Tissue expansion device

Abstract

To provide a tissue expansion device that can be used to treat humans and / or animals.SOLUTION: A tissue expansion device that can be implanted temporarily beneath skin of a patient through a surgery and removed upon predetermined expansion of overlying tissue, includes: an expandable shell that can form an expandable chamber and have an anterior portion and a posterior portion; a plurality of tabs coupled to the posterior portion of the expandable shell, the first tab among the plurality of tabs being disposed at a lower portion of the expandable shell, and the first tab having an attribute different from the attributes of the other tabs among the plurality of tabs; and an injection port configured to enable injection of fluid to the expandable chamber.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of and priority to related U.S. Provisional Patent Application No. 62 / 731,033, filed September 13, 2018, the entirety of which is incorporated herein by reference.

[0002] The present disclosure relates generally to systems and methods for tissue expansion, and more particularly to expanding a patient's tissue in preparation for receiving an implant. [Background technology]

[0003] Implantable prostheses are commonly used to replace or supplement bodily tissues. In cases of breast cancer, a mastectomy may be necessary to remove some or all of the breast and surrounding tissue, resulting in a void. This void can be filled with a fluid-filled implantable prosthesis. The implant serves to support the surrounding tissue and maintain the appearance of the body. Restoring the body's normal appearance has a highly beneficial psychological effect on the post-operative patient, alleviating much of the emotional shock and depression that often follows major surgical procedures.

[0004] Soft implantable prostheses typically include a relatively thin and very flexible envelope or shell made of a silicone elastomer. The shell is filled with a silicone gel or saline solution. Filling of the shell can occur before the shell is implanted in the patient, or after the shell is implanted in the patient.

[0005] Saline-filled implants include an outer shell made of several layers of silicone elastomer with a valve or fill port on one side. The prosthesis is typically implanted into the breast cavity empty or partially filled. The valve or fill port then allows the implant to expand to its final size. This helps reduce the size of the required incision and allows the surgeon to adjust and even fine-tune the implant volume.

[0006] In breast reconstruction, it is common practice to utilize more temporary implants, known as "tissue expanders" or "tissue spreaders," to gradually create the space required for a long-term prosthesis prior to implantation. In some situations, such as mastectomy, breast tissue may be flat and cramped, and an expander may be used to prepare the body to receive a long-term prosthesis. Tissue expanders may also be used elsewhere in the body to stretch healthy tissue and replace nearby defects, such as burns or scars. Essentially, a tissue spreader comprises an inflatable body with an inflation valve connected to the inflatable body. The valve may be formed in the inflatable body itself or may be located remotely and connected to the inflatable body by an elongated conduit.

[0007] The expandable body of the tissue stretching device is placed subcutaneously under the patient at the location where the tissue is to be stretched. The inflation valve, whether on the implant or remotely located, is also placed or embedded subcutaneously and is configured to allow fluid, typically saline, to be gradually introduced into the expansion body by injection with a syringe. After a predetermined interval of incremental expansion, the skin and subcutaneous tissue overlying the expander are consequently stretched in response to the pressure that the expandable body exerts on such tissue as the solution is gradually introduced into the expandable body.

[0008] After gradual expansion at predetermined intervals, which may extend to weeks or months, the skin and subcutaneous tissue stretch to an extent that further medical procedures can be performed, such as the implantation of long-term prostheses, plastic and reconstructive surgery, or utilization of the skin and subcutaneous tissue for use in other parts of the body. Summary of the Invention

[0009] The present application discloses various improvements related to tissue expansion devices and related procedures that can be used to treat humans and / or animals. The devices and procedures can be used, for example, in the context of breast reconstruction surgery, breast augmentation surgery, and skin graft surgery.

[0010] Implantable devices such as breast implants and tissue expansion devices may be rounded or anatomically shaped. In accordance with aspects of at least some of the embodiments disclosed herein, it is understood that if anatomically shaped, the breast implant will be generally symmetrical about a centerline, and thus the surgeon will need to be aware of that centerline so that the device is implanted in the proper orientation.

[0011] According to some embodiments disclosed herein, tissue stretching devices can be configured in a manner that improves upon the current state of the art by providing a more effective and more economical means of orientation. For example, instead of applying a separate material, such as a strip of contrasting colored material, to the implant shell in a manufacturing step separate from the creation of the shell, the present disclosure provides devices and methods that can provide visually contrasting lines on the shell during the silicone shell casting / molding process.

[0012] For example, in some embodiments, a shell casting tool can be provided for producing tissue spreading devices, which may be a mold or mandrel, but may be finished with a surface roughened by sandblasting or other means except for the desired orientation line features, which are left as a polished or shiny surface. The resulting silicone shell fabricated from this tool can thus inherently and clearly exhibit these two different surface finishes by providing contrasting visible orientation lines on the shell surface without the need for additional components or assembly steps.

[0013] Optionally, in at least one embodiment, the tissue stretching device can be provided with suture tabs located around its periphery to help stabilize the position of the device during implantation. The suture tabs can be located, for example, at the 6 or 12 o'clock position to provide the clinician with a means of visual orientation.

[0014] However, according to at least some embodiments disclosed herein, it is understood that if all the suture tabs look the same, as in traditional devices, the device may unintentionally rotate slightly during the implantation process, causing one suture tab to be mistaken for another. For example, the 6 o'clock suture tab may be mistaken for an adjacent suture tab, such as the 4 o'clock or 8 o'clock suture. Thus, according to some embodiments, a tissue stretching device may be provided that uses visually distinct, unique looking, or different colored suture tabs only in a single position, such as the 6 o'clock position. In this way, the clinician may more clearly distinguish the suture tabs from one another to identify the proper orientation of the device during the procedure.

[0015] Additional features and advantages of the subject technology will be set forth in the description which follows, and in part will be obvious from the description, or may be learned by the practice of the subject technology. The advantages of the subject technology will be realized and attained by the structure particularly pointed out in the specification and its embodiments as well as the accompanying drawings.

