TW201130531A - 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 is 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

201130531 VI. INSTRUCTIONS OF THE INVENTION: TECHNICAL FIELD OF THE INVENTION The present invention relates generally to a system and method for promoting tissue growth, and more particularly to a method for decompressing a tissue site Tissue treatment system. [Prior Art] Decompression therapy is being gradually used to promote wound healing of soft tissue wounds that heal very slowly or not heal without using decompression therapy. Typically, the reduced pressure is applied to the wound site by an open-cell foam that acts as a manifold to distribute the reduced pressure. The open-cell foam is sized to be suitable for existing wounds, in contact with the wound, and then periodically replaced with a smaller foam as the wound begins to heal and become smaller. In order to minimize the amount of tissue growing into the pores of the foam, it is necessary to frequently replace the open 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 of the soy/α is subcutaneous tissue, and in other cases, the tissue is located in or on the skin tissue. Traditionally, decompression therapy has been mainly applied to soft and woven. Decompression therapy has not generally been used to treat closed deep tissue wounds due to the difficulty of accessing such wounds. In addition, decompression therapy has not been used in conjunction with the treatment of bone defects or the promotion of bone growth, which is mainly due to the difficulty in accessing the bone path. Applying decompression therapy by exposing a bone path through surgery may cause more problems than the problem it solves. Finally, the development of devices and systems for the treatment of decompression has barely exceeded the open-cell foam member 154474.doc 201130531 ~ The shape of the open-cell foam is adapted to the wound site by hand and subsequently treated at ~ decompression Remove it after the cycle. SUMMARY OF THE INVENTION The system and method of the present invention addresses the problems associated with prior wound healing systems and methods. In accordance with an embodiment of the present invention, a reduced pressure therapeutic delivery system is provided for applying a reduced pressure to a tissue site. The reduced delivery system includes a manifold delivery tube having a passageway and a distal end configured to be inserted through the skin and placed adjacent to the tissue site. A flowable material can be transported through the skin to the tissue site by the manifold delivery tube to enable the flowable material to fill a void adjacent the tissue site to form a plurality of flow channels in fluid communication with the tissue site The official. 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, comprising: positioning a distal end adjacent tissue portion of a manifold delivery tube 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. The tissue site is subjected to a reduced pressure 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 Hereinafter, the preferred embodiments will be described in detail with reference to the accompanying drawings in which: FIG. In order to enable those skilled in the art to practice the invention, the embodiments are described in sufficient detail, and it should be understood that other embodiments may be utilized, and modifications may be made in the logical structure, mechanical, electrical, and chemical aspects. It is a departure from the spirit or scope of the invention. To avoid obscuring the details required to practice the invention, those skilled in the art may omit certain information that is familiar to those skilled in the art. Therefore, it should not be under

The detailed description is to be construed as having a limited vocabulary, and the scope of the present invention is defined only by the scope of the accompanying claims. In this article, the term "elasticity" means having the characteristics of an elastomer. The term "elastomer" refers to a polymer material having rubber-like properties. More specifically, most elastomers have an elongation greater than just % and a significant degree of resilience. The material can be recovered from elastic deformation. Examples of the elastomer may include, but are not limited to, natural rubber, polyisoprene, styrene butadiene rubber, diced rubber, polybutadiene, rubber/butyl Rare rubber, ethylene propylene rubber, ethylene propylene diene monomer rubber, gas sulfonated polyethylene 'polysulfide rubber' polyurethane urethane, and poly stone oxygen. = The term "flexible" used in the text An object or material capable of f-bending or flexing a non-elastic material is generally flexible, but the reversible material referred to in this document does not necessarily limit the selected material to only the elastomer to be flexible. The combination of moon material or decompression conveying device makes the pool + # a mouth use large system means that the material can be attached or tightly matched to a tissue part Jin Jingxin (for example, 'for the treatment of skeletal skeletal deficiency The deflection or package of the decompression conveyor The part of the bone network with the defect can make the 5H device capable of winding 154474.doc 201130531 The term "fluid" as used herein, may generally include any other flowable material, or foam. The upper means gas or liquid includes But not limited to gels but also colloids The term "impervious" as used herein generally refers to the ability of a film, covering or other material to block or slow the penetration of a liquid or gas. Impermeability can be used to refer to a cover, sheet or other film that is resistant to the passage of the film while allowing the gas to pass through the film. Although the impermeable film may be impermeable to liquids' however, the film may simply reduce the transmission of all or only certain liquids. The use of the term "imperviousness" is not intended to imply that the impervious film is above or below any particular industry standard impermeability measurement, such as a specific value for water vapor transmission rate (WVTR). The term, manifold, macrosystem refers to a substance or structure that is provided to help reduce pressure on a tissue site, deliver fluid to or remove fluid from the tissue site. The manifold typically contains a plurality of Interconnected flow channels or passages to improve the distribution of fluids provided to or removed from the tissue region surrounding the manifold. Examples of manifolds may include extensions that are not limited to structural elements that are configured to form flow channels. Spread, honeycomb foam (eg open pore foam), porous tissue collection device, and liquid, gel and foam containing or containing flow channels after solidification. The term "reduced pressure" as used herein. Large system refers to the pressure at the tissue site that is receiving treatment that is less than the surrounding pressure. In most cases, this reduced pressure will be less than the environmental pressure at the patient's location. Another option is that the reduced pressure can be less than the hydrostatic pressure of the tissue at the tissue site. Although the terms "vacuum" and "negative pressure" can be used to describe the pressure applied to the tissue site 154474.doc 201130531, the actual pressure applied to the tissue site can be significantly lower than the pressure typically 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. • “tissue position” 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 that is intended 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, and then 6 MW extra tissue can 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 213 having a ridge portion 215 and a pair of wing portions 219. A wing portion 219 is positioned along the opposite side of the ridge portion 215. The ridge portion 215 defines an arcuate channel 223 that extends over or without the entire wing manifold 211 Length. 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 offset as shown in Figure _5, thereby One of the wing portions 219 is wider than the other wing portion 219. If the wing manifold 211 is used in conjunction with bone regeneration or healing and the wider wing manifold 211 will be wrapped around the fixed hardware attached to the bone Surrounding, the extra width of one of the wing portions 219 may be particularly useful. The flexible barrier 213 is preferably made of an elastic material such as a polyoxyl polymer. One example of a suitable polyoxyl polymer includes

MED-6015 manufactured by Nusil Technologies of California. However, it should be noted that the flexible barrier 213 can be made of any other biocompatible 'flexible material. The flexible barrier 213 encloses a flexible backing 227 to enhance the strength and durability of the flexible barrier 213. The flexible barrier 213 enclosing the flexible backing 227 may have a thickness in the arcuate channel 223 that is less than the thickness in the wing portion 219. If a polyphthalocyanine polymer is used to form the flexible barrier 213, a poly-xylene adhesive can also be used to help bond the flexible backing 227. Examples of polyoxynoxy binders include MED-1011, also sold by Nusil Technologies. The flexible backing 227 is preferably made of a polyester knit fabric, such as Bard 6〇13 manufactured by cR Bard, Inc. of Tempe, Arizona. However, the flexible backing 227 can be reinforced by any flexible barrier 2丨3 is made of biocompatibility and flexible material for strength and durability. In some cases, the flexible backing 227 can be omitted if the flexible barrier 2丨3 is made of a material of suitable strength. Preferably, the flexible barrier 213 or the flexible backing 227 is impermeable to liquids, air, and other gases, or alternatively, both the flexible backing 227 and the flexible barrier 213 are impermeable to liquids, air, and Other gases. The flexible barrier 213 and flexible backing 227 can also be made of a bioresorbable material that does not have to be removed from the patient after use of the reduced pressure delivery device 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 scaffold or a scaffold material can be used in conjunction with the flexible barrier 213 and the flexible backing 227 to promote cell growth. Suitable scaffolding materials can include, but are not limited to, phosphoric acid, collagen, PLA/PGA, sphagite, 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 2 13, the flexible backing 227 can also be secured to the flexible barrier 213 using a polyoxyxylene adhesive. Although the adhesive is preferred when the surface of the flexible backing 227 is bonded 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 a portion of each protrusion 231 is located at a different plane than the protrusion 231 is fixed to the flexible backing 213. The side associated with the plane can be. In this regard, even 154474.doc -10·201130531 does not require a special protrusion 231 having the same shape or size as the other protrusions 231; in fact, the protrusions 231 may comprise a random mixture of different shapes and sizes. Therefore, the distance at which each of the protrusions 231 protrudes from the flexible barrier 213 can be different, but it can also coincide in the plurality of protrusions 23A. 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 2 31 are equally uniform. The size and shape of the flow passage 3 can also be changed by the change in the size, shape and pitch of the projection 23 1 . 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 barrier 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 2W 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 distal aperture 243 is located at approximately the midpoint along the longitudinal length of the arcuate channel 223. Preferably, the distal aperture 243 is formed into an elliptical or oval shape by cutting the tube 24 1 along the plane at an angle of less than ninety (90) degrees with respect to the longitudinal axis of the tube 241. Although the aperture 243 may also be circular, the expanded circular shape of the aperture 243 enhances fluid communication with the flow passage 233 formed between the projections 23 1 . The reduced pressure delivery tube 241 is preferably made of polypyrene or urethane coated with paraiyne. However, any medical grade tubing material can also be used to construct the reduced pressure 154474.doc 11 201130531 Delivery tube 241» Other coatings that can be applied to the tube include heparin, anticoagulant, antifibrinogen, anti-adhesion agent, Anti-prothrombin, and a hydrophilic coating. In one embodiment 'as an alternative to or in addition to the distal aperture 243, the reduced pressure delivery tube 241 may also include a discharge opening or discharge orifice 25 positioned along the reduced pressure delivery tube 241. To further enhance the fluid communication between the reduced pressure delivery tube 241 and the flow channel 233. The reduced pressure delivery tube 241 can be positioned only along one of the longitudinal lengths of the arcuate channel 223 as shown in Figures 1-5' or another option It is 'positionable along the entire longitudinal length of the arched passage 223. If positioned such that the reduced pressure delivery tube 241 occupies the entire length of the arcuate passage 223, the distal aperture 243 can be capped such that all fluid communication between the tube 241 and the flow passage 233 is via the discharge opening 25 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 _3, 4 and 5 contains only a single lumen or passage 259. However, it can

