ASSEMBLIES, SYSTEMS, AND METHODS FOR VACUUM ASSISTED INTERNAL DRAINAGE DURING WOUND HEALING

Abstract

Assemblies, systems, and methods convey fluid from an internal wound site or body cavity by applying negative pressure from a source outside the internal wound site or body cavity through a wound drain assembly that, is placed directly inside the internal wound site or body cavity.

Claims

1-36. (canceled)

37. A drain system, comprising: a branched array that includes a plurality drain assemblies configured to be inserted into a volume within a body, each drain assembly including a housing having: an open interior; and at least one perforation; and a main tube configured to couple to a source of negative pressure and communicate with the branched array, such that negative pressure from the source of negative pressure is conveyed to the open interiors of the plurality of drain assemblies, wherein the at least one perforation is configured such that, in a presence of the negative pressure in the open interior, matter accumulated in the volume within the body passes through the at least one perforation and into the open interior.

38. The drain system of claim 37, wherein the plurality of drain assemblies are further configured such that the presence of the negative pressure in the open interiors of the plurality of drain assemblies draws and holds together internal tissue forming the volume within the body.

39. The drain system of claim 37, wherein the plurality of drain assemblies are further configured such that the presence of the negative pressure in the open interiors of the plurality of drain assemblies reduces a size of the volume within the body.

40. The drain system of claim 37, wherein: the branch array is removable from the plurality of drain assemblies, such that the branch array and main tube are removable from the body; and the plurality of drain assemblies consist of material that is absorbable by the body.

41. The drain system of claim 40, wherein at least a portion of the material of the plurality of drain assemblies is at least one of impregnated or coated with a bioactive or chemotherapeutic agent.

42. The drain system of claim 41, wherein the agent includes one or more of a hormone, a growth factor, an antibiotic, or an antibacterial.

43. The drain system of claim 37, further comprising: the source of negative pressure, wherein the source of negative pressure is configured to apply the negative pressure to the main tube.

44. The drain system of claim 43, wherein the source of negative pressure is portable.

45. The drain system of claim 37, further comprising: a tubular sleeve including: a bore configured to pass the housing of a drain assembly; and a tissue-penetrating distal tip forming an end of the bore; wherein the tubular sleeve is configured to provide access to the volume within the body and enable deployment of the plurality of drain assemblies therein.

46. The drain system of claim 37, wherein each of the plurality of drain assemblies further includes an open cell component positioned within the open interior of the housing, and configured to take in the matter accumulated in the volume within the body that passes through the at least one perforation and into the open interior. Application No.: Attorney Docket No.: 00181-0003-02000

47. A method of treating a body, comprising: deploying a branched array that includes a plurality of drain assemblies into a volume within the body; operating a source of negative pressure to apply a negative pressure to an open interior of respective housings of the plurality of drain assemblies, wherein: the negative pressure is applied via a main tube coupled to the source of negative pressure and to the branched array; and each of the respective housings has a plurality of perforations at least one perforation that provide provides communication between the open interior of the housing and the volume within the body.

48. The method of claim 47, further comprising: via the negative pressure in the plurality of drain assemblies, drawing and holding together internal tissue forming the volume within the body.

49. The method of claim 47, further comprising: via the negative pressure in the plurality of drain assemblies, reducing a size of the volume within the body.

50. The method of claim 47, further comprising: via the negative pressure in the plurality of drain assemblies, drawing matter accumulated in the volume within the body through the at least one perforation pluralities of perforations and into the open interiors of the plurality of drain assemblies. Application No.: Attorney Docket No.: 00181-0003-02000

51. The method of claim 47, further comprising: inserting at least one housing of the plurality of drain assemblies into a bore of a tubular sleeve; advancing a penetrating distal tip of the tubular sleeve into the volume of the body; advancing the at least one housing to the penetrating distal tip; holding the at least one housing in place, and withdrawing the tubular sleeve to deploy the at least one housing into the volume of the body.

52. The method of claim 47, wherein, after the plurality of drain assemblies are deployed, the main tube passes from within the body to outside of the body.

53. The method of claim 47, further comprising: decoupling the plurality of drain assemblies from the branched array; and removing the main tube and the branched array.

54. The method of claim 53, wherein: the plurality of drain assemblies consist of material that is absorbable by the body; and the method further comprises allowing the plurality of drain assemblies to be absorbed by the body. Application No.: Attorney Docket No.: 00181-0003-02000

55. The method of claim 47, wherein: the plurality of drain assemblies include material that is at least one of coated or impregnated with a bioactive or chemotherapeutic agent; and the method further comprises delivering the agent to the body via the plurality of drain assemblies.

