Source: http://www.google.de/patents/US7499757
Timestamp: 2013-05-25 10:30:42
Document Index: 619552305

Matched Legal Cases: ['art 12', 'art 12', 'art 12', 'art 12', 'art 12', 'art 12', 'art 12', 'art 12', 'art 12', 'art 12']

Patent US7499757 - Absorbable myocardial lead fixation system - Google PatenteSuche Bilder Maps Play YouTube News Gmail Drive Mehr » Erweiterte Patentsuche | Webprotokoll | Anmelden Erweiterte Patentsuche PatenteA myocardial lead attachment system for securing a distal end of a lead within a myocardium of a patient's heart. The system includes a lead body, an anchor mechanism formed of a bioabsorbable or biodegradable polymer for engaging a surface of the patient's heart and a surface feature formed on a portion...http://www.google.de/patents/US7499757?utm_source=gb-gplus-sharePatent US7499757 - Absorbable myocardial lead fixation system Ver�ffentlichungsnummerUS7499757 B2PublikationstypErteilung Anmeldenummer10/971,577 Ver�ffentlichungsdatum3. M�rz 2009Eingetragen22. Okt. 2004 Priorit�tsdatum24. Okt. 2003Auch ver�ffentlicht unterEP1682215A1EP1682215B1US7418298US20050113900US20050113901US20050119718US20050137672US20080249596WO2005039691A1 ErfinderM. Sean CoeJr. Ronald W. HeilPeter T. KelleyII Donald F. PalmeJason Alan ShiroffRandy W. WestlundUrspr�nglich Bevollm�chtigterCardiac Pacemakers, Inc. US-Klassifikation607/120607/126Internationale KlassifikationA61B5/0492A61B17/04A61B17/06A61N1/05 UnternehmensklassifikationA61B5/0492A61B17/0469A61N1/0587A61B17/06109A61B2017/06042A61B2017/0417A61N2001/0578A61N2001/058A61N1/0568A61B2017/0608 Europ�ische KlassifikationA61B17/06N12A61B17/04EA61N1/05PReferenzenPatentzitate (82)Nichtpatentzitate (17) Referenziert von (1)Externe LinksUSPTO USPTO-Zuordnung EspacenetAbsorbable myocardial lead fixation systemUS 7499757 B2 Zusammenfassung A myocardial lead attachment system for securing a distal end of a lead within a myocardium of a patient's heart. The system includes a lead body, an anchor mechanism formed of a bioabsorbable or biodegradable polymer for engaging a surface of the patient's heart and a surface feature formed on a portion of the lead body for promoting formation of scar tissue around said portion of the lead body.
an anchor mechanism configured formed of a bioabsorbable or biodegradable polymer, the anchor mechanism configured to advance through myocardial tissue in a first orientation and configured to anchor against an epicardial surface in a second orientation;
a tether having a proximal end and a distal end, wherein the anchor mechanism is coupled to the distal end of the tether; and
a lead body having a proximal end, a distal end, a surface feature formed on a portion of the lead body for promoting formation of scar tissue around the portion, and a lumen extending through the lead body, wherein the lead body and the lumen are configured such that the lead body can be threaded over the proximal end of the tether and slideably advanced over the tether toward the anchor mechanism during implantation;
wherein the anchor mechanism and the tether are configured to couple to the lead body, thereby chronically retaining the distal end of the lead body in the heart after implantation.
2. The system of claim 1 wherein the anchor mechanism is configured to dissolve after scar tissue forms around a portion of the lead body located within the myocardium.
3. The system of claim 1 wherein the anchor mechanism is made from a material selected from the group including: Polyglycolide (�PGA�), Polylactide (�PLA�), Polydioxanone (�PDA�), and Polylactide-co-glycolide.
5. The system of claim 1 wherein the anchor mechanism further includes biologic or pharmacological agents in the bioabsorbable or biodegradable polymer that are released in order to modify the healing response to the lead placement.
6. The system of claim 1 wherein at least a portion of the tether is formed of a biodegradable or bioabsorbable polymer.
7. The system of claim 1 wherein the surface feature is a rough surface finish on the lead body.
8. The system of claim 1 wherein a portion of the lead body adapted to reside within the myocardium has the surface feature.
9. The system of claim 1 wherein substantially the entire lead body has the surface feature.
10. The system of claim 1 wherein the lead body further includes an electrode and wherein the surface feature is formed on at least a portion of the electrode.
11. The system of claim 10 wherein the surface feature is a conductive coating provided on the electrode.
12. The system of claim 10 wherein the surface feature is a rough surface finish on the electrode.
13. The system of claim 1 and further comprising a dissolvable coating applied over the surface feature.
14. The system of claim 13 wherein the dissolvable coating is water soluble.
15. The system of claim 13 wherein the dissolvable coating has a smooth outer surface.
16. The system of claim 1 and further comprising a dissolvable coating applied over the anchor mechanism, said coating having a trauma-reducing outer profile.
17. The system of claim 1 and further comprising a dissolvable coating applied over the anchor mechanism, said coating having a tissue-dissecting edge.
