Patent Grant
10814049
A variety of wounds are now being treated using negative pressure wound therapy. However, many of these wounds have characteristics that limit the effectiveness of existing techniques. Wound dehiscence, in which the wound margins have substantial separation, pose significant problems in reapproximation of tissue and wound drainage. For example, there are a large number of patients undergoing amputations in the United States every year. These have different causes including traumatic injury, peripheral vascular disease, diabetes mellitus and chronic venous insufficiency. Patients with diabetic conditions, for example, often suffer from restricted blood flow that can lead to tissue necrosis at the body extremities. For patients with severe symptoms, a transmetatarsal amputation (TMA) may be recommended to remove afflicted tissue while still salvaging a portion of the foot. In many cases, a transtibial or below-knee amputation (BKA) must be performed. An important factor in the recovery of a patient from amputation is how quickly the wound can be closed. Because the gap between tissue margins can be large, the wound is manually closed by suturing. There must be ongoing attention to prevent complications such as infection, wound dehiscence, and/or ischemia. The use of an immediate post-operative prosthesis (IPOP) is commonly employed to reduce the recovery period for BKA procedures, for example.
Other examples of wounds that can be difficult to achieve approximation of the wound margins can include ulcers in which the wound opening is surrounded by tissue overlying a cavity. The undermining of the tissue surrounding the wound opening can often present problems in drainage and rapid wound closure. There are also open wounds that can occur in both the extremities and the abdominal regions in which the wound margins must rotate over a substantial distance, often up to several centimeters or more, to achieve approximation of the margins. Thus a continuing need exists for improvements in wound closure devices and methods.
This disclosure relates to embodiments of negative pressure wound closure devices, systems, and methods for wounds resulting from amputation or other open wounds having non-aligned wound margins. In preferred embodiments, the system includes a negative pressure source and a collapsing structure that is placed on the wound to provide directed preferential closure. The collapsing structure can include embodiments in which a compressive force is imparted to tissue surrounding the wound or to tissue on the sides of a wound opening with a compression wound closure device that is operative to assist in the closure of a wound cavity. Thus, the collapsing structure can include, be attached to, or operate in conjunction with, a compression structure that operates to apply a force to the tissue adjoining an open wound to move a wound margin to a more closed position. In a preferred embodiment, a collapsing compression structure includes a number of cells separated by rigid or semi-rigid membranes that are hinged together at joints. In a preferred embodiment of the compression wound closure device, the structure changes conformation during a procedure to facilitate closure of the wound. The structure, in combination with the application of negative pressure, exerts a force to the wound to facilitate closure of the wound from the deepest internal point. The structure can be rigid, or alternatively, be pre-stressed to exert a compression force on the wound to more quickly bring the wound margins together.
Preferred embodiments of wound closure devices described herein can include scale elements that enable collapse of structures within an open wound and/or above the wound. The scales can comprise a detached collapsible layer, or can comprise discrete elements mounted to an overlying collapsing structure. The scale elements can have different shapes and sizes, such as circular or combinations of curved and flat edges, operative to interact with adjacent elements that enable collapse of the connected structures and provide fluid flow through the structure during application of negative pressure. The scale elements can have one or more rounded edges to facilitate sliding relative to tissue during placement and/or operation. The scale elements can have surfaces and/or edges that have a convex or concave shape. The scale elements can have shapes that generally conform to the arcuate shape of the wound or tissue surfaces contacting the scale elements. Thus, as the collapsing structure moves along an arcuate path, the scale elements move to facilitate an efficient movement of the structure which provides for closure of the wound margins. The arcuate shape can extend along one axis, such as a cylindrical shaped path or along two arcuate paths as in a domed structure. Alternatively, the scale elements can be curved or flat and sized to enable collapse without overlapping adjacent scale elements, scale elements can also include elastic elements or covering to enable movement and reducing friction with the tissue surfaces. The smaller sized scales are consequently spaced apart during wound closure but can abut one another after collapse. Note that a collapsing structure can comprise a single unit that is both positioned in the wound and above the wound.
The device can be used without any sutures in cases where the skin on opposite sides of the wound is sufficiently aligned. Alternatively, sutures can be used to provide alignment in the case of a wound where the margins and/or the overlying skin are not well aligned or are not amenable to restructuring to make them so aligned.
Wound closure of open wounds in which the wound margins are not substantially parallel can include the amputation of limbs or other regions of the body having substantially curved contoured regions. Wound closure devices fitting over and/or within the wound can require an arcuate shape to be effective to close such wounds. Often different depths within the wound will close at different rates upon the application of negative pressure. It is critical to provide arcuately shaped devices that are effective to close the deeper portions of the wound margins in advance of the shallower portions to avoid the creation of separated wound margin regions that are not visible.
