Apparatus and method for forming a subcutaenous pocket

Abstract

A device may include a handle extending from a proximal end to a distal end, and include a spoon extending from the distal end of the handle, the spoon having an arm having a first width and a head having a second width, wherein the second width is substantially equal to a width of the implant device. The device may include a blunt edge defining a distal end of the spoon configured to separate tissue. The device may further include a guide extending from the handle, wherein the guide is vertically offset from the spoon.

Description

APPARATUS AND METHOD FOR FORMING A SUBCUTAENOUS POCKETCROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims priority to U.S. Provisional Application No. 63 / 559,609, filed February 29, 2024, the entirety of which is incorporated herein by reference.FIELD OF INVENTION

[0002] The present disclosure is directed to an apparatus, system, kit, and method for forming a subcutaneous pocket for an implant device and, in particular, a pocket creation tool that creates a subcutaneous pocket dimensioned to snuggly receive and secure the implant device.BACKGROUND

[0003] During an implantation procedure for implanting a device into a patient, a subcutaneous pocket is formed to receive the device. Generally, a surgeon uses their fingers or a generic instrument to form a subcutaneous pocket between fascia tissue and an outer layer of the patient’s skin. For example, the surgeon may incise the user’s skin, insert their fingers or tool into the incision between two layers of tissue, swipe their fingers / tool side to side as they translate their fingers / tool subcutaneously to an implant site under the user’s skin to form the subcutaneous pocket between the two layers of tissue. Typically, the subcutaneous, unguided movement of the surgeon’s fingers / tool may create a subcutaneous pocket that is too small or too large for the implant device. In instances where the subcutaneous pocket is too small, the surgeon must attempt to enlarge the pocket to fit the device. Accordingly, pockets formed in such a manner are not precise and may be too large or improperly aligned to securely receive the implanted device. That is, the implanted device may shift or otherwise move within the subcutaneous pocket, thereby disrupting any connection, e.g., via anchors, leads, or electrodes, between the implanted device and a desired target. For example, any movement of the implanted device within the subcutaneous pocket may apply excess tension or load to the connection or target, and may disrupt any signal conducted between the implanted device and desired target.

[0004] Accordingly, a tool capable of easily and reliably forming a subcutaneous pocket dimensioned to snuggly receive and secure an implantable device that overcomes the above noted deficiencies is desired.SUMMARY

[0005] The techniques presented herein provide an apparatus, system, kit, and method for improved creation of a subcutaneous pocket for receiving an implanted device. According to one embodiment, the present application is directed to a pocket creation tool for creating a subcutaneous pocket for an implant device, including: a handle extending from a proximal end to a distal end; a spoon extending from the distal end of the handle, the spoon having an arm having a first width and a head having a second width, wherein the second width is substantially equal to a width of the implant device; a blunt edge defining a distal end of the spoon configured to separate tissue; and a guide extending from the handle, wherein the guide is vertically offset from the spoon.

[0006] In some instances, the blunt edge is configured to form the subcutaneous pocket within a patient having a dimension that substantially matches a dimension of the implant device.

[0007] In some aspects, the first width is less than the second width.

[0008] In some implementations, the pocket creation tool further includes a cross guard disposed between the handle. The handle is angled with respect to the cross guard to facilitate creation of the subcutaneous pocket.

[0009] In some instances, the guide is configured to maintain a desired depth of the spoon with a patient.

[0010] In other embodiments, the techniques described herein relate to a method of performing a surgical procedure. The method includes: subcutaneously inserting a pocket creation tool into a patient; translating the pocket creation tool along a longitudinal axis of the pocket creation tool; and separating layers of tissue via a blunt edge at a distal end of the pocket creation tool to form a subcutaneous pocket having a dimension that substantially matches a dimension of an implant device.

[0011] In some aspects, the subcutaneous pocket is formed without translating the pocket creation tool in a direction transverse to the longitudinal axis.

[0012] In some instances, separating the tissue with the blunt edge avoids trauma to a surgical site. The trauma may include tearing, cutting, or otherwise injuring the layers of tissue.

[0013] In some implementations, the method further includes disposing the implant device at a distal end of a pusher tool; and implanting the implant device, via the pusher tool, into a distal end of the subcutaneous pocket. The method may further include applying a force, via the pusher tool, to a rear end of the implant device.

[0014] In yet other embodiments, the techniques described herein relate to a kit including: a pocket creation tool for forming a subcutaneous pocket, an implant device including a main body having a third width substantially equal to the second width, and a pusher tool configured to insert the implant device into the subcutaneous pocket. The pocket creation tool includes a handle extending from a proximal end to a distal end; a spoon extending from the distal end of the handle, the spoon having an arm having a first width and a head having a second width greater than the first width; a blunt edge defining a distal end of the spoon configured to separate tissue; and a guide extending from the handle, wherein the guide is vertically offset from the spoon.

[0015] In some implementations, the blunt edge is configured to form the subcutaneous pocket having a dimension within a patient that substantially matches a dimension of the implant device.

[0016] In some instances, the techniques described herein relate to a kit, further including a cross guard disposed at a distal end the handle, wherein the handle is angled with respect to the cross guard to facilitate creation of the subcutaneous pocket.

[0017] In some aspects, the guide is configured to maintain a desired depth of the spoon within a patient.

[0018] In some implementations, the implant device includes one or more leads extending from the main body.

[0019] In some instances, the implant device includes an implantable cardioverter defibrillator, pacemaker, or a pulse generator.

[0020] In some aspects, the pusher tool further includes an upper jaw and a lower jaw disposed at a distal end of the pusher tool.

[0021] In some instances, the upper jaw and lower jaw are configured to grip and push the implant device into the subcutaneous pocket created by the pocket creation tool.

[0022] Stil further, in some embodiments, the techniques described herein relate to a pusher tool for an implanting a device including: a handle extending from a proximal end to a distal end; an arm extending from the distal end of the handle; and an applicator disposed at a distal end of the arm, the applicator including an upper jaw and a lower jaw configured to receive the device.

[0023] In some implementations, the pusher tool further includes a cross guard disposed at the distal end of the handle.

