WO2021222644A1

WO2021222644A1 - Dermal implant devices, systems, and methods of implanting thereof

Info

Publication number: WO2021222644A1
Application number: PCT/US2021/029994
Authority: WO
Inventors: Nicholas BOULIS; Saumya GURBANI; Orion KEIFER; Alexandre BETOURNE; Eric Catalano; Sanika SUBHASH; Allison BRANDVOLD; Justin STEINER; Grace MULCAHY; Elizabeth SINNER; Nadia ZARAGOZA
Original assignee: Emory University
Priority date: 2020-04-29
Filing date: 2021-04-29
Publication date: 2021-11-04

Abstract

The disclosure relates to systems, devices and methods for a dermal implant for an external object (e.g., nipple prosthetic). A dermal implant may include a base member. The base member may include a base and a post. The post may be disposed on the base and extending perpendicular to the length of the base. The base may include a set of one or more openings. Each set of openings may form a channel within the base. The device may include an attachment member disposed on the post and configured to temporarily attach to an external object. The device may include a securing member configured to be removably disposed on the post. The device may include one or more arms configured to be disposed within each set of openings of the base.

Description

DERMAL IMPLANT DEVICES, SYSTEMS, AND METHODS OF IMPLANTING

THEREOF

CROSS-REFERENCE TO RELATED APPLICATIONS

(0001) This application claims the benefit of U.S. Provisional Application No. 63/017,152 filed April 29, 2020. The entirety of this application is hereby incorporated by reference for all purposes.

BACKGROUND

(0002) In the United States alone, about one in eight women will develop breast cancer. Many of those woman undergo mastectomies. Breast reconstruction following mastectomies has become common to restore the breasts’ shape and appearance. The nipple is often not preserved in majority of mastectomies. While breast reconstruction surgery has become a common and successful way to restore the for mastectomy patients, nipple reconstruction surgery can be typically painful or excluded entirely from the breast reconstruction process.

(0003] Recently, prosthetic nipples (e.g., stickers, tattoos, piercings ) has been viewed as an alternative to the nipple reconstruction surgery. Prosthetic nipples can address emotional and physical void associated with the absence of nipples and the trauma of mastectomies. However, currently available prosthetic nipple devices and techniques can be generally inconvenient, visually inadequate, uncomfortable, irritating or aggravating to the skin of the reconstructed breast, as well as be prohibitively expensive.

SUMMARY

(0004) Thus, there is a need for an affordable, low maintenance, and accessible devices and systems that can be used in a reconstructed breast for a prosthetic nipple.

(0005) For example, the devices and systems according to embodiments can be configured to provide stable support for an external object, such as a prosthetic nipple, in a reconstructed breast without irritating or aggravating the skin of the reconstructed breast.

(0006) In some embodiments, a dermal anchor system may include a dermal implant. The dermal implant may include a base member. The base member may include a base and a post. The base may have a first end, a second end, and a length therebetween. The post may be disposed on the base and extending perpendicular to the length of the base. The base may include a set of one or more openings. Each set of openings may form a channel within the base. In some embodiments, the device may include an attaching member disposed on the post and configured to temporarily attach to an external object. The device may include a securing member configured to be removably disposed on the post. The device may also include one or more arms configured to be disposed within each set of openings of the base.

[0007] In some embodiments, the external object may be a prosthetic or an ornamental object. The prosthetic may be a nipple prosthetic. The securing member and/or the post may be configured to be accessible through an incision site of a subject.

(0008j In some embodiments, the attachment member may be configured to mechanically and/or magnetically connect to the external object.

[0009] In some embodiments, the dermal implant may include two set of openings and two arms.

[0010j In some embodiments, each set of openings may include a first opening. Each arm may include an engaging member complimentary to the first opening so that the engaging member mates with the base when inserted. In some embodiments, each arm may be configured to extend past the base when inserted and mated with the base.

[0013] In some embodiments, the securing member may include the attachment member.

[03312] In some embodiments, the post may include an inner channel with threads. In some embodiments, the securing member may include a body having a first end, a second end, and a length therebetween. The securing member may include the attachment member at the first end, an opening at the second end, and a channel disposed partially along the length from the opening. In some embodiments, the coupling member may be disposed in the channel. The coupling member may include threads complimentary to the threads of the inner channel.

[0013] In some embodiments, when the securing member is attached to the post of the base member, the body of the securing member may be configured to be disposed to surround the post and the coupling member is disposed within the channel of the post. In some embodiments, when the securing member is attached to the post of the base member, the securing member may include a portion that is configured to be protrude from an incision site. [0014] In some embodiments, each arm may include a protruding portion. The protruding portion may include one or more engaging members configured to mate with complimentary engaging members of an instrument.

[0015] In some embodiments, the system may include an instrument having one or engaging members complimentary to the one or more engaging members of the arm. The instrument may be configured to insert each arm into each set of openings in the base.

[0016] In some embodiments, the system may include an instrument having a tip portion configured to engage the inner channel of the post. The instrument may be configured to removably hold the base member for inserting into an incision site and for insertion of the one or more arms into the one or more sets of openings. In some embodiments, the tip portion of the instrument may include threads complimentary to the threads disposed in the inner channel of the post.

[0017] In some embodiments, the methods may include a method of implanting a dermal anchor system within dermis of a subject. The method may include inserting a base member of a dermal implant into an incision of the dermis so that a post disposed on the base partially protrudes through the incision. The base of the dermal implant may include one or more sets of openings, each set of openings forming a channel within the base. In some embodiments, the method may further include inserting an arm into each set of openings until an engaging member of the arm is engaged with the base. In some embodiments, the method may include providing a securing member on the post of the base member by mating the engaging member of the securing member with a complimentary engaging member disposed in an inner channel of the post. The engaging member and the complimentary engaging member may be complimentary threads.

