Patent Grant
9744274
Field of the Invention
The present invention relates to improvements in methods of and apparatus for sampling, processing and collecting tissue samples using aspiration processes.
Brief Description of the State of Knowledge in the Art
There are many applications where human tissue is harvested, processed and transplanted back into human beings for various cosmetic, reconstructive and biomedical reasons.
In general, there are various types of human tissue involved in such transplantation procedures, including autologous and allogeneic forms of adipose (i.e. fat) and musculoskeletal (i.e. bone, ligament, cartilage and skin) tissue, for use in autografting and allografting.
Also, in recent times, public confidence in and comfort with synthetic materials (e.g., silicone and teflon) and foreign tissues (e.g., bovine collagen) has declined. Conversely, the interest in and demand for autologous adipose tissue transplantation has risen.
Typically, autologous adipose tissue transplantation involves the procurement of adipose tissue by liposuction techniques from an area of abundance, and re-injection of the harvested adipose tissue into a different site of the same individual for cosmetic/reconstructive augmentation or enhancement purposes.
Generally, adipose tissue must be as ‘clean’ or refined as possible before re-introduction to maximize the chances of graft survival. Such refinement preferably is done with as little exposure of the tissue to air as possible (i.e., “anaerobic tissue handling”).
Unfortunately, the nature of conventional liposuction procedures have precluded easy tissue isolation after initial harvest (especially on a large scale) because the volume and/or viscosity of ‘raw’ liposuction effluent also contains unwanted components, e.g., oil, blood and anesthetic solution.
Currently, there are no standard techniques, methods, or devices that exist for the simple, large scale isolation and refinement of liposuction-harvested adipose tissue. Although cannulas, needles and methods for tissue harvest and preparation exist, these techniques are tedious, inefficient and require a pseudo-sterile centrifugation step.
Several devices exist for the isolation of certain cells.
For example, U.S. Pat. Nos. 5,035,708 and 5,372,945, issued to Alchas et al., describe an endothelial cell procurement and deposition kit and a device and method for collecting and processing fat tissue and procuring microvessel endothelial cells to produce endothelial cell products.
U.S. Pat. No. 6,316,247 to Katz et al discloses a method of and apparatus for separating adipose tissue for autologous tissue transplantation. Liposuctioned tissue removed from the patient is transferred into the device through the inlet port that is contiguous with the inner flexible porous container. Pieces of adipose tissue are “trapped” within the inner flexible container whereas waste components (free oil, blood, serum) are able to drain through the pores and out the outlet port. After all the desired liposuction effluent is transferred, the trapped tissue may be rinsed thoroughly with saline or buffer. For very thorough cleansing, the outlet port is sealed, buffer is added, and the inlet port is sealed. The device is agitated to encourage thorough rinsing of the tissue, and then the device is held upright and the bottom outlet port unsealed to allow for drainage of waste or active suction of the effluent. This step can be repeated several times as necessary to achieve tissue that is highly “purified”. Finally, the washed tissue can be expressed from the inner flexible container by ‘rolling’ the tissue out through the inlet port (from bottom to top) into receptacles, e.g., syringes, for re-implantation or any other desired receptacle for further preparation before injection. Alternatively, a receptacle can be attached directly to the port such that the tissue can be anaerobically re-injected into the body.
While U.S. Pat. No. 6,316,247 to Katz et al discloses an improved device for harvesting and processing fat tissue during liposuction operations, it involves complex tissue cleansing operations, and handling operations which make it either impractical or undesirable in surgical environments.
Thus, there is a great need in the art for a new and improved method of and apparatus for safely harvesting, processing (i.e. preparing) and collecting adipose and other forms of tissue for immediate autologous tissue transplantation, explant culture endeavors or cell dissociations, while avoiding the shortcomings and drawbacks of the prior art methods and apparatus.
Accordingly, it is a primary object of the present invention to provide a new and improved method of and apparatus for safely harvesting, processing (i.e. preparing) and collecting adipose and other forms of tissue for immediate autologous tissue transplantation, explant culture endeavors or cell dissociations, while avoiding the shortcomings and drawbacks of the prior art methods and apparatus.
Another object of the present invention is to provide a new tissue sampling, processing and injection syringe device which avoids the shortcomings and drawbacks of the prior art apparatus and methodologies.
Another object of the present invention is to provide an improved method of harvesting a tissue sample from a patient or donor using the tissue sampling, processing and injection syringe device.