A separate fluid communication path is provided between 233. For example

Any other fluid. The right desire to introduce a plurality of streams 154474.doc -12- 201130531 into the flow channel 233 via separate fluid communication paths allows the reduced pressure delivery tube to have more than two lumens. Still referring to Fig. 4B, the horizontal spacer 271 separates the first and second lumens 263, 265 of the reduced pressure delivery tube 261 such that the first lumen 263 is positioned above the first lumen 265. The relative positions of the first lumen and the second lumen 263, 265 may vary depending on how fluid communication is provided between the lumens 263, 265 and the flow channel 233. For example, when the first lumen is not clamped as shown in the drawing, a discharge opening similar to the discharge opening 25 1 may be provided to communicate with the flow passage 233. When the second lumen is as shown in the figure: the second lumen 265 can be in communication with the flow channel 233 via a distance = orifice similar to the distal orifice 243. Alternatively, the plurality of lumens in a reduced delivery tube can be positioned side by side by a plurality of vertical spacers, or the lumens can be positioned concentrically or coaxially. It will be readily apparent to those skilled in the art that independent fluid communication paths can be achieved in a number of different ways, including as described above. Alternatively, it may be selected to provide a separate fluid communication path by securing the single lumen tube, removing the single lumen, or by means of a plurality of single fixed tubes with single or multiple lumens. The tube alone provides fluid communication with the flow channel 233. The second' ridge portion 215 can include a plurality of dome channels 223, each of which has an arcuate channel 2 23 . Another optional pendulum* accommodates multiple answers. The option is to enlarge the arched passage 223 to secure the pipe. An example of a reduced-pressure delivery tube powder-reducing device having a fluid delivery tube and a fluid delivery tube will be described in more detail in ^ s m T U Figure 9. Referring to Figures 6-8, a reduced pressure delivery device or wing 154474.doc • 13· 201130531 manifold 311 according to the present invention includes a flexible barrier 313 having a ridge portion 315 and a pair of wings Part 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 315 can be centrally positioned on the wing manifold 311 such that the widths of the wing portions 319 are equal 'however, the ridge portions 315 can also be offset as shown in FIG. 6-8 to cause one of the wings The shaped portion 319 is wider than the other wing portion 3 19 . If the wing manifold 3 11 is used in conjunction with bone regeneration or healing and the wider wing manifold 311 will wrap around the fixed hardware attached to the bone 'the extra width of one of the wing portions 3 19 may Particularly useful. A honeycomb material 327 is secured to the flexible barrier 313 and may be provided as a single piece of material that covers the entire surface of the flexible barrier 3 from the ridge portion 3 15 and the two wing portions 3 19 . The honeycomb material 327 includes a fixed surface (not visible in Fig. 6) disposed adjacent to the flexible barrier 313, a distribution surface 329 opposite the fixed surface, and a plurality of peripheral surfaces 33A. In a thin example, the flexible barrier 3 1 3 can be similar to the flexible barrier 2 13 and include a flexible backing. Although the adhesive is a preferred method for securing the honeycomb material 327 to the flexible barrier 3丨3, the flexible barrier 313 and the honeycomb material may be fixed by any other suitable fixing method, or It is left to the user for assembly at the treatment site. The flexible barrier 3 13 and/or the flexible backing acts as an impermeable barrier to block the passage of fluids such as liquids, air or other gases. In an embodiment, the flexible barrier and flexible backing may not be provided in a separate manner to support the honeycomb material 327. Rather, the honeycomb material 327 can have a 154474.doc 201130531 integral barrier layer that is an impermeable portion of the honeycomb material 327. The barrier layer may be formed of a closed cell material to prevent fluid from passing through thereby replacing the flexible barrier 313. If a monolithic barrier layer is used with the honeycomb material 327, the barrier layer may comprise a raised ridge portion and a wing portion as described above for the wall 3. The ',, and the flexible barrier 3 13 is preferably made of an elastic material such as a polyoxyl polymer. An example of a suitable polyoxyl polymer includes the one located in Carpinteria.

The iMED6〇15 is manufactured by Nusil Technoiogiess of California. However, it should be noted that the flexible barrier 3 i 3 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, for example by

Tempe, made by Bard 6〇13 manufactured by C.R. Bard of Arizona. 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, networked urethane foam having a pore size in the range of about 400 to 600 microns. An example of such a foam may be included by being located in San Antonio,

GranuFoam, manufactured by Kinetic Concepts, Texas. Honeycomb material 327 can also be a gauze, felt pad, or any other biocompatible material that provides fluid communication in a plurality of dimensions in a plurality of channels. The honeycomb material 327 is primarily an "open-hole" material comprising a plurality of pores fluidly connected to adjacent pores. By the "open pores" of the honeycomb material 327, in the "open pore" Forming a plurality of flow channels therebetween. The flow channels can be in the entire portion of the honeycomb material 327 having open pores 154474.doc •15·201130531 achieving fluid communication. The cells and flow channels can have a uniform shape and size. 'Or may include patterned or random shapes and dimensional changes. Variations in the size and shape of the holes in the honeycomb material 327 may cause changes in the flow channels, and such characteristics may be used to alter the flow of fluid through the honeycomb material 327. The honeycomb material 327 may further comprise a portion containing a "closed hole". The closed cell portion of the honeycomb material 327 comprises a plurality of holes, most of which are not fluidly connected to the late neighboring holes. An example of a closed-hole portion is described herein as a barrier layer that can replace the flexible barrier 3丨3. Similarly, it can be selectively disposed in the honeycomb material 327. The closed hole portion is disposed to prevent fluid from passing through the peripheral surface 33 of the honeycomb material 327. The flexible barrier 3 1 3 and the honeycomb material 327 may also be removed from the patient after the use of the reduced pressure delivery device 31 Prepared from a resorbable material. Suitable bioresorbable materials may 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, poly. The carbonate barrier, the polyfumarate, and the capraUct〇. The flexible barrier 313 and the honeycomb material 327 can be further used as a new cell growth scaffold, or a scaffold material and a flexible barrier 3 13 , a flexible backing 327 and/or honeycomb material 327 are used in combination to promote cell growth. Suitable scaffold materials may include, but are not limited to, calcium phosphate, collagen, PLA/pGA, coral hydroxyapatite, carbonate, or treated allograft material. Preferably, the stent material will have a high void ratio (i.e., high air content). A reduced pressure delivery tube 341 is positioned within the arched channel 323 and secured to the flexible barrier 313. The reduced pressure delivery tube 341 is also Fixed to the honeycomb material 327, or in the case where only the honeycomb material 327 is present, the reduced pressure delivery tube 341 can be 154474.doc •16·201130531 fixed only to the honeycomb material 327. The decompression delivery tube (4) (4) (4) The distal end includes a distal aperture 3G which is similar to the distal aperture 243 of Figure 5. The reduced pressure delivery tube 3" can be positioned such that the distal aperture (4) is located at any point along the arcuate channel 323, but The longitudinal length of the arcuate channel 323 is preferably located at approximately the midpoint. Preferably, the end opening 343 is formed in an elliptical or circular 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, the elliptical shape of the aperture enhances fluid communication with the flow channels 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 FIG. As an alternative to or in addition to the distal orifice 343, a discharge opening is provided along the tube 341 to enhance fluid communication between the reduced pressure delivery tube 341 and the flow channel. As previously described, the reduced pressure delivery tube (4) may be positioned only partially along one of the longitudinal lengths of the arcuate passage 323, or alternatively may be positioned along the entire longitudinal extent of the arcuate passage 323. If positioned so that the reduced pressure conduit 3 occupies the entire chevable passage 323, the distal orifice (4) can be capped so that all fluid communication between the tube 34! and the flow passage is via the discharge opening. Preferably, the honeycomb material 327 covers and directly contacts the reduced pressure delivery tube 341. The honeycomb material 327 can be attached to the reduced transport tube 341, or the honeycomb material 327 can be fixed only to the flexible barrier 313. If the dust-removing duct mi is positioned such that it extends only to the point of the chevron-shaped passage 323, the honeycomb material (2) may also not include (4) the area of the duct 341 in the arched passage 323 + is connected to I54474.doc -17 201130531 The convex ridge portion 315 of the flexible barrier 313. The reduced pressure delivery tube 341 further includes a proximal port 355 at the proximal end of the tube 341. The proximal port 355 is configured to cooperate with a source of reduced pressure, which will be described in more detail below with respect to FIG. source. The reduced pressure delivery tube 341 shown in Figures 6-8 contains only a single f-cavity or passage 359. However, the reduced pressure delivery tube 341 can be provided with a plurality of lumens, such as the plurality of lumens previously described with reference to Figures. As previously described, the use of a multi-lumen tube provides a separate fluid communication path between the proximal end of the reduced pressure delivery tube 341 and the flow channel. The separate fluid communication paths may also be provided by separate tubes having single or multiple lumens in communication with the flow channels. Referring to Figures 8A and 8B, a reduced pressure delivery device 371 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 3M. A plurality of protrusions 385 are disposed on an inner surface 387 of one of the reduced pressure delivery members 373 to form a plurality of flow passages 391 between the protrusions 385. The size, shape and spacing of the protrusions 385 can be similar to the protrusions described with reference to Figure _5. The reduced pressure delivery device 371 is particularly suitable for applying reduced