Temporary medical electrical lead having biodegradable electrode mounting pad loaded with therapeutic drug

• US 6,385,491 B1
• Filed: 10/04/1999
• Issued: 05/07/2002
• Est. Priority Date: 10/04/1999
• Status: Expired due to Fees

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Lindemans, Fredric W., Gebhardt, Ursula, Hendriks, Marc
• Primary Examiner(s): Evanisko, George R.
• Assistant Examiner(s): Oropeza, Frances P.
• Application Number:
  US09/411,837
• Time in Patent Office: 946 Days
• Field of Search: 600/374, 600/375, 607/116, 607/119, 607/120, 607/122, 607/129, 607/130, 607/131, 607/132, 424/422, 424/423, 424/424, 424/425, 424/426, 424/428, 424/484
• US Class Current: 607/120
• CPC Class Codes: A61N 1/0587 Epicardial electrode systems; Endocardial electrodes piercing the pericardium
• CPC Class Codes: Y10T 29/49147 Assembling terminal to base
• CPC Class Codes: Y10T 29/49169 Assembling electrical component directly to terminal or elongated conductor
• CPC Class Codes: Y10T 29/49174 Assembling terminal to elongated conductor
• CPC Class Codes: Y10T 29/49208 by assembling plural parts

Abstract

A temporary cardiac electrical stimulating lead comprises a stimulating electrode mounted in or on a biodegradable electrode mounting pad disposed at a distal end of the lead. The electrode mounting pad is capable of biodegradably dissolving over time in human body fluids and is loaded with a drug for therapeutically treating a medical condition of a patient'"'"'s heart. The electrode mounting pad may be loaded with any of a variety of different drugs, such anti-arrhythmia or anti-inflammatory drugs. When the lead body is pulled away from the electrode mounting pad and removed from the patient, any portion of the electrode mounting pad remaining within the patient dissolves over time and disappears.

Claims

1. A temporary medical electrical lead for pacing or defibrillating a heart of a patient, the lead having distal and proximal ends, comprising:

(a) a lead body having proximal and distal ends, comprising;

(i) at least one electrical conductor having proximal and distal ends;

(ii) an insulative sheath formed of biocompatible and electrically insulative material, the sheath extending over and covering at least portions of the at least one electrical conductor;

(b) an electrical connector assembly attached to the proximal end of the at least one electrical conductor for attachment to a device capable of providing pacing or defibrillation pulses therethrough;

(c) an electrode mounting pad comprising lower and upper surfaces separated by a pad thickness, the pad having outer edges disposed between the lower and upper surfaces, the lower surface being configured for engagement with an outer surface of a human heart, the electrode mounting pad being disposed near the distal end of the lead body, at least one of the distal end of the at least one electrical conductor and an electrode member secured to the distal end of the at least one electrical conductor being attached to or integrated into the electrode mounting pad such that all portions of the distal end of the conductor are disposed at locations disposed upwardly from the lower surface such that no such portions of the conductor distal end penetrate the lower surface of the electrode mounting pad, the distal end of the single electrical conductor forming a sinusoidally-shaped or semi-sinusoidally shaped electrode disposed on or in the electrode mounting pad such that at least portions of the sinusoldally-shaped or semi-sinusoidally shaped electrode are disposed along the outer edges of the electrode mounting pad and such that the electrode may be removed from a patient'"'"'s body after implantation therein through the application of a pulling force exerted by a physician the electrode mounting pad comprising a biodegradable, biocompatible material soluble in human body fluids, the material forming a matrix having open voids or spaces disposed therein, and

(d) a drug for treating a medical condition of the patient'"'"'s heart, the drug being incorporated in, or disposed on or in at least portions of the matrix, the drug being released to body fluids following implantation of the pad within the patient'"'"'s body adjacent the heart.

2. The temporary medical electrical lead of claim 1, wherein the biodegradable, biocompatible material comprises collagen.

3. The temporary medical electrical lead of claim 1, wherein the biodegradable, biocompatible material comprises crosslinked collagen.

4. The temporary medical electrical lead of claim 1, wherein the biodegradable, biocompatible material is selected from the group consisting of albumin, silk, ploy(L)lysin, fibrin, elastin, hyaluronic acid, salts of hyaluronic acid, glycos-amino-glycans, polysacharndes, poly lactic acid, poly hydroxy butyrate, poly eslen amides, keratin, chondroitin sulfates, dermatan sulfate, karatan sulfate, heparan, heparan sulfate, heparan substitutes, cellulose, cellulose derivatives, starch, gelatin, dextrans, dextran derivatives, heparin, heparin substitutes, chitin, chitosan, aliphatic polyester, polyamide, polyesteramide, polyorthoester, polyanhydride, polyphosphazene, Poly(glycolic acid), Poly(L-lactic acid), Poly(DL-lactic acid), Poly(p-ioxanone), Poly(,-caprolactone), Poly(3-hydroxypropionic acid), Poly(3-hydroxybutyric acid), Poly(∀

-malic acid), Poly(∃

-malic acid), and Poly(serine ester).