[0024] In some instances, the handle includes a main portion and a grip portion disposed near the distal end. The grip portion may include a plurality of ribs.

[0025] In some aspects, the upper jaw and the lower jaw are configured to conform to a rear end of the device.

[0026] In some implementations, the arm includes longitudinally extending grooves disposed between an upper surface and a lower surface of the arm. The grooves may be configured to receive one or more leads extending from the device.BRIEF DESCRIPTION OF THE DRAWINGS

[0027] To complete the description and in order to provide for a better understanding of the techniques presented in this application, a set of drawings is provided. The drawings form an integral part of the description and illustrate an embodiment of the present application, which should not be interpreted as restricting the scope of the present application, but just as an example of how the techniques presented herein can be carried out. The drawings comprise the following figures:

[0028] FIG. l is a front perspective view of an implant kit having a pocket creation tool, a pusher tool, and an implant device, according to an embodiment of the present disclosure.

[0029] FIG. 2 is a side view of the pocket creation tool of FIG. 1.

[0030] FIG. 3 is bottom side view of the pocket creation tool of FIG. 1.

[0031] FIG. 4 is a bottom perspective view of the pocket creation tool of FIG. 1.

[0032] FIG. 5 is a method of creating a subcutaneous pocket, according to an embodiment of the present disclosure.

[0033] Like reference numerals have been used to identify like elements throughout this disclosure.DETAILED DESCRIPTION

[0034] The following description is not to be taken in a limiting sense but is given solely for the purpose of describing the broad principles of the invention. Embodiments of the invention will be described by way of example, with reference to the above-mentioned drawings showing elements and results according to the present invention.

[0035] Generally, the techniques described herein relate to an implant kit for creating a subcutaneous pocket and securely implanting an implant device (e.g., an implantable cardioverter defibrillator, pacemaker, and / or a pulse generator). The subcutaneous pocketsecurely receives the implant device to prevent movement of the implant device. The implant kit further includes a pocket creation tool (sometimes referred to herein as a “tool” or “tunneller”) having a longitudinal axis to easily and reliably form a subcutaneous pocket with a shape that substantially matches one or more dimensions (e.g., height, width, volume, length, contours etc.) of the implant device. Thus, a surgeon may insert the pocket creation tool into an incision, align the pocket creation tool with the patient’s body, and translate the pocket creation tool, subcutaneously, along a longitudinal axis (e.g., without translating the pocket creation tool transverse to the longitudinal axis) to form the subcutaneous pocket that substantially matches one or more dimensions of the implant device. Consequently, the subcutaneous pocket is sized and shaped to substantially match the dimensions of the implant device. Accordingly, the implant device may then be inserted into and securely received in the subcutaneous pocket. That is, once implanted, the subcutaneous pocket prevents the implant device from translating, shifting, or otherwise moving within the patient’s body.

[0036] Referring to FIG. 1, an implant kit 10 including a pocket creation tool 100, a pusher tool 200, and an implant device 300, is illustrated. The pocket creation tool 100 is configured to create a subcutaneous pocket for receiving the implant device 300. The pusher tool 200 is configured to insert the implant device 300 into the subcutaneous pocket created by the pocket creation tool 100. The implant device 300 may be an implantable cardioverter defibrillator, pacemaker, and / or an electrical pulse generator.

[0037] In the depicted embodiment, the implant device 300 includes a main body 310 having a rear end 312 and a front end 314 and a pair of leads 320 extending from the rear end 312. The main body 310 includes a top surface 310A, side surfaces 310B, a front wall 314A, and a rear wall 312 A. The side surfaces 310B, the front wall 314 A, and the rear wall 312A are substantially perpendicular to the top surface 310A.

[0038] The main body 310 further includes a first width W1 and a first thickness Tl. The first width W1 is the widest portion of the main body 310 between two opposing side surfaces 310B. The first thickness Tl is substantially constant across the main body 310 as measured between the top surface 310A and an opposing bottom surface. However, an outer perimeter of the main body 310 may include chamfered or filleted edges to transition a top surface 310A and / or the bottom surface to the side surfaces 310B, front wall 314A, and rear wall 312A. The chamfered or filleted edges prevent any sharp edges that may tear, cut, or otherwise cause trauma to the one or more layers of tissue defining the subcutaneous pocket during implantation.

[0039] To further avoid trauma to the one or more layers of tissue defining the subcutaneous pocket, the front end 314 is convex. That is, the front wall 314A may define an arcuate shape that facilitates smooth translation of the implant device 300 during implantation into, and / or translation through, the subcutaneous pocket of the patient. For example, the arcuate front wall 314A may facilitate moving and / or lifting separated layers of tissue of the subcutaneous pocket without tearing, ripping, or otherwise causing trauma to the one or more layer of tissue forming the subcutaneous pocket.

[0040] Still referring to FIG. 1, the main body 310 defines a cavity (not shown) for receiving one or more internal components (not shown) for generating a therapeutic signal to be delivered to a target within the patient and / or sensing a physiological condition (e.g., nerve signal, heartbeat, etc.) of the target. The pair of leads 320 may electrically couple the one or more internal components of the implant device 300 to one or more electrodes (not shown). For example, the leads 320 may include a junction for electrically coupling to the one or more electrodes. The one or more electrodes may be anchored and / or otherwise contact a target (e.g., a nerve, bundle, muscle, etc.) within a patient’s body and conduct signals between the target and the leads 320. Thus, the leads 320 electrically couple the one or more internal components of the implant device 300 to the target via the one or more electrodes. Consequently, the one or more internal components may generate and transmit a therapeutic signal and / or receive and monitor one or more physiological conditions of the target when implanted in the subcutaneous pocket.

