Patent Application
20200078035
The present invention is directed to an implant excision aid for aiding in the removal of subdermal or subcutaneous, palpable implant. Specifically, the implant excision aid described herein is designed to make implant removal easier for the implant remover, usually a physician or medical caregiver, and to reduce technique variability from implant remover to implant remover.
Subdermal or subcutaneous implants are routinely used for therapeutic value pertaining to adherence. Products such as IMPLANON®, NEXPLANON®, PROBUPHINE®, EVERSENSE®, VANTAS®, JADELLE®, SUPPRELIN® and NALTREXONE® are inserted subdermally or subcutaneously using application devices designed to insert them in the proper anatomical location and orientation and at the recommended depth, typically to achieve long-acting drug release.
At some point all non-biodegradable implants must be excised from the patient. Usually removal of the implant is at the conclusion of the useful life of the implant, but under certain circumstances, the implant might have to be removed prematurely. Excising of an implant requires first locating the implant by palpation, then manipulating the implant under the skin to cause “popping” of the implant up toward the surface of the skin which results in “tenting” of the skin above the implant. Once the implant is in this position, the implant remover makes an incision proximal to the location of the implant where the skin is tented, and then, preferably while continuing to ‘pop-up’ the implant, withdraws the implant with forceps.
The technique of manual popping of the implant toward the skin to achieve tenting requires a great deal of skill which is acquired through training and practice. Unfortunately, variation in remover to remover skill level contributes to inconsistencies in the process of positioning the implant for making the incision. Medical caregivers, such as physicians, who do not often perform this procedure often may not feel confident or comfortable performing this procedure. Moreover, some medical caregivers consider the current practice of popping as being awkward and in some instances painful to perform. The current practice of popping, to support/perform implant excision, can also be time-consuming and a resource burden, sometimes requiring a second person.
A means of standardizing the procedure of positioning the implant for removal can eliminate the need for training and reduce the level of skill and practice needed for successful removal of implants. To remedy this, described herein is an excision aid that potentially shortens the excision procedure duration, reduces the amount of training needed to acquire the skill for the procedure, making it easier for the remover to gain procedure proficiency, reduces the risk for contamination at or near the incision site and reduces technique variability from remover to remover.
Described herein are implant excision aids for removal of a subdermal or subcutaneous, palpable implant from a patient comprising a first plate comprising an external surface, an internal surface, a top portion, a bottom portion, a right side and a left side, wherein the bottom portion of the first plate is in communication with the patient's skin during use; a second plate comprising an external surface and an internal surface, a top portion, a bottom portion, a right side and a left side, wherein the bottom portion of the second plate is in communication with the patient's skin during use, wherein at least a portion of the bottom portion of the first or second plate or the internal surface of the first plate or second plate comprises a polymer or a metal, wherein the polymer or the metal generates enough friction so that the portion of the bottom of the first or second plate or the internal surface of the first plate or second plate is capable of moving the patient's skin during use; and a hinge wherein the hinge connects the top portion of the first plate to the top portion of the second plate.
In certain embodiments, the implant excision aids described herein have a first plate, wherein the first plate further comprises a window located at the bottom portion of the first plate. In certain embodiment, the window and the bottom portion of the first plate are adjacent and/or in contact with the patient's skin during use.
In certain embodiments, the implant excision aids described herein have a first plate and a second plate wherein, at least a portion of the internal surface of the first plate or second plate further comprises a textured surface, wherein, during use, the texture on the surface increases the friction between the bottom portion of the first or the bottom portion of the second plate or the internal surface of the first plate or the internal surface of the second plate, and the patient's skin. In certain embodiments described herein, the textured surface located on at least a portion of the bottom portion or the internal surface of the first plate or the bottom portion or the internal surface of second plate comprises a pattern of protrusions. In certain embodiments described herein, the textured surface located on at least a portion of the bottom portion or the internal surface of the first plate or the bottom portion or internal surface of the second plate comprises one or more ribs. In certain embodiments described herein, the ribs are in a pattern that is parallel to the hinge. In certain embodiments described herein, the ribs are in a pattern that is oblique to the hinge. In certain embodiments described herein, the ribs are in a pattern comprising a combination of oblique and parallel orientations relative to the hinge. In certain embodiments described herein, the ribs are curved.
In certain embodiments, the implant excision aids described herein have a first plate and a second plate wherein, the first and the second plates are generally planar. In other embodiments, the first and the second plate are generally curved. In yet other embodiments, the first and the second plates independently comprise a combination of planar and curved elements.
In certain embodiments, the hinge of the implant excision aids described herein comprises a living hinge. In certain embodiments, the hinge comprises an integral hinge pin and a receptacle. In certain embodiments, the hinge comprises an integrally molded flexible element. In certain embodiments, the hinge of the implant excision aids described herein comprises a hinge pin connecting the first and second plates.