56. A treatment system, comprising: a branched array that includes a plurality of drain assemblies configured to be inserted into a volume within a body, each drain assembly formed from material that is absorbable by the body and including a housing having: an open interior; and a plurality of perforations at least one perforation; and a main tube configured to couple to a source of negative pressure and communicate with the branched array, such that negative pressure from the source of negative pressure is conveyed to the open interiors of the plurality of drain assemblies, wherein the plurality of drain assemblies are further configured such that a presence of the negative pressure in the open interiors of the plurality of drain assemblies draws and holds together internal tissue forming the volume within the body and at least partially closes the volume; and wherein the main tube is removable from the plurality of drain assemblies.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0038] FIG. 1 is an anatomic side section prior art view of a human abdomen showing an interior wound void and a tube that is placed according to conventional techniques to drain fluid from a seroma at the wound site.

[0039] FIG. 2 is an anatomic side section prior art view of an exterior wound void showing an external VAC device placed according to conventional techniques to drain fluid from a seroma only at an external wound site.

[0040] FIG. 3 is an anatomic, somewhat diagrammatic prior art view of the limited drainage area achieved by the external VAC device shown in FIG. 2.

[0041] FIG. 4A is an anatomic side section view of a human abdomen, like that shown in FIG. 1, but showing a drain system that embodies features of the invention, comprising an internally placed wound drain assembly coupled to an external source of negative pressure to convey extracellular exudates from the wound.

[0042] FIG. 4B is an anatomic side section view of the human abdomen, as show in FIG. 4A, showing the drain system that embodies features of the invention serving, while the extracellular exudates are conveyed in response to the negative pressure from the wound, to draw together the separated interior tissue surfaces, thereby promoting adherence of the tissue surfaces and a normal wound healing process.

[0043] FIG. 5 is an anatomic, somewhat diagrammatic view of the enhanced drainage area achieved by the drain system. shown in FIGS. 4A and 4B.

[0044] FIG. 6 is a perspective, exploded view of a representative embodiment of a wound drain assembly of the type shown in FIGS. 4A and 4B.

[0045] FIGS. 7A and 7B are enlarged views of representative forms of open cell material comprising a sponge foam material that the wound drain assembly shown in FIG. 6 may carry.

[0046] FIG. 8 is a perspective, assembled view of the wound drain assembly shown in FIG. 6.

[0047] FIGS. 9 to 13 are perspective views of other representative embodiments of a wound drain assembly of the type shown in FIGS. 4A and 4B.

[0048] FIGS. 14 and 15 are representative views of various systems of a type shown in FIGS. 4A and 4B.

[0049] FIGS. 16 and 17 show, respectively, a wound drain assembly of the type shown in FIGS. 4A and 4B before and during the application of negative pressure.

[0050] FIG. 18 shows, in an anatomic view, a system like that shown in FIGS. 4A and 4B, comprising a wound drain assembly coupled to a portable source of negative pressure that can be carried by an individual, but also be fixed or attached to a wall section.

[0051] FIGS. 19A, 19B, and 19C show, in an anatomic view, a system like that shown in FIGS. 4A and 4B, comprising an absorbable would drain assembly.

[0052] FIG. 20A is another representative embodiment of a wound drain assembly that can be used in the manner shown in FIGS. 4A and 4B.

[0053] FIG. 20B is a section view of the wound drain assembly taken generally alone line 20B-20B in FIG. 20A.

[0054] FIGS. 20C and 20D are enlarged views of a portion of the wound drain assembly shown as 20C in FIG. 20A, showing a perforation in the housing that has been slotted or slotted into an x-shape to emulate a one-way valve, FIG. 20C showing the emulated valve in a substantially closed condition and FIG. 20D showing the emulated valve in an opened condition.

[0055] FIG. 21A is another representative embodiment of a wound drain assembly that can be used in the manner shown in FIGS. 4A and 4B.

[0056] FIGS. 21B and 21C are enlarged views of a portion of the wound drain assembly shown as 21B in FIG. 21A, showing a perforation in the housing that has been slotted or slotted into a semi-lunar shape to emulate a one-way valve, FIG. 21B showing the emulated valve in a substantially closed condition and FIG. 21C showing the emulated valve in an opened condition.

[0057] FIGS. 22A, 223 and 22C are, respectively, a perspective top view, side view, and end view a family of wound drain assemblies of differing lengths that can be used in the manner shown in FIGS. 4A and 4B, e.g., following reconstructive surgery.

[0058] FIGS. 23A, 23B and 23C are, respectively, a perspective top view, side view, and end view a family of wound drain assemblies of differing lengths that can be used in the manner shown in FIGS. 4A and 4B, e.g., following cosmetic surgery.

[0059] FIG. 24A shows an internal drain system comprising a serial, in-line array of individual wound drain assemblies, each being like that shown, e.g., in FIGS. 22A/B/C.

[0060] FIG. 24B shows the series, in-line array of individual wound drain assemblies shown in FIG. 24A in use along the longitudinal axis of a wound void, e.g., formed as a result of spinal fusion.