[0041] Referring to FIGS. 2-4 with continued reference to FIG. 1, the pocket creation tool 100 is configured to create the subcutaneous pocket. The pocket creation tool 100 includes a handle 110, a cross guard 120, a spoon 130, and a guide 160. The handle 110 extends along a longitudinal axis 112 from a proximal end 114 to a distal end 116 where it integrally connects to the cross guard 120. The handle 110 may be rounded and extends from the cross guard 120 along the longitudinal axis 112 towards the proximal end 114 at a canted angle 01 with respect to a vertical axis 122 of the cross guard 120. Said another way, the longitudinal axis 112 of the handle 110 intersects the vertical axis 122 of the cross guard 120 at the canted angle 91. The canted angle 91 may be less than ninety degrees. For example, the canted angle 91 may be between about 85 degrees and about 40 degrees. That is, the canted angle 91 may be about 85 degrees, about 80 degrees, about 75 degrees, about 70 degrees, about 65 degrees, about 60 degrees, about 55 degrees, about 50 degrees, about 45 degrees, and / or about 40 degrees. The canted angle 91 provides an ergonomic and comfortable angle at which a user may grip the handle 110 to create a subcutaneous pocket with the pocket creation tool 100.

[0042] The handle 110 further includes a main portion 110A and a grip portion 118 disposed at the distal end 116 near the cross guard 120. The main portion 110A provides a handle area to be gripped by a user’s palm and a plurality of fingers. As best illustrated in FIGS. 2 and 3, the grip portion 118 transitions from the main portion 110A of the handle 110 to the cross guard 120.

[0043] The grip portion 118 provides a grip area for a user to grip with their thumb and index finger. As shown in FIG. 3, the grip portion 118 has a smaller width W2 than a width W3 of the handle 110. For example, the grip width W2 may be about a quarter, about a third, or about a half the width W3 of the main portion 110A. In some implementations, the handle 110 may taper from the handle width W3 to the grip width W2 at an angle 06. In the depicted embodiment, the angle 96 is with reference to the longitudinal axis 112 of the handle. The angle 96 may be about 25 degrees, about 30 degrees, about 40 degrees, about 45 degrees, about 50 degrees, or about 55 degree. That is, the handle width W3 may taper down to the grip width W2 at the angle 96 ranging between about 25 and about 55 degrees.

[0044] The grip portion 118 further includes a plurality of outwardly extending ribs 118A for providing a better grip for the user. That is, the ribs 118A extend substantially parallel to the cross guard 120 to provide a contoured surface that increases the friction (e.g., friction coefficient) of the handle 110. The increased friction helps prevent the pocket creation tool 100 from slipping in the user’s hand during a subcutaneous pocket creation procedure.

[0045] The grip portion further includes a curved lower surface 118B and a curved upper surface 118C. The lower surface 118B extends substantially perpendicularly from the cross guard 120 and curves upwards (e.g., via a convex curve) towards the longitudinal axis 112 before curving back via a concave surface 118D towards the main portion 110A of the handle 110 as it extends towards the proximal end 114. Meanwhile, the upper surface 118C extends substantially perpendicularly from the cross guard 120 and curves upwards and away from the longitudinal axis 112 (e.g., a concave curve) as it extends towards the proximal end 114. Consequently, the curved lower surface 118B, the curved upper surface 118C, and the concave surface 118D provides the grip portion 118 with a large surface area that can be easily gripped by the user. The larger surface area of the grip portion 118 further provides the user with greater control of the pocket creation tool 100 than a handle without a grip portion 118.

[0046] Still referring to FIGS. 1-4, the cross guard 120 may also prevent the pocket creation tool 100 from slipping in the user’s or surgeon’s hand by serving as a thrust guard. The cross guard 120 includes a substantially rectangular and flat main body 124 that extends along the vertical axis 122 and perpendicularly beyond an outer perimeter of the grip portion 118 of thehandle 110. That is, the cross guard 120 may have a height and a width that is larger than a height and width of the grip portion 118. The height and width of the main body 124 may be large enough to define a first shoulder or first bearing surface 124A that is sufficient to receive a load or thrust from a surgeon’s hand (e.g., top surfaces of the surgeon’s thumb and index finger) and prevent the surgeon’s hand from slipping past the cross guard 120. For example, the main body 124 may extend past an outer perimeter of the grip portion 118 (e.g., transverse to the longitudinal axis 112) by about 0.5 cm to about 1 cm. However, as noted above, the bottom surface of the cross guard 120 may be substantially parallel and coplanar with a portion of the curved lower surface 118B of the grip portion 118 and the lower surface 140B of the arm 140 of the spoon 130, as best shown in FIGS. 2 and 3. That is a lower surface 140B of the arm 140, a lower surface of the cross guard 120, and at least a portion of the curved lower surface 118B of the grip portion 118 define a continuous smooth surface to prevent irritation to the patient’s incision, skin, and / or layers of tissue.

[0047] Meanwhile, the cross guard 120 may further include a second bearing surface 124B opposite the first bearing surface 124 A to prevent the spoon 130 from being inserted too far from the incision and into the patient. For example, the second bearing surface 124B may bear against the patient’s skin thereby preventing over insertion of the spoon 130. That is, the second bearing surface 124B may prevent the head 150 from being inserted beyond a length defined between a spoon distal end 136 and the cross guard 120. The defined length may be determined based on the size of the implant device 300 including the leads 320.

[0048] As best shown in FIG. 2, but with continued reference to FIGS. 1, 3, and 4, the spoon 130 and the guide 160 extend from the second bearing surface 124B of the cross guard 120 at a spoon angle 02. That is, the spoon 130 includes a spoon longitudinal axis 132 that extends from a spoon proximal end 134 to the spoon distal end 136. The spoon proximal end 134 is fixed to or otherwise adjacent to the second bearing surface 124B of the cross guard 120. The spoon longitudinal axis 132 may be substantially perpendicular to the vertical axis 122 of the cross guard 120. For example, a spoon angle 92 between the spoon longitudinal axis 132 and the vertical axis 122 may be substantially perpendicular.

[0049] In some implementations, the spoon angle 92 may be askew to the cross guard 120. For example, the spoon angle 92 may be about 100 degrees, about 95 degrees, about 85 degrees, about 80 degrees, about 75 degrees, or about 70 degrees. Accordingly, the spoon angle 92 may be between about 100 degrees and about 70 degrees.

