Insertion devices and methods of use thereof

Abstract

Aspects of the present disclosure relate to devices for inserting an expandable balloon into an implantation site of a patient. Such an apparatus may include a substrate (326) having a longitudinal axis and defining a cavity (322); an expandable balloon (330) disposed within the cavity in a collapsed configuration; and a flexible lumen (310) extending proximally from the balloon to a pump (302), the flexible lumen fluidly connecting the balloon to the pump. The base may include a protrusion extending distally parallel to the longitudinal axis, wherein at least a portion of the balloon is coupled to the protrusion. Further, for example, the device may include a cover (324) coupled to the base and movable relative to the base to selectively cover and expose the cavity to deploy the balloon.

Description

[0001] This application is a divisional of a Chinese application filed on October 3, 2019, with application number 201980074632.3 and invention name “Insertion device and method of use thereof”.

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application claims priority to U.S. Provisional Application No. 62 / 740,506, filed on October 3, 2018, which is incorporated herein by reference in its entirety. Technical Field

[0004] The present disclosure generally relates to devices and methods for inserting an expandable balloon into a surgical site. Background Art

[0005] Breast implants are among the largest implantable medical devices used in the human body today. Due to their size, mass, and surface area, these implants can induce unique physiological effects in surrounding tissues. These effects may be caused in part by the minimally invasive techniques used to introduce breast implants, which in some cases can cause trauma to breast tissue and surrounding tissues.

[0006] Current techniques for inserting medical implants (e.g., breast implants) may result in surgical wounds, leading to prolonged, complex, and / or dynamic healing processes, for example, to replace inactivated and missing cellular structures and / or tissue layers in the patient's body. For example, many current techniques require relatively large incisions at or near the surgical implant site (e.g., tissue pocket). While physically manipulating the implant into the implant site, it may be necessary to manipulate the incision and / or implant site by a retractor and / or tissue expander to expand and keep it open. In addition, in order to accommodate the implant, it may be necessary to use a retractor and / or tissue expander to enlarge or expand the incision and / or implant site. Producing an implant site, expanding it or keeping it open may produce pain, scarring, infection, and / or other undesirable effects at the implant site. In addition, during and after healing, larger incisions may increase the potential incidence of keloids and hypertrophic scars. Some patients are also more susceptible to keloid formation and have a higher risk of forming keloids. Summary of the invention

[0007] The present disclosure includes insertion devices and related kits and methods. For example, the present disclosure includes an insertion device, which includes: a substrate having a longitudinal axis and defining a cavity; an expandable balloon, the expandable balloon being disposed in the cavity in a collapsed configuration; and a flexible lumen, the flexible lumen extending proximally from the balloon to a pump, the flexible lumen connecting the balloon fluid to the pump. The substrate may include a protrusion extending distally parallel to the longitudinal axis, wherein at least a portion of the balloon is coupled to the protrusion. The balloon may be attached to the protrusion with an adhesive, and / or the longitudinal length of the protrusion is at least half of the longitudinal length of the tube defining the cavity. According to some aspects, the device includes a cover, the cover is coupled to the substrate and is movable relative to the substrate to selectively cover and expose the cavity so that the balloon is deployed. The cover may slide relative to the substrate along the longitudinal axis, or wherein the cover is coupled to the substrate by a removable clip. The cover may be configured to completely enclose the balloon within the cavity. In any such insertion device, the distal end of the substrate may include a tapered atraumatic tip, the proximal portion of the substrate may include a handle, and / or the substrate may include a plurality of measurement markings. Further, for example, the diameter of the balloon in the collapsed configuration is between about 10 mm and about 15 mm. The balloon may be in fluid communication with an air supply. In at least one example, the cross-sectional dimension of the substrate is less than about 3 cm, such as about 0.5 cm to 3 cm.

[0008] The present disclosure also includes a kit comprising an insertion device as described above and / or as described elsewhere herein. The kit may also define a cup of an internal volume, the cup being configured to be placed outside of a target site and limit expansion of the balloon within the target site, optionally wherein the cup comprises a side opening.

[0009] Various aspects of the present disclosure relate to an insertion device comprising: a base having a longitudinal axis and defining a cavity, the base comprising a protrusion extending distally from a distal portion of the cavity parallel to the longitudinal axis; an expandable balloon connected to the protrusion in a collapsed configuration; and a flexible lumen extending proximally from the balloon to a pump, the flexible lumen connecting the balloon fluid to the pump.

[0010] Optionally, the balloon is attached to the projection with an adhesive. Optionally, the longitudinal length of the projection is at least half of the longitudinal length of the tube defining the cavity. Optionally, the distal end of the substrate comprises a tapered atraumatic tip. Optionally, the substrate comprises a rigid material. Optionally, the proximal portion of the substrate comprises a handle. Optionally, the substrate comprises a plurality of measurement markings. Optionally, the diameter of the balloon in the collapsed configuration is between about 10 mm and about 15 mm. Optionally, the balloon is in fluid communication with an air supply. Optionally, the cross-sectional dimensions of the substrate are less than about 3 cm, such as about 0.5 cm to 3 cm.

[0011] Additionally, some aspects of the present disclosure relate to a kit comprising: a device according to the present disclosure; and a cup defining an interior volume, the cup being configured to be placed outside a target site and to limit expansion of the balloon within the target site. Optionally, the cup comprises a side opening.

[0012] Some aspects of the present disclosure relate to an insertion device comprising: a base comprising a proximal portion, a distal portion and a cavity, the cavity comprising an opening; a balloon disposed in the cavity in a collapsed configuration; a cover movably connected to the base, wherein the cover limits movement of the balloon when in a closed configuration with the base; and a flexible lumen extending from the balloon through the proximal portion of the base to a pump, the flexible lumen connecting the balloon fluid to the pump.

[0013] Optionally, the distal portion of the substrate is tapered. Optionally, the cover partially blocks the opening of the cavity in a closed configuration with the substrate. Optionally, the cavity is disposed at or near the distal portion of the substrate, and the device further comprises a handle at the proximal portion of the substrate. Optionally, the cover is slidable relative to the substrate in a direction parallel to the proximal-distal axis of the substrate. Optionally, the cover is frangibly connected to the substrate. Optionally, the cover comprises parallel extensions configured to limit the movement of the balloon.

[0014] Optionally, the substrate and the cover define a length extending along a proximal-distal axis and a width perpendicular to the length, wherein the length is greater than the width. Optionally, the substrate and the cover include complementary features that limit rotational movement of the substrate and the cover relative to each other. Optionally, the complementary features of the substrate and the cover allow the substrate and the cover to slide relative to each other along the proximal-distal axis. Optionally, the substrate and the cover are coupled to each other by a clip extending at least partially around the circumference of the device. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] Embodiments of the present disclosure may be implemented in conjunction with the various aspects shown in the accompanying drawings. These drawings show different aspects of the present disclosure, and in appropriate cases, the reference numerals showing similar structural components, materials and / or elements in different figures are marked in a similar manner. It should be understood that various combinations of structures, assemblies and / or elements other than the specifically shown structures, assemblies and / or elements are considered, and the various combinations are within the scope of the present disclosure. Further, even if not specifically mentioned, the various aspects described with reference to one embodiment may also be applicable to other embodiments and may be used together with other embodiments.

[0016] In addition, the present disclosure is neither limited to any single aspect or embodiment, nor to any combination and / or arrangement of such aspects and / or embodiments. Each aspect (e.g., device, method, etc.) and / or its variations of the present disclosure may be adopted alone or in combination with one or more of the other aspects and / or its variations of the present disclosure. For the sake of brevity, certain arrangements and combinations are not discussed and / or described separately herein. It is noteworthy that the embodiments or implementations described herein as "exemplary" should not be interpreted as being preferred or advantageous over, for example, other embodiments or implementations. On the contrary, the embodiments or implementations are intended to reflect or indicate that one or more embodiments are one or more "example" embodiments.

[0017] Figures 1A-1F Views of exemplary insertion devices according to aspects of the present disclosure are shown.

[0018] Figure 2A Another exemplary insertion device according to aspects of the present disclosure is presented.

