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Número de publicaciónUS9131927 B2
Tipo de publicaciónConcesión
Número de solicitudUS 12/504,076
Fecha de publicación15 Sep 2015
Fecha de presentación16 Jul 2009
Número de publicación12504076, 504076, US 9131927 B2, US 9131927B2, US-B2-9131927, US9131927 B2, US9131927B2
InventoresLouis C. Argenta, David L. Carroll, James E. Jordan, Nicole H. Levi, Jie Liu, Michael J. Morykwas, William D. Wagner
Cesionario originalWake Forest University Health Sciences
Exportar citaBiBTeX, EndNote, RefMan
Enlaces externos: USPTO, Cesión de USPTO, Espacenet
Apparatus and method for cardiac tissue modulation by topical application of vacuum to minimize cell death and damage
US 9131927 B2
Resumen
A method and apparatus are provided for treating cardiac tissue to modulate ischemic heart tissue with topical sub-atmospheric pressure to minimize cell death and damage.
Imágenes(13)
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Reclamaciones(49)
What is claimed is:
1. A method for treating damaged cardiac tissue using sub-atmospheric pressure, comprising:
i. placing a porous material proximate the damaged cardiac tissue to provide gaseous communication between one or more pores of the porous material and the damaged cardiac tissue, the porous material comprising at least one of an electrospun material, a cast material, an open-cell foam, and a printed material;
ii. sealing the porous material in situ over the damaged cardiac tissue to provide a region about the damaged cardiac tissue for maintaining sub-atmospheric pressure at the damaged cardiac tissue, and locating a bio-incorporable cover over the damaged cardiac tissue and sealing the bio-incorporable cover to cardiac tissue proximate the damaged cardiac tissue;
iii. operably connecting a vacuum source in gaseous communication with the porous material for producing sub-atmospheric pressure at the damaged cardiac tissue; and
iv. activating the vacuum source to provide sub-atmospheric pressure at the damaged cardiac tissue.
2. The method for treating damaged cardiac tissue according to claim 1, wherein the porous material comprises a bio-incorporable material.
3. The method for treating damaged cardiac tissue according to claim 2, wherein the rate of bio-incorporation of the dressing is higher at the periphery of the dressing than at the center of the dressing.
4. The method for treating damaged cardiac tissue according to claim 1, wherein the porous material comprises a polyethylene, polyurethane, polyester material, or combinations thereof.
5. The method for treating damaged cardiac tissue according to claim 1, wherein the step of placing a porous material proximate the damaged cardiac tissue comprises placing a polyvinyl alcohol foam in direct contact with the damaged cardiac tissue.
6. A method for treating damaged cardiac tissue using sub-atmospheric pressure, comprising:
i. placing a porous bio-incorporable material proximate the damaged cardiac tissue to provide gaseous communication between one or more pores of the porous material and the damaged cardiac tissue;
ii. sealing the porous material in situ over the damaged cardiac tissue to provide a region about the damaged cardiac tissue for maintaining sub-atmospheric pressure at the damaged cardiac tissue, and locating a bio-incorporable cover over the damaged cardiac tissue and sealing the bio-incorporable cover to cardiac tissue proximate the damaged cardiac tissue;
iii. operably connecting a vacuum source in gaseous communication with the porous material for producing sub-atmospheric pressure at the damaged cardiac tissue; and
iv. activating the vacuum source to provide sub-atmospheric pressure at the damaged cardiac tissue.
7. The method for treating damaged cardiac tissue according to claim 6, wherein the rate of bio-incorporation of the dressing is higher at the periphery of the dressing than at the center of the dressing.
8. The method for treating damaged cardiac tissue according to claim 1 or 6, wherein the porous material comprises myocardial, peripheral muscle cells, or combinations thereof.
9. The method for treating damaged cardiac tissue according to claim 1 or 6, wherein the step of operably connecting a vacuum source comprises connecting a tube between the vacuum source and the porous material, the tube having a distal end in contact with the porous material.
10. The method for treating damaged cardiac tissue according to claim 1 or 6, wherein the step of placing a porous material proximate the damaged cardiac tissue comprises placing the porous material in direct contact with the damaged cardiac tissue.
11. The method for treating damaged cardiac tissue according to claim 10, wherein the porous material comprises an open-cell foam.
12. The method for treating damaged cardiac tissue according to claim 1 or 6, wherein the step of placing a porous material proximate the damaged cardiac tissue comprises placing the porous material in indirect contact with the damaged cardiac tissue by locating a porous intermediate material between the porous material and the damaged heart tissue, with the porous intermediate material disposed in contact with both the porous material and the damaged heart tissue.
13. The method for treating damaged cardiac tissue according to claim 12, wherein the porous material comprises an open-cell foam.
14. The method for treating damaged cardiac tissue according to claim 1 or 6, wherein the cover comprises a vacuum port for receiving sub-atmospheric pressure from the vacuum source, and wherein the step of operably connecting a vacuum source in gaseous communication with the porous material comprises connecting the vacuum source with the vacuum port.
15. The method for treating damaged cardiac tissue according to claim 1 or 6, wherein the step of sealing the cover to tissue surrounding the damaged cardiac tissue comprises adhesively sealing and adhering the cover to cardiac tissue surrounding the damaged cardiac tissue.
16. The method for treating damaged cardiac tissue according to claim 1 or 6, wherein the step of locating a cover comprises locating a self-adhesive sheet over the damaged cardiac tissue, and wherein the step of sealing the cover comprises adhesively sealing and adhering the self-adhesive sheet to cardiac tissue surrounding the damaged cardiac tissue to form a seal between the sheet and surrounding cardiac tissue.
17. The method for treating damaged cardiac tissue according to claim 1 or 6, wherein the cover comprises an electrospun material.
18. The method for treating damaged cardiac tissue according to claim 1 or 6, wherein the cover comprises a cast material.
19. The method for treating damaged cardiac tissue according to claim 1 or 6, wherein the cover comprises collagen.
20. The method for treating damaged cardiac tissue according to claim 17, wherein the cover comprises collagen.
21. The method for treating damaged cardiac tissue according to claim 1 or 6, wherein the cover comprises a diol citrate.
22. The method for treating damaged cardiac tissue according to claim 17 wherein the cover comprises a diol citrate.
23. The method for treating damaged cardiac tissue according to claim 1 or 6, wherein the cover comprises poly 1,8-octanediol citrate.
24. The method for treating damaged cardiac tissue according to claim 17, wherein the cover comprises poly 1,8-octanediol citrate.
25. The method for treating damaged cardiac tissue according to claim 1 or 6, wherein the cover comprises chitosan.
26. The method for treating damaged cardiac tissue according to claim 19, wherein the cover comprises chitosan.
27. The method for treating damaged cardiac tissue according to claim 1 or 6, wherein the cover comprises polylactic acid.
28. The method for treating damaged cardiac tissue according to claim 17, wherein the cover comprises polylactic acid.
29. The method for treating damaged cardiac tissue according to claim 1 or 6, comprising maintaining the sub-atmospheric pressure at the damaged cardiac tissue for a time sufficient to decrease edema in the damaged cardiac tissue.
30. The method for treating damaged cardiac tissue according to claim 1 or 6, comprising maintaining the sub-atmospheric pressure at the damaged cardiac tissue for a time sufficient to decrease mediators, degradation products, toxins, or combinations thereof that enhance the inflammatory and pathophysiological response in the damaged cardiac tissue.
31. The method for treating damaged cardiac tissue according to claim 1 or 6, comprising maintaining a sub-atmospheric pressure of about 25 mm Hg below atmospheric pressure at the damaged cardiac tissue.
32. The method for treating damaged cardiac tissue according to claim 1 or 6, comprising maintaining sub-atmospheric pressure of between about 25 and 125 mm Hg below atmospheric pressure at the damaged cardiac tissue.
33. The method for treating damaged cardiac tissue according to claim 1 or 6, wherein the step of placing a porous material comprises placing a porous material having pores sufficiently small to prevent the ingrowth of tissue therein.
34. The method for treating damaged cardiac tissue according to claim 33, wherein the step of placing a porous material comprises placing a porous material having a pore size smaller than the size of fibroblasts.
35. The method for treating damaged cardiac tissue according to claim 1 or 6, wherein the porous material comprises collagen.
36. The method for treating damaged cardiac tissue according to claim 1 or 6, wherein the porous material comprises chitosan.
37. The method for treating damaged cardiac tissue according to claim 1 or 6, wherein the porous material comprises polycaprolactone.
38. The method for treating damaged cardiac tissue according to claim 1 or 6, wherein the porous material comprises a polyglycolic, polylactic acid, or combinations thereof.
39. The method for treating damaged cardiac tissue according to claim 1 or 6, wherein the porous material comprises a porous, open-cell collagen material.
40. The method for treating damaged cardiac tissue according to claim 1 or 6, wherein the porous material comprises a porous synthetic polymer material.
41. The method for treating damaged cardiac tissue according to claim 1 or 6, wherein the porous material comprises at least one of a porous sheet and a flexible, sheet-like mesh.
42. The method for treating damaged cardiac tissue according to claim 1 or 6, wherein the porous material comprises two or more layers, with the layer closest to the damaged cardiac tissue containing pores sufficiently small at the interface between the porous material and the damaged cardiac tissue to prevent the growth of tissue therein.
43. The method for treating damaged cardiac tissue according to claim 42, wherein the porous material comprises a pore size sufficiently large to promote the formation of granulation tissue at other tissues in the spaces surrounding the damaged cardiac tissue.
44. The method for treating damaged cardiac tissue according to claim 1 or 6, wherein the porous material comprises pores sufficiently small at the interface between the porous material and the damaged cardiac tissue to prevent the growth of tissue therein.
45. The method for treating damaged cardiac tissue according to claim 1 or 6, wherein the porous material comprises a pore size large enough to allow movement of proteins the size of albumin therethrough to permit undesirable compounds to be removed.
46. The method for treating damaged cardiac tissue according to claim 1 or 6, wherein the porous material is sealed to prevent the transmission of sub-atmospheric pressure on all surfaces but one.
47. The method for treating damaged cardiac tissue according to claim 1 or 6, comprising infusing peripheral muscle cells into the damaged cardiac tissue.
48. The method for treating damaged cardiac tissue according to claim 1 or 6, comprising infusing myocardial cells into the damaged cardiac tissue.
49. The method for treating damaged cardiac tissue according to claim 1 or 6, comprising infusing pleuripotent progenitor cells into the damaged cardiac tissue.
Descripción
RELATED APPLICATIONS

The present application claims the benefit of priority of U.S. Provisional Application 61/088,558, filed on Aug. 13, 2008 and U.S. Provisional Application No. 61/081,997, filed on Jul. 18, 2008, the entire contents of which are incorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates generally to a method and apparatus for treating cardiac tissue, and more particularly, but not exclusively, to modulating ischemic and reperfused heart tissue with topical sub-atmospheric pressure to minimize cell death and damage.

BACKGROUND OF THE INVENTION

Myocardial ischemia occurs when a portion of the heart does not receive sufficient oxygen and energy substrates to meet its demand. This usually occurs because of a blockage in the artery due to either atherosclerotic plaque or thrombus formation. In a myocardial infarction there is an area of injury where the cells, because of lack of blood flow, will die immediately. There is a layer adjacent where there is impaired blood flow that is equivalent to the zone of stasis and there is a more peripheral unaffected zone. Unfortunately the infarcted heart will attempt to increase rate of contracture and overall work to compensate for areas of the heart that are not functioning adequately. Consequentially the areas that are in the “zone of stasis” are called upon to do more work which will increase the energy requirements placed upon them and will subsequently result in further progression of death. If left untreated, this ischemia will lead to an expanding zone of infarction that may eventually extend transmurally across the thickness of the ventricle.

Limiting the degree of infarction resulting from myocardial ischemia is paramount to improving both short- and long-term outcomes in patients. Therefore, in order to salvage this myocardial tissue, timely reperfusion (re-establishment of coronary blood flow) of the tissue must take place. The amount of salvageable tissue within an ischemic zone is dependent on the timeliness of reperfusion. While reperfusion halts the ischemic processes by delivering oxygen and nutrients (including energy substrates), this process also rapidly sets into motion a series of events and cascades that exacerbates injury, extending the area of necrosis beyond that encountered during ischemia alone. Much of this reperfusion injury appears to be inflammatory in nature, but inappropriately directed against host tissues instead of foreign substances. Being able to reduce this reperfusion injury allows for the salvage of the greatest amount of myocardium.

Reperfusion injury manifests itself in a number of ways, including myocardial dysfunction (myocardial stunning), arrhythmias, and a collection of events that result in lethal reperfusion injury. Currently, there are effective pharmacologic therapies to treat reperfusion arrhythmias, and myocardial stunning will generally resolve by itself given time, leaving the mediators of lethal reperfusion injury as the logical targets in an attempt to preserve ischemic-reperfused, but viable tissue.

There are a large number of potential mediators of lethal reperfusion injury including calcium overload, oxygen radicals, changes in osmotic gradients (and subsequent cell swelling), the mitochondrial permeability transition pore, and inflammation (itself a complex set of cascades and mediators including complement activation, leukocyte infiltration and pro-inflammatory cytokines and mediators). In addition, the cardioprotective effects of selective inhibition of any and all of these phenomenon, including antioxidants, sodium-hydrogen exchange inhibitors, anti-inflammatory agents (including adenosine, adhesion molecule antibodies and complement inhibitors) in animal models of myocardial ischemia-reperfusion are known. However, very few have demonstrated any degree of clinical success in people, likely due to the fact that these therapeutics act selectively at a single point within a cascade of events, or on a single facet of a very complex and multifaceted process. Thus, though the application of negative (or sub-atmospheric) pressure therapy to wounded cutaneous and subcutaneous tissue demonstrates an increased rate of healing compared to traditional methods (as set forth in U.S. Pat. Nos. 5,645,081, 5,636,643, 7,198,046, and 7,216,651, as well as US Published Application Nos. 2003/0225347, 2004/0039391, and 2004/0122434, the contents of which are incorporated herein by reference), there remains a need in the art for devices and methods for treating myocardial ischemia. In these type wounds of cutaneous and subcutaneous wounds the screen/dressing can often be easily and non-invasively changed at routine, pre-determined intervals without significant disruption to the healing tissues. However, when techniques are used to treat tissues or organs in which the overlying skin is intact, the overlying skin must be surgically disrupted by the deliberate creation of a wound through the overlying tissue to expose the tissue or organ that was originally injured. The overlying, originally healthy tissues which were disrupted to expose the injured tissue can be sutured closed over top of the injured tissue. This allows for negative pressure treatment of the wounded tissues with restoration of the suprawound tissues. Current commercially available embodiments of negative pressure dressings and cover are not biodegradable or bioresorbable. This lack of biodegradability/bioresorbability necessitates re-opening of the sutured incision, removal of the dressing and cover, placement of a new dressing and cover, and again suturing the incision closed. This sequence would have to be repeated until the original wounded tissue is healed, with one final re-opening of the incision to remove the dressing and cover. Every time the incision is opened to change or remove the dressing and cover, it increases the risk that the site will become infected.

SUMMARY OF THE INVENTION

The present invention relates to devices and methods for treating damaged heart tissue, such as myocardial infarction in the ischemic or early reperfusion phase, by treatment with sub-atmospheric (or negative) pressure. Treatment with the devices and methods of the present invention may salvage cells in the zone of stasis and thereby decrease the size of the infarct. Such treatment would be especially efficacious in endstage myocardial disease where bypass or stenting would not be possible. The treatment would also be useful as an adjunct to ECMO (extracorporeal membrane oxygenation) for resting the heart, following cardiac arrest, in situations with left main artery lesions, etc.

An exemplary negative pressure therapy device of the present invention may include a vacuum dressing, e.g., porous material, for placement over the tissue to be treated. The vacuum dressing may be bio-incorporable in nature so that a second stage for removal would not be required. (As used herein the term “bio-incorporable” is defined to describe a material that may be left in the patient indefinitely and is capable of being remodeled, resorbed, dissolved, and/or otherwise assimilated or modified.) The device of the present invention may also include a bio-incorporable overlay cover for placement over the vacuum dressing to form a sealed enclosure in which sub-atmospheric pressure may be provided and maintained to the vacuum dressing and the tissue to be treated. The overlay cover may be adherent to the dressing and extend beyond the vacuum dressing to permit attachment of the overlay cover to surrounding non-damaged heart tissue. The overlay cover may be gelatinous in nature to contour to the heart and may be sufficiently pliable so as not to interfere with cardiac function. The overlay cover may be secured to the myocardium with fibrin glue, mini-staples, or sutures.

In use, the device of the present invention may be placed thoracoscopically over the area of muscle that has infarcted and over the adjacent zone of stasis. The device may be placed through a small incision made in the chest wall and perforated through the pericardium. The vacuum dressing may be collapsible in structure such that it can be rolled up or folded so as to be small enough for insertion through a thoracoscope tube. The epicardium may be perforated with a CO2 or similar laser or other cutting instrument to expose the underlying ischemic myocardium. The vacuum dressing may then be placed directly over this ischemic area. The overlay cover may also be placed and secured to surrounding heart tissue endoscopically as well. A vacuum tube, e.g., a small catheter, may then be introduced so that the distal end of the vacuum tube is in gaseous communication with the enclosure under the overlay cover to supply sub-atmospheric pressure to the enclosure and the tissue to be treated. The other end of the vacuum tube may then be placed in gaseous communication with a vacuum source to produce sub-atmospheric pressure, and the vacuum source may be activated to supply the sub-atmospheric pressure to effect negative pressure therapy of the damaged heart tissue. In addition, the sub-atmospheric pressure may be supplied intermittently at a rate that is matched to the heart rate.

The present invention may also provide delayed treatment of myocardial infarction where there is already a stable zone of myocardial cell death. Again through an endoscope and a small incision in the chest wall, a bio-incorporable vacuum dressing may be placed on the area that is infarcted. Again, exposure of the myocardium involved and adjacent myocardium may be required and provided with a CO2 or similar cutting device to perforate the epicardium. The vacuum dressing may be modified so that a lattice of myocardial or peripheral muscle cells may be incorporated within it. The vacuum dressing may also incorporate a small catheter with the ability to reinfuse additional myocardial cells, pleuripotent progenitor cells, or peripheral muscle cells at subsequent serial times. In areas where there is near complete cell death or there is little or no contraction of the muscle cells in the damaged cardiac tissue, new contractile cells could be seeded to replace and restore the contractile function of the damaged cardiac tissue. Initially, peripheral muscle or peripheral muscle cells grown from culture could be used. These cells have a finite life cycle and would be expected to fatigue over time. The myocardium could be biopsied at the time of the treatment of the initial treatment and myocardial cells removed and cultured to create a larger mass of viable of cells. The harvested myocardial cells could be maintained in culture and used for later periodic infusion to develop a myocardial patch that would cover the area of previous infarction. Also, progenitor cells could be harvested and immediately infused to the area of damaged cardiac tissue, or they could be grown in culture and periodically infused to the area of damaged cardiac tissue with the expectation that they would develop into cardiac myocytes. Over time the introduced cells would be induced to undergo mitosis or self-replication thus increasing the functional mass of the heart. The ability to progressively add cells that would be progressively vascularized is a major step in regenerative medicine where presently only a sheet of cells can be expected to survive.

More specifically, in one of its aspects the present invention provides a method for treating damaged cardiac tissue using sub-atmospheric pressure. The method comprises placing a porous material in direct or indirect contact with the damaged cardiac tissue to provide gaseous communication between one or more pores of the porous material and the damaged cardiac tissue. The porous material may comprise at least one of an electrospun material, a cast material, an open-cell foam, or a printed material. Alternatively or additionally, the porous material may comprise a bio-incorporable material. The porous material may include, for example, collagen, chitosan, polycaprolactone, polyglycolic acid, polylactic acid, and combinations thereof. In addition, the porous material may be a polyvinyl alcohol foam which may be disposed in direct contact with the damaged cardiac tissue.