[0050] The spoon 130 further includes an arm 140 and a head 150. The arm 140 extends from the cross guard 120 at the spoon proximal end 134 to an arm distal end 142. The arm 140has an arm width W4 (e.g., transverse to the spoon longitudinal axis 132). The head 150 is disposed at the arm distal end 142 and extends towards the spoon distal end 136. In the depicted embodiment, the head 150 flairs out at the arm distal end 142 to a head width W5 and tapers or otherwise reduces back down towards a rounded blunt edge 152 (see FIG. 3). That is, the spoon distal end 136 is substantially convex or rounded. The head 150 may flair out from the arm 140 at an angle 05 with respect to the longitudinal axis 132 as depicted in FIG. 3. The angle 95 may be about 20 degrees, about 30 degrees, or about 45 degrees. That is, the head 150 may flair out at the angle 95 ranging between about 20 degrees and about 45 degrees to the head width W5. Alternatively, in some implementations, the edge 152 may be sharp to be inserted into and separate two layers of tissue.

[0051] Meanwhile, the head 150 is dimensioned to substantially match dimensions of the implant device 300. That is, the head 150 is sized and shaped to substantially match a size and shape of the implant device 300. For example, the head width W5 and a head thickness T2 substantially matches the width W1 and thickness T1 of the implant device 300. That is, the head width W5 is substantially the same as or slightly less than the width W1 of the implant device 300, and the head thickness T2 is substantially the same as or slightly less than the thickness T1 of the implant device 300. Additionally, the rounded blunt edge 152 may be contoured to substantially match the shape of the front wall 314A of the implant device 300. Accordingly, the pocket creation tool 100 creates a subcutaneous pocket with dimensions and / or volume that substantially matches the implant device 300 such that the tissue defining the subcutaneous pocket is stretched and grips the implant device 300 when implanted. Consequently, the subcutaneous pocket applies a compressive force to an outer surface of the implant device 300 thereby securing it in the subcutaneous pocket such that the implant device 300 does not move after being implanted.

[0052] During use, the blunt edge 152 of the head 150 creates the subcutaneous pocket by separating and / or lifting layers of tissue without causing trauma, or at least minimizing trauma, to the separated layers of tissue. That is, the blunt edge 152 creates the subcutaneous pocket without tearing, ripping, piercing or otherwise breaking individual layers of tissue. The blunt edge is substantially round (see FIG. 3) and includes a first angled surface 152A and a second angled surface 152B. As best shown in FIG. 2, the first angled surface 152A extends from an upper surface 150 A of the head 150 downwards and towards the spoon distal end 136. In some implementations, the first angled surface 152A is a fillet or chamfer surface. Meanwhile, the second angled surface 152B extends from the spoon distal end 136 downwards towards a lower surface 150B at an edge angle 1. The edge angle 01 is set to separate two layers of tissuewithout causing trauma to the layers of tissue. For example, the blunt edge 152 may be disposed between two layers of tissue. The spoon 130 may then be translated causing the first angled surface 152A to lift a first layer of tissue while the second angled surface 152B pushes down on the second layer of tissue to separate the two layers. The edge angle pi avoids unnecessary trauma to the layers of tissue. In some instances, the edge angle pi between the second angled surface 152B and the spoon longitudinal axis 132 may be about 25 degrees, about 30 degrees, about 35 degrees, about 40 degrees, or about 45 degrees. Therefore, the edge angle pi may be between about 25 degrees and about 45 degrees. Accordingly, the blunt edge 152 tunnels between the layers of tissue while the first angled surface 152A and the second angled surface 152B guide and separate the layers of tissue without causing trauma to the layers of tissue when the user translates the pocket creation tool 100 along the spoon longitudinal axis 132 with the spoon 130 inserted subcutaneously into a patient.

[0053] In some implementations, the blunt edge 152 has a radius of one half (1 / 2) of the head width W5. In some implementations, the blunt edge 152 may have a curvature that substantially matches a curvature of the front wall 314A of the implant device 300. That is, when viewed from the top, the shape of the blunt edge 152 substantially matches the shape of the front end 314 of the implant device 300. Regardless of the curvature of the spoon distal end 136 of the head 150, the blunt edge 152 separates the layers of tissues and guides them to the upper surface 150A and lower surface 150B of the head 150.

[0054] Still referring to FIGS. 1-4, a depth at which the head 150 is inserted into the body of a patient to create the subcutaneous pocket is set by the guide 160. That is, the guide 160 determines a depth at which the head 150 can be inserted under the skin. The guide 160 extends from the cross guard 120 at a proximal end 162 to a distal end 164. A guide longitudinal axis 166 extends from the proximal end 162 to the distal end 164 and is vertically offset and parallel to the spoon longitudinal axis 132. Consequently, a lower surface 160B of the guide 160 is parallel to an upper surface 140A of the arm 140 and the upper surface 150A of the head 150. The guide 160 includes an upper surface 160 A opposite the lower surface 160B. The guide 160 tapers from the proximal end 162 to the distal end 164. For example, the upper surface 160A is angled with respect to the lower surface 160B at a taper angle 03. In some implementations, the upper surface 160A and the lower surface 160B are substantially parallel.

[0055] Regardless of the shape of the upper surface 160A, the guide 160 is configured to set a depth of the spoon 130 when inserted into a patient via a gap between the upper surface 140A and the lower surface 160B. As best shown in FIG. 2, a gap distance DI between the lower surface 160B and the upper surface 140A of the arm 140 is set to the desired depth ofthe subcutaneous pocket. For example, during use, the lower surface 160B of the guide 160 contacts an outer surface of the patient’s skin thereby guiding the spoon 130 to the desired subcutaneous depth, e.g., the gap distance DI, and maintain the spoon 130 at that depth throughout the pocket forming procedure. Said another way, the guide 160 prevents the spoon 130 from being inserted into the patient beyond a desired depth from an exterior of the patient’s body.

