Abstract:
When replacing an implanted medical device, the physician may have difficulty locating the new unit in exactly the same space or cavity within the body that held the old unit. Various embodiments and combinations of embodiments of a medical removal/insertion tool are proposed which can be inserted temporarily, as “place holders,” in the space of the implanted medical device to be removed, and used to guide the insertion of the replacement unit and to ensure that the replacement unit is properly situated within the body. In its simplest form, the removal/insertion tool has a “first part” which is configured to facilitate the positioning of the new unit in approximately the same space as the old unit, and a “second part” which serves as a handle for gripping, during use, to insert, position and subsequently remove the first part within the body cavity when replacement is complete.

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
       [0001]    This present application claims benefit of priority from U.S. Provisional Application Ser. No. 61/478,563, filed Apr. 25, 2011, entitled “IMPLANTABLE MEDICAL DEVICE REMOVAL/INSERTION TOOL”. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    When an implantable pacemaker battery is substantially depleted of energy, the entire pacemaker gets replaced (not just the battery—because the battery is hermetically sealed inside the pacer)—an event that occurs about every 7 years. 
         [0003]    A pacemaker is shaped like an elliptical silver dollar, but has about 2.5 times the thickness of an actual silver dollar. 
         [0004]    Occasionally there is a problem with the positioning of a new pacemaker unit wherein the new unit is not put exactly where the old one was, but in a location which:
       is less deep (from the skin surface) than the old one, but   has similar coordinates to the old one along the right-left axis, and   has similar coordinates to the old unit along the head-foot axis.       
 
         [0008]    When such a problem occurs, it may cause patient discomfort, and may be a cosmetic problem—because the new (i.e. replacement) unit is not buried as far below the surface of the skin, and at times it sticks out noticeably. In extreme cases, a unit that is too near to the skin surface will, over a period of time, ultimate break the surface of the skin and need to be entirely replaced. 
         [0009]    The problem (shown in the sequence of  FIGS. 1A to 1B ) may occur because once the surgeon pulls out the old (i.e. depleted) pacemaker unit, the tissue on one side of the space initially occupied by the old unit ( FIG. 1A ) approaches and may contact the tissue that is on the other side of that space, resulting in the space substantially closing itself up ( FIG. 1B ). As the surgeon tries to insert the new unit, he or she may get it back into the old space, or may get into a newly created space which is nearer to the surface of the skin, or may insert the unit so that it is partially situated in the old space and partially situated in a new space. 
         [0010]    Everything stated herein about pacemakers is applicable to implantable defibrillators, implantable cardioverter defibrillators, implantable insulin pumps, implantable glucose sensing devices, implantable nerve and brain stimulators, implantable drug infusion pumps and other implantable medical devices. 
       SUMMARY OF THE INVENTION 
       [0011]    The need exists, therefore to provide the surgeon who implants and replaces such devices with means to assure that the new device is situated in an appropriate location and orientation within a patient. In the case of device location, often the preferred location is where the old device was situated. 
         [0012]    The current invention provides a variety of means to accomplish this task. They include 
         [0000]    (A) A Spatula-shaped device, and variants, for marking the place of a previously implanted device prior to its removal;
 
(B) A glove-like device with tearable section for guidewire introduction. This device may have inboard sheaths to allow for the placement of guidewires.
 
(C) A glove-like device with outboard sheaths for guidewire introduction;
 
(D) A 3 component system with inner, intermediate, and large bore outer sheath. The intermediate and outer sheaths are shaped like the implantable device (“IMD”).
 
(E) A first type of balloon device—inserted over guide wire, which fills the old pocket. The balloon may deflate as the IMD is advanced into pocket.
 
(F) A second type of balloon device—also inserted over guide wire. The IMD is inserted into the balloon. The inflated balloon allows for easing the IMD into the cavity. The balloon is removed by its tear-away feature.
 
(G) The IMD has one or more holes that accommodate guiding devices. The holes do not communicate with the internal electronics of the IMD.
 
(H) An elastic-like belt is strapped onto the IMD. The belt has receptacles for at least one guiding device. After implant positioning, the belt and guide(s) are removed.
 
(I) A long flexible guidewire is inserted into the cavity. It curls around in the cavity and eventually the distal end emerges. This leaves both the proximal and the distal ends sticking out of the cavity. A large-bore intermediate guiding device with 2 parallel holes is slid in over these two protruding guide wire ends. A large-bore sheath surrounds the intermediate guiding device. The IMD is then inserted via the large-bore sheath.
 