[0016] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory and are intended to provide further explanation of the subject technology.

[0017] Various features of exemplary embodiments of the present disclosure are described below with reference to the drawings, in which the illustrated embodiments are intended to illustrate, but not to limit, the present disclosure. The drawings include the following figures: [Brief description of the drawings]

[0018] [Figure 1] 1 is a perspective view of a tissue expansion device according to some embodiments. [Diagram 2] 2 is a front view of the tissue expansion device of FIG. 1 according to some embodiments. [Diagram 3] 2 is a rear view of the tissue expansion device of FIG. 1 according to some embodiments. [Figure 4A] 2 is a side view of a portion of the tissue expansion device of FIG. 1 according to some embodiments. [Figure 4B] 2A-2C are exploded and assembled views of the tabs and engagement assemblies of the tissue stretching device of FIG. 1 according to some embodiments. [Diagram 5] 5 is a cross-sectional side view of the tissue expansion device of FIG. 1 taken along section line 5-5 according to some embodiments. [Figure 6] 2 is an exploded view of the tissue expansion device of FIG. 1 according to some embodiments. [Figure 7A] 1A-1C are side views of a mandrel for manufacturing a tissue expansion device according to some embodiments. [Figure 7B] FIG. 7B is a front view of the mandrel of FIG. 7A according to some embodiments. [Figure 8] 13 is a front view of another embodiment of a tissue expansion device, in accordance with some embodiments. [Figure 9] 13 is a front view of another embodiment of a tissue expansion device, in accordance with some embodiments. [Figure 10]13 is a front view of another embodiment of a tissue expansion device, in accordance with some embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0019] In the following detailed description, numerous specific details are set forth in order to provide a thorough understanding of the subject technology. It should be understood that the subject technology may be practiced without some of these specific details. In other instances, well-known structures and techniques have not been shown in detail so as not to obscure the subject technology.

[0020] Moreover, while the description herein sets forth specific details of various embodiments, it will be understood that the description is merely illustrative and should not be construed as limiting in any way. Moreover, while certain embodiments of the present disclosure may be disclosed or presented in the context of breast reconstruction or augmentation, it is believed that such embodiments can be used with a variety of devices and implants. Moreover, various applications and modifications of such embodiments that may occur to those skilled in the art are also encompassed by the general concepts described herein.

[0021] 1 shows a perspective view of a tissue spreader 10 that can be used for temporary surgical implantation in a patient prior to another procedure such as breast augmentation, breast reconstruction, or skin grafting. The tissue spreader 10 can be placed beneath the skin and left in place for a period of time to allow the overlying tissue and skin to grow or adjust to the volume of the tissue spreader 10.

[0022] As shown in Figures 1 and 2, a clinician can inject or fill the tissue spreading device 10 with fluid as needed through the injection port 12 of the device 10. For example, a clinician can use a syringe needle to puncture the tissue spreading device 10 at the injection port 12 to fill the device 10. The injection port 12 can provide a controllable flow into and out of the tissue spreading device 10. Additionally, the injection port 12 can be self-sealing upon removal of the needle.

[0023] 1, the tissue spreader 10 can include an anterior portion 14, a posterior portion 16, an upper pole 20, and a lower pole 22. Additionally, the tissue spreader 10 can further include an expandable shell 30. The expandable shell 30, or portions thereof, can be formed from a biocompatible polymeric material, such as silicone rubber, various forms of silicone laminates, silicone copolymers, polyurethane, and various other elastomers in various combinations.

[0024] As shown in the front view of FIG. 2, the expandable shell 30 of the tissue expansion device 10 can define a midpoint or center location 18 that is located between the upper pole 20 and the lower pole 22. In some embodiments, the center location 18 of the expandable shell 30 can be located at the geometric center of a circular shell. For example, FIG. 2 shows that the center location 18 is located at the midpoint of a diameter between opposing edges, circumferences, or boundaries of the expandable shell 30. However, in embodiments in which the shell 30 is not circular, the center location 18 need not necessarily represent the geometric center of the shell; for example, the center location 18 can represent the midpoint along a line (e.g., a height dimension or span) extending from an edge of the upper portion 24 of the shell 30 to an edge of the lower portion 26 of the shell 30.

[0025] According to at least one embodiment, the exterior surface 32 of the shell 30 can have a smooth or glossy finish. The device 10 can be round, circular, oval, crescent, anatomical, or other suitable shape to mimic a natural or desired breast shape.

[0026] In at least one embodiment, the tissue spreader 10 can include a number of tabs 40 coupled to the rear 16 of the shell 30. The tabs 40 can be used by a clinician to anchor, engage, or secure the tissue spreader 10 to surrounding tissue at a patient's implantation site. As shown in Figures 1 and 2, the tabs 40 can optionally include openings 42 through which sutures or other fastening means can be coupled to the tabs 40 to facilitate anchoring the tissue spreader 10 to the patient's tissue.

[0027] 3, the tabs 40 can be circumferentially spaced apart about the rear of the shell 30. The tabs 40 can extend radially outward relative to a center location 18 of the inflatable shell 30. For example, if the device 10 uses six tabs, the tabs 40 can be circumferentially spaced apart at an angle 50 of approximately 60°. However, if the device uses two, three, four, five, seven, eight, nine, ten, eleven, twelve, or more tabs, the tabs can be spaced apart at an angle 50 based on or corresponding to the number of tabs. For example, in at least one embodiment, the tabs can be circumferentially spaced apart at equal intervals depending on the number of tabs (e.g., the tabs are circumferentially spaced apart at an angle equal to 360 degrees divided by the number of tabs), as in the embodiment shown in FIG. Thus, in FIG. 3, six tabs 40 are located around the rear circumference of the shell at the 12 o'clock, 2 o'clock, 4 o'clock, 6 o'clock, 8 o'clock, and 10 o'clock positions, respectively.