The porous material may be sealed in situ over the damaged cardiac tissue to provide a region about the damaged cardiac tissue for maintaining sub-atmospheric pressure at the damaged cardiac tissue. The porous material may be operably connected with a vacuum source for producing sub-atmospheric pressure at the damaged cardiac tissue, and the vacuum source activated to provide sub-atmospheric pressure at the damaged cardiac tissue. The sub-atmospheric pressure may be maintained at the damaged cardiac tissue for a time sufficient to reduce edema (thus restoring contractility and compliance), decrease interstitial pressure, remove inflammatory mediators, remove inflammatory amplifiers, modulate intracellular mediators, increase reperfusion and microvascular flow, decrease microvascular plugging, and/or decrease retention of inflammatory cells within the damaged cardiac tissue. Micro and macro deformation of the cardiac tissue being treated would increase vasculoneogenesis or the formation of new blood vessels in the ischemic tissue. This would increase the survivability of the cardiocytes and ultimately improve function of the ischemic portion of the heart. In addition, macro and micro deformation of small arterioles already existing in the heart would result in their physical reorientation into the areas of ischemic tissue, thus increasing perfusion and ultimately function.

For example, the sub-atmospheric pressure may be maintained at about 25-125 mm Hg below atmospheric pressure. The method may also include locating a cover, such as a bio-incorporable cover, over damaged cardiac tissue and sealing the cover to tissue proximate the damaged cardiac tissue, e.g., to non-damaged cardiac tissue, for maintaining sub-atmospheric pressure at the damaged cardiac tissue. The cover may be provided in the form of a self-adhesive sheet which may be located over the damaged cardiac tissue. In such a case, the step of sealing the cover may include adhesively sealing and adhering the self-adhesive sheet to tissue surrounding the damaged cardiac tissue to form a seal between the sheet and tissue surrounding the damaged cardiac tissue.

In another of its aspects the present invention provides an apparatus for treating damaged cardiac tissue. The apparatus includes a porous material for treating damaged cardiac tissue having a pore structure configured to permit gaseous communication between one or more pores of the porous material and the cardiac tissue to be treated. The porous material may include at least one of an electrospun material, a cast material, and a printed material. Alternatively or additionally, the porous material may comprise a bio-incorporable material. In such instances, it may also be beneficial for the porous material to be formulated in such a manner that the outer edges of the porous material would be resorbed or degraded more quickly than the inner portion. The rate of removal (resorption/degradation) of the porous material could be matched to the rate of formation of new tissue. One way to control the rate of degradation or resorption is by varying the number of crosslinks introduced into the porous material.

The apparatus may also include a vacuum source for producing sub-atmospheric pressure; the vacuum source may be disposed in gaseous communication with the porous material for distributing the sub-atmospheric pressure to the cardiac tissue. The porous material may have, at least at a selected surface of the porous material, pores sufficiently small to prevent the growth of tissue therein. In addition, the porous material may have, at least at a selected surface of the porous material, a pore size smaller than the size of fibroblasts and cardiac cells, and may have a pore size at a location other than the selected surface that is larger than that of fibroblasts and cardiac cells. The pore size of the porous material may be large enough to allow movement of proteins the size of albumin therethrough. Also, the porous material may include at least one surface that is sealed to prevent the transmission of sub-atmospheric pressure therethrough. The apparatus may also include a cover, such as a bio-incorporable cover, configured to cover the damaged cardiac tissue to maintain sub-atmospheric pressure under the cover at the damaged cardiac tissue.

The bio-incorporable porous material and/or cover may be constructed from synthetic materials such as polyglycolic acid, polylactic acid, or poly-o-citrate, or they can be constructed of naturally occurring molecules such as collagen, elastin, or proteoglycans. Combinations of synthetic molecules, combinations of naturally occurring molecules, or combinations of synthetic with naturally occurring molecules can be used to optimize the material properties of the porous material and cover.

An example of a material which may be used to fabricate the porous material is polycaprolactone (PCL). In one exemplary formulation, polycaprolactone is mixed with sodium chloride (1 part caprolactone to 10 parts sodium chloride) and placed in a sufficient volume of chloroform to dissolve the components. The solution is poured into an appropriately sized and shaped container and allowed to dry for twelve hours. The sodium chloride is then leached out in water.

A second exemplary cast formulation for the porous material is chitosan, 1.33% (weight/volume) in 2% acetic acid. The solution (20 ml) is poured into an appropriately sized container and frozen for 2 hours at −70° C., then transferred to a lyophylizer and vacuum applied for 24 hours. The freeze dried dressing is then crosslinked with 2.5 to 5% glutaraldehyde vapor for 12 to 24 hours.

Thus, the present invention provides devices and methods for minimizing the progression of pathologic processes, minimizing the disruption of physiological cardiac integrity, and minimizing the interference with cardiac blood flow and nutrition and increasing revascularization of ischemic areas of the heart by vascular neogenesis and reorientation of existing vessels. By decreasing cardiac edema and interstitial pressure the risk of cardiac cell death and compromise may be minimized. In addition, the present invention facilitates the removal of mediators, degradation products, and toxins that enhance the inflammatory and pathophysiological response in the damaged cardiac tissue.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing summary and the following detailed description of the preferred embodiments of the present invention will be best understood when read in conjunction with the appended drawings, in which:

FIG. 1 schematically illustrates a partial cross-sectional view of an exemplary configuration of an apparatus of the present invention in situ prior to the application of sub-atmospheric pressure;

FIG. 2 schematically illustrates the partial cross-sectional view of FIG. 1 as a sub-atmospheric pressure is being applied;

FIG. 3 schematically illustrates the partial cross-sectional view of FIG. 1 after sub-atmospheric pressure has been applied;

FIG. 4 schematically represents a cross-sectional view of an exemplary configuration of the present invention in situ in which the tissues overlying the heart have been closed around the tube to create a space capable of maintaining a vacuum so no overlay cover is required;

FIG. 5 schematically represents a partial cross-sectional view of the apparatus of the present invention in situ in which the porous material is layered with a smaller pore layer adjacent to the damaged tissue and a layer with larger pores above the smaller pore layer;

FIG. 6 schematically represents a view of an exemplary configuration of a porous material of the present invention in which only one side of the porous material is open and not sealed;

FIG. 7 schematically represents a cross-sectional view of an exemplary configuration of the present invention in which an overlay cover has been placed over the porous material and potential leaks sealed with fibrin glue;

FIG. 8 schematically represents a partial cross-sectional view of an exemplary configuration of the present invention in which the edges of the overlay cover have been turned under;

FIG. 9 schematically represents a cross-sectional view of an exemplary configuration of the present invention in which the overlay cover is self adhesive;

FIG. 10 schematically represents an exemplary configuration of the cover of the present invention in which the tube passes through the overlay cover;

FIG. 11 schematically represents a partial cross-sectional view of the vacuum tube attaching to the overlay cover;

FIG. 12 schematically represents a kidney, with artery and vein;

FIG. 13 schematically represents an open clamshell or bi-valve chamber for application of sub-atmospheric pressure; and

FIG. 14 schematically represents a kidney disposed within the chamber of FIG. 13.

DETAILED DESCRIPTION OF THE INVENTION

Referring now to the figures, wherein like elements are numbered alike throughout, the present invention relates to devices and methods that use sub-atmospheric (or negative) pressure for treating damaged cardiac tissue, where “damaged” tissue is defined to include tissue that is injured, compromised, or in any other way impaired, such as damage due to trauma, disease, infection, surgical complication, or other pathologic process, for example. More specifically, the devices and methods of the present invention can effect treatment of myocardial infarction.

An exemplary configuration of a sub-atmospheric cardiac treatment device 100 of the present invention may include a vacuum source 30 for supplying sub-atmospheric pressure via a tube 20 to a porous material 10, such as a bio-incorporable porous material, disposed in direct or indirect contact with the damaged cardiac tissue 7, FIGS. 1-4. As used here, “indirect contact” is defined to mean placement of an intermediate material for transmitting sub-atmospheric pressure in contact with both the damaged cardiac tissue 7 and the porous material 10. In this regard, the porous material 10 may be structured to deliver and distribute sub-atmospheric pressure to the damaged cardiac tissue 7. Alternatively, the porous material 10 may be comprised of a material that needs to be removed after sub-atmospheric therapy is given, which could require a second surgery. The cardiac treatment device 100 may be applied to a patient by locating a porous material 10 in contact with the damaged cardiac tissue 7 to provide gaseous communication between one or more pores of the porous material 10 and the damaged cardiac tissue 7. A tube 20 may be connected to the porous material 10 at a distal end 22 of the tube 20, and the porous material 10 may be sealed in situ by sutures 8 in the skin 1 and subcutaneous tissues 2 to provide a region about the damaged cardiac tissue 7 for maintaining sub-atmospheric pressure, FIG. 4. The proximal end 24 of the tube 20 may be attached to a vacuum source 30 to operably connect the porous material 10 to the vacuum source 30 for producing sub-atmospheric pressure at the damaged cardiac tissue 7 upon activation of the vacuum source 30. Optionally, an overlay cover 40, such as a bio-incorporable overlay cover 40, may be located over the damaged cardiac tissue 7 and sealed proximate the damaged cardiac tissue 7 to maintain sub-atmospheric pressure at the damaged cardiac tissue 7.

Turning to FIGS. 1-4 in greater detail, an exemplary configuration of a sub-atmospheric pressure cardiac treatment device 100 of the present invention is illustrated in partial cross-section with the porous material 10 in contact with the damaged cardiac tissue 7. An overlay cover 40 covers the porous material 10 and may extend onto healthy cardiac tissue 6 creating an enclosed space 48. An adhesive 41, such as fibrin glue or other material, may be placed between the overlay cover 10 and the healthy cardiac tissue 6. The adhesive 41 may also or alternatively be placed around the periphery of the overlay cover 10 to prevent leaks, and may also be placed around a passthrough 52 where the tube exits from the overlay cover 10 to prevent leaks. FIG. 1 depicts the device 100 prior to application of sub-atmospheric pressure. FIG. 2 depicts the device 100 as sub-atmospheric pressure is being applied, and the enclosed space 48 decreases in volume as fluid and gas are evacuated from the enclosed space 48 and the overlay cover 40 conforms to the porous material 10. FIG. 3 depicts the device 100 after sub-atmospheric pressure has been applied, with the overlay cover 40 conforming to the shape of the porous material 10.

Turning to FIG. 4 specifically, an exemplary configuration of a sub-atmospheric cardiac treatment device 100 of the present invention is illustrated in situ in a patient with surrounding tissues shown in partial cross-section. The tissues illustrated include the skin 1 and subcutaneous tissue 2, muscle 3, bone 4, pericardium 5, healthy non-damaged cardiac tissue 6, the damaged cardiac tissue 7, and the pleural tissues 12. To provide access to the damaged cardiac tissue 7, a portion of the pericardium 5 may be missing due to surgical dissection or injury. A porous material 10, such as an open-cell collagen material, may be placed in the subcutaneous space in contact (direct or indirect) with the cardiac tissue 7 to be treated with sub-atmospheric pressure to decrease edema and interstitial pressure, oxygen radicals, inflammatory mediators, and other molecules which may adversely affect cellular resuscitation or viability within the damaged cardiac tissues to improve physiologic function, for example. The distal end 22 of the tube 20 may connect to the porous material 10 and the tube 20 may exit the body through an incision. The tube 20 may have one or more fenestrations 23 in that portion of the tube 20 in contact with the porous material 10, FIG. 6. The tissues between the cardiac tissue 7 up to and including the skin 1 are closed with, for example sutures 8, to create an airtight seal capable of maintaining a vacuum. When sub-atmospheric pressure is applied, the edges of the incised tissues 1-5 are drawn together and the pleural tissues 12 are drawn toward the porous material to help maintain the vacuum. The proximal end of the tube 24 may be connected to a vacuum source 30 and the level of sub-atmospheric pressure controlled by a controller 32. The vacuum source 30 may include a canister to collect any fluid removed.

The cover 40 may serve to further confine the region about the damaged cardiac tissue 7 at which sub-atmospheric pressure is maintained. That is, as illustrated in FIGS. 1-3, 7-9, the cover 40, 50 provides an enclosed space/region 48, 58 about the damaged cardiac tissue 7 under the cover 40, 50, which can serve to isolate the tissues exterior to the cover 40, 50 from exposure to the sub-atmospheric pressure applied to the damaged cardiac tissue 7. In contrast, as illustrated in FIG. 4, in the absence of an overlay cover, sub-atmospheric pressure delivered to the porous material 10 and damaged cardiac tissue 7 may draw the surrounding tissues, such as the pericardium 5 and pleural tissues 12, inward towards the tube 20 and porous material 10 along the directions of the arrows shown in FIG. 4. In this regard the stretched and/or moved tissues, such as pericardium 5 and pleural tissues 12 can help to confine the applied sub-atmospheric pressure to a region between the pericardium 5 and the damaged cardiac tissue 7. In addition the covers 40, 50 may further protect the damaged cardiac tissue 7 from exogenous infection and contamination beyond the protection already afforded by the porous material 10 and sutured skin 1 and subcutaneous tissue 2. Likewise, the covers 40, 50 may further protect the damaged cardiac tissue 7 from the spread of infections from the surrounding tissues (such as cardiac abscesses and mediastinitis).

To assist in maintaining the sub-atmospheric pressure at the damaged cardiac tissue 7, a flexible overlay cover 40 (FIG. 7), or a self adhesive flexible overlay cover 50 (FIG. 9) may be provided over the damaged cardiac tissue 7 to provide a region 48, 58 about the damaged cardiac tissue 7 where sub-atmospheric pressure may be maintained, FIGS. 7, 8. Specifically, with reference to FIGS. 7, 8, and 9, an overlay cover 40, 50 may be provided over the damaged cardiac tissue 7 and porous material 10 by adhering the cover 40, 50 to cardiac tissues proximate the damaged cardiac tissue 7 to define an enclosed region 48, 58 about the damaged cardiac tissue 7 and porous material 10. For instance, the cover 40 may be glued to cardiac tissue using an adhesive 41, such as a fibrin glue. The adhesive 41 may comprise an auto-polymerizing glue and/or may desirably include a filler to provide the adhesive 41 with sufficient bulk to permit the adhesive 41 to conform to the shapes of the potentially irregular surfaces which the adhesive 41 contacts. The adhesive 41 may be provided as a separate component or as a portion of the cover 40. For the flexible overlay cover 40, an outside edge or border of the flexible overlay cover 40 may either be rolled away from (or laid flat on) the non-damaged cardiac tissue 6 or rolled under (or toward) the damaged cardiac tissue 7, FIGS. 7, 8. The adhesive 41 may be placed between the edge of the overlay cover 40 and the healthy cardiac tissue 6 to promote an airtight seal. The adhesive 41 may also be placed around the tube 20 where it exits through the overlay cover 40. Alternatively, a self-adhesive flexible overlay cover 50 may be curled out away from the damaged cardiac tissue 7 so that the underside of the cover 50 (that side facing the porous material 10) may then contact with the surrounding non-damaged cardiac tissue 6, FIG. 9.

In addition to an open-cell collagen material, the porous material 10 may also include a polyglycolic and/or polylactic acid material, a synthetic polymer, a flexible sheet-like mesh, an open-cell polymer foam, a foam section, a porous sheet, a polyvinyl alcohol foam, a polyethylene and/or polyester material, or other suitable materials which may be fabricated by electrospinning, casting, or printing, for example. Such materials include a solution of chitosan (1.33% weight/volume in 2% acetic acid, 20 ml total volume) which may be poured into an appropriately sized mold. The solution is then frozen for 2 hours at −70° C., and then transferred to the lyophylizer and vacuum applied for 24 hours. The dressing may be cross-linked by 2.5%-5% glutaraldehyde vapor for 12-24 hours to provide a cast porous material.

Additionally, the porous material 10 may be made by casting polycaprolactone (PCL). Polycaprolactone may be mixed with sodium chloride (1 part caprolactone to 10 parts sodium chloride) and placed in a sufficient volume of chloroform to dissolve the components. A desired amount, e.g., 8 ml, of the solution may be poured into an appropriately sized and shaped container and allowed to dry for twelve hours. The sodium chloride may then be leached out in water for 24 hours.

The overlay cover 40 may also be bio-incorporable and may consist of an electrospun mixture of Type I collagen and poly 1,8-octanediol citrate (POC) (80%:20% weight/weight). The solution concentration may be 15% dissolved in hexafluoro-2 proponal (HFP) with a total volume of 9.5 ml. The solution may then be ejected from a syringe through an 18 gauge needle at a flow rate of 1-3 ml/hour. The voltage may be 25 KV with a working distance of 20-25 cm. The film may then be heat polymerized at 80° C. for 48 hours (of 90° C. for 96 hours) and cross-linked in 2.5%-10% glutaraldehyde vapor for 24 hours.

It is also possible to use electrospun materials for the porous material 10 and cast materials for the overlay cover 40. One example of a formulation and method for making an electrospun porous material 10 is a combination of collagen Type I:chondroitin-6-sulfate (CS):poly 1,8-octanediol citrate (POC) in a ratio of 76%:4%:20%: by weight. Two solvents were utilized for the collagen/CS/POC. The CS was dissolved in water and the collagen and POC were dissolved in 2,2,2-trifluoroethanol (TFE). A 20% water/80% TFE solution (volume/volume) solution was then used. For electrospinning, the solution containing the collagen:CS:POC mixture was placed in a 3 ml syringe fitted to an 18 Ga needle. A syringe pump (New Era Pump Systems, Wantaugh, N.Y.) was used to feed the solution into the needle tip at a rate of 2.0 ml/hr. A voltage of 10-20 kV was provided by a high voltage power supply (HV Power Supply, Gamma High Voltage Research, Ormond Beach. FL) and was applied between the needle (anode) and the grounded collector (cathode) with a distance of 15-25 cm. The dressings were then cross-linked with glutaraldehyde (Grade II, 25% solution) and heat polymerized (80° C.) for 48 hours. It is also possible to electrospin collagen Type I dressings starting with an initial concentration of 80 mg/ml of collagen in 1,1,1,3,3,3-hexafluoro-2-propanol (HFP), then use the same electrospinning conditions as the collagen:CS:POC combination.

Examples of cast overlay cover formulas include the use of 1,8 poly (octanediol) citrate (POC) or other combinations of diol citrates, which could be 1,6 hexanediol or 1,10 decanediol, for example. To make the cast overlay cover 40, equimolar amounts of anhydrous citric acid and the diol of choice may be combined in a round bottom flask. (As an example: 38.4 g citric acid and 29.2 g octanediol). The solution may be heated in an oil bath for 10 min at 165° C. until melted, then continued to be heated at 140° C. for 45 min. The polymer may be used in this form although unreacted monomers are also present. To remove the unreacted monomer, equivolume amounts of polymer and 100% acetone may be added to a flask and shaken until the polymer is completely dissolved, then poured into an appropriately shaped mold. The acetone may be evaporated overnight in a chemical hood at room temperature. The films may be polymerized at 80° C. for 36 hr and then 18 hr at 110° C.

Alternatively, to cast overlay covers 40 of chitosan, a solution of 2% acetic acid in water may be added to 1% chitosan weight/volume. (For example 400 μl acetic acid may be added to 20 ml water, then 200 mg chitosan added.) Films may be prepared by pouring the mixture directly into the mold and allowing the solution to dry overnight. Cast overlay covers 40 of poly L (lactic acid) or poly D,L (co-glycolic lactic acid) dissolved in chloroform can also be made by pouring the solution into molds and evaporating the solvent (chloroform) off.