pressure to connective tissue that can be received in the incision 381 and regenerating tissue on the connective tissue. The ligaments, tendons, and cartilage are non-limiting examples of tissue that can be treated by the reduced pressure delivery device 371. Referring to Figure 9, a decompression group m is applied to a tissue site 413 (e.g., human bone 154474.doc 201130531 415 of the patient) using a reduced pressure delivery device 411 similar to other reduced pressure delivery devices described herein. At tissue growth, decompressive tissue treatment can provide a rate of healing associated with fractures, non-union, voids, or other bone defects. Further, it is believed that decompression tissue treatment can be used to improve the recovery of osteomyelitis. This treatment can be used to improve the local bone density of patients with osteomyelitis. Finally, reduced pressure tissue treatment can be used to accelerate and improve the oseointegration of orthopedic implants such as implants, knee implants, and fixation materials. Still referring to Figure 9, the reduced pressure delivery device 411 includes a reduced pressure delivery tube 419, The reduced pressure delivery tube 419 has a fluid connection to the proximal end 421 of the reduced pressure source 427. The reduced pressure source 427 is a pump or any other number that can be associated with the reduced pressure delivery device 411 via the reduced pressure delivery tube 41 9 The flow channel applies a reduced pressure to the tissue site 413. Applying the 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, in this particular example. This involves wrapping the wing portion around the void defect 429 in the bone 415. The reduced pressure delivery device 4n can be inserted by surgery or through the skin. When inserted through the skin, the reduced pressure delivery tube 419 preferably passes through a penetration. The sterile insertion of the patient's skin tissue is inserted into the sheath. Treatment with decompression tissue typically produces granulation tissue in the area surrounding the tissue site 413. The granulation tissue is often found in humans. Common tissue formed before tissue repair in the body. Under normal circumstances, granulation tissue may form during the presence of foreign bodies or during wound healing. Granulation tissue is often used as a scaffold for healthy replacement tissue and further causes some scar formation Tissue. The granulation tissue is highly vascularized, and the increased growth rate of such highly vascularized tissue in the presence of reduced pressure promotes the growth of new tissue at the tissue site 413 154474.doc •19·201130531. 9, a fluid delivery tube 431 can be fluidly coupled to a flow channel of the reduced pressure delivery device 411 at a distal end. The fluid delivery tube 431 includes a proximal end 432 fluidly coupled to a fluid delivery source 433. If delivered to the tissue For the air of the melon system, it is preferred to purify and sterilize the air by means of a filter 434 capable of filtering particles as small as the claws, especially when the tissue site 413 is located below the surface of the skin. It is very important to introduce air into the tissue site 413, which facilitates good dredge of the tissue site 413, thereby reducing or preventing decompression The obstruction of the delivery tube 419. The fluid delivery tube 43 1 and the grasping body delivery source 433 can also be used to introduce other fluids to the tissue site 4丨3 including, but not limited to, antibacterial agents, antiviral agents, cell growth promoters, irrigation bodies, or Other chemically active agents. When inserted through the skin, the reduced pressure delivery tube 43 1 is preferably inserted through a sterile insertion sheath that penetrates the patient's skin tissue. A pressure sensor 4 3 5 can be operatively coupled to The fluid delivery tube 431 is configured to expand whether the fluid delivery tube 43 1 is blocked by blood or other bodily fluids. The pressure sensor 435 can be operatively coupled to the fluid delivery source 433 to provide feedback to control introduction to the tissue site 4 13 The amount of fluid. A non-return (not shown) may also be operatively coupled adjacent the distal end of the fluid delivery tube 43 to prevent blood or other bodily fluids from entering the fluid delivery tube 431. The separate fluid communication paths provided by the reduced pressure delivery sump 419 and the fluid delivery tube 431 can be achieved in a number of different ways, including < single multi-lumen tube as previously described with reference to the Figures. One of ordinary skill in the art will recognize that a multi-lumen tube is used to the right, and the sensor associated with the fluid transfer tube 43 154474.doc 201130531 'Valves and other components can similarly be associated with a reduced pressure delivery tube One of the 419 is associated with the lumen. Preferably, any lumen or e-white fluid in fluid communication with the tissue site is coated with a U-coagulant to prevent body fluids or blood from plugging in the lumen or tube. Other coatings such as tubes or tubes include but not Limited to heparin, anticoagulant, anti-fibrinogen, anti-adherent, anti-prothrombin, and hydrophilic coating. See Figure 10-1. The 9' test has shown that when decompressive tissue treatment is applied to bone tissue, a positive effect is obtained. In a particular experiment, the skulls of a few rabbits were treated with decompressive tissue to determine their effects 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 in skull _L, the effect of decompressive tissue treatment on rabbits with critical size defects on the skull, and the decompression of a scaffold material Tissue Therapy - The effect of using a critical dimension for the treatment of skulls. The specific test protocol and number of rabbits are listed in Table 1 below. Rabbit test protocol number 4 No defects on the skull; in the intact bone compression tissue treatment (RPTT) for 6 days by means of honeycomb foam (GranuFoam), immediately after harvesting the tissue skull without defects; without decompression tissue In the case of treatment (RPTT), a honeycomb foam (GranuF〇am) was placed on top of the intact membrane for 6 days, and immediately the tissue was harvested ___ with a critical dimension defect on which the stainless steel mesh was placed; one on top 1 The critical size defect of the Wei 33 stent was placed; the two defects were applied 2 to RPTT 'after 2 weeks of surgery, the group sensitivity was found to have a critical dimension defect in the upper sulfur steel wire 154474.doc 201130531 4 Qing Gan·“Chou Qiu and the critical size of the screen mesh is missing. The critical size defect of the calcium phosphate stent is placed on the surface; j shell, one in the upper RPTT; harvesting the tissue after 2 weeks of surgery' Day 4 has a critical size defect placed on top of a stainless steel surface; the two RPTTs; harvested tissue after 12 weeks of surgery ^ 4 has one placed on top and no one placed on the 7 side弼 之Boundary size defect; no control is applied to harvest tissue 2 weeks after surgery. There is a critical size defect on which stainless steel mesh is placed; a critical size defect in which a bowl of acid is placed on top; no J^PTT is applied Control); harvested tissue 12 weeks after surgery ______ natural control (no surgery; no RPTT) 4 sham surgery (no defect 'no RPTT'): harvested tissue after 6 days of surgery Table 1: Test protocol £» Boundary size defects are defects in tissues (such as the skull) that are large enough to heal without being recovered by themselves. For rabbits, a full thickness hole of approximately 15 mm in diameter is drilled through the head of the month to form a critical dimension defect of the skull. Referring more 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 is illustrated after administration of reduced-pressure tissue treatment for 6 days and subsequent immediate harvesting of tissue. The bones and periosteum can be seen and a layer of granulation tissue has formed. In Figure 12, a rabbit skull is illustrated after treatment with reduced pressure tissue for 6 days followed by immediate harvesting of tissue. The woven blade of Figure 12 is characterized by the formation of new bone path tissue beneath the granulation tissue. 154474.doc •22· 201130531 This skeleton system is highlighted by a yellow asterisk. In the figure ", the rabbit skull is illustrated after administration of the money tissue treatment for 6 days and subsequent harvesting of the tissue immediately. You can see new bones and periosteum. # The tissue appearance of the bone path tissue formed by the decompression tissue treatment is very similar to the tissue appearance of the bone path formed in very young animals that are undergoing extremely rapid new bone growth and deposition. Referring more specifically to Figures 14·19', which illustrates several photographs and tissue cuts, the procedure and results for decompressing tissue treatment of a rabbit skull having a critical size defect are shown. In Fig. 14, a rabbit skull in which two critical size defects have been formed is illustrated. The full-thickness critical dimension defect of Yanhai is about 15 mm in diameter. In Figure 15, a stainless steel wire mesh has been placed over one of the critical dimension defects and a barium sulphate stent has been placed within the second critical dimension defect. In Figure 16, the reduced pressure is applied to the critical size defects using a reduced pressure tissue treatment device similar to that described herein. The pressure applied to each defect is _125 mm Hg gauge. The reduced pressure was applied according to one of the test protocols listed in Table 1. In Fig. 17, a skull is illustrated after administration of a 6-day decompression tissue treatment and harvesting tissue after 12 weeks of surgery. The slice shown contains a calcium phosphate scaffold, which is indicated by a red arrow. Treatment with decompression tissue will result in significant growth of new bone tissue in the map, highlighted by a yellow asterisk. The amount of bone growth is significantly greater than the amount of bone growth in critical size defects that are treated with the same calcium phosphate scaffold but not treated with decompression tissue. The observations indicate that there may be a therapeutic threshold for the induction of a new bone formation reaction or a continuous portal decompression tissue treatment. The sample collected at 12 weeks after surgery is 154474.doc -23- 201130531 shows that this indicates that dust-reducing tissue treatment causes a series of biological events, thereby enhancing the formation of new bone tissue. The critical size defect covered with a stainless steel mesh (Fig. 15) but without the stent material in the defect was used as an intra-animal control with minimal bone growth. These data highlight the advantages of proper scaffolding materials and the positive effects of dust 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 stent is still clearly visible. Figure 19 illustrates the defect after twelve weeks of surgery and shows that the critical dimension defect is almost completely healed and the main stent architecture is nearly completely lost due to tissue fusion (i.e., the formation of new bone within the stent matrix). Referring to Fig. 20, a reduced pressure delivery system 7i i according to an embodiment of the present invention performs decompression tissue treatment on a tissue site 71 3 of a patient. The reduced pressure delivery system 711 includes a manifold delivery tube 721. The manifold delivery tube 721 can be a catheter or cannula' and can include means for enabling the manifold delivery tube 721 to be directed to the tissue site 713, such as a guide unit 725 and a guide wire 727. The placement and guidance of the guide wire 727 and the manifold delivery tube 721 can be accomplished using endoscopy, ultrasound, fluoroscopy, auscultation, palpation, or any other suitable localization technique. A manifold delivery tube 721 is provided for inserting a reduced pressure delivery device through the skin into the tissue site of the patient. 7[3] When inserted through the skin, the manifold delivery tube 721 preferably passes through a sterile insertion through the patient's skin tissue. The sheath is inserted. In Figure 20, the tissue site 713 is on the fracture adjacent to the patient's bone 733. 