Reusable surgical training applicator for subdermal implants

Abstract

An applicator device for training medical practitioners is provided. The applicator device is configured for practicing a surgical procedure for delivering a rod-like implant under the skin of a human or animal. The applicator device includes an actuator that retracts a needle to deploy an artificial implant loaded inside a lumen of the needle. The needle is locked in a retracted position to prevent injury from an accidental forward deployment of the needle. A reset mechanism releases the needle to allow the applicator device to be reset and reused for repeated training. The reset mechanism is unlocked when a needle cap is attached to prevent injury. A kit includes the applicator device and simulated tissue structures for practicing the procedure on the simulated tissue structures with the applicator device.

Description

REUSABLE SURGICAL TRAINING APPLICATOR FOR SUBDERMAL IMPLANTSCROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 508,700, filed June 16, 2023, which is incorporated by reference herein in its entirety.TECHNICAL FIELD

[0002] This application generally relates to surgical training tools, and in particular, to simulated medical devices for teaching and practicing various surgical techniques and procedures related to insertion of implant medication under the skin.BACKGROUND

[0003] Simulated medical devices provide a functional, inexpensive, and practical means for introducing new medical devices to medical professionals, training basic skills and typical techniques necessary to use them, educating and demonstrating surgical procedures, and giving practitioners a safe and accurate model for practice and familiarization.BRIEF SUMMARY

[0004] In accordance with one or more embodiments, a reusable applicator device for surgical training may include a button needle slidably connected to a housing, the button needle including a finger button and a needle connected to a carnage, the needle having a lumen configured to receive a placebo implant, a needle guide pivotally connected to the housing, a needle cap removably attachable to the housing, and a reset mechanism connected to the housing.

[0005] In accordance with one or more embodiments, a kit for surgical training may include an applicator device for inserting a placebo implant and an artificial tissue model, the tissue model including a frame having a curved surface, a removable artificial muscle layer, a removable artificial intermediate tissue layer, and an artificial skin layer, wherein the muscle layer is located between the frame and the intermediate tissue layer, and the intermediate tissue layer is located between the muscle layer and the skin layer.

[0006] In accordance with one or more embodiments, a method may include the steps of inserting a first placebo into a needle of an applicator device, moving the needle proximally todeploy the first placebo, attaching a needle cap to the applicator device to release a reset mechanism from a locked position, and moving the reset mechanism to unlock the needle.BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

[0007] The various advantages of the embodiments of the present disclosure will become apparent to one skilled in the art by reading the following specification and appended claims, and by referencing the following drawings in which:

[0008] FIG. 1A is a top perspective view of an applicator device, according to one or more embodiments;

[0009] FIG. IB is a front elevational view of an applicator device, according to one or more embodiments;

[0010] FIG. 1C is a rear elevational view of an applicator device, according to one or more embodiments;

[0011] FIG. ID is a top view of an applicator device, according to one or more embodiments;

[0012] FIG. IE is a bottom view of an applicator device, according to one or more embodiments;

[0013] FIG. IF is a right elevational view of an applicator device, according to one or more embodiments;

[0014] FIG. 1G is a left elevational view of an applicator device, according to one or more embodiments;

[0015] FIG. 2 is an exploded view of an applicator device, according to one or more embodiments;

[0016] FIG. 3A is a side elevational view of a right-side housing, according to one or more embodiments;

[0017] FIG. 3B is a side elevational view of a left-side housing, according to one or more embodiments;

[0018] FIG. 4A is a top view of a bottom housing, according to one or more embodiments;

[0019] FIG. 4B is a bottom view of a bottom housing, according to one or more embodiments;

[0020] FIG. 4C is a cross-sectional view of a bottom housing, according to one or more embodiments;

[0021] FIG. 5A is a side elevational view of a button needle, according to one or more embodiments;

[0022] FIG. 5B is a bottom view of a button needle, according to one or more embodiments;

[0023] FIG. 6 is a side elevational view of a back cover, according to one or more embodiments;

[0024] FIG. 7A is a side elevational view of a needle guide, according to one or more embodiments;

[0025] FIG. 7B is a cross-sectional view of a needle guide, according to one or more embodiments;

[0026] FIG. 7C is a top view of a needle guide, according to one or more embodiments;

[0027] FIG. 7D is a bottom view of a needle guide, according to one or more embodiments;

[0028] FIG. 8A is a top perspective view of a reset button body and a reset button, according to one or more embodiments;

[0029] FIG. 8B is a side elevational view of a reset button body, according to one or more embodiments;

[0030] FIG. 8C is a top view of a reset button body connected to a reset button, according to one or more embodiments;

[0031] FIG. 8D is a bottom view of a reset button body connected to a reset button, according to one or more embodiments;

[0032] FIG. 9A is a side elevational view of a needle cap, according to one or more embodiments;

[0033] FIG. 9B is a cross-sectional view of a needle cap, according to one or more embodiments;

[0034] FIG. 9C is a top view of a needle cap, according to one or more embodiments;

[0035] FIG. 9D is a bottom view of a needle cap, according to one or more embodiments;

