TW200808394A - System and method for percutaneously administering reduced pressure treatment using a flowable manifold - Google Patents

Abstract

A reduced pressure delivery system for applying a reduced pressure to a tissue site includes a manifold delivery tube having a passageway and a distal end, the distal end configured to be percutaneously inserted and placed adjacent the tissue site. A flowable material is provided and percutaneously deliverable through the manifold delivery tube to the tissue site. The flowable material is capable of filling a void adjacent the tissue site to create a manifold having a plurality of flow channels in fluid communication with the tissue site. A reduced pressure delivery tube is provided that is capable of fluid communication with the flow channels of the manifold.

Description

200808394 IX. INSTRUCTIONS OF THE INVENTION: TECHNICAL FIELD OF THE INVENTION The present invention relates generally to a method of use, and more particularly to a system for the treatment of tissue. Application in systems and tissue sites that promote tissue growth [prior art]

Decompression therapy is increasingly being used to promote wound healing in soft tissue wounds that heal very slowly or not heal without the use of decompression therapy. Typically, a reduced pressure is applied to the wound site by an open-cell foam. The open-cell foam acts as a manifold to distribute the reduced pressure. The open hole hair: the body is sized to fit the existing wound, is in contact with the wound, and is 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 pore foam. During the removal of the foam, the large amount of tissue that is growing can cause pain to the patient. Decompression therapy is usually applied to non-healing open wounds. In some cases, the tissue to be treated is subcutaneous tissue, and in other cases, the tissue is located in or on the skin tissue. Traditionally, decompression therapy has been primarily used in soft tissue. Decompression therapy is not currently used to treat closed deep tissue wounds because it is difficult to access such wounds. In addition, decompression therapy has not been used in conjunction with the treatment of collateral defects or the promotion of osteogenesis, which is mainly due to the difficulty of accessing the collaterals. Applying decompression therapy by surgically exposing the bone may cause more problems than the problem it solves. Finally, the development of devices and systems for the application of decompression therapy has barely exceeded the open-cell foam 119639.doc 200808394. The shape of the open-cell foam is manually adapted to the wound site and then after a decompression treatment cycle. Remove it. 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 reduced pressure treatment delivery system is provided for applying 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 to the tissue site to form a plurality of fluid communication with the tissue site. The manifold of the flow channel. A reduced pressure delivery tube is provided that is in fluid communication with the flow channels of the manifold. In accordance with another embodiment of the present invention, a method of decompressing a tissue site is provided which includes positioning a distal end of a manifold delivery tube adjacent a tissue site through the skin. A flowable material is delivered to the tissue site through the skin via the manifold delivery tube. 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. A reduced pressure is applied to the tissue site via the flow passage of the manifold. Other objects, features, and advantages of the present invention will be apparent from the description and appended claims. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The preferred embodiments are described in detail below with reference to the accompanying drawings in which: FIG. To enable those skilled in the art to practice the invention, the embodiments are described in sufficient detail, and it should be understood that the potted embodiments may also be utilized and may be modified in structural, mechanical, electrical, and chemical aspects. This is not intended to obscure the details of the present invention, and the description may omit certain information that is familiar to those skilled in the art. The following detailed description is not to be taken as limiting, and the scope of the invention is defined by the scope of the appended claims. The term "elastic" as used herein means having the properties of an elastomer. Twisted "elastomer·, large system refers to a polymer material that has the same properties as rubber. More specifically, most elastomers have an elongation of greater than 1% and a significant degree of resilience. The resilience of a material means that the material recovers from elastic deformation. Examples of the elastomer may include, but are not limited to, natural rubber, polystyrene dioxime, styrene butadiene rubber, chloroprene rubber, polybutylene, rubber, isobutylene rubber, ethylene propylene rubber, ethylene propylene Dilute monomer rubber 'chlorosulfonated polyethylene' polysulfide rubber polyurethane urethane, and polyoxynium. The term "flex" as used herein refers to an object or material that can bend or flex. Elastomeric materials are generally flexible' but flexible materials as referred to herein: The selected materials are not necessarily limited to only elastomers. The term "flex" is combined with the material (4) recording device of the present invention. The material can be applied or closely matched to the shape of the tissue site. For example, the flexible nature of a reduced pressure delivery device for treating a collateral defect allows the device to wrap or wrap around a bone portion having a defect. The term "fluid" as used herein generally refers to a gas or liquid' but may also be any other flowable material including, but not limited to, a gel, a gel or a bubble bed. As used herein, the term "impermeable" generally refers to the ability of a film, covering or other substance to block or slow the penetration of liquids or gases. It can be used to impede the passage of liquids through the use of I* raw materials. At the same time, the gas is allowed to pass through the cover, sheet or other film of the film. Although the impermeable film may not be permeable to liquid, the film may only reduce the transmittance of all or only certain liquids. The term "impermeable" is not used. Implicit impervious films are above or below any special industry standard impermeability measurements, such as specific values for water vapor transmission rate (WVTR). As used herein, the term "manifold" refers to a substance or structure that is provided to aid in the application of reduced pressure to a tissue site, delivery of fluid to or removal of fluid from the tissue site. A plurality of interconnected flow channels or passages are included to improve the distribution of fluids provided to or removed from the tissue region surrounding the manifold. Examples of manifolds can include, but are not limited to, structures having channels configured to form flow channels Device of components, honeycomb foam (for example, open cell foam), porous tissue collecting device, and liquid, gel and foam containing flow channels after solidification. The term used herein, reducing pressure" Large system refers to the pressure at the tissue site that is receiving treatment that is less than the pressure of the Zhouyuan. In most cases, this reduced pressure will be less than the environmental pressure at the patient's location. Alternatively, the reduced pressure can be less than the hydrostatic pressure of the tissue at the tissue site. The term "vacuum" and "negative pressure" can be used to describe the pressure applied to the tissue site. However, the actual pressure applied to the tissue site can be significantly lower than the pressure 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 "scaffold" 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. "组织部" means 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 area of any tissue that is not necessarily injured or defective, but rather wants to enhance or promote the growth of additional tissue in such areas. For example, Decompression tissue treatment is used in these tissue areas to grow additional tissue, which can then be harvested and moved To another 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 having a ridge portion 215 and a pair of wing portions 219. The portion 219 is along the ridge portion 119639.doc -10- 200808394

Set the side positioning. The ridge portion 215 defines 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 shown in Figure u, thereby making one of the wings Portion 219 is wider than the other wing portion 219. The extra width of one of the wing portions 219 may be particularly useful if the wing manifold 211 is used in conjunction with bone regeneration or healing and the wider wing manifold 211 will wrap around a fixed hardware attached to the bone. . The flexible barrier 213 is preferably made of an elastic material such as a polyoxymethylene polymer. An example of a suitable polyoxyl polymer includes med_6〇i5 manufactured by Nusil Techn〇1〇gies, Inc. of Carpimeria, 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 the flexible backing 227 to enhance the strength and _ durability of the pull-up P early wall 213. The flexible backing and the flexible barrier 2 13 may have a thickness in the arcuate channel 223 that is less than the thickness in the wing portion 2 IQ and may also be formed using the polyoxopolymer to form the flexible barrier 213. A polysulfide adhesive is used to help bond the flexible backing m. An example of a polyoxo-oxygen binder may include a med 1011 H-backed backing 227, also sold by the company Nusil Techn〇1〇gies, preferably made of a poly-knit fabric, such as CR·Bard, located in Tempe, Arlzona. The β-〇13 manufactured by the company is made of... and the backing 227 can be made of any biocompatible, flexible material which can enhance the strength and durability of the flexible barrier 213. In some cases, the right flexible barrier 213 is made of a material of suitable strength, then a backing 227. 119639.doc -11 - 200808394 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 213 are impermeable to liquids. , air and other gases. The flexible barrier 213 and the 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 211. 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 the flexible backing 227 can be further used as a new cell growth support, or a stent material can be used in combination with the flexible barrier 213 and the 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 adhesively secured to the surface of the flexible barrier 213. If a polysiloxane polymer is used to form the flexible barrier 213, the flexible backing 227 can also be secured to the flexible P early wall 213 using a polyoxyxylene 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 may be used. The flexible barrier 213 includes a plurality of protrusions 231 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 at least some portion of each protrusion 231 is in a plane different from that of the flexible back view (1) 119639.doc -12 - 200808394 It is sufficient to fix the plane associated with the side of the protrusion 231. In this regard, it is not even required that the specific projections 231 have the same shape or size as the other projections 231; in fact, the projections 231 may comprise random blends of different shapes and sizes. Therefore, the distance from each of the protrusions 231 from the flexible barrier 可 can vary, but can also be consistent in the plurality of protrusions 231. 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 may be fixed only to the flexible barrier 213 or the flexible backing 227, or the tube 241 may be simultaneously secured to both the flexible P early wall 213 and the flexible backing 227. The reduced pressure delivery tube 241 includes a distal opening 243 at the distal end of the tube 241. The tube 241 can be positioned such that the distal aperture 243 is located at any point along the arcuate channel 223, but the tube 241 is preferably positioned such that the return aperture 243 is located at approximately the midpoint along the longitudinal extent of the dome shaped channel 223. The distal aperture 243 is preferably formed in an elliptical or circular shape by cutting the tube 241 along a plane oriented at an angle of less than ninety (9 angstroms) relative to the longitudinal axis of the tube 241. Although the aperture 243 may also be circular, the elliptical shape of the aperture 243 enhances fluid communication with the flow passage 233 formed between the projections 231. 119639.doc -13 - 200808394 The reduced pressure transporter 241 is preferably made of polypyrene or urethane coated with paralyne. However, any medical grade tube material can be used to construct the reduced pressure delivery g 241. Other coatings that can be applied to the tube include heparin, anticoagulant, anti-fibrinogen, anti-adherent, anti-prothrombin, and hydrophilic coatings.