[0019] Figure 2B Another exemplary insertion device according to aspects of the present disclosure is presented.

[0020] Figure 3 is an illustration of an exemplary insertion device assembly including a balloon according to aspects of the present disclosure.

[0021] Figures 4A-4D Shown Figure 3 Additional views of components of an exemplary insertion device.

[0022] Figures 5A-5C Shown are views and components of another exemplary insertion device according to aspects of the present disclosure.

[0023] Fig. 6A and 6B Shown are views of additional exemplary insertion devices according to aspects of the present disclosure.

[0024] Figure 7Exemplary balloons and inflation tubes according to aspects of the present disclosure are shown.

[0025] Figure 8 Exemplary balloons, inflation tubes, and pumps according to aspects of the present disclosure are shown.

[0026] Fig. 9 Another exemplary balloon, inflation tube, and pump according to aspects of the present disclosure are shown.

[0027] Figures 10A-10D Shown are views of another exemplary insertion device, components thereof, and accessories in accordance with aspects of the present disclosure.

[0028] Fig.11 An exemplary method of using an insertion device according to aspects of the present disclosure is presented in the form of a flow chart. DETAILED DESCRIPTION

[0029] Examples of the present disclosure relate to systems, devices, and methods for inserting an expandable component, such as a balloon, into an implantation site in a patient's body. Such systems, devices, and methods may include an insertion component and an expandable component.

[0030] If there is a conflict with the terms and / or definitions of the art or the terms and / or definitions incorporated by reference, the terms and definitions provided herein shall prevail. The term "comprises / comprising" or other variations of the term used herein are intended to cover non-exclusive inclusions, so that the process, method, article or equipment including a series of elements not only includes those elements, but also may include other elements not clearly listed or other elements inherent to such processes, methods, articles or equipment. In addition, the term "exemplary" is used herein in the sense of "example" rather than "exemplary". The terms "about", "substantially" and "approximately" used herein indicate a range of values ​​within + / - 5% of a specified value.

[0031] The terms "proximal" and "distal" are used herein to refer to the relative and directional positions of components of an exemplary introducer device. "Proximal" or "proximally" refers to a position relatively closer to an operator of the device. In contrast, "distal" or "distally" refers to a position relatively further away from an operator of the device and or closer to the interior of the patient's body.

[0032] The present disclosure includes devices and methods for accurately and precisely inserting expandable devices into the human body. Although portions of the present disclosure refer to inserting a balloon such as a dissector balloon into a patient's body (e.g., into a chest as part of or in preparation for a breast implant surgery), the devices, systems, and methods disclosed herein can be used to insert other devices or structures (e.g., tissue expanders, etc.) into other locations of the body (e.g., gluteal muscles, calves, arms, back, buttocks, etc.). In some embodiments, the devices, systems, and methods disclosed herein can provide for introducing a structure into a location (e.g., an implant site) of the human body in a minimally invasive procedure.

[0033] Some aspects of the present disclosure provide a sterile, biocompatible insertion device for inserting an expandable device into a human body. Suitably, the expandable device according to the present disclosure can be partially or completely flexible (e.g., elastic, contractible, compressible, foldable and / or elastically deformable). In certain embodiments, the expandable device can include a balloon comprising a sterile, biocompatible material. The expandable device and / or insertion device according to the present disclosure can have low friction surface properties to facilitate smooth delivery and implantation of an implant in a patient's body.

[0034] Insertion devices according to the present disclosure can be configured to be inserted through a relatively small incision, such as an incision of about 4 cm or less, about 3 cm or less, about 2 cm or less, or about 1 cm or less, for example, an incision of about 0.5 cm to about 4 cm, or about 2 cm to about 3 cm. In some embodiments, for example, a device according to the present disclosure can be inserted through an incision of about 2 cm. Although insertion devices according to the present disclosure can be inserted through an incision greater than, for example, about 4 cm, it should be understood that some embodiments of the present disclosure may be particularly useful during minimally invasive procedures. Minimally invasive procedures can reduce damage to the patient's tissue at and around the implantation site / incision, thereby reducing recovery time and reducing scarring at one or more insertion sites.

[0035] In some embodiments, an insertion device according to the present disclosure can be sized to take into account the shape and contours of the implantation site (e.g., the contours of the breast area, gluteal area, calf area, etc.). Thus, in some embodiments, an insertion device according to the present disclosure can help create a passage, opening, or canal between the incision and the implantation site to facilitate safe and effective delivery of the expandable device to the desired site in the proper orientation.

[0036] Device according to the present disclosure can be suitable for being inserted into the patient's skin through an incision, and is introduced into a body cavity and / or between tissue planes or layers. For example, in the case where the insertion device is configured to deliver an expandable balloon to the chest region, the insertion device can be advanced to a desired balloon deployment region, such as below / posterior of one or more mammary glands, the space between the pectoralis major and the pectoralis minor. Once the insertion device is positioned in the desired region, the balloon can be deployed and inflated to help the generation and / or expansion of the cavity, by, for example, dissecting tissue from other adjacent tissues to insert a breast implant into the cavity. Additionally or alternatively, such balloon can be deployed to, for example, stop or stop the bleeding generated during the tissue dissection process by, for example, applying direct pressure to an internal wound.

[0037] Insertion devices according to the present disclosure may have one integral component, or may include multiple components that may be assembled.The component of the insertion device configured to hold an expandable component, implant, or instrument (eg, balloon, tissue expander, etc.) is referred to herein as a base.

[0038] Reference will now be made to the drawings of the present disclosure. It should be understood that the characteristics or aspects (e.g., size, shape, accessories, materials, etc.) of one embodiment are applicable to each of the other embodiments disclosed herein. For the sake of brevity, the characteristics shared in the various embodiments will not be repeatedly described herein.

[0039] Figures 1A-1F 1 shows a view of an exemplary insertion device 100. The insertion device 100 includes a base 150 and an inner member 110. The base 150 (see Figure 1A , 1B , 1D, 1E) can be generally cylindrical in shape and can include a proximal portion 152, a distal portion 154, an open proximal end 158, and an open distal end 156, and can include depth markings 160. The interior 164 of the base 150 (e.g., see Figure 1D ) may include a plurality of internal protrusions 162 extending along the longitudinal length of the base 150 (see, for example, Figure 1E ), creating a plurality of longitudinal cavities or recesses between each protrusion. Figure 1A , 1C , 1F) can include a proximal cap 112 having a proximal side 118, a distal portion 114, a distal tip 116, and a longitudinal ridge 122. The inner member 110 can also include a depth marking 120.

[0040] Inner member 110 can be sized and configured to slide longitudinally into interior 164 of substrate 150 and move radially relative to the interior. In some embodiments, inner member 110 and substrate 150 can be concentric cylinders or tubes, each concentric cylinder or tube defining a lumen therein. However, this example is non-restrictive. For example, inner member 110 and substrate 150 can have any other shape that allows inner member 110 to be installed in substrate 150 (e.g., and slide relative to substrate). In some embodiments, substrate 150 can define a lumen corresponding to interior 164, and inner member 110 can be solid or have a closed interior (that is, inner member 110 does not contain a lumen).

[0041] The size of inner member 110 can be selected to allow inner member 110 to be placed in substrate 150 and slide relative to the substrate. In some embodiments, the scope of the outer diameter (or other cross-sectional dimensions) of substrate 150 can be about 1.0cm to about 3.0cm. For example, the scope of the outer diameter (or other cross-sectional dimensions) of substrate 150 can be about 1.5cm to about 3.0cm, about 1.5cm to about 2.5cm, or about 1.8cm to about 2.0cm, such as about 1.8cm, 1.9cm or 2.0cm. In some embodiments, the scope of the inner diameter (or other cross-sectional dimensions) of substrate 150 can be about 0.5cm to about 2.8cm, such as about 0.5cm to about 2.5cm, about 1.0cm to about 2.0cm, about 1.5cm to about 2.0cm, or about 1.6cm to about 1.7cm, such as about 1.5cm, about 1.6cm, about 1.7cm, about 1.8cm or about 1.9cm. Additionally or alternatively, the outer diameter (or other cross-sectional dimension) of the inner member 110 can range from about 0.5 cm to about 2.5 cm, such as about 0.5 cm to about 2.0 cm, about 0.5 cm to about 1.5 cm, about 1.0 cm to about 1.5 cm, or about 1.2 cm to about 1.3 cm, such as about 1.0 cm, about 1.1 cm, about 1.2 cm, about 1.3 cm, about 1.4 cm, or about 1.5 cm.

