SYSTEM AND METHODS FOR SOFT-TISSUE AUGMENTATION

FIELD

The field of the present disclosure generally relates to soft-tissue augmentation. More particularly, the field of the present disclosure relates to a system and methods for soft-tissue augmentation of the feet or other parts of the body.

BACKGROUND

A number of age-related pathologies develop as a result of atrophy of the soft tissues of the feet, including atrophy of the plantar fat pad. These conditions can be extremely painful, often leading to corns on the digits and calluses on the plantar aspect of the ball of the foot. In addition to the painful skin lesions, prolonged pressure against the resulting boney prominences can further break down the skin through ulceration, commonly leading to infection. These conditions can be much more serious in individuals suffering from peripheral vascular disease, diabetes, peripheral neuropathy, or a combination thereof. Provided herein, in some embodiments, are systems and methods for soft-tissue augmentation of the feet or other parts of the body.

SUMMARY

In an exemplary embodiment, provided herein, an injectable composition includes a soft-tissue augmenting agent and a vehicle for the soft-tissue augmenting agent formulated for augmenting one or more soft tissues of a human or animal.

In another exemplary embodiment, the soft-tissue augmenting agent includes a combination of saline and micronized dermis. In another exemplary embodiment, the soft-tissue augmenting agent includes a combination of hydrolyzed collagen and micronized dermis. In another exemplary embodiment, the soft-tissue augmenting agent further includes human- or animal-derived amino acids, polypeptides, cells, tissues, placentas, or a combination thereof. In another exemplary embodiment, the soft-tissue augmenting agent further includes synthetic amino acids, polypeptides, cells, tissues, or a combination thereof. In another exemplary embodiment, the soft-tissue augmenting agent further includes micronized silicone particles, acrylic beads, polyethylene, polyether ether ketone, other synthetics, or a combination thereof. In another exemplary embodiment, the vehicle includes water, saline, buffered saline, liquid collagen, silicone liquid, or a combination thereof.

In another exemplary embodiment, the injectable composition is formulated for augmenting soft tissue in a human plantar fat pad. In another exemplary embodiment, the injectable composition is formulated for augmenting soft tissue in a human hand. In another exemplary embodiment, the injectable composition is formulated for augmenting soft tissue in a human face.

In an exemplary embodiment, provided herein, a soft-tissue augmenting kit includes a syringe and an injectable composition formulated for augmenting one or more soft tissues of a human or animal. The syringe is configured for delivering the injectable composition to the one or more soft tissues of the human or animal. The injectable composition includes a soft-tissue augmenting agent and a vehicle for the soft-tissue augmenting agent.

In another exemplary embodiment, the injectable composition is provided in a single container configured for drawing the injectable composition into the syringe. In another exemplary embodiment, the soft-tissue augmenting agent is provided in a first container, the vehicle is provided in a second container, and the first container is configured for suspending or diluting the soft-tissue augmenting agent with the vehicle in the first container. In another exemplary embodiment, the soft-tissue augmenting kit further includes a targeting arm for the syringe and a marking pen.

In an exemplary embodiment, provided herein, a method for augmenting one or more soft tissues of a human or animal includes injecting an injectable composition into the one or more soft tissues of the human or animal. The injectable composition includes a soft-tissue augmenting agent and a vehicle for the soft-tissue augmenting agent. The soft-tissue augmenting agent includes a combination of saline and micronized dermis. In some embodiments, the soft-tissue augmenting agent includes a combination of hydrolyzed collagen and micronized dermis, and the vehicle includes water, saline, buffered saline, liquid collagen, silicone liquid, or a combination thereof.

In another exemplary embodiment, the method further includes drawing the injectable composition into a syringe before injecting the injectable composition into the one or more soft tissues of the human or animal. In another exemplary embodiment, the method further includes suspending or diluting the soft-tissue augmenting agent with the vehicle before drawing the injectable composition into the syringe.