[0028] Additionally, in at least one embodiment, one or more of the tabs may have attributes that are different from attributes of one or more of the remaining tabs. The attributes may include at least one of a tab color, a tab size, a tab shape, or a tab material. One or more of the tabs may be a different color or have a different shape, size, or material than one or more of the remaining tabs. In at least one embodiment, one or more of the tabs may be white, tan, yellow, orange, red, pink, purple, blue, green, brown, gray, black, and / or any shade thereof.

[0029] For example, in at least one embodiment having six tabs, the tab 60 at 6 o'clock may be white, and the remaining tabs located at 12 o'clock, 2 o'clock, 4 o'clock, 8 o'clock, and 10 o'clock may be blue.

[0030] Additionally, in at least one embodiment, all but one tab may be white, with the remaining tab having a non-white color.

[0031] Further, in at least one embodiment, one or more tabs may be a first color, one or more tabs may be a second color, one or more tabs may be a third color, one or more tabs may be a fourth color, one or more tabs may be a fifth color, and / or one or more tabs may be a sixth color.

[0032] As described further herein, the distinguishing attributes of one or more tabs may aid the clinician in positioning the device 10 within a patient. For example, the tab 40 may aid the clinician in identifying or recognizing the top 24, and / or bottom 26, and / or side 28 of the device 10. For example, the clinician may recognize that the top 24 is adjacent to the top pole 20, the bottom 26 is adjacent to the bottom pole 22, and the side 28 is located between the top and bottom, which may assist the clinician in positioning or aligning the device 10 to ensure that the shape of the device 10 is properly aligned with the patient's body. Additionally, as disclosed in more detail herein, certain attributes, such as the color, texture, or shape of the tabs, may be altered or designed to aid the clinician in quickly identifying the site or portion of the device 10 in which a given tab is located.

[0033] For example, multiple tabs may be positioned about the top 24, bottom 26, and / or sides 28 of the shell 30 to aid the clinician in identifying or recognizing the top, bottom, and / or alignment of the device 10. In at least one embodiment, six tabs are positioned at the 12, 2, 4, 6, 8, and 10 o'clock positions, and the tabs at the 4, 6, and 8 o'clock positions may be a first color, while the tabs at the 2 and 10 o'clock positions may be a second color. Optionally, the 12 o'clock tab may be a first color or a second color. In such an embodiment, the tabs at the 4, 6, and 8 o'clock positions may serve to indicate the top or bottom of the device 10. Additionally, in an embodiment where the 12 o'clock tab is a first color (the same color as the tabs at the 4, 6, and 8 o'clock positions), the clinician may be able to easily recognize both the top and bottom of the device 10, as well as the alignment of the device 10. Additionally, in at least one embodiment, the color scheme can be varied such that the tabs at the 4 o'clock and 8 o'clock positions have a different color than the remaining tabs.

[0034] Optionally, the tissue spreading device 10 may further comprise an orientation indicator 70. As mentioned above, the present disclosure draws attention to the understanding that, when anatomically shaped, breast implants are generally symmetrical about a centerline, and thus the surgeon must recognize that centerline so that the device is implanted in the proper orientation. Although certain tissue spreading devices have previously incorporated raised silicone dots on the surface of the shell to provide a tactile and visual indicator, or visible lines on the shell of a contrasting color, such as blue or white, to indicate the centerline, these dots or lines are applied to the implant's shell in ancillary assembly operations. Thus, manufacturing costs are high, additional material or color may be lost, or may not be applied accurately. Thus, in addition to the challenge of properly aligning the tissue spreading device or breast implant with respect to the patient's anatomy, the manufacturing process that produces the indicator dots and lines may be improper or inaccurate, which may be difficult for the clinician to recognize or overcome. In contrast, the present disclosure provides a solution for producing an orientation indicator 70 that is formed by and / or along the inner surface of the shell 30, thereby avoiding additional manufacturing costs and ensuring that the orientation indicator 70 is precisely positioned relative to the shell 30 and its shape.

[0035] In at least one embodiment, the orientation indicator 70 is visible along the front 14 of the shell 30. The orientation indicator 70 can be located along the lower pole 22 of the shell 30. However, the orientation indicator 70 can also extend along the upper pole 20 of the shell 30. Additionally, in some embodiments, the orientation indicator 70 can extend along both the upper pole 20 and the lower pole 22.

[0036] The orientation indicator 70 may extend to and / or beyond the central location 18 of the shell 30. Additionally, the orientation indicator 70 may extend past, through, or only to the injection port 12.

[0037] As shown in FIG. 2, the orientation indicator 70 can extend as a vertical line along the vertical dimension. However, the orientation indicator 70 can also extend as a generally horizontal line along the horizontal dimension. The longitudinal extent of the orientation indicator 70 can correspond to the vertical or horizontal dimension. For example, referring to the front view of FIG. 2, the orientation indicator 70 can extend from the lower portion 26 upwardly across at least 50% of the diameter or height of the inflatable shell 30. According to some embodiments, the orientation indicator 70 can extend up to about 50%, at least about 50%, at least about 55%, at least about 60%, at least about 65%, at least about 70%, at least about 75%, at least about 80%, at least about 85%, at least about 90%, at least about 95%, or even entirely across a given dimension, diameter, or height of the inflatable shell 30. The width, pattern, shape, and / or longitudinal extent of the orientation indicator 70 can be advantageously designed to provide an easy visual tool for placement and alignment of the device 10. This dedicated feature provides unique cost-effective advantages from both a manufacturing and clinical standpoint.

