Minimally invasive implant surgery and system

Abstract

An implant insertion system includes a tissue dilator or separator including an inflatable balloon having a posterior side that flexes upon inflation; and an implant having a posterior side that is curved when positioned against an anatomical surface, where the curved posterior side of the implant substantially matches the curved posterior side of the tissue expander. The implant may have an anterior side substantially similar to the posterior side. The implant insertion system may have a syringe configured to insert the implant into a target location.

Description

Priority claim

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 435,929, filed on December 29, 2022, the benefit of priority of which is hereby claimed and is incorporated herein by reference in its entirety. Technical Field

[0002] The present invention generally relates to implants, tools, systems and surgical methods for inserting implants into the human body. More specifically, the present invention relates to compressible breast implants, breast implant tools and surgical methods for performing minimally invasive breast implant surgery. Background Art

[0003] Breast implants are one of the largest implantable medical devices to be inserted into the human body. Inserting a breast implant into the human body typically requires making a large incision in the patient's body in close proximity to the target site of the implant. A large incision is typically required not only to allow passage of the breast implant into the patient's body, but also to allow room for the tools needed to perform the procedure. As can be imagined, a large incision increases the likelihood of tissue damage, inflammatory response, etc.

[0004] Breast implant surgery can be a time-consuming, invasive procedure with a long recovery time. Due to the length of the surgery, the incisions, and the manipulations that the medical professional must perform during the surgery, the patient will typically receive general anesthesia, so the patient is unconscious during the surgery. After the surgery is complete, the patient may have a large and visible scar where the medical professional made the incisions to properly place the implant in the patient's body. The patient may also face complications caused by making large incisions in the patient's body to facilitate the proper insertion of the implant. The patient may also experience an uncomfortable or painful recovery process as the implant is accepted in the patient's body and as the incisions heal. Summary of the invention

[0005] The inventors have recognized that minimally invasive devices and methods of use may help address, among other issues, issues associated with surgical implant procedures that require large incisions to be made in a patient's body.

[0006] The inventors have recognized that an implant having a substantially uniform shape in at least one orientation can help solve the problem of inserting the implant in the correct orientation. The inventors have also recognized that inserting an implant having rounded posterior and anterior surfaces into a cavity prepared in a manner that causes minimal damage to connective tissue, such as ligaments or soft tissue, can produce a more natural anatomical appearance. Additionally, the inventors have recognized that performing a minimally invasive breast implant surgical procedure can shorten the length of the surgical procedure, minimize damage to the patient's body tissue, avoid the use of general anesthesia, and promote a faster and less painful recovery process.

[0007] An example implant insertion system may include a tissue expander or tissue separator having an inflatable balloon having a posterior side that curves when inflated; and an implant having a posterior side that curves when positioned against an anatomical surface, wherein the curved posterior side of the implant substantially matches the curved posterior side of the tissue expander.

[0008] For example, a kind of implant insertion system compatible with implant may be useful, and this implant has, for example, the front side and the rear side that are bent in a similar manner basically, and the longitudinal axis that is positioned equidistantly with the front side apex and the rear side apex basically.Implant system can also have extra parts, such as tissue expansion or separation balloon, and it can arrange size and have the profile that is similar to required implant.

[0009] An implant insertion system can be envisioned, comprising, for example, a syringe comprising a nozzle defining a housing and an implant. The syringe of the implant insertion system can include a handle detachably coupled to the nozzle, wherein the handle includes an expandable film configured to expand into the nozzle under a supply of pressurized fluid. The implant can be configured such that in a first form, the front and rear sides of the implant each protrude a substantially similar distance away from the longitudinal axis. The implant can also be configured such that in a second form, the front and rear sides are substantially uniformly compressed. The implant can be a breast implant.

[0010] The inventors have recognized a method of inserting and implanting an implant that may include using a balloon, for example, to form a nested cavity in a breast region of a patient's body that may assist in the implantation process. The exemplary method may include making an incision, such as a small incision, and inserting a tissue expander or separator, such as a balloon, into a target site in the patient's body, inflating the balloon between at least two layers of connective tissue at the target site to separate the at least two layers of connective tissue and form a cavity having a contour that substantially matches the contour of the breast implant.

[0011] The method of inserting an implant may also include inserting the implant into a target site using a syringe having a nozzle having a cavity, a nozzle end, and a nozzle end opening, wherein the implant is compressed within the cavity of the nozzle between the nozzle end and the expandable membrane. The method may also include applying a force to the implant with the expandable membrane within the housing to cause the implant to pass through the nozzle end and be discharged from the nozzle end opening and into the target site.

[0012] This summary is intended to provide an overview of the subject matter of this patent application. It is not intended to provide an exclusive or exhaustive explanation of the invention. Specific embodiments are included to provide further information about this patent application. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] In the drawings, which are not necessarily drawn to scale, the same numerals may describe similar components in different views. The same numerals with different letter suffixes may represent different instances of similar components. These drawings generally illustrate, by way of example (but not by way of limitation), various examples discussed in this document.

[0014] Figure 1A is a top view of an implant having an elliptical or spherical shape according to at least one example of the present invention.

[0015] Figure 1B is a top view of an implant having an elliptical or spherical shape according to at least one example of the present invention.

[0016] Figure 1C is a top view of an implant having an elliptical or spherical shape with a substantially flat posterior side according to at least one example of the present invention.

[0017] Figure 1D is a side view of an implant having a teardrop shape according to at least one example of the present invention.

[0018] Figure 1E to Figure 1F is a diagram illustrating size, volume, and protrusion distance according to at least one example of the present invention.

[0019] Figure 2 is a cross-section of an implant according to at least one example of the present invention.

[0020] FIG. 3A to FIG. 3D is a cross-section of a shell of a breast implant according to at least one example of the present invention.

[0021] Figure 4 is a top view of a marking tool according to at least one example of the present invention.

[0022] Figure 5 is an isometric view of a cannula according to at least one example of the present invention.

[0023] Figure 6 is a side view of a tissue dissector according to at least one example of the present invention.

[0024] Fig. 7A is a top view of an assembled tissue expander according to at least one example of the present invention.

[0025] Figure 7B is an isometric view of a support extension of a tissue expander according to at least one example of the present invention.

[0026] Figure 8 is an exploded isometric view of a syringe according to at least one example of the present invention.

[0027] Fig. 9 is a cross-section of a syringe according to at least one example of the present invention.

[0028] Fig.10 is a rear view of a syringe according to at least one example of the present invention.

[0029] Fig.11 is a side view of a syringe according to at least one example of the present invention.

[0030] FIG. 12A to FIG. 12E is a top view of a nozzle tip and nozzle tip opening according to at least one example of the present invention.

[0031] Fig.13 is a front view of a patient's torso in accordance with at least one example of the present invention.

[0032] FIG. 14A to FIG. 14D is an illustration of steps in a surgical procedure utilizing a marking tool in accordance with at least one example of the present invention.

[0033] Fig.15 is an image of an area for infiltration according to at least one example of the present invention.

[0034] FIG. 16A to FIG. 16B are exemplary images of an area for use of a tissue dissector in accordance with at least one example of the present invention.

[0035] FIG. 17A to FIG. 17G are exemplary images of a procedure using a tissue expander in accordance with at least one example of the present invention.

[0036] 18A to 18C is an exemplary side profile image of a balloon position within a breast in accordance with at least one example of the present invention.

[0037] FIG. 19A to FIG. 19N is an exemplary image of a procedure for inserting an implant into a breast in accordance with at least one example of the present invention.

[0038] Fig. 20A A cross-sectional view of a breast in an oblique orientation with an implant inserted is shown in accordance with at least one example of the present invention.

[0039] Fig. 20B A cross-sectional view of a breast in an upright orientation with an implant inserted is shown in accordance with at least one example of the present invention. DETAILED DESCRIPTION

[0040] The present invention relates to minimally invasive surgery, devices and systems for inserting an implant into a target site in a patient's body. The present invention relates to an implant inserted into a patient's body, for example, during a minimally invasive surgery. The present invention also relates to devices, appliances or tools that can be used in minimally invasive surgery to insert an implant into a target site in a patient's body.

[0041] In an example surgical procedure, a medical professional, such as a doctor, nurse, or surgeon, may perform a surgical procedure to implant a breast implant at a target site. The implant surgical procedure may be a minimally invasive surgical procedure that may be performed as an inpatient or outpatient surgical procedure using local anesthesia. A minimally invasive surgical procedure for inserting an implant may utilize, for example, at least one, several, or all of the following tools: a marking tool 400 (e.g., Figure 4 As shown), sleeve 500 (as Figure 5 As shown), tissue stripper 600 (as shown Figure 6 ), a tissue expander or a tissue separator (hereinafter referred to as "tissue expander" may refer to an implant that can separate tissue layers, such as a balloon) 700 (as shown in Fig. 7A As shown), syringe 800 (as Figure 8 100, 150, 170, 180, 200, or 1110). Each of these tools can be used alone or together during a surgical procedure to insert and place an implant in a target site, such as a cavity, in a patient's body in a manner that the patient may be minimally impacted during the surgical procedure.

[0042] In an example surgical procedure, the surgeon may use a marking tool to indicate or guide where the target site where the implant is located, where the insertion incision may be made, how far the tissue stripper may be inserted, how much the balloon may be inflated, and the approximate location of the implant. After the breast is marked accordingly, the medical professional may use a cannula to inject a local anesthetic into the breast area. With a local anesthetic, the patient may be numb to the surgical procedure, for example, but remain awake during the surgical procedure, thereby providing the possibility of a shorter recovery time. The medical professional may then make an incision at the desired location and enter the target site by using a tissue stripper or tissue separator. The tissue stripper may be inserted through the incision in a manner to form a passage or pathway from the incision to the target site. The tissue expander may then be inserted through a small incision and passed through the pathway until the target site is reached. The tissue expander may then expand within the target site to create a cavity similar in size and shape to the implant without damaging a large amount of connective tissue surrounding the target site. The tissue expander may expand to a size and shape substantially similar to the implant, or slightly expand to exceed the size of the implant to help stop bleeding during the surgical procedure. For example, after the tissue expander has been deployed for a certain period of time, it can be deflated and subsequently removed through a small incision. In one example, the syringe can be preloaded with a compressible implant. The syringe can have a nozzle end (such as, Figure 8 The nozzle end 812 in the nozzle end 812 can be designed to be within the small incision and suitable for passing through the passage. The nozzle end can have a nozzle end opening (such as, Figure 8 The nozzle end opening 912 in the passageway can be provided through which the implant can be expelled or ejected from the syringe. To insert the implant into the target site, the nozzle end of the syringe can be placed in the incision, and then the nozzle end can be extended in the passageway. When the nozzle end of the syringe is at a predetermined depth in the passageway, the medical professional can activate an actuator (such as, Figure 8 The actuator 840 in the embodiment of the present invention can cause a handle (such as, Figure 8 The expandable membrane (such as, Fig. 9 The expandable film 932 in the syringe or the diaphragm applies a predetermined amount of pressure to the implant, thereby expelling or ejecting the implant from the syringe through the nozzle end opening. In this example, the implant can thus be placed or implanted at the desired location of the target site. The medical professional can then remove the syringe from the incision and close the incision. The process can then be repeated on the opposite side of the patient's body.

[0043] Implants

[0044] Figure 1AThe top view of the implant 100 of at least one exemplary implant insertion system according to the present invention is shown, and the implant has an elliptical or spherical shape. The implant 100 may be substantially symmetric about one or more axes, such as a longitudinal axis 110, a transverse axis 120, or a vertical axis 130.

[0045] The longitudinal axis 110 may separate the front side 112 from the rear side 114. The longitudinal axis 110 may also refer to a longitudinal plane passing through the implant 100 that separates the front side 112 from the rear side 114. The front side 112 may refer to the front of the patient or an orientation away from the medial orientation. For example, the side of a breast implant closest to the skin may be considered the front side 112. In another example, the side of a buttock implant closest to the skin may be considered the front side 112. The rear side 114 may refer to the side of the implant 100 closest to the patient's back. For example, the side of a breast implant closest to the patient's ribs may be considered the rear side 114. In another example, the side of a buttock implant closest to the patient's pelvic region may be considered the rear side 114.

[0046] As Figure 1A shown, the implant 100 may also be symmetric about the transverse axis 120. The transverse axis 120 may separate the right side 122 of the implant 100 from the left side 124 of the implant 100. The transverse axis 120 may also refer to or represent a transverse plane passing through the implant 100 that separates the right side 122 of the implant 100 from the left side 124 of the implant 100. In various examples, the transverse axis 120 may be perpendicular to the longitudinal axis 110, the transverse axis may be substantially perpendicular to the longitudinal axis 110, or the transverse axis 120 may be skewed with respect to the longitudinal axis 110.

[0047] As Figure 1A shown, the implant 100 may also be symmetric about the vertical axis 130. The vertical axis 130 may separate the top or upper portion 132 of the implant 100 from the bottom or lower portion 134 of the implant 100. The vertical axis 130 may also refer to or represent a vertical plane passing through the implant 100 that separates the top 132 of the implant 100 from the bottom 134 of the implant 100. In various examples, the vertical axis 130 may be perpendicular to at least one of the longitudinal axis 110 or the transverse axis 120, the vertical axis may be substantially perpendicular to at least one of the longitudinal axis 110 or the transverse axis 120, or the vertical axis may be skewed to at least one of the longitudinal axis 110 or the transverse axis 120.

[0048] As Figure 1AAs further described in the foregoing, the front side 112 of the implant 100 can have an arcuate profile. The arcuate profile can also be referred to as a convex profile, a rounded profile, a curved profile, etc. The arcuate profile of the front side 112 can protrude at a first vertex 116, which is located approximately equidistant between the right side 122 and the left side 124 of the implant 100. The arcuate profile of the front side 112 can terminate at Figure 1A The first vertex 116 may be located at each of the first end 126 and the second end 128 on the right side 122 and the left side 124 of the device. In one example, the first vertex 116 may be equidistant from the first end 126 and the second end 128.

[0049] The rear side 114 of implant 100 may also have an arcuate profile similar in shape to the arcuate profile of the front side 112. Furthermore, the arcuate profile may also be referred to as a convex profile, a circular profile, a curved profile, etc. In the implant position, when against the anatomical surface, implant 100 may have a curved profile. The curved profile of the rear side 114 may be prominent at a second vertex 118, which is located at a substantially equidistant position between the right side 122 and the left side 124. The arcuate profile of the rear side 114 may terminate at each of the first end 126 and the second end 128, thereby intersecting at the same point as the arcuate profile of the front side 112. In one example, the second vertex 118 may be equidistant from the first end 126 and the second end 128.

[0050] Figure 1B A top view of a replacement implant 150 having an anterior side 152 and a posterior side 154 is shown in accordance with at least one example of the present invention. Figure 1B An implant 150 is shown that can be symmetrical about two axes, such as about a transverse axis 151 (e.g., separating a right side 155 from a left side 157) and a vertical axis 164 (e.g., separating a top side 165 from a bottom side 167). Figure 1B As shown, the implant 150 can have an asymmetric profile about a longitudinal axis 160. The longitudinal axis 160 can represent the point or plane where the front side 152 transitions to the rear side 154, or the position where the curve changes. Therefore, the longitudinal axis 160 can separate the front side 152 from the rear side 154. The longitudinal axis 160 can be located between a first vertex 156 on the front side 152 and a second vertex 158 on the rear side 154. The longitudinal axis 160 can also refer to or represent a transverse plane passing through the implant 150, which separates the front side 152 of the implant 150 from the rear side 154 of the implant 150. The distance that the first vertex 156 protrudes from the longitudinal axis 160 is greater than the distance from the longitudinal axis 160 to the second vertex 158.