[0042] In certain embodiments, the length range of each in substrate 150 and inner member 110 is about 15cm to about 35cm, such as about 18cm to about 32cm, about 18cm to about 30cm, about 18cm to about 28cm, about 18cm to about 25cm, about 19cm to about 23cm or about 19cm to about 21cm, such as about 16cm, about 18cm, about 20cm, about 22cm, about 24cm, about 26cm, about 28cm, about 30cm, about 32cm or about 34cm. All the measurement results in the above-mentioned measurement results are exemplary, and the measurement results of the embodiments of the present disclosure are not limited thereto. Although the above-mentioned measurement results have been given about insertion device 100, these measurement results may also be applied to the size of similar features of other exemplary insertion devices disclosed herein.

[0043] The base 150 can be configured to accommodate an expandable device or component (e.g., a balloon, a tissue expander, etc.) therein. Such an expandable device can be foldable or rollable so as to be mounted in the interior 164 of the base 150 in an unexpanded configuration. Suitable expandable devices can include, for example, balloons, such as the balloons 700, 800, 900 discussed further herein. When inserted into the interior 164 of the base 150 at the proximal end 158 of the base 150, the inner member 110 can be sized and configured to push the expandable device distally within the base 150 so that the expandable device is discharged from the distal end 156 of the base 150. In some embodiments, the inner member 110 can also define a lumen through which a tube can pass from the balloon or other expandable device within the interior 164 of the base 150 through (e.g., a fluid supply tube) to a pump or fluid source positioned proximally. Therefore, a balloon or other expandable device to be inserted using the insertion device 100 can be connected to a pump or fluid source and communicated with it before being deployed in the surgical site.

[0044] like Figure 1D and 1E As shown, the inner wall of the base 150 can include one or more internal protrusions 162, which can help reduce friction caused by the relative movement of the base 150 and the inner member 110, and thus help the expandable device to deploy distally from the interior 164. In addition, the protrusions 162 can reduce or inhibit the expandable device from rotating about the longitudinal axis of the base 150. The protrusions 162 can extend longitudinally parallel to each other along the length of the base 150 (optionally along the entire length of the base 150 or a portion thereof), and can protrude radially inward from the inner surface of the base 150. Although the base 150 is depicted as including five protrusions 162, the base 150 can alternatively have one, two, three, four, six, seven or more protrusions 162. In some embodiments, the base 150 does not include a protrusion 162.

[0045] Inner member 110 can include longitudinal ridge 122, and described longitudinal ridge can cooperate with corresponding space (for example, the space between two protrusions 162) in base 150. Ridge 122 can be longitudinal extension piece that protrudes radially outward from the outer surface of inner member 110, or the outer surface of inner member 110 can include ridge 122 as an integral part of inner member 110. According to some aspects of this paper, the shape of ridge 122 can be selected to be installed between two protrusions 162 in base 150. This arrangement can help prevent or inhibit inner member 110 from rotating relative to base 150 around the central longitudinal axis of assembled insertion device 100. In addition or alternatively, the outer surface of inner member 110 can include at least one or more protrusions (for example, similar to protrusion 162), and the inner surface of base 150 can include one or more longitudinal ridges (for example, similar to ridge 122).

[0046] The distal portion 114 of the inner member 110 and the distal portion 154 of the base 150 can each taper radially inward. This shape can help insert the base 150 into an incision at the implantation site of interest, and can help insert the inner member 110 into the open proximal end 158 of the base 150. The proximal portion 152 of the base 150 and / or the proximal cap 112 of the inner member 110 can each have a larger diameter than the remaining portion of each of the base 150 and the inner member 110. This can allow the insertion device 100 to be more easily manipulated using the proximal portion 152 and the proximal cap 112, and can further act as a stopper during the insertion of the inner member 110 into the interior 164 of the base 150.

[0047] The base 150 and the inner member 110 can include depth markings 160, 120, respectively. The depth markings 160, 120 can provide visual assistance to the user (e.g., a medical professional, such as a physician) during a medical procedure. For example, during the insertion of the insertion device 100 into the body, the depth marking 160 can help to properly position the distal portion 154 of the base 150 in the desired location (e.g., a tissue pocket) (e.g., to achieve an appropriate insertion distance). Further, for example, the depth marking 120 can help determine the distance that the inner member 110 has traveled into the base 150 to determine whether the inner member 110 has moved sufficiently to push the expandable device contained in the interior 164 out of the distal end 156 of the base 150.

[0048] In some embodiments, the insertion device 100 (that is, substrate 150 and / or inner member 110) can include a biocompatible lubricant to reduce the friction between the two components and promote to move more smoothly relative to each other. Such lubricants can also be used to slide expandable devices (e.g., balloons) along the interior 164 of substrate 150. Lubricants can be applied to one or both of the interior and / or exterior of substrate 150 and inner member 110. Lubricants can be applied in the form of gel, spray or using any other suitable method. In addition or alternatively, inner member 110 and substrate 150 can be made of a material with a low friction coefficient or have a coating with a low friction coefficient, or otherwise produce a smooth surface, thereby allowing inner member 110, substrate 150 and / or the expandable device contained in substrate 150 to move smoothly relative to each other.

[0049] According to some examples herein, the distal portion 154 of the base 150 and / or the distal portion 114 of the inner member 110 can include an LED or other light source for assisting in the placement of the insertion device 100 and / or an expandable device loaded within the insertion device 100. The light emitted by the LED or other light source can be observed through the patient's tissue and / or skin to ensure that the distal portion 154 and / or the distal portion 114 are positioned in one or more appropriate locations during use.

[0050] During the exemplary method of use, the distal portion 154 of the substrate 150 can be placed in the incision in the tissue. The substrate 150 can be pushed into a tissue bag or other space (e.g., between tissue layers or planes). In some embodiments, the substrate 150 can be pushed between two layers of tissue to dissect the layers apart from each other. Once the distal portion 154 is positioned in the desired area for the expandable device to be deployed, the expandable device can be inserted into the interior 164 of the substrate 150 through the open proximal end 158. Placing the expandable device in the interior 164 can include rolling up the expandable device itself or folding it in other ways to minimize its cross-sectional size. Once the expandable device is placed in the interior 164, the flexible lumen (e.g., an inflation tube) connected to the proximal end of the expandable device can be inserted into the distal end 116 of the inner member 110 and passed through the inner member 110. A pump or fluid source (e.g., an inflation pump, a manual pump, a pressurized fluid source or other suitable device) can be attached to the proximal end of the flexible lumen (opposite to the end of the expandable device in the interior 164 attached to the substrate 150).

[0051] In some embodiments, placement of the expandable device within interior 164 and placement of the flexible lumen through inner member 110 may be accomplished prior to inserting base 150 into the incision.

[0052] Once the expandable device is positioned in the base 150 and the flexible lumen is exposed from the proximal end of the inner member 110, the distal portion 114 of the inner member 110 can be slid into the proximal end 158 of the base 150. As the inner member 110 is advanced distally toward the distal portion 154 of the base 150, the distal portion 114 of the inner member 110 can push the expandable device distally along the interior 164 of the base 150. As the distal portion 114 approaches the distal portion 154, the expandable device is pushed distally from the open distal end 156 into a desired position (e.g., between tissue layers or planes to be dissected or in other desired locations).

