US20110213336A1 - Method of and apparatus for sampling, processing and collecting tissue and reinjecting the same into human patients - Google Patents
Method of and apparatus for sampling, processing and collecting tissue and reinjecting the same into human patients Download PDFInfo
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- US20110213336A1 US20110213336A1 US12/955,420 US95542010A US2011213336A1 US 20110213336 A1 US20110213336 A1 US 20110213336A1 US 95542010 A US95542010 A US 95542010A US 2011213336 A1 US2011213336 A1 US 2011213336A1
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- tissue
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
- A61B10/02—Instruments for taking cell samples or for biopsy
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
- A61B10/02—Instruments for taking cell samples or for biopsy
- A61B10/0233—Pointed or sharp biopsy instruments
- A61B10/0283—Pointed or sharp biopsy instruments with vacuum aspiration, e.g. caused by retractable plunger or by connected syringe
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/89—Suction aspects of liposuction
- A61M1/892—Suction aspects of liposuction with treatment of the collected fat
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/89—Suction aspects of liposuction
- A61M1/895—Suction aspects of liposuction with means for reinjection of collected fat
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/71—Suction drainage systems
- A61M1/77—Suction-irrigation systems
Definitions
- the present invention relates to improvements in methods of and apparatus for sampling, processing and collecting tissue samples using aspiration processes.
- adipose i.e. fat
- musculoskeletal i.e. bone, ligament, cartilage and skin
- 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.
- 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”).
- 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.
- waste components free oil, blood, serum
- 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”.
- 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.
- a receptacle can be attached directly to the port such that the tissue can be anaerobically re-injected into the body.
- 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.
- FIG. 1 is a graphical illustration showing the various phases of tissue sampling, collection, processing and re-injection using the devices and methods of the present invention
- FIG. 2 is a perspective view of an illustrative embodiment of the tissue sampling, processing and injection syringe device of the present invention, to which a cannula is connected via a Leur locking connector;
- FIG. 2 A 1 is a perspective view of a tissue collection tube employed in the tissue sampling, processing and collection devices of the present invention shown in FIGS. 9B and 13C , comprising a distal end opening for receipt of a distal tip capping element (i.e. cap), an proximal end opening for receiving a rubber plunger connected to a push shaft (or piston) shown in FIG. 2 A 2 , and two sets of micro-pores formed along one side of the collection tube for allowing fluids to pass therethrough and concentrating cellular material, when un-occluded by the rotatable micro-pore occluder shown in FIG. 2C ;
- a distal tip capping element i.e. cap
- a rubber plunger connected to a push shaft (or piston) shown in FIG. 2 A 2
- two sets of micro-pores formed along one side of the collection tube for allowing fluids to pass therethrough and concentrating cellular material, when un-occluded by the rotatable micro-pore occluder shown in
- FIG. 2 A 2 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. 2 A 1 ;
- a push shaft i.e. piston
- FIG. 2 A 3 is a perspective view of the micro-pore occluder that slides on and fits about the tissue collection tube shown in FIG. 2 A 1 , 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. 2 A 4 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. 2 A 1 ;
- FIG. 3 is a perspective view showing the assembly of the components of the tissue sampling, processing and injection syringe device of the present invention, depicted in FIGS. 2 , 7 A, 11 A, and 15 A;
- FIG. 4A is a perspective view of the tissue sampling, processing and injection syringe device of the present invention, shown configured with its micro-pores arranged in its occluded state;
- FIG. 4B is a perspective view of the tissue sampling, processing and injection syringe device of the present invention, shown configured with its micro-pores arranged in its non-occluded state;
- FIG. 5 is a flow chart describing the primary steps carried out when practicing the method of harvesting a tissue sample from a patient or donor using the tissue sampling, processing and injection syringe device of the present invention, shown in FIGS. 2 through 4B ;
- FIG. 5A is a partially cut-away perspective view of the tissue sampling, processing and injection syringe device of FIG. 2 , showing its cap being removed from its distal end opening;
- FIG. 5B is a perspective view of the tissue sampling, processing and injection syringe device of FIG. 2 , showing its occluder being slid down its collection barrel and rotating same to cover the micro-pores of the tissue sampling, processing and injection syringe device of the present invention;
- FIG. 5C is a perspective view of the tissue sampling, processing and injection syringe device of FIG. 2 , showing a cannula being attached to the distal end opening of the collection barrel;
- FIG. 5 D 1 is a perspective view of the tissue sampling, processing and injection syringe device of FIG. 2 , showing its plunger being drawn back from the tissue sampling, processing and injection syringe device (from state 1 to state 2 ) to create vacuum pressure within the tissue collection tube and aspirate a sample of fat tissue therein;
- FIG. 5 D 2 is a perspective view of the tissue sampling, processing and injection syringe device of FIG. 2 , being used to aspirate fat tissue sample, by surgeon inserting the syringe device, with micro-pores occluded, and cannula mounted, into desired donor or treatment site, and maintaining backward pressure on plunger/piston to create vacuum, and aspirate a sample of fat tissue from a patient or donor;
- FIG. 5E is a perspective view of the tissue sampling, processing and injection syringe device of FIG. 2 , shown filled with fat tissue;
- FIG. 6A is a perspective view of the tissue sampling, processing and injection syringe device of FIG. 2 , shown with its cannula removed and its distal end opening capped;
- FIGS. 6 B 1 through 6 B 6 set forth a series of illustrations showing the tissue sampling, processing and injection syringe device of FIG. 2 being manually reconfigured from (i) its occluded state shown in FIG. 6 B 1 , during which a sample of tissue can be aspirated/sampled into the collection tube when the plunger is manually withdrawn from its collection barrel while its micro-pores are occluded (i.e. blocked) and ejected from the collection tube when the plunger is pushed into the collection tube while the micro-pores are occluded, into (ii) its non-occluded state shown in FIG.
