TWI355948B - System and method for percutaneously administering - Google Patents

Description

1355948 IX. 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] People are gradually using decompression therapy to promote wound healing of a soft tissue wound that heals very slowly or does 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 in contact with the wound, and is then brought into contact with the wound, and then periodically replaced with a foam to provide a smaller foam as the wound begins to heal and become smaller. In order to minimize the amount of tissue grown in the pores of the foam, it is necessary to frequently replace the open-cell foam. During the removal of the foam, the growth of the body is large: the tissue can cause pain to the patient. Decompression therapy is usually applied to non-complexity. Winning an open injury. In some cases, the tissue being treated is subcutaneous tissue, and in other situations, the tissue is located in or on the skin tissue. Traditional decompression therapy has been used primarily in soft tissue. Decompression therapy is usually not used to treat closed deep tissue wounds because it is difficult to access such wounds. Forced external decompression therapy has not been combined with the treatment of skeletal skeletal defects or the promotion of bone growth ^ ^ a. This is mainly due to the difficulty of accessing bones. By surgical harvesting, it is possible to deal with it - stop the sputum and fight & 1 violently out of the bones to apply decompression treatment. 叮月 b a becomes more problematic than the rhyme it solves. Finally, the benefits and system for the application of decompression therapy are shown in 4 hands without opening the open-cell foam 119639-990610.doc 2 by hand to make the shape of the open-cell foam suitable for the wound site and then in-minus It is removed after the treatment cycle. SUMMARY OF THE INVENTION The system and method of the present invention solves the problems of prior art σ treatment systems and methods. In accordance with an embodiment of the present invention, a reduced pressure treatment delivery system is provided for applying a reduced pressure to a tissue site. The decompression system ─ first includes a manifold duct having a passage and a distal end, the far

The end is 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 flow having a plurality of fluid communication with the tissue site The manifold of the channel. A decompression transfer tube is provided that is in fluid communication with the flow passage of the manifold.

Another embodiment of the present invention provides a method of performing a reduction therapy on a tissue site comprising: locating a distant adjacent tissue site through a skin-manifold delivery tube. The transport tube is routed through the skin via the skin to the tissue site - a flowable material. 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 EMBODIMENT(S) In the following, the preferred embodiment is described in detail with reference to the accompanying drawings in which: 119639-990610.doc 1355948 constitutes a part of the present invention and the accompanying drawings show the specific preferred embodiments of the present invention. Example. The embodiments are described in sufficient detail to enable those skilled in the art to practice the invention, and it should be understood that other embodiments may be utilized and may be modified in the logical, mechanical, electrical, and chemical aspects. The spirit or scope of the invention is not departed. In order to avoid obscuring the details required to enable the skilled artisan to practice the invention, the description may omit certain information that is familiar to those skilled in the art. The <RTI ID=0.0>>>"""""" The term "elastic" as used herein means having the properties of an elastomer. Art "elastomer" large system refers to a polymer material having rubber-like properties; 1 more specifically, most elastomers have an elongation of more than 1% and a degree of resilience. The resilience of the material means that the material can recover from elastic deformation. Examples of the elastomer may include, but are not limited to, natural rubber, poly pentylene dilute, styrene butadiene rubber 'gas butadiene rubber, polybutadiene, nitrile rubber 'isobutylene rubber, ethylene (iv), ethylene propylene Diluted single ^ gum 'chlorine continuous polyethylene, polysulfide rubber, polyurethane, oxygen. As used herein, the term "transformability" refers to the ability of an object or material to bend or flex. The elastic material is generally flexible, but the flexible materials referred to herein do not necessarily define the selected material only as an elastomer. The term "flexibility" is used in conjunction with the (four) or minus (four) delivery device of the present invention in combination with the large system (iv) material capable of adhering or closely matching the shape of the tissue site. For example [for the treatment of decompression transport of bone defect The flexible nature of the device may be (4) device (4) wrapped around 119639-990610.doc 1355948 wound or wrapped around the bone path portion with a defect. Generally referred to as gas or liquid, but also includes 'including but not limited to gel, colloid used in this article The term "fluid" may always include any other flowable material or foam. The term "permeability" as used herein generally refers to a film, covering or other material barrier or vinegar A 6 .

The specific value of the rate (WVTR). «/ The term "manifold" as used herein, refers to a substance or structure provided to help reduce pressure on a tissue site, deliver fluid to or remove fluid from the tissue site. . The manifold typically includes 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 can include, but are not limited to, devices having structural elements configured to form flow channels, honeycomb foams (eg, open cell foams), porous tissue collection devices, and containment or containment after solidification Liquid, gel and soak in the channel. ‘The pressure used in this article to reduce the pressure" 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. Alternatively, the reduced pressure can be less than the hydrostatic pressure of the tissue at the tissue site. 119639-990610.doc 1355948: The terms "vacuum" and "negative pressure" can be used to describe the pressure applied to the tissue site, however the actual pressure applied to the tissue site can be significantly lower than the usual and purely true The waste of association. The reduced I force can initially create fluid flow in the area of the tube and tissue p-position. 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 indicated, the pressure values described herein are by reference. The term "stent" as used herein refers to a substance or structure used to enhance or promote cell growth and/or tissue formation. The porous structure provides a template for cell growth. The scaffold can be infused with, coated with, or composed of a nutrient for growth of cells or other nutrients for promoting cell growth, and can be used as a support according to embodiments described herein. Tube, in the treatment of decompression tissue treatment of tissue sites. The term "tissue site" used in this document refers to an injury or defect located on or in any tissue, including but not limited to bone tissue 'fatty tissue, muscle And weaving nerve tissue, skin tissue, vascular tissue, connective tissue, cartilage, tendon, or ligament. The term "tissue site" may further refer to any tissue region, such as "Hai and other regions may not be injured or defective" but want Enhance or promote the growth of additional tissues in these areas. For example, in some tissue areas, use reduced pressure tissue treatment (4) to grow additional groups, weave, The additional tissue can then be harvested and transplanted 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 - having the flexibility of a ridge portion 215 A barrier 213 and a pair of wing portions 219. Each wing portion 219 is positioned laterally along the pair of ridge portions 215 119639-990610.doc 1355948. The ridge portion 2 15 forms an arched passage 223, an arched passage 223 The entire length of the wing manifold 211 may or may not extend. Although the ridge portions 215 may be centrally positioned on the wing manifold 211 such that the widths of the wing portions 219 are equal, the ridge portions 215 are also It can be biased as shown in the figures such that one of the wing portions 219 is wider than the other wing portion 219. If the winged manifold 211 is used in conjunction with bone regeneration or healing and the wider winged 211 will The extra width of one of the wing portions 219 may be particularly useful for wrapping around the fixed hardware attached to the bone. The flexible barrier 213 is preferably made of an elastic material such as a polyoxyl polymer. One of Shixi Oxygen Polymers Located includes a

Calif (10) ia Manufactured by NUsil Technologies, Inc. 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 barrier 213. The flexible barrier 2 encapsulating the flexible backing (2) may have a thickness in the arcuate channel 223 that is less than the thickness in the wing portion 219. If a polysulfide polymer is used to form the flexible barrier 213, a polysulfide adhesive can also be used to help bond the reversible backing (2). An example of a polysulfide adhesive may include a _10 UH raw backing 227, also sold by Nusil Techn () lc) gies, preferably made of a woven knit fabric, such as by CR (4), located in Tempe, Arizona. The manufactured B (four) (4) is formed. However, the flexible backing 227 can be made of any biocompatible, flexible material that enhances the strength and durability of the flexible barrier 213. In some cases, if the flex wall 213 is made of a material of a suitable shirt, the backing 227 is used. ^ 119639-990610.doc 1355948 Preferably, the flexible barrier 21 3 or the flexible backing 227 is impermeable to liquids, air and other gases, or alternatively, the flexible backing 227 and the flexible barrier 2] 3 It does not penetrate 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, polycarbonate, polyfumarate, and capralact〇ne. The flexible barrier 213 and the flexible backing 227 can be further used as a new cell growth support, or a stent material can be used in combination with the flexible barrier 213 and the flexible backing 227 to promote cell growth. Suitable scaffolding materials may include, but are not limited to, bowl acid, collagen, PLA/PGA, Shenton-based paddy, carbonate, or treated (4) implants (4). Preferably, the (four) material will have a high void fraction (i.e., a high air content). In one embodiment, the flexible backing 227 can be secured to the surface of the flexible barrier 213 in an adhesive manner. If a poly-molecular polymer is used to form the barrier barrier 213, the shot can be applied to the flexible barrier 213 using a material oxygen bonding_flexible backing 227@. Although the adhesive is a preferred method of attachment when bonding the surface of the flexible backing 227 to the flexible backing 213, any suitable method of attachment can be used. The flexible barrier 2U includes a plurality of protrusions 231 extending from the portion W on the surface of the flexible barrier 213. The protrusions 231 may be cylindrical, swivel, hemispherical, cubic, or any other shape, as long as each of the emergents is called at least some of the plane is different from the flexible back (1) on H9639-990610 .doc -12- 1355948 • It is sufficient to fix the plane associated with the side of the protrusion 23 1 . In this case, it is not necessary to require a specific protrusion 231 to have the same shape or size as the other protrusions 23; in fact, the protrusions 231 may comprise random shapes of different shapes and sizes. Therefore, the distance from each of the protrusions 231 from the flexible barrier 213 may vary, but may also be uniform 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 23 have the shape and size and are uniformly spaced on the flexible barrier 213, the flow passages 233 formed between the projections 231 are equally uniform. The size and shape of the flow path 233 can also be varied by utilizing changes in the size, shape and spacing of the protrusions 231. As shown in Fig. 5, a reduced pressure delivery tube 241 is located in the arcuate passage 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 fixed 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 241 can be positioned such that the distal aperture 243 is located at any point along the arcuate channel 223, but the tube 24 is preferably positioned such that the distal aperture 243 is located at approximately the midpoint along the longitudinal length of the arcuate channel 223. The distal aperture 243 is preferably formed in an elliptical or oval shape by cutting the tube 241 along a plane oriented 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 elliptical shape of the aperture 243 enhances fluid communication with the flow passage 233 formed between the projections 231. 119639-990610.doc 13 1355948 The reduced pressure delivery tube 241 is preferably made of a polyioxa or amino acid ester coated with paraiyne. However, any medical grade tubing material can also be used to construct the reduced pressure delivery tube 241. Other coatings that can coat the tube include heparin anticoagulants, antifibrinogen, anti-adhesion agents, anti-coagulogens, and Hydrophilic coating. In one embodiment, as an alternative to or in addition to the distal aperture 243, the reduced pressure delivery tube 241 can also include a discharge opening or discharge orifice 251 positioned along the reduced pressure delivery tube 24j. 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 extents of the arcuate passage 223 as shown in Figures 1-5, or alternatively, can be positioned along the entire longitudinal extent of the arcuate passage 223. If positioned such that the reduced pressure delivery tube 241 occupies the entire length of the arcuate passage 223, the distal aperture 243 can be capped such that all fluid communication between the tube 24 and the flow passage 233 is via the discharge opening 25 Hey. 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, 4A and 5 contains only a single lumen or passage 259. However, the reduced pressure delivery tube 241 can be provided with a plurality of lumens, such as the dual lumen tube 261 shown in Figure 4B. The double lumen tube 26A includes a first lumen 263 and a second lumen 265. The use of a dual lumen tube provides a separate fluid communication path between the proximal end of the reduced pressure delivery tube 241 and the flow channel 233. For example, a dual lumen tube 261 can be used to achieve communication between the reduced pressure source and the flow channel 233 along the first lumen 263. The second lumen 265 can be used to introduce fluid into the flow channel 119639-990610.doc 1355948 233. The fluid can be filtered air or other gas, antibacterial, antiviral, cell growth promoter, irrigation fluid, chemically active fluid or any other fluid. If it is desired to introduce a plurality of fluids into the flow channel 233 via separate fluid communication paths, the reduced pressure delivery tube can have more than two lumens.