[0053] Once the expandable device is inserted, the user can expand the expandable device by supplying fluid to the expandable device. Fluid can include, for example, gas (e.g., inert or relatively inert gas, such as air, nitrogen, helium, etc.) or liquid (e.g., water, saline solution, etc.). Expanding the expandable device can achieve various results, such as expanding tissue bags or other cavities in the body, dissecting tissues and / or applying pressure to internal tissues, such as to stop bleeding or reduce bleeding during surgery. During this time, the substrate 150 and the inner member 110 can be kept placed in the patient's tissue or can be removed. In order to remove the substrate 150 and the inner member 110, any pump or fluid supply attached to the proximal end of the flexible lumen can be separated so that the substrate 150 and the inner member 110 can slide out of the proximal end of the lumen. After the purpose of the expandable device is completed, the proximal end attached to the expandable device of the flexible lumen can be pulled out via the open distal end 156 to collapse the expandable device (e.g., deflate, shrink or otherwise collapse) and retract into the interior 164. The base 150, the inner member 110, and the expandable device disposed within the base 150 may all be removed from the incision.

[0054] After removal of the expandable device and insertion device 100, the medical procedure can be continued or completed (including, for example, inserting an implant, suturing the incision, etc.).

[0055] Figure 2A Another exemplary insertion device 200 according to some aspects of the present disclosure is shown. The insertion device 200 as shown includes a base 230 and a cover 210, which can be movable (e.g., slidable) relative to the base 230. Although the insertion device 200 is depicted as having a generally cylindrical shape, the insertion device can have any shape suitable for inserting an expandable device into an implantation site, an anatomical site, or other surgical site.

[0056] The base 230 and the cover 210 can define a cavity (e.g., cavity 232), wherein the base 230 and the cover 210 can slide radially relative to each other to expose or close the cavity 232. When the cavity 232 is exposed (that is, not closed by the cover 210), an expandable device (such as a balloon) can be placed in the cavity 232 in a compact configuration (e.g., a rolled or otherwise collapsed configuration intended to reduce or minimize the cross-sectional size of the expandable device). The cover 210 can then be moved relative to the base 230 (e.g., slide radially distally relative to the base 230) to cover and close the cavity 232 and limit the removal of the expandable device. The base 230 and the cover 210 can include an open end or hole facing proximally, and a flexible lumen can extend through the open end or hole to provide, for example, a fluid supply to the expandable device within the insertion device 200. When the insertion device 200 is inserted into the incision, the flexible lumen may be left outside the incision to enable deployment of the expandable device by introducing fluid into the expandable device as it is deployed.

[0057] The base 230 may include one or more handles 212, 214, which may act as grips for a user using the insertion device 200 (e.g., to move the cover 210 relative to the base 230, or to move the insertion device 200 as a whole in a proximal or distal direction). Additionally or alternatively, such handles may act as stops or obstacles, such as to prevent over-insertion of the insertion device 200 into an incision or to act as a circumferential clamp, closure, or ring to prevent radial separation of the cover 210 and base 230. The handles 212, 214 may be any size or shape that allows a user to manipulate the insertion device 200 and / or act as obstacles. Although two handles (212, 214) are depicted, in some embodiments, the insertion device 200 may include only one handle. Additionally or alternatively, the insertion device 200 may include Figure 2B The distal end portion 234 of the insertion device 200 may be tapered, for example, to allow easy insertion of the insertion device 200 into an incision and / or a site of interest. Further, similar to the insertion device 100, an LED or other light source may be placed at the distal end portion 234 to assist in placement and delivery of the insertion device 200 and / or an expandable device therein.

[0058] One or more longitudinal ridges and / or internal projections (e.g., similar to the longitudinal ridges 122 and internal projections 162 of the insertion device 100) may be provided on either or both of the base 230 and / or the cover 210 to allow the base 230 and the cover 210 to interact and slide longitudinally relative to each other without radially rotating relative to each other. A lubricant may be applied to reduce friction between the base 230, the cover 210, and or the expandable device in the cavity 232. Additionally or alternatively, one or more portions of the insertion device 200 may be made using a lubricating material or coating.

[0059] Figure 2B The invention shows a method according to various aspects of the present disclosure. Figure 2A 200 is rotated approximately 90 degrees to depict another exemplary insertion device 250. The insertion device 250 can include a base 270 and a cover 260, which can be movable (e.g., slidable) relative to the base 270. Although the insertion device 250 is depicted as having a generally cylindrical shape, the insertion device can have any shape suitable for inserting an expandable device into an implantation site, a site requiring dissection, or other surgical site.

[0060] The base 270 and the cover 260 can define a cavity (e.g., cavity 272), wherein the base 270 and the cover 260 can slide radially relative to each other to expose or close the cavity 272. When the cavity 272 is not closed by the cover 260, the expandable device in a compact configuration (e.g., a rolled or otherwise collapsed configuration intended to reduce or minimize the cross-sectional size of the expandable device) can be placed in the cavity 262. Then, the cover 260 can move relative to the base 270 (e.g., slide radially distally relative to the base 270) to cover and close the cavity 272 and limit the removal of the expandable device. Similar to the cover 210 of the insertion device 200, the cover 260 can include an open end facing the proximal side, and the flexible lumen can extend through the open end to provide, for example, a fluid supply to the expandable device in the insertion device 250. When the insertion device 250 is inserted into the incision, the flexible lumen is retained outside the incision to achieve the expansion of the expandable device by introducing the fluid into the expandable device when the expandable device is expanded.

[0061] The base 270 may include handles 276, 262 that a user may grasp when using the insertion device 250 (e.g., to move the cover 260 relative to the base 270, or to move the insertion device 250 as a whole in a proximal or distal direction). Additionally or alternatively, the handle 276 may act as a circumferential clamp, closure, or ring that prevents radial separation of the cover 260 and the base 270. Additionally or alternatively, the handles 276, 262 may be obstacles for preventing over-insertion of the insertion device 250 into the incision. In some embodiments, the insertion device 250 may include only one or the other of the handles 276, 262. Additionally or alternatively, the insertion device 250 may include Figure 2A The distal end portion 274 of the insertion device 200 may be tapered, for example, to allow easy insertion of the insertion device 200 into an incision and / or a site of interest. Further, an LED or other light emitting device may be placed at the distal end portion 274 to assist in placement and delivery of the insertion device 250 and / or an expandable device therein.

[0062] In an exemplary method of using insertion device 200 or insertion device 250, a distal portion (e.g., 234 or 274) can be placed at an incision near a site of interest, and the insertion device (200 or 250) can be inserted into the site of interest (e.g., into a tissue pocket or other cavity, between tissue layers or planes, to be dissected apart from each other or otherwise inserted into the site of interest). Once the distal portion (e.g., 234 or 274) is positioned at a desired location for deploying an expandable device from a cavity (e.g., cavity 232 or cavity 272) of the insertion device, a user can slide a cover (e.g., cover 210 or cover 270) proximally to expose the expandable device disposed in the cavity (e.g., cavity 232 or cavity 272).

[0063] as Figures 1A-1F Like the insertion device 100 in the embodiment of the present invention, the insertion device (e.g., insertion device 200 or 250) can be retained in the incision while the expandable device is deployed. In order to deploy the expandable device, a pump, a fluid source or other expansion mechanism can be attached to the proximal portion of the flexible lumen attached to the expandable device, and the expandable device can be expanded using the expansion mechanism. The expansion of the expandable device makes the expandable device become too large for the cavity (e.g., cavity 232 or cavity 272) in which it is placed, thus causing the expandable device to be deployed from the cavity. Further expansion of the expandable device can be performed to achieve desired results (e.g., anatomical tissue layers or planes, applying pressure to internal wounds, expanding internal tissue bags or other cavities, or other surgical results).

[0064] Alternatively, the insertion device (e.g., insertion device 200 or 250) can be removed from the incision before the expansion expandable device. As discussed about the insertion device 100, the insertion device (e.g., 200 or 250) can slide proximally on the flexible lumen, and remove before the proximal portion of the pump, fluid supply or other mechanism is attached to the flexible lumen. Once the insertion device is located outside the incision, and the flexible lumen attached to the expandable device is removed from the proximal opening of the insertion device, a pump, fluid supply or other expansion mechanism can be attached to the flexible lumen, and the user can expand the expandable device. After the desired use of the expandable device is completed (e.g., dissecting tissue, applying pressure to blood flow or other purposes), the expandable device can be made to be contractible or deflated, and the expandable device can be removed from the target site via the incision. When removing the insertion device before the expansion expandable device, the contracted expandable device can be removed by the pipeline produced by the insertion device.