[0036] FIG. 9E is a front end view of a needle cap, according to one or more embodiments;

[0037] FIG. 9F is a rear end view of a needle cap, according to one or more embodiments;

[0038] FIG. 10A is a top perspective view of a reloading dock, according to one or more embodiments;

[0039] FIG. 10B is a side elevational view of a reloading dock, according to one or more embodiments;

[0040] FIG. 10C is a right end elevational view of a reloading dock, according to one or more embodiments;

[0041] FIG. 10D is a left end elevational view of a reloading dock, according to one or more embodiments;

[0042] FIG. 10E a top view of a reloading dock, according to one or more embodiments;

[0043] FIG. 10F is a bottom view of a reloading dock, according to one or more embodiments;

[0044] FIG. 10G is an exploded view of a reloading dock, according to one or more embodiments;

[0045] FIG. 11A is a top perspective view of a placebo, according to one or more embodiments;

[0046] FIG. 1 IB is an end view of a placebo, according to one or more embodiments;

[0047] FIG. 12 is a side elevational view of an applicator device in a ready-to-use position, according to one or more embodiments;

[0048] FIG. 13A is a side elevational view of an applicator device with a needle cap removed in an initial position, according to one or more embodiments;

[0049] FIG. 13B is a cross-sectional view of an applicator device with a needle cap removed in an initial position, according to one or more embodiments;

[0050] FIG. 14 is a side elevational view of an applicator device and placebo in a halfway deployed position, according to one or more embodiments;

[0051] FIG. 15A is a side elevational view of an applicator device and placebo in a fully- deployed position, according to one or more embodiments;

[0052] FIG. 15B is a cross-sectional view of an applicator device and placebo in a fully- deployed position, according to one or more embodiments;

[0053] FIG. 15C is a cross-sectional view of an applicator device in a fully-deployed position, according to one or more embodiments;

[0054] FIG. 16A is a side elevational view of an applicator device in an initial reset position, according to one or more embodiments;

[0055] FIG. 16B is a cross-sectional view of an applicator device in an initial reset position, according to one or more embodiments;

[0056] FIG. 17 is a side elevational view of an applicator device in a half-way reset position, according to one or more embodiments;

[0057] FIG. 18A is a cross-sectional view of an applicator device in a half-way reset position with a needle cap attached, according to one or more embodiments;

[0058] FIG. 18B is a detailed cross-sectional view of an applicator device in a half-way reset position showing a buttle needle reset hook dragging a reset button body forward, according to one or more embodiments;

[0059] FIG. 19A is a side elevational view of an applicator device in a fully reset position, according to one or more embodiments;

[0060] FIG. 19B is a cross-sectional view of an applicator device in a fully reset position, according to one or more embodiments;

[0061] FIG. 20 is a side elevational view of an applicator device with a needle cap attached in a fully reset position, according to one or more embodiments;

[0062] FIG. 21 is a side elevational view of an applicator device with a placebo in a ready-to-reload position, according to one or more embodiments;

[0063] FIG. 22 a side elevational view of an applicator device with a partially loaded placebo, according to one or more embodiments;

[0064] FIG. 23 a side elevational view of an applicator device with a loaded placebo and a reloading dock, according to one or more embodiments;

[0065] FIG. 24A a side elevational view of an applicator device with a fully-loaded placebo and a reloading dock, according to one or more embodiments;

[0066] FIG. 24B is a cross-sectional view of an applicator device with a fully-loaded placebo and a reloading dock, according to one or more embodiments;

[0067] FIG. 25 is an exploded view of an applicator device kit, according to one or more embodiments;

[0068] FIG. 26 is a top view of an applicator device kit, according to one or more embodiments; and

[0069] FIG. 27 is a cross-sectional view of an applicator device kit taken along line A-A of FIG. 26, according to one or more embodiments.DETAILED DESCRIPTION

[0070] FIGs. 1A-1G show various views of an applicator device 10. The applicator device 10 is configured to simulate a medical device used for implanting birth control implants under a patient’s skin.

[0071] A reusable training applicator is particularly advantageous for repeated practice and use. A training kit may include the simulated medical device along with artificial tissue structures configured into an anatomical model on which to practice implant insertion and removal. A kit includes reusable components such as the device, other instruments such as forceps and a scalpel, ruler, and artificial implants. Consumable components such as artificial implants and tissue structures can be replaced when needed. The embodiments describe a simulated medical device used for the insertion of an implant (e.g., birth control) under the skin of a patient. The training kit includes an artificial tissue model of a portion of a human arm. Since the implant is typically inserted in a patient’s non-dominant arm, an artificial tissue structure of the left arm is provided. The arm model includes several layers of artificial tissue representative of the skin, underlying fatty layers, fascia, muscle, and bone. The reusable training applicator closely simulates the actual medical device and includes several safety features to prevent accidental injury to the practitioner.

