TWI362951B - System and method for percutaneously administering reduced pressure treatment using a flowable manifold - Google Patents

Description

1362951 6. INSTRUCTIONS OF THE INVENTION: TECHNICAL FIELD OF THE INVENTION The present invention relates generally to a system and method for promoting tissue growth, and more particularly to a method for decompressing a tissue site Tissue treatment system. [First as technology] People are gradually using decompression therapy to promote wound healing in soft tissue wounds that heal very slowly or not heal without using decompression therapy. Typically, the reduced pressure is applied to the wound site by an open-cell foam that acts as a manifold to distribute the reduced ink force. The open-cell foam is sized to be suitable for existing wounds, in contact with the wound, and then periodically replaced with a smaller foam as the wound begins to heal and become smaller. In order to minimize the amount of tissue growing into the pores of the foam, it is necessary to frequently replace the open-cell foam. "The large amount of tissue that is growing during the removal of the foam can cause pain to the patient. Decompression therapy is usually applied to non-healing open wounds. In some cases, the tissue being treated is subcutaneous tissue, and in other instances, the tissue is located in or on the skin tissue. Traditionally, decompression therapy has been primarily used in soft tissue. Decompression therapy has not generally been used to treat closed deep tissue wounds due to the difficulty of accessing such wounds. In addition, 'decompression therapy has not been combined with healing bone: defect or promotion of bone growth, which is mainly due to difficulty in approaching the month.] The problem of surgical treatment of exposure to bone loss may result in less waste treatment than it is solved. More questions about the problem. Finally, the development of devices and systems for the application of decompression therapy has barely exceeded the open-cell foam member 154474.doc 1362951 - the shape of the open-cell foam is adapted to the wound site by hand and subsequently treated under reduced pressure Remove it after the cycle. SUMMARY OF THE INVENTION The system and method of the present invention addresses the problems associated with prior wound healing systems and methods. In accordance with an embodiment of the present invention, a decompression therapy delivery system is provided for applying a reduced pressure to a tissue site. The reduced pressure delivery system includes a manifold delivery tube having a passageway and a distal end configured to be inserted through the skin and placed adjacent to the tissue site. A flowable material can be transported through the skin to the tissue site by the manifold delivery tube to enable the flowable material to fill a void adjacent the tissue site to form a plurality of flow channels in fluid communication with the tissue site The manifold. A reduced pressure wheel is provided that is in fluid communication with the flow passages of the manifold. Another embodiment according to the present invention provides a method of performing a decompression treatment on a tissue site, which comprises positioning a distal end of a manifold delivery tube adjacent to a tissue site through the skin. A flowable material is delivered to the tissue site through the skin via the manifold. The flowable material is capable of filling a void adjacent the tissue site and forming a manifold having a plurality of flow channels in fluid communication with the tissue site. The tissue site is subjected to a reduced pressure via the flow passage of the manifold. Other objects and features of the present invention will become apparent from the following detailed description. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Hereinafter, preferred embodiments will be described in detail with reference to the accompanying drawings, which form a part of the present invention and in which . In order to enable those skilled in the art to practice the invention, the embodiments are described in sufficient detail, and it should be understood that embodiments may be utilized and modifications may be made in the logical, mechanical, electrical, and chemical aspects. The spirit or scope of the invention is not departed. To avoid obscuring the details required to practice the invention, those skilled in the art may omit certain information that is familiar to those skilled in the art. Therefore, the following detailed description is not to be considered as limiting, and the scope of the invention is defined by the scope of the appended claims. The term "elastic" used in this article means having the properties of an elastomer. The term "elastomer" large system refers to a polymer material having properties like rubber. More specifically, most elastomers have greater than earned. Elongation and apparent resilience. The resilience of the material means that the material can recover from elastic deformation. Examples of the physical body may include, but are not limited to, natural rubber, polyisophthalide dilute styrene butyl rubber, gas butyl rubber, polybutadiene, Guess rubber, isobutyl rubber 'ethylene (four) rubber, ethylene propylene dilute rubber, chlorosulfonated polyethylene, polysulfide rubber 'polyurethane vinegar, and polyfluorene. The term "flex" as used herein refers to an object or material that can bend or flex. Elastomeric materials are generally ductile' but the flexible materials referred to herein do not define the selected material only as an elastomer. The use of the term "tractability" in conjunction with the materials of the present invention or a reduced pressure delivery device means that the material can be applied or closely matched to the shape of a tissue. For example, the flexible nature of a reduced-bulk delivery device for treating a bone defect can enable the device to wrap or wrap around a bone portion having a defect. 154474.doc 1362951 The term "fluid" is used herein to refer to a gas or liquid, but may also include any other flowable material, including but not limited to a gel. , colloid or bubble. The term "• impermeability" as used herein generally refers to the ability of a film, covering or other material to block or slow the penetration of a liquid or gas. Impermeability can be used to refer to a covering, sheet or other film that blocks the passage of liquid while allowing gas (4) film. Although the impervious film can be impervious

Body, however, the film may simply reduce the transmission of all or only certain liquids. The use of the term "imperviousness" is not intended to imply that the impermeable film is above or below any particular X-value (IV) value, such as a specific value for water vapor transmission rate (WVTR). The term "management" large system refers to a substance or structure provided to help reduce pressure on a tissue site, deliver fluid to or remove fluid from the tissue site. The manifold typically contains plural Interconnected flow channels or passages to improve the distribution of fluids provided to or removed from the tissue area surrounding the manifold. Examples of manifolds may include, but are not limited to, structural elements that are not disposed to form flow channels Device, honeycomb foam (e.g., open cell foam), porous tissue collection device, and liquid, gel, and foam containing flow channels after solidification. The term "reduced pressure" is used herein. The system refers to the pressure at the tissue site that is receiving treatment that is less than the surrounding pressure. In most cases, this reduced pressure will be less than the environmental pressure at the patient's location. Another option is that the reduced pressure can be less than the hydrostatic pressure of the tissue at the tissue site. Although the vacuum can be used to describe the pressure applied to the tissue site 154474.doc 1362951, the actual pressure applied to the tissue site can be significantly lower than the force normally associated with pure vacuum. . The reduced pressure creates fluid flow in the area of the tube and tissue at the beginning. As the hydrostatic pressure around the tissue site approaches the desired reduced pressure, the flow may slow down and then maintain the reduced pressure. Unless otherwise stated, the pressure values described herein are gauge pressures. The term "stent" as used herein refers to a substance or structure used to enhance or promote cell growth and/or tissue formation. The scaffold is typically a three-dimensional porous structure that provides a template for cell growth. Coated with or consisting of cells, growth factors or other nutrients for promoting cell growth. A stent can be used as a manifold according to embodiments described herein to treat tissue sites with reduced pressure tissue treatment. By "tissue site" is meant a wound or defect located above or within any tissue, including but not limited to bone tissue, adipose tissue, muscle tissue, nerve tissue, skin tissue, vascular tissue, connective tissue, cartilage, tendon, or ligament. The term "tissue site" may further refer to the region of any tissue that is not necessarily injured or defective, but which is intended to enhance or promote the growth of additional tissue in such regions. For example, in certain organizations Decompression tissue treatment is used in the area to grow additional tissue, which can then be harvested and transplanted to On a tissue site. Referring to Figures 1-5, a reduced pressure delivery device or wing manifold 211 in accordance with the principles of the present invention includes a flexible barrier 213 having a ridge portion 215 and a pair of wing portions 219. The portions 219 are all located along opposite sides of the ridge portion 215. The ridge portions 215 form an arcuate passage 223 that may or may not extend over the entire length of the wing manifold 211. Although the ridge portions 215 can be centrally positioned on the wing manifold 211 such that the widths of the wing portions 219 are equal, the ridge portions 215 can also be unbiased as in Figure 15, thereby making one of the wings The portion 219 is wider than the other wing portion 219. If the wing manifold 211 is used in conjunction with bone regeneration or healing and the wider wing manifold 211 will wrap around the fixed hardware attached to the bone, then The extra width of one of the wing portions 21 9 may be particularly useful. The flexible barrier 213 is preferably made of an elastomeric material such as a polyoxyl polymer. One example of a suitable polyoxyl polymer includes that it is located in Carpinteda>

