction;a first electrode disposed on the first cuff body and electrically connected to the first conductor; anda second cuff secured relative to the distal portion of the lead body, the second cuff including: a second cuff body;a third tendril extending from the second cuff body, the third tendril biased to a curved configuration in which the third tendril curves in a third direction;a fourth tendril extending from the second cuff body, the fourth tendril biased to a curved configuration in which the fourth tendril curves in a fourth direction opposite the third direction; anda second electrode disposed on the second cuff body and electrically connected to the second conductor.
  • 15. The neurostimulation lead of claim 14, wherein the first cuff is secured relative to the distal portion of the lead body via a first lead extension, the first lead extension secured to the lead body and the first cuff being attached to the first lead extension.
  • 16. The neurostimulation lead of claim 14, wherein the second cuff is secured relative to the distal portion of the lead body via a second lead extension, the second lead extension secured to the lead body and the second cuff being attached to the second lead extension.
  • 17. The neurostimulation lead of claim 14, further comprising a strain relief secured to the distal portion of the lead body.
  • 18. The neurostimulation lead of claim 14, wherein the first direction is the same as the third direction, and the second direction is the same as the fourth direction.
CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit under 35 U.S.C. section 119(e) to U.S. Provisional Application 61/764,306, entitled “CUFF ELECTRODE WITH INTEGRATED TENDRIL”, filed on Feb. 13, 2013, which is herein incorporated by reference in its entirety.

US Referenced Citations (147)
Number Name Date Kind
4177818 De Pedro Dec 1979 A
4573481 Bullara Mar 1986 A
4590946 Loeb May 1986 A
4590949 Pohndorf May 1986 A
4602624 Naples et al. Jul 1986 A
4628942 Sweeney et al. Dec 1986 A
4740170 Lee et al. Apr 1988 A
4920979 Bullara May 1990 A
4940065 Tanagho et al. Jul 1990 A
4979511 Terry, Jr. Dec 1990 A
5031621 Grandjean et al. Jul 1991 A
5095905 Klepinski Mar 1992 A
5215089 Baker et al. Jun 1993 A
5218089 Mariotti et al. Jun 1993 A
5251634 Weinberg Oct 1993 A
5259394 Bens Nov 1993 A
5282468 Klepinski Feb 1994 A
5324322 Grill, Jr. et al. Jun 1994 A
5334438 Saugnac Aug 1994 A
5344438 Testerman et al. Sep 1994 A
5351394 Weinberg Oct 1994 A
5358516 Myers et al. Oct 1994 A
5375594 Cueva Dec 1994 A
5505201 Grill et al. Apr 1996 A
5531778 Maschino et al. Jul 1996 A
5674272 Bush et al. Oct 1997 A
5689877 Grill et al. Nov 1997 A
5755766 Chastain et al. May 1998 A
5782892 Castle et al. Jul 1998 A
5871530 Williams et al. Feb 1999 A
5913876 Taylor et al. Jun 1999 A
5964702 Grill et al. Oct 1999 A
6038479 Werner et al. Mar 2000 A
6051017 Loeb et al. Apr 2000 A
6093197 Bakula et al. Jul 2000 A
6174329 Callol et al. Jan 2001 B1
6178349 Kieval Jan 2001 B1
6249708 Nelson et al. Jun 2001 B1
6292703 Meier et al. Sep 2001 B1
6296659 Foerster Oct 2001 B1
6308104 Taylor et al. Oct 2001 B1
6308105 Duysens et al. Oct 2001 B1
6381499 Taylor et al. Apr 2002 B1
6423080 Gellman et al. Jul 2002 B1