In an embodiment, the decompression delivery tube 241 may also include a discharge opening or discharge orifice 251 positioned along the reduced pressure delivery tube 241 as an alternative to or in addition to the distal aperture 243. To further enhance the fluid communication between the reduced pressure delivery 241 and the flow channel 233. The reduced pressure delivery tube 24 can be positioned only along one of the longitudinal extents of the arcuate passage 223 as shown in Figures 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 greater detail below with respect to Figure 9. The reduced pressure delivery tube 241 shown in Figures 1-3, 々A 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 261 shown in Figure 4B. The double lumen tube 261 includes a first lumen 263 and a second lumen 265. The use of a dual lumen tube provides a separate fluid communication path between the proximal end of the reduced pressure delivery tube 241 and the flow channel 23 3 . For example, a dual lumen tube 261 can be used to achieve communication between the reduced pressure source and the flow channel 233 along the first lumen 263. The second lumen 265 can be used to introduce fluid into the flow channel 119639.doc -14 · 200808394 233. The fluid can be filtered air or other gas, antibacterial, antiviral, cell growth promoter, irrigation fluid, chemically active fluid or any other fluid. If it is desired to introduce a plurality of fluids into the flow channel 233 via separate fluid communication paths, the reduced pressure delivery tube can have more than two lumens.

Still referring to Fig. 4B, a horizontal spacer 271 separates the first and first official lumens 263' 265 of the reduced pressure delivery tube 261 such that the first lumen 263 is positioned above the first official lumen 265. The relative positions of the first and second lumens 263, 265 may vary depending on how fluid communication is provided between the lumens 263, 265 and the flow channel 2D. For example, the #1 lumen 263, when not positioned in Figure 4B, can provide a discharge opening similar to the discharge aperture 1 to achieve communication with the flow channel 233. When the second lumen is in position as shown in Fig. 1, the first lumen 265 can be in communication with the flow channel 233 via a retreat similar to the distal aperture 243: the orifice. Alternatively, a plurality of lumens in a reduced pressure delivery tube can be positioned side by side by a vertical spacer separating the s lumens or the lumens can be positioned concentrically or coaxially. It will be readily apparent to one of ordinary skill in the art that the provision of independent fluid communication paths can be accomplished in a number of different ways, including providing a f lumen tube as described above. Alternatively, the independent fluid communication path can be provided by securing the single lumen tube to another single lumen or by means of a plurality of separate, unsecured tubes with single or multiple lumens. The right uses a separate tube to provide separate fluid communication with the flow channel 233 = the diameter, and the ridge portion 215 can include a plurality of arcuate channels 223, each of which is an arcuate channel 223. Alternatively, the enlarged arched passage 223 can accommodate a plurality of tubes at 119639.doc -15-200808394. An example of a reduced pressure delivery tube pressure reducing delivery device having a separation from a fluid delivery tube will be described in greater detail below with reference to FIG. Referring to Figures 6-8, a reduced pressure delivery device or wing 311 according to the principles of the present invention includes a flexible barrier 313 having a ridge portion 315 and a pair of wing portions 319. Each wing portion 319 is positioned along the opposite side of the ridge portion 315. 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 3 15 can be centrally positioned on the wing manifolds 3 11 such that the widths of the wing portions 319 are equal, the ridge portions 315 can also be unbiased as in Figure 6-8. One of the wing portions 319 is wider than the other wing portion 3 19 . If the winged manifold 3丨丨 is used in conjunction with bone regeneration or healing and the winged manifold 3 11 will wrap around the fixed hardware attached to the bone, the extra width of one of the wing portions 319 may be Particularly useful. 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 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 330. • In an embodiment, the flexible barrier 3 13 can be similar to the flexible barrier 213 and includes a flexible backing. Although the adhesive is a preferred method for securing the honeycomb material 327 to the flexible barrier 313, the flexible barrier 3 13 and the honeycomb material 327 may be secured by any other suitable fastening method, or It is left to the user for assembly at the treatment site. The flexible barrier 313 I19639.doc -16 - 200808394 and/or the flexible backing acts as an impervious barrier to resist fluid permeation such as liquids, air or other gases. The flexible barrier and flexible backing may be provided in an embodiment to support the honeycomb material 327 in a separate manner. Rather, the honeycomb material 327 can have a one-(four) barrier layer that is one of the honeycomb-like materials 327 that is impermeable to the 14-chopper. The early wall layer can be formed of a closed-cell material to prevent fluid permeation, thereby replacing Flexible barrier 313. If a monolithic barrier layer is used with the honeycomb material 327, the barrier layer may comprise a ridge portion and a wing portion as described above with reference to the flexure barrier wall 313. The flexible P early wall 313 is preferably made of an elastic material such as a polyfluorene polymer. An example of a suitable poly-stone polymer includes the ia, which is located in the enamel.

MED6〇15 manufactured by Nusil Technologies of California. However, it should be noted that the flexible barrier 313 can be made of any other biocompatible, flexible material. If the flexible barrier encloses or otherwise comprises a flexible backing, the flexible backing is preferably made of a polyester knit fabric, such as Bard 6 manufactured by CR Bard, Inc., Ariz_, TemPe. 13 made. However, the flexible backing 227 can be made of any biocompatible, flexible material that enhances the strength and durability of the flexible fence 313. - In one embodiment, the honeycomb material 327 is an open cell, reticulated polyether amine phthalate foam having a pore size in the range of from about 400 to about 600 microns. An example of such a foam may include GranuF〇am manufactured by Kinetic Concepts, Inc. of San Am〇ni〇, 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. 119639.doc -17- 200808394 Honeycomb material 327 is primarily an "open-cell" material that includes a plurality of pores that are fluidly connected to adjacent pores. 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. 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 passages' and such characteristics can be used to alter the flow characteristics of the fluid flowing through the honeycomb material 327. The honeycomb material 327 can further include a portion containing, closed pores. The closed cell portion of the honeycomb material 327 contains 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 3 。3. Similarly, a closed hole portion can be selectively provided in the honeycomb material 327 to prevent fluid from passing through the peripheral surface 33 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 311. Suitable bioresorbable materials can include, but are not limited to, polymeric blends of polylactic acid (PLA) and polyglycolic acid (PGA). The polymeric blend may also include, but is not limited to, polycarbonic acid, polyfumaric acid vinegar, and e. The flexible barrier 313 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, the flexible backing 327, and/or the honeycomb material 327 to promote the cells. Growing. Suitable stent materials can include, but are not limited to, calcium phosphate, collagen, pla/pgA, coral hydroxyapatite, carbonate, or treated allograft materials. Preferably 119639.doc -18- 200808394 The scaffold material will have a high void ratio (i.e., high air content). The reduced pressure transport operator 341 is positioned within the arched 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 tube 341 can be only ported to the honeycomb material 327. The reduced pressure delivery tube 341 is wrapped at the distal end of the tube 341 with an end opening 343 which is similar to the distal opening 243 of FIG. 5 and the decompression bearing 341 can be positioned such that the distal opening 343 is arched The shaped passage 323 is located at any point, but is preferably positioned at approximately the midpoint along the longitudinal length of the arcuate passage 323. The distal aperture 343 is preferably formed in 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 341. Although the aperture may also be circular' however, the elliptical shape of the aperture enhances fluid communication with the flow channel in the honeycomb material 327. In one embodiment, the reduced pressure delivery tube 341 may also include a discharge opening or discharge orifice (not shown) similar to the discharge opening 25 in Figure 5. As an alternative to or in addition to the distal orifice 343, a discharge opening ' is also disposed along the tube 341 to further enhance fluid communication between the reduced pressure delivery conduit 34 and the flow passage. As previously described, the reduced pressure delivery tube 34i can be positioned only partially along one of the longitudinal lengths 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 arcuate passage 323, the distal aperture 343 can be capped such that all fluid communication between the tube 341 and the flow passage is through the discharge opening. Preferably, the honeycomb material 327 is covered and directly in contact with the reduced pressure delivery pipe 119639.doc -19- 200808394 341. The honeycomb material 327 can be attached to the reduced pressure delivery tube 341, or the honeycomb material 327 can be attached only to the flexible barrier 313. If the reduced pressure delivery tube (4) is clamped so that it extends only to the midpoint of the arched channel milk, the honeycomb material may also be in the region of the arched passage 323 that does not contain the reduced pressure delivery tube (4) - connected to the flexible barrier The ridge portion 315 of 313. The 'salt pressure delivery officer 341 step-step includes a proximal orifice 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 pressure delivery shown in Figures 6-8, tube 341 contains only a single lumen or passage 359. However, the reduced pressure delivery e 341 can be provided with a plurality of official chambers, such as the plurality of lumens previously described with reference to the drawings. As described above, 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 m φ 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 Figures 1-5. The reduced pressure delivery device 371 is particularly useful for reducing the amount of connective tissue that can be received in the incision 381 and regenerating tissue on the connective tissue. (d), tendon and cartilage are non-limiting examples of tissue that can be treated by the reduced delivery device 371. #See Figure 9 using a sputum delivery device 411 similar to other reduced pressure delivery devices described herein to apply tissue reduction therapy to a tissue site 413 (e.g., a patient's human bone 415). When used to promote bone cohesion 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 used to increase the local (4) density of 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 419 having a proximal end 421 fluidly coupled to a reduced pressure source. The reduced pressure source 427 is a pump or any other device capable of applying a reduced pressure to the tissue site 413 via a plurality of flow channels associated with the reduced pressure delivery tube 419 and the reduced pressure delivery device 411. Applying a reduced pressure to the tissue site 413 is accomplished by arranging the wing portion of the reduced pressure delivery device 411 adjacent the tissue site 413, which in this particular example involves wrapping the scorpion 429 around the two of the bones 415 Wing around the wing. The reduced pressure delivery device 411 can be inserted by surgery or through the skin. When inserted through the skin, the reduced pressure delivery tube 419 is preferably inserted through a sterile insertion sheath that penetrates the skin tissue of the patient. Treatment with decompression tissue typically produces granulation tissue in the area surrounding the tissue site 4 i 3 . Granulation tissue is a common tissue formed before 119639.doc •21- 200808394, which is often repaired in humans. Under normal conditions, granulation tissue may form during the presence of foreign bodies or during wound healing. Granulation tissue is commonly used as a scaffold for healthy replacement tissue and further to form certain scar tissue. The granulation tissue is a localized vascularized tissue' and in the presence of reduced pressure, the enhanced growth rate of such localized vascularized tissue promotes the growth of new tissue at tissue site 413. Still referring to Fig. 9, a fluid delivery tube 43 1 can be fluidly coupled to the flow passage 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 system air is being delivered to the tissue site, it is preferred to filter and sterilize the air by filtering the air through a filter 434 that filters the particles as small as 〇·22. Especially when the tissue site 413 is positioned beneath the surface of the skin, it may be important to introduce air into the tissue site 413, which facilitates good clearance of the tissue site 413, thereby relieving or preventing clogging of the reduced pressure delivery tube 419. The fluid delivery officer 431 and the fluid transfer source 433 can also be used to introduce other bodies to the tissue site 413 including, but not limited to, antibacterial agents, antiviral agents, cell growth promoters, irrigation fluids, decompression delivery tubes 431, preferably through or other Chemically active agent. When inserted through the skin, the parent inserts through a sterile insertion sheath that penetrates the patient's skin tissue. A pressure sensor 435 can be operatively coupled to the fluid delivery tube 431' to indicate whether the fluid delivery tube 431 is blocked by blood or other bodily fluids. The pressure sensor 4 3 S T T is operatively coupled to the fluid delivery source 433