[0056] Referring back to FIG. 1 , once the pocket creation tool 100 creates the subcutaneous pocket, the pusher tool 200 deposits the implant device 300 into the subcutaneous pocket. The pusher tool 200 includes a handle 210, a cross guard 220, an arm 230 and an applicator head 240. The handle 210 extends along a longitudinal axis 212 from a proximal end 214 to a distal end 216. The handle 210 is canted with respect to a vertical axis 222 of the cross guard 220. That is, a canted angle 4> 1 between the longitudinal axis 212 and the vertical axis 222 is acute. Said another way, the longitudinal axis 212 of the handle 210 intersects the vertical axis 222 of the cross guard 220 at the canted angle (|> 1. The canted angle 4> 1 may be less than or equal to about 90 degrees. For example, the canted angle 4> 1 may be between about 90 degrees and about 40 degrees. That is, the canted angle 4>1 may be about 90 degrees, about 85 degrees, about 80 degrees, about 75 degrees, about 70 degrees, about 65 degrees, about 60 degrees, about 55 degrees, about 50 degrees, about 45 degrees, or about 40 degrees. The canted angle 4> 1 provides an ergonomic and comfortable angle at which a user may grip the handle 210 to insert the implant device 300 into the subcutaneous pocket with the pusher tool 200.

[0057] The handle 210 further includes a main portion 210A and a grip portion 218 disposed at the distal end 216 near the cross guard 220. The main portion 210A provides an area to be gripped by a user’s palm and plurality of fingers. The grip portion 218 transitions from the main portion 210A of the handle 210 to the cross guard 220.

[0058] The grip portion 218 provides a grip area for a user to grip with their thumb and index finger. In the depicted embodiment, the grip portion 218 has a smaller width than a width of the handle 210. For example, the grip width may be a quarter, a third, or a half of the width of the handle portion 210A. In some implementations, the handle 210 may taper from the handle width to the grip width at an angle. The angle may be with reference to the longitudinal axis 212 of the handle. The angle may be about 25 degrees, 30 degrees, 40 degrees, 45 degrees, 50 degrees, or 55 degrees. That is, the width of the main portion 210A may taper down to the width of the grip portion 218 at the angle ranging between about 25 and about 55 degrees.

[0059] The grip portion 218 further includes a plurality of outwardly extending ribs 218A for providing a better grip for the user. That is, the ribs 218A extend substantially parallel tothe cross guard 220 to provide a contoured surface that increases the friction (e.g., friction coefficient) of the handle 210. The increased friction helps prevent the pusher tool 200 from slipping in the user’s hand during a subcutaneous implant procedure.

[0060] Still referring to FIG. 1, the cross guard 220 may also prevent the pusher tool 200 from slipping in the user’s or surgeon’s hand by serving as a thrust guard. The cross guard 220 includes a substantially rectangular and flat main body 224 that extends along the vertical axis 222 beyond an outer perimeter of the grip portion 218 of the handle 210. That is, the cross guard 220 may have a height and a width that is larger than a height and width of the grip portion 218. The height and width of the main body 224 may be large enough to define a first shoulder or first bearing surface 224A that is sufficient to receive a load or force from a surgeon’s hand (e.g., top surfaces of the surgeon’s thumb and index finger) and prevent the surgeon’s hand from slipping past the cross guard 220. For example, the main body 224 may extend past an outer perimeter of the grip portion 218 (e.g., transverse to the longitudinal axis 212) by about 0.5 cm to about 1 cm. However, the bottom surface of the cross guard 220 may be substantially parallel and coplanar with a portion of the lower of the grip portion 218 and the arm 230 to prevent trauma or other irritation to the patient’s skin. That is, a portion of a lower surface of the arm 230, a lower surface of the 220, and a portion of the lower surface of the 218 may define a smooth continuous surface.

[0061] The cross guard 220 may further include a second bearing surface 224B opposite the first bearing surface 224A to prevent the applicator head 240 (and thus, the implant device 300) from being inserted too far from the incision and into the patient. For example, the second bearing surface 224B may bear against the patient’s skin thereby preventing over insertion of the applicator head 240. That is, the second bearing surface 224B prevents the applicator head 240 from being inserted beyond a length defined between the distal end 236 and the cross guard 220.

[0062] In the depicted embodiment, the arm 230 extends from the second bearing surface 224B of the cross guard 220 at an arm angle (|)2. That is, the arm 230 includes a longitudinal axis 232 that extends from an arm proximal end 234 to an arm distal end 236. The proximal end 234 is fixed to or otherwise adjacent to the second bearing surface 224B of the cross guard 220. The longitudinal axis 232 may be substantially perpendicular to the vertical axis 222 of the cross guard 220. For example, the arm angle (|)2 between the arm longitudinal axis 232 and the vertical axis 222 may be substantially perpendicular.

[0063] In some implementations, the arm angle (|)2 may be askew to the cross guard 220. For example, the arm angle (|)2 may be about 100 degrees, about 95 degrees, about 85 degrees,about 80 degrees, about 75 degrees, or about 70 degrees. Accordingly, the arm angle (|>2 may be between about 100 degrees and about 70 degrees. In some implementations, the arm angle (|)2 may be substantially the same as the spoon angle 02.

[0064] The arm 230 may have an “I-shaped” cross-section. That is, a middle portion 230A of the arm 230 may be narrower than an upper portion 230B and lower portion 230C of the arm 230. Said another way, each side of the middle portion 230A may define a groove between the upper portion 230B and the lower portion 230C. The middle portion 230A may be sized and shaped to conform to an outer surface of the leads 320 extending from the main body 310 of the implant device 300. That is, the leads 320 may be received by the grooves defined by the middle portion 230A when the implant device 300 is disposed at the applicator head 240 of the pusher tool 200.

[0065] The applicator head 240 is disposed at the distal end 236 of the arm 230 and includes an upper jaw 242 and a lower jaw 244. The upper jaw 242 and the lower jaw 244 conform to the rear end 312 of the main body 310 of the implant device 300. That is, the internal contours of the applicator head 240 defined by the upper jaw 242 and the lower jaw 244 substantially match the contours of the rear end 312 of the main body 310. For example, the upper jaw 242 and the lower jaw 244 may be separated by a distance that substantially matches, or slightly smaller than, the first thickness T1 of the implant device 300 to hold the main body 310 via friction. Therefore, the applicator head 240 may secure the implant device 300 during implantation into the subcutaneous pocket.