         [0013]    Combinations of these approaches may be best suited for any individual patient. For example, at the time of device replacement, the glove device described hereinabove in paragraph (C) may be ideal for initially securing access to a previously formed pocket. Following the placement of the distal end of a guidewire into the pocket by the glove device, the apparatus and method described in paragraph (I) hereinabove may be used to place a large sheath into the pocket, which, in turn, facilitates the placement of the IMD. 
         [0014]    Another example of combined approaches is guidewire placement by a glove of the type described in paragraph (B) hereinabove, followed by the insertion of either the balloon device of paragraphs (E) or (F) hereinabove. 
         [0015]    Numerous other combinations of approaches will be evident to those skilled in the art. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0016]      FIG. 1 , comprising  FIGS. 1A and 1B , shows the prior art. 
           [0017]      FIG. 2A  is a top view of one type of insertion/removal device. 
           [0018]      FIG. 2B  is a side view of one type of insertion/removal device. 
           [0019]      FIG. 2C  is a schematic view of the device of  FIGS. 2A and 2B  in place in an IMD pocket in a patient undergoing an IMD insertion or replacement procedure. 
           [0020]      FIG. 3A  is a cross sectional/schematic view of the steps involved in using a 1-element version of the device of  FIGS. 2A and 2B . 
           [0021]      FIG. 3B  is a cross sectional/schematic view of the steps involved in using a 2-element version of the device of  FIGS. 2A and 2B . 
           [0022]      FIG. 3C  is a cross sectional/schematic view of the steps involved in using a 3-element version of the device of  FIGS. 2A and 2B . 
           [0023]      FIG. 3D  is a cross sectional/schematic view of the steps involved in using a 4-element version of the device of  FIGS. 2A and 2B . 
           [0024]      FIG. 3E  is a cross sectional/schematic view of the steps involved in using another type of 4-element version of the device of  FIGS. 2A and 2B . 
           [0025]      FIG. 4A  is a side view of the 2-element device of  FIGS. 2A and 2B , showing a removable device element, and an attachment device. 
           [0026]      FIG. 4B  shows a detail of the removable element of the device of  FIG. 4A . 
           [0027]      FIG. 4C  shows a detail of another removable element of the device of  FIG. 4A . 
           [0028]      FIG. 5  is a side view of the 4-element described in  FIG. 3D , showing two removable device elements, and an attachment device. 
           [0029]      FIGS. 6A and 6B  show closed and open schematic view of a  2  element device which may be expanded laterally after insertion into a pocket. 
           [0030]      FIGS. 7A and 7B  show closed and open schematic view of another 2 element device which may be expanded laterally after insertion into a pocket. 
           [0031]      FIG. 8A  shows a schematic view of a  3  element device which may be expanded laterally after insertion into a pocket. 
           [0032]      FIG. 8B  shows a schematic view of a  5  element device which may be expanded laterally after insertion into a pocket. 
           [0033]      FIGS. 9A and 9B  show schematic views of two types of the 1-element device of  FIGS. 2A and 2B , with guiding devices. 
           [0034]      FIG. 10A  is a frontal view of an IMD with guiding receptacles placed laterally. 
           [0035]      FIG. 10B  is a perspective view of the IMD of  FIG. 10A , during insertion over guiding devices, into an IMD pocket. 
           [0036]      FIG. 10C  is a top/oblique view of an IMD showing both a guiding receptacle not contiguous with the IMD lateral border, and another guiding receptacle which is contiguous with the lateral border. 
           [0037]      FIG. 10D  is a side/schematic view of the device of  FIG. 10C . 
           [0038]      FIG. 11A  is a side view of an IMD with an attached implant/removal-facilitating belt, oriented horizontally, with two lateral guiding receptacles on the belt. 
           [0039]      FIG. 11B  is a perspective view of the IMD of  FIG. 11A , during insertion over guiding devices, into an IMD pocket. 
           [0040]      FIG. 11C  is a side/perspective view of an IMD with an attached implant/removal-facilitating belt, oriented vertically, with one lateral guiding receptacle on the belt. 
           [0041]      FIG. 12A  is a side view of an IMD with lateral indentations to more securely accommodate the horizontal belt shown in  FIG. 11A . 
           [0042]      FIG. 12B  is a side view of an IMD with lateral clips to facilitate implant and/or removal. 
           [0043]      FIG. 12C  is a schematic bottom and side view of an IMD with both implant/removal-facilitating protuberances and depressions. 
           [0044]      FIG. 13  is a schematic view of the insertion and operation of one type of balloon device. 
           [0045]      FIG. 14  is a schematic view of the insertion and operation of another type of balloon device. 