[0072] With continuing reference to FIGs. 1A-1G and with particular reference to FIGs.2, 3A-3B, and 4A-4C, the applicator device 10 includes a right-side housing 12 connected to a left-side housing 14 in a clamshell-like manner. When connected together, the right-side housing12 and the left-side housing 14 define a longitudinal hutton slot 34 along the curved top of the applicator device 10. Beneath the button slot 34, the right-side housing 12 and the left-side housing 14 define an interior channel 42 sized and configured to receive a button needle flange 48 of the button needle 24. The right-side housing 12 and the left-side housing 14 further define a needle opening 44 sized and configured to receive a needle 52, a small forward hole 41, and a bottom opening 51. The right-side housing 12 and the left-side housing 14 include a back cover hook 43 for connecting the housing 12, 14 to a bottom housing 16. The back cover 18, a bottom housing 16, and a needle guide 20 are connected to the right-side housing 12 and the left-side housing 14 to form an interior of the applicator device 10. A pin 38 extends into the interior from the right-side housing 12 to capture the needle guide 20 such that the needle guide 20 can pivot about the pin 38 with respect to the housing 12, 14. A needle guide spring 32 is located in a spring holder 45 formed on the right-side housing 12. The needle guide spring 32 is configured to bias the needle guide 20 such that it springs away from the housing 12, 14. Ledges 39 are formed for interconnection with tabs 55 on the button needle 24. The bottom housing 16 defines a reset slot 36. The reset slot 36 is configured to connect the reset button body 26 and the reset button 28 to the bottom housing 16 such that the reset button body 26 and reset button 28 are slidably movable in a longitudinal direction inside the reset slot 36. The reset button body 26 resides in the interior of the bottom housing 16 and the reset button 28 resides outside the bottom housing 16. Retainers 47 formed on the inside of the bottom housing 16 retain the reset button body 26. Retaining features 49 formed on the inside of the right-side housing and 12 and leftside housing 14 also retain the reset button body 26. The bottom housing 16 includes a rear opening 40 sized and configured to receive and connect to the back cover 18. The needle cap 22 is removably connected to the front and bottom part of the housing 12, 14. The reloading dock 30 is removably connectable to the needle cap 22. The applicator device 10 is used to deploy a placebo 33 which mimics a real birth control implant.

[0073] FIGs. 5A-5B illustrate a button needle 24 that is located inside the housing 12, 14. The button needle 24 includes a button needle carriage 46. A flexible flange 48 is connected to the rear end of the button needle carriage 46. The flange 48 includes a finger button 50 and is configured to bend and flex with respect to the button needle carriage 46 when moved within the channel 42 of the housing 12, 14. A cannulated needle 52 is connected to the front of the buttonneedle carriage 46. The needle 52 defines a lumen and a sharp beveled tip 54 for penetrating artificial tissue structures. The needle 52 includes an aperture 53 into the lumen. This aperture 53 is sized and configured for engagement with a correspondingly sized and shaped stop 78 on the needle guide 20 to retain a placebo 33 loaded inside the lumen of the needle 52. The button needle 24 resides in the interior of the housing 12, 14 and is longitudinally movable with respect to the housing 12, 14. The finger button 50 resides outside of the housing 12, 14 and is guided along the button slot 34 by the user between a forward ready position and rearward deployed position. The button needle 24 includes a reset hook 56 extending downwardly from the button needle carriage 46 for locking the button needle 24 to the back cover 18 when in a deployed position. The button needle 24 is aligned with respect to the housing 12, 14 such that the needle 52 protrudes through the needle opening 44 at the front of the housing 12, 14. Tabs 55 are formed on the button needle 24. The tabs 55 are sized and configured to make a positive surface- to-surface contact with ledges 39 on the housing 12, 14 shown in FIGs. 3A-3B. When the button needle 24 is in a distal position, the tabs 55 create an initial lock that ensures that the button needle 24 does not slide back while trying to puncture the skin on an artificial tissue structure. During reset, the tabs 55 ramp over the bottom surface of the ledges 39 and snap over the edge of each ledge 39 and lock again to complete the reset process.

[0074] FIG. 6 illustrates the back cover 18. The back cover 18 is sized and configured to cover the real' opening 40. The back cover 18 includes a back wall 58 interconnected between a top wall 60 and a bottom wall 62. The bottom wall 62 includes a needle locking hook 64 and first connecting hook 66. The first connecting hook 66 is configured to connect the back cover 18 to the bottom housing 16. A second connecting hook 68 extends from the back wall 58 and it serves to connect the back cover 18 to the bottom housing 16. The needle locking hook 64 is angled with respect to the bottom wall 62 and configured to lock the button needle 24 in a rearward deployed position to prevent forward movement of the needle and prevent injury from the sharp needle 52. The bottom wall 62 deflects downwardly as the button needle reset hook 56 ramps over the needle locking hook 64 to enter into a locking engagement therewith. The back cover 18 further includes a push rod 70 connected to the back wall 58. The push rod 70 is sized and configured to fit inside the lumen of the needle 52. As the button needle 24 is moved back, the push rod 70 pushes a placebo 33 loaded inside the needle 52 out of the needle 52. The push rod70 is configured to have a length to completely deploy the placebo 33 as well as to set the insertion depth of the placebo 33 inside the needle 52 when it is loaded. When the button needle 24 is moved back all the way to the end, the push rod 70 will be long enough to extend to the needle tip 54 or slightly beyond the needle tip 54 and slightly beyond needle opening 44 formed by housing 12, 14.