[0038] The orientation indicator 70 can provide one or more geometric patterns or shapes that can enable a clinician to identify aspects and / or orientations of the tissue spreader 10 when implanting the tissue spreader 10 within a patient cavity. As shown in FIG. 2, the orientation indicator 70 can include a band, strip, or line that extends along the shell 30 and is visible along the shell 30. Additionally, the orientation indicator 70 can be aligned with one or more components or aspects of the tissue spreader 10. For example, the orientation indicator 70 can be aligned with at least one of the plurality of tabs 40. In the case of a line or linear pattern, the orientation indicator 70 can extend along a vertical axis, a horizontal axis, or other axis. Visual perception of the orientation indicator 70 can enable a clinician to adjust the position of the tissue spreader 10 within the cavity by aligning the orientation indicator 70 with respect to a horizontal or vertical plane or other indicia.

[0039] While various configurations can be produced, the embodiment shown in Figure 2 illustrates the orientation indicator 70 extending generally along a vertical plane between the edge of the shell 30 adjacent the 6 o'clock tab 60 and the injection port 12. The orientation indicator 70 can extend partially or completely along such a path along the lower pole 22 of the shell 30. Optionally, the orientation indicator 70 can extend along the upper pole 20 along the same vertical plane. However, the embodiment shown in Figure 2 advantageously provides a clear indication to the clinician as to the orientation of the tissue stretching device 10 because it only appears at the lower pole 22 while also providing a sufficiently long line as a visual indicator.

[0040] In some embodiments, the orientation indicator 70 includes a line having a first end 72 adjacent an edge of the shell 30 and a second end 74 distal to the edge of the shell. The injection port 12 can intersect with the second end of the orientation indicator 70. Optionally, the second end 74 of the orientation indicator extends to or is aligned with the perimeter 13 of the injection port 12.

[0041] In addition to facilitating alignment and proper placement of the device within a patient, the orientation indicator 70 may also be advantageously used to facilitate manufacturing of the device 10, according to some embodiments. For example, the orientation indicator 70 may be used to improve the efficiency and accuracy of manufacturing each device 10, as well as the consistency of manufacturing among a plurality of devices 10. For example, after the shell 30 is manufactured with the orientation indicator 70, the injection port 12 may be positioned along the shell 30 by aligning a portion of the injection port 12 with a portion of the orientation indicator 70. For example, the perimeter 13 of the injection port 12 (e.g., a bottom or central portion of the perimeter) may be positioned to abut or otherwise align with the second end 74 of the orientation indicator.

[0042] 3-4B, the tab 40 may be bonded to the shell 30 by adhesive or may be molded with a portion of the shell 30. FIGS. 4A and 4B show a side view and perspective assembly view of the tab 40. FIG. 4A shows the 6 o'clock tab 60 and its engagement structure 80 in a side view. FIG. 4B shows an exploded view and assembly view of the engagement structure 80 with the tab 40. The engagement structure 80 may include upper and lower engagement layers 82, 84 that sandwich the tab 40. The engagement structure 80 and the tab 40 may be attached to the shell 30 and vulcanized. The tab 40 may include a surface structure or mesh pattern along its outer surface that may aid in gripping the tab 40 to manipulate the position of the device 10 and further enhance engagement with the upper and lower engagement layers 82, 84. As shown in FIG. 4A, the engagement structure 80 and the tab 40 may be bonded to the rear 16 of the shell 30.

[0043] Figures 5 and 6 show side cross-sectional views of tissue expansion device 10 in an assembled and disassembled state, respectively. As shown in Figure 5, injection port 12 of device 10 can be disposed within cavity 90 of shell 30. Injection port 12 can include an injection reservoir assembly 100 coupled to an inner surface 102 of shell 30. Injection reservoir assembly 100 can be manufactured similar to the injection reservoir assembly disclosed in commonly owned U.S. Patent No. 4,671,255, which is incorporated herein by reference in its entirety.

[0044] In the present disclosure, the injection reservoir assembly 100 can include an injection reservoir 110 coupled to or laminated to the inner surface 102 of the shell 30. The injection reservoir assembly 100 can provide a self-sealing valve or injection port that tends to seal any puncture or opening caused by a needle as the needle is advanced into and subsequently withdrawn from the injection port 12.

[0045] 5 shows the upper pole 20 located between the center location 18 of the shell 30 and the upper end of the shell 30 at the upper portion 24, and the lower pole 22 located between the center location 18 of the shell 30 and the lower end of the shell 30 at the lower portion 26. The injection port 12 can be located completely within the upper pole 20. However, in some embodiments, only a portion of the injection port 12 may be located within the upper pole 20, with a portion of the injection port 12 extending across the center location 18. In some embodiments, at least 50% of the injection port 12 is located within the upper pole 20.

[0046] 2, orientation indicator 70 can extend from injection port 12 toward the bottom end of shell 30. Additionally, in some embodiments, orientation indicator 70 can extend from injection port 12 toward another edge of shell 30, such as a top or side edge of shell 30. Additionally, in some embodiments, orientation indicator 70 can extend from injection port 12, across a portion of upper pole 20, and across lower pole 22.

[0047] 6, the injection reservoir 110 can be bonded to the inner surface 102 via a bonding layer 112. In at least one embodiment, the bonding layer 112 can include a reinforcing ring 114 and a filler plug 116. The reinforcing ring 114 can include a mesh or fabric material molded with a polymer, such as silicone. The reinforcing ring 114 can help increase the durability of the injection reservoir assembly 100. The reinforcing ring 114 can optionally be configured as a tear-resistant layer.

[0048] The injection reservoir 110 can include a reservoir body 111 and a flange 113 extending radially outward from the reservoir body 111. The flange 113 can have a thickness that tapers away from the reservoir body 111. The reservoir body 111 can form a mid-periphery of the injection reservoir 110, while the flange 113 can form or extend along the injection port's outer periphery 13. If the orientation indicator 70 is used as a manufacturing reference point, for example for locating the injection port 12, the flange 113 can be positioned to align with the orientation indicator's second end 74 when the injection reservoir 110 is coupled to the device 10.