MED-6015 manufactured by Nusil Technologies of California. However, it should be noted that the flexible barrier 213 can be made of any other biocompatible, flexible material. The flexible barrier 213 encloses a flexible backing 227 to enhance the strength and durability of the flexible barrier 213. The flexible barrier 213 enclosing the flexible backing 227 may have a thickness in the arcuate channel 223 that is less than the thickness in the wing portion 219. If a polysiloxane polymer is used to form the flexible barrier 2丨3, a polyoxynitride adhesive can also be used to help bond the flexible backing 227. Examples of polyoxynoxy binders include viED_1011, also sold by Nusil Technologies. The flexible backing 227 is preferably made of a polyester knit fabric, such as Bard 6〇13 manufactured by CR Bard, Inc. of Tempe, Arizona. However, the flexible backing 227 can be reinforced by any flexible barrier 2 3 is made of biocompatibility and flexible material for strength and durability. In some cases, the flexible backing 227 can be dispensed with if the flexible barrier 2 is made of a material of suitable strength. Preferably, the flexible barrier 213 or the flexible backing 227 is impermeable to liquids, air, and other gases, or alternatively, both the flexible backing 227 and the flexible barrier 2i3 are impermeable to liquids, air, and Other gases. The flexible barrier 213 and flexible backing 227 can also be made of a bioresorbable material that does not have to be removed from the patient after use of the reduced pressure delivery device 21 . Suitable bioresorbable materials can include, but are not limited to, polymeric blends of polylactic acid (PLA) and polyglycolic acid (PGA). The polymeric blends can also include, but are not limited to, polycarbonates, polyfumarates, and capralact〇ne. The flexible barrier 213 and flexible backing 227 can be further utilized as a new cell growth scaffold or a scaffold material can be used in conjunction with the flexible barrier 213 and flexible backing 227 to promote cell growth. Suitable scaffolding materials can include, but are not limited to, calcium phosphate, collagen, PLA/PGA, coral hydroxyapatite, carbonate, or treated allograft materials. Preferably, the scaffold material will have a high void fraction (i.e., a high air content). In one embodiment, the flexible backing 227 can be secured to the surface of the flexible barrier 213 in an adhesive manner. If a polysiloxane polymer is used to form the flexible barrier 213, the flexible backing 227 can also be secured to the flexible barrier 213 using a polyoxynene adhesive. Although the adhesive is a preferred method of attachment when bonding the surface of the flexible backing 227 to the flexible backing 213, any suitable method of attachment can be used. The flexible barrier 213 includes a plurality of protrusions 23 extending from the wing portion 219 on the surface of the flexible barrier 213. The protrusions 231 may be cylindrical, spherical, hemispherical, cubic, or any other shape as long as each The plane in which at least a portion of a protrusion 231 is located is different from the plane associated with the side on which the protrusion 231 is fixed on the flexible backing η]. In this regard, even 154474.doc • 10· 1362951 does not require that a particular protrusion 231 have the same shape or size as the other protrusions 23 i. In fact, the protrusions 231 may comprise random blends of different shapes and sizes. Therefore, the distance each protrusion 231 protrudes from the flexible barrier 213 can be varied 'but can also coincide in the plurality of protrusions 23ι. The projections 231 are disposed on the flexible barrier 213 to form a plurality of flow passages 233 between the projections. When the projections 231 have the same shape and size and are evenly spaced across the flexible barrier 213, the flow passages 233 formed between the projections 231 are equally uniform. The size and shape of the flow path 233 can also be varied by utilizing changes in the size, shape and spacing of the protrusions 231. As shown in Fig. 5, a reduced pressure delivery tube 241 is located in the arcuate passage 223 and is fixed to the flexible barrier 213. The reduced pressure delivery tube 241 can be secured only to the flexible barrier 2 13 or the flexible backing 227, or the tube 24 1 can be simultaneously secured to both the flexible barrier 213 and the flexible backing 227. The reduced pressure delivery tube contains a distal opening 243 at the distal end of the tube 241. The tube 241 can be positioned such that the distal aperture M3 is located at any point along the arcuate channel 223, but the tube is preferably positioned such that the distal aperture 243 is located at approximately the midpoint along the longitudinal length of the arcuate channel 223. Preferably, the distal aperture 243 is formed into an elliptical or circular shape by a planar cutting tube 241' oriented at an angle of less than ninety (9 degrees) relative to the longitudinal axis of the tube 241. Although the aperture 243 may also be circular, the expanded circular shape of the aperture 243 enhances fluid communication with the flow passage 233 formed between each projection 23. The reduced pressure delivery tube 241 is preferably made of polypyrene or aminic vinegar coated with paraiyne. However, any medical grade pipe material can be used to construct a reduced pressure transmission 154474.doc 1362951. Other coatings that can be applied to the tube include heparin, anticoagulants, anti-fibrinogen, anti-adherent agents, anti-prothrombin, and hydrophilic coatings. In one embodiment, 'as an alternative to or in addition to the distal orifice 243, the reduced pressure delivery tube 241 may also include a discharge opening or discharge orifice 25 along the reduced pressure delivery conduit 24i. 1, to further enhance the fluid communication between the reduced pressure delivery official 241 and the flow channel 233. The reduced pressure delivery tube si can be positioned only along one of the longitudinal extents of the arcuate passage 223 as shown in Figure 1-5, or alternatively, can be positioned along the entire longitudinal extent of the arcuate passage 223. If positioned such that the reduced pressure delivery tube 241 occupies the entire length of the arcuate passage 223, the distal opening 243 can be capped such that all fluid communication between the tube 241 and the flow passage 233 is via the discharge opening 25 1 get on. The reduced pressure delivery tube 241 further includes a proximal aperture 255 at the proximal end of the tube 241. The proximal orifice 255 is configured to cooperate with a source of reduced pressure, which will be described in more detail below with reference to circle 9. The reduced pressure delivery tube 241 shown in Figures _3, 4A and 5 contains only a single lumen or passage 259. However, the reduced pressure delivery tube 241 can be provided with a plurality of lumens, such as the dual lumen tube 26! shown in Figure 4A. The double lumen tube 261 includes a first lumen 263 and a second lumen 265. The dual lumen tube is used between the proximal end of the reduced pressure delivery tube 241 and the flow channel 233. . For example, a dual s cavity & 261 can be used to achieve communication between the reduced pressure source and the flow channel 3 along the first lumen 263. The second lumen 265 can be used to introduce fluid into the flow channel 233. The fluid may be passed through a gas or other gas, an antibacterial agent, an antiviral agent, a cell growth promoter, a rinse drool, a chemically active fluid, or any other fluid. If it is desired to introduce a plurality of streams 154474.doc -12. 1362951 into the flow channel 233 via separate fluid communication (iv), the reduced pressure delivery tube can have more than two lumens. Still referring to Fig. 4B', the horizontal spacer 271 separates the first and first official chambers 263, 265 of the reduced pressure delivery tube 261 such that the first lumen 263 is positioned above the first official chamber 265. The relative positions of the first lumen and the second lumens 263, 265 may be differentiated depending on how fluid communication is provided between the lumens 263, 2 65 and the flow channel 233. For example, when the first lumen is not positioned as in FIG. 4B, a discharge opening similar to the discharge opening 251 can be provided to achieve communication with the flow channel 233. When the second lumen is in the image In the illustrated orientation, the second lumen 265 can be in communication with the flow channel 233 via a distal orifice similar to the distal orifice. Alternatively, the plurality of lumens in a reduced pressure delivery tube can be positioned side by side by a vertical spacer separating the lumens or the lumens can be positioned concentrically or coaxially. It will be readily apparent to those skilled in the art that the provision of independent fluid communication paths can be accomplished in a number of different ways including the provision of a multi-lumen tube as described above. Alternatively, a separate fluid communication path can be provided by securing a single lumen to another single lumen tube or by means of a plurality of separate, unsecured tubes with single or multiple lumens. If a separate tube is used to provide the flow channel buckle: the separate fluid communication path' ridge portion 215 can include a plurality of contoured channels 223, each of which has a chevable channel (2). Alternatively, the chevron channel 223 can be enlarged to accommodate a plurality of tubes. An example of a reduction with a fluid delivery tube will be described in more detail below with reference to Figure 9: See Figure 6.8, a pressure delivery device or wing 154474.doc 13. 1362951 manifold in accordance with the principles of the present invention The 311 includes a flexible barrier 313 having a ridge portion 315 and a pair of wing portions 319. Each wing portion 3 19 is positioned along the opposite side of the ridge portion 3丨5. The ridge portion 315 defines an arcuate passage 323 that may or may not extend over the entire length of the wing manifold 311. Although the ridge portions 315 can be centrally positioned on the wing manifold 311 such that the widths of the wing portions 319 are equal, the ridge portions 315 can also be offset as shown in Figure 68, thereby causing one of the wings The portion 319 is wider than the other wing portion 319. If the wing manifold 311 is used in conjunction with bone regeneration or healing and the wider wing manifold 311 will wrap around the fixed hardware attached to the bone, the extra width of one of the wing portions 3 19 may be exceptional it works. A honeycomb material 327 is secured to the flexible barrier 313 and is provided as a single piece of material that covers the entire surface of the flexible barrier 313 across the ridge portion 315 and the two wing portions 319. The honeycomb material 327 includes a fixed surface (not visible in Fig. 6) disposed adjacent to the flexible barrier 313, a distribution surface 329 opposite the fixed surface, and a plurality of peripheral surfaces 33A. In an embodiment, the flexible barrier 313 can be similar to the flexible barrier 213 and includes a flexible backing. Although the adhesive system is a preferred method for solidifying the honeycomb material 327 to the flexible barrier 313, it may be fixed by any suitable fixing method to fix the barrier 313 material. This is left to the user to perform a set of flexible barriers (1) and/or flexible backings at the treatment site to act as an impervious barrier to block the passage of fluids such as liquids, air or other gases. In the real case, the flexible barrier and the flexible backing may be provided in a separate manner to support the honeycomb material 327. Rather, the honeycomb material 327 can have a 154474.doc 1362951 integral barrier layer that is impervious to one of the honeycomb materials 327. P knife. The barrier layer may be formed of a closed-cell material to prevent fluid from penetrating, thereby replacing the flexible barrier 313. If the integral barrier layer is used with the honeycomb material 327, the barrier layer may comprise a raised ridge portion and a wing portion as described above with reference to the flexible barrier 313. The flexible barrier 313 is preferably made of an elastic material such as a polyoxy 7 polymer. An example of a suitable polyoxyl polymer includes the presence of it. Coffee (10), με〇 (4)5 manufactured by Nusil Techn〇1〇gies of CaHfornia. However, it should be noted that the flexible fence 313 can be made of any other biocompatible, inert material. If the flexible barrier encloses or otherwise includes a flexible backing, the flexible backing is preferably made of a woven knit fabric, such as Bard 6〇13 manufactured by CR Bard, Inc. of Tempe, Arizona. to make. However, the flexible backing 227 can be made of any biocompatible, flexible material that enhances the strength and durability of the flexible barrier 3丨3. In the known crucible, the honeycomb material 327 is an open-cell, network polyether urethane foam having a pore size of about 4 〇〇 6 6 μm. An example can be included by located in San Antonio,

GranuFoam, manufactured by Kinetic Concepts, Texas. Honeycomb material 327 can also be a gauze, felt pad, or any other biocompatible material that provides fluid communication in a plurality of dimensions in a plurality of channels. Honeycomb 枓 327 is primarily a "open-hole" material that contains a plurality of holes that are fluidly connected to the adjacent hole. A plurality of flow channels are formed between the "open holes" by the "open holes" of the honeycomb material 327. The flow channels are capable of achieving fluid communication in the entire portion of the honeycomb material 327 having open pores 154474.doc • 15· 1362951. The cells and flow channels can have a uniform shape and size' or can include patterned or random shapes and dimensional changes. Variations in the size and shape of the apertures in the honeycomb material 327 can cause variations in the flow path' and such characteristics can be used to alter the flow characteristics of the fluid flowing through the honeycomb material 327. The honeycomb material 327 may further include a portion containing a "closed hole". The closed cell portion of the honeycomb material 327 includes a plurality of holes, most of which are not fluidly connected to her adjacent holes. An example of a closed hole portion is described above as a barrier layer that can replace the flexible barrier 313. A closed hole portion may be selectively disposed in the honeycomb material 327 to prevent fluid from penetrating the peripheral surface 330 of the honeycomb material 327. The flexible barrier 313 and the honeycomb material 327 can also be made of a bioresorbable material that does not have to be removed from the patient after use of the reduced pressure delivery device 31. Suitable bioresorbable materials can include, but are not limited to, polymeric blends of polylactic acid (PLA) and polyglycolic acid (pga). The polymeric blends can also include, but are not limited to, polycarbonates, polyfumarates, and capralact〇ne. The flexible barrier 3 13 and the honeycomb material 327 can be further used as a new cell growth scaffold' or a scaffold material can be used in combination with the flexible barrier 313 'flexible backing 327 and/or honeycomb material 327 to promote cell growth. . Suitable stent materials can include, but are not limited to, calcium phosphate, collagen, PLA/PGA, coral hydroxyapatite, carbonate, or treated allograft materials. Preferably, the material will have a void ratio (i.e., a high air content). A reduced pressure delivery tube 341 is positioned within the arcuate passage 323 and secured to the flexible barrier 313. The reduced pressure delivery tube 341 can also be secured to the honeycomb material 327, or in the presence of only the honeycomb material 327, the reduced pressure delivery tube 341 can be 154474.doc -16 - 1362951 only secured to the honeycomb material 327. The reduced pressure delivery tube 341 includes a distal opening 343 at the distal end of the tube 341 which is similar to the distal opening 243 of FIG. The reduced pressure delivery tube 341 can be positioned such that the distal aperture 343 is located at any point along the arcuate channel 323 but is preferably positioned at approximately the midpoint along the longitudinal extent of the arcuate channel 323. Preferably, the distal aperture 343 is formed into an elliptical or oval shape by cutting the tube 341 along a plane oriented at an angle of less than ninety (90) degrees with respect to the longitudinal axis of the tube 34. Although the aperture can also be circular