[0075] FIGs. 7A-7D illustrate the needle guide 20. The needle guide 20 is connected to the housing 12, 14 via pin 38 inserted into corresponding apertures 72 in the needle guide 20 such that the needle guide 20 pivots about the pin 38 with respect to the housing 12, 14. The needle guide 20 includes a spring-receiving location 74 sized and configured to receive the spring 32. The spring 32 serves to bias the needle guide 20 outwardly away from the housing 12, 14. The needle guide 20 includes a bottom channel 76 and a stop 78. The stop 78 blocks the distal end of the bottom channel 76. When the button needle 24 is moved proximally from an undeployed position to deploy the placebo 33, the needle 52 is substantially outside of the bottom channel 76 and moves along the bottom surface of the stop 78. The stop 78 is biased against the needle 52. Once the needle 52 is pulled proximal to the stop 78, the needle guide 20 pivotally springs downwardly to locate the needle 52 within the bottom channel 76. When the needle 52 is in the bottom channel 76, the stop 78 abuts against the needle 52 and blocks it from moving forward. The stop 78 advantageously prevents the user from accidental injury in the event the button needle 24 is actuated in the forward direction before the reset hook 56 is locked hy the needle locking hook 64. The needle guide 20 includes two oppositely disposed tabs 80 integrally formed at the top of the needle guide 20. The tabs 80 cooperate with the needle cap 22 such that the needle cap 22 cannot be removed until the reset button 28 and reset button body 26 are actuated into a full reset position and the button needle 24 is reset as will be described in greater detail below. Preventing removal of the needle cap 22 serves as a further precaution reminding the user to retract the button needle 24 completely and to reset the button needle 24 with the reset button 28 and reset button body 26 before attempting to remove the needle cap 22 and expose the needle 52 to potential injury to the user. The needle guide 20 is made of transparent plastic so that the user can observe the operation of the applicator device 10 and observe the position of the needle 52 and placebo 33 which is covered by the needle guide 20.

[0076] FIGs. 8A-8D illustrate the reset button body 26 and the reset button 28. The reset button 28 is connected to the reset button body 26. The reset button 28 serves as a finger switch for sliding the reset button body 26 longitudinally along inside the applicator device 10. Movement of the reset button body 26 is retained by the retaining features 49 on the housing 12, 14 and retainers 47 on the bottom housing 16. The reset button body 26 includes a plate 82 having a beveled proximal end 84. A deflectable flange 86 is connected to the distal end of the plate 82. The deflectable flange 86 can flex with respect to the plate 82. When deflected, the flange 86 springs back to its normal undeflected configuration as shown in FIGs. 8A-8D. The flange 86 includes a downwardly-facing reset locking hook 88. The reset locking hook 88 includes an angled leading end 90. The top surface of the deflectable flange 86 includes a recess 92. The recess 92 is sized and configured to releasably engage with the button needle reset hook 56.

[0077] FIGs. 9A-9F illustrate the needle cap 22. The needle cap 22 is removably attachable to the front, bottom end of the housing 12, 14 and covers the needle guide 20. The needle cap 22 forms a cap channel 110 having an open top and an open proximal end for placing and sliding the front, bottom end of the applicator device 10 into the cap channel 110. The needle cap 22 includes oppositely located detents 112 projecting into the cap channel 110. The detents 112 are sized and configured to mate with corresponding recesses 114, shown in FIG. 13A, formed on either side of the housing 12, 14. The needle cap 22 attaches to the housing 12, 14 in a sliding and snap-fit engagement of the detents 112 with the recesses 114. The sides of needle cap 22 include oppositely disposed cutouts 118 along the top edge. These cutouts 118 are size and configured to mate with the tabs 80 on the needle guide 20. The front end of the needle cap 22 includes a small protrusion 116 for snapping into the small forward hole 41 formed in the housing 12, 14. Proximal to each of the cutouts 118 is a flat edge 119. The flat edges 119 raise the needle guide 20 slightly to allow the needle 52 to pivot the needle guide 20 as it is moved distally to be reset. The inside of the bottom wall of the needle cap 22 includes a needle cradle 120 configured to support and align the needle 52 as it advanced to a forward reset position. The outer sides of the needle cap 22 include oppositely disposed protrusions 98 for connecting to the reloading dock 30. The front end of the needle cap 22 includes a loading opening 104 forengagement with the reloading dock 30. The needle cap 22 is transparent to allow the user to see the position and operation of the needle 52.