Wound closure devices in accordance with the invention can include one or more device components that are inserted within the wound to facilitate wound closure. A preferred embodiment can employ a double sided anchoring matrix that is inserted in all or a portion of the wound that will attach to both wound margins. The matrix can have apertures extending through the matrix to facilitate wound margin contact through the apertures. One or both sides of the matrix can have tissue anchors to grasp the margin surfaces. Adhesive material can also be used as a tissue anchor material. The matrix can comprise a bio-absorbable material that does not need to be removed from the wound upon wound closure. A further preferred embodiment uses an arcuately shaped closure device in which an outer portion has a larger dimension then an inner portion as the outer portion has a substantially greater length upon insertion into the wound.
In another preferred embodiment for treating an open wound, a common problem involves the drainage and closure of ulcerative conditions. A collapsing structure using negative pressure around therapy and a compression device that is operative to apply a force to the tissue surrounding the wound can also be used to facilitate wound closure. This procedure can also be used with or without sutures to close the wound.
Embodiments of the present invention relate to negative pressure wound closure devices, systems, and methods for wounds resulting from amputation or other open wound in which the wound margins undergo rotation to align and close. The embodiments as described herein include a negative pressure source and a compression structure that is placed on the wound to provide directed preferential closure. The compression structure can include a number of cells separated by rigid or semi-rigid membranes that are hinged together at joints. The structure changes conformation during a procedure to facilitate closure of the wound.
Although the wound closure device 100 is described as having a dome shape (i.e., a curvature along two axes), it is also contemplated that embodiments of the present invention can have curvature in only one dimension (i.e., a cylindrical geometry). As a non-limiting example, a wound closure device 100 in accordance with the present disclosure can cover a wound on a lateral surface of a bodily limb or extremity such as the thigh. The device can have a range of values of curvature to accommodate wounded extremities as varied as fingers or toes to legs or arms. In some embodiments, the radius of curvature of the device is different from the radius of curvature of the tissue under treatment such that, as a result, the device is at least partially spatially separated from the tissue surface.
The wound 150 can have a width (X) 152 and a depth (Y) 154. In some embodiments, the depth 154 of the wound 150 can be between 0.1 and 1 times the width 152 of the wound 150. Previously available treatments may incompletely treat wounds with such large aspect ratios of depth to width because they typically force the margins of the wound at a shallow portion 150b of the wound to approximate (i.e., come into contact) before the margins of the wound at a deep portion 150a of the wound. In the case where the shallow margins approximate first, the potential arises for seroma formation or infection of the wound below the surface. Embodiments of the present invention can ameliorate this problem by preferentially applying a greater lateral force 110a at the deep portion 150a of the wound 150 than at the shallow portion 150b of the wound as will be described in more detail below.
The compression structure 102 can be situated outside of the wound as shown in
The flaps 108 can be attached to the compression structure 102 and can extend to the peripheral edge 101 of the wound closure device 100. In some embodiments, the flaps 108 may include a first section 108a and a second section 108b that are made of different materials or have different properties. In certain embodiments, the first section 108a may be more flexible, stretchable, or elastic than the second section 108b. In some embodiments, the first section 108a, the second section 108b, or both may include anchoring elements 104. The anchoring elements 104 can be used with the flaps 108 on some or all sides of the wound 150 to attach the structure to a wrap 106 that surrounds the limb just proximal to the wound opening. In some embodiments, the second section 108b of the flaps 108 can be made of a stiff material that will not substantially change conformation as the compression structure 102 moves. This stiffness in a section of the flaps 108 can increase the closure force applied to the wound 150.
The wound closure device 100 can be covered with a cover element that can be custom-designed to fit the shape of a particular patient. In some embodiments, the cover element can include a foam or other biocompatible substance. The cover element may include prostheses or can be specially designed to distribute force due to body weight or pressure to prevent adverse wound events such dehiscence.
In some embodiments, a pump or other vacuum source can be used to apply negative pressure to the wound closure device 100. The pump can attach to the inlet 105 of the wound closure device 100. Additional vacuum sources can also be connected through an array of spaced inlets 105 in order to spatially distribute the suction force so that the force exerted on the compression structure 102 can be controlled separately from a fluid suction force. The amount of applied negative pressure can be adjusted depending on the size and shape of the wound. Pressures above 125 mm to as much as 250 mm or more can be used to assist in wound closure. The pressure can be reduced over time as the wound heals and reduces in size and depth. The vacuum source or pump can be further connected in some embodiments with a surgical drain device as described in greater detail below with reference to
In accordance with various embodiments, the inlet(s) 105 can be disposed on an attachment plate 115. The attachment plate 115 may or may not be rigid along certain directions and may be smooth on one or more surfaces. The attachment plate 115 can overlay the compression structure 102 and may also exhibit elastic or stretching properties. The material of the attachment plate 115 can be biocompatible film such as that provided in conjunction with the Renasys® system available from Smith & Nephew. A preferred embodiment can also be used with a gauge as also provided in the Renasys® system. The smooth attachment plate 115 enables the compression structure 102 to contract and expand freely without interference from the underlying tissue, and without damaging the underlying tissue. In a preferred embodiment, the attachment plate 115 includes micropores that allow the passage of fluid through the attachment plate 115 and into the inlet 105 for removal from the wound site. In some embodiments, the attachment plate 115 can contact a wound filling material as described in greater detail below with reference to
In some embodiments, the micropores can have different sizes in different regions and/or can have different pore densities in different regions in order to direct different force levels of the vacuum source to different regions of the device 100. Similarly, the compression structure 102 can be engineered with different internal cell sizes and/or cell densities to direct the distribution of forces from the vacuum source to different areas of the device 100.
