Summary of the invention
In order to promote the healing of wound, the invention provides a kind of wound contact material, a kind of method and a kind of processing method of utilizing this wound contact material that is used to make this wound contact material.
According to an exemplary embodiment of the present invention, provide a kind of treatment articles that is used on mammalian body, promoting wound healing.These articles for use comprise that has a permeable substrate or a structural member that is formed on its lip-deep a plurality of recesses, and wherein, the described surface with described recess is positioned to wound and is in surperficial contact condition.
According to another illustrative embodiments of the present invention, provide a kind of treatment articles that is used on mammalian body, promoting wound healing.These articles for use comprise a permeable structure, and this structural member has the wound surface contact element between a plurality of ends that are arranged on structural member and has a plurality of by space that described contact element defined.
According to another illustrative embodiments of the present invention, a kind of treatment articles that is used to promote wound healing on the mammalian body is provided, these articles for use comprise a permeable structure, this structural member comprises that many connect fiber each other, and wherein said structural member has a plurality of wound surface contact element and a plurality of spaces of being defined by described contact element that are arranged between the structural member end.
According to another illustrative embodiments of the present invention, a kind of treatment articles that is used to promote wound healing on the mammalian body is provided, these articles for use comprise a polyester felt, and this felt has a plurality of wound surface contact element and a plurality of spaces of being defined by described contact element that are arranged between the structural member end.
According to another illustrative embodiments of the present invention, provide a kind of manufacturing to be used to promote the method for the treatment articles of wound healing on the mammalian body, comprise step: provide a fused matrix material; One mould that defines and form a plurality of recesses and a plurality of contact elements is provided; And fused matrix material is coated with (applying) to mould.
According to one of the present invention illustrative embodiments further, provide a kind of manufacturing to be used to promote the method for the treatment articles of wound healing on the mammalian body, comprise step: provide a permeable structure; And in the surface of described permeable structure, form a plurality of recesses.
According to another illustrative embodiments of the present invention, a kind of method of handling wound is provided, comprise step: a permeable structure is provided, and wherein said structural member comprises a plurality of wound surface contact element and a plurality of spaces of being defined by described contact element that are arranged between the structural member end; Permeable structure is applied at least one surface of wound; And power is applied on the structural member, closely contact with wound surface to keep structural member.
By following description part, above-described and other aspect and purpose will become apparent.
The specific embodiment
A kind of wound dressings with interrupted contact layer, has following advantage, promptly under the effect of wound surface contact element and promote the growth of tissue, and make tissue to grow by being provided with for the follow-up required voidage (void volume) of tissue growth at interrupted place.Ideally, the structure of contact material is wanted enough gauffers on entity, can be not flattened when being applied to power on the material, can resist, and described power is required for material is pressed onto wound surface.
Material ideal can keep its structure on being exposed to aqueous fluid or other body fluid the time.The deliquescing when making moist of many traditional patch materials makes its geometry change.Contact layer is a permeability, and the wound below making can be breathed freely, and makes it possible to wound is carried out drain.The absorbability of contact layer should be not excessive, causes structural failure because cross conference.Described layer is made of such base material, and promptly described base material can be resisted the generation of variation in the presence of dampness and waterborne liquid.
In current embodiment, when being pressed onto structural member (structure) on the wound surface, the size that is retained in the space on the wound surface is preferably 0.1mm at least.Width by the space that contact element defined that is close to the space is preferably more than 0.1mm.The width that is more preferably is between about 0.5 to 10mm, and the height that is more preferably is then between about 0.2 to 5mm.
Wound healing is considered to be complicated process.When will be as described when the wound contact material is pressed onto on the wound surface, think some biological processes can take place.Mechanical stress is applied to following tissue.Interrupted place in the contact surface will cause the power of stretched wire shape (catenary shape) to be pressurizeed organizationally.These mechanical stresses promote that cell survives and angiogenesis, and interrupted place then begins to be filled out with granular tissue (granular tissue).Excessive fluid shifts out from wound, organizes and then reaches pattern growth by this way, promptly makes after removing contact surface, the breakage that tissue caused of new growth is reached minimum.
