Not applicable.
The present disclosure generally relates to tissue harvesting devices, actuator strips, and methods for same.
Skin or tissue grafts involve the transplantation of tissue or skin. Tissue grafts can be used, for example, when a person has sustained a serious injury, undergone certain surgical procedures (e.g., wide local excision of a breast tumor or melanoma), has suffered radiation burn from cancer treatment, or has a chronic wound such as diabetic, pressure or venous ulcers resulting from neuropathy, vascular disease or other trauma. Before the skin or tissue can be transplanted in a graft procedure, the tissue must first be harvested from a donor site. Various devices exist for harvesting or cutting thin strips of tissue from donor sites, such as scalpels for full-thickness tissue grafts, and dermatomes for partial thickness grafts, but those devices can be difficult to use and do not provide an easy-to-use, single step sterile solution for cutting thin strips of tissue or for repairing damage done to the donor site tissue during the harvesting.
Improved tissue grafting methods, tissue arrangements for grafts, and tissue harvesting devices and methods for both full-thickness and partial thickness grafts are accordingly needed.
According to one embodiment of the present disclosure, a tissue harvesting and wound closing device includes a panel and an actuator strip. The panel includes first and second panel guides extending along at least a portion of a length of the panel. The actuator strip is coupled to the panel and includes a base. First and second actuator strip guides extend along at least a portion of the length of the base and are slideable along the first and second panel guides, respectively. A first section of the base has a substantially uniform width between the first and second actuator strip guides. A second section of the base has a gradually decreasing width between the first and second actuator strip guides. A third section of the base has a substantially uniform width between the first and second actuator strip guides that is smaller than the substantially uniform width of the first section. A cutter is coupled to the first section of the base. The device is configured such that when the device is secured to the donor site and the actuator strip is pulled, the first and second actuator guides slide along the first and second panel guides, respectively, such that the cutter cuts a strip of the tissue from the donor site creating an open wound, and the panel pulls together tissue proximal tissue on opposite sides of the open wound to at least partially close the open wound.
According to another embodiment of the present disclosure, a tissue harvesting and wound closure method is provided that includes securing a panel to a donor site and pulling first and second actuator strip guides along first and second panel guides of the panel, respectively, to (i) cut a strip of tissue from the donor site thereby creating an open wound and (ii) pull together proximal tissue on opposite sides of the open wound to at least partially close the open wound.
In yet another embodiment of the present disclosure, a tissue harvesting and wound closing actuator strip is provided that includes a base. The actuator strip further includes first and second actuator strip guides each extending along at least a portion of a length of the base and structured to be slideable along first and second panel guides of a panel, respectively. A first section of the base has a substantially uniform width between the first and second actuator strip guides. A second section of the base has a gradually decreasing width between the first and second actuator strip guides. A third section of the base has a substantially uniform width between the first and second actuator strip guides. A cutter is coupled to the first section of the base. When the actuator strip is secured to a donor site and the actuator strip is pulled, the first and second actuator guides slide along the first and second panel guides, respectively, such that the cutter cuts a strip of the tissue from the donor site thereby creating an open wound, and the panel pulls together proximal tissue on opposite sides of the open wound to at least partially close the open wound.
According to still another embodiment of the present disclosure, a tissue harvesting device includes a panel having first and second panel guides extending along at least a portion of a length of the panel. An actuator strip is coupled to the panel and includes a base. The actuator strip includes first and second actuator guides extending along at least a portion of a length of the base and slideable along the first and second panel guides, respectively. A bandage and an antiseptic and anesthetic/analgesic gel pack are positioned on the base. When the device is secured to the donor site and the actuator strip is pulled, the first and second actuator strip guides slide along the first and second panel guides, respectively, such that a cutter coupled to the base cuts the strip of tissue from the donor site thereby creating an open wound, the antiseptic and anesthetic/analgesic from the gel pack is applied to the donor site, and the bandage is placed over the open wound.
In yet another embodiment of the present disclosure, a tissue harvesting method includes securing a panel to a donor site, pulling first and second actuator strip guides of an actuator strip along first and second panel guides of the panel, respectively, to cut a strip of tissue from the donor site thereby creating an open wound, apply an antiseptic and anesthetic/analgesic to the donor site, and place a bandage over the open wound.
In still another embodiment, a skin grafting method includes coiling a full thickness strip of tissue, and placing the coiled full thickness tissue on a graft site.