[0078] FIGs. 10A-10G illustrate the reloading dock 30. The reloading dock 30 is removably attachable to the needle cap 22. The reloading dock 30 forms a reloading channel 94 having an open top and an open proximal back end for sliding the front bottom end of the applicator device 10 with attached needle cap 22 into the reloading dock 30. The reloading dock 30 includes oppositely disposed elongated recesses 96 on the inside of reloading channel 94. The recesses 96 are sized and configured mate with outwardly extending protrusions 98 formed on the needle cap 22 to removably connect the reloading dock 30 to needle cap 22 such that it does not fall off. The reloading dock 30 further includes a loading pin 100. The loading pin 100 is connected to and extends proximally from the end wall 102. The loading pin 100 is sized and configured for insertion into a loading opening 104 formed in the distal end of the needle cap 22 and for insertion into at least the beveled needle tip 54. Connecting the reloading dock 30 to the needle cap 22 pushes a placebo 33 already loaded inside the needle 52 into a fully loaded and seated position with respect to the needle tip 54. The outside of the bottom wall of the reloading dock 30 includes a storage compailment 106 having a sliding door 108. The storage compartment 106 is sized and configured for storing placebos 33. The reloading dock 30 includes oppositely disposed ribs 99 near the distal end that guide and align the applicator device 10 with the loading pin 100.

[0079] FIGs. 11 A-11B illustrate a placebo 33. The placebo 33 is an elongated solid cylindrical and flexible piece of plastic sized and configured to mimic a real birth control implant that is implanted into the patient. The placebo 33 has an outer diameter sized to fit inside the lumen of the needle 52. The placebo 33 is approximately 1.5-2.0 inches long.

[0080] In use, an applicator device 10, loaded with a placebo 33, is presented with the needle cap 22 in a ready-to-use position as shown in FIG. 12. The needle cap 22 is removed to expose the needle 52, loaded with a placebo 33, in a forward initial position as shown in FIGs. 13A-13B. In the initial position, the stop 78 on the needle guide 20 is aligned with the top aperture 53 in the needle 52. Since the needle guide 20 is spring-biased, the stop 78 exerts a downward force on the placebo 33 through the top aperture 53. This force of the stop 78 onto the placebo 33 advantageously keeps the placebo 33 from accidentally falling out of the needle 52 inthe event the user angles the front of the applicator device 10 downwardly. The user will position the applicator device 10 at the target location and insert the needle 52 under the artificial skin of a tissue model and move the needle 52 into position with respect to the artificial tissue with the applicator device 10 remaining above the tissue model. The user will commence deployment by moving the finger button 50 back. Moving the finger button 50 back also moves the entire button needle 24 back. FIG. 14 shows the finger button 50 moved approximately half-way back along the button slot 34 exposing the front portion of the placebo 33. As the needle 52 is moved back, the push rod 70, resident inside the lumen of the needle 52, keeps the placebo 33 in a forward position preventing it from moving back along with the needle 52. As the needle 52 moves to a position proximal to the stop 78, the spring-loaded needle guide 20 will no longer exert a force on the needle 52 and will exert a force onto the placebo 33 pushing it slightly as it pivots downwardly with respect to the housing 12, 14. With the needle 52 behind the stop 78, the needle 52 is prevented by the stop 78 from being inadvertently moved forward by the user. FIGs. 15A-15C illustrate a fully-deployed position in which the finger button 50 is moved all the way back in the button slot 34 exposing and freeing the entire placebo 33. FIG. 15C illustrates the needle guide 20 pivoted all the way down under the force of the spring 32 covering the push rod 70 which extends beyond the distal end of the needle 52. As the button needle 24 moves back into the fully-deployed position, the button needle reset hook 56 ramps over the needle locking hook 64 on the back cover 18. Since the needle locking hook 64 is connected to a flexible bottom wall 62 of the back cover 18, the bottom wall 62 deflects downwardly permitting the reset hook 56 to ramp over the needle locking hook 64 and enter into locking engagement therewith to lock the button needle 24 with respect to the housing 12, 14. The locked button needle 24 is prevented from being moved forward by the user via the finger button 50.

[0081] To reuse the applicator device 10, the user must reattach the needle cap 22 to the housing 12, 14. The needle cap 22 is reattached to protect the user from accidental injury when the button needle 24 is subsequently moved forward. Prior to reattaching the needle cap 22, the reset locking hook 88 protrudes from the bottom opening 51 and is hooked to the bottom housing 16. When the needle cap 22 is attached, the bottom wall of the needle cap 22 contacts the leading end 90 of the reset button body 26. Upon contact, the needle cap 22 ramps over the leading end 90 and deflects the flange 86 upwardly to unlock the reset locking hook 88 from the bottomhousing 16. When the reset button body 26 is unlocked, it is free to be moved proximally. Also, when the needle cap 22 is attached to the housing 12, 14, the detents 112 on the needle cap 22 engage the recesses 114 on the housing 12, 14. The needle cap 22 slides onto the housing, 12, 14 into a snap-fit engagement such that the needle cap 22 is connected to the housing 12, 14. When the needle cap 22 is connected, the tabs 80 on the needle guide 20 are located past the cutouts 118 in the distal direction. When the user tries to take off the needle cap 22 by moving the needle cap 22 in a distal direction, the tabs 80 fall into the cutouts 118 and abut the cutouts 118 to prevent the user from removing the needle cap 22. This prevents accidental injury due to the needle coming out from the needle opening 44 during the reset process. Also, the detents 112 located in the recesses 114 will prevent removal of the needle cap 22 in the downward direction. Furthermore, the protrusion 116 on front of the needle cap 22 snaps into the forward hole 41 in the housing 12, 14.

