Method For Implanting A Medical Device In The Body Tissue Of A Human Or Animal Patient

Abstract

A device that is implantable in body tissue of a human or animal. The device is comprised of a header comprising at least one terminal adapted for removable connection to a lead and an open ended case closed by a plate to form a housing. The housing is comprised of a surrounding edge wall joined to a first side wall and a second side wall opposed to the first side wall. At least a first suture port extends through the edge wall and the second side wall but not the first side wall at an upper edge region of the housing. A second suture port may extend through the surrounding edge wall and the second side wall but not the first side wall in a similar manner. A third suture port may extend through the header. The three suture ports may define a triangular attachment configuration.

1 . A method for implanting a medical device in the body tissue of a human or animal patient, comprising the steps of:
 a) providing the medical device, comprising:
 i) a header comprising at least one terminal adapted for removable connection to a lead; 
 ii) a housing connected to the header, the housing comprised of an exterior facing side wall that is parallel to and lesser in area than an interior facing side wall, wherein a surrounding edge wall is joined to and at least in part slopes from the interior facing side wall to the exterior facing side wall, and wherein at least a portion of the surrounding edge wall between the interior facing and exterior facing side walls is flat; 
 iii) electronic circuitry contained in the housing, wherein the electronic circuity is electrically connected to the at least one terminal in the header and is configured to produce electrical pulses for conduction into the body tissue; and 
 iv) at least one suture port extending through the sloped surrounding edge wall and the interior facing side wall but not through the exterior facing side wall of the housing; 
   b) positioning the medical device in the human or animal patient so that the exterior facing side wall of the housing contacts the body tissue and the exterior facing side wall faces outwardly, away from the body tissue;   c) looping a first suture into the at least one suture port and through local body tissue to thereby immobilize the medical device with respect to location and angular orientation in the body tissue;   d) connecting a lead from the at least one terminal in the header to body tissue that is intended to receive an electrical pulse; and   e) closing the human or animal patient to thereby implant the medical device in the patient.   
     
     
         2 . The method of  claim 1 , further including providing the medical device having a second suture port extending through the surrounding edge wall and the interior facing side wall but not through the exterior facing side wall of the case, and looping a second suture into the second suture port and through local body tissue to further immobilize the medical device with respect to location and angular orientation in the body tissue. 
     
     
         3 . The method of  claim 2 , further including providing the medical device having a third suture port extending through the surrounding edge wall and the interior facing side wall but not through the exterior facing side wall of the case, and looping a third suture into the third suture port and through local body tissue to further immobilize the medical device with respect to location and angular orientation in the body tissue. 
     
     
         4 . The method of  claim 2 , further including providing a third suture port extending through the header, and looping a third suture into the third suture port in the header and through local body tissue to further immobilize the medical device with respect to location and angular orientation in the body tissue. 
     
     
         5 . The method of  claim 4 , including canting the first, second, and third suture ports at an outward angle with respect to the exterior facing side wall of the housing. 
     
     
         6 . The method of  claim 4 , including forming the first, second, and third suture ports proximate to a perimeter edge of the medical device to thereby define a triangular attachment configuration for the medical device in the body tissue. 
     
     
         7 . The method of  claim 1 , including joining at least one of the interior facing and exterior facing side walls of the housing to the flat portion of the surrounding edge wall by a curved region. 
     
     
         8 . The method of  claim 4 , further including providing a fourth suture port extending through the medical device. 
     
     
         9 . The method of  claim 8 , including providing the exterior facing side wall and the interior facing side wall of the housing for the medical device being substantially rectangular-shaped side walls. 
     
     
         10 . The method of  claim 9 , including providing the exterior facing and interior facing substantially rectangular-shaped side walls defining first and second corner regions of the medical device, and the header defining third and fourth corner regions of the medical device, and forming the first, second, third, and fourth suture ports extending through the first, second, third, and fourth corner regions of the medical device, respectively. 
     
     
         11 . The method of  claim 10 , including aligning the first, second, third, and fourth suture ports substantially perpendicular to the interior facing side wall of the housing. 
     
     
         12 . The method of  claim 8 , including providing an upper edge region of the header with an upwardly extending protuberance, and forming the fourth suture port in the upwardly extending protuberance. 
     
     
         13 . The method of  claim 8 , further including providing a second terminal in the header, and inserting a proximal end of a terminal plug in the second terminal with a distal end of the terminal plug having a terminal plug suture port. 
     