In certain embodiments, the implant excision aids described herein, further comprise a ratcheting system, wherein the ratcheting system comprises at least one ratcheting arm located on the upper portion of the first or second plate, wherein each ratcheting arm comprises at least one tooth; and at least one opening located on the upper portion of the opposite plate, wherein the opening is capable of receiving the ratcheting arm as the ratcheting arm moves forward and wherein, the tooth on the ratcheting arm interacts with the edge of the opening to prevent the ratcheting arm from moving backwards.
In certain embodiments, the implant excision aids described herein, comprise a coil-type compression spring connecting the first and second plate. In other embodiments, the implant excision aids described herein, comprise one or more leaf springs connecting the first and second plate.
In certain embodiments, the implant excision aids described herein, have a first or second plate, wherein at least a portion of the bottom of the first or second plate or the internal surface of the first plate or second plate comprises polypropylene.
Also described herein are methods for aiding in the removal of a subdermal or subcutaneous implant from a patient using the implant excision aids described herein, comprising contacting a patient's skin with the bottom of the first and second plate, wherein the majority of the implant is located between the internal surfaces of the first and second plate of the excision aid; exerting a force on the excision aid wherein the excision aid locally displaces the proximal end of the implant toward the skin surface, causing tenting of the patient's skin. In certain embodiments, the method further includes, moving the skin in the distal direction to exaggerate the tenting of the skin, facilitate creating an incision in the skin and extracting the implant.
Also described herein, are processes of making or manufacturing the implant excision aids described herein. In certain embodiments, described herein is a process of making an implant excision aid, wherein the implant excision aid is injection molded from plastics. In certain embodiments, described herein is a process of making an implant excision aid, wherein the excision aid is machined from plastics. In certain embodiments, described herein is a process of making an implant excision aid, wherein the implant excision aid is machined from metal. In certain embodiments, described herein is a process of making an implant excision aid described herein, wherein the implant excision aid is printed using a 3D printer.
For the purposes of clarity and consistency, the term “proximal” refers to a direction away from the body of the patient and towards the implant remover. The term “distal” refers to a direction towards the body of the patient and away from the implant remover.
The term “implant”, refers herein to any subdermal or subcutaneous implant. In certain embodiments the implant contains etonogestrel. In certain embodiments the implant is NEXLANON® or IMPLANON NXT®.
The term “popping” of the implant, as used herein means, to locally displace the proximal end of the implant toward the skin's surface.
The term “tenting” of the skin, as used herein means, applying a force that causes a portion of the skin to take on a triangular or tent-like appearance.
Described herein is an implant excision aid for simplifying and standardizing the procedure for preparing the skin for excision of a subdermal or subcutaneous implant and for incising the skin to expose and remove the implant. The implant targeted for removal may have any shape. For example, most implants will be cylindrical in shape. However, the implant excision aids described herein can be used to aid in the removal of non-cylindrically shaped implants. Additionally, the targeted implant may have a wide range of width/length ratios. In certain embodiments described herein, the implant excision aids described herein are used to aid in the removal of a polymeric cylinder implant, measuring 2 mm in diameter and 40 mm long. In certain embodiments the implant is NEXLANON® or IMPLANON NXT®.
In certain embodiments the implant is non-biodegradable. In certain embodiments, the implant is palpable i.e. able to be felt.
Embodiments of the invention are discussed in detail below. In describing embodiments, specific terminology is employed for the sake of clarity. However, the invention is not intended to be limited to the specific terminology so selected. All references cited herein are incorporated by reference as if each had been individually incorporated.
A preferred embodiment of the invention is discussed in detail below. While specific exemplary embodiments are discussed, it should be understood that this is done for illustration purposes only. A person skilled in the relevant art will recognize that other components and configurations can be used without parting from the spirit and scope of the invention.
Described herein are implant excision aids for removal of a subdermal or subcutaneous implant from a patient comprising a first plate comprising an external surface, an internal surface, a top portion, a bottom portion, a right side and a left side, wherein the bottom portion of the first plate is in communication with the patient's skin during use; a second plate comprising an external surface and an internal surface, a top portion, a bottom portion, a right side and a left side, wherein the bottom portion of the second plate is in communication with the patient's skin during use, wherein at least a portion of the bottom portion of the first or second plate or the internal surface of the first plate or second plate comprises a polymer or a metal, wherein the polymer or the metal generates enough friction so that the portion of the bottom of the first or second plate or the internal surface of the first plate or second plate is capable of moving the patient's skin during use or alternatively, capable of applying a force to the implant to cause the proximal end of the implant to move toward the surface of the skin to cause tenting of the skin; and a hinge wherein the hinge connects the top portion of the first plate to the top portion of the second plate.