6600956 Maschino et al. Jul 2003 B2
6725096 Chinn et al. Apr 2004 B2
7047081 Kuzma May 2006 B2
7054692 Whitehurst et al. May 2006 B1
7160298 Lawew et al. Jan 2007 B2
7212867 Van Venrooij et al. May 2007 B2
7502650 Kieval Mar 2009 B2
7536227 Poore et al. May 2009 B1
7561923 Libbus et al. Jul 2009 B2
7711421 Shafer et al. May 2010 B2
7749273 Cauthen, III et al. Jul 2010 B2
7807925 Zarembo Oct 2010 B2
7831311 Cross, Jr. et al. Nov 2010 B2
7891085 Kuzma et al. Feb 2011 B1
7925352 Stack et al. Apr 2011 B2
7925358 Belden et al. Apr 2011 B2
7933662 Marshall et al. Apr 2011 B2
7957817 Gillespie et al. Jun 2011 B1
7974706 Moffitt et al. Jul 2011 B2
7996092 Mrva et al. Aug 2011 B2
8100141 Slupecki et al. Jan 2012 B2
8155757 Neisz et al. Apr 2012 B1
8244372 Zhulati et al. Aug 2012 B1
8295948 Barker et al. Oct 2012 B2
8326418 Sommer et al. Dec 2012 B2
8417343 Bolea et al. Apr 2013 B2
8452406 Arcot-Krishnamurthy et al. May 2013 B2
8483845 Sage Jul 2013 B2
8548593 Ternes et al. Oct 2013 B2
8639355 Soltis Jan 2014 B2
20020116042 Boling Aug 2002 A1
20020128700 Cross, Jr. Sep 2002 A1
20030040785 Maschino et al. Feb 2003 A1
20030236558 Whitehurst et al. Dec 2003 A1
20040010303 Bolea et al. Jan 2004 A1
20040111139 McCreery Jun 2004 A1
20050209655 Bradley et al. Sep 2005 A1
20050234512 Nakao Oct 2005 A1
20050283246 Cauthen, III et al. Dec 2005 A1
20060030919 Mrva et al. Feb 2006 A1
20060122675 Libbus et al. Jun 2006 A1
20060190042 Stone et al. Aug 2006 A1
20060259078 Libbus Nov 2006 A1
20070071568 Dorstewitz Mar 2007 A1
20070083236 Sikora et al. Apr 2007 A1
20070100406 Kollatschny et al. May 2007 A1
20070118177 Libbus et al. May 2007 A1
20070142871 Libbus et al. Jun 2007 A1
20070173914 Kollatschny Jul 2007 A1
20070203556 Rutten et al. Aug 2007 A1
20070239243 Moffitt et al. Oct 2007 A1
20070255320 Inman et al. Nov 2007 A1
20080046058 Cross et al. Feb 2008 A1
20080051839 Libbus et al. Feb 2008 A1
20080058871 Libbus et al. Mar 2008 A1
20080058874 Westlund et al. Mar 2008 A1
20080058901 Ternes et al. Mar 2008 A1
20080086181 Amurthur et al. Apr 2008 A1
20080091255 Caparso et al. Apr 2008 A1
20080103407 Bolea et al. May 2008 A1
20080103545 Bolea et al. May 2008 A1
20080132987 Westlund et al. Jun 2008 A1
20080140092 Stone et al. Jun 2008 A1
20080172101 Bolea et al. Jul 2008 A1
20080177365 Bolea et al. Jul 2008 A1
20080177366 Bolea et al. Jul 2008 A1
20080183258 Inman Jul 2008 A1
20080195188 Libbus et al. Aug 2008 A1
20080234780 Smith et al. Sep 2008 A1
20080255613 Kaiser et al. Oct 2008 A1
20090048641 Libbus Feb 2009 A1
20090210042 Kowalczewski Aug 2009 A1
20090259260 Bentley et al. Oct 2009 A1
20090275997 Faltys et al. Nov 2009 A1
20090276024 Bonde et al. Nov 2009 A1
20090318961 Stone et al. Dec 2009 A1
20100023088 Stack et al. Jan 2010 A1
20100036451 Hoffer Feb 2010 A1
20100121405 Ternes et al. May 2010 A1
20100145221 Brunnett et al. Jun 2010 A1
20100168831 Korivi et al. Jul 2010 A1
20100211131 Williams et al. Aug 2010 A1
20100286553 Feler et al. Nov 2010 A1
20100305674 Zarembo et al. Dec 2010 A1
20100312320 Faltys et al. Dec 2010 A1
20100331938 Sommer et al. Dec 2010 A1
20110004281 Jones Jan 2011 A1
20110022142 Barker et al. Jan 2011 A1
20110040257 Behymer et al. Feb 2011 A1
20110060395 Cantlon Mar 2011 A1