- FIG. 6C is a perspective view of the tissue sampling, processing and injection syringe device of FIG. 2 , shown being used to concentrate a fat tissue sample within the collection tube by manually pushing its plunger into the collection tube while the micro-pores in the collection tube are in a non-occluded state, allowing fluid in the tissue sample to be expressed (i.e. filtered) through the non-occluded micro-pores and the collected tissue sample to be concentrated for re-injection into the patient, or subsequent processing at a tissue bank;
- FIG. 6D is perspective view of the tissue sampling, processing and injection syringe device of the present invention, showing its plunger being manually pushed into the collection tube while the micro-pores in the collection tube are in a non-occluded state, allowing fluid in the tissue sample to be expressed through the non-occluded micro-pores and the collected tissue sample to be concentrated for rejection into the patient or subsequent processing at a tissue bank;
- FIG. 7 is a flow chart describing the primary steps carried out when practicing the method of injecting processed tissue into a patient using the tissue sampling, processing and injection syringe device of FIG. 2 ;
- FIG. 7B is a perspective view of the tissue sampling, processing and injection syringe device of the present invention, shown configured for injecting fat tissue sample into a patient, by depressing the plunger piston while the micro-pores are arranged in the occluded state;
- FIG. 7C is a perspective view of a patient having a tissue sample injected beneath her skin a surgeon using the tissue sampling, processing and injection syringe device of the present invention
- FIG. 7D is a perspective view of the tissue sampling, processing and injection syringe device of the present invention, shown configured in a state after the surgeon completes the injection of the fat tissue sample into the patient;
- FIG. 8 is a flow chart describing the primary steps carried out when practicing the 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, depicted in FIGS. 1 through 7D ;
- FIG. 9B is a perspective exploded view of the 3-pack tissue sampling, processing and collection device of FIG. 9A , shown comprising a lid with a barbed connector (provided on the vacuum side), a 3-syringe base plate suction mount for mounting three syringe collection tubes, and a chamber with a screw-on connector to mount directly on rear of hand-held tissue aspiration instrument;
- FIG. 9C is a perspective view of the 3-pack tissue sampling, processing and collection device of the present invention shown completely assembled, and connected to a hand-supportable power-assisted tissue aspiration instrument;
- FIG. 9D is a perspective exploded view of the 3-pack tissue sampling, processing and collection device of the present invention, connected to a vacuum source by way of the hand-supportable power-assisted tissue aspiration instrument, while aspirating tissue samples from a patient, and filtering the same during aspiration to produce concentrated tissue prepared for immediate re-injection into the patient, or subsequent processing at a tissue bank;
- FIG. 9E is a cross-sectional diagram of the 3-pack tissue sampling, processing and collection device shown in FIG. 9D , illustrating how aspirated tissue flows from the input side, through the micro-pores formed in the walls of the tissue collection tubes mounted within the device, and out through the vacuum source side of the system, to leave concentrated tissue samples in the collection tubes, prepared for immediate reinjection into the body of the donor patient, or other patient requiring tissue injection;
- FIG. 10 is a flow chart describing the steps carried out when practicing the 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;
- FIG. 10A is a perspective view of the 3-pack tissue sampling, processing and collection device shown in FIG. 9D , being detached from the hand-supportable powered tissue aspiration instrument;
- FIG. 10B is a perspective view of the 3-pack tissue sampling, processing and collection device shown in FIG. 9D , shown with its lip being removed to provided access to the tissue-filled collection tubes contained within the container housing;
- FIG. 10C is a perspective view showing the removal of the tissue collection tubes from the 3-pack tissue sampling, processing and collection device of the present invention.
- FIG. 11 is a flow chart describing the primary steps carried out when practicing the method of injecting processed tissue samples into a patient using a fat-filled tissue injection syringe device of present invention assembled using a fat-filled tissue collection tube from the device of FIG. 10A , to be converted into the tissue injection syringe device shown in FIG. 2 ;
- FIG. 11B is a perspective view of the fat-filled tissue injection syringe device of present invention constructed in FIG. 11A , shown being used by a surgeon to inject tissue into a patient by depressing the piston into the collection tube while its micro-pores are in their occluded state;
- FIG. 11C is a perspective view of the fat-filled tissue injection syringe device of present invention being used to inject processed tissue back into the patient to achieve a desired achieve correction;
- FIG. 11D is a perspective view of the tissue injection syringe device of FIG. 11D after it has been emptied of its tissue sample;
- FIG. 12 is a flow chart describing the primary steps carried out when practicing the method of harvesting, processing and injecting a tissue sample into a patient using the tissue sampling, processing, collection and injection device, depicted in FIGS. 9 through 11D ;
- FIG. 13 is a flow chart describing the primary steps carried out when practicing the method of sampling aspirated tissue samples using 6-pack tissue sampling, processing and collection device of the present invention, shown in FIGS. 13A and 13B , allowing the surgeon to select which collection tubes to fill at any given moment, while coupled in-line with a hand-held tissue aspiration instrument;
- FIG. 13C is a first exploded perspective view of the 6-pack tissue sampling, processing and collection device shown in FIGS. 13A and 13B , shown comprising a collection chamber, a lid with barbed connector for connection to the suction tubing, a suction plate having six projections for supporting six tissue collection tubes (i.e. within the collection chamber), a selector with a passageway/flowpath extending from the center of the chamber to periphery thereof to control the flow of aspirated fat sample into the selected tissue collection tube, and a barbed connector for connecting to tubing extending to the hand-supportable tissue aspiration instrument, and a spring pushing up the turning knob and keeping the selector at the bottom of the collection chamber;
- FIG. 13D is a second exploded perspective view of the 6-pack tissue sampling, processing and collection device shown in FIGS. 13A , 13 B and 13 C;
- FIG. 13E is a cross-sectional view of the in-line tissue sampling, processing and collection device shown in FIGS. 13A through 13D , illustrating the passage of aspirated tissue within the selector component, extending from the center of the device to the periphery thereof to control the flow of aspirated fat samples into the selected syringe;
- FIG. 13F is a perspective view of the six-pack tissue sampling, processing and collection device connected to a hand-held power-assisted tissue aspiration instrument of the present invention by way of a second of flexible tubing;
- FIG. 13G is perspective view of the six-pack tissue sampling, processing and collection device and hand-held power-assisted tissue aspiration instrument shown in FIG. 13F , being used to aspirate tissue samples from a patient;
- FIG. 14B is a perspective view of the six-pack tissue sampling, processing and collection device of the present invention, showing the removal of the tissue collection tube suction plate from the collection chamber of the six-pack tissue sampling, processing and collection device;
- FIG. 14C is a perspective view of the six-pack tissue sampling, processing and collection device of the present invention, showing the detachment of the tissue collection tubes (i.e. syringe barrels) from the tissue collection tube suction plate;
- tissue collection tubes i.e. syringe barrels
- FIG. 15 is a flow chart describing the primary steps carried out when practicing the method of injecting processed tissue into a patient using a fat-filled tissue injection syringe device of the present invention which is constructed by attaching a flanged occluder to the tissue collection tube and inserting a plunger and piston into the proximal end opening of the tissue collection tube, shown in FIGS. 3 , 5 C, and 15 A;
- FIG. 15A is a perspective view of a fat-filled tissue injection syringe device of present invention, constructed by attaching a micro-pore occluder to a fat-filled collection tube removed from the dissembled 6-pack tissue sampling, processing and collection device of FIGS. 13A through 13C to occlude its micro-pores, and then inserting a plunger and piston into the proximal end opening of the collection tube (i.e. barrel), and finally attaching a cannula to the distal end opening of the collection tube, by way of a Leur locking connector assembly;
- FIG. 15B is a perspective view of the fat-filled tissue injection syringe device of present invention constructed in FIG. 15A , shown being used by a surgeon to inject tissue into a patient by depressing the piston into the collection tube while its micro-pores are in their occluded state;
- FIG. 15C is a perspective view of the fat-filled tissue injection syringe device of present invention being used to inject processed tissue back into the patient to achieve a desired achieve correction;
- FIG. 15D is a perspective view of the tissue injection syringe device of FIG. 15D after it has been emptied of its tissue sample.
- FIG. 16 is a flow chart describing the primary steps carried out when practicing the method of harvesting, processing and injecting a tissue sample into a patient using the tissue sampling, processing, collection and injection devices of the present invention, depicted in FIGS. 13 through 15D .
- FIG. 1 shows the various phases of tissue sampling, collection, processing and re-injection using the modular devices and methods of the present invention disclosed herein, wherein modular, disposable tissue aspiration, processing, collection and/or re-injection components can be used in different tissue sampling, processing and collection system designs, providing significant improvements in flexibility, convenience, and economy.
- 3D computer imaging techniques are typically used to survey a patient's body contour and plan out fat tissue transplantation for corrective purposes.
- 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 FIGS. 2 through 5E .
- tissue is harvested in medium or large volumes using either 3-pack tissue sampling, processing and collecting device of the present invention shown in FIGS. 9A through 9E , or the 6-pack tissue sampling, processing and collecting device of the present invention shown in FIGS. 13A through 13F , each being connected in-line to outlet port of a hand-supportable power-assisted tissue aspiration instrument 10 as disclosed in Applicant's copending U.S. application Ser. Nos. 12/850,786, 12/462,596 and 12/813,067, incorporated herein by reference.