[0066] During use, the pusher tool 200 pushes the implant device 300 into the subcutaneous pocket. That is, during implantation, the distal end 236 of the arm 230 applies a force or load to the rear wall 312A of the implant device 300 until the implant device 300 reaches a desired location. Once the implant device 300 reaches the desired location within the subcutaneous pocket, the pusher tool 200 can be withdrawn, leaving the implant device 300 in place. For example, once in the desired location, the subcutaneous pocket grips, or secures, the implant device 300 with sufficient force to overcome the frictional forces between the applicator head 240 and the main body 310. Consequently, the pusher tool 200 can be removed, or withdrawn (e.g., translated along the longitudinal axis 232) while the implant device 300 is retained by the subcutaneous pocket.

[0067] In some implementations, a combined length of the implant device 300 and the arm 230 of the pusher tool 200 may be substantially equal to a length of the spoon 130. That is, the length between the spoon proximal end 134 and the blunt edge 152 of the spoon 130 may be equivalent to the distance between the proximal end 234 and the distal end 236 of the arm 230plus the distance between the rear wall 312A and the front wall 314A of the implant device 300. Accordingly, the pusher tool 200 is capable of implanting the implant device 300 into a distal end of the subcutaneous pocket. In some implementations, the arm 230 is substantially the same length as the arm 140 to ensure the pusher tool 200 can reach and dispose the implant device 300 into the distal end of the subcutaneous pocket.

[0068] FIG. 5 is a flowchart of an example method 500 for performing a surgical procedure including subcutaneously inserting a pocket creation tool into a patient in operation 510, translating the pocket creation tool along a longitudinal axis of the pocket creation tool in operation 520, and separating layers of tissue via a blunt edge at a distal end of the pocket creation tool to form the subcutaneous pocket having a dimension that substantially matches a dimension of the implant device in operation 530.

[0069] In operation 520, the subcutaneous pocket may be formed without translating the pocket creation tool in a direction transverse to the longitudinal axis of the pocket creation tool. That is, during use, the pocket creation tool may be translated only along the longitudinal axis to prevent over extension of the subcutaneous pocket. Thus, a user may easily align the pocket creation tool with the patient’s body and translate the tool in a single direction to create a subcutaneous pocket that is sized and shaped to securely receive the implant device.

[0070] In operation 530, the blunt edge avoids trauma to a surgical site while separating the layers of tissue. Trauma may be defined as including tearing, cutting, and / or otherwise injuring the layers and surrounding tissues.

[0071] After the subcutaneous pocket is formed, the method 500 may further include disposing the implant device at a distal end of a pusher tool, and implanting the implant device, via the pusher tool, into a distal end of the subcutaneous pocket. For example, the pusher tool may apply a force to a rear end of the implant device until the implant device reaches the distal end of the subcutaneous pocket.

[0072] When the implant device reaches the desired location at the distal end of the subcutaneous pocket, the user may withdrawal the pusher tool. In response to the pusher tool being withdrawn, the subcutaneous pocket may grip the implant device with sufficient force to remove the implant device from the jaws of the pusher tool. Consequently, the implant device remains secured in the desired position within the subcutaneous pocket while a user withdrawals the pusher tool.

[0073] Accordingly, using the techniques presented herein, a subcutaneous pocket may be quickly, easily, and reliably created to securely receive an implant device. A user can create the subcutaneous pocket with a single motion of the tool while ensuring the subcutaneouspocket has a desired alignment with respect to the patient body and is sized and shaped to substantially match the size and shape of the implant device. Consequently, the implant device may be reliably aligned and secured within the patient's body thereby preventing excess movement of the implant device within the pocket and, thus, providing reliable connection of the leads and / or electrodes to a physiological target.

[0074] Embodiment 1. A pocket creation tool for creating a subcutaneous pocket for an implant device, comprising: a handle extending from a proximal end to a distal end; a spoon extending from the distal end of the handle, the spoon having an arm having a first width and a head having a second width, wherein the second width is substantially equal to a width of the implant device; a blunt edge defining a distal end of the spoon configured to separate tissue; and a guide extending from the handle, wherein the guide is vertically offset from the spoon.

[0075] Embodiment 2. The pocket creation tool of embodiment 1, wherein the blunt edge is configured to form the subcutaneous pocket within a patient having a dimension that substantially matches a dimension of the implant device.

[0076] Embodiment 3. The pocket creation tool of embodiment 1, wherein the first width is less than the second width.

[0077] Embodiment 4. The pocket creation tool of embodiment 1, further comprising a cross guard disposed between the handle, wherein the handle is angled with respect to the cross guard to facilitate creation of the subcutaneous pocket.

[0078] Embodiment 5. The pocket creation tool of embodiment 1, wherein the guide is configured to maintain a desired depth of the spoon with a patient.

[0079] Embodiment 6. A method of performing a surgical procedure, the method comprising: subcutaneously inserting a pocket creation tool into a patient; translating the pocket creation tool along a longitudinal axis of the pocket creation tool; and separating layers of tissue via a blunt edge at a distal end of the pocket creation tool to form a subcutaneous pocket having a dimension that substantially matches a dimension of an implant device.

[0080] Embodiment 7. The method of embodiment 6, wherein the subcutaneous pocket is formed without translating the pocket creation tool in a direction transverse to the longitudinal axis.

[0081] Embodiment 8. The method of embodiment 6, wherein separating the tissue with the blunt edge avoids trauma to a surgical site.

[0082] Embodiment 9. The method of embodiment 8, wherein the trauma comprises tearing, cutting, or otherwise injuring the layers of tissue.

[0083] Embodiment 10. The method of embodiment 6, further comprising: disposing the implant device at a distal end of a pusher tool; and implanting the implant device, via the pusher tool, into a distal end of the subcutaneous pocket.

[0084] Embodiment 11. The method of embodiment 10, further comprising: applying a force, via the pusher tool, to a rear end of the implant device.