[0082] With the reset button body 26 unlocked from the bottom housing 16, the reset button 28 can be moved freely by the user to an initial reset position as shown in FIGs. 16A-16B. Moving the reset button 28 moves the reset button body 26 along with it. As the reset button body 26 moves back, the proximal end 84 moves beneath the button needle carriage 46 and into contact with the needle locking hook 64. The proximal end 84 will ramp over and deflect the needle locking hook 64 out of engagement with the button needle reset hook 56. With the button needle reset hook 56 unhooked, the button needle 24 is unlocked and free to be moved forward by the user. Also, when the reset button body 26 is moved back, the reset locking hook 88, is moved clear of the bottom opening 51 in the bottom housing 12, 14 in which it was previously hooked to bottom housing 16.

[0083] With the reset button 28 in a proximal position freeing the button needle 24, the user can then move the finger button 50 forward. Moving the finger button 50 forward also moves the needle 52 forward through the needle opening 44 in the housing 12, 14. The push rod 70 remains inside the lumen of the needle 52. As the needle 52 is moved forward, it is guided above the needle cradle 120 in the needle cap 22. Also, the needle 52 contacts the stop 78 as the needle 52 moves forward. Because the flat edge 119 on the needle cap 22 have slightly raised the needle guide 20 upwardly, the needle 52 is able to pivot the spring-biased needle guide 20 further upwardly as it contacts the stop 78 and the needle 52 will ramp over the stop 78. Whenthe needle guide 20 is pivoted upwardly by the needle 52, the tabs 80 on the needle guide are lifted up out of the cutouts 118 on the needle cap 22. At this point, the needle cap 22 is detachable from the housing 12, 14; however, the needle cap 22 is kept attached to the housing 12, 14.

[0084] FIGs. 18A-18B show the applicator device 10 with the finger button 50 moved further distally from the half-way reset position of FIG. 17. Moving the button needle 24 causes the button needle reset hook 56 to catch into the recess 92 on the button body 26 and to pull the button body 26 and reset button 28 distally along with the button needle 24. The reset locking hook 88 aligns with the distal end of the bottom housing 16 so that when the needle cap 22 is removed during the next usage cycle, the reset locking hook 88 is able to lock in with the distal end of the bottom housing 16 as can be seen in FIGs. 19A-19B. When the proximal end 84 of the button body 26 clears the needle locking hook 64, the flexible bottom wall 62 of the back cover 18 springs upwardly to its undeflected state into a ready position. FIG. 20 illustrates the fully- reset position. After the applicator device 10 is fully reset, a placebo 33 is loaded. The same placebo 33 previously deployed into an artificial tissue model may be reused or a new placebo 33 may be employed.

[0085] FIG. 21 illustrates an applicator device 10 and a placebo 33 located in front of the loading opening 104 parallel to the needle 52. The placebo 33 is inserted through the loading opening 104 and into the lumen of the needle 52 which is aligned with the loading opening 104. Once inserted, as shown in FIG. 22, the placebo 33 is not fully seated in the needle 52. The applicator device 10 is ready for the reloading dock 30 to be attached to fully seat the placebo 33 inside the needle 52. FIG. 23 shows the reloading dock 30 in front of the applicator device 10. The front bottom end of the applicator device 10 is moved into the reloading channel 94 of the reloading dock 30. The protrusions 98 on the needle cap 22 slide into the recesses 96 on the reloading dock 30 and the front end of the applicator device 10 is moved all the way to the end wall 102 of the reloading dock 30 into a friction-fit engagement such that the reloading dock 30 is removably attached to the applicator device 10. FIGs. 24A-24B show the reloading dock 30 fully attached to the applicator device 10. When the reloading dock 30 is attached, the loading pin 100 on the inside end wall 102 of the reloading dock 30 passes through the loading opening 104 and pushes the placebo 33 further into the lumen of the needle 33 to fully seat the placebo 33inside the needle 52. The reloading dock 30 is removed and the applicator device 10 is again in the rcady-to-usc position shown in FIG. 12. The placebo 33 may be deployed again and the process repeated as many times as is desired by the user. Placebos 33 that are implanted into an artificial tissue model may be recovered and reused as well. Additional placebos 33 are conveniently stored in the storage compartment 106 on the bottom of the reloading dock 30. The reusable applicator device 10 is effective for repeated practice and provides several safety features described that prevent accidental injury from an exposed needle 52.

[0086] FIGs. 25-27 illustrate an applicator device kit 200 that includes a reusable applicator device 10, an artificial tissue model 202, flat forceps 204, curved forceps 206, a scalpel 208, a ruler 210, and replacement tissue 212 packaged inside a container 214. The artificial tissue model 202 includes a frame 216, an artificial muscle layer 218, an artificial intermediate tissue layer 220, and an artificial skin layer 222. The artificial tissue model 202 is configured to mimic a portion of a human arm. Since the implant is typically implanted in a patient’s non-dominant arm, the artificial tissue model 202 is configured to mimic a left arm.

