Patent Grant
11166726
A number of techniques have been developed for treatment of wounds, including wounds resulting from accident and wounds resulting from surgery. Often, wounds are closed using sutures or staples. However, inserting these mechanical closure techniques requires making additional punctures or wounds to the skin, which can result in tissue injury and in the case of excess swelling, possible ischemia and tissue loss. Also, mechanical wound closures such as staples and sutures can cause highly-localized stresses at the insertion points that can impede and damage the normal wound healing processes of the skin.
In recent years, there has been increased interest in using negative pressure devices for the treatment of wounds. Negative pressure wound treatment utilizes devices that remove wound fluids by applying negative pressure suction to the wound. It is believed that such negative pressures promote wound healing by facilitating the formation of granulation tissue at the wound site and assisting the body's normal inflammatory process while simultaneously removing excess fluid, which may contain adverse cytokines bacteria. However, further improvements in negative pressure wound therapy are needed to fully realize the benefits of treatment.
The present invention relates to a negative pressure wound closure device that specifically exerts force at the edges of the wound to facilitate closure of the wound. The device operates to reduce the need for repetitive replacement of wound filler material currently employed and can advance the rate of healing. The device simultaneously uses negative pressure to remove wound fluids and to assist in closure of the wound.
In one embodiment, a negative pressure wound closure device includes a wound filler material that is sized and shaped to fit within a wound opening and which contracts along at least one dimension upon application of a negative pressure to the filler material. The filler material is thus configured to preferentially contract in at least one direction and inhibit contractions in one or more additional directions. Prior negative pressure devices did not assist in wound closure, but were used to drain fluids. By providing for the controlled movement of tissue during the healing process in conjunction with the drainage of fluids from wounds as described in connection with the present invention, a substantial improvement in the rate of healing can be realized. Note that depending on the size of the wound, increased negative pressure can be used.
In another preferred embodiment, a tissue grasping surface extends over an outer peripheral surface of the wound filler material and includes a plurality of tissue anchors that engage the tissue at the wound margin. Upon application of negative pressure, the tissue at the wound margin is displaced to facilitate closure of the wound. A negative pressure source, such as a vacuum pump, is coupled to the wound filler material to provide the negative pressure.
The wound filler material generally comprises a porous material, such as a foam. For embodiments employing tissue anchors, these can be integrally formed in the filler material. In other embodiments, the tissue anchors are provided on a separate covering or film that is secured to the filler material.
In preferred embodiments, the filler material includes a stabilizing structure that enables the material to collapse in at least one first direction and inhibits collapse in at least one second direction. The stabilizing structure can include regions of relatively rigid material surrounded by regions of relatively compressible material. In preferred embodiments, the stabilizing structure is an endoskeleton formed of rigid and/or semi-rigid materials.
In exemplary embodiments, the regions of compressible material may include one or more sections of a compressible material configured, e.g., sized and shaped, for association with one or more surfaces defined by the stabilizing structure. For example, a stabilizing structure may define a top surface, a bottom surface and one or more side surfaces each, of which being associated with a corresponding section of a compressible material. In exemplary embodiments, each section of the compressible material can be configured, e.g., sized and shaped, to match the corresponding surface. Thus, the sections of compressible material cooperate to envelope the stabilizing structure, e.g. to facilitate structural characteristics as described in the present application. In some embodiments, a tissue grasping surface, such as described above, may extend over an outer peripheral surface of the compressible material, e.g. of the side sections of the compressible material that can engage the wound margins of an open wound.
In exemplary embodiments the sections of compressible material can define a plurality of surface features on the inner peripheral surfaces thereof. For example, the sections of compressible material may define an “egg crate” pattern of ridges and valleys. Advantageously, the surface features defined on the inner peripheral surface of the sections of compressible material can be configured for operative association with an inner volume of stabilizing structure. In exemplary embodiments, each surface of the stabilizing structure may define a lattice pattern of stabilizer elements. Thus, the surface features defined on the inner peripheral surface of each section of compressible material may be configured, e.g., patterned, to match the lattice pattern of the corresponding surface of the stabilizer element. In exemplary embodiments, the surface features defined on the inner peripheral surface of each section may provide tensile forces to the stabilizing structure, e.g., during the collapse thereof, to facilitate a structured collapse, e.g., in one or more directions. In some embodiments, the surface features defined on the inner peripheral surface of each section may be configured to impart a pre-selected force profile to the stabilizing structure, e.g., during the collapse thereof. In some embodiments, a pre-selected force profile can control the collapse of the stabilizing structure, e.g., providing for a non-uniform collapse such as by resisting collapse in one or more directions and/or in one or more regions. The shaped wound filler material provides for fluid transport across the device during the application of negative pressure. Consequently, a preferred embodiment provides for continuous contact of wound filler elements to facilitate continuous flow of fluid from the tissue margins and underlying tissue to the fluid exit port(s) for drainage from the wound.