[0051] The longitudinal axis 160 can be off-center between the first apex 156 and the second apex 158. In one example, the posterior side 154 of the implant 150 can have an arcuate, curved, or rounded profile that is flatter than the anterior side 152.

[0052] Figure 1C A top view of a replacement implant 180 having an anterior side 182 and a posterior side 184 is shown in accordance with at least one example of the present invention. Figure 1C An implant 180 is shown that can be symmetrical about two axes, such as about a transverse axis 192 (e.g., separating a right side 195 from a left side 197) and a vertical axis 194 (e.g., separating a top side 185 from a bottom side 187). Figure 1C As shown, the implant 180 can have an asymmetrical profile about a longitudinal axis 190. The longitudinal axis 190 can represent the point or plane where the front side 182 transitions to the back side 184 or the curve changes. Thus, the longitudinal axis 190 can separate the front side 182 from the back side 184. The longitudinal axis 190 can be located between the first vertex 186 on the front side 182 and the back side 184. Figure 1C In the example shown, the rear side 184 can be substantially flat or horizontal. The rear side 184 can be substantially or nearly parallel to a plane extending along the longitudinal axis 190. The longitudinal axis 190 can also refer to or represent a transverse plane passing through the implant 180, which separates the front side 182 of the implant 180 from the rear side 184 of the implant 180. The first vertex 186 can protrude from the longitudinal axis 160 a greater distance than the distance from the longitudinal axis 190 to the rear side 184. The longitudinal axis 190 can be off-center between the first vertex 156 and the rear side 184. Such an implant can be referred to as a "flat back" implant.

[0053] Figure 1D A replacement implant 170 is shown having a right side 171 and a left side 172 . Figure 1D The implant 170 can be symmetrical about an axis, such as a transverse axis (eg, separating the right side from the left side). Figure 1DThe implant 170 can be asymmetric about the longitudinal axis 175 and / or the vertical axis 176. The longitudinal axis 175 can separate the front side 177 from the rear side 178. In one example, the rear side 178 can be substantially flat so that the profile can be similar to a pectoralis muscle. In one example, the rear side 178 can have a flat curved profile with a minimum vertex 173. The front side 177 can have a vertex 179 that can protrude at a position lower than the vertex on the rear side 178. The vertical axis 176 can separate the top side 181 from the bottom side 191. The top side 181 can have a profile that narrows or decreases as the implant 170 further protrudes upward from the vertical axis 176. The bottom side 191 can widen or increase as the implant 170 further protrudes downward from the vertical axis. This implant can be referred to as a "teardrop" shaped implant.

[0054] Implants similar to any of the shapes, contours or forms previously discussed may be used for body shaping implants such as breast implants, pectoral implants, buttock implants, and facial implants without departing from the intended scope of the present invention.

[0055] In one example, when inserted into a target part of the body, the back side 114 / 154 / 174 / 184 of the implant 100 / 150 / 170 / 180 can flatten, conform, or compress against, for example, the pectoralis muscle or similarly located tissue in the breast area. When the back side 114 / 154 / 174 / 184 flattens, conforms, or compresses, the front side 112 / 152 / 176 / 186 can expand or protrude into the breast tissue and away from the pectoralis muscle. This "volume" or "shape" conversion will be discussed in further detail below.

[0056] Figure 1E is a diagram showing an exemplary protrusion of a series of implants similar to implant 180 which may have a "flat back", such as Figure 1C As shown in the example implants in , their sizes range from about 8.0 cm in diameter to about 15.0 cm in diameter. Figure 1E The implant 180 can be similar to the implant 180 discussed above, which can be symmetrical about two axes, such as a transverse axis and a vertical axis. Figure 1E The exemplary implant 180a shown in can have a generally flat rear side 184a. The exemplary implant 180a shown in example A can have a filler volume between about 135 cubic centimeters (hereinafter referred to as "cc") and about 825cc. The implant 180a of example A can have a base or rear side 154a, whose diameter can be between about 8.0 centimeters and about 15.0 centimeters. In example A, the expansion portion or protrusion 183a of the front side 182a can be between about 3.3 centimeters and about 6.1 centimeters, as measured from the rear side 184a to the front side vertex 156a.

[0057] Figure 1E The exemplary implant 180b shown in FIG. 1 may have a generally flat rear side 184b. Figure 1E In example B, exemplary implant 180b can have an increased volume when compared to the volume of exemplary implant 180a shown in example A. For example, implant 180b in example B can have a filler volume between 160cc and 1060cc. Implant 180b as shown in example B can have a base or rear diameter similar to example A, which can be between about 8.0 centimeters and about 15.0 centimeters. The expanded portion or protrusion of the front side 182b can be between about 3.8 centimeters and about 7.8 centimeters, as measured from the rear side 184b to the front side vertex 186b.

[0058] Figure 1F is a diagram showing exemplary projections for a range of implants ranging in size from about 8.0 centimeters in diameter to about 15.0 centimeters in diameter. Figure 1E The implant 100 of can be similar to the implant 100 discussed above, which can be symmetrical about three axes, such as the longitudinal axis, the transverse axis and the vertical axis. These exemplary implants can have a generally circular rear side 114 profile and a diameter between about 7.0 centimeters and about 10.0 centimeters.

[0059] In example C, Figure 1F As shown in the figures shown, an exemplary implant can have a filler volume between 100cc and 190cc. The implant can have a flared portion or projection 133c of the anterior side 112c, which can be between about 2.8 centimeters and about 3.4 centimeters, when the implant is measured from the flat bearing surface to the projection, measured from the posterior vertex 118c to the anterior vertex 116c.

[0060] In example D, Figure 1F As shown in the illustrated figures, the exemplary implant can have a filler volume between about 120cc and about 220cc. The implant in Example D can have a flared portion or projection 133d of the anterior side 112d, between about 3.3 centimeters and about 4.0 centimeters measured from the posterior vertex 118d to the anterior vertex 116d when the implant is measured from the flat bearing surface to the projection.

[0061] In Example E, if Figure 1F As shown in the illustrated figures, an exemplary implant can have a filler volume between about 135cc and about 265cc. The implant can have a flared portion or projection 133e of the anterior side 112e, between about 3.7 centimeters and about 4.6 centimeters from the posterior vertex 118e to the anterior vertex 116e when the implant is measured from the flat bearing surface to the projection.

[0062] In example F, Figure 1F As shown in the illustrated figures, the exemplary implant can have a filler volume between about 145cc and about 290cc. The implant in Example F can have a flared portion or projection 133f of the anterior side 112f, between about 3.9 centimeters and about 5.0 centimeters from the posterior vertex 118f to the anterior vertex 116f when the implant is measured from the flat bearing surface to the projection.

[0063] Implants described herein (such as, implants 100, 150, 170, 180, 200 or 1110) in one or more surfaces can have surface texture (e.g., microtexture or nanotexture) to promote biocompatibility. For example, implants can have surface textures as disclosed in WO2017 / 196973, WO2015 / 121686 and / or WO2017 / 093528, each of which is incorporated herein by reference in its entirety. For example, surface texture can include uniform surface features of nanometer to micrometer magnitude.

[0064] Figure 2A cross-sectional view of an implant 200 according to at least one example of the present invention is shown. The implant 200 may include a shell 210 and a filler 220 (e.g., a fluid, such as a gel or liquid) in a cavity formed by the shell 210. The shell 210 and the filler 220 may each include a biocompatible material, such as silicone. The filler 220 may be in the form of a fluid, such as a gel filler, having a viscosity or penetration value that can simulate the movement of natural breast tissue. The penetration value is an example indication of a qualitative determination of the firmness of the filler 220. For example, the filler 220 may include a gel having a penetration value, which is defined as the vertical distance penetrated by a point of a standard needle and is typically measured in tenths of a millimeter, ranging from about ten tenths of a millimeter to about sixty tenths of a millimeter. The penetration value may be defined as a factor that measures the firmness of a colloid, such as a silicone gel. The penetration value may be measured according to ISO standard 14607 and / or ASTM F703. Any of the materials and / or features discussed in U.S. Patent No. 9,901,438, U.S. Patent Publication No. 2015 / 0150675 and / or WO2017 / 196973, each of which is incorporated herein by reference in its entirety, can be used for implants described herein. In one example, filler 220 can be a viscoelastic silicone gel with superior adaptability to maintain high cohesion and elasticity during any compression or force that the implant may be subjected to. The higher the viscosity in the example gel, the more natural the appearance of the breast after the implant is implanted in the breast. In another example, a high elastic gel showing low rigidity can also give a more natural appearance to the breast after the implant is implanted. In an example implant surgery, where the implant is compressed or deformed when the implant is inserted into the breast, the high elastic gel can allow the implant to return to its original form (e.g., the form of the implant when not subjected to external stress or force) or close to the original form.

[0065] According to some examples of this paper, the shell 210 of implant 200 can have a scope of about 0.010 inch to about 0.040 inch total thickness, such as about 0.013 inch to about 0.040 inch, about 0.010 inch to about 0.020 inch, about 0.012 inch to about 0.015 inch, about 0.010 inch to about 0.015 inch, about 0.013 inch to about 0.025 inch, about 0.015 inch to about 0.030 inch or about 0.020 inch to about 0.040 inch. Shell 210 can include at least one or more layers, for example, with at least 0.01 inch, at least 0.012 inch, at least 0.015 inch, at least 0.02 inch, at least 0.025 inch, at least 0.03 inch, at least 0.035 inch or at least 0.04 inch total thickness. The elongation and ultimate breaking force of the shell may be measured in accordance with Inactive Surgical Implants - Breast Implants - Particular Requirements ISO 14607 or Standard Specification for Implantable Breast Prostheses ASTM F703-18.

[0066] Figure 3A is a cross-sectional view of a portion of an implant 300 according to at least one example of the present invention. Figure 3A As shown, implant 300 may include shell 310 and filler 320. Exemplary implant 300 may be formed with at least one of the properties of shell 210 or filler 220 described above. Figure 3A As further shown in FIG. 3 , the implant housing 310 can include multiple layers 312. For example, the housing 310 can include from 1 to 15 layers, from 2 to 8 layers, from 3 to 7 layers, from 4 to 15 layers, from 6 to 8 layers, from 10 to 13 layers, or from 12 to 15 layers. In some examples, one or more or all of the layers 312 can include silicone.

[0067] According to some examples herein, the shell 310 may include at least two different types of layers, such as one or more standard shell layers 313 and one or more low diffusion barrier layers 314 having different chemical compositions. Each of the one or more standard shell layers 313 and each low diffusion barrier layer 314 may have the same thickness, or one or more layers may have a thickness different from one or more other layers of the shell 310. The shell 310 may include at least two low diffusion barrier layers 314. One or more low diffusion barrier layers 314 may be useful, for example, in implants intended to remain in the patient's body for a relatively long period of time. One or more low diffusion barrier layers 314 may, for example, inhibit the material within the implant 300 (e.g., in the filler 328) from leaking into the patient's body. However, implants that do not include a low diffusion barrier layer are also within the scope of the present invention. Exemplary implants that do not include a barrier layer may include, but are not limited to, a sizer, a tissue expander, and a tissue stripper.

[0068] When present, one or more low diffusion barrier layers 314 can be colored and have any desired color, such as blue, green, yellow, pink, orange, purple, etc. In some examples, one or more low diffusion barrier layers 314 can have the same color as other layers present in the shell 310, including one or more standard shell layers 313. Low diffusion barrier layers 314 having a different color than the standard shell layers 313 can help medical professionals detect the presence of cracks or defects in the implant 300 and / or confirm that the implant 300 has been properly manufactured.

[0069] One or more low diffusion barrier layers 314 may have a chemical composition that is different from the chemical composition of other layers 312 (such as, one or more standard layers 313). For example, one or more low diffusion barrier layers 314 may include a silicone elastomer having a polysiloxane backbone and a substituted or pendant functional group that can inhibit the penetration of silicone through the layer. The silicone elastomer may include polydimethylsiloxane. Exemplary functional groups include, but are not limited to, phenyl and fluoro groups. For example, one or more barrier layers 314 may include a silicone substituted with one or more diphenyl, methylphenyl, trifluoropropyl, and combinations thereof.

[0070] One or more standard shell layers 313 may include silicone. In one example, the silicone may include polydimethylsiloxane. When one or more standard shell layers 313 are present, the chemical composition of one or more of the layers may be different from the chemical composition of the other layers. In one example, one or more standard shell layers 313 may include a high strength silicone dispersion of siloxane and silicone, dimethyl vinyl terminated and silane amine, 1,1,1-trimethyl-N-, and a hydrolyzate of silicon dioxide.

[0071] like Figure 3A As depicted, one or more low diffusion barrier layers 314 may form the innermost layer of the shell 310, which may be adjacent to the filler 320, and one or more standard shell layers 313 may form the outermost layer of the shell 310. In particular, Figure 3A A single low diffusion barrier layer 314 is depicted in contact (such as direct contact) with one of the one or more standard shell layers 313 and filler 320 .

[0072] The location of the one or more low diffusion barrier layers 314 may vary. For example, Figure 3B A single low diffusion barrier layer 314 is shown disposed or sandwiched between adjacent standard layers 313. In other examples, such as Figure 3C As shown, the housing 310 may include a plurality of low diffusion barrier layers 314 disposed or sandwiched between adjacent standard layers 313. In other examples, such as Figure 3DAs shown, one or more low diffusion layers 314 may form the outermost layer of the housing 310. Many other orientations and compositions are discussed, for example, in US Pat. No. 10,111,744, which is incorporated herein by reference in its entirety.

[0073] Marking tools

[0074] Figure 4 4 is a top view of a marking tool 400 according to at least one example of the present invention. The marking tool 400 can be useful for use by a medical professional to better assist in the correct positioning and placement of an implant. As will be discussed in further detail below, the marking tool 400 can provide a plurality of navigation or reference lines that the medical professional can use to mark or draw to indicate the placement of a medical tool or to indicate where surgery can occur. The marking tool 400 can also provide a way for the medical professional to draw substantially similar or identical lines on another breast.

[0075] The marking tool 400 can be sized and shaped according to the desired implant to be inserted. Figure 4 In the example shown, the marking tool 400 can be made of a flexible material, such as paper or plastic, which can allow the marking tool 400 to conform to the shape of the breast. The marking tool 400 can be circular in shape and / or similar in shape to the desired cavity to be formed in the patient's body. The marking tool 400 can have a central opening 402 in which the patient's nipple can be placed as a center point.

[0076] exist Figure 4 In the example shown, the marking tool 400 can have at least one of a plurality of navigation lines or reference lines. Such a reference line can be at least one of a plurality of size indicators 401. At least one of the plurality of size indicators 401 can correspond to different sizes of implants to be implanted. For example, at least one of the plurality of size indicators 401 can be the outer perimeter 406 of the marking tool 400, which can correspond to a large implant. At least one of the plurality of size indicators 401 can be the inner perimeter 422, which can correspond to a small implant. At least one of the plurality of size indicators 401 can be arranged on the marking tool between the outer perimeter 406 and the inner perimeter 422 as an intermediate marking area, thereby indicating a medium-sized implant.