However, the elliptical shape of the orifice enhances fluid communication with the flow channels in the honeycomb material 327. In the example, the reduced pressure delivery tube 341 may also include a discharge opening or discharge orifice (not shown) similar to the discharge opening 25 of Figure 5. In addition to or in addition to the distal orifice 343, a discharge opening is disposed along the tube 341 to further enhance fluid communication between the reduced pressure delivery tube 341 and the flow passage. As previously described, the reduced pressure delivery tube 341 can be positioned only partially along one of the longitudinal extents of the arcuate passage 323, or alternatively, can be positioned along the entire longitudinal extent of the arcuate passage 323. If positioned such that the reduced pressure delivery tube 341 occupies the entire arched passage 323, the distal opening can be covered' so that all fluid communication between the tube 341 and the flow passage is via the discharge opening. Preferably, the honeycomb material 327 covers and directly contacts the reduced pressure delivery tube W. The honeycomb material 327 can be attached to the reduced pressure transport (4) or the honeycomb material (4) can be fixed only to the flexible barrier 313. If the reduced pressure delivery tube 34i is positioned such that it extends only to a point in the meandering passage 323, the honeycomb material 327 can also be connected to the 154474.doc in the region of the arched passage 323 that does not include the reduced pressure delivery tube (4). 1362951 The ridge portion 315 of the flexible barrier 313. The reduced pressure delivery tube 34! further includes a proximal aperture 355 at the proximal end of the tube 341. The proximal orifice 355 is configured to cooperate with a source of reduced pressure, which will be described in greater detail below with respect to Figure 9. The reduced house, tube 30, shown in Figure 68, contains only a single lumen or passage (10). However, the reduced pressure delivery tube 341 can be provided with a plurality of lumens, such as the plurality of lumens previously described with reference to the drawings. As previously described, the use of a multi-lumen tube provides a separate fluid communication path between the proximal end of the reduced pressure delivery tube 341 and the flow channel. The separate fluid communication paths may also be provided by separate tubes having single or multiple lumens in communication with the flow channels. Referring to Figures 8A and 8B, a reduced pressure delivery device 37i in accordance with the principles of the present invention includes a reduced pressure delivery tube 373 having an extension 375 at a distal end 377 of the reduced pressure delivery tube 373. The extension portion 375 is preferably arched to match the curvature of the reduced pressure delivery tube 373. The extension portion 375 can be formed by removing a portion of the reduced pressure delivery tube 373 at the distal end 377, thereby forming a slit 381 having a shoulder 383. A plurality of protrusions 385 are disposed on an inner surface 387 of the reduced pressure delivery tube 373 to form a plurality of flow channels 391 between the protrusions 385. The size, shape and spacing of the protrusions 385 can be similar to the protrusions described with reference to the figures. The reduced pressure delivery device 371 is particularly suitable for applying reduced pressure to connective tissue that can be received in the incision 381 and regenerating tissue on the connective tissue. The band, the tendon and the cartilage are non-limiting examples of tissue that can be treated by the reduced pressure delivery device 371. Referring to Figure 9, a tissue site 413 (e.g., human bone 154474.doc -18-1362951 415 of the patient) is treated with reduced pressure tissue using a reduced pressure delivery device 411 similar to other reduced pressure delivery devices described herein. When used to promote bone tissue growth, decompression tissue treatment increases the rate of healing associated with fractures, non-union, voids, or other bone defects. It is further believed that reduced pressure tissue treatment can be used to improve the recovery of osteomyelitis. This treatment can be further used to improve local f road stimuli in patients with osteomyelitis. Finally, reduced pressure tissue treatment can be used to accelerate and improve oseointegration of orthopedic implants such as hip implants, knee implants, and fixation devices. Still referring to Fig. 9, the reduced pressure delivery device 411 includes a reduced pressure delivery tube 9μ having a proximal end 42i fluidly coupled to a reduced pressure source 427. The reduced pressure source 427 is a pump or any other device capable of applying a reduced pressure to the tissue portion 4丨3 via a plurality of flow passages associated with the reduced pressure delivery tube 々Μ and the reduced pressure It delivery device 411. Applying the reduced pressure to the tissue site 413 is accomplished by arranging the wing-shaped portion of the reduced-pressure delivery device 4 ii, in this particular example, which involves wrapping around the void defect 429 in the bone μ; Wings & The reduced pressure delivery device 4ι can be inserted by surgery or through the skin. When inserted through the skin, the reduced pressure delivery S 419 is preferably inserted through a sterile insertion sheath that penetrates the skin tissue of the patient. The application of decompression, sputum and weaving treatment usually produces granulation in the area around the tissue site 413, which is a common tissue formed by tissue repair in the human body. Under normal conditions, granulation tissue m may be formed in the presence of foreign bodies or during wound healing and is typically used as a scaffold for healthy replacement tissue and further to form a certain type of mad tissue. The granulation tissue is highly vascularized, and the increased growth rate of such highly vascularized tissue promotes the growth of new tissue at the tissue site 413 154474.doc 1362951 in the presence of reduced pressure. Still see Figure 9' The fluid delivery tube 431 can be fluidly coupled to the flow channel of the reduced pressure delivery device 411 at a distal end. Fluid delivery tube 431 includes a proximal end 432 that is fluidly coupled to a fluid delivery source 433. If the flow system air being delivered to the tissue site is preferably filtered by a filter 434 capable of filtering particles as small as 22 μm, the air is purified and sterilized, in particular, the S tissue portion 41 3 is located on the skin surface. In the following, it is very important to introduce air into the tissue site 413, which facilitates the good dredge of the tissue site 413 'to reduce or prevent the obstruction of the reduced pressure delivery tube 419. The beta fluid delivery tube 43 1 and the fluid delivery source 433 can also be used to the tissue. Site 413 introduces other fluids including, but not limited to, antibacterial agents, antiviral agents, cell growth promoters, irrigation fluids, or other chemically active agents. When inserted through the skin, the reduced pressure delivery tube 43 1 is preferably inserted through a sterile insertion sheath that penetrates the skin tissue of the patient. A pressure sensor 43 5 can be operatively coupled to the fluid delivery tube 43 1 ' to indicate whether the fluid delivery tube 43 1 is blocked by blood or other bodily fluids. Pressure sensor 435 can be operatively coupled to fluid delivery source 433 to provide feedback to control the amount of fluid introduced to tissue site 4丨3. A check valve (not shown) may also be operatively coupled to the vicinity of the distal end of the fluid delivery tube 43 to prevent blood or other bodily fluids from entering the fluid delivery tube 431. The separate fluid communication paths provided by the reduced pressure delivery tube 419 and the fluid delivery tube 43 1 can be accomplished in a number of different ways, including providing a single multi-lumen tube as previously described with reference to Figure 4A. Those of ordinary skill in the art will recognize that if a multi-lumen tube is used, the sensors associated with the fluid delivery tube 43 154474.doc -20·, valves and other batches, and Associated with one of the specific lumens of the reduced pressure delivery tube 419. It is preferred that any lumen or tube in fluid communication with the tissue site be coated with an anti-beta blood dance agent to prevent body fluid or blood from clogging within the lumen or tube. Other coatings that can be applied to the sputum, including the heparin, anticoagulant, total fibrinogen, anti-adherent, anti-prothrombin, and hydrophilic coatings. See Figure 10-19, 4 λ & The test has proved that the effect of ##||丨子子 is positive when applying decompression tissue treatment to bone tissue. In a particular trial, a logarithmic rabbit " decompressive tissue treatment' was used to determine its effect on bone path growth and regeneration. The specific goal of the % gentleman Ji head & /, test is to find the effect of decompression tissue treatment on rabbits with defects or injuries, decompression tissue treatment for the skull on the skull

The effect of the rabbit with size I defect and the effect of using a stent material with decompression tissue; A σ therapy for the treatment of critical dimensions on the skull. Dan, Office, Bl, and the number of rabbits are listed in Table 1 below. Test protocol 4 4 4 4 Membrane sound "', defect, in the intact bone-salt tissue treatment (RPTT) by honeycomb foam (GranuFoam) for 6 days, and immediately harvested the first two defects on the tissue; No decompression tissue treatment was applied (in the case of Ding Nai, the honeycomb foam (GranuFoam) was placed on the top of the membrane for 6 days, and immediately the harvested tissue had a critical size defect on which the stainless steel mesh was placed; The critical size defect of the phosphate stent was placed on it; the two defects were subjected to a 24-hour RPTT; the tissue was harvested 2 weeks after the surgery _ with a critical dimension defect on which the wire was placed; one placed on top of the calcium phosphate The critical size defect of the stent; 24 small _Τ?ΐ>Τ1^ for the two defects; harvested tissue after 12 weeks of surgery____ 21 - J54474.doc 1362951 4 has a criticality for placing stainless steel mesh on it Dimensional defect; a critical size defect in which the calcium phosphate scaffold was placed; 6 days of RPTT were applied to the two defects; harvested tissue 2 after 2 weeks of surgery had a criticality of placing stainless steel mesh on it Dimensional defect; a critical size defect in which the calcium phosphate scaffold was placed; 6 days of RPTT were applied to the two defects; harvested tissue 12 after 12 weeks of surgery had a critical dimension defect on which the stainless steel mesh was placed; one above Place the critical size defect of the calcium phosphate stent; do not apply RPTT (control); harvest tissue 4 after 2 weeks of surgery with a critical size defect on which the stainless steel mesh is placed; a critical size defect on which the calcium phosphate stent is placed; No RPTT (control); tissue harvested after 12 weeks of surgery 4 natural controls (no surgery; no RPTT) 4 sham surgery (no defect, no RPTT): harvested tissue 6 days after surgery : Test scenario Critical size defect A defect in a tissue (eg skull) that is large enough to be able to heal only by self-recovery. For rabbits, a diameter of approximately 15 mm is drilled through the skull. A full thickness hole will form a critical size defect of the skull. More specifically, see Figure 10, which illustrates a rabbit head with an original, undamaged bone path. The tissue section is sliced. The bone tissue of the skull is magenta 'The surrounding soft tissue is white' and the periosteal layer is highlighted by a yellow asterisk. In Figure 11, the illustration is given after treatment with decompressed tissue for 6 days and immediately after harvesting the tissue. Bunny skull. The bone and periosteum can be seen and a layer of granulation tissue has been formed. In Figure 12, the rabbit skull is treated after treatment with reduced-pressure tissue for 6 days and immediately after harvesting the tissue. It is characterized by the formation of new skeletal tissue under the granulation tissue. '54474.doc -22· 1362951 The skeletal woven fabric is shown by yellow afl Λ ιν ^ 琉 犬 在 在 在 在 在 在 在 在 在 在 在 在 在After treatment for 6 days and immediately after harvesting the tissue, the rabbits formed diterpene to see the new (four) and periosteum. The appearance of the tissue of the skeletal tissue formed by tissue treatment is similar to that of being experienced in a very fast appearance. The tissue formed by the bones in the very young and long-deposited animals is more closely seen in Figure 14.19, which illustrates several photographs and tissue cuts to demonstrate decompression tissue/σ on rabbit skulls with critical size defects. , private order and results. In Fig. 4, ^ ^ ^ ^ ^ ^ ^ ^ The body of the critical dimension defect... The circular solution shows that the rabbit skull with two inches of phase has been formed. These full thickness critical dimension defects have a diameter of approximately 15 faces. In Figure 15, a non-sense screen has been placed over one of the critical dimension defects and a stent is placed within the second critical dimension defect. In Figure 16, the reduced pressure is applied to the critical dimension defects using a reduced pressure tissue twisting device similar to that described herein. The pressure applied to each of the missing shells is 125 and the pressure of Hg. The reduced pressure is applied according to the test protocol listed in the Table. In Fig. 2, the skull is shown after 6 days of decompression tissue treatment and tissue harvesting after 12 weeks of surgery. The slice shown contains a calcium phosphate scaffold, which is indicated by a red arrow. Treatment with decompression tissue will result in significant growth of new bone tissue, ^ in Figure 17, highlighted by a yellow asterisk. The amount of bone growth is significantly greater than the amount of bone growth in critical size defects that are treated with the same calcium phosphate scaffold but not treated with decompressed tissue. This observation indicates that there is a need for Sb to induce a new bone formation reaction. The effect of treatment threshold or continuous time decompression tissue treatment is too high in the 12 weeks after surgery. The most obvious is 154474.doc -23- 1362951, which indicates that decompression tissue treatment causes a series of organisms. Events that enhance the formation of new bone tissue. The critical size defect covered with a non-recorded wire mesh (Fig. 15) but not placed in the defect was used as an intra-animal control, and the new bone growth was minimal. These data highlight the advantages of proper scaffold materials and the positive effects of decompressive tissue treatment on stent fusion and bioavailability. Radiographs of critical dimension defects filled with stents after six days of decompression tissue treatment are illustrated in Figures 18 and 19. Figure 18 illustrates a defect two weeks after surgery and shows that a certain new bone has been deposited in the stent. The main structure of the stent is still clearly visible. Figure 19 illustrates the defect after twelve weeks of surgery and shows that the critical dimension defect is almost completely healed and the main stent architecture is nearly completely lost due to tissue fusion (i.e., the formation of a new bone path within the stent matrix). Referring to Fig. 20, a reduced pressure delivery system 71 according to an embodiment of the present invention performs decompression tissue treatment on a tissue site 713 of a patient. The reduced pressure delivery system 711 includes a manifold delivery tube 721. The manifold delivery tube 721 can be a catheter or cannula' and can include a device that enables the manifold delivery tube 72 to be guided to the tissue portion 713, such as a guide unit 725 and a guide wire 727. The placement and guidance of the guide wire 727 and the manifold delivery tube 721 can be accomplished using endoscopy, ultrasound, fluoroscopy, auscultation, palpation, or any other suitable localization technique. A manifold delivery tube 72 is provided for inserting a reduced pressure delivery device through the skin into the tissue site 713 of the patient. ^When inserted through the skin, the manifold delivery tube 721 preferably passes through a sterile insertion shield that penetrates the patient's skin tissue. Insert A. In Fig. 20, the tissue site 713 contains bone tissue at a fracture 154474.doc -24-1362951 position 731 adjacent to the patient's bone 733. The manifold delivery tube 721 is inserted through the skin 735 of the patient and any soft tissue 739 surrounding the bone 733. As mentioned previously, the tissue site 713 can also comprise any type of tissue including, but not limited to, adipose tissue, muscle tissue, nerve tissue, skin tissue, vascular tissue, connective tissue, cartilage, tendon, or ligament. Referring to Figures 21 and 22, a reduced pressure delivery system 711 is further illustrated. The manifold delivery tube 721 can include a tapered distal end 743 for easy insertion through the patient's skin 735 and soft tissue 739. The tapered distal end 743 can be further configured to flex radially outwardly to an open position' such that the inner diameter of the distal end 743 will be substantially the same or greater than the inner diameter of other portions of the tube 721. The opening position of the distal end 743 is schematically shown by dashed line 737 in FIG. The manifold delivery tube 721 further includes a passageway 751 in which a reduced pressure delivery device 761 or any other reduced pressure delivery device is included. The reduced pressure transport device 761 includes a flexible barrier 765 and/or honeycomb material 767, as described with reference to Figures 6-8. The flexible barrier 765 and/or the honeycomb material 767 are preferably wound, folded or otherwise compressed around the reduced pressure delivery tube 769 to reduce the cross-sectional area of the reduced pressure delivery device 761 within the passageway 751. The reduced pressure delivery device 761 can be placed within the passageway 751 and directed to the tissue site 713 after the distal end 743 of the manifold wheel tube 721 is placed at the tissue site 713. Alternatively, the reduced pressure delivery device 761 can be pre-positioned in the passage 751 at a month 'J when the manifold delivery tube 721 is inserted into the patient. To push the pressure reducing delivery device 761 through the passage 75, a biocompatible lubricant can be used to reduce the friction between the reduced pressure delivery device 761 and the manifold delivery tube 721. When the distal end 743 has been positioned at the tissue site 713 and the reduced pressure delivery device 154474.doc -25·1362951 761 is delivered to the distal end 743, then the reduced pressure delivery device 761 is pushed toward the distal end 743, thereby enabling the distal end The 743 expands radially outward to the open position. The reduced pressure delivery device 761 is pushed out of the manifold delivery tube 721, preferably into a void or space adjacent the tissue site 713. This void or space is usually formed by incision of soft tissue, which can be accomplished by a route through the skin. In some cases the tissue site 713 can be located at the wound site and there is a natural void due to the anatomy of the wound. In other cases, the void may be formed by balloon separation, sharp separation, blunt separation, hydraulic separation, pneumatic separation, ultrasonic green separation, circuit shunting, laser separation, or any other suitable separation technique. When the reduced pressure delivery device 761 enters the gap adjacent the tissue site 713, the flexible barrier 765 of the reduced pressure delivery device 761 and/or the honeycomb material 767 is unwound to unfold or uncompress (see Figure 22), thereby reducing The pressure delivery device 761 can be placed in contact with the tissue site 713. Although not required, the flexible barrier 765 and/or the honeycomb material 767 can be subjected to a vacuum or reduced pressure provided via the reduced pressure delivery tube 769 to compress the flexible barrier 765 and/or the honeycomb material 767. The unfolding of the flexible barrier 765 and/or the honeycomb material 767 is achieved by releasing the reduced pressure delivered via the reduced pressure delivery tube 769 or providing a positive pressure via the reduced pressure delivery tube 769 to assist in the completion of the unwinding The process. The final placement and manipulation of the reduced pressure delivery device 761 can be accomplished using endoscopy, ultrasound, fluoroscopy, auscultation, palpation, or any other suitable localization technique. After placing the reduced pressure delivery device 761, the manifold delivery tube 72 is preferably removed from the patient but the reduced delivery officer associated with the reduced pressure delivery device 761 remains in place to enable passage through the skin to tissue site 154474 .doc •26· 1362951 Apply pressure to reduce. Referring to Figures 23-25, a reduced pressure delivery system 811 in accordance with an embodiment of the present invention includes a manifold delivery tube 821 having a tapered distal end 843 that is configured to flex radially outwardly to An open position such that the inner diameter of the distal end 843 will be substantially the same or greater than the inner diameter at other portions of the tube 821. The position of the opening of the distal end 843 is shown schematically by dashed line 837 in Figures 23-25. Manifold delivery tube 821 further includes a passageway in which a reduced pressure delivery device 861 similar to other reduced pressure delivery devices described herein is included. The reduced pressure delivery device 86 1 includes a flexible barrier 865 and/or honeycomb material 867 'the flexible barrier 865 and/or the honeycomb material 867 is preferably wound, folded or otherwise compressed around the reduced pressure delivery tube 869 to The cross-sectional area of the reduced pressure delivery device 861 within the passage is reduced. An impervious film 871 having an inner surface 873 is disposed around the reduced pressure delivery device 861 such that the reduced pressure delivery device 861 is contained within the inner surface 873 of the impermeable membrane 871. The impervious membrane 871 can be inflated. The bladder 'sheath, or any other type of film that is capable of preventing fluid permeation, such that the impermeable membrane 871 can assume a compressed position (see Figure 23), a relaxed position (see Figure 24), and an expanded position (see Figures 25 and 25). At least one of the positions in A). The impermeable membrane 87! is sealingly coupled to the manifold delivery tube 821 such that the interior space 873 of the impermeable membrane 871 is in fluid communication with the passage of the manifold delivery tube 821. Alternatively, the impermeable membrane 871 can be secured to the reduced pressure delivery tube 869 such that the interior space 873 of the impermeable membrane 871 is in fluid communication with the passage of the reduced pressure delivery tube 869. The impermeable membrane 871 is rotated;; 154474.doc -27- 1362951 is attached to a separate control tube or control lumen in fluid communication with the interior space 873 (see, for example, circle 25A). In one embodiment, an impermeable membrane 871 can be provided to further reduce the cross-sectional area of the reduced pressure delivery device 861 within the passageway. For this purpose, a lower than impervious membrane is applied to the interior space 873 of the impermeable membrane 871. The pressure of the pressure around the environment. Thereby discharging a relatively large one in the internal space 873