- 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 FIGS. 3 and 5B .
- a single tissue collection tube 5 is filled with fat tissue during manually powered aspiration operations, illustrated in FIGS. 5 D 1 , 5 D 2 , and 5 E.
- the multiple tissue collection tubes 5 shown in FIG. 2 A 1 , without a micro-occluder 7 installed, are supported on the mounting posts of (i) suction mounting plate 38 within the collection chamber of the 3-pack device 30 shown in FIGS. 9B and 10C , and (ii) suction plate 68 within the collection chamber of the 6-pack device shown in FIGS. 13C and 14C .
- each tissue collection tube 5 used to construct the tissue sampling, processing and injection syringe device of FIG. 2 is also used in multiples within the 3-pack and 6-pack tissue sampling, processing and collection devices of FIGS. 9A and 13A .
- 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 5 A adapted to receive a cannula 3 via a Leur lock connector fitting 4 , and a proximal end opening 5 B adapted to receive a plunger 8 A and piston 8 B subassembly 8 .
- Each tissue collection tube 5 is also adapted with a flange 9 having opposite flat side edge surfaces 9 A and 9 B, for engagement with a flat rectangular flange 11 extending from the micro-pore occluder 7 , as shown in FIGS. 2 A 2 and 3 .
- the micro-pore occluder 7 is slid around and rotatable about the tissue collection tube, in either one of two possible configurations.
- tissue can be aspirated into the tissue collection tube.
- a cap 12 is applied to the distal tip of the tissue collection tube 5 and pressure is applied against a collected tissue sample in the tissue collection tube (i.e. by pushing its plunger and piston into the tissue collection tube), fluid is expressed out of the micro-pores 6 formed in the side walls of the tissue collection tube, filtering and concentrating the cellular in situ within the collection tube.
- 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.
- 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.
- 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 FIG. 1 to achieve desired results.
- FIG. 2 shows an illustrative embodiment of the tissue sampling, processing and injection syringe device of the present invention 2 , to which a cannula 3 is connected via a Leur locking connector 4 .
- the components of this syringe device 2 are shown in FIGS. 2A through 2D , as comprising: tissue collection tube 5 having (i) distal end opening 5 A for receipt of distal tip capping element (i.e. cap) 12 , (ii) proximal end opening 5 B and (iii) interior volume 5 C; a rubber plunger 8 A connected to a push shaft (or piston) 8 B shown in FIG.
- micro-pore occluder 7 sliding on and fitting about the tissue collection tube 5 , and being rotatably configured to occlude its micro-pores 6 in its occluded state, or allow its micro-pores 6 to remain exposed and open to the ambient environment; and cap 12 adapted to fit over and close off (i.e. create fluid seal over) the distal end opening 5 A, or tip portion of the tissue collection tube shown in FIG. 2A .
- FIG. 3 shows the components of the tissue sampling, processing and injection syringe device 2 , depicted in FIGS. 2 , 7 A, 11 A, and 15 A, being assembled in accordance with the principles of the present invention.
- FIG. 4A shows the tissue sampling, processing and injection syringe device 2 of FIG. 2 , arranged with its micro-pores in its occluded state
- FIG. 4B shows the tissue sampling, processing and injection syringe device of FIG. 2 arranged with its micro-pores in its non-occluded state.
- the flow chart of FIG. 5 describes the primary steps carried out when practicing the method of harvesting a tissue sample from a patient or donor using the tissue sampling, processing and injection syringe device of FIGS. 2 through 4B .
- Step 1 of FIG. 5 the tip cap 12 is removed from the syringe device 2 as shown in FIG. 5A .
- Step 2 of FIG. 5 the micro-pores 6 are occluded on the syringe device by rotating the micro-pore occluder 7 into place as shown in FIG. 4A , so that the micro-pores are occluded, as shown in FIG. 5B .
- a suitable cannula is attached to the syringe device 2 as shown in FIG. 5C , and then inserting the cannula 3 into donor site of patient, as shown in FIG. 5 D 2 .
- the plunger 8 B is withdrawn to create vacuum and collect fat in syringe device, until full, as shown in FIG. 5 D 1 .
- the tissue collection tube 5 is made from optically transparent plastic material, the surgeon is able to visually detect the status of tissue filling operations at any moment in time with a simple visual glance at the syringe device.
- a volume of irrigation solution e.g. insulin and/or growth factor enrichment solution
- a volume of irrigation solution is aspirated through the syringe device, containing a collection tissue sample, for the purpose of cleansing and conditioning the tissue sample after harvesting.
- the cannula 3 is removed from patient when the optically transparent tissue collection tube 5 is filled with tissue, as indicated in FIG. 5E .
- the cap 12 is attached to the distal end opening (i.e. tip) of the tissue collection tube of the syringe device.
- the flow chart of FIG. 6 describes the primary steps carried out when practicing the method of processing an aspirated tissue sample using the tissue sampling, processing and injection syringe device of the present invention shown in FIGS. 2 through 4D .
- the cannula 3 is removed from the distal end portion of the tissue collection tube 4 , and a cap 12 is attached to the tip thereof to close off the distal end opening of the tissue collection tube 5 , as shown in FIG. 6A .
- the surgeon's finger can be placed over the distal tip portion, to close off the same, during the following operations described in Steps 2 and 3 below.
- Step 2 the micro-pores of the syringe device are exposed (i.e. configured in the non-occluded state) as shown in FIG. 6B .
- fluid in a collected tissue sample can be filtered/expressed through the micro-pores 6 of the collection tube 5 when the plunger 8 B is manually pushed into the collection tube while the micro-pores are non-occluded to concentrate the collected tissue sample for re-injection into a patient, or subsequent processing at a tissue bank.
- Step 3 the surgeon gently depresses the piston's plunger 8 B 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 FIGS. 6C , and 6 D, for rejection into the patient or subsequent processing at a tissue bank.
- 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 FIG. 6B .
- the sample of concentrated tissue can be ejected from the collection tube 5 when the plunger 8 B is pushed into the collection tube while the micro-pores 6 are occluded.
- the flow chart of FIG. 7 describes the steps involved when carrying out the method of injecting a processed tissue sample into a patient using a filled tissue sampling, processing and injection syringe device of the present invention.
- Step 1 of FIG. 7 the tip cover 12 is removed from the syringe device 2 .
- 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 FIG. 4B .
- a cannula 3 is attached to the distal end opening of the tissue collection tube 5 , as shown in FIG. 7A , and then inserted into a patient where correction is required, by depressing plunger's piston 8 B to inject fat into the patient as required, as shown in FIGS. 7B and 7C .
- 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.
- the flow chart of FIG. 8 describes the primary steps carried out when practicing the method of harvesting, processing and re-injecting a tissue sample into a patient using the tissue sampling, processing and injection syringe device of the present invention, depicted in FIGS. 1 through 7D . These steps are a compilation of the steps previously described in the flow charts of FIGS. 5 , 6 and 7 , and will not be repeated here for sake of brevity.
- FIG. 9 describes the primary steps carried out when practicing the method of harvesting tissue samples from a patient using the 3-pack tissue sampling, processing and collection device of the present invention, shown in FIGS. 9A , 9 B and 9 C, while connected in-line with hand-held power-assisted tissue aspiration instrument 10 as disclosed in Applicant's copending U.S. application Ser. Nos. 12/850,786, 12/462,596 and 12/813,067, incorporated herein by reference incorporated herein by reference.