[0077] In the example of the marking tool 400, the alignment portion 404 extends from the first side 410 of the inner perimeter 422 of the marking tool 400 to the second side 412 of the inner perimeter 422 of the marking tool 400. The alignment portion 404 can have an extension portion 414 that extends beyond the outer perimeter 406 of the marking tool 400. The extension portion 414 can provide an incision location identifier 405 or a line pointing in the direction of the incision location. In one example, the extension portion 414 can face the medical professional so that an incision can be made in the axillary skin crease behind the pectoralis major contour. The outer contour 413 of the extension portion 414 can be outlined, and the farthest point 415 can be marked as the location of the incision. The alignment portion 404 can provide a guide line 416 as an example of a navigation line for the surgeon to track or mark which can extend between the central opening 402 and the point of the incision. In one example, the guide line 416 can be an opening formed in the alignment portion 404. The alignment portion 416 may extend from the central opening 402 toward the outer perimeter 406 of the marking tool 400. The point at which the size indicator 401 (such as the outer perimeter 406, the inner perimeter 422, or the intermediate marking area 424) and the guide line 416 meet may indicate or identify the junction point to be marked as the final peel mark 1416 (as discussed further below).

[0078] The outer perimeter 406 of the marking tool 400 can be in a continuous form, such as a continuous circular shape, or other shape corresponding to the implant to be inserted. Figure 4 As shown in , the outer perimeter 406 is a somewhat continuous circular outline. However, the outer perimeter 406 can be of any shape, as dictated by the intended use. The junction 417 of the extension 414 and the outer perimeter 406 can be indicated with a marking, for example, in an area known as the Spencer's tail. The Spencer's tail is an anatomical description for an extension from tissue in the upper lateral quadrant of the breast to the axillary region. In Figure 4 In the illustration shown, the circular outline of the outer perimeter 406 can represent the widest dimension indicator (such as a diameter) used to mark the patient's body on the marking tool 400. In one example, the diameter can be approximately 10.0 centimeters, although various other diameters are possible, as will be understood by those skilled in the art.

[0079] The outline of the marking tool 400 can provide another size indicator, which can also correspond to the implant to be inserted. For example, in the circular outline of the marking tool 400, the outline can be opened in the inner area 418 of the marking tool 400, so that the skin of the breast is exposed. The inner perimeter 422 of the inner area 418 can be a size indicator for a specified size on the breast area. The diameter of the inner perimeter 422 can be between about 6.0 and about 10.0 centimeters, such as about 8.0 centimeters. However, the inner area 418 can be a smaller incision, as long as there is enough space for a writing or drawing tool, such as a pen or marker, to be inserted and allow a medical professional to draw a mark on the breast or other implant area.

[0080] Another area that a medical professional can use as a size indicator can be a middle marking area 424 that can be provided on the marking tool 400. The middle marking area 424 can correspond to a medium-sized implant. For example, the middle marking area 424 can be a designated distance removed from the central opening 402 and the inner perimeter 422. For example, the diameter of the middle marking area 424 can be between about 7.0 and about 11.0 centimeters, such as about 9.0 centimeters.

[0081] The intermediate marking area 424 may include an opening or slit in the marking tool 400 at a specified distance. The opening or slit of the intermediate marking area 424 may have a contour that allows a medical professional to accurately mark a distance at or around a target site. Figure 4 In the example shown, the intermediate marking area 424 can be a series of openings or slits dispersed in an arcuate manner around the marking tool 400. In another example, the intermediate marking area 424 can be a somewhat continuous circular opening or slit in the marking tool 400.

[0082] Although in Figure 4 Only one distance of the intermediate marking area 424 is shown in the figure, but there can be more than one intermediate marking area 424, so that the marking tool 400 can be used for implants of different sizes. For example, there can be a first intermediate marking area 424 with a diameter of about 8.5 cm, 9.0 cm, 9.5 cm, but these sizes can vary.

[0083] casing

[0084] Figure 5 is a perspective view of a cannula 500 according to at least one example of the present invention. The cannula can include an elongated shaft 501 and one or more openings or holes 510 in a distal end 502 of the shaft 501. The number of holes 510 can be determined based on the purpose and flow rate of the fluid to be dispensed from the cannula 500. For example, there can be about 1 hole to about 16 holes.

[0085] In one example, a cannula 500 having a shaft 501 having a diameter of about 1.8 mm to about 3.5 mm can be used. However, these dimensions can vary. A handle 512 can be located at the proximal end 504 of the shaft 501. The cannula 500 can be attached to an external fluid supply by the handle 512 or at any location along the cannula 500, as determined by the application. Fluid, for example, a saline-based anesthetic solution.

[0086] In one example, when the cannula 500 is inserted into a designated location around or in close proximity to a target site, fluid can flow out of the shaft 501 through the hole 510. The user can control the flow rate or amount of the inserted fluid with a handle 512 or another external control. In one example, when the patient's body is pierced by the cannula 500, the fluid flowing from the cannula 500 into the patient's body can cause hydrodissection.

[0087] Tissue dissector

[0088] Figure 6 600 (hereinafter, the tissue stripper may include a tissue separator) according to at least one example of the present invention. The tissue stripper 600 is an example of an instrument that can be inserted into a patient's body to assist in forming a cavity at a target site. The tissue stripper 600 can be configured to be inserted through a relatively small incision, such as an incision between about 2.0 cm and about 4.0 cm in length. Relatively small incisions may be particularly useful during minimally invasive surgery. Minimally invasive surgery can reduce damage to the patient's tissue at and around the implant site or incision, thereby reducing recovery time and reducing scarring at the incision site.

[0089] In some examples, tissue stripper 600 can help form a passage, tunnel, opening or pipeline extending from an incision to a target site for placement of an implant. Tissue stripper 600 can have a distal end 602, which is designed to cut or separate tissue, such as a layer of connective tissue, so a passage can be formed. The distal end 602 can terminate in a tapered profile 610 with a top 612. In one example, the top 612 can be blunt. In another example, the top 612 can be sharp. The distal end 602 can be formed with any profile that allows a user to separate or cut tissue through the patient's body.

[0090] The tissue stripper 600 can generally have an elongated profile with a central portion 620, the size and shape of which can be similar to the size and shape of the desired passage extending from the incision to the target site. In one example, the central portion 620 can be shaped as a substantially cylindrical profile. In another example, the central portion 620 can be shaped as a tubular profile. The central portion 620 can have a maximum diameter between about 1.0 cm and about 4.0 cm, such as about 2.0 cm. The length of the tissue stripper 600 from the top to the proximal portion of the central portion 620 can be between about 10 cm and about 30 cm.

[0091] In one example, the center portion 620 can have graduated markings 622. The graduated markings 622 can be formed on the outer surface of the center portion 620, or if the tissue dissipator 600 is made of a transparent material, on the interior of the center portion 620. The graduated markings 622 can be painted, stamped, embossed, indented, etc. on the surface of the center portion 620 or in the center portion 620. The graduated markings 622 can be placed at predetermined measurement points along the length of the center portion 620. For example, the graduated markings 622 can indicate distances in millimeters, centimeters, inches, etc. The graduated markings 622 can be measurements taken from the top 612 of the tapered profile 610. The graduated markings 622 can be used by a medical professional to determine the depth to which the tissue dissipator 600 has been inserted through the incision, and can thereby indicate or can be a visual reference to the length of the passage that the tissue dissipator 600 has formed from the incision to the target site.

[0092] At the proximal end 604 of the tissue stripper 600, there may be a handle or grip 630. In one example, the grip 630 may be formed in a manner that allows a medical professional to fully grip and manipulate the tissue stripper 600. The grip 630 may be formed with anti-slip features, such as ribs, grooves, protrusions, etc., to help the medical professional manipulate the tissue stripper 600 through the tissue without causing the tissue stripper 600 to slip during use. In another example, the grip 630 may be covered with a material that may have an anti-slip function. In one example, the grip 630 may be formed in a manner that allows a medical professional to effectively use the tissue stripper 600 to separate or cut tissue in a patient's body, so that a passage may be formed. In one example, the grip 630 may have a bulbous, rounded, or other shape that may be ergonomically designed to fit the user's hand.

[0093] Tissue expander

[0094] Fig. 7A700 according to at least one example of the present invention. A tissue expander may refer to any device or implant that is capable of separating tissue layers or forming a gap or space between tissue layers when expanded in size. Fig. 7A As shown, tissue expander 700 may include a balloon 750, a flexible chamber 720, an adapter 722 or other connecting element, and a pump 710 configured to be connected to adapter 722. Tissue expander 700 may be a device that expands, inflates, or otherwise increases in size to separate or form a cavity within at least two layers of tissue, ligament, muscle, etc.

[0095] The balloon 750 can be an inflatable and deflated balloon and can be positioned at the distal end 719 of the flexible cavity 720, and the pump 710 can be positioned at the proximal end 724 of the cavity 720. The pump 710 can be a one-way pump. In one example, when the first side 711 of the pump 710 is coupled to the proximal end 724 of the cavity 720, the balloon 750 connected to the pump 710 via the flexible cavity 720 can be inflated using the pump 710. In particular, when the first side 711 of the pump 710 is coupled to the flexible cavity 720, actuating the pump 710 can inflate the balloon 750. When the pump 710 is actuated, attaching the second end 713 of the pump 710 to the flexible cavity 720 can deflate the balloon 750.

[0096] In one example, the pump 710 can be a manually operated bulbous pump that a user can actuate by applying a compressive force to the pump 710. Pressurized air can be forced to and / or from the balloon 750 through the flexible chamber 720, thereby inflating or deflating the balloon 750. In another example, the pump 710 can be an electronically controlled mechanism that a medical professional can activate or control, and that can cause fluid or air to be transferred to and / or from the balloon 750, thereby inflating or deflating the balloon 750.

[0097] The clip 730 can be attached to the flexible cavity 720 to control the flow of fluid or air through the flexible cavity 720. In one example, the clip 730 can be a Luer lock fitting, a clamp, or other similar mechanism to control the flow of fluid. In one example, when the balloon 750 is expanded to a desired size, the clip 730 can be closed. Closing the clip 730 can prevent air, pressurized air, or other pressurized fluid from being discharged from the expanded or inflated balloon 750. The air, pressurized air, or other pressurized fluid can be released from the balloon 750 by removing or opening the clip 730, thereby deflating the balloon 750.

[0098] The balloon 750 of the tissue expander 700 can have a circular or other generally circular shape when deflated, and can have a spherical, ellipsoidal, oval or other generally circular shape when expanded. However, it should be understood that any shaped balloon 750 can be used for an expandable appliance or device. In some examples, the balloon 750 can be shaped to form a desired cavity in the anatomical structure according to the desired surgery. The balloon 750 can be inflated to expand in both the rear side and the front side. The balloon 750 can be inflated so that the front side protrudes from the center point of the inflated balloon farther than the rear side protrudes from the center point. The balloon 750 can have a circular rear side and / or a circular front side. In one example, the balloon 750 can form a nested cavity in a target site, as discussed further below. The circular shaped balloon can be suitable for, for example, a target site where a circular implant is intended to be inserted.

[0099] Balloon 750 can have any suitable thickness and size. In some examples, balloon 750 can have a wall thickness between about 0.1 mm and about 0.5 mm, such as about 0.1 mm, about 0.15 mm, about 0.2 mm, about 0.25 mm, about 0.3 mm, or about 0.35 mm. In some examples, balloon 750 can have an uninflated diameter between about 10.0 cm and about 20.0 cm, such as between about 10.0 cm and about 15.0 cm, such as about 12.0 cm.

[0100] At least one of the balloon 750 and the flexible chamber 720 disclosed herein can be made of a flexible biocompatible polymer, such as silicone. In some examples, the balloon 750 and the flexible chamber 720 can be made of a single material, and in alternative examples, can be made of different materials.

[0101] The flexible lumen 720 can extend from the outer wall of the balloon 750 and can be in fluid communication with the interior of the balloon 750. The flexible lumen 720 can have any suitable length, such as, for example, between about 20.0 centimeters and about 50.0 centimeters. The length of the flexible lumen 720 can vary to ensure that the flexible lumen 720 extends from the balloon 750 positioned in the patient's body cavity to the outside of the patient.

[0102] like Fig. 7AAs shown, the tissue expander 700 may include an introducer 740. The introducer 740 may be disposed between the pump 710 and the balloon 750. In one example, the introducer 740 may be a hollow tube or tubular member through which the flexible cavity 720 may pass. The length of the introducer 740 may be similar to or shorter than the length of the tissue stripper 600. In one example, the introducer 740 may have graduated markings 741. The graduated markings 741 may be at regular intervals on the outer or inner surface of the introducer 740. The graduated markings 741 should be visible to medical professionals. The graduated markings 741 may be measured from the top 746 of the support extension 745. The graduated markings 741 may be used by medical professionals to determine how far the introducer 740 has been inserted into the passage extending from the incision to the target site. The graduated markings 741 may indicate to medical professionals when the balloon 750 is located at the target site. The graduated markings 741 may be placed in predetermined measurement points along the length of the introducer 740. For example, graduation markings 741 may indicate distances in millimeters, centimeters, inches, etc.

[0103] The proximal end 744 of the introducer 740 may include a handle 742. The handle 742 may be bulbous, rounded, or in any other ergonomically designed form. In one example, a medical professional may grasp or hold the introducer 740 by the handle 742 while inserting the introducer 740 and the balloon 750 into the incision and passage. In one example, the flexible cavity 720 may enter the first opening 741a of the handle 742.

[0104] The distal end 743 of the introducer may include a second opening 743a through which the flexible lumen 720 may pass and exit the introducer 740. The flexible lumen 720 may be coupled to the balloon 750 at the second opening 743a or the flexible lumen 720 may extend a predetermined distance past the second opening 743a and the balloon 750 may be coupled at the distal end 721 of the lumen away from the introducer 740.

[0105] In one example, the introducer 740 can have a support extension 745 protruding from the second opening 743a. When the introducer is in an orientation to be inserted into the incision, the support extension 745 can extend from the bottom side 743b of the second opening 743a. In one example, the support extension 745 can have a top 746, such as Figure 7B As shown, it can bisect tissue in the target site. The support extension 745 can be made of any material that can bisect or separate tissue without damage during insertion of the support extension 745 and the coupled balloon 750 through the passage formed by the tissue stripper 600.

[0106] The balloon 750 can be coupled to the support extension 745 so that the balloon 750 can be supported when the balloon 750 is in an inflated or deflated or contracted state. The support extension 745 can be coupled to the rear side 751 of the balloon 750 with an adhesive material, a band, such as a silicon dioxide band, or with a mechanical coupling, such as a snap-fit ​​coupling. The support extension 745 can remain substantially stationary relative to the balloon 750 when the balloon 750 is expanded or contracted. Before the balloon 750 can be introduced into the incision, the balloon 750 can be contracted, such as folded, rolled up, wrapped around or otherwise shortened in size around or on the support extension 745 so that its size can fit into the incision. For example, the width of the balloon 750 in a compressed form can be between about 1.0 centimeters and about 4.0 centimeters. In another example, the width of the balloon 750 in a compressed form can be between about 1.0 centimeters and about 3.0 centimeters. In another example, the width of the balloon 750 in the compressed form can be between about 1.0 centimeters and about 2.0 centimeters.

[0107] The length of the support extension 745 can be determined by the size of the balloon 750 used. In one example, the length of the support extension 745 can be longer than the diameter of the balloon 750. In another example, the length of the support extension 745 can be substantially equal to or smaller than the diameter of the balloon 750.

[0108] In one example, the back side 751 of the balloon 750 can be coupled to the support extension 745, so that the balloon 750 can remain substantially flat on the back side 751, while the outer perimeter of the back side 751 can have a curved or slightly curved profile, while the balloon 750 can be coupled to the support extension. The balloon 750 can be supported or cradle so that the balloon 750 can remain stationary during expansion of the balloon 750 to an inflated state. The balloon 750 can protrude from the support extension 745 and expand into the tissue at the target site.