[0085] Embodiment 12. A kit comprising: a pocket creation tool for forming a subcutaneous pocket, the pocket creation tool comprising: a handle extending from a proximal end to a distal end; a spoon extending from the distal end of the handle, the spoon having an arm having a first width and a head having a second width greater than the first width; a blunt edge defining a distal end of the spoon configured to separate tissue; and a guide extending from the handle, wherein the guide is vertically offset from the spoon; an implant device comprising a main body having a third width substantially equal to the second width; and a pusher tool configured to insert the implant device into the subcutaneous pocket.

[0086] Embodiment 13. The kit of embodiment 12, wherein the blunt edge is configured to form the subcutaneous pocket having a dimension within a patient that substantially matches a dimension of the implant device.

[0087] Embodiment 14. The kit of embodiment 12, further comprising a cross guard disposed at the distal end the handle, wherein the handle is angled with respect to the cross guard to facilitate creation of the subcutaneous pocket.

[0088] Embodiment 15. The kit of embodiment 12, wherein the guide is configured to maintain a desired depth of the spoon within a patient.

[0089] Embodiment 16. The kit of embodiment 12, wherein the implant device comprises one or more leads extending from the main body.

[0090] Embodiment 17. The kit of embodiment 16, wherein the implant device comprises an implantable cardioverter defibrillator, pacemaker, or a pulse generator.

[0091] Embodiment 18. The kit of embodiment 12, wherein the pusher tool further comprises an upper jaw and a lower jaw disposed at a distal end of the pusher tool.

[0092] Embodiment 19. The kit of embodiment 18, wherein the upper jaw and lower jaw are configured to grip and push the implant device into the subcutaneous pocket created by the pocket creation tool.

[0093] Embodiment 20. A pusher tool for an implanting a device comprising: a handle extending from a proximal end to a distal end; an arm extending from the distal end of the handle; and an applicator disposed at a distal end of the arm, the applicator including an upper jaw and a lower jaw configured to receive the device.

[0094] Embodiment 21. The pusher tool of embodiment 20, further comprising a cross guard disposed at the distal end of the arm.

[0095] Embodiment 22. The pusher tool of embodiment 20, wherein the handle includes a main portion and a grip portion disposed near the distal end.

[0096] Embodiment 23. The pusher tool of embodiment 22, wherein the grip portion comprises a plurality of ribs.

[0097] Embodiment 24. The pusher tool of embodiment 20, wherein the upper jaw and the lower jaw are configured to conform to a rear end of the device.

[0098] Embodiment 25. The pusher tool of embodiment 20, wherein the arm includes longitudinally extending grooves disposed between an upper surface and a lower surface of the arm.

[0099] Embodiment 26. The pusher tool of embodiment 25, wherein the grooves are configured to receive one or more leads extending from the device.

[0100] Each example embodiment disclosed herein has been included to present one or more different features. However, all disclosed example embodiments are designed to work together as part of a single larger system or method. This disclosure explicitly envisions compound embodiments that combine multiple previously-discussed features in different example embodiments into a single system or method.

[0101] While the invention has been illustrated and described in detail and with reference to specific embodiments thereof, it is nevertheless not intended to be limited to the details shown, since it will be apparent that various modifications and structural changes may be made therein without departing from the scope of the inventions and within the scope and range of equivalents of the claims. In addition, various features from one of the embodiments may be incorporated into another of the embodiments. Accordingly, it is appropriate that the appended claims be construed broadly and in a manner consistent with the scope of the disclosure as set forth in the following claims.

[0102] It is also to be understood that pocket creation tool 100, pusher tool 200 and / or implant device 300 described herein, or portions thereof, may be fabricated from any suitable material or combination of materials, such as plastic, foamed plastic, metal, supple natural or synthetic materials including, but not limited to, cotton, elastomers, polyester, plastic, rubber, derivatives thereof, and combinations thereof. Suitable plastics may include high-density polyethylene (HDPE), low-density polyethylene (LDPE), polystyrene, acrylonitrile butadiene styrene (ABS), polycarbonate, polyethylene terephthalate (PET), polypropylene, ethylenevinyl acetate (EVA), or the like. Suitable foamed plastics may include expanded or extrudedpolystyrene, expanded or extruded polypropylene, EVA foam, derivatives thereof, and combinations thereof.

[0103] Reference may be made to the spatial relationships between various components and to the spatial orientation of various aspects of components as depicted in the attached drawings. However, as will be recognized by those skilled in the art after a complete reading of the present disclosure, the devices, components, members, apparatuses, etc. described herein may be positioned in any desired orientation. Thus, the use of terms such as “above,” “below,” “upper,” “lower,” “top,” “bottom,” or other similar terms to describe a spatial relationship between various components or to describe the spatial orientation of aspects of such components, should be understood to describe a relative relationship between the components or a spatial orientation of aspects of such components, respectively, as the components described herein may be oriented in any desired direction. When used to describe a range of dimensions and / or other characteristics (e.g., time, pressure, temperature, distance, etc.) of an element, operations, conditions, etc., the phrase “between X and Y” represents a range that includes X and Y.

[0104] For example, it is to be understood that terms such as “left,” “right,” “top,” “bottom,” “front,” “rear,” “side,” “height,” “length,” “width,” “upper,” “lower,” “interior,” “exterior,” “inner,” “outer” and the like as may be used herein, merely describe points of reference and do not limit the present invention to any particular orientation or configuration. Further, the term “exemplary” is used herein to describe an example or illustration. Any embodiment described herein as exemplary is not to be construed as a preferred or advantageous embodiment, but rather as one example or illustration of a possible embodiment.

[0105] Further, the present disclosure may repeat reference numerals and / or letters in the various examples. This repetition is for the purpose of simplicity and clarity and does not in itself dictate a relationship between the various embodiments and / or configurations discussed.