           [0046]      FIGS. 15A and 15B  show a side and top view of an exemplary IMD. 
           [0047]      FIG. 15C  shows a cross-sectional view of (i) a 1-element inner guiding device, (ii) an intermediate apparatus, and (iii) an outer sheath, for facilitation of the implantation of the IMD of  FIGS. 15A and 15B . 
           [0048]      FIG. 15D  is a cross sectional view showing the IMD of  FIG. 15B . inside of the outer sheath of  FIG. 15C . 
           [0049]      FIG. 15E  is a perspective view of the apparatus of  FIG. 15C  situated such that the distal ends of each of the three components is within a space in the body for IMD placement. 
           [0050]      FIG. 16A  shows another top view of exemplary IMD. 
           [0051]      FIG. 16B  shows a cross-sectional view of (i) a 3-element inner guiding device, (ii) an intermediate apparatus which accommodates the three inner guides, and (iii) an outer sheath, for facilitation of the implantation of the IMD of  FIG. 16A . 
           [0052]      FIG. 16D  is a perspective view of the apparatus of  FIG. 16B  situated such that the distal ends of each of the five components is within a space in the body for IMD placement. 
           [0053]      FIG. 17  is a perspective view of a guidewire which has been caused to form a semi-circular loop in an IMD pocket, also showing an intermediate apparatus which accommodates both ends of the guidewire, and an outer sheath. 
           [0054]      FIG. 18  shows a perspective view of a glove device for introducing guiding devices into an IMD pocket. 
           [0055]      FIG. 19A  is shows a side/schematic view of one finger segment of a glove-device with an outboard guiding receptacle for a guidewire. 
           [0056]      FIG. 19B  is a schematic view of an outboard guiding receptacle placed at the top of the glove-device, showing a guidewire within the receptacle. 
           [0057]      FIGS. 19C and 19D  are schematic views of an outboard guiding receptacle placed at the bottom and at the side of the glove-device, each figure not showing a guidewire within the receptacle. 
           [0058]      FIG. 19E  is a schematic view of two outboard guiding receptacles in top/lateral positions on the glove-device, showing guidewires within the receptacle. 
           [0059]      FIG. 19F  is a schematic view of an outboard guiding receptacle placed between two finger segments of the glove-device, showing a guidewire within the receptacle. 
           [0060]      FIG. 20  is a side/schematic view of a glove-device without guiding receptacle, with tearable segment, for placement over a gloved hand of a surgeon. 
           [0061]      FIG. 21A  is a side/schematic view of a glove-device with inboard guiding receptacle, with tearable segment. 
           [0062]      FIG. 21B  is a schematic view of an inboard guiding receptacle placed at the top of the glove-device showing a guidewire within the receptacle. 
           [0063]      FIGS. 21C and 21D  are schematic views of an inboard guiding receptacle placed at the bottom and at the side of the glove-device, each figure not showing a guidewire within the receptacle. 
           [0064]      FIG. 21E  is a schematic view of two outboard guiding receptacles in top/lateral positions on the glove-device, not showing guidewires within the receptacle. 
           [0065]      FIG. 22  is a top/schematic view of a glove-device without guiding receptacle, with tearable segments on each of two finger portions, for placement over a gloved hand of a surgeon. 
           [0066]      FIG. 23A  shows a linear tearable segment of the device of  FIG. 22   
           [0067]      FIG. 23B  shows a curved tearable segment of the device of  FIG. 22   
           [0068]      FIG. 23C  shows another curved tearable segment of the device of  FIG. 22   
           [0069]      FIG. 24  is a schematic view of a glove-device with multiple guiding receptacles within the glove material. 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0070]    The Removal/Insertion Tool (hereinbelow referred to as the “R/I tool”) facilitates the replacement of the unit with the depleted battery (hereinbelow referred to as the “old unit”) with a unit powered by an adequate battery (hereinbelow referred to as the “new unit”). Specifically, the R/I tool facilitates the positioning of the new unit in approximately the same space as the old unit. 
         [0071]    In the text and figures, pacemaker is at times referred to as “pacer.” The words and abbreviations “pacer”, “pacemaker” “implantable medical device” and “IMD” are each intended to include all manner of implantable medical device as delineated in the previous paragraph. Also in the figures, the R/I tool is in some instances referred to as “Insertion/Removal tool” and is also referred to as “removal tool”. Broken lines indicate the edge of an element which lies behind that of another element as shown in the figure. 
         [0072]    The invention, the medical device R/I tool is shown in  FIGS. 2A and 2B , with
       (a) a handle  100 , attached to   (b) a roughly flat segment  102 , which may have a shape similar to that of the pacemaker, but is considerably thinner.       
 