5. The temporary medical electrical lead of claim 1, wherein the electrode mounting pad has one or more holes disposed therethrough.

6. The temporary medical electrical lead of claim 1, wherein the electrode mounting pad has a thickness ranging between one of about 2 mm and about 3 mm, about 1 mm and about 4 mm, and about 0.5 mm and about 5 mm.

7. The temporary medical electrical lead of claim 1, wherein the electrical connector assembly comprises a break-away piercing needle.

8. The temporary medical electrical lead of claim 1, wherein the drug is an anti-arrhythmic drug.

9. The temporary medical electrical lead of claim 8, wherein the anti-arrhythmic drug is selected from the group consisting of quinidine, procainamide, disopyramide, lidocaine, mexiletine, propafenone, flencainide, a beta-adrenergic antagonist, bretylium, sotalol, amiodarone, ibutilide, verpamil, diltazem, and andenosine.

10. The temporary medical electrical lead of claim 1, wherein the drug is an anti-inflammatory drug.

11. The temporary medical electrical lead of claim 10, wherein the anti-inflammatory drug is selected from the group consisting of dexamethasone, dexamethasone phosphate, a steroid, ibuprofen, aspirin, and baclomethasone.

12. The temporary medical electrical lead of claim 1, wherein the drug is an anti-biotic drug.

13. The temporary medical electrical lead of claim 12, wherein the anti-biotic drug is selected from the group consisting of genamyacin, penicillin, methacillin and tertracycline.

14. The temporary medical electrical lead of claim 1, wherein the drug is selected from the group consisting of a local anesthetic and a pain relief agent.

15. A temporary medical means for electrically stimulating a heart of a patient, the stimulating means having distal and proximal ends, comprising:

(a) a lead body having proximal and distal ends, comprising;

(i) at least one means for conducting electricity having proximal and distal ends;

(ii) means for electrically insulating formed of biocompatible and electrically insulative material, the insulating means extending over and covering at least portions of the at least one electrical conducting means;

(b) an electrical means for connecting attached to the proximal end of the at least one electrical conducting means for attachment to a means for providing electrical stimulatior pulses therethrough;

(c) means for securing a stimulating electrode to the patient'"'"'s heart comprising lower and upper surfaces separated by a thickness, the securing means having outer edges disposed between the lower and upper surfaces, the lower surface being configured for engagement with an outer surface of a human heart, the securing means being disposed near the distal end of the lead body, at least one of the distal end of the at least one electrical conducting means and an electrode member secured to the distal end of the at least one electrical conducting means being attached to or integrated into the stimulating electrode securing means such that all portions of the distal end of the conducting means are disposed at locations disposed upwardly from the lower surface such that no such portions of the conducting means distal end penetrate the lower surface of the securing means, the distal end of the conducting means forming a sinusoidally-shaped or semi-sinusoidally shaped electrode disposed on or in the securing means such that at least portions of the sinusoidally-shaped or semi-sinusoidally shaped electrode are disposed along the outer edges of the securing means such that the electrode may be removed from a patient'"'"'s body after implantation therein through the application of a pulling force exerted by a physician, the stimulating electrode securing means comprising a biodegradable, biocompatible material soluble in human body fluids, the material forming a matrix having open voids or spaces disposed therein, and

(d) a drug for treating a medical condition of the patient'"'"'s heart, the drug being incorporated In, or disposed on or in at least portions of the matrix, the drug being released to body fluids following implantation of the pad within the patient'"'"'s body adjacent the heart.

16. The temporary medical electrical lead of claim 15, wherein the biodegradable, biocompatible material comprises collagen.

17. The temporary medical electrical lead of claim 15, wherein the biodegradable, biocompatible material comprises crosslinked collagen.

