Fractionated Tissue Attachment Device And Method

Abstract

Methods and devices of tissue attachment with one or more tissue layers being attached using an adhesive to bone or other tissue layers including moving skin and surrounding tissues of the face or any other body part in relationship to the bone or cartilage structures below thus effecting a “skin tightening” or lifting procedure. Methods and devices for minimally invasively locating a precise tissue layer, repositioning the tissue layer in relation to the surrounding tissue layers, creating a specific potential space, delivering an adhesive material within the tissue and depositing an amount of adhesive/sealant material to allow for tissue adhesion.

Claims

1. A method of re-configuring tissue on a human comprising assessing a current tissue configuration; urging said tissue to a desired tissue configuration; designating at least one fixation point associated said desired tissue configuration; cutting tissue at each fixation point; creating a pocket space beneath the surface of said tissue; introducing an adhesive into said pocket space; holding said tissue at said fixation point until said tissue is retained at said fixation point without the need for holding.

2. A method according to claim 1, wherein pocket space is created in a supra periosteal space.

3. A method according to claim 1, wherein the pocket space is created in subcutaneous space.

4. A method according to claim 1, wherein said desired tissue configuration is a brow lift.

5. A method according to claim 1, wherein said desired tissue configuration is a facelift.

6. A method according to claim 1, wherein said desired tissue configuration is a necklift.

7. A method according to claim 1, wherein said creating a pocket space comprises inserting a tipped tool into said tissue and undermining the tissue below a skin layer.

8. A method according to claim 1, wherein said cutting comprising making an incision of around 2 mm

9. A method according to claim 1, wherein said creating a pocket space comprises creating a space about 2 cm in diameter.

10. A method according to claim 1, wherein said introducing of said adhesive comprises introducing a volume of adhesive in the range of about 0.1 cc to 5 cc.

11. A device used in tissue re-configuration of a human comprising: a proximal end having a port and handle; a distal end having a curve; a fine point tip disposed at the end of said curve; said fine point tip configured for undermining tissue beneath an external layer of said tissue; an orifice disposed at said fine point tip; and a lumen extending between said port and said orifice;

12. A device according to claim 11, wherein said lumen is configured for mixing components of an adhesive.

13. A system for re-configuring tissue of a human comprising: a device for cutting tissue; a device for undermining tissue; an adhesive; a device for delivering adhesive.

14. A system for according to claim 13, wherein the device for undermining tissue and the device for delivering adhesive are the same device.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0016] These and other aspects, features and advantages of which embodiments of the invention are capable of will be apparent and elucidated from the following description of embodiments of the present invention, reference being made to the accompanying drawings, in which:

[0017] FIG. 1 is a front view of the face of a human depicting example treatment regions in accordance with the present invention;

[0018] FIG. 2A is a cross-sectional view of facial tissue in the brow area;

[0019] FIG. 2B is a cross-sectional view of facial tissue in the cheek area;

[0020] FIGS. 3A-3F depict steps of a method in accordance with one preferred embodiment of the present invention;

[0021] FIGS. 3D′-3F′ depict alternative steps in the method depicted in FIGS. 3A-3F;

[0022] FIGS. 4A-4F depict steps of a method in accordance with one preferred embodiment of the present invention;

[0023] FIGS. 4D′-4F′ depict alternative steps in the method depicted in FIGS. 4A-4F;

[0024] FIG. 5 is a side view of a human face depicting example treatment regions for the present invention;

[0025] FIG. 6 is an embodiment of a delivery tool in accordance with present invention; and,

[0026] FIGS. 7A-7C depict steps of a method in accordance with one preferred embodiment of the present invention using the delivery tool of FIG. 6.

DESCRIPTION OF EMBODIMENTS

[0027] Specific embodiments of the invention will now be described with reference to the accompanying drawings. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art. The terminology used in the detailed description of the embodiments illustrated in the accompanying drawings is not intended to be limiting of the invention. In the drawings, like numbers refer to like elements

[0028] The present invention generally relates to methods and devices for tissue attachment, with one or more tissue layers being attached to bone or other tissue layers. More specifically, the present invention involves repositioning the skin and/or surrounding tissues, of the face or any other body part, in relationship to associated bone, cartilage or tissue structures, then securing the tissue in the new position.