         [0075]    The flat segment gets inserted into the tissue space before the old pacemaker is pulled out. A handle which is curved, or one which is angled with respect to the flat segment facilitates the insertion of the R/I tool. 
         [0076]      FIG. 2C  shows a partial view of a patient  204  lying supine (i.e. on a procedure table which is not shown in the figure) with the R/I tool inserted into left pectoral incision  206 . The handle  200  is visible above the surface of the patient&#39;s skin, while the flat portion  202  is shown with broken lines indicating its location beneath the surface of the skin. 
         [0077]    The R/I tool may also be used for a de-novo device implantation, to facilitate the entry and positioning of a medical device which is being implanted, once a pocket has been created for it, beneath the skin surface. 
         [0078]      FIG. 3A  and Table 1 indicate the sequence of events involved in the use of the R/I tool. 
         [0000]    
       
         
               
               
             
           
               
                 TABLE 1 
               
               
                   
               
               
                 Step # 
                 Action 
               
               
                   
               
             
             
               
                 1 
                 Insert R/I tool, below (i.e. deep to) the old pacemaker 
               
               
                 2 
                 Remove old pacemaker 
               
               
                 3 
                 Insert new pacemaker above (i.e. nearer to the skin 
               
               
                   
                 surface than) the R/I tool 
               
               
                 4 
                 Remove the R/I tool 
               
               
                   
               
             
          
         
       
     