18. The temporary medical electrical lead of claim 15, wherein the biodegradable, biocompatible material is selected from the group consisting of albumin, silk, ploy(L)lysin, fibrin, elastin, hyaluronic acid, salts of hyaluronic acid, glycos-aminoglycans, polysacharrides, poly lactic acid, poly hydroxy butyrate, poly eslen amides, keratin, chondroitin sulfates, dermatan sulfate, karatan sulfate, heparan, heparan sulfate, heparan substitutes, cellulose, cellulose derivatives, starch, gelatin, dextrans, dextran derivatives, heparin, heparin substitutes, chitin, chitosan, aliphatic polyester, polyamide, polyesteramide, polyorthoester, polyanhydride, polyphosphazene, Poly(glycolic acid), Poly(L-lactic acid), Poly(DL-lactic acid), Poly(p-dioxanone), Poly(,-caprolactone), Poly(3-hydroxypropionic acid), Poly(3-hydroxybutyric acid), Poly(∀

-malic acid), Poly(∃

-malic acid), and Poly(serine ester).

19. The temporary medical electrical lead of claim 15, wherein the stimulating electrode securing means has one or more holes disposed therethrough.

20. The temporary medical electrical lead of claim 15, wherein the stimulating electrode securing means has a thickness ranging between one of about 2 mm and about 3 mm, about 1 mm and about 4 mm, and about 0.5 mm and about 5 mm.

21. The temporary medical electrical lead of claim 15, wherein the electrical connecting means comprises a break-away piercing needle.

22. The temporary medical electrical lead of claim 15, wherein the drug is an anti-arrhythmic drug.

23. The temporary medical electrical lead of claim 22, wherein the anti-arrhythmic drug is selected from the group consisting of quinidine, procainamide, disopyramide, lidocaine, mexiletine, propafenone, flencainide, a beta-adrenergic antagonist, bretylium, sotalol, amiodarone, ibutilide, verpamil, diltazem, and andenosine.

24. The temporary medical electrical lead of claim 22, wherein the drug is an anti-inflammatory drug.

25. The temporary medical electrical lead of claim 24, wherein the anti-inflammatory drug is selected from the group consisting of dexamethazone, dexamethazone phosphate, a steroid, ibuprofen, aspirin, and baclomethazone.

26. The temporary medical electrical lead of claim 22, wherein the drug is an anti-biotic drug.

27. The temporary medical electrical lead of claim 26, wherein the anti-biotic drug is selected from the group consisting of genamyacin, penicillin, methacillin and tertracycline.

28. The temporary medical electrical lead of claim 22, wherein the drug is selected from the group consisting of a local anesthetic and a pain relief agent.

29. A temporary medical electrical lead for pacing or defibrillating a heart of a patient, the lead having distal and proximal ends, comprising:

(a) a lead body having proximal and distal ends, comprising;

(i) a single electrical conductor having proximal and distal ends;

(ii) an insulative sheath formed of biocompatible and electrically insulative material, the sheath extending over and covering at least portions of the at least one electrical conductor;

(b) an electrical connector assembly attached to the proximal end of the single electrical conductor for attachment to a device capable of providing pacing or defibrillation pulses therethrough;

(c) an electrode mounting pad comprising lower and upper surfaces separated by a pad thickness, the pad having outer edges disposed between the lower and upper surfaces, the lower surface being configured for engagement with an outer surface of a human heart, the electrode mounting pad being disposed near the distal end of the lead body, the distal end of the single electrical conductor being attached to or integrated into the electrode mounting pad such that all portions of the distal end of the conductor are disposed at locations disposed upwardly from the lower surface such that no such portions of the conductor distal end penetrate the lower surface of the electrode mounting pad, the distal end of the single electrical conductor forming a sinusoidally-shaped or semi-sinusoidally shaped electrode disposed on or in the electrode mounting pad such that at least portions of the sinusoidally-shaped or semi-sinusoidally shaped electrode are disposed along the outer edges of the electrode mounting pad and such that the electrode may be removed from a patient'"'"'s body after implantation therein through the application of a pulling force exerted by a physician[the single electrical conductor being detachable from the electrode mounting pad and removable from the patient'"'"'s body after implantation therein through the application of a pulling force exerted by a physician], the electrode mounting pad comprising a biodegradable, biocompatible material soluble in human body fluids, the material forming a matrix having open voids or spaces disposed therein, and

(d) a drug for treating a medical condition of the patient'"'"'s heart, the drug being incorporated in, or disposed on or in at least portions of the matrix, the drug being released to body fluids following implantation of the pad within the patient'"'"'s body adjacent the heart.

30. The temporary medical electrical lead of claim 29, wherein the biodegradable, biocompatible material comprises collagen.

31. The temporary medical electrical lead of claim 29, wherein the biodegradable, biocompatible material comprises crosslinked collagen.