[0018] In some embodiments, the method may include attaching an instrument to the post of the base member. The instrument may be used to insert the dermal implant into the incision. The instrument may be used to angle the base within and respect to the incision so as to provide access to each set of openings when inserting each arm. In some embodiments, the method may include removing the instrument when the arms are inserted into each opening.

[0019] In some embodiments, the method may include using an additional instrument to engage and insert each arm into the base. [8020] In some embodiments, the method may include attaching the securing member to the base member by causing a coupling member of the securing member to engage with an inner channel of the post.

[8021] In some embodiments, the portion of the securing member may include an attachment member. The method may further comprise mechanically and/or magnetically attaching an external object to the attachment member. In some embodiments, the external object may be a nipple prosthetic. In some embodiments, the incision can be made in a reconstructed breast. [6022] Additional advantages of the disclosure will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the disclosure. The advantages of the disclosure will be realized and attained by means of the elements and combinations particularly pointed out in the appended claims. It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the disclosure, as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

[0023] The disclosure can be better understood with the reference to the following drawings and description. The components in the figures are not necessarily to scale, emphasis being placed upon illustrating the principles of the disclosure.

]8024] Figure 1 shows a view of an example of a dermal implant system according to some embodiments;

[0025] Figure 2 shows a view of the system for implanting the dermal implant shown in Figure 1 according to some embodiments;

[8826] Figure 3 shows a view of a member of the system shown in Figure 2;

[0027] Figure 4 shows a view of another member of the system shown in Figure 2;

[0028] Figure 5 shows a view of the base member of the system shown in Figure 2;

[6029] Figure 6 shows a view of another base member according to embodiments;

[8030] Figure 7 shows a view of another base member according to embodiments;

[0031] Figures 8A and 8B show a view of another example of a dermal implant device according to some embodiments; Figure 8A shows a view of the dermal implant device and Figure 8B shows a partial enlarged view of the dermal implant device shown in Figure 8A; [0032] Figure 9 shows a view of the base member of the device shown in Figures 8A and 8B;

[0033] Figures 10A and B show the securing member of the device shown in Figures 8 A and

8B; Figure 10A shows a view of the securing member and Figure 10B shows a cross-sectional view of the securing member shown in Figure 10B;

[0034] Figure 11 shows a view of the arm of the device shown in Figures 8A and 8B;

[0035] Figure 12 shows an example of an instrument for implanting the device shown in

Figures 8A and 8B;

[0036] Figures 13 A and B show an example of another instrument for implanting the device shown in Figures 8 A and 8B; Figure 13 A shows a view of the another instrument and Figure 13B shows an enlarged partial view of the another instrument shown in Figure 13 A;

[0037] Figures 14-22 show views illustrating exemplary method steps of implanting the device shown in Figures 8-11 using the instruments shown in Figures 11 and 12 in a desired region; [0038] Figure 14 shows a view of the instrument shown in Figure 12 mated with the base member for insertion into an incision site;

[0039] Figure 15 shows a view of the base member inserted into the incision site and under the respective skin;

[0040 ] Figure 16 shows a partial view of the instrument shown in Figure 13 being mated with an arm for insertion;

[0041 ] Figures 17A and B show views of an arm being inserted into the base member positioned within the insertion site; Figure 17A shows a view of the arm being inserted into the base member within the incision site and Figure 17B shows a partial enlarged view of the arm and instrument shown in Figure 17 A;

[0042] Figure 18 shows a view of the base member and arms mated with base member inserted in the incision site;

[0043] Figure 19 shows a view of a securing member being attached to the inserted base member;

[0044] Figure 20 shows a view of the implanted device;

[0045] Figure 21 shows a view of an external object being attached to the implanted device; and

[0046] Figure 22 shows a view of the implanted system according to embodiments. DESCRIPTION OF THE EMBODIMENTS

[0047] In the following description, numerous specific details are set forth such as examples of specific components, devices, methods, etc., in order to provide a thorough understanding of embodiments of the disclosure. It will be apparent, however, to one skilled in the art that these specific details need not be employed to practice embodiments of the disclosure. In other instances, well-known materials or methods have not been described in detail in order to avoid unnecessarily obscuring embodiments of the disclosure. While the disclosure is susceptible to various modifications and alternative forms, specific embodiments thereof are shown by way of example in the drawings and will herein be described in detail. It should be understood, however, that there is no intent to limit the disclosure to the particular forms disclosed, but on the contrary, the disclosure is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the disclosure.

[0048] In some embodiments, the disclosure may relate to dermal implant systems and devices, and methods for implanting thereof. In some embodiments, the devices and systems according to the disclosure can relate to a dermal anchor (implant) configured to receive a prosthetic (e.g., a nipple), a decorative object (e.g., jewelry, other objects, etc.), among others, or any combination thereof.

[6049] For example, the disclosure may relate to being implanted in a reconstructed breast. The devices may be configured to for shallow deployment with respect to an incision site. The dermal anchor may be configured to evenly distribute the weight of the device on a reconstructed breast. This way, the anchor may be configured to stay in place once inserted, as well as be able to stabilize and support the load of the prosthetic and/or the decorative object disposed thereon. Additionally, the system and devices of the disclosure may be able prevent cellulitis or other infection.

[0050] It will be understood that the disclosure is not limited to being implanted in the breast region, such as a reconstructed breast, and/or be configured to receive a nipple prosthetic. The systems and devices may be implanted in any region of the body, face, etc., be configured to be used with any object, among others, or any combination thereof.

[0051] Figures 1-13B show examples of the dermal implant systems and devices, and Figures 14-22 show an exemplary method of an implanting a dermal implant according to some embodiments. It will be understood that the devices and /or systems may not be limited to the configuration and/or combination of the components as shown and described with respect to the figures. The dermal devices and/or systems may include any one and/or any combination of the embodiments of the components.