In certain embodiments, the stabilizing structure inhibits the filler material from collapsing along its height dimension, while enabling the filler material to collapse within the plane defined by the wound margins. This is useful in the case of abdominal surgery, for example, in which the surgical incision is along a straight line and opens laterally to form an oval shaped wound. This generally oval shaped wound can extend through muscle and fatty tissue having variable mechanical properties. Wound healing is better served through the use of an oval shaped structure adapted to preferentially collapse towards the original line of incision. In preferred embodiments, the stabilizing structure promotes collapse of the filler material in a manner to effect reapproximation of the wound tissue. Fasciotomy wounds, or other wound dehiscences, or any open wound can be successfully treated using embodiments of the present invention.
The wound closure device can be used to treat wounds in the mediastinum, for pressure ulcers, for wounds in the extremities (arms or legs) etc. The wound closure device can also be used to treat wounds of different shapes, such as circular, square, rectangular or irregularly shaped wounds. A plurality of wound closure elements can be shaped to fit within a wound and can attach together to preferentially close the wound in a desired direction. The different elements can comprise different materials or have different characteristics, such as pore size and/or anchor size and distribution to form a composite structure.
In one embodiment, an endoskeleton stabilizing structure includes a plurality of spaced-apart rigid members forming a cross-hatched configuration. The endoskeleton enables the filler material to collapse along its width dimension and elongate to a smaller degree along its length dimension. In certain embodiments, a plurality of rigid members extend along the height of the filler material and inhibit collapse of the material in its height dimension, for example. According to certain embodiments, the endoskeleton comprises a network of interconnected rigid members that can articulate with respect to one another during collapse of the filler material. The endoskeleton can include truss supports to inhibit tilting motion of the filler material. In some embodiments, the tissue anchors can be integrally formed in the endoskeleton. The endoskeleton can have flexure elements with elastic properties such that the lateral force imparted by the skeleton is a function of displacement. The endoskeleton or frame prevents tilting of the wound closure device during use. The frame can include hollow tubes or cavities that alter the flex characteristics of the frame. The tubes or cavities can be used for the delivery of media into the wound.
A preferred embodiment of the invention utilizes a wound healing device for the treatment of wounds in which seromas can form. The wound healing device can include apertures to provide for tissue contact through the apertures to promote wound healing. The device can include removalable drain elements for the application of negative pressure.
In certain embodiments, the wound filler material includes a smooth bottom surface having micropores to allow the passage of fluid from the wound through the bottom surface and into the device for removal. The micropores can have variable pore size and/or pore density to direct the distribution of vacuum force from the negative pressure source. In some embodiments, the wound filler material can have variable internal pore sizes and/or pore density to direct the distribution of vacuum force.
In one embodiment, a negative pressure wound treatment component for managing and/or removing fluid is coupled to the wound filler material. A single negative pressure source can be used for wound closure and fluid management/drainage. A sliding surface is provided at the interface between the wound closure and fluid management components.
In yet another embodiment, the filler material includes removable portions to adjust the size of the wound closure device. The filler material can be provided with pre-determined cleavage lines for tearing or cutting away portions of the material. In certain embodiments, sets of tissue anchors are embedded in the filler material, and become exposed by removing excess portions of the material.
According to another embodiment, the tissue anchors are provided with a variable force profile. The force profile can vary based on the depth of tissue or the type of tissue engaged. In some embodiments, the force profile of the tissue grasping surface varies around the perimeter of the wound closure device. The force profile is varied, for instance, by varying one or more of the length of the tissue anchors, the shape of the anchors, the materials of the anchors and the density of the anchors.
The present invention also relates to methods of closing a wound using a wound closure device as described above. For example, a linear incision in the skin overlying the abdomen provides access to a surgical site such as the gastrointestinal system of the human or animal body. Following completion, the wound must be treated by negative pressure therapy to facilitate recovery. Thus, a wound closure device in accordance with preferred embodiments of the invention is inserted for wound closure treatment.
