Enhanced stability implantable medical device

Abstract

An implantable medical device is provided which has a housing of an elongate form to minimize a size of an incision required for implantation. A stabilizing element is associated with the elongated form housing for the medical device. The stabilizing element transitions from a low profile initial form to a higher width final form to provide the medical device with a stabilized footprint after implantation. The stabilizing element is in the form of a rotating wing in one embodiment. In another embodiment, the stabilizing element is in the form of an expanding loop that can bend to extend out of side openings of a cavity within the housing, to provide such stabilization at the implantation site. The medical device can be in the form of a pacemaker, infusion pump, vascular access port or other subcutaneously implanted medical device.

1 : A method for minimally invasive implantation of a subcutaneous medical device, the method including the steps of:
 configuring the medical device to be at least partially contained within a housing having an elongate form with a long axis between ends greater than a lateral axis non-parallel with the long axis;   making an incision large enough to pass the housing through the incision along the long axis;   passing the housing through the incision to a subcutaneous implantation site; and   manipulating a stabilizing element coupled to the housing to enhance a lateral width of the housing, such that the stabilizing element resists rotation of the housing about the long axis.   
     
     
         2 : The method of  claim 1  including the further steps of:
 configuring the stabilizing element as a rotating wing pivotably attached to the housing; and 
 said manipulating step including the step of rotating the stabilizing element from a first position aligned with the long axis to a second position extending laterally a distance greater than a width of the housing. 
 
     
     
         3 : The method of  claim 2  including the further step of configuring the rotating wing to have a length greater than a width of the housing so that ends of the rotating wing extend laterally from sides of the housing upon rotation of the rotating wing at least 45° from initially aligned with the long axis. 
     
     
         4 : The method of  claim 2  wherein said manipulating step includes the step of manipulating a pair of the stabilizing elements in the form of a pair of rotating wings in opposite directions relative to the housing. 
     
     
         5 : The method of  claim 4  including the further step of advancing a spreader rod toward the housing and between the two wings to cause rotation of the two wings in opposite directions away from each other and relative to the housing. 
     
     
         6 : The method of  claim 1  including the further steps of:
 configuring the housing to include a cavity therein with a rear opening and at least one side opening; and 
 configuring the stabilizing element to be in the form of an expandable element which can pass through the rear opening and expand laterally out of said at least one side opening. 
 
     
     
         7 : The method of  claim 6  including the further steps of:
 configuring the cavity to include at least two side openings opposite each other; and 
 extending said expandable element laterally out of both side openings simultaneously. 
 
     
     
         8 : The method of  claim 7  including the further steps of configuring the expandable element as a loop. 
     
     
         9 : The method of  claim 8  including the further steps of configuring the expandable element to include four legs joined together by four joints including two side joints which extend away from each other and out of the side openings when a rear joint of the loop is moved toward a front joint of the loop. 
     
     
         10 : A method for reconfiguring a subcutaneous medical device, the method including the steps of:
 identifying a subcutaneous medical device at least partially contained within a housing and having an elongate form between a front end spaced from a rear end by a longest dimension and extending along a long axis, the housing having lateral sides spaced from each other by a lateral width that is less than the longest dimension; and   manipulating a stabilizing element to be coupled to the housing and enhance the lateral width of the housing, such that the stabilizing element resists rotation of the housing about the long axis after the stabilizing element is coupled to the housing.   
     
     
         11 : The method of  claim 10  wherein said manipulating step includes the step of deforming the stabilizing element from a first configuration that is narrower than the width of the housing between the lateral sides, into a second configuration that is wider than the width of the housing between the lateral sides. 
     
     
         12 : The method of  claim 11  including the further step of extending the stabilizing element laterally in opposite directions past each of the lateral sides of the housing. 
     
     
         13 : The method of  claim 12  including the further steps of identifying a cavity in the housing with lateral side openings and a rear opening, and inserting the stabilizing element into the rear opening and causing the stabilizing element to extend laterally out of the side openings in the cavity of the housing. 
     
     
         14 : The method of  claim 13  including the step of configuring the stabilizing element to maintain plastic deformation after extending out of the side openings in the cavity. 
     
     
         15 : The method of  claim 14  including the further step of identifying the stabilizing element having a resilient character and with a bias toward a width sufficient to extend out of the openings in the cavity of the housing unless forces are applied to the stabilizing element to elastically compress the stabilizing element to a width less than the width of the housing. 
     
     
         16 : The method of  claim 10  including the further step of coupling the stabilizing element to the housing with the stabilizing element having a longest dimension greater than the lateral width of the housing, with the stabilizing element coupled in an orientation which enhances an overall lateral width of the housing when the stabilizing element is coupled thereto. 
     
     
         17 : A method for stabilizing a subcutaneous medical device, the method including the steps of:
 identifying a subcutaneous medical device at least partially contained within a housing and having an elongate form between a front end spaced from a rear end by a longest dimension and extending along a long axis, the housing having lateral sides spaced from each other by a lateral width less than the longest dimension; and   manipulating a stabilizing element coupled to the housing, to move the stabilizing element from a first orientation with the stabilizing element inboard of the lateral sides of the housing to a second orientation with at least one tip of the stabilizing element extending past at least one lateral side of the housing, such that the stabilizing element resists rotation of the housing about the long axis.   
     
     
         18 : The method of  claim 17  wherein said manipulating step includes pivoting an elongate wing that defines a portion of the stabilizing element about an axle extending perpendicular to the long axis, the wing including at least one tip spaced from the axle sufficient to cause the tip to extend past at least one lateral side of the housing when the pivoting wing is pivoted away from an orientation parallel with the housing long axis. 
     
     
         19 : The method of  claim 18  including the further step of configuring the stabilizing element to include a pair of wings each attached about a common axle perpendicular to the long axis of the housing, the wings each pivoting from a first position corresponding with a first orientation and substantially within an outline of the housing and a second position corresponding with the second orientation with tips of the wings extending from the lateral sides of the housing, such that the stabilizing elements resist rotation of the housing about the long axis. 
     
     
         20 : The method of  claim 19  including the further step of providing a push rod which can push between adjacent ends of the two wings to spread the adjacent ends of the two wings away from each other and cause the two wings to rotate from the first position to the second position.