[0109] syringe

[0110] Figure 8 is an exploded perspective view of a syringe 800 that can be used to insert an implant (such as implant 100, 150, 170, 180, 200, 1110) into a cavity formed at a target site according to at least one example of the present invention. In some examples, syringe 800 can be configured to be used to advance the implant into the target site one-handed. Figure 8As shown, the syringe 800 may include a nozzle 810 and a handle 820. The nozzle 810 may define a housing 910 configured to hold an implant and may include a nozzle end 812 having a nozzle end opening or distal opening 912, an intermediate portion 911, and a nozzle engagement region 816 for engagement with a complementary handle engagement region 826 of the handle 820. The handle 820 may also include a fluid supply conduit or cavity 830 and an actuator 840.

[0111] The syringe 800 can have any of a variety of suitable sizes, shapes, and characteristics suitable for holding and delivering implants. In some examples, the syringe 800 can be a single-use (e.g., disposable) device, or some or all of the syringe 800 (e.g., handle 820 and / or nozzle 810) can be reusable, such as after sterilization.

[0112] Nozzle 810 can be a single piece, or can include multiple pieces, which can be assembled, slotted, assembled, clamped, welded or otherwise joined together at one or more joints. Nozzle 810 can also have additional profiles and features (for example, related to the housing 910 for holding the implant and / or related to the nozzle end opening 912), as further described herein. Nozzle 810 can be formed by one or more biocompatible polymers or copolymer materials or can include them. Exemplary materials can include polyurethane, polyethylene, silicone, polycarbonate or a combination thereof. Nozzle 810 can be rigid, semi-rigid, flexible or a combination thereof. For example, the nozzle end 812 of nozzle 810 can have enough rigidity to expand the incision, but not widen the incision, and the implant is directed to the incision site, but it is soft enough to avoid tearing or damaging the site and / or avoid deformation of the implant. In addition, nozzle end 812 can be more flexible than, for example, nozzle joint area 816, which can be more rigid to promote engagement with handle 820.

[0113] The nozzle end 812 can be sized so that it extends through the passage formed by the tissue stripper 600 and is suitable for passing through the passage. The length of the nozzle end 812 can be, for example, between about 5.0 centimeters and about 15.0 centimeters. The nozzle end 812 can be a hole at or near the distal portion 923 of the middle portion 911 of the nozzle 810, through which an implant contained in the housing 910 of the syringe 800 can leave the nozzle 810 during the implantation surgery. In one example, the distal portion 923 including the nozzle end 812 can be connected (in a separately molded nozzle or a nozzle assembled from parts) to the middle portion 911, including the housing 910 having a tapered region 914. In one example, the nozzle end 812 can be an elongated cylindrical chamber extending from the tapered region 914 of the nozzle 810 to the nozzle end opening 912. The nozzle end 812 and the tapered region 914 can be any suitable length so that the implant can be accurately placed in the target site with minimal follow-up work by medical professionals.

[0114] The tapered region 914 can help reduce any stress applied to the implant 100 as the implant 100 can be expelled from the middle region 911. The diameter of the tapered region 914 can decrease from the middle portion 911 to the nozzle end 812. As the implant passes through the tapered region 914 and into the nozzle end 812, the implant can be further compressed.

[0115] The middle part 911 of nozzle 810 can limit housing 910 and can be configured to load and hold or keep implant with radial compression and / or elongated form, so as to import target site.In some examples, as shown in the figure, the distal part 923 of nozzle 810 can be more tapered (with less cross-sectional dimensions) than middle part 911, so that the implant loaded into the middle part 911 is not compressed as in nozzle end 812.In some examples, middle part 911 can have the approximately equal diameter along its length.For example, in some examples, the shape of middle part 911 can be roughly cylindrical.The nozzle joint area 816 of nozzle 810 can be opened, to allow implant to be loaded into the housing 910 limited by middle part 911.

[0116] Fig. 9 800 according to at least one example of the present invention. As described above, the nozzle 810 can define a housing 910 for holding the implant in a compressed, coiled, or otherwise compacted form prior to implantation. The size of the nozzle 810 can be selected based on the size (e.g., size and shape) of the implant to be delivered using the syringe 800 and / or vice versa (e.g., the characteristics of the implant can be selected based on the size of the nozzle 810).

[0117] The cross-sectional dimensions of nozzle end 812 can have any suitable dimensions to allow the implant to pass through. In some examples, the cross-sectional dimensions of nozzle end 812 can range from about 0.5 cm to about 5.0 cm, about 1.0 cm to about 3.0 cm, or about 1.0 cm to about 2.0 cm.

[0118] Any one or more portions of the nozzle 810, such as the inner surface 918 of the nozzle 810, can include a lubricious coating to reduce the coefficient of friction between one or more portions (e.g., inner surface) of the syringe 800 and one or more portions of the implant contained therein. For example, the lubricious coating can be a water-activated coating fixed on one or more inner surfaces 918 of the nozzle 810. Additionally or alternatively, the lubricious coating can include a biocompatible lubricant and / or any other biocompatible coating. The coating can reduce the coefficient of friction between the implant housing (e.g., housing 210 or 310) and the inner surface 918 of the nozzle 810, thereby facilitating a smooth transition between the insertion configuration and the deployed configuration of the implant, for example, when the implant leaves the syringe 800.

[0119] The nozzle 810 can be designed to reduce the risk of tearing or other damage to the implant or patient tissue. The nozzle 810 can be designed to help achieve the required discharge pressure of the implant when the syringe 800 puts down the implant. The nozzle 810 can help achieve the required ejection speed of the implant through the nozzle end opening 912 of the nozzle 810. In some examples, for example, the characteristics of the nozzle end opening 912 can be designed or selected to achieve the required implant ejection speed or implant ejection pressure, or can be designed or selected to improve the placement accuracy of the syringe 800, the biocompatibility of the syringe 800 with the patient's tissue, the compatibility with a specific incision size, and / or other goals.

[0120] like Fig.10 and Fig.11 As shown, handle 820 may be configured to be attached, detached, and / or reattached to nozzle 810 via a suitable mechanism. Fig.10 and Fig.11 A perspective view and a side view of the syringe 800 are shown, respectively, depicting an attachment mechanism 950 according to at least one example of the present invention. The attachment mechanism 950 may include components that may be disposed at, on, and / or around a handle engagement region 826 of the handle 820 and / or a nozzle engagement region 816 of the nozzle 810. In some examples, the handle engagement region 826 may include a plurality of threads that are complementary to the plurality of threads of the nozzle engagement region 816. In further examples, the handle engagement region 826 and the nozzle engagement region 816 may include other mating features (e.g., clips, protrusions and recesses, clamps, adhesives, etc.) to facilitate permanent or reversible attachment of the handle 820 to the nozzle 810.

[0121] like Fig.10 As shown, a sliding protrusion 1052 can be provided on the nozzle 810, which is configured to be placed in a channel 1054 on the handle 820. Each protrusion 1052 can slide into a circumferential portion of the channel 1054 to secure the nozzle 810 to the handle 820. The channel 1054 can be of any shape, for example, the channel 1054 can have an L-shape so that rotating the nozzle 810 relative to the handle 820 can lock the protrusion 1052 in the channel 1054. In one example, when the sliding protrusion 1052 reaches the end sliding point of the channel 1054, the engagement (e.g., the protrusion 1052 engages the channel 1054) can lock the nozzle 810 with the handle 820. In another example, when the sliding protrusion 1052 reaches the end sliding point of the channel 1054, the engagement may create an audible noise, which can indicate to the medical professional that the nozzle is fixed with the handle 820.

[0122] The handle 820 and the nozzle 810 can be coupled in a manner such that a seal is formed within the nozzle engagement region 816. For example, the nozzle engagement region 816 and the handle engagement region 826 can be coupled together with a friction fit and attachment mechanism 950 such that a fluid-impermeable seal can be formed between the handle 820 and the nozzle 810. The fluid-impermeable seal can be coupled, placed, formed, or otherwise attached proximate to the distal end of the handle engagement region 826. The fluid-impermeable seal can also be coupled, placed, formed, or otherwise attached proximate to the proximal end of the nozzle engagement region 816.

[0123] The handle 820 can define or surround a fluid supply chamber 830, which can be configured to allow fluid, for example, (not shown) from a fluid source to pass. The fluid supply chamber 830 can be connected to the fluid source at one end through the handle 820, and is connected to a fluid supply port 924. When the actuator 840, such as a button, is pressed, it activates the fluid supply port 924, thereby allowing air to continue to flow inside the expandable chamber 930. The fluid supply chamber 830 can be connected or can be connected to the fluid supply via any suitable connection, such as but not limited to, a Luer connection, a threaded connection, a clip connection, a locking connection, etc. The supplied fluid can include a pressurized fluid source, such as a pressurized gas or liquid. In some examples, the pressurized fluid source can include, for example, a portable compressed fluid tank, a pressurized fluid pipeline (e.g., a gas pipeline or a water pipeline), etc. In some examples, the fluid source can be a disposable or refillable compressed gas tank. In some examples, the fluid supply cavity 922 and the fluid supply port 924 can be configured to transfer the pressurized fluid from the fluid supply cavity 922 to an expandable film chamber 930 or cavity defined by an expandable film 932 (e.g., a balloon, a diaphragm), which is connected to the distal end of the handle 820. When the handle 820 is connected to the nozzle 810, the expandable film 932 can be at least partially disposed in, adjacent to, or in close proximity to the nozzle engagement area 816 of the nozzle 810. The pressure from the pressurized fluid to the expandable film chamber 930 can expand the expandable film 932, the balloon wall, or the cavity wall to apply pressure on the implant and drive the implant distally. As described elsewhere herein (e.g., with respect to the syringe 800), the handle 820 can also include or be connected to a pressure regulator 860, which can allow the pressurized fluid to be discharged from the expandable film chamber 930.

[0124] A vent switch 842 can be provided on the handle 820, which can control a vent that fluidically couples the interior of the nozzle 810 with the exterior of the syringe 800. According to some aspects, when the vent switch 842 is closed, the vent switch 842 prevents fluid from escaping from the expandable membrane chamber 930. In addition, for example, when actuated or opened, the vent switch 842 can allow the fluid within the expandable membrane chamber 930 to be discharged from the syringe 800, thereby deflating or reducing the fluid pressure within the expandable membrane chamber 930 to the extent that the expandable membrane chamber 930 is pressurized relative to the exterior of the syringe 800. The vent switch 842 can be operated mechanically or electronically. In some embodiments, for example, the vent switch 842 can include a power-on switch that can, for example, activate suction, a fan, or a blower to actively remove fluid from the expandable membrane chamber 930. Thus, the vent switch 842 can be used to stop or reduce the vent pressure within the nozzle 810, for example, to stop or slow the venting of the implant from the nozzle 810 and / or to reset the injector 800 after the implant has been vented from the nozzle 810.

[0125] The handle 820 may also include an actuator 840 for selectively supplying and terminating the flow of pressurized gas or other pressurized fluid from the fluid supply through the fluid supply port 924. The actuator 840 may include, for example, a button, a knob, a valve, a switch, a clip, or a combination thereof, which may open / create and / or close a connection between a more proximal portion of the fluid supply lumen 922 and the fluid supply port 924. In some examples, the actuator 840 may be spring loaded, or in other cases may employ a constant pressure to maintain an open flow of pressurized fluid toward an implant contained in the housing 910 of the nozzle 810. In one example, the actuator 840 may be located on an upper or top surface of the handle 820 so that the actuator 840 may be easily accessible to a medical professional while preventing accidental triggering or activation.

[0126] like Fig.11 As shown, implant 1110 can be any implant previously described in the present invention, or any similar implant that can be suitable for the purpose. Before handle 820 is connected to middle part 911, an implant (such as, implant 1110) can be loaded through nozzle engagement area 816 of middle part 911. Fig.11 The expandable membrane 932 is shown in a compressed or deflated configuration with the implant 1110 within the housing 910. The implant 1110 can be inserted into the housing 1110 of the nozzle 810 of the syringe 810 by compressing the implant 1110. For example, the implant 1110 can be pre-loaded or inserted into the intermediate portion 911 to facilitate aseptic loading of the implant into the nozzle, and / or manipulation (e.g., compression, elongation, etc.) of the implant 1110 toward the insertion configuration.

[0127] A vacuum or suction may be used to load the implant 1110 into the housing 910. For example, the vacuum cup 960 (see Figure 8 and 9) can be attached above the nozzle opening 912, for example, to form a fluid-tight seal. Vacuum can be applied through the vacuum opening 962 of the vacuum cup 960. The vacuum can be supplied via an external vacuum or suction generating source. The vacuum source can be a source generated indoors, a portable source, or any similar negative airflow source designed for the desired purpose. The vacuum source can be any known vacuum source used for surgery, such as liposuction, endoscopy, etc. For example, a vacuum pressure of about 508.0 to about 762.0 mmHg (about 20.0 to about 30.0 inches of mercury) can be supplied to the vacuum opening 962 and the vacuum cup 960 through the cavity. The implant 1110 can be placed at or near the open proximal end of the nozzle 810. The pressure reduction that may be caused by the applied vacuum can pull the implant 1110 into the proximal opening of the nozzle 810 and into the housing 910, for example, into the middle portion 911 of the nozzle 810.

[0128] Power supply conduit 970 (see Fig. 9 ) can provide power to one or more directions of the syringe 800. In some examples, the power conduit 970 can provide power to a vacuum source disposed in the handle 820, which can be used to create suction and load the implant 1110 into the middle portion 911 of the nozzle 810. However, in other examples, the electrical system can be an internal component.

[0129] Once the implant 1110 is loaded into the syringe 800, a pressurized fluid may be delivered to an area proximal to the implant 1110 through the fluid supply lumen 922 and the fluid supply port 924. Such pressurized fluid, when delivered, may apply pressure to the implant 1110 to drive the implant 1110 distally toward and through the nozzle end opening 912 of the nozzle 810. The pressure generated in the expandable membrane chamber 930 may cause the expandable membrane 932, the balloon wall, or the cavity wall to expand and / or move in a distal direction to apply pressure to the implant 1110 and drive it distally through the distal opening 912.

[0130] In some examples, the nozzle end opening 912 can have an angled profile such that an upper portion 915 of the nozzle end opening 912 extends further from the nozzle end 812 than a lower portion 917 of the nozzle end opening 912. By providing a larger effective diameter at the nozzle end opening 912, the angled profile of the nozzle end opening 912 can allow an implant to be aspirated or pulled from the nozzle 810 during a medical procedure.

[0131] Nozzle end opening 912 may be the distal-most portion of nozzle 810 . FIG. 12A to FIG. 12E1210, 1212, 1214 or 1216 according to various examples of the present invention. Nozzle end opening 912 can have any form suitable for placing an implant (such as, implant 100, 150, 200 or 1110) in a target site, for example, as described herein and / or in WO2017 / 181144, which is incorporated herein by reference in its entirety. Nozzle end opening 912 is located at the distal end of nozzle end 913, which can have a perimeter determined by the purpose or profile of the implant. For example, nozzle end opening 912 can have a semi-elliptical or angular shape to accommodate non-circular implants. The angle of nozzle end opening 912 and / or the diameter of nozzle end opening 912 can also be customized. Nozzle end opening 912 can have different exemplary shapes, such as those associated with nozzle end openings 1210, 1212, 1214 and 1216. For example, the perimeter of the nozzle end opening 912 may be generally round, circular, elliptical, rectangular, trapezoidal, or asymmetrical in shape.The nozzle end opening 912 may have a larger diameter or cross-sectional dimension at its proximal portion than at its distal portion.