Fibrous matrix or structural member have and spin the various flexibility that the fabrication technique technology is brought.Can be by some in affiliated field known method, fabric made be used for structural member of the present invention.In these methods, knitting, weaving method, embroidery method, weave, felt weave, spun-bond process, meltblown, melt-spun method are arranged.Can further make each method in these methods be suitable for producing the material that its structure and material structure of the present invention are complementary.For meltblown, can be by for example melted material being sprayed directly on the mould and in the production process of structural member, obtain ideal structure.Alternatively, can make described structure by after producing, the structural member that has been shaped being processed, for example by drop stamping or vacuum forming method.In addition, can make binding agent on the fiber mixing, and it is sprayed onto on the textured surface.
The multifunctionality of fabric is also prolonged and the easy adaptability aspect applied in any combination.Can change individual fiber materials to optimize physical parameter, such as rigidity or pliability.Also can help the known ability of wound healing and it is selected at individual fiber materials.The example of these fibrous materials is calcium alginate and collagen.Alternatively, available known Wound-healing agent is handled fiber, such as hyaluronic acid or antimicrobial silver (antimicrobial silver).Can change the ratio of fibrous material, to be fit to the needs of wound.According to a gratifying aspect of the present invention, can have the different fibers of various wound healing characteristic in the interpolation as required.
Other estimate to comprise as the fibre structure spare of useful additive:
1, the fiber of absorption fluids
2, non-adsorbent fibers
3, bio-absorbable fibers
4, wound surface is carried out the core suction type fiber of drain
5, the fiber that has known healing effect is such as calcium alginate
6, be used for discharging the biological erodable fiber of firming agent by controlled way
7, the conductive fibers that is used for transmission charge or electric current
8, be used for optionally adhesiveness fiber with harmful structure, material or removal of microorganisms
9, be used to protect the non-adhesive fiber of delicate tissue
Fig. 1 shows an exemplary embodiment of the present invention.As shown in Figure 1, the wound dressings 100 that is provided with conduit is made of a polyester felt material 102 that has stickiness substantially.Alternative other fabrics are also applicable to the application of majority, such as knitting, weaving or braided fabric.Also can consider to use polyolefin and the polyurethane with similar physical properties, described polyolefin is such as polyethylene or polypropylene, and described polyurethane is such as nylon.What especially need is the creep resistance that polymer has.Void channels 104 is cut in the felt material 102, promotes the upwards interrupted place of growth of new organization to provide.In use, the wound dressings 100 that is provided with conduit is pressed onto on the wound, it is contacted with injured tissue tight.Ideally, 0.1psi or bigger power are applied on the contact layer, so that contact element is pressed onto on the wound surface.Wound contact element 106 thereby be in tight contact condition with injured tissue.
Fig. 2 A and 2B show wound dressings assembly 200, are made of the adhesive backed sheet 202 of a patch 100 that is provided with conduit and a water vapor permeable.Usually, the tergite of cohesive water vapor permeable is a known technology in affiliated field, and thinks that described tergite is by keeping helping with respect to the best wetness of some specific wound the healing of wound.In use, patch assembly 200 is placed on the wound surface, its patch part 100 that is provided with conduit is contacted with wound.Cohesive sheet 202 covers the patch 100 that is provided with conduit, and is adhered on the skin of contiguous wound.The advantage that assembly 200 provides the patch 100 that is provided with conduit to be had.Additionally, when moisture vapor can be transmitted, 202 pairs of assemblies of cohesive sheet 200 carried out fastening and the protection wound makes it avoid bacterial infection or the like.
Fig. 3 A, 3B, 3C and 3D show another gratifying embodiment of the present invention.Being used for being provided with the matrix of wound dressings 300 of shrinkage pool or structural member can be by being similar to the material that utilized at the patch 100 that is provided with conduit and forming by production method structure similar with it.Fig. 3 A has drawn the axonometric chart of the patch 300 that is provided with shrinkage pool, above its contact surface 320 is positioned among the figure.Fig. 3 D is depicted as the profile of the patch 300 that is provided with shrinkage pool, shows several contact elements 332 and dimple voids 330 among the figure best.Preferably, total dimple voids area occupies at least 25% of total patch area.More preferably, total dimple voids area occupies at least 50% of total patch area.Dimple voids 330 is defined by sidewall 332 parts.332 of sidewalls play inflexible effect partly are provided, and wherein said rigidity is compacted required for opposing dimple patch 300.Preferably, contact element is configured to have arc contact surface.One preferred embodiment in, contact radius (radius ofcontact) at about 0.1mm between the 1mm.