This present disclosure provides tissue harvesting and wound closing devices, methods, and components for same that enable relatively thin strips of either partial thickness tissue or full-thickness tissue (e.g., skin containing epidermis and full dermis, and often some subcutaneous fat) to be easily harvested from a donor site. The harvested tissue can be arranged in a strip, a coil, a plug or can be stacked so that the arrangement can be used, for example, as a skin construct for grafting. The tissue harvesting and wound closing devices cut tissue from a donor site creating an open wound, which can be closed at substantially the same time that the tissue is being cut (i.e., in a single-step or substantially simultaneous process). In one aspect, a cutting device is integrated or coupled to an actuator strip that is secured to a donor site by, for example, an adhesive panel. Downward pressure can be applied to the device, if needed (e.g., exerting a force on the panel pieces to keep the device in place on the donor site), and guides extending along the length of the actuator strip can be pulled along cooperating guides or rails of the panel so that a thin strip of tissue or skin can be cut and harvested from a donor site in a controlled, precise manner. The pull or pulling that is performed in each of the devices, methods and actuator strips of the present disclosure is a generally continuous, smooth pulling action that is performed substantially along the longitudinal or lengthwise axis of the actuator. The devices and methods herein accordingly function such that a donor site can be opened and closed simultaneously and a thin strip of tissue can be harvested with minimal displacement of the surrounding donor site tissue. Once the cut has been made and the tissue has been harvested, the device can be left in place on the donor site so that the wound can heal with minimal scarring. The cutting device can be removed from the actuator strip after the cut has been made, by, for example, removing a portion of the actuator strip.
Alternatively or additionally, certain devices, actuator strips and methods herein allow a thin strip of tissue to be cut while an antiseptic and anesthetic/analgesic, as well as a bandage are applied substantially simultaneously with the cutting action so that the process of tissue harvesting can occur in a precisely controlled, single step, sterile process. If desired, scaffold/matrix materials can be combined with the harvested tissue strips to produce, for example, a skin construct having structural, nutritional, biochemical, or other forms of support. When the harvested tissue is full-thickness skin, the construct can greatly improve the quality of a post-graft skin, since the construct contains all components of the full-thickness skin, including dermal cells and adnexal structures that are usually missing from partial-thickness grafts or artificial skin substitutes.
Turning now to the figures and referring primarily to
Actuator strip 14 includes a base 40 having a length 16 and defining first 20, second 22 and third sections 24. Length 16 can be any length suitable for harvesting or cutting a desired thin strip of tissue from a donor site, and in one embodiment can be approximately 450 mm (e.g., the first section 20 having a length of 200 mm, the second section 22 having a length of 25 mm, and the third section 24 having a length of 225 mm). First and second actuator strip guides 26, 28 each extend along the length of base 40, but in certain embodiments, do not extend along the entire length of the base 40, and instead extend only along a portion of the length. Actuator strip 14 further includes a stop 34 located at an end of the first section 20 of the actuator strip, and a pull tab 36 located at and end of the first section 20 of the actuator strip opposite the end at which the stop 34 is located. An anti-septic and anesthetic/analgesic gel pack 32 is located in the first section 20 of base 40, while a bandage 30 is located in the third section 24 of base 40. The anesthetic/analgesic in gel pack 32 can include an anesthetic alone, an analgesic alone or a combination of an anesthetic and an analgesic. Similarly, the anesthetic/analgesic used in any of the devices or methods described herein can include an anesthetic alone, an analgesic alone or a combination of an anesthetic and an analgesic. A cutter or cutting device 38 is coupled to the first section 20 of base 40 between the first and second actuator guide strips 26, 28, which can be located in a channel defined between the actuator guide strips 26, 28. Cutting device 38 is described in more detail below with respect to
Regarding the first and second actuator strip guides 26, 28, and their cooperating panel guides 41, 42, first and second actuator strip guides 26, 28 are structured to be slideably coupled to or engaged with the first and second panel guides 41, 42. In the illustrated embodiment, first actuator guide 26 includes outer and inner actuator guides 26a, 26b, respectively, each of which extends along the length of base 40 and near or along an edge of base 40. The second actuator strip guide 28 likewise includes outer and inner actuator strip guides 28a, 28b, respectively, each of which extends along the length of base 40 and near or along an edge of base 40. First panel guide 41 similarly includes outer and inner panel guides 41a, 41b, respectively, each of which extends generally along the length of the panel 12 and outwardly from the underside portion of panel 12. Second panel guide 42 likewise includes outer and inner panel guides 42a, 42b, each of extends generally along the length of the panel 12 and generally outwardly from the underside portion of the panel 12. Actuator guides 26a, 26b, 28a, 28b can be in the form of a guide post or stick, while panel guides 42a, 42b can be in the form of clamping rails structured to interlock, clamp, or engage with the guide posts or sticks such that actuator guides 26a, 26b, 28a, 28b can guidingly move or slide along the respective panels guides 41a, 41b, 42a, 42b.