Still referring to Fig. 4B', a horizontal spacer 27 separates the first and first official chambers 263, 265 of the reduced pressure delivery tube 26 so that the first lumen 263 is positioned above the first official chamber 265. The relative positions of the first lumen and the second lumens 263, 265 may vary, depending on how the lumens 263, 265 and flow channels 233

Depending on the fluid connection between them. For example, when the first lumen 263 is not positioned as in Figure 4B, a discharge opening similar to the discharge opening 25 1 can be provided to achieve communication with the flow passage 233. When the second lumen is positioned as shown in the figure, the second lumen 265 can be in communication with the flow channel 233 via a distal orifice similar to the distal orifice M3. Alternatively, the plurality of lumens in the reduced pressure delivery tube can be positioned side by side by a vertical spacer separating the e lumens or the lumens can be positioned concentrically or coaxially. It will be readily apparent to one of ordinary skill in the art that independent fluid communication paths can be provided in a number of different ways, including providing a s-cavity as described above. Alternatively, the independent fluid communication path can be provided by attaching the single lumen tube to another single lumen tube or by means of a plurality of separate, unsecured tubes with single or multiple lumens. A separate tube is used to provide a separate fluid communication path with the flow channel 233. The ridge portion 215 can include a plurality of chevron channels 223, each of which is a dome-shaped channel. Alternatively - the selected chevable channel 223 can accommodate multiple tubes with H9639-990610.doc -15. 1355948. An example of a reduced pressure delivery tube pressure reducing delivery device having a separation from a fluid delivery tube will be described in greater detail below with reference to FIG. Referring to Figures 6-8, a reduced pressure delivery device or wing manifold 3 11 in accordance with the principles of the present invention includes a flexible barrier 3 13 having a raised portion 3 15 and a pair of wing portions 319. Each wing portion 319 is positioned along the opposite side of the ridge portion 315. The ridge portion 3 15 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 3 U such that the width of each wing portion 319 is equal, the ridge portion 315 can also be offset as shown in Figure 68, thereby causing one of the wings The portion 319 is wider than the other wing portion 319. If the wing manifold 311 is used in conjunction with bone regeneration or healing and the wider wing manifold 311 will wrap around the fixed hardware attached to the bone, the extra width of one of the wing portions 3 1 9 may Particularly useful. A honeycomb material 327 is secured to the flexible barrier 313, and the ridge material (1) and the two wing portions 319 are provided to cover the monolithic material of the labyrinth barrier. The honeycomb material 3.27 includes a fixed surface (not visible in Fig. 6) disposed adjacent to the flexible barrier 3U, a distribution surface 329 opposite the fixed surface, and a plurality of peripheral surfaces 33A. In an embodiment, the flexible barrier 313 can be similar to the flexible barrier 213 and includes a flexible backing. Although the binder is a preferred method for securing the honeycomb material 327 to the flexible barrier 313, the flexible barrier 313 and the honeycomb material (2) may be fixed by any other suitable fixing method, or It is intended for the user to assemble at the material site. Flexible barrier (1) 119639-990610.doc •16·1355948 . and/or flexible backing acts as an impervious barrier to block the passage of fluids such as liquids, air or other gases. • In one embodiment, the flexible barrier and the flexible back may not be provided in a separate manner. The liner supports the honeycomb material 327. Rather, the honeycomb material 327 can have an integral barrier layer that is impermeable to one of the honeycomb materials 327. The P1 layer can be formed by a closed-cell material. , thereby replacing the flexible barrier 313. If a monolithic barrier layer is used with the honeycomb material 327, the barrier layer may comprise a ridge portion and a wing portion as described above with reference to the barrier barrier zero wall 313. 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 MED 6® 15 manufactured by Nusil Technologies, Inc. of California. However, it should be noted that the flexible barrier 3 13 can be made of any other biocompatible, flexible material. If the flexible barrier encloses or otherwise comprises a flexible backing, the flexible backing is preferably made of a polyester knit fabric, such as Bard 6〇13 manufactured by CR Bard, Inc., Tempe, Arizona. production. However, the flexible backing 227 can be made of any biocompatible, flexible material that enhances the strength and durability of the flexible barrier 313. In one embodiment, the honeycomb material 327 is an open cell, reticulated polyether urethane foam having a pore size between about 4 Å and 6 Å microns. An example of such a foam may be included by San Ant〇ni〇.

GranuF〇am, manufactured by Kinetic Concepts of Texas. Honeycomb material 327 can also be a gauze, felt pad, or any other biocompatible material that provides fluid communication in a plurality of dimensions in a plurality of channels. 119639-990610.doc -17· 1355948 Honeycomb material 327 is primarily an "open-hole" material comprising a plurality of pores fluidly connected to the adjacent pores. By the honeycomb material 3 2 7 "open hole" a plurality of flow channels are formed between the "open holes". The flow passages flb are sufficient to achieve fluid communication in the entire portion of the honeycomb material 327 having open pores. The cells and flow channels can have a uniform shape and size' or can include patterned or random shapes and dimensional changes. Variations in the size and shape of the apertures in the honeycomb material 327 can cause variations in the flow passages' and such characteristics can be used to alter the flow characteristics of the fluid flowing through the honeycomb material 327. The honeycomb material 327 can further include a portion containing, closed pores. The closed cell portion of the honeycomb material 327 includes a plurality of holes, most of which are not fluidly connected to the adjacent holes. An example of a closed hole portion is described above as a barrier layer that can replace the flexible barrier 3丨3. Similarly, a closed hole portion can be selectively provided in the honeycomb material 327 to prevent fluid from penetrating the peripheral surface 330 of the honeycomb material 327. The flexible barrier 3 13 and the honeycomb material 327 may also be made of a bioresorbable material that does not have to be removed from the patient after use of the reduced pressure delivery device 31. Suitable bioresorbable materials may include, but are not limited to, A polymeric blend of polylactic acid (PLA) and polyglycolic acid (pga). The polymeric blend may also include, but is not limited to, polycarbonate, polyfumarate, and capralactone ° J J. biodegradable wall 313 and honeycomb material 327 may be further used as a new cell growth scaffold' or a scaffold The material is used in conjunction with a flexible barrier 313, a flexible backing 327, and/or a honeycomb material 327 to promote cell growth. Suitable stent materials can include, but are not limited to, calcium phosphate, collagen, PLA/PGA, wallstone, carbonate, or treated allograft materials. Preferably, the stent material will have a high void fraction (i.e., a high air content), preferably 119639-990610.doc -18- 1355948. • A reduced pressure delivery tube 341 is positioned within the arched channel 323 and secured to the flexible barrier wall 313. The reduced pressure delivery tube 341 can also be secured to the honeycomb material 327. Alternatively, in the presence of only the honeycomb material 327, the reduced pressure delivery tube 341 can be secured only to the honeycomb material 327. The reduced pressure delivery tube 341 includes a distal opening 343 at the distal end of the tube 341 which is similar to the distal opening 243 of FIG. The reduced pressure delivery tube 341 can be positioned such that the distal aperture 343 is located at any point along the arcuate channel 323, but is preferably located at approximately the midpoint along the longitudinal length of the arcuate channel 323. Preferably, the distal aperture 343 is formed into an elliptical or oval shape by a planar cutting tube 34i 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 rounded, the elliptical shape of the aperture enhances fluid communication with the flow passage in the honeycomb material 327. In a conventional example, the reduced pressure delivery tube 34A may also include a discharge opening or discharge orifice (not shown) similar to the discharge opening 251 of FIG. As an alternative to or in addition to the distal % orifice 343, a discharge opening is also provided along the tube 341 to further enhance fluid communication between the reduced pressure delivery conduit 34 and the flow passage. As previously described, the reduced pressure delivery tube 341 can be positioned only partially along the longitudinal length of the chevable channel 323, or alternatively, can be positioned along the entire longitudinal length of the chess channel 323. If positioned so that the reduced pressure delivery tube occupies the entire arcuate passage 323, the distal orifice (4) can be shrouded so that all fluid communication between the g 34 1 and the flow passage is via the discharge opening. Preferably, the honeycomb material 327 covers and directly contacts the reduced pressure delivery tube 119639-990610.doc 1355948 341 the honeycomb material 3 27 can be connected to the reduced pressure delivery tube 341, or the honeycomb material 327 can be fixed only to the flexible barrier 313 on. If the reduced pressure delivery tube 341 is positioned such that it extends only to a point in the arcuate passage 323, the honeycomb material 327 can also be connected to the flexible barrier in the region of the arched passage 323 that does not include the reduced pressure delivery tube 341. The ridge portion 315 of 313. The reduced pressure delivery tube 341 further includes a proximal aperture 3 55 at the proximal end of the tube 341. The proximal orifice 355 is configured to cooperate with a source of reduced pressure, which will be described in greater detail below with respect to Figure 9. The reduced pressure delivery tube 341 shown in Figures 6-8 contains only a single lumen 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 Figure 4B. As described above, the use of a multi-lumen tube provides a separate fluid communication path between the proximal end of the reduced pressure delivery tube 341 and the flow channel. The separate fluid communication paths may also be provided by separate tubes having single or multiple lumens in communication with the flow channels. Referring to Figures 8A and 8B, a reduced pressure delivery device 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 383. A plurality of protrusions 385 are disposed on an inner surface 387 of the reduced pressure delivery tube 373 to form a plurality of flow channels 391 between the protrusions 385. The size, shape and spacing of the protrusions 385 can be similar to the protrusions described with reference to Figures 1-5. The reduced pressure delivery device 3 71 is particularly suitable for reducing connective tissue that can be received in the incision 381