An additional method for creating porous materials 10 and overlay covers 40 is to use thermal inkjet printing technologies. Bio-incorporable materials such as collagen, elastin, hyaluronic acid, alginates, and polylactic/polyglycolic acid co-polymers may be printed. As examples, Type I collagen (Elastin Products Co., Owensville, Mo.) dissolved in 0.05% acetic acid, then diluted to 1 mg/ml in water can be printed, as can sodium alginate (Dharma Trading Co., San Raphael, Calif.) 1 mg/ml in water. A mixture of Type I collagen (2.86 mg/ml in 0.05% acetic acid) and polylactic/polyglycolic acid (PURAC America, Blair, Nebr.) (14.29 mg/ml in tetraglycol (Sigma Aldrich, St. Louis Mo.)) can also be printed. Hardware from a Hewlett Packard 660c printer can be attached to a platform for which the height can be adjusted for printing in layers. With minimal changes to the hardware, no software changes need to be made.

Turning to FIG. 5, the porous material 10 may comprise layers, with the layer 112 closest to the damaged cardiac tissue containing pores sufficiently small at the interface between the porous material 110 and the damaged cardiac tissue 7 to prevent the growth of tissue therein, e.g., a pore size smaller than the size of fibroblasts and cardiac cells. Otherwise the porous material 110 may stick to the damaged cardiac tissue 7 and cause bleeding or trauma, and potentially even disruption of the ventricular wall when the porous material 110 is removed. Additionally, growth of tissues into the porous material 110 may result in eventual erosion through the ventricular wall or pleural tissues with continual movement and rubbing of the porous material 110 against these tissues if the porous material 110 is left in the patient. Further, growth of tissues into the porous material 110 may result in non-contractible scar formation within the porous material or potential calcification of tissues within the porous material 110 if the porous material 110 is left within the patient. In addition, the pore size at the interface between the porous material 10, 110 and the damaged cardiac tissue 7 may be sufficiently small so as to avoid the excessive production of granulation or scar tissue at the damaged cardiac tissue 7 which may interfere with the physiologic function of the heart. At the same time, the pore size of the porous material 10, 110 may be large enough to allow movement of proteins the size of albumin therethrough to permit undesirable compounds to be removed, such as mediators, degradation products, and toxins.

The porous material 10, 110 may, however, have a larger pore size (e.g., larger than that of fibroblasts and cardiac cells) interior to the porous material 10, 110 or at any other location of the porous material 10 that is not in contact with cardiac tissue 7. For example, the porous material 110 may comprise a multi-layer structure with a non-ingrowth layer 112 having a sufficiently small pore size to prevent the growth of tissue therein for placement at the cardiac tissue 7, and may have an additional layer 114 of a different material that has a relatively larger pore size in contact with the non-ingrowth layer 112.

Alternatively, as depicted in FIG. 6, the porous material 210 may be homogeneous in composition and/or morphology. At a location away from the interface with the damaged cardiac tissue, the porous material 210 may have a pore size sufficiently large to promote the formation of granulation tissue at other tissues in the spaces surrounding the damaged cardiac tissue, such as promotion of granulation tissue in areas where cardiac disruption has occurred. In addition, the porous material 210 may have a configuration in which one or more sides or surfaces 212 of the porous material 210 are sealed to prevent the transmission of sub-atmospheric pressure through such a sealed surface 212, while at the same time having at least one surface 214 through which sub-atmospheric pressure may be transmitted. Such a configuration of the porous material 210 can present preferential treatment of tissue on one side of the porous material 210 while not treating tissue on the other side. For instance, the damaged cardiac tissue could be treated with the non-sealed interface on one side 214 of the porous material 210.

In addition, the porous material 10 may comprise a non-metallic material so that an MRI can be performed while the porous material 10 is in situ. The porous material 10 may also comprise a material that is sufficiently compliant so that it does not interfere with cardiac function. At the same time, the porous material 10 may comprise a material that is sufficiently firm so that the porous material 10 does not collapse so much as to create a pull on, or distortion of, the cardiac tissue 6, 7 that might interfere with cardiac function.

Turning to FIG. 7, to deliver sub-atmospheric pressure to the porous material 10 for distribution to the damaged cardiac tissue 7, a tube 20 may be connected directly or indirectly in gaseous communication with the porous material 10 at the distal end 22 of the tube 20. For example, the distal end 22 of the tube 20 may be embedded in the porous material 10 or may be placed over the porous material 10. The distal end 22 of the tube 20 may also include one or more fenestrations 23 to assist in delivering the sub-atmospheric pressure to the porous material 10 and the damaged cardiac tissue 7. The tube 20 may extend through an opening in the skin 1 and subcutaneous tissue 2 which may be secured about the tube 20 with a suture 8 to assist in providing a seal about the tube 20. The proximal end 24 of the tube 20 may be operably connected to a vacuum source 30 (e.g., The V.A.C., Model 30015B, Kinetic Concepts, Inc., San Antonio, Tex.) to provide sub-atmospheric pressure that is transmitted via the tube 20 to the porous material 10 and the damaged cardiac tissue 7.

The vacuum source 30 may include a controller 32 to regulate the production of sub-atmospheric pressure. For instance, the vacuum source 30 may be configured to produce sub-atmospheric pressure continuously or intermittently; e.g., the vacuum source 30 may cycle on and off to provide alternating periods of production and non-production of sub-atmospheric pressure. The duty cycle between production and non-production may be between 1 to 10 (on/off) and 10 to 1 (on/off). In addition, intermittent sub-atmospheric pressure may be applied by a periodic or cyclical waveform, such as a sine wave, or may be cycled after initial treatment to mimic a more physiologic state, such as the heart rate. The sub-atmospheric pressure may also be cycled on-off as-needed as determined by monitoring of the pressure in the damaged cardiac tissue 7. In general, the vacuum source 30 may be configured to deliver sub-atmospheric pressure between atmospheric pressure and 200 mm Hg below atmospheric pressure to minimize the chance that the sub-atmospheric pressure may result in reduction in localized blood flow due to either constriction of capillaries and small vessels or due to congestion (hyperemia) within the damaged cardiac tissue 7 or otherwise be deleterious to the damaged cardiac tissue 7. The application of such a sub-atmospheric pressure can operate to remove edema from the damaged cardiac tissue 7, thus preserving cardiac function to increase the probability of recovery and survival in a more physiologically preserved state.

Turning to FIG. 10, sub-atmospheric pressure may be delivered under the cover 50 by cooperation between the cover 50 and the tube 20. Specifically, the flexible overlay cover 40 (or self-adhesive flexible overlay cover 50) may include a passthrough 52 through which the distal end 22 of the tube 20 passes to provide gaseous communication between the tube 20 and the space under the flexible overlay cover 40 over the damaged cardiac tissue.

In another of its aspects, the present invention also provides a method for treating damaged cardiac tissue using sub-atmospheric pressure with, by way of example, the devices illustrated in FIGS. 1-4. In particular, the method may comprise locating a porous material 10 proximate the damaged cardiac tissue 7 to provide gaseous communication between one or more pores of the porous material 10 and the damaged cardiac tissue 7. The porous material 10 may be sealed in situ proximate the damaged cardiac tissue 7 to provide a region about the damaged cardiac tissue 7 for maintaining sub-atmospheric pressure at the damaged cardiac tissue 7. In this regard, the muscles 3, and bone 4 may be loosely re-approximated over top of the porous material 10 with the tube 20 exiting through the skin 1 and subcutaneous tissue 2 and the skin 1 and subcutaneous tissue 2 sutured closed. A further airtight dressing may optionally be placed over the suture site to promote an airtight seal. The porous material 10 may be operably connected with a vacuum source 30 for producing sub-atmospheric pressure at the damaged cardiac tissue 7, and the vacuum source 30 activated to provide sub-atmospheric pressure at the damaged cardiac tissue 7. For example, the sub-atmospheric pressure may be maintained at about 25 to 125 mm Hg below atmospheric pressure. The sub-atmospheric pressure may be maintained at the damaged cardiac tissue 7 for a time sufficient to decrease edema at the damaged cardiac tissue 7. In addition, the sub-atmospheric pressure may be maintained at the damaged cardiac tissue 7 for a time sufficient to prepare the cardiac tissue 7 to achieve a stage of healing and diminution of edema and inflammatory mediators or amplifiers. The method may be used for at least 2 hours, or can be used for many days. At the end of the vacuum treatment, the sutures 8 may be removed and the skin 1, subcutaneous tissue 2, muscles 3 and bone 4 re-opened. The porous material 10 may then be removed and the skin 1, subcutaneous tissue 2, and/or muscles 3 re-sutured closed.

The method may also include locating an overlay cover 40, 50, such as a bio-incorporable cover 40, 50, over the damaged cardiac tissue 7 and sealing the overlay cover 40, 50 to tissue proximate the damaged cardiac tissue 7 for maintaining sub-atmospheric pressure at the damaged cardiac tissue 7. The step of sealing the overlay cover 40, 50 to tissue surrounding the damaged cardiac tissue 7 may comprise adhesively sealing and adhering the overlay cover 40, 50 to tissue surrounding the damaged cardiac tissue 7. The overlay cover 50 may be provided in the form of a self-adhesive sheet 50 which may be located over the damaged cardiac tissue 7. In such a case, the step of sealing the overlay cover 50 may include adhesively sealing and adhering the self-adhesive overlay cover 50 to non-damaged cardiac tissue 6 surrounding the damaged cardiac tissue 7 to form a seal between the overlay cover 50 and the non-damaged cardiac tissue 6 surrounding the damaged cardiac tissue 7. In addition, the step of operably connecting a vacuum source 30 in gaseous communication with the porous material 10 may comprise connecting the vacuum source 30 to the tube 20 which attaches to the vacuum port 42 of the cover 140 FIG. 11.

In still another aspect of the present invention, in addition to injured tissues and organs, the devices and methods may also be used to increase the size and function of diseased or damaged organs. For example, the size of a partially functioning kidney may be increased to a size sufficient to return the total filtering capacity to normal levels, FIGS. 12-14, such as the increase in size of the remaining kidney 301 as is observed in patients who only have one functioning kidney 301. In such a situation, a rigid or semi-rigid bi-valved enclosure 304 with an opening 305 for the vascular pedicle may be placed around the kidney 301. When the bi-valved enclosure 304 is closed, the area where the two halves meet creates an air tight seal. The vascular pedicle enters (artery 302) and exits (vein 303) through the opening 305. Fibrin glue 306 or other biocompatible sealant may be placed around the artery 302 and vein 303 at the site of the opening 305 to create an airtight seal. The enclosure 304 may include a second opening 305 or a nipple 308. A tube 309 may be inserted through the second opening 305 or attached to the nipple 308. The tube 309 may exit through the skin, be connected to a collection vessel, and then connected to a vacuum source. A controlled vacuum of up to 125 mm Hg sub-atmospheric pressure may be applied either intermittently, with an ‘on’ time of up to five minutes and an ‘off’ time of up to 10 minutes. Alternatively, the vacuum may be applied in a periodic or cyclical manner, such as a sine wave, in which the absolute value of the lower (closest to atmospheric pressure) values of the applied vacuum are less than the diastolic blood pressure to allow blood to flow out of the treated organ. The time in which the applied vacuum is greater (in absolute value) than the diastolic blood pressure may be up to five minutes, with the time in which the applied vacuum is lower (in absolute value) than the diastolic blood pressure may be up to ten minutes. The technique is continued until the treated organ has either reached the desired level of function or fills the container. As an additional example, this device and technique may similarly be used on lobes of the liver or for increasing the size of the pancreas.

EXAMPLES Example 1

The porcine heart has anatomy similar to that of humans with the main vasculature consisting of the right and left coronary arteries. The left main coronary artery splits into the circumflex coronary artery and the left anterior descending (LAD) coronary artery. The LAD runs down along the anterior septum and perfuses the anterior portion of the left ventricle with diagonal branches. For these studies, a porcine model of ischemia-reperfusion was used that included the temporary ligation of 2-3 diagonal branches of the LAD in order to create an ischemic area on the anterior portion of the heart. These coronary arteries were occluded for 75 minutes and then reperfused for 3 hours to allow for ischemia/reperfusion injury to develop. The negative pressure therapy was applied only during the reperfusion phase of the experiments to simulate a clinically relevant treatment window.

To begin the study, the animals were sedated and transported to the operating room. The first 13 animals had the heart exposed through a thoracotomy, all subsequent animals had the heart exposed through a sternotomy. The 2-3 diagonal branches of the LAD were ligated (occluded with suture) in order to create an ischemic area on the anterior portion of the heart. These coronary arteries were occluded for 75 minutes and then reperfused for 3 hours to allow for reperfusion injury to develop. The negative pressure therapy was applied only during the reperfusion phase of the experiments to simulate a clinically relevant treatment window. Five control animals were created from the first 13 animals of the study.

Following successful completion of control animals to validate the study design, the subsequent 5 successful (sternotomy) animals had negative pressure therapy treatment to the ischemic area of the heart for 3 hours during the reperfusion time. For the first 5 successfully treated animals, the vacuum dressing included use of a polyvinyl alcohol porous material (Versafoam, KCl, San Antonio Tex.), cut to approximately 1 mm thickness and trimmed to match the ischemic area. The evacuation tube was either embedded into a slit cut into the porous material (2 animals), or was sutured to the outer surface of the porous material (3 animals). This vacuum dressing was then covered with a biologically derived overlay cover. These biological coverings included: 1 animal treated with E•Z DERM™ (Non-perforated porcine biosynthetic wound dressing, Brennen Medical, St. Paul, Minn.); 1 animal treated with bovine pericardium; and 3 animals treated with AlloDerm® (human dermis) (LifeCell). The overlay covers were attached to the heart by three means: suturing, fibrin glue, and self sealing due to a relatively large ‘apron’ of the cover material around the periphery of the vacuum dressing. The evacuation tube exited from under the edge of the ‘apron’ of the overlay covers. The fibrin glue was used in conjunction with suturing and also with spot sealing for the self sealing application (at wrinkles, where the evacuation tube exited, etc.). Negative pressure of 125 mm Hg (i.e., 125 mm Hg below atmospheric) was then applied for 3 hours during the reperfusion period using The V.A.C., Model 30015B, Kinetic Concepts, Inc., San Antonio, Tex.

To determine the effects of ischemia/reperfusion, the sutures were re-tied at the end of the 3 hour reperfusion period. Blue dye (patent blue, Sigma-Aldrich Inc, St. Louis, Mo.) was injected into the right atrium. This stained the areas of the heart that were normally perfused. The left ventricle was dissected free from the rest of the heart and weighed (LV in Table). The area of ischemia (non-blue area) was further dissected from the left ventricle. The blue area of the left ventricle was then weighed (Blue in Table). The ischemic area (non-blue tissue) was then stained with a dye (2,3,5-triphenyltetrazolium chloride, Sigma-Aldrich Inc., St Louis Mo.) which stains live cells red. The red areas were dissected from the area of ischemia and were weighed (Red in Table), leaving areas of pale dead tissue (area of necrosis—AN in Table), and these pale tissue samples were weighed (Pale in Table). The combined Red and Pale areas constitute the area at risk (AAR in Table). The AN/AAR is the size of the infarct (percent of tissue that died during the ischemia/reperfusion time periods).

The results for the 5 control animals were:

TABLE 1
Control Animals
AAR/ AN/
Pale LV AAR
Blue Red (AN) LV AAR (%) (%)
Animal 1 75.6 5.85 2.18 83.63 8.03 9.60 27.15
Animal 2 90.5 10.63 2.44 103.57 13.07 12.62 18.67
Animal 3 85.39 12.16 4.26 101.81 16.42 16.13 25.94
Animal 4 92.45 8.17 3.47 104.09 11.64 11.18 29.81
Animal 5 81.24 9.86 4.34 95.44 14.20 14.88 30.56
Mean 97.71 12.67 12.88 26.43
Std Dev 8.59 3.13 2.66 4.73
N 5.00 5.00 5.00 5.00
Std Err 3.84 1.40 1.19 2.12

The results for the 5 treated animals were:

TABLE 2
−125 mm Hg Treated Animals
AAR/ AN/
LV AAR
Group Blue Red Pale LV AAR (%) (%)
Animal 1 73.06 10.31 1.23 84.60 11.54 13.64 10.66
Animal 2 73.2 5.9 0.61 79.71 6.51 8.17 9.37
Animal 3 75 11.15 2.05 88.20 13.20 14.97 15.53
Animal 4 54.1 4.85 0.52 59.47 5.37 9.03 9.68
Animal 5 62.12 8.63 1.42 72.17 10.05 13.93 14.13
Mean 76.83 9.33 11.95 11.87
Std Dev 11.41 3.32 3.11 2.78
N 5.00 5.00 5.00 5.00
Std Err 5.10 1.48 1.39 1.24

Thus, the mean sizes of the infarct (AN/AAR; percent of tissue that died during the ischemia/reperfusion time period) for the control and treated animals were:

Control 26.43+/−2.12% (mean+/−SEM) (n=5)

Treated 11.87+/−1.24% (mean+/−SEM) (n=5),

with T-test results of P<0.001 for infarct size and P<0.625 for area at risk.

Example 2

Another experiment was conducted using 50 mm Hg vacuum for treatment for comparison to original control animals from Example 1 above. The surgical technique in this experiment was similar to that used for those of Example 1. These animals were sedated and prepped for surgery. The heart was exposed through a midline sternotomy. Branches of the left anterior descending artery were ligated for 75 minutes. A polyvinyl alcohol vacuum dressing was placed over the ischemic area and an AlloDerm® cover was placed over the vacuum dressing and sealed into place with a combination of sutures and fibrin glue. Negative pressure of 50 mm Hg was applied for 3 hours. At the end of this time the heart was stained for area of risk, removed and then counter stained for area of necrosis. The infarct size results for these five, 50 mm Hg negative pressure therapy animals were significantly smaller (P<0.001) than for the control animals. The infarct size for the 50 mm Hg treated animals was smaller than the infarct size for the 125 mm Hg treated animals, but was not significantly smaller.

Group AAR/LV (%) AN/AAR
Control 12.9 ± 1.2 26.4 ± 2.1 
 50 mm Hg negative 11.8 ± 2.0  9.3 ± 1.8 **
pressure
125 mm Hg negative 11.9 ± 1.4  11.9 ± 1.2 **
pressure
** p < 0.001 compared to Control animals

The mean arterial pressure and heart rate of animals in all three groups (control, −125 mm Hg, −50 mm Hg) were comparable during the course of these experiments.

Fifteen micron neutron-activated microspheres (BioPAL, Inc, Worcester, Mass.) were injected into the left atrium at baseline, end of ischemia, 30 minutes into reperfusion and at 180 minutes of reperfusion (end of the experiment). A reference sample of arterial blood was simultaneously drawn from the femoral artery at a rate of 7 mL per minute for ninety seconds. Following infarct sizing procedures, tissue samples from the non-ischemic (blue tissue), ischemic non-necrotic (red tissue), and ischemic necrotic areas (pale tissue) were collected and sent to the manufacturer for blood flow analysis (BioPAL, Inc., Worchester, Mass.). Blood flow was calculated as [(FR×CPMT)/CPMR)/tissue weight in grams, where FR=reference sample flow rate (7 mL/min), CPMT=counts per minute in tissue samples and CPMR=counts per minute in the reference blood sample. Blood flow is reported as mL/min/gram tissue.

Analysis of blood flow reveals that both treated groups had similar baseline blood flows in all 3 regions. In the normally perfused non-ischemic zone, blood flow remained relatively constant throughout the experiment with no significant group or time related differences. (Table 3) In the ischemic, non-necrotic (red) and ischemic, necrotic zones (pale), ischemia was characterized by an equivalent and nearly complete loss of blood flow among all three groups. These zones also exhibited normal reactive hyperemia (30 minutes after reperfusion), and blood flow that returned approximated baseline flow levels by the end of the 3 hour reperfusion time. (Table 4).