32. The temporary medical electrical lead of claim 29, wherein the biodegradable, biocompatible material is selected from the group consisting of albumin, silk, ploy(L)Iysin, fibrin, elastin, hyaluronic acid, salts of hyaluronic acid, glycos-aminoglycans, polysachamdes, poly lactic acid, poly hydroxy butyrate, poly eslen amides, keratin, chondroitin sulfates, dermatan sulfate, karatan sulfate, heparan, heparan sulfate, heparan substitutes, cellulose, cellulose derivatives, starch, gelatin, dextrans, dextran derivatives, heparin, heparin substitutes, chitin, chitosan, aliphatic polyester, polyamide, polyesteramide, polyorthoester, polyanhydride, polyphosphazene, Poly(glycolic acid), Poly(L-lactic acid), Poly(DL-lactic acid), Poly(p-dioxanone), Poly(,-caprolactone), Poly(3-hydroxypropionic acid), Poly(3-hydroxybutyric acid), Poly(∀

-malic acid), Poly(∃

-malic acid), and Poly(serine ester).

33. The temporary medical electrical lead of claim 29, wherein the electrode mounting pad has one or more holes disposed therethrough.

34. The temporary medical electrical lead of claim 29, wherein the electrode mounting pad has a thickness ranging between one of about 2 mm and about 3 mm, about 1 mm and about 4 mm, and about 0.5 mm and about 5 mm.

35. The temporary medical electrical lead of claim 29, wherein the electrical connector assembly comprises a break-away piercing needle.

36. The temporary medical electrical lead of claim 29, wherein the drug is an anti-arrhythmic drug.

37. The temporary medical electrical lead of claim 36, wherein the anti-arrhythmic drug is selected from the group consisting of quinidine, procainamide, disopyramide, lidocaine, mexiletine, propafenone, flencainide, a beta-adrenergic antagonist, bretylium, sotalol, amiodarone, ibutilide, verpamil, diltazem, and andenosine.

38. The temporary medical electrical lead of claim 29, wherein the drug is an anti-inflammatory drug.

39. The temporary medical electrical lead of claim 38, wherein the anti-inflammatory drug is selected from the group consisting of dexamethazone, dexamethazone phosphate, a steroid, ibuprofen, aspirin, and baclomethazone.

40. The temporary medical electrical lead of claim 29, wherein the drug is an anti-biotic drug.

41. The temporary medical electrical lead of claim 40, wherein the anti-biotic drug is selected from the group consisting of genamyacin, penicillin, methacillin and tertracycline.

42. The temporary medical electrical lead of claim 29, wherein the drug is selected from the group consisting of a local anesthetic and a pain relief agent.

43. A system for pacing or defibrillating a heart of a patient, comprising:

(a) means for generating electrical stimulating pulses suitable for delivery to the heart of the patient, and

(b) an electrical lead having distal and proximal ends, comprising;

(i) a lead body having proximal and distal ends, comprising;

(1) at least one electrical conductor having proximal and distal ends;

(2) an insulative sheath formed of biocompatible and electrically insulative material, the sheath extending over and covering at least portions of the at least one electrical conductor;

(ii) an electrical connector assembly attached to the proximal end of the at least one electrical conductor for attachment to the electrical stimulating pulse generating means;

(iii) an electrode mounting pad comprising lower and upper surfaces separated by a pad thickness, the pad having outer edges disposed between the lower and upper surfaces, the lower surface being configured for engagement with an outer surface of a human heart, the electrode mounting pad being disposed near the distal end of the lead body, the distal end of the single electrical conductor being attached to or integrated into the electrode mounting pad such that all portions of the distal end of the conductor are disposed at locations disposed upwardly from the lower surface such that no such portions of the conductor distal end penetrate the lower surface of the electrode mounting pad, the distal end of the single electrical conductor forming a sinusoidally-shaped or semi-sinusoidally shaped electrode disposed on or in the electrode mounting pad such that at least portions of the sinusoidally-shaped or semi-sinusoidally shaped electrode are disposed along the outer edges of the electrode mounting pad and such that the electrode may be removed from a patient'"'"'s body after implantation therein through the application of a pulling force exerted by a physician, the electrode mounting pad comprising a biodegradable, biocompatible material soluble in human body fluids, the material forming a matrix having open voids or spaces disposed therein, and

(iv) a drug for treating a medical condition of the patient'"'"'s heart, the drug being incorporated in, or disposed on or in at least portions of the matrix, the drug being released to body fluids following implantation of the pad within the patient'"'"'s body adjacent the heart.

