Abstract:
An apparatus for displacing an implant, such as a pacemaker or ICD generator or loop recorder, which can be used during surgical procedures to facilitates manipulation of the implanted device. The apparatus can be used to apply force to the implant in order for the operator to tug to loosen the implanted device without causing unnecessary movement or dislodgement of implanted leads that are connected to the implanted device. The apparatus can have features of various shapes and sizes depending on the size of the patient as well as size and shape of the implanted device.

Description:
FIELD OF INVENTION 
       [0001]    The present invention is related to an apparatus for enabling the extraction of an implant, such as an implanted device from the body while minimizing excessive cutting of the skin or cavity pocket. 
       BACKGROUND OF THE INVENTION 
       [0002]    Implantable devices, such as a pacemaker ICD generator or a loop recorder, are often implanted into the human body to aid specific biological functions. When the device has served its usefulness, doctors often need to perform surgical procedures to remove the implanted device. Under certain circumstances, doctors may remove and replace parts of the implanted device, such as a battery, or components of artificial hips, artificial knees, spinal prosthetics, or components used in traumatic fracture repair, or tunneling tools and their accessories, rather than removing the implanted device itself. 
         [0003]    Typically, when an implanted device is being removed, such as when a pacemaker generator is being removed, the general area where the implanted device is located is prepared with anesthetics. An incision is made in the skin and tissues and scar tissues around the device are resected. Sutures anchoring silicone covered leads or wires attached to the implanted device or anchoring the device itself are cut. Typically, these leads and wires are sutured into the bottom aspect of the open pocket, typically to the bottom side/inner edge of the pocket using the wire suture tabs sleeves, which wrap around the leads or wires. Sutures are generally not cut from the wire suture tab sleeves. Wires are only removed when there is a lead or wire fracture, or the lead or wire is infected, or when there is a manufacture recall on the product and the product needed to be explanted. 
         [0004]    Once the device or generator is loosened from the scar tissue and is ready to be taken out, the clinician will need a tool to extract the generator or battery from the pocket. 
         [0005]    Methods presently available generally involve the use of multiple surgical tools. A conventional method for extracting an implanted device is to cut the skin and fillet the skin to create a pocket to see the exact location of the implanted device. Once the pocket is opened, it is often kept open with a retractor such as a Weitlaner Retractor or equivalent. Doctors often have to over stretch the opening pocket in order to allow other tools, such as a sponge forceps, curved Kelley, or curved, straight or angled hemostats, or skin retractor to be inserted and used to extract the implanted device out of its implanted cavity. 
         [0006]    There are several drawbacks associated with the conventional method. First, the opening pockets are stretched out unnecessarily to create an opening sufficient wide for the surgeon to see and pinpoint the exact location of the implanted device and for insertion of multiple surgical tools for extraction. Sutures that may or may not anchor the device to the opening pocket are cut in attempts to free the device. A Weatlander retractor stretches the pocket or cavity where the generator is recessed in. Once the pocket is held open by the Weatlander retractor, a sponge forceps, curved Kelley, hemostat or skin retractor is used to try and excavate the generator out of the pocket or cavity. Many attempts are made to explant the generator that has surrounding scar-tissue. Often, numerous attempts are made to grab the implanted device, with curved Kelleys, sponge forceps, hemostat or skin retractor and other surgical apparatus, causing the implanted device&#39;s casing to become marred, sometimes damaged. Furthermore, some of the apparatus used to extricate the device have raised edges or teeth. Those teeth can scrape small parts of metal into the tissue pocket from where the device is being extricated. 
         [0007]    The tugging and manipulation of the implanted device to extract it from the body can also cause movement or dislodgment of implanted leads in the body or heart that are connected to the implanted device. This can increase the overall cost of a simple procedure, such as a generator replacement procedure, and compromise the safety of the patient. The cost can increase from a simple generator change to a dual lead revision and generator replacement. 
         [0008]    Accordingly, it is desirable to provide an improved apparatus and method that overcome drawbacks and inadequacies of known devices and methods. 