[0061] FIG. 24C shows the series, in-line array of individual wound drain assemblies shown in FIG. 24A in use in a wound void that extends at least partially in an anterior and posterior, or circumferential aspects, e.g., formed as a result of abdominoplasty.

[0062] FIG. 25A shows an internal drain system comprising a parallel, branched array of individual wound drain assemblies, each being like that shown, e.g., in FIGS. 22A/B/C.

[0063] FIG. 25B shows the parallel, branched array of individual wound drain assemblies shown in FIG. 24A in use in a wound void that extends at least partially in an anterior and posterior, or circumferential aspects, e.g., formed as a result of abdominoplasty.

[0064] FIGS. 26A to 26G show the installation of a wound drain assembly in an operative dead. space or seroma site through a trocar.

DESCRIPTION OF THE PREFERRED EMBODIMENT

[0065] Although the disclosure hereof is detailed and exact to enable those skilled in the art to practice the invention, the physical embodiments herein disclosed merely exemplify the invention that may be embodied in other specific structure. While the preferred embodiment has been described, the details may be changed without departing from the invention, which is defined by the claims.

[0066] FIG. 4 shows a wound drainage system 10 comprising an internal drain assembly 12 that is sized and configured for surgical placement within a wound void W or body cavity). The wound void W may be anywhere in a human or animal, e.g., within a body cavity, or beneath the skin, or in muscle, or within the soft tissues.

[0067] As shown in FIG. 4, the wound W can be defined as an interior dead space or void having a volume enclosed between interior tissue surfaces consisting of muscle, connective, or skin tissue containing blood vessels that have been separated by surgery or trauma within a body beneath substantially intact skin. As previously described, extracellular exudates comprising serous fluid, wound exudate, blood cells, blood products, blood clots, thrombus, wound debris, dead cells and other viscous materialsthe byproducts of the wound healing processescaping from the blood vessels can accumulate in the dead space and, if not removed, form a seroma.

[0068] As will be described in greater detail later (see also FIG. 6) , the internal drain assembly 12 includes a housing 18. The housing 18 comprises an inert, biocompatible, non-tissue adherent material, which does not adhere to or activate the body's natural foreign body defense mechanism. The material can comprise, e.g., non-sticky or lubricated silicone rubber, polyurethane, or other biocompatible plastics. The housing 18 is sized and configured for placement entirely within the interior dead space. The housing 18 can be formed. e.g., by extrusion, molding, or machining. As will be described in greater detail later, the housing 18 can be formed in various shapes and sizes, depending upon the requirements and morphology of the wound site and function and use of the drain. In the configuration shown in FIG. 8, a representative size measures about 5 (length)about (width)about (height).

[0069] The housing 18 may be impregnated or coated with bioactive agents, such as silver, antibiotics, antibacterials, or growth factors, which may decrease infection and promote wound healing. The housing 18 may also include other hormone or natural or manmade stimulating factors that can decrease the chance of infection and/or accelerate wound healing. The housing 18 can also be impregnated or coated with a bioactive agent such ad methotrexate.

[0070] The housing 18 is formed to include a hollow interior chamber 28, which is enclosed by the side and end walls of the housing 18. The interior chamber 28 encloses an open cell component 16. The open cell component 16 is characterized in that it does not particulate in the presence of fluid and pressure, and that it takes in, e.g., by adsorption and/or absorption) the extracellular exudates found in an interior, surgically created dead space. The open cell structure can comprise, e.g., gauze, or a foam sponge material comprising, e.g., an open-cell porous structure (see FIG. 7A) or a granulated foam construction (see FIG. 7B) e.g., sponge materials in the 40 to 60 range pore size can be used, made of polyurethane or various other nonreactive plastics that exist now or may come into existence in the future. The open cell component 16 can be variously constructed from a biocompatible material that does not activate the body's natural foreign body defense mechanism.

[0071] The open cell component 16 is desirably compressible for easy insertion into and removal from the housing 18 for replacement. The configuration of the housing 18 can also provide a contour facilitates sliding of the internal drain assembly 12, easing removal from the body.

[0072] The open cell component 16 may also be impregnated with bioactive agents such as silver, or antibiotics, or antibacterials, or growth factors, which may decrease infection and promote wound healing. The open cell component may also include other hormone or natural or manmade stimulating growth factors that can decrease the chance of infection and/or accelerate wound healing. For wound drains installed following cancer surgery, the open cell component 16 can also be impregnated or coated with a bioactive agent such as methotrexate or other chemotherapeutic agents.

[0073] In this arrangement, the housing 18 is also formed to include one or more through-slots, through-apertures, or through-perforations 20 in the side and/or end walls of the housing 18. The through-slots, through-holes, or through-perforations open the hollow interior chamber to communication with the wound site environment outside the housing 18. The open cell component 16 communicates with the wound void W through the through-slots, through-apertures, or through-perforations 20 that perforate the housing 18.