Il9639-9906l0.doc •20- 1355948 . The pressure and re-generation of tissue on connective tissue. Ligaments, tendons, and cartilage are a non-limiting example of a tissue that can be treated by a reduced pressure delivery device 37!. Referring to Figure 9, a tissue site 413 (e.g., a human bone 415 of a patient) is treated with reduced pressure tissue using a reduced pressure delivery device 411 similar to other reduced pressure delivery devices described herein. When used to promote bone tissue growth, decompression tissue treatment can increase the rate of healing associated with fractures, incompatibility, voids, or other bone defects. It is further believed that decompression tissue treatment can be used to recover the good osteomyelitis. This treatment can be used to improve the local bone density of patients with osteomyelitis. Finally, decompression tissue therapy can be used to accelerate and improve orthopedic implants such as hip implants, knee implants, and fixation devices. Body oseointegration. Still referring to Fig. 9, the reduced pressure delivery device 411 includes a reduced pressure delivery tube 419 having a fluidly coupled proximal end of the reduced pressure source 427, a C source 427, a pump or any other capable A means for applying a reduced pressure to the tissue % portion 413 via a reduced pressure delivery tube 4 19 and a plurality of flow channels associated with the reduced pressure delivery device 4 [i]. Applying the reduced pressure to the tissue site 413 is accomplished by arranging the wing portion of the reduced pressure delivery device 41 adjacent the tissue site 4 1 3 , which in this particular example involves a void defect 429 around the bone 415 . Wrap the wing. The reduced pressure delivery device 411 can be inserted by surgery or through the skin. When inserted through the skin, the reduced pressure delivery s 419 preferably passes through a patient's skin, and the sterile insertion sheath of the skin tissue is inserted into the 0. Decompression treatment is typically performed in the area surrounding the tissue site 413 to produce granulation tissue. Granulation tissue is a common tissue formed before 119639-990610.doc 1355948, which is often repaired in the human body. Under normal conditions, granulation tissue may form during the presence of foreign bodies or during wound healing. Granulation tissue is commonly used as a scaffold for healthy replacement tissue and further to form certain scar tissue. The granulation tissue is a highly vascularized tissue, and the increased growth rate of such highly vascularized tissue promotes the growth of new tissue at the tissue site 413 in the presence of reduced pressure. Still referring to Fig. 9, a fluid delivery tube 431 can be fluidly coupled to the flow channel of the reduced pressure delivery device 411 at a distal end. Fluid delivery tube 431 includes a proximal end 432 that is fluidly coupled to a fluid carrier 433. If air is being delivered to the system of the tissue site, the air is preferably filtered and sterilized by a filter 434 capable of filtering microparticles as small as 0.22 μm. Especially when the tissue site 413 is positioned beneath the surface of the skin, it may be important to introduce air into the tissue site 41 3 which facilitates good drainage of the tissue site 13 to mitigate or prevent occlusion of the reduced pressure delivery tube 41 9 . Fluid delivery tube 43 1 and fluid delivery source 433 can also be used to introduce other fluids to the tissue site*, including but not limited to antimicrobial agents, antiviral sputum, cell growth promoter rinsing bodies, or other chemically active agents. When inserted through the skin, the reduced pressure delivery s 43 1 is preferably inserted through a sterile insertion sheath that penetrates the skin tissue of the patient. The pressure sense 435 can be operatively coupled to the fluid delivery tube 431 ' to indicate whether the fluid delivery tube is blocked by blood or other bodily fluids. Pressure sensing 435 can be operatively coupled to the fluid delivery source (3) to provide feedback to control the amount of fluid introduced into the tissue site. A check valve (not shown) may also be operatively coupled adjacent the distal end of the fluid delivery tube (3) 119639-990610.doc -22. 1355948 to prevent blood or other bodily fluids from entering the fluid delivery tube 43 1 .

The separate fluid communication paths provided by the reduced pressure delivery tube 419 and the fluid delivery tube 43 1 can be accomplished in a number of different ways, including providing a single multi-lumen tube as previously described with reference to Figure 4B. One of ordinary skill in the art will recognize that if a multi-lumen tube is used, the sensors, valves, and other components associated with fluid delivery tube 43 1 can similarly be associated with a reduced pressure delivery tube 4 1 9 A specific lumen is associated. Preferably, any lumen or tube in fluid communication with the tissue site is coated with an anticoagulant to prevent clogging of bodily fluids or blood within the lumen or tube. Other coatings that can coat such lumens or tubes include, but are not limited to, heparin, anticoagulants, anti-fibrinogen, anti-adherents, anti-prothrombin, and hydrophilic coatings.

Referring to Figure 1 0-19, trials have shown that when applied to decompressed tissue treatment of bone tissue, a positive effect is obtained. In a specific experiment, the skulls of several rabbits were treated with decompression 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 on the skull, the effect of decompressive tissue treatment on rabbits with critical size defects on the skull, and the placement of a scaffold material with decompressed tissue. The effect of treatment together on the treatment of critical size defects on the skull. The specific test protocol and number of rabbits are listed in Table 1 below. Rabbit number test protocol 4 No defects on the skull; decompression tissue treatment (RPTT) was applied to the top of the intact periosteum by a honeycomb foam (GranuFoam) for 6 days, followed immediately by harvesting the tissue 4 skull without defects; Place the honeycomb foam (GranuFoam) on top of the intact periosteum for 6 days under the condition of decompression tissue treatment (RPTT), and then immediately harvest the tissue 119639-990610.doc -23- 1355948 ^ I with one placed on top Record the wire, the ash; a critical size defect on the top of the f-acid #5 stent, apply a 24-hour RPTT to the two defects; harvest the tissue after 2 weeks of surgery __ 4 has a placed on top Record the critical damage of the wire mesh; one is placed on the top, and the critical size of the acid-supported stent is missing, and the two defects are applied for 24 hours RPTT. After 12 weeks of surgery, the harvested tissue _, , , 4 has one on top. Linyi placed on the steel wire without a wire mesh ^^ A top-level defect in the top of the #化酸#5 head is applied to the two defects for 6 days, and the tissue is harvested after 2 weeks of surgery_ Put on the top of the application - put a calcium acid on the top The critical size defect, the 6-day ruler is applied to the two defects{>1^丨The tissue is harvested after 12 weeks of surgery __ not recorded in the inch; the upper part of the If size defect is placed on the top; Control); 2 weeks of defects in the surgery; secrets are ridiculous) '· In the surgery η week, you ^ red from 〇 ^ 2··.——--_) 4 Table 1: Test protocol critical size defect tissue (The case is a defect in the column (such as the tibia), the size is sufficient

The big one will not be able to heal only by the recovery of Bai I Ji Tian himself. For rabbits, a full thickness hole of approximately 15 mm in diameter through the skull is drilled through the skull to form a Ba boundary defect in the skull. Referring more specifically to Figure 1 , jg_ ® *2 illustrates a smear of a rabbit skull with primitive, undamaged bones, and an iron slice. The skeleton of the skull is magenta, the surrounding soft tissue is white, and the periosteum is highlighted by a yellow asterisk. In Figure 11, the illustrated sentence is too & fresh condition treated with decompression tissue for 6 days and then