In an exemplary embodiment, an injectable composition for augmenting one or more soft tissues of a human or an animal comprises: a soft-tissue augmenting agent; and a vehicle for the soft-tissue augmenting agent.

In another exemplary embodiment, the soft-tissue augmenting agent includes partially demineralized tissue. In another exemplary embodiment, the soft-tissue augmenting agent includes human- or animal-derived partially demineralized tissue. In another exemplary embodiment, the soft-tissue augmenting agent includes a first portion comprising demineralized bone and a second portion comprising mineralized hydroxyapatite. In another exemplary embodiment, the first portion comprises between about 20% to about 60% by volume of the soft-tissue augmenting agent. In another exemplary embodiment, the second portion comprises between about 40% to about 80% by volume of the soft-tissue augmenting agent.

In another exemplary embodiment, the soft-tissue augmenting agent and the vehicle are supplied together by way of a single syringe. In another exemplary embodiment, the vehicle includes water, saline, buffered saline, liquid collagen, silicone liquid, or a combination thereof. In another exemplary embodiment, the injectable composition is formulated for augmenting soft tissue in a human plantar fat pad. In another exemplary embodiment, the injectable composition is formulated for augmenting soft tissue in a human hand. In another exemplary embodiment, the injectable composition is formulated for augmenting soft tissue in a human face.

In an exemplary embodiment, a method for an injectable composition for augmenting one or more soft tissues of a human or an animal comprises: preparing a soft-tissue augmenting agent; forming a mixture comprising a vehicle and the soft-tissue augmenting agent; and supplying the mixture by way of a syringe for delivering the injectable composition to the one or more soft tissues of the human or animal.

In another exemplary embodiment, preparing includes combining a first portion comprising demineralized bone and a second portion comprising mineralized hydroxyapatite. In another exemplary embodiment, combining includes portioning the first portion to comprise between about 20% to about 60% by volume of the soft-tissue augmenting agent. In another exemplary embodiment, combining includes portioning the second portion to comprise between about 40% to about 80% by volume of the soft-tissue augmenting agent.

In another exemplary embodiment, supplying includes combining the vehicle and the soft-tissue augmenting agent in a single syringe. In another exemplary embodiment, forming the mixture includes providing the vehicle comprising any of water, saline, buffered saline, liquid collagen, silicone liquid, or a combination thereof.

In an exemplary embodiment, a soft-tissue augmenting kit for augmenting one or more soft tissues of a human or animal comprises: a first syringe containing a soft-tissue augmenting agent; a second syringe containing a vehicle for the soft-tissue augmenting agent; a syringe connector for coupling the first syringe and the second syringe; at least one needle for being coupled with the first syringe or the second syringe; and a targeting arm for the syringe.

In another exemplary embodiment, the syringe connector is configured for placing the first syringe into fluid communication with the second syringe. In another exemplary embodiment, the syringe connector comprises a female-to-female Luer Lock connector. In another exemplary embodiment, the syringe connector is configured to facilitate mixing the soft-tissue augmenting agent with the vehicle to form an injectable composition. In another exemplary embodiment, the syringe connector is configured to facilitate retaining the injectable composition in either the first syringe or the second syringe. In another exemplary embodiment, the at least one needle is configured to facilitate delivering the injectable composition from either the first syringe or the second syringe to the one or more soft tissues.

In another exemplary embodiment, the targeting arm is configured to snap onto a barrel of either the first syringe or the second syringe. In another exemplary embodiment, the targeting arm includes a longitudinal member configured to control an injection depth for an injection of the injectable composition. In another exemplary embodiment, the longitudinal member is configured to extend parallel to the at least one needle when connected to either the first syringe or the second syringe. In another exemplary embodiment, the longitudinal member is short of the at least one needle in correspondence with a recommended injection depth.

In another exemplary embodiment, the soft-tissue augmenting agent is contained in a first ampoule in lieu of the first syringe. In another exemplary embodiment, the vehicle is contained in a second ampoule in lieu of being contained in the second syringe.