TABLE 3
Blood flow (ml/minute/gram tissue) from microsphere analysis
Baseline
Control −125 mm Hg −50 mm Hg
Animal blue Red Pale blue Red Pale blue Red Pale
1 0.36 0.328 0.333 0.596 1.1 0.77
2 1.072 0.709 0.716 0.308 0.401 0.448 0.474 0.321 0.551
3 0.378 0.347 0.505 0.392 0.411 0.353 0.531 0.444 0.422
4 0.577 0.729 0.599 0.643 1.32 0.82 0.625 0.629 0.699
5 0.376 0.495 0.412 0.423 0.687 0.482 0.393 0.57 0.596
Mean 0.603 0.57 0.558 0.4252 0.629 0.487 0.524 0.613 0.608
SD 0.33 0.18 0.13 0.13 0.41 0.20 0.09 0.30 0.13
N 4 4 4 5 5 5 5 5 5
SEM 0.16 0.09 0.07 0.06 0.18 0.09 0.04 0.13 0.06
During Occlusion
Control −125 mm Hg −50 mm Hg
Animal Blue Red pale blue Red pale blue Red pale
1 0.345 0.065 0.012 0.387 0.056 0.025
2 1.031 0.073 0.0255 0.335 0.064 0.029 0.352 0.008 0.029
3 0.3 0.016 0.022 1.196 0.06 0.051 0.714 0.024 0.041
4 0.428 0.129 0.017 0.454 0.084 0.071 0.494 0.038 0.035
5 0.4 0.024 0.011 0.509 0.054 0.029 0.441 0.037 0.1
Mean 0.540 0.061 0.0189 0.568 0.065 0.038 0.478 0.033 0.046
SD 0.33 0.05 0.01 0.36 0.01 0.02 0.14 0.02 0.03
N 4 4 4 5 5 5 5 5 5
SEM 0.17 0.03 0.00 0.16 0.01 0.01 0.06 0.01 0.01
Reperfusion 30 minutes
Control −125 mm Hg −50 mm Hg
Animal blue red pale blue Red pale blue red pale
1 0.379 1.341 1.022 0.441 1.355 2.361
2 1.102 1.522 1.872 0.37 0.559 0.692 0.402 0.628 0.708
3 0.348 0.54 0.286 0.298 0.878 0.6 0.741 1.699 1.626
4 0.439 1.054 1.225 1.439 0.909 1.288 0.603 1.126 1.477
5 0.496 1.272 1.4 0.676 1.866 1.147
Mean 0.596 1.097 1.196 0.622 0.922 0.901 0.573 1.335 1.464
SD 0.34 0.42 0.67 0.55 0.32 0.32 0.15 0.49 0.61
N 4 4 4 4 4 4 5 5 5
SEM 0.17 0.21 0.33 0.27 0.16 0.16 0.07 0.22 0.27
Reperfusion 180 minutes
Control −125 mm Hg −50 mm Hg
Animal blue red pale blue Red Pale blue red Pale
1 0.404 0.367 0.795 0.467 0.385 0.837
2 1.102 1.522 1.872 0.291 0.365 0.6 0.593 0.186 0.649
3 0.348 0.54 0.286 0.38 0.303 0.515 0.804 0.649 0.699
4 0.439 1.054 1.225 0.513 0.449 0.845 0.912 0.803 0.946
5 0.496 1.272 1.4 0.53 0.477 0.76 0.483 0.471 0.495
Mean 0.596 1.097 1.196 0.424 0.392 0.703 0.652 0.499 0.725
SD 0.34 0.42 0.67 0.10 0.07 0.14 0.20 0.24 0.17
N 4 4 4 5 5 5 5 5 5
SEM 0.17 0.21 0.33 0.04 0.03 0.06 0.09 0.11 0.08

TABLE 4
Regional Myocardial blood flow (mL/min/100 g tissue)
Control −50 mm Hg −125 mm Hg
Blue Red Pale Blue Red Pale Blue Red Pale
Baseline 0.60 ± 0.16 0.57 ± 0.09 0.56 ± 0.07 0.52 ± 0.04 0.61 ± 0.13 0.61 ± 0.06 0.43 ± 0.06 0.63 ± 0.18 0.49 ± 0.09
Occlusion 0.54 ± 0.17 0.06 ± 0.03 0.02 ± 0.00 0.48 ± 0.06 0.03 ± 0.01 0.05 ± 0.01 0.57 ± 0.16 0.07 ± 0.01 0.04 ± 0.01
R30 0.60 ± 0.17 1.10 ± 0.21  1.2 ± 0.33 0.57 ± 0.07 1.33 ± 0.22 1.46 ± 0.27* 0.62 ± 0.27 0.92 ± 0.16 0.90 ± 0.16
R180 0.41 ± 0.04 1.39 ± 0.35 0.95 ± 0.16 0.65 ± 0.09 0.50 ± 0.11 0.73 ± 0.08 0.42 ± 0.04 0.39 ± 0.03 0.70 ± 0.06*
Regional myocardial blood flow was determined in 3 regions of the heart: 1) non-ischemic left ventricle; 2) ischemic, non-necrotic left ventricle; 3) necrotic left ventricle.
*p < 0.05 vs Control within a time period and within tissue area;
p < 0.05 vs. Baseline within group and tissue area.

Example 3

A subsequent study was performed to examine resorbable vacuum dressings and overlay covers. One animal was sedated, prepared for surgery as described, and the heart exposed through a mid-line sternotomy. Branches of the LAD were ligated for 90 minutes. The dressing was prepared by freeze drying. A solution of chitosan (1.33% weight/volume in 2% acetic acid, 20 ml total volume) was poured into an appropriately sized mold. The solution was frozen for 2 hours at −70° C., then transferred to the lyophylizer for 24 hours. The dressing was cross-linked by 2.5% glutaraldehyde vapor for 12 hours to provide a porous material. The overlay cover was an electrospun mixture of Type I collagen and poly 1,8-octanediol citrate (POC) (80%:20% weight/weight). The solution concentration was 15% dissolved in hexafluoro-20proponal (HFIP) with a total volume of 9.5 ml. The solution was ejected from a syringe through an 18 gauge needle at a flow rate of 3 ml/hour. The voltage was 25 KV with a working distance of 25 cm. The film was then heat polymerized at 80° C. for 48 hours and cross-linked in 2.5% glutaraldehyde vapor for 24 hours. The overlay cover was able to maintain the vacuum for the duration of the experiment. However, the vacuum dressing did not distribute the vacuum equally throughout the dressing due to collapse and flow of the material under vacuum.

Example 4

A further study was performed to test variations of the overlay cover. Three animals were sedated and the heart exposed through a midline sternotomy. No infarct was created in this study of materials. The overlay cover was created similar to Example 3, but with variations, including changes in voltage, flow rate, and concentration of glutaraldehyde vapor for cross-linking. For these animals, the porous material vacuum dressing was formed from a solution of 80% Type I collagen/20% POC, 12% total concentration in 8.5 ml HFIP was used. The flow rate was 2 ml/hour, with the fluid ejected through an 18 gauge needle at 35 KV with a working distance of 25 cm. The film was heat polymerized at 80° C. for 48 hours, then cross-linked with exposure to 5% glutaraldehyde vapor for 24 hours. The evacuation tube was sutured to a thin polyvinyl alcohol dressing. The dressing was placed over a portion of the left ventricle and tacked in place with 2-4 sutures. The overlay cover was placed over the dressing and fibrin glue was placed around the edges of the overlay cover to insure a vacuum seal. 50 mm Hg was applied continuously to the dressing. For two animals a small air leak developed after approximately 2.5 hours, the source of the leak was not identified despite a diligent search for the source. The source of the leak could have been at the site of a wrinkle in the overlay cover, a tail of the suture material could have punctured a hole in the overlay cover, fluid collecting in the pericardial sack could have ‘floated’ a small portion of the cover off the heart tissue, etc. For the third animal, the negative pressure was maintained for the duration of the study (4 hours application of negative pressure).

Example 5

Two animals were used to test the dressing. The surgical technique was similar to that used above. These animals were sedated, prepped for surgery and the heart exposed through an midline sternotomy. Branches of the left anterior descending artery were ligated for 75 minutes. A dressing was made by casting polycaprolactone (PCL). Polycaprolactone was mixed with sodium chloride (1 part caprolactone to 10 parts sodium chloride) and placed in a sufficient volume of chloroform to dissolve the components. 8 ml of the solution was poured into an appropriately sized and shaped container and allowed to dry for twelve hours. The sodium chloride was then leached out in water for 24 hours. The dressing was cut to the size of the ischemic area. The evacuation tube was sutured to the dressing and the dressing placed over the ischemic area and tacked into place. At the end of the 75 minutes of ischemia the tissue was reperfused. The dressing was covered with AlloDerm® and fibrin glue was placed around the edges of the AlloDerm®. 50 mm Hg vacuum was applied for 3 hours. At the end of this time the heart was stained for area of risk, removed and then counter stained for area of necrosis as described for Examples 1 and 2. For the first animal, the area at risk (ischemic area, AAR) was fairly small at 7.9% of the left ventricle (LV). The infarct size (area of necrosis divided by area at risk (AN/AAR×100%) was very small at 2.6% of the area at risk. For the second animal, the area at risk was larger at 14.3% (AAR/LV), with an infarct size (AN/AAR) of 11.52%.

These and other advantages of the present invention will be apparent to those skilled in the art from the foregoing specification. Accordingly, it will be recognized by those skilled in the art that changes or modifications may be made to the above-described embodiments without departing from the broad inventive concepts of the invention. It should therefore be understood that this invention is not limited to the particular embodiments described herein, but is intended to include all changes and modifications that are within the scope and spirit of the invention as set forth in the claims.