[0065] If before expanding expandable device, do not remove insertion device (for example, insertion device 200 or 250), then expandable device can be deflated, and by moving both insertion device and expandable device proximally until both insertion device and expandable device are located outside patient and remove expandable device together with insertion device.In some cases, the doctor can first pull out the flexible tube chamber connected to expandable device in the proximal direction, therefore expandable device is retracted into the cavity (for example, cavity 232 or 272) of insertion device.Once expandable device is therefore retracted, the cover (for example, cover 210,260) of insertion device just can move distally, to limit expandable device to remove from cavity.Can pull out the insertion device (for example, insertion device 200 or 250) containing expandable device in cavity (for example, cavity 232 or 272) in the proximal direction, and remove described insertion device from incision.

[0066] Figure 3 is an illustration of an exemplary insertion device assembly 300 according to aspects of the present disclosure, and Figures 4A-4D 300. The insert device assembly 300 includes an insert device 320 including a base 322 and a cover 324 defining a cavity 332 (see FIG. Figure 4B ). The base 322 includes a support 326, and the cover 324 includes a rod 328. The support 326 is connected to a handle 325, which includes a groove through which the rod 328 can pass. The insertion device assembly 300 further includes a pump 302, a flexible lumen 310, and a balloon 330 (expandable device) in a folded configuration, which is disposed within a cavity 332 of the insertion device 320 (see, e.g., Figures 4A-4D ). Figures 4A-4DAn additional view of the insertion device 320 is shown (the insertion device assembly 300 without the pump 302, lumen 310, or balloon 330).

[0067] The cavity 332 of the insertion device 300 can be sized and configured to accommodate the balloon 330 in a folded state. The cover 324 can fix the balloon 330 in the cavity 332 during the insertion of the device 300 into the incision and the target site, and can be connected, attached or otherwise attached to the base 322 by a tab, a clip connection or any other suitable coupling mechanism. The cover 324 can include, for example, parallel extensions (prongs) in a generally forked configuration as shown, or can have other shapes or configurations (e.g., a variety of rods, bars or other blocking shapes) configured to limit the movement of the balloon 330. In the example shown, the prongs of the cover 324 extend radially over the cavity 332 to fix the balloon 330 in the cavity 332. The distal end of the prong can be configured to protrude into the cavity 332 to better fix the balloon 330 in the cavity 332, and / or to avoid getting stuck or hooking the patient's tissue when the insertion device 320 is inserted. The distal end of the tip optionally may include a protrusion or projection configured to interact with a corresponding feature (e.g., one or more notched portions) on the base 322 to lock the cover 324 or otherwise secure the cover to the base 322.

[0068] The handle 325 can have any suitable configuration or shape that allows a user to hold the insertion device 320. For example, as shown, the handle 325 can be generally spherical, or can have any other suitable shape (e.g., ergonomic, rectangular, etc.). The rod 328 of the cover 324 can be snap-fit ​​or friction-fit into a groove in the handle 325. Alternatively and / or in addition, the rod 328 can rest in a groove in the handle 325. During use, the user can hold the insertion device 320 so that the rod 328 is fixed in the groove of the handle 325. Any other mechanism (such as a clip, a tab, or an adhesive) can be used to fix the rod 328 to the handle 325, or otherwise fix the cover 324 to the base 322. For example, in some embodiments, the cover 324 can be frangibly connected to the base 322.

[0069] As shown, the balloon 330 (or any other expandable device used in conjunction with the insertion device 320) can be partially exposed to tissue at, for example, a target site. Figures 4A-4C The illustrated cover 324 does not completely enclose the balloon 330 and / or cavity 332. Alternatively, the cover 324 can have a shape and size configured to completely enclose the balloon 330 within the cavity 332.

[0070] The materials, sizes, shapes, characteristics, measurements of the components of the insertion device 320 and the insertion device assembly 300 (e.g., the dimensions, materials, etc. of the insertion device 320 and the insertion device assembly 300) can correspond to similar materials, sizes, shapes, characteristics, and measurements of any other one or more embodiments disclosed herein. For example, the insertion device 320 can include a rigid biocompatible material, such as silicone, that can maintain the force applied thereto during the insertion procedure. Any suitable biocompatible lubricant or lubricating coating can be applied to part or all of the insertion device assembly 300, such as to help the cover 324 move relative to the substrate 322, to help the substrate 322 and the cover 324 move relative to the patient's tissue, and / or to help the balloon 330 and / or the lumen 310 move relative to the substrate 322, the cover 324, and / or the patient's tissue. As with other exemplary insertion devices disclosed herein, a light source such as an LED or other visual indicator can be placed at or near the distal end of the insertion device 320, such as to help position the device 320. As other exemplary devices disclosed herein, the insertion device 320 can have a suitable longitudinal length (extending along the proximal-distal axis) for performing insertion or implantation procedures. For example, the longitudinal length range of the insertion device 320 can be about 15cm to about 35cm, such as about 18cm to about 32cm, about 18cm to about 30cm, about 18cm to about 28cm, about 18cm to about 25cm, about 19cm to about 23cm or about 19cm to about 21cm, such as about 16cm, about 18cm, about 20cm, about 22cm, about 24cm, about 26cm, about 28cm, about 30cm, about 32cm or about 34cm. As in the case of other devices disclosed herein, the cross-sectional dimensions (perpendicular to the longitudinal length measured along the proximal-distal axis) of the insertion device 500 can be relatively small (for example, less than about 3cm, less than about 2cm or less than about 1cm wide), to promote minimally invasive procedures and minimize scarring or other tissue trauma.

[0071] The balloon 330 , lumen 310 , and pump 302 are exemplary and may be used in any other exemplary device or assembly disclosed herein. Further, these components may share features with any other embodiment disclosed herein, such as expandable devices 700 , 800 , 900 .

[0072] In an exemplary method of use, the distal end of the insertion device assembly 300 (that is, the distal end of the insertion device 320) can be placed in an incision and can be manipulated to a target site (e.g., between tissues for dissection, internal tissue pockets or other cavities, areas for application of pressure, etc.). The proximal end of the lumen 310 and the pump 302 can remain outside the incision (that is, outside the patient).

[0073] Once the cavity 332 of the insertion device 320 is positioned at the desired area, the balloon 330 can be deployed by exposing the cavity 332. To this end, the cover 324 can be moved relative to the base 322 and optionally removed from the base 322. The user can inflate the balloon 330 using the pump 302 (thus introducing a fluid such as air or other gas or liquid), while the cover 324 and base 322 remain positioned at or near the target site. When the procedure is completed, the balloon 330 can be collapsed and retracted into the cavity 332 by, for example, pulling the proximal end of the lumen 310 outside the incision. The insertion device 320 can then be removed from the patient.

[0074] Alternatively, once the balloon 330 is deployed, but before it is inflated, the cover 324 and base 322 can be removed from the target site. For example, the cover 324 and base 322 can be moved radially in the proximal direction until the cover and base pass distally through the incision. The pump can be attached to the proximal end of the lumen 310 before or after the cover 324 and base 322 are removed. The balloon 330 can then be inflated. After inflation is completed as desired, the balloon 330 can be collapsed and retracted by, for example, pulling on the proximal end of the lumen 310. After removing the balloon 330, the user can complete a medical procedure, such as inserting a breast implant into a tissue pocket or cavity formed by the inflation of the balloon 330.

[0075] Figures 5A-5C A view of another exemplary insertion device 500 according to aspects of the present disclosure is shown. The insertion device 500 includes a base 550, a cover 510, and a clip 505. The base 550 includes a body 556 defining a cavity 552, a distal portion 554, and a handle portion 558 defining a groove 560. The handle portion 558 includes two curved wings 564 separated by a groove 562. The cover 510 includes a cap 512 complementary to the cavity 552 and a handle portion 514.