[0074] The through-slots, through-apertures, or through-perforations 20 perforating the housing 10 are sized and configured to pass, without substantial plugging, the extracellular exudates comprising serous fluid, wound exudate, blood cells, blood products, blood clots, thrombus, wound debris, dead cells and other viscous materials, which can be expected to reside in the wound void W. In a representative embodiment, the through-slots, through-apertures, or through-perforations 20 are sized and configured to present a mean pore diameter of between about 0.5 mm to about 5 mm. Other desirable sizes and configurations for the apertures 20 will be described in greater detail later.

[0075] The materials conveyed through the through-slots, through-apertures, or through-perforations 20 into the open interior are taken in (e.g., by adsorption and/or absorption) by the open cell material 18.

[0076] As before described, the housing 18 comprises a non-tissue adherent covering for the open cell component 16. This allows easy removal of the internal drain assembly 12, because there is no departiculation or adherence of the open cell component 16 to the surrounding soft tissues. Due to the enclosure of the open cell component 16 within the non-tissue adherent housing 18, there is also no bleeding upon removal of the internal drain assembly 12, because there is no sticking adherence of the internal drain assembly 12 to the soft tissues internally.

[0077] An end of a drain tubing 14 is coupled to the housing 18 and opens into the hollow interior chamber 28. The drain tubing 14 is desirably flexible and made of medical grade, inert material. e.g., silicone rubber, polyurethane, or other biocompatible plastics. The tubing is desirably sized and configured to accommodate sufficient fluid flow with a relatively small and tolerable incision size (e.g., about 2-3 in diameter).

[0078] The drain tubing 14 extends outside the wound void W. The drain tubing 14 can extend through a percutaneous incision in the skin overlying any wound void W. Alternatively, the drain tubing 14 can extend through an opening in a skin flap bounding the wound void. The flexible drain tubing 14 includes a terminal end 22 that extends outside the body.

[0079] The terminal end 22 desirably includes a quick release connector 24. The connector 24 is sized and configured to be connected to a conventional external negative pressure suction device 26 (such as a V.A.C. device made by KCI International, or a conventional wall suction or other regulated vacuum device).

[0080] In use (as FIGS. 4A and 4B show), the drain tubing 14 is connected to the suction device 26. The suction device 26 is operated to apply a requisite negative pressure through the internal drain assembly 12. The extracellular exudates comprising serous fluid, wound exudate, blood cells, blood products, blood clots, thrombus, wound debris, dead cells and other viscous byproducts of the wound healing process that accumulate in the wound cavity (as previously described), are taken in (e.g., by adsorption and/or absorption) by the open cell component 16. Concurrently, the extracellular exudates comprising serous fluid, wound exudate, blood cells, blood products, blood clots, thrombus, wound debris, dead cells and other viscous materials of the wound healing process are drawn by the negative pressure through the open cell component 16 from the wound void W.

[0081] The drain tubing 14 desirably includes an inline reservoir 30 to collect the withdrawn extracellular exudates comprising serous fluid, wound exudate, blood cells, blood products, blood clots, thrombus, wound debris, dead cells and other viscous byproducts of the wound healing process for disposal.

[0082] As FIG. 5 shows, occupying the interior of the wound void F, the internal drain assembly 12 conveys negative pressure throughout the entire open volume of the wound space. The negative pressure applied by the internal drain assembly 12 clears the extracellular exudates comprising serous fluid, wound exudate, blood cells, blood products, blood clots, thrombus, wound debris, dead cells and other viscous byproducts of the wound healing process from the entire wound volume. As FIG. 4B also shows, the removal of these materials from the entire wound volume promotes tissue adherence within the wound void, to close the wound void and seal the wound.

[0083] The internal drain assembly 12 makes possible the placement of the perforated, non-tissue adherent housing 18 enclosing the large surface area of the open cell component 16 entirely within the interior wound void or dead space, with the drain tubing 14 extending from the interior wound void or dead space through a percutaneous access to a location outside the body, as FIG. 4A shows. The drain tubing 14 can be coupled to a source of negative pressure outside the body, and the source of negative pressure operated to convey negative pressure into the open interior of the housing for application through the perforations internally throughout the interior wound void or dead space (as FIGS. 4B and 5 show). The internal drain assembly 12 makes possible, in response to the applied negative pressure, the conveyance of the extracellular exudates comprising serous fluid, wound exudate, blood cells, blood products, blood clots, thrombus, wound debris, dead cells and other viscous byproducts of the wound healing process taken in (e.g., by adsorption and/or absorption) by the open cell component 18 from the interior wound void or dead space to decrease the volume of the wound void or dead space and subsequent seroma formation. The internal drain assembly 12 makes possible, in response to the applied negative pressure, the drawing together of the separated interior tissue surfaces to promote adherence of the tissue surfaces and a normal wound healing process, as FIG. 4E shows.