Immediately after harvesting the organization, the labor is long. The bones and periosteum can be seen and a layer of granulation tissue has formed. *圄1〇 + % In Fig. 12, the rabbit skull after administration of the decompression group 119639-990610.doc -24·1355948 for 6 days and immediately after harvesting the tissue was illustrated. The tissue section of Figure 12 is characterized by the formation of a new skeletal tissue beneath the granulation tissue. The skeletal structure is highlighted by a yellow asterisk. In Fig. 13, the figure illustrates the rabbit skull after the tissue was treated with palladium under reduced pressure for 6 days and immediately after harvesting the tissue. You can see new bones and periosteum. The tissue appearance of skeletal tissue formed by decompression tissue treatment is very similar to the tissue appearance of bone formation in very young animals undergoing extremely rapid new bone growth and deposition. Referring more specifically to Figures 14-19, several photographs and tissue cuts are illustrated which show procedures and results for decompressing tissue treatment of rabbit skulls having critical size defects. In Fig. 14, a rabbit skull having two critical size defects formed thereon is illustrated. These full thickness critical dimension defects have a diameter of approximately 15 mm. In Figure 15, a stainless steel wire mesh has been placed over one of the critical dimension defects and a calcium phosphate stent has been placed within the second critical dimension defect. In Figure 16, a 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 results in significant growth of new bone tissue, which is highlighted by a yellow asterisk in Figure 17. The amount of bone growth is significantly greater than the amount of bone growth in critical size defects that are treated with the same calcium phosphate scaffold but not treated with decompression tissue. This observation suggests that there may be a 119639-990610.doc •25· 1355948 one that is the therapeutic threshold or duration gate required to induce a new bone formation response. The effect of decompression tissue treatment was most pronounced in the samples collected 12 weeks after surgery, suggesting that decompression tissue treatment caused a cascade of biological events that reluctantly formed 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 scaffold materials and the positive effects of decompressive tissue treatment on stent fusion and bioavailability. Radiographs of critical dimension defects filled with stents after six days of decompression tissue treatment are illustrated in Figures 18 and 19. Figure 18 illustrates a defect two weeks after surgery and shows that a certain new bone has been deposited in the stent. The main structure of the bracket is still clearly visible. Figure 19 illustrates the defect after twelve weeks of surgery and shows that the critical dimension defect is almost completely healed and the main stent architecture is nearly completely lost due to tissue fusion (i.e., the formation of new bone within the stent matrix). Referring to Fig. 20, a reduced pressure delivery system 7丄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 a device that enables the manifold delivery tube 721 to be guided to the tissue portion 713, such as a guide unit 725 and a guide wire 727. The placement and guidance of the guide wire 727 and the manifold delivery tube 721 can be accomplished using endoscopy, ultrasound, fluoroscopy, auscultation, palpation, or any other suitable localization technique. A manifold delivery tube 72 is provided for insertion of a reduced pressure delivery device through the skin into the tissue site 71 3 of the patient. When the skin is inserted, the manifold delivery tube 721 preferably passes through a penetrating patient skin group 119639-990610.doc • 26·1355948. The woven sterile insertion sheath is inserted. • In Figure 20, the tissue site 713 contains bone tissue at the fracture site 731 adjacent the patient's bone 733. The manifold delivery tube 721 is inserted through the patient's skin • 735 and any soft tissue 739 surrounding the bone 733. As mentioned previously, the tissue site 713 can also comprise any type of tissue including, but not limited to, adipose tissue, muscle tissue, nerve tissue, skin tissue, vascular tissue, connective tissue, cartilage, tendon, or ligament. Referring to Figures 21 and 22, a reduced pressure delivery system 71i is further illustrated. The manifold delivery tube 72 1 can include a tapered distal end 743 for easy insertion through the patient's skin 735 and soft tissue 739. The tapered distal end 743 can be further configured to flex radially outwardly to an open position such that the inner diameter of the distal end 743 will be substantially the same or greater than the inner diameter of other portions of the tube 721. The opening position of the distal end 743 is schematically shown by dashed line 737 in FIG. The manifold transport camp 721 further includes a passage 751 in which a reduced pressure delivery device 761 or any other reduced pressure delivery device is included. The reduced pressure transmission 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 honeycomb material 767 is preferably rolled, 'rolled or otherwise compressed around the waste reduction conduit 769 to reduce the cross-sectional area of the reduced pressure delivery device 761 within the passage 751. - The reduced pressure delivery device 761 can be placed in the passage 751 and guided to the tissue site after the distal end 743 of the manifold delivery tube 721 is placed at the tissue site 713, alternatively selected as the patient can be inserted into the manifold delivery tube 721 In the body, the decompression transfer device 761 is pre-positioned in the passage 751. To push the subtractive delivery device 761 through the passage 75, a biocompatible moisturizing 119639-990610.doc -27-1355948 slip agent can be used to reduce the loss between the delivery device 761 and the manifold delivery tube 721. friction. After the distal end 743 has been positioned at the tissue site 7丨3 and the reduced pressure delivery device 761 is delivered to the distal end 743, the reduced pressure delivery device 761 is then pushed toward the distal end 743 such that the distal end 743 is oriented radially External expansion to the open position. The reduced pressure delivery device 761 is pushed out of the manifold delivery tube 721, preferably into a void or space adjacent the tissue site 713. This void or space is usually formed by incision of soft tissue, which can be accomplished by a route through the skin. In some cases, the tissue site 713 can be located at the wound site and there is a natural void due to the anatomy of the wound. In other cases, the void may be formed by balloon separation, sharp separation, blunt separation 'hydraulic separation, pneumatic separation, ultrasonic 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 not required, the burnt barrier 765 and/or the honeycomb material 767 can be subjected to a vacuum or reduced pressure provided via the reduced pressure delivery tube 769 to compress the flexible barrier 765 and/or the honeycomb material 767. The unfolding of the flexible barrier 765 and/or the honeycomb material 767 can be achieved by releasing the reduced pressure delivered by the pressurized pressure delivery tube 769 or by providing a positive pressure via the reduced pressure delivery officer 769 to assist in the completion. Unwind the winding process. 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. After the decompression delivery device 761 is placed, it is preferably taken out from the patient's body 119639-990610.d〇c -28· 1355948, and the delivery is 7 72 1 'but the decompression transport associated with the reduced pressure delivery device 76丨It remains in place so that a reduced pressure can be applied to the tissue site 713 through the skin. Referring to Figures 23-25, a reduced pressure delivery system 81^ according to 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. Curved to an open position ' & and the inner diameter of the distal end 843 will be substantially the same or greater than the open position of the inner position return 843 at the other portion of the tube 82丨 is schematically shown by dashed line 837 in FIG. 23-25 . Manifold delivery tube 821 further includes a passageway in which a reduced pressure delivery device 861 similar to other reduced pressure delivery devices described herein is included. The reduced pressure delivery device 861 includes a flexible barrier 865 and/or honeycomb material 867 that is preferably wound, folded, or otherwise compressed around the reduced pressure delivery tube 869 to reduce The cross-sectional area of the small reduced pressure delivery device 861 within the passage. An impervious film 871 having an inner surface 873 is disposed around the reduced pressure delivery device 861 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 capable of preventing fluid permeation such that the impermeable membrane 871 can assume a compressed position (see Figure 23) and a relaxed position (see Figure 24). And at least one of the expansion positions (see FIGS. 25 and 25): the impermeable membrane 87 is sealingly connected to the manifold delivery tube 821 to allow the internal space 873 of the impermeable membrane 87 to be transported to the manifold The passage of tube 821 is in fluid communication. Alternatively, the impermeable film 871 can be fixed to the reduced pressure H9639-990610.doc -29· 1355948 delivery tube 869 such that the internal space 873 of the impermeable membrane 871 is in fluid communication with the passage of the reduced pressure delivery tube 869. . The impermeable membrane 871 can in turn be secured to a separate control tube or control lumen in fluid communication with the interior space 873 (see, for example, Figure 25A). In one embodiment, an impermeable membrane 871 can be provided to further reduce the cross-sectional area of the reduced pressure delivery device 86 within the passage. To this end, a pressure lower than the ambient pressure of the impervious film 871 is applied to the inner space 873 of the impervious thin layer (4). Thereby, a considerable amount of boring work or other fluid in the internal space 873 is discharged to place the impermeable film 1 in the compressed position shown in Fig. In this compressed position, the impervious film 871 is attracted inwardly, thereby applying a pressure to the reduced pressure conveying means 861 to further reduce the sectional area of the reduced pressure conveying means 861. The reduced pressure delivery device 861 can be delivered to the tissue site after the distal end (4) of the manifold delivery tube (2) is disposed at the tissue site as previously described with reference to FIG. Endoscopy, ultrasound, fluoroscopy, auscultation, palpation, or any other suitable procedure can be used. The p-technique is used to achieve the placement and manipulation of the impervious film 87 and the reduced pressure delivery device. The impermeable film 871 may contain a radiopaque standard 4 881 ' which will improve the visibility of the impermeable film 871 under the camp screen inspection prior to its removal. After the reduced pressure delivery device 861 is pushed through the distal end 843, the reduced pressure applied to the (four) space 873 can be released to place the impermeable membrane 871 in a relaxed position "Moxibustion f£|〇zl, 1 U see Figure 24), thereby facilitating easier removal of the decompression transfer device from the impermeable membrane 871. A removable device 885 (e.g., a sleeve, a needle or other sharp device) may be provided to break the impermeability. Film J19639-990610.doc -30- 1355948 . 871 In a relatively sloppy manner, the removal device 885 is inserted through the reduced pressure delivery tube 869 and '(4) is advanced to contact the impermeable film (7). After breaking the impervious film '871 'The removal device 885 and the non-permeable membrane 871' can be withdrawn via the manifold delivery tube 821 to enable the flexible barrier 865 and/or the honeycomb material 867 of the reduced pressure delivery device 86 to be unwound, unfolded, or The compression is released 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 be automatically released after releasing the internal space (7) the reduced pressure of the towel and removing the impermeable film 871. Occurs. In some In this case, the positive pressure can be delivered via the reduced pressure wheel 869 to help unwind or uncompress the flexible barrier 865 and/or the honeycomb material 867. After the final placement of the reduced pressure delivery device 861, preferably from the patient The manifold delivery tube 821 is removed from the body, but the reduced pressure delivery tube 869 associated with the reduced pressure delivery device (6) remains in place so that a reduced pressure can be applied across the skin (4) g. The impermeable membrane 871 can also be used in The tissue adjacent to the tissue site is separated prior to placement of the reduced pressure delivery device 861 against the tissue site. After pushing the reduced pressure delivery device 861 and the intact impervious film 87i through the distal end 843 of the manifold transporter 821 Air or another fluid is injected or pumped into the inner space 873 of the impermeable film 871. It is preferred to use a liquid to swell the impermeable film 871 because the incompressibility of the liquid enables the impermeable film 871 to The more uniform and more swellable/impermeable film 871 can be expanded radially as shown in Figure 25, or expanded in orientation, depending on the method of manufacture and the manner in which it is secured on the manifold tube 82. When the impervious film 871 is expanded outward to the expanded position due to the pressure of air or fluid (see 119639-990610.doc • 31 · Figure 25), a gap is separated from the tissue portion. When the gap is sufficient When large, air or other fluid in the interior space 873 can be released to enable the impermeable membrane 871 to assume a relaxed position. Then, the impervious membrane 871 can be broken as explained above and decompressed adjacent to the tissue site. Conveying device 861. Referring to Figure 25A, if the impermeable membrane 871 is primarily used to separate tissue adjacent to the tissue site, the impermeable membrane 871 can be sealingly secured to the manifold delivery tube 821 such that the interior space 873 is The auxiliary lumen or tube 891 associated with or fixed to the manifold delivery tube 821 is in fluid communication. The auxiliary lumen 891 can be used to deliver liquid, air or other fluid to the interior space 873 to place the non-permeable membrane 871 in the expanded position. After the separation, the impermeable film 871 can be relaxed and broken as described above with reference to Fig. 24. Referring to Figure 26, a reduced pressure delivery system 91i according to an embodiment of the present invention includes a manifold delivery tube 921 having a tapered distal end 943 that is configured to flex outwardly along a controllable direction. The open position is such that the inner diameter of the distal end 943 will be substantially the same or greater than the inner diameter at other portions of the tube 92. The open position of the distal end 943 is schematically shown by dashed line 937 in Figure 26. The manifold delivery tube 921 further includes a passageway containing a reduced pressure delivery device similar to other reduced pressure delivery devices described herein. 961. The reduced pressure delivery device 961 includes a flexible barrier 965 and/or honeycomb material 967 that is preferably wound, folded or otherwise compressed around the reduced pressure delivery tube 969 to reduce The wearing area of the small pressure reducing conveying device 961 in the passage of the manifold conveying pipe 921. 119639-990610.doc • 32. The impervious film 971 having the surface 973 is disposed around the reduced pressure delivery device 96i such that the reduced pressure delivery device 96 is contained within the inner surface 973 of the impermeable film 971. The impermeable film 971 comprises a glue seal 977 on one end of the impermeable film 971 to provide an alternative to removing the reduced pressure delivery device 961 from the impermeable film 971. The impermeable membrane state is sealingly coupled to the manifold delivery tube 921 such that the interior space 973 of the impermeable membrane 971 is in fluid communication with the passage of the manifold delivery tube 921. Alternatively, the impermeable membrane 971 can be secured to a separate control tube (not shown) in fluid communication with the interior space 973. Similar to the impermeable film 871 of Fig. 23, the impermeable film "capable" prevents fluid from penetrating so that the impermeable film 971 can take at least one of a compressed position, a relaxed position, and an expanded position. The procedure for placing the impermeable film 97丨 in the compressed position and the expanded position is similar to the impervious film 87丨, and thus only the process of removing the reduced pressure delivery device %1 is explained. Sonic, fluoroscopy, auscultation, palpation, or any other suitable localization technique transfers the reduced pressure delivery device 961 to the tissue site within the impermeable membrane 971 and then properly positions it. 971 may include a radiopaque marker 98 i which will improve the visibility of the impermeable film 971 under the fluorescent screen inspection prior to its removal. The reduced pressure delivery device 961 is then passed through the manifold delivery tube 92. The distal end 943 pushes. The reduced pressure applied to the interior space 973 can be released to place the impermeable membrane 971 in the relaxed position. Then, the reduced pressure delivery device 961 is passed through the glue seal 97. 7 Pushing to introduce an impermeable film 971. 119639-990610.doc -33- 1355948 Referring to Figure 26A, a reduced pressure delivery system 985 in accordance with an embodiment of the present invention may not include a manifold delivery tube 921 similar to that shown in Figure 26. The manifold delivery system 985 can include a guide wire 987, a reduced pressure delivery tube 989, and a reduced pressure delivery device 991. The reduced pressure delivery device 991 includes a plurality of fluid connections to the reduction. The flow passage of the pressure delivery tube 989. Instead of using a separate manifold delivery tube to deliver the reduced pressure delivery device 991, the reduced pressure delivery device 991 and the reduced pressure delivery tube 989 are placed on the guide wire 987' through the skin. The guiding wire 987 is guided to a tissue portion 993. Preferably, the 'wire wire 987 and the reduced pressure delivery tube 798 are penetrated through the skin of the patient by a sterile sheath. The wire 987 guides the decompression delivery tube 989 and the decompression delivery device 991, and the decompression delivery device 991 can be placed at the tissue site 913 to achieve a decompression tissue treatment through the skin. Device 991 is delivered to tissue site 993 and Constrained in a manifold delivery tube, it is preferred to maintain the reduced pressure delivery device 991 in a compressed position during delivery. If an elastic foam is used as the reduced pressure delivery device 991, the foam can be coated with a living organism. The compatibility dissolves the binder and compresses the foam. 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, the compressed hydrogel can be made into a reduced pressure delivery device 991. The hydrogel absorbs moisture after being delivered to the tissue site 99; 3, thereby enabling decompression delivery. Device 991 is inflated. Still another reduced pressure delivery device 991 can be made from a thermally active material, such as polyethylene glycol, which expands upon exposure to the patient's body temperature. In yet another embodiment, the 减压119639-990610.doc-34· compressed reduced pressure delivery device 991 can be delivered to the tissue site 993 in a dissolvable film. Referring to Fig. 27, a reduced pressure delivery system ι〇ι ^ according to an embodiment of the present invention includes a manifold delivery tube 1〇21 having a distal end 〇43, and a distal end 1〇43 inserted through one of the heart tissue The tissue portion 1025 is accessed. The tissue site 1 〇 25 can be 3 voids 1029 associated with the altar or other defect, or alternatively can be formed by separation (including the separation techniques described herein) to form a void. After the k 1043 adjacent tissue site 25 is placed in the gap 1, an injectable pourable or flowable decompression device 1035 is delivered to the tissue site 1 through the manifold tube 1〇21. At the office. The reduced pressure delivery device 1035 is preferably present in a flowable state during delivery to the tissue site, and then, upon arrival, a plurality of flow channels are formed to distribute the reduced pressure or fluid. In some cases, the flowable material can be hardened to a solid state by a drying process, a curing process, or other chemical or physical reaction after reaching the tissue site. In other cases, the flowable material can form a foam in situ after delivery to the tissue site. Still other materials may exist in the gel state at the tissue site 1 〇 25, but still have a plurality of flow channels for delivering reduced pressure. The amount of reduced pressure delivery device 1 035 delivered to the tissue site 丨〇 25 may be sufficient to partially or completely fill the void 1029. The reduced pressure delivery device 1A can include both the manifold and the stent. As a discriminator, the reduced pressure conveying device 1 〇 35 includes a plurality of holes or open holes which can be formed in the material after being conveyed to the gap 丨〇29. The holes or open holes communicate with each other, thereby forming a plurality of flow channels. These flow channels are used to apply and reduce the pressure on the tissue site 1〇25 119639-990610.doc •35-1355948. As a stent, the reduced pressure delivery device 1035 is bioresorbable and serves as a substrate on which new tissue can be grown. In one embodiment, the reduced pressure delivery device 1035 can comprise a poragen, such as NaCl or other salt, distributed throughout the liquid or viscous gel. After the liquid or viscous gel is delivered to the tissue site 1025, the material is applied to the void 1029 and subsequently cured into a solid. The water solubility is dissolved in the presence of body fluids, leaving a structure with interconnected pores or flow channels. The reduced flow and/or fluid is delivered to the flow channels. As the new organization is formed, the tissue will grow into the bore of the reduced pressure delivery device 1 并 35 and then eventually replace the pressure reducing delivery device 1035 with the degradation of the reduced pressure delivery device 1035. In this particular example, the reduced pressure delivery device 1〇35 is used not only as a manifold but also as a new tissue growth scaffold. In another embodiment, the reduced pressure delivery device 1035 is an alginate mixed with 400 μπ mannose granules. The p〇ragen or particles may be dissolved at the tissue site by local bodily fluids or by other fluids being flushed or delivered to the reduced pressure delivery device 1035. After 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 foaming 119639-990610.doc -36-1355948 body or solid in situ, the body fluid will cause an acid-base reaction between sodium bicarbonate and citric acid. The formed carbon dioxide gas particles form larger pores and flow channels throughout the reduced pressure delivery device 1〇35 as compared to the technique of relying on poragen dissolution.