119639.doc The amount of fluid at tissue site 413. Alternatively, the method may be connected to the vicinity of the distal end of the fluid delivery tube 431 -22-200808394 to prevent blood or other body fluid from entering the fluid delivery tube 43 1 . 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 4B. One of ordinary skill in the art will recognize that if a multi-lumen tube is used, the sensors, valves, and other components associated with fluid delivery tube 43 1 can similarly be associated with one of the reduced pressure delivery tubes 419. The lumen is associated. Preferably, any lumen or tube in fluid communication with the tissue site is coated with an anticoagulant to prevent body fluids or blood from clogging within the lumen or tube. Other coatings that can coat such lumens or tubes include, but are not limited to, heparin, anticoagulant, anti-fibrinogen, anti-adherent, anti-prothrombin, and hydrophilic coatings. Referring to Figures 10-19, trials have shown that when applied to decompressed tissue treatment of bone tissue, a positive effect is obtained. In a specific experiment, the skull of a rabbit was treated with decompressive tissue to determine its effect on bone growth and regeneration. The specific goal of this test was to find the effect of decompressed tissue treatment on rabbits that were not deficient or damaged on the skull, the effect of decompressive tissue treatment on rabbits with critical size defects on the skull, and the placement of a scaffold material with decompressed tissue. The effect of treatment together on the treatment of critical dimension loss-loss on the skull. The specific test protocol and number of rabbits are listed in Table 1 below. Rabbit number test protocol 4 No defects on the skull; decompression tissue treatment (RPTT) was applied to the top of the intact periosteum by a honeycomb foam (GranuFoam) for 6 days, followed immediately by harvesting the tissue 4 skull without defects; In the case of decompression tissue treatment (RPTT), place the honeycomb foam (GranuFoam) on the top of the intact periosteum for 6 days, and then immediately harvest the tissue 119639.doc •23· 200808394 ¥There is a ^Top placement: 3⁄43⁄4网临临_ Jia factory __ harvested tissue after 12 weeks of surgery _ Bay application 24 small day RPTT, a placement of non-network on the top ^ surgical size, the two defects should be torn; in 4 surgery; no Execution--- False SSir does not perform RPTT): In the hand of the master 1: Test the critical dimension of the defect system (such as the skull), the size is large enough to heal and can not be healed by self-recovery. For rabbits, a full-thickness hole with a diameter of about 15 inches is drilled into the skull to form a critical dimension defect of the skull. Referring specifically to Figure 10, a tissue section of a rabbit skull having primitive, undamaged bones is illustrated. The skeleton of the skull is magenta. The surrounding soft tissue is white, and the periosteum is highlighted by a yellow asterisk. In Fig. 11, a rabbit skull after application of reduced pressure tissue treatment for 6 days and subsequent immediate harvesting of tissue is illustrated. The bone and periosteum can be seen and a layer of granulation woven fabric has been formed. In Fig. 12, the rabbit skull after application of the decompression group 119639.doc -24 - 200808394 for 6 days and immediately after harvesting the tissue is illustrated. The tissue section of Figure 12 is characterized by the formation of a new bone network under the granulation tissue. The bone tissue is highlighted by a yellow asterisk. In the figure, the figure illustrates the rabbit skull after applying decompression tissue treatment for 6 days and then immediately harvesting the tissue. You can see the new (four) and periosteum. The appearance of the skeletal tissue formed by decompression tissue treatment is very similar to the tissue appearance of osteogenesis in very young animals that are undergoing rapid growth and deposition. Referring more specifically to Figures 14-19, several photographs and tissue cuts are illustrated which show procedures and results for decompressing tissue treatment of a rabbit skull having a critical size defect. In Fig. 14, a rabbit skull having two critical size defects formed thereon is illustrated. These full thickness critical dimension defects have a diameter of approximately 15 mm. In Figure 15, a stainless steel wire mesh has been placed over one of the critical dimension defects and a % I calcium stent has been placed within the second critical dimension defect. In Figure i6, a reduced pressure is applied to the critical dimension defects using a reduced pressure tissue treatment device similar to that described herein. The pressure applied to each of the missing applications is _125 mm Hg gauge. The reduced pressure is applied according to one of the test protocols listed in Table 1. In Fig. 17, the figure illustrates the skull after 6 days of decompression tissue treatment and tissue harvested after 12 weeks of surgery. The slice shown contains a calcium phosphate scaffold, which is indicated by a red arrow. The use of decompression tissue treatment results in significant growth of new bone tissue, which is highlighted by a yellow asterisk in Figure 17. 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 decompressive tissue. This observation suggests that there can be a treatment threshold or duration required to induce a new bone formation reaction at 119639.doc -25-200808394. The effect of decompression tissue treatment was most pronounced in the samples collected 12 weeks after surgery, suggesting that decompression tissue treatment caused a cascade of biological events that enhanced the formation of new bone tissue. The g-shaped boundary defect covered with stainless steel mesh (Fig. 15) but without the stent material in the defect was used as an intra-animal control, and the new bone growth was minimal. The poor materials such as sputum highlight the advantages of proper scaffold materials and the positive effects of decompressive tissue treatment on stent fusion and bioavailability. In Figures 18 and 19, a radiograph of a critical dimension defect filled with a stent after six days of decompression tissue treatment is illustrated. 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 bracket 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 7 is applied to a tissue site 713 of a patient in accordance with an embodiment of the present invention. 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 means for enabling the manifold delivery tube 721 to be guided to the tissue site 713, such as a guide unit 725 and a guide wire. The placement and guidance of the guide wire 727 and the manifold delivery tube 721 is accomplished using endoscopy, ultrasound, fluoroscopy, auscultation, palpation, or any other suitable localization technique. Manifold delivery tube 721 is provided. Used to insert a decompression delivery device through the skin into the tissue site of the patient 7丨3. When inserted through the skin, the manifold delivery tube 721 preferably passes through a patient skin group 119639.doc •26- 200808394 The sterile insertion sheath is inserted. In Figure 20, the tissue site 713 contains bone tissue at a fracture site 731 adjacent 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 7丨3 may also comprise any type of tissue including, but not limited to, adipose tissue, muscle tissue, nerve tissue, skin tissue, vascular tissue, connective tissue, cartilage, sputum, See FIGS. 21 and 22, which further illustrate a reduced pressure delivery system 711. 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 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 the other portions of the tube 721. The open position of the distal end 743 is in Figure 21 The manifold tube 721 further includes a passage 751 that includes a pressure relief delivery device 761 or any other reduced pressure delivery device. The reduced pressure delivery device 761 includes a flexible barrier 765. And/or honeycomb material 767, which is similar to that described with reference to Figures 6-8. The flexible barrier 765 and/or honeycomb material 767 is 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 passage 751. • The reduced pressure delivery device 761 can be placed within the passage 751 and directed to the tissue site 713 after the distal end 743 of the manifold delivery tube 721 is placed at the tissue site 713 .another Alternatively, the reduced pressure delivery device 761 can be pre-positioned in the passage 751 prior to insertion of the manifold delivery tube 721 into the patient. To facilitate pushing the reduced pressure delivery device 761 through the passage 751, a biocompatible can be used. Sexual moist 119639.doc -27- 200808394 slip agent 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 is set 761 After delivery to the distal end 743, the reduced pressure delivery device 761 is then pushed toward the distal end 743, thereby expanding the distal end 743 radially outward to the open position. The reduced pressure delivery device 761 is pushed out of the manifold delivery tube 721, preferably in the space or space of the adjacent tissue portion 713. The void or space is usually formed by incision of the soft tissue, which can be by the skin route, the tissue portion at the wound site, and due to the injury = naturally present - voids. In other cases, the void can be formed by aeration of bladder separation, sharp separation, blunt separation, hydraulic separation, pneumatic separation, ultrasonic separation, electrocautery separation, laser separation, or any other suitable separation. When the reduced pressure delivery device 761 enters the gap adjacent the tissue site 713, the flexible barrier 765 and/or the honeycomb material 767 of the reduced pressure delivery device 761 is unwound, unfolded, or decompressed (see figure), 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 honeycomb material 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 can be 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 aid in the release. The process of winding. The final placement and manipulation of the reduced pressure delivery device 76i 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 721 is preferably removed from the patient's body 119639.doc -28-200808394, but the reduced pressure delivery tube associated with the reduced pressure delivery device 761 remains in place so that A reduced pressure can be applied to the tissue site 713 through the skin. 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. The curve is bent to an open position such that the inner end 843 of the distal end 843 will be substantially the same or larger 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 861 includes a flexible barrier 865 and/or honeycomb material 867 that is preferably wound, folded, or otherwise compressed around the reduced pressure delivery tube 869 to reduce The cross-sectional area of the small reduced pressure delivery device 861 within the passage. An impervious film 871 having an inner surface 873 is disposed around the reduced pressure delivery device 861 to allow the reduced pressure delivery device 86i to be contained within the inner surface 873 of the impermeable membrane 871. The impermeable membrane 871 can be an inflatable bladder, a sheath, or any other type of membrane 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 at least one of the expansion positions (see FIGS. 25 and 25). The impervious film 871 is sealingly coupled to the manifold delivery tube 821 such that the internal space 873 of the biofilm 871 is in communication with the passage of the manifold delivery tube 821. Alternatively, the impermeable membrane can be fixed to a reduced pressure of 119639.doc -29. 200808394 on the delivery tube 8 6 9 'so that the internal space of the impermeable membrane 8 71 and the passage of the reduced pressure delivery tube 869 Fluid communication. The impermeable membrane 871 can in turn be secured to a separate control tube or control lumen in fluid communication with the interior space 873 (see, for example, Figure 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. To this end, a pressure lower than the ambient pressure of the impermeable film 871 is applied to the inner space 873 of the impermeable film 871. Thereby, a considerable amount of sulphur or other fluid in the internal space 873 is discharged, thereby placing the impermeable film 8 71 in the compressed position shown in Fig. 23. In this compressed position, the impervious film 87i is attracted inwardly, thereby applying a pressure to the reduced pressure conveying means 861 to further reduce the sectional area of the reduced pressure conveying means 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. Endoscopic examination, ultrasound, fluoroscopy, auscultation, palpation, or any other suitable localization technique can be used to achieve placement and manipulation of the impermeable membrane 87 and the reduced pressure delivery device 861. The impermeable film 871 can include a radiopaque marker 881 which improves the visibility of the impermeable film 871 under the screen inspection prior to its removal. After pushing the reduced pressure delivery device 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 The pressure reducing conveying device 86ι is removed from the impermeable film 871. A removal device 885 (e.g., cannula, needle or other sharp instrument) can be provided to break the impermeable film 119639.doc -30- 200808394 871. Preferably, the removal tool 885 is inserted through the reduced pressure delivery tube 869 and is capable of being advanced to contact the impermeable membrane 871. After the impervious film 87 is broken, the removal device 885 and the impermeable film 871' can be withdrawn via the manifold delivery tube 821 to enable the flexible barrier 865 and/or the honeycomb material 867 of the reduced pressure delivery device 861 to be unwound. Winding, unfolding or uncompressing allows the reduced pressure delivery device 861 to 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 releasing the reduced pressure in the interior space 873 and removing the impermeable film 871. 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 816, the manifold delivery tube 821 is preferably removed from the patient, 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 pair The tissue site is subjected to reduced pressure. The impermeable film 871 can also be used to separate tissue adjacent to the tissue site prior to placement of the reduced pressure delivery device 861 against the tissue site. After the reduced pressure delivery device 861 and the intact impermeable membrane 871 are pushed through the distal end 843 of the manifold delivery tube 821, air or another fluid is injected or pumped into the interior space 873 of the impermeable membrane 871. It is preferred to use a liquid to swell the impermeable film 871 because the incompressibility of the liquid allows the impervious film 871 to expand more uniformly and more uniformly. The impermeable film 871 may expand radially as shown in Figure 25, or may expand in an orientation depending on the method of manufacture and the manner in which it is secured on the manifold tube 821. When the impervious film 871 is expanded outward to the expanded position due to the pressure of air or fluid (see 119639.doc -31 - 200808394 Fig. 25), a gap is separated from the adjacent tissue portion. When the gap is large enough, air or other fluid in the interior space 873 can be released to enable the impermeable membrane 871 to take a relaxed position. Then, the impervious film 87 ^ . . . ^ Α 膘 871 can be broken as explained above, and the decompression device 861 can be inserted adjacent to the tissue site.

