Implantable electrical stimulation leads

• US 9,498,619 B2
• Filed: 02/26/2014
• Issued: 11/22/2016
• Est. Priority Date: 02/26/2013
• Status: Active Grant

• Current Assignee: Paras Holdings LLC
• Original Assignee: EndoStim, Inc.
• Inventors: Goode, Paul V., Glasberg, Ofer, Sharma, Virender K.
• Primary Examiner(s): Leubecker, John P
• Application Number:
  US14/191,085
• Publication Number:
  US 20140243593A1
• Time in Patent Office: 1,000 Days
• Field of Search: 606/48, 606/51, 607/40
• US Class Current: 1/1
• CPC Class Codes: A61B 1/00082 Balloons
• CPC Class Codes: A61B 1/00087 Tools A61B17/00234 takes precedence
• CPC Class Codes: A61B 18/082 Probes or electrodes therefor
• CPC Class Codes: A61B 2017/0034 adapted to be inserted through a working channel of an endoscope
• CPC Class Codes: A61B 2018/00595 Cauterization
• CPC Class Codes: A61F 5/0026 Anti-eating devices using electrical stimulation
• CPC Class Codes: A61N 1/0509 Stomach and intestinal electrodes
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control

Abstract

An implantable electrical stimulation lead for the treatment of biological conditions includes a lead body with an electrical connector at one end and a pair of monopolar branches at the other end. The lead body has a length ranging from 390 mm to 490 mm to allow for implantation from an incision site further removed from the final positioning site of the electrodes. The branches have lengths ranging from 50 mm to 120 mm for the both branches. These lengths facilitate successful laparoscopic implantation at sites with confined anatomy, such as, near the gastroesophageal junction. The branches include needles and sutures at their ends for suturing anchors positioned on the branches to surrounding tissue. The needles have curves designed to facilitate maneuvering in confined anatomy. A separate lead includes a suture loop connecting the ends of the first and second branches rather than needles. The loop is used to pull the lead through the working channel of an endoscope. The anchors on the lead are porous and allow for the ingrowth of surrounding tissue for fixing the branches in place.

Claims

1. A lead delivery catheter to be used with an endoscope or a laparoscope and for implanting an electrical stimulation lead in a patient, said catheter comprising:

a catheter body having a proximal end, a distal end, and a lumen within;

an inflatable balloon attached to said distal end of said catheter body;

a grasping mechanism comprising a pair of opposing grasping members, each of said grasping members having a plurality of teeth, wherein said grasping mechanism is attached to said distal end of said catheter body for grasping said lead;

a bipolar electrocautery electrode positioned on said grasping mechanism; and

an electrical stimulation lead for use in the stimulation of biological tissues comprising;

an elongate lead body having a proximal end and a distal end, said lead body comprising an electrically conductive inner coil, an electrically conductive outer coil, a first insulating sheath covering said electrically conductive inner coil, and a second insulating sheath covering said electrically conductive outer coil;

a connector attached to and in electrical communication with said proximal end of said lead body;

a first elongate branch having a proximal end and a distal end, said first elongate branch comprising said electrically conductive inner coil and said first insulating sheath covering said electrically conductive inner coil and not comprising said electrically conductive outer coil and said second insulating sheath; and

a second elongate branch having a proximal end and a distal end, said second elongate branch comprising said electrically conductive outer coil and said second insulating sheath covering said electrically conductive outer coil and not comprising said electrically conductive inner coil and said first insulating sheath, wherein said proximal end of said first branch and said proximal end of said second branch join to form said distal end of said lead body, wherein said first insulating sheath extends over a proximal portion of a first electrode and said second insulating sheath extends over a proximal portion of a second electrode such that, after said lead is implanted, said insulating sheaths are configured to be pulled partially in a proximal direction to expose said proximal portions of said first and second electrodes.

2. The lead delivery catheter of claim 1 further comprising a light source adapted to provide illumination and positioned at the distal end.

3. The lead delivery catheter of claim 1 further comprising a camera positioned at the distal end.

4. The lead delivery catheter of claim 1 wherein said lead body has a length within a range of 390 mm to 490 mm.

5. The lead delivery catheter of claim 1 wherein said first branch has a length within a range of 50 mm to 120 mm.

6. The lead delivery catheter of claim 1 wherein said second branch has a length within a range of 50 mm to 120 mm.

7. The lead delivery catheter of claim 1 further comprising a first anchoring element.

8. The lead delivery catheter of claim 1 further comprising a second anchoring element.

9. The lead delivery catheter of claim 1 further comprising a first length of suturing material and a second length of suturing material, each having a proximal end and a distal end, wherein said proximal end of said first length of said suturing material is attached to said distal end of said first branch and said proximal end of said second length of said suturing material is attached to said distal end of said second branch.

10. The lead delivery catheter of claim 9, wherein said first and second lengths of suturing material are each in a range of 55 to 65 mm.

11. The lead delivery catheter of claim 9 further comprising a first needle attached to said distal end of said first length of suturing material and a second needle attached to said distal end of said second length of suturing material, wherein said first needle and said first length of suturing material are used to suture a first anchoring element to a biological tissue and said second needle and said second length of suturing material are used to suture a second anchoring element to a biological tissue.

12. The lead delivery catheter of claim 11 wherein said first and second needles are each within a range of ¼

to ⅜

of a circle curve needles with a length ranging from 18 to 23 mm and include a base having a diameter in a range of 0.68 mm to 0.78 mm.

13. The lead delivery catheter of claim 1 further comprising a sleeve covering the distal end of said lead body and the proximal ends of said first branch and said second branch.

14. The lead delivery catheter of claim 1 further comprising a marking element on said first branch to serve as a visual indicator.

15. A lead delivery catheter to be used with an endoscope or a laparoscope and for implanting an electrical stimulation lead in a patient, said catheter comprising:

a catheter body having a proximal end, a distal end, and a lumen within;

an inflatable balloon attached to said distal end of said catheter body;

a grasping mechanism comprising a pair of opposing grasping members, each of said grasping members having a plurality of teeth, wherein said grasping mechanism is attached to said distal end of said catheter body for grasping said lead;

a bipolar electrocautery electrode positioned on said grasping mechanism; and

an electrical stimulation lead for use in the stimulation of biological tissues, said lead comprising;

an elongate lead body having a proximal end and a distal end, said lead body comprising an electrically conductive inner coil, an electrically conductive outer coil, a first insulating sheath covering said electrically conductive inner coil, and a second insulating sheath covering said electrically conductive outer coil;

a connector attached to and in electrical communication with said proximal end of said lead body;

a first elongate branch having a proximal end and a distal end, said first elongate branch comprising said electrically conductive inner coil and said first insulating sheath covering said electrically conductive inner coil and not comprising said electrically conductive outer coil and said second insulating sheath;

a second elongate branch having a proximal end and a distal end, said second elongate branch comprising said electrically conductive outer coil and said second insulating sheath covering said electrically conductive outer coil and not comprising said electrically conductive inner coil and said first insulating sheath, wherein said proximal end of said first branch and said proximal end of said second branch join to form said distal end of said lead body; and

an additional electrically conductive coil having a proximal end and a distal end, wherein the proximal end of the additional electrically conductive coil is attached to a distal end of the outer coil, wherein a second anchoring element and an electrode are attached to the distal end of the additional electrically conductive coil and wherein the second insulating sheath extends over said additional electrically conductive coil.