Another object of the present invention is to provide an improved method of processing aspirated tissue sample using the tissue sampling, processing and injection syringe device. Another object of the present invention is to provide an improved method of injecting a processed tissue sample into a patient using a filled tissue sampling, processing and injection syringe.
Another object of the present invention is to provide an improved method of harvesting, processing and injecting a tissue sample into a patient using the tissue sampling, processing and injection syringe device.
Another object of the present invention is to provide an improved in-line three-pack tissue sampling, processing and collection device.
Another object of the present invention is to provide an improved method of processing aspirated tissue during harvesting using the 3-pack tissue sampling, processing and collection device of the present invention, coupled in-line to a hand-held powered tissue aspiration instrument.
Another object of the present invention is to provide an improved method of injecting processed tissue samples into a patient using a fat-filled tissue injection syringe device.
Another object of the present invention is to provide an improved method of harvesting, processing and injecting a tissue sample into a patient using the tissue sampling, processing and injection syringe device.
Another object of the present invention is to provide an improved in-line six-pack tissue sampling, processing and collection device.
Another object of the present invention is to provide an improved method of processing aspirated tissue during harvesting using the six-pack tissue sampling, processing and collection device
Another object of the present invention is to provide an improved method of injecting processed tissue into a patient using a fat-filled tissue injection syringe device.
Another object of the present invention is to provide an improved method of harvesting, processing and injecting a tissue sample into a patient using the tissue sampling, processing and injection syringe device.
Another object of the present invention is to provide improved tissue sampling, processing and collection devices which can be designed for single-use, as sterile consumables with a high profit margin.
Another object of the present invention is to provide improved tissue sampling, processing and collection devices which can be easily integrated with stem cell storage banks and cellular differentiation and enrichment programs.
Another object of the present invention is to provide improved tissue sampling, processing and collection devices which obviate the need for decanting, tissue transfers, autoclaving, or straining operations.
Another object of the present invention is to provide improved tissue sampling, processing and collection devices which enable gentle tissue harvesting operations, without heat, tissue trauma, blood loss, or surgeon effort.
Another object of the present invention is to provide a tissue sampling, collection, processing and re-injection system employing the modular and disposable tissue collection components which can be used in both manually-powered and vacuum-powered tissue sampling, processing and collection systems, providing significant levels of improvement in flexibility, convenience, and economy.
Another object of the present invention is to provide improved tissue sampling, processing and collection methods which work with both integrated and independent single-use sterile devices for aspirating, collecting, selectively sampling, processing, and re-injecting tissue.
Another object of the present invention is to provide such tissue sampling, processing and collection methods which can be practiced using low vacuum aspiration pressures, to minimize cellular rupture and oils.
Another object of the present invention is to provide improved tissue sampling, processing and collection methods, wherein aspirated and collected fat tissue is gently cleaned by tumescent fluid used during tissue aspiration operations, and wherein fluids and oils within tissue aspirants filtered through non-occluded micro-pores formed in tissue collection tubes employed in the apparatus.
Another object of the present invention is to provide improved tissue sampling, processing and collection methods which lavage harvested fat cells within the tissue collection apparatus of the present invention, along with an insulin or a growth factor enriched solution aspirated during tissue aspiration operations.
Another object of the present invention is to provide improved tissue sampling, processing and collection methods which result in lower cellular injury leading to higher graft survival rates.
Another object of the present invention is to provide improved tissue sampling, processing and collection methods, wherein collected tissue autografts can be stored for up to two years in an ordinary freezer (2-3° F.) without requiring cryopreservation.
Another object of the present invention is to provide improved tissue sampling, processing and collection platform which provides an autograft concentrate for an integrated banking program with optional further processing of adipocytes and stem cells.
Another object of the present invention is to provide improved tissue sampling, processing and collection methods which can be used for treating: facial wrinkles; scars and over-treated areas; Romberg's hemifacial atrophy; AIDS wasting; microsomia; facial revoluminization and youthfulization; breast augmentation; breast reconstruction; butt augmentation; and calf augmentation.
Another object of the present invention is to provide improved tissue sampling, processing and collection methods which minimize allergy or rejection from autograft.
Another object of the present invention is to provide improved tissue sampling, processing and collection methods which allow living tissue to provide better and more sustained results.
Another object of the present invention is to provide improved tissue sampling, processing and collection methods which help to “reboot” the face with non-apoptotic primitive precursor adipocytes and stem cells.
Another object of the present invention is to provide improved tissue sampling, processing and collection methods which can be used in mesotherapy volume restoration to lessen sagging and youthen skin tissue.