- FIGS. 9A , 9 B and 9 C it is appropriate to describe the 3-pack tissue sampling, processing and collection device of the present invention, shown in FIGS. 9A , 9 B and 9 C.
- the 3-pack tissue sampling, processing and collection device 30 comprises: an optically-transparent collection chamber 31 having closed end 31 A with a central aperture 32 , and an open end 31 B with hollow inner chamber/space 31 C disposed between the closed end 31 A and the open end 31 B; a removable lid 33 for threaded connection to the open end of the collection chamber, and having a central flow channel 34 terminated in a first barbed connector 35 for connecting the device to vacuum source 36 by way of a section of flexible vacuum tubing 37 ; a stationary suction plate 38 having three hollow projections 39 A through 39 C for supporting the open ends of three tissue collection tubes (i.e.
- syringe barrels 5 A through 5 C, each having micro-pores or perforations 6 formed in the walls thereof (to allow fluid to flow and filter therethrough while in the collection chamber) and being keyed for registration with the collection chamber (to prevent rotation); and a second connector 40 connected by threads to the hollow selector post 32 allowing the 3-pack tissue sampling, processing and collection device 30 to be directly connected to the hand-held power-assisted tissue aspiration instrument 10 , indirectly by way of a second section of flexible vacuum tubing 41 , as may be desired by the surgeon.
- These components are assembled as shown in FIGS. 9C and 9D .
- Step 1 of FIG. 9 the barbed connector 35 on back of hand-held tissue aspiration instrument 10 is removed, preparing the device for connection in-line with a hand-held power-assisted tissue aspiration instrument.
- the 3-pack tissue sampling, processing and collection device 30 is attached (i.e. by threads) to the outlet port of the hand piece portion of a powered tissue aspiration instrument 10 , as described above.
- 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 FIG. 9C .
- the collection chamber 31 is labeled for orientation, indicating the side to patient and the side to vacuum source.
- the suction plate 38 has numbers 1 through 3 for each of the capped (i.e. stoppered) tissue collection tubes (i.e. syringe barrels) 5 A through 5 C connected to the suction plate 38 and contained within the collection chamber 31
- Step 4 the selected area is irrigated with fluid during tissue aspiration, as desired, as shown in FIG. 9D .
- fat tissue is aspirated from the patient as shown in FIG. 9D , until the three (3) tissue collection tubes 5 A through 5 C within the collection chamber 31 are filled with fat tissue.
- the collection chamber and tissue collection tubes are all made from optically transparent plastic material, the surgeon is able to visually detect the status of tissue filling operations at any moment in time with a simple visual glance at the tissue sampling, processing and collection device.
- aspirated fat tissue flows from the sampled region of the patient, through the hand-held tissue aspiration instrument 10 through tubing 41 and the hollow post 32 , through passageway/flow 43 , into the tissue collection tubes 5 A through 5 C supported on the stationary suction plate 38 and capped with cap portions 12 A through 12 C, respectively.
- Fat cells are concentrated within the tissue collection tubes while excess fluid is expressed and filtered through micro-pores 6 formed in the side walls of the tissue collection tubes, and passed out through the barded connector 35 towards to vacuum source 36 , in a conventional manner.
- This process occurring within the 3-pack device, leaves concentrated tissue samples in the tissue collection tubes, prepared for reinjection into the body of the donor patient, or other patient requiring tissue injection.
- 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.
- the flow chart of FIG. 10 describes the steps carried out when practicing the method of processing aspirated tissue during harvesting using the 3-pack tissue sampling, processing and collection device of the present invention 30 , coupled in-line to a hand-held powered tissue aspiration instrument 10 , described above.
- Step 1 the processing (i.e. filtration, cleansing and concentration) of tissue samples contained within the tissue collection tubes 5 A through 5 C, occurs automatically during tissue aspiration and collection operations.
- processing i.e. filtration, cleansing and concentration
- Such processes have been detailed in Steps 4 , 5 and 6 in the method described in FIG. 9 , above.
- Step 2 the vacuum tubing is removed from the 3-pack tissue sampling, processing and collection device 30 .
- 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 .
- Step 4 the barbed connector 35 is replaced on back of hand piece of the tissue aspiration instrument 10 , as shown in FIG. 10A .
- Step 5 the lid on the 3-pack tissue sampling, processing and collection device 30 is removed, as shown in FIG. 10B , revealing the fat-filled tissue collection tubes 5 A through 5 C mounted on the suction plate 38 .
- the fat-filled tissue collection tubes 5 A through 5 C are removed from the collection chamber 41 , as shown in FIG. 10C , with the capped distal tips of the collection tubes facing downwardly.
- 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.
- 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.
- the flow chart of FIG. 11 describes the primary steps carried out when practicing the method of injecting processed tissue samples into a patient using a fat-filled tissue injection syringe device of present invention, constructed by attaching a flanged micro-pore occluder onto a fat-filled tissue collection tube and inserting a plunger and piston into the proximal end opening of the tissue collection tube, as described below.
- Step 1 the distal tip cap is removed from the fat-filled tissue collection tube.
- 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 FIGS. 3B and 4A .
- 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 FIG. 11A .
- Step 4 the cannula 3 is the inserted into the patient in the area of correction, as shown in FIG. 11C .
- plunger's piston 8 B is gently depressed into the tissue collection tube (i.e. syringe barrel) 5 as shown in FIG. 11B , to inject sufficient tissue into the patient to obtain the desired correction.
- the flow chart of FIG. 12 describes the primary steps carried out when practicing the 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, depicted in FIGS. 9 through 11D .
- steps are a compilation of the steps previously described in the flow charts of FIGS. 9 , 10 and 11 , they will not be repeated here for sake of brevity.
- FIG. 13 describes the primary steps carried out when practicing the method of harvesting tissue samples from a patient using the 6-pack tissue sampling, processing and collection device of the present invention 60 , shown in FIGS. 13A through 13E , while connected in-line with hand-held power-assisted tissue aspiration instrument 10 as disclosed in Applicant's copending U.S. application Ser. Nos. 12/850,786, 12/462,596 and 12/813,067, incorporated herein by reference incorporated herein by reference.
- FIGS. 13A through 13E it is appropriate to describe the 6-pack tissue sampling, processing and collection device of the present invention, shown in FIGS. 13A through 13E .
- the 3-pack tissue sampling, processing and collection device 60 comprises: an optically-transparent collection chamber 61 having closed end 61 A with a central aperture 62 , and an open end 61 B with hollow inner chamber/space disposed 61 C between the closed end 61 A and the open end 61 B; a removable lid 63 for threaded connection to the open end of the collection chamber, and having a central flow channel 64 terminated in a first barbed connector 65 for connecting the device to vacuum source 36 by way of a section of flexible vacuum tubing 37 ; a stationary suction plate 68 having six hollow projections 69 A through 69 H for supporting the open proximal ends of six tissue collection tubes (i.e.
- syringe barrels 5 A through 5 H respectively, each having micro-pores (i.e. perforations) 6 A, 6 B formed in the side walls thereof (to allow fluid to flow and filter therethrough while in the collection chamber), capped with caps 12 A through 12 H, and being keyed for registration with the collection chamber 61 (to prevent rotation); a rotatable selector 70 , shown in FIG.
- the tissue sampling, processing and collection device 60 inline between the fat aspiration instrument 10 and the vacuum source 36 as shown in FIG. 13F .
- the collection chamber 61 is labeled for orientation, indicating the side to patient and the side to vacuum source.
- the turning knob 75 has an arrow on it.
- the suction plate 69 has numbers 1-6 for each of the capped and perforated tissue collection tubes (i.e. syringe barrels) 5 A through 5 H mounted on the projections of the suction plate 68 .