It should be appreciated that the first and second actuator strip guides and their respective cooperating panel guides can be any structure suitable to allow the actuator strip guides to guidingly engage and slide or move along the panel guides. In one embodiment, instead of the first actuator strip guide having inner and outer actuator strip guides as illustrated, the first actuator strip guides can be a single guide or three or more guides that extend from the actuator strip base and slideably or moveably engage with a single panel guide or three or more panel guides that likewise extend from the panel. Similarly, instead of the second actuator strip guide having inner and outer actuator strip guides, the second actuator strip guide can be a single guide or three or more guides that extend from the actuator strip base and slideably or moveably engage with a single panel guide or three or more panels guide that extend from the panel. In other embodiments, the first actuator strip guide may have multiple actuator strip guides cooperating with multiple corresponding panel guides, while the second actuator strip guide and its cooperating panel guide may have any number of guides different from the first actuator and panel guides, or vice versa. It should likewise be appreciated that instead of the actuator strip guide(s) and panel guide(s) being in the form of a guide post(s) or stick(s), and the panel guide(s) being in the form of rails that cooperatively engage the guide post(s) or stick(s), the panel guides can instead be in the form of the guide post(s) or stick(s) while the panel guides are in the form of the engaging guide rail(s).
Regarding the first, second and third sections 20, 22, 24 of the actuator strip 14, first section 20 includes or defines a substantially uniform width 20a between the first and second actuator guides 26, 28. Second section 22 includes or defines a gradually decreasing width 22a in the direction moving rightwardly from the first section 20a towards the second section 22 as shown in the figures, which is a direction opposite to the direction that the actuator strip is pulled during use, which is illustrated as “PULL DIRECTION” and discussed more below. Third section 24 includes or defines a substantially uniform width 24a that is smaller than the dimeter of the first section 20a. In the illustrated embodiment, the widths 20a, 22a, 24a are each defined by the distance between the inner actuator strip guides 26a, 26b. It should be appreciated, however, that in alternative embodiments, the widths of each of the sections can be defined by the distance between any of the actuator strip guides. For example, the widths of each section can be defined by the distance between an inner actuator guide extending on side of the base to and outer actuator strip guide on the opposite side of the base, by the distance between an inner or outer actuator strip guide on one side of the base to a middle actuator strip guide on an opposite side of the base, or by the distance between a single actuator strip guide on one side of the base to a single actuator strip guide on an opposite side of the base. It should also appreciated that in certain embodiments, neither the width 20a of first section 20 nor the width 24a of third section 24 needs to be substantially uniform so long as the width 24a third section 24 is smaller than the width 20a of section 20 so that the device can provide the wound closing feature described herein.
Referring to
Referring more specifically to the cutter or cutting device 38,
The floor 46 of cutting device 38 extends from the base 40 of actuator strip 14 at an angle Θ relative to the base 40, such that when the actuator device 14 is pulled to cut or harvest tissue from the donor site (e.g., skin tissue), the cutting device 38 cuts a strip of skin without bunching, resulting in a relatively thin strip of tissue that can be used advantageously, for example, as a coiled-up skin graft construct that includes both a layer of epidermis and dermis (i.e., full thickness), or just the epidermis or the epidermis and an upper portion of the dermis (i.e., partial thickness). Coiling-up a strip of full thickness tissue and placing the coiled tissue in or on a graft site ensures that the dermis and epidermis orientation is consistent across the graft site, which results in better and quicker healing, as discussed in more detail below. In certain embodiments, the width of the thin strip of tissue harvested is, in the range of 0.5 mm (0.019685 inches) to 4.7625 mm ( 3/16 inch) or 1.5875 mm ( 1/16 inch) to 4.7625 mm ( 3/16 inch) for full thickness, and in the range of 12.7 mm (½ inch) to 50.8 mm (2 inch) for partial thickness. In certain embodiments, the angle Θ is in the range of 15 degrees to 60 degrees. The size and dimensions of cutting device 38 can be selected to allow the device 10 to advantageously cut or harvest a strip of tissue suitable for a particular use. For example, the width of the cutting edge 46a of floor 46 (i.e., the distance between walls 48 and 50) can be in the range of 0.15875 mm ( 1/16 inch) to 0.635 mm ( 3/16 inch), and in one particular embodiment can be 1.9 mm wide. The depth at which the edge 46a of floor 46 extends from the underside of the actuator strip base 40 can be in the range of 0.635 mm ( 1/40 inch) to 2.54 mm ( 1/10 inch), and in one particular embodiment can be 2.2 mm. In some embodiments, the cutting device 38 does not need wings and/or a guide plate, and can instead have a single piece extending downwardly from the actuator strip base or the base plate of cutting device 38.