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146Bucknall, T.E. ed., et al., "Wound healing for surgeons," Introduction, Chapter 1 the healing wound, Chapter 2 Wound strength, Chapter 3 Factors affecting healing, Chapter 4 Sutures and dressings, Chapter 5 Clinical trials, Chapter 6 Skin healing and burns, and Chapter 7 the abdominal wall, (1984).
147Bucknall, T.E., et al.. eds., "Sutures and dressings," p. 88-93 in Wound Healing for Surgeons, (1984).
148Bui, T.D., et al., "Negative pressure wound therapy with off-the-shelf components," Am. J. Surg., 192:235-237, (2006).
149Buschbaum, H.J., ed., et al., Strategies in Gynecologic Surgery, pp. 203, Springer-Verlag, NY, (1986).
150Byers, R.M., "Clinical effects of closed suction drainage on wound healing in patients with head and neck cancer,"Arch. Otolaryngol., vol. 108:723-6, (Nov. 1982).
151Calne, S., ed., Position Document: Pain at wound dressings changes, pp. 1-17 and 3 additional sheets, supported by Molnlycke Health Care, (allegedly dated 2002).
152Campbell, P.E., et al., "Retrospective clinical evaluation of gauze-based negative pressure wound therapy," Int. Wound J., 5(2):280-286, (2008).
153Campton-Johnston, S., et al., "Infected wound management: advanced technologies, moisture-retentive dressings, and die-hard methods", Crit. Care Nurs. Q, 24(2):64-77 (Aug. 2001).
154Caniano, D.A., et al., "Wound management with vacuum-assisted closure: experience in 51 pediatric patients", J. Pediatr. Surg., 40(1):128-32 (Jan. 2005).
155Cardozo, M., "A case study of holistic wound management in intensive care", Br. J. Nurs., 12(11 Suppl):S35-37, S40-42 (Jun. 2003).
156Carroll, P., "The Principles of Vacuum and Its Use in the Hospital Environment", Ohmeda, pp. 1-30 and cover sheet.
157Carson, S.N., et al., "Vacuum-assisted closure used for healing chronic wounds and skin grafts in the lower extremities", Ostomy Wound Manage., 50(3):52-8 (9 sheets) (Mar. 2004).
158Catarino, Pedro A., et al., "High-Pressure Suction Drainage via a Polyurethane Foam in the Management of Poststernotomy Mediastinitis", Ann Thorac Surg 2000; 70:1891-5.
159Causa, F., et al., "A multi-functional scaffold for tissue regeneration: The need to engineer a tissue analogue," Biomaterials, 28(34):5093-5099 (Dec. 2007; available online Aug. 6, 2007).
160Cesany, P., "Suction in the Treatment of Torpid Ulcerations," Rozhledy v chirurgii, 48-9, MINCO22894-MINCO22898, cover sheet and pp. 406-409 English abstract on p. 409 (1 sheet printout from PubMed) (Sep. 1969).
161Chardak, W.M., et al., "Experimental studies on synthetic substitutes for skin and their use in the treatment of bums," Ann. Surg., 155(1):127-139, (Jan. 1962).
162Chariker, M. E. et al. (eds), "Effective Management of Incisional and Cutaneous Fistulae with Closed Suction Wound Drainage," Contemporary Surgery, vol. 34, Jun. 1989, pp. 59-63.
163Chariker, M.E., et al., "An algorithmic approach to the use of gauze-based negative-pressure wound therapy as a bridge to closure in pediatric extremity trauma," Plast Reconstr. Surg., 123:1510-1520, (2009).
164Chariker, M.E., Presentation entitled, "Closed wound suction", (Chariker deposition exhibit No. 1219), dated Mar. 17, 2005.
165Chariker, M.E., Presentation entitled, "Vacuum therapy in wound management", (Chariker deposition exhibit No. 1220), dated Oct. 27, 2005.
166Chariker/Jeter/Tintle Slides "Closed Wound Suction" by Dr. Mark Chariker et al., 41 sheets, pp. 1-10, 19, 55-84 (D-041) (allegedly dated 1985 and 1986).
167Chariker-Jeter Status Link from the website www.trademark.com/cbi-bin/tmlist, Oct. 14, 2005, 1 page.
168Chariker-Jeter Technique Tutorial by Penny E. Campbell, Wound Care Solutions, 1 page tutorial chart.
169CHARIKER-JETER® Wound Drainage Kit Instructions, Item #500.7777, BlueSky Medical, 2 pages.
170CHARIKER-JETER® Wound Drainage Kit, BlueSky Medical, 2 page advertisement with copy of business card from Quality Medical Supply.
171CHARIKER-JETER® Wound Sealing Kit, Would Application Instructions, 1 page advertisement.
172Chen, D., et al., "Application of electrostatic spinning technology in nano-structured polymer scaffold," Zhongguo Xiu Fu Chong Jian Wai Ke Za Zhi, 21(4):411-415 (Apr. 2007), 1 sheet abstract.
173Chen, K.D., et al., "Mechanotransduction in response to shear stress", J. Biol. Chem., 274(26):18393-18400, (Jun. 25, 1999).
174Chen, S.Z., et al., "Effect of vacuum-assisted closure on the expression of proto-oncogenes and its significance during wound healing", Zhonghua Zheng Xing Wai Ke Za Zhi, (English abstract on first page, 2 sheets printout from PubMed); 21:197-200 (May 2005).
175Chen, S.Z., et al., "Effects of vacuum-assisted closure on wound microcirculation: an experimental study", Asian J. Surg., 28(3):211-7 (Jul. 2005).
176Chen, Y., et al., "Increased osteoblast functions in the presence of BMP-7 short peptides for nanostructured biomaterial applications," J. Biomed. Mater. Res. A 91:296-304 (2009; published online Nov. 3, 2008).
177Chester, D., et al., "Adverse Alteration of Wound Flora with Topical Negative-Pressure Therapy: A Case Report", British Journal of Plastic Surgery, 2002, pp. 510-511.
178Chinn, S.D., "Closed wound suction drainage," J. Foot Surg., vol. 24: 76-81, (Jan.-Feb. 1985).
179Chronakis, I.S., "Novel nanocomposites and nanoceramics based on polymer nanofibers using electrospinning process-A review," Journal of Materials Processing Technology 167:283-293 (2005).
180Chung, C.J., et al., "Case review: management of life-threatening sepsis and wound healing in a Klippel-Trenaunay patient using serial surgical debridements and vacuum-assisted closure", Eur. J. Plast. Surg., 26:214-216 (2003).
181Clare, M.P., et al., "Experience with the vacuum assisted closure negative pressure technique in the treatment of non-healing diabetic and dysvascular wounds", Foot Ankle Int., 23(10):896-901 (Oct. 2002).
182Claxton, M.J., et al., "Healing the diabetic wound and keeping it healed: modalities for the early 21st century", Curr. Diab. Rep., 2(6):510-B (Dec. 2002).
183Clubley, L., et al., "Using negative pressure therapy for healing of a sternal wound", Nurs. Times. 101(16):44-6 (Apr. 19, 2005).
184Cobb, J., "Why Use Drains", The Journal of Bone and Joint Surgery, Nov. 1990, pp. 993-995, vol. 72-B, No. 6.
185Coggrave, M., et al., "Topical negative pressure for pressure ulcer management", Br. J. Nurs., 11(6 Suppl):S29-31, S33-34, S36 (Mar. 2002).
186Cohen-Adad J, Leblond H, Delivet-Mongrain H, Martinez M, Benali H, Rossignol S. Wallerian degeneration after spinal cord lesions in cats detected with diffusion tensor imaging. Neuroimage, 2011. 57(3): p. 1068-76. NPL-1006.
187Collier, M., "Know how: Vacuum assisted closure (VAC)", Nurs. Times, 93(5):32-3 (Jan. 29-Feb. 4, 1997).
188Collier, M., "Topical negative pressure therapy", Nurs. Times, 99(5):54-5 (Feb. 4-10, 2003).
189Colwell, A.S., et al., "Management of early groin vascular bypass graft infections with sartorius and rectus femoris flaps", Ann. Plast. Surg., 52(1):49-53 (Jan. 2004).
190Connolly, T.P., "Necrotizing surgical site infection after tension-free vaginal tape", Obstet. Gynecol., 104(6):1275-6 (4 pages) (Dec. 2004).
191Conquest, A.M., et al., "Hemodynamic effects of the vacuum-assisted closure device on open mediastinal wounds,"J. Surg. Res., 115(2):209-13 (Dec. 2003).
192ConstaVac™ Closed Wound Drainage System, Stryker Instruments, 2 pages. NPL-092.
193Cook Pneumothorax Catheter Set, Wayne Pneumothorax Catheter Set, Emergency Medicine, Videotape advertisement.
194Cooper, D., "Optimizing Wound Healing: A Practice Within Nursing's Domain", Nursing Clinics of North America, Mar. 1990, pp. 165-180, vol. 25, No. 1.
195Cooper, D., "Wound Healing", Nursing Clinics of North America, pp. 163-164 (Mar. 1990).
196Cooper, D., et al., "Postsurgical Nursing Intervention as an Adjunct to Wound Healing", Nursing Clinics of North America, Dec. 1979, pp. 713-726, Nursing Clinics of North America, vol. 14, No. 4. NPL-097.
197Cooper, S.M., et al., "Topical negative pressure", Int. J. Dermatol., 39(12):896-8 (Dec. 2000).
198Cooper, Susan Mary, "Topical negative pressure in the treatment of pressure ulcers", Letters posted in the Journal of the American Acad of Dermatology, August, Part 1, 1999, p. 280.
199Copson, D., "Topical negative pressure and necrotising fasciitis", Nurs. Stand., 18(6):71-2, 74, 76, 78, 80 (Oct. 22, 2003).
200Cornelius, M., "Care in the air Bringing the wounded closer to home," Plast Surg. Nurs., 29(3):165-168, (Jul.-Sep. 2009).
201Cosker, T., et al., "Choice of Dressing Has a Major Impact on Blistering and Healing Outcomes in Orthopaedic Patients", Journal of Wound Care, Vo. 14, No. 1, Jan. 2005, pp. 27-29.
202Covey, D.C. et al., "Orthopaedic war injuries: From combat casulty care to definitive treatment: A current review of clinical advances, basic science, and research opportunities," Instr. Course Lect. 57:65-86 (2008).
203Covey, D.C., "Combat orthopaedics: A view from the trenches," J. Am. Acad. Orthop. Surg., 14:S10-S17, (2006).
204Coyle, M., et al., "A Case Study: Positive Outcomes to Negative Pressure Wound Therapy-A collaborative assessment", Hospital of Saint Raphael, 1 page chart.
205Cozart, R.F., et al., "The use of controlled subatmospheric pressure to promote wound healing in preparation for split-thickness skin grafting in a fourth degree burn", Tenn. Med., 92(10):382-4 (Oct. 1999).
206Cro, C., et al., "Vacuum assisted closure system in the management of enterocutaneous fistulae," Postgrad. Med. J., 78(925):364-5 (Nov. 2002).
207Cruse, P., et al., "A Five-Year Prospective Study of 23,649 Surgical Wounds", Surgical Wounds/Cruse and Foord, Aug. 1973, pp. 206-210, vol. 107. NPL-105.
208Curtin, L., "Wound Management: Care and Cost-An Overview", Nursing Management, Feb. 1984, pp. 22-25, vol. 15.
209Dahlin, P.A., et al., "Cerebrospinal fluid leak because of pressure sore fistula in a quadriplegic," Spine, 12(1):72-75, (1987).
210Dainty, L.A., et al., "Novel techniques to improve split-thickness skin graft viability during vulvo-vaginal reconstruction", Gynecol. Oncol., 97(3):949-52 (Jun. 2005).
211Datiashvili, R.O., et al., "Negative pressure dressings: An alternative to free tissue transfers?"Wounds, 17 (8):206-212 (Aug. 2005).
212David, L.R., et al., "Proboscis lateralis: a rare craniofacial anomaly, reconstruction, and long-term evaluation," J. Craniofac. Surg., 19(4):1107-1113, (Jul. 2008).
213Davidov, Y.A., et al., "Justifying the usage of forced early secondary sutures in treatment of purulent wounds by the vacuum therapy," Vestnik Chirugia 126-129, (2 sheets in English and 3 sheets in Russian) (Mar. 1990).
214Davies , J.W.L, "Synthetic materials for covering burn wounds: Progress towards perfection. Part I. Short term dressing materials", Burns, Nov. 1983;10(2), 94-103.
215Davydov IA, Abramov AI, Larichev AB. Vakuum-terapiia v preduprezhdenii posleoperatsionnoi ranevoi infektsii. [Vacuum therapy in the prevention of postoperative wound infection]. Russian Vestnik Khirurgii Imen I-I-Grekova 1991; 147:91-5, with English Translation.
216Davydov IA, Larichev AB, Smirnov AP, Flegontov VB. Vakuum-terapiia v lechenii ostrykh gnoinykh zabolevanii miagkikh tkanei I gnoinykh ran. [Vacuum therapy of acute suppurative diseases of soft tissues and suppurative wounds]. Russian Vestnik Khirurgii Imeni I-I-Grekova 1988; 141: 43-6 with Eng.Trans.
217Davydov, et al., "Bacteriological and cytological evaluation of the vacuum therapy of suppurative wounds". Vestn. Khir., Oct. 1988 (with English translation).
218Davydov, et al., "Basis of the use of forced early secondary suture in the treatment of suppurative wounds by the vacuum therapy method". Vestn. Khir., Mar. 1990 (with English translation).
219Davydov, et al., "Pathenogenic mechanism of the effect of vacuum therapy on the course of the wound process". Khirurgiia, Jun. 1990 (with English translation).
220Davydov, et al., "Vacuum therapy in the treatment of suppurative lactation mastitis". Vestn. Khir., Nov. 1986 (with English translation).
221Davydov, et al., "Would Healing Under the Conditions of Vacuum Draining", Khirurgiia (Mosk). 1992, (7-8): 21-6 (with English translation by Scientific Translation Services). DV14.
222Davydov, I.A., et al., "Concept of clinico-biological control of the wound", Vestnik khirurgii imeni I.I. Grekova, v. 146, issue 2, 1991, 132-6 (with English translation).
223Davydov, Y., et al., "Bacteriological and Cytological Assessment of Vacuum Therapy of Purulent Wounds," Vestn. Khir., 48-52, English translation by IRC, (Oct. 1988). (Exhibit D-290).
224Davydov, Y., et al., "Vacuum Therapy in the Treatment of Purulent Lactation Mastitis," Vestn. Khir. P. 66-70, English translation by IRC, (Sep. 1986), (Exhibit D-292).
225Davydov, Y.A., et al., "Bacteriological and cytological assessment of vacuum therapy of purulent wounds," (7 sheets of translation, pp. 48-52 of Russian text and English abstract on p. 52); 141(10):48-52 (Oct. 1988).
226Davydov, Y.A., et al., "Bacteriological and cytological evaluation of vacuum therapy of purulent wounds", Vestnik khirurgii, 10:48-52, (5 sheets English, 5 sheets Russian, English abstract on pp. 52) (Received 1987).
227Davydov, Y.A., et al., "Device and method for vacuum therapy of purulent lactation mastites," Khirurgiya, (4):131-132, (Apr. 1988).
228Davydov, Y.A., et al., "Pathogenic mechanisms of the effect of vacuum therapy on the course of the wound process," Khirurgiya, 6:42-47 (7 sheets English and 8 sheets Russian, with English abstract on pp. 46-47) (1990).
229Davydov, Y.A., et al., "The bacteriological and cytological assessment of vacuum therapy of purulent wounds", Vestnik Khirurgii imeni I.I. Grekova, (1 sheet of title page and pp. 48-52, 5 sheets of Russian text and English abstract on p. 52); 141(10):48-52, (Oct. 1988).
230Davydov, Y.A., et al., "Vacuum therapy in the treatment of acute purulent diseases of soft tissues and purulent wounds", (4 sheets of Translation, 4 sheets of Russian text and English abstract on p. 46); 141(9):43-46 (Sep. 1988).
231Davydov, Y.A., et al., "Vacuum therapy in the treatment of acute purulent diseases of soft tissues and purulent wounds", Vest. Khir. 141(9):43-46 (6 sheets English, 6 sheets Russian, English abstract on pp. 46) (1988).
232Davydov, Y.A., et al., "Vacuum therapy in the treatment of purulent lactation mastitis", (8 sheets of English translation, pp. 66-70 of Russian text, and English abstract on p. 70); 137(11):66-70, (Nov. 1986).
233Davydov, Y.A., et al., "Vacuum therapy in the treatment of purulent lactation mastitis", Vestnik Khirurgii Imeni I.I. Grekova, ( 1 Sheet of Title page and pp. 66-70, 6 sheets of Russian text and English abstract on p. 70); 137 (11):66-70, (Nov. 1986).
234Davydov, Y.A., et al., "Vacuum therapy in the treatment of purulent lactation mastitis," pp. 66-70 (5 sheets English, 5 sheets Russian, English abstract on pp. 70) (Received 1986).
235Davydov, Y.A., et al., "Vacuum therapy in treatment of acute purulent diseases of soft tissues and purulent wounds," Vestnik Khirurgii (Surgeon's Herald), No. 9 Medicine Publishers, (5 sheets of translation), (1986).
236De Filippo, R.E., et al., "Stretch and growth: the molecular and physiologic influences of tissue expansion". Plast. Reconstr. Surg., 109(7):2450-2462 (Jun. 2002).
237De Geus, H.R.H., et al., "Vacuum-assisted closure in the treatment of large skin defects due to necrotizing fasciitis", Intensive Care Med., 31(4): 601 (1 page) (Apr. 2005) (Epub Jan. 22, 2005).
238de la Torre, Jorge I., MD, et al., "Healing a Wound with an Exposed Herrington Road: A Case Study", Ostomy Wound Management, pp. 18-19, May 2002, vol. 48, Issue 5.
239de Lange, M.Y., et al., "Vacuum-assisted closure: indications and clinical experience", Eur J Plast Surg (2000) 23:178-182.
240De Leon, J., "Negative pressure wound therapy in pressure ulcer management", Ostomy Wound Manage., 51(2A suppl):3S-8S (Feb. 2005).
241De Vooght, A., et al., "Vacuum-assisted closure for abdominal wound dehiscence with prosthesis exposure in hernia surgery,"Plast. Recont. Surg., 112(4):1186-9 (Sep. 15, 2003).
242Dedmond, B.T., et al., "Subatmospheric pressure dressings in the temporary treatment of soft tissue injuries associated with type III open tibial shaft fractures in children", J. Pediatr. Orthop., 26(6):728-732, (Nov.-Dec. 2006).
243Dedmond, B.T., et al., "The use of negative-pressure wound therapy (NPWT) in the temporary treatment of soft tissue injuries associated with high-energy open tibial shaft fractures", J. Orthop. Trauma, 21(1):11-17, (Jan. 2007).
244Defranzo, A., et al., "4: Vacuum-assisted closure in extremity trauma," in Soft Tissue Surgery, S.L. Moran et al., p. 49-60 and additional sheet, Lippincott Williams & Wilkins (Pub. Apr. 1, 2008).
245Defranzo, A.J., et al., "109: Use of Sub-Atmospheric Pressure for Treatment of Gunshot Injuries", Plastic Surgical Forum, V. XXIII, Los Angeles, CA, Oct. 14-18, 2000, pp. 180-181.
246Defranzo, A.J., et al., "The use of V.A.C. therapy for treatment of lower extremity wounds with exposed bone", 68th Annual Meeting of the American Society of Plastic and Reconstructive Surgeons, New Orleans, LA, pp. 37-38; 2 sheets of abstract (Oct. 24-27, 1999). WFU-42.
247Defranzo, A.J., et al., "The Use of Vacuum-Assisted Closure Therapy for the Treatment of Lower-Extremity Wounds with Exposed Bone", Plastic and Reconstructive Surgery, Oct. 2001, V. 108, N. 5, pp. 1184-1191.
248DeFranzo, A.J., et al., "Vacuum assisted closure for the treatment of abdominal wounds," Clin. Plast. Surg. 33(2):.213-224 (Apr. 2006).
249Defranzo, A.J., et al., "Vacuum assisted closure of the abdominal wall", 73rd annual Meeting, American Association of Plastic Surgeons, Philadelphia, PA (2004), 1 sheet of abstract.
250DeFranzo, A.J., et al., "Vacuum-assisted closure for defects of the abdominal wall," Plast. Reconstr. Surg., 121(3):832-839, (Mar. 2008).
251Defranzo, Anthony J., et al., "Vacuum-Assisted Closure for the Treatment of Degloving Injuries." Plastic and Reconstructive Surgery 104 (7) 2145-48: (1999).
252Deknatel, Div. of Howmedica, Inc. Quenns Village, NY 11429. "Pleur-evac."
253Demaria, R.G., et al., "Topical negative pressure therapy. A very useful new method to treat severe infected vascular approaches in the groin,"J. Cardiovascular Surg., 44(6):757-61 (Dec. 2003).
254Demorest, R.L., "New standards in water vapour permeability testing," British Plastics & Rubber, 3 sheets, (handwritten label on first sheet shows "Exhibit TT"), (May 1995).
255Deng, M., et al., "Biomimetic, bioactive etheric polyphosphazene-poly(lactide-co-glycolide) blends for bone tissue engineering," J. Biomed Mater Res A 92:114-125 (2010; published online Jan. 22, 2009).
256Deng, M., et al., "Miscibility and in vitro osteocompatibility of biodegradable blends of poly[(ethyl alanato) (p-phenyl phenoxy) phosphazene] and poly(lacitic acid-glycolic acid)," Biomaterials 29:337-349 (2008; available online Oct. 17, 2007).
257Deva, A.K., et al., "Vacuum-assisted closure of a sacral pressure sore", J. Wound Care, 6(7):311-312, (Jul. 1997).
258Deva, Anand, K., et al., "Topical negative pressure in wound management", MJA, Vo. 173, pp. 128-131, Aug. 7, 2000.
259Dewan, P.A., et al., "An Alternative Approach to Skin Graft Donor Site Dressing", Aust. N.Z. J. Surg. 1986, 56, 509-510.
260Dieu, T., et al., "Too Much Vacuum-Assisted Closure", ANZ J. Surg. 2003; 73: 1057-1060.