154474.doc • 24·201130531 The location contains bone tissue. The manifold delivery tube 72i is inserted through the skin 735 of the patient and any soft tissue 739 surrounding the bone 733. As previously described, the woven site 713 can also comprise any type of tissue including, but not limited to, adipose tissue, muscle tissue, nerve tissue, skin tissue, vascular tissue, connective tissue, cartilage, tendon, or ligament. Referring to Figures 21 and 22', the reduced pressure delivery system is further illustrated. The manifold delivery tube 721 can include a tapered distal end (4) for easy insertion through the patient's skin 735 and soft tissue 739. The tapered distal end 743 can be flexed radially outwardly to the -open position 1 such that the distal end 743 is substantially the same or larger than the inner diameter of the other portion of the tube 721. The open position of the distal % is schematically shown by dashed line 737 in FIG. Manifold delivery tube 721 further includes a passageway 751 in which a reduced pressure delivery device 761 or any other reduced pressure delivery device is included. The reduced pressure delivery device 761 includes a flexible barrier 765 and/or honeycomb material 767, as described with reference to Figures 6-8. The flexible barrier 765 and/or the honeycomb material 767 are preferably wound, folded or otherwise compressed around the reduced pressure delivery tube 769 to reduce the cross-sectional area of the reduced pressure delivery device 761 within the passageway 751. The reduced pressure delivery device 761 can be placed within the passageway 751 and directed to the tissue site 713 after the distal end 743 of the manifold delivery tube 721 is placed at the tissue site 713. Alternatively, the reduced pressure delivery device 761 can be pre-positioned in the passage 751 after the manifold delivery tube 721 is inserted into the patient. To push the pressure reducing delivery device 761 through the passage 751, a biocompatible lubricant can be used to reduce the friction between the reduced pressure delivery device 76 and the manifold delivery tube 72. When the distal end 743 has been positioned at the tissue site 713 and the reduced pressure delivery device 154474.doc -25 - 201130531 761 is delivered to the distal end 743, then the reduced pressure delivery device 761 is pushed toward the distal end 743, thereby enabling the distal end The 743 expands radially outward to the open position. The reduced pressure delivery device 761 is pushed out of the manifold delivery tube 721, preferably into the void or space of the Bib adjacent tissue site 713. This void or space is usually formed by incision of soft tissue, which can be accomplished by a route through the skin. In some cases, the tissue site 713 can be located at the wound site and there is a natural void due to the anatomy of the wound. In other cases, the void may be formed by balloon separation, sharp separation, blunt separation, hydraulic separation, pneumatic separation, ultrasonic separation, electrocautery separation, laser separation, or any other suitable separation technique. When the reduced pressure delivery device 761 enters the gap adjacent the tissue site 713, the flexible barrier 765 and/or the honeycomb material 767 of the reduced pressure delivery device 761 is unwound, unfolded, or decompressed (see Figure 22), thereby reducing The pressure delivery device 761 can be placed in contact with the tissue site 713. Although it is not necessary to do so, however, the flexible barrier 765 and/or the honeycomb material 767 can be subjected to a vacuum or reduced pressure provided by a reduced pressure delivery 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. End placement, ultrasound, fluoroscopy, auscultation, palpation, or any other suitable localization technique can be used to achieve final placement and manipulation of the reduced pressure delivery device 761, after placement of the reduced pressure delivery device 761, The manifold delivery tube 721 is removed from the patient, but the reduced pressure delivery tube associated with the reduced pressure delivery device 761 remains in place so as to be able to be applied to the tissue site 713 154474.doc •26· 201130531 through the skin. pressure. Referring to Figures 23-25, a reduced pressure delivery system 811 in accordance with an embodiment of the present invention includes a manifold delivery tube 821 having a tapered distal end 843 that is configured to flex radially outwardly to An open position such that the inner diameter of the distal end 843 will be substantially the same or greater than the inner diameter at other portions of the tube 82 1 . 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 a honeycomb material 867 'the flexible barrier 865 and/or the honeycomb material 867 is preferably wound, folded or otherwise compressed around the reduced pressure delivery tube 869 to 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 such that the reduced pressure delivery device 861 is 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 25A): the impermeable film 871 is sealingly coupled to the manifold delivery tube 821 such that the inner space 873 of the impermeable membrane 871 and the manifold delivery tube 821 The passages are in fluid communication. Alternatively, the impervious film 871 can be secured to the reduced pressure delivery tube 869 such that the interior space 8^3 of the impermeable membrane 871 is in fluid communication with the passage of the reduced pressure delivery tube 869. The impervious film is twisted and can be attached to a separate control tube or control tube that is in fluid communication with the interior space 873 (see, for example, Figure 25A). In one embodiment, an impermeable membrane 87 can be provided to further reduce the cross-sectional area of the reduced pressure delivery device 861 within the passage. 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. A substantial portion of the air or other fluid within the interior space 873 is thereby expelled to place the impermeable membrane 87 to the compressed position shown in FIG. In this compressed position, the impervious film 87 i is attracted inwardly to apply a pressure to the reduced pressure conveying device 861 to further reduce the cross-sectional area of the reduced pressure conveying device 861. As previously described with reference to Figures 21 and 22, the reduced pressure delivery device 86 1 can be delivered to the tissue site after the distal end 843 of the manifold delivery tube 821 is disposed at the tissue site. Placement and manipulation of the impermeable membrane 871 and the reduced pressure delivery device 861 can be accomplished using endoscopic examination, ultrasound, fluoroscopy, auscultation, palpation, or any other suitable localization technique. The impermeable film 87A can include a radiopaque marker 881 which improves the visibility of the impermeable film 871 under the fluorescent 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 87 松弛 in the relaxed position (see Figure 24), thereby facilitating The pressure reducing conveying device 86ι is easily removed from the impermeable film 871. A removal device 885 (e.g., a cannula, a needle or other sharp instrument) can be provided to break the impermeable membrane 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 breaking the impervious film 154474.doc -28- 201130531 87, the removal device 885 and the impermeable film 871 can be withdrawn through the manifold delivery tube 821, thereby making the flexible barrier of the reduced pressure delivery device %// Or the honeycomb material 867 can be unwound, unfolded, or decompressed, so that the reduced pressure delivery device 861 can be placed in contact with the tissue site. The unwinding of the flexible barrier 865 and/or the honeycomb material 867 can occur automatically after releasing the reduced pressure in the interior space (7) and removing the impervious film 871. In some cases, positive pressure may be delivered via the reduced pressure delivery tube 869 to help unwind or unwind the flexible barrier 865 and/or the honeycomb material (6). After the final placement of the reduced pressure delivery device 861, the manifold delivery tube is preferably removed from the patient's body but the dust reduction delivery tube associated with the subtractive (four) delivery device 861 remains in place so as to be able to pass through the skin to the tissue site Apply a reduced pressure. The impervious film 871 can also be used to separate the tissue of the adjacent tissue site prior to placing the peak-reducing device 861 against the tissue site. After pushing the reduced pressure delivery device (6) and the intact impermeable = membrane 871 through the distal end 843 of the manifold delivery tube 821, air or another fluid is injected or tethered into the interior space 873 of the non-seepage (7). It is preferred to use a liquid to make the impermeability of the impermeable liquid to expand the impermeable film in a more uniform manner. The non-permeable film 871 can be expanded as in the process of "expansion" or in the direction of the II, or the direction of its manufacture ... makes the impermeability thinner: When the air or flow pattern is taken to the position of the face (see large, it can be separated from the gap - when the gap is sufficient to release the air or other fluid in the internal space 873 so that it does not penetrate 154474.doc •29- 201130531 The flexible film 871 can assume a relaxed position. Then, the impervious film 87A can be broken as explained above, and the reduced pressure delivery device 861 can be inserted adjacent to the tissue site. Referring to Fig. 25A, if the impermeable film 871 is mainly used for separation Adjacent to the tissue at the π position of the tissue, the impermeable membrane 871 can be sealingly secured to the manifold delivery tube 821 such that the interior space 873 is associated with or secured to the auxiliary lumen or tube 891 of the manifold delivery tube 821. Fluid communication. The auxiliary lumen 891 can be used to deliver liquid, air or other fluid to the interior space 873 to place the impermeable membrane 871 in the expanded position. After separation, the impermeable membrane can be as described above with reference to Figure 24. 871 relaxes and breaks. Referring to Figure 26, a reduced pressure delivery system [mu] according to an embodiment of the invention includes a manifold delivery tube 921 having a tapered distal end 943, a tapered distal configuration Flexing outwardly in the radial direction to an open position such that the inner diameter of the distal end M3 will be substantially the same or greater than the inner diameter at other portions of the tube 921. The opening position of the distal end 943 is indicated by the dashed line in FIG. 937 is shown schematically. Manifold delivery tube 921 further includes a passageway containing a reduced pressure delivery device 961 similar to other reduced pressure delivery devices described herein. Reduced delivery device 196! Contains - flexible barrier 965 and/or honeycomb material 967, flexible barrier 965 and/or honeycomb material 967 are preferably wound, folded or otherwise compressed around reduced pressure delivery tube 969 to reduce the delivery of reduced pressure delivery device 961 in the manifold The cross-sectional area in the passage of the tube 921. An impervious film 971 having an inner surface 973 is disposed around the reduced pressure delivery device 961 such that the reduced pressure delivery device 961 is contained within the inner surface 973 of the impermeable membrane 971. The impervious film 971 comprises a glue seal 977 on one end of the impervious film 154474.doc • 30-201130531 to provide a m (four) permeable film state that removes the reduced pressure delivery device 961 from the impermeable film 97i. Sealedly connected to The manifold conveys the 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 fluid communication with the interior space 973. Control tube (not shown) ▲ Similar to Figure 23 < The impervious film 871, the impervious film 971 can prevent fluid from passing through so that the impervious film 971 can take at least one of a compressed position, a relaxed position, and an expanded position. Since the procedure for placing the impervious enamel film 97 1 in the compressed position and the expanded position is similar to the impervious film 871', only the process of removing the pressure reducing conveying means