Another object of the present invention is to provide improved tissue sampling, processing and collection methods which may be used with power assisted injector guns.
Another object of the present invention is to provide improved tissue sampling, processing and collection methods which can be used in conjunction with multi-needle injectors and rollers.
Another object of the present invention is to provide a more efficient, versatile, cost-effective, sterile method and system for refining adipose tissue samples for immediate transplantation.
Another object of the present invention is to provide improved tissue sampling, processing and collection devices which are realized as disposable, single use small volume collection, processing and reinjection devices for manual subcutaneous tissue sampling and re-injection
Another object of the present invention is to provide improved reusable small, medium and large volume collection, processing, and reinjection devices employing single use disposable components.
Another object of the present invention is to provide improved tissue sampling, processing and collection devices for use in bone marrow harvesting & processing operations carried out intra-operatively on live patient donors, or on deceased human donors on a post-mortem basis.
Another object of the present invention is to provide disposable, single use small volume manual collection, processing and reinjection devices.
Another object of the present invention is to provide reusable small, medium and large volume collection, processing, and reinjection devices that are used in conjunction with air or electrically powered hand-held tissue aspiration instruments, and also employing single use disposable components.
Another object of the present invention is to provide a disposable device for the refinement of adipose tissue.
Another object of the present invention is to provide a more efficient, cost-effective, sterile method and system that overcomes the deficiencies of prior devices and systems for the refinement of adipose tissue for autologous adipose transplantation.
Another object of the present invention is to provide surgeons with an improved method of and apparatus for harvesting tissue for autologous adipose transplantation.
Another object of the present invention is to provide an improved method and apparatus of harvesting, processing and collecting tissue for use in immediate clinical applications, as well as support of individuals engaged in cell-based science, developmental biology, tissue engineering research and genetic engineering.
These and other objects and advantages of the present invention will become apparent hereinafter and the claims to invention appended hereto.
The above objects of the present invention will be more fully understood when taken in conjunction with the following figure Drawings, wherein like elements are indicated by like reference numbers, wherein:
FIG. 2A1 is a perspective view of a tissue collection tube employed in the tissue sampling, processing and collection devices of the present invention shown in
FIG. 2A2 is a perspective view of a rubber plunger connected to a push shaft (i.e. piston), which is adapted to slide into the interior volume of the tissue collection tube shown in FIG. 2A1;
FIG. 2A3 is a perspective view of the micro-pore occluder that slides on and fits about the tissue collection tube shown in FIG. 2A1, and which can be rotatably configured to occlude the micro-pores in its occluded state, or allow the micro-pores to remain exposed and open to the ambient environment;
FIG. 2A4 is a perspective view of the cap adapted to fit over and close off (i.e. create fluid seal over) the distal end opening or tip of the tissue collection tube shown in FIG. 2A1;
FIG. 5D1 is a perspective view of the tissue sampling, processing and injection syringe device of
FIG. 5D2 is a perspective view of the tissue sampling, processing and injection syringe device of
FIGS. 6B1 through 6B6 set forth a series of illustrations showing the tissue sampling, processing and injection syringe device of
Referring to the figures in the accompanying Drawings, the various illustrative embodiments of the present invention will be described in great technical detail, wherein like elements will be indicated using like reference numerals.
Overview of the Methods and Apparatus of the Present Invention
The illustration in
In the case of cosmetic surgical planning, in particular, 3D computer imaging techniques are typically used to survey a patient's body contour and plan out fat tissue transplantation for corrective purposes.
As shown, tissue is harvested in small volumes from the patient/donor using the tissue sampling, processing and injection syringe device 2 with cannula 3, forming device 1, shown and described
Alternatively, tissue is harvested in medium or large volumes using either 3-pack tissue sampling, processing and collecting device of the present invention shown in
In either case, fat tissue is collected in individual tissue collection tubes 5 having micro-pores 6 which are selectively occluded or non-occluded simply by rotation of a micro-pore occluder 7 that snap fits about the tissue collection tube, as shown in
In the case of the tissue sampling, processing and injection syringe device 2 shown and described
In the case of the 3-pack tissue sampling, processing and collecting device of the present invention shown in
As will be described in greater detail hereinafter, each tissue collection tube 5 used to construct the tissue sampling, processing and injection syringe device of
As shown in FIG. 2A1, the tissue collection tube 5 has the appearance of a syringe barrel, with micro-pores 6 formed in the tube walls normally open for fluid filtration therethrough during tissue collection operations. Each tissue collection tube 5 has a distal end opening 5A adapted to receive a cannula 3 via a Leur lock connector fitting 4, and a proximal end opening 5B adapted to receive a plunger 8A and piston 8B subassembly 8. Each tissue collection tube 5 is also adapted with a flange 9 having opposite flat side edge surfaces 9A and 9B, for engagement with a flat rectangular flange 11 extending from the micro-pore occluder 7, as shown in FIGS. 2A2 and 3.