[0106] Similarly, when used herein, the term “comprises” and its derivations (such as “comprising,” etc.) should not be understood in an excluding sense, that is, these terms should not be interpreted as excluding the possibility that what is described and defined may include further elements, steps, etc. Meanwhile, when used herein, the term “approximately” and terms of its family (such as “approximate,” etc.) should be understood as indicating values very near to those which accompany the aforementioned term. That is to say, a deviation within reasonable limits from an exact value should be accepted, because a skilled person in the artwill understand that such a deviation from the values indicated is inevitable due to measurement inaccuracies, etc. The same applies to the terms “about” and “around” and “substantially”. As used herein, “approximately”, “about,” “around,” and “substantially” include a deviation of ± 5% or 10% from the stated value.

[0107] As used herein, unless expressly stated to the contrary, use of the phrase “at least one of,” “one or more of,” “and / or,” variations thereof, or the like are open-ended expressions that are both conjunctive and disjunctive in operation for any and all possible combination of the associated listed items. For example, each of the expressions “at least one of X, Y and Z,” “at least one of X, Y or Z,” “one or more of X, Y and Z,” “one or more of X, Y or Z” and “X, Y and / or Z” can mean any of the following: 1) X, but not Y and not Z; 2) Y, but not X and not Z; 3) Z, but not X and not Y; 4) X and Y, but not Z; 5) X and Z, but not Y; 6) Y and Z, but not X; or 7) X, Y, and Z.

[0108] Additionally, unless expressly stated to the contrary, the terms “first,” “second,” “third,” etc., are intended to distinguish the particular nouns they modify (e.g., element, condition, node, outlet, inlet, valve, module, activity, operation, etc.). Unless expressly stated to the contrary, the use of these terms is not intended to indicate any type of order, rank, importance, temporal sequence, or hierarchy of the modified noun. For example, “first X” and “second X” are intended to designate two “X” elements that are not necessarily limited by any order, rank, importance, temporal sequence, or hierarchy of the two elements. Further as referred to herein, “at least one of’ and “one or more of’ can be represented using the “(s)” nomenclature (e.g., one or more element(s)).

Claims

CLAIMSClaims:

1. A pocket creation tool for creating a subcutaneous pocket for an implant device, comprising: a handle extending from a proximal end to a distal end; a spoon extending from the distal end of the handle, the spoon having an arm having a first width and a head having a second width, wherein the second width is substantially equal to a width of the implant device; a blunt edge defining a distal end of the spoon configured to separate tissue; and a guide extending from the handle, wherein the guide is vertically offset from the spoon.

2. The pocket creation tool of claim 1, wherein the blunt edge is configured to form the subcutaneous pocket within a patient having a dimension that substantially matches a dimension of the implant device.

3. The pocket creation tool of claim 1, wherein the first width is less than the second width.

4. The pocket creation tool of claim 1, further comprising a cross guard disposed between the handle, wherein the handle is angled with respect to the cross guard to facilitate creation of the subcutaneous pocket.

5. The pocket creation tool of claim 1, wherein the guide is configured to maintain a desired depth of the spoon with a patient.

6. A method of performing a surgical procedure, the method comprising: subcutaneously inserting a pocket creation tool into a patient; translating the pocket creation tool along a longitudinal axis of the pocket creation tool; and separating layers of tissue via a blunt edge at a distal end of the pocket creation tool to form a subcutaneous pocket having a dimension that substantially matches a dimension of an implant device.

7. The method of claim 6, wherein the subcutaneous pocket is formed without translating the pocket creation tool in a direction transverse to the longitudinal axis.

8. The method of claim 6, wherein separating the tissue with the blunt edge avoids trauma to a surgical site.

9. The method of claim 8, wherein the trauma comprises tearing, cutting, or otherwise injuring the layers of tissue.

10. The method of claim 6, further comprising: disposing the implant device at a distal end of a pusher tool; and implanting the implant device, via the pusher tool, into a distal end of the subcutaneous pocket.

11. The method of claim 10, further comprising: applying a force, via the pusher tool, to a rear end of the implant device.

12. A kit comprising: a pocket creation tool for forming a subcutaneous pocket, the pocket creation tool comprising: a handle extending from a proximal end to a distal end; a spoon extending from the distal end of the handle, the spoon having an arm having a first width and a head having a second width greater than the first width; a blunt edge defining a distal end of the spoon configured to separate tissue; and a guide extending from the handle, wherein the guide is vertically offset from the spoon; an implant device comprising a main body having a third width substantially equal to the second width; and a pusher tool configured to insert the implant device into the subcutaneous pocket.

13. The kit of claim 12, wherein the blunt edge is configured to form the subcutaneous pocket having a dimension within a patient that substantially matches a dimension of the implant device.

14. The kit of claim 12, further comprising a cross guard disposed at the distal end the handle, wherein the handle is angled with respect to the cross guard to facilitate creation of the subcutaneous pocket.

15. The kit of claim 12, wherein the guide is configured to maintain a desired depth of the spoon within a patient.

16. The kit of claim 12, wherein the implant device comprises one or more leads extending from the main body.

17. The kit of claim 16, wherein the implant device comprises an implantable cardioverter defibrillator, pacemaker, or a pulse generator.

18. The kit of claim 12, wherein the pusher tool further comprises an upper jaw and a lower jaw disposed at a distal end of the pusher tool.

19. The kit of claim 18, wherein the upper jaw and lower jaw are configured to grip and push the implant device into the subcutaneous pocket created by the pocket creation tool.

20. A pusher tool for an implanting a device comprising: a handle extending from a proximal end to a distal end; an arm extending from the distal end of the handle; and an applicator disposed at a distal end of the arm, the applicator including an upper jaw and a lower jaw configured to receive the device.

21. The pusher tool of claim 20, further comprising a cross guard disposed at the distal end of the arm.

22. The pusher tool of claim 20, wherein the handle includes a main portion and a grip portion disposed near the distal end.

23. The pusher tool of claim 22, wherein the grip portion comprises a plurality of ribs.

24. The pusher tool of claim 20, wherein the upper jaw and the lower jaw are configured to conform to a rear end of the device.

25. The pusher tool of claim 20, wherein the arm includes longitudinally extending grooves disposed between an upper surface and a lower surface of the arm.

26. The pusher tool of claim 25, wherein the grooves are configured to receive one or more leads extending from the device.

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