[0049] The tapered flange 113 can provide a flexible (or more rigid) portion of the infusion reservoir 110. For example, the flange 113 can flex relative to the reservoir body 111 to provide a smoother, less abrupt transition between the infusion reservoir 110 and adjacent portions of the device 10. Thus, when a force (such as a bending force or point stress applied to the shell 30) is directed against the infusion reservoir 110 or an area adjacent to the infusion reservoir 110, the flange 113 can tend to flex or provide a rigid, tactilely identifiable perimeter of the infusion port 12. Additionally, the flange 113 can advantageously ensure a larger seal between the infusion reservoir 110 and the inner surface 102 by providing an increased surface area with respect to the reservoir body 111 for coupling the infusion reservoir 110 to the inner surface 102 of the shell. Thus, the material, structure, and radial extent of the flange 113 can be selected to provide a desired amount of surface area and a desired structural behavior for the infusion port 12.

[0050] Additionally, the tissue expansion device 10 may include a stable base 120 coupled to the inner surface 102 of the shell 30 along the rear portion 16 of the shell. As shown, the shell 30 may include a mandrel opening 122 extending through the rear portion of the shell 30. The stable base 120 may be coupled to the rear portion 16 to provide structural support to the rear portion 16, particularly around the mandrel opening 122. Additionally, the tissue expansion device may include a filler plug 124 and a patch 126 that may be used to fill and seal the mandrel opening 122.

[0051] According to at least one embodiment, as previously mentioned, the shell 30 can have an opaque or translucent appearance. To achieve the opaque or translucent appearance, the shell 30 can be manufactured such that the inner surface 102 has a roughened texture. Thus, light passing through the shell 30 is diffracted, preventing the light from passing through, thus achieving the opaque or translucent appearance of the shell 30.

[0052] In accordance with the implementation of at least one embodiment disclosed herein, when the stable base 120 is bonded or laminated to the inner surface 102 of the shell 30, many of the microscopic gaps and pockets in the roughened texture of the inner surface 102 are filled and removed with material from the stable base 120 as a result of the lamination process. As the roughened texture of the inner surface 102 is removed by the lamination process, light diffraction is greatly reduced, thus creating a transparent or light-transmitting appearance along these areas of bond between the stable base 120 and the shell 30. In some cases, the now transparent or light-transmitting appearance along these areas may tend to draw attention to air pockets, streaks, breaks, or other imperfections in the lamination between these components. A similar result may be found in the lamination between the infusion reservoir assembly 110 and the inner surface 102 of the shell 30, although the reinforcing ring 114 may be configured to include a mesh pattern that may tend to mask or hide visual imperfections in the lamination process.

[0053] To provide an attractive appearance and hide visual imperfections in the lamination between the stable base 120 and the inner surface 102 of the shell 30, at least one embodiment can be configured such that the stable base 120 includes a textured inner surface 130. The textured inner surface 130 can provide an appearance visually similar to the mesh pattern of the reinforcement ring 114. Because the laminated stable base 120 and inner surface 102 provide a mostly transparent view of the textured inner surface 130, the tissue stretching device can include a consistent pattern along the injection port 12, the rear portion 16, and the tab 40 of the front portion 114 of the device 10. Furthermore, although the pattern in the illustrated embodiment is described as being a mesh pattern, other patterns can be provided. Furthermore, the pattern of the textured inner surface 130 can be selected to be different from the pattern provided by the reinforcement ring 114 and / or the tab 40 of the injection port 12.

[0054] The shell 30 has a thickness extending between the outer surface and the inner surface 102 of the shell. The shell thickness may be approximately constant along each of the anterior 14 and posterior 16 of the device. The constant thickness of the shell 30 may result in consistent light transmission and / or diffraction in the shell 30 and may provide consistent resistance along all portions of the shell 30. However, in some embodiments, the thickness of the shell 30 may increase and / or decrease along any portion of the shell. For example, the thickness of the shell 30 may decrease from the anterior 114 to the posterior 16. In some embodiments, the thickness of the shell 30 may decrease from the lower pole 22 to the upper pole 20. Such a change in thickness may advantageously provide desired tactile feedback to assist a clinician in aligning the device 10 relative to a patient's anatomy.

[0055] When viewed in cross-section, for example as shown in Figure 5, the device 10 has a width extending between the rear portion 16 and the front portion 14. The width of the device 10 tapers from the lower pole 22 to the upper pole 20. In some embodiments, when moving from the lower portion 26 to the upper portion 24, the width of the device 10 increases along the lower pole 22 and then the width of the device 10 decreases along the upper pole 20. In some embodiments, the device 10 has a maximum width near the center position 18 at the lower pole 22 and a minimum width adjacent the upper portion 24 at the upper pole 20.

[0056] According to some embodiments, the exterior surface of the shell 30 along the front portion 14 can have a generally convex shape. However, it should be noted that a portion of the shell 30 can have a convex or concave shape. For example, the exterior surface of the shell 30 along a portion of the lower pole 22 can be convex, while the exterior surface of the shell 30 along a portion of the upper pole 20 can be concave. In some embodiments, the exterior surface of the shell 30 transitions from a convex shape to a concave shape along a portion of the upper pole 20.

[0057] 7A and 7B, a mandrel 150 is shown that may be used in the manufacture of at least one embodiment disclosed herein. The casting tool or mandrel 150 may include an exterior surface 152. During manufacture of the apparatus 10, the mandrel 150 may be coupled to another tool or support device using a coupling recess 154 in the mandrel. In some embodiments, the coupling recess 154 is located at a center 156 of the mandrel. The coupling recess 154 may correspond to the mandrel opening 122 of a shell, and the center 156 of the mandrel may correspond to the center location 18 of a shell, such as the shell 30 discussed in the embodiment of FIGS. 1-6.