261Dillon, R. Angiology-The Journal of Vascular Diseases, pp. 47-56, Jan. 1986, "Treatment of Resistant Venous Stasis Ulcers and Dermatitis with the End-Diastolic Pneumatic Compression Boot".
262Dobke, M.K., et al., "A novel approach to acute infection of the glenohumeral joint following rotator cuff repair-a case series", Wounds, 17(6):137-40 (6 sheets) (Jun. 2005).
263Domkowski, P.W., et al., "Evaluation of vacuum-assisted closure in the treatment of poststerotomy mediastinitis," J. Thorac. Cardiovasc. Surg., 126(2):386-90 (Aug. 2003).
264Dong, B., et al., "Electrospinning of collagen nanofiber scaffolds from benign solvents," Macromolecular Rapid Communications 30(7):539-542 (Feb. 5, 2009).
265Dongaonkar RM, Stewart RH, Geissler HJ, et al. Myocardial microvascular permeability, interstitial oedema, and compromised cardiac function. Cardiovasc Res Jul. 15, 2010;87(2):331-9. NPL-992.
266Dorland's Illustrated Medical Dictionary , Twenty-Fifth Edition, 1974, pp. 1112.
267Dow Corning Silastic® Foam Dressing: A New Concept in the Management of Open Granulating Wounds, 2 pages of advertisements.
268Downie, P.A., ed., Cash's textbook of medical conditions for physiotherapists, Chapter 1 Inflammation and healing, Chapter 2 Oedema, Chapter 19 Skin conditions, Chapter 20 Bums, B. Lippincott Co., (1979).
269Draper, J., "Make the dressing fit the wound", Nursing Times, Oct. 9, 1985, pp. 32-35. NPL-122.
270Dunbar, A., et al., "Addressing the pain: Silicone net dressings as an adjunct with negative pressure wound therapy", Ostomy Wound Manage., 51(4):18-20 (4 sheets) (Apr. 2005).
271Dunford, C., "Hypergranulation tissue", J. Wound Care, 8(10):506-507 (Nov. 1999).
272Dunford, C.E., "Treatment of a wound infection in a patient with mantle cell lymphoma", Br. J. Nurs., 10(16):1056, 1060, 1062, 1064-5 (Sep. 13-26, 2001).
273Dunlop et al., Br. J. Surg., 77: 562-563 (1990), "Vacuum drainage of groin wounds after vascular surgery: a controlled trail".
274Dunphy, J.E., ed., et al., "Current Surgical Diagnosis & Treatment" 5th ed., pp. 946-951, with 5 additional sheets, Lange Medical Publications, Los Altos, CA (1981).
275DuoDERM Hydroactive™ Dressing, "In wound management-Now, a proven environment for fast healing", 1 page advertisement.
276Durandy, Y., et al., "Mediastinal infection after cardiac operation", J. Thorac. Cardiovasc. Surg., 97:282-5, (1989).
277Duxbury, M.S., et al., "Use of a vacuum assisted closure device in pilonidal disease,"J. Wound Care, 12(9):355 (Oct. 2003).
278Eaglstein, W., et al., "Wound Dressings: Current and Future", Clinical and Experimental Approaches to Dermal and Epidermal Repair; Normal and Chronic Wounds, Progress in Clinical and Biological Research, vol. 365, © 1991 Wiley-Liss, Inc., pp. 257-265.
279Eaglstein, William H., "Experiences with Biosynthetic Dressings", Journal of the American Academy of Dermatology, vol. 12, No. 2, Part 2, Feb. 1985, pp. 434-440. NPL-129.
280Edlich, R., et al., "Evaluation of a New, Improved Surgical Drainage System", The American Journal of Surgery, Feb. 1985, pp. 295-298, vol. 149.
281Edlich, R.F., et al., "Surgical Devices in Wound Healing Management", Wound Healing Biochemical & Clinical Aspects, W.B. Saunders Company, © 1992, pp. 581-599.
282Eginton, M.T., et al., "A prospective randomized evaluation of negative-pressure wound dressings for diabetic foot wounds", Ann. Vasc. Surg., 17(6):645-9 (2003).
283Egnell Minor, Instruction Book, First Addition [Edition], allegedly dated Feb. 1987, 21 pages Swedish, 3 pages English.
284Egnell Minor, Instruction Book, First Edition allegedly dated Feb. 1987, 34 pages of English translation.
285Eisenbud, D., "Modern Wound Management", Adadem Publishing, pp. 109-116 (Jan. 1999).
286Eisenhardt SU, Schmidt Y, Thiele JR, et al. Negative pressure wound therapy reduces the ischaemia/reperfusion-associated inflammatory response in free muscle flaps. J Plast Reconstr Aesthet Surg Dec. 1, 2011. NPL-985.
287Ekaputra, A.K., et al., "Composite electrospun scaffolds for engineering tubular bone grafts," Tissue Eng. Part A 15 (12):3779-3788 (Dec. 8, 2009) (published online Jul. 20, 2009; online ahead of print: Jul. 24, 2009; online ahead of editing: Jun. 15, 2009).
288Eldad, A., et al., "Vacuum-A novel method for treating chronic wounds", Harefuah, (English abstract on last 2 pp. and 1 sheet printout from PubMed); 142(12):834-6, 878, 877 (Dec. 2003).
289Ellingson, B.M., S.N. Kurpad, and B.D. Schmit, Ex vivo diffusion tensor imaging and quantitative tractography of the rat spinal cord during long-term recovery from moderate spinal contusion. J Magn Reson Imaging, 2008. 28(5): p. 1068-79. NPL-1002.
290Elwood, Eric T., et al., "Negative-Pressure Dressings in the Treatment of Hidradenitis Suppurativa", Ann Plast Surgery Jan. 2001; 46:49-51.
291Email dated Jan. 14, 2002 with attachments, including "Report of Meeting with DG Consulting" dated Jan. 10, 2002, 5 sheets, (Exhibit D-157).
292Emerson, J. H. Emerson Co., (address: same as above). "Emerson Transport Suction Unit."
293Emerson, Series 55. J. H. Emerson Co., 22 Cottage Park Ave., Cambridge, MA 02140. "Emerson Post-Operative Suction Pumps."
294Emohare, O., et al., "Vacuum-assisted closure use in calciphylaxis", J. Bum Care Rehabil., 25(2):161-4 (Mar.-Apr. 2004).
295Engdahl, O., et al., "Quantification of Aspirated Air Volume Reduces Treatment Time in Pneumothorax", Eur Respir J., 1990, 3, pp. 649-652. NPL-140.
296Erdmann, D., et al., "Abdominal Wall Defect and Enterocutaneous Fistula Treatment with the Vacuum-Assisted Closure (V.A.C.) System", Plastic and Reconstructive Surgery, vol. 108, No. 7, pp. 2066-2068 (Dec. 2001).
297Ersh, Z. Ya., "Use of polyurethane foam for cleaning of purulent cavities and wounds," I.I. Grekov J. of Surg., 133 (9):134-135 and additional sheets (10 sheets in English and 5 sheets in Russian) (1984).
298Ersh, Z. Ya., "Use of polyurethane foam for treating purulent cavities and wounds," Purulent Septic Unit of Hospital No. 35, (2 sheets English and 2 sheets Russian), allegedly submitted for publication Mar. 21, 1984.
299Espensen, E.H., et al., "Use of subatmospheric (VAC) therapy to improve bioengineered tissue grafting in diabetic foot wounds", J. Am. Podiatr. Med. Assoc., 92(7):395-7 (Jul.-Aug. 2002).
300Etoz, A., et al., "The use of negative pressure wound therapy on diabetic foot ulcers: A preliminary controlled trial", Wounds, 16(8):264-9 (Aug. 2004).
301Evans, D. and Land, L., "Topical negative pressure for treating chronic wounds: a systematic review", British Journal of Plastic Surgery (2001), 54, 238-242.
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457Jordan JE, Zhao Z-Q, Sato H, et al. Adenosine A2 receptor activation attenuates reperfusion injury by inhibiting neutrophil accumulation, superoxide generation and coronary endothelial adherence. J Pharmacol Exp Ther 1997;280 (1):301-9. NPL-986.
458Jordan JE, Zhao ZQ, Vinten-Johansen J. The role of neutrophils in myocardial ischemia-reperfusion injury. Cardiovasc Res Sep. 1999;43(4):860-78. NPL-976.
459Joseph, Emmanuella, MD, et al., "A Prospective Randomized Trial of Vacuum-Assisted Closure Versus Standard Therapy of Chronic Nonhealing Wounds", Wounds 2000: 12(3): 60-67.
460Josty, I.C., et al., "Vacuum-assisted closure: an alternative strategy in the management of degloving injuries of the foot", British Journal of Plastic Surgery (2001), 54, pp. 363-365.
461Juchli, L., "Krankenpflege [Nursing] Practice and Theory of Promoting Health and Patient Care," Georg Theme Verlag Stuttgart, labeled as "Anlage 6.1" 1991 (allegedly dated Feb. 1991), and email dated May 30, 2007 labeled as "Anlage 6.2," both in German with English translations.
462Kahlson, G., et al., "Wound healing as dependent on rate of histamine formation," The Lancet, pp. 230-234, (Jul. 30, 1960).
463Kajstura J, Cheng W, Reiss K, et al. Apoptotic and necrotic myocyte cell deaths are independent contributing variables of infarct size in rats. Lab Invest 1996;74(1):86-107. NPL-981.
464Kalailieff, D., "Vacuum-assisted closure: wound care technology for the new millennium", Perspectives, 22(3):28-9 (Fall 1998).
465Kall, S., et al., "Influence of foam- and tubing material of the vacuum assisted closure device (V.A.C.) on the concentration of transforming growth factor beta 1 in wound fluid", Zentralbl. Chir., (English abstract on first page, 2 sheets printout from PubMed); 129 Suppl 1: S113-S115 (May 2004).
466Kamolz, L.P., et al., "Use of subatmospheric pressure therapy to prevent bum wound progression in human: first experiences", Burns, 30(3):253-8 (May 2004) (Available online Mar. 16, 2004).
467Kanshin, N.N., "Closed treatment of suppurative processes by the method of active lavage drainage," Third Surgical Clinic of the N.V. Sklifosovkiy Moscow Scientific Research Institute of Emergency Care, pp. 18-23, (6 sheets in English, 6 sheets in Russian and English abstract on pp. 22-23), allegedly submitted 1979.
468Kaplan, M., "Managing the open abdomen", Ostomy Wound Manage., 50(1A suppl):C2, 1-8, and 1 sheet of quiz (Jan. 2004).
469Kaplan, M., "Negative pressure wound therapy in the management of abdominal compartment syndrome", Ostomy Wound Manage., 50(11A suppl):20S-25S, (Nov. 2004).
470Kaplan, M., "Negative pressure wound therapy in the management of abdominal compartment syndrome", Ostomy Wound Manage., 51(2A suppl):29S-35S (Feb. 2005).
471Karev, I.D., et al., "Foam drainage system for treating purulent wounds," pp. 87-88, (2 sheets English translation, 2 sheets Russian and certifcation of translation dated Apr. 6, 2009) (allegedly dated 1986).
472Karl, T., et al., "Indications and results of V.A.C. therapy treatments in vascular surgery-state of the art in the treatment of chronic wounds", Zentralbl. Chir., (English abstract on first page, 1 sheet printout from PubMed); 129 Suppl 1:S74-S79 (May 2004).
473Katz, Stuart, et al., "Semipermeable Occlusive Dressings", Arch Dermatol., vol. 122, Jan. 1986, pp. 58-62. NPL-231.
474Kaufman, M.W., et al., "Vacuum-assisted closure therapy: wound care and nursing implications", Dermatol. Nurs., 15 (4):317-20, 323-236 (Aug. 2003).
475KCI, "The V.A.C. operations summary," 7 sheets, (1999).
476Keith, C., "Would Management Following Head and Neck Surgery", Nursing Clinics of North America, Dec. 1979, pp. 761-778, vol. 14, No. 4. NPL-233.
477Kercher, K.W., et al., "Successful salvage of infected PTFE mesh after ventral hernia repair", Ostomy Wound Manage., 48(10):40-5 (Oct. 2002).
478Kidoaki, S., et al., "Mesoscopic spatial designs of nano- and microfiber meshes for tissue-engineering matrix and scaffold based on newly devised multilayering and mixing electrospinning techniques," Biomaterials 26(1):37-46 (Jan. 2005) (available online Mar. 2, 2004).
479Kiernan, M., "The process of granulation and its role in wound healing", Community Nurse, 5(5):47-48 (Jun. 1999).
480Kim, H.W., et al., "Bioactive glass nanofiber-collagen nanocomposite as a novel bone regeneration matrix," J. Biomed. Mater. Res. A 79:698-705 (2006; published online Jul. 18, 2006).
481Kim, S.S., et al., "Accelerated bonelike apatite growth on porous polymer/ceramic composite scaffolds in vitro," Tissue Eng. 12(10):2997-3006 (Oct. 2006).
482Kinetic Concepts, Inc., et al., v. Bluesky Medical Corporation, et al., Civil Action No. SA-03-CA-0832-RF, U.S. District Court, W. Dist. of Texas San Antonio Div., Promotional Slide Presentation BlueSky Medical Negative Pressure Wound Care with Versatile 1 Presentation Presented by Penny Campbell and Shelly Burdette-Taylor 27 pages (dated Oct. 14, 2005).
483Kinoshita M, Hasimoto N, Goto T, et al. Fractional anisotropy and tumor cell density of the tumor core show positive correlation in diffusion tensor magnetic resonance imaging of malignant brain tumors. Neuroimage, 2008. 43(1): p. 29-35. NPL-1014.
484Kirk-Othmer Encyclopedia of chemical technology, 3d ed., vol. 8, pp. 201-203 (1979).
485Kirk-Othmer, Encyclopedia of Chemical Technology, 2nd completely revised edition, vol. 14, pp. 227, John Wiley & Sons, Inc., (1967).
486Kirk-Othmer, Encyclopedia of Chemical Technology, 2nd completely revised edition, vol. 9, pp. 220-232, John Wiley & Sons, Inc., (1966).
487Klemm, K.W., "Antibiotic bead chains", Clin. Orthop. Rel. Res., (295):63-76 (Oct. 1993).
488Klemp et al., The Journal of Investigative Dermatology, pp. 725-726 (1989), "Subcutaneous Blood Flow in Early Male Pattern Baldness".
489Kloth, L.C., "5 questions-and answers-about negative pressure wound therapy", Adv. Skin Wound Care, 15(5):226, 228-9 (Sep.-Oct. 2002).
490Kochnev VA. Primenenie vakuum-drenazhnoi sistemy dlia profilaktiki posleoperatsionnykh ranevykh oslozhnenii u bol'nykh opukholiami. [The use of a vacuum drainage system in the prevention of postoperative wound complications in tumor patients]. Russian. Voprosy Onkologii 1967; 13:102-5, w/Eng. Trans.
491Kohlman, P., et al., "Pouching Procedure to Collect Drainage From Around a Biliary Drainage Catheter", Ostomy/Wound Management, Nov./Dec. 1991, pp. 47-50, V. 37. NPL-240.
492Konomi T, Fujioshi K, Hikishima K, et al.Conditions for quantitative evaluation of injured spinal cord by in vivo diffusion tensor imaging and tractography: preclinical longitudinal study in common marmosets. Neuroimage, 2012. 63(4): p. 1841-53. NPL-1008.
493Korasiewicz, L.M., "Abdominal Wound With a Fistula and Large Amount of Drainage Status After Incarcerated Hernia Repair", Journal of Wound, Ostomy & Continence Nursing. 31(3):150-153, (May-Jun. 2004).
494Kortesis, B., et al., "Vacuum-assisted closure for the treatment of open tibia fractures", 72nd Annual Meeting of the American Society of Plastic Surgeons, San Diego, CA, pp. 172-173; 1 sheet of abstract (Oct. 25-29, 2003). WFU-41.
495Kostiuchenok, B.M., et al., "Vacuum Treatment in the Surgical Management of Suppurative Wounds", Izdatelstvo Meditsina, St. Petersburg, Sep. 1986; 137(9): 18-21 (with English Translation).
496Kostyuchenok, B.M., et al., "Vacuum treatment of purulent wounds," Soviet Medicine, pp. 18-21, (4 sheets English, 4 sheets Russian, with English abstract on last page), (1984).
497Kozier, B., et al., Techniques in Clinical Nursing, 3d ed., pp. 559-560, pp. 603-605, Addison-Wesley Publishing Company, Inc., Health Sciences, Redwood City, CA, (1989).
498Kozlowski P, Raj D, Liu J, Lam C, Yung AC, Tetzlaff W. Characterizing white matter damage in rat spinal cord with quantitative MRI and histology. J Neurotrauma, 2008. 25(6): p. 653-76. NPL-1000.
499Kremers, L., et al., "Effect of topical sub-atmospheric pressure treatment on angiotensin I and II levels post burn", 35th Annual Meeting, Abstract printed in J. Burn Care Rehabilitation, p. S44, Abstract No. 3 American Burn Association, Miami, Florida (Apr. 1-4, 2003).
500Kremers, L., et al., "Serum interleukin levels post burn with and without application of sub-atmospheric pressure", 35th Annual Meeting, Abstract printed in Burn Care Rehabilitation, p. S43, Abstract No. 2, American Burn Association, Miami, Florida, (Apr. 1-4, 2003). WFU-53.
501Krizek, T.J., et al., "The use of prophylactic antibacterials in plastic surgery: A 1980s update," Plast. Reconstr. Surg., 76(6): 953-962, (Dec. 1985).
502Krogman, N.R., et al., "The influence of side group modification in polyphosphazenes on hydrolysis and cell adhesion of blends with PLGA," Biomaterials 30:3035-3041 (2009: available online Apr. 5, 2009).
503Kumar, A.R., "Standard wound coverage techniques for extremity war injury," J. Am. Acad. Orthop. Surg., 14:S62-S65, (2006).
504Kumar, A.R., et al., "Lessons from Operation Iraqi Freedom: Successful subacute reconstruction of complex lower extremity battle injuries," Plast. Reconstr. Surg., 123:218-229, (2009).
505Kusel, C., "Use of V.A.C. (vacuum-assisted closure) therapy in general surgery: problem wounds deprived of air", Pflege Z., (and 1 sheet printout from PubMed); 55(6):408-412 (Jun. 2002).
506Kutschka, I., et al., "Vacuum assisted closure therapy improves early postoperative lung function in patients with large sternal wounds", Zentralbl. Chir., (English abstract on first page, 1 sheet printout from PubMed); 129 Suppl 1: S33-S34 (May 2004).
507Kuzin, M.I., ed., et al., "Vacuum treatment of a purulent wound," Wounds and Wound Infection, Handbook for Physicians, 2nd revised and supplemented ed., pp. 243-246, (3 sheets) (1990).
508Kuzin, M.I., et al., "Method of vacuum treatment of wounds," Wounds and Wound Infection, pp. 348-350, (2 sheets) (1981).
509Kuznetsov, V.A. et al., Report on Practical Application entitled "Method of vacuum-sorption treatment of purulent wounds," Kazan Municipal Hospital No. 8, (1 sheet in English, 1 sheet in Russian and certificate of translation dated Apr. 28, 2009) (allegedly dated May 19, 1986). (Practical Report II).
510Kuznetsov, V.A., "Vacuum and vacuum-sorption treatment of open septic wounds," in II All-union conference "Wounds and wound infection" "(Abstracts of presentations)" in Russian with English translation, and card with English translation, Moscow, Oct. 28-29, 1986. (Bagautdinov II).
511Kuznetsov, V.A., "Vacuum and vacuum-sorption treatment of open septic wounds," in II All-union conference "Wounds and wound infections" "(Presentation abstracts)" in Russian with English translation dated Apr. 2, 2009, with table of contents, Moscow, Oct. 28-29, 1986.
512Kuznetsov, V.A., et al., "Vacuum and vacuum-sorption treatment of open purulent wounds," II All-Union Conference "Wounds and Wound Infections" Moscow, pp. 91-92, with library card and table of contents, in English and Russian, (KCI-Con00220660-89) (1986).
513Kuznetsov, V.A., et al., Report on Practical Application entitled "Method of vacuum-sorption treatment of purulent wounds," Kazan Municipal Hospital No. 8, (1 sheet in English, 1 sheet in Russian and certificate of translation dated Apr. 28, 2009), (allegedly dated May 19, 1986).
514Labler, L., et al., "New application of V.A.C. (vacuum assisted closure) in the abdominal cavity in case of open abdomen therapy", Zentralbl. Chir., (English abstract on first page, 2 sheets printout from PubMed); 129 Suppl 1:S14-S19 (May 2004).
515Labler, L., et al., "Vacuum sealing of problem wounds", Swiss Surg., (English abstract on first page, 1 sheet printout from PubMed); 8(6)266-7 (2002).
516Labler, L., et al., "Wound conditioning by vacuum assisted closure (V.A.C.) in postoperative infections after dorsal spine surgery," Eur. Spine J., 15 (9): 1388-1396 (Sep. 2006).
517Laine GA, Allen SJ. Left ventricular myocardial edema. Lymph flow, interstitial fibrosis, and cardiac function. Circ Res Jun. 1991;68(6):1713-21. NPL-991.
518Lambert, K.V., et al., "Vacuum assisted closure: a review of development and current applications", Eur. J. Vasc. Endovasc. Surg., 29(3):219-226 (Mar. 2005).
519Lamke, L.O., et al., "The evaporative water loss from burns and the water-vapour permeability of grafts and artificial membranes used in the treatment of burns", Burns, 3, 159-165, 1977.
520Landes, R., "An Improved Suction Device for Draining Wounds", Arch. Surg., May 1972, pp. 707, vol. 104.
521Landis, et al., Robinette Foundation of the Hospital of the University of Pennsylvania, "The Effects of Alternate Suction and Pressure on Blood Flow to the Lower Extremities" (Sep. 1933).
522Langley-Hawthorne, C., "Economics of negative pressure wound therapy", Ostomy Wound Manage., 50(4A suppl):35, 36, C3 (Apr. 2004).
523Langworthy, M., et al., "Treatment of the Mangled Lower Extremity After a Terrorist Blast Injury", Clinical Orthopaedics and Related Research, No. 422, pp. 88-96 (May 2004).