As shown in
Several options are available after tissue samples have been collected and processed within individual tissue collection tubes within the collection chamber of multi-pack tissue sampling, processing and collection device 30 or 60.
A first option is to readily adapt each tissue-filled collection tube into a tissue injection syringe device by capping their distal end openings with cap 12, and inserting a plunger piston 8 partially into the proximal end openings thereof. Then these tissue-filled injection syringe devices 2 can be placed in autograft storage, or used immediately in autograft tissue re-injection procedures by simply removing the cap from the distal end opening of the syringe device and connecting a cannula thereto via Leur locking mechanism. Alternatively, the tissue collection tubes, filled with filtered and concentrated cellular material, can be subjected to further processing and cellular concentration, prior to being place in autograft storage. Thereafter, the tissue collection tubes can be removed from autograft storage and used in autograft tissue re-injection procedures.
Once the surgeon makes use of autograft injections to achieve corrections in the patient, 3D computer imaging is used again to see how closely the surgeon was able to achieve planned body sculpting during a first round of surgery. If necessary, the surgeon can repeat the phases indicated in
Having provided an overview of the apparatus and methods of the present invention, it is appropriate at this juncture to describe the same in greater technical detail below.
Specification of the Tissue Sampling, Processing and Injection Syringe Device of the Present Invention
Method of Harvesting a Tissue Sample from a Patient or Donor Using the Tissue Sampling, Processing and Injection Syringe Device of the Present Invention
The flow chart of
As indicated in Step 1 of
As indicated in Step 2 of
As indicated in Step 3 of
As indicated in Step 4 of
Optionally, as indicated in Step 5 of
As indicated in Step 6 of
As indicated in Step 7 of
Method of Processing Aspirated Tissue Sample Using the Tissue Sampling, Processing and Injection Syringe Device of the Present Invention
The flow chart of
As indicated in Step 1 of
As indicated Step 2, the micro-pores of the syringe device are exposed (i.e. configured in the non-occluded state) as shown in
As indicated in Step 3, the surgeon gently depresses the piston's plunger 8B to express extra fluid from the collected tissue sample, is expressed through the non-occluded micro-pores 6 and the collected tissue sample is concentrated (in terms of cellular content) as shown in
As in Step 4, the micro-pores on the tissue collection tube are then occluded by manually rotating the micro-pore occluder 7 into its micro-pore occlusion state, as illustrated in
Method of Injecting a Processed Tissue Sample into a Patient Using a Filled Tissue Sampling, Processing and Injection Syringe Device of the Present Invention
The flow chart of
As indicated in Step 1 of
As indicated in Step 2, the micro-pores 6 on the tissue collection tube are occluded by rotating the micro-pore occluder 7 to the micro-pore occlusion state, shown in
As indicated in Step 3, a cannula 3 is attached to the distal end opening of the tissue collection tube 5, as shown in
Optionally, as indicated in Step 4, the tissue sample material can be ejected out of the tissue collection tube of the syringe device 2, and into an empty (no air) plastic bag for the purpose of delivering tissue material to tissue bank.
Method of Harvesting, Processing and Injecting a Tissue Sample into a Patient Using the Tissue Sampling, Processing and Injection Syringe Device of the Present Invention
The flow chart of
Specification of the in-Line Three-Pack Tissue Sampling, Processing and Collection Device of the Present Invention
The flow chart of
As shown in
As indicated in Step 1 of
As indicated in Step 2 of
As indicated Step 3, the barb connector removed from the hand-held tissue aspiration instrument is attached to the rear portion of the 3-pack tissue sampling, processing and collection device, to allow for the connection of flexible tubing between the 3-pack tissue sampling, processing and collection device 30 and a vacuum source 36, as shown in
As indicated in Step 4, the selected area is irrigated with fluid during tissue aspiration, as desired, as shown in
As indicated in Step 5, fat tissue is aspirated from the patient as shown in
As shown in
Optionally, as indicated in Step 6, a volume of irrigation solution is aspirated through the tissue sampling, processing and collection device so as to lavage (i.e. cleanse or wash) the tissue samples contained in the tissue connection tubes, while still contained within the device. This will facilitate further filtration and concentration of the cellular materials within the tissue collection tubes.