Dimple voids 330 can be made multiple rule or irregular shape.Preferably, it is not " undercutting (undercut) " that dimple voids is configured to make it, thereby makes the periphery in each aperture less than the periphery of corresponding internal pore." undercutting " or netted gap structure can cause tissue breakage when removing patch 300, reason be when with material when wound is removed, can tear any tissue in the progress space.Additionally, undercutting or netted gap structure more likely cause the patch material to be shed in the wound tissue of new growth.
One preferred embodiment in, the base material that is used for patch 300 is Masterflo RTM, is made by the BBA group of masschusetts, u.s.a Wakefield.In this illustrative embodiments, the thickness of base material is approximately 1.0mm.Make dimple voids 330 drop stampings in base material, its degree of depth is approximately 0.75mm, its diameter then is approximately 2mm.
Because general contact layer whenever just is replaced in a few days, therefore important part is to consider the aligned probability in space of the tissue that makes new formation and new contact layer.Thereby, according to illustrative embodiments of the present invention: 1) can carry out random arrangement, make each patch recurve interporal lacuna 330 of changing not come into line with new tissue growth to dimple voids 330; 2) can provide the different contact layers of shrinkage pool with different-diameter; Perhaps 3) can use the shrinkage pool of different interval when each time material being changed.
Fig. 3 B and 3C show the corresponding top and bottom perspective views of the patch 300 that is provided with shrinkage pool respectively.Can imagine a version that obtains this embodiment in addition, promptly have the top and dimple voids on the bottom 330 and/or the contact element 322 that are arranged on the patch 300 that is provided with shrinkage pool simultaneously.Also can imagine and obtain relevant second version that is provided with the wound dressings 300 of shrinkage pool, wherein, some or all of dimple voids 330 are substituted by the eyelet that passes the whole thickness of structural member, make the top and bottom perspective views of this version will seem the view shown in Fig. 3 B.
In an illustrative embodiments, dimple voids 330 can partly be filled therapeutant.For example, Fungicidal substance can be placed in the space 330, so that infected wound is handled.In addition, biological consolidant can be transferred in the space, to improve neoblastic formation speed.In another illustrative embodiments, the layer body of patch 300 can have different functions on each sidepiece.For example, a side of patch 300 can be optimized at neoblastic growth, and opposite side then can be optimized at the transmission of antibacterial.
The use of patch that is provided with shrinkage pool is shown by Fig. 4 A, 4B and 4C.Fig. 4 A is depicted as wound surface 400.Notice that wound surface 400 can be represented the little interior section of dark tissue wounds or the great majority in the shallow superficial cut.Fig. 4 B is depicted as the patch 300 that will be provided with shrinkage pool and is applied on the wound surface 400, and the corresponding tissue growth 410 that is arranged in dimple voids 330.At last in Fig. 4 C, show the patch 300 that to be provided with shrinkage pool and remove and only leave tissue growth 410.Provide one to be used to make patch 300 to keep being pressed onto external force on the wound surface as touching upon in detail following, and being desirably.
Fig. 5 A and 5B show another embodiment of the present invention, promptly coarse irregular patch 500.Referring to axonometric chart, Fig. 5 A has drawn the situation that irregular patch 500 has irregular space 510 and irregular contact surface 520, wherein said contact surface 520 play " hook-type " element effect, it can contact and bond on the slough when being placed on matrix in the wound.When with matrix when wound is removed because slough bonds on the hook-type jut 520, thereby it can be removed from wound.The dismounting of matrix is removed wound.Removing of slough is the pith that cicatrizes a wound.The matrix of patch 500 can be made by polyester felt or floccule (batting).In an illustrative embodiments, with hot-air described felt is burnt, thus the fibers melt of certain percentage and form textured surface with some hook elements 520.Another suitable configuration can be for example with hook material (hook material) hook-shaped or that toward endless fabrics is together used.
Although employed method and matrix help neoblastic growth, after suitably removing slough, wound still can be subjected to infecting and can handle it with the material that for example comprises antimicrobial silver, and wherein said material plays effect aspect killing bacteria.