The conversion of the reduced pressure delivery device from the liquid or viscous gel to the solid or foam can be by pH, temperature, light, or reaction with body fluids, chemicals or other substances delivered to the tissue site. trigger. This transformation can also be carried out by mixing multiple reaction-generating group injuries. 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 spheroid-gel mixture is exposed to light for a brief period of time to partially crosslink the hydrogel and immobilize the hydrogel on the microspheres. Excess solution is drained and the microspheres are subsequently dried. The microspheres are delivered to the tissue site by injection or pouring, and after delivery, the mixture absorbs moisture' and the hydrogel coating becomes a hydrated coating. The mixture is then exposed to light again, thereby crosslinking the microspheres, thereby forming a plurality of flow channels. The crosslinked microspheres are then used as a manifold for delivering reduced pressure to the tissue site and a porous scaffold for promoting new tissue growth. With the exception of the foregoing embodiments herein, the reduced pressure delivery device 1035 can be fabricated from a wide variety of materials including, but not limited to, acid, collagen, alginate, cellulose, or any other gas, liquid, Gel, paste, putty, serum, suspension or other flowable material is delivered to the group 119639-990610.doc -37-1355948 and can form an equivalent of a plurality of flow paths in fluid communication with the tissue site. The flowable material may further comprise solid particles, such as particles, which are capable of flowing through the manifold wheel 1021 if the particle size of the solid particles is sufficiently small. The material delivered to the tissue site in a flowable state can be polymerized in situ or form a gel. As described above, the reduced pressure delivery device 1035 can be directly injected or poured into the gap 1〇29 of the adjacent tissue site 1〇25. Referring to Fig. 27A, the manifold delivery tube 1021 can be located at the manifold delivery tube 1021. An impermeable or semipermeable membrane 1051 is included at the end 1〇43. 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 1〇61. The reduced pressure delivery device 1035 can be injected or poured through the auxiliary lumen 1〇57 to fill the internal space 1〇55 of the membrane 1051. When the fluid or gel fills the film 1051, the film 1〇51 expands to fill the voids 1〇29, thereby causing the film to contact the tissue site 1025. When the film 1〇51 is inflated, the film 1〇51 can be used to separate additional tissue adjacent to or 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 103 5 contacts the tissue site 1〇25. Alternatively, film 1〇51 can be made from a soluble material that will dissolve in the presence of body fluids or biocompatible solvents delivered to film 1051. If the film 1〇51 is semi-permeable, the film 1051 can remain in place. The semi-permeable membrane 1〇51 is capable of delivering reduced pressure and possibly other fluids to the tissue site 1 025. Referring to Fig. 28, a method for performing decompressive tissue treatment includes a method of inserting a manifold at an adjacent tissue site by surgery at I19639-9906I0.doc • 38-1355948 U15, which has a self-defense A plurality of protrusions projecting from the barrier to form a plurality of flow channels between the protrusions. The manifold is positioned at 丨丨丨9 such that at least a portion of the projections contact the tissue site. At 11 23 ', a reduced pressure is applied to the tissue site via the manifold. Referring to Figure 29, a method of applying reduced-pressure tissue treatment to a tissue site 12 11 includes inserting a manifold through the skin at 12 15 adjacent to the tissue site.

The ambiguity 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. At 丨 2 19 , the manifold is positioned such that at least a portion of the flow channels are in fluid communication with the tissue site. At 1223, a reduced pressure is applied to the tissue site via the manifold. Referring to Fig. 30, a method of performing decompressive tissue treatment on a tissue site 1311 includes inserting a tube having a passage through the skin through a skin at 1315 such that the distal end of the tube is placed adjacent to the tissue site. At 1319, an inflatable bladder associated with the tube can be inflated to separate tissue adjacent the tissue portion to form a void. At 1323, a manifold is conveyed through the passage. The manifold can include a plurality of protrusions ' extending from a flexible barrier to form a plurality of flow channels between the protrusions. Alternatively, the manifold may comprise a honeycomb material having 119639-990610.doc 39· 1355948 in the honeycomb material.