- the surgeon then pushes down on turning knob 75 against the biasing force of spring 76 and that pushes the selector 70 slightly forward so the knob 75 can be turned to select which tissue collection tube (i.e.
- the selector 70 has a passageway/flow director 80 which extends to the selected tissue collection tube to complete the fluid communication channel, set up by the selector and director, as shown in FIG. 13E .
- the spring 76 maintains the selector 70 in its selected position.
- suction plate 68 has two flanges 68 A and 68 B which snap over the selector 70 , and grip a groove 70 A that runs around it to secure it in place relative to the selector 70 , as shown in FIG. 13E .
- an aspirated fat sample flows from the sampled region of the patient, through the hand-held tissue aspiration instrument 10 , through tubing 79 and the hollow selector post 71 , through passageway/flow director 80 , into the selected collection tube (i.e. syringe) 5 A through 5 H supported on the stationary suction plate 68 and capped with cap portion 12 A and 12 H, respectively.
- Fat cells are collected within the selected tissue collection tube (i.e. syringe barrel) 5 A through 5 H, while excess fluid is expressed through micro-pores 6 A, 6 B formed in the selected collection tube, and passed out through the barded connector 65 towards to vacuum source 36 .
- 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 FIG. 13F .
- the 6-pack tissue sampling, processing and collection device 60 has six separate tissue collection tubes (i.e. chambers) which may be independently selected by the surgeon, and filled with tissue or aspirate from different areas within a patient during tissue sampling operations. To do so, the surgeon simply turns the selector knob 75 to control the passage of aspirated tissue into the selected tissue collection tube 5 A through 5 H, providing an unprecedented level of control over tissue sampling operations.
- Step 2 the aspiration area is irrigated as desired, as shown in FIG. 13G .
- fat tissue is aspirated from the irrigated area in the patient, ass shown in FIG. 13G , until the six tissue collection tubes contained in its collection chamber 61 are filled with aspirated fat tissue.
- the collection chamber 61 and tissue collection tubes 5 A through 5 H are all made from optically transparent plastic material, the surgeon is able to visually detect the status of tissue filling operations at any moment in time with a simple visual glance at the tissue sampling, processing and collection device 60 .
- 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.
- FIG. 13H clearly shows the flow path of the fluid and cellular components of aspirated tissue through the 6-pack tissue sampling, processing and collection device 60 during tissue aspiration and processing operations.
- aspirated tissue flows from the patient, through the fat aspiration instrument, to the selector component 70 of the tissue sampling, processing and collection device, then through the passageway/flow director 80 , into the selected tissue collection tube (i.e. syringe barrel) 5 A through 5 H, whereupon fat cells are collected within the selected collection tube, while excess fluid (i.e. serum and tumescent solution) is expressed through micro-pores (i.e.
- the flow chart of FIG. 14 describes the primary steps carried out when practicing the method of processing aspirated tissue during harvesting using the six-pack tissue sampling, processing and collection device of the present invention, described in detail hereinabove.
- 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.
- processing i.e. filtration, cleansing and concentration
- Such processes have been detailed in Steps 2 , 3 and 4 in the method described in FIG. 13 , above.
- vacuum tubing 67 is removed from the six-pack tissue sampling, processing and collection device 60 .
- 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).
- the barbed connector 65 is replaced on the back of the hand piece of the hand-held tissue aspiration device 10 .
- Step 5 the lid on the 3-pack tissue sampling, processing and collection device 60 is removed, as shown in FIG. 14A , and the tissue collection tubes 5 A through 5 H mounted on the suction plate removed from collection chamber 61 , as shown in FIG. 14B .
- Step 6 the fat-filled capped tissue collection tubes 5 A through 5 H are removed from the collection chamber 61 , as shown in FIG. 14C , with the capped distal tips of the collection tubes faced downwardly.
- 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.
- 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.
- the flow chart of FIG. 15 describes the primary steps carried out when practicing the method of injecting processed tissue samples into a patient using a fat-filled tissue injection syringe device of present invention 2 , constructed by attaching a flanged micro-occluder 7 onto the tissue collection tube and inserting a plunger and piston 8 into the proximal end opening of the tissue collection tube, 5 A through 5 H as described below.
- Step 1 the distal tip cap 12 is removed from the fat-filled tissue collection tube 5 .
- 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 FIGS. 3B and 4A .
- 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 FIG. 15A .
- Step 4 the cannula 3 is the inserted into the patient in the area of correction, as shown in FIG. 15C .
- plunger's piston 8 is gently depressed into the syringe barrel (i.e. tissue collection tube) 5 , as shown in FIG. 15B to inject sufficient tissue into the patient to obtain the desired correction.
- syringe barrel i.e. tissue collection tube
- the flow chart of FIG. 16 describes the primary steps carried out when practicing the method of harvesting, processing and injecting a tissue sample into a patient using the tissue sampling, processing and injection syringe device 2 of the present invention, depicted in FIGS. 13 through 15D . As these steps are a compilation of the steps previously described in the flow charts of FIGS. 13 , 14 and 15 , these steps will not be repeated here for sake of brevity.
- 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.
- adipose i.e. fat
- autologous and allogeneic forms of musculoskeletal (i.e. bone, ligament, cartilage and skin) tissue for use in autografting and allografting purposes.
- 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.
Abstract
Methods of and apparatus for safely harvesting, processing (i.e. preparing), collecting and re-injecting adipose and other forms of tissue for immediate autologous tissue transplantation, explant culture endeavors or cell dissociations and the like.
Description
- This application is a Continuation-in-Part (CIP) of copending application Ser. No. 12/850,786 filed on Aug. 5, 2010, which is a CIP of application Ser. No. 12/462,596 filed Aug. 5, 2009, 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.
- 1. 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.