[0058] As shown in the front view of mandrel 150 in Figure 7B, exterior surface 152 can have smooth regions 160 and rough regions 162. Smooth regions 160 can correspond to an orientation indicator, such as orientation indicator 70 discussed in the embodiment of Figures 1-6. In some embodiments, a rough region of exterior surface 152 can correspond to an orientation indicator, and another portion of exterior surface 152 can have a smooth region. Figure 7B further illustrates how smooth region 160, which can correspond to an orientation indicator, extends across center 156 of the mandrel, which can correspond to center location 18 of the shell.

[0059] According to at least one method of manufacturing the tissue expansion device 10, the shell can be manufactured by dipping the mandrel 150 into a polymer solution and then drying. The shell can have a shape that matches the shape of the outer surface 152 of the mandrel 150. In addition, however, the shell can have an inner surface that corresponds to the smooth regions 160 and rough regions 162 of the outer surface 152 of the mandrel 150. In this manner, a desired texture of the inner surface 102 of the shell 30, as described above, as well as any shape or pattern of the orientation indicator 70 can be achieved. In this manner, various advantages can be achieved over previous devices and manufacturing methods.

[0060] 8, 9, and 10 show various embodiments of tissue spreader 10. For example, FIG. 8 shows an embodiment of tissue spreader 170 with multiple tabs 40, orientation indicators 70, and other such features similar to tissue spreader 10, the details of which are not described here for brevity, but are incorporated by reference from the disclosure above. However, device 170 can be configured with an injection port 172 having a visible or outer ring 174. Injection port 172 can be compact and have a bonded area along outer ring 174 that is smaller in size than the bonded area of ​​injection port 12.

[0061] 9, an embodiment of tissue stretching device 180 is shown that does not include tabs. Features of device 180 may be similar to those discussed above with respect to device 10 and will not be described here for brevity, but are incorporated by reference from the disclosures above. However, device 180 may be manufactured and used without the tabs already disclosed with respect to device 10. Additionally, device 180 may be configured without tabs, although other embodiments may be configured to include one or more tabs as disclosed herein.

[0062] For example, Fig. 10 shows an embodiment of tissue spreader 190 with three tabs circumferentially offset at 120 degrees from one another. Features of device 190 may be similar to those described above with respect to device 10 and will not be described here for brevity, but are incorporated by reference from the disclosure above. Additionally, injection port 192 may form a transparent or opaque non-white portion of device 190 without an underlying pattern from a reinforcing ring. Additionally, device 190 may be configured with a corresponding or different appearance of the rear of the device and / or tabs relative to injection port 192.

[0063] Further considerations In some embodiments, any clause herein may be dependent on any one of the independent clauses or any one of the dependent clauses. In one aspect, any clause (e.g., dependent clause or independent clause) may be combined with any other one or more clauses (e.g., dependent clause or independent clause). In one aspect, a claim may include some or all of the words (e.g., steps, operations, means, or components) recited in a clause, sentence, phrase, or paragraph. In one aspect, a claim may include some or all of the words recited in one or more clauses, sentences, phrases, or paragraphs. In one aspect, some of the words in each clause, sentence, phrase, or paragraph may be deleted. In one aspect, additional words or elements may be added to a clause, sentence, phrase, or paragraph. In one aspect, the subject technology may be implemented without utilizing some of the components, elements, functions, or operations described herein. In one aspect, the subject technology may be implemented with additional components, elements, functions, or operations.

[0064] The subject technology is exemplified according to various aspects, for example, as described below. Various examples of aspects of the subject technology are described as numbered clauses (1, 2, 3, etc.) for convenience. These are presented as examples and are not intended to limit the subject technology. It should be noted that any dependent clauses can be combined in any combination and placed in their respective independent clauses, such as clause 1 or clause 5. Other clauses can be presented in a similar manner.

[0065] Clause 1. A tissue stretching device for temporary surgical implantation beneath a patient's skin and for removal following a predetermined stretching of overlying tissue, the device comprising: an inflatable shell forming an inflatable chamber and having a front and a rear; an orientation indicator visible at said front of said inflatable shell and extending across at least 50% of a vertical dimension of said inflatable shell when viewed from the front; and an injection port coupled to said front of said shell and in communication with said chamber, the injection port configured to permit injection of a fluid into said chamber from a hypodermic needle.

[0066] Clause 2. The apparatus of clause 1, further comprising a plurality of tabs coupled to the rear portion of the shell.

[0067] Clause 3. The apparatus of clause 1, further comprising a plurality of tabs disposed near a top, bottom, and sides of the inflatable shell.

[0068] Clause 4. The device of clause 2, wherein each of the plurality of tabs extends in a radial outward direction relative to a central location of the device.

[0069] Clause 5. The apparatus of any one of clauses 2-4, wherein the plurality of tabs includes six tabs.

[0070] Clause 6. The apparatus of any one of clauses 2-5, wherein the plurality of tabs includes six tabs, the six tabs being circumferentially disposed around the rear portion of the shell at the 12 o'clock position, the 2 o'clock position, the 4 o'clock position, the 6 o'clock position, the 8 o'clock position, and the 10 o'clock position, respectively.

[0071] Clause 7. The apparatus of any one of clauses 2-6, wherein at least one tab of the plurality of tabs has attributes that are different from attributes of remaining tabs of the plurality of tabs.

[0072] Clause 8. The apparatus of clause 7, wherein the attributes include at least one of a tab color, a tab size, a tab shape, or a tab material.

[0073] Clause 9. The apparatus of any one of clauses 2-8, wherein the plurality of tabs includes six tabs, a first tab of the six tabs having a first color and a remaining tab of the six tabs having a second color.

[0074] Clause 10. The apparatus of clause 9, wherein the first of the six tabs is disposed on a bottom portion of the inflatable shell.