[0132] like Fig.12E As shown, the nozzle end opening 1218 can be surrounded, enclosed, and / or defined by one or more slits, fins, petals, or extensions disposed about the perimeter of the nozzle end opening 1218. Such features can be disposed in a circumferential arrangement about the nozzle end opening 1218, or can be disposed symmetrically or asymmetrically about the nozzle end opening 1218. In some examples, such features can help position the nozzle end 812 through the incision and / or guide placement of the implant through the nozzle end 812 and the nozzle end opening 912 and into the implantation site.

[0133] In some examples, the nozzle may have a tapered profile with different taper sizes, such as FIG. 12A to FIG. 12EAs shown. For example, a relatively small percentage of the nozzle end opening 912 may include a tapered profile (e.g., about 50% to about 25% of the nozzle end opening 912 may have a tapered profile, or less if the design dictates). In some examples, the nozzle end opening 912 may be characterized as flexible (e.g., flexible enough to bend when pressure is applied to it by the passage of the implant, or in some examples, more flexible than the proximal region of the nozzle 810). At least a portion of the nozzle 810, such as the periphery of the nozzle end 812, may be configured to flex, for example, when an implant passes through the nozzle end opening 912 of the nozzle 810. In another example, the cross-sectional size of the nozzle end 812 may increase as the implant passes through it (e.g., from about 0.5 cm to about 2.0 cm, to about 2.5 cm, to about 3.0 cm, or to about 3.5 cm). In another example, the cross-sectional size of the nozzle end opening 912 may remain stationary when the implant passes through the nozzle end opening 912.

[0134] Surgical method

[0135] Surgical method, such as minimally invasive surgery can be used to insert implants into the target site in the patient's body. Although the implant can be placed in any known position in the target site, such as at the calf or around the gluteal muscle, the surgical method or surgery for placing the implant in the breast region of the patient will also be further described. In addition, although the surgical method or surgery will be described with reference to implant 1110, it will be understood by those skilled in the art that the surgical method described herein can also be used for any one (such as, implant 100,150,170 or 200) or the implantation of any known implant in the above-mentioned implant. Similar surgical tools used in the following methods can be applied to buttocks implants, calf implants or other implants.

[0136] In one example, the minimally invasive surgical procedure described below can be a monitored conscious sedation surgical procedure. In one example, the minimally invasive surgical procedure described below can utilize a local anesthetic.

[0137] Fig.13 A front view of a patient's torso as discussed in the present invention is shown. When the implant can be inserted into the breast 1300, a small incision can be made at a desired location, such as an inframammary incision, a circum-areolar incision, or an axillary incision. Fig.13 As shown, a submammary incision 1310 can be made below the breast 1300. A circumareolar incision can be made around the areola or nipple. An axillary incision can be made in or near the axillary region 1304.

[0138] While minimally invasive surgical procedures are envisioned in which incisions such as the inframammary incision 1310 or the circumareolar incision 1312 may be made, minimally invasive surgical procedures utilizing an exemplary axillary incision 1314 will also be described. However, the concepts and methods described with respect to the axillary incision 1314 may also be applied to incisions made in the inframammary region or the circumareolar region.

[0139] Use of marking tools

[0140] FIG. 14A to FIG. 14D Several exemplary images of steps in a surgical procedure utilizing a marking tool according to at least one example of the present invention are shown. Figure 4 The marking tool 400 or any other suitable device may be used to mark the surgical area using at least one of a plurality of navigation lines or reference lines on the breast 1400. In one example, the marking tool 400 may be placed on the breast 1400 with the center of the marking tool 400 substantially aligned with the areola 1402 or nipple before or after drawing an incision mark 1410 indicating the incision site, such as Fig.14A As shown. An incision mark 1410 can be marked on the breast by tracing or drawing a line at the incision location identifier 405. The incision mark 1410 indicating the incision location can be drawn on a pre-existing axillary skin crease 1415, such as behind the outline of the pectoralis major muscle. The incision mark 1410 can extend along the axillary skin crease 1415 between about 1.0 centimeters and about 4.0 centimeters, for example, a length of about 2.5 centimeters.

[0141] A medical professional may use the marking tool 400 to mark parallel lines 1412 extending from the sides of the incision mark 1410, such as Fig. 14B Alternatively, the medical professional may draw parallel lines 1412 freehand. Parallel lines 1412 may be parallel to the muscle fiber orientation. Parallel lines 1412 may, for example, extend from about 3.0 cm to about 5.0 cm from the lateral end of incision mark 1410 toward breast 1400.

[0142] like Fig. 14CAs shown, the medical professional can place the marking tool 400 on the breast 1400, with the patient's nipple or areola 1402 as the center point. The medical professional can use a pen, a marker, or other writing instrument to mark, trace, or draw at least one of the multiple reference lines corresponding to the size indicator, such as the circumferential outline of the implant to be inserted. The circumferential shape can be the outer perimeter 406 of the marking tool 400 on the breast 1400. The outer perimeter 406 of the marking tool may be related to the target site of the implant. The medical professional can trace or draw a mark at the middle marking area 424 or the inner perimeter 422 on the marking tool 400 when, for example, a smaller implant is to be inserted. The outer perimeter 406, the middle marking area 424, or the inner perimeter 422 can indicate the expanded diameter of the tissue expander and the corresponding diameter of the implant 1110. In one example, the marking tool 400 can be used to draw the diameter of the target site, such as the inner perimeter 422 is about 8.0 centimeters, the middle marking area 424 is about 9.0 centimeters, or the outer perimeter 406 is about 10.0 centimeters.

[0143] like Fig. 14C As shown, the medical professional can then connect parallel line 1412 to the drawn diameter, such as outer perimeter 406, with extension line 1414. Fig.14D As shown, the connection of the extension line 1414 with, for example, the outer periphery 406 can define a transition zone 1417 at an angle between 100° and 120°. The transition zone can be in an area known as the Spencer's tail. The transition zone 1417 can be marked. The transition zone 1417 can be the area within the patient's body where the medical professional changes or slightly changes the insertion direction of any of the previously discussed tools (such as, tissue stripper 600, balloon dilator 700, or syringe 800) to a direction toward the areola 1402.

[0144] The medical professional can also draw or trace along a navigation line such as a guide line 416 extending from the proximal incision location to the target site. The guide line 416 can correspond to a pathway extending from the proximal incision location to the target site. Where the guide lines 416 meet or extend to the outer perimeter 406, the medical professional can draw or mark a final peel mark 1416. The final peel mark 1416 can indicate the final insertion distance of the tissue stripper 600.

[0145] anaesthetization

[0146] In one example surgical procedure, when the medical professional has finished marking the breast 1400, a cannula may be inserted around the marked area, if desired, such as described above with respect to Figure 5 The cannula 500. In one example, the cannula 500 can be coupled to a pump via lumen 513, which can be connected to a fluid source for anesthesia.

[0147] Fig.15 An exemplary image of an area for infiltration using a cannula is shown in accordance with at least one example of the present invention. In one example, a cannula 500 can be inserted subcutaneously and into breast tissue at several locations that have been marked using marking tool 400. Cannula 500 can deliver a tumescent solution into breast tissue via a lumen 513 attached to a pump.

[0148] The tumescent solution may be a saline solution mixed with an anesthetic. In one example, the tumescent solution may be injected into the breast 1400, which may numb the breast tissue to any further incisions, punctures, or forces applied to the breast 1400 or breast area and / or to the breast. The saline solution may assist in saturation of connective tissue, such as ligaments or tissue within the breast. Saturation of ligaments and tissue may also allow for stretching and expansion. In one example, approximately 500cc of tumescent solution may be delivered to each breast via a single injection or multiple injections.

[0149] In such Fig.15 In one example shown, infiltration may be initiated with cannula 500 on or around incision mark 1410 on or around axillary skin crease 1415. The medical professional may infiltrate the area around incision mark 1410 with approximately 50 cc of tumescent solution. However, different amounts of tumescent solution may be delivered as dictated by the surgical procedure.

[0150] Infiltration of the tumescent solution may also occur in a clock-like manner at or around the areola 1402, e.g. Fig.15 1402, or any other amount as prescribed by the patient and / or surgical procedure. Continued infiltration may occur at or near opposing locations along, for example, the outer periphery 406, such as marked at approximately the 2 o'clock and 7 o'clock positions or the 5 o'clock and 11 o'clock positions. In one example, approximately 50 cc of tumescent solution may be delivered at each of the opposing locations 1512.

[0151] In another example, the infiltration may also occur at or near the final peel mark 1516. In one example, about 10 cc of the tumescent solution may be delivered at or near the final peel mark 1516.

[0152] It is also contemplated that other injections may be used and alternative amounts of tumescent solution may be delivered.

[0153] incision

[0154] In the above example surgical procedure, after the tumescent solution is delivered to all desired areas of the breast 1400, an incision 1600 can be made at the previously marked axillary skin crease 1415. In one example, the length of the incision 1600 can be between about 1.0 centimeters and about 4.0 centimeters, such as about 2.5 centimeters. The incision 1600 can pass through the dermis to the subcutaneous tissue. The depth of the incision 1600 can be about 3.0 millimeters to about 5.0 millimeters. The incision 1600 can be small enough to make the surgical procedure minimally invasive, but also large enough to allow insertion of any desired or necessary tools required for the surgical procedure.

[0155] Channel formation

[0156] Fig.16A and Fig. 16B An exemplary use of a tissue dissector according to at least one example of the present invention is shown. Any suitable tissue dissector, such as the one described above with respect to Figure 6 The tissue stripper 600 described can be used for tissue dissection. In the next step of the example surgical procedure, the tissue stripper 600 can be inserted through the incision 1600, such as Fig.16A Tissue dissector 600 may be a reusable surgical instrument for brief use that may form a surgical corridor by dissecting soft tissue in an area, such as between an axillary skin crease 1415 and a final dissect mark 1416 or other end location.

[0157] The tissue stripper 600 can be sterilized in any known manner prior to insertion into the incision 1600. The tissue stripper 600 can be inserted through the incision 1600 and, for example, over the pectoralis muscle and through the breast tissue. The tissue stripper 600 can be inserted into the incision 1600 at an approximate center point of the incision 1600. The medical professional can change or slightly alter the insertion path of the tissue stripper 600 at or near the transition zone 1417 to form a passage 1610 that can be slightly angled. At the transition point, the tissue stripper 600 can be advanced over the pectoralis muscle and toward the areola 1402. The tissue stripper 600 can be advanced until it reaches the final stripping mark 1416 or the lower medial border of the breast. In one example, the tissue stripper 600 can be advanced from about 15.0 centimeters to about 17.0 centimeters. When inserting the tissue stripper 600, the medical professional can grasp and lift the breast 1400 to facilitate the advancement of the tissue stripper 600, which can help avoid interference from the breast tissue.

[0158] A medical professional may, for example, follow the marked guide line 416 (see Fig. 14C) The tissue dissector 600 is advanced toward the areola 1402. The medical professional can maintain the tissue dissector 600 in a superficial plane by pushing the tissue dissector 600 at an appropriate angle or along the contours of the patient's body. In this example, the tissue dissector 600 can form a passage 1610 within the breast tissue, the width of which can be approximately the same as the diameter of the tissue dissector 600. The passage 1610 can be formed such that the tissue dissector 600 can have a maximum width that is substantially similar to the size of the incision. In one example, when the medical professional advances the tissue dissector 600 through the incision 1600, the medical professional can try to avoid damaging the breast tissue or ligaments.

[0159] The medical professional can advance the tissue dissipator 600 a desired distance to reach the target site, for example, to the final dissipation mark 1416. The medical professional can use the graduated marks 622 to determine the depth of the tissue dissipator 600 within the passage 1610. The medical professional can then remove the tissue dissipator 600 from the incision 1600. The medical professional can remove the tissue dissipator 600 along or within the passage 1610 so as not to form a passage that is wider than the passage formed when the tissue dissipator was inserted or so as not to form the passage in a manner that would otherwise dilate the passage 1610.

[0160] Target site formation

[0161] FIG. 17A to FIG. 17G An exemplary image of a procedure using an instrument, such as a tissue expander, according to at least one example of the present invention is shown. Any suitable tissue expander, such as the one described above with respect to Fig. 7A and Figure 7B The tissue expander 700 described above can be used to expand the patient's tissue near a target site to create a pocket cavity for receiving an implant. In an example surgical procedure, the passage 1610 can be used to introduce the tissue expander 700 including the balloon 750 (as previously discussed) into the target site 1712. Fig.17A As shown, when supplied by the manufacturer, the balloon 750 can be supplied to the medical professional in a manner surrounded, wrapped, or otherwise compressed and combined with a removable retaining device 1710, such as a band, belt, string, clip, etc. When supplied, the size of the balloon 750 can be reduced so that the balloon 750 can be inserted to minimize any unwanted interaction with previously inserted tools or anatomical structures. In one example, the removable retaining device 1710 can be removed from the balloon 750.

[0162] The medical professional may then subject the balloon 750 to a hydrating solution 1711, such as Fig. 17B As shown, balloon 750 is hydrated. For example, balloon 750 can be hydrated in a sterile saline solution.

[0163] During an exemplary surgical procedure, after hydrating the balloon 750, a medical professional may refold, rewind, or otherwise compress the balloon 750 to a size or profile suitable for insertion within the incision 1600, as Fig. 17C shown.

[0164] 18A to 18C A side profile view is shown depicting exemplary balloon placement positions within a target site in accordance with various examples of the present invention. As Fig.18A shown, in one example, the balloon 750 may be advanced beneath the breast or beneath the breast tissue 1850, but above the fascial layer surrounding the pectoral muscle 1860. In another example, as Fig.18B shown, the balloon 750 may be advanced beneath the pectoral muscle or beneath the pectoral muscle 1860. In another example, as Fig. 18C shown, the balloon 750 may be inserted in a biplane or partially beneath both the pectoral muscle 1860 and the breast tissue 1850. The implantation location may be determined by the medical professional and based on the patient's anatomy.

[0165] Returning to FIG. 17A to FIG. 17G and in particular Fig.17D , the medical professional may insert the folded, wound, or otherwise compressed balloon 750 through the incision 1600. The balloon 750 may be inserted with a support extension portion 745 oriented as the posterior base of the balloon 750. The support extension 745 may assist in advancing the balloon 750 through the access path 1610. In one example, if any breast tissue prevents advancing the balloon 750 to the target site 1712, the tip 746 of the support extension portion 745 may be used to advance the balloon 750.

[0166] As Fig.17E shown, the medical professional may advance the balloon 750 until the tip 746 of the support extension portion 745 reaches the final peel mark 1416 and the target site. The medical professional may also use the graduation marks 741 on the introducer 740 to determine or position how far the balloon 750 has been inserted.

[0167] A pump, such as a manual pump 710, may be used to inflate or expand the balloon 750. The manual pump 710 may be coupled to a flexible lumen 720 such that the flexible lumen 720 extends from the manual pump 710 to the balloon 750. As Fig.17FAs shown, the medical professional can then activate the pump 710 by, for example, squeezing the pump 710 until the balloon 750 reaches a desired expansion or inflation state, such as fully inflated. In one example, the medical professional can squeeze the pump about 3 times to about 12 times, such as about 4 times or about 5 times, to bring the balloon 750 to its fully expanded or desired state. In one example, the fully expanded balloon 750 can have a base width or diameter of between about 10 cm and about 20 cm, or between about 12 cm and 16 cm, or, for example, about 14 cm. Other suitable pumps, such as electric pumps, can be used instead of the manual pump.