The fluid is in fluid communication with the tissue site. , / / Earth · Ί dump material formation. At least the part of the flow channel is made. The reduced pressure is applied to the tissue site by the manifold at 1331' via a reduced pressure delivery tube or any other delivery route. Referring to Fig. 31, a method 1411 for performing a decompressive tissue treatment on a tissue site, including a tissue through a skin through a patient, inserts a tube having a passage so that the distal end of the tube is adjacent to the tissue site. Place. At 1423, a manifold is conveyed through the passage to the tissue portion in an impervious jacket which has been subjected to a first reduced pressure at 1419 that is less than the sheath ambient pressure. At 1427, the sheath is broken to contact the manifold with the tissue site. At 丨43丨, a second reduced pressure is applied to the tissue portion via the manifold. Referring to Figures 32 and 33, a reduced pressure delivery device 151 according to an embodiment of the present invention includes a plastic surgical hip prosthesis 1515 for replacing an existing femoral head of a patient's leg section 5丨7. The hip prosthesis 1515 includes a post portion 1521 and a head portion 1525. The post portion 1521 is elongate for insertion into a passage 1529 that is twisted out of the backbone of the leg section 15 17 . A porous coating 1535 is disposed around the post portion and is preferably constructed of sintered or vitrified ceramic or metal. Alternatively, a honeycomb material having a porous property may be disposed around the column portion. A plurality of flow channels 1541 are disposed within the post portion 1521 of the hip prosthesis 1515 to fluidly communicate the flow channel 1541 with the porous coating 1535. A connection 埠1545 is fluidly coupled to the flow channel 1541, the raft is configured to be releasably connected to H9639-990610.doc • 40·1355948. Connected to a reduced pressure delivery tube 155A and a reduced delivery source 1553. Flow Channels • 1541 is used to deliver a reduced pressure to the porous coating 1535 and/or bone around the hip prosthesis 1515 after implantation of the ankle prosthesis 1515. The flow channel 丨 541 can include a main feed line 1543 in fluid communication with a plurality of lateral branch lines 1547, the plurality of lateral branch lines 1547 being in communication with the porous coating. The secret knife branch line 1545 can be The orientation is oriented perpendicular to the main feed line 1543 as shown in Figure 32, or may 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 A honeycomb-like (preferably open-cell) material capable of being in fluid communication with the porous coating 1535 fills the interior of the prosthesis. Referring more specifically to Figure 33, the hip prosthesis 1515 can further include a portion within the column portion 1521 A plurality of flow channels 1561 are provided to provide fluid to the porous coating 1535 and/or bone surrounding the hip prosthesis 1515. The fluid may include filtered air or other gases, antibacterial agents, antiviral agents, cell growth promoting^ "IL body, chemically active fluid or any other fluid. If it is desired to introduce a plurality of fluids into the bone surrounding the hip prosthesis 1515, an additional fluid communication path may be provided. 65 is fluidly coupled to a flow channel 1561 that is configured to be releasably coupled to a fluid delivery tube 1571 and a fluid delivery source 1573. The flow channel 1561 can include a primary feed in fluid communication with a plurality of lateral branch lines '1585 Line 1583, the plurality of lateral branch lines 1585 are in communication with the porous coating 1535. The lateral branch line 585 can be oriented perpendicular to the main feed line 1583 as shown in Figure 33 or can be at some angle to the main feed line 1583 Orientation. The delivery of reduced pressure to the first plurality of flow channels 1541 and the transport of fluid to the second plurality of flow channels 1561 119639-990610.doc 1355948 may be by separate tubes (eg, reduced pressure delivery tubes 1551 and fluid delivery tubes) 1571) to complete. Alternatively, a tube having a plurality of lumens as described herein above may be used to separate the communication path for the delivery of reduced pressure and fluid. Further attention should be paid to A separate fluid communication path is provided within the hip prosthesis 1515, however, the first plurality of flow channels 1541 can also be used to deliver both the reduced pressure and fluid to the surrounding hip prosthesis 1515 The bones. As described above, the application of reduced pressure to bone tissue promotes and accelerates the growth of new bone tissue. By using the hip prosthesis 1515 as a manifold, the reduced pressure is delivered to the bone area surrounding the hip prosthesis. Will make the leg section 1517 recover faster' and the hip prosthesis 15 15 will more successfully engage the bone. Providing the second plurality of flow channels 1561 to discharge the bone surrounding the hip prosthesis 15 15 will improve the surrounding prosthesis Successful regeneration of the new bone path. After applying the reduced pressure via the hip prosthesis 1515 for a selected amount of time, the decompression delivery tube 1551 and the fluid delivery tube 1571 can be disconnected from the connected bees 1545, 1565 and from the patient. Removal from the body - preferably without the use of surgical invasive procedures. The connection between the ports 1545, 1565 and the tubes 1551, 1571 can be performed - the release of the hand can be released by the application of an axial pull on the tubes 1551, 1571 outside the body of the patient. Alternatively, the ports 1545, 1565 can be bioresorbable or soluble in the presence of the selected fluid or chemical so that the ports 1545, (5) can be exposed to fluids or chemicals. In the middle of the tube, 1551, 1571 release. The tubes 1551 and 1571 may also be activated by a bioresorbable material that dissolves in a period of time or in the presence of a specific chemical or other substance. 119639-990610.doc • 42-1355948 production.

The reduced pressure delivery source 1 553 can be provided outside the patient and connected to the reduced pressure delivery tube 1551' to deliver the reduced pressure to the hip prosthesis 1515. Alternatively, the reduced pressure delivery source 1 5 5 3 can be implanted into the patient, on or near the body prosthesis 1 5 15 . Placing the reduced pressure delivery source 1553 into the patient does not require the use of a fluid connection through the skin. The implanted reduced pressure delivery source 15 53 can be operatively coupled to the conventional pump of flow channel 1 541. The pump can be powered by a battery implanted in the patient's body or by an external battery that is electrically connected to the pump via the skin. The pump can also be directly driven by a chemical reaction that delivers reduced pressure through the flow passages 1541, 1561 and circulates fluid through the flow passages 丨54丨,丨56丨. Although only the column portion 1521 and the head portion 1525 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 prostheses. Any component of the 1515 that contacts the bone or other tissue, including, for example, a white cup.

Referring to Figure 3 4', a method for repairing a patient's joint includes the implantation of a prosthesis within the bone at 1615. 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 36, a reduced pressure delivery device 1711, in accordance with an embodiment of the present invention, includes an orthopaedic fixation device 1715 for fastening a bone 1717 of a patient that includes a fracture site 19 or other defect. 119639-990610.doc -43- 1355948 No. Orthopedic fixation device 1715 is a plate having a plurality of passages ΐ72ι, which are used for the use of screws 1725 'pins, bolts or other tights The firmware anchors the orthopaedic fixation device 1715 to the bone 1717. A porous coating 1735 can be placed on the surface of the orthopedic fixation device 1715 contacting the bone 1717. The porous coating is preferably constructed of sintered or vitrified ceramic or metal. Alternatively, a honeycomb material having a porous property may be disposed between the bone 1717 and the orthopaedic fixation device 1715. The plurality of flow channels 1741 are disposed within the orthopaedic fixation device 1715 to make the flow channel 174i and porous The coating 1735 is in fluid communication... the port 1745 fluid is coupled to a flow channel 1741 that is configured to be coupled to a reduced pressure delivery port ΐ75i and a reduced pressure delivery source 1753. The flow channel 1741 is used to secure the orthopaedic fixation device 1715 After the bone network 1717, the reduced pressure is delivered to the porous coating (10) and/or the bone path surrounding the orthopedic fistula device 1715. The flow channel 44 can contain a A plurality of lateral branch lines 1747 are in fluid communication with a main feed line 1743 that is in communication with the porous coating line. The lateral branch line 1747 can be oriented perpendicular to the main feed line 1743 as shown in Figure 35, or It can be oriented at some angle with the main feed line. An alternative method for distributing the reduced pressure includes providing a hollow orthopedic fixation device and a honeycomb that can communicate with the porous coating body. A (preferably open-cell) material is used to fill the interior of the orthopaedic fixation device. A panel is shown in Figure 35, or a device such as a cannula, orthosis, or a stabilizing device. The orthopedic orthopedic fixation device 1715 can As another option, a fixed device, column, or any other device for making a bone can be further + for a fixed prosthesis or other orthopedics = or Fasteners for implanted tissue (e.g., bone path tissue or cartilage), where the fasteners contain flow passages for pressure to reduce or reduce the pressure around the (four) solids. Examples of firmware 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, The porous coating (10) and/or the bone network surrounding the orthopaedic fixation device 1-15 provides fluid. The fluid may include air or other gas, antibacterial agent, antiviral agent, cell growth promoter, irrigation fluid, chemical activity.剡 or any other fluid. If it is desired to introduce multiple fluids into the iliac bone surrounding the hip prosthesis 1715, an additional fluid communication path may be provided. 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 channel 1761 can include a main feed line 1783 in fluid communication with a plurality of lateral branch lines 1785, the plurality of lateral branch lines 1785 being in communication with the porous coating port. The branch line 1785 can be vertical as shown in FIG. Oriented at the main feed line 1783, or may be oriented at some angle to the main feed line 1783. The delivery of the reduced pressure to the first plurality of flow channels 74 and the flow of fluid to the second plurality of flow channels 1761 may be A separate tube (eg, reduced pressure delivery tube 1751 and fluid delivery tube 1771) is used. Alternatively, a tube having multiple lumens as previously described herein can be used to separate the reduced pressure and fluid for delivery. The communication path. It should be further noted that although a separate fluid communication path is preferably provided within the hip prosthesis 1715, it is also possible to use 119639-990610.doc • 45. 1355948 to use the plurality of flow channels 1 741 to reduce the pressure and fluid The two are delivered to the bone of the adjacent orthopedic fixation device 1 7 15 . The orthopedic fixation device 1715 is used as a manifold to the bone of the adjacent orthopedic fixation device 1715. The reduced pressure of the regional delivery will speed up and improve the recovery of the defect 1719 of the bone. Provide a second plurality of flow channels 176ι. Transfer the 々L body to the surrounding orthopaedic fixation device. The bones of the orthopaedic fixation device will improve the vicinity of the orthopedic fixation device. Successful regeneration of the new bone. See Figure 37. A method 1810 for healing a bone defect in a bone includes securing the bone using an orthopaedic fixation device at 1815. The orthopaedic fixation device is disposed in the orthopedic fixation device a plurality of flow channels therein. At 1819, a reduced pressure is applied to the bone defect via the plurality of flow channels. See Figure 38. A method for performing decompression tissue treatment on a tissue site. A manifold having a plurality of flow channels is clamped at 1 9 15 such that at least a portion of the flow channels are in fluid communication with the tissue site. At 1919, the tissue site is applied by the flow channels at 1919. Pressure, and at 1923, delivers a fluid to the tissue site via the flow channels. See Figure 39, The method for performing decompression tissue treatment on a tissue site includes: positioning the distal end of a manifold delivery tube adjacent to the tissue site at 2015. At 2, 19, via the manifold delivery tube The tissue site delivers a fluid that is capable of filling a void adjacent the tissue site and becoming a solid manifold having a plurality of flow channels in fluid communication with the tissue site. At 2023, the flow path through the solid manifold Group 119639-990610.doc -46- 1355948 Apply reduced pressure to the weaving site.