will be described. Delivery of the reduced-pressure delivery device 916 to the tissue site within the impermeable membrane 917 using endoscopy, ultrasound, fluoroscopy, auscultation, palpation, or any other suitable localization technique and subsequent It is positioned in a positive position. The impermeable film 971 can include a radiopaque marker 981 which improves the impervious film 97 to be examined under the glare screen prior to its removal. The reduced pressure delivery device 96 is then pushed through the distal end of the manifold delivery tube 92. The reduced pressure applied to the interior space 973 can be released to place the impervious sheet 971 in a relaxed position. Then, the reduced pressure delivery mechanism 961 is pushed through the glue seal 977 to push out the impervious film 971. Referring to Figure 26A, a reduced pressure delivery system in accordance with an embodiment of the present invention may not include a manifold delivery tube similar to manifold delivery tube 921 of Figure 26. Alternatively, the reduced pressure delivery system 985 can include a guide wire 987 decompression I54474. Doc • 31 · 201130531 Delivery tube 989, and a reduced pressure delivery device 991. The reduced pressure delivery device 991 includes a plurality of fluid passages connected to the reduced pressure delivery tube 989. Instead of using a separate manifold tube to deliver the reduced pressure delivery device 991, the reduced pressure delivery device 991 and the reduced pressure delivery tube 989 are placed on the guide wire 987, which guides the guide wire 987 through the skin. To a tissue part 993. Preferably, the guide wire 987 and the reduced pressure delivery tube 989 penetrate the skin of the patient by means of a sterile sheath. By guiding the reduced pressure delivery tube 989 and the reduced pressure delivery device 991 along the guide wire 987, the reduced pressure delivery device 991 can be placed at the tissue site 993 to effect decompression tissue treatment through the skin. Since the reduced pressure delivery device 991 is not constrained in a manifold delivery tube during delivery to the tissue site 993, it is preferred to maintain the reduced pressure delivery device 991 in the compressed position during delivery. If an elastic foam is used as the reduced pressure conveying means 991, the foam can be coated with a biocompatible soluble adhesive and the foam can be compressed. After reaching the tissue site, the body fluid or other fluid delivered via the reduced pressure delivery tube 989 dissolves the 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 body temperature of the patient. In yet another embodiment, a soluble film can be used. The compressed reduced pressure delivery device 991 is delivered to the tissue site 993. Referring to Figure 27, a reduced pressure delivery system 丨〇i i according to an embodiment of the present invention includes a manifold delivery tube 1021 having a distal end 1043, and a distal end 〇43 is inserted through 154474. Doc •32· 201130531 Passed one of the patient's tissues and reached the tissue site丨〇25. The tissue site 25 can include a void 1029 associated with a wound or other defect, or alternatively, a void can be formed by separation, including the separation techniques described herein. An injectable, pourable or flowable reduced-pressure delivery device 1035 is delivered to the tissue site 1 via the manifold tube 2 after the distal end 1 043 is placed adjacent to the tissue site 1〇25 in the void volume 29 〇25 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 is delivered to, . And weaving. The foam can be formed in situ after the p-position. Still other materials may be present in the gel state at the tissue site 1 〇 25 for delivery of reduced pressure flow channels. Delivery to the tissue section The # of the reduced pressure delivery device 1 () 35 may be sufficient to partially or completely fill the empty i (four). The reduced pressure delivery device 1035 can include both a manifold and a stent. The reduced pressure delivery device 1035 includes a plurality of holes or open holes that can be formed in the material after delivery to the gaps 1〇29. The holes or open holes communicate with each other, thereby forming a plurality of streams (four) tracks. The flow channels are used for the application and division of the tissue site 1 () 25, and the 5 series bioresorbable two are used for the decompression transport; 基材 The substrate of the new tissue is grown thereon. In an embodiment, the reduced pressure delivery device may comprise a distribution throughout the liquid 154474. Doc -33- 201130531 Poragen in body or viscous gels, such as NaCl or other salts. After the liquid or viscous gel is delivered to the tissue site 1025, the material is applied to the void 1029 and subsequently cured into a solid. The water-soluble NaC1 is dissolved by the presence of bodily fluids (3), leaving a structure with interconnected pores or flow channels. The reduced flow of ink and/or fluid is delivered to the flow channels. As the new tissue is formed, the tissue will grow into the bore of the reduced pressure delivery device 1 〇 35 and then eventually replace the reduced pressure delivery device 1035 with the degradation of the reduced pressure delivery device 1035. In this particular example, the 'reduced delivery device IQ' is used not only as a manifold but also as a new tissue growth scaffold. In another embodiment, the reduced pressure delivery device 1035 is an alginate mixed with 4 〇〇 μη mannose particles. The p0ragen 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 the poragen or particles are dissolved, the space previously occupied by the poragen or particles becomes a void which is interconnected to each other to form a flow passage in the reduced pressure conveying device 1035. The use of poragen in materials to form flow channels is effective, but it also forms pores and flow channels that are limited in size to the particle size of the selected poragen. A chemical reaction can be used in place of poragen to form larger pores by forming gaseous by-products. For example, in one embodiment, a flowable material comprising sodium bicarbonate and citric acid microparticles (which may be non-stoichiometric) may be delivered to tissue site 1025. When the flowable material forms a foam or solid in situ, the body fluid will cause an acid reaction between sodium bicarbonate and citric acid. Compared to the technique of relying on poragen dissolution, the formed carbon dioxide gas particles will form larger pores throughout the reduced pressure delivery device 1035 and 154474. Doc •34· 201130531 Flow channel. The conversion of the reduced pressure delivery device 1 035 from a liquid or viscous gel to a solid or foam can be triggered by pH, temperature, light, or reaction with body fluids, chemicals, or other materials 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 dumping, 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 to form 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. Except for the various embodiments described herein, the reduced-pressure delivery device 1 〇3 5 can be made from a variety of materials including, but not limited to, calcium phosphate, collagen, alginate, cellulose, or any other gas capable of An equivalent material that is delivered to the tissue site in the form of a liquid, gel, paste, putty, serum, suspension, or other flowable material and capable of forming a plurality of flow paths in fluid communication with the tissue site. The flowable material may further comprise solid particles, such as particles, which can be transported via a manifold 154474 if the particle size of the solid particles is sufficiently small. Doc •35· 201130531 1021 flow. The material delivered to the tissue site in a flowable state can be polymerized in situ or form a gel. The reduced pressure delivery device 丨〇 35 can be directly injected or poured into the space 1 〇 29 adjacent to the tissue site 1025, as described above. Referring to Figure 27A, the manifold delivery tube 1021 can include an impermeable or semi-permeable membrane 1051 at the distal end 1〇43 of the manifold delivery tube 1〇21. The membrane 1〇51 includes an internal space 1〇55, and the internal space 1055 is in fluid communication with an auxiliary lumen 1〇57 fixed to the manifold delivery tube 1〇21. The manifold delivery tube 1021 is guided to a tissue portion 1025 on a guide wire 丨〇6丨. The reduced pressure delivery device 1035 can be injected or poured through the auxiliary lumen 1057 to fill the interior space 1055 of the membrane 1051. When the fluid or gel fills the film 195 1 'film 1 〇 51 expands to fill the void 丨〇 29, thereby causing the film to contact the tissue site 1025. When the film 丨051 is inflated, the film 1〇51 can be used to separate additional tissue adjacent to or near the tissue site 1025. If the film 1〇51 is an impermeable film, it can be physically broken and removed, so that the reduced pressure delivery device 1035 contacts the tissue site 1〇25. Alternatively, film 1〇51 can be made from a soluble material that will dissolve in the presence of body fluids or biocompatible solvents delivered to film 1〇51. If the film 1〇5丨 is semi-permeable, the film 105 1 can remain in place. The semi-permeable membrane 丨〇5丨 is capable of delivering reduced pressure and possibly other fluids to the tissue site 1025. Referring to Figure 28, a method of performing reduced pressure tissue treatment includes surgically inserting a manifold at an adjacent tissue site at 1115, the manifold having a plurality of protrusions extending from a flexible barrier To form a plurality of flow channels between the protrusions. Positioning the manifold at 1119 154474. Doc-36-201130531, at least a portion of the projections contacting the tissue site. At ii23, a reduced pressure is applied to the tissue site via the manifold. Referring to Fig. 29, a method of applying reduced pressure tissue treatment to a tissue site 1211 includes inserting a manifold at 121 5 through the skin adjacent the tissue site. The e-discovery may 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 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 and that forms a plurality of flow channels upon reaching the tissue site. The manifold is positioned at 1219 to cause at least one of the flow channels to communicate with the tissue site fluid. At 1223, a reduced pressure is applied to the tissue site via the manifold. Referring to 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 f is placed adjacent to the tissue site. At 13 ,, the balloon associated with the tube can be inflated to separate the tissue adjacent to the tissue site, thereby forming a void. At 1323, the manifold is transported through the passage. The manifold may include a plurality of protrusions extending from the baffle barrier to form a plurality of flow materials between the protrusions t. Alternatively, the manifold can comprise a honeycomb material having a plurality of flow channels within the nest 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. Positioning at the assisted (4) manifold to make at least one of the flow channels 154474. Doc -37- 201130531 is in fluid communication with the tissue site. At 1331, the reduced pressure is applied to the tissue site via the manifold via a reduced pressure delivery tube or any other delivery route. Referring to Fig. 3, a method of applying reduced pressure tissue treatment to 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 423, a manifold is delivered to the tissue site via the passageway in an impervious sheath. The impervious sheath 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 Torr, 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 to be inserted into a passage 1529 that is hinged in the backbone of the leg section ι517. 