         [0079]    Referring to Table 1 and  FIG. 3A , after the R/I tool is inserted (Step #1), the old pacemaker is removed (Step #2), and the new pacemaker is slid in along/over the R/I tool (Step #3)—allowing the new unit to enter the same space that the old unit occupied. Finally (Step #4), the R/I tool is removed after the new unit has been successfully inserted. 
         [0080]    The process of pacemaker replacement may also be accomplished using an R/I tool with two elements (or by using two such R/I tools), as shown in the sequence in  FIG. 3B . One element of the R/I tool is inserted below the pacemaker (i.e. deep to the pacemaker, with respect to the skin surface), and one element of the R/I tool is inserted above it (i.e. nearer to the skin surface than the pacemaker). The below-the-pacemaker R/I tool element and the above-the-pacemaker R/I tool element are joined at a handle. 
         [0081]      FIG. 3C  schematically illustrates the performance of a 3 element version. In the variation shown in the figure, all 3 elements are introduced into the pocket, two above and one below the pacer (or, as indicated hereinabove, and as is applicable hereinabove and hereinbelow, implantable medical device). The pacer is then removed along with the middle element (which may be able to grip the device by a hook type apparatus [not shown in this figure] either on the pacer or on the tool). The remaining two elements “keep the place” of the pacer. In Step 3, a new pacer is inserted between the two remaining elements. And in Step 4, the remaining elements of the tool are removed. 
         [0082]      FIG. 3D  schematically illustrates the performance of one type of 4 element version. In the variation shown in the figure, all 4 elements are introduced into the pocket, two above and two below the pacer. The pacer is then removed along with the middle two elements. The remaining two elements “keep the place” of the pacer. In Step 3, a new pacer is inserted between the two remaining elements. And in Step 4, the remaining elements of the tool are removed. 
         [0083]    The 4 element apparatus functions similarly in  FIG. 3E , except that in this variation one element is introduced above and three below the pacer. The pacer is then removed along with the upper two elements. The remaining two elements “keep the place” of the pacer. 
         [0084]      FIG. 4A  shows the 2-element device of  FIGS. 2A and 2B , with a removable device element  240 , and an attachment device  250 .  240  has a hook at its end, for mating with an appropriately shaped depression in an IMD.  250  may be any one of a variety of fastening devices allowing detachment known in the art. It may have a screw-type element, or not have threading.  FIG. 4B  shows a detail of  FIG. 4A , illustrating a top view of removable element  260 .  FIG. 4C  shows a top view of another removable element  240 , attached to handle  270 . 
         [0085]      FIG. 5  is a side view of the 4-element described in  FIG. 3D , showing two removable device elements  280  and  282 , and an attachment device  284 . In this variation, the pacer (IMD) would be removed along with the  280 / 282  composite element gripping the pacer. Elements  288  and  286  remain behind, as a placeholder. Attachment device  284  allows adjustment of the distance between the upper and middle elements and between the middle and lower element. 
         [0086]    The flat portion of the R/I tool may be less wide than the pacemaker (facilitating insertion into the patient) or the shape and/or width of the R/I tool may be designed to conform to the shape of the old unit or the new unit. Each manufacturer might therefore have their own R/I tools, since there is no universal pacemaker (or other implantable device) shape. In fact, a device manufacturer may have multiple device shapes. Manufacturers&#39; kits would likely contain R/I tools of different thicknesses (as well as different shapes). 
         [0087]      FIGS. 6A and 6B  show an embodiment of the invention in which the shape of the R/I tool is able to be manipulated once it is inside the patient, in order to more fully conform to the shape of the pacemaker, after the tool has been inserted into the patient. 
         [0088]      FIG. 6B  shows the extended configuration of an R/I tool with two flat portions  300 A and  300 B, which are moveable with respect to each other;  FIG. 5A  shows the collapsed configuration. The device is inserted into the patient in the collapsed configuration, in which element  300 B lies below  300 A. (Elements  300 A and  300 B serve an analogous function to  100 A of  FIG. 2A .) Once inside the patient, the proximal portions handles  302 A and  302 B are moved apart, which causes the device to assume the extended configuration shown by  FIG. 6B . As the proximal portions of  302 A and  302 B are moved, the central portion of these members is constrained by pivot apparatus  304 , resulting in the distal portions of  302 A and  302 B also moving apart. The distal portion of  302 A is linked to member  300 C via pivot apparatus  306 A;  300 C has a fixed relationship to flat portion  300 A; Similarly, the distal portion of  302 B is linked to member  300 D via pivot apparatus  306 B;  300 D has a fixed relationship to flat portion  300 B. The central portion of members  300 C and  300 D is constrained by pivot apparatus  308 . Thus, by a dual scissoring action about each of pivot apparatus  304  and  308 , the movement of the proximal portion of  302 A away from  302 B results in the separation of  300 A from  300 B, thereby allowing the composite of  300 A and  300 B to transition from a circular shape (in the collapsed configuration) to a somewhat elliptical shape (in the extended configuration). (As referred to herein, the term “elliptical” is not intended to have the precise geometric definition of an actual ellipse, but rather to indicate a somewhat oval shape which is roughly similar to that of some pacemakers and implantable defibrillators.) 
         [0089]    Many other configurations of a variable shape tool will be apparent to those skilled in the art. For example: 
         [0090]    Devices in which a larger number or a smaller number of pivot points are possible.  FIGS. 7A and 7B  show a version with only a single pivot point. 
         [0091]    Devices in which elements  300 A and  300 B are not circular are possible. In general, the shape of such elements will be such that the composite shape may approximate that of the old device, the new device or both. 
         [0092]    The position of the pivot points along each of elements  502 A and  502 B, and along each of elements  500 C and  500 D as shown in the figure are exemplary, and the positioning of these pivot points at relatively more proximal or more distal locations are possible. 
         [0093]    Embodiments with 3 or more flat portions are possible, including, for example, that shown in  FIG. 8A  (3 elements [ 400 A,  400 B and  400 C] in a row) and that shown in  FIG. 8B  (5 elements in 2 rows [ 500 A,  500 B,  500 C,  500 D and  500 E]). Many other such variations are also possible. 
         [0094]    Embodiments in which a releasable locking apparatus secures the R/I tool in either or both of the extended of the collapsed configurations. Many forms of locking apparatus will be apparent to those skilled in the art. 
         [0095]    Additional features of the R/I tool are:
       Variations in the handle geometry (see  FIGS. 2A and 2B ) facilitate manipulation of the flat portion of the R/I device. Handles of various shapes, and with variable (or no) angulation with respect to the flat portion are possible. A device with a removable handle is possible.   Materials have been designed for medical procedures which are especially slippery. These would be advantageous for coating the side of the inserted/flat portion of the R/I tool which is contacts the pacemaker. Alternatively such a slippery coating may be applied to both sides of the flat portion.       
 