Method of Processing Aspirated Tissue During Harvesting Using the 3-Pack Tissue Sampling, Processing and Collection Device of the Present Invention, Coupled in-Line to a Hand-Held Powered Tissue Aspiration Instrument
The flow chart of
As indicated in Step 1, the processing (i.e. filtration, cleansing and concentration) of tissue samples contained within the tissue collection tubes 5A through 5C, occurs automatically during tissue aspiration and collection operations. Such processes have been detailed in Steps 4, 5 and 6 in the method described in
As indicated in Step 2, the vacuum tubing is removed from the 3-pack tissue sampling, processing and collection device 30.
As indicated in Step 3, the 3-pack tissue sampling, processing and collection device 30 is disconnected from hand piece portion of the hand-held power tissue aspiration instrument 10, by way of an unscrewing action of the 3-pack device 30 relative to the hand piece portion of the hand-held power-assisted tissue aspiration instrument 10.
As indicated in Step 4, the barbed connector 35 is replaced on back of hand piece of the tissue aspiration instrument 10, as shown in
As indicated in Step 5, the lid on the 3-pack tissue sampling, processing and collection device 30 is removed, as shown in
As indicated in Step 6, the fat-filled tissue collection tubes 5A through 5C are removed from the collection chamber 41, as shown in
As indicated in Step 7, a plunger and piston subassembly 8 is inserted into the proximal end opening of each capped tissue collection tube, and returned to the surgeon for immediate reinjection into the patient.
Optionally, as indicated in Step 7, the tissue filled injection syringes, completed in Step 7, can be delivered, plunger up, to a tissue banking facility, where a musculoskeletal stem cell line or hematopoietic line can be grown out to recoup a stem cell enriched culture of cells that may be returned to the surgeon for auto-graft into the patient, with adipose cell markers, ideal for facial rejuvenation.
Method of Injecting Processed Tissue Samples into a Patient Using a Fat-Filled Tissue Injection Syringe Device of Present Invention
The flow chart of
As indicated in Step 1, the distal tip cap is removed from the fat-filled tissue collection tube.
As indicated in Step 2, a micro-pore occluder 7 is slid over the tissue collection tube 5 so as to cover the micro-pores 6, and snap flange 11 in place, to form a tissue injection syringe device 2, as shown in
As indicated in Step 3, a luer lock cannula 3 is screwed onto the distal tip portion of the tissue injection syringe device 2 for reinjection of harvested and processed tissue sample, as shown in
As indicated in Step 4, the cannula 3 is the inserted into the patient in the area of correction, as shown in
As indicated in Step 5, plunger's piston 8B is gently depressed into the tissue collection tube (i.e. syringe barrel) 5 as shown in
When all tissue has been emptied from the syringe device 2, it will be configured as shown in
Method of Harvesting, Processing and Injecting a Tissue Sample into a Patient Using the Tissue Sampling, Processing and Injection Syringe Device of the Present Invention
The flow chart of
Specification of the in-Line Six-Pack Tissue Sampling, Processing and Collection Device of the Present Invention
The flow chart of
As shown in
Surgeon installs the tissue sampling, processing and collection device 60 inline between the fat aspiration instrument 10 and the vacuum source 36 as shown in
As shown in
Having described the 6-pack tissue sampling, processing and collection device of the present invention above, it is appropriate at this juncture to described how it can be used in tissue sampling, processing and collection operations carried out in accordance with the principles of the present invention.
As indicated in Step 1, the 6-pack tissue sampling, processing and collection device 60 is inserted (i.e. installed) between the hand piece of the hand-held tissue aspiration instrument 10 and the vacuum source 36, as shown in
As indicated in Step 2, the aspiration area is irrigated as desired, as shown in
As indicated in Step 3, fat tissue is aspirated from the irrigated area in the patient, as shown in
Optionally, as indicated in Step 4, a volume of irrigation solution can be aspirated from patient, in the sampling region, to lavage (i.e. clean and filter) the tissue samples contained in the tissue collection tubes, after harvesting, processing and collection.
Method of Processing Aspirated Tissue During Harvesting Using the Six-Pack Tissue Sampling, Processing and Collection Device of the Present Invention
The flow chart of
As indicated in Step 1, processing (i.e. filtration, cleansing and concentration) of tissue samples contained within the tissue collection tubes 5, occurs automatically during tissue aspiration and collection operations. Such processes have been detailed in Steps 2, 3 and 4 in the method described in
As indicated in Step 2, vacuum tubing 67 is removed from the six-pack tissue sampling, processing and collection device 60.