     
         14 . The method of  claim 1 , including providing a first area of the exterior facing side wall being from about 85% to about 95% of a second area of the interior facing side wall of the housing for the medical device. 
     
     
         15 . The method of  claim 1 , including providing a first area of the exterior facing side wall being from about 75% to about 85% of a second area of the interior facing side wall of the housing for the medical device. 
     
     
         16 . The method of  claim 1 , including providing a first area of the exterior facing side wall being from about 65% to about 75% of a second area of the interior facing side wall of the housing for the medical device. 
     
     
         17 . The method of  claim 1 , including selecting the medical device from the group of a cardiac pacemaker, a cardioverter-defibrillator, a deep brain stimulator, a gastric electrical stimulator, a spinal cord stimulator, and a dorsal root ganglion stimulator. 
     
     
         18 . A method for implanting a medical device in the body tissue of a human or animal patient, comprising the steps of:
 a) providing the medical device, comprising:
 i) a header comprising at least one terminal adapted for removable connection to a lead; 
 ii) a housing connected to the header, the housing comprised of an exterior facing side wall that is parallel to and lesser in area than an interior facing side wall, wherein a surrounding edge wall is joined to and at least in part slopes from the interior facing side wall to the exterior facing side wall, and wherein at least a portion of the surrounding edge wall between the interior facing and exterior facing side walls is flat; 
 iii) electronic circuitry contained in the housing, wherein the electronic circuity is electrically connected to the at least one terminal in the header and is configured to produce electrical pulses fox conduction into the body tissue; 
 iv) at least a first suture port spaced from a second suture port, both the first and second suture ports extending through the sloped surrounding edge wall and the interior facing side wall but not through the exterior facing side wall of the housing; and 
 v) a third suture port extending through the header of the medical device; 
   b) positioning the medical device in the human or animal patient so that the exterior facing side wall of the housing contacts the body tissue and the exterior facing side wall faces outwardly, away from the body tissue;   c) looping a first suture into the first suture port, a second suture Into the second suture port, and a third suture into the third suture port, each of the first, second and third sutures extending through local body tissue to thereby immobilize the medical device with respect to location and angular orientation in the body tissue;   d) connecting a lead from the at least one terminal in the header to body tissue that is intended to receive electrical pulses from the medical device; and   e) closing the human or animal patient to thereby implant the medical deice in the patient.   
     
     
         19 . The method of  claim 18 , including forming the first, second and third suture ports proximate to a perimeter edge of the medical device to thereby define a triangular attachment configuration in the body tissue of the human or animal patient. 
     
     
         20 . A method for implanting a medical device in the body tissue of a human or animal patient, comprising the steps of:
 a) providing the medical device, comprising:
 i) a header comprising at least one terminal adapted for removable connection to a lead; 
 ii) a housing connected to the header, the housing comprised of an exterior facing side wall that is parallel to and lesser in area than an interior facing side wall, wherein a surrounding edge wall is joined to and at least in part slopes from the interior facing side wall to the exterior facing side wall, and wherein at least a portion of the surrounding edge wall between the interior facing and exterior facing side walls is flat; 
 iii) electronic circuitry contained in the housing, wherein the electronic circuity is electrically connected to the at least one terminal in the header and is configured to produce electrical pulses for conduction into the body tissue; 
 iv) at least a first, a second and a third spaced apart suture ports extending through the sloped surrounding edge wall and the interior facing side wall but not through the exterior facing side wall of the housing, wherein the first, second and third suture ports are canted at an outward angle with respect to the exterior facing side wall of the housing; and 
 v) a fourth suture port extending through the header of the medical device; 
   b) positioning the medical device in the human or animal patient so that the exterior facing side wall of the housing contacts the body tissue and the exterior facing side wall faces outwardly, away from the body tissue;   c) looping a first suture into the first suture port, a second suture into the second suture port, a third suture into the third suture port and a fourth suture into the fourth suture port, each of the first, second, third and fourth sutures extending through local body tissue to thereby immobilize the medical device with respect to location and angular orientation in the body tissue;   d) connecting a lead from the at least one terminal in the header to body tissue that is intended to receive electrical pulses from the medical device; and   e) closing the human or animal patient to thereby implant the medical device in the patient.   
     
     
         21 . The method of  claim 18 , including forming a protuberance extending from the header of the medical device and providing the fourth suture port in the protuberance, and looping the fourth suture into the fourth suture port and through local body tissue to thereby immobilize the medical device with respect to location and angular orientation in the body tissue.