Referring to Fig. 25A, if the impermeable film 871 is mainly used to separate the position of the adjacent tissue, and the woven 'impermeable film 871 can be sealingly fixed to the manifold wheel 821', thereby making the internal space 873 is in fluid communication with an auxiliary lumen or tube 891 associated with or fixed to the skeletal transport ♦ 821. 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 further to Figure 26, a reduced pressure delivery system $u according to 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 An open position such that the inner diameter of the distal end 943 will be substantially the same or greater than the inner diameter at other portions of the tube 921. The open position of the distal end 943 is schematically indicated by dashed line 937 in FIG. 26. The delivery tube 921 further includes a passageway including a reduced pressure delivery device similar to the other reduced pressure delivery devices described herein. 961. The reduced pressure delivery device 961 includes a flexible barrier 965 and/or honeycomb material 967 that is preferably wound, folded or otherwise compressed around the reduced pressure delivery tube 969 to reduce The cross-sectional area of the small reduced pressure delivery device 961 within the passage of the manifold delivery tube 921. 119639.doc -32- 200808394 - The impervious film 971 having the inner surface 973 is disposed around the decompression transfer device 961 such that the reduced pressure delivery device 961 is contained within the inner surface 973 of the impermeable film 971. The impermeable film 971 includes a seal 977 on one end of the impervious sheet to provide an alternative method of removing the reduced pressure delivery device 961 from the impervious sheet 971. The impermeable membrane 971 is sealingly coupled to the manifold delivery tube 921 such that the interior space 973 of the impermeable membrane 971 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 impermeable film 871 of Fig. 23, the impermeable film 97 can prevent fluid from permeating so that the impermeable film 971 can take at least one of a compressed position, a relaxed position, and an expanded position. Since the procedure for placing the impermeable film 971 on the compression position and the expansion position is similar to the impermeable film 871, only the process of removing the decompression conveying device 961 will be described. Delivery of the reduced-pressure delivery device 96 to the tissue site within the impermeable membrane 971 using endoscopy, ultrasound, fluoroscopy, auscultation, palpation, or any other suitable localization technique and then correcting it Positioning. The non-permeable film 971 may comprise a radiopaque label 981 which will improve the visibility of the film 971 under the 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 921. 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 glue seal 977 to push out the impervious film 971. Referring to FIG. 26A, a reduced pressure delivery system 985 in accordance with an embodiment of the present invention may not include a manifold transfer tube similar to manifold delivery tube 921 of FIG. Rather, the reduced pressure delivery system 985 can include a guide wire 987, a reduced pressure transport officer 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 delivery tube to deliver the reduced pressure delivery device 991, the reduced pressure delivery device 991 and the reduced pressure delivery tube 989 are placed over 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 skin of the patient by a sterile sheath. By guiding the reduced pressure delivery tube 989 and the reduced pressure delivery device 991 along the guide wire 987, the fistula of the reduced pressure delivery device can be placed at the tissue site "3 to achieve application of reduced pressure tissue 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 binder, thereby expanding the foam to 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 expands upon exposure to the patient's body temperature. In still another embodiment, the reduced pressure delivery device 99 compressed by I19639.doc • 34-200808394 can be delivered to the tissue site 993 in a dissolvable film. Referring to Fig. 27, a decompression delivery system ι〇ιι according to an embodiment of the present invention includes a manifold delivery tube 1〇21 having a distal end 1043 through which a distal end 1〇43 is inserted. The tissue site is 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 end 1043 is placed adjacent to the tissue site 1〇25 in the void 1〇29, an injectable, pourable or flowable reduced-pressure delivery device 10 3 5 is delivered to the tissue site 1 via the manifold delivery tube 1021. 2 5 places. 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 be present in the gelatinous state at the tissue site 1025, but still have a plurality of flow channels for delivering reduced pressure. The amount of reduced pressure delivery device 1035 delivered to the tissue site 丨〇 25 may be sufficient to partially or completely fill the void 1029. The reduced pressure delivery device 1〇35 can include both the manifold and the stent. As the manifold, the reduced pressure delivery device 1035 includes a plurality of holes or open holes which may be formed in the material after being transported to the gaps 〇29. The holes or open holes communicate with each other, thereby forming a plurality of flow channels. These flow channels are used to apply and reduce the pressure on the tissue site 1 〇 25 119639.doc -35 - 200808394. As a stent, the reduced-pressure delivery device 1 is bioresorbable and serves as a substrate on which new tissue can be grown. In one embodiment, the reduced pressure delivery device 1〇35 may comprise a poragen' such as NaCl or other salt distributed throughout the liquid or viscous gel. 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 Naci 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 organization is formed, the tissue will grow into the bore of the reduced pressure delivery device 1 〇 35 and then eventually replace the pressure reducing delivery device 1035 with the degradation of the reduced pressure delivery device 1035. In this particular example, the reduced pressure delivery device 1〇35 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 granules. The P〇ragen or particles may be dissolved at the tissue site by local bodily fluids or by other fluids being flushed or delivered to the reduced pressure delivery device 1035. After dissolving P〇ragen or particles, the space previously occupied by the porage or particles becomes a void which interconnects each other to form a flow channel within the reduced pressure delivery 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 the particle size of the selected p0ragen. 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 foaming body or solid in situ, the body fluid will cause an acid reaction between sodium bicarbonate and citric acid. The formed carbon dioxide gas particles form larger pores and flow channels throughout the reduced pressure delivery device 1〇35 as compared to the technique of relying on poragen dissolution. The conversion of the reduced pressure delivery device from the liquid or viscous gel to the solid or foam can be triggered by pH, temperature, light, or reaction with body fluids, chemicals or other substances delivered to the tissue site. . This transformation can also be carried out by mixing a plurality of reactive components. 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 moisture and the hydrogel coating becomes a hydrated coating. Then, the mixture is again exposed to light, whereby the microspheres are crosslinked, thereby forming a plurality of flow channels. The crosslinked microspheres are then used as a manifold for delivering reduced pressure to the tissue site and a porous scaffold for promoting new tissue growth. With the exception of the foregoing embodiments herein, the reduced pressure delivery device 1〇35 can be made from a variety of materials including, but not limited to, calcium phosphate, collagen, alginate, cellulose, or any other capable of being a gas or a liquid. , gel, paste, putty, serum, suspension or other flowable material is delivered to the group 119639.doc -37 - 200808394 and can form a plurality of flow-passing equivalent materials in fluid communication with the tissue site. The flowable material may further comprise solid microparticles which are capable of flowing via the manifold wheel 1021 if the particle size of the solid particles is sufficiently small. 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 1035 can be directly injected or poured into the void 1 〇 29 adjacent the tissue site 1025. Referring to Fig. 27A, the manifold wheel 1021 can include an impermeable or semi-permeable membrane 1 〇 51 at the distal end 1〇43 of the manifold delivery tube 1021. The membrane 1 〇 5 1 includes an interior space 1 〇 5 5 that is in fluid communication with the auxiliary lumen 1〇 57 that is fixed to the manifold delivery tube 1021. The manifold delivery tube 1021 is guided to a tissue portion 1025 on a guide wire 〇 61. The reduced pressure delivery device 1035 can be injected or poured through the auxiliary lumen 1〇57 to fill the interior space 1055 of the membrane 1051. When the fluid or gel fills the film 1051, the film 1051 is swollen 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 additional tissue adjacent to or adjacent to the tissue site 1025. If the film 1 〇 5 1 is an impermeable film, it can be physically broken and removed, thereby bringing the reduced pressure delivery device 1035 into contact with the tissue site 1025. Alternatively, the film ι 51 can be made from a soluble material that will dissolve in the presence of body fluids or in the biocompatible solvent delivered to the film 1 〇 51. If the film 1051 is semi-permeable, the film 105 1 can remain in place. The semi-permeable membrane 1 〇5 1 is capable of delivering reduced pressure and possibly other fluids to the tissue site 1025. Referring to Figure 2, a method 1111 for performing reduced pressure tissue treatment includes surgically inserting a manifold at an adjacent tissue site at 119639.doc-38-200808394 1115, the manifold having a self-flexible barrier a plurality of protrusions to form a plurality of flow channels between the protrusions. The manifold is positioned in U19 (4) such that at least a portion of the canines contact the tissue site. At 1123, a reduced pressure is applied to the tissue site via the manifold. A more common method for performing decompression tissue treatment on a tissue site 1211 includes inserting a manifold at 1215 through the skin adjacent to the tissue site. 