[0168] The inflated balloon 750 can push or apply force laterally against connective tissue, such as soft tissue or ligament 2010 (hereinafter "connective tissue" may refer to ligament or tissue) in the breast 1400, such as Figure 17G As shown. Connective tissue 2010 can be Cooper's ligament that can shape and support the breast. In one example, when balloon 750 is inflated, it can protrude away from support extension 745 or protrude forward. By protruding forward, balloon 750 can assist in forming cavity 1750, which can maintain the anatomically original connective tissue structure and muscle tissue on the posterior side 751 of balloon 750. During expansion of balloon 750, connective tissue 2010 can be minimally separated around the rounded edge 752 of the posterior side 751 of balloon 750. When balloon 750 is expanded, balloon 750 can retain at least one attachment point 1116 of connective tissue 2010. At least one attachment point 1116 can be located lateral to the expanded balloon 750. Attachment point 1116 can also be located below the expanded balloon 750. The attachment point 1116 can be located near the curved posterior side 751 of the balloon 750 so that the attachment point of the ligament is formed posteriorly relative to the expansion balloon.

[0169] During the expansion of the balloon 750, the passage 1610 can remain substantially intact or remain substantially maintained. The expansion of the balloon 750 can only form the cavity 1750 around the balloon 750, and will not expand the passage 1610 through which the balloon 750 passes to reach the target site. The size of the incision 1314 can also be substantially maintained as originally formed.

[0170] In one example, the balloon 750 can expand and protrude forward, thereby separating the connective tissue 2010 as it is advanced away from, for example, the pectoralis muscle 1860. The balloon 750 can expand, for example, against the connective tissue 2010 so that the connective tissue 2010 can surround, enclose, bind, or nest around the balloon 750. The connective tissue 2010 surrounding the balloon 750, such as Figure 17GAs shown, a nested cavity 1750 can be formed to hold the balloon 750 so that the balloon 750 can apply force laterally, medially, and / or downwardly against the connective tissue 2010. In one example, the balloon 750 can push the connective tissue 2010 laterally. The balloon 750 can separate the connective tissue 2010 in a manner that preserves the connective tissue and minimizes damage to the internal structure of the breast 1400. In one example, the structure of the separated connective tissue 2010 can maintain an almost original anatomical structure.

[0171] The medical professional can then close the clip 730 when the balloon 750 has expanded a desired amount. In one example, the clip 730 can be closed to keep the balloon 750 inflated for a predetermined amount of time. In one example, the predetermined amount of time that the balloon can remain inflated is between about 3 minutes and about 7 minutes, such as about 5 minutes. Keeping the balloon 750 in an inflated state can allow the balloon to act as a hemostatic device and assist in stopping or minimizing any bleeding that may occur in the breast area. The inflated balloon 750 can be slightly over-inflated to apply pressure to the surrounding tissues and ligaments, which can assist in stopping or minimizing any bleeding. The balloon 750 can remain in an inflated or expanded state for a predetermined amount of time. In one example, when the balloon 750 remains in an inflated state for a predetermined amount of time, the medical professional can repeat the steps discussed above for the patient's other breast. The medical professional can open the clip 730 to deflate the balloon 750 after the balloon 750 remains for the desired amount of time. The deflated balloon 750 can then be removed from the patient's breast.

[0172] Balloon 750 can be withdrawn through passageway 1610. In one example, balloon 750 can be passed through passageway 1610 without increasing or only minimally increasing the width or diameter of passageway 1610. In one example, balloon 750 can be withdrawn and removed through incision 1600 while maintaining (or at least substantially maintaining) the original size of incision 1600.

[0173] In one example, the balloon 750 can be sized, shaped, or otherwise configured to simulate or at least substantially resemble the implant 1110 to be inserted, so that the resulting cavity 1750 is sized to tighten or nest the implant 1110 after insertion. The balloon 750 can be sized to resemble the implant to be inserted. The balloon 750 can be sized so that the balloon 750 can form a cavity that is minimally smaller than the desired implant. In one example, it is not preferred that the balloon 750 is significantly larger than the desired implant. In one example, it is not preferred that the balloon 750 is larger than the minimally overinflated, so that the balloon 750 can form a cavity larger than the desired implant. Minimizing the amount of "extra" space formed in the cavity 1750 can prevent or minimize the movement of the implant 1110 after insertion. In one example, the balloon 750 can be sized, shaped, or otherwise configured such that the resulting cavity 1750 is slightly smaller than the implant 1110 to ensure that the implant 1110 is securely placed and positioned within the cavity 1750.

[0174] Insertion of the implant

[0175] FIG. 19A to FIG. 19N An exemplary image of a procedure for inserting an implant into a target site in a breast according to at least one example of the present invention is shown. In one example, a syringe 800 having a nozzle end opening 912 can be used to insert an implant 1110 into a cavity 1750 formed by a balloon 750.

[0176] like Fig.19A As shown, a medical professional can select an appropriately sized nozzle 810 to accommodate and subsequently discharge the implant 1110. Fig.19A , a medical professional can select between a nozzle 810a with a nozzle end opening 912a having a first diameter 1913 and a nozzle 810b with a nozzle end opening 912b having a second diameter 1915. In one example, the first diameter 1913 can be between about 15 mm and about 25 mm, and the second diameter 1915 can be between about 20 mm and about 32 mm. In one example, the first diameter 1913 can be about 20 mm, and the second diameter 1915 can be about 23 mm. However, any nozzle 810 having a nozzle end opening 912 of any suitable size can be used.

[0177] Medical professionals can use an external pneumatic system to aspirate the implant 1110 into the nozzle 810 and then expel the implant 1110 from the nozzle 810. In one example, a separate pneumatic system can be used to aspirate the implant 1110, and another pneumatic system can be used to expel the implant 1110 from the nozzle 810. In one example, the external pneumatic system can be calibrated to between about 4.8 and about 5.6 bar (about 70 to about 80 pounds per square inch).

[0178] Before the implant 1110 is aspirated into the nozzle 810, the implant 1110 can have a first or neutral form. The first form can be a form in which each of the front side and the back side projects away from the longitudinal axis. When the implant 1110 can be contained within the housing of the nozzle 810, the implant 1110 can then have a second form such that the front side and the back side can be compressed toward the longitudinal axis. When the implant has been expelled from the nozzle 810, the implant 1110 can have an implanted form such that the back side is compressed against the patient's anatomy, and the front side of the implant projects further from the longitudinal axis than in the first or neutral form.

[0179] As Fig.19B shown, a medical professional can connect the pressure regulator 860 to the external pneumatic system via medical-grade tubing 1912. In one example, the medical-grade tubing 1912 can have an outer diameter of about 6.35 millimeters (about 0.25 inches). The distal end 1914 of the medical-grade tubing 1912 can be connected to the proximal end of the handle 820, and the proximal end 1916 of the medical-grade tubing 1912 can be connected to the pressure regulator 860.

[0180] As Fig.19C shown, a vacuum cup 960 with a vacuum cap 964 can be connected to the nozzle end 812. The vacuum cup 960 and the vacuum cap 964 can cover and seal the nozzle end opening 912. However, other means of sealing the nozzle end 812 can be used according to the device and surgical requirements.

[0181] As Fig.19D shown, the nozzle 810 can be held, for example, with the nozzle end 812 facing down and the vacuum cup 960 facing down. The medical professional can then at least partially fill the nozzle 810 with a sterilizing solution, such as a sterile saline solution. In one example, an inner coating on the inner surface 811 of the nozzle 810 can be activated when the inner coating comes into contact with the sterilizing solution. In another example, the inner surface 811 of the nozzle 810 does not have a coating. In another example, the inner coating can be activated with a different liquid solution or without a liquid solution.

[0182] As Fig.19EAs shown, nozzle 810 may then be emptied after holding the sterilizing solution for a predetermined amount of time, such as a few seconds or minutes after use of the sterilizing solution.

[0183] like Fig.19F As shown, the vacuum cap 964 can be removed from the vacuum cup 960. The vacuum cup 960 can remain on the nozzle end 812. The vacuum cup 960 can then be attached to an external air pressure system or another similar system. For example, the external air pressure system can be connected to the vacuum cup 960 through a sterile suction tubing 966. The sterile suction tubing 966 can have an outer diameter between about 4.75 mm and about 6.4 mm, or any diameter specified by the user.

[0184] like Figure 19G The implant 1110 shown may be a compressible implant such that when subjected to external pressure, the implant 1110 may expand in a lateral direction, which is approximately equivalent in any expansion direction. Figure 19G In the example shown, when the implant 1110 rests on a surface, the posterior side 1112 or the side that rests on or against the surface can be flattened and the opposite or anterior side 1114 can protrude in a direction away from the surface, or protrude forwardly.

[0185] Implant 1110 can then be hydrated, as Fig.19H , in saline solution or any other suitable solution. The saline solution can help expel the implant 1110 from the nozzle 810, through the nozzle end 812 and the nozzle end opening 912. The implant 1110 can be hydrated in a container from which the implant 1110 can be removed without being touched by a non-sterile source, such as hands or non-sterile medical tools.

[0186] like Fig.19HAs shown, the nozzle 810 can be connected to an external air vacuum system via a sterile suction tubing 966. The medical professional can place the nozzle 810 so that the nozzle engagement area 816 can face downward and open toward the implant 1110 in a container for hydrating the implant 1110. In one example, the medical professional can activate or turn on the external air vacuum system so that a low pressure environment can be formed in the nozzle 810. When the nozzle 810 can be placed adjacent to the implant 1110, the low pressure environment or vacuum can suck the implant 1110 into the nozzle 810. A vacuum pressure of about 508.0 to about 762.0 mmHg (about 20.0 to about 30.0 inches of mercury) can be supplied to the vacuum opening 962 and the vacuum cup 960 through the cavity. In another example, when the nozzle 810 can be placed above the implant 1110, the low pressure environment in the nozzle can suck the implant 1110 into the interior. In one example, when sucked into the middle portion 911 of the nozzle 810, the implant 1110 can be substantially uniformly compressed and stretched. In one example, when in the middle portion 911 of the nozzle 810, the implant 1110 can be compressed in the longitudinal and vertical directions. The implant 1110 can be compressed so that the rear side and the front side are closer to each other, and the top side and the bottom side are closer to each other. For example, the implant 100 can be substantially uniformly compressed around the longitudinal axis 151 and the vertical axis 130.

[0187] In one example, a medical professional can verify the expansion of the expandable membrane 932, such as Fig.19JAs shown. The medical professional can first activate or turn on the external air pressure system in a manner that can transmit a specified external air pressure from the external air pressure system through the handle 820. Then, the medical professional can depress or otherwise engage the actuator 840, such as via a button or any manner that can control the expansion of the expandable film 932. In one example, activating the actuator 840, such as depressing a button, can cause pressurized air or any suitable fluid to enter the expandable film chamber 930 connected to the handle 820. When the actuator 840 is depressed, it can cause the fluid supply cavity 922 to meet, connect or connect with the fluid supply port 924. Then, the pressurized air can enter the expandable film chamber 930 through the fluid supply port 924 and enter the expandable film 932. Then, the expandable film 932 can expand. The medical professional can release the actuator 840, and the actuator 840 can cause the pressurized air to leave the expandable film chamber 930 by using the exhaust switch 842. When the pressurized air leaves the expandable membrane chamber 930, the expandable membrane 932 may deflate. In another example, the actuator 840 may remain in a depressed state or otherwise in position to maintain expansion of the expandable membrane 932. When the actuator 840 is released, the pressurized air in the expandable membrane chamber 930 may be released through the fluid supply port 924. The expandable membrane 932 may then substantially return to its original position and shape.

[0188] The nozzle 810 having the implant 1110 contained within the middle portion 911 can be coupled to the handle 820, such as Figure 19K As shown. In one example, the attachment mechanism 950 on the handle 820 and the nozzle 810 can be aligned. The nozzle engagement area 816 can be coupled to the handle engagement area 826 using the attachment mechanism 950. In one example, there may be an audible notification, such as a click, when the nozzle engagement area 816 completes the coupling with the handle engagement area 826. The audible notification can indicate that the nozzle 810 and the handle 820 are substantially or completely sealed. The attachment mechanism 950 can provide a visual indication, such as proper alignment, for example, with an "L" shaped engagement.

[0189] When the handle 820 and the nozzle 810 are coupled, the vacuum cup 960 can be detached from the nozzle end 812. The medical professional can then prepare to insert the implant 1110 into the target site 1712 after removing the vacuum cup 960.

[0190] A medical professional can insert nozzle end 812 through incision 1600, such as Figure 19LThe medical professional can then advance the nozzle 812 through the passage 1610 until the nozzle end 812 reaches the target site 1712. As the medical professional advances the nozzle end 812 through the passage 1610, the medical professional can strive to avoid increasing the width or size of the passage 1610. The medical professional can use markings, such as the parallel lines 1412 and the guide lines 416, to guide the nozzle end 812 to the target site 1712.

[0191] When the nozzle end 812 reaches the target site 1712, the medical professional can depress or engage the actuator 840. The actuator 840 can connect, meet or otherwise couple the fluid supply chamber 922 to the fluid supply port 924. The connection, meeting or other connection of the fluid supply chamber 922 to the fluid supply port 924 can provide a path for the pressurized fluid to enter the expandable film 932. Then, the expandable film 932 can be expanded or inflated. The expandable film 932 can be quickly filled with the pressurized fluid, and therefore the expandable film 932 can expand at a rate at which the expandable film 932 applies pressure or force against the implant 1110 in the middle portion 911. The pressure or force from the expandable film 932 can push the implant 1110 toward the nozzle end opening 912.

[0192] The expandable membrane 932 may expand an amount sufficient to push the expandable membrane 932 against the implant 1110. This force may cause the implant 1110 to further compress as the implant 1110 enters the nozzle end 812, as shown in FIG. Fig.19M and Fig.19N The implant 1110 can then be further compressed within the nozzle end 812 and the force from the expandable membrane 932 that can be applied against the implant 1110 can expel the implant 1110 from the nozzle end opening 912 and into the target site 1712, as shown. Fig.19N The delivery pressure can be adjusted to about 3.0 bar to about 4.5 bar (about 50 psi to about 60 psi). The delivery pressure can be higher than the vacuum pressure previously described.

[0193] In one example, the nozzle end opening 912 can have an angled, tapered, or otherwise shaped opening, such as FIG. 12A to FIG. 12DIn the example shown in . The size and shape of the nozzle end opening 912 can provide a length to place the implant 1110 more closely in the target site. The size and shape of the nozzle end opening 912 can allow the stress against the implant 1110 to be reduced in a way that does not damage the implant 1110. The size and shape of the nozzle end opening 912 can allow the implant 1110 to expand more gradually or otherwise enter the target site without damage or with minimal damage. When the implant 1110 is released from the nozzle end 812 through the nozzle opening 912, the implant 1110 can expand to a substantially original form. In one example, the nozzle end 812 combined with the geometry of the nozzle end opening 912 can pull the implant 1110 out of the nozzle end 812. The implant 1110 can expand through an angled or larger nozzle end opening and can be released from the nozzle end opening 912 subsequently. The angled nozzle end opening 912 can allow stress and force applied to the implant 1110 to be applied gradually, so that the implant 1110 can be implanted with minimal, if any, damage to the implant 1110. The angled nozzle end opening 912 can cause the implant 1110 to gradually expand to its original form. The stress or force applied to the implant can be reduced against different surfaces of the implant 1110 at different times.