[0087] The frame 216 is made of hard plastic. The frame 216 has a bottom surface interconnected to a top surface. The bottom surface includes four supports 224 for locating the tissue model 202 on a surface such as a tabletop. The supports 224 are provided with an anti-skid surface to stabilize the tissue model 202 and to prevent it from sliding. The frame 216 includes a central curved portion 226 in which the top surface is convex and the bottom surface is concave. The curved portion 226 has a generally semi-frustoconical shape configured to simulate the narrowing width of the arm. Flat, horizontally-parallel side surfaces 228 are formed on either side of the longitudinal length of the curved portion 226. Vertical stop surfaces 230 are integrally formed with the frame 216 at the proximal and distal ends of the curved portion 226. The stop surfaces 230 are configured to retain the muscle layer 218, intermediate tissue layer 220, and skin layer 222 therebetween and to prevent them from sliding longitudinally relative to the frame 216 during use. The bottom surface of the curved portion 226 includes two longitudinal strips 232 of one of a hook and loop type fastener extending along the side surfaces 228.

[0088] The muscle layer 218 is made of silicone that is dyed a red color to mimic the color of muscle. The muscle layer 218 is correspondingly curved to conform to the curved portion 226 of the frame 216. The inner surface of the muscle layer 218 is smooth and the outersurface includes a longitudinally extending concavity 234 or ridge that simulates the natural arm musculature. The concavity 234 is a feature that helps the practitioner locate a target location for implanting the placebo 33. The intermediate tissue layer 220 is made of white-colored batting made of polyester material to simulate intermediate tissue found in the arm such as fatty tissue. The intermediate tissue layer 220 is the target layer for implanting the placebo 33.

[0089] The skin layer 222 is made of stretchable silicone having a natural skin color. The inner surface of the skin layer 222 includes two longitudinally extending strips of one of a hook and loop type fastener configured for attachment to the longitudinal strips 232 on the underside of the frame 216. The muscle layer 218 is placed over the curved portion 226 of the frame 216. The intermediate tissue layer 220 is placed over the muscle layer 218. A longitudinal strip of hook-and-loop type fastener material along one side of the skin layer 222 is attached to one of the longitudinal strips 232 of hook-and-loop type fastener material on the underside of the frame 216. The skin layer 222 is wrapped upwardly and over the intermediate tissue layer 220 and the other strip of hook-and-loop type fastener on the skin layer 222 is connected to the other longitudinal strip 232 of hook-and-loop type fastener on the underside of the frame 216. The skin layer 222 can be stretched as desired to moderate the tension and compression of the layers beneath the skin layer 222. The skin layer 222 is easily removable by the user to access the other layers, retrieve implanted placebos 33, and to replace tissue layers as needed.

[0090] The tissue model 202 is configured to simulate an arm but may also be configured to simulate other anatomy such as a leg. The kit 200 may include layers of replacement tissue 212. In particular, the kit 200 includes at least one replacement skin layer. The skin layer 222 will have multiple puncture holes after repeated use and so a replacement skin layer is included in the kit. A used skin layer can be replaced by the user as needed. Instruments such as the forceps 204, 206 and scalpel 208 which may be needed to hold or cut artificial layers complement the items needed for practicing the surgical techniques. The applicator device 10 is located in a device tray 236 and the forceps 204, 206 and scalpel 208 are located in an instrument tray 238. The instrument tray 238 is connected to the inside of one of the container panels.

[0091] The container 214 serves as a convenient training station as panels of the container 214 fold out from a central box 254. A pocket 240 on the inside surface of the box 254 provides a location for a ruler 210 which the user may need to measure and mark a targetlocation. The ruler 210 is flexible and made of paper. A first panel 242 is interconnected between a second panel 244 and a bottom edge 250 of the box 254. A third panel 246 is interconnected between a fourth panel 248 and top edge 252 of the box 254. Each of the first panel 242 and the fourth panel 248 includes an opening for passing a handle 256 that is connected to the box 254. The third panel 246 includes the instrument tray 238 connected thereto. The applicator device 10 is located inside a removable device tray 236. The replacement tissue 212 is sized and configured to neatly lay within the box 254 such as between the folded over second panel 244 and the third panel 246. When the panels 242, 244, 246, 248 are folded over the box 254, the handle 256 extends through the openings for conveniently carrying the kit 200.