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 152 1 of the hip prosthesis 15 15 to fluidly communicate the flow channel 1541 with the porous coating 1535. A port 1545 is fluidly coupled to the flow passage 1541 which is configured to be releasably coupled to a reduced pressure delivery line 1551 and a reduced pressure delivery source 1553. The flow channel 1541 is used to deliver a reduced pressure to the porous coating 1535 and/or the bone path surrounding the hip prosthesis 1515 after implantation of the hip prosthesis 15 15 . The flow channel 1541 can comprise a 154474. Doc • 38· 201130531 Main feed line 1 543 in fluid communication with a plurality of transverse branch lines 1547, the plurality of transverse branch lines 1547 being in communication with the porous coating 153 5 . The lateral branch line 1545 can be oriented perpendicular to the main feed line 1543 as shown in Figure 32, or can be oriented at some angle to the main feed line 1543. An alternative method for distributing the reduced pressure includes providing a hollow hip prosthesis and filling the interior of the prosthesis with a honeycomb-like (preferably open-cell) material capable of being in fluid communication with the porous coating 1535. . Referring more specifically to Figure 33, the body prosthesis 1515 can further include a first plurality of flow channels within the column portion 1521. 15 61, providing fluid to the porous coating 1 5 3 5 and/or bone of the surrounding body prosthesis 1 5 1 5 . The fluid may include filtered air rolling or other gas 'antibacterial agents, antiviral agents, cell growth promoters, irrigation fluids, chemically active fluids, or any other fluid. If it is desired to introduce multiple 6 il bodies into the bone path of the surrounding prosthesis 1 5 1 5, an additional fluid communication path can be provided. A port 1565 is fluidly coupled to a flow channel ι 561 which is configured to be releasably coupled to a fluid delivery port 丨 75 丨 and a _ fluid delivery source 1573. The flow channel 1 56 1 can include a main feed line 1583 in fluid communication with a plurality of lateral branch lines 1585 that are in communication with the porous coating 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 1 54 1 and the transfer of fluid to the second plurality of flow channels 1561 can be accomplished by separate tubes (e.g., reduced pressure delivery tube 1551 and fluid delivery tube 1571). Alternatively, a tube having multiple lumens as previously described herein can be used for separation for 154474. Doc -39- 201130531 The path of communication between the reduced pressure and the fluid. It should be further noted that although a separate fluid communication path is preferably provided within the hip prosthesis 15 15 , the first plurality of flow channels 541 can be used to deliver both the reduced pressure and fluid to the surrounding hip prosthesis 1515. skeleton. As described earlier, the application of reduced stress to bone tissue promotes and accelerates the growth of new bone tissue. By using the hip prosthesis 丨5丨5 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 1515 will more successfully engage the bone complex. Together. Providing a second plurality of flow channels 丨5 6丨 to discharge the bone surrounding the hip prosthesis 丨5丨5 will improve the successful regeneration of the new bone surrounding the prosthesis. After applying the reduced pressure through the prosthesis 1 5 1 5 for a selected amount of time, the reduced pressure delivery tube 1551 and the fluid delivery tube 1571 can be disconnected from the connection ports 1545, 1565 and removed from the patient's body. Good does not use surgical invasive procedures. The connection between the ports 1545, 1565 and the tubes 1551, 1571 can be a hand release connection which can be effected by applying an axial pull to the tube 155, 1571 outside the body of the patient. Another option is to connect 埠. ", 1565 can be bioresorbable or soluble in the presence of a selected fluid or chemical so that tube 1551 can be achieved by exposing port 545, 丨565 to fluid or chemicals. Release of 1571. 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 substance. It can be provided outside the patient and connected to the reduced pressure delivery tube ^51 to deliver the reduced pressure to the hip prosthesis 1515. Alternatively, 154474. Doc -40- 201130531 A decompression delivery source 1 553 can be implanted in a patient, on or near the hip prosthesis 5丨5. Placing the reduced-pressure delivery source 1 553 into the patient eliminates the need for fluid connections through the skin. The implanted reduced pressure delivery source 1 553 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' or can be powered by a battery that is electrically connected to the pump via the skin. The pump can also be directly driven by a chemical reaction that delivers reduced pressure via flow channels 1 54 1 , 1 56 1 and circulates fluid through flow channels 1 541, 1 561. Although only the column portion 1521 and the head portion 1 525 of the hip prosthesis 1515 are illustrated in Figures 32 and 33, it should be noted that the flow channels described herein and components for applying reduced pressure tissue treatment may also be applied to hip falsehood. Any component of the body 5丨5 that contacts bone or other tissue, including, for example, a cup. Referring to Fig. 34', a method 161 for repairing a joint of a patient includes implanting a prosthesis in the bone path adjacent to the joint at 16 15 b. The prosthesis can be a hip prosthesis as described above or any other prosthesis that can help restore joint mobility in a patient. The prosthesis includes a plurality of flow channels configured to be in fluid communication with the bone. At 1619, the reduced pressure is applied to the bone via the plurality of flow channels to improve the oseointegration of the prosthesis. Referring to Figures 35 and 3, a reduced pressure delivery device 1711 according to an embodiment of the present invention includes an orthopaedic fixation device 1715 for fastening a bone 1717 of a patient comprising a fracture site 1719 or other defect. The orthopaedic fixation device 1715 of FIGS. 35 and 36 is a plate having a plurality of passages 1721'. A plurality of passages 1721 are used to anchor the orthopaedic fixation device 1715 to the shaft using screws 1725, pins, bolts or other fasteners. On the bone 1717. Available at 154474. Doc •41- 201130531 A multi-hole coating 1 735 is placed on the surface of the contact bone 1717 of the orthopedic fixation device 715. 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 171 5 . 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 175 and a reduced pressure delivery source 1753. The flow channel 174 is used to deliver a reduced pressure to the bone of the porous coating 1 735 and/or the surrounding orthopaedic fixation device 1715 after the orthopaedic fixation member 1715 is secured to the bone 17 7 . The flow channel 1741 can include a main feed line 1743 in fluid communication with a plurality of lateral 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 hollow orthopedic fixation device and filling the orthopedic fixation device with a honeycomb (preferably open pore) material capable of being in fluid communication with the porous coating 1735 The interior space. The orthopaedic fixation device 1715 can be a plate as shown in Figure 35, or alternatively, can be a fixation device such as a cannula, orthosis, struts, or any other device for stabilizing a portion of the bone. . The orthopaedic fixation device 1715 can further be used to secure a prosthesis or other orthopedic device or fastener of the implanted tissue (eg, bone tissue or cartilage) with the proviso that the fasteners are included for contiguous or surrounding Group of fasteners 154474. Doc •42- 201130531 The flow path for weaving the reduced pressure. Examples of such fasteners may include pins, bolts, screws or any other suitable fastener. Referring more specifically to Figure 36, the orthopaedic fixation device 1715 can further include a second plurality of flow channels 1761 within the orthopaedic fixation device 1715 to provide a porous coating 1735 and/or bone support for the %-wound orthopaedic fixation device 1715. fluid. The fluid may include air or other gases, antibacterial agents, antiviral agents, cell growth promoters, irrigation fluids, chemical active 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 body prosthesis 1715. A port 1765 is fluidly coupled to a flow channel 1761 that is configured to be coupled to a fluid delivery tube 1771 and a fluid delivery source 1773. The flow passage port can include a main feed line 1 783 in fluid communication with a plurality of transverse branch lines 785, the plurality of transverse branch lines 1 785 being in communication with the porous coating 1735. The transverse branch line 1785 can be "oriented" perpendicular to the main feed line as shown in Figure 33, or can be oriented at some angle to the main feed line 1783. Reduced I force to the first-plural flow (four) track (10) Delivery and delivery of fluid to the second plurality of flow channels 1761 can be accomplished by separate tubes (e.g., reduced pressure delivery port 1 751 and fluid delivery tube 1771). Alternatively, one can be used as previously described herein. A tube having a plurality of lumens separates the communication path for delivering reduced pressure to the fluid. It should be further noted that although a separate fluid communication path is preferably provided within the hip prosthesis 1715, the first plurality of flows may be used. The channel 1741 rotates both the reduced force and the fluid to the bone of the adjacent orthopaedic fixation device 1715. 'Using the orthopedic fixation device 1715 as a manifold to the adjacent orthopedics 154474. Doc •43- 201130531 The reduced pressure in the bone area of the 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 orthopedic 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: positioning a manifold having a plurality of flow channels at 1915 to cause at least a portion of the flow channels to be associated with the tissue site. Fluid communication. At 19 19, 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 performing decompression tissue treatment on a tissue site includes positioning the distal end of a manifold tube adjacent to the tissue site at 2〇15. At 2019, a fluid is delivered to the tissue site via the manifold delivery tube. The fluid is capable of filling a void adjacent the tissue site and becoming a solid manifold having a plurality of flow channels in fluid communication with the tissue site. At 2023, a reduced pressure is applied to the tissue portion via the flow path of the solid manifold. Referring to Figures 40-48, a reduced pressure delivery system 2111 includes a main manifold 2115. The main profile 2115 has a flexible wall 2117 154474 surrounding a main flow path 2121. Doc 201130531. The flexible wall 2117 is connected at the proximal end 2123 to the reduced pressure delivery tube 2 (2). 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 main manifold 2115 can be different from the circular shape (i.e., in the figure). 45 is a rectangle - and is triangular in Figs. 46-48, and thus the tube η is decompressed. A transition zone 2129 is provided between the main manifold 2115. The main manifold 2ι5 can be joined by adhesive means to the reduced pressure delivery tube 2125, joined using other means such as fusion or insert molding, or alternatively selected to be integrally joined by coextrusion. The reduced pressure delivery tube 2125 delivers the reduced pressure to the primary manifold 2115 for distribution at or near the tissue site. An anti-blocking member 2i35 is positioned within the main manifold to prevent the main manifold 2115 from collapsing and thereby blocking the main flow path 2121 during application of the reduced pressure. In one embodiment, the anti-blocking member 2135 can be provided with a plurality of protrusions 2137 (see FIG. 4, the plurality of protrusions 2137 are disposed on one of the inner surfaces 2141 of the flexible wall 2117 and extend into the main flow path 2121. In another embodiment, the anti-blocking component 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 2315 can comprise The honeycomb material 2丨49 in the main flow path, such as shown in Figure 47. The anti-blocking member 21 35 can be any that can be embedded in the flow path or can be integrally or otherwise secured to the flexible wall 2117. The material or structure. The anti-blocking member 2135 is capable of preventing the flexible wall 2117 from completely collapsing while still allowing fluid to flow through the main flow path 2121. The flexible wall 211 7 further includes a plurality of holes 21 penetrating the flexible wall 2117. 