[0076] The cover 510 can be coupled to, e.g., removably secured to, the base 550 by means of a clip 505, which can have an opening configured to receive at least a portion of the cover 510 and the base 550. The clip 505 can have an opening configured to receive at least a portion of the base 550 and the cover 510. The clip 505 can include one or more mating features that cooperate with complementary mating features (e.g., grooves, detents, snap-fit ​​connections, etc.) of the base 550 and / or the cover 510.

[0077] The handle portion 514 of the cover 510 can have a concave shape configured to fit over a portion of the base 550 (e.g., the groove 560). The handle portion 514 can optionally be configured to fit (e.g., radially inwardly) within the handle portion 558, such as by passing the slot 562 between the wings 564. After the handle portion 514 and the handle portion 558 have been connected, the clip 505 can secure the cover 510 to the base 550. In this manner, the cover 510 can be fastened to the base 550 (e.g., Figure 5B ). The clip 505 may be positioned distally from both the handle portion 514 and the handle portion 558, or may be positioned anywhere else suitable for securing the cover 510 to the base 550. When the clip 505 is disengaged, the cover 510 may move radially in a proximal direction relative to the base 522 (e.g., radially inward) due to pressure exerted on the wings 564. Figure 5C ). In this way, radial movement of the cover 510 can be controlled by, for example, removing the clip 505 and by pressure on the wings 564. The cover 510 can be moved proximally until the entire cover 512 is proximal to the cavity 552 of the base 550.

[0078] In some aspects, the cover 510 may also be removed by pulling it in a direction substantially perpendicular to the radial extension of the base 550. This movement may allow the wings 564 to flex outwardly away from the central axis of the insertion device 500, thereby allowing the handle portion 514 to move through the slot 562 and disengage the cover 524 from the base 550. The cover 524 may then be completely removed.

[0079] The materials, sizes, shapes, properties, measurements of the components of the insertion device 500 (e.g., the dimensions, materials, etc. of the insertion device 500) can correspond to similar materials, sizes, shapes, properties, and measurements of any other examples disclosed herein. For example, the insertion device 500 can include a rigid biocompatible material, such as silicone, that can sustain forces applied thereto during the insertion procedure. The wings 564 of the insertion device 500 can include a semi-rigid material, such as a semi-rigid polymer, thereby allowing the wings 564 to flex to accommodate their movement as described herein.

[0080] Any suitable biocompatible lubricant or lubricating coating can be applied to the insertion device 500 to help the parts of the insertion device 500 move relative to other parts, and / or to help the insertion device 500 move relative to tissue. LEDs, other light sources or other visual indicators can be provided at the distal end of the insertion device 500 to help it locate. As with other examples disclosed herein, the longitudinal length (extending along the proximal-distal axis) range of the insertion device 500 can be about 15cm to about 35cm, such as about 18cm to about 32cm, about 18cm to about 30cm, about 18cm to about 28cm, about 18cm to about 25cm, about 19cm to about 23cm, or about 19cm to about 21cm, such as about 16cm, about 18cm, about 20cm, about 22cm, about 24cm, about 26cm, about 28cm, about 30cm, about 32cm, or about 34cm. As with other devices disclosed herein, the cross-sectional dimension (perpendicular to the longitudinal length measured along the proximal-distal axis) of the insertion device 500 can be relatively small (e.g., less than about 3 cm, less than about 2 cm, or less than about 1 cm wide), such as to be suitable for minimally invasive medical procedures.

[0081] In an exemplary method of use, the distal end (e.g., distal portion 554) of the assembled insertion device 500 can be inserted into an incision and directed toward a target site. The expandable device can be disposed in a collapsed configuration within a cavity 552 covered by a cover 512. A flexible lumen suitable for providing air or other fluid to the expandable device can be disposed through the proximal end of the device 500, through, for example, the groove 560, and attached to the expandable device in the cavity 552. Alternatively, the flexible lumen can extend proximally from the cavity 552 without passing through the proximal end of the device 500.

[0082] Once the cavity 552 is positioned at the target site, the expandable device can be deployed. To do this, the clip 505 can be removed and the cover 510 can be slid proximally relative to the base 550 (alternatively, the cover 510 can be moved perpendicular to the central longitudinal axis of the base 550, twisting the cover until it is pulled out of the wing 564 through the groove 562). Removing the cover 510 exposes the expandable device in the cavity 552. The expandable device can then be expanded while the base 550 and the cover 510 remain in the incision. After the expansion procedure, the expandable device can be collapsed (e.g., by withdrawing fluid from the expandable device) and retracted into the cavity 552 (e.g., by pulling the fluid supply lumen attached to the expandable device). The expandable device in the base 550, the cover 510 and the cavity 552 can then be retrieved through the incision.

[0083] Alternatively, the cover 510 and base 550 can be removed from the target site (e.g., by radially moving the cover and base through the incision in a proximal direction) before expanding the expandable device. A pump can be attached to the proximal end of the lumen connected to the expandable device before or after removing the cover 510 and base 550. The expandable device can then be expanded. After expansion, the expandable device can be collapsed and pulled out of the target site using the lumen connected to the expandable device. The medical procedure can then be continued or completed as desired (e.g., an implant can be inserted into the expanded area created by the expandable device).

[0084] Fig. 6A and 6B A view of an additional exemplary insertion device 600 is shown in accordance with aspects of the present disclosure. The insertion device 600 includes a handle 602, a body 604 (which may serve as a base), a scoop-shaped recess 606, and a distal tip 608. Fig. 6A A side view of the insertion device 600 is depicted, and Figure 6B A view of the distal end of device 600 is depicted.

[0085] The materials, sizes, shapes, properties, measurements of the components of the insertion device 600 (e.g., the dimensions, materials, etc. of the insertion device 600) can correspond to similar materials, sizes, shapes, properties, and measurements of any other examples disclosed herein. For example, the insertion device 600 can include a rigid biocompatible material, such as silicone, that can maintain the forces applied thereto during the insertion procedure. The distal portion of the insertion device 600 (e.g., the distal tip 608) can include an LED or other light source or visual indicator for assisting in accurately inserting and positioning the expandable device.

[0086] As with other examples disclosed herein, the longitudinal length (extending along the proximal-distal axis) of the insertion device 600 can range from about 15 cm to about 35 cm, such as about 18 cm to about 32 cm, about 18 cm to about 30 cm, about 18 cm to about 28 cm, about 18 cm to about 25 cm, about 19 cm to about 23 cm, or about 19 cm to about 21 cm, such as about 16 cm, about 18 cm, about 20 cm, about 22 cm, about 24 cm, about 26 cm, about 28 cm, about 30 cm, about 32 cm, or about 34 cm. As with other devices disclosed herein, the cross-sectional dimensions (perpendicular to the longitudinal length measured along the proximal-distal axis) of the insertion device 600 can be relatively small (e.g., less than about 3 cm, less than about 2 cm, or less than about 1 cm wide) for use in minimally invasive medical procedures. In addition, the expandable device for use with the insertion device 600 can be adjusted to the shape of the surrounding environment, so that the insertion device 600 can manipulate the expandable device to the desired position at the target site through a relatively small incision, thereby causing minimal trauma to the tissue. As described elsewhere herein, a lubricant or lubricating coating can be optionally included on part or all of the insertion device 600 to assist in moving the insertion device 600 and / or the expandable device thereon through the patient's tissue.

[0087] The handle 602 can include a generally spherical component with a recess therein. The spherical shape can improve the maneuverability of the insertion device 600, while the recess can allow a lumen to pass through, for example, a pump and / or a fluid supply to reach an expandable device disposed in the recess 606. It should be understood that the handle 602 can be any shape suitable for allowing a user to manipulate the insertion device 600. For example, in some embodiments, the handle 602 can be ergonomic, rectangular, or any other shape that assists a user in manipulating the insertion device 600.

[0088] The body 604 can include a groove in which a flexible lumen of an expandable device (e.g., an inflation tube for a balloon) can be positioned, such that the lumen can extend distally along the length of the body 604 beyond the handle 602 to a recess 606 where the body can be in fluid communication with the expandable device. The groove can extend along the entire longitudinal length of the body 604, as well as through the handle 602. The groove can create or maintain a reduced profile for the insertion device 600, which can be beneficial in preventing trauma, snagging of the lumen, or other complications when inserting the device 600 into an incision during a medical procedure.