44. The system of claim 43, wherein the biodegradable, biocompatible material comprises collagen.

45. The system of claim 43, wherein the biodegradable, biocompatible material comprises crosslinked collagen.

46. The system of claim 43, wherein the biodegradable, biocompatible material is selected from the group consisting of albumin, silk, ploy(L)lysin, fibrin, elastin, hyaluronic acid, salts of hyaluronic acid, glycos-amino-glycans, polysacharrides, poly lactic acid, poly hydroxy butyrate, poly eslen amides, keratin, chondroitin sulfates, dermatan sulfate, karatan sulfate, heparan, heparan sulfate, heparan substitutes, cellulose, cellulose derivatives, starch, gelatin, dextrans, dextran derivatives, heparin, heparin substitutes, chitin, chitosan, aliphatic polyester, polyamide, polyesteramide, polyorthoester, polyanhydride, polyphosphazene, Poly(glycolic acid), Poly(L-lactic acid), Poly(DL-lactic acid), Poly(p-dioxanone), Poly(,-caprolactone), Poly(3-hydroxypropionic acid), Poly(3-hydroxybutyric acid), Poly(∀

-malic acid), Poly(∃

-malic acid), and Poly(serine ester).

47. The system of claim 43, wherein the electrode mounting pad has one or more holes disposed therethrough.

48. The system of claim 43, wherein the electrode mounting pad has a thickness ranging between one of about 2 mm and about 3 mm, about 1 mm and about 4 mm, and about 0.5 mm and about 5 mm.

49. The system of claim 43, wherein the electrical connector assembly comprises a break-away piercing needle.

50. The system of claim 43, wherein the drug is an anti-arrhythmic drug.

51. The system of claim 50, wherein the anti-arrhythmic drug is selected from the group consisting of quinidine, procainamide, disopyramide, lidocaine, mexiletine, propafenone, flencainide, a beta-adrenergic antagonist, bretylium, sotalol, amiodarone, ibutilide, verpamil, diltazem, and andenosine.

52. The system of claim 43, wherein the drug is an anti-inflammatory drug.

53. The system of claim 52, wherein the anti-inflammatory drug is selected from the group consisting of dexamethazone, dexamethazone phosphate, a steroid, ibuprofen, aspirin, and baclomethazone.

54. The system of claim 43, wherein the drug is an anti-biotic drug.

55. The system of claim 54, wherein the anti-biotic drug is selected from the group consisting of genamyacin, penicillin, methacillin and tertracycline.

56. The system of claim 43, wherein the drug is selected from the group consisting of a local anesthetic and a pain relief agent.

57. A method of employing a medical electrical lead for pacing or defibrillating a heart of a patient, the lead having distal and proximal ends and comprising a lead body having proximal and distal ends, the lead body comprising at least one electrical conductor having proximal and distal ends, an insulative sheath formed of biocompatible and electrically insulative material, the sheath extending over and covering at least portions of the at least one electrical conductor, an electrical connector assembly attached to the proximal end of the at least one electrical conductor for attachment to a means for generating electrical stimulating pulses, and an electrode mounting pad comprising lower and upper surfaces separated by a pad thickness, the pad having outer edges disposed between the lower and upper surfaces, the lower surface being configured for engagement with an outer surface of a human heart, the electrode mounting pad being disposed near the distal end of the lead body, at least one of the distal end of the at least one electrical conductor and an electrode member secured to the distal end of the at least one electrical conductor being attached to or integrated into the electrode mounting pad such that all portions of the distal end of the conductor are disposed at locations disposed upwardly from the lower surface such that no such portions of the conductor distal end penetrate the lower surface of the electrode mounting pad, the distal end of the single electrical conductor forming a sinusoidally-shaped or semi-sinusoidally shaped electrode disposed on or in the electrode mounting pad such that at least portions of the sinusoidally-shaped or semi-sinusoidally shaped electrode are disposed along the outer edges of the electrode mounting pad and such that the electrode may be removed from a patient'"'"'s body after implantation therein through the application of a pulling force exerted by a physician, the electrode mounting pad comprising a biodegradable, biocompatible material soluble in human body fluids, the material forming a matrix having open voids or spaces disposed therein, and a drug for treating a medical condition of the patient'"'"'s heart the drug being incorporated in, or disposed on or in at least portions of the matrix, the drug being released to body fluids following implantation of the pad within the patient'"'"'s body at a location adjacent the heart, the method comprising:

(a) securing the electrode mounting pad to the heart of the patient;

(b) connecting the connector-assembly to the means for generating electrical stimulating pulses;

(c) providing electrical stimulating pulses to the heart with the electrode or the distal end of the electrical conductor and the electrical stimulating pulse generating means;

(d) delivering at least some of the drug to body fluids near the location;

(e) removing the electrical conductor from the patient by applying a pulling force to the proximal end thereof, and

(f) permitting the electrode mounting pad to dissolve in the body fluids.