[0052 j Figures 1-5 show an example of a dermal implant system according to some embodiments. In some embodiments, the dermal anchor system may include an dermal implant 100. In some embodiments, the dermal implant 100 may include a base member (also referred to as “anchor”) 110, a securing member 150, and one or more arms (also referred to as “tines”) 160. 10053j In some embodiments, the base member 110 may include a base 120 and a post 140 that extends from the base 110. The base 120 may be an elongated plate having a first end 121, a second end 123, and a length therebetween. The base 120 may include a top (first) surface 125, a bottom (second) surface, and a side surface 126 disposed therebetween. In some embodiments, the base 120 may have a tapered height of the side surface 126 (between the top surface 125 and the bottom surface) along its length so that the height of the side surface 126 at the first end 121 is higher than the height of the side surface 126 at the second end 123. M54] In some embodiments, the base 120 may have any shape. For example, the base 120 may have an elongated shape with rounded and/or square ends, a rounded shape, a square shape, among others, or any combination thereof.

[6055] In some embodiments, the base member 110 may include one or more sets of openings 132 disposed on the top of the base 120, side(s) of the base 120, and/or the bottom of the base 120. In some embodiments, the one or more sets of openings 132 may be disposed on the base 120 so as to be on one or more sides of the post 140. In this example, each set of openings 132 may include two openings. In some embodiments, each set of openings 132 may form a channel in the base 120. In some embodiments, the openings 132 may be disposed so as to form a channel in the base 120 that is vertical (parallel to the post 140) as shown. In some embodiments, the channel/openings 132 may be disposed may be disposed so as to form channels substantially vertically, curved and/or horizontal.

[6056] In this example, the base member 110 may include three sets of openings 132. Each set of openings 132 may be disposed so as to form a vertical channel in this example. In some embodiments, the base member 110 may include more or less sets of openings 132. For example, the base member 110 may include two sets of openings 132. j0057] In some embodiments, each set of openings 132 may include a first opening 131 disposed on the top (first) surface 125, a second opening 133 disposed on the side surface 126 of the base 120, and a channel disposed there between, as shown in Figures 1, 2 and 5. In some embodiments, the first opening 131 and/or the second opening 133 may be disposed at different position(s) on the base 120. For example, each first opening may be disposed on the top surface

125 and side surface 126 of the base, each bottom opening may be disposed on the side surface

126 and bottom surface, among others, or any combination thereof.

10058j In some embodiments, the base member 110 may include one or more holes 136 disposed along the length of the base 120. The one or more holes 136 may have a rounded shape. In some embodiments, the one or more holes 136 may have the same circumference or perimeter. In some embodiments, the one or more holes 136 may have each have a different circumference or perimeter. When the base member 110 is implanted, the holes 136 may be configured to allow tissue healing to bridge through the base 120 so as to stabilize it.

[0059) In some embodiments, the post 140 may be disposed on the base 120 and extending perpendicular to the length of the base 120. The post 140 may be disposed so as to extend from the top surface 125 of the base 120. In some embodiments, the post 140 may be disposed on the base 120 between the one or more sets of openings 132 and the one or more holes 136.

[6060] In some embodiments, the post 140 may include a first end 141, a second end 143, and a length therebetween. The second end 143 of the post 140 may be disposed on the top surface 125 of the base 120. In some embodiments, the post 140 may include an opening 142 to a channel that is extends at least partially along the length of the post 140.

[0061] In some embodiments, the device 100 may include an attachment member 190 disposed on the post 140. In some embodiments, the attachment member may be disposed on the first end 141 of the post 140, as shown in Figure 1. The attachment member 190 may be configured to removably couple or attach to an external object. For example, the attachment member 190 may be configured for mechanical and/or magnetic attachment. For example, the attachment member 190 may include but is not limited to one or more magnets/magnetic material, a clamp, a locking mechanism, a twisting and locking mechanism (e.g., a bayonet), among others, or any combination thereof. For example, the one or more magnetic materials of the attachment member 190 may include but is not limited to neodymium. The one or magnetic materials may be magnetic resonance imaging (MRI) compatible. (0062] In some embodiments, the external object may include but is not limited to a prosthetic device (e.g., nipple prosthetic), jewelry (e.g., earring, horns, etc.), other ornamental object, among others, or any combination thereof. In some embodiments, the system may further include the external object.

(0063] In some embodiments, the external object may include an attachment member complimentary to the attachment member 190 so that the external object may be removably attached to the post. The external object and the post may be configured to be removably attached using nonuniform pressure. For example, the device 100 may be configured to reduce pressure points when the external object is detached.

(0064] In some embodiments, the device 100 may include the one or more arms (also referred to as “tines”) 160. In some embodiments, the one or more arms 160 may be configured to engage the one or more sets of openings 132.

(0065] In some embodiments, the number of sets of openings 132 may correspond to the number of arms 160. In this example, the device 100 may include three arms 160 and three sets of openings 132. In some embodiments, the device 100 may include more or less arms 160 and/or sets of openings 132. For example, the device 100 may include two arms 160 and two sets of openings 132.

(6066] In some embodiments, when the one or more arms 160 are secured to the base 120, the arms 160 may be disposed within the channel of each set of openings 132 of the base 120. In some embodiments, when secured, the arms 160 may be configured to extend through and past the base 120

(6067] In some embodiments, the securing member 150 may include or be configured to engage the one or more arms 160. In some embodiments, the securing member 150 may include a radial member 152 that includes an opening 154. In some embodiments, the arms 160 may be disposed along the circumference of the radial member 152 so as to extend from the radial member 152.

(6068] In some embodiments, the opening 154 may have a diameter larger than a diameter of the post 140 so that the radial member 152 may be configured to move along the length of the post 140. In some embodiments, the radial member 152 of the securing member 150 may be configured to move along the post 140 toward the base 120 so that the arms 160 extends toward the base 120 and engage the complimentary set of opening(s) 132 of the base 120. [ 069] When the securing member 150 is disposed in the securing state, the post 140 may be configured to accessible through an incision site of a subject.

(0070] In some embodiments, the base 120 and the post 140 may be made of one or more biocompatible and MRI compatible materials. For example, the one or more material may include but is not limited to titanium alloy, such as Ti-64 (Ti-6A1-4V).