       SUMMARY OF THE INVENTIONS 
       [0009]    An implant extracting apparatus generally can include two handles connected to two jaw portions through a connecting mechanism that can transfer force applied to the two handles to the jaw portions to create gripping force between the jaw portions. According to the invention, the implant extracting apparatus can include a first handle, a second handle, a first jaw portion having a tapered distal end, a second jaw portion; and a connecting mechanism, where in the connecting mechanism transfers a force applied to the first and second handles to the first and second jaw portions, creating a gripping force between the first and second jaw portions, and the gripping force is controlled by selectively altering the distance between the first and second handles. 
         [0010]    Furthermore, according to the invention, an apparatus for removing an implant can include a first leg having a first proximal end on a first plane and a first distal end on a second plane different from the first plane, a second leg having a second proximal end on the first plane and a second distal end on the second plane, and a connecting mechanism connecting the first leg and second leg, constructed and arranged such that when the distance between the first and second proximal ends are selectively altered on the first plane, the distance between the first and second distal ends are correspondingly altered on the second plane. The apparatus&#39; proximal ends can each comprise a handle and the distal ends can each comprise a jaw portion. The handles can be constructed and arranged within a selected distance from each other. In one embodiment, increasing the distance between the handles increases the distance between the jaw portions. Alternative, reducing the distance between the handles increases the distance between the jaw portions in another embodiment. The apparatus can also include a bolt. The displacement of the bold can alter the distance between the two proximal ends. Alternatively, the apparatus can include a spring. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0011]    For a fuller understanding of the invention, reference is made to the following description taken in connection with the accompanying drawings, in which: 
           [0012]      FIG. 1  is a side view of an implant extraction apparatus in accordance with an embodiment of the present invention; 
           [0013]      FIG. 2  shows various shapes of the jaw portions; 
           [0014]      FIG. 3  is a side view of a second implant extraction apparatus in accordance with an embodiment of present invention; 
           [0015]      FIG. 4  shows various shapes of the handles; 
           [0016]      FIG. 5  is a three-quarter perspective of an implant extraction apparatus in accordance with an embodiment of the present invention; 
           [0017]      FIG. 6  illustrates the embodiment of  FIG. 3  at an opened position; 
           [0018]      FIG. 7  illustrates the embodiment of  FIG. 3  at a closed position; 
           [0019]      FIG. 8  illustrates the extraction of a generator using an embodiment of the present invention; 
           [0020]      FIG. 9  is an exploded view of the jaw portion of an embodiment of the present invention, illustrating surface texture; 
           [0021]      FIG. 10  illustrates an embodiment with handles with complementing lock-steps. 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0022]    Certain exemplary embodiments of the present invention will now be described with reference to the drawings. In general, such embodiments relate to an apparatus or a method of extracting an implanted device. Whereas reference is made to removing an implanted device, it is to be understood that any displacement, including insertion, adjustment and removal of any object, regardless of size, shape or construction, is within the scope of the invention. 
         [0023]    A first embodiment of an implant-extracting apparatus is shown in  FIG. 1  and will be described herein. The implant extracting apparatus  10  includes two elongated legs, a first leg  101  and a second leg  102 . Each leg has a jaw portion in the distal end and a handle in the proximal end. The first handle  11  is at the proximal end of the first leg  101 , which also has a first jaw portion  13  at its distal end. Similarly, the second handle  12  is at the proximal end of the second leg  102 , which also has a second jaw portion  14 . The first handle  11  can control the movement of the first jaw  13 , while the second handle  12  can control the movement of the second jaw  14 , wherein the jaws  13 ,  14  define a receiving area  200  for receiving an implanted device. Handles  11  and  12  can reside on the same plane as jaws  13  and  14 . Alternatively handles  11  and  12  can reside on a first plane while jaws  13  and  14  reside on a second plane. 