524Larichev, A.B., et al., "Vacuum-therapy in the complex of treatment of festering wounds," Khirurgiia (Mosk.), 6:22-26, (13 sheets English translation, 5 sheets in Russian, English abstract on pp. 22), (2008).
525Laverty, D., et al., "Negative pressure wound therapy in the management of orthopedic wounds", Ostomy Wound Manage., 50(11A suppl):18S-9S (Nov. 2004).
526Leaper, D.J., "The Wound Healing Process," Advances in Wound Management, T.D. Turner, et al., eds., pp. 7-16, New York: John Wiley and Sons, (1986).
527Lee, S.S., et al., "Management of intractable sternal wound infections with topical negative pressure dressing", J. Card. Surg., 20(3):218-22 (May-Jun. 2005).
528Leininger, B.E., et al., "Experience with wound VAC and delayed primary closure of contaminated soft tissue injuries in Iraq", J. Trauma, 61(5):1207-1211 (Nov. 2006).
529Leonelli, C., et al., "Synthesis and characterization of cerium-doped glasses and in vitro evaluation of bioactivity," Journal of Non-Crystalline Solids 316:198-216 (2003).
530Leroy, S.C., et al., "Severe penile erosion after use of a vacuum suction device for management of erectile dysfunction in a spinal cord injured patient. Case report", Paraplegia, 32(2):120-123 (Feb. 1994).
531Letsou et al. "Stimulation of Adenylate Cyclase Activity in Cultured Endothelial Cells Subjected to Cyclic Stretch." Cardiovascular Surgery 3. Toronto. Sep. 1989. 634-639.
532Letter to Mr. Urs Tanner from Michael Baniak regarding: Updated Opinion of Non-infringement and Invalidity of Zamierowski U.S. Patent 4,969,880 and Argenta U.S. Patent 5,636,643, 30 pp., (Exhibit D-140) (dated Aug. 23, 2004).
533Lewis, R.T., "Knitted Polypropylene (Marlex) Mesh in the Repair of Incisional Hernias", The Canadian Journal of Surgery, vol. 27, No. 2, Mar. 1984, pp. 155-157. NPL-256.
534Li, C., et al., "Electrospun silk-BMP-2 scaffolds for bone tissue engineering," Biomaterials, 27(16):3115-3124 (Jun. 2006) (available online Feb. 3, 2006).
535Li, M., et al., "Co-electrospun poly(lactide-co-glycolide), gelatin, and elastin blends for tissue engineering scaffolds," J. Biomed. Mater. Res. A. 79(4):963-973 (Dec. 15, 2006) (published online Aug. 31, 2006).
536Li, M., et al., "Electrospun blends of natural and synthetic polymers as scaffolds for tissue engineering," Conf. Proc. IEEE Eng. Med. Biol. Soc. 6:5858-5861 (2005), 1 sheet abstract.
537Li, M., et al., "Electrospun protein fibers as matrices for tissue engineering," Biomaterials 26(30):5999-6008 (Oct. 2005) (available online May 13, 2005).
538Li, W.J., et al., "Fabrication and characterization of six electrospun poly(alpha-hydroxy ester)-based fibrous scaffolds for tissue engineering applications," Acta Biomater. 2(4):377-385 (Jul. 2006; published online May 6, 2006).
539Lindstedt S, Johansson M, Hlebowicz J, et al. Myocardial topical negative pressure increases blood flow in hypothermic, ischemic myocardium. Scand Cardiovasc J Mar. 4, 2008;1-9. NPL-984.
540Lindstedt S, Malmsjo M, Ingemansson R. No hypoperfusion is produced in the epicardium during application of myocardial topical negative pressure in a porcine model. J Cardiothorac Surg 2007;2:53. NPL-993.
541Lindstedt S, Malmsjo M, Sjogren J, et al. Impact of different topical negative pressure levels on myocardial microvascular blood flow. Cardiovasc Revasc Med Jan. 2008;9(1):29-35. NPL-994.
542 *Lindstedt, et al. "Myocardial topical negative pressure increases blood flow in hypothermic, ischemic myocardium". Scand Cardiovasc J. Mar. 4, 2008 ; 1-9.
543Lindstedt, S., et al., "A compare between myocardial topical negative pressure levels of -25 mmHg and -50 mmHg in a porcine model", BMC Cardiovascular Disorders 2008 8:14, BioMed Central, pp. 1-7.
544Lindstedt, S., et al., "Blood Flow Changes in Normal and Ischemic Myocardium During Topically Applied Negative Pressure", Ann Thorac Surgery 2007;84:568-73.
545Livshits, V.S., "Polymer dressings for wounds and bums (review)," All-Union Scientific-Research Institute for Medical Polymers, Moscow, pp. 515-522, (allegedly published in Pharmaceutical Chemical Journal, 22(7):790-798, translated from Russian (allegedly dated Jul. 1988)), Plenum Publishing Corp., (1989).
546Lohman, R., et al., "Discussion: Vacuum Assisted Closure: Microdeformations of Wounds and Cell Proliferation", Plastic and Reconstructive Surgery, Oct. 2004, pp. 1097-1098.
547Lokhvitskii, S.V., et al., "External vacuum aspiration in the treatment of purulent disorders of the soft tissues," Inpatient Surgery Clinic of the Therapeutic Department at Karagandy Medical Institute, Municipal Hospital No. 1, Temirtau, pp. 130-134 (5 sheets English, 5 sheets Russian), allegedly submitted Sep. 22, 1982.
548Lore, Jr., J.M., "An Atlas of Head and Neck Surgery", Second Edition, vol. II, W.B. Saunders Company, Ó 1973.
549Loree, S., et al., "Is vacuum assisted closure a valid technique for debriding chronic leg ulcers?"J. Wound Care, 13 (6):249-52 (Jun. 2004).
550Lower Extremity Ulcers, Chapter 9, pp. 47-57. NPL-259.
551Lu, X.L., et al., "Shape memory property of poly(L-lactide-co-ε-caprolactone) copolymers," Materials Science and Engineering A 438-440:857-861 (2006).
552Luckraz, H., et al., "Vacuum-assisted closure as a treatment modality for infections after cardiac surgery", J. Thorac. Cardiovasc. Surg., 125(2):301-5 (Feb. 2003).
553Lumley, J., et al., "The Physical and bacteriological Properties of Disposable and Non-Disposable Suction Drainage Units in the Laboratory", Br. J. Surg, 1974, pp. 832-837, vol. 61.
554Lundvall et al., Acta Physiol Scand, 136: 403-409, accepted Jan. 28, 1989, "Transmission of externally applied negative pressure to the underlying tissue. A study on the upper arm of man".
555Lynch, J.B., et al., "Vacuum-assisted closure therapy: a new treatment option for recurrent pilonidal sinus disease. Report of three cases", Dis. Colon Rectum, 47(6):929-32 (Jun. 2004) (Published online May 4, 2004).
556M. Gosta Arturson, The Pathophysiology of Severe Thermal Injury, JBCR, 6(2):129-146 Mar.-Apr. 1985.
557M.J. Morykwas and L.C. Argenta, "Techniques in Use of V.A.C. Treatment (in English)", Acta Chir. Austriaca Supplement Nr. 150, 1998, p. 3-4 of 2-28.
558Ma, Z., et al., "Potential of nanofiber matrix as tissue-engineering scaffolds," Tissue Engineering 11(1/2):101-109 (2005).
559Machen, M. S., "Management of traumatic war wounds using vacuum-assisted closure dressings in an austere environment," Army Medical Department J., pp. 17-23, (Jan.-Mar. 2007).
560Maddin et al., International Journal of Dermatology, 29: 446-450 (1990), "The Biological Effects of a Pulsed Electrostatic Field with Specific Reference to Hair: Electrotrichogenesis".
561Magee, C., et al., "Potentiation of Wound Infection by Surgical Drains", The American Journal of Surgery, May 1976, pp. 547-549, vol. 131. NPL-264.
562Malli, S., "Keep a close eye on vacuum-assisted wound closure", Nursing, 35(7):25 (Jul. 2005).
563Malone, W.D., "Wound dressing adherence: a clinical comparitive study," Archives of Emergency Medicine, 4:101-105, (1987).
564Mang, R., et al., "Vacuum therapy in a pre- and postsurgical ulcera crurum", Zentralbl. Chir., (English abstract on first page, 1 sheet printout from PubMed); 129 Suppl 1:S101-S103 (May 2004).
565Manka R, Kozerke S, Rutz AK, et al. A CMR study of the effects of tissue edema and necrosis on left ventricular dyssynchrony in acute myocardial infarction: implications for cardiac resynchronization therapy. J Cardiovasc Magn Reson 2012;14:47. NPL-988.
566Manualectric Breastpump, Catalog pages (4 pages), diagrams and descriptions.
567Marathe, U.S., et al., "Use of the vacuum-assisted closure device in enhancing closure of a massive skull defect", Laryngoscope, 114(6):961-4 (8 sheets) (Jun. 2004).
568Marie Knight, "A Second Skin for Patients with Large Drainage Wounds," Nursing 6(1) p. 37, 1976.
569Marks, M., et al., "Management of Complex Soft Tissue Defects in Pediatric Patients Using the V.A.C. Wound Closure", Plastic Surgical Forum, V. XXI, Boston, MA, Oct. 3-7, 1998, pp. 215-216.
570Marks, M.W., et al., "Principles & Applications of Vacuum Assisted Closure (VAC)" Plastic Surgery Secrets, 2nd ed., Mosby Elsevier, (2010).
571Marston, W.A., et al., "The efficacy and safety of Dermagraft in improving the healing of chronic diabetic foot ulcers: results of a prospective randomized trial", Diabetes Care, 26(6) 10 pp., (Exhibit 271) (Jun. 1, 2003).
572Masters, J., "Reliable, inexpensive and simple suction dressings", Letters to the Editor, p. 267, labeled 1998.
573Mayo, C., "The One-Stage Combined Abdominoperineal Resection for Carcinoma of the Rectum, Rectosigmoid and Sigmoid", Surgical Clinics of North America, Aug. 1939, pp. 1011-1019. NPL-268.
574McCallon, S., et al., "Vacuum-Assisted Closure versus Saline-Moistened Gauze in the Healing of Postoperative Diabetic Foot Wounds", Ostomy Wound Management, Aug. 2000, v.46, Issue 8.pp. 28-29, 31-32, 34.
575McCulloch JM, Kemper CC. Vacuum-Compression Therapy for the Treatment of an Ischemic Ulcer. Physical Therapy 1993;73:165-9.
576McFarlane, R., "The use of Continuous Suction Under Skin Flaps", British Journal of Plastic Surgery, pp. 77-86 (1958-1959).
577McGee, M.P., et al., "Swelling and pressure-volume relationships in the dermis measured by osmotic-stress technique," Am. J. Physiol. Regul. Integr. Comp. Physiol., 296:R1907-R1913, (Mar. 25, 2009).
578McGuinness, J.G., et al., "Vacuum-assisted closure of a complex pilonidal sinus", Dis. Colon Rectum, 46(2):274-6 (Feb. 2003).
579McKinney, P.E., "Out-of-hospital and interhospital management of crotaline snakebite", Ann. Emerg. Med., 37 (2):168-174, (Feb. 2001).
580McLean, W. C., "The role of closed wound negative pressure suction in radial surgical procedures of the head and neck," The Laryngoscope, 74(1)70-94, (Jan. 1964).
581Meara, John G., et al., "Vacuum-Assisted Closure in the Treatment of Degloving Injuries". Annals of Plastic Surgery 42(6) 589-594 (1999).
582Medela Dominant promotional literature (2 pages of photos) (labeled circa 1984-1985). NPL-274.
583Medical Technology & Innovation, "Medical Technology is Extending Life, Reducing Costs", vol. 1, Issue 46, Dec. 4, 2000.
584Meehan, P., "Open Abdominal Wounds: A Creative Approach to a Challenging Problem", Pregressions, 1992, pp. 3-8, 11, vol. 4, No. 2.
585Melano, E., et al., "The effects of Panafil when using topical negative pressure to heal an infected sternal wound,"J. Wound Care, 13(10):425-6 (Nov. 2004).
586Mendez-Eastman S. Negative pressure wound therapy. Plastic Surgical Nursing 1998;18:27-9, 33-37.
587Mendez-Eastman, S., "Determining the appropriateness of negative pressure wound therapy for pressure ulcers", Ostomy Wound Manage., 50(4A suppl):13-16 (Apr. 2004).
588Mendez-Eastman, S., "Guidelines for using negative pressure wound therapy", Adv. Skin Wound Care, 14 (6):314-323. (16 pp.) (Nov.-Dec. 2001).
589Mendez-Eastman, S., "New advances in wound therapy", printout from Wounds1.com; 7 sheets (Apr. 15, 2005).
590Mendez-Eastman, S., "New treatment for an old problem: negative-pressure wound therapy", Nurs., 32(5):58-64. (12 sheets) (May 2002).
591Mendez-Eastman, S., "Using negative-pressure for positive results", Nursing, 35(5):48-50 (May 2005).
592Mendez-Eastman, Susan, RN, CPSN, CWCN, Clinical Management Extra, Guidelines for Using Negative Pressure Wound Therapy, Advances in Skin & Wound Care, Nov./Dec. 2001, vol. 14, No. 6, p. 314-323.
593Mendez-Eastman, Susan., "Use of Hyperbaric Oxygen and Negative Pressure Therapy in the Multidisciplinary Care of a Patient with Nonhealing Wounds". JWOCN 26(2) 67-76 (1999).
594Mendez-Eastman, Susan., "When wounds won't heal". RN 20-24 (1998).
595Merriam-Webster Online, "reepithelialization," printout of webpage dated Apr. 17, 2009.
596Meyer, W., et al., "Bier's Hyperemic Treatment," W.B. Saunders & Co., 1908 (Exhibit D246).
597Meyer, W., et al., excerpts from "Bier's Hyperemic Treatment", W.B. Saunders and Co., (48 sheets) (1908).
598Microtek Heritage, Inc. P.O. Box 2487, Columbus, MS 39704. "Wound-Evac ET."
599Microtek Medica, Inc. "The Microtek Complete Closed Wound Drainage System", 6 pages. NPL-285.
600Miles, W., "Technique of the Radical Operation for Cancer of the Rectum", The British Journal of Surgery, 1914-1915, pp. 292-305. NPL-286.
601Miles, W., et al., "A Method of Performing Abdominoperineal Excision for Carcinoma of the Rectum and of the Terminal Portion of the Pelvic Colon", The Lancet, Dec. 19, 1908, pp. 1812-1813. NPL-287.
602Miller, M.S., et al., "Negative pressure wound therapy: 'A rose by any other name'", Ostomy Wound Manage., 51 (3):44-9 (11 sheets) (Mar. 2005).
603Miller, P., et al., "Late Fascial Closure in Lieu of Ventral Hernia: The Next Step in Open Abdomen Management", the Journal of TRAUMA Injury, Infection and Critical Care, Nov. 2002, V. 53, N. 5, pp. 843-849.
604Miller, Q., et al., "Effect of subatmospheric pressure on the acute healing wound", Cuff. Surg., 61(2):205-8 (Mar.-Apr. 2004).
605Miller, S.H., et al., "An inexpensive wound suction device", Surg. Gyencol. Obstet., 141(5):768 (Nov. 1975).
606Miller, S.J., "Surgical wound drainage system using silicone tubing", J. Am. Podiatry Assn., 71(6): pp. 287-296, (Jun. 1981).
607Mills, N., Polymer Foams Handbook: engineering and biomechanics applications and design guide, pp. 2-3, (2007).
608Milner, R.H., et al., "Plasticized polyvinyl chloride film as a primary burns dressing: a microbiological study," Bums, 14(1):62-65 (1988).
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773Ratliff, C.R., "Negative-pressure wound therapy. Adjunct relief for chronic wounds", Adv. Nurs. Pract., 12(7):47-9 (3 sheets) (Jul. 2004) (Issue date: Jul. 1, 2004).
774Registration No. 1982349. Owner, KCI Inc., 3440 E. Houston Street San Antonio Texas 78219. Source: United States Patent and Trademark Office official website. Filing date May 1, 1995 Registration Date Jun. 25, 1996.
775Reid, D., "Information on Cupping or Using Suction Cups on Wounds and for Healing Purposes", from Chines Herbal Medicine (2 pages). NPL-345.
776Riccio, M., et al. "Delayed microsurgical reconstruction of the extremities for complex soft-tissue injuries", Microsurgery, 25:272-83 (2005).
777Robson, M.C., et al., "Bacterial quantification of open wounds," Military Medicine, pp. 19-24, (Jan. 1969).
778Robson, M.C., et al., Chapter 10 "Wounds and wound healing," p. 107-114 in Essentials of General Surgery, P.F. Lawrence ed., Williams & Wilkins, (1988).
779Robson, M.C., et al., Chapter 11 "Wounds and wound healing," p. 119-126 in Essentials of General Surgery, 2nd edition, P.F. Lawrence ed., Williams & Wilkins, (1992).
780Rollins, H., "Hypergranulation tissue at gastrostomy sites", J. Wound Care, 9(3):127-129 (Mar. 2000).
781Rose, M.P., et al., "The Clinical Use of a Tubular Compression Bandage, Tubigrip, for Burn-Scar Therapy: A Critical Anaylis", Burns (1985) 12, 58-64.
782Roshi, R.A., "Nanoporous biodegradable elastomers," Adv. Mater. 21:188-192 (2009).
783Rosser, Charles J., et al., "A New Technique to Manage Perineal Wounds". Infections in Urology 13(2) 45-47, 56 (2000).
784Roth, B., et al., "Ubersichtsarbeit: Indication for suction-rinse drainage and hygienic certainty in drainages," GMS Krankenhaushyg. Interdiszip, 1(1):Doc27 (7 sheets in German with English abstract on first sheet) (2006).
785Rovee, David T., et al., "Effect of Local Wound Environment on Epidermal Healing", Dept. of Skin Biology, Johnson & Johnson Research, New Brunswick, NJ, pp. 159-181 (1972). NPL-348.
786Roylance, L., "Nancy Sujeta, Amanda Clark,"DOME, vol. 55, Mar. 2004, 2 sheets of website printout www.hopkinsmedicine.org/dome/0405/feature4.cfm.
787Royle, G., et al., "Disposable Drains", Annals of the Royal College of Surgery of England, 1984, 1 page, vol. 66.
788Ryan, T.J., "Evans (1966) exchange and the skin in the light of vacuum-assisted closure, yoga, and maggots", Low. Extrem. Wounds, 3(3):121-2 (Sep. 2004).
789Saechtling, Kunststoff-Taschenbuch, 24. Ausgabe 1989, S. 439, 477. English Translation attached.
790Safronov, A.A., "Vacuum therapy for trophic ulcers of the tibia with concurrent skin autoplasty," Dissertation abstract, additional abstract, Moscow, 20 sheets of English translation, (1967).
791Safronov, A.A., Abstract of Invention No. 240188, "Device for wound or ulcer treatment," (2 sheets English translation and 2 sheets in Russian) (1969).
792Safronov, A.A., Dissertation Abstract, "Vacuum therapy of trophic ulcers of the lower leg with simultaneous autoplasty of the skin," (Central Scientific Research Institute of Traumotology and Orthopedics, Moscow, U.S.S.R.) (23 sheets English translation; 23 sheets in Russian; certification dated May 8, 2008; alleged index card(English translation; 1 sheet Russian; certification dated May 14, 2008), (1967).
793Sagi, A., et al., "Burn Hazard From Cupping-An Ancient Universal Medication Still in Practice", Burns, 1988, pp. 323-325, vol. 14, No. 4. NPL-351.
794Saklani, A.P., et al., "Vacuum assisted closure system in the management of enterocutaneous fistula", Poslgrad. Med. J., 78(925):699 (Nov. 2002).
795Salameh, J.R., et al., "Laparoscopic harvest of omental flaps for reconstruction of complex mediastinal wounds", JSLS, 7(4):317-22 (Oct.-Dec. 2003).
796Saltzman, C.L., "Salvage of diffuse ankle osteomyelitis by single-stage resection and circumferential frame compression arthrodesis", Iowa Orthop. J., 25:47-52 (2005).
797Sames CP. Sealing of wounds with vacuum drainage [letter] Br Med J 1977;2:1123.
798Samson, D., et al., "Wound-healing technologies: low level laser and vacuum-assisted closure", Evid. Rep. Technol. Assess. (Summ.),(111):1-6, (Dec. 2004).
799Sanden, G., et al., "Staphylococcal wound infection in the pig: Part II. Inoculation, quanitification of bacteria, and reproducibility," Ann. Plast. Surg., 23(3):219-223, (Sep. 1989).
800Sanger, C., et al., "Dynamic spring mediated cranioplasty in an experimental model with resorbable foot plates," J. Craniofac. Surg., 18(1):54-59, (Jan. 2007).
801Saran Resins and Films, "Fresh Thinking". website printout, 6 pages, Jan. 20, 2004.
802Sarsam, S.E., et al., "Management of wound complications from cesarean delivery,"Obstet. Gynecol. Surv., 60 (7):462-73 (Jul. 2005).
803Sartipy, U., et al., "Cardiac rupture during vacuum-assisted closure therapy," Ann. Thorac. Surg., 82:1110-1 (2006).
804Sasaki, N., et al., "Stress-strain curve and Young's Modulus of a collagen molecule as determined by the x-ray diffraction technique," J. Biomechanics, 29(5):655-658 (1996).
805Satas, Donatas, "Handbook of Pressure-Sensitive Adhesive Technology", Silicone Release Coatings, Van Nostand Reinhold Company, 1982, pp. 384-403. NPL-355
806Sato H, Jordan JE, Zhao ZQ, et al. Gradual reperfusion reduces infarct size and endothelial injury but augments neutrophil accumulation. Ann Thorac Surg Oct. 1997;64(4):1099-107. NPL-987.
807Saunders, J. W., The Lancet, pp. 1286-1287, Jun. 28, 1952, "Negative-Pressure Device for Controlled Hypotension during Surgical Operations".
808Saxena, V., et al., "Vacuum-assisted closure: microdeformations of wounds and cell proliferation", Plast. Reconstruct. Surg., 114(5):1086-96 (Oct. 2004).
809Schaffer, D., "Closed Suction", Nursing97, Nov., http://www.springnet.com, pp. 62-64.
810Schaffzin, D.M., et al., "Vacuum-assisted closure of complex perineal wounds", Dis. Colon Rectum, 47:1745-8 (Oct. 2004) (Published online Aug. 24, 2004).