55 'The holes 2155 are in communication with the main flow path 2121. The holes 2155 allow the reduced pressure delivered to the main flow path 2 121 to be distributed to the tissue site. Doc • 45· 201130531 The aperture 2155 can be selectively positioned around the circumference of the manifold 2115 to preferentially direct the delivery of vacuum. For example, in Figure 51, the apertures can be placed facing the bone, facing the tissue, or both. The reduced pressure 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. This helps drive the flushing fluid through the main flow path 2121 into the first conduit 2161. The spacer used as the anti-blocking member 2135 is also illustrated in FIG. The centrally positioned spacer branches the main flow path 2121 into the two chambers, which causes the main manifold 2115 to continue to operate when one of the chambers is blocked and cannot be dissolved by the cleaning. 154474. Doc -46- 201130531 See Figure 49 and 50, a minus one round misunderstanding secret, ~,. The reduced seat delivery system 2 2 11 includes a main manifold 2215 that is integral with the reduced pressure delivery conduit 2217. The lowering|transport tube up includes a central lumen 2223 and a plurality of auxiliary f-cavities. Although the auxiliary hub (2) can be used to measure the pressure at or near the tissue site, the auxiliary lumen assist can be used to clean the central lumen 2223 to prevent or dissolve the obstruction. A plurality of apertures 223^the central lumens 2223 are in communication to distribute the reduced pressure delivered by the central lumens. As shown in Fig. 5A, it is preferred that the aperture 223 does 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 2241 outside the end of the auxiliary lumen 2225. If the tissue, stent or other material engages the end of the reduced pressure delivery tube 2217 during application of the reduced pressure, the headspace 2241 will continue to allow delivery of cleaning fluid to the central lumen 2223. During use, the reduced-pressure delivery systems 2丨丨丨, 22 i i described in Figures 40-5 0 can be applied directly to the tissue site to distribute the reduced pressure to the tissue site. The low profile of the Master is very beneficial for the installation and removal of the techniques described herein. Similarly, the main manifold can also be embedded by surgery. Referring to Figure 51, the main manifolds 2115, 22 15 can be used in conjunction with an auxiliary manifold 2321. In Fig. 51, the auxiliary manifold 2321 includes a two-layer felt pad. The first layer of the auxiliary manifold 2321 is placed in contact with a bone tissue site containing the fracture site. 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 2 11 5 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 discrimination 154474. Doc •47· 201130531 Tube 2321 can remain in place after the decompression treatment is completed... Dan * Pressure treatment 'can be almost no 岑 了 a ★ ~ ~ 疋 卞 卞 会 + will not disturb the organization at all The primary manifold 2115 is removed from between the layers of the auxiliary manifold. In ^, the main manifold may be coated with a matte material or a material that will form a hydrogel: It is easy to remove the main 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, f-caprolactone, polyhydroxybutyrate, polyvaleric acid, polydioxane Indoleamine, poly〇rth〇esthers, polyphosphazene, polyurethane 'collagen, hyaluronic acid, polyaminoglucose, hydroxyaluminum 1 : calcium phosphate, calcium sulfate, calcium carbonate, bioglass, stainless steel, titanium , button, allograft and autologous tissue grafts. The cleaning functions of the reduced pressure delivery systems 2Π1, 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. 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 or adjacent to one of the outlets of the first conduit. Although the air may be pressurized or "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 '154474. Doc -48- 201130531 Two (2) seconds of air being delivered at intervals of sixty (60) seconds during the application of reduced pressure is sufficient to prevent the formation of obstructions. This cleaning program provides sufficient air to adequately move the manifold and the fluid within the first conduit while preventing the introduction of the moon's air. Introducing too much air, or introducing air at too high a frequency interval, will result in a decompression system that cannot return to a reduced target pressure between wash cycles. The amount of time selected to deliver the cleaning fluid and the interval between the selected cleaning fluids will generally vary depending on the design and specifications of the system components (eg, pumps, tubes, etc.). However, the amount and frequency of the delivered air should be two enough to adequately remove the blockage while still recovering the full target pressure between each under-clean cycle. Referring to Fig. 52, in an exemplary embodiment, a reduced pressure delivery system 2411 includes a manifold 2415 that 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 that is positioned in fluid communication with the manifold 2415 and adjacent the outlet of the first conduit 2419. The second conduit 2423 is fluidly coupled to a valve 2439 which, when the valve 2439 is placed in the open position, is capable of achieving communication between the second guide 2423 and ambient air. Valve 2439 is operatively coupled to a controller 2453 that is capable of controlling the opening and closing of valve 2439 to regulate cleaning of the second conduit using ambient air to prevent memory in manifold 2415 and first conduit 2419 In the obstruction. It should be noted that any fluid (including liquids or gases) can be used to achieve the techniques described herein. Although the force for cleaning the fluid is preferably a suction that is formed at the tissue site by the reduced pressure, similar to that described with reference to Figure 9, fluid 154474. Doc •49· 201130531 The transport member can also deliver fluid in a similar manner. According to the system and method described herein, the tissue site is subjected to decompression and tissue treatment, which is achieved by the following method. A sufficiently low pressure is applied to the tissue site and then the pressure is sufficiently low for a selected period of time. Alternatively, the reduced pressure applied to the tissue site can be cyclic. More specifically, the magnitude of the applied reduced pressure may vary depending on the selected time cycle. Yet another method of applying the reduced pressure can randomly vary the magnitude of the reduced pressure. Similarly, the rate or amount of fluid delivered to the tissue site can be constant, periodic, or random. If it is periodic, the fluid delivery can be carried out during the application of the reduced pressure or during the cycle in which the reduced pressure is not applied. Although the magnitude of the reduced pressure applied to the tissue site will generally vary depending on the pathology of the tissue site and the environment in which the decompressive tissue treatment is performed, the reduced pressure is typically between about -5 mm Hg and -500 mm Hg. However, the better is between about _5 mm Hg and -300 mmHg. Although the systems and methods of the present invention are described above with reference to tissue growth and patient healing, it should be understood that such systems and methods for applying reduced pressure tissue treatment can be used in any living body in which tissue growth or healing is desired to be promoted. . Similarly, the systems and methods of the present invention are applicable to any tissue including, but not limited to, bone path tissue, adipose tissue, muscle tissue, nerve tissue, skin tissue, vascular tissue, connective tissue, cartilage tissue, tendon or ligament. Although tissue healing may be a focus of application of reduced-pressure tissue therapy as described herein, decompression tissue therapy (especially for tissues located beneath the patient's skin) may also be used in the absence of disease, defect or injury. Organization J54474. Doc •50- 201130531 Forming tissue growth. For example, it may be desirable to use a skin 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 stent material to increase the growth and growth rate of new tissue, which is also important. The stent material can be placed between the tissue site and the reduced pressure delivery device, or the reduced pressure delivery device itself can be made from a bioresorbable material that is used as a new tissue growth stent. It should be apparent from the above description that this document provides an invention with significant advantages. While the present invention has been shown in its several forms, the present invention is not limited thereto, but various modifications and changes can be made without departing from the spirit of the invention. [Simple description of the schema] This patent or application file contains at least one graphic with color. The patent or patent application publication with color drawings may be provided by the Patent Office upon request and after payment of the necessary fee. Figure 1 is a perspective view of a delivery device in accordance with the present invention. The reduced pressure delivery device has a plurality of protrusions extending from a flexible barrier to form a plurality of flow channels; Figure 2 illustrates a diagram 3 is a top view of the reduced pressure conveying device shown in FIG. 1; FIG. 4A illustrates a side view of the reduced pressure conveying device shown in Fig. 1, the reduced pressure 154474. Doc 51 201130531 The delivery device has a single lumen decompression delivery tube; Figure B's a side view of an alternative embodiment of the non-decompression delivery device of Figure 1; the reduced pressure delivery device has a dual lumen decompression delivery tube; Graphical illustration! An enlarged perspective view of one of the non-dusting conveyors; Figure 6 depicts a perspective view of a reduced pressure conveyor according to the present invention - the subtractive (four) delivery device has a honeycomb-attached to the flexible barrier The material 'the flexible barrier has a ridge portion and a pair of wing portions, the honeycomb material having a plurality of flow passages; FIG. 7 illustrates a front view of the reduced pressure delivery device of FIG. 6; Figure 7 is a cross-sectional side view of the reduced pressure conveying device taken at χνπ_χνιι; ° Fig. 8A illustrates a cross-sectional front view of a reduced pressure conveying split according to the present invention - an embodiment; Figure 8A is a side elevational view of the reduced pressure delivery device; Figure 9 illustrates a front view of a reduced pressure delivery device in accordance with the present invention - for applying decompressive tissue treatment to a patient's bone network Figure 10 depicts a colored tissue section of a rabbit skull showing the original, undamaged bone; Figure η illustrates a colored tissue section of a rabbit skull showing granulation tissue induced after application of reduced-pressure tissue treatment; ~ Figure 12 shows a rabbit Color tissue section of the sub-skull showing deposition of new bone after application of reduced-pressure 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; & 154474. Doc -52· 201130531 'There are two figures in the skull that are formed in the color photograph of the rabbit skull. The figure shows the color of the rabbit skull shown in circle 14. The display shows the size of the 4 a sour mother stent in the defect and a stainless steel mesh covering the second critical dimension defect; Figure 16 illustrates a color photograph of the rabbit skull shown in Figure 14 showing the application of reduced pressure tissue treatment to a critical size defect; Figure 7 illustrates After the application of decompression tissue treatment - the color of the rabbit skull, And the woven section, 9 hai tissue section shows the deposition of new bone in the strontium sulphate scaffold, Figure 18 depicts the ray of the critical dimension defect filled by the stent shown in Figure 15 after six days of decompression tissue treatment and two weeks of surgery. Figure 19 is a photographic photograph of a critical dimension defect filled with a stent as shown in Figure 15 after six days of decompression tissue treatment and twelve weeks of surgery; Figure 20 illustrates a decompression according to an embodiment of the present invention. a front view of the delivery system, the reduced pressure delivery system having a manifold delivery tube for inserting a reduced pressure delivery device through the skin into a tissue site; FIG. 21 illustrates a magnified elevation of the manifold delivery tube of FIG. The