         [0024]    A connecting mechanism  103  joins the two legs  101 ,  102  and allows the jaw portions  13 ,  14  to move between an opened position and a closed position. Although the connecting mechanism  103  may serve as a fulcrum, pivotally connecting the legs  101 ,  102 , as shown in  FIG. 1 , the legs  101 ,  102  may also be connected parallel to each other. In such a parallel arrangement, the legs may be squeezed and released to create a gripping force upon the jaw portions of the legs. Other arrangements of the legs can be provided in accordance with application specific design choice without deviating from the scope of the invention. 
         [0025]    The first and second handles  11  and  12  preferably are ergonomically designed. They can have optional curvatures  111 ,  112 ,  113  that may allow the operator to get a better grip to manipulate the apparatus and extricate the implanted device. For example, the ergonomic curve  112  on the first leg  101  can support the pinky finger and the curve  112  on the second leg  102  can support the adjacent bottom palm edge, which can provide a comfortable grip when the first handle  11  and second handle  12  are squeezed together simultaneously. The curve  113  on the first leg  101  can sit on the upper edge of the index finger&#39;s second joint and curve  113  on the second leg  102  can sit on or above the webbing or crux of the hand where the thumb and index finger meet. The shape of handles  11  and  12  can be angled, curved, straight or any other shape according to application design choice.  FIG. 4  illustrates non-limiting examples of handles  41 ,  42 ,  43 ,  44 , and  45 . 
         [0026]    The first jaw portion  13  preferably has a tapered end  133 , with decreasing thickness toward the distal end. The tapering  133  may better facilitate sliding and leading the first jaw portion  13  into the skin or device pocket, and/or tunneling the first jaw portion  13  under or around the implanted device in, out or through the derma to reach an optimal position for extraction. The first jaw portion  13  may also be tapered along its width or depth or be in any shape that is suitable for facilitating insertion and manipulation in, out or through the derma and/or cavity of the body or the device pocket. 
         [0027]    In the embodiment shown, the first jaw portion  13  has an elongated body, providing a surface  131  upon which the implanted device can rest. The surface  131  may include an anti-slip surface to prevent slipping when the apparatus is being used to displace an implanted device. The anti-slip surface can have textures, such as rough, raised, grooved, score lines, ridges and/or raised teeth surfaces. See  FIG. 9 . 
         [0028]    The first jaw portion  13  may also have a raised edge  132  defining the distal end of the surface  131 , the raised edge  132  preferably protruding toward the second jaw portion  14 . The shape of the raised edge  132  can be angled, curved, straight or any other shape according to application design choice.  FIG. 2  illustrates non-limiting examples of raised edge  20 ,  21 ,  22 ,  23 . The raised edge  132  is preferably constructed and arranged such that if the implanted device moves toward the distal end of the apparatus  10 , the raised edge  132  can abut the implanted device, thus preventing the implanted device from being displaced out of the receiving area  200  between jaw portions  13 ,  14 , for example, during extraction. If the length of the implanted device to be removed is less than the length of the surface  131 , the device may rest on the surface  131  within the length of the surface  131 . If the length of the implanted device is greater than the length of the surface  131 , then a portion of the implanted device may rest on top of the raised edge  132  and the implanted device may extend beyond the receiving area  200 . 
         [0029]    The second jaw portion  14 , preferably coordinating with the first jaw portion  13 , may provide a gripping force to hold the implanted device in place during displacement, such as removal. It may have a tapered distal end, being tapered along its length, width and/or depth. The second jaw  14  may contain a gripping surface  141  that can vary in size or shape. The gripping surface  141  may have anti-slipping features, such as rough, raised, grooved, score lines, ridges and/or raised teeth surface. A textured surface  141  may prevent slipping when clamping onto a device. 