In certain embodiments, the actuator strip 14 is structured so that at least a portion of the actuator strip 14 (including the portion having the cutting device 38) can be removed from the rest of the actuator strip 14 once the device has been pulled to cut the thin strip of tissue. The removal of the portion of the actuator strip allows the device to remain in place over the open wound immediately after pulling the strip to allow the wound to heal, as discussed below. Cutting device 38 itself can also be structured and arranged to be removably coupled to actuator strip 14. For example, in one embodiment, wings 58 and 60 are removably coupled to the base plate 52 via one or more fastener mechanisms such as simple screws or nails. Alternatively or additionally, base plate 52 or the single piece cutting device 38 can be sized and dimensioned to be removably secured between the actuator strip guides (or the channel defined in the base of the actuator strip) with a frictional or snap-fit engagement.
To harvest or cut a thin strip of tissue using the device 10, the device 10 is initially removed from a closed, sterile packaging. Once removed from the sterile packaging, a hermetic seal 44 is secured to the underside of actuator strip 12 and the adhesive backing on the underside of panel 12 are removed so that the panel 12 (and the actuator strip 14 coupled to or integrated with the panel) is secured to the donor site via adhering the panel 12 to the donor site. Once the device 10 is adhered to the donor site, the actuator strip 14 pull tab 36 is pulled in a direction generally leftward as seen in the figures (labeled as “PULLING DIRECTION”) until the stop 34 of the actuator strip 14 engages an edge 12c of the panel 12. The pulling causes actuator strip guides 26, 28 to slide or move in the corresponding panel guides 41, 42, causing the cutter 38 to cut a thin strip of tissue and create an open wound at the donor site. As the actuator strip guides 26, 28 move along the panel guides 41, 42, the gradually decreasing width 22a between the actuator guides 26, 28 causes the width between the panel guides 41, 42 to likewise gradually decrease, which in turn causes the panel 12 (e.g., each of panel pieces 12a, 12b adhered to the donor site) to pull on the tissue on opposite sides of the open wound to at least partially close the open wound. The pulling of the actuator strip 14 also causes the gel pack 32 to apply its antiseptic and anesthetic/analgesic to the donor site, and the bandage 30 to be applied to the open wound. Downward pressure can be applied to the device 10 while pulling, as needed. The actuator strip 14 is pulled to the point where the stop 34 engages the edge 12c of the panel 12, a leftward portion of the actuator strip including the cutting device 38 coupled thereto can be removed from the rest of the actuator strip 14 (e.g., via cutting the portion of the actuator strip) so that the device can remain on the donor site with the bandage in place for a period of time necessary for the wound to heal (e.g., approximately seven days).
It should accordingly be appreciated that one embodiment of a tissue harvesting and wound closing method of the present disclosure includes securing a panel to a donor site (e.g., adhering the panel), and pulling first and second actuator strip guides along first and second panel guides of the panel, respectively, to cut a strip of tissue from the donor site thereby creating an open wound, and pull together tissue on opposite sides of the open wound to at least partially close the open wound. The method further includes pulling the actuator strip until a stop of the actuator strip engages an edge of the panel, thereby preventing further pulling of the first and second actuator guide strips along the first and second guide panels, and removing (e.g., cutting or tearing) a portion of the actuator strip after said pulling the first and second actuator strips, thereby allowing the device to remain secured to the donor site so that the wound can heal.