[0092] A user opens the box 254 and removes the applicator device 10 and tissue model 202 from the kit 200. The applicator device 10 is placed into a ready-to-use position described above. The user finds the desired target implant location on the tissue model 202 locating anatomical features such as the ridge / concavity 234 in the muscle layer 218. The user may further employ the paper ruler 210 to measure and mark the desired location. The user will remove the needle cap 22 from a loaded applicator device 10 or loads a placebo 33 into the applicator device 10 as described above. The user punctures the skin layer 222 of the model 202 and moves the needle 52 under and past the skin layer 222 maintaining the needle 52 substantially parallel to the skin layer 222 and within the intermediate tissue layer 220. The user will notice a tactile resistance if the needle 52 contacts the relatively harder muscle layer 218 and will know to pull back the needle 52 or angle the needle 52 into a position above the muscle layer 218. When positioned in the desired location, the user will retract the finger button 50 to deploy the placebo 33. As the needle 52 is retracted, the placebo 33 will remain implanted under the skin layer 222. The user removes the needle 52 from under the skin layer 222 and can then proceed to reuse the applicator device 10 by attaching the needle cap 22 and moving the reset button 28 proximally, pushing the finger button 50 forward, loading a placebo 33 through the needle cap 22, attaching the reloading dock 30 to fully seat the placebo 33, removing the reloading dock 30, and removing the needle cap 22. The applicator device 10 can be reused as many times as desired. Implanted placebos 33 may be easily retrieved by deconstructing the tissue model 202. With the skin layer 222 removed, the user may inspect accuracy of the implanted placebos 33 and easily remove them from the intermediate tissue layer 220 for reuse.

[0093] Those skilled in the art will appreciate from the foregoing description that the broad techniques of the examples of the present disclosure can be implemented in a variety of forms. Therefore, while the examples of this disclosure have been described in connection with particular examples thereof, the true scope of the examples of the disclosure should not be so limited since other modifications will become apparent to the skilled practitioner upon a study of the drawings, specification, and following claims.

Claims

CLAIMSWe claim:

1. A reusable applicator device for surgical training, comprising: a housing; a button needle slidably connected to the housing, the button needle including a finger button and a needle connected to a carriage; the needle having a lumen configured to receive a placebo implant; a needle guide pivotally connected to the housing; a needle cap removably attachable to the housing; and a reset mechanism connected to the housing.

2. The reusable applicator device of claim 1, wherein the button needle has a undeployed configuration in which the needle is in a distal position and a deployed configuration in which the needle is in a proximal position, the button needle being locked and immovable with respect to the housing when in the deployed configuration.

3. The reusable applicator device of claim 2, wherein the reset mechanism is configured to unlock the button needle when in the deployed configuration.

4. The reusable applicator device of claim 1, wherein the reset mechanism includes a reset button connected to a reset button body, the reset mechanism having a locked configuration in which the reset button body is locked to the housing and an unlocked configuration in which the reset button body is unlocked from the housing, the reset mechanism being movable with respect to the housing in the unlocked configuration and immovable with respect to the housing in the locked configuration.

5. The reusable applicator device of claim 4, wherein attachment of the needle cap to the housing places the reset mechanism into an unlocked configuration.

6. The reusable applicator device of claim 4, wherein moving the button needle from a deployed configuration to an undeployed configuration moves the reset mechanism from the unlocked configuration to the locked configuration.

7. The reusable applicator device of claim 1, wherein the needle guide is spring biased away from the housing.

8. The reusable applicator device of claim 1, wherein the needle guide includes a stop.

9. The reusable applicator device of claim 8, wherein the stop is configured to block distal movement of the needle.

10. The reusable applicator device of claim 1, wherein the needle includes a side aperture in communication with the lumen, and the stop being sized and configured to fit inside the aperture.

11. The reusable applicator device of claim 1, wherein the needle guide includes tabs sized and configured to mate with cutouts on the needle cap, the needle cap and housing being configured such that the needle cap is not removable when the tabs are mated with the cutouts.

12. The reusable applicator device of claim 1, wherein the needle cap includes a loading opening aligned with the distal end of the needle.

13. The reusable applicator device of claim 12, further including a reloading dock removably attachable to the needle cap and having a loading pin aligned with the loading opening on the needle cap, the loading pin being sized and configured to fully seat a placebo inside the lumen of the needle.

14. The reusable applicator device of claim 1, further including a push rod connected to the housing, the push rod extending inside the needle from a proximal end of the needle.

15. A kit for surgical training, comprising: an applicator device for inserting a placebo implant; and an artificial tissue model; the tissue model including: a frame having a curved surface; a removable artificial muscle layer; a removable artificial intermediate tissue layer; and an artificial skin layer; wherein the muscle layer is located between the frame and the intermediate tissue layer, and the intermediate tissue layer is located between the muscle layer and the skin layer.

16. The kit of claim 15, wherein the muscle layer includes a longitudinally extending concavity.

17. A method, comprising the steps of: inserting a first placebo into a needle of an applicator device; moving the needle proximally to deploy the first placebo; attaching a needle cap to the applicator device to release a reset mechanism from a locked position; and moving the reset mechanism to unlock the needle.

18. The method of claim 17 further including: moving the needle distally; wherein moving the needle distally moves the reset mechanism into the locked position; and inserting a second placebo through the needle cap into the needle.

19. The method of claim 18 further including: attaching a reloading dock to the needle cap; wherein attaching a reloading dock includes moving a loading pin into the needle cap to seat the second placebo inside the needle.

0. The method of claim 19 further including: removing the reloading dock; removing the needle cap; and moving the needle proximally to deploy the second placebo.

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