Referring to Figures 40-48, a reduced pressure delivery system 2111 includes a primary manifold M115 having a flexible wall 2117 surrounding the primary flow path 2121. The flexible wall 2117 is coupled to a reduced pressure delivery tube 2125 at a proximal end 2123. Since the shape of the reduced pressure delivery tube 2125 will generally be a circular cross section, and since the cross-sectional shape of the primary manifold 2115 can be different from the circular shape (i.e., rectangular in Figures 4A-45, and triangular in Figures 46-48) Thus, a transition zone 2129 is provided between the reduced pressure delivery tube 2125 and the primary manifold 2115. The main manifolds 2丨15 may be adhesively joined to the reduced pressure delivery tubes 2125, joined using other means such as fusion or insert molding, or alternatively may be integrally joined by coextrusion. The reduced pressure delivery tube 2125 delivers the reduced pressure to the primary visor 2115 for distribution at or near the tissue site. An anti-blocking member 2135 is positioned within the main manifold to prevent the main manifold 2115 from collapsing and thereby blocking the main flow path 2121 during application of the reduced pressure. In one embodiment, the anti-blocking member 2135 can be provided with a plurality of protrusions 2137 (see FIG. 44) disposed on an inner surface 2141 of the flexible wall 2117 and extending into the main flow path 2121. In another embodiment, the anti-blocking member 2135 can be provided with a single or multiple ridges 2145 on the inner surface 2141 (see Figures 40 and 41). In yet another embodiment, the anti-blocking member 2 13 5 can comprise a honeycomb material 2 丨 49 disposed within the main flow path, such as shown in Figure 47. The anti-blocking member 2135 can be any material or structure that can be embedded within the flow passage or that can be integrally or otherwise secured to the flexible wall 2117. The anti-blocking member 2135 is capable of preventing the flexible wall 2117 from being fully pop & while still allowing fluid to flow through the main flow path 2121 119639-9906l0.doc • 47-1355948. The ductile wall 2117 further includes a plurality of apertures 2155' that penetrate the flexible wall 2117. The apertures 2155 are in communication with the main flow path 2121. The aperture 2155 enables the reduced pressure delivered to the main flow path 2121 to be distributed to the tissue site. Aperture 2155 is selectively positionable about the circumference of manifold 2115 to preferentially direct the delivery of vacuum. For example, in Figure 51, the apertures may 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 guide 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 2m opposite to the end of the reduced pressure delivery tube 2125 can be open as shown in FIG. 4A, it has been found that the end covering the flexible wall 2117 can be improved for cleaning. Functional effectiveness and reliability. Preferably, the covered end of the flexible wall is adjacent to the second conduit η. Provided between the ends - 217 b: 2171 can achieve accumulation of cleaning fluid during the cleaning process 'This helps drive the rinsing fluid into the first conduit 2161 through the main flow path 2121. 119639-990610.doc • 48· ' The spacer used as the anti-blocking member 2135 is also illustrated in FIG. The spacer in the middle position causes the main flow path 2121 to branch into the two chambers, which causes the main officer 2115 to remain in operation when one of the chambers is blocked and cannot be dissolved by the cleaning. Referring to Figures 49 and 50, a reduced pressure delivery system 2211 includes a primary manifold 2215 integral with reduced pressure delivery = 2217. The reduced pressure delivery tube up includes a central tube = 2223 and a plurality of auxiliary lumens 2225. Although the auxiliary lumen can be used to measure the pressure at or near the tissue site, the auxiliary lumen 2225 can be further used to clean the central lumen 2223 to prevent or dissolve the obstruction. A plurality of apertures 2231 are in communication with the central lumen 2223 to distribute the reduced pressure delivered by the central lumen. As shown in Fig. 50, it is preferable that the hole 223 1 does not pass through the auxiliary lumen. Also shown in Fig. 50 is the head end of the reduced pressure delivery tube which forms a top gap outside the end of the auxiliary lumen 2225. If the tissue 'bracket or other material d teeth are applied during the application of the reduced pressure At the end of the combined pressure delivery tube 2217, the headspace 2241 will continue to allow delivery of cleaning fluid to the central lumen 2223. During use, the reduced pressure delivery system 2111 '2211 of Figures 40-50 can be directly applied to the tissue site Above, the pressure is reduced to distribute to the tissue site. The low profile of the subject is very beneficial for the installation and removal of the techniques described herein. Similarly, it can also be surgically embedded into the main manifold. Figure 5 can be used in conjunction with the auxiliary manifold 2321. In Figure 51, the auxiliary manifold 2321 includes a two-layer felt pad. The auxiliary layer 232 1 is in contact with the first layer - including the fracture site. The bone path tissue site is placed 119639-990610.doc • 49-1355948. The primary manifold 211 5 is placed in contact with the first layer, and the second layer of the auxiliary manifold 2321 is placed on top of the primary manifold 2115 and the first layer. Auxiliary manifold 2321 can reach primary manifold 2115 and group The fluid communication between the woven portions and still prevents direct contact between the tissue portion and the primary manifold 2115. Preferably, the auxiliary manifold 2321 is bioabsorbable, which enables the auxiliary manifold 2321 to be completed under reduced pressure therapy After remaining in situ, once the decompression treatment is completed, the primary manifold 2丨丨5 can be removed from between the layers of the auxiliary manifold with little or no disturbance to the tissue site. In one example, the primary manifold may be coated with a lubricating material or a material that will form a water condensate to facilitate removal of the primary manifold from between the layers. The secondary manifold is preferably used as a support for new tissue growth. The auxiliary manifold may be composed of at least one material selected from the group consisting of polylactic acid, polyglycolic acid, polycaprolactone, polyhydroxybutyrate, polyvaleric acid, polydioxane, p 〇ly〇rth〇esthers, poly-disc nitrile, polyurethane, collagen, hyaluronic acid, polyaminoglucose, hydroxyapatite, calcium phosphate, calcium sulfate, calcium carbonate, bioglass, stainless steel, titanium, group Allografts and autologous groups The grafting function of the reduced-pressure delivery system 21 i丨, 221丨 described above can be used with any of the manifolds described herein. The ability to deliver a reduced pressure to the manifold or guide Prevents the formation of obstructions that impede the exertion of reduced pressure. These obstructions are typically formed when the pressure near the tissue site reaches equilibrium and the flow of fluid around the tissue site slows down. It has been found that air is used at a selected interval. Cleaning the manifold and decompression catheter for a desired amount of time will help prevent or dissolve the obstruction. 119639-990610.doc -50- 1355948

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 "push" to the outlet of the second catheter, it is preferred to draw air through the second conduit by the reduced pressure at the tissue site. It has been found that in many cases, delivering air for six (2) seconds at intervals of sixty (60) seconds during application of reduced pressure is sufficient to prevent the formation of obstructions. "This cleaning program provides sufficient air to adequately The fluid in the manifold and the first conduit is moved while preventing excessive air introduction. Introducing too much air, or introducing air at too high a frequency interval, will result in a decompression system that cannot return to a reduced target pressure between wash cycles. The amount of time selected to deliver the cleaning fluid and the interval between the selected cleaning fluids will generally vary depending on the design and specifications of the system components (eg, pumps, tubes, etc.). However, the amount and frequency of delivery air should be high enough to adequately remove obstructions while still recovering the full target pressure between wash cycles. Referring to Fig. 52, in an exemplary embodiment, a reduced pressure delivery system 2411 includes a manifold 241S that is fluidly coupled to a first conduit 24A and a second conduit 2423. The first conduit 2419 is coupled to a reduced pressure 2 2429 to provide a 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 the valve 2439 which is capable of achieving communication between the second guide 2423 and ambient air when the valve 2439 is placed in the open position. Valve 2439 is operatively coupled to a controller 2453 'controller 2453 is capable of controlling valve 24 to open 119639-990610.doc • 51 - 1355948 to open and close to regulate the cleaning of the second conduit using ambient air, thereby An obstruction is prevented from being present in the manifold at 15 with the first conduit 2419. It should be noted that any fluid (including liquids or gases) can be used to achieve the techniques herein. Although the force for cleaning the fluid is preferably a suction that is formed at the tissue site by the reduced pressure, however, similar to that described with reference to Figure 9, the fluid delivery member can also deliver fluid in a similar manner. Decompression tissue treatment of tissue sites in accordance with the systems and methods described herein can be accomplished by applying a sufficiently low pressure to the tissue site and then maintaining the sufficiently low pressure for a selected period of time. Alternatively, the reduced pressure applied to the tissue site can be cyclic. More specifically, the magnitude of the applied reduced pressure may vary depending on the selected time cycle. Yet another method of applying the reduced pressure can randomly vary the magnitude of the reduced pressure. Similarly, the rate or amount of fluid delivered to the tissue site can be constant, periodic, or random. In the case of periodicity, the fluid delivery can be carried out during the application of the reduced pressure or during the cycle in which the 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. More preferably, the system is between about 5 mm Hg and -300 mm Hg. Although the systems and methods of the present invention are described above with reference to tissue growth and patient healing, it should be understood that such systems and methods for applying reduced pressure tissue treatment can be used in any living body in which tissue growth or healing is desired to be promoted. . Similarly, the system and method of the present invention can be applied to any tissue, including 119639-990610.doc -52-1355948 including but not limited to bone tissue, adipose tissue, muscle tissue, nervous 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. Tissue growth is formed in the tissue. For example, it may be desirable to apply a decompressed tissue treatment using a skin implant technique to grow additional at a tissue site.

Organize and subsequently harvest the additional organization. The harvested tissue can be planted to another, and the σ position can be replaced 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 transfer 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 waste reducing 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 color pattern. The patent or patent application publication with color drawings may be provided by the Patent Office upon request and after payment of the necessary fee. ^ 119639-990610.doc -53 · Figure 'The reduced pressure delivery device has a plurality of protrusions extending from a barrier barrier to form a plurality of flow channels; Figure 2 illustrates a front view of the reduced pressure delivery device of Figure 1 Figure 3 is a plan view of the reduced-pressure conveying device shown in Figure 1; Figure 2 is a side view of the reduced-lift conveying device shown in Figure i, the dust-reducing conveying device has a single-tube decompression conveying pipe; 4B is a side view of an alternative embodiment of the reduced pressure delivery device of FIG. 1 having a dual lumen decompression delivery tube; FIG. 5 illustrates one of the reduced pressure delivery devices shown in FIG. 6 is a perspective view of a reduced pressure conveying device having a honeycomb material attached to a flexible barrier having a convex shape according to an embodiment of the present invention. a ridge portion and a pair of wing portions, the honeycomb material having a plurality of flow passages; Fig. 7 is a front view showing one of the decompression transfer devices shown in Fig.; Fig. 8 is a view showing the pressure reduction conveying device shown in Fig.剖νπ_χνπ section cutaway side view; Figure 8Α illustration A cross-sectional front view of a reduced pressure delivery device in accordance with an embodiment of the present invention; FIG. 8A is a side elevational view of the reduced pressure delivery device of FIG. 8A; FIG. 9 illustrates a reduced pressure in accordance with an embodiment of the present invention. A front view of one of the delivery devices for applying decompression tissue treatment to the bone of the patient; Figure 10 depicts a colored tissue section of a rabbit skull showing the original, undamaged bone; Figure 11 illustrates a rabbit skull Color tissue sections showing the granulation tissue induced after treatment with decompressed tissue at 庑119639-990610.doc -54· 1355948; Figure 12 green shows a color tissue section of a rabbit skull showing the application of decompressed tissue treatment Figure 13 illustrates a color tissue section of a rabbit skull showing the deposition of new bone after application of decompressed tissue treatment; Figure 14 depicts a color photograph of a rabbit skull in which two are formed Critical dimension defect; Figure 15 illustrates a color photograph of the rabbit skull shown in Figure 14 showing the calcium phosphate scaffold embedded in one of the critical size defects and A stainless steel mesh covering the second critical dimension defect; Figure 16 illustrates a color photograph of the rabbit skull of Figure 14 showing the application of reduced pressure tissue treatment to a critical size defect; Figure 17 illustrates the implementation of reduced pressure tissue treatment __ a color tissue section of a rabbit skull showing the deposition of new bone within the calcium phosphate scaffold;