[0084] The negative pressure can be, e.g., 75 mmHg to 200 mmHg, and is desirably about 125 mmHg below ambient pressure, although the negative pressure may fail slightly above that range and may also decrease below that range over time. The amount of negative vacuum pressure can be regulated in a continuous, discontinuous, or otherwise variable manner, to maximize wound healing and closure. In this way, the system 10 promotes primary wound healing while also decreasing or minimizing seroma formation. The pressure required to keep the tissues approximated may also decrease over time and fall to the negative 20 mmHg to 100 mmHg range.

[0085] As FIGS. 16 and 17 show, the introduction of negative pressure into the housing 18 can cause the housing 18 itself to collapse against the open cell component 16 (as FIG. 17 shows). However, the through-perforations 20 of the housing 18 maintain open paths for fluid to be taken in (e.g., by adsorption and/or absorption.) by the open cell component 16. The Example that follows demonstrates that this, in fact, occurs in an interior wound environment.

[0086] As FIGS. 4A/B and 5 show, the drain tubing 14 desirably includes an inline one-way backflow valve V. The one-way backflow valve V allows fluid to be drawn from the wound volume into the reservoir 30. Upon disconnection of the drain tubing 14 from the external negative pressure suction device 26 (via the connector 24), the one-way backflow valve V prevents air or fluid to flow backward into the wound or body. The one-way backflow valve V keeps the internal drain assembly 12 closed when not connected to the external negative pressure suction device 26.

[0087] As FIGS. 9 to 13 show, the housing 18 can be formed in various dimensions, shapes, and sizes, and the open cell component 16 cut to corresponding dimensions, shapes, and sizes. These dimensions, shapes, and sizes can comprise, e.g., square (FIG. 9); oval (FIG. 10); hexagonal (FIG. 11); round (FIG. 12); or rectangular (FIG. 13); or any linear or curvilinear shape or combinations thereof. The ends of the housing 18 can be tapered or not tapered (as FIGS. 9 to 13 demonstrate). The through-perforations 20 can also be variously shaped and sized (as FIGS. 9 to 13 demonstrate). The through-perforations 20 can also be tapered or not tapered along their axes. The perforations 20 can form an array of apertures substantially around the entire periphery of the housing 18, or the apertures can be confined to one surface or a portion of a surface of the housing 18.

[0088] A further representative embodiment is shown in FIGS. 20A and 20B. In this embodiment, the housing 18 is generally circular in cross section, enveloping the open cell component 16. The drain tubing 14 extends into the open cell component 16 for substantially the entire length of the housing 18. Spaced-apart ports P are formed along the extension of the drain tubing 14 within the open cell component 16, through which negative pressure is uniformly distributed into the housing 18. The distal end of the drain tubing 14 is sealed within the distal tip 22 of the housing 18.

[0089] As shown in FIGS. 20C/D, the through-perforations 20 can take the form of slots or slits 32 that are sized and configured to emulate a one-way valve.

[0090] For example, as shown in FIGS. 20C/D, each perforation can comprise a pattern of: crossing slots or slits 32, forming an x. The x slit forms four leaflets 34 of a valve. In the absence of negative pressure (see FIG. 20B), the leaflets 34 of the crossing slots or slits 32 are generally coplanar, forming a normally, substantially closed valve configuration. The substantially normally closed valve configuration prevents tissue in-growth into the open cell component 16. However, when negative pressure is applied by the drain tubing 14 within the housing 18 (see FIG. 20B), the leaflets 34 are mutually drawn inward in response to the negative pressure (i.e., mutually drawn toward the negative pressure applied to the open cell component 16), forming an opened valve configuration. The opened valve configuration passes the extracellular exudates comprising serous fluid, wound exudate, blood cells, blood products, blood clots, thrombus, wound debris, dead cells and other viscous byproducts of the wound healing process from the interior wound void or dead space into the open cell component 16, without substantial plugging, to decrease the volume of the wound void or dead space and subsequent seroma formation.

[0091] Another representative emulation of a one way valve is shown in FIGS. 21A/B/C. In this embodiment, each perforation comprises a slot or slit 32 forming a semilunar flap in the housing 18. In the absence of negative pressure (see FIG. 21B), flap forms the leaflet of a normally substantially closed valve configuration. The normally substantially closed valve configuration prevents tissue in-growth into the open cell component 16. However, in the presence of negative pressure (see FIG. 21B), the leaflet 36 is drawn inward in response to the negative pressure applied by the drain tubing 14 within the open cell component 16 (i.e., drawn toward the open cell component 16), forming an opened valve configuration. The opened valve configuration passes the extracellular exudates comprising serous fluid, wound exudate, blood cells, blood products, blood clots, thrombus, wound debris, dead cells and other viscous byproducts of the wound healing process from the interior wound void or dead space into the open cell material, to decrease the volume of the wound void or dead space and subsequent seroma formation.

[0092] By way of example, the pore size can range between 0.5 mm to 5 mm, and the separation between pores can be, e.g. about 8 mm, although the magnitudes can vary upward or downward.