- 2. 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. 1 is a graphical illustration showing the various phases of tissue sampling, collection, processing and re-injection using the devices and methods of the present invention; -
FIG. 2 is a perspective view of an illustrative embodiment of the tissue sampling, processing and injection syringe device of the present invention, to which a cannula is connected via a Leur locking connector; - 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
FIGS. 9B and 13C , comprising a distal end opening for receipt of a distal tip capping element (i.e. cap), an proximal end opening for receiving a rubber plunger connected to a push shaft (or piston) shown in FIG. 2A2, and two sets of micro-pores formed along one side of the collection tube for allowing fluids to pass therethrough and concentrating cellular material, when un-occluded by the rotatable micro-pore occluder shown inFIG. 2C ; - 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. 3 is a perspective view showing the assembly of the components of the tissue sampling, processing and injection syringe device of the present invention, depicted inFIGS. 2 , 7A, 11A, and 15A; -
FIG. 4A is a perspective view of the tissue sampling, processing and injection syringe device of the present invention, shown configured with its micro-pores arranged in its occluded state; -
FIG. 4B is a perspective view of the tissue sampling, processing and injection syringe device of the present invention, shown configured with its micro-pores arranged in its non-occluded state; -
FIG. 5 is a flow chart describing the primary steps carried out when practicing the method of harvesting a tissue sample from a patient or donor using the tissue sampling, processing and injection syringe device of the present invention, shown inFIGS. 2 through 4B ; -
FIG. 5A is a partially cut-away perspective view of the tissue sampling, processing and injection syringe device ofFIG. 2 , showing its cap being removed from its distal end opening; -
FIG. 5B is a perspective view of the tissue sampling, processing and injection syringe device ofFIG. 2 , showing its occluder being slid down its collection barrel and rotating same to cover the micro-pores of the tissue sampling, processing and injection syringe device of the present invention; -
FIG. 5C is a perspective view of the tissue sampling, processing and injection syringe device ofFIG. 2 , showing a cannula being attached to the distal end opening of the collection barrel; - FIG. 5D1 is a perspective view of the tissue sampling, processing and injection syringe device of
FIG. 2 , showing its plunger being drawn back from the tissue sampling, processing and injection syringe device (fromstate 1 to state 2) to create vacuum pressure within the tissue collection tube and aspirate a sample of fat tissue therein; - FIG. 5D2 is a perspective view of the tissue sampling, processing and injection syringe device of
FIG. 2 , being used to aspirate fat tissue sample, by surgeon inserting the syringe device, with micro-pores occluded, and cannula mounted, into desired donor or treatment site, and maintaining backward pressure on plunger/piston to create vacuum, and aspirate a sample of fat tissue from a patient or donor; -
FIG. 5E is a perspective view of the tissue sampling, processing and injection syringe device ofFIG. 2 , shown filled with fat tissue; -
FIG. 6 is a flow chart describing the primary steps carried out when practicing the method of processing aspirated tissue sample using the tissue sampling, processing and injection syringe device of the present invention shown inFIG. 2 ; -
FIG. 6A is a perspective view of the tissue sampling, processing and injection syringe device ofFIG. 2 , shown with its cannula removed and its distal end opening capped; - FIGS. 6B1 through 6B6 set forth a series of illustrations showing the tissue sampling, processing and injection syringe device of
FIG. 2 being manually reconfigured from (i) its occluded state shown in FIG. 6B1, during which a sample of tissue can be aspirated/sampled into the collection tube when the plunger is manually withdrawn from its collection barrel while its micro-pores are occluded (i.e. blocked) and ejected from the collection tube when the plunger is pushed into the collection tube while the micro-pores are occluded, into (ii) its non-occluded state shown in FIG. 6B6, during which fluid in a collected tissue sample can be filtered/expressed through the micro-pores of the collection tube when the plunger is manually pushed into the collection tube while the micro-pores are non-occluded to concentrate the collected tissue sample for re-injection into a patient or subsequent processing at a tissue bank; -
FIG. 6C is a perspective view of the tissue sampling, processing and injection syringe device ofFIG. 2 , shown being used to concentrate a fat tissue sample within the collection tube by manually pushing its plunger into the collection tube while the micro-pores in the collection tube are in a non-occluded state, allowing fluid in the tissue sample to be expressed (i.e. filtered) through the non-occluded micro-pores and the collected tissue sample to be concentrated for re-injection into the patient, or subsequent processing at a tissue bank; -
FIG. 6D is perspective view of the tissue sampling, processing and injection syringe device of the present invention, showing its plunger being manually pushed into the collection tube while the micro-pores in the collection tube are in a non-occluded state, allowing fluid in the tissue sample to be expressed through the non-occluded micro-pores and the collected tissue sample to be concentrated for rejection into the patient or subsequent processing at a tissue bank; -
FIG. 7 is a flow chart describing the primary steps carried out when practicing the method of injecting processed tissue into a patient using the tissue sampling, processing and injection syringe device ofFIG. 2 ; -
FIG. 7A is a perspective view of the tissue sampling, processing and injection syringe device of the present invention, showing a cannula being installed on its distal end opening, connected using a Leur lock connector; -
FIG. 7B is a perspective view of the tissue sampling, processing and injection syringe device of the present invention, shown configured for injecting fat tissue sample into a patient, by depressing the plunger piston while the micro-pores are arranged in the occluded state; -
FIG. 7C is a perspective view of a patient having a tissue sample injected beneath her skin a surgeon using the tissue sampling, processing and injection syringe device of the present invention; -
FIG. 7D is a perspective view of the tissue sampling, processing and injection syringe device of the present invention, shown configured in a state after the surgeon completes the injection of the fat tissue sample into the patient; -
FIG. 8 is a flow chart describing the primary steps carried out when practicing the 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, depicted inFIGS. 1 through 7D ; -
FIG. 9 is a flow chart describing the primary steps involved when practicing the method of harvesting tissue samples from a patient using the 3-pack tissue sampling, processing and collection device of the present invention shown inFIGS. 9A and 9B , being connected in-line with hand-held tissue aspiration instrument; -
FIG. 9A is a perspective view of the 3-pack tissue sampling, processing and collection device of the present invention being prepared for connection in-line with a hand-held power-assisted tissue aspiration instrument, by removing its barbed connector for connection of the 3-pack tissue sampling, processing and collection device: -
FIG. 9B is a perspective exploded view of the 3-pack tissue sampling, processing and collection device ofFIG. 9A , shown comprising a lid with a barbed connector (provided on the vacuum side), a 3-syringe base plate suction mount for mounting three syringe collection tubes, and a chamber with a screw-on connector to mount directly on rear of hand-held tissue aspiration instrument; -
FIG. 9C is a perspective view of the 3-pack tissue sampling, processing and collection device of the present invention shown completely assembled, and connected to a hand-supportable power-assisted tissue aspiration instrument; -
FIG. 9D is a perspective exploded view of the 3-pack tissue sampling, processing and collection device of the present invention, connected to a vacuum source by way of the hand-supportable power-assisted tissue aspiration instrument, while aspirating tissue samples from a patient, and filtering the same during aspiration to produce concentrated tissue prepared for immediate re-injection into the patient, or subsequent processing at a tissue bank; -
FIG. 9E is a cross-sectional diagram of the 3-pack tissue sampling, processing and collection device shown inFIG. 9D , illustrating how aspirated tissue flows from the input side, through the micro-pores formed in the walls of the tissue collection tubes mounted within the device, and out through the vacuum source side of the system, to leave concentrated tissue samples in the collection tubes, prepared for immediate reinjection into the body of the donor patient, or other patient requiring tissue injection; -