[0089] As with other examples disclosed herein, the distal tip 608 of the insertion device 600 can be tapered and / or rounded (having rounded edges) to allow easy insertion of the distal tip 608 (and the remainder of the device 600) into the incision and through the tissue to the target site. In some embodiments, the distal tip 608 can be squared, pointed, or otherwise shaped.

[0090] The recess 606 can be concave and can serve as a cavity configured to receive an expandable device in a retracted or collapsed orientation. Although a particular shape of the recess 606 is shown, its shape can vary depending on the procedure for which the insertion device 600 is intended to be used. For example, the recess 606 can be sized and configured to accommodate a desired expandable device in a retracted / folded position. The expandable device can be coupled to the recess 606 by, for example, a biocompatible adhesive or by any other suitable method.

[0091] In an exemplary method of use, the user can insert the distal tip (e.g., distal tip 608) of the insertion device 600 into the incision. As the insertion device 600 is further pushed into the incision, the expandable device connected to the recess 606 can also be advanced into the incision. The user can position the expandable device at the target site for tissue dissection, tissue expansion or pressure application. Once the expandable device is positioned at the target site, the expandable device can be launched. Since the expandable device is connected to the recess 606, the user can use the insertion device 600 to reposition the expandable device during the expansion process. This can be used to solve the problem that, for example, the expandable device hooks onto body tissue or is otherwise stuck or trapped in an undesirable positioning. The user can manipulate the handle 602 to adjust the positioning of the recess 606 and the expandable device connected thereto.

[0092] In some instances, the expandable device is not disconnected from the insertion device 600 during its deployment at the target site. For example, in the case where the expandable device is a sacculus, an air pump can be connected to the proximal end of the flexible lumen, and the distal end of the flexible lumen is communicated with the balloon fluid. Before or after the insertion device 600 is introduced into the incision, the air pump can be connected to the flexible lumen. During the balloon inflation (or other expansions of the expandable device), the insertion device 600 can be retained in the incision at the target site. After the purpose of the expandable device is completed (for example, after the tissue is dissected, the tissue bag or other cavity is enlarged, or pressure has been applied as required, etc.), the insertion device 600 is pulled out in the proximal direction by, for example, handle 602, and the expandable device shrinks / collapses and is removed from the target site together with the insertion device 600.

[0093] Figure 7 , 8 9 show various expandable devices and components thereof according to further aspects of the present disclosure. Specifically, Figure 7 An exemplary expandable device 700 is shown that includes a balloon 706, a flexible lumen 704, and an adapter 702 or other connection elements to which a pump (not shown) can be connected. Figure 8 An exemplary expandable device 800 is shown comprising a balloon 806, a flexible lumen 804, and an adapter 802 or other connection element to which a pump 801 is connected. A clip 805 is shown attached to the lumen 804. Fig. 9 An exemplary expandable device 900 is shown comprising a balloon 906, a flexible lumen 904, and an adapter 902 or other connecting element, and a pump 901 connected to the adapter 902. A clip 905 and an adjustable clamp 907 are shown attached to the lumen 904.

[0094] According to the present disclosure, expandable device can include balloon, such as balloon 706,806,906. The balloon of expandable device can have circular (circular) or other generally circular (rounded) shape when deflated, and has spherical, oval or other shape when expanded. However, it should be understood that balloon of any shape can be used for expandable device. In some embodiments, balloon can be shaped to produce certain cavities in dissected tissue according to desired procedures. Circular shape may be particularly suitable for target sites that circular implants are intended to implant, for example. Balloon can have any suitable thickness and size. In some embodiments, the wall thickness of balloon can be between about 0.1mm and about 0.5mm, such as about 0.1mm, about 0.15mm, about 0.2mm, about 0.25mm, about 0.3mm or about 0.35mm. In some embodiments, the uninflated diameter of the balloon can be between about 10 cm and about 20 cm, such as between about 10 cm and about 15 cm, such as 10 cm, 12 cm, 14 cm, 16 cm, 18 cm, or 20 cm.

[0095] Flexible lumen (such as lumen 704,804,904) can extend from the outer wall of the sacculus of expandable device, and can be communicated with the internal fluid of sacculus.Lumen can be any suitable length, for example between about 20cm and about 50cm.For example, the length of lumen can be between about 20cm and about 40cm, or between about 30cm and about 40cm, such as about 30cm, about 32cm, about 34cm, about 36cm, about 38cm or, about 40cm.The length of flexible lumen can vary, to ensure that pipe extends to the outside of patient from the sacculus positioned in the main body cavity.

[0096] The balloons and / or lumens disclosed herein can be made of, for example, a flexible biocompatible polymer (e.g., silicone). In some embodiments, the balloon and lumen can be made of a single material, and in alternative embodiments, can be made of different materials.

[0097] Devices 800 and 900 are depicted as including manually operated one-way pumps 801, 901 attached to the proximal ends of lumens 804, 904, respectively, via adapters 802, 902, respectively. When a first side of each pump 801, 901 is coupled to lumen 804 or lumen 904, the pumps can be used to inflate a respective balloon 806, 906 connected to the pumps, for example, via lumens 804, 904. Specifically, when a first side of each pump 801, 901 is coupled to the respective lumen 804, 904, actuating the pumps 801, 901 can inflate the balloons 806, 906. When the pumps 801, 901 are actuated, attaching the opposite ends of the pumps 801, 901 to the lumens 804, 904 can deflate the balloons 806, 906.

[0098] The pumps 801, 901 may use any other suitable method or mechanism (such as pressurized air or pressurized fluid) to expand the balloons 806, 906, and may be electrically operated, mechanically operated, or a combination thereof. The clamps 805, 905 and / or adjustable clamps 907 may be used on the lumens 804, 904 to prevent the balloons 806, 906 from deflation once inflated.

[0099] Optionally, a string can be disposed in a lumen (e.g., lumen 804, 904), with a first end of the string attached at an internal equatorial point of a balloon (e.g., balloon 806, 906), and a second end of the string extending through the lumen (e.g., lumen 804, 904) and out the proximal end. As the balloon expands, the string is pulled into the lumen, thereby allowing a user to measure the expansion of the balloon by using a marker on the opposite end of the proximal end extending out of the tube. As the balloon is inflated, the balloon expands, and the string is pulled into the conduit, thereby allowing a physician to measure the expansion of the balloon. In some embodiments, markers can be provided on the lumen to assist in measuring movement of the string.

[0100] Figures 10A-10D Shown are views of another exemplary insertion device, components thereof, and accessories in accordance with aspects of the present disclosure. Fig. 10A A conical cup 1002 is depicted, comprising an interior 1004 and a side opening 1006 . Fig. 10BAn insertion device assembly 1000 is depicted, which includes an insertion device 1010 having a handle (e.g., a knob 1012 located at or near a proximal end 1013 of the device 1010) and a distally extending protrusion 1011. A balloon 1016 is coupled to the protrusion 1011 and is in fluid communication with a flexible lumen 1052 that passes through a cavity defined by a tube of the insertion device 1010 and exits the proximal end 1013. At least a portion of the balloon 1016 may optionally be disposed within the cavity (e.g., within the tube) while a portion of the balloon is coupled to the protrusion 1011. The proximal end of the lumen 1052 is connected to a pump 1050. A clip 1054 is disposed on the lumen 1052. Fig. 10C and 10D Additional views of the insertion device 1010 and, in particular, the distal protrusion 1011 which may include a tapered distal tip are depicted.