811Schaum, K.D., "Medicare Part B negative pressure wound therapy pump policy. A partner for Medicare Part A PPS," Home Healthc. Nurse, 20(1):57-8 (Jan. 2002).
812Schaum, K.D., "Payment perspective: Negative pressure wound therapy pumps and ostomy supplies", Ostomy Wound Manage., 51(3):20-22 (2 sheets) (Mar. 2005).
813Schaum, K.D., "Payment strategies: a new medicare part B wound care policy", Adv. Skin & Wound Care, 14 (5):238-240 (Sep./Oct. 2001).
814Scherer, L, et al., "The Vacuum Assisted Closure Device: A Method of Securing Skin Grafts and Improving Graft Surival", Arch. Surg., V. 137, Aug. 2002, pp. 930-934.
815Scherer, S.S., et al., "The mechanism of action of the vacuum-assisted closure device," Plast. Reconstr. Surg., 122: 786-797, (presented at the Wound Healing Society Meeting 2007 in Tampa, Florida, Apr. 28-May 1) (2008).
816Schimp, V.L., et al., "Vacuum-assisted closure in the treatment of gynecologic oncology wound failures", Gynecol. Oncol., 92(2):586-91 (Feb. 2004).
817Schintler, M.V., et al., "The impact of the VAC-treatment for locally advanced malignancy of the scalp", Zentralbl. Chir., (English abstract on first page, 1 sheet printout from PubMed); 129 Suppl: 1:S141-S146 (May 2004).
818Schipper, J., et al., "The preconditioning and prelamination of pedicled and free microvascular anastomised flaps with the technique of vacuum assisted closure", Laryngorhinootologie, (English abstract on first page, and 2 sheets printout from PubMed); 82(6).421-7, (Jun. 2003).
819Schlatterer, D., et al., "Orthopedic indications for negative pressure wound therapy", Ostomy Wound Manage., 51 (2A suppl):27S-8S (Feb. 2005).
820Schmiedl A, Haasis G, Schnabel PA, et al. Morphometric evaluation of volume shifts between intra-and extra-cellular space before and during global ischemia. Anat Rec Mar. 1995;241(3):319-27. NPL-990.
821Schneider, A.M., et al., "Muscle flap survival after complete venous occlusion by application of a negative pressure device", 66th Annual Meeting of the American Society of Plastic and Reconstructive Surgeons, San Francisco, CA, pp. 300-302; 2 sheets of abstract (Sep. 21-24, 1997). WFU-38.
822Schneider, A.M., et al., "Re: use of specialized bone screws for intermaxillary fixation: reply", Ann. Plast. Surg., 47 (1): 93, (Jul. 2001).
823Schneider, A.M., et al., "Treatment of brown recluse spider bite wounds by external application of sub-atmospheric pressure", 68th Annual Meeting of the American Society of Plastic and Reconstructive Surgeons, New Orleans, LA, p. 35; 1 sheet of abstract (Oct. 24-27, 1999).
824Schneider, Andrew M., et al., "A New and Reliable Method of Securing Skin Grafts to the Difficult Recipient Bed". Plastic and Reconstructive Surgery 102(4) 1195-98 (1998).
825Schneider, F.R., Handbook for the Orthopaedic Assistant, 2nd ed., pp. 185, The C.V. Mosby Company, St. Louis, (1976).
826Schoemann, M.B., et al., "Treating surgical wound dehiscence with negative pressure dressings", Ostomy Wound Manage., 51(2A suppl.):15S-20S, (Feb. 2005).
827Schofer, M.D., et al., "Characterization of a PLLA-collagen I blend nanofiber scaffold with respect to growth and osteogenic differentiation of human mesenchymal stem cells," ScientificWorldJournal 9:118-129 (Feb. 15, 2009).
828Scholl, L., et al., "Sternal osteomyelitis: use of vacuum-assisted closure device as an adjunct to definitive closure with sternectomy and muscle flap reconstruction", J. Card. Surg., 19(5):453-61 (Sep.-Oct. 2004).
829Schumann, D., et al., "Preoperative Measures to Promote Wound Healing", Nursing Clinics of North America, Dec. 1979, pp. 683-699, vol. 14, No. 4. NPL-361.
830Sethuraman, S., et al., "Novel low temperature setting nanocrystalline calcium phosphate cements for bone repair: Osteoblast cellular response and gene expression studies," J. Biomed. Mater. Res. A 82:884-891 (2007; published online Mar. 2, 2007).
831Shaer, W.D., "Inexpensive vacuum-assisted closure employing a conventional disposable closed-suction drainage system", Plast. Reconstr. Surg., 107(1):292-3 (Jan. 2001).
832Shah, P.N., et al., "Electrospinning of L-tyrosine polyurethanes for potential biomedical applications," Polymer 50:2281-2289 (May 2009; available online Mar. 19, 2009).
833Shein M, Saadia R, Jameson JR, Decker GAG. The "sandwich technique" in the Management of the Open Abdomen. Br J Surg 1986;73:369-70.
834Sheppard, M.D., "Sealed drainage of wounds," The Lancet, Jun. 14, 1952, pp. 1174-1176. NPL-410.
835Shi, B., et al., "Effects of vacuum-assisted closure (VAC) on the expressions of MMP-1, 2, 13 in human granulation wound", Zhonghua Zheng Xing Wai Ke Za Zhi, (English abstract on first page and 1 sheet printout from PubMed); 19 (4):279-81 (Jul. 2003).
836Shilt, J.S., et al., "Role of vacuum-assisted closure in the treatment of pediatric lawnmower injuries", J. Pediatr. Orthop., 24(5):482-7 (Sep.-Oct. 2004).
837Shoufani, A., et al., "Vacuum assisted closure-a new method for wound control and treatment", Harefuah, (English abstract on last page; 1 sheet printout from PubMed); 142(12):837-40, 877 (Dec. 2003).
838Shvartsman, H.S., et al., "Use of vacuum-assisted closure device in the treatment of recurrent Paget's disease of the vulva", Obstet. Gynecol., Supplement, 102(5, part 2):1163-6 (Nov. 2003).
839Sibbald, R.G., et al., "A consensus report on the use of vacuum-assisted closure in chronic, difficult-to-heal wounds", Ostomy Wound Manage., 49(11):52-66 (Nov. 2003).
840Silicone from CUI (Cox-Uphoff International), "Flexability", 1 page advertisement.
841Silver, F.H., et al., "Mechanobiology of force transduction in dermal tissue", Skin Res. Technol., 9(1):3-23 (Feb. 2003).
842Silver, F.H., et al., "Mechanosensing and mechanochemical transduction: how is mechanical energy sensed and converted into chemical energy in an extracellular matrix?" Crit. Rev. Biomed. Eng., 31(4):255-331 (2003).
843Silvis, R., et al., "The Use of Continuous Suction Negative Pressure Instead of Pressure Dressing", Annals of Surgery, Aug. 1955, pp. 252-256, vol. 142, No. 2.
844Simman, R., et al., "A comparative histological study of skin graft take with tie-over bolster dressing versus negative pressure wound therapy in a pig model: a preliminary study [brief communication]", Wounds, 16(2):76-80 (7 sheets) (Feb. 2004).
845Sjogren, J., et al., "Clinical outcome after poststernotomy mediastinitis: vacuum-assisted closure versus conventional treatment", Ann. Thorac. Surg., 79(6):2049-55 (Jun. 2005).
846Sjogren, J., et al., "The impact of vacuum-assisted closure on long-term survival after post-stemotomy mediastinitis", Ann. Thorac. Surg., 80(4):1270-5, (Oct. 2005).
847Sjogren, J., et al., "Vacuum-assisted closure therapy in mediastinitis after heart transplantation", J. Heart Lung Transplant., 23(4):506-7 (Apr. 2004).
848Skillman, J., et al., "Vacuum assisted closure (VAC) dressing for skin graft application following exenteration of the orbit", Orbit, 22(1):63-5 (Mar. 2003).
849Skover, G., et al., "45: New Technologies: An Overview," Chronic Wound Care, pp. 425-430 (allegedly dated 1990).
850Slides and photographs of patient treatment, 19 sheets, (Exhibit D-152) (allegedly dated 1987).
851Slides regarding use of V.A.C.
852Slides, drawings, photographs of patient treatment and presentation slides, 20 sheets, (Exhibit D-151) (allegedly dated 1987).
853Smith LA, Barker DE, Chase CW, et al. Vacuum Pack Technique of Temporary Abdominal Closure: A Four-Year Experience. Amer Surg 1997;63:1102-8.
854smith&nephew website printout, Would Management, FAQs.
855Smith, D.J. Jr., et al., Chapter 7 "Wounds and wound healing," p. 113-122 in Essentials of General Surgery, 3d edition, P.F. Lawrence ed., Lippincott Williams & Wilkins, (2000).
856Smith, I.O., et al., "Nanostructured polymer scaffolds for tissue engineering and regenerative medicine," Interdisciplinary Reviews: WIREs Nanomed. Nanobiotechnol. 1(2):226-236 (Mar./Apr. 2009) (Jan. 12, 2009).
857Smith, L.A., et al., "Nano-fibrous scaffolds for tissue engineering," Colloids and Surfaces B: Biointerfaces 39 (3):125-131 (Dec. 10, 2004; available online Feb. 4, 2004).
858Smith, N., "The benefits of VAC Therapy in the management of pressure ulcers", Br. J. Nurs., 13(22):1359-60, 1362, 1364-65 (Dec. 9, 2004-Jan. 12, 2005).
859Smith, S.R.G., "Surgical drainage", Br. J. Hosp. Med., 33(6):308-315 (Jun. 1985).
860Snyder, R.J., "Negative pressure wound therapy (NPWT)/ vacuum-assisted closure® (VAC®) as an adjunct in the treatment of pyoderma gangrenosum", Wound repair and regeneration, 13:A29 (Mar. 2005).
861Soletti, L., et al., "A bilayered elastomeric scaffold for tissue engineering of small diameter vascular grafts," Acta Biomaterialia 6:110-122 (2010; available online Jun. 18, 2009).
862Solovev, V.A., "The method of treatment of immature external fistulas in the upper gastrointestinal tract," S.M. Kirov Gorky State Medical Institute, Gorky, U.S.S.R., (Exhibit J of Third party comments) (1987).
863Solovev, V.A., "Treatment and prevention of suture failures after gastric resection," Dissertation abstract, with alleged index card, S.M. Kirov Gorky State Medical Institute, Gorky, U.S.S.R., (Exhibit I of Third party comments) (1988).
864Son SM, Park SH, Moon HH, et al. Diffusion tensor tractography can predict hemiparesis in infants with high risk factors. Neurosci Lett, 2009. 451(1): p. 94-7. NPL-1013.
865Song, D.H., et al., "Vacuum assisted closure for the treatment of sternal wounds: the bridge between debridement and definitive closure", Plast. Recontr. Surg., 111(1):92-7 (Jan. 2003).
866Spahn, J.G., "Soft tissue challenges in the head and neck region,"Clinical Seminar Handout, EHOB, (46 pages).
867Sparta Instrument Corp. 26602 Corporate Ave., Hayward, CA 94545. "Power Source Multi-Purpose Surgical Aspirator."
868Spartanburg Regional Medical Center Operative reports, 35 sheets, dated 1989.
869Spengler, M., et al., "Performance of Filtered Sump Wound Drainage Tubes", Surgery, Gynecology & Obstetricsq, Mar. 1982, pp. 333-336, vol. 154. NPL-384.
870Spurlock, Gareth, "The Management of Open Joint Injuries", Wound Management, Veterinary Clinics of North American Equina Practice, vol. 5, No. 3, Dec. 1989.
871Standard Operating Procedure, The determination of moisture vapour permeability (MVP) and water transmission rate (WTR), implementation date: Sep. 11, 2006 and QA Operational Laboratories Analytical Report dated Nov. 13, 2008.
872Stannard, J., "Complex orthopaedic wounds: prevention and treatment with negative pressure wound therapy", Orthop. Nurs., 23 Suppl 1:3-10 (10 sheets) (Mar.-Apr. 2004), presented at the 17th Annual Clinical Symposium on Advances in Skin & Wound Care, Dallas, TX (Sep. 23, 2002).
873Stansby, G., et al., "Vacuum Drainage of Groin Wounds After Vascular Surgery", Br. J. Surg., Oct. 1990, pp. 1194-1195, vol. 77, No. 10.
874Stechmiller, J.K., et al., "Effect of negative pressure wound therapy on the expression of TNF-alpha, IL-1beta, MMP-2, MMP-3, and TIMP-1 in wound fluids of adults with pressure ulcers", Wound Repair Regen., 13(2):A16 (Mar.- Apr. 2005).
875Stedman's Medical Dictionary, 25th ed., pp. 1739, Williams & Wilkins, (1990).
876Stedman's Medical Dictionary, 25th ed., pp. 554, 667-668, and 1603-1604, Williams & Wilkins, (1990).
877Steenvoorde, P., et al., "Combining topical negative pressure and a Bogota bag for managing a difficult laparostomy", J. Wound Care, 13(4):142-3 (Apr. 2004).
878Steenvoorde, P., et al., "Deep infection after ilioinguinal node dissection: vacuum-assisted closure therapy?"Low. Extrem. Wounds, 3(4):223-226 (Dec. 2004).
879Steenvoorde, P., et al., "Vacuum-assisted closure therapy and oral anticoagulation therapy", Plast. Reconstruct. Surg., 113(7):2220-1 (Jun. 2004).
880Steiert, A.E., et al., "The V.A.C. system (vacuum assisted closure) as bridging between primary osteosynthesis in conjunction with functional reconstructed of soft tissue-open fractures type 2 and type 3", Zentralbl. Chir., (English abstract on first page, 2 sheets printout from PubMed); 129 Suppl 1:S98-100 (May 2004).
881Stewart, A., et al., "Cleaning v. healing," Community Outlook, pp. 22, 24 & 26 (Aug. 14, 1985).
882Stoeckel, W.T., et al., "30: Vacuum assisted devices for difficult wounds of the face and neck," Essential Tissue Healing of the Face and Neck, p. 399-408, and additional sheet, Horn, et al., (Pub. Jan. 28, 2009).
883Stone, P., et al., "Bolster versus negative pressure wound therapy for securing split-thickness skin grafts in trauma patients", Wounds, 16(7):219-23 (5 sheets) (2004) (Posted Aug. 4, 2004).
884Stone, P.A., et al., "Vacuum-assisted fascial closure for patients with abdominal trauma", J. Trauma, 57:1082-6 (Nov. 2004).
885Sturr, R., Evaluation of Treatment of Peripheral Vascular Disease by Alternating Positive and Negative Pressure, Philadelphia, Archives of Physical Therapy, Sep. 1938, pp. 539-543.
886Sumpio, B.E., et al., "Role of negative pressure wound therapy in treating peripheral vascular graft infections," Vascular, 16(4):194-200, (2008).
887Sundgren PC, Dong Q, Gomez-Hassan D, Mukherji SK, Maly P, Welsh R. Diffusion tensor imaging of the brain: review of clinical applications. Neuroradiology, 2004. 46(5): p. 339-50. NPL-1004.
888Svedman, "A dressing system providing fluid supply and suction drainage used for continuous or intermittent irrigation," Ann. Plast. Surg., vol. 17, 9 pages, (Aug. 1986).
889Svedman, "Irrigation treatment in split thickness skin grafting of intractable leg ulcers," Scand. J. Plast. Reconstr. Surg., vol. 19:211-213, (1985).
890Svedman, "Irrigation Treatment of Leg Ulcers", The Lancet, Sep. 3, 1983, pp. 532-534.
891Svedman, P. et al., "A dressing system providing fluid supply and suction drainage used for continuous or intermittent irrigation", Ann. Plast. Surg., 17(2):125-33 (Aug. 1986).
892Svedman, P., "A dressing allowing continuous treatment of a biosurface," IRCS Medical Science: Biomedical Technology; Clinical Medicine; Surgery and Transplantation, 7:221 (1979). (Exhibit D-407).
893Svedman, P., "A dressing allowing continuous treatment of a biosurface,"IRCS Medical Science: Biomedical Technology; Clinical Medicine; Surgery and Transplantation, 7:221 (1979), with annotations.
894Svedman, P., et al., "Staphylococcal wound infection in the pig: Part I. Course," Ann. Plast. Surg., 23(3):212-218, (Sep. 1989).
895Swearingen, P.L., "The Addison-Wesley Photo-Atlas of Nursing Procedures", 9 pages, © 1984.
896Taber's Cyclopedic Medical Dictionary, 16th edition, pp. 613-614, 643, 679, 1444, and 1686-1688, (1989).
897Taber's Cyclopedic Medical Dictionary, Edition 18, pp. 937, 942 and 1375.
898Taber's Cyclopedic Medical Dictionary, Edition 20, pp: 306-309, 728-729, 765, 1726, and 2006-2009. (2005).
899Tachi, M., et al., "Topical negative pressure using a drainage pouch without foam dressing for the treatment of undetermined pressure ulcers", Ann. Plast. Surg., 53(4):338-42 (7 sheets) (Oct. 2004).
900Takei, T., et al., "Molecular basis for tissue expansion: clinical implications for the surgeon", Plast. Reconstr. Surg., 102(1):247-258 (Jul. 1998).
901Talboy, G.E., et al., "Chapter 8: Wounds and wound healing," p. 147-161 in Essentials of General Surgery, B. Sun ed., Lippincott Williams & Wilkins, (2006).
902Tang, A.T.M., et al., "Vacuum-assisted closure to treat deep sternal wound infection following cardiac surgery", J. Wound Care, 9(5):229-30 (May 2000).
903Tang, S.Y., et al., "Influence of vacuum-assisted closure technique on expression of Bcl-2 and NGF/NGFmRNA during wound healing", Zhonghua Zheng Xing Wai Ke Za Zhi, (English abstract on first page 1 sheet printout from PubMed); 20(2):139-42 (Mar. 2004).
904Tauro, L.F., et al., "A comparative study of the efficacy of topical negative pressure moist dressings and conventional moist dressings in chronic wounds," Indian J. Plast. Surg. 40(2):133-140 (Jul.-Dec. 2007).
905Taylor, V., "Meeting the Challenge of Fistulas & Draining Wounds", Nursing80, June, pp. 45-51.
906Techno Takatsuki Co., Ltd., 8-16 Hatchonishimachi, Takatsuki City, Osaka, Japan, "HiBlow Air Pump".
907Teder H, Sanden G, Svedman P. Continuous Wound Irrigation in the Pig. J Invest Surg 1990;3:399-407.
908Tennant, C.E., "The use of hyperemia in the postoperative treatment of lesions of the extremities and thorax," Jour. A.M.A., 64(19):1548-1549, (May 8, 1915).
909Tenta, L., et al., "Suction Drainage of Wounds of the Head and Neck", Surgery, Gynecology. & Obstetrics, Dec. 1989, p. 558, vol. 169. NPL-401.
910Teo, W.E., et al., "Electrospun scaffold tailored for tissue-specific extracellular matrix," Biotechnology Journal, 1 (9):918-929 (Sep. 2006) (published online Aug. 28, 2006).
911Thomas, S., "Atraumatic dressings," World Wide Wounds, sponsored by Molnylcke Health Care, 11 sheets, published Jan. 2003, website printout dated Jun. 29, 2009.
912Thomas, S., "Pain and wound management," Community Outlook, pp. 11-13, 15 and one extra sheet, (Jul. 1989).
913Thomas, S., "Selecting dresssings," Community Outlook, vol. 6, 4 sheets, (Jun. 1991).
914Thomas, S., "Wound management and dressings," cover sheet, preface, sheet labeled "Chapter 5" and pp. 36-39 (1990).
915Thomas, S., "Wound Management and Dressings," The Pharmaceutical Press, London, 223 sheets, (1990).
916Thomas, S., et al., "Comparative Review of the Properties of Six Semipermeable Film Dressings", The Pharmaceutical Journal, Jun. 18, 1988, pp. 785-789.
917Thomas, S., Wound Management and Dressings, Chapter 4: Semipermeable film dressings (continued onto pp. 26-34), Chapter 5: Foam dressings (continued onto pp. 36-42), and pp. 166, The Pharmaceutical Press, London, (1990).
918Thompson, J.T., et al., "Outcome analysis of helmet therapy for positional plagiocephaly using a three-dimensional surface scanning laser," J. Craniofasc. Surg., 20(2):362-365, (Mar. 2009).
919Timmers, et al., "The effects of varying degrees of pressure delivered by negative-pressure wound therapy on skin perfusion," Ann Plast Surg (2005) 55:665-671. NPL-972.
920Tintle, T.E., et al., "Early experience with a calcium alginate dressing," Ostomy/Wound Management, pp. 74-81, (May/Jun. 1990).
921Tittel, K., et al., "VariDyne-new standards in postoperative wound drainge", Jahrgang 14 (1988), Nr. 2, April, vol. 14 (1988), No. 2, April, pp. 104-107.
922Townsend, P.L.G., "The Quest for a Cheap and Painless Donor-Site Dressing", Burns, 2, pp. 82-85 (Jan. 1976).
923Trammell, T.R., et al., "Closed-wound drainage systems: the Solcotrans Plus versus the Stryker-CBC ConstaVAC", Orthopaedic Review, 20(6):536-542 (Jun. 1991).
924Tranchell, H.G., et al., Circulatory Ulcers a Physicial Approach, John Wright & Sons Ltd., Bristol, Foreword, I. Ulcers: a comparison, II. The ulcer, pp. 44-47, and 54-55, (1960).
925Transeal transparent wound dressing, DeRoyal, 4 sheets (2003).
926Tribble, D.E., "An improved sump drain-irrigation device of simple construction," Arch. Surg., 105:511-513, (Sep. 1972).
927Trivedi R, Husain N, Rathore RK, et al. Correlation of diffusion tensor imaging with histology in the developing human frontal cerebrum. Dev Neurosci, 2009. 31(6): p. 487-96. NPL-1012.
928Turner, T.D., "A Look at Wound Dressings", Health and Social Service Journal, May 4, 1979, pp. 529-531. NPL-405.
929Turner, T.D., "Recent Advances in Wound Management Products", pp. 3-6. NPL-406.
930Turner, T.D., "Semipermeable Films as Wound Dressings", Welsh School of Pharmacy, University of Wales, Great Britain (Jul. 31, 1984). NPL-407.
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