         [0098]      FIG. 9A  shows a variation in which tool  600  has an attached receptacle  602  for a guiding device. The guiding device allows introduction of a guide wire into the IMD pocket, which thereafter allows for the introduction of other hardware into the pocket, as discussed hereinbelow.  FIG. 9A  shows a variation in which the receptacle extends onto the handle.  FIG. 9B  shows a variation in which a shorter receptacle  606  is only on the proximal portion of the tool  604 . 
         [0099]    Another approach to facilitating device placement is to secure access to a pocket with appropriately placed guiding devices, and then slide an IMD (with receptacles for the guiding devices) into the pocket using the guiding devices. 
         [0100]    One variation of this approach is shown in  FIG. 10 . In  FIG. 10A , IMD  800  has two guiding receptacles  802 A and  802 B which are part of the device housing. Although two are shown in the figure, any number and placement of the receptacles is possible.  FIG. 10B  shows the IMD of  FIG. 10A  being slid into IMD pocket  806  over guiding devices  804 A and  804 B,  804 A and  804 B will be sufficiently stiff to execute their support function as the IMD is advanced into the pocket. 
         [0101]      FIGS. 10C and 10D  show geometric variants of the aforementioned device.  842  represents a centrally placed round hole in IMD  840 , and  844  represents a laterally placed rectangular hole, neither of which is not in physical communication with the device&#39;s inner contents. Holes of other shapes and placements are possible, as are holes which run in non-vertical directions. 
         [0102]      FIGS. 11A-C  show an arrangement in which the guiding receptacles are not on the IMD proper, but are attached to a removable belt. In  FIGS. 11A  and B, IMD  900  is fitted with belt  910  made of stretchable material that tightly grips the device. Fastener  912  allows for any of size and/or tension adjustment. Two guiding receptacles  914 A and  914 B are shown, which accommodate guiding devices  916 A and  916 B respectively, for guiding the IMD into pocket  920 . After deployment of the IMD, the belt is removed.  FIG. 11C  shows a vertically oriented belt  950 , with fastening device  952  and guiding receptacle  954  surrounding IMD  940 . The deployment of this version is analogous to that of the horizontally oriented belt version. 
         [0103]      FIG. 12A  shows an IMD housing design which further secures the horizontal belt, using depressions in the lateral portion of the housing. An analogous version of the housing, not shown, would function with a vertically oriented belt. 
         [0104]      FIG. 12B  shows clips  1000 A-D which are part of the IMD housing. Each pair may be a single entity, or the four may be separate. A wide variety of geometric shapes, positions, locking mechanisms, placements and clip number are possible. 
         [0105]      FIG. 12C  shows additional geometric IMD variations to facilitate insertion and removal.  1010  and  1012  are depressions in the IMD,  1014  and  1016  are elevations. A wide variety of shapes, heights, depths, placements and number are possible. 
         [0106]    Balloon devices have the advantage of being able to inflate to the shape of an already existing cavity.  FIG. 13  shows a scenario in which a balloon device  1100  is first inserted into a pocket to mark/maintain its location. A guide wire  1106  aids in the placement of the balloon device. The balloon device has a valve  1102  which keeps inserted liquid or gas inside and allows its measured removal. The balloon device has a neck  1104  which facilitates balloon device removal after the task is done. After balloon insertion in the deflated state (Panel I) the balloon is inflated (II). Next the IMD  1110  is inserted (III). One approach is to gradually collapse the balloon as the IMD is inserted. In (IV), the balloon is fully collapsed, and is removed. In one embodiment, the balloon may be inserted in the collapsed state before the IMD is removed, and inflated as it is removed. 
         [0107]      FIG. 14  shows an alternative type of balloon device  1200 . In this arrangement, the IMD  1210  is inserted through a closable opening  1204  in the balloon. The opening is closed. The balloon is inflated. The balloon with its IMD contents is then manipulated into the IMD cavity/pocket, and the IMD is moved to the most distal region of the balloon interior. Valve  1202  controls fluid Ingress/egress. The balloon plus IMD may be fully inflated or partially inflated at the time of insertion. Optional guidewire receptacle  1206  may also facilitate insertion. Following IMD placement tearable segment  1220  allows removal of the balloon. 
         [0108]    The balloons of  FIGS. 13 and 14  may either be generic, or may be specifically tailored to the shape (or a modification thereof) of the IMD. 