[0101] Insertion device assembly 1000 can be utilized as described in any other example of the insertion device disclosed herein. The materials, sizes, shapes, characteristics and measurements of the parts (e.g., insertion device 1010, balloon 1016, lumen 1052, pump 1050 and clip 1054) of insertion device assembly 1000 can also correspond to the materials, sizes, shapes, characteristics and measurements of any other similar components of the insertion device disclosed herein. For example, insertion device 1010 can include depth markings or measurement marks on its surface to help users determine the extent to which the insertion device has extended into the incision. As with other exemplary insertion devices disclosed herein, the longitudinal length (extending along the proximal-distal axis) of the insertion device 1010 can range from about 15 cm to about 35 cm, such as about 18 cm to about 32 cm, about 18 cm to about 30 cm, about 18 cm to about 28 cm, about 18 cm to about 25 cm, about 19 cm to about 23 cm, or about 19 cm to about 21 cm, such as about 16 cm, about 18 cm, about 20 cm, about 22 cm, about 24 cm, about 26 cm, about 28 cm, about 30 cm, about 32 cm, or about 34 cm. As with other devices disclosed herein, the cross-sectional dimension (perpendicular to the longitudinal length measured along the proximal-distal axis) of the insertion device 1010 can be very small (e.g., less than about 3 cm, less than about 2 cm, or less than about 1 cm wide).

[0102] The tapered or anchor-shaped tip of the insertion device 1010 can aid in inserting the device 1010 through an incision. Additionally and / or alternatively, the narrowed portion of the tip on the protrusion 1011 can be used to couple the protrusion 1011 to an expandable device, such as a balloon 1016. The protrusion 1011 can be disposed within the balloon 1016, or can be coupled, adhered, or attached to the exterior of the balloon.

[0103] The cup 1002 can be configured for use with the insertion device assembly 1000. The inner circumference, diameter or volume of the cup 1002 can roughly correspond to the corresponding circumference, diameter or volume of the implant to be introduced at the target site. Before the expandable device (e.g., balloon 1016) is deployed in the target site, the cup 1002 can be placed on the outside of the target site. When the balloon 1016 expands in the target site, the cup 1002 can limit the expansion by limiting the expansion of the patient's tissue at the target site from the outside. Once the balloon 1016 expands to the extent allowed by the cup 1002, the clip 1054 can engage with the compression lumen 1052 and limit the flow of fluid out of the balloon 1016, thereby keeping the size and shape of the balloon 1016 corresponding to the desired size and shape as defined by the cup 1002. In this way, the insertion device assembly 1000 combined with the cup 1002 can be used to insert the expandable device and expand it to the extent required to make the patient's tissue conform to the desired shape and size. Once this is accomplished, an implant can be selected for implantation into the space created by the expandable device of the insertion device assembly 1000 .

[0104] As will be appreciated by one of ordinary skill in the art, the cup 1002 can have any size or shape suitable for defining a desired size or shape of patient tissue. In some embodiments, the size and shape of the cup 1002 and the interior 1004 can be customized for a particular patient. The cup 1002 can include one or more openings, such as a side opening 1006. The side opening 1006 can allow the cup 1002 to be placed over the target site without covering, for example, an incision for insertion of the insertion device 1010.

[0105] Any device described herein may optionally employ a biocompatible lubricant and / or lubricating coating in any suitable form to assist in reducing friction caused by the device resisting other components and / or resisting tissue movement. In addition, any device disclosed herein may include markings, such as depth markings, incremental measurements, etc., to assist the user (e.g., physician) in visually inspecting and adjusting the position of the device in the incision, and / or the deployment of the expandable device at the target site. In addition, any device disclosed herein may include a light emitting device, a radiopaque marking, or other indicators positioned at, for example, the distal portion of the device to assist in positioning the device at the target site (e.g., between tissue layers or planes to be dissected). In addition, any feature of the exemplary device described herein may be combined with any other feature and / or the device described. For example, cup 1002 may be used with insertion device 100, 200, 320, 500, and / or 600.

[0106] Although various aspects of the use of various insertion devices have been described herein, Fig.11An exemplary general method 1100 for inserting an expandable device using an insertion device according to various aspects of the present disclosure is depicted in the form of a flow chart. The method 1100 and its variations can be applicable to any insertion device described or covered by the present disclosure, as well as other insertion devices. A person of ordinary skill in the art will consider that Fig.11 Only exemplary methods are depicted, many variations are possible. In some embodiments, the Fig.11 The steps of method 1100 and variations of the steps may be performed by one or more users (eg, medical professionals, technicians, assistants, etc.).

[0107] According to step 1102 of method 1100, an incision can be prepared. This can be done by, for example, a physician, such as an access surgeon or other surgeon performing a medical procedure. In some embodiments, as described elsewhere herein, the incision can be a minimally invasive incision, which is configured to be just large enough to allow insertion of an insertion device. For example, the length of the incision according to the present disclosure can be about 5 cm or less, about 4 cm or less, about 3 cm or less, about 2 cm or less, or about 1 cm or less. For example, in some embodiments, the incision can be between about 1.5 and about 2.5 cm, such as 1.5 cm, 1.7 cm, 1.9 cm, 2.1 cm, 2.3 cm, or 2.5 cm.

[0108] According to step 1104, the distal end of the insertion device can be inserted into the incision. As described elsewhere herein, the distal end of the insertion device according to the present disclosure can be tapered and / or circular, to allow easy insertion. The insertion device can then advance distally through the incision until the distal portion reaches the desired position (e.g., at or near the position intended to expand the expandable device, such as the target site). According to step 1106, the expandable component (e.g., expandable device) can be deployed from the insertion device (e.g., the cavity in the insertion device) to the target site that can be entered from the incision. According to step 1108, the insertion device can be removed from the incision. As described elsewhere herein, the insertion device can be removed from the incision before the expandable component is removed from the target site. In an additional or alternative embodiment, the insertion device is not removed until the expandable component shrinks (e.g., deflates, compresses, etc.) and retracts into the insertion device (e.g., in the cavity of the insertion device). Therefore, in such examples, the insertion device can be used to take out the expandable component.

[0109] Although the principles of the present disclosure are described herein with reference to the illustrative aspects of specific applications, it should be understood that the present disclosure is not limited thereto. Those of ordinary skill in the art and those who obtain the teachings provided herein will recognize that other modifications, applications, aspects, and replacements of equivalents all fall within the scope of the various aspects described herein. Therefore, the present disclosure is not to be considered as being limited by the foregoing description.

Claims

1. An insertion device, comprising: a handle located at or adjacent to a proximal end of the device; a protrusion extending distally from the handle; an expandable device coupled to the protrusion; A fluid supply tube is coupled to the expandable device and is connectable to a proximally located pump or fluid source.

2. An insertion device according to claim 1, wherein the uninflated diameter of the balloon is between about 10 cm and about 20 cm.

3. An insertion device according to claim 1 or 2, wherein the expandable device is configured to adapt to the shape of the surrounding environment.

4. An insertion device according to any of the preceding claims, wherein the shape of the insertion device is configured to insert the expandable device into an implantation site, an anatomical site or other surgical site.

5. An insertion device according to any of the preceding claims, wherein the device is sized to adapt to the shape and contours of the implantation site, preferably the contours of the breast area, gluteal area or calf area.

6. An insertion device according to any preceding claim, wherein a visual indicator is provided at or adjacent the distal end of the insertion device.

7. The insertion device of claim 6, wherein the visual indicator is a light source, more preferably, the light source is an LED.

8. The insertion device according to any one of claims 1 to 5, comprising an indicator for assisting in positioning the device at a target site, preferably, the indicator is a luminous device or a radiopaque marker.

9. The insertion device of claim 8, wherein the indicator is located at a distal portion of the insertion device.

10. An insertion device according to any preceding claim, wherein the expandable device comprises a balloon made of a sterile, biocompatible material, preferably the balloon is made of a flexible, biocompatible polymer.

11. An insertion device according to any preceding claim, wherein a biocompatible lubricant or lubricating coating is applied to part or all of the insertion device.

12. An insertion device according to any preceding claim, comprising a pump coupled to the fluid supply tube, preferably the pump being a manually operated one-way pump.

13. An insertion device according to any preceding claim, comprising markings, such as depth markings or incremental measurement markings.

14. A kit comprising an insertion device according to any of the preceding claims and a cup, wherein the cup has an internal circumference, diameter or volume corresponding to the circumference, diameter or volume of an implant to be introduced at a target site, wherein the cup is configured to limit the expansion of the balloon by limiting the expansion of patient tissue at the target site.

15. The kit of claim 14, wherein the cup includes a side opening.

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