(0071 ) In some embodiments, the base member 110 may have a different configuration. For example, the base member 110 may have a different number of openings, location of openings, among others, or any combination thereof. For example, Figures 6 and 7 show examples of different base members.

(0072 j In some embodiments, the arm(s) 160 may include one or more biocompatible and MRI compatible materials. In some embodiments, the arm(s) 160 may be stiff, semi-flexible and/or flexible. In some embodiments, the arm(s) 160 may be made of a material that is configured to be at least semi-flexible when implanted and configured to transition to more stiff material upon a stimulus (e.g., temperature).

(0073] In some embodiments, the one or more arms 160 may be made of one or more biocompatible and MRI compatible materials. For example, the one or more materials of the arms(s) 160 may include but is not limited to a polymer, such as high density polyethylene (HDPE), low density polyethylene (LDPE), polyethylene (PE), among others, or any combination thereof.

(0074] In some embodiments, the system may include a securing instrument 170, for example, as shown in Figures 2 and 4. The securing instrument 170 may be configured to engage the securing member 150 for delivery the securing member 150 onto the base member 110. In some embodiments, the securing instrument 150 may be configured to move the securing member 150 along the post 140 to a securing state.

(0075] In some embodiments, the securing instrument 170 may include a post 172. The post 172 may have a first end, a second end, and a length therebetween. In some embodiments, the post 140 of the base member 110 may be configured to receive the post 172 of the securing instrument 170.

(0076] In some embodiments, the securing instrument 170 may include a support member 176 disposed at a first end of the post 172. The support member 176 may be configured to receive a handle (e.g., 180), a different steering instrument, etc. In some embodiments, the support member 176 may include an adapter configured receive a steering instrument or handle.

[0077] In some embodiments, the securing instrument 170 may include a radial member 174 that is radially disposed about the post 172 along the length of the post 172. The radial member 174 may be configured to engage the securing member 150.

(0078) In some embodiments, the securing instrument 170 may include one or more arms 178 disposed on along an outer circumference of the support member 176 and the radial member 174 so as to extend from the support member 176.

(0079) In some embodiments, the one or more arms 178 may be configured to radially expand as the securing instrument is moved towards the base member. In use, the one or more arms 178 may be configured to engage the tissue surrounding an incision site as the arms 178 radially expand so that the securing member 150 may be secured to the base member 110 without pinching the skin.

( 080) In some embodiments, the dermal implant 100 may be removed after implantation. For example, the system may include an instrument configured to remove the implant 100 from a subject that minimized the trauma of the surrounding tissue. For example, the instrument may be configured to disengage the arm(s) 160 from the base 110 so that the arm(s) 160 can be removed before removing the base 110.

(0081 ) In some embodiments, the disclosure may relate to a method of implanting a dermal anchor system within dermis of a subject. The method may include making an incision at the desired site of a subject. For example, for a nipple prosthetic, the site may be at a location of areola/areola tattoo on a reconstructed breast.

(0082) After making an incision, the base member 110 of a dermal implant may be inserted into the incision of the skin so that (i) the base may be disposed underneath the skin and (ii) a portion of the post 140 partially may be exposed and accessible through the incision site. Next, the securing member 150 may be moved along the post 140 of the base member 110 towards the base 120 so that the one or more arms 136 of the securing member 130 engages the complimentary opening(s) 112 and is in the secured state.

(0083) In some embodiments, the method may use an instrument, such as the securing instrument 170. For example, if using the securing instrument 170, after the placement of the base member 110, the securing instrument 170 may engage the securing member 150 to move the securing member along the post 140 of the base member 110 towards the base 120 while the arms 178 of the securing instrument 170 radially expand to engage the tissue surrounding the incision. [0084] In some embodiments, the arms 160 may be disposed on the securing member 150 so that the instrument 170 moves both the arms 160 and the securing member 150 towards the base 120. In this example, the securing instrument 170 may move the securing member 150 until the one or more arms 160 engage the complimentary set of opening(s) 132 of the base 120.

[0085] In another example, the securing instrument 170 may be used to move only the securing member 150 with respect to the post 140. After the securing member 150 is secured to the post 140, the arms 180 may be attached (mechanically or magnetically) to the securing member 150 and/or the complimentary set of openings 132 of the base 120.

[0080] After the securing member 150 is in the secured state, the instrument 170 may be removed. The attachment member (e.g., 190) may then be removably attached to the post 140. For example, the attachment member 190 may be removably attached so as to cover the opening 142 of the post 140, as shown in Figure 1. It will be understood that the arms 160 and the securing member 150 are not shown in Figure 1.

[0087] For example, the attachment member 190 may be configured to be screwed into the post 120. In this example, the attachment member 190 may have threads complimentary to threads providing along the internal surface of the opening 142 of the post 140. After the attachment member 190 is secured, the external object may be attached, for example, using a complimentary mechanism (e.g., magnetic and/or mechanical) to the attachment member 190. The user (e.g., subject, patient, etc.) may be capable of removing the object from the attachment member 190, replacing the object with a different object, among others, or any combination thereof.

[ 8 j In some embodiments, the obj ect and/or the attachment member 190 may be configured to exert nonuniform pressure. For example, the object and/or the attachment member 190 may be configured to have nonuniform weight and/or engage the one or more arms to adjust the pressure on the surrounding tissue. In some examples, the system may include more than one object and/or attachment member 190. For example each obj ect/ attachment member may be configured to exert different pressures.

[0089] It will be understood that the implant 100 may be delivered with a different instrument and is not limited to the securing instrument 150 shown and described. [ 090] Figures 6 and 7 show additional examples of base members having two set of openings. Figure 6 shows an example of a base member 610. Like the base member 110, the base member 610 may include a base 620 and a post 640 disposed so as to extend from the base 620. Like the base member 110, the base member 620 may include openings 636 disposed along the length. Like the base member 110, the post 640 may include an opening 642 to a channel that is extends at least partially along the length of the post 640.