18. The myocardial lead attachment system of claim 1 wherein the first orientation of the anchor mechanism is substantially orthogonal to the second orientation of the anchor mechanism.
an anchor mechanism formed of a bioabsorbable or biodegradable polymer, the anchor mechanism configured to advance through myocardial tissue in a first orientation and configured to anchor against an epicardial surface in a second orientation;
a lead body having a proximal end, a distal end, and a lumen extending through the lead body, wherein the lead body and the lumen are configured such that the lead body can be threaded over the proximal end of the tether and slideably advanced over the tether toward the anchor mechanism during implantation;
wherein the anchor mechanism and the tether are configured to couple to the lead body, thereby chronically retaining the distal end of the lead body in the heart after implantation; and
wherein the anchor mechanism is configured to dissolve after scar tissue forms around a portion of the lead body located within the myocardium.
20. A myocardial lead attachment system for securing a distal end of a lead within a myocardium of a patient's heart, the system comprising:
an anchor mechanism configured to advance through myocardial tissue in a first orientation and configured to anchor against an epicardial surface in a second orientation;
21. The myocardial lead attachment system of claim 20 wherein first orientation of the anchor mechanism is substantially orthogonal to the second orientation of the anchor mechanism. Beschreibung
CROSS REFERENCES The present application claims the benefit of the following U.S. Provisional Applications: Application Ser. No. 60/514,037 filed Oct. 24, 2003, entitled �Absorbable Myocardial Lead Fixation System�, Application Ser. No. 60/514,665 filed Oct. 27, 2003, entitled �Lead Electrode Arrangement for Myocardial Leads�, Application Ser. No. 60/514,042 filed Oct. 24, 2003, entitled �Tapered Tip for Myocardial Lead�, Application Ser. No. 60/514,714 filed Oct. 27, 2003, entitled �Minimally-Invasive Fixation Systems for Over-the-Tether Myocardial Leads�, Application Ser. No. 60/514,039 filed Oct. 24, 2003, entitled �Distal or Proximal Fixation of Over-the-Suture Myocardial Leads�, Application Ser. No. 60/514,146 filed Oct. 24, 2003, entitled �Myocardial Lead with Fixation Mechanism�, Application Ser. No. 60/514,038 filed Oct. 24, 2003, entitled �Delivery Instrument for Myocardial Lead Placement� and Application Ser. No. 60/514,713 filed Oct. 27, 2003, entitled �Drug-Eluting Myocardial Leads�, all of which are incorporated herein by reference.
Reference is hereby made to the following commonly assigned U.S. patent application Ser. No. 10/821,421, filed Apr. 9, 2004 entitled �Cardiac Electrode Anchoring System� and the following commonly assigned U.S. patent applications filed on an even date herewith, all of which are incorporated herein by reference: application Ser. No. 10/972,049, entitled �Myocardial Lead�, application Ser. No. 10/972,298, entitled �Distal or Proximal Fixation of Over-the-Tether Myocardial Leads�, application Ser. No. 10/971,549, entitled �Myocardial Lead with Fixation Mechanism� and application Ser. No. 10/971,551, entitled �Myocardial Lead Attachment System.�
PARTIES TO A JOINT RESEARCH AGREEMENT The claimed invention was made subject to a joint research agreement between Cardiac Pacemakers, Inc. and Dr. Osypka, GmbH.
FIELD OF THE INVENTION This invention relates generally to implantable lead assemblies for stimulating and/or sensing electrical signals in muscle tissue. More particularly, it relates to myocardially-implanted leads for cardiac stimulation and systems for anchoring and removing the leads.
BACKGROUND OF THE INVENTION Cardiac rhythm management systems are used to treat heart arrhythmias. Pacemaker systems are commonly implanted in patients to treat bradycardia (i.e., abnormally slow heart rate). A pacemaker system includes an implantable pulse generator and leads which form the electrical connection between the implantable pulse generator and the heart. An implantable cardioverter defibrillator (�ICD�) is used to treat tachycardia (i.e., abnormally rapid heart rate). An ICD also includes a pulse generator and leads that deliver electrical energy to the heart.
The treatment of congestive heart failure (�CHF�), however, often requires left ventricular stimulation either alone or in conjunction with right ventricular stimulation. For example, cardiac resynchronization therapy (�CRT�) (also commonly referred to as biventricular pacing) is an emerging treatment for heart failure which requires stimulation of both the right and the left ventricle to increase cardiac output. Left ventricular stimulation requires placement of a lead in or on the left ventricle near the apex of the heart. One technique for left ventricular lead placement is to expose the heart by way of a thoracotomy. The lead is then positioned so that one or more electrodes contact the epicardium or are embedded in the myocardium. Another method is to advance an epicardial lead endovenously into the coronary sinus and then advance the lead through a lateral vein of the left ventricle. The electrodes are positioned to contact the epicardial surface of the left ventricle.
SUMMARY OF THE INVENTION In one embodiment, the present invention is a myocardial lead attachment system for securing a distal end of a lead within a myocardium of a patient's heart. The system includes a lead body, an anchor mechanism coupled to the lead body for engaging the heart and a surface feature formed on a portion of the lead body. The anchor mechanism is formed of a bioabsorbable or biodegradable polymer. The surface feature promotes the formation of scar tissue around said portion of the lead body.
BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a sectional view of a portion of the vasculature and a myocardial lead attachment and pacing system according to one embodiment of the present invention.
FIG. 7 is a flowchart depicting a method for attaching a myocardial lead within the myocardium with an anchor mechanism according to one embodiment of the present invention.
DETAILED DESCRIPTION FIG. 1 is a sectional view of a myocardial lead attachment and pacing system 10 deployed in a human heart 12 according to one embodiment of the present invention. As shown in FIG. 1, the heart 12 includes a right atrium 14 and a right ventricle 16 separated from a left atrium 18 and a left ventricle 20 by a septum 22. During normal operation of the heart 12, deoxygenated blood is fed into the right atrium 14 through the superior vena cava 24 and the inferior vena cava 26. The deoxygenated blood flows from the right atrium 14 into the right ventricle 16. The deoxygenated blood is pumped from the right ventricle 16 into the lungs, where the blood is re-oxygenated. From the lungs the oxygenated blood flows into the left atrium 18, then into the left ventricle 20. The left ventricle 20 beats forcefully to pump the oxygenated blood throughout the body.
Placement of the lead 36 and anchor mechanism 44 in the heart 12 may be accomplished by exposing a portion of the heart 12, for example by way of a sternotomy, thoracotomy or mini-thoracotomy. According to other embodiments, the heart 12 may be accessed via an endoscopic procedure according to known methods. The lead 36 and anchor mechanism 44 are inserted through a tract in the heart 12 with the assistance of a delivery instrument. Suitable anchor mechanisms 44, delivery instruments and methods of implanting the anchor mechanism 44 and lead 36 are described in above-identified �Myocardial Lead Attachment System�. The lead 36 is shown placed near the apex 38 of the heart 12. However, the lead 36 may be positioned in the heart 12 anywhere pacing therapy is needed.
In the embodiment shown in FIG. 1, the anchor mechanism 44 is configured to abut an epicardial surface. In other embodiments, the anchor mechanism 44 can be configured to abut an endocardial surface, a pericardial surface, or to be retained within the myocardium 32.
Over time, collagenous encapsulation tissue (�scar tissue�) forms around the system 10. The formation of such scar tissue sometimes acts to secure the lead 36 in position.
According to one embodiment, the anchor mechanism 44 is made from a material formulated to dissolve or be absorbed over a period of time greater than a period of time necessary for the formation of scar tissue around the myocardial lead 36 following implantation. In one embodiment, the material is configured to dissolve in a period of time greater than a period of time necessary to secure the myocardial lead 36 to the myocardium 32 by scar tissue formation around the myocardial lead 36. Such material may be any bioabsorbable or biodegradable material, including, for example, polyglycolide (�PGA�), polylactide (�PLA�), polydioxanone (�PDA�), or polylactide-co-glycolide. In one embodiment, any combination of these polymers is used.
The system 100 is further provided with a porous or roughened surface feature(s) 114 into which collagenous encapsulation tissue (�scar tissue�) invades, resulting in natural tissue anchoring. The scar tissue encapsulation that forms about the roughened surface feature(s) 114 provides a gripping action strengthened as the encapsulation tissue invades the surface feature(s) 114. Natural tissue anchoring strengthens the fixation between the lead 36 and the heart 12, reducing dislodgment and repositioning of the lead 102.
According to another embodiment, the distal electrode 110, proximal electrode 108 or anchor mechanism 104 can be fabricated from fused metallic particles so as to provide internal voids and channels forming surface feature 114 and into which tissue ingrowth takes place. According to another embodiment, the electrodes 108 and 110 or anchor mechanism 104 can be fabricated from metallic wire and/or screen mesh components that when compressed into an �electrode shape� create internal voids and channels to form surface feature 114.
FIG. 6B shows another embodiment in which the coating 156 is applied to the anchor mechanism 144 to generate a shape configured to facilitate tissue dissection. In the embodiment shown, coating 156 is shaped to form a sharp edge 158. An anchor mechanism 144 including this feature may be used in conjunction with a stylet delivery instrument as described in above-identified �Myocardial Lead Attachment System� to form a tract through the myocardium 32. Upon implantation, the coating 156 dissolves to expose the anchor mechanism 144.
FIG. 7 is a flowchart depicting a method 700 for attaching a myocardial lead 142 having an anchor mechanism 144 within the myocardium 32 according to one embodiment of the present invention. An anchor mechanism 144 coupled to a tether 146 is inserted through the epicardium 28 and into the myocardium 32 (block 710). A lead 142 having a lead body 102, a lumen 155 for receiving the tether 146 extending through the lead 142, and a porous surface feature 154 formed on a portion of the lead body 102. The lead 142 is threaded over a proximal end of the tether 146 (block 720). The lead 142 is advanced over the tether 146 toward the anchor mechanism 144 and into the myocardium 32 (block 730). Tissue is allowed to invade the porous surface feature 154 (block 740). The anchor mechanism 144 is allowed to dissolve (block 750).
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