[0075] Clause 11. The device of any one of clauses 2-10, wherein each of the plurality of tabs includes an opening through which a suture passes.

[0076] Clause 12. The device of any one of clauses 1-11, wherein the orientation indicator is formed along an inner surface of the shell.

[0077] Clause 13. The apparatus of any one of clauses 1-12, wherein the orientation indicator comprises a line.

[0078] Clause 14. The apparatus of any one of clauses 1-13, wherein the orientation indicator includes a line extending from the injection port toward an edge of the shell.

[0079] Clause 15. The device of any one of clauses 1-14, wherein the orientation indicator extends across at least about 50% of a dimension of the expandable shell.

[0080] Clause 16. The device of any one of clauses 1-15, wherein the orientation indicator extends across at least about 55% of a dimension of the expandable shell.

[0081] Clause 17. The device of any one of clauses 1-16, wherein the orientation indicator extends across at least about 60% of a dimension of the expandable shell.

[0082] Clause 18. The device of any one of clauses 1-17, wherein the orientation indicator extends across at least about 65% of a dimension of the expandable shell.

[0083] Clause 19. The device of any one of clauses 1-18, wherein the orientation indicator extends across at least about 70% of a dimension of the expandable shell.

[0084] Clause 20. The device of any one of clauses 1-19, wherein the orientation indicator extends across at least about 75% of a dimension of the expandable shell.

[0085] Clause 21. The apparatus of any one of clauses 1-17, wherein the orientation indicator extends across a central location of the expandable shell.

[0086] Clause 22. The device of any one of clauses 1-14, wherein the orientation indicator extends across at least about 50% of a vertical dimension of the expandable shell.

[0087] Clause 23. The device of clause 1, further comprising a plurality of tabs coupled to the rear of the shell, a first of the plurality of tabs coupled to the shell at a 6 o'clock position, the orientation line extending from the injection port toward the first tab at the 6 o'clock position.

[0088] Clause 24. The device of clause 1, further comprising a plurality of tabs coupled to the rear portion of the shell, the orientation indicator being aligned with at least one of the plurality of tabs.

[0089] Clause 25. The device of any one of clauses 1-24, wherein the orientation indicator comprises a surface texture of the expandable shell.

[0090] Clause 26. The device of any one of clauses 1-25, wherein the orientation indicator comprises a surface texture on an inner surface of the expandable shell.

[0091] Clause 27. The device of any one of clauses 1-26, wherein an outer surface of the expandable shell comprises a smooth finish, the orientation indicator comprises a smooth finish on an inner surface of the expandable shell, and a remainder of the inner surface of the expandable shell comprises a rough finish.

[0092] Clause 28. The apparatus of any one of clauses 1-27, wherein the orientation indicator includes a line having a first end adjacent an edge of the shell and a second end distal to the edge of the shell, the second end intersecting the injection port.

[0093] Clause 29. The apparatus of clause 28, wherein the second end of the orientation indicator is aligned with a periphery of the injection port.

[0094] Clause 30. The device of any one of clauses 1-29, wherein the orientation indicator is a transparent portion of the shell.

[0095] Clause 31. The apparatus of any one of clauses 1-30, wherein an outer surface of the shell has a smooth finish.

[0096] Clause 32. A method of implanting a tissue stretching device according to any one of clauses 1 to 31, comprising positioning said tissue stretching device within a cavity of a patient and adjusting the position of said tissue stretching device within said cavity by aligning an orientation indicator with respect to a horizontal or vertical plane.

[0097] Clause 33. The method of clause 32, wherein the orientation indicator comprises a transparent portion of the shell of the tissue stretching device, and the adjusting step comprises aligning the orientation indicator with a vertical plane.

[0098] Clause 34. The method of clause 33, wherein the tissue stretching device comprises a plurality of tabs coupled to a rear portion of the tissue stretching device, the orientation indicator is aligned with a first one of the plurality of tabs located at a six o'clock position, and the adjusting step includes aligning the orientation indicator and the first tab with respect to a vertical plane.

[0099] Clause 35. A method of manufacturing a tissue expansion device, comprising: immersing a casting tool having an exterior surface having textured and smooth portions into a polymer solution to form a shell along the exterior surface of the casting tool, allowing the shell to dry, and removing the shell from the casting tool, the shell having an interior surface with a first portion corresponding to the textured portion and a second portion corresponding to the smooth portion, the shell having a smooth exterior surface, the smooth exterior surface of the shell and the second portion cooperating to define a transparent orientation indicator, the smooth exterior surface of the shell and the first portion of the shell interior surface cooperating to define a translucent or opaque portion of the shell that provides visual contrast to the transparent orientation indicator, the orientation indicator extending across at least 50% of a diameter of the expandable shell.

[0100] Clause 36. The method of clause 35, further comprising coupling a plurality of tabs to a rear portion of the shell.

[0101] Clause 37. The method of clause 36, wherein the bonding step includes bonding the plurality of tabs circumferentially around the rear portion of the shell at a 12 o'clock position, a 2 o'clock position, a 4 o'clock position, a 6 o'clock position, an 8 o'clock position, and a 10 o'clock position, respectively.

[0102] Clause 38. The method of clause 37, wherein a first tab of the plurality of tabs comprises attributes that are different from attributes of remaining tabs of the plurality of tabs, the method further including positioning the first tab at a six o'clock position of the rear of the shell.

[0103] Clause 39. The method of clause 38, wherein the attributes include at least one of a tab color, a tab size, a tab shape, or a tab material.

[0104] Clause 40. The method of any one of clauses 35-39, further comprising coupling an injection reservoir assembly to the shell interior surface at an injection port portion of the shell interior surface to change the translucent or opaque portion at the injection port portion to transparent.

[0105] Clause 41. The method of clause 40, wherein the injection reservoir assembly includes a reinforcing ring having a first pattern formed thereon, the first pattern being visible through the transparent injection port portion when the injection reservoir assembly is coupled to the shell.