In a preferred embodiment, the wound closure device does not include tissue anchors, but instead utilizes a structure having a shape memory such that it expands to fill the wound cavity. Thus, the expanding frame exerts an expansion force when compressed so that the lateral peripheral elements of the device maintain contact with the wound margins around the peripheral surfaces of the wound closure device. The laterally directed outward expansion force is less than the closure force exerted on the tissue upon application of negative pressure that operates to close the wound margins and compress the wound closure device.
By using the negative pressure wound closure device of the invention, patients with large or severe wounds are able to be discharged or engage in rehabilative physical therapy, changed at home and then brought back to have their wounds simply stitched closed. By improving wound closure treatment and thereby reducing cost, there is an opportunity for these devices to be a significant part of the instruments used for wound care.
A preferred embodiment of the invention uses a wound healing device in combination with a wound closure device for treatment of wounds requiring both components.
Other features and advantages of the present invention will be apparent from the following detailed description of the invention, taken in conjunction with the accompanying drawings of which:
Extending over at least one surface of the filler material 102, and preferably extending over an outer perimeter surface of the filler material 102 is a tissue grasping surface 104. In one embodiment, the tissue grasping surface 104 is a flexible covering, such as a mesh film, that is secured to the outer perimeter surface of the filler material 102 and can expand and contract with the expansion and contraction of the filler material 102. In one embodiment, the tissue grasping surface 102 is a mesh film or a composite polyester mesh film, such as the Parietex™ mesh from Covidien (Mansfield, Mass.). The tissue grasping surface 104 includes a plurality of outward-facing tissue anchor elements 106, which in the preferred embodiment are a plurality of closely-spaced barbs, hooks or tissue grasping elements, which can be integrally formed in the mesh film.
In other embodiments, the tissue grasping surface 104 with anchor elements 106 can be integrally formed in the filler material 102. The tissue grasping surface and/or anchor elements can also be formed using a resorbable material.
The tissue anchor elements 106 are preferably provided over an entire outer perimeter surface of the filler material 102. When the filler material 102 is placed within a wound, the anchor elements 106 become buried within the tissue at the wound margins and secure the device 100 within the wound opening. The tissue anchor elements 106 are preferably spread out over the entire surface of the wound margin to provide sufficient strength in the grasping force. The tissue grasping surface 104 is preferably designed to allow the wound closure device 100 to be easily placed but also easily removed and replaced with a new device 100 or other wound dressing as needed (e.g., 2-7 days later). The grasping surface 104 can be configured to have high grasping strength over at least a portion of its surface, but easily removable by, for example, pulling away at an edge. The tissue grasping surface 104 is preferably designed to be removed from a wound without damaging the surrounding tissue. The anchor elements 106 are preferably designed to accommodate various tissue applications, such as muscle, fat, skin and collagen, and various combinations of these. The anchor elements 106 can also be designed to remain securely attached to particular tissues for a selected time period in certain embodiments.
In embodiments in which the grasping surface 104 is formed from a covering on the outer peripheral surface of the filler material 102, the grasping surface can be attached to the filler material 102 using any suitable technique, such as with an adhesive or a mechanical fastening system. In a preferred embodiment, the tissue grasping surface 104 includes filler-grasping anchor elements, which can be barbs, that secure the grasping surface to the filler material. As shown in the cross-section view of
Returning to
Furthermore, in preferred embodiments the filler material 102 is configured to preferentially collapse in length and/or width (i.e., along the x- and y-axes) to reapproximate the tissue at the wound margins. Note that certain types of wounds can be treated without the anchor elements described herein.
There are several ways in which the filler material 102 is configured to exhibit preferential collapse characteristics. For example, portions of the filler material 102 can be made from more rigid material than the surrounding material, causing the filler material to preferentially collapse in a particular direction. In one embodiment, the filler material 102 can include a stabilizing endoskeleton made from a suitable rigid material embedded within a “collapsible” filler, such as an open cell foam. Note that the amount of applied negative pressure can be adjustable 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 contracts.