[0091] In some embodiments, the base member 610 may include two sets of openings 632. In this example, each set of openings 632 may include a first opening 631 disposed on the top surface 625 of the base 620 and a second opening 633 disposed on the side surface 626 of the base 620, and a channel therebetween. Each set of openings 632 may be configured to form a curved channel disposed on one side of the base 620.

[9092] Figure 7 shows an example of a base member 710. Like the base members 110 and 610, the base member 710 may include a base 720 and a post 740 disposed so as to extend from the base 720. Like the base members 110 and 610, the base member 720 may include openings 736 disposed along the length. In this example, the post 740 may be solid. In some embodiments, the post 740 may include an opening to a channel like posts 140 and 640.

[9093] In some embodiments, like the base member 610, the base member 710 may include two sets of openings 732. In this example, each set of openings 732 may include a first opening 731 disposed on the side surface 726 adjacent to the top surface of the base 720 and a second opening 733 disposed on the side surface 726 adjacent to the bottom surface of the base 720, and a channel therebetween. Each set of openings 732 may be configured to form a channel that traverses opposite sides of the base 720.

[9994 j Figures 8A-13B show another example of a dermal implant system. In some embodiments, the dermal implant system may include a dermal implant 800 as shown in Figures 8A-11.

[9995] In some embodiments, the dermal implant 800 may include a base member (also referred to as “anchor”) 810, securing member(s), and one or more arms (also referred to as “tines”) 860.

[0096] In some embodiments, like the base members 110, 610, and 710, the base member 810 may include a base 820 and a post 840 that extends from the base 810. The base 820 may be an elongated plate having a first end 821, a second end 823, and a length therebetween. The base 820 may include a top (first) surface 825, a bottom (second) surface, and a side surface 826 disposed therebetween. In some embodiments, the base 820 may have a tapered height of the side surface 826 (between the top surface 825 and the bottom surface) along its length so that the height of the side surface 826 at the first end 821 is higher than the height of the side surface 826 at the second end 823.

(0097) In some embodiments, the base 820 may have any shape. For example, the base 820 may have an elongated shape with rounded and/or square ends, a rounded shape, a square shape, a different shape, among others, or any combination thereof.

(0098) In some embodiments, the base member 810 may include one or more sets of openings

832 disposed on the top of the base 820, side(s) of the base 820, and/or the bottom of the base 820. In some embodiments, the one or more sets of openings 832 may be disposed on the base 820 so as to be on one or sides of the post 840. In this example, each set of openings 832 may include two openings. In some embodiments, each set of openings 832 may form a channel in the base 820. In this example, the base member 810 may include two sets of openings 832. In some embodiments, the base member 810 may include more or less sets of openings 832.

[0099) In some embodiments, each set of openings 832 may include a first opening 831 disposed on the top (first) surface 825 of the post 820 on one side of the post 840, a second opening

833 disposed on the side surface 826 of the base 820 on a different side of the post 840, and a channel disposed there between, as shown in Figures 8A-9. As shown, the first opening 835 of the second set may be disposed above the second opening 833 of the first set one side, and the first opening 833 of the first set may be disposed above the second opening of the second set on the opposing side. This way, the channels defined by the sets of openings 832 may traverse each other and extend through opposite sides of the base 820.

{06190) In some embodiments, each set of openings 832/channels may be configured to receive an arm. In some embodiments, the first opening 831, 835 of each set may be shaped so as to be complimentary to a shape of the corresponding end of the arm 860 so that the arm 860 can be (removably) securely attached to the base 820. In this example, each first opening may have a rectangular shape. For example, each arm 860 may be (removably) securely attached to the base 820 when inserted into a respective first opening and slide through until the end of the arm 860 mates with that first opening. (00101] In some embodiments, the base member 810 may include one or more holes 836 disposed along the length of the base 820. The one or more holes 836 may have a rounded shape. In some embodiments, the one or more holes 836 may have the same circumference or perimeter. In some embodiments, the one or more holes 836 may have each have a different circumference or perimeter. The holes 836 may be configured to allow tissue healing to bridge through the holes 836 of the base 120, thereby improving the retention and stability of the device 800 after the base implantation. In some embodiments, each of the holes 836 may also have sharp edges around the respective circumference. These sharp edges may be configured to cut the derma when the base member is removed.

(60162] In some embodiments, the post 840 may be disposed on the base 820 and extending perpendicular to the length of the base 820. The post 840 may be disposed so as to extend from the top surface 825 of the base 820. In some embodiments, the post 840 may be disposed on the base 820 between the one or more sets of openings 832 and the one or more holes 836.

( 01 31 In some embodiments, the post 840 may include a first end 841, a second end 843, and a length therebetween. The second end 843 of the post 840 may be disposed on the top surface 825 of the base 820. In some embodiments, the post 840 may include an opening 842 to a channel 844 that is extends at least partially along the length of the post 840. In some embodiments, the post 840 may include threads 846 disposed along at least a portion of the channel 844.

(60164] The first end 841 of the post 840 may be configured to receive an attachment member 890, as shown in Figures 8 A and 8B. The attachment member 890 may be configured to removably couple or attach to an external object. For example, the attachment member 890 may be configured for mechanical and/or magnetic attachment. For example, the attachment member 890 may include but is not limited to one or more magnets/magnetic material, a clamp, a locking mechanism, a twisting and locking mechanism (e.g., a bayonet), among others, or any combination thereof. For example, the one or more magnetic materials of the attachment member 890 may include but is not limited to neodymium. The one or magnetic materials may be MRI compatible. (60105] In some embodiments, the external object may include but is not limited to a prosthetic device (e.g., nipple prosthetic), jewelry (e.g., earring, horns, etc.), other ornamental object, among others, or any combination thereof. In some embodiments, the system may further include the external object. [ 01061 In some embodiments, the external object may include an attachment member complimentary to the attachment member 890 so that the external object may be removably attached to the post. The external object and the post may be configured to be removably attached using nonuniform pressure. For example, the device 800 may be configured to reduce pressure points when the external object is detached.