         [0109]      FIGS. 15A-E  show the insertion of an IMD using a technique known in the art of vascular medicine, in which an initial thin guidewire is placed, following which a combination of an intermediate diameter cylindrical device (for mechanical support) and outer sheath are advanced into the vessel over the guidewire. The guidewire and intermediate device are then removed, leaving the sheath in place to allow for the insertion of devices far larger than the initial guidewire. In the invention of  FIG. 15 , the technique and hardware are modified to conform to the shape of an IMD in a projection in which it is to be inserted.  FIGS. 15A and 15B  show the IMD  1301 .  FIG. 15C  shows a cross sectional view of the guidewire  1300  plus intermediate apparatus (“IA”)  1302  and outer sheath  1304  situated one within the other. These three elements are shown placed into the IMD pocket in  FIG. 15E : an initial step of guidewire  1300  insertion would be followed by a second step of IA plus outer sheath insertion, followed by a third step of guidewire and IA removal. The IMD  1301  is then inserted into sheath  1304 , as is shown in the cross sectional view of  FIG. 15D ; and the IMD is advanced into the most distal portion of the sheath/pocket. The outer sheath is then removed.  FIGS. 16A-D  show an analogous arrangement for an IA which is supported/guided by three guidewires, for better stability. Numerous variations with different numbers, placements and sizes of guidewires are possible. 
         [0110]      FIG. 17  shows a variation of the above-mentioned with a guidewire  1600  which loops in pocket  1620 , leaving two protruding ends. IA  1602  accommodates both guidewire segments, and introduces sheath  1604  into the pocket. 
         [0111]    The tactile abilities and sensitivities of the fingers of a surgeon are a highly effective means of delivering and positioning a guidewire.  FIG. 18  shows a glove with guiding receptacles  1702  and  1704  for guidewires  1706  and  1708 . Numerous variations on this theme are possible, including guiding receptacles which are on the outside of the glove (“outboard”), the inside of the glove (“inboard”), or within the glove material itself. Numerous possible placements at the top of a glove finger, the bottom, sides, or in between fingers are possible. There may be one wire to a finger or glove, or many wires to a finger or glove. 
         [0112]      FIG. 19A  shows glove finger  1804  with outboard guiding receptacle  1800  and guidewire  1802 .  FIG. 19B  shows the guidewire  1806  in the receptacle  1808  at the top of the finger. 
         [0113]      FIGS. 19C and 19D  show positioning (without wire) at the bottom and laterally.  FIG. 19E  shows positioning, with one wire in each receptacle, for receptacles on one glove finger.  FIG. 19F  shows positioning between fingers. 
         [0114]      FIG. 20  shows an arrangement with an inner glove  1900  worn by the surgeon inside of outer glove or finger device  1902 . This device does not have a separate guiding receptacle guidewire  1904  is advanced to tearable segment  1906 , and the wire can be poked through to the outside to the outer glove.  FIG. 22  shows various locations for the tearable segment, and  FIGS. 23A-C  shows various geometries of the tearable segment. 
         [0115]      FIG. 21A  shows a glove arrangement with an inboard guiding receptacle  2000  and a tearable segment  2002  at its distal end.  FIGS. 21B to 21E  show various positions for the inboard receptacles and are analogous to  FIGS. 19B to 19E . 
         [0116]      FIG. 24  shows a glove finger in which multiple guiding receptacles are within the glove material. 
         [0117]    In each of the glove arrangements, attention to the sterile technique is executed, so that a surgeon&#39;s finger is never in contact with a guidewire or with any material that enters or traverses the body of a patient. 
         [0118]    As mentioned hereinabove, numerous combinations of the aforementioned approaches, apparatus and methods will allow the surgeon to more efficiently insert and replace implantable medical devices in a living being. 
         [0119]    Still other variations of the invention will be apparent to those skilled in the art, and are intended to be included in the disclosure of the medical device insertion and removal tool. 
         [0120]    There has thus been shown and described a novel implantable medical device removal/insertion tool which fulfills all the objects and advantages sought therefor. Many changes, modifications, variations and other uses and applications of the subject invention will, however, become apparent to those skilled in the art after considering this specification and the accompanying drawings which disclose the preferred embodiments thereof. All such changes, modifications, variations and other uses and applications which do not depart from the spirit and scope of the invention are deemed to be covered by the invention, which is to be limited only by the claims which follow.