[0106] Clause 42. The method of clause 41, wherein the first pattern comprises a mesh pattern.

[0107] Clause 43. The method of any one of clauses 35 to 42, further comprising bonding a stable base to the shell interior surface at the rear of the shell to change the translucent or opaque portion to transparent in a portion of the rear.

[0108] Clause 44. The method of clause 43, wherein the stable base comprises a patterned inner surface having a second pattern formed thereon, the second pattern being visible through the transparent portion of the rear portion when the stable base is coupled to the shell.

[0109] Clause 45. The method of clause 44, wherein the second pattern comprises a mesh pattern.

[0110] Clause 46. The method of any one of clauses 35-45, further comprising coupling an injection reservoir assembly to the shell interior surface at an injection port portion of the shell, the coupling step comprising aligning a periphery of the injection reservoir with an end of the orientation indicator.

[0111] The above description is presented to enable one of ordinary skill in the art to practice the various configurations described herein. Although the subject technology has been described in detail with reference to various figures and configurations, it should be understood that these are for illustrative purposes only and should not be construed as limiting the scope of the subject technology.

[0112] There may be many other ways of implementing the subject technology. Various functions and elements described herein may be implemented in ways different from those shown herein without departing from the scope of the subject technology. Various modifications to these configurations will be readily apparent to those skilled in the art, and the general principles defined herein may be applied to other configurations. Thus, numerous changes and modifications may be made to the subject technology by those skilled in the art without departing from the scope of the subject technology.

[0113] It should be understood that the specific order or hierarchy of steps in the processes disclosed is merely an illustration of exemplary approaches. Based upon design preferences, it should be understood that the specific order or hierarchy of steps in the processes may be rearranged. Some of the steps may also be performed simultaneously. The accompanying method claims present elements of the various steps in a sample order, and are not intended to be limited to the specific order or hierarchy presented.

[0114] As used herein, with respect to a list of items separated in any way by the terms "and" or "or," the phrase "at least one of" preceding such a list of items does not modify each member of the list (i.e., each item), but rather the list as a whole. The phrase "at least one of" does not require the selection of at least one of each item in the list; rather, the phrase can mean including at least one of any one of the items, and / or including at least one of any combination of the items, and / or including at least one of each item. By way of example, the phrase "at least one of A, B, and C" or "at least one of A, B, or C" refers, respectively, to only A, only B, or only C, any combination of A, B, and C, and / or at least one of each of A, B, and C.

[0115] As used in this disclosure, terms such as "upper", "lower", "front", "rear" and the like should be understood to refer to any frame of reference other than the usual gravitational frame of reference. Thus, the upper, lower, front and rear surfaces can extend upward, downward, diagonally or horizontally in the gravitational frame of reference.

[0116] Furthermore, to the extent that terms such as "include," "have," and the like are used in this specification or the claims, such terms are intended to be inclusive in a similar manner to the interpretation of the term "comprise" when used as a transitional term in the claims.

[0117] The word "exemplary" is used herein to mean "serving as an example, instance, or illustration." Any embodiment described herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other embodiments.

[0118] Reference to an element in the singular is not intended to mean "one and only one" but rather "one or more" unless specifically stated otherwise. Masculine pronouns (e.g., "his") include feminine and neuter genders (e.g., "her" and "it"), and vice versa. The term "several" refers to one or more. Underlined and / or italicized headings and subheadings are used for convenience only and are not intended to limit the subject technology, nor are they to be referenced in connection with interpreting the subject technology description. All structural and functional equivalents of the elements of the various configurations described throughout this disclosure that are known or later become known to those skilled in the art are expressly incorporated herein by reference and are intended to be encompassed by the subject technology. Furthermore, nothing disclosed herein is intended to be open to the public, whether or not such disclosure is expressly set forth in the above description.

Claims

1. 1. A tissue stretching device that is temporarily surgically implanted beneath a patient's skin and removed following a predetermined stretching of the overlying tissue, an inflatable shell defining an inflatable chamber and having a front and a rear; a plurality of tabs coupled to the rear portion of the inflatable shell, a first tab of the plurality of tabs disposed at a bottom portion of the inflatable shell, the first tab having attributes that are different from attributes of other tabs of the plurality of tabs; an injection port configured to allow injection of a fluid into the expandable chamber; An apparatus comprising:

2. The apparatus of claim 1 or 2, wherein the attributes include at least one of a color of the tab, a size of the tab, a shape of the tab, or a material of the tab.

3. The device of claim 1 or 2, wherein the first tab is white or transparent and other tabs of the plurality of tabs are non-white or opaque.

4. The device of claim 1 or 2, wherein the plurality of tabs other than the first tab are blue in color.

5. The device of claim 1 or 2, wherein each of the plurality of tabs extends in a radially outward direction relative to a central location of the device.

6. 6. The device of claim 5, wherein the plurality of tabs are disposed around the periphery of the rear portion of the expandable chamber, and each of the plurality of tabs is spaced approximately 60 degrees from an adjacent one of the plurality of tabs.

7. 7. The device of claim 6, wherein the plurality of tabs includes six tabs located at the 12 o'clock, 2 o'clock, 4 o'clock, 6 o'clock, 8 o'clock, and 10 o'clock positions around the circumference of the rear of the shell.

8. 8. The device of claim 7, wherein the first tab is located at the six o'clock position.

9. The device of claim 1 , further comprising an orientation indicator comprising a vertical line extending from the injection port.

10. The device of claim 9 , wherein the vertical line extends from the injection port to the first tab.

11. 11. A tissue expansion device according to claim 9 or 10, wherein the orientation indicator extends across at least 50% of the vertical dimension of the expandable shell when viewed from the front of the expandable shell.

12. 11. The tissue expansion device of claim 9 or 10, wherein the orientation indicator extends across a central location of the expandable shell.

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