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 may comprise a honeycomb material having a plurality of flow channels within the honeycomb material, and alternatively the manifold may be formed from an injectable or pourable material, the primary or the pourable The material is delivered to the tissue site and forms a plurality of flow channels upon reaching the tissue site. At the Η丨9, the ambiguity 2 is positioned such that at least a portion of the flow channels are in communication with the tissue site grasping body. At 1223, a reduced pressure is applied to the tissue site via the manifold. Further, see Fig. 30, a method of applying reduced-pressure tissue treatment to a tissue site 1311 includes inserting a tube having a passage through the skin through a skin at 1315 such that the distal end of the tube is placed adjacent to the tissue site. At 1319, a balloon associated with the officer can be inflated to separate tissue adjacent the tissue site to form a void. At 1323, the 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 can comprise a honeycomb material having 119639.doc -39. 200808394 a plurality of flow channels within the honeycomb material. Alternatively, the manifold can be formed from an injectable or pourable material that is delivered to the tissue site as described above with reference to FIG. At 1327, the manifold is positioned such that at least a portion of the flow channels are in fluid communication with the tissue site. At 13 31, 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 1 'A method of performing decompressive tissue treatment on a tissue site 1411 includes inserting a tube having a passage through the skin through a skin at 1415 such that the distal end of the tube is placed adjacent to the tissue site. At 1423, a manifold is delivered to the tissue site via the passageway in an impervious jacket which has been subjected to a first reduced pressure at 1419 that is less than the sheath ambient pressure. At 1427, the sheath is broken to contact the manifold with the tissue site. At 143 1 , a second reduced pressure is applied to the tissue portion via the manifold. Referring to Figures 32 and 33, a reduced pressure delivery device 1511 in accordance with an embodiment of the present invention includes a plastic surgical hip prosthesis 1515 for replacing an existing femoral head of a patient leg segment 1517. The hip prosthesis 1515 includes a post portion 1521 and a head portion 1525. The post portion 1521 is elongated for insertion into a passage 1529 that is hinged in the backbone of the leg portion 15 17 . A porous coating 1535 is disposed around the post portion 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 within the post portion 1521 of the hip prosthesis 1515 to fluidly communicate the flow channel 1541 with the porous coating 1535. A connection 埠1545 is fluidly coupled to the flow passage 1541 which is configured to releasably connect the 119639.doc -40 - 200808394 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 include a main feed line 1543 in fluid communication with a plurality of lateral branch lines 1547 that are in communication with the porous coating 1535. The yoke 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 hollow hip 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. space. Referring more specifically to Figure 33, the hip prosthesis 15 15 can further include a plurality of flow channels 15 61 within the post portion 1521 to provide fluid to the porous coating 1535 and/or bone surrounding the bid body 1 $ 1 $ . The fluid may include filtered air or other gases, antibacterial agents, antiviral agents, cell growth promoting d, irrigation fluids, chemically active fluids, or any other fluid. Additional fluid communication paths may be provided if it is desired to introduce multiple fluids into the bone path surrounding the hip prosthesis 15 15 . A port 1565 is fluidly coupled to the flow channel 1561 which is configured to be releasably coupled to a fluid delivery tube 1571 and a fluid delivery source 1573. The flow channel 1561 can include a main feed line 1583 in fluid communication with a plurality of lateral branch lines 15 85 that are in communication with the porous coating 1535. 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 1583. The delivery of the reduced pressure to the first plurality of flow channels 15 41 and the delivery of fluid to the second plurality of flow channels 15 61 can be carried out by separate tubes (eg, reduced pressure delivery tubes 1551 and fluid delivery) Tube 1571) is completed. 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 1515, the first plurality of flow channels 1541 can be used to deliver both the reduced pressure and fluid 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 15 15 as a manifold to deliver the reduced pressure to the bone area surrounding the hip prosthesis, the recovery of the leg section 1517 is faster and the hip prosthesis 15 15 is more successfully integrated with the bone. . Providing a second plurality of flow channels 1561 to discharge the bone around the hip prosthesis 丨5丨5 will improve the successful regeneration of the new bone surrounding the prosthesis. After the reduced pressure is applied via the hip prosthesis 15 15 for a selected amount of time, the reduced pressure delivery tube 1551 and the fluid delivery tube 1571 can be disconnected from the connecting bees 1545, 1565 and removed from the patient's body. Use surgical invasive procedures. The connection between the ports 1545, 1565 and the tubes 1551, 1571 can be a connection that can be released by hand, which can be performed by applying an axial pulling force 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 the 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. Tubes 1551, 1571 can also be made from a bioresorbable material that will dissolve over a period of time or an activating material that will dissolve in the presence of a particular chemical or other material. A reduced pressure delivery source 1 553 can be provided outside the patient and connected to a reduced pressure delivery tube 1551 to deliver the reduced pressure to the hip prosthesis 1515. Alternatively, the reduced-pressure delivery source 1553 can be implanted into the patient's body, hip prosthesis! 5〗 5 or near. Placing the reduced pressure delivery source 1553 into the patient does not require the use of a fluid connection through the skin. The implanted reduced pressure delivery source 1553 can be operatively coupled to the conventional pump of the flow channel 1541. The pump can be powered by a battery implanted in the patient's body or by an external battery that is electrically connected to the pump via the skin. The pump can also be directly driven by a chemical reaction that reduces the pressure through the flow passages i54, i 56 and circulates the fluid through the flow passages 丨54丨,丨56 i. Although only the column portion 1521 and the head portion 1525 of the hip prosthesis i 5 15 are illustrated in Figures 32 and 33, it should be noted that the flow channels described herein and components for applying reduced pressure tissue therapy may also be applied to the hip. Any component of the prosthesis 1515 that contacts the osseous or other tissue, including, for example, a cup. Referring to Figure 34, a method 1611 for repairing a patient's joint includes implanting a prosthesis within the bone adjacent the joint at 1615. The prosthesis can be a hip prosthesis as described above or any other food that helps restore the joint mobility of the patient. The prosthesis includes a plurality of flow channels configured to be in fluid communication with the bone. At 1619, the reduced pressure is applied to the bone via the plurality of flow channels to improve the aseointegJ:atiQn of the prosthesis. 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. 311639.doc • 43· 200808394 shown in Figures 35 and 36 is an orthopaedic fixation device 1715 which is a plate having a plurality of passages 1721 that are used for shaping using screws 1725, pins, bolts or other fasteners. The surgical fixation device 1715 is anchored to the bone 1717. A porous coating 173 5 may be provided on the surface of the contact bone j 7 i 7 of the orthopedic fixation device 171 5 . The porous coating is preferably constructed of sintered or vitrified ceramic or metal. Alternatively, a honeycomb material having porous characteristics 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 1735. A port 1745 is fluidly coupled to the flow channel 1741 which is configured to be coupled to a reduced pressure delivery tube 1751 and a reduced pressure delivery source 1753. The flow channel 1741 is used to deliver a reduced pressure to the bone of the porous coating 1735 and/or the orthopaedic fixation device 1715 after the orthopedic fixation device 1715 is secured to the bone 1717. The flow passage 1741 can include a main feed line 1743 in fluid communication with a plurality of transverse branch lines 1747 that are in communication with the porous coating 1735. The lateral branch line 1747 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 a medium open v surgical fixation device and filling the shaping with a honeycomb (preferably open pore) material capable of being in fluid communication with the porous coating. The internal space of the surgical fixation device. The orthopedic fixation device 1715 can be a plate as shown in Figure 35, or alternatively, can be a fixation device such as a cannula, orthosis, stud, or any other means for stabilizing a portion of the bone. Orthopedic 119639.doc 200808394 The art fixation device 1715 can be further used to fix 5| /λ _ι> _ > or /, his orthopedic state or implanted tissue (for example, the skeletal tissue system conditions are such Fasteners are included for winding around