. The squeegee or other fluid is placed to place the impermeable membrane 871 in the compressed position shown in Figure U. In this compressed position, the impermeable film 871

It is sucked inwardly to apply a pressure to the reduced pressure conveying device 861 to further reduce the sectional area of the reduced pressure conveying device 861. As previously described with reference to Figures 21 and 22, the reduced pressure delivery device 861 can be delivered to the tissue site after the distal end 843 of the manifold delivery tube 821 is disposed at the tissue site. Placement and manipulation of the impermeable membrane 871 and the reduced pressure delivery device 861 can be accomplished using endoscopic examination, ultrasound, fluoroscopy, auscultation, palpation, or any other suitable localization technique. The impervious film 87ι may contain a radiopaque label

This will improve the visibility of the impermeable film 871 under the camp screen inspection before it is removed. After pushing the dust-reducing conveyor 861 through the distal end 843, the reduced pressure applied to the interior space 873 can be released to place the impermeable membrane 871 in a relaxed position (see Figure 24), thereby facilitating easier Removal from the impermeable film (7) minus the delivery crack (4) may provide - removing the device 885 (eg, a set of g, ^ needles or other sharp tools) to break the impermeable film 871. Preferably, the removal device (8) is inserted through the reduced pressure delivery tube 869 and is capable of being advanced to contact the non-permeable membrane 871. After the permeable membrane 154474.doc *28-1362951 871 is broken, the removal device 885 and the impermeable film 871' can be withdrawn via the manifold delivery tube 821 to thereby make the flexible barrier 865 and/or the pressure-reducing device 861 The honeycomb material 867 can be unwound, unfolded, or decompressed, so that the reduced pressure delivery device 861 can be placed in contact with the tissue site. The unwinding of the flexible barrier 865 and/or the honeycomb material 867 can occur automatically after the reduced pressure is released and the impermeable film 871 is removed. In some cases, positive pressure may be delivered via the reduced pressure delivery tube 869 to help unwind or uncompress the flexible barrier 865 and/or the honeycomb material 867. After the final placement of the reduced pressure delivery device 861, the manifold delivery tube 821' is preferably removed from the patient's body but the reduced pressure delivery tube 869 associated with the reduced pressure delivery device 861 remains in place so as to be able to pass through the skin to the tissue Apply a reduced pressure to the area. The impervious film 871 can also be used for tissue that has just been placed in the tissue of the adjacent tissue where the reduced pressure delivery device 861 is placed against the tissue. After pushing the pressure reducing conveying device 861 and the intact impervious film 87 1 through the distal end 843 of the manifold conveying pipe 821, air or another fluid is injected or pumped into the interior of the impervious film 87 Within space 873. It is preferred to use a liquid to swell the impermeable film 871 because the incompressibility of the liquid causes the impervious film 871 to expand more uniformly and more uniformly. The impervious film 87 can be expanded radially or in an orientation as shown in Figure 25, depending on the method of manufacture and the fixed configuration on the manifold tube 821. When the pressure is due to the pressure of air or fluid, the permeable 871 expands outward to the expanded position (see Figure 25), and a gap is separated from the tissue site. When the void is large enough, the air or other fluid in the interior space 873 can be released so that the permeable membrane 871 can take a relaxed position. Then, the impervious film 871 can be broken as explained above, and the decompression transfer device 861 can be inserted adjacent to the tissue site. Referring to Figure 25A, if the impermeable membrane 871 is primarily used to separate tissue adjacent to the tissue site, the impermeable membrane 871 can be sealingly secured to the manifold transfer tube 821, thereby associating the interior space 873 with one or The auxiliary lumen or tube 891 secured to the manifold delivery tube 821 is in fluid communication. The auxiliary lumen 891 can be used to deliver liquid, air or other fluid to the interior space 873 to place the impermeable membrane 871 in the expanded position. After the separation, the impermeable film 871 can be relaxed and broken as described above with reference to Fig. 24. Referring to Figure 26, a reduced pressure delivery system 91A in accordance with an embodiment of the present invention includes a manifold delivery tube 921 having a tapered distal end 943 that is configured to flex radially outwardly to a The open position is such that the inner bore of the distal end 943 will be substantially the same or larger than the inner diameter at other portions of the tube 921. The opening position of the eye 943 is schematically shown by a broken line 937 in FIG. Manifold delivery tube 921 further includes a passageway in which a reduced pressure delivery device 961 similar to other reduced pressure delivery devices described herein is included. The reduced pressure delivery device 961 includes a flexible barrier 965 and/or a honeycomb material %?, and the flexible barrier 965 and/or the honeycomb material 967 is preferably wound, folded or otherwise compressed around the reduced pressure delivery tube 969 to The wearing area of the reduced pressure conveying device 961 in the passage of the manifold conveying pipe 921 is reduced. An impervious film 971 having an inner surface 973 is disposed around the reduced pressure delivery device 961 such that the reduced pressure delivery device 96 is contained within the inner surface 973 of the impermeable membrane. Impervious film 971 is impervious. Film 971) 54474.doc • 30- 丄 951 - The end contains a glue seal 977 to provide a # generation method for removing the reduced pressure delivery device 961 from the non-permeable film 97i. The non-sex thin "71 is sealingly coupled to the manifold delivery tube 921 such that the interior space 973 of the impermeable membrane (7) is in fluid communication with the passage of the manifold delivery tube 921. Alternatively, the impermeable membrane 971 can be secured to a separate control tube (not shown) in fluid communication with the interior space 973. Similar to the impervious film 871 in FIG. 23, the impervious film 971 can be

The fluid material can be prevented such that the transmissive (four) film 971 can take at least one of a compression position, a loose position and an expanded position. Since the procedure for placing the impermeable film 971 on the compressed position and the expanded position is similar to the impermeable film 871, only the process of removing the decompression conveying device "" will be described.