[601971 In some embodiments, the device 800 may include the one or more arms (also referred to as “tines”) 860. In some embodiments, the one or more arms 860 may be configured to engage the one or more sets of openings 832.

[661681 In some embodiments, the number of sets of openings 832 may correspond to the number of arms 860. In this example, the device 800 may include two arms 860 and two sets of openings 832. In some embodiments, the device 800 may include more or less arms 860 and/or sets of openings 832.

[661691 In some embodiments, when the one or more arms 860 are secured to the base 820, the arms 860 may be disposed within the channel of each set of openings 832 of the base 820. In some embodiments, when secured, the arms 860 may be configured to extend through and past the base 820 as shown in Figure 8 A.

[661161 As shown in Figure 11, each arm 860 may include a first end 861, a second end 863, and a length therebetween. In some embodiments, each arm 860 may include one or more portions. In some embodiments, each arm 860 may include a first portion 862, a second portion 864, and a third portion 866. In some embodiments, the first portion 862 may be configured to be shaped complimentary to the shape of each first opening of the set of openings 832 so that the first portion 862 mates with the respective first opening when the arm 860 is inserted fully into that first opening so it abuts the base 820. For example, the first portion 862 may have the same shape and slightly smaller dimensions (height, width, length) than the shape and dimensions of each first opening. In this example, the first portion 862 may have a rectangular shape.

[661111 The first portion 862/first opening of each set of openings 832 may also have a different shapes. For example, the first portion 862/first opening of each set of openings 832 may have a curved or rounded shape, a polygonal shape, among others, or any combination thereof.

[66112] In some embodiments, the length of each arm 860, for example, the length of the second portion 862 and third portion 864, may depend on the diameter of the nipple prosthetic and/or desired external object. For example, the length of the arms 860 may be substantially the same as the diameter of the nipple prosthetic. jOOl j In some embodiments, the device 800 may include arms 860 having substantially the same length. In some embodiments, the device 800 may include arms 860 of different lengths. (Q0Ί 14j In some embodiments, each arm 860 may include one or more engaging members 865 disposed on one or more surfaces of the first portion 862 and configured to engage an instrument. In this example, each arm 860 may include two engaging members 865: a first engaging member disposed on the top surface of the first portion 862 and a second engaging member disposed at (front) surface of the first end 861. The engaging members 865 may be indents as shown, as well as divots, holes, among others, or any combination thereof. The engaging members 865 may be of the same size and shape. In some embodiments, the engaging members 865 may be of different sizes, different shapes, among others, or any combination thereof.

[001 IS] In some embodiments, the second portion 864 may be disposed between the first portion 862 and the third (tip) portion 866. The second portion 864 may have an elongated, flattened shape and sized/shaped to be disposed and inserted within each channel of each set of openings 832. In some embodiments, the third portion 866 may have a tapered shape that the ends with a tip at the second end 863. In some embodiments, the tip may be straight. In some embodiments, the tip may be pointed. In some embodiments, the first portion 862 may protrude from the second portion 864 and third portion 864.

(00116J In some embodiments, each arm 860 may be made of one or more biocompatible and MRI compatible materials.. In some embodiments, the first portion 862, the second portion 864, and the third portion 866 may be integrally formed of the one or more materials. For example, each arm 860 may be made of one or more MRI compatible metals.

{061171 In some embodiments, the second portion 864 and the third portion 866 may have a different shape. For example, the second portion 864 may be a rigid wire and the third portion 866 may have a coil/spring shape. This way, any discomfort from the breast being squeezed around the base member 820 can be prevented.

{001181 In some embodiments, the device 100 may include the securing member 850 configured to be removably disposed on the post 840. When disposed on the post 840, the securing member 850 may be configured to clamp against the top surface of the base 820 and the one or more arms 860 thereby preventing the arm(s) 860 from moving. In some embodiments, the securing member 850 may be a cap configured to couple to the post 840.

(60119J As shown in Figures 10A and 10B, the securing member 850 may have a body including a first end 851, a second end 853, and a length therebetween. In some embodiments, the securing member 850 may include a channel 855 disposed at least along a length of the securing member 850. In some embodiments, the channel 855 may include an opening 859 disposed at the second end 853.

[66120] In some embodiments, the securing member 850 may include a coupling member 857 disposed in the channel and configured to mate with the channel 844/threads 846 when disposed on the post 840. In this example, the coupling member 857 may be a screw having complimentary threads to the threads 846. By way of example, when the securing member 850 is attached to the post 840, the coupling member 857 may be disposed within the channel 844 of the post 840 and the body of the securing member 850 may be disposed so as to surround the post 840.

(901211 In some embodiments, the securing member 850 may include an opening 854 in which the attachment member 890 may be disposed. In some embodiments, the attachment member 890 may be removable. In some embodiments, the attachment member 890 may be fixedly disposed or integrated with the securing member 850.

(601221 In some embodiments, the body of the securing member 850 may include one or more portions. In some embodiments, the securing member 850 may include a first portion 856 and a second portion 858. When the securing member 850 is disposed on the post 840 of the implanted base member 810, the second portion 858 may be configured to be disposed completely under the skin and the first portion 856 may be configured to be accessible through an incision site within the skin.

(601231 In some embodiments, the first portion 856 and the second portion 858 may be of different sizes and/or shapes. For example, the first portion 856 may have a square shape and the second portion 858 may have a rounded shape. In some embodiments, the first port portion 856 may have a smaller diameter/perimeter than the second portion 858. In some embodiments, the first portion 856 and the second portion 858 may have a different shape and/or size.

(60124] In some embodiments, the system may include additional and/or alternative securing members. For example, the system may include an additional securing member that has a smaller height so as to be disposed within the skin so as not to protrude through the incision site. (001251 In some embodiments, the base 820 and the post 840 may be made of one or more biocompatible and MRI compatible materials. For example, the one or more materials may include but is not limited to titanium alloy, such as Ti-64 (Ti-6A1-4V).