As indicated in Step 3, six-pack tissue sampling, processing and collection device 60 is then disconnected from hand piece of the hand-held tissue aspiration device 10 (e.g. by an unscrewing operation).
As indicated in Step 4, the barbed connector 65 is replaced on the back of the hand piece of the hand-held tissue aspiration device 10.
As indicated in Step 5, the lid on the 3-pack tissue sampling, processing and collection device 60 is removed, as shown in
As indicated in Step 6, the fat-filled capped tissue collection tubes 5A through 5H are removed from the collection chamber 61, as shown in
As indicated in Step 7, a plunger and piston subassembly 8 is inserted into the proximal end opening of each capped tissue collection tube, and returned to the surgeon for immediate reinjection into the patient.
Optionally, as indicated in Step 7, the tissue filled injection syringes, completed in Step 7, can be delivered, plunger up, to a tissue banking facility, where a musculoskeletal stem cell line or hematopoietic line can be grown out to recoup a stem cell enriched culture of cells that may be returned to the surgeon for auto-graft into the patient, with adipose cell markers, ideal for facial rejuvenation.
Method of Injecting Processed Tissue into a Patient Using a Fat-Filled Tissue Injection Syringe Device of the Present Invention
The flow chart of
As indicated in Step 1, the distal tip cap 12 is removed from the fat-filled tissue collection tube 5.
As indicated in Step 2, a micro-pore occluder 7 is slid over the tissue collection tube 5 so as to cover the micro-pores 6, and snap the flange 11 in place, to form a tissue injection syringe device 2, as shown in
As indicated in Step 3, a luer lock cannula 3 is screwed onto the distal tip portion of the tissue injection syringe device 2 for reinjection of harvested and processed tissue sample, as shown in
As indicated in Step 4, the cannula 3 is the inserted into the patient in the area of correction, as shown in
As indicated in Step 5, plunger's piston 8 is gently depressed into the syringe barrel (i.e. tissue collection tube) 5, as shown in
When all tissue has been emptied from the syringe device 2, it will be configured as shown in
Method of Harvesting, Processing and Injecting a Tissue Sample into a Patient Using the Tissue Sampling, Processing and Injection Syringe Device of the Present Invention
The flow chart of
While the tissue sampling, processing, collecting and re-injection devices of the illustrative embodiments of the present invention described above have been illustrated in connection with adipose (i.e. fat) tissue in the human body, it is understand that the methods and apparatus of the present invention can be used to sample, process, collection and re-inject other types of human tissue including, but not limited to, including autologous and allogeneic forms of musculoskeletal (i.e. bone, ligament, cartilage and skin) tissue, for use in autografting and allografting purposes.
Also, while it is preferred that the devices of the present invention be made from disposable, optically transparent, bio-compatible plastic materials, well known in the art, it is understood that such devices can be made from plastic and other types of materials that are not intended to be disposable, and capable of being processed using autoclaving and other sterilization processes known in the medical and surgical arts.
Several modifications to the illustrative embodiments have been described above. It is understood, however, that various other modifications to the illustrative embodiment of the present invention will readily occur to persons with ordinary skill in the art. All such modifications and variations are deemed to be within the scope and spirit of the present invention as defined by the accompanying Claims to Invention.
This application is a Continuation of application Ser. No. 12/955,420 filed Nov. 29, 2010 now abandoned; which is a Continuation-in-Part (CIP) of application Ser. No. 12/850,786 filed on Aug. 5, 2010 now U.S. Pat. No. 8,465,471, which is a CIP of application Ser. No. 12/462,596 filed Aug. 5, 2009 now U.S. Pat. No. 8,348,929, and copending application Ser. No. 12/813,067 filed Jun. 10, 2010; wherein each said application is owned by Rocin Laboratories, Inc., and incorporated herein by reference in its entirety.
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| Entry |
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| International Search Report dated Jul. 2, 2012 issued in International Application No. PCT/US 11/62346. |
| Number | Date | Country | |
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| 20120172834 A1 | Jul 2012 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 12955420 | Nov 2010 | US |
| Child | 13315232 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 12850786 | Aug 2010 | US |
| Child | 12955420 | US | |
| Parent | 12462596 | Aug 2009 | US |
| Child | 12850786 | US |