As shown in
In certain embodiments, the device 100 can include a flexible covering comprising peripheral stabilizer element 111 that extends around the outer periphery of the filler material 102, as shown in
In some embodiments, the tissue grasping anchor elements 106 can be included on the peripheral stabilizer element 111, and project out from the periphery of the filler material 102. This can be as an alterative to, or in addition to, providing the anchor elements 106 on a separate mesh or film. The peripheral stabilizer element 111 is preferably configured to expand and contract as necessary with the expansion and contraction of the wound filler material 102. Thus, in a preferred embodiment, the stabilizer element 111 has sufficient flexibility to contract and expand in the x- and y-directions (i.e., around the periphery of the filler material 102), but has adequate rigidity along the z-direction (i.e. along the height of the filler) to inhibit collapse or tilting in this direction.
An embodiment of a peripheral stabilizer element 111 is shown in elevation view in
One embodiment of an endoskeleton for a wound filler material of the invention is shown in
In another embodiment, shown in
A preferred embodiment of the present invention employs an endoskeleton structure in which one or more of the stabilizer or flexure elements 108, 112 comprise hollow tubes or cavities 115. The hollow tube elements 108, 112 can be used to alter the elastic characteristics of the structure and thereby adjust the lateral displacement and force characteristics of structure. The diagonal flexures 112 extend between the planes formed by the lateral elements 108a and 108b.
The use of hollow tube elements in the elastic structure can also be used for the delivery of drainage fluid, medication, oxygen or other media into the wound. The tubes 108, 112 can contain media upon implant into the wound that is subsequently released into the wound or can be connected to an external source. The tube walls can have pores that open to accommodate fluid flow into the wound from within the tube elements or cavities therein. The location of tubular elements, as opposed to solid rods or flexures, can be selectively positioned within the structure depending on the preferred delivery location. For example, the flexures 108 along the lateral walls can be used for delivery to the regions being drawn together under negative pressure. Alternatively, the flexures in the bottom plane of the skeleton can be used for delivery to the underlying tissue structure or organs.
The stabilizing endoskeleton 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 endoskeleton is the “collapsed” configuration of the wound closure device, or the shape that will bring about wound reapproximation. When the wound closure device is initially inserted in the wound opening, the endoskeleton is in a deformed or temporary state and embedded within the filler material. The endoskeleton can preferentially revert to its original or “collapsed” state or, alternatively, cause the device to expand to engage the tissue. The “collapse” force of the shape memory endoskeleton 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, which can cause the endoskeleton to revert to its original state.
In some embodiments, the micropores 116 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 filler material 102 can be engineered with different internal pore sizes and/or pore densities to direct the distribution of forces from the vacuum source to different areas of the device 100.
In the embodiment of
In general, the inward collapse of the filler material along the y-direction is undesirable. In fact, during tissue reapproximation, the wound 200 will tend to elongate in y-direction as the wound margins close in the x-direction. In preferred embodiments, the internal stabilizer elements 108 promote the collapse of the filler material in a manner that provides wound reapproximation. In the embodiment of
The wound closure device 200 can remain in this configuration for a period of several days or weeks to facilitate closing and healing of the wound 200. After a period of healing, the device 100 can be removed and optionally replaced with a smaller device. After the wound has been sufficiently closed using the present device, it can be stitched closed.
In a preferred embodiment, the filler material 102 is able to “slide” within the total NPWT/NPWC device 300. The filler material 102 includes a sliding surface 303 at the interface between the wound closure and fluid management components. The sliding surface can comprise a treated surface or a separate layer of material. The sliding surface 303 facilitates the free contraction of the wound closure component, without interference from the fluid management component. The underlying fluid management component 301 can be specifically configured to manage fluid only and to not generate granulation, as this can slow down or inhibit the “slide.”
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. In
The wound closure device of the invention can be provided in kits for closing different types of wounds (e.g., abdominal, fasciotomy, etc.). The tissue grasping surface can be optimized for different types of tissue such as collagen, fatty tissue and muscle, depending on the structure of the tissue at the wound site.