Examples of fasteners such as flow channels 1 for transporting reduced pressure may include pins, bolts, screws or any other suitable fastener. L

Referring more specifically to Figure 36, the orthopaedic fixation device 1715 can be further inserted into the orthopaedic fixation device m5 to include a second plurality of flow channels 17 = for the porous coating 1735 surrounding the orthopaedic fixation device 1715 and/or bone Provide fluid. The fluid may include transient air or other gases, antibacterial agents, disease resistance, cell growth promoting, irrigation fluids, chemical agents, or any other fluid. Additional fluid communication paths may be provided if it is desired to introduce multiple fluids into the bone surrounding the hip prosthesis 1715. A port 765 1765 is fluidly coupled to a flow channel ι 761 that is configured to be coupled to a fluid delivery tube 1771 and a fluid delivery source 1773. The flow channel 1761 can include a main feed line 1783' that is in fluid communication with a plurality of lateral branch lines 1785. The plurality of lateral branch lines 1785 are in communication with the porous coating 1735. 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 丨 741 and the delivery of fluid to the second plurality of flow channels 1761 can be accomplished by separate tubes (e.g., pressure relief conduit 1751 and fluid delivery conduit 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 it is preferred to provide a separate fluid communication path within the hip prosthesis 1715, but it is also possible to use the first plurality of flow channels 1741 to deliver both the reduced pressure and the fluid adjacent to each other in the 119639.doc -45-200808394. The bone of the orthopedic fixation device 1715. The use of the orthopedic fixation device 171 5 as a manifold to deliver reduced pressure to the bone region of the adjacent orthopaedic fixation device 1715 accelerates and improves the recovery of the defect 1719 of the bone 1717. Providing the second plurality of flow channels 1761 to deliver fluid to the bone surrounding the orthopaedic fixation device 1715 improves the successful regeneration of new bone adjacent the orthopaedic fixation device. Referring to Figure 37, a method 1811 for healing a bone defect in a bone includes using an orthopaedic fixation device at 1815 to secure the bone. The orthopedic fixation device includes a plurality of flow channels disposed within the orthopaedic fixation device. At 1819, a reduced pressure is applied to the bone defect via the plurality of flow channels. Referring to Fig. 38, a method 1911 for performing decompression tissue treatment on a tissue site includes: at 1915, a manifold having a plurality of flow channels is pre-positioned such that at least a portion of the flow channels are The tissue site is 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 Fig. 39, a method for applying reduced pressure tissue treatment to a tissue site 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, the reduced pressure is applied to the set of 119639.doc .. -46 - 200808394 webs via the flow path of the solid manifold. Referring to Figures 40-48, a reduced pressure delivery system 2111 includes a primary manifold 2115. The primary manifold 2115 has a flexible wall 2117 that surrounds a primary flow path 2121. 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 since the cross-sectional shape of the primary manifold 2115 can be different from the circular shape (i.e., rectangular in Figures 4A-45, and triangular in Figures 46-48) Thus, a transition zone 2129 is provided between the reduced pressure delivery tube 2125 and the primary manifold 2115. The main manifold 2115 can be joined to the reduced pressure delivery tube 2125 by adhesive means, 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 211 5 for distribution at or near the tissue site. An anti-blocking member 213 5 is positioned within the main manifold to prevent the main manifold 2115 from collapsing and thereby blocking the main flow path 211 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 FIG. The anti-blocking member 2135 can be any material or structure that can be embedded within the flow passage or that 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 119639.doc '-47-.. 200808394. The flexible wall 2117 further includes a plurality of apertures 2155 that penetrate the flexible wall 2117, the apertures 2155 being in communication with the main flow path 2121. The aperture 2155 enables the reduced pressure to be delivered to the primary iliac iL path 2121 to be distributed to the tissue site. Aperture 2155 is selectively positionable about the circumference of manifold 2115 to preferentially direct the delivery of vacuum. For example, in Fig. 51, the holes may be placed facing the bone, facing the covering tissue, or both. The reduced pressure delivery tube 2125 preferably includes a first conduit 2161 having at least one outlet fluidly coupled to the main flow passage 2i2i for delivering 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 2117 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. 119639.doc -48- 200808394 Also illustrated in Figure 41 is a spacer used as an anti-blocking component. The centrally located spacer causes the main flow path 2121 to enter the two chambers again, which causes the main manifold 2U5 to continue to operate when one of the chambers is blocked and cannot be dissolved by the cleaning. Referring to Figures 4 9 and 50, a decompression transfer system 9 9 1 1 a h ^ reversal crucible, and a death 2211 includes a main manifold 2215 which is formed integrally with the decompression delivery tube 2217. The reduced pressure delivery tube 2217 includes a central lumen 2223 and a plurality of auxiliary lumens 2225. Although the auxiliary lumen plus can be used to measure the pressure at or near the tissue site, the auxiliary lumen can be flushed to the lumen 2223' to prevent or dissolve the obstruction. A plurality of apertures 2231 are in communication with the central lumen to distribute the pressure from the central lumen period: the delivery is reduced. As shown in Fig. 5A, it is preferred that the apertures do not extend through the auxiliary lumen 2225. The counterbore end of the reduced pressure delivery tube is also illustrated in Fig. 50, which forms a headspace MW outside the end of the auxiliary lumen 2225. If the tissue, stent or other material is engaged during the application of the reduced pressure, the end portion 2241 of the reduced pressure delivery tube 2217 will continue to allow delivery of cleaning fluid to the central lumen 2223. During use, the reduced-pressure delivery systems 2111, 2211 described in Figures 40-50 can be directly applied to the tissue site to distribute the reduced pressure to the tissue site. The low profile of the main eccle is very beneficial for skin placement and removal. In addition to the techniques described herein. Similarly, the main manifold can also be embedded by surgery. Referring to Figure 51, the main manifolds 2115, 2215 can be used in conjunction with an auxiliary manifold 232]. In Figure 51, the auxiliary manifold 2321 includes a two layer felt pad. The first layer of the auxiliary manifold 2321 contacts a bone tissue site containing the fracture site and is placed 119639.doc -49 - 200808394. The primary manifold 2115 is placed in contact with the first layer, and the second layer of the secondary manifold 2321 is placed on top of the primary manifold 2115 and the first layer. The auxiliary manifold 2321 is capable of achieving fluid communication between the primary manifold 2115 and the tissue site and still prevents direct contact between the tissue site and the primary manifold 2115. Preferably, the auxiliary manifold 2321 is bioabsorbable, which enables the auxiliary manifold 2321 to remain in place after the decompression therapy is completed. Once the depressurization treatment is completed, the main 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-filled nitrile, polyurethane, collagen, hyaluronic acid, polyaminoglucose, hydroxyapatite, acid-filled mom, sulfuric acid, carbonic acid, bioglass, stainless steel, Titanium, group, allograft tablets and autologous tissue grafts. The cleaning functions of the reduced pressure delivery systems 2111, 2211 described above can be used with any of the manifolds described herein. The ability to clean the manifold or conduit that delivers reduced pressure prevents the formation of obstructions that would 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. 119639.doc -50- 200808394 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 adjacent to the manifold or one of the outlets of one of the conduits. Although the air may be pressurized or fl pushed "to the outlet of the second 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, during the application of reduced pressure Transporting air for six (2) seconds at intervals of sixty (60) seconds is sufficient to prevent the formation of obstructions. This cleaning program provides sufficient air to adequately move the manifold and fluid in the first conduit while preventing introduction. Excessive air. Introducing too much air, or introducing air at too high a frequency, will result in a decompression system that cannot return to the reduced target pressure between wash cycles. The amount of time and the interval between 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 simultaneously The target full pressure can still be restored between wash cycles. Referring to Figure 52, in an exemplary embodiment, a reduced pressure delivery system 2411 includes a manifold 2415 The manifold 2415 is 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 reduced pressure to the manifold 2415. The second conduit 2423 includes an outlet 2435, the outlet 2435 is positioned in fluid communication with manifold 2415 and adjacent the outlet of first conduit 2419. Second conduit 2423 is fluidly coupled to a valve 2439 which, when valve 2439 is placed in the open position, is capable of achieving second conduit 2423 and ambient air Inter-connect. Valve 2439 is operatively coupled to controller 2453, and controller 2453 is capable of controlling opening and closing of valve 2439 119639.doc -51 - 200808394 to regulate the cleaning of the second conduit using ambient air, thereby Prevention of obstructions within the manifold 2415 and the first conduit 2419. It should be noted that any fluid (including liquid or gas) may be used to achieve the techniques described herein, although the force used to clean the fluid is preferably reduced. The suction formed at the tissue site, however, similar to that described with reference to Figure 9, the fluid delivery member can also deliver fluid in a similar manner. Systems and Methods Decompression tissue treatment of a tissue site can be achieved by applying a sufficiently low pressure to the tissue site and then maintaining the pressure low enough for a selected period of time. Another option is The reduced pressure applied to the tissue site can be cyclical. More specifically, the magnitude of the applied reduced pressure can vary depending on the selected time cycle. Yet another method of applying the reduced pressure can randomly change the reduced pressure. Similarly, the rate or amount of fluid delivered to the tissue site can be constant, periodic, or random. If periodic, fluid delivery can occur during the application of reduced pressure, or can be absent This is done during the cycle of applying the reduced pressure. 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 decompressive tissue treatment is performed, the reduced pressure is typically between about -5 mm Hg and _500 mm Hg, More preferably, the system is between about 5 mm Hg and dOOmmHg. 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 system and method of the present invention can be applied to any tissue, including, but not limited to, skeletal tissue, adipose tissue, muscle tissue, nerve tissue, skin tissue, vascular tissue, connective tissue, cartilage tissue, 119639.doc-52-200808394 , sputum 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. Tissue growth is formed in the tissue. For example, it may be desirable to use a transdermal implant technique to apply reduced pressure tissue treatment 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 the scaffold material to increase the growth and growth rate of the 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 schema] This patent or application file contains at least one graphic with color. The patent or patent application publication with color picture 2 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 delivery device according to an embodiment of the present invention, 119639.doc-53-200808394, the pressure-reducing device having a plurality of protrusions extending from a flexible barrier to form a plurality of flow channels Figure 2 illustrates a front view of the reduced pressure delivery device of Figure 1; Figure 3 illustrates a top view of the reduced pressure delivery device of Figure 1; Figure 4A illustrates the Figure! A side view of the reduced pressure delivery device having a single lumen decompression delivery tube; Figure 4B is a diagram! A side view of an alternative embodiment of the reduced pressure delivery device having a dual lumen decompression delivery tube; FIG. 5 illustrates an enlarged perspective view of one of the reduced pressure delivery devices illustrated in FIG. A perspective view of a reduced pressure conveying device according to an embodiment of the present invention. The reduced pressure conveying device has a honeycomb material attached to a flexible barrier having a ridge portion and a pair a wing portion having a plurality of flow passages; Fig. 7 is a front view showing one of the pressure reducing conveying devices shown in Fig. 6; Fig. 8 is a sectional view showing the pressure reducing device shown in Fig. 7 at χνπ_χνπ Figure 8A illustrates a cross-sectional front view of a reduced-pressure delivery device in accordance with an embodiment of the present invention; Figure 8A is a side elevational view of the reduced-pressure delivery device illustrated in Figure 8A; Figure 9 illustrates a A front view of a reduced pressure delivery device of one embodiment for applying a reduced pressure tissue treatment to a patient's bone; FIG. 10 depicts a colored tissue section of a rabbit skull showing the original, undamaged bone; 11 illustrates a color tissue section of a rabbit skull showing granulation tissue induced after treatment with decompressing tissue at 119639.doc -54 - 200808394; Figure 12 shows a colored tissue section of a rabbit skull, which is shown in application minus Deposition of new bone after compression tissue treatment; Figure 13 illustrates a color tissue section of a rabbit skull showing deposition of new bone after application of reduced pressure tissue treatment; Figure 14 depicts a color photograph of a rabbit skull in which the skull is Two critical dimension defects are formed; Figure 15 illustrates a color photograph of the rabbit skull shown in Figure 14, showing a calcium phosphate scaffold embedded in one of the critical dimension defects and a stainless steel mesh covering the second critical dimension defect; 16 illustrates a color photograph of the rabbit skull shown in Figure 14, which shows the application of a reduced-pressure tissue treatment to a critical size defect; Figure 17 illustrates a color tissue section of a rabbit skull after performing a reduced-pressure tissue treatment, the tissue section showing a new bone Deposition in a calcium phosphate scaffold; Figure 1 8 shows the implementation of decompression tissue treatment for six days and surgery Figure 15 shows the radiograph of the critical dimension defect filled with the stent shown in Figure 15 after the week; Figure 119 shows the ray of the critical dimension defect filled with the stent shown in Figure 15 after performing the decompression tissue treatment for six days and twelve weeks after the operation. 20 is a front view of a reduced pressure delivery system having a manifold delivery tube for inserting a reduced pressure delivery device through a skin into a tissue site, in accordance with an embodiment of the present invention. Figure 21 illustrates an enlarged elevational view of the manifold delivery tube of Figure 2A, the differential delivery tube including a reduced pressure delivery device having a deflection 119639.doc -55 - 200808394 barrier and / Or a honeycomb material in a compressed position; FIG. 22 is an enlarged front elevational view of the manifold delivery tube of FIG. 21 showing the flexible barrier of the reduced pressure delivery device after being pushed in from the manifold delivery tube And/or the honeycomb material is in an expanded position; FIG. 23 illustrates a front view of a reduced pressure delivery system having a reduced pressure delivery device through the skin, in accordance with an embodiment of the present invention. A manifold to the tissue site into the tube the delivery tube, the display in FIG Save