In an exemplary embodiment, a method for a soft-tissue augmenting kit for augmenting one or more soft tissues of a human or animal comprises: pre-filling a first syringe with a soft-tissue augmenting agent; pre-filling a second syringe a vehicle for the soft-tissue augmenting agent; including a syringe connector for coupling the first syringe and the second syringe; providing at least one needle for being coupled with the first syringe or the second syringe; and configuring a targeting arm for the syringe.

In another exemplary embodiment, pre-filling the first syringe comprises pre-filling a first ampoule in lieu of pre-filling the first syringe. In another exemplary embodiment, pre-filling the second syringe comprises pre-filling a second ampoule in lieu of pre-filling the second syringe. In another exemplary embodiment, including the syringe connector comprises including a female-to-female Luer Lock connector to facilitate a practitioner mixing the soft-tissue augmenting agent with the vehicle to form an injectable composition.

In another exemplary embodiment, including the syringe connector comprises enabling the practitioner to retain the injectable composition in either the first syringe or the second syringe. In another exemplary embodiment, providing the at least one needle comprises enabling the practitioner to deliver the injectable composition from either the first syringe or the second syringe to the one or more soft tissues. In another exemplary embodiment, configuring the targeting arm includes configuring to snap onto a barrel of either the first syringe or the second syringe. In another exemplary embodiment, configuring the targeting arm includes configuring the targeting arm to control an injection depth for an injection of the injectable composition.

In an exemplary embodiment, an injectable composition for augmenting one or more soft tissues of a human or animal comprises: a soft-tissue augmenting agent; and a vehicle for the soft-tissue augmenting agent.

In another exemplary embodiment, the soft-tissue augmenting agent includes a combination of hydrolyzed collagen and demineralized cortical bone. In another exemplary embodiment, the soft-tissue augmenting agent includes collagen and hydroxyapatite crystals in a saline solution.

In another exemplary embodiment, the soft-tissue augmenting agent further includes human- or animal-derived amino acids, polypeptides, cells, tissues, placentas, or a combination thereof. In another exemplary embodiment, the soft-tissue augmenting agent further includes synthetic amino acids, polypeptides, cells, tissues, or a combination thereof. In another exemplary embodiment, the soft-tissue augmenting agent further includes micronized silicone particles, acrylic beads, or a combination thereof.

In another exemplary embodiment, the vehicle includes water, saline, buffered saline, liquid collagen, silicone oil, or a combination thereof. In another exemplary embodiment, the injectable composition is formulated for augmenting soft tissue in a human plantar fat pad. In another exemplary embodiment, the injectable composition is formulated for augmenting soft tissue in a human hand. In another exemplary embodiment, the injectable composition is formulated for augmenting soft tissue in a human face.

In an exemplary embodiment, a soft tissue-augmenting kit comprises: an injectable composition formulated for augmenting one or more soft tissues of a human or animal; and a syringe configured for delivering the injectable composition to the one or more soft tissues of the human or animal.

In another exemplary embodiment, the injectable composition includes a soft-tissue augmenting agent and a vehicle for the soft-tissue augmenting agent. In another exemplary embodiment, the soft-tissue augmenting agent includes a combination of hydrolyzed collagen and demineralized cortical bone. In another exemplary embodiment, the soft-tissue augmenting agent includes collagen and hydroxyapatite crystals in a saline solution. In another exemplary embodiment, the soft-tissue augmenting agent further includes human- or animal-derived amino acids, polypeptides, cells, tissues, placentas, or a combination thereof.

In another exemplary embodiment, the soft-tissue augmenting agent further includes synthetic amino acids, polypeptides, cells, tissues, or a combination thereof. In another exemplary embodiment, the soft-tissue augmenting agent further includes micronized silicone particles, acrylic beads, or a combination thereof. In another exemplary embodiment, the vehicle includes water, saline, buffered saline, liquid collagen, silicone oil, or a combination thereof. In another exemplary embodiment, the injectable composition is provided in a single sterile syringe and is ready for implantation in a patient.