[0194] Implant 1110 can be symmetrical about the longitudinal axis. In examples with symmetrical implants, such as implant 100, the posterior side can be the anterior side, and vice versa. Implant 100 can be inserted in any orientation with respect to the posterior side and the anterior side.

[0195] In one example, when the implant 1110 is expelled from the nozzle end 812, the actuator 840 can be released immediately or shortly thereafter and the expandable membrane 932 can thereby deflate. The medical professional can then remove the nozzle end 812 from the incision 1600 along the same pathway 1610 as formed by the tissue dissector 600. The medical professional can then close the incision 1600 with sutures or any known method of closing an incision.

[0196] Fig. 20A A cross-sectional view of a breast with an implant inserted in an oblique orientation is shown in accordance with at least one example of the present invention. Fig. 20B A cross-sectional view of a breast with an implant inserted in an upright orientation is shown in accordance with at least one example of the present invention. Fig. 20A and Fig. 20BAs shown, the implant can be inserted into the target site 1712 according to the previously discussed surgery. The implant 1110 can then be stabilized by the connective tissue 2010 surrounding the implant 1110. In one example, the implant 1110 can be nested within the target site 1712 so that the ligament can be tightened, surrounded or otherwise retained by the implant 1110. In one example, the connective tissue 2010 (which is carefully pushed aside and remains intact when the balloon 750 is inflated) can surround or support the implant 1110. The connective tissue 2010 can surround or support portions of the implant 1110 on all sides including the back side 1112 of the implant 1110. The connective tissue 2010 can be bent below at least one of the top side, bottom side, right side and left side of the implant 1110 and below the back side 1112. The connective tissue 2010 can be bent below the implant 1110. The connective tissue 2010 can surround the implant 1110 to achieve ligament-to-surface contact with substantially all surfaces of the implant 1110. The posterior side 1112 of the implant 1110, which can be supported by the connective tissue 2010 surrounding and underneath the posterior side, can provide a greater protrusion of the anterior side 1114 of the implant 1110. The connective tissue 2010 can provide nesting or cupping support to the posterior side 1112 of the implant.

[0197] The connective tissue 2010 can provide at least one attachment point 1116 that can support the implant 1110. The attachment point 1116 can be a point of the connective tissue 2010 where the connective tissue 2010 is not separated but can remain attached as in the original anatomical form. The attachment point 1116 can be located on the side of the implant 1110 so that the connective tissue 2010 can help resist lateral movement of the implant 1110. The attachment point 1116 can be located below the implant 1110 to help resist inferior movement of the implant 1110.

[0198] like Fig. 20A and Fig. 20B As shown, the implant 1110 can be located in the target site 1712 and can have a form in which the rear side 1112 can be flatter than the front side 1114. In this example, the filler 1120 within the implant 1110 can form the shell of the implant 1110 into a substantially D-like shape, wherein the rear side 1112 can conform to the pectoralis muscle and the front side 1114 can protrude forward and away from the pectoralis muscle 1860. In one example, the connective tissue 2010 at the target site 1712 can maintain the substantially D-like shape of the implant 1110. The connective tissue 2010 can function to minimize lateral and downward movement of the implant 1110 substantially due to the nesting effect of the ligaments that hold the implant 1110 in place.

[0199] In one example, implant 1110 can be inserted into a higher area of ​​the breast than implants known in the art. In one example, target site 1712 can be more closely aligned with the upper area of ​​the breast than target sites previously known in the art. The posterior side 1112 of implant 1110 can rest against a pectoral muscle 1860, such as a pectoral muscle wall, which can cause anterior side 1114 to protrude into breast tissue 1850. Fig. 20A and Fig. 20B In the example shown, the implant 1110 can remain above the inframammary fold 2020. The alignment of the implant 1110 within the target site 1712 can provide the patient with an anatomy similar to that prior to insertion of the implant 1110. In one example in which the implant 1110 can be inserted in the above method, the implant 1110 can remain substantially stationary and not slide or move laterally when the patient tilts.

[0200] Implants, such as implant 1110, which have been surgically implanted into a patient using the procedures described herein, have demonstrated greater implant and / or breast projection than conventional flat back implants surgically implanted into a patient using previously known breast implant methods. For example, the inventors have discovered that implants (such as implant 1110) inserted by the above methods can project about 10% to 40% further than flat back implants inserted by previously known breast implant methods. In other examples, the above implant methods can provide an increased projection of between 20% and 30%, such as 22%, compared to implants inserted by previously known breast implant methods.

[0201] Various annotations and aspects

[0202] Aspect 1 may include an implant insertion system comprising a tissue expander including an inflatable balloon having a posterior side that curves when inflated; and an implant having a posterior side that curves when positioned against an anatomical surface, wherein the curved posterior side of the implant substantially matches the curved posterior side of the tissue expander.

[0203] Aspect 2 may include or may optionally be combined with the subject matter of Aspect 1 to optionally include: an anterior side; a longitudinal axis positioned between the anterior side and the curved posterior side; and a posterior apex disposed on the curved posterior side, the posterior apex extending further from the longitudinal axis in the first form than when the implant is positioned against the anatomical surface.

[0204] Aspect 3 may include or may optionally be combined with the subject matter of Aspect 1 or Aspect 2 to optionally include: the anterior side of the implant is curved in a manner substantially similar to the curved posterior side, the anterior side of the implant includes an anterior apex, and the longitudinal axis is positioned substantially equidistant from the anterior apex and the posterior apex.

[0205] Aspect 4 may include, or may optionally be combined with the subject matter of any of Aspects 1 to 3 to optionally include: the implant further comprising an anterior side having a curved profile with an apex substantially similar to the curved anterior side of a balloon.

[0206] Aspect 5 may include or may alternatively be combined with the subject matter of any of aspects 1 to 4, wherein the balloon has a compressed configuration and an inflated configuration.

[0207] Aspect 6 may include or may optionally be combined with the subject matter of any of aspects 1 to 5, wherein when the balloon is in the compressed configuration, the balloon is sized to fit through the small incision.

[0208] Aspect 7 may include, or may optionally be combined with the subject matter of any of Aspects 1 to 6, wherein the balloon is configured to have substantially similar diameters in the compressed configuration and the inflated configuration.

[0209] Aspect 8 may include a method of forming a nested cavity in a breast region of a patient's body, comprising: making an incision of a specified size at a desired location in the patient's body; inserting a tissue expander having a balloon into a target site in the patient's body; inflating the balloon at the target site between at least two layers of connective tissue to separate the at least two layers of connective tissue and form a cavity having a contour substantially matching the contour of a breast implant. Wherein the front side of the balloon has a curved contour, and the rear side has a curved contour. Wherein when the balloon is inflated, the balloon protrudes in an anterior and posterior direction. Wherein when the balloon is substantially fully inflated, at least two layers of connective tissue surround the balloon. The method may include maintaining the balloon in an inflated state; after a predetermined period of time, deflating the balloon; and removing the tissue expander and the balloon from the patient's body.

[0210] Aspect 9 may include, or may optionally be combined with the subject matter of aspect 8 to optionally include: wherein the balloon is inflated to expand anteriorly to separate connective tissue.

[0211] Aspect 10 may include or may optionally be combined with the subject matter of either Aspect 8 or Aspect 9 to optionally include: wherein the at least two layers of connective tissue are at least one of ligaments and soft tissue; and wherein at least one of the ligaments and soft tissue surrounds the posterior side of the balloon with minimal separation.

[0212] Aspect 11 may include, or may optionally be combined with the subject matter of any of aspects 8 to 10 to optionally include: at least two layers of ligaments surrounding, enveloping, cinching or nesting the balloon.

[0213] Aspect 12 may include, or may optionally be combined with the subject matter of any of aspects 8 to 10 to optionally include: wherein after separation, at least two layers of the ligament retain a nearly original anatomical structure.

[0214] Aspect 13 may include a method of implant insertion comprising: expanding a tissue expander to form a target site in a patient's body, the tissue expander having a curved posterior side, the curved posterior side maintaining at least one ligament attachment point at the posterior portion of the tissue expander; and inserting an implant into the target site in the patient's body, the implant having a curved posterior side, the curved posterior side supported by at least one ligament attachment point at the posterior portion of the implant.

[0215] Aspect 14 may include or may optionally be combined with the subject matter of Aspect 13 to optionally include: wherein at least one ligament attachment point is located: laterally of a center point of the implant to resist lateral movement of the implant; or below the implant to resist downward movement of the implant.

[0216] Aspect 15 may include, or may optionally be combined with the subject matter of any of Aspect 13 or Aspect 14 to optionally include: wherein the tissue expander comprises a balloon having a compressed configuration and an expanded configuration.

[0217] Aspect 16 may include or may optionally be combined with the subject matter of any of Aspects 13 to 15 to optionally include: expanding a tissue expander to separate at least two layers of connective tissue at a target site to form a cavity while maintaining at least one ligament attachment point posteriorly of the tissue expander; wherein the tissue expander includes a balloon that protrudes posteriorly and anteriorly to separate the at least two layers of the ligament.

[0218] Aspect 17 may include or may optionally be combined with the subject matter of any of Aspects 13 to 16 to optionally include: wherein the at least two layers of connective tissue further comprise ligaments; wherein the ligaments surround and support the implant when the implant is inserted into the target site.

[0219] Aspect 18 may include or may optionally be combined with the subject matter of any of Aspects 13 to 17 to optionally include: making a small incision in a desired area of ​​the patient's body; inserting a tissue expander through the small incision; and inserting an implant through the small incision.

[0220] Aspect 19 may include, or may optionally be combined with the subject matter of any of aspects 13 to 18 to optionally include: wherein the implant is inserted into the target site with a syringe.

[0221] Aspect 20 may include, or may optionally be combined with the subject matter of any of Aspects 13 to 19 to optionally include: wherein the target site is in a breast region of the patient.

[0222] Aspect 21 may include, or may optionally be combined with the subject matter of any of aspects 13 to 20 to optionally include: wherein the tissue expander is similar in size and shape to the implant when in the expanded state.

[0223] Aspect 22 may include or may optionally be combined with the subject matter of any of aspects 13 to 21 to optionally include: inserting the implant into the target site includes loading the implant into a syringe having a nozzle, the nozzle having a cavity, a nozzle end, and a nozzle end opening, wherein the implant is compressed within the cavity of the nozzle between the nozzle end and the expandable membrane; an actuator coupled to the syringe, the actuator coupled to a pressurized fluid source and coupled to the expandable membrane, wherein the fluid source provides pressurized fluid into the expandable membrane. The method may also include applying a force to the implant with the expandable membrane; expelling the implant through the nozzle end and out of the nozzle end opening and into the target site; and maintaining at least one ligament attachment point during and after expelling the implant into the target site.

[0224] Aspect 23 may include an implant insertion system comprising: a syringe comprising a nozzle defining a shell; and an implant comprising a front side, a rear side, and a longitudinal axis between the front side and the rear side, the implant having: a first form in which each of the front side and the rear side protrudes away from the longitudinal axis, wherein the first form comprises a neutral form; a second form in which each of the front side and the rear side is compressed toward the longitudinal axis when contained within the shell of the nozzle; and an implant form in which the rear side is compressed against the anatomical structure and the front side protrudes further from the longitudinal axis than in the first form.

[0225] Aspect 24 may include or may alternatively be combined with the subject matter of aspect 23, wherein in the first configuration, the anterior side and the posterior side of the implant each protrude away from the longitudinal axis by a substantially similar distance.

[0226] Aspect 25 may include or may optionally be combined with the subject matter of either Aspect 23 or Aspect 24 to optionally include: wherein in the implanted configuration, the anterior side of the implant protrudes about 10% to about 40% further than in the first configuration.

[0227] Aspect 26 may include, or may optionally be combined with the subject matter of any of aspects 23 to 25 to optionally include: wherein in the implanted configuration, the anterior side of the implant protrudes about 20% to about 30% further than in the first configuration.

[0228] Aspect 27 may include, or may optionally be combined with the subject matter of any of aspects 23 to 26 to optionally include: wherein in the second configuration, the front side and the back side are substantially uniformly compressed.

[0229] Aspect 28 may include, or may optionally be combined with the subject matter of any of aspects 23 to 27 to optionally include: wherein the implant is a breast implant.

[0230] Aspect 29 may include, or may optionally be combined with the subject matter of any of aspects 23 to 28 to optionally include: wherein the implant is symmetrical about at least two axes.

[0231] Aspect 30 may include or may optionally be combined with the subject matter of any of Aspects 23 to 29 to optionally include: wherein the syringe further comprises: a handle detachably coupled to the nozzle. The handle comprises an expandable membrane configured to expand into the nozzle having a supply of pressurized fluid. The handle comprises an actuator for opening and closing a connection between the pressurized fluid source and the expandable membrane.

[0232] Aspect 31 may include a method of inserting an implant having a front side, a rear side, and a longitudinal axis between the front side and the rear side, the method comprising: pulling the implant into a nozzle cavity of a syringe nozzle to transform the implant from a first configuration to a second configuration, in which both the front side and the rear side of the implant protrude away from the longitudinal axis and in which both the front side and the rear side of the implant are compressed toward the longitudinal axis; coupling a handle having an expandable membrane to the syringe nozzle so that the implant is disposed between the nozzle end opening and the expandable membrane; applying a force against the proximal end of the implant with the expandable membrane; and expelling the implant through the nozzle end opening and into a target site. Wherein expelling the implant into the target site allows the implant to expand to an implant configuration in which the rear side is compressed against the anatomical structure and the front side protrudes further from the longitudinal axis than in the first configuration.

[0233] Aspect 32 may include, or may optionally be combined with the subject matter of aspect 31 to optionally include: wherein in the first configuration, the anterior apex and the posterior apex each protrude a similar distance away from the longitudinal axis.

[0234] Aspect 33 may include or may optionally be combined with the subject matter of aspect 31 or aspect 32 to optionally include: wherein in the implanted configuration, the anterior side protrudes about 10% to about 40% further from the longitudinal axis than in the first configuration.

[0235] Aspect 34 may include or may optionally be combined with the subject matter of any of Aspects 31 to 33 to optionally include: the syringe nozzle having a nozzle end between the nozzle cavity and the nozzle end opening; the nozzle end having a smaller diameter than the nozzle cavity; and the nozzle end opening having an angled profile.

[0236] Aspect 35 may include an implant insertion system comprising: a breast implant; and a marking tool comprising: a center point corresponding to a patient's nipple; at least one size indicator configured to identify a target site for the breast implant; and a guide wire configured to locate a pathway extending from an incision to the target site.

[0237] Aspect 36 may include, or may optionally be combined with the subject matter of aspect 35 to optionally include: the marking tool including a plurality of size indicators corresponding to different sized breast implants.

[0238] Aspect 37 may include or may optionally be combined with the subject matter of either Aspect 35 or Aspect 36 to optionally include: the marking tool further includes an incision location identifier, the incision location identifier corresponding to an incision location identifier of the incision location in the access passage.

[0239] Aspect 38 may include, or may optionally be combined with the subject matter of any of Aspects 35 to 37 to optionally include: a marking tool identifying a final peel mark at a junction between the at least one size indicator and the guide line.

[0240] Aspect 39 may include, or may optionally be combined with the subject matter of any of Aspects 35 to 38 to optionally include: a tissue dissector configured to be inserted to a final dissection mark.