manifold delivery tube includes a reduced pressure delivery device having a flexible barrier and/or a honeycomb material in a compressed position; FIG. 22 is a manifold delivery tube shown in FIG. Enlarged front view showing the flexible barrier and/or honeycomb material of the reduced pressure delivery device in an expanded position after being pushed in from the manifold delivery tube; FIG. 23 illustrates an embodiment in accordance with the present invention Example The reduced pressure delivery system 154 474. Doc •53· 201130531 Front view, the decompression conveying system is a floating float. You have a manifold wheel for the skin to be decompressed/: inserted into the tissue part. The pressure reducing conveying device is located outside the manifold conveying pipe, but is restrained by a non-permeable membrane at a compression position; the film drawing 24 is shown in the front view of the conveying system shown in Fig. 23, and the drawing is dried: The delivery device is outside the manifold tube but is constrained to a relaxed position by an impermeable membrane; Figure 25 illustrates a front view of the reduced pressure delivery system of Figure 23, showing that the reduced pressure delivery device is in the disambiguation The outer side of the tube is constrained to an expanded position by a non-permeable membrane, ^ Figure 25A illustrates a front view of the reduced transport system of Figure 23, showing the reduced pressure delivery device in the The outer side of the tube, but in the expanded position, is surrounded by an impermeable membrane; FIG. 26 illustrates a front view of a reduced pressure delivery system according to an embodiment of the invention. Skin will be delivered under reduced pressure Inserting a human-to-tissue portion of the delivery tube, the pressure reducing delivery device is shown outside the manifold delivery tube, but is bound by a non-permeable membrane with a glue seal; FIG. 26A illustrates a 4 is a front elevational view of a reduced pressure delivery system in accordance with an embodiment of the present invention, the reduced pressure delivery system having a manifold delivery tube for use over the skin The reduced pressure delivery device is injected into a tissue site; Figure 27A illustrates a reduced pressure delivery system 154474 in accordance with an embodiment of the present invention. Doc -54- 201130531 Orthodox view 'The reduced pressure delivery system has a manifold delivery tube for delivering the percutaneously reduced-pressure delivery device to the impermeable membrane at the tissue site; FIG. 28 depicts a 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. 29 is a flow chart showing a method of performing decompression tissue treatment on a tissue site in accordance with an embodiment of the present invention; A flow chart of a method for performing decompression tissue treatment on a tissue site according to the present invention - a diagram of a method according to the present invention - an implementation (four) - a method for performing decompression tissue treatment at a tissue site Figure 3 2 shows a front view of a decompression feeding device according to an embodiment of the present invention. The decompression conveying device comprises a hip prosthesis, the hip prosthesis; a plurality of flow passages for use Applying a reduced pressure to the bone (4) domain surrounding the body prosthesis; FIG. 33 illustrates a cross-sectional elevation view of the prosthetic body of FIG. 32 having a second plurality of flow channels for fluid application And is directed to a bone region surrounding the hip prosthesis; FIG. 34 is a flow chart showing a method of repairing a patient's joint using reduced pressure tissue treatment in accordance with an embodiment of the present invention; FIG. 35 illustrates a subtraction in accordance with an embodiment of the present invention. A cross-sectional elevation view of a pressure delivery device comprising a short surgical fixation device. The Hebridge-shaped surgical fixation device has a plurality of flow channels for applying a reduced pressure to the bone (four) domain of the bridge-shaped surgical device; 154474. Doc 55-201130531 Figure 36 is a cross-sectional elevation view of the orthopedic fixation device of Figure 35 having a second plurality of flow channels for delivering fluid to the orthopedic fixation Figure 3 7 illustrates a flow chart of a method for treating a bone defect of a bone road using a tissue reduction treatment in accordance with the present invention - an embodiment of the invention - Figure 38 illustrates a seed according to the present invention - EXAMPLES A flow chart of a method for performing reduced pressure tissue treatment with 5 to one (four) portions; and FIG. 39 illustrates a flow chart of a method for performing reduced pressure tissue treatment on a tissue site in accordance with an embodiment of the present invention. 40-48 illustrate various views of a reduced pressure delivery system having a primary manifold including a flexible wall surrounding a primary flow channel and located therein, in accordance with an embodiment of the present invention a plurality of holes in the flexible wall; FIG. 49-50 illustrates a perspective view and a top cross-sectional view of a reduced pressure delivery system having an integral connection to a reduced pressure delivery tube in accordance with an embodiment of the present invention. FIG. 51 is a perspective view of the main manifold shown in FIGS. 40-50 applied to a skeletal tissue site with an auxiliary manifold; and FIG. 52 illustrates an embodiment in accordance with the present invention. A schematic view of a reduced pressure delivery system fluidly coupled to a valve of a second conduit. [Main component symbol description] 211 decompression conveying device or wing manifold 213 flexible barrier 215 ridge portion 154474. Doc . 56· 201130531 219 wing section 223 arched channel 227 flexible backing 231 protrusion 233 flow channel 241 decompression delivery tube 243 distal orifice 255 proximal orifice 259 lumen or passage 261 double lumen tube 263 first Catheter 265 Second lumen 271 Horizontal spacer 311 Vacuum delivery device or wing manifold 313 Flex barrier 315 Ridge portion 319 Wing portion 323 Arched channel 327 Honeycomb material 329 Distribution surface 330 Peripheral surface 341 Decompression Delivery tube 343 distal orifice 355 proximal orifice 154474. Doc -57- 201130531 359 lumen or passage 371 decompression delivery device 373 decompression delivery 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 body Bone 419 decompression delivery tube 421 proximal end 427 decompression source 429 void defect 431 fluid delivery tube 432 proximal end 433 fluid delivery source 434 filter 435 pressure sensor 711 decompression delivery system 713 tissue site 154474. Doc -58- 201130531 721 Manifold tube 725 Guide unit 727 Guide wire 731 Fracture site 733 Patient bone 735 Skin 739 Soft tissue 743 Tapered distal end 751 Path 761 Pressure reducing device 765 Flexure barrier 767 Honeycomb material 769 Subtraction Pressure delivery tube 811 decompression delivery system 821 manifold delivery tube 837 dashed line 843 distal end 861 decompression delivery device 865 flexible barrier 867 honeycomb material 869 decompression delivery tube 871 impervious membrane 873 inner surface 881 logo, I54474. Doc - 59 - 201130531 885 Removal device 891 Auxiliary lumen or tube 911 Reduced pressure delivery system 921 Manifold delivery tube 937 Dotted line 943 Remote end 961 Reduced pressure delivery device 965 Flexible barrier 967 Honeycomb material 969 Decompression delivery tube 971 Impervious Film 973 Inner surface 977 Sealing 981 Marking 985 Pressure reducing conveying system 987 Guide wire 989 Pressure reducing pipe 991 Pressure reducing conveying device 993 Tissue part 1011 Pressure reducing conveying system 1021 Manifold conveying pipe 1025 Tissue part 1029 Void 1035 Reduced pressure delivery device 154474. Doc •60- 201130531 1043 distal end 1055 internal space 1057 auxiliary lumen 1061 guiding wire 1511 decompression delivery device 1515 orthopedic hip prosthesis 1517 patient leg section 1521 column section 1525 head section 1529 pathway 1535 porous coating 1541 flow channel 1543 Main feed line 1545 Transverse branch line 1547 Transverse branch line 155 1 Reduced pressure line 1553 Reduced pressure supply 1565 Connection 埠 1571 Fluid transfer line 1573 Fluid supply source 1583 Main feed line 1585 Transverse branch line 1711 Reduced pressure delivery device 1715 Plastic surgery Fixing device 154474. Doc •61 · 201130531 1717 Bone 1719 Fracture 1721 Path 1725 Screw 1735 Porous Coating 1741 Flow Channel 1743 Main Feed Line 1745 Connection 埠 1747 Lateral Branch Line 1751 Vacuum Delivery Line 1753 Reduced Pressure Delivery Source 1761 Flow Channel 1765 Connection 埠 1771 Fluid Duct 1773 fluid delivery source 1783 main feed line 1785 lateral branch line 2111 decompression delivery system 2115 main manifold 2117 flexible wall 2121 main flow path 2123 proximal end 2129 transition zone 2135 anti-blocking component 154474. Doc -62- 201130531 2137 Protrusion 2141 Inner surface 2145 Ridge 2149 Honeycomb material 2155 Sub L 2161 First conduit 2163 Second conduit 2171 Headspace 2211 Reduced pressure delivery system 2215 Main manifold 2217 Pressure relief tube 2223 Central lumen 2225 Auxiliary lumen 2231 Sub L 2241 Headspace 2321 Auxiliary manifold 2411 Decompression delivery system 2415 Manifold 2419 First conduit 2423 Second conduit 2429 Decompression source 2435 Outlet 2439 Valve 2453 Controller 154474. Doc •63-

Claims (1)

201130531 VII. Scope of application: 1. A vacuum delivery system for the application of the tissue-decompression tissue, comprising: a pathway and a distal manifold tube, the distal end being configured to pass The skin is inserted and placed adjacent to the tissue site; an injectable or pourable material can be delivered to the tissue by the manifold to enable the injectable or pourable material to fill the p-position adjacent the tissue-胄p Song to form a manifold having a plurality of flow channels in fluid communication with the tissue site; and a reduced pressure delivery tube capable of being in flow communication with the flow channels of the manifold. The system of month length item 1, wherein the manifold pipe is the same pipe as the pressure reducing pipe. The system of the Moonman 1 wherein the manifold is bioresorbable. A system such as β, wherein the manifold is used as a tissue growth scaffold. 5. A system according to π, 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 the present invention, wherein the manifold further comprises a bioresorbable polymer β 7 dissolved in a bath and mixed with sodium bicarbonate and citric acid. A system wherein the bioresorbable polymer is a polyglycol-co-glycolide (PLAGA) polymer and a polyethylene glycol-PLAGA copolymer. 8. The system of claim 6, wherein the solvent is digas methane. 154474.doc 201130531 9. The system of claim i, wherein the injectable is from ττ Λ ^. The fly T dumping material is selected from the group consisting of: 液体下成成:liquid, serum, sound spider, > heart Liquid 'sticky gel, poor shade, putty, and particulate solids. i. The system of claim i, wherein: = the injectable or pourable material undergoes a phase change in the presence of at least one of body fluid and body temperature; and = the injection or pourable material comprises - in the injectable Or can pour the material to dissolve after the solidification of the por as a number of flow channels. The system of claim 1, wherein the injectable or pourable material comprises a microsphere having a coating that is capable of delivering the injectable or pourable material to the tissue site It is then selectively crosslinked. 12. The system of claim U, wherein the coating is selectively crosslinked in response to at least one of heat, light, and a chemical. 13. The system of claim " wherein the microspheres form the plurality of flow channels after crosslinking. 14. The system of claim 1 wherein: the injectable or pourable material is selected from the group consisting of a paste having an initial viscosity and a putty; the injectable or during delivery to the tissue site The viscosity of the pourable material drops below the initial viscosity in the presence of shear force; and after the injectable or pourable material is delivered to the tissue site, the viscosity of the injectable or pourable material returns to the Initial viscosity. 154474.doc