The reduced pressure delivery device 961 is delivered to the tissue site within the impermeable membrane 971 using endoscopy, ultrasound, fluoroscopy, auscultation, palpation, or any other suitable localization technique and then correctly Positioning. The impermeable film 971 can include a radiopaque marker 981 which improves the visibility of the impermeable film 971 under fluorescent screen inspection prior to its removal. The reduced pressure delivery device 961 is then pushed through the distal end 943 of the manifold delivery tube 92 1 . The reduced pressure applied to the interior space 973 can be released to place the impermeable membrane 971 in a relaxed position. Then, the reduced pressure conveying device 961 is pushed through the rubber seal 977 to push out the impervious film 971. Referring to Figure 26A, a reduced pressure delivery system 985 in accordance with an embodiment of the present invention may not include a manifold delivery tube similar to the manifold delivery tube 921 of Figure 26. Rather, the reduced pressure delivery system 985 can include a guide wire 987 and a reduced pressure 154474. Doc 31 - 1362951 A delivery tube 989 and a reduced pressure delivery device 991. The reduced pressure delivery device 991 includes a plurality of fluid passages connected to the reduced pressure delivery tube 989. Instead of using a separate manifold tube to deliver the reduced pressure delivery device 991, the reduced pressure delivery device 991 and the reduced pressure delivery tube 989 are placed on the guide wire 987, which guides the guide wire 987 through the skin. To a tissue part 993. Preferably, the guide wire 987 and the reduced pressure delivery tube 989 penetrate the patient's skin with a sterile sheath. By guiding the reduced pressure delivery tube 989 and the reduced pressure delivery device 991 along the guide wire 987, the reduced pressure delivery device 991 can be placed at the tissue site 993 to effect decompression tissue treatment through the skin. Since the reduced pressure delivery device 991 is not constrained in a manifold delivery tube during delivery to the tissue site 993, it is preferred to maintain the reduced pressure delivery device 991 in the compressed position during delivery. If an elastic foam is used as the reduced pressure conveying means 991', the foam can be coated with a biocompatible soluble adhesive and the foam can be compressed. After reaching the tissue site, the body fluid or other fluid delivered via the reduced pressure delivery tube 989 dissolves the adhesive, thereby causing the foam to swell and contact the tissue site. Alternatively, a reduced pressure delivery device 991 can be formed from a compressed dry hydrogel. The hydrogel absorbs moisture after being transported to the tissue site 993, so that the reduced pressure delivery device 991 can be inflated. Still another reduced pressure delivery device 991 can be made from a thermally active material, such as polyethylene glycol, which will swell when subjected to the patient's body temperature. In a further embodiment, the compressed reduced pressure delivery device 991 can be delivered to the tissue site 993 in a __ dissolvable film. Referring to Figure 27, a reduced pressure delivery system 1011 according to the present invention includes a manifold delivery tube 1021 having a distal end 1043, and a distal end 1043 inserted through 154474. Doc -32- 1362951 A tissue of one of the patients is exposed to the tissue site 1〇25. The tissue site 1 〇 25 may comprise a void 1 〇 29 associated with a wound or other defect, or alternatively, a void may be formed by separation, including the separation techniques described herein. .  After the distal jaw 043 is placed adjacent to the tissue site 1025 within the void 1029.  An injectable, pourable or flowable pressure reducing delivery device 1035 is delivered to the tissue site 1〇25 via a manifold transfer tube 1〇2丨. The reduced pressure delivery device 1035 is preferably present in a flowable state during delivery to the tissue site, and then, upon arrival, a plurality of flow channels are formed to distribute the reduced pressure or fluid. In some cases, the flowable material can be hardened to a solid state by a drying process, a curing process, or other chemical or physical reaction after reaching the tissue site. In other cases, the flowable material can form a foam in situ after delivery to the tissue site. Still other materials may exist in the gel state at the tissue site 1 〇 25, but still have a plurality of flow channels for delivering reduced pressure. The amount of φ reduced pressure delivery device 1035 delivered to the tissue site 1 〇 25 may be sufficient to partially or completely fill the void 1029. The reduced pressure delivery device 1035 can include both a manifold and a stent. As a manifold, the reduced pressure delivery device 1A 35 includes a plurality of holes or open holes which are formed in the material after being conveyed to the gaps 1〇29. The holes or open rituals are interconnected to form a plurality of flow channels. These flow channels are used to apply and distribute reduced pressure to the tissue site 1025. As a stent, the reduced pressure delivery device 1 〇 35 is bioresorbable and serves as a substrate on which new tissue can be grown. In an embodiment, the reduced pressure delivery device 1035 can comprise a distribution throughout the liquid 154474. Doc -33- 1362951 Poragen in body or sticky condensate, such as NaCl or other salts. After the liquid or viscous gel is delivered to the tissue site 1025, the material is applied to the void 1029 and subsequently cured into a solid. The water-soluble NaCl P〇ragen dissolves in the presence of body fluids leaving a structure with interconnected pores or flow channels. The reduced flow and/or fluid is delivered to the flow channels. As the new tissue is formed, the tissue will grow into the bore of the reduced pressure delivery device 1 〇 35 and then eventually replace the reduced pressure delivery device 1035 with the degradation of the reduced pressure delivery device 1035. In this particular example, the 'reduced delivery device IQ' is used not only as a manifold but also as a new tissue growth scaffold. In another embodiment, the reduced pressure delivery device 1035 is an alginate mixed with 400 μη mannose particles. The P〇ragen or granules may be dissolved at the tissue site by a local bodily fluid or by a flushing fluid or other fluid delivered to the reduced pressure delivery device i035. After the poragen or particles are dissolved, the space previously occupied by the poragen or particles becomes a void which is interconnected to each other to form a flow passage in the reduced pressure conveying device 1035. The use of poragen in materials to form flow channels is effective, but it also forms pores and flow channels that are limited in size to only the pores of the selected poragen. A chemical reaction can be used in place of poragen to form larger pores by forming gaseous by-products. For example, in one embodiment, a flowable material comprising sodium bicarbonate and citric acid microparticles (which may be non-stoichiometric) may be delivered to tissue site 1025. When the flowable material forms a foam or solid in situ, the body fluid will cause an acid-base reaction between sodium bicarbonate and citric acid. Compared with the technique of relying on poragen dissolution, the formed oxidized gas particles will form larger pores in the entire pressure reducing conveying device 1035 and 154474. Doc -34· 1362951 Flow channel. The transition of the reduced pressure delivery device 1035 from a liquid or viscous gel to a solid or foam can be triggered by enthalpy, temperature, light, or reaction with body fluids, chemicals, or other materials delivered to the tissue site. It can also be mixed by a variety of counters.  This change is made in response to the component. In one embodiment, the reduced pressure delivery device 1035 is prepared by selecting bioresorbable microspheres made from a bioresorbable polymer. The microspheres are dispersed in a solution containing a photoinitiator and a hydrogel forming material such as hyaluronic acid, collagen or polyethylene glycol. The microsphere-gel mixture is exposed to light for a brief period of time to partially crosslink the hydrogel and immobilize the hydrogel on the microspheres. Excess solution is drained and the microspheres are subsequently dried. The microspheres are delivered to the tissue site by injection or pouring, and after delivery, the mixture absorbs water' and the hydrogel coating becomes a hydrated coating. Then, the mixture is again exposed to light, whereby the microspheres are crosslinked to form a plurality of flow channels. The crosslinked microspheres are then used as a manifold for the delivery of reduced pressure to the tissue site and a porous scaffold for promoting the growth of new tissue. With the exception of the foregoing embodiments herein, the reduced pressure delivery device 1 can be made from a variety of materials including, but not limited to, phosphate feed, ray, alginate, quasi-prime or any other gas, Liquid, knee, paste, • ash H suspension or other flowable material is delivered to the tissue and is capable of forming an equivalent of a plurality of flow paths in fluid communication with the tissue site. The flowable material may further comprise solid particles, such as particles, which can be transported via a manifold if the particle size of the solid particles is sufficiently small. Doc -35· 1362951 1021 〃IL move. The material delivered to the tissue site in a flowable state can be polymerized in situ or form a gel. As previously described, the reduced pressure delivery device 1〇35 can be directly injected or poured into the void 1029 adjacent the tissue site 1025. Referring to FIG. 27A, the manifold delivery S 1021 may include an impermeable or semi-permeable membrane 1〇51 at the distal end 1043 of the manifold tube 1021, the membrane 1〇51 includes an internal space 1〇55, and the internal chamber 1055 It is in fluid communication with an auxiliary lumen fixed to the manifold delivery tube 1〇21. The manifold delivery tube 1021 is guided to a tissue portion 1025 on a guide wire 1〇61. The reduced pressure delivery device 1〇35 can be injected or poured through the auxiliary lumen 1057 to fill the internal space 1055 of the membrane 1051. When the fluid or gel fills the film 1051, the film 1〇51 expands to fill the voids 1〇29' so that the film contacts the tissue site 1025. When the film 1〇51 is inflated, the film 1〇51 can be used to separate the additional tissue of the adjacent or sinus proximal tissue site. If the film 丨〇5 不 does not penetrate the 丨 film, it can be physically broken and removed, so that the reduced pressure delivery device 1035 contacts the tissue site 1 〇 25. Alternatively, film 1〇51 can be made from a soluble material that will dissolve in the presence of body fluids or biocompatible solvents delivered to film 1051. If the film 丨05丨 is semi-permeable, the film 1051 can remain in place. The semi-permeable membrane 丨〇5丨 is capable of delivering reduced pressure and possibly other fluids to the tissue site 1025. Referring to Figure 28, a method of performing reduced pressure tissue therapy includes surgically inserting a manifold at an adjacent tissue site at 1115, the manifold having a plurality of protrusions extending from a flexible barrier. To form a plurality of flow channels between the protrusions. Positioning the manifold at 1119 154474. Doc • 36- is called 951 ' at least a portion of the projections are in contact with the tissue site. At ι 23, a reduced pressure is applied to the tissue site via the manifold. See Figure 29, a method of applying reduced-pressure tissue treatment to a tissue site. U11 includes inserting a manifold at 1215 through the skin adjacent to the tissue site. A plurality of protrusions extending from a flexible barrier may be included to form a plurality of flow channels between the protrusions. Alternatively, the manifold I comprises a honeycomb material having a plurality of fluids in the honeycomb material, and the 5H manifold may be formed of an injectable or pourable material: The poured material is delivered to the tissue site and forms a plurality of flow channels after reaching the woven site. At 1219, the manifold is clamped such that at least a portion of the flow channels are in fluid communication with the tissue site. At 1223, a reduced pressure is applied to the tissue site via the manifold. Referring to Fig. 30, a method of performing decompressive tissue treatment on a tissue site U11 includes inserting a tissue having one of the patients through the skin at 1315 to insert the end of the 5th tube to the tissue site. At 13 1 9 , an inflatable bladder associated with the tube can be inflated to separate tissue adjacent to the tissue portion to form a void. At 1323, a manifold is transported through the passage. The manifold can include a plurality of protrusions extending from a flexible barrier to form a plurality of flow channels between the protrusions. Alternatively, the manifold 彳 comprises a honeycomb material having a plurality of flow channels therein. Alternatively, the disparity f can be formed from an injectable or pourable material delivered to the tissue site as described above with reference to FIG. At 1327, the locator is positioned such that at least one of the flow channels is 154474. Doc -37· ^362951 is in fluid communication with the tissue site. At 1331, the reduced pressure is applied to the tissue site via the manifold via a reduced pressure delivery tube or any other delivery route. Referring to Fig. 3, a method for performing decompression tissue treatment on a tissue site 14丨1 includes inserting a tube having a passage through the skin through a skin at 1415 such that the distal end of the tube is adjacent to the tissue site. Place. At 1423, a manifold is delivered to the tissue site via the passageway in an impervious sheath that has been subjected to a first reduction in the ambient pressure of the sheath at the 丨41 9 pressure. At 1427, the sheath is broken to contact the manifold with the tissue site. At 丨43 1 , a second reduced pressure p is applied to the tissue site via the manifold. Referring to Figures 32 and 33, a reduced-pressure delivery device 151 according to an embodiment of the invention includes a replacement for a patient's leg. Fistula 5丨7 of the existing femoral head plastic surgery prosthesis 1515. The hip prosthesis 1515 includes a post portion 1521 and a head portion 1525. The post portion 1521 is elongate for insertion into a passage 1529 that is hinged in the backbone of the leg portion 1517. A porous coating 1 535 is disposed around the portion of the column and is preferably constructed of sintered or vitrified ceramic or metal. Alternatively, a honeycomb material having a porous property may be disposed around the column portion. A plurality of flow channels 1541 are disposed in the column portion 1 52 1 of the hip prosthesis 1 5 1 5 to fluidly communicate the flow channel 1541 with the porous coating 1535. A port 1545 is fluidly coupled to the flow passage 1541 which is configured to be releasably coupled to a reduced pressure delivery line 1551 and a reduced pressure delivery source 1553. The flow channel 1541 is used to deliver a reduced pressure to the porous coating 1535 and/or bone surrounding the hip prosthesis 1515 after implantation of the hip prosthesis 1515. The flow channel 1541 can comprise a 154474. Doc • 38. A main feed line 1543 in fluid communication with a plurality of transverse branch lines 1547, the plurality of lateral branch lines 1547 being in communication with the porous coating 1535. The lateral branch line 1545 can be oriented perpendicular to the main feed line 1543 as shown in Figure 32, or can be oriented at some angle to the main feed line 1543. An alternative method for distributing reduced pressure includes providing a hollowed out prosthesis and filling the interior of the prosthesis with a honeycomb-like (preferably open-cell) material that is in fluid communication with the porous coating 1535. . Referring more specifically to Figure 33, the hip prosthesis 1515 can include a second plurality of flow channels 1561 within the column portion 1521 to provide fluid to the smear coating 1535 and/or bone surrounding the hip prosthesis 515. The fluid can include filtered air or other gases, antibacterial agents, antiviral agents, cell growth promoters, irrigation fluids, chemically active fluids, or any other fluid. Additional fluid communication paths may be provided if multiple fluids are desired to be introduced into the bone surrounding the hip prosthesis 1515. A port 1565 is fluidly coupled to the flow channel 丨56, which is configured to be releasably coupled to a fluid delivery tube 1571 and a fluid carrier source 1573. The flow channel 1561 can include a main feed line 1583 in fluid communication with a plurality of lateral branch lines 1585 that are in communication with the porous coating 153 5 . The lateral branch line 1585 can be oriented perpendicular to the main feed line 1583 as shown in Figure 33, or can be oriented at some angle to the main feed line 158. The delivery of the reduced pressure to the first plurality of flow channels 154 and the delivery of fluid to the second plurality of flow channels 1561 can be accomplished by separate tubes (e.g., reduced pressure delivery tube 1551 and fluid delivery tube 1571). Alternatively, a tube having multiple lumens as previously described herein can be used for separation for 54474. Doc •39- Conveying reduced pressure and fluid communication path. It should be further noted that although a separate fluid communication path is preferred within the hip prosthesis 1515, the first plurality of flow channels 1541 can be used to reduce the pressure and Both fluids are delivered to the bone surrounding the hip prosthesis 15 15 . As mentioned earlier, applying reduced stress to bone tissue promotes and accelerates the growth of new bone tissue. By using the hip prosthesis 1 5 1 5 as a manifold to deliver the reduced pressure to the bone path area of the surrounding prosthesis, the recovery of the leg section 1517 will be faster and the hip prosthesis 15 5 will be more successful with The combination of the bone path and the second plurality of flow channels 1561 to discharge the bone surrounding the hip prosthesis 1515 improves the successful regeneration of the new bone surrounding the prosthesis. After applying the reduced pressure through the competitive body 1 5 1 5 for a selected amount of time, the reduced pressure delivery tube 1551 and the fluid delivery tube 1571 can be disconnected from the ports 1545, 1 565 and removed from the patient body - It is preferred not to use a surgical invasive procedure. The connection between the ports 1545, 1565 and the tubes 1551, 1571 can be by hand release. This can be accomplished by applying an axial pull to the tubes 1551, 1571 outside the body of the patient. Alternatively, the ports 1545, 1565 can be bioresorbable or soluble in the presence of a selected fluid or chemical so that the ports 1545, 1565 can be exposed to fluids or chemicals. And the release of the tubes 1551, 1571 is achieved. The tubes 1551, 1571 can also be made from a bioresorbable material that will dissolve over a period of time or a viable material that will dissolve in the presence of a particular chemical or other material. A reduced pressure delivery source 1553 can be provided outside the patient and attached to the reduced pressure delivery tube 155' to deliver the reduced pressure to the hip prosthesis 1515. Another option is, 154474. Doc •40· 1362951 A reduced-pressure delivery source 1553 can be implanted in a patient, on or near the hip prosthesis 15 15 . Placing the reduced pressure delivery source 1553 into the patient eliminates the need for fluid connections through the skin. The implanted reduced pressure delivery source 1553 can be a conventional pump operatively coupled to the flow channel 1541. The pump can be powered by a battery implanted in the patient's or can be electrically connected to the pump via the skin. External battery powered. The pump can also be directly driven by a chemical reaction that delivers reduced pressure via flow channels 1 541, 1561 and circulates fluid through flow channels 1541, 1561. Although only the column portion 1521 and the head portion 1 525 of the hip prosthesis ι515 are illustrated in Figures 32 and 33, it should be noted that the flow channels described herein and the components for applying