[001261 Figures 12 and 13A-B show examples of instruments 1200 and 1300 that can be used with the dermal implant 800 according to embodiments. In some embodiments, the system may include the instruments 1200 and 1300. In some embodiments, the system may include additional and/or alternative instruments.

[0012?! Figure 12 shows the instrument 1200 that can be configured to removably hold the base member 810 so that the base member 810 can be implanted within an incision site according to embodiments. As shown, the instrument 1200 may have a first end 1201, a second end 1203, and a length therebetween. In some embodiments, the instrument 810 may be an elongated rod with a tapered tip portion 1210. In some embodiments, the instrument 1200 may include an engaging member 1220 disposed at the second end 1203 (tip of the tapered tip portion 1210). The engaging member 1220 may be configured to engage the post 840. By way of example, the engaging member 1220 may include threads that are complimentary to the threads 846.

[00128] Figures 13 A and B show the instrument 1300 that can be configured to removably hold each arm 860 so that it can be delivered to each set of openings 832. For example, the instrument 1300 may be a hinged, locking clamp instrument. For example, the instrument 1300 may include a pair of sections (also referred to as “jaws”) 1310 that are pivotally adjoined by a pin 1330 in a scissor-like configuration to allow a user to place and secure each arm within the base member 810. Each section 1310 may include a first end 1310, a second end 1313, and a length therebetween 1311. In some embodiments, each section 1310 may include a ring handle 1320. [001291 In some embodiments, each section 1310 may include one or more engaging members

1350 configured to engage the one or more engaging members 865 of each arm 860. The one or more engaging members 1350 may be complimentary to the one or more engaging members 865 of each arm 860. In some embodiments, the total number of engaging members 1350 may correspond to the number of engaging members 865. For example, in this example, the instrument 1300 may include two engaging members 1350. Each section 1310 may include one engaging member 1350 on the inner surface at the first end 1310.

[00130] In some embodiments, each engaging member 1350 may be a protruding member that corresponds to the respective opening 865. In this example, each engaging member 1350 may be of the same size and shape. In some embodiments, the engaging members 1350 may be of different size, different shape, among others, or any combination thereof.

|00I31| In some embodiments, the members 1310 may be the same and connected by the pin 1330 so as to be symmetric. In some embodiments, the members 1310 may be of different size, may be of different shape, may be connected by the pin 1330 so as to be asymmetric, among others, or any combination thereof.

[00132] In some embodiments, the instrument 1300 may include a locking member 1340 that may be connected to the members 1310 and can be configured to removably lock the members 1310 in position. In some embodiments, the locking member 1340 may be a ratchet.

[ 0133] Figures 14-22 show an example of a procedure for inserting the device 800 using the instruments 1200 and 1300 into an incision site so that an external object can be attached. In this example, the procedure may be implanting the device 800 in an incision site of a breast of a subject so that an external object, such as a nipple prosthetic as shown, may be attached.

[00134] As shown in Figure 14, a user (e.g., medical professional) may use the instrument 1200 may be removably attached to the base member 810, for example, by screwing the engaging member 1220 into the channel 844 of the post 840 so that the engaging member 1220 engages the complimentary threads 846. After the instrument 1200 is attached to the base member 810, the user may position the base member 810 within an incision site in the breast using the instrument 1200. As shown in Figure 15, the base member 810 may be positioned so that the post 840/the instrument 1200 is disposed within and extending from an incision site 1512 and the base 820 is disposed under the skin 1511 ofabreast 1510. It will be understood that the breast/skin 1510/1511 and associated dermis is illustrated as a box in the figures for illustrated purposes.

[00135) Once the base member 810 is properly inserted into the incision site 1510, as shown in Figure 15, the user may insert the arms 860 into the base member 810, for example, using the instrument 1300. To prepare an arm 860 for placement, the user may position the sections 1310 of the instrument 1300 so that each engaging members 1350 interfaces with the engaging members 865 of the arm 860. In this example, the engaging members 1350, 865 interface when each engaging member 1350 is mated with the respective engaging member 865. Figure 16 shows the instrument 1300 being moved from an open position to a closed position so that the each engaging member 1350 is mated with the respective engaging member 865. In this figure, the arm 860 is illustrated as transparent for illustrative purposes. After the engaging members are mated as shown in Figures 17A and 17B, the instrument may be locked into position with the locking member 1340.

[0006] Once the arm 860 is secured in the instrument 1300, the user may move the base member 810 using the instrument 1200 to provide access to the respective opening 832 within the incision site 1512. For example, the user may move the instrument 1300 toward the side opposite of the respective opening 832 as shown in Figure 17A. The user may insert the arm 860 so that the first portion 862 abuts against the respective first opening 831, 835. After one arm 860 is disposed in one of the openings 832 so it abuts against the respective first opening, the user may move the base member 810 towards to the other side so that the other arm 860 may be disposed in the other opening 832 so that the respective first portion 862 abuts against that first opening. (001371 Figure 18 shows a view of the arms 860 being securely positioned in the base member 810 and in the incision site 1512. As shown, the post 840 can be accessible via the incision site 1512. A user may now attach a securing member to the post 840. In some embodiments, the securing member 850 may be attached to the post 840 by screwing the member 850 onto the post 840 as shown in Figure 18 and 19. As shown in Figure 19, the securing member 850 may be disposed so as to be accessible via the incision site 1512.