[0029] The overall effect is to restore tissue to a preferred position, such as might be done in a browlift or other cosmetic procedure or in orthopedic procedures such as tendon reattachment due to traumatic injuries to the face such as might be caused by automobile accidents or battlefield injuries. The present invention also has utility in treating common tendon avulsion injuries such as mallet or baseball finger. In other words, notwithstanding the specific embodiments disclosed herein in the area of dermatology/plastic surgery, the present invention is useful in many fields beyond those disclosed in the preferred embodiments herein.

[0030] As disclosed with respect to specific embodiments below, a method in accordance with the present invention includes moving the soft tissue layer to a new position in relation to the bone or cartilage below; positioning a device through a small incision to the deep layer of bone, cartilage or soft tissue through a superficial soft tissue layer, and repositioning the tissue; holding the superficial soft tissue layer in the new position in relation to the bone, cartilage or soft tissue and creating a precise space or pocket; and, deploying a precise amount of attachment material which will fix the new position of the soft tissue layer without the use of any implantable anchors or sutures. This approach can be used in a plurality of locations allowing for fractional fixation at point adhesions tailored to the specific clinical indication allowing for the optimum tailored clinical result.

[0031] Prior to the present invention, the inventors are not aware of any approach to tissue repositioning involving fractionated point fixation without the use of implantable devices or suture material. To date there is no method for durable tissue repositioning of minimal deep dissection through several fractionated point skin incisions using a fixation process which does not require sutures or any other anchoring device that would need to be drilled, screwed or sutured into place. Anyone knowledgeable in the field would tell you this could not be done.

[0032] While tissue glue has been used in brow and face lifting procedures, such use has been as merely an adjunct to surgical removal of tissue with large areas of tissue dissection and large incisions and/or the use of implantable devices and/or sutures. For example, there has been at least one known instance of tissue glue in an endoscopic brow lift as a sole attachment material, however, the approach involved a full periosteal forehead dissection and lifting of the whole forehead tissue and removing excess tissue. It did not use or contemplate fractional point fixation in accordance with the present invention. Moreover, an extensive dissection of this nature requires significant healing time and risks of significant side effects such as seroma, bleeding, irregular nodules and infections. It also must be performed under significant patient sedation.

[0033] Turning now to specific embodiments depicted in the drawings, FIGS. 1-7 depict a device and method for attaching tissue to bone or cartilage in a shifted position using only small skin incisions less than 2 mm and without requiring drilling or implanting anything into the bone or cartilage. After making an incision through the tissue, which is less than 2 mm, a device of the invention is inserted through this incision to the bone or cartilage and used to prepare the precise space or pocket for the attachment material, which is between 0.1 cc to 5 cc in volume, and then used to reposition the outer tissues. After tissues are located in the correct location, the device is used to deliver the attachment material in the precise amount, being between 0.1 cc to 5 cc in volume, into the prepared space or pocket. The device is then removed, and the tissue held in place with the attachment material.

[0034] Referring to FIG. 1, two exemplary treatments on the face of a patient are shown, namely, brow elevation (or brow lift) treatment 100 and facelift treatment 200. The arrows depict the direction in which the treatment will reposition the tissue.

[0035] Referring to FIG. 2A, the layers of tissue associated with a brow lift treatment 100 include a skin layer S, a fatty layer F, a galea frontalis layer GF, a periosteum layer P and the frontal bone, FB.

[0036] Referring to FIG. 2B, the layers of tissue associated with a facelift treatment 200 include a skin layer S, a fatty layer F, a superficial musculoaponeurotic system layer SMAS, a periosteum layer P, and the zygoma bone Z.

[0037] Supra-Periosteal Brow Lift

[0038] Referring to FIG. 3A, the first step in performing a brow lift in accordance with a first embodiment of the invention is to manually displace the tissue associated a patient's brow 101 to the desired position.

[0039] Referring to FIG. 3B, points of fixation 102 (i.e., fixation points) are then determined and, in most cases, marked on the patient signifying where the tissue is to be fixed in order to secure the tissue at the desired position.