         [0030]    The second jaw portion  14  preferably includes a protrusion  14 A extending toward the first jaw portion  13 , wherein the protrusion  14 A defines the distal end of the gripping surface  141 . The protrusion  14 A is preferably constructed and arranged such that that if the implanted device moves toward the distal end of the apparatus  10 , the protrusion  14 A can abut the implanted device, thus preventing the implanted device from being displaced out of the receiving area  200 .  FIG. 2  illustrates non-limiting examples of the protrusion  25 ,  26 ,  27 ,  28 . The protrusion  14 A preferably also includes anti-slipping features. In the embodiment shown in  FIG. 1 , the second jaw portion  14  is shorter than the first jaw portion  13 , such that an implanted device having a length equal to or less than the length of the surface  141  of the second jaw portion  14  may be received between the connecting mechanism  103  and the protrusion  14 A. If the implanted device has a length greater than the length of the surface  141  of the second jaw portion  14 , the protrusion  14 A may apply a clamping force onto the implanted device toward the first jaw portion  13 . Both the shape and the surface areas of first and second jaw portions  13 ,  14  can be specifically made to fit and extract specific implanted devices. The devices may include, but are not limited to, wires, generators, batteries, and the like. 
         [0031]    The embodiment of the apparatus  10  illustrated has an opened position and a closed position. When the first handle  11  and second handle  12  are drawn apart, the first jaw portion  13  and the second jaw portion  14  are also drawn apart and the apparatus  10  is in the opened position. The width of the opening between the first jaw portion  13  and the second jaw portion  14  depends on the distance between the first handle  11  and the second handle  12 . When the handles  11  and  12  are squeezed together, the jaws  13  and  14  move closer together in a clamp like manner. When the apparatus is in this closed position, the first and second jaw portions  13  and  14  together form a gripping mechanism, with the second jaw portion  14  biting down on the implanted device while the first jaw  13  holds the device in place. 
         [0032]    The first and second jaw portions  13  and  14  can be fitted together in a predetermined manner so that when the two are in the closed position, the first jaw portion  13  provides adequate spacing for the implanted device, while the second jaw portion  14  provides adequate force to grip the implanted device, allowing the handler to hold on to and manipulate the implanted device in, within, or out of the implanted cavity. This can allow the clinicians to apply and transfer the gripping and/or torqueing force from the handles to the jaws efficiently, and to conduct a quick and exact extraction of the implanted device, avoiding unnecessary movement or dislodgment of implanted leads. 
         [0033]    Extraction of the implanted device through the skin surface can be performed by widening the gap between the first jaw portion  13  and the second jaw portion  14 . The operator can control and manipulate the first handle  101  while the apparatus  10  is in the opened position, to cause the first jaw portion  13  to tunnel and wedge into the device pocket under the object desired for removal. Once the first jaw  13  is in the proper position, with the implanted device resting within the receiving area  200 , the operator can then squeeze the handles  11  and  12  together to close the jaw portions  13  and  14 . The jaw portions  13  and  14  together can clamp onto the device, gripping the device. The operator can maneuver the handles  11 ,  12  to apply torqueing and/or pulling forces until the implanted device is free from the pocket without excessive tugging and over-cutting of the pocket opening. See  FIG. 8 . 
         [0034]    The present invention preferably allows the implanted device to be grabbed and facilitates the extrication of the device, allowing for minimal tugging and dislodging of the leads. Furthermore, certain embodiments of the present invention can be used to assist in the insertion or positioning of an implantable device, for example, where resistance is met upon attempting to place a device into the skin pocket. In one embodiment, when a patient is of small stature and/or the patient does not want a large scar, the clinician can attach the implantable device&#39;s leads onto the implantable device and use an embodiment of the present invention to insert the device into the small pocket. The clinician may also grasp and hold the present invention with one hand and use the other hand to support the pocket opening to insure proper fitting and seating of the device in the pocket. A device constructed in accordance with the invention may help wedge the device in smaller pockets without excessive cutting of skins and tissues. The same approach may be used when the clinician&#39;s hand digits are larger than the pocket opening. 