These and other features of the concepts provided herein may be better understood with reference to the drawings, description, and appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

The drawings refer to embodiments of the present disclosure in which:

FIG. 1A is a schematic illustrating an exemplary embodiment of an injectable composition in a syringe for augmenting one or more soft tissues of a human or animal in accordance with the present disclosure;

FIG. 1B is a schematic illustrating an exemplary embodiment of an injectable composition in a syringe with a targeting arm for augmenting one or more soft tissues of a human or animal in accordance with the present disclosure;

FIG. 2A is a schematic illustrating an exemplary embodiment of a soft-tissue augmenting kit including a syringe with an injectable composition in accordance with the present disclosure;

FIG. 2B is a schematic illustrating an exemplary embodiment of a soft-tissue augmenting kit including a syringe and a container with an injectable composition in accordance with the present disclosure;

FIG. 2C is a schematic illustrating an exemplary embodiment of a soft-tissue augmenting kit including a syringe, a first container with a soft-tissue augmenting agent, and a second container with a vehicle for a soft-tissue augmenting agent in accordance with the present disclosure;

FIG. 3 is a schematic illustrating sites on a human foot wherein deterioration of pressure-bearing tissue is commonly caused by bony prominence;

FIG. 4 is a schematic illustrating sites on a human foot wherein bony pressure points typically manifest as corns, calluses, and thinning tissue;

FIG. 5 illustrates an exemplary-use environment wherein an injectable allograft implant is applied to a treatment site by way of a single sterile syringe, according to the present disclosure;

FIG. 6 is a schematic illustrating areas of sensitivity that have been surrounded by injection site margins to serve as a guide during implant injection in accordance with the present disclosure;

FIG. 7 illustrates an exemplary-use environment wherein a syringe is used to treat subdermal tissue near a bony prominence, according to the present disclosure;

FIG. 8 illustrates an exemplary-use environment wherein a fanning technique is used during treating subdermal tissue in accordance with the present disclosure; and

FIG. 9 illustrates an exemplary-use environment wherein a pad is applied around a treatment site for off-loading the treatment site during recovery, according to the present disclosure.

While the present disclosure is subject to various modifications and alternative forms, specific embodiments thereof have been shown by way of example in the drawings and will herein be described in detail. The invention should be understood to not be limited to the particular forms disclosed, but on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure.

DETAILED DESCRIPTION

Before some particular embodiments are provided in greater detail, it should be understood that the particular embodiments provided herein do not limit the scope of the concepts provided herein. It should also be understood that a particular embodiment provided herein can have features that can be readily separated from the particular embodiment and optionally combined with or substituted for features of any of a number of other embodiments provided herein.

Regarding terminology used herein, it should also be understood the terminology is for the purpose of describing some particular embodiments, and the terminology does not limit the scope of the concepts provided herein. Unless indicated otherwise, ordinal numbers (e.g., first, second, third, etc.) are used to distinguish or identify different features or steps in a group of features or steps, and do not supply a serial or numerical limitation. For example, “first,” “second,” and “third” features or steps need not necessarily appear in that order, and the particular embodiments including such features or steps need not necessarily be limited to the three features or steps. It should also be understood that, unless indicated otherwise, any labels such as “left,” “right,” “front,” “back,” “top,” “bottom,” “forward,” “reverse,” “clockwise,” “counter clockwise,” “up,” “down,” or other similar terms such as “upper,” “lower,” “aft,” “fore,” “vertical,” “horizontal,” “proximal,” “distal,” and the like are used for convenience and are not intended to imply, for example, any particular fixed location, orientation, or direction. Instead, such labels are used to reflect, for example, relative location, orientation, or directions. It should also be understood that the singular forms of “a,” “an,” and “the” include plural references unless the context clearly dictates otherwise.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the art.