[0040] Referring to FIGS. 3C and 3D, a cut is made at each fixation point 102, preferably no more than 2 mm, and a tool used to create a space or pocket 103 in the supra-periosteal plane, i.e. in the plane above the periosteum, i.e., in the GF layer. In a preferred embodiment the pocket 103 is about 2 cm in diameter and has a volume in the range of 0.1 cc to 5 cc.

[0041] Referring to FIGS. 3E and 3F, an adhesive A is deposited in the pocket 103, the tool removed, the incision closed and the tissue at the fixation point 102 being held in the fixation position until the adhesive A cures and thereby holds the tissue at the new desired position.

[0042] These steps are performed for each fixation point 102 needed to secure the brow tissue at the desired position as depicted in FIGS. 3A and 3B.

[0043] Subcutaneous Brow Lift

[0044] An alternative to the supra-periosteal brow lift treatment is a subcutaneous brow lift treatment, with the primary difference being that the pocket 103 is created in the fatty layer F instead of the GF layer. The first steps of the subcutaneous brow lift treatment are essentially identical to the first steps depicted in FIGS. 3A-3C for the supra-periosteal brow lift treatment. However, as set forth in FIGS. 3A′-3F′, the pocket 103 is created in the fatty layer F (FIG. 3D′), the adhesive A then being inserted into the pocket 103 located in the fatty layer F (FIG. 3E′) and then the fixation point 102 being held in place until the adhesive A cures and thereby secures the tissue at the new desired position.

[0045] These steps are performed for each fixation point 102 needed to secure the brow tissue at the desired position as depicted in FIGS. 3A and 3B.

[0046] Supra-Periosteal Facelift

[0047] Referring to FIG. 4A, the first step in performing a facelift in accordance with a preferred embodiment of the invention is to manually displace the tissue associated a patient's cheek area 201 to the desired position.

[0048] Referring to FIG. 4B, points of fixation 202 (i.e., fixation points) are then determined and, in most cases, marked on the patient signifying where the tissue is to be fixed in order to secure the tissue at the desired position.

[0049] Referring to FIGS. 4C and 4D, a cut is made at each fixation point 202, preferably no more than 2 mm, and a tool used to create a space or pocket 203 in the supra-periosteal plane, i.e. in the plane above the periosteum, i.e., in the SMAS layer. In a preferred embodiment the pocket 203 is about 2 cm in diameter and has a volume in the range of 0.1 cc to 5 cc.

[0050] Referring to FIGS. 4E and 4F, an adhesive A is deposited in the pocket 203, the tool removed, the incision closed and the tissue at the fixation point 202 being held in the fixation position until the adhesive A cures and thereby holds the tissue at the new desired position.

[0051] These steps are performed for each fixation point 202 needed to secure the brow tissue at the desired position as depicted in FIGS. 4A and 4B.

[0052] Subcutaneous Facelift

[0053] An alternative to the supra-periosteal facelift treatment is a subcutaneous facelift treatment, with the primary difference being that the pocket 203 is created in the fatty layer F instead of the SMAS layer. The first steps of the subcutaneous brow lift treatment are essentially identical to the first steps depicted in FIGS. 4A-4C for the supra-periosteal facelift treatment. However, as set forth in FIGS. 4D′-4F′, the pocket 203 is created in the SMAS layer F (FIG. 4D′), the adhesive A then being inserted into the pocket 203 located in the SMAS layer F (FIG. 4E′) and then the fixation point 202 being held in place until the adhesive A cures and thereby secures the tissue at the new desired position.

[0054] These steps are performed for each fixation point 202 needed to secure the cheek tissue at the desired position as depicted in FIGS. 4A and 4B.

[0055] Referring to FIG. 5, an embodiment of the present invention is depicted on the face of a patient having both a brow lift treatment and a face lift treatment. The round areas 505 are fixation points as discussed above.

[0056] In this regard, it is contemplated that in order to achieve optimal treatment results, the dissection level for each fixation point 505 in various regions of the face may be different. For example, the region of the cheek 501, dissection of the fixation points 505 are a subcutaneous dissection, i.e., the pocket is created in the fatty layer F of the tissue.

[0057] In the region of the temple 502, the dissection of the fixation points 505 is between superficial and deep fascia.

[0058] Lastly, in the region of the brow 503, the dissection of the fixation points 505 are a supra-periosteal dissection, i.e., in the GF layer of the tissue.