FIG. 10 is a flow chart describing the steps carried out when practicing the 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; -
FIG. 10A is a perspective view of the 3-pack tissue sampling, processing and collection device shown inFIG. 9D , being detached from the hand-supportable powered tissue aspiration instrument; -
FIG. 10B is a perspective view of the 3-pack tissue sampling, processing and collection device shown inFIG. 9D , shown with its lip being removed to provided access to the tissue-filled collection tubes contained within the container housing; -
FIG. 10C is a perspective view showing the removal of the tissue collection tubes from the 3-pack tissue sampling, processing and collection device of the present invention; -
FIG. 11 is a flow chart describing the primary steps carried out when practicing the method of injecting processed tissue samples into a patient using a fat-filled tissue injection syringe device of present invention assembled using a fat-filled tissue collection tube from the device ofFIG. 10A , to be converted into the tissue injection syringe device shown inFIG. 2 ; -
FIG. 11A is a perspective view of a fat-filled tissue injection syringe device of present invention, constructed by attaching a micro-pore occluder to a fat-filled collection tube removed from the dissembled 3-pack tissue sampling, processing and collection device ofFIG. 10C to occlude its micro-pores, and then inserting a plunger and piston into the proximal end opening of the collection tube (i.e. barrel), and finally attaching a cannula to the distal end opening of the collection tube, by way of a Leur locking connector assembly; -
FIG. 11B is a perspective view of the fat-filled tissue injection syringe device of present invention constructed inFIG. 11A , shown being used by a surgeon to inject tissue into a patient by depressing the piston into the collection tube while its micro-pores are in their occluded state; -
FIG. 11C is a perspective view of the fat-filled tissue injection syringe device of present invention being used to inject processed tissue back into the patient to achieve a desired achieve correction; -
FIG. 11D is a perspective view of the tissue injection syringe device ofFIG. 11D after it has been emptied of its tissue sample; -
FIG. 12 is a flow chart describing the primary steps carried out when practicing the method of harvesting, processing and injecting a tissue sample into a patient using the tissue sampling, processing, collection and injection device, depicted inFIGS. 9 through 11D ; -
FIG. 13 is a flow chart describing the primary steps carried out when practicing the method of sampling aspirated tissue samples using 6-pack tissue sampling, processing and collection device of the present invention, shown inFIGS. 13A and 13B , allowing the surgeon to select which collection tubes to fill at any given moment, while coupled in-line with a hand-held tissue aspiration instrument; -
FIG. 13A is a first perspective view of the 6-pack tissue sampling, processing and collection device of the present invention shown completely assembled, adapted for in-line connection with a hand-held power-assisted tissue aspiration instrument, and having six separate tissue collection tubes (i.e. chambers) which may be independently selected by the surgeon, by the manual rotation of the selector knob, and then filled with tissue biopsy or aspirate from different areas within a patient during surgical operations; -
FIG. 13B is a second perspective view of the 6-pack tissue sampling, processing and collection device shown inFIG. 13A ; -
FIG. 13C is a first exploded perspective view of the 6-pack tissue sampling, processing and collection device shown inFIGS. 13A and 13B , shown comprising a collection chamber, a lid with barbed connector for connection to the suction tubing, a suction plate having six projections for supporting six tissue collection tubes (i.e. within the collection chamber), a selector with a passageway/flowpath extending from the center of the chamber to periphery thereof to control the flow of aspirated fat sample into the selected tissue collection tube, and a barbed connector for connecting to tubing extending to the hand-supportable tissue aspiration instrument, and a spring pushing up the turning knob and keeping the selector at the bottom of the collection chamber; -
FIG. 13D is a second exploded perspective view of the 6-pack tissue sampling, processing and collection device shown inFIGS. 13A , 13B and 13C; -
FIG. 13E is a cross-sectional view of the in-line tissue sampling, processing and collection device shown inFIGS. 13A through 13D , illustrating the passage of aspirated tissue within the selector component, extending from the center of the device to the periphery thereof to control the flow of aspirated fat samples into the selected syringe; -
FIG. 13F is a perspective view of the six-pack tissue sampling, processing and collection device connected to a hand-held power-assisted tissue aspiration instrument of the present invention by way of a second of flexible tubing; -
FIG. 13G is perspective view of the six-pack tissue sampling, processing and collection device and hand-held power-assisted tissue aspiration instrument shown inFIG. 13F , being used to aspirate tissue samples from a patient; -
FIG. 13H is a cross-sectional view of the in-line tissue sampling, processing and collection device shown inFIG. 13G , illustrating the flow of an aspirated tissue sample from the patient, through the fat aspiration instrument, to the selector component of the tissue sampling, processing and collection device, through the passageway/flow director, into the selected tissue collection tube, whereupon fat cells are collected within the selected collection tube while excess fluid (i.e. serum and tumescent solution) is expressed through micro-pores (i.e. perforations or fine holes) in the selected tissue collection tube, and passed out through the barded connector towards to vacuum source, leaving cellular components behind because concentrated adipocytes and stem cells are too big to pass through micro-pores and remain within collection tube; -
FIG. 14 is a flow chart describing the primary steps carried out when practicing the method of processing aspirated tissue during harvesting using the six-pack tissue sampling, processing and collection device of the present invention, shown inFIGS. 13A and 13B ; -
FIG. 14A is a perspective view of the six-pack tissue sampling, processing and collection device of the present invention, showing its collection lid being removed after the device has been disconnected from the hand-hand power-assisted tissue aspiration instrument shown inFIG. 13F ; -
FIG. 14B is a perspective view of the six-pack tissue sampling, processing and collection device of the present invention, showing the removal of the tissue collection tube suction plate from the collection chamber of the six-pack tissue sampling, processing and collection device; -
FIG. 14C is a perspective view of the six-pack tissue sampling, processing and collection device of the present invention, showing the detachment of the tissue collection tubes (i.e. syringe barrels) from the tissue collection tube suction plate; -
FIG. 15 is a flow chart describing the primary steps carried out when practicing the method of injecting processed tissue into a patient using a fat-filled tissue injection syringe device of the present invention which is constructed by attaching a flanged occluder to the tissue collection tube and inserting a plunger and piston into the proximal end opening of the tissue collection tube, shown inFIGS. 3 , 5C, and 15A; -
FIG. 15A is a perspective view of a fat-filled tissue injection syringe device of present invention, constructed by attaching a micro-pore occluder to a fat-filled collection tube removed from the dissembled 6-pack tissue sampling, processing and collection device ofFIGS. 13A through 13C to occlude its micro-pores, and then inserting a plunger and piston into the proximal end opening of the collection tube (i.e. barrel), and finally attaching a cannula to the distal end opening of the collection tube, by way of a Leur locking connector assembly; -
FIG. 15B is a perspective view of the fat-filled tissue injection syringe device of present invention constructed inFIG. 15A , shown being used by a surgeon to inject tissue into a patient by depressing the piston into the collection tube while its micro-pores are in their occluded state; -
FIG. 15C is a perspective view of the fat-filled tissue injection syringe device of present invention being used to inject processed tissue back into the patient to achieve a desired achieve correction; -
FIG. 15D is a perspective view of the tissue injection syringe device ofFIG. 15D after it has been emptied of its tissue sample; and -
FIG. 16 is a flow chart describing the primary steps carried out when practicing the method of harvesting, processing and injecting a tissue sample into a patient using the tissue sampling, processing, collection and injection devices of the present invention, depicted inFIGS. 13 through 15D . - 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.