For example, a preventive therapy is provided, in some embodiments, for patients suffering from the foregoing foot related pathologies. Such a therapy includes an injectable composition for the soft tissues or the plantar fat pad of the foot that replaces the atrophied fatty tissue. Not only does such a therapy minimize a progression of the foregoing foot related pathologies, but such a therapy relieves pain as well.

FIGS. 1A and 1B are schematics illustrating an injectable composition 104 in a syringe 108 for augmenting one or more soft tissues of a human or animal in accordance with some embodiments. FIG. 1B additionally provides a targeting arm 112 for the syringe 108. While the soft-tissue augmenting injectable composition 104 is shown in relation to augmenting soft tissue of a plantar foot pad 116, it should be understood that the injectable composition 104 is not limited thereto. The injectable composition 104 can be formulated to augment any one or more soft tissues of a human or animal, without limitation. For example, the injectable composition 104 may be formulated for augmenting soft tissue in a human hand or face.

In general, the soft-tissue augmenting injectable composition 104 includes, but is not limited to, a soft-tissue augmenting agent and a vehicle for the soft-tissue augmenting agent. The soft-tissue augmenting agent includes a combination of saline and micronized dermis. In some embodiments, the soft-tissue augmenting agent may include a combination of hydrolyzed collagen and micronized dermis. The soft-tissue augmenting agent may further include human- or animal-derived amino acids, polypeptides (e.g., proteins such as human-serum albumin [“HSA”], bovine-serum albumin [“BSA”], etc.), cells (e.g., stem cells), tissues (e.g., allografts or xenografts), placentas, or a combination thereof. Additionally or alternatively, the soft-tissue augmenting agent can further include synthetic amino acids, polypeptides, cells, tissues, or a combination thereof. Additionally or alternatively, the soft-tissue augmenting agent can further include micronized (e.g., micron sized), powdered, or pulverized silicone particles, acrylic beads, polyethylene, polyether ether ketone, other synthetics, or a combination thereof.

Moreover, in some embodiments, the soft-tissue augmenting agent may include human- or animal-derived partially demineralized tissue. For example, in some embodiments, the soft-tissue augmenting agent may include a first portion comprising demineralized bone and a second portion comprising mineralized hydroxyapatite. In some embodiments, the portion of demineralized comprises between about 20% to about 60% by volume of the soft-tissue augmenting agent. Further, in some embodiments, the portion of mineralized hydroxyapatite comprises between about 40% to about 80% by volume of the soft-tissue augmenting agent.

The vehicle for the soft-tissue augmenting agent can include water, saline, buffered saline (e.g., phosphate-buffered saline), liquid collagen (e.g., hydrolyzed collagen in water, saline, buffered saline, etc.), silicone liquid, or a combination thereof.

The soft-tissue augmenting injectable composition 104 may be provided in a soft-tissue augmenting kit including one or more additional components for augmenting one or more soft tissues of a human or animal. Each additional component of the one or more additional components can include, but is not limited to, a needle (e.g., a needle with a gauge sufficient for injecting the injectable composition without occlusion thereof and significant pain to a patient, such as 20 gauge or smaller), one or more syringes (e.g., a syringe including a plunger and a graduated barrel for measuring an amount of the injectable composition 104), a targeting arm for syringes, a syringe connector, an ampoule, and a marking pen. The injectable composition 104 and the optional one or more additional components of the soft-tissue augmenting kit may be sterile for immediate use upon unpacking the soft-tissue augmenting kit.

FIG. 2A is a schematic illustrating an exemplary embodiment of a soft-tissue augmenting kit 120 that includes a first syringe 124 and a second syringe 128. Either of the first and second syringes 124, 128 may be pre-filled with a soft-tissue augmenting agent and the other of the syringes may be pre-filled with a vehicle for the soft-tissue augmenting agent. An optional syringe connector 132 may be included in the soft-tissue augmenting kit 120 and configured to facilitate coupling the first syringe 124 with the second syringe 128. The syringe connector 132 may be any suitable connector for placing the first syringe 124 into fluid communication with the second syringe 128, such as a female-to-female Luer Lock connector. During coupling the first and second syringes 124, 128, the soft-tissue augmenting agent may be mixed with the vehicle for the soft-tissue augmenting agent thereby forming the injectable composition 104 for delivery to the one or more soft tissues of the human or animal.