[0241] Aspect 40 may include, or may optionally be combined with the subject matter of any of Aspects 35 to 39 to optionally include: a tissue expander configured to be inserted to a final dissection marker.

[0242] Aspect 41 may include, or may optionally be combined with the subject matter of any of aspects 35 to 40 to optionally include: the tissue dilator having a compressed configuration and an expanded configuration, and wherein in the compressed configuration the tissue dilator is sized for insertion through the incision.

[0243] Aspect 42 may include or may optionally be combined with the subject matter of any of aspects 35 to 41 to optionally include: a marking tool having an incision location identifier configured to identify the length of the incision; a tissue dissector; a tissue expander; and a syringe that contains a breast implant and inserts the breast implant into a target site through the incision. At least one of the tissue dissector, the tissue expander, and the syringe has an insertion size that is substantially similar to or less than the length of the incision.

[0244] Aspect 43 may include a method of positioning an implant within a target site in a patient's body, comprising: placing a marking tool on a breast of the patient, wherein a center of the marking tool is substantially aligned with the nipple; marking a surgical area using a plurality of reference lines on the breast comprising: tracing along at least one of the plurality of reference lines corresponding to a size indicator; and tracing along a navigation line of a pathway extending from an incision location to the target site.

[0245] Aspect 44 may include or may optionally be combined with the subject matter of Aspect 43 to optionally include: a reference mark indicating a circumferential outline of the implant.

[0246] Aspect 45 may include, or may optionally be combined with the subject matter of either Aspect 43 or Aspect 44 to optionally include: the marking tool having at least two size indicators corresponding to different sizes of the implant.

[0247] Aspect 46 may include, or may optionally be combined with the subject matter of any of Aspects 43 to 45 to optionally include marking a final dissection mark corresponding to a final insertion distance of the tissue dissector.

[0248] Aspect 47 may include, or may optionally be combined with the subject matter of any of aspects 43 to 46 to optionally include: marking an incision location identifier having lateral ends; and marking parallel lines between each of the lateral ends and the size indicator.

[0249] Aspect 48 may include, or may optionally be combined with the subject matter of any of Aspects 43 to 47 to optionally include: the incision location identifier being between about 1.0 centimeters and about 3.0 centimeters.

[0250] Aspect 49 may include, or may optionally be combined with the subject matter of any of Aspects 43 to 48 to optionally include: the incision location identifier corresponding to an incision made along an axillary skin crease.

[0251] Each of these non-limiting aspects may stand alone or may be combined with one or more of the other aspects in various permutations or combinations.

[0252] The above description includes references to the accompanying drawings, which form a part of the detailed description. The accompanying drawings illustrate specific examples in which the present invention can be practiced by way of illustration. These examples are also referred to as "aspects" or "embodiments" in this article. Such aspects or examples may include elements other than those shown or described. However, the inventors also contemplate aspects or examples in which only those elements shown or described are provided. In addition, the inventors also contemplate aspects or examples using any combination or arrangement of those elements shown or described (or one or more features thereof), which may be related to a particular aspect or example (or one or more features thereof), or related to other aspects (or one or more features thereof) shown or described herein.

[0253] In the event of an inconsistency in usage between this document and any document incorporated by reference, the usage in this document controls.

[0254] In this document, as is common in patent documents, use of the term "a" or "an" includes one or more, independent of any other instance or usage of "at least one" or "one or more." In this document, the term "or" is used to refer to non-exclusivity, or so that "A or B" includes "A but not B," "B but not A," and "A and B," unless otherwise noted. In this document, the terms "including" and "wherein" are used as the plain English equivalents of the respective terms "comprising" and "wherein." In addition, in the following claims, the terms "including" and "comprising" are open-ended, that is, a system, device, article, composition, formulation, or process that includes elements other than those listed after such terms in a claim is still considered to fall within the scope of the claim. In addition, in the following claims, the terms "first," "second," and "third," etc., are used merely as labels and are not intended to impose numerical requirements on their objects.

[0255] Geometric terms such as "parallel," "perpendicular," "circular," or "square" are not intended to require absolute mathematical precision unless the context indicates otherwise. Rather, these geometric terms allow for variations due to manufacturing or equivalent functions. For example, if an element is described as "circular" or "substantially circular," the description still includes components that are not exactly circular (e.g., components that are slightly elliptical or polygonal).

[0256] The above description is intended to be illustrative, not restrictive. For example, the above aspects or examples (or one or more aspects thereof) may be used in combination with each other. Other examples may be used, such as by a person of ordinary skill in the art when reviewing the above description. The abstract is provided to comply with 37 CFR § 1.72 (B) to allow readers to quickly determine the nature of the technical disclosure. Its submission should be understood as not being used to interpret or limit the scope or meaning of the claims. In addition, in the above detailed description, various features may be combined together to simplify the present invention. This should not be interpreted as intended to be necessary for any claim to disclose features that are not claimed. On the contrary, the subject matter of the present invention may not lie in all the features of a particular disclosed example. Therefore, the following claims are hereby incorporated into the detailed description as aspects, examples or embodiments, wherein each claim exists independently as a separate example, and it is conceivable that these examples may be combined with each other in various combinations or arrangements. The scope of the present invention should be determined with reference to the appended claims, together with the scope of all equivalents enjoyed by these claims.

Claims

1. An implant insertion system, include: a tissue expander comprising an inflatable balloon having a rear side that bends when inflated; as well as An implant having a posterior side that curves when positioned against an anatomical surface, wherein the curved posterior side of the implant substantially matches the curved posterior side of the tissue expander.

2. The implant insertion system according to claim 1, wherein the implant further include: front side; a longitudinal axis positioned between the front side and the curved rear side; as well as A posterior apex is disposed on a posterior side of the curvature, the posterior apex extending further from the longitudinal axis in the first configuration than when the implant is positioned against the anatomical surface.

3. An implant insertion system according to claim 2, wherein the front side of the implant is curved in a manner substantially similar to the curved rear side, the front side of the implant includes an anterior apex, and the longitudinal axis is positioned substantially equidistant from the anterior apex and the rear apex.

4. The implant insertion system according to claim 1, wherein the implant further include: A front side having a curved profile with an apex substantially similar to the curved front side of the balloon.

5. The implant insertion system of claim 1, wherein the balloon has a compressed configuration and an inflated configuration.

6. The implant insertion system of claim 5, wherein when the balloon is in the compressed configuration, the balloon is sized to fit through a small incision.

7. An implant insertion system according to claim 6, wherein the balloon is configured to have a substantially similar diameter in the compressed form and the inflated form.

8. A method of forming a nested cavity in the breast region of a patient's body, wherein include: making an incision of a specified size at a desired location in the patient's body; inserting a tissue expander having a balloon into a target site in the patient's body; inflating the balloon at the target site between at least two layers of connective tissue to separate the at least two layers of connective tissue and form a cavity having a contour substantially matching the contour of a breast implant; wherein the front side of the balloon has a curved profile, and the rear side has a curved profile; wherein when the balloon is inflated, the balloon protrudes in the anterior and posterior directions; wherein the at least two layers of connective tissue surround the balloon when the balloon is substantially fully inflated; maintaining the balloon in an inflated state; After a predetermined period of time, deflation of the balloon; as well as The tissue expander and the balloon are removed from the patient's body.

9. The method of forming the nest-like cavity in the breast region of the patient's body according to claim 8, wherein the balloon is inflated to expand anteriorly to separate the connective tissue.

10. The method of forming the nest-like cavity in the breast region of the patient's body according to claim 9, wherein the at least two layers of connective tissue are at least one of ligament and soft tissue; Wherein at least one of the ligament and soft tissue surrounds the posterior side of the balloon with minimal separation.

11. The method of forming the nest-like cavity in the breast region of the patient's body according to claim 8, wherein the at least two layers of ligaments surround, enclose, bind or nest the balloon.

12. The method of forming the nest-like cavity in the breast region of the patient's body according to claim 8, wherein after separation, the at least two layers of ligaments maintain a nearly original anatomical structure.

13. A method for inserting an implant, wherein include: expanding a tissue expander to form a target site in a patient's body, the tissue expander having a curved posterior side that retains at least one ligament attachment point at a posterior portion of the tissue expander; as well as An implant is inserted into the target site in the patient's body, the implant having a curved posterior side supported by the at least one ligament attachment point at the posterior portion of the implant.

14. The implant insertion method of claim 13, wherein the at least one ligament attachment point is located: lateral to the center point of the implant to resist lateral movement of the implant; or The implant is disposed below the surface of the implant to resist downward movement of the implant.

15. The implant insertion method of claim 13, wherein the tissue expander comprises a balloon having a compressed configuration and an expanded configuration.

16. The implant insertion method according to claim 13, further comprising: include: expanding the tissue expander to separate at least two layers of connective tissue at the target site to form a cavity while maintaining the at least one ligament attachment point behind the tissue expander; The tissue expander comprises a balloon which projects in posterior and anterior directions to separate the at least two layers of the ligament.

17. The implant insertion method of claim 16, wherein the at least two layers of connective tissue further comprise ligaments; Wherein when the implant is inserted into the target site, the ligament surrounds and supports the implant.

18. The implant insertion method according to claim 13, further comprising: include: making a small incision in a desired area of ​​the patient's body; inserting the tissue expander through the small incision; as well as The implant is inserted through the small incision.

19. The implant insertion method of claim 18, wherein the implant is inserted into the target site using a syringe.

20. The implant insertion method of claim 13, wherein the target site is in a breast region of a patient.

21. The implant insertion method of claim 13, wherein the tissue expander is similar in size and shape to the implant when in the expanded state.

22. The implant insertion method of claim 13, wherein the implant is inserted into the target site include: loading the implant into a syringe having a nozzle, the nozzle having a cavity, a nozzle end, and a nozzle end opening, wherein the implant is compressed within the cavity of the nozzle between the nozzle end and an expandable membrane; an actuator engaged on the syringe, the actuator coupled to a source of pressurized fluid and to the expandable membrane; wherein the fluid source provides a pressurized fluid into the expandable membrane; applying a force to the implant with the expandable membrane; expelling the implant through the nozzle end and out of the nozzle end opening and into the target site; as well as The at least one ligament attachment point is maintained during and after expulsion of the implant to the target site.

23. An implant insertion system, include: a syringe comprising a nozzle defining a housing; as well as An implant comprising a front side, a rear side, and a longitudinal axis between the front side and the rear side, the implant having: a first configuration wherein each of the front side and the rear side projects away from the longitudinal axis, wherein the first configuration comprises a neutral configuration; a second configuration wherein each of the front side and the rear side is compressed toward the longitudinal axis when contained within the housing of the nozzle; as well as An implanted configuration in which the posterior side is compressed against the anatomical structure and the anterior side protrudes further from the longitudinal axis than in the first configuration.

24. The implant insertion system of claim 23, wherein in the first configuration, the anterior side and the posterior side of the implant each protrude away from the longitudinal axis a substantially similar distance.

25. The implant insertion system of claim 23, wherein in the implanted configuration, the anterior side of the implant protrudes about 10% to about 40% further than in the first configuration.

26. The implant insertion system of claim 23, wherein in the implanted configuration, the anterior side of the implant protrudes about 20% to about 30% further than in the first configuration.

27. The implant insertion system of claim 23, wherein in the second form, the anterior side and the posterior side are substantially uniformly compressed.

28. The implant insertion system of claim 23, wherein the implant is a breast implant.

29. The implant insertion system of claim 23, wherein the implant is symmetrical about at least two axes.

30. The implant insertion system of claim 23, wherein the syringe further include: a handle detachably coupled to the nozzle; wherein the handle includes an expandable membrane configured to expand into the nozzle with a supply of pressurized fluid; Wherein the handle includes an actuator for opening and closing a connection between a source of pressurized fluid and the expandable membrane.

31. A method of inserting an implant into a patient's body, the implant comprising a front side, a rear side, and a longitudinal axis between the front side and the rear side, the method include: pulling the implant into a nozzle cavity of a syringe nozzle to transform the implant from a first configuration in which both the front side and the rear side of the implant protrude away from the longitudinal axis to a second configuration in which both the front side and the rear side of the implant are compressed toward the longitudinal axis; coupling a handle having an expandable membrane to the syringe nozzle such that the implant is disposed between the nozzle end opening and the expandable membrane; applying a force with the expandable membrane against a proximal end of the implant; as well as expelling the implant through the nozzle end opening and into the target site; Wherein expelling the implant into the target site allows the implant to expand to an implanted configuration in which the posterior side is compressed against the anatomical structure and the anterior side protrudes further from the longitudinal axis than in the first configuration.

32. The method of inserting an implant of claim 31, wherein in the first configuration, the anterior apex and the posterior apex each protrude a similar distance away from the longitudinal axis.

33. The method of inserting an implant of claim 31, wherein in the implanted configuration, the anterior side protrudes from the longitudinal axis about 10% to about 40% further than in the first configuration.

34. A method of inserting an implant according to claim 31, in: The syringe nozzle has a nozzle end between the nozzle cavity and the nozzle end opening; The nozzle end has a smaller diameter than the nozzle cavity; as well as The nozzle end opening has an angular profile.

35. An implant insertion system, include: Breast implants; as well as A marking tool, comprising: corresponding to a center point of a patient's nipple; at least one size indicator configured to identify a target site for the breast implant; and A guide wire is configured to locate a pathway extending from the incision to the target site.

36. The implant insertion system of claim 35, wherein the marking tool includes a plurality of size indicators corresponding to different sized breast implants.

37. An implant insertion system according to claim 35, wherein the marking tool also includes an incision location identifier, which corresponds to the incision location into the passage.

38. The implant insertion system of claim 35, wherein the marking tool identifies a final peel mark at a junction between the at least one size indicator and the guide wire.

39. The implant insertion system of claim 38, further comprising: include: A tissue dissector is configured to be inserted to the final dissect mark.

40. The implant insertion system of claim 38, further comprising: include: A tissue expander is configured to be inserted to the final peel mark.

41. The implant insertion system of claim 40, wherein the tissue expander has a compressed configuration and an expanded configuration, and wherein in the compressed configuration the tissue expander is sized for insertion through the incision.

42. The implant insertion system of claim 35, further comprising: include: the marking tool having an incision location identifier configured to identify a length of the incision; Tissue strippers; Tissue expanders; as well as a syringe that contains the breast implant and inserts the breast implant into the target site through the incision; Wherein at least one of the tissue dissector, the tissue expander and the syringe has an insertion dimension that is substantially similar to or less than the length of the incision.

43. A method of positioning an implant within a target site in a patient's body, wherein include: placing a marking tool on a breast of the patient, wherein a center of the marking tool is substantially aligned with the nipple; as well as The surgical area is marked using multiple reference lines on the breast including: tracing along at least one of the plurality of reference lines corresponding to the size indicator; as well as The guideline is followed along a pathway extending from the incision site to the target site.

44. A method of positioning the implant according to claim 43, wherein the reference mark indicates a circumferential outline of the implant.

45. The method of positioning the implant of claim 43, wherein the marking tool has at least two size indicators corresponding to different sizes of the implant.

46. ​​The method of positioning the implant according to claim 43, further comprising: include: A final dissection mark is marked corresponding to the final insertion distance of the tissue dissector.

47. The method of claim 43, further comprising: include: marking a cutout location identifier having a lateral end; as well as Mark parallel lines between each of the lateral ends and the size indicator.

48. The method of positioning the implant of claim 47, wherein the incision location identifier is between about 1.0 centimeters and about 3.0 centimeters.

49. The method of positioning the implant of claim 47, wherein the incision location identifier corresponds to an incision made along an axillary skin crease.

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