Turning now to
Device 100 can be utilized for cutting a thin strip of full thickness tissue (epidermis and full dermis) or for cutting a thin strip of partial thickness tissue (e.g., epidermis only or epidermis and upper portion of dermis). For harvesting a thin strip of partial thickness tissue, the device 100 can have a uniform width between the actuator guides 126, 128 that is in the range of 12.7 mm (i.e., ½ inch) to 50.8 mm (i.e., 2 inch), and in one particular embodiment is 2.54 mm (i.e., 1 inch). For a full thickness tissue application, the width of the thin strip of tissue harvested can be, for example, in the range of 0.5 mm (0.019685 inch) to 4.7625 mm ( 3/16 inch) or 1.5875 mm (i.e., 1/16 inch) to 4.7625 mm (i.e., 3/16 inch). The angle Θ at which the cutting edge or blade extends from the actuator strip 114 can be in the range of 15 to 60 degrees, and in one particular embodiment, 35 degrees.
It should be appreciated from the foregoing that one embodiment of a tissue harvesting method of the present disclosure includes securing or adhering a panel to a donor site, and pulling first and second actuator strip guides of an actuator strip along first and second panel guides of the panel, respectively, to (i) cut a strip of tissue from the donor site thereby creating an open wound, (ii) apply an anti-septic and anesthetic/analgesic to the donor site, and (iii) place a bandage over the open wound.
Turning to
Cutting device 238 includes a base 262 and a blade plate 264 coupled to or integrated with base 262. Blade plate 264 can be coupled to the actuator strip 14 similar to the couplings described above with respect to devices 10 and 100. Blade plate 264 includes a sharp or razor portion or edge 266 that extends downwardly through an opening defined in the base 262. Blade plate 264 extends at an angle relative to the actuator strip 14 that is sufficient to cut a thin strip of tissue from a donor site as described above in connection with devices 10 and 100. Like the cutting device 38 discussed above, razor portion 266 of cutting device 238 can also include a right wall, left wall, and middle floor, each of which has a razor edge. Cutting device 238 further includes a blade actuator, power and switch assembly 270. Assembly 270 includes a motor 272, a power source 274 and a switching mechanism. A tissue shield 280 can extend over the assembly 270 to protect the assembly 270 from unwanted and potentially damaging materials. Shield 280 also protects the tissue and donor site from any possible contamination from assembly 270. Motor 272 rests or is coupled to a curved bed 278, and is operatively coupled to a blade plate 264 via a motor output shaft 276 and extending wall 282. When the assembly 270 is switched on, the blade plate 264 is configured to oscillate back-and-forth in a direction that is generally along the width w of the cutting device 238 and base 262. The back-and-forth oscillation causes the razor portion or extending cutting blade to also oscillate back-and-forth, which during the cutting process, reduces the chance that the thin strip of tissue being cut will bunch, particularly when the tissue is a partial skin, which is more elastic and susceptible to such bunching. In one embodiment, the motor and assembly oscillates at a rate of 30 to 60 cycles per second. Partial thickness tissue is typically fenestrated before grafting, and thus to simplify the process, an additional component can be added to fenestrate the partial thickness tissue as it is harvested or collected.
As discussed above, the devices and methods of the present disclosure can be used to cut or harvest a strip of either partial or full thickness tissue.
It should therefore be appreciated that one non-limiting embodiment of the present disclosure includes a skin grafting method in which strip of full thickness tissue is coiled and placed on or in a graft site, and another non-limiting embodiment of the present disclosure includes a coiled-up full thickness strip of harvested tissue for use in a grafting procedure. The arrangement of the coiled-up tissue in either embodiment can be any suitable shape that maintains the orientation of the full-thickness tissue across a graft site, including, but not limited to, circular, triangular, or rectangular arrangements.
While the present disclosure has been described above in connection with particular embodiments and examples, the disclosure is not necessarily so limited, and that numerous other embodiments, examples, uses, modifications and departures from the embodiments, examples and uses are intended to be encompassed by the claims attached hereto.
This application is based upon and claims the benefit of U.S. provisional application number 62/455,002, filed on Feb. 6, 2017 and U.S. provisional application number 62/479,761, filed on Mar. 31, 2017, each of which is incorporated herein by reference and relied upon in its entirety.
Filing Document | Filing Date | Country | Kind |
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PCT/US18/14805 | 1/23/2018 | WO | 00 |
Number | Date | Country | |
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62455002 | Feb 2017 | US | |
62479761 | Mar 2017 | US |