Once mixed, the injectable composition 104 may be retained in either of the first and second syringes 124, 128 (e.g., syringe 124) prior to delivery to the human or animal. Upon being coupled with a needle 136, which may also be included in the soft-tissue augmenting kit 120, the syringe 124 may be configured for delivering the injectable composition 104 to the one or more soft tissues of the human or animal. It is contemplated, however, that in some embodiments, the soft-tissue augmenting kit 120 may be implemented with a single syringe 124 that is filled with a pre-mixed portion of the injectable composition 104, thereby obviating a step of manually mixing the soft-tissue augmenting agent with the vehicle as described hereinabove.

Also shown in FIG. 2A is an optional targeting arm 112 configured to snap onto a barrel of the syringe 124 as shown in FIG. 1B. The targeting arm 112 may include a longitudinal member 140 parallel to and extending in the same direction as the needle 136 when the targeting arm 112 and the needle 136 are both connected to the syringe 124. The longitudinal member 140 can have a fixed length in the targeting arm 112 useful in controlling an injection depth for an injection of the injectable composition 104 with the syringe 124. The targeting arm 112 can be configured to snap onto the barrel of the syringe 124 at a particular location on the barrel such that a distal end 144 of the longitudinal member 140 is short of the needle 136 in correspondence with a recommended injection depth. The targeting arm 112 can also be configured to snap onto the barrel of the syringe 124 at any desired location on the barrel such that the distal end 144 of the longitudinal member 140 is short of the needle 136 in correspondence with a desired injection depth. For example, a leading or trailing edge of the targeting arm 112 around the barrel of the syringe 124 may be adjusted per graduations on the barrel such that the distal end 144 of the longitudinal member 140 is short of the needle 136 in correspondence with the desired injection depth.

FIG. 2B is a schematic illustrating an exemplary embodiment of a soft-tissue augmenting kit 160 including a syringe 124 and a container with the injectable composition 104 in accordance with the present disclosure. As shown, the container is comprised of an ampoule 164 that is filled with the injectable composition 104 formulated for augmenting one or more soft tissues of a human or animal. Upon coupling the syringe 124 with a needle, such as the needle 136 which may also be included in the soft-tissue augmenting kit 160, the syringe 124 can be configured for drawing the injectable composition 104 into the syringe from the ampoule 164 and subsequently delivering the injectable composition to the one or more soft tissues of the human or animal.

Also shown in FIG. 2B the soft-tissue augmenting kit 160 may further include an optional targeting arm 112 that is configured to snap onto a barrel of the syringe 124 as shown in FIG. 1B and discussed in connection with FIG. 2A.

FIG. 2C is a schematic illustrating an exemplary embodiment of a soft-tissue augmenting kit 180 that includes a syringe 124, a first ampoule 184 that is pre-filled with a soft-tissue augmenting agent, and a second ampoule 188 that is pre-filled with a vehicle for the soft-tissue augmenting agent. Upon coupling the syringe 124 with a needle, such as the needle 136 which may also be included in the soft-tissue augmenting kit 180, the syringe 124 can be configured for drawing the vehicle into the syringe 124 from the second ampoule 188 and subsequently delivering the vehicle to the first ampoule 184, thereby mixing the agent and the vehicle within the first ampoule to form the injectable composition 104. Once the vehicle and the agent are suitably mixed, the resulting injectable composition 104 may be drawn into the syringe 124 from the first ampoule 184 and subsequently delivered to the one or more soft tissues of the human or animal as discussed hereinabove.

Also shown in FIG. 2C the soft-tissue augmenting kit 180 may further include an optional targeting arm 112 that is configured to snap onto a barrel of the syringe 124 as shown in FIG. 1B and discussed in connection with FIG. 2A.