[0093] As before described, the internal drain assembly 12 as described can be inserted through relatively small and tolerable percutaneous incision size (e.g., about 2-3 in diameter).

[0094] Furthermore, as shown in FIGS. 26A to 26E, the internal drain assembly 12 can be sized and configured for insertion through a cannula or tubular sleeve 38 (which can also be called a trocar) made, e.g., of a rigid plastic or metallic material. The cannula has an open interior bore 40 and a penetrating distal tip 42 (see FIG. 26A). The tip 42 of the cannula incises or separates tissue when the cannula 38 is axially advanced into tissue (typically through an initial incision), to allow advancement of the distal end 42 of the cannula 38 into the operative dead space or seroma site W (see FIG. 26B). The open interior bore 40 of the cannula 38 provides an access path or lumen into the operative dead space or seroma site W.

[0095] In a representative embodiment, the bore 40 of the cannula 28 comprises ah interior diameter of, e.g., 4.5 mm, and the housing 18 of the internal drain assembly is sized and configured (e.g., outside diameter of about 3 mm) for insertion thorough the proximal end of cannula 38 and advancement though the bore 40 (see FIG. 26C). The housing 18 can, if desired, be lubricated (wetted) for passage through the bore 40.

[0096] The housing 18 is pushed distally (i.e., advanced axially), until the housing 18 rests at distal tip 42 of cannula 38. The cannula 38 is withdrawn (retracted) while holding internal drain assembly 12 stationary (see FIG. 26D). This places the housing 18 of the internal drain assembly 12 in communication with the operative dead space or seroma site W (see FIG. 26E), where it can serve to remove extracellular exudates comprising serous fluid, wound exudate, blood cells, blood products, blood clots, thrombus, wound debris, dead cells and other viscous byproducts of the wound healing process, to decrease the volume of the operative dead space and subsequent seroma formation at the site.

[0097] The housing 18 can be formed in different dimensions, shapes, and sizes, and the open cell component 16 cut to corresponding dimensions, shapes, and sizes, to create different families of wound drains sized and configured to meet the particular requirements of a given surgical procedure or class of surgical procedures.

[0098] For example, as shown in FIGS. 22A/B/C, a family 44 of wound drains 12(1), 12(2), and 12(3) can be sized and configured with a similar oval cross section profile, but in different lengths, to serve as a family 44 of wound drains 12(1), 12(2), and 12(3) useful, e.g., after reconstructive surgery. Each wound drain assembly 12(1), 12(2), and 12(3) includes a perforated housing 18 enclosing an open cell component 16 through which negative pressure is applied. A. representative oval cross section profile for a reconstructive drain family 44 can be, e.g., 15 mm by 10 mm. Representative lengths for the reconstructive drain family can range, e.g., from 10 mm to 200 mm.

[0099] As another example, as shown in FIGS. 23A/B/C, a family 46 of wound drains 12(4), 12(5), and 12(6) can be sized and configured with a similar circular cross section profile but in different lengths, to serve as a family 46 of: wound drains 12(4), 12(5), and 12(6) useful, e.g., after cosmetic surgery. Each wound drain assembly 12(4), 12(5), and 12(6) includes a perforated housing 18 enclosing an open cell component 16 through which negative pressure is applied. The cross section profile and lengths of the cosmetic drain family 46 are shown to be smaller than those of the reconstructive drain family, because, due to the anatomy of the surgical site, cosmetic surgery typically forms smaller, more compact wound voids than reconstructive surgery. A representative circular cross section profile for a cosmetic drain family 46 can be, e.g., 8 mm. Representative lengths for the cosmetic drain family can range, e.g., from 10 mm to 150 mm.

[0100] Another representative embodiment is shown in FIG. 24A. In this embodiment, an internal drain system 10 can comprise a serial array of individual, in-line wound drain assemblies 12, which are coupled serially by flexible intermediate lengths of drain tubing 14. Each wound drain assembly 12 includes a perforated housing 18 enclosing an open cell component 16 through which negative pressure is applied. In use, the in-line internal drain system 12 can be placed, depending upon the morphology of a given wound void, along the axis of a longitudinally elongated wound void (e.g., as a result of spinal fusion surgery) (see, e.g., FIG. 24E), or from front to back within a wound void that extends at least partially in anterior and posterior, or circumferential, aspects (e.g., as a result of abdominoplasty or total joint replacement surgery) (see, e.g., FIG. 24C), or a wound site that requires, e.g., drainage both inside and outside the abdomen.

[0101] Another representative embodiment is shown in FIG. 25A. In this embodiment, an internal drain system 50 can comprise a parallel or branched array of individual wound drain assemblies 12, which is coupled in parallel branches from a main drain tube 14 by flexible intermediate lengths 52 of drain tubing. Each wound drain assembly 12 includes a perforated housing 18 enclosing an open cell component 16 through which negative pressure is applied in use, the parallel internal drain system 50 can be placed from front to back within a wound void that extends at least partially in anterior and posterior, or circumferential, aspects (e.g., as a result of abdominoplasty or total joint replacement surgery) (see, e.g., FIG. 25B), or a wound site that requires, e.g., drainage both inside and outside the abdomen.