The wound closure device 100 can be used without any sutures in cases where the skin edges on opposite sides of the wound 150 are sufficiently aligned. Alignment of the skin can be facilitated by surgically trimming the wound margins in advance of closure. In other cases, sutures can be selectively utilized to better align the skin on opposite sides of the wound 150. In various embodiments, the device can be used to treat a range of extremities including legs, arms, fingers, toes, hands and feet. After a period of healing, the device 100 can be removed and optionally replaced with a smaller device.
As described briefly above, the peripheral edge 101 can be designed to impart a greater lateral force 110a than, for example, the lateral force at a point 110b within the wound closure device 100. This gradient of closure force as shown in
In some embodiments, a seal may be included on the flaps 108 or cover element to seal the wound closure device 100 and prevent air from entering or leaving the device while the pressure is changed inside, e.g., by application of negative pressure. The seal can include elastics or adhesives to press a portion of the device 100 such as the peripheral edge 101 against the skin of the patient to produce an airtight seal. In certain embodiments, the seal is included at the peripheral edge 101 of the wound closure device 100.
As shown in
In some embodiments, the interior of each cell 503 contains internal membranes or walls 505 to enhance structural stiffness in one or more directions. The internal membranes or walls 505 can be connected by hinged elements 506. As a result of this enhanced stiffness, the cells 503 can preferentially collapse along a specific dimension (e.g., length, width, or height) as shown in
The surgical drain device 660 can include apertures to allow wound margins on opposite sides of the drain device 660 to come into contact. In some embodiments, the surgical drain device 660 has a plurality of removable drainage tubes that can be withdrawn from the device. In various embodiments, the surgical drain device 660 is made of a bio-absorbable material such that the body of the device can be left in the wound 150 without needing to be removed. The material 670 can be attached to the tube elements 675 such that removal of material 670 from the wound 150 will extract the tubes 675 from drain device 660. The surgical drain device is described in greater detail below with reference to
One embodiment of a cell framework for a compression structure 102 according to the invention is shown in
In another embodiment, shown in
The cells 502 in certain embodiments can be made, in whole or in part, from a shape memory material. Various shape memory materials can be used which return from a deformed state (temporary shape) to their original (permanent) shape. This change in shape can be induced by an external stimulus or trigger. In one embodiment, the original or “permanent” shape of the wound closure device is the “collapsed” configuration. When the wound closure device is initially applied at the wound, the device can be deformed in a temporary expanded state. The device can preferentially revert to its original or “collapsed” state or, alternatively, cause the device to first expand to engage the tissue. The “collapse” force of the shape memory structure can be in addition to or an alternative to the vacuum force induced by the negative pressure source. In certain embodiments, the application of a negative pressure to the wound closure device can cause the device to revert to its original state.
In some embodiments, the flaps 108 can attach at least in part to the tissue of a patient including dermal tissue. As the tissue to be grasped by the flaps 108 has different structural characteristics then the wrap 106, a second group of anchor elements can be adapted to grasp tissue and can have a different shape and grasping force then the first anchor elements 404. As discussed in greater detail below, barbs can have bilateral prongs that tend to collapse upon insertion in tissue and yet expand when pulled in an opposite direction such that a certain pulling force can be applied to tissue as the compression structure 102 collapses. However, the prongs or cone shape anchor element can have a release force such that the barbs can be manually pulled from the tissue without causing injury. In some embodiments, the flaps 108 attach to both tissue and the wrap 106.
The characteristics of the anchors, and their resulting force profiles, can vary by a number of parameters, such as the length of the anchor, the shape of the anchor, the structure of grasping features, the material(s) used for the anchor, the relative flexibility/rigidity of the anchors, and the spacing/density of the anchors.
The number of drain tubes in the surgical drain device 660 can vary depending upon the needs of the device, including the amount of fluid to be drained and the size of the wound and shape of the device. Typically, the device will contain from 2 to about 20 drain tubes. In a preferred embodiment, the device contains preferably at least 3 tubes, and for larger areas from about 5 to about 12 tubes.