As described herein, deterioration of the pressure-bearing tissues of the foot is a common condition caused by bony prominences. Collapse of the shock-absorbing tissue padding of the foot can create complications such as skin breakdown and chronic morbidity leading to prolonged pain, discomfort, and impaired mobility. These conditions can result in the loss of protective cushioning at bony pressure points and generally manifest as corns, calluses, and thinning tissue leading to increased pressure and pain. Embodiments hereinbelow provide an injection-ready allograft implant that may be used to facilitate the reduction of pressure and pain in the foot by forming a cushion between skin and bony prominences.

FIGS. 3 and 4 are schematics illustrating sites on a human foot 200 wherein collapse of shock-absorbing tissue padding can create complications such as skin breakdown and chronic morbidity leading to prolonged pain, discomfort, and impaired mobility. In particular, FIG. 3 illustrates sites 204 of the foot 200 wherein deterioration of pressure-bearing tissue is commonly caused by bony prominences. FIG. 2 illustrates sites 208 on the foot 200 wherein bony pressure points typically manifest as corns, calluses, and thinning tissue.

FIG. 5 illustrates an exemplary-use environment wherein an injectable implant 212 is applied to a treatment site 216 by way of a single sterile syringe 220, according to the present disclosure. The injectable implant 212 may, in some embodiments, comprise a soft tissue-augmenting injectable composition. The injectable implant 212 can be formulated to augment any one or more soft tissues of a human or animal. For example, the injectable implant 212 can be formulated for augmenting soft tissue in a human face.

The soft tissue-augmenting injectable composition may include, but is not limited to, a soft-tissue augmenting agent and a vehicle for the soft-tissue augmenting agent. The soft-tissue augmenting agent may include a combination of hydrolyzed collagen and demineralized cortical bone. In some embodiments, the soft-tissue augmenting agent may comprise collagen and hydroxyapatite crystals in a saline solution that can be delivered in a single sterile syringe. The soft-tissue augmenting agent can further include human- or animal-derived amino acids, polypeptides (e.g., proteins such as human-serum albumin [“HSA”], bovine-serum albumin [“BSA”], etc.), cells (e.g., stem cells), tissues (e.g., allografts or xenografts), placentas, or a combination thereof. Additionally or alternatively, the soft-tissue augmenting agent can further include synthetic amino acids, polypeptides, cells, tissues, or a combination thereof. Additionally or alternatively, the soft-tissue augmenting agent can further include micronized (e.g., micron sized) silicone particles, acrylic beads, or a combination thereof.

The soft tissue-augmenting injectable composition can be provided in a soft tissue-augmenting kit including one or more additional components for augmenting one or more soft tissues of a human or animal. Each additional component of the one or more additional components may include, but is not limited to, a needle (e.g., a needle with a gauge sufficient for injecting the injectable composition without occlusion thereof and significant pain to a patient), a syringe (e.g., a syringe including a plunger and a graduated barrel for measuring an amount of the injectable composition), a targeting arm for a syringe, an ampoule, and a marking pen. The injectable composition and the optional one or more additional components of the soft tissue-augmenting kit may be sterile for immediate use upon unpacking the soft tissue-augmenting kit.

FIG. 6 is a schematic illustrating areas of sensitivity 224 that have been surrounded by injection site margins 228 to serve as a guide during implant injection in accordance with the present disclosure. During treatment, in some embodiments, a patient's skin can be prepared by using 70% isopropyl alcohol followed by a sterile skin wipe. In some instances, prior to needle entry, a local anesthesia, such as lidocaine, may be used if there is concern about pain. Injection sites (e.g., the areas of sensitivity 224) can be determined by applying firm pressure to the skin of the foot 200. Over areas of sensitivity, firm pressure elicits pain and coincides with underlying bony prominences. Surrounding such locations with margins 228 serves as a guide during implant injection.