The pressure conveying device is located outside the manifold conveying pipe but is restrained by a non-permeable film at a compression position; FIG. 24 is a front view showing one of the pressure reducing conveying systems shown in FIG. 23, and the pressure reducing conveying device is shown Located on the outside of the manifold, but constrained by a non-permeable membrane to a relaxed position; Figure 25 illustrates a front view of the reduced-pressure delivery system of Figure 23, showing the reduced-pressure delivery device in the The tube is outside the tube but is constrained to an expanded position by an impermeable membrane; Figure 25A illustrates a front view of the reduced pressure delivery system of Figure 23, showing the waste delivery device in the manifold tube The outer side, but in an expanded position, is surrounded by an impervious film; Figure 26 illustrates a front view of a reduced pressure delivery system according to the present invention, the reduced pressure delivery system having a The manifold delivery tube inserted into a tissue site of the reduced pressure delivery device is shown in the figure (4) outside the manifold delivery tube, but is bound by an impermeable membrane with a glue seal; Figure 26A FIG. 27 illustrates a front view of a reduced pressure delivery system having a reduced pressure delivery system according to an embodiment of the present invention, showing a front view of a reduced pressure delivery system according to the present invention. FIG. a manifold delivery tube for injecting a reduced pressure delivery device through the skin to a tissue site; FIG. 27A illustrates a front view of a reduced pressure delivery system having a decompression delivery system in accordance with an embodiment of the present invention; a manifold delivery tube for delivering a reduced pressure delivery device through the skin to an impermeable membrane at a tissue site; FIG. 28 illustrates a decompression tissue treatment of a tissue site in accordance with an embodiment of the present invention Figure 2 is a flow chart showing a method for performing decompression tissue treatment on a tissue site according to an embodiment of the present invention; Figure 30 is a diagram showing an organization according to an embodiment of the present invention. A flow chart of a method for performing decompression tissue treatment at a site; FIG. 31 illustrates a method for performing decompression tissue treatment on a tissue site in accordance with an embodiment of the present invention. Figure 32 is a cross-sectional elevation view of a reduced pressure delivery device in accordance with an embodiment of the present invention, the reduced pressure delivery device including a hip prosthesis having a plurality of flow channels for surrounding FIG. 33 illustrates a cross-sectional elevation view of the hip prosthesis of FIG. 32 having a second plurality of flow channels for routing fluid to the surrounding Figure 34 depicts a flow chart of a method of repairing a patient's joint using 119639.doc-57-200808394 using a reduced-pressure tissue treatment in accordance with an embodiment of the present invention; Figure 35 illustrates a seed according to the present invention. - a cross-sectional elevation view of the reduced pressure delivery of the embodiment 'The decompression delivery device comprises a continuation surgical fixation, the orthopedic fixation device having a plurality of flow channels for slanting the bone adjacent to the orthopedic fixation device The pressure applied to the area is reduced. Figure 36 is a cross-sectional elevational view of the bridge surgical fixation device shown in Figure 35, the surgical fixation device having a second plurality of flow channels for The fluid is delivered to a bone region adjacent to the orthopedic fixation device; Figure 37 illustrates a flow chart of a method for treating bone defects in bone using reduced pressure tissue chemotherapy in accordance with an embodiment of the present invention; Θ 8, ' A flow chart of a method for performing decompression tissue treatment on a tissue site in accordance with an embodiment of the present invention, and FIG. 39 illustrates a method for decompressing tissue of a tissue site in accordance with an embodiment of the present invention. A flow chart of the method. 40-48 illustrate various views of a reduced pressure delivery system having a main manifold including a flexible wall surrounding a main flow channel and a main manifold A plurality of holes in the flexible wall; Figures 49-50 illustrate a perspective view and a top cross-sectional view of a reduced pressure delivery system having an integral connection to a unit in accordance with an embodiment of the present invention. Figure 5 illustrates a perspective view of the main manifold shown in Figures 40-50 applied to a skeletal tissue site with an auxiliary manifold; and Figure 52 illustrates a first embodiment of the present invention. The embodiment has a schematic view of a reduced pressure delivery system with a fluid connection 119639.doc -58 - 200808394 to a second conduit valve. [Main component symbol description]