The top portion of the first plate 26 and the top portion of the second plate 36 are joined together to form a hinge 50. As shown in the embodiment of
In the embodiment shown in
In the embodiment of the excision aid shown in
In the embodiment of the excision aid shown in
In the embodiment of the excision aid shown in
In certain embodiments, wherein the implant excision aid has a window located on the bottom portion of the first plate. The window reduces the chance for direct contact between the excision aid and an excision wound. The existence of a window contributes to a more sterile procedure wherein no portion of the excision aid touches the incision site. Reducing the risk of contact between the excision aid (or any device or tool) can reduce the risk of infection. Also, the window can further improve the function of the excision aid. The window can allow for the proximal end of the implant to lift without any restriction or barrier, thus better enabling the popping action of the proximal end of the implant.
When the implant excision aid is positioned in a way that is shown in
As described herein, the excision aids have a first and second plate. In certain embodiments of the excision aids described herein and shown in
Depending on the nature of the specific application for excision, including size of the patient and the location of implant, the implant excision aid may comprise a range of sizes, ranging from 15 mm to 100 mm in height and 15 mm to 75 mm in width. In certain embodiments, the implant excision aid may be about 15 mm, 16 mm, 17 mm, 18 mm, 19 mm, 20 mm, 21 mm, 22 mm, 23 mm, 24 mm, 25 mm, 26 mm, 27 mm, 28 mm, 29 mm, 30 mm, 31 mm, 32 mm, 33 mm, 34 mm, 35 mm, 36 mm, 37 mm, 38 mm, 39 mm, 40 mm, 41 mm, 42 mm, 43 mm, 44 mm, 45 mm, 46 mm, 47 mm, 48 mm, 49 mm, 50 mm, 51 mm, 52 mm, 53 mm, 54 mm, 55 mm, 56 mm, 57 mm, 58 mm, 59 mm, 60 mm, 61 mm, 62 mm, 63 mm, 64 mm, 65 mm, 66 mm, 67 mm, 68 mm, 69 mm, 70 mm, 71 mm, 72 mm, 73 mm, 74 mm, 75 mm, 76 mm, 77 mm, 78 mm, 79 mm, 80 mm, 81 mm, 82 mm, 83 mm, 84 mm, 85 mm, 86 mm, 87 mm, 88 mm, 89 mm, 90 mm, 91 mm, 92 mm, 93 mm, 94 mm, 95 mm, 96 mm, 97 mm, 98 mm, 99 mm or 100 mm in height, measuring from the top of the first or second plate to the bottom of the first or second plate.
In certain embodiments, the implant excision aid may be about 15 mm, 16 mm, 17 mm, 18 mm, 19 mm, 20 mm, 21 mm, 22 mm, 23 mm, 24 mm, 25 mm, 26 mm, 27 mm, 28 mm, 29 mm, 30 mm, 31 mm, 32 mm, 33 mm, 34 mm, 35 mm, 36 mm, 37 mm, 38 mm, 39 mm, 40 mm, 41 mm, 42 mm, 43 mm, 44 mm, 45 mm, 46 mm, 47 mm, 48 mm, 49 mm, 50 mm, 51 mm, 52 mm, 53 mm, 54 mm, 55 mm, 56 mm, 57 mm, 58 mm, 59 mm, 60 mm, 61 mm, 62 mm, 63 mm, 64 mm, 65 mm, 66 mm, 67 mm, 68 mm, 69 mm, 70 mm, 71 mm, 72 mm, 73 mm, 74 mm or 75 mm in width, measuring from the right side of the first or second plate to the left side of the first or second plate.
In certain embodiments, wherein the excision aid contains a window located on the first or proximal plate, the width of window may comprise a range extending from 10% of the width of the first or proximal plate to 75% of the width of the first or proximal plate. In certain embodiments, the width of the window may comprise 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 21%, 22%, 23%, 24%, 25%, 26%, 27%, 28%, 29%, 30%, 31%, 32%, 33%, 34%, 35%, 36%, 37%, 38%, 39%, 40%, 41%, 42%, 43%, 44%, 45%, 46%, 47%, 48%, 49%, 50%, 51%, 52%, 53%, 54%, 55%, 56%, 57%, 58%, 59%, 60%, 61%, 62%, 63%, 64%, 65%, 66%, 67%, 68%, 69%, 70%, 71%, 72%, 73%, 74% or 75% of the width of the first or proximal plate.