20110172682 Brady et al. Jul 2011 A1
20110172701 Wales et al. Jul 2011 A1
20120022617 Tockman et al. Jan 2012 A1
20120035691 Tockman et al. Feb 2012 A1
20120065702 Arcot-Krishnamurthy et al. Mar 2012 A1
20120158082 Katra Jun 2012 A1
20120221087 Parnis et al. Aug 2012 A1
20130005169 Soltis et al. Jan 2013 A1
20130013045 Soltis Jan 2013 A1
20130172973 Tockman et al. Jul 2013 A1
20130253615 Arcot-Krishnamurthy et al. Sep 2013 A1
20130253624 Tockman et al. Sep 2013 A1
20140094888 True et al. Apr 2014 A1
Foreign Referenced Citations (16)
Number Date Country
2012275666 Jun 2015 AU
0585553 Jun 1993 EP
2005058456 Mar 2005 JP
2008526299 Jul 2008 JP
2015511857 Apr 2015 JP
WO9929366 Jun 1999 WO
WO2004052176 Jun 2004 WO
WO2006093685 Sep 2006 WO
WO2007024164 Jan 2007 WO
WO2008088798 Jul 2008 WO
WO2008094349 Aug 2008 WO
WO2009020639 Feb 2009 WO
WO2009025817 Feb 2009 WO
WO2009100242 Aug 2009 WO
WO2011053766 May 2011 WO
2013142053 Sep 2013 WO
Non-Patent Literature Citations (19)
Entry
International Preliminary Examination Report, Chapter II, issued in PCT/US2013/029306, completed Aug. 19, 2014, 16 pages.
Written Opinion of the International Preliminary Examining Authority Issued in PCT/US2013/029306, mailed May 8, 2014, 6 pages.
International Search Report and Written Opinion Issued in PCT/US2009/063442, mailed Feb. 1, 2010, 11 pages.
International Search Report and Written Opinion Issued in PCT/US2010/026350, mailed Jun. 2, 2010.
International Search Report and Written Opinion issued in PCT/US2011/020699, mailed Jul. 26, 2011, 24 pages.
International Search Report and Written Opinion Issued in PCT/US2011/049585, mailed Dec. 19, 2011.
International Search Report and Written Opinion Issued in PCT/US2012/044020, mailed Sep. 11, 2012, 9 pages.
International Search Report and Written Opinion issued in PCT/US2012/044028, mailed Oct. 1, 2012, 9 pages.
International Search Report and Written Opinion issued in PCT/US2012/071812, mailed Sep. 13, 2013, 12 pages.
International Search Report and Written Opinion issued in PCT/US2013/029306, mailed Jul. 18, 2013, 13 pages.
International Search Report and Written Opinion issued in PCT/US2013/062560, mailed Dec. 17, 2014, 13 pages.
International Search Report and Written Opinion issued in PCT/US2013/062608, mailed Dec. 17, 2014, 13 pages.
International Search Report and Written Opinion issued in PCT/US2013/077949, mailed Jun. 20, 2014, 15 pages.
International Search Report and Written Opinion issued in PCT/US2014/015590, mailed May 28, 2014, 14 pages.
Kirsch, Robert F. et al., “Restoration of Hand and Arm Function by Functional Neuromuscular Stimulation”, Period covered: Jun. 1, 2001-Aug. 31, 2006, 71 pages.
Partial International Search Report issued in PCT/US2011/020699, mailed Mar. 24, 2011,6 pages.
International Preliminary Report on Patentability issued in PCT/US2013/062560, completed Apr. 7, 2015, 9 pages.
International Preliminary Report on Patentability issued in PCT/US2013/062608, completed Apr. 7, 2015, 8 pages.
International Preliminary Report on Patentability issued in PCT/US2014/015590, mailed Aug. 27, 2015, 10 pages.
Related Publications (1)
Number Date Country
20140228923 A1 Aug 2014 US
Provisional Applications (1)
Number Date Country
61764306 Feb 2013 US