reduced pressure tissue treatment may also be applied to hip falsehood. Any component of the body 1515 that contacts the osseous or other tissue, including, for example, a cup. Referring to Fig. 34, a method 161 for repairing a joint of a patient includes implanting a prosthesis in the bone adjacent to the joint at 1 615. The prosthesis can be a hip prosthesis as described above or any other prosthesis that can help restore joint mobility in a patient. The prosthesis includes a plurality of flow channels configured to be in fluid communication with the bone. At 1619, a reduced pressure is applied to the bone via the plurality of flow channels to improve the prosthesis se〇integrati〇n. Referring to Figures 35 and 36, a reduced pressure delivery device 1711, in accordance with an embodiment of the present invention, includes an orthopaedic fixation device 1715 for fastening a bone 1717 of a patient that includes a fracture site 1719 or other defect. The orthopaedic fixation device 1715, shown in the drawings, is a plate having a plurality of passages 1721 for anchoring the orthopaedic fixation device 1715 to the bone using screws 1725, pins, bolts or other fasteners. On 1717. Available at 154474. Doc -41 · 1362951 A multi-hole coating 1735 is placed on the surface of the contact ι 71 7 of the orthopedic fixation device 1715. The porous coating is preferably constructed of sintered or vitrified ceramic or metal. Alternatively, a honeycomb material having a porous nature can be disposed between the bone 1717 and the orthopaedic fixation device 1715. A plurality of flow channels 1741 are disposed within the orthopaedic fixation device 1715 to fluidly communicate the flow channel 1741 with the porous coating port 35. A port 1745 is fluidly coupled to the flow channel 1741, the crucible being configured to be coupled to the decompression delivery tube 1751 and a reduced pressure delivery source 1753. The flow channel 1741 is for use after securing the orthopaedic fixation device 1715 to the bone 1717. The coating 1735 and/or the orthopedic surgery S) is configured to reduce the pressure of the bone path delivery device 1715. The flow channel 1741 can include a main feed line m3' in fluid communication with a plurality of lateral branch lines 1747. The plurality of lateral branch lines 1747 are in communication with the porous coating 1735. The lateral branch line m7 can be oriented perpendicular to the main feed line 1743 as shown in Figure 35 or can be oriented at some angle to the main feed line 1743. An alternative method for distributing the reduced pressure includes providing an orthopaedic solid; t device and filling with a honeycomb (preferably open pore) material capable of communicating with the porous coating 1735 The internal space of the orthopaedic fixation device. ° The orthopaedic fixation device 1715 can be a tether as shown in Figure 35, or alternatively selected as a "fixable device, such as a cannula, a bridge", a struts, and other parts (4). U pieces. The orthopedic fixation device m5 can be used for fastening the prosthesis or other orthopedic device or the implanted tissue (such as bone tissue or cartilage). The basin limitation condition is that the tightness is included. In the group of adjacent or surrounding such fasteners 154474. Doc •42· Weaving the wheel to deliver a reduced flow of dust. Examples of such fasteners may include pins, bolts, screws or any other suitable fastener. Referring more specifically to Figure 36, the orthopaedic fixation device 1715 can further include a second plurality of flow channels 在 ι ι ι ι ι ι ι ι ι , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , *body. The fluid may include filtered air or other gas, anti-bacterial antiviral agent, cell growth promoter 'flushing fluid, chemically active m or any U. Additional fluid communication paths are provided if it is desired to introduce multiple fluids into the meniscus of the body prosthesis. A port 1765 body is coupled to the flow channel 1761 which is configured to be coupled to a fluid delivery tube 177! and a fluid delivery source 1773. The flow channel ride can include a main feed line 1783 in fluid communication with a plurality of lateral branch lines 1785. The mysterious branch line 1785 is in communication with the porous coating 丨735. The lateral branch line 1785 can be oriented perpendicular to the main feed line 1783 as shown in Figure 33, or can be oriented at some angle to the main feed line 1783. The delivery of the reduced pressure to the first plurality of flow channels 74 and the transfer of fluid to the first plurality of flow channels 1761 can be accomplished by separate tubes (e.g., reduced pressure delivery tube 1751 and fluid delivery tube 1771). Alternatively, a tube having a plurality of lumens as previously described herein can be used to separate the communication path for delivery of reduced pressure and fluid. It should be further noted that although a separate fluid communication path is preferably provided within the hip prosthesis 171 5, the first plurality of flow channels 1741 can be used to deliver both the reduced pressure and fluid to the bone of the adjacent orthopaedic fixation device 1715. . Use orthopedic fixation device 1715 as a manifold to access adjacent orthopedics 154474. Doc •43· 1362951 The reduced pressure of the bone area of the fixation device 1715 accelerates and improves the recovery of the defect 1719 of the bone 1717. Providing a second plurality of flow channels 1761 to deliver fluid to the bone surrounding the orthopaedic fixation device 715 improves the successful regeneration of new bone adjacent the orthopaedic fixation device. Referring to Fig. 37', a method 1811 for healing a bone defect in a bone includes using an orthopedic fixation device at 1815 to secure the bone path. The orthopedic fixation device includes a plurality of flow channels disposed within the orthopaedic fixation device. Applying a reduced pressure to the bone defect via the plurality of flow channels at 1 819'. Referring to Figure 3 8 'A method 1910 for performing a reduced-pressure tissue treatment on a tissue site includes: positioning a manifold having a plurality of flow channels at 1915 to cause at least a portion of the flow channels to be associated with the tissue The parts are in fluid communication. At 1919, the reduced pressure is applied to the tissue site via the flow channels, and at 1923, a fluid is delivered to the tissue site via the flow channels. Referring to Figure 3, a method for performing decompressive tissue treatment on a tissue site 2011 includes positioning a distal end of a manifold delivery tube adjacent the tissue site at 2015. At 2019, a fluid is delivered to the tissue site via the manifold delivery tube. The fluid is capable of filling a void adjacent the tissue site and becoming a solid manifold having a plurality of flow channels in fluid communication with the tissue site. At 2023, a reduced pressure is applied to the tissue portion via the flow path of the solid manifold. Referring to Figures 40-48, a reduced pressure delivery system 2111 includes a main manifold 2115. The main manifold 2115 has a ductal wall 2117 154474 surrounding a main flow path 2121. Doc -44 - 1362951. The flexible wall 2117 is coupled to a reduced pressure delivery tube 2125 at a proximal end 2123. Since the shape of the reduced pressure delivery tube 2125 will generally be a circular cross section, and because the shape of the wear surface of the primary manifold 2115 can be different from the circular shape (i.e., rectangular in Figures 4A-45, and in Figures 46-48) Triangle) thus provides a transition zone 2129 between the reduced pressure delivery tube 2125 and the primary manifold 2115. The main manifold 2115 can be adhesively joined to the reduced pressure delivery tube 2125, joined using other means such as fusion or insert molding, or alternatively selected to be integrally joined by coextrusion. The reduced pressure delivery tube 2125 delivers the reduced pressure to the primary manifold 2115 for distribution at or near the tissue site. An anti-blocking member 2135 is positioned within the main manifold to prevent the main manifold 2115 from collapsing and thereby blocking the main flow path 2121 during application of the reduced pressure. In one embodiment, the anti-blocking member 2135 can be provided with a plurality of protrusions 2137 (see FIG. 44) disposed on an inner surface 2141 of the flexible wall 2117 and extending into the main flow path 2121. In another embodiment, the anti-blocking member 2135 can be provided with a single or multiple ridges 2145 on the inner surface 2141 (see Figures 40 and 41). In yet another embodiment, the anti-blocking component 2135 can comprise a honeycomb material 2149 disposed within the main flow path, such as shown in Figure 47. The anti-blocking member 2135 can be any material or structure that can be lost in the flow path or can be integrally or otherwise secured to the flexible wall 2117. The anti-blocking member 2135 is capable of preventing the flexible wall 2117 from completely collapsing while still allowing fluid to flow through the main flow path 2121. The flexible wall 2117 further includes a plurality of apertures 2155' that penetrate the flexible wall 2117. The apertures 2155 are in communication with the main flow path 2121. The aperture 2155 enables the reduced pressure delivered to the main flow path 2121 to be distributed to the tissue site. 154474. Doc • 45· 1362951 The aperture 2155 can be selectively positioned around the circumference of the manifold 2115 to preferentially direct the delivery of vacuum. For example, in Figure 51, the apertures can be placed facing the bone, facing the tissue, or both. The reduced pressure transfer tube 2125 preferably includes a first guide B1 having at least one outlet fluidly coupled to the main flow passage 2121. to deliver a reduced pressure to the main flow passage 2121. A second conduit 2163 can also be provided to clean the main flow path 2121 and the first conduit 2161 with a fluid to prevent or dissolve blockages caused by wound secretions and other fluids aspirated from the tissue site. The second conduit 2163 preferably includes at least one outlet positioned adjacent at least one of the main flow passage 2121. and the at least one outlet of the first conduit 2161. Referring more specifically to Figures 40 and 41, in the reduced pressure delivery system 2111, the second conduit 2163 can include a plurality of conduits for flushing the main flow path 2121. and the first conduit 2161. Although the end of the flexible wall 2117 opposite the end fixed to the reduced pressure delivery tube 2125 can be open as shown in Fig. 40, it has been found that covering the end of the flexible wall 211 7 can improve the cleaning function. Performance and reliability. Preferably, a head gap 2171 is provided between the covered end of the flexible wall and the end of the second conduit 2163. The headspace 2171 is capable of achieving accumulation of cleaning fluid during the cleaning process, which helps drive the flushing fluid to flow into the first conduit 2161 through the primary flow path 2121. The spacer used as the anti-blocking member 2135 is also illustrated in FIG. The centrally located spacer causes the main flow path 2121. to again enter the two chambers, which causes the main manifold 2115 to continue to operate when one of the chambers is blocked and cannot be dissolved by cleaning. 154474. Doc • 46· 1362951 Round 49 and 50, a decompression wheel This abortion system, the Leda system 22 11 includes a main manifold 2215 with a reduced pressure delivery = 2217. The reduced pressure delivery tube 2217 includes a central officer = 2223 and a plurality of auxiliary lumens 2225. Although the auxiliary lumen 2225 can be used to measure the pressure at or near the tissue site, the auxiliary lumen Mb can be further used to clean the central lumen 2223, (4) to stop or dissolve the obstruction. A plurality of apertures 2231 are in communication with the central lumen 2223 to distribute the reduced waste force delivered by the central lumen. As shown in Fig. 5A, it is preferred that the aperture 2231 does not extend through the auxiliary lumen 2225. Also shown in Fig. 50 is the countersunk end of the reduced pressure wheel tube which forms a headspace outside the end of the auxiliary lumen 2225. If the tissue, stent or other material is engaged during the application of the reduced pressure At the end of the pressure delivery tube 2217, the headspace 2241 will continue to allow delivery of the cleaning fluid to the central lumen 2223. During use, the reduced pressure delivery systems 2ηι, 2211 illustrated in Figures 40-50 can be applied directly to the tissue site. The reduced pressure is distributed to the tissue site. The low profile of the primary manifold is highly advantageous for erecting and removing the techniques described herein. Similarly, the primary manifold can also be surgically inserted. See Figure 51. The primary manifolds 2115, 22 15 can be used in conjunction with an auxiliary manifold 2321. In Figure 51, the secondary manifold 2321 includes a two-layer felt pad. The first layer of the auxiliary manifold 23 21 contacts a fracture site. The bone path tissue site is placed. The primary manifold 2115 is in contact with the first layer and the first layer of the auxiliary manifold 2321 is placed on top of the primary manifold 2115 and the first layer. The secondary manifold 2321 can reach the primary profile 2 11 5 and the flow between the tissue parts Communication, and still preventing tissue site with a direct contact between the primary manifold 2115. Preferably 'secondary manifold 2321 is bioabsorbable lines, this auxiliary manifold I54474. Doc •47– 1362951 Officer 2321 can remain in place after decompression therapy is completed. Once the decompression therapy is completed, the primary manifold 2115 can be removed from between the layers of the auxiliary manifold with little or no disturbance to the tissue site. In one embodiment, the primary manifold may be coated with a lubricating material or a material that will form a hydrogel to facilitate removal of the primary manifold from between the layers. The auxiliary manifold is preferably used as a support for new tissue growth. As a stent, the auxiliary manifold may be composed of at least one material selected from the group consisting of polylactic acid, polyglycolic acid, polycaprolactone, polyhydroxybutyrate, polyvaleric acid, polydioxane Amine, P〇ly〇rth〇esthers, poly-disc nitrile polyformate, collagen, hyaluronic acid, polyaminoglucose, hydroxyapatite, calcium phosphate, calcium sulfate, calcium carbonate, bioglass, stainless steel, Titanium, tantalum, allograft tablets and autologous tissue grafts. The cleaning functions of the reduced pressure delivery systems 21 Π, 2211 described above can be used with any of the manifolds described herein. The ability to clean the manifold 输送 conduit for reduced pressure prevents the formation of obstructions that impede the pressure to perform the reduction. Such obstructions are typically formed when the pressure near the tissue site reaches equilibrium and the flow of fluid around the tissue site slows. It has been found that the use of air to purge the manifold and decompression catheter at a selected interval for a desired amount of time can help prevent or dissolve the obstruction. More specifically, air is delivered via a second conduit that is separated from the first conduit that delivers the reduced pressure. One of the outlets of the second conduit is preferably sinister or near one of the outlets of the first conduit. Although the air can be pressurized or pushed to the outlet of the first conduit, it is preferred to draw in air through the second conduit by the reduced pressure at the tissue site. It has been found that in many cases, 154474. Doc •48· 1362951 Two (2) seconds of air delivery at intervals of sixty (60) seconds during the application of reduced pressure is sufficient to prevent the formation of obstructions. “This cleaning program provides enough air to move sufficiently The tube and the fluid in the first conduit while preventing the introduction of excess air. Introducing too much air, or introducing air at too high a frequency interval, will result in a decompression system that cannot return to a reduced target pressure between wash cycles. The amount of time selected to deliver the cleaning fluid and the interval between the selected cleaning fluids will generally vary depending on the design and specifications of the system components (eg, pumps, tubes, etc.). However, the amount and frequency of delivery air should be high enough to adequately remove obstructions while still recovering the full target pressure between wash cycles. Referring to Fig. 52, in an exemplary embodiment, a reduced pressure delivery system 2411 includes a manifold 2415' manifold 24 15 fluidly coupled to a first conduit 2419 and a second conduit 2423. The first conduit 2419 is coupled to a reduced pressure source 2429 to provide a reduced pressure to the manifold 24. The second conduit 2423 includes an outlet 2435' outlet 2435 that is positioned in fluid communication with the manifold 241 5 and adjacent the outlet of the first conduit 2419. The second conduit 2423 is fluidly coupled to a valve 2439 which, when the valve 2439 is placed in the open position, is capable of achieving communication between the second guide 2423 and ambient air. Valve 2439 is operatively coupled to a controller 2453 that is capable of controlling opening and closing of valve 2439 to regulate cleaning of the second conduit using ambient air to prevent memory in manifold 2415 and first conduit 2419 In the obstruction. It should be noted that any fluid (including liquids or gases) may be used to achieve the techniques described herein. Although the force for cleaning the fluid is preferably a suction that is formed at the tissue site by the reduced pressure, similar to that described with reference to Figure 9, fluid 154474. Doc • 49· 1362951 The transport member can also deliver fluid in a similar manner. Decompression tissue treatment of a tissue site in accordance with the systems and methods described herein can be accomplished by applying a sufficiently low pressure to the tissue site and then maintaining the sufficiently low pressure for a selected period of time. Alternatively, the reduced pressure applied to the tissue site can be cyclic. More specifically, the magnitude of the applied reduced pressure may vary depending on the selected time cycle. Yet another method of applying the reduced pressure can randomly vary the magnitude of the reduced pressure. Similarly, the rate or amount of fluid delivered to the tissue site can be constant, periodic or random. If it is periodic, the fluid delivery can be carried out during the application of the reduced pressure or during the cycle in which the reduced pressure is not applied. Although the magnitude of the reduced pressure applied to the tissue site will generally vary depending on the pathology of the tissue site and the environment in which the decompressed tissue treatment is performed, the reduced pressure is typically between about -5 mm Hg and -500 mm Hg. However, the better is between about _5 mm Hg and -300 mm Hg. Although the systems and methods of the present invention are described above with reference to tissue growth and patient healing, it should be understood that such systems and methods for applying reduced pressure tissue treatment can be used in any living body in which tissue growth or healing is desired to be promoted. . Similarly, the systems and methods of the present invention are applicable to any tissue including, but not limited to, bone tissue, adipose tissue, muscle tissue, nerve tissue, skin tissue, vascular tissue, connective tissue, cartilage tissue, tendon or ligament. Although tissue healing may be a focus of application of reduced-pressure tissue therapy as described herein, decompression tissue therapy (especially for tissues located beneath the patient's skin) may also be used in the absence of disease, defect or injury. Organization 154474. Tissue growth was formed in doc -50· 1362951. For example. It may be desirable to apply a decompressed tissue treatment using a skin implant technique to grow additional tissue at a tissue site and subsequently harvest the additional tissue. The harvested tissue can be transplanted to another tissue site to replace the diseased or damaged tissue, or alternatively, the harvested tissue can be transplanted to another patient.