The drain tubes 30 can be fabricated from any biocompatible thermoplastic or thermoset material. Examples include surgical grade silicone rubber, polyurethane, polyamide, polyimide, PEEK (polyether ether ketone), polycarbonate, PMMA (polymethylmethacrylate), and polyvinylchloride. The drain tubes 30 are intended to be removed after fluid build-up has reduced to a level that is stable without drainage. However, in an alternative embodiment, the drain tubes 30 can be made of a biodegradable material and can be left in place. The drain tubes 30 can be flexible so as to conform to the tissues surrounding the device and to accommodate movement of the patient without causing discomfort. The drain tubes can be open ended or close ended. In a preferred embodiment, the drain tubes are close ended and possess apertures or holes along their length for the uptake of fluid.
The adhesion matrix 25, including any drain tube channels 35 and hooks or barbs, can be fabricated from a biodegradable polymer material, as these structures are intended to remain in place in the patient's body after removal of the drain tubes 30, so as not to disrupt the healing process. Examples of suitable biodegradable or resorbable materials include Vicryl (polyglycolic acid), Monocryl (glycolic acid-ε-caprolactone copolymer), PDS (polydioxanone, PDO), PLA (polylactic acid, polylactide), PLLA (poly-L-lactic acid), PDLA (poly-D-lactic acid), PGA (polyglycolic acid, polyglycolide), PLGA (poly(lactic-co-glycolic acid)), MB (polyhydroxybutyrate), and PCL (polycaprolactone). In a preferred embodiment, the adhesion matrix 25, including any drain tube channels 35, is formed of an open network of polymer chains that has sufficient porosity to allow infiltration by cells and fluid flow across the material. Cellular infiltration can promote tissue adhesion and the biodegradation of the polymer after the wound has healed. In some embodiments, the adhesion matrix 25 including any drain tube channels 35 is permeable to seroma fluid but not permeable to cells. In other embodiments, the adhesion matrix 25, including any drain tube channels 35, is permeable to fluid and electrolytes but is impermeable to proteins. The permeability properties of the matrix polymer material that makes up the basic substrate of the adhesion matrix 25 can be the same or different compared to the material that makes up the drain tube channels 35. In a preferred embodiment, the polymer chains, or fibers composed of polymer chains, of the adhesion matrix 25 are aligned along an axis substantially perpendicular to the axes of the nearest drain tubes 30. This alignment pattern promotes the flow of fluid through or along the surface of the adhesion matrix 25 towards the drain tubes.
The adhesion matrix 25, and thus the overall drain device 660, can have any form suitable for insertion into the wound or seroma where it is to be inserted. Generally, the form is that of a thin sheet or flexible planar mesh having an essentially rectangular shape. However, the shape can be rounded, circular, elliptical, oval, or irregular. Preferably the corners are rounded so as to minimize mechanical irritation of surrounding tissues. The size of the device is also determined by the particular use and anatomy of the patient. For example, the adhesion matrix can have an overall width and length in the range from about 2 cm to 25 cm, such as about 10 cm×12 cm or about 20 cm×25 cm. The thickness of the adhesion matrix 25 can be from about 0.5 mm to about 1 cm; where the sheet of material is preferably less than 5 mm in thickness and preferably the adhesion matrix 25 is about 1-2 mm thick. The thickness of the entire drain device 660, including the sheet of the adhesion matrix 25, drain tubes 30, and any hooks or glue pads is about 5 mm or less, 10 mm or less, or about 5-10 mm.
The adhesion matrix 25 can be coated with an adhesive material such as surgical glue either in addition to or instead of using hook or barb structures that stabilize tissue layers on either side of the drain device. Any type of surgical adhesive suitable for use within the body can be used, including polyethylene glycol polymers, adhesive proteins, gelatin-thrombin mixtures, albumin-glutaraldehyde, and fibrin-based sealants. Cyanoacrylates are to be avoided, as they cause inflammation if used internally. An adhesive coating can be placed on one or both surfaces of the adhesion matrix 25. Adhesive coatings can be applied to the device prior to its placement in a patient, i.e., as part of the device fabrication process. An adhesive coating can cover all or a portion of a surface of the device 660. A surgical adhesive can be used in the form of a fibrous mat or pad that is soaked or coated with an adhesive composition. The mat or pad is preferably fabricated from a biodegradable polymer, such as the type used to prepare the adhesion matrix 25. One or more layers of adhesive material can be placed between the device and surrounding tissue at the time of placement in the patient.
When the wound closure device 100 containing the compression structure 102 is applied to a wound 150 and negative pressure is applied, the wound margins will begin to approximate beginning with the deep portion of the wound 150a. As the wound margins rotate towards one another, the compression structure 102 must also compress along the lateral direction 117. Compression or collapse of the compression structure 102 can be achieved by several methods.
Although the wound closure device 100 is described as having a dome shape (i.e., a curvature along two axes), it is also contemplated that embodiments of the present invention can have curvature in only one dimension (i.e., a cylindrical geometry). As a non-limiting example, a wound closure device 100 in accordance with the present disclosure can cover a wound on a lateral surface of a bodily limb or extremity such as the thigh. The device can have a range of values of curvature to accommodate wounded extremities as varied as fingers or toes to legs or arms. In some embodiments, the radius of curvature 116 of a portion of the device (RC2) is different from the radius of curvature 156 of the tissue (RC1) under treatment such that, as a result, the device is at least partially spatially separated from the tissue surface.
The wound 150 can have a width (X) 152 and a depth (Y) 154. In some embodiments, the depth 154 of the wound 150 can be between 0.1 and 1 times the width 152 of the wound 150. Previously available treatments may incompletely treat wounds with such large aspect ratios of depth to width because they typically force the margins of the wound at a shallow portion 150b of the wound to approximate (i.e., come into contact) before the margins of the wound at a deep portion 150a of the wound. In the case where the shallow margins approximate first, the potential arises for seroma formation or infection of the wound below the surface. Embodiments of the present invention can ameliorate this problem by preferentially applying a greater lateral force 110a at the deep portion 150a of the wound 150 than at the shallow portion 150b of the wound as will be described in more detail below. In accordance with various embodiments, a portion 114 of the wound closure device 100 can be positioned over tissue adjacent to the wound 150. In some embodiments, the length of the portion 114 adjacent to the wound 150 can be 0.4 to 0.8 times the depth 154 of the wound 150.
The collapsible structure 102 can be situated outside of the wound as shown in
The collapsible structure 102 can include rigid or semi-rigid membranes 109 connecting walls 107 between cells 103. The lower set of membranes 109 can form a surface having a smaller radius of curvature 116 than the radius of curvature 156 of the surface of the tissue proximate to the wound. In some embodiments, the smaller radius of curvature is enforced by stiffened or firm elements within the collapsible structure 102. The difference in the radius of curvature 116 of the collapsible structure 102 relative to the radius of curvature of the tissue surface can impart additional force at the lateral ends of the collapsible structure 102. In some embodiments, the firmness or stiffness of the radius of curvature of the collapsible structure 102 can help allow the structure to resist buckling when a negative pressure is applied at the port 105. In some embodiments, the collapsible structure 102 can include a lateral portion that can apply an inward force to the deep portion 150a of the wound 150 to cause the deep portion 150a to close before the shallow portion 150b. In accordance with various embodiments, the collapsible structure 102 can contact the portion of the tissue adjacent to the wound opening and can include a stiff edge.
The drape 118 can provide a leak-free seal between the wound closure device 100 and the tissue surface. In some embodiments, the drape 118 can be made from materials including plastics or tapes and further including biocompatible materials. In some embodiments, the drape 118 can include adhesives or surgical glues as described above with reference to the adhesion matrix 25. The drape 118 can improve sterility of the wound 150 during healing by preventing ingress of dirt or bacteria. In some embodiments, the drape 118 can affix a lateral portion of the collapsible structure 102 to tissue surrounding at least the deep portion 150a of the wound 150.
The wound closure device 100 can be covered with a cover element that can be custom-designed to fit the shape of a particular patient. In some embodiments, the cover element can include a foam or other biocompatible substance. The cover element may include prostheses or can be specially designed to distribute force due to body weight or pressure to prevent adverse wound events such dehiscence.
In some embodiments, a pump or other vacuum source can be used to apply negative pressure to the wound closure device 100. The pump can attach to the inlet 105 of the wound closure device 100. Additional vacuum sources can also be connected through an array of spaced inlets 105 in order to spatially distribute the suction force so that the force exerted on the collapsible structure 102 can be controlled separately from a fluid suction source. The amount of applied negative pressure can be adjusted depending on the size and shape of the wound. Pressures above 125 mm to as much as 250 mm or more can be used to assist in wound closure. The pressure can be reduced over time as the wound heals and reduces in size and depth. The vacuum source or pump can be further connected in some embodiments with a surgical drain device as described in greater detail above with reference to
In accordance with various embodiments, the inlet(s) 105 can be disposed on an attachment plate 115. The attachment plate 115 may or may not be rigid along certain directions and may be smooth on one or more surfaces. The attachment plate 115 can overlay the collapsible structure 102 and may also exhibit elastic or stretching properties. The material of the attachment plate 115 can be biocompatible film such as that provided in conjunction with the Renasys® system available from Smith & Nephew. A preferred embodiment can also be used with a gauge as also provided in the Renasys® system. The smooth attachment plate 115 enables the collapsible structure 102 to contract and expand freely without interference from the underlying tissue, and without damaging the underlying tissue. In a preferred embodiment, the attachment plate 115 includes micropores that allow the passage of fluid through the attachment plate 115 and into the inlet 105 for removal from the wound site. In some embodiments, the attachment plate 115 can contact a wound filling material as described in greater detail above with reference to
In some embodiments, the micropores can have different sizes in different regions and/or can have different pore densities in different regions in order to direct different force levels of the vacuum source to different regions of the device 100. Similarly, the collapsible structure 102 can be engineered with different internal cell sizes and/or cell densities to direct the distribution of forces from the vacuum source to different areas of the device 100.
The wound closure device 100 can be used without any sutures in cases where the skin edges on opposite sides of the wound 150 are sufficiently aligned. Alignment of the skin can be facilitated by surgically trimming the wound margins in advance of closure. In other cases, sutures can be selectively utilized to better align the skin on opposite sides of the wound 150. In various embodiments, the device can be used to treat a range of extremities including legs, arms, fingers, toes, hands and feet. After a period of healing, the device 100 can be removed and optionally replaced with a smaller device.
In many cases, the ends of the wound 105 undergo much smaller translation then the center. To accommodate this, the collapsible structure 102 can be configured with larger cells in the center and smaller cells at the ends of the wound in some embodiments.
The wound closure device 100 can also include a compression element 121 such as a clamp to increase the amount of force applied at the deep portion 150a of the wound. In some embodiments, the compression element 121 can include only discrete points of contact around the wound such as with a surgical clamp or distractor or can surround the wound at all sides such as with an elastic band. In some embodiments, the compression element 121 can include a tacky or rubberized surface or an adhesive to improve contact with the tissue and prevent relative movement of the compression element 121 over the tissue surface during wound closure.
Some types of incisions and wounds are characterized by a greater area at the base (i.e., the deepest portion) of the wound than at the skin surface.
In some embodiments, the surgical drain device 660 can include tissue anchors 440 as described previously. The tissue anchors 440 can attach to the wound margins on the underside of the skin flaps 1604 and at the base of the wound. In some embodiments, the tissue anchors 440 can improve approximation of wound margins that, due to tissue inelasticity or wound geometry, simply cannot stretch enough to meet under pressure from the bladder 1010.
In accordance with various embodiments, the stem 1020 can be a collapsible element that can collapse in both the horizontal and vertical directions (i.e., the depth and lateral directions according to the wound geometry). As negative pressure is applied, the stem 1020 can collapse in the vertical direction to allow wound margins in the undermined portion 1612 of the wound 1610 to approximate. The stem 1020 can also collapse in the horizontal direction to allow the wound margins in the surface portion of the wound (i.e., the skin flaps 1604) to approximate. In some embodiments, the stem 1020 can contain a collapsible structure as described above with reference to previous embodiments.
The bladder 1010 of the wound closure device 1000 can be made of any suitable material including, but not limited to, plastics, rubbers, or fabrics. The bladder 1010 can have a level of malleability and compliance such that it can mold to fill irregularities across a tissue surface. In some embodiments, the bladder 1010 may be filled with air or other gases, liquids such as saline, or colloidal materials such as gels or foams. In some embodiments, the bladder can be inflated by introducing filler material through the port 1012. As a non-limiting example, the bladder 1010 can be filled by a pump such as a hand- or battery-operated portable pump. One skilled in the art will appreciate that other methods of filling the bladder 1010 are also contemplated as being within the scope of the present invention including in-house and other stationary pressure sources, mouth-blowing, and integrated pumps or micro-pumps mounted within or on the bladder 1010. In some embodiments, the pressure within the bladder 1010 can be adjusted by the patient. In some embodiments, the bladder 1010 can include an integrated or detachable pressure gauge to measure the level of pressure within the bladder 1010.
The porous stem 1020 can be made of any suitable material including, but not limited to, biocompatible foam or gauze. In accordance with various embodiments, the porous stem 1020 can compress as negative pressure is applied as shown in the transformation of the stem between
As with most wounds, an inset wound 1610 may be sensitive to the applied pressure. If the applied pressure is too great, adverse healing may ensue due to restricted blood flow or other causes. The pressure sensor 1014 can detect the magnitude of the applied force on the tissue at the surface of the skin. In some embodiments, the pressure sensor 1014 may be connected to the inlet 1012 to relieve overpressure within the bladder 1010 when the level of pressure on the tissue surface is too high.
When applied to a wound 1610, the wound closure device 1000 can include a drape 1050 to create a leak-free seal between the wound closure device 1000 and the surface of the tissue 1600. In some embodiments, the drape 1050 can be made from materials including plastics or tapes and further including biocompatible materials. In some embodiments, the drape 1050 can include adhesives or surgical glues as described above. The drape 1050 can improve sterility of the wound 1610 during healing by preventing ingress of dirt or bacteria. In some embodiments, the drape 1610 can extend from the wound 1610 to beyond at least the high points 1602 of the surrounding tissue surface. In some embodiments, the drape 1050 includes an inlet 105 through which negative pressure may be applied to the wound closure device 1000.
In some embodiments, the wound closure device can define one or more curved axes along which collapsing motion can occur. In an exemplary embodiment, the curved axes can be parallel azimuthal lines at nearly constant radius in a cylindrical coordinate system at different points along the height of the cylinder. The wound closure device can collapse primarily along the curved axis in some embodiments. In some embodiments, the wound closure device can define at least two curved axes that are perpendicular. For example, a first curved axis can be an azimuthal line at nearly constant radius in a cylindrical coordinate system with the height axis across the wound margins and a second curved axis can be an azimuthal line at nearly constant radius in a cylindrical coordinate system with the height axis along the wound margins.
As shown in
In various embodiments, elements of structure 2005 can include, but is not limited to, biocompatible plastics such as polytetrafluoroethylene-based polymers. The structure can be biocompatible and/or sterile in various embodiments.
In exemplary embodiments, the structure 2005 can include scales or lamellae 2010. The scales can be thin with thickness of less than 2 mm and have rounded edges to reduce friction. The shapes and thicknesses can vary across the array of scale elements. The scales 2010 can be layered in the structure 2005 to reduce or prevent gaps that allow tissue ingrowth or adhesion. In some embodiments, each scale 2010 can be attached to the structure 102. For example, each scale can be attached at a pivot point 2002 on a wall 107 where the wall 107 connects to a rigid or semi-rigid membrane 109. In various embodiments, the attachment 2020 between a scale 2010 and the wall 107 can be a mechanical attachment such as a peg or can be an adhesive. The pivot points 2002 can be hinges or flexure points. In some embodiments, the scales 2010 can include channels 2012 along portions of the scale 2010. The channels 2012 can allow fluid flow and scale movement while preventing tissue ingrowth between scales 2010. The scales can overlap adjacent scales, can be dovetailed or interleaved to accommodate relative movement between adjacent scale elements or rows of elements as illustrated. Note, for example, as elements 109 pivot about hinge points 2002, elements on a first side of panel 107 rotate in a first direction 2007 towards panel 107 under negative pressure. Elements 2011 on the opposite side of panel 107 rotate in a second direction 2009 towards the panel 107. In preferred embodiments, the elements 2010, 2011 can be mounted rigidly to the overlying structure 102 at a single point or at a plurality of points for each element. Alternatively, that can rotate around a single point or be limited to rotate through an angle or range. The scale elements can form an array that is used to contract a flat tissue surface or a curved surface or surfaces as described herein. The scales can extend peripherally over skin tissue, for example, or can extend peripherally from a structure positioned within the wound and between tissues and extend laterally from the wound opening. The scales can also be mounted to a domed structure as shown in
A procedure known as a fasciotomy can be performed to relieve pressure or tension in an area of tissue or muscle and can be used to treat acute compartment syndrome among other conditions. The fasciotomy includes creation of an incision that can be 5 to 10 inches (12.7 to 25.4 cm) long and cutting of the fascia surrounding the muscle to relieve pressure. As a result, muscle often can intrude or bulge out of the wound and make subsequent closure of the wound by bringing together the wound margins significantly more difficult. If the wound is not closed within 7-10 days, for example, the configuration of skin and muscle tissue can “freeze” in place as tissue adhesions take hold. Thus, it can be crucial to address wound closure in as timely a manner as possible. Systems and methods described herein can facilitate closure of fasciotomy wounds and other types of wounds as described previously herein.
In another preferred embodiment, the wound closure device 2170 can have tissue anchors 2057 on peripheral surfaces to engage adjacent tissue. Anchors 2057 are described, for example, in U.S. Pat. No. 9,421,132 and also in U.S. Pat. No. 9,597,484, the entire contents of these patents being incorporated herein by reference. Also, scales that extend outside the peripheral edges of structure 2170 can also optionally include tissue anchors 2055 on one or both sides. In the depicted embodiment, anchors 2055 can grasp the overlying tissue 2100, thereby applying a lateral force toward the opposing wound margin to aid in closure while the scales 2050 slide over the underlying tissue 2150.
The structure or wound filler material 2170 can connect to scaled elements 2050 in some embodiments. Alternatively, a layer of scales can be provided separately in which the scales comprising an interconnected array of elements that form a flexible layer positioned between the collapsing structure and a tissue layer such as muscle or facia, or at layer of fat, for a surface of skin or dermis. The elements 2050 can be placed between the underlying muscle tissue 2150 and the skin and/or fatty tissue 2100 to promote relative translation between the components as the wound closes. As the wound closes, the scales 2050 can slide across one another and move or slide relative to the underlying and overlying tissue. The scale elements 2050 can prevent adhesion between the muscle tissue 2150 and the overlying fatty tissue or skin 2100. In some embodiments, the scale elements 2050 and wound filler material 2170 can replace the use of foam in wound recovery.
The wound closure device 1000 can be applied in several stages. First, the deflated bladder 1010 can be placed over the wound and the drape 1050 can be pulled taut over the bladder 1010 and secured to surrounding tissue at the perimeter of the drape 1050. Next, the bladder can be inflated through the inlet 1012. As the bladder 1010 inflates, it is confined between the tissue surface and the drape 1050 and the pressure inside the bladder 1010 begins to increase. As a result, the pressure on the tissue causes the overhanging tissue in the undermined portion to press down on the base of the wound and stabilize.
In some embodiments, the wound and overlying tissue layers can be substantially concave. This type of wound can be difficult to heal because force cannot be leveraged from adjacent or surrounding tissue into the depression caused by the concavity. Systems and methods described herein can address this difficulty by providing the inflated bladder 1010 confined by the drape 1050. In some embodiments, the volume of the inflated bladder 1010 is such that it can still apply a sufficient pressure to the concave wound to stabilize the tissue layers within the wound.
In some embodiments, each inflatable section 2811 can have an inlet 2810 to allow inflation of the section. In some embodiments, a pressure regulator 2815 can be located near the inlet 2810 to supply a consistent air pressure. In some embodiments, the pressure regulator 2815 can act as a vent that prevents overpressure inside the inflatable section. In some embodiments, the pressure regulator 2815 can be operatively connected to a sensor 2820 within the inflatable member 2811. If the sensor detects an overpressure condition, the pressure regulator 2815 can vent the inflatable member until an appropriate pressure is reached.
In various embodiments, the sensor 2820 can include a pressure sensor that directly detects the pressure within each of the inflatable members. In some embodiments, the sensor 2820 can measure the gas or fluid pressure directly in each section or indirectly through its effect on the tissue. For example, the sensor 2820 can include an optical sensor that can perform a colorimetric measurement on the tissue and determine a level of perfusion of the tissue. If perfusion is minimal, it may be an indication that the wound closure device 1000 is pressing too hard on the tissue and cutting off blood flow in the microvasculature. In such an embodiment, the pressure regulator 2815 can receive a signal to reduce the pressure at that area until normal perfusion is restored.
A pump 2850 can provide positive pressure, negative pressure, or both to the wound closure device 1000. The pump 2850 can be connected to a drain outlet 2805 to provide negative pressure to the interior of the wound closure device. Negative pressure applied through the drain outlet 2805 can help the inflatable sections 2811 apply pressure to the wound. In addition, any fluid that exits through the stitches 2605 can be pulled out of the wound closure device 1000 and into the pump 2850.
The pump 2850 can also provide the positive pressure needed to inflate the inflatable sections 2811. In some embodiments, a manifold can be used to connect a single pump 2850 to a myriad of inflatable sections 2811 simultaneously. In alternative embodiments, separate tubes can be used to connect the inlet 2810 of each inflatable section 2811 with separate pumps 2850. The manifold can include valves that close off individual lines to individual inflatable sections 2811.
The pump 2850 can be mechanical, electrical, or hand-operated (e.g., a syringe pump). Although a single pump 2850 is shown in
In some embodiments, inflatable bladder sections 2811 can be used in conjunction with systems and methods described herein to promote healing of wounds 150 at extremities caused, for example, as a result of amputation. As shown in
In some embodiments, a sequential inflation procedure can be used to apply pressure in stages as the wound 150 closes from deep to shallow. The inflatable sections 2911 nearest the edge of the drape 2920 can first be inflated to create pressure laterally at the deepest portion. Next, the adjacent inflatable sections 2911 can progressively be inflated in sequence until even the inflatable sections 2911 laterally adjacent to the shallowest portion 150b of the wound 150 are inflated. This sequence can progress over time periods from seconds to minutes to days as tissue healing proceeds.
While the present inventive concepts have been described with reference to particular embodiments, those of ordinary skill in the art will appreciate that various substitutions and/or other alterations may be made to the embodiments without departing from the spirit of the present inventive concepts. Accordingly, the foregoing description is meant to be exemplary and does not limit the scope of the present inventive concepts.
A number of examples have been described herein. Nevertheless, it should be understood that various modifications may be made. For example, suitable results may be achieved if the described techniques are performed in a different order and/or if components in a described system, device, or method are combined in a different manner and/or replaced or supplemented by other components or their equivalents. Accordingly, other implementations are within the scope of the present inventive concepts.
This application is a continuation-in-part of International Patent Application No. PCT/US2016/067051, filed Dec. 15, 2016, which is a continuation-in-part of U.S. patent application Ser. No. 15/066,527, filed Mar. 10, 2016, and claims priority to U.S. Provisional Patent Application 62/267,728, filed Dec. 15, 2015, the contents of the above applications being incorporated herein by reference in their entirety.
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| Number | Date | Country | |
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| Number | Date | Country | |
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| Number | Date | Country | |
|---|---|---|---|
| Parent | PCT/US2016/067051 | Dec 2016 | US |
| Child | 15629596 | US | |
| Parent | 15066527 | Mar 2016 | US |
| Child | PCT/US2016/067051 | US |