[0059] Delivery Tool

[0060] Referring to FIG. 6, a delivery tool 601 is used for creating the pocket space 103, 203 and delivering adhesive A as discussed above. The delivery tool 601 has a proximal end 603 that is used as a handle and has a port with which the adhesive A can be inserted, a middle shaft with a channel 605 for adhesive A to travers to the distal end 602. The distal end has a dissection portion 604 to precisely prepare the pocket space 103, 203 with specific volume to receive the adhesive A. The distal end 602 can grab the tissue to help position the tissue to the correct location in relation to the bone or cartilage. It further includes a distal port with which the adhesive A can be deposited in the pocket space 103, 203 where such distal end 602 is located, for example, below an epidermis and below a periosteum of the tissue layer.

[0061] Once a user has made a cut at a fixation point 102, 202, 505, the delivery tool 601 is used to create the pocket space 103, 203 in the desired layer of tissue. A user then urges the adhesive A through the point 604 of the tool 601 to fill the pocket space with adhesive.

[0062] In one preferred embodiment, the delivery tool 601 has an internal configuration to mix two or more constituents of a curable adhesive. Representative configurations of such mixing structure can be found in U.S. Pat. No. 6,079,868, the contents of which is incorporated by reference herein.

[0063] Adhesive/Sealant

[0064] An adhesive/sealant that is biocompatible with human implantation and provides the necessary adhesive strength and durability is preferred for use in the present invention. Examples of such adhesives may include those disclosed in the following U.S. patents, each of which is incorporated herein by reference: U.S. Pat. Nos. 10,391,198; 5,386,606. In one embodiment, the adhesive also promotes healing.

[0065] There are many types of biocompatible adhesives/sealants that could be used for this purpose. In preferred embodiments, adhesive/sealants generally fall into 1 of 3 categories.

[0066] (1) Natural polymer-based adhesive/sealants (e.g. fibrin, collagen, and albumin based)

[0067] Examples, include: (a) BioGlue (Cryolife Inc, Kennesaw, Ga.) which is based on Bovine Serum Albumen and glutaraldehyde; (b) PreveLeak (Baxter Healthcare Corporation, Westlake Village, Calif.) which is based on purified BSA and a polyaldehyde.

[0068] (2) Synthetic polymer-based adhesive/sealants (e.g., polyurethane, polyethylene glycol [PEG]

[0069] Examples include: (a) Tridyne VS (BD, Franklin Lakes, N.J.) which is based on PEG and human serum albumin; (b) Coseal (Baxter Healthcare Corporation, Westlake Village, Calif.) which is based on 2 cytocompatible PEGs, a dilute hydrogen chloride solution, and a sodium phosphate/sodium carbonate solution.

[0070] (3) Polyester-based and cyanoacrylate adhesive/sealants

[0071] Examples include: (a) Dermabond; (b) Histocryl; (c) Omnex (Ethicon which can be absorbable; and, (d) VenaSeal (Medtronic).

[0072] Butyl esters provide stronger bond but are rigid. Octyl esters, while providing weaker bond, are more flexible. Blends of octyl cyanoacrylate and n-butyl cyanoacrylate are available (such as GLUture) which offer both flexibility and a strong bond. n-Butyl cyanoacrylate is also used for embolization of cerebral arteriovenous malformations before their surgical treatment. https://en.wikipedia.org/wiki/Butyl_cyanoacrylate, M. Dossi, G. Storti, D. Moscatelli, Synthesis of poly(alkyl cyanoacrylates) as biodegradable polymers for drug delivery applications, in: Macromolecular Symposia 289 (Polymer Reaction Engineering VII), 2010, pp. 124-128 (incorporated herein by reference).

[0073] The above is not an exhaustive list as there are other such adhesives/sealants such as citrate-based biomaterials that are seen in nature within mollusks (Biomater Sci. 2013 January 1; 1(1): 52-64. doi:10.1039/C2BM00026A (incorporated by reference), Citrate-based Biodegradable Injectable hydrogel Composites for Orthopedic Applications Dipendra Gyawali, a, b, Parvathi Nair, a, b, Harry K. W. Kim, c, and Jian Yang (incorporated by reference).