It should be noted that the reduced pressure delivery device described herein can be combined with a stent material to increase the growth and growth rate of new tissue, which is also important. The stent material can be placed between the tissue site and the reduced pressure delivery device, or the reduced pressure delivery device itself can be made from a bioresorbable material that is used as a new tissue growth stent. It should be apparent from the above description that this document provides an invention with significant advantages. While the present invention has been shown in its several forms, the present invention is not limited thereto, but various modifications and changes can be made without departing from the spirit of the invention. [Simple description of the map]

This patent or application file contains at least one color pattern. The patent or patent application publication with color drawings may be provided by the Patent Office upon request and after payment of the necessary fee. 1 is a perspective view of a reduced pressure conveying device having a plurality of protrusions extending from a flexible barrier to form a plurality of flow passages according to an embodiment of the present invention; FIG. 2 illustrates FIG. 4 is a top view of the reduced pressure conveying device shown in FIG. 1; the pressure reducing FIG. 4A illustrates a side view of the reduced pressure conveying device shown in FIG. 1 154474.doc • 51 1362951 The conveying device has a single lumen decompression conveying pipe; the cabinet diagram (10) shows one of the minus 1 conveying devices shown in FIG. 1 , and the side of the decompression conveying device has a double lumen decompression conveying pipe; 5 illustrates an enlarged perspective view of the reduced pressure delivery device of FIG. 1; FIG. 6 depicts a perspective view of a reduced pressure delivery device according to the present invention - an embodiment of the reduced pressure delivery device having a - attaching property a honeycomb on the barrier: a flexible barrier having a ridge portion and a pair of wing portions, the honeycomb material having a plurality of flow passages; FIG. 7 is a front view showing one of the pressure reducing conveying devices shown in FIG. Figure 8 is a cross-sectional view of the vacuum conveying device shown in Figure 7 at XVH-XVH Figure 8A illustrates a cross-sectional front view of the present invention in accordance with the present invention. Figure 8B is a side elevational view of the reduced-pressure delivery device of Figure 8A; Figure 9 illustrates a A front view of a reduced pressure delivery of an embodiment of the invention is used to apply a reduced pressure tissue treatment to a patient's bones. Figure 10 depicts a colored tissue section of a rabbit skull showing the original damaged bone; '°' Figure 11 illustrates a color histological section of a rabbit skull, which is not a granulation tissue induced after extensive decompression tissue treatment; Figure 12 depicts a colored tissue section of a rabbit skull showing new bones after application of compression tissue therapy Deposition; < Salt Figure 13 illustrates a color tissue section of a rabbit skull, Α ', 廯 廯 廯 沉积 减压 减压 减压 减压 减压 减压 ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; a color photograph in which two critical size defects are formed; Figure 5 illustrates a color photograph of the rabbit skull shown in Figure 14 showing that it dares to enter one of the critical dimension defects Calcium acid scaffold and a stainless steel mesh covering the second critical dimension defect; Figure 16 illustrates a color photograph of the rabbit skull shown in Figure 14 showing the application of reduced pressure tissue treatment to a critical size defect; Figure 17 illustrates the implementation of decompression A tissue section of a rabbit skull after tissue treatment, the tissue section showing deposition of new bone in a calcium phosphate scaffold; Figure 18 depicts stent-filled as shown in Figure 15 after performing decompression tissue treatment for six days and two weeks of surgery Radiograph of critical dimension defect; FIG. 19 is a radiograph of the critical dimension defect filled by the stent shown in FIG. 15 after performing decompression tissue treatment for six days and performing twelve weeks of surgery; FIG. A front view of a reduced pressure delivery system of an embodiment of the present invention, the reduced pressure delivery system having a manifold delivery tube for inserting a reduced pressure delivery device through a skin into a tissue site; FIG. 21 illustrates FIG. An enlarged front view of the manifold delivery tube, the manifold delivery tube comprising a reduced pressure delivery device having a flexible barrier and/or a compression position Figure 12 is an enlarged front elevational view of the manifold delivery tube of Figure 21 showing the flexible barrier and/or honeycomb of the reduced pressure delivery device after being pushed from the manifold delivery tube The material is in an expanded position; FIG. 23 illustrates a front view of a reduced pressure delivery system 154474.doc-53·1362951 in accordance with an embodiment of the present invention. The reduced pressure delivery system has a reduced pressure delivery device for transcutaneous administration. a manifold delivery tube inserted into a tissue site, the figure showing that the reduced pressure delivery device is outside the manifold delivery tube but is constrained to a compressed position by an impermeable membrane; FIG. 24 depicts the reduction shown in FIG. A front view of a pressure delivery system showing the reduced pressure delivery device outside the manifold delivery tube but constrained to a relaxed position by a non-permeable membrane; Figure 25 illustrates the reduced pressure delivery system of Figure 23 a front view showing the reduced pressure delivery device outside the manifold delivery tube but constrained by a non-penetrating film in an expanded position; FIG. 25A illustrates one of the reduced pressure delivery systems illustrated in FIG. The view shows that the reduced pressure delivery device is outside the manifold tube but is surrounded by an impermeable membrane in an expanded position; FIG. 26 illustrates a front view of a reduced pressure delivery system in accordance with an embodiment of the present invention. The shai reduced pressure delivery system has a manifold delivery tube for inserting a decompression delivery device through the skin into a tissue site, the figure showing that the reduced pressure delivery device is outside the manifold delivery tube, but is subjected to a FIG. 26A illustrates a front view of a reduced pressure delivery system in accordance with an embodiment of the present invention, and FIG. 27 illustrates a front view of a reduced pressure delivery system in accordance with an embodiment of the present invention. The reduced pressure delivery system has a manifold delivery tube for injecting a reduced pressure delivery device through the skin to a tissue site; FIG. 27A illustrates a reduced pressure delivery system 154474.doc in accordance with an embodiment of the present invention. -54 - 1362951 In elevation, the reduced pressure delivery system has a manifold delivery tube for delivering a reduced pressure delivery device through the skin to a tissue site Permeable film; FIG. 28 is a flow chart showing a method for performing decompression tissue treatment on a tissue site according to an embodiment of the present invention; FIG. 29 is a view illustrating decompression of a tissue site according to an embodiment of the present invention. Figure 30 is a flow chart of a method of tissue decompression treatment according to an embodiment of the present invention; Figure 31 illustrates an embodiment of a tissue site according to an embodiment of the present invention. FIG. 32 is a cross-sectional elevation view of a reduced pressure delivery device including a hip prosthesis having a plurality of flows, in accordance with an embodiment of the present invention; a channel for applying a reduced pressure to a region of the bone surrounding the hip prosthesis; Figure 33 illustrates a cross-sectional elevation view of the hip prosthesis of Figure 32 having a second plurality of flow channels for Transferring fluid to a bone region surrounding the hip prosthesis; FIG. 34 illustrates a method of repairing a patient's joint using reduced pressure tissue treatment in accordance with an embodiment of the present invention Figure 35 illustrates a cross-sectional elevation view of a reduced pressure delivery device including an orthopedic fixation device having a plurality of flow channels for use with a plurality of flow channels, in accordance with an embodiment of the present invention. Applying a reduced pressure to the bone region of the orthopaedic fixation device; 154474.doc • 55· 1362951 FIG. 36 is a cross-sectional elevation view of the orthopedic fixation device of FIG. 35 having a second plurality of orthopedic fixation devices a flow channel for delivering fluid to a bone region adjacent to the orthopedic fixation device; FIG. 37 illustrates a flow chart of a method for treating bone defects in bone using reduced pressure tissue therapy in accordance with an embodiment of the present invention; Figure 38 is a flow chart showing a method for performing decompression tissue treatment on a tissue site in accordance with an embodiment of the present invention; and Figure 39 illustrates a method for decompressing a tissue site in accordance with an embodiment of the present invention. Flow chart of a method of organizing treatment. 40-48 illustrate various views of a reduced pressure delivery system in accordance with an embodiment of the present invention. The reduced pressure delivery system has a main manifold including a flexible wall surrounding a main flow channel and located therein. A plurality of apertures in a flexible wall; Figures 49-50 illustrate perspective and top cross-sectional views of a reduced pressure delivery system having a body-to-body connection to a subtraction, in accordance with an embodiment of the present invention. a primary manifold of the pressure delivery tube; FIG. 51 is a perspective view of the primary manifold shown in FIGS. 40-50 applied to a bone tissue site with an auxiliary manifold; and FIG. 52 illustrates an embodiment in accordance with the present invention. A schematic view of a reduced pressure delivery system having a valve fluidly coupled to a second conduit. [Main component symbol description] 211 Pressure reducing device or wing manifold 213 Flexural barrier 215 Ridge portion 154474.doc •56· 1362951