[0102] Any given wound drainage system 10, 48, 50 can be variously configured and assembled. For example, as shown in FIG. 14, the in-line reservoir 30 is intended, in use, to be placed at a gravity position at or below the drain assembly 12 and includes separate fluid inlet and vacuum outlet paths arranged along the top of the reservoir 20, coupled, respectively, to the internal drain assembly 12 and. the external negative pressure suction device 26. As FIG. 15 shows, the reservoir 30 is intended, in use, to be placed at a gravity position above the drain assembly 12 and includes an fluid inlet path arranged along the bottom of the reservoir 30 (coupled to the drain assembly 12) and a vacuum outlet port arranged along the top of the reservoir 30 (coupled to the external negative pressure suction device 26).

[0103] As FIG. 18 shows, the system 10 may include a battery powered external negative pressure suction device 26 that can be carried by the individual. The system 10 can therefore be operated while the individual ambulates, so that the individual need not be bed-bound during the recovery period.

[0104] As shown in FIG. 19A, a internal drain assembly 56 can comprise a mesh structure 54 coupled to the tubing 14 comprising a material that is bioabsorbable, meaning that it transforms over time within the wound volume from a solid state to a state that can be cleared or absorbed by the body. The absorbable material of the mesh structure can be made of sterile material, such as, e.g., Vicryl, moncryl, PDS, polyvinyl alcohol, polyurethane, or animal or human tissue, or other absorbable material that could be woven into a foam-like construct. In this arrangement, the internal drain assembly 56 can also include a perforated housing 18 made of an absorbable material, which encloses the absorbable mesh structure 54.

[0105] In this embodiment, when the internal drain assembly 56 has completed its job (see FIG. 19B), the silicone or plastic tubing 14 is detached from absorbable mesh structure 40 (or the absorbable housing 18 enclosing the absorbable mesh structure) and removed, leaving the absorbable mesh structure 54 (or housing and absorbable mesh structure) inside the body, to dissolve and absorb just like absorbable suture, as shown in FIG. 19C.

EXAMPLE

[0106] Wound drain assemblies having the technical features described above were placed into internal wound voids surgically created in a porcine model. Also concurrently placed into surgical created wound voids in the same porcine model were conventional wound drains. The performance of efficacy of the wound drain assemblies were compared to the performance and efficacy of the conventional drains over a period of eight days.

[0107] More particularly, following induction of general anesthesia, prefascial pockets were elevated with scissor dissection through ten (10) cm incisions on left and right lateral sides of a pig over the latissimus dorsi muscles and external oblique muscles, just posterior to the front legs. The left and right side pockets were placed six (6) cm off the midline to assure the pockets were kept separate. Bovie cautery was used for hemostatsis and pockets were irrigated with a triple antibiotic solution used in implant surgery, comprising 1 gm of Ancef, 80 mg of Gentamicin, and 50,000 IU units of Bacitracin/500 cc NS.

[0108] Conventional Silastic Blake Drains (Ethicon, Inc., a Johnson & Johnson Company; Somerville, N.J.) were placed through the incisions into the subcutaneous pocket on the animal's left side. The Blake Drains (15 mm in diameter) were identical to those used clinically in practice in humans.

[0109] A wound drain assembly, like that shown in FIGS. 21 A/B/C (with a foam sponge component 16 and semilunar slits 32 perforating the housing) (hereafter, in shorthand, the WDA), was placed in the triple antibiotic solution, and then placed into the subcutaneous pocket on the animal's right side.

[0110] Closure was performed in multiple layers on both sides with additional PDO Quill closure (Angiotech Pharmaceuticals), Dermabond liquid skin adhesive (Ethicon, Inc., a. Johnson & Johnson Company; Somerville, N.J.) applied to the skin, and Opsite Post-Op waterproof dressings (Smith & Nephew), for a complete water tight seal at the operative sites.

[0111] Standard suction bulbs were placed on the Blake Drains to mimic current clinical usage.

[0112] A portable negative pressure V.A.C. pump (NCI), set to deliver a standard 125 mmHg of suction pressure, was coupled to the WDA to apply a uniform continuous suction in the wound void throughout the course of the study.

[0113] The animal was dressed in a specially designed post-surgical vest, with zippered pockets worn on the animals' backs. The drains were brought out of separate incisions beneath the vest and into a zipper pockets on the vest.

[0114] The same set up of a Blake Drain and a WDA was performed on a second pig, with a standard Blake Drain on the left side and the WDA on the right side.

[0115] The pigs did very well postoperatively. The drains remained intact attached to the animals and carried within the specially designed jacket pockets worn on the animals' backs. The animals received antibiotics daily and all wound pockets healed well with no infection.