Similarly, the height of the window may comprise a range extending from 10% of the height of the first or proximal plate to 75% of the height of the first or proximal plate. In certain embodiments, the height of the window may comprise 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 21%, 22%, 23%, 24%, 25%, 26%, 27%, 28%, 29%, 30%, 31%, 32%, 33%, 34%, 35%, 36%, 37%, 38%, 39%, 40%, 41%, 42%, 43%, 44%, 45%, 46%, 47%, 48%, 49%, 50%, 51%, 52%, 53%, 54%, 55%, 56%, 57%, 58%, 59%, 60%, 61%, 62%, 63%, 64%, 65%, 66%, 67%, 68%, 69%, 70%, 71%, 72%, 73%, 74% or 75% of the height of the first or proximal plate.
In certain embodiments of the excision aids described herein, wherein the excision aid has a window, the periphery of the window in the implant excision aid can take on any shape including, but not limited to, a quadrilateral periphery such as rectangular, square or rhombus shape or a circular periphery. In certain embodiments, the window in the implant excision aid may comprise a combination of linear and circular elements. As shown in
In certain embodiments of the excision aids described herein, the bottom portion of the first plate or the second plate may comprise features for aiding in gripping and moving the skin when the first plate and second plate are forced closer together. In certain embodiments of the excision aids described herein, the internal surface or the edge of either the first plate or the second plate may comprise features for aiding in gripping and moving the skin when the first plate and second plate are forced closer together. In certain embodiments of the excision aids described herein, the internal surface of the bottom portion of the first plate or the second plate may comprise features for aiding in gripping and moving the skin when the first plate and second plate are forced closer together. In the embodiment shown in
In certain embodiments of the excision aids described herein, the bottom portion of the first or second plate may include one or more ribs in various configurations. In certain embodiments of the excision aids described herein, the internal surface of the first or second plate may include one or more ribs in various configurations. In certain embodiments of the excision aids described herein, the internal surface of bottom portion of the first or second plate may include one or more ribs in various configurations. In the embodiment shown in
The implant excision aids described herein include a hinge connecting the top portion of the first and second plate. In certain embodiments, as shown in
In many instances, it may be difficult for the remover to consistently maintain the appropriate amount of closure or force on the implant excision aid during the excision procedure. In certain embodiments, the implant excision aid can comprise a feature that prevents it from re-opening once it has been applied to the extraction site.
In certain embodiments of the implant excision aids described herein, the excision aids comprise a feature that maintains the correct distance between the first plate and second plate. In certain embodiments, such a feature could be a non-return feature. In certain embodiments the excision aid described herein can include a ratchet system that includes at least one ratchet arm and at least one complementary opening to receive the ratchet arm.
Also disclosed herein are methods for aiding in the removal of a subdermal or subcutaneous implant using the implant excision aid described herein. In certain embodiments, the method for aiding in the removal of a subdermal or subcutaneous implant using the implant excision aid described herein includes the steps of contacting the bottom portion of the first and second plate with the patient's skin, wherein the majority of the implant is located between the internal surfaces of the first and second plate of the excision aid; exerting a force on the excision aid to move the skin in the distal direction and/or to locally displace the proximal end of the implant toward the skin surface resulting in the tenting of skin external to the implant to facilitate creating an incision in the skin and extracting the implant.
In certain embodiments, wherein the implant excision aid has a window, the bottom portion of the first plate is placed adjacent to the proximal end of the implant or, alternatively; the bottom portion of the first plate is placed in front of the proximal end of the implant. In such an embodiment, the bottom portion of the second plate is placed at the distal end of the implant to provide a backstop for the implant or, alternatively; the second plate is placed on top of the distal end of the implant so that a vertical force can be applied to the distal end of the implant to further facilitate the popping of the proximal of end of the implant.
In certain embodiments, wherein the implant excision aid does not include a window, the bottom of the first plate is placed adjacent to proximal end of the implant or, alternatively; the bottom of the first plate is placed just behind the proximal end of the implant. In such an embodiment, the bottom of the second plate is placed at the distal end of the implant to provide a backstop for the implant or, alternatively; the second plate is placed on top of the distal end so that a vertical pressure can be applied to the distal end of the implant to further facilitate the popping of the proximal of end of the implant.
Also disclosed herein are processes of making and manufacturing the implant excision aids described herein. Described herein are processes of manufacturing the implant excision aid described herein wherein the implant excision aid made by injection molding and the implant excision aid is an injection molded part. The implant excision aid described herein can also be molded in structural foam, machined from plastic or fabricated from metal. Suitable plastics may include, but are not limited to, polypropylene, polyethylene, ABS, nylon, polyester, and POM. Suitable metals include, but are not limited to, stainless steel and aluminum. In an alternate embodiment, the implant excision aid can be 3D printed using a 3D printer.
| Number | Date | Country | |
|---|---|---|---|
| Parent | 62728114 | Sep 2018 | US |
| Child | 16533989 | US |