219 wing portion 223 arched channel 227 flexible backing 231 protrusion 233 flow channel 241 decompression delivery tube 243 distal orifice 255 proximal orifice 259 lumen or passage 261 double lumen tube 263 first lumen 265 Second lumen 271 horizontal spacer 311 decompression delivery device or wing manifold 313 flexible barrier 315 ridge portion 319 wing portion 323 arcuate channel 327 honeycomb material 329 distribution surface 330 peripheral surface 341 decompression conduit 343 Distal orifice 355 proximal orifice 154474.doc -57- 1362951 359 lumen or passage 371 decompression delivery device 373 decompression delivery tube 375 extension 377 distal end 381 incision 383 shoulder 385 projection 387 inner surface 391 flow Channel 411 decompression delivery device 413 tissue site 415 human bone 419 decompression delivery tube 421 proximal end 427 decompression source 429 void defect 431 fluid delivery tube 432 proximal end 433 fluid delivery source 434 filter 435 pressure sensor 711 decompression Conveying system 713 Tissue site 154474.doc -58- 1362951 ❿ 721 Manifold duct 725 Guide unit 727 Guide wire 731 fracture site 733 patient bone 735 skin 739 soft tissue 743 tapered distal end 751 pathway 761 decompression delivery device 765 flexible barrier 767 honeycomb material 769 decompression delivery tube 811 decompression delivery system 821 manifold delivery tube 837 dotted line 843 distal 861 Pressure reducing device 865 Flexure barrier 867 Honeycomb material 869 Pressure reducing pipe 871 Impervious film 873 Inner surface 881 Mark, 154474.doc -59- 1362951 885 Removal device 891 Auxiliary lumen or tube 911 Reduced pressure delivery system 921 manifold pipe 937 dotted line 943 distal end 961 decompression conveying device 965 flexible barrier 967 honeycomb material 969 decompression pipe 971 impervious film 973 inner surface 977 rubber seal 981 mark 985 decompression conveying system 987 guide Wire 989 Pressure reducing pipe 991 Pressure reducing device 993 Tissue part 1011 Pressure reducing system 1021 Manhole pipe 1025 Organization part 1029 Void 1035 Pressure reducing device 154474.doc -60- 1362951 1043 1055 1057 1061 1511 1515 1517 1521 Call 1525 1529 1535 1541 1543 1545 1547 1551

1553 1565 1571 1573 1583 1585 1711 1715 distal internal space assisted lumen guiding wire decompression delivery device orthopedic hip prosthesis patient leg section part head section passage porous coating flow channel main feed line lateral branch line lateral branch line Decompression delivery tube decompression delivery source connection 埠 fluid delivery tube fluid delivery source main feed line lateral branch line decompression delivery device orthopedic fixation device 154474.doc •61 · 1362951 1717 bone 1719 fracture site 1721 pathway 1725 screw 1735 porous coating 1741 Flow channel 1743 Main feed line 1745 Connection 埠 1747 Lateral branch line 1751 Reduced pressure line 1753 Reduced pressure supply source 1761 Flow channel 1765 Connection 埠 1771 Fluid transfer line 1773 Fluid supply source 1783 Main feed line 1785 Lateral branch line 2111 Reduced pressure delivery System 2115 main manifold 2117 flexible wall 2121 main flow path 2123 proximal end 2129 transition zone 2135 anti-blocking component -62- 154474.doc 1362951

2137 protrusion 2141 inner surface 2145 ridge 2149 honeycomb material 2155 sub L 2161 first conduit 2163 second conduit 2171 headspace 2211 decompression delivery system 2215 main manifold 2217 decompression delivery tube 2223 central lumen 2225 auxiliary lumen 2231 hole 2241 Headspace 2321 Auxiliary Manifold 2411 Reduced Pressure Delivery System 2415 Manifold 2419 First Catheter 2423 Second Catheter 2429 Decompression Source 2435 Outlet 2439 Valve 2453 Controller 154474.doc •63-

Claims (1)

1362951 Announcement Seventh, the scope of application for patents: -- 1- A vacuum pumping system for applying a decompression tissue treatment to a tissue site, comprising: a manifold tube having a passage and a distal end The distal end is configured to be inserted through the skin and placed adjacent to the tissue site; an injectable or pourable material can be delivered to the tissue site by the manifold to enable the injectable or pourable material to be adjacent to the tissue a void in the portion to form a manifold having a plurality of flow passages in fluid communication with the tissue portion; and a reduced pressure delivery conduit fluidly connectable to the flow passages of the manifold The system wherein the manifold delivery tube is the same tube as the reduced pressure delivery tube. 3. 4. 5. For example, the system of claim 1 'where the manifold is bioresorbable. The system of claim 1, wherein the manifold is used as a tissue growth scaffold. The system of claim 1, wherein the manifold is foamed and solidified in the presence of at least one of the integral liquid and the integral temperature. 6. The system of claim 1 wherein the manifold further comprises a bioresorbable polymer dissolved in a gluten and mixed with sodium bicarbonate and citric acid. The system of claim 6, wherein the bioresorbable polymer is one of a polylactide-co-glycolide (PLAGA) polymer and a polyethylene glycol-pLAGA copolymer. " 8. The system of claim 6, wherein the solvent is a gas chamber. 154474.doc 1362951 9·:: The system of the project! The group of which can be injected or tilted = liquid: liquid, slurry, suspension, (iv) = self paste, putty, and particulate solids 0 > iO. The system of claim 1, wherein: the injectable or pourable material undergoes a phase change in the presence of at least one of the integral fluid and the body temperature; and/ the injectable or pourable material comprises one in the 蚪m ^ J Zhuang shot or pourable material, after the dissolution of P〇ragen, the dissolution of the P〇ragen points a number of flow channels. Decomposing the complex system of claim 1, wherein the injectable or pourable material comprises a layer of microspheres, the coating being capable of being selected after delivery of the injectable or pourable material to the tissue site Cross-linking sexually. 12. The system of claim 11, wherein the coating is selectively crosslinked in response to at least one of heat, light, and a vapor. A system of long term 11 wherein the microspheres form the plurality of flow channels after crosslinking. 14. The system of claim 1 wherein: the injectable or pourable material is selected from the group consisting of a paste having an initial viscosity and a putty; during delivery to the weaving site, the & The degree of pourable material drops below the initial viscosity in the presence of shear force; and the viscosity of the injectable or pourable material returns to the point after the sputum/main shot or pourable material is delivered to the tissue site Initial viscosity. ]54474.doc