Figure 1 is a radiograph showing the critical size defect of the It stent filled in Figure 15 after performing the decompression tissue treatment for six days and two weeks after the operation; Figure 19 shows the implementation of the decompression tissue treatment for six days and the operation of the surgery Figure 2 shows a radiograph of the critical dimension defect of the alpha stent after two weeks; Figure 20 depicts a front view of the vacuum delivery system according to the present invention - the (four) delivery system has - manifold delivery a tube for inserting a decompression delivery device through the skin to a tissue site; FIG. 2 illustrates an enlarged front view of the micromanifold, and the official delivery tube includes a decompression wheel read The decompression conveying device has a deflection 119639-990610.doc • 55-1355948 barrier and/or a honeycomb material in a compressed position; FIG. 22 illustrates the manifold conduit of FIG. Amplified elevational view showing the flexible barrier and/or honeycomb material of the reduced pressure delivery device in an expanded position after being pushed from the manifold delivery tube; FIG. 23 illustrates an embodiment of the present invention in accordance with an embodiment of the present invention. Front view of the pressure delivery system' The reduced pressure delivery system has a manifold delivery tube for inserting a reduced pressure delivery device through the skin into a tissue site, the figure showing that the reduced pressure delivery device is outside the manifold delivery tube but is impervious Figure 24 is a front elevational view of the reduced pressure delivery system of Figure 23, showing that the "Xuan reduced pressure delivery device" is outside the manifold delivery tube but is constrained by a non-permeable membrane Figure 25 illustrates a front elevational view of the reduced pressure delivery system of Figure 23, showing the reduced pressure delivery device outside of the manifold delivery tube but constrained to an expanded position by an impermeable membrane Figure 25A illustrates a front view of the reduced pressure delivery system of Figure 23, showing the reduced pressure delivery device outside the delivery tube, but surrounded by an impermeable membrane at an expanded position, Figure 26 illustrates a front view of a decompression delivery system according to the present invention, which is used to insert a decompression delivery device through the skin to the tissue site. a delivery tube, the figure shows that the reduced pressure transport device is outside the manifold transport tube, but is bound by an impervious film with a glue seal; FIG. 26A illustrates a decompression loss of a case according to the present invention. Vision of the transport system 119639-990610.doc -56-1355948 Γ5Π · Figure, Figure 27 illustrates a front view of a reduced pressure delivery system having a manifold delivery tube, in accordance with an embodiment of the present invention, For use in injecting a reduced pressure delivery device through a skin to a tissue site; FIG. 27A illustrates a front view of a reduced pressure delivery system having a manifold delivery tube, in accordance with an embodiment of the present invention, For transporting a reduced pressure delivery device through the skin to an impermeable film located at a tissue site;

4 is a flow chart showing a method of performing decompression tissue treatment on a tissue site according to an embodiment of the present invention; and FIG. 29 is a diagram illustrating a method for performing decompression tissue treatment on a tissue site according to an embodiment of the present invention. FIG. 30 is a flow chart showing a method for performing decompression tissue treatment on a tissue site according to an embodiment of the present invention; FIG. 31 is a view illustrating a decompression tissue treatment of a tissue site according to an embodiment of the present invention; Figure 32 is a cross-sectional elevational view of a reduced pressure delivery device in accordance with an embodiment of the present invention. The reduced pressure delivery device 4 includes an integral prosthesis having a plurality of flow channels for use in a pair A reduced pressure is applied around the bone region of the hip prosthesis; Figure 33 illustrates a cross-sectional elevation view of the hip prosthesis of Figure 32 having a second plurality of flow channels for delivering fluid to the surrounding The skeletal region of the body prosthesis; ' Figure 3 4 illustrates a method for repairing a patient's joint using a reduced-pressure tissue treatment according to an embodiment of the invention 119639-990610.doc • 57· θ 图 图 图 图 图 图 图 图 图 图 图 图 图 图 图 图 图 图 图 图 图 图 图 图 图 图 图 图 图 图 图 图 图 图 图 图 图 图 图 图 图 图 图 图 图 图 图 图 图 图 图 图 图 图In order to apply a reduced pressure to the bone (four) domain of the orthopaedic fixation device; FIG. 36 is a cross-sectional elevation view of the orthopedic fixation device of FIG. 35 having a second plurality of flow channels. For conveying fluid to a skeletal region adjacent to the orthopedic fixation device; FIG. 37 illustrates a flow chart of a method for treating bone defects in bone using reduced pressure tissue treatment in accordance with an embodiment of the present invention; A flow chart of a method for performing decompression tissue treatment on a tissue site in accordance with an embodiment of the present invention; and FIG. 39 illustrates a method for decompressing tissue treatment of a tissue site in accordance with an embodiment of the present invention. Flow chart of the method. 40-48 illustrate various views of a reduced pressure delivery system having a main manifold including a flexible wall surrounding a main flow passage and located in accordance with an embodiment of the present invention. a plurality of sub-Ls in the flexible wall; Figures 49-50 illustrate a perspective view and a top cross-sectional view of a reduced pressure delivery system having a body connected to a body in accordance with an embodiment of the present invention. a main manifold of the reduced pressure delivery tube; FIG. 51 is a perspective view of the main manifold shown in FIGS. 40-50 for application to an osteopath tissue site with an auxiliary manifold; and FIG. 52 illustrates a method according to the present invention. An embodiment has a schematic view of a reduced pressure delivery system with a fluid connection of 119639-990610.doc -58-1355948 to a second conduit valve. [Main component symbol description]

211 decompression delivery device or wing manifold 213 flex barrier 215 ridge portion 219 wing portion 223 arched channel 227 flexible backing 231 protrusion 233 flow channel 241 decompression delivery tube 243 distal aperture 255 proximal end Orifice 259 lumen or passage 261 double lumen tube 263 first lumen 265 second lumen 271 horizontal spacer 311 decompression delivery device or wing manifold 313 flexible barrier 315 ridge portion 319 wing portion 323 arch Shaped channel 327 Honeycomb material 119639-990610.doc -59- 1355948 329 Distribution surface 330 Peripheral surface 341 Decompression delivery tube 343 Distal orifice 355 Proximal orifice 359 Catheter or passage 371 Reduced pressure delivery device 373 Reduced pressure 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 bone 419 decompression delivery tube 421 proximal end 427 decompression source 429 void defect 43 1 fluid Duct 432 proximal end -60- 119639-990610.doc 1355948 . 433 fluid delivery source 434 filter - 435 pressure sensor 711 decompression Delivery system 713 Tissue site 721 Manifold delivery tube 725 Guide unit 727 Guide wire, exhaust 731 Fracture site 733 Patient bone 735 Skin 739 Soft tissue 743 Tapered distal end 751 Path 761 Pressure reducing device ^ 765 ♦ Flex barrier 767 Honeycomb material 769 decompression delivery tube 811 decompression delivery system 821 manifold delivery tube 837 dashed line 843 distal end 861 decompression delivery device 865 flexible barrier 119639-990610.doc -61 - 1355948 867 869 871 873 881 885 891 911 921 921 937 943 961 965 967 969 971 973 977 981 985 987 989 991 993 Honeycomb-shaped material decompression tube Impermeable membrane inner surface marking, removal device auxiliary lumen or tube decompression delivery system manifold delivery tube dashed distal decompression Conveying device flexible barrier honeycomb material decompression conveying pipe impervious film inner surface sealing mark, decompression conveying system guiding wire decompression conveying pipe decompression conveying device tissue part

119639-990610.doc -62- 1355948 . 1011 Reduced pressure delivery system 1021 Manifold delivery tube 1025 Tissue site • 1029 Void 1035 Decompression delivery device 1043 Remote 1055 Internal space 1057 Auxiliary lumen slightly 1061 Guide wire 1511 Decompression Conveyor 1515 orthopedic hip prosthesis 1517 patient leg section 1521 column section 1525 head section 1529 access. 1535 porous coating ▼ 1541 flow channel 1543 main feed line 1545 lateral branch line 1547 lateral branch line. 1551 decompression tube 1553 decompression Conveying source 1565 Connection 埠1571 Fluid delivery tube 119639-990610.doc -63- 1355948 1573 1583 1585 1711 1715 1717 1719 1721 1725 1735 1741 1743 1745 1771 1773 1783 1785 2111 2115 119639-990610.doc Fluid delivery source Main feed line lateral branch line decompression conveying device orthopedic fixation device bone fracture site access screw porous coating flow channel main feed line connection 埠 lateral branch line decompression delivery tube decompression delivery source flow channel connection 埠 fluid delivery tube fluid delivery source Main feed Pipeline lateral branch line decompression delivery system main manifold -64- 1355948

2117 2121 2123 2129 2135 2137 2141 2145 2149 2155 2161 2163 2171 2211 2215 2217 2223 2225 223 1 2241 2321 2411 2415 2419 Flexible wall main flow path proximal transition zone anti-blocking member protrusion inner surface ridge honeycomb material tie first conduit Second catheter headspace vacuum delivery system main manifold decompression delivery tube central lumen auxiliary lumen hole headgap auxiliary manifold decompression delivery system manifold first conduit 119639-990610.doc -65- 1355948 2423 second catheter 2429 Pressure source 2435 outlet 2439 Valve 2453 Controller 119639-990610.doc ·66·

Claims (1)

1355948 Announcement (V-month-No. 096111827 Patent Application Replacement of Chinese Patent Application Range (March 100). 1. A reduction of i-transport for the application of a decompression tissue treatment to a tissue site.." A system comprising: • a manifold delivery tube having a passageway and a distal end, the distal end being configured to be inserted through the skin and placed adjacent to the tissue site; "IL movable material can be by the manifold The delivery tube is delivered to the tissue site through the skin such that the flowable material can fill a void adjacent the tissue site to form a manifold having a plurality of flow channels in fluid communication with the tissue site; and φ decompression delivery officer The system of claim 1, wherein the manifold conduit is the same tube as the reduced pressure conduit. A system wherein the manifold is bioresorbable. 4. A system as claimed in claim 1, wherein the manifold is used as a tissue growth scaffold. 5. The system of claim 1 wherein the integral fluid and the integral temperature are At least one In the presence of the manifold, the manifold is foamed and cured. 6. The system of claim 1, wherein the manifold further comprises a bioresorbable material dissolved in a solvent and mixed with sodium bicarbonate and citric acid. [7] The system of claim 6, wherein the bioresorbable polymer is a polyglycolide-co-glycolide (PLAGA) polymer and a polyethylene glycol ρΑ(Α) copolymer One of the following: ' 8. The system of claim 6 wherein the solvent is dichlorohydrazine. 9. The system of claim 1 wherein the flowable material is selected from the group consisting of 119639-1000309.doc 1355948 Groups of liquids, slurries, suspensions, viscous gels, pastes, putties, and particulate solids. 1 0. The system of claim 1, wherein: the flowable material is in one piece with one body and at least ten One undergoes a phase change in the presence of one; and the flowable material comprises a poragen dissolved after the flowable material solidifies, the dissolution of the poragen forming the plurality of flow channels. H. The flowable material comprises a coating Microspheres 'The coating is capable of selectively crosslinking after transporting the flowable material to the tissue site.) 12. Coating as claimed, wherein the coating is responsive to heat, light, and a chemistry Selectively cross-linking at least one of the products. " 13. The system of claim ", wherein the microspheres form the plurality of flow channels after crosslinking. 14·System as requested! Wherein the flowable material is selected from the group consisting of a paste having an initial viscosity and a putty; the viscosity of the flowable material drops to the presence of shear during transport to the tissue site to Below the initial viscosity; and after the a<IL material is delivered to the tissue site, the viscosity of the flowable material returns to the initial viscosity. '19639-1000309.doc