- The illustration in
FIG. 1 shows the various phases of tissue sampling, collection, processing and re-injection using the modular devices and methods of the present invention disclosed herein, wherein modular, disposable tissue aspiration, processing, collection and/or re-injection components can be used in different tissue sampling, processing and collection system designs, providing significant improvements in flexibility, convenience, and economy. - 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 withcannula 3, formingdevice 1, shown and describedFIGS. 2 through 5E . - 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
FIGS. 9A through 9E , or the 6-pack tissue sampling, processing and collecting device of the present invention shown inFIGS. 13A through 13F , each being connected in-line to outlet port of a hand-supportable power-assistedtissue aspiration instrument 10 as disclosed in Applicant's copending U.S. application Ser. Nos. 12/850,786, 12/462,596 and 12/813,067, incorporated herein by reference. - In either case, fat tissue is collected in individual
tissue collection tubes 5 havingmicro-pores 6 which are selectively occluded or non-occluded simply by rotation of amicro-pore occluder 7 that snap fits about the tissue collection tube, as shown inFIGS. 3 and 5B . - In the case of the tissue sampling, processing and
injection syringe device 2 shown and describedFIGS. 2 through 5E , a singletissue collection tube 5 is filled with fat tissue during manually powered aspiration operations, illustrated in FIGS. 5D1, 5D2, and 5E. - In the case of the 3-pack tissue sampling, processing and collecting device of the present invention shown in
FIGS. 9A through 9E , or the 6-pack tissue sampling, processing and collecting device of the present invention shown inFIGS. 13A through 13F , the multipletissue collection tubes 5, shown in FIG. 2A1, without amicro-occluder 7 installed, are supported on the mounting posts of (i)suction mounting plate 38 within the collection chamber of the 3-pack device 30 shown inFIGS. 9B and 10C , and (ii)suction plate 68 within the collection chamber of the 6-pack device shown inFIGS. 13C and 14C . - As will be described in greater detail hereinafter, each
tissue collection tube 5 used to construct the tissue sampling, processing and injection syringe device ofFIG. 2 , is also used in multiples within the 3-pack and 6-pack tissue sampling, processing and collection devices ofFIGS. 9A and 13A . - As shown in FIG. 2A1, the
tissue collection tube 5 has the appearance of a syringe barrel, withmicro-pores 6 formed in the tube walls normally open for fluid filtration therethrough during tissue collection operations. Eachtissue collection tube 5 has a distal end opening 5A adapted to receive acannula 3 via a Leurlock connector fitting 4, and a proximal end opening 5B adapted to receive aplunger 8A andpiston 8B subassemblytissue collection tube 5 is also adapted with aflange 9 having opposite flat side edge surfaces 9A and 9B, for engagement with a flatrectangular flange 11 extending from themicro-pore occluder 7, as shown in FIGS. 2A2 and 3. - As shown in
FIG. 3B , themicro-pore occluder 7 is slid around and rotatable about the tissue collection tube, in either one of two possible configurations. When themicro-occluder 7 is arranged in its micro-pore occlusion state shown inFIG. 4A , and a vacuum is applied at the proximal end opening, tissue can be aspirated into the tissue collection tube. When themicro-occluder 7 is arranged in its micro-pore non-occlusion state shown inFIG. 4B , acap 12 is applied to the distal tip of thetissue collection tube 5 and pressure is applied against a collected tissue sample in the tissue collection tube (i.e. by pushing its plunger and piston into the tissue collection tube), fluid is expressed out of the micro-pores 6 formed in the side walls of the tissue collection tube, filtering and concentrating the cellular in situ within the collection tube. - 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 - 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 aplunger piston 8 partially into the proximal end openings thereof. Then these tissue-filledinjection 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
FIG. 1 to achieve desired results. - 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.
-
FIG. 2 shows an illustrative embodiment of the tissue sampling, processing and injection syringe device of thepresent invention 2, to which acannula 3 is connected via aLeur locking connector 4. The components of thissyringe device 2 are shown inFIGS. 2A through 2D , as comprising:tissue collection tube 5 having (i) distal end opening 5A for receipt of distal tip capping element (i.e. cap) 12, (ii) proximal end opening 5B and (iii) interior volume 5C; arubber plunger 8A connected to a push shaft (or piston) 8B shown inFIG. 2B , for insertion into the interior volume 5C; two sets of micro-pores 6A and 6B formed along one side of the collection tube for allowing fluids to pass therethrough and concentrating cellular material, when un-occluded by the rotatable micro-pore occluder shown inFIG. 2C ; andmicro-pore occluder 7 sliding on and fitting about thetissue collection tube 5, and being rotatably configured to occlude itsmicro-pores 6 in its occluded state, or allow itsmicro-pores 6 to remain exposed and open to the ambient environment; andcap 12 adapted to fit over and close off (i.e. create fluid seal over) the distal end opening 5A, or tip portion of the tissue collection tube shown inFIG. 2A . -
FIG. 3 shows the components of the tissue sampling, processing andinjection syringe device 2, depicted inFIGS. 2 , 7A, 11A, and 15A, being assembled in accordance with the principles of the present invention. -
FIG. 4A shows the tissue sampling, processing andinjection syringe device 2 ofFIG. 2 , arranged with its micro-pores in its occluded state, whereasFIG. 4B shows the tissue sampling, processing and injection syringe device ofFIG. 2 arranged with its micro-pores in its non-occluded state. - The flow chart of
FIG. 5 describes the primary steps carried out when practicing the method of harvesting a tissue sample from a patient or donor using the tissue sampling, processing and injection syringe device ofFIGS. 2 through 4B . - As indicated in
Step 1 ofFIG. 5 , thetip cap 12 is removed from thesyringe device 2 as shown inFIG. 5A . - As indicated in
Step 2 ofFIG. 5 , themicro-pores 6 are occluded on the syringe device by rotating themicro-pore occluder 7 into place as shown inFIG. 4A , so that the micro-pores are occluded, as shown inFIG. 5B . - As indicated in
Step 3 ofFIG. 5 , a suitable cannula is attached to thesyringe device 2 as shown inFIG. 5C , and then inserting thecannula 3 into donor site of patient, as shown in FIG. 5D2. - As indicated in
Step 4 ofFIG. 5 , theplunger 8B is withdrawn to create vacuum and collect fat in syringe device, until full, as shown in FIG. 5D1. As thetissue collection tube 5 is made from optically transparent plastic material, the surgeon is able to visually detect the status of tissue filling operations at any moment in time with a simple visual glance at the syringe device. - Optionally, as indicated in
Step 5 ofFIG. 5 , a volume of irrigation solution (e.g. insulin and/or growth factor enrichment solution) is aspirated through the syringe device, containing a collection tissue sample, for the purpose of cleansing and conditioning the tissue sample after harvesting. - As indicated in
Step 6 ofFIG. 5 , thecannula 3 is removed from patient when the optically transparenttissue collection tube 5 is filled with tissue, as indicated inFIG. 5E . - As indicated in
Step 7 ofFIG. 5 , thecap 12 is attached to the distal end opening (i.e. tip) of the tissue collection tube of the syringe device. - The flow chart of
FIG. 6 describes the primary steps carried out when practicing the method of processing an aspirated tissue sample using the tissue sampling, processing and injection syringe device of the present invention shown inFIGS. 2 through 4D . - As indicated in
Step 1 ofFIG. 6 , thecannula 3 is removed from the distal end portion of thetissue collection tube 4, and acap 12 is attached to the tip thereof to close off the distal end opening of thetissue collection tube 5, as shown inFIG. 6A . Alternatively, the surgeon's finger can be placed over the distal tip portion, to close off the same, during the following operations described inSteps - As indicated
Step 2, the micro-pores of the syringe device are exposed (i.e. configured in the non-occluded state) as shown inFIG. 6B . In this non-occluded state, fluid in a collected tissue sample can be filtered/expressed through themicro-pores 6 of thecollection tube 5 when theplunger 8B is manually pushed into the collection tube while the micro-pores are non-occluded to concentrate the collected tissue sample for re-injection into a patient, or subsequent processing at a tissue bank. - As indicated in
Step 3, the surgeon gently depresses the piston'splunger 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 inFIGS. 6C , and 6D, for rejection into the patient or subsequent processing at a tissue bank. - As in
Step 4, the micro-pores on the tissue collection tube are then occluded by manually rotating themicro-pore occluder 7 into its micro-pore occlusion state, as illustrated inFIG. 6B . In this occluded state, the sample of concentrated tissue can be ejected from thecollection tube 5 when theplunger 8B is pushed into the collection tube while themicro-pores 6 are occluded. - The flow chart of
FIG. 7 describes the steps involved when carrying out the method of injecting a processed tissue sample into a patient using a filled tissue sampling, processing and injection syringe device of the present invention. - As indicated in
Step 1 ofFIG. 7 , thetip cover 12 is removed from thesyringe device 2. As indicated inStep 2, themicro-pores 6 on the tissue collection tube are occluded by rotating themicro-pore occluder 7 to the micro-pore occlusion state, shown inFIG. 4B . - As indicated in
Step 3, acannula 3 is attached to the distal end opening of thetissue collection tube 5, as shown inFIG. 7A , and then inserted into a patient where correction is required, by depressing plunger'spiston 8B to inject fat into the patient as required, as shown inFIGS