[0116] The suction bulbs (on Blake Drains) and pumps (on the WDA's) were checked every four hours for the first twenty-four hours, every eight hours for the next three days, and then every twelve hours to completion of the study (on day 8). The dressings were changed, fluid recorded, bulbs recharged and canisters changed. The drain canisters were changed at the above schedule during animal feedings, and they tolerated the changes very well while they were feeding.

[0117] The canisters were weighed per-placement and weighed. on removal. The drainage recorded from the animals is as follows:

TABLE-US-00001 Blake Drain WDA Pig 1 200 cc over 8 days 170 gm over 8 days (1 gm is ~=1 cc fluid) Pig 2 400 cc over 8 days 180 gm over 8 days

[0118] The following observations were made:

[0119] i) Over 80% of the WDA drainage occurred in the first 24 hours. In contrast, drainage on the standard drain side remained constant throughout the study period.

[0120] (ii) The exudates of the standard Blake Drains remained bloody and viscous throughout the study. In contrast, the exudates of the WDA had a quicker return on day 3 from bloody and viscous to a serum-straw colored fluid.

[0121] Following eight days of drain placement, the animals were brought back to surgery, and the wound voids were evaluated. The incisions had healed well and there was no evidence of infection.

[0122] Both Blake Drains had healed directly around the wound voids. However, the wound voids had not closed completely. As is typically experienced in human clinical situations, both of the Blake Drain sites in the porcine model had peripheral seroma pockets in the prior surgical spaces.

[0123] Both WDA's had complete closure of the prior surgical spaces around the entire periphery of the wound void, up to the point of the WDA itself. It was difficult to redevelop and finger fracture this space back open. Biopsy specimens show complete closure of the surgical space and healing.

[0124] Neither WDA had absolutely any adherence to the soft tissues, and there was no fragmentation of any open cell material in the surgical space. There was mild imprinting in the pocket where the WDA was located. (this was also visualized on the Blake Drain side). The pocket surrounding the WDA was small, snug and tight, and just slightly larger than the WDA itself. There continued excellent flow through the WDA through the 8th day. Forces to remove the WDA were reasonably low.

[0125] The foregoing Example demonstrates that wound drain assemblies having the technical features described herein function very well, serving as an internal wound closure device to effectively close a large surgically created space. The entire surgical space was completely occluded and healed down to a pocket just surrounding the wound drain assembly itself, to the point it was very difficult to open the surgical space back up. There was no adherence or departiculation of the open cell material in the surgical space. The semilunar flaps performed well, maintaining easy and complete flow through them on suction, but not allowing any ingrowth or adherence of the assembly. Eighty percent (80%) of the fluid removed with the wound drain assembly occurred in the first day, then tapered off dramatically, with the exudates turning straw-colored on the third day.

[0126] The foregoing Example demonstrates that peripheral seroma cavities occurred in both animals with standard Blake Drains and bulbs, mimicking what occurs clinically in humans, where seroma cavities remain problems and the soft tissues often do not come together to allow approximation and healing through the natural body processes greater flow volumes continued throughout the study, with the evacuates remaining very bloody in the standard Blake Drain groups.

[0127] The Example demonstrates that applying a vacuum of significant pressure internally and directly in a wound void or body cavity using a wound drain assembly as disclosed herein results in the relatively quick and effective removal of the extracellular exudates comprising serous fluid, wound exudate, blood cells, blood products, blood clots, thrombus, wound debris, dead cells and other viscous byproducts of the wound healing process from the interior wound void, without substantial plugging, as well as results in an enhanced formation of tissue adherence and would healing. Applying a vacuum of significant pressure internally and directly in a wound void or body cavity using a wound drain assembly as disclosed herein accelerates healing by the application of a universal negative force to the entire wound volume, drawing the wound edges together, assisting closure, enhancing wound healing, and decreasing dead space and seroma. Applying a vacuum of significant pressure internally and directly in a wound void or body cavity using a wound drain assembly as disclosed herein brings about beneficial changes to the surgical site, including changes in microvascular blood flow dynamic; changes in interstital fluid; the removal of wound exudates; the stimulation of growth factors and collagen formation; the reduction in bacterial colonization; the mechanical closure of wound by reverse tissue expansion; increased adherence of the soft tissue and internal wound healing; and decreased dead space and seroma formation.

[0128] The invention provides assemblies, systems, and methods that not just manage blood and fluid collection in an internal wound cavity, but also close and eliminate the dead. interior space, drawing the separated interior tissue surfaces together to promote adherence of the tissue surfaces and a normal wound healing process.

[0129] The foregoing is considered as illustrative only of the principles of the invention. Furthermore, since numerous modifications and changes will readily occur to those skilled in the art, it is not desired to limit the invention to the exact construction and operation shown and described. While the preferred embodiment has been described, the details may be changed without departing from the invention, which is defined by the claims.