Flexible hermetic enclosure for implantable medical devices

Abstract

A flexible, hermetically sealed enclosure device allows for the controlled insertion of an implantable device into the body of a patient. A series of bellows can be used to interconnect a number of rigid containers, each containing electronic or other components necessary for the implantable device. The bellows provide flexibility, columnar strength, and torqueability (for steering), while protecting the internal components. The bellows also can be welded to the containers to form a hermetic seal that can be electrically continuous, whereby standard wiring and components can be used without fear of corrosion or contamination. Such an enclosure can be used with systems such as an intravascular implantable pacing, drug delivery, or defibrillation system.

1 . A flexible enclosure for implantation in a body, comprising:
 a plurality of first means for housing at least one electrical component wholly within that means, the plurality of first means configured to be implanted into the body as part of a chronically implanted device wholly implanted within the body; and   a plurality of second means for interconnecting two of the first means to form an elongated series of first means and second means, each second means further having an internal passage through which the components in adjacent first means may be connected.   
   
   
       2 . A flexible enclosure according to  claim 1 , wherein the flexible enclosure is adapted to be implanted in the vasculature of the body. 
   
   
       3 . A flexible enclosure according to  claim 1 , wherein each of the first means and second means has a diameter in the range of about 3 mm to about 8 mm. 
   
   
       4 . A flexible enclosure according to  claim 1 , wherein each second means provides for three-dimensional flexing. 
   
   
       5 . A mechanical bellows, configured to connect two rigid containers as part of a flexible enclosure for chronic implantation wholly in the vasculature of a body, wherein each container is configured to contain at least one electronic component wholly within that container, the bellows having an internal passage allowing for interconnection of components in the rigid containers. 
   
   
       6 . A mechanical bellows according to  claim 5 , wherein the bellows provides for three-dimensional flexing. 
   
   
       7 . A mechanical bellows according to  claim 5 , wherein the bellows is formed of a biocompatible material. 
   
   
       8 . A mechanical bellows according to  claim 5 , wherein the bellows is formed of a material selected from the group consisting of titanium, nitinol, stainless steel, nickel, and biocompatible polymers. 
   
   
       9 . A mechanical bellows according to  claim 5 , wherein the bellows comprises two or more ridge portions. 
   
   
       10 . A method of implanting an intravascular device, comprising:
 providing an intravascular device including a flexible enclosure consisting of a plurality of rigid containers, each container containing at least one component of the intravascular device, and a plurality of mechanical bellows, each bellows connecting two of the rigid containers to form an elongated chain of containers and bellows, each bellows further having an internal passage allowing for interconnection of the components in the rigid containers;   introducing the intravascular device into the vasculature of a patient;   advancing the intravascular device to a target location within the vasculature; and   anchoring the intravascular device within the target location.   
   
   
       11 . The method of  claim 10 , further comprising:
 providing at least one electrode coupled to the intravascular device;   positioning the at least one electrode within the cardiovascular system.   
   
   
       12 . The method of  claim 10 , wherein the flexible enclosure includes an electrode positioned on the outside of the flexible enclosure, the electrode coupled to the intravascular device. 
   
   
       13 . The method of  claim 10 , wherein the anchoring step includes placing an anchor in contact with the flexible enclosure and expanding an anchor into contact with a wall of the target location. 
   
   
       14 . A method of implanting an intravascular device, comprising:
 providing an intravascular device including a flexible enclosure consisting of a plurality of rigid containers, each container containing at least one component of the intravascular device, and a plurality of mechanical bellows, each bellows connecting two of the rigid containers to form an elongated chain of containers and bellows, each bellows further having an internal passage allowing for interconnection of the components in the rigid containers;   providing instructions for implanting the intravascular device, comprising:   introducing the intravascular device into the vasculature of a patient;   advancing the intravascular device to a target location within the vasculature; and   anchoring the intravascular device within the target location.   
   
   
       15 . The method of  claim 14 , further comprising:
 providing at least one electrode coupled to the intravascular device;   positioning the at least one electrode within the cardiovascular system.   
   
   
       16 . The method of  claim 14 , wherein the flexible enclosure includes an electrode positioned on the outside of the flexible enclosure, the electrode coupled to the intravascular device. 
   
   
       17 . The method of  claim 14 , wherein the anchoring step includes placing an anchor in contact with the flexible enclosure and expanding an anchor into contact with a wall of the target location.