         [0035]    Another embodiment of the invention is shown in  FIG. 3 . The apparatus as shown has handles  31 ,  32 , jaw portions  33 ,  34 , a connecting mechanism  35 , and a screw  36 . As shown, the screw  36  has a head  361  and a threaded body  362 . The threaded body  362  is inserted into the handle  31  through a threaded receiver  311 , constructed and arranged to receive the threading of the threaded body  362 . When the head  361  of the screw-like screw  36  is rotated clockwise, the distance between handles  31  and  32  is increased, moving the apparatus&#39;s jaw an opened position to a closed position. See  FIGS. 6 and 7 . Accordingly, the jaw portion  33  and the jaw portion  34  can be moved closer to each other clamping down on the object, if any, positioned between jaw portions  33  and  34 . When the head  361  is rotated counter-clockwise, the jaw portions  33 ,  34  will separate. In this embodiment, force is applied indirectly to the jaws to grip the implanted device by applying force onto the screw  36 , which force is then transferred to the handles  31 ,  32 , then to the jaw portions  33 ,  34 , whereby the connecting mechanism  35  serves as a fulcrum, providing a pivot point. Whereas a threaded screw  36  is illustrated and described herein, it is to be understood that a bolt having a smooth surface, grooves, protrusions, and/or other adjustment mechanisms for adjusting the position of the bolt within handle  31 , are contemplated without deviating from the scope of the invention. Likewise, handle  31  may include a receiving mechanism complementing such adjustment mechanism of the bolt, instead of the threaded receiver  311 .  FIG. 6  illustrates non-limiting examples of raised edge  20 ,  21 ,  22 ,  23 . 
         [0036]    In another embodiment of the invention, the opening and closing of the jaw portions can be accomplished either applying direct pressure to the handles, or applying direct or indirect pressure through the use of screws, springs or other mechanisms. For example, the handles may have complementing lock-steps, see  FIG. 10 , on the handles. When pressure is applied to move the handles closer to each other, the lock-steps can lock with each other, preventing the handles from moving away from each other without the clinician having to apply continuous squeezing pressure onto the handles. 
         [0037]    In addition, the movement of the handles can alter the distance between the jaw portions reciprocally or inversely. For example, in one embodiment, squeezing the handles toward each other can cause the jaw portions to move toward each other, thus applying a gripping force on a device positioned therebetween. In another embodiment, pulling the handles apart can cause the jaw portions to move toward each other, thus applying a gripping force on a device positioned therebetween. 
         [0038]    The design of the retracting apparatus shown may reduce excessive tugging and difficulty in pulling an implanted device currently performed by alternative tools not meant for generator or implanted device extractions. 
         [0039]    The examples provided are merely exemplary, as a matter of application specific to design choice, and should not be construed to limit the scope of the invention in any way. 
         [0040]    Thus, while there have been shown, described and pointed out novel features of the present invention as applied to preferred embodiments thereof, it will be understood that various omissions and substitutions and changes in the form and details of the disclosed invention may be made by those skilled in the art without departing from the spirit of the invention. For example, the length of the legs, the angle between of the jaw portion and its respective handle portion, the shape of the curves on the handles, etc. can be changed without deviating from the scope of the invention as a matter of application specific to design choice. By way of non-limiting example, the handles may have hooks, loops, or other mechanisms for keeping finger(s) or hand in place while opening and closing the extraction apparatus. For example, the handles may have loops such as the handles of scissors or the handles may be U-shaped, which may facilitate the opening of the apparatus without releasing the apparatus. Alternatively, the jaw portions may be curved to facilitate receiving rounded devices therein, or have a specific shape to receive a specific device. Whereas the first jaw portion  13  is illustrated as being longer than the second jaw portion  14 , it is contemplated that the jaw portions can be of equal length, or the second jaw portion  14  may be longer than the first jaw portion without deviating from the scope of the invention. Moreover, the jaw portions  13 ,  14 , may have more than one raised edge  132  or protrusion  14 A, respectively, protruding at either the same or varying height from the respective jaw portion  13 ,  14 . Additionally, other alterations can be made, as a way of non-limiting example, the thickness, width, or shape of the legs may vary along the length of the legs as a matter of application specific to design choice, without deviating from the scope of the invention. It is the intention, therefore, to be limited only as indicated by the scope of the claims appended hereto. 
         [0041]    It is also to be understood that the following claims are intended to cover all of the generic and specific features of the invention herein described and all statements of the scope of the invention which, as a matter of language, might be said to fall therebetween.