FIG. 7 illustrates an exemplary-use environment wherein a syringe 232 is used to treat subdermal tissue 236 near a bony prominence, according to the present disclosure. In the illustrated embodiment, the syringe 232 is used to deliver the injectable implant 212 (see FIG. 5) to the subdermal tissue 236. In an embodiment, the syringe 232 can be a 1-cc syringe that is coupled with a 25 or 27 gauge sterile needle 240. As shown in FIG. 7, the needle 240 can be inserted at an angle 244, such as, by way of non-limiting example, about 30-degrees, to the surface 248 of the foot 200, positioned at the edge of the designated injection site. The needle 240 can then be advanced into the subdermal tissue near the bony prominence, targeting the area beneath the treatment zone 236. The injectable implant 212 can be injected slowly while the needle 240 is slowly withdrawn.

FIG. 8 illustrates an exemplary-use environment wherein a “fanning” technique is used during treating subdermal tissue at a treatment site 236 in accordance with the present disclosure. As indicated in FIG. 8, the fanning technique comprises partially withdrawing the needle 240 of a syringe 232 during the implant injection and then redirecting the needle 240 along a direction 252 three or four more times. Depending on the patient's tolerance, multiple pressure sites can be treated in a single session.

FIG. 9 illustrates an exemplary-use environment wherein a pad 256 is applied around a treatment site 236 of a foot 200 for off-loading the treatment site 236 during recovery, according to the present disclosure. It is contemplated that patients can resume their regular activities but should avoid applying excessive pressure or massaging the treatment site 236 for about seven days after treatment. For injectable implants 212 in the plantar foot 200, weight-bearing and walking barefoot on hard surfaces without adequate padding should be avoided. Further, foot bathing should not be permitted on the day of the treatment. It is contemplated that additional injections may be given at around four-week intervals.

Methods for augmenting one or more soft tissues of a human or animal include, in some embodiments, injecting the injectable composition 104 into one or more soft tissues of the human or animal. The injectable composition 104 includes the soft-tissue augmenting agent and the vehicle for the soft-tissue augmenting agent.

The methods can further include drawing the injectable composition 104 into a syringe 124 before injecting the injectable composition into the one or more soft tissues of the human or animal. However, in some embodiments, the syringe 124 may be pre-filled with the injectable composition 104 in a soft-tissue augmenting kit, thereby obviating such a step of drawing the injectable composition into the syringe.

The methods can further include coupling together a first syringe 124 that is pre-filled with a soft-tissue augmenting agent and a second syringe 128 that is pre-filled with a vehicle for the soft-tissue augmenting agent, drawing the vehicle into the first syringe 124 from the second syringe 128, and mixing the vehicle and the agent in the first syringe 124 to form the injectable composition 104. In some embodiments, the first syringe 124 and the second syringe 128 may be coupled by way of the optional syringe connector 132.

The methods can further include suspending or diluting the soft-tissue augmenting agent with the vehicle to form the injectable composition 104 before drawing the injectable composition into the syringe 124 for injection. However, in some embodiments, an ampoule 164 or the syringe 124 in a soft-tissue augmenting kit may include the injectable composition 104, thereby obviating such a step of forming the injectable composition.

While the invention has been described in terms of particular variations and illustrative figures, those of ordinary skill in the art will recognize that the invention is not limited to the variations or figures described. In addition, where methods and steps described above indicate certain events occurring in certain order, those of ordinary skill in the art will recognize that the ordering of certain steps may be modified and that such modifications are in accordance with the variations of the invention. Additionally, certain of the steps may be performed concurrently in a parallel process when possible, as well as performed sequentially as described above. To the extent there are variations of the invention, which are within the spirit of the disclosure or equivalent to the inventions found in the claims, it is the intent that this patent will cover those variations as well. Therefore, the present disclosure is to be understood as not limited by the specific embodiments described herein, but only by scope of the appended claims.

	Number	Date	Country
Parent	17165371	Feb 2021	US
Child	19172392		US
Parent	15987732	May 2018	US
Child	17165371		US

SYSTEM AND METHODS FOR SOFT-TISSUE AUGMENTATION

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