Usually, the wound healing stage of new organization formation refers to proliferative phase.In case fully heal at the proliferative phase wound, and amount of bacteria fully descends, and then can use not contain matrix antimicrobial silver and that randomly contain the growth material, is beneficial to the continuous hypertrophy of new cell tissue.
Fig. 5 B is depicted as the random cross section of irregular patch 500.Can be by making suitable matrix through below the fusing point that is in the matrix composition material or near the convection of heat the fusing point, and make the roughened surface of irregular patch 500.For example, polymeric material is usually from about 250 degrees centigrade of fusions to about 290 degrees centigrade scope.Polyester felt material below the of short duration process source of conductive heating of operating under this scope will be gone through melt surface and the alloying process that is positioned at its lip-deep polymer filaments subsequently.Can be by temperature and open-assembly time and the fused degree of control surface, the surface that has the desired roughness that shows irregular space 510 and irregular contact element with generation.Although shown irregular patch 500 only has a roughened surface, the present invention is not subjected to this limit limit, and is former because can similarly all carry out roughening to upper surface and lower surface.Such patch will be quite useful when impaired wound is treated.
As mentioned above, the processing of using the invention of this Wound bandage to carry out comprises depresses creative binder, makes itself and wound surface be in tight contact condition.Usually, described power 0.1psi at least.Can imagine the whole bag of tricks and the system that obtain being used to keep described tight contact condition.These method and systems can comprise: be attached to bonding film on the creative binder and be attached to contiguous wound surface part; Make binder be entangled on the patch and make it twine injured area; And airbag or other inflatable bladder things be fastened on the structural member, make bladder fill gas or liquid with.In an illustrative embodiments, off and on pressure is applied on the bladder.Conformable seal can be placed on the wound, and make its contact structures part, then again rigid seal is fastened on wound above, contact with structural member, be delivered on the contact structures part thereby exert all one's strength.Then between rigid seal and pliability sealing member, exert pressure, the contact structures part is pressed onto on the wound surface.Can apply suction simultaneously and improve tight contact by using conformable cover to seal up wound area.When using suction, the wound dressings 300 that is provided with shrinkage pool is applicable to described application especially well.Usually, the magnitude range of suction is between 0.25PSI and 5psi.By the wound dressing material being wrapped up on the back side of patch, can further improve the use of suction.A kind of this type of suitable wound dressing material is described in No. the 60/554th, 158, the U.S. Provisional Patent Application, and its applying date is on March 18th, 2004.
Case study 1
Patient A, 70 years old, the male, RG secondary decubital ulcer is obviously festered.Contact structures part of the present invention is applied on the wound, bonding film is placed on above the wound, and contact with structural member.Below bonding film, apply the suction of 1.1psi, so that power is delivered on the contact structures part.Continue to keep suction substantially.Changed contact material every two to four days.Using these articles for use after 30 days, the basic healing of the part of festering of wound, the open area of wound narrows down to 45 square centimeters from 66 square centimeters.Wound is carried out split thickness skin graft.
Case study 2
Patient B, 50 years old, the male, right ankle fracture (facture) exposes bone.Use plate carrying out the reduction of the fracture, and the rectus abdominis m. flap processing that dissociate, the bone and the hardware (hardware) that expose covered.Only part survival of flap causes forming and has bone and a wound hard thing, that have opening that exposes.Contact structures part of the present invention is applied on the wound, and bonding film is placed on the top of wound and makes its contact structures part.By making fabulous binder twine ankle, or power is applied on the contact structures part by the application of suction.Usually, apply suction about half a day, and in the remaining time on the same day, maintain the power of binder jacket, after some days, only use the binder jacket so that power to be provided.When providing power, use the suction between 1 to 2psi by suction.Less than fortnight, new organization grows on the hard thing that exposes.In the time period in 7 week, wound area narrows down to 28 square centimeters from 50 square centimeters.
Although in present specification, show and described preferred implementation of the present invention, should understand, provide these embodiments only to act on presented for purpose of illustration.The those skilled in the art can imagine and obtains many variation, modification and alternatives that do not depart from spirit of the present invention.Therefore, claims will be contained all and fall into described variation scheme within the scope and spirit of the present invention.