[0008] In some embodiments, a different securing member may be attached to the post 840. For example, before the securing member 850 is attached, an additional securing member may be attached to the post 840 by engaging its coupling member with the complimentary threads 846 disposed in the inner channel 842 of the post 8410. The additional securing member may have a profile (height) that is lower than the securing member 850. When the attached to the post 840, the additional securing member may be disposed so as to lie under the skin. This additional securing member can be attached for a period of time to allow the incision site to heal forming a capsule of dense scar/fibrotic tissue to form around the base member 820 and the arms 860 under sterile conditions. This fibrotic capsule can protect the reconstructed breast from, for example, infection. After that period of time, the additional securing member can be removed and the securing member 850 may be attached the post 840 by twisting the securing member 850 so that the threads of the coupling member 857 engages the threads 846 of the post 840.

(00139] After the securing member 850 is attached to the post 840 as shown in Figure 19, an external object may be attached to the device 800. As shown, the securing member 850 may be configured to accessible through the incision site 1512 when attached to the post 840. In the example shown in Figures 21 and 22, the external object may be a nipple prosthetic 2110 including an attachment member that is magnetic and complimentary to the attachment member 890. Figure 22 shows the nipple prosthetic 2110 securely attached to the attachment member 890. With the device 800 implanted as shown in Figure 19, the subject (e.g., patient) can be attach and remove the nipple prosthetic 2110 as needed, as well as remove and replace the prosthetic 2110 with other external objects.

[00140] In some embodiments, the implant device (e.g., device 100 and/or 800) and/or system may be part of a kit. In some embodiments, the kit may include a base member, one or more securing members (e.g., the additional securing member, the securing member 150/850, among others, or any combination thereof), one or more arms (e.g., the arms 160, the arms 860, among others, or any combination thereof), one or more of the instruments (the instrument 1200, the instrument 1300, among others, or any combination thereof), among others, or any combination thereof. In some embodiments, the kit may also include one or more external objects (e.g., nipple prosthetic). In some embodiments, the kit may include one or more arms that have a length that corresponds to the external object(s) to be attached. The kit may be provided in a container that indicates the length of the included arms, indicate the external object(s) to be used, among others, or any combination thereof.

[00141] While the disclosure has been described in detail with reference to exemplary embodiments, those skilled in the art will appreciate that various modifications and substitutions may be made thereto without departing from the spirit and scope of the disclosure as set forth in the appended claims. For example, elements and/or features of different exemplary embodiments may be combined with each other and/or substituted for each other within the scope of this disclosure and appended claims.

Claims

CLAIMS What is claimed:

1. A dermal anchor system comprising: a dermal implant, comprising: a base member, the base member including a base and a post; the base having a first end, a second end, and a length therebetween; the post disposed on the base and extending perpendicular to the length of the base; the base including a set of one or more openings, each set of openings forming a channel within the base; an attachment member disposed on the post and configured to temporarily attach to an external object; a securing member configured to be removably disposed on the post; and one or more arms configured to be disposed within each set of openings of the base.

2. The dermal anchor system of claim 1, wherein the external object is a prosthetic or an ornamental object.

3. The dermal anchor system of claim 2, wherein the prosthetic is a nipple prosthetic.

4. The dermal anchor system of any of claims 1-3, wherein the securing member and/or the post is configured to be accessible through an incision site of a subject.

5. The dermal anchor system of any of claims 1-4, wherein the attachment member is configured to mechanically and/or magnetically removably couple to the external object.

6. The dermal anchor system of any of claims 1-5, wherein the dermal implant includes two set of openings and two arms.

7. The dermal anchor system of claim 1-6, wherein: each set of openings includes a first opening; and each arm includes an engaging member complimentary to the first opening so that the engaging member mates with the base when inserted.

8. The dermal anchor system of claim 7, wherein each arm is configured to extend past the base when inserted and mated with the base.

9. The dermal anchor system of any claims 1-8, wherein the securing member includes the attachment member.

10. The dermal anchor system of any of claims 1-9, wherein: the post includes an inner channel with threads; the securing member includes: a body having a first end, a second end, and a length therebetween; the attachment member at the first end, an opening at the second end, and a channel disposed partially along the length from the opening; and a coupling member disposed in the channel; and the coupling member includes threads complimentary to the threads of the inner channel.

11. The dermal anchor system of any of claims 1-10, wherein when the securing member is attached to the post of the base member: the body of the securing member is configured to be disposed to surround the post and the coupling member is disposed within the channel of the post; and the securing member includes a portion that is configured to be protrude from an incision site.

12. The dermal anchor system of any of claims 1-11, wherein each arm includes a protruding portion, the protruding portion including one or more engaging members configured to mate with complimentary engaging members of an instrument.

13. The dermal anchor system of claim 12, further comprising; an instrument having one or engaging members complimentary to the one or more engaging members of the arm; the instrument being configured to insert each arm into each set of openings in the base.

14. The dermal anchor system of any of claims 10-13, further comprising: an instrument having a tip portion configured to engage the inner channel of the post; wherein the instrument is configured to removably hold the base member for inserting into an incision site and for insertion of the one or more arms into the one or more sets of openings.

15. The dermal anchor system of claim 14, wherein the tip portion of the instrument includes threads complimentary to the threads disposed in the inner channel of the post.

16. A method of implanting a dermal anchor system within dermis of a subject, comprising: inserting a base member of a dermal implant into an incision of the dermis so that a post disposed on a base of the base member is accessible through the incision; the base of the dermal implant including one or more sets of openings, each set of openings forming a channel within the base; inserting an arm into each set of openings until an engaging member of the arm is engaged with the base; providing a securing member on the post of the base member by mating the engaging member of the securing member with a complimentary engaging member disposed in an inner channel of the post.

17. The method of claim 16, further comprising: attaching an instrument to the post of the base member; wherein the instrument is used to insert the base member into the incision; wherein the instrument is used to angle the base within and with respect to the incision so as to provide access to each set of openings when inserting each arm.

18. The method of claim 17, further comprising: removing the instrument when the arms are inserted into each opening.

19. The method of any of claims 16-18, further comprising: attaching the securing member to the base member by causing a coupling member of the securing member to engage with an inner channel of the post.

20. The method of claim 19, wherein the portion of the securing member includes an attachment member, the method further comprising: attaching an external object to the attachment member.