In certain embodiments, the force profile of the wound closure device is variable around the periphery of the wound. An exemplary embodiment is illustrated in
The variation in the force profile around the periphery of the wound closure device can be achieved in a variety of ways, such as varying the spacing/density of the tissue anchors, the types of anchors, length of anchors, or configuration thereof, etc. For example, in
On one embodiment, a method of fabricating a wound closure device of the invention includes forming a stabilizing endoskeleton of rigid or semi-rigid material and forming a collapsible filler material over the endoskeleton. The stabilizing endoskeleton can be formed using a molding process, and can be molded as an integral unit or in one or more components that are then assembled to form the endoskeleton. Different components of the endoskeleton can have different thicknesses and/or degrees of rigidity to provide varying levels of rigidity and flexibility along different directions. The endoskeleton can be assembled by joining components, such as by using a suitable adhesive or other joining process such as by inserting rods into tubular segments. In certain embodiments, at least some of the components can be assembled to provide articulating joints. In preferred embodiments, the filler material is formed by mixing together appropriate metered amounts of constituent substances, (e.g., isocyanates, polyols, catalysts, surfactants, blowing agents and the like in the case of polyurethane foam), dispensing the reacting mixture into a mold, and then curing and demolding the material. Optionally, the material can then be cut or trimmed to the finished shape. In preferred embodiments, the endoskeleton support structure is assembled and placed into the mold, and the filler material is molded around the endoskeleton. An example of a biodegradable foam product suitable for the present wound closure device, and methods of fabricating such a foam, is described in U.S. Published Application No. 2009/0093550 to Rolfes et al., the entire contents of which are incorporated herein by reference.
A method of performing a surgical procedure 800 using a wound closure device in accordance with preferred embodiments of the invention as illustrated in
In a preferred embodiment in which tissue anchors are not used, a method 900 for wound closure is described in connection with
Certain types of wounds that can be treated with negative pressure wound therapy involve the separation by incision of subcutaneous tissue to form a wound opening. This procedure is frequently used to access underlying structures, organs or injuries. The lateral displacement of subcutaneous tissue can contribute additional difficulties for the treatment of the resulting wound.
Illustrated in
Additionally, there can be separation between the fascia 909, 911 and abdominal muscle and the overlying subcutaneous tissue 906, 908. Consequently in
After insertion of layer 925, the compressible wound closure element 918 is inserted followed by sealing drape 905 and the closer device 940 and fluid control tube 942. The pad 907 operates to drain fluid 910 from the abdominal cavity by negative pressure through elements 925 and 918.
In the case where adjoining tissues need treatment utilizing negative pressure or require stabilization such as by pad 925, a wound treatment system can be used in combination with the systems and methods described herein. Shown in
Thus a preferred embodiment of the present invention provides a pad or surgical drain device 925 for the prevention and treatment of seromas as well as for general use in promoting drainage of surgical wounds and wound closure. The drain device can include a plurality of drain tubes 935 disposed on a substrate termed an “adhesion matrix,” which is designed to promote tissue adhesion within the seroma or wound space. The adhesion matrix has a conformable configuration and is made of a compliant material having planar surfaces that can bend to adapt to the shape of the wound space.
In a preferred embodiment, the adhesion matrix contains a plurality of apertures 927, or gaps in the matrix material, which allow tissue contact across the matrix, so as to promote adhesion and wound closure. Thus, a tissue surface on a first side of the matrix can directly contact a tissue surface on a second, or opposite, side of the matrix to promote rapid healing and stabilization of the wound. The number, size and distribution of the apertures 927 extending through the matrix can be selected based on the geometry of the wound. For abdominal wounds, for example, the drain tubes can be positioned in a fan shaped array with a plurality of three or more tubes extending from a manifold. The matrix and/or the tubing can be cut or shaped by the user to conform to the shape of the wound. The matrix can also be used as a medication carrier to assist in the administration of a drug to a patient. The matrix can optionally include a layer of adhesive on at least a portion of any of its surfaces. The drain tubes can be removed from the device once drainage flow is sufficiently reduced, and the adhesion matrix can remain within the body, where it is degraded and absorbed over time, remaining in place to optimize tissue healing. The matrix can comprise a porous biodegradable polymer material. As the plurality of tubes extend from a single exit site into the wound with spaced apart distal ends, a user can readily remove all the tubes simultaneously from the wound.
As shown in more detail in
Another aspect of the invention is a system for surgical wound drainage. The system includes the drain device coupled to a wound closure device 918 as described generally herein together with a vacuum source, such as a pump, and a tube connecting the vacuum source to the drain tubes of the drain device. The system optionally also can include a fluid trap to collect drained fluid and a control unit to monitor and control the application of vacuum and the collection of fluid. Further components of the system can include a vacuum or pressure gauge, a flow meter, and a computer to monitor vacuum and flow and to regulate vacuum or flow. The pressure measurement can be used to control the level of applied pressure using a feedback control circuit. The wound closure device 918 can include the endoskeleton structure as described herein having external ribs extending from the outer surface and flexure arms or beams that have an intrinsic restoring force that varies as a function of position of each flexure element. The different flexure elements can have different restoring force depending upon their position within the structure as shown in
Another aspect of the invention is a method for treating or preventing a seroma, or promoting the drainage or closure of a surgical wound. The method includes positioning the drain device described above into a seroma, or a surgical wound, such as a wound at risk of forming a seroma, and allowing the device to drain fluid from the wound for a period of time. The device can include surgical adhesive and/or barbs or hooks on its surface to create adhesion between tissue layers within the wound and to anchor the device in place. Drainage can be by gravity flow or can be vacuum assisted by attaching a vacuum source to the drain tubes of the device, using a manifold to merge the flow paths of the drain tubes to a common drain tube for collection. Negative pressure applied to the drain tubes can be used to hold the tissue layers above and below the device together until a surgical adhesive has set, or until the wound healing process binds the tissues together. The application of negative pressure further facilitates contact between tissue on opposite sides of the matrix through the apertures in the matrix to promote tissue adhesion. This improves the rate of healing while at the same time providing for drainage. Optionally, the drain tubes of the device have apertures 933 extending along their length and can be removed from the body after drainage flow is reduced, thereby reducing the burden for resorption by the body. Removal of the drain tubes can be facilitated by the inclusion of drain tube channels, or drain tube release tabs, within the adhesion matrix. Release of the drain tubes is then accomplished by sliding the tubes out of the channels or appropriately maneuvering the drain tube assembly to break release tabs. The adhesion matrix is allowed to remain in the seroma or surgical wound where it is resorbed over time.
The flow rate from the drain tubes can be regulated by flow control elements. The flow rate can also be measured or the pressure of fluids can be measured by ultrasound devices or by other methods. The system can also be used in conjunction with wound dressings that can also be attached to a negative pressure source to remove fluids from the wound.
A preferred embodiment of the of the invention includes a negative pressure wound closure device 1000 for the treatment of surgically repaired ulcers as shown in
Illustrated in
Shown in
The systems in
In some embodiments, each section 2102A, 2102B, 2102C or 2102D of the filler material 2102 can define a plurality of surface features 2103 on the inner peripheral surface thereof. For example, each of the depicted sections 2102A, 2102B, 2102C or 2102D of compressible material 2102 defines an “egg crate” pattern of protrusions 2103A and 2103B valleys. Advantageously, the surface features 2103 defined on the inner peripheral surface of the sections 2102A-D of the filler material 2102 may be configured for operative association with an inner volume of stabilizing structure 2101.
As described in previous sections, each surface 2101A, 2101B, 2101C or 2101D of the stabilizing structure 2101 may define a lattice pattern of structural elements including frame or stabilizer elements in the x-y plane (such as stabilizer elements 2108 of
In some embodiments, the tensile forces applied by protrusions 2103a may facilitate a structured collapse of the structural element 2101, e.g., in one or more directions. For example, the surface features 2103 defined on the inner peripheral surface of each section 2102A, 2102B, 2102C or 2102D of the filler material 2102 may be configured to impart a pre-selected force profile to the stabilizing structure 2101, e.g., during the collapse thereof. In some embodiments, the pre-selected force profile may control the collapse of the structural element 2101, e.g., providing for a non-uniform collapse of filler material such as by resisting collapse in one or more directions and/or in one or more regions. With reference to
With reference to
While the invention has been described in connection with specific methods and apparatus, those skilled in the art will recognize other equivalents to the specific embodiments herein. It is to be understood that the description is by way of example and not as a limitation to the scope of the invention and these equivalents are intended to be encompassed by the claims set forth below.
This application is a continuation of U.S. application Ser. No. 13/942,493, filed Jul. 15, 2013 and assigned U.S. Pat. No. 9,421,132, which is a continuation-in-part of U.S. application Ser. No. 13/365,615, filed Feb. 3, 2012 and now U.S. Pat. No. 9,226,737, which claims the benefit of U.S. application Ser. No. 61/439,525, filed Feb. 4, 2011. U.S. application Ser. No. 13/942,493 also claims the benefit of U.S. application Ser. No. 61/672,173, filed Jul. 16, 2012, U.S. application Ser. No. 61/679,982, filed Aug. 6, 2012, and U.S. application Ser. No. 61/779,900, filed Mar. 13, 2013. The entire contents of the above applications are incorporated herein by reference.
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| Number | Date | Country | |
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| Parent | 13942493 | Jul 2013 | US |
| Child | 15243320 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 13365615 | Feb 2012 | US |
| Child | 13942493 | US |