211 decompression delivery device or wing manifold 213 flex barrier 215 ridge portion 219 wing portion 223 arched channel 227 flexible backing 231 protrusion 233 flow channel 241 decompression delivery tube 243 distal aperture 255 proximal end 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 arch Shaped channel 327 Honeycomb material 119639.doc -59- 200808394 329 Distribution surface 330 Peripheral surface 341 Decompression delivery tube 343 Distal orifice 355 Proximal orifice 359 Catheter or passage 371 Pressure reducing device 373 Pressure reducing tube 375 Extension 377 distal end 381 incision 383 shoulder 385 protrusion 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 Near end 119639.doc -60- 200808394

433 Fluid delivery source 434 Filter 435 Pressure sensor 711 Reduced pressure delivery system 713 Tissue site 721 Manifold delivery tube 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 conveying device 765 flexible barrier 767 honeycomb material 769 decompression conveying pipe 811 decompression conveying system 821 manifold conveying pipe 837 dotted line 843 distal end 861 decompression conveying device 865 flexible barrier 119639.doc -61- 200808394

867 Honeycomb material 869 Pressure reducing tube 871 Impervious film 873 Inner surface 881 Marking, 885 Removal device 891 Auxiliary lumen or tube 911 Pressure reducing system 921 Manifold tube 937 Dotted line 943 Far end 961 Pressure reducing device 965 Flexible barrier 967 Honeycomb material 969 Pressure reducing pipe 971 Impervious film 973 Inner surface 977 Sealing 981 Marking 985 Pressure reducing system 987 Guide wire 989 Pressure reducing pipe 991 Pressure reducing device 993 Organization site 119639.doc -62- 200808394

1011 decompression delivery system 1021 manifold delivery tube 1025 tissue site 1029 gap 1035 decompression delivery device 1043 distal end 1055 internal space 1057 auxiliary lumen 1061 guiding wire 1511 decompression delivery device 1515 orthopedic hip prosthesis 1517 patient leg 1521 Column section 1525 Head section 1529 Passage 1535 Porous coating 1541 Flow channel 1543 Main feed line 1545 Transverse branch line 1547 Transverse branch line 1551 Decompression line 1553 Reduced pressure supply 1565 Connection 埠 1571 Fluid transfer line 119639.doc -63- 200808394

1573 Fluid delivery source 1583 Main feed line 1585 Transverse branch line 1711 Reduced pressure delivery device 1715 Orthopedic fixation device 1717 Bone 1719 Fracture 1721 Access 1725 Screw 173 5 Porous coating 1741 Flow channel 1743 Main feed line 1745 Connection 埠 1747 Transverse branch line 1751 Pressure reducing tube 1753 Pressure reducing source 1761 Flow channel 1765 Connection 埠 1771 Fluid delivery tube 1773 Fluid delivery source 1783 Main feed line 1785 Transverse branch line 2111 Reduced pressure delivery system 2115 Main manifold 119639.doc -64- 200808394 2117 2121 2123 2129 2135 2137 2141 2145 _ 2149 2155 2161 2163 2171 2211 2215 2217

2223 2225 2231 2241 2321 2411 2415 2419 Flexible wall main flow path proximal transition zone anti-blocking component protrusion inner surface ridge honeycomb material hole first conduit second conduit headspace decompression conveying system main manifold decompression duct central Catheter-assisted lumen hole headgap auxiliary manifold decompression delivery system manifold first conduit 119639.doc -65- 200808394 2423 2429 2435 2439 2453 second conduit decompression source outlet valve controller

119639.doc -66-

Claims (1)

200808394 X. Patent application scope: 1 · A decompression transport system for applying a decompression tissue treatment to a tissue site, which comprises: a manifold tube having a passage and a distal end, the distal end Constructed 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 to the tissue site Forming a manifold having a plurality of flow passages in fluid communication with the tissue portion; and a reduced pressure wheel tube in fluid communication with the flow passages of the manifold. 2. The system of claim 1, wherein the manifold delivery tube is the same tube as the reduced pressure delivery tube. 3 The system of claim 1, wherein the manifold is bioresorbable. A 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 solvent φ A ^ and mixed with sodium hydrogen hydride and citric acid. The system of the above-mentioned item, wherein the bioresorbable polymer is one of -> a parental ester (PLAGA) polymer and one of polyethylene glycol-PLAGA. , 8 · If request box, system 6, where the solvent is dichloromethane. The system of claim 1, wherein the flowable material is selected from the group consisting of a liquid, a slurry, a suspension, a viscous gel, a paste, a putty, and a particulate solid. 10. The system of claim 1, wherein: the flowable material undergoes a phase change in the presence of at least one of the integral liquid and the integral temperature; and the flowable material comprises a P that dissolves after the flowable material cures 〇ragen, the dissolution of the poragen forms the plurality of flow channels. 11. The system of claim 1 wherein the flowable material comprises a microsphere having a coating that is selectively crosslinkable after delivery of the flowable material to the tissue site. 12. The system of claim 丨i, wherein the coating is selectively crosslinked in response to at least one of heat, light, and a chemical. 13. The system of claim 11, wherein the microspheres form the plurality of flow channels after crosslinking. 14. The system of claim 1 wherein: the flowable material is selected from the group consisting of a paste having an initial viscosity and a putty; the viscosity of the flowable material during transport to the tissue site is The presence of the severing force drops below the initial viscosity; and after the flowable material is delivered to the tissue site, the viscosity of the flowable material returns to the initial viscosity. 15. A method for performing a decompression treatment on a tissue site, comprising: transposing a distal end of a manifold tube to a tissue site adjacent to a tissue site 119639.doc 200808394; transporting through the manifold The tube carries a flowable material through the skin to the tissue site, the fluid being capable of filling a void adjacent the tissue site to form a manifold having a plurality of flow channels in fluid communication with the tissue site; These flow channels of the manifold apply a reduced pressure to the tissue site. The method of claim 15, wherein the manifold is bioresorbable. The method of claim 15, wherein the manifold is used as a tissue growth scaffold. 18. The method of claim 15, wherein the manifold is foamed and undergoes a phase change in the presence of at least one of the integral liquid and the integral temperature. The method of claim 18, wherein the manifold is a thermoreversible gel. The method of claim 15, wherein the manifold further comprises a bioresorbable polymer dissolved in the mono-valley A and mixed with sodium hydrogencarbonate and citric acid. The method of claim 20, wherein the bioresorbable polymer is one of a polyglycolide co-glycolide (PLAGA) polymer and a polyethylene glycol_PLAGA copolymer. 22. The method of claim 18, wherein the solvent is dichloromethane. 23. The method of claim 15, wherein the flowable material is selected from the group consisting of liquids, slurries, suspensions, viscous gels, pastes, putties, and particulate solids. The method of claim 15, wherein: the flowable material undergoes a phase change in the presence of at least one of the integral liquid and the integral temperature via 119639.doc 200808394; and the far flowable material comprises a flowable material After dissolution, 25 is dissolved, and the dissolution of n: ap〇ragen forms the plurality of flow channels. The method of clause 15 wherein the flowable material comprises a microsphere having a coating that is selectively crosslinkable after delivering the flowable material to the tissue. 26. The method of claim 25, wherein the coating is selectively crosslinked in response to at least one of heat, light, and a chemical. 27. The method of claim 25, wherein the microspheres form the plurality of flow channels after crosslinking. The method of claim 15, wherein: the flowable material is selected from the group consisting of a paste having an initial viscosity and a putty; the viscosity of the flowable material during transport to the tissue site is The presence of the rhythmic force drops below the initial viscosity; and after the flowable material is delivered to the tissue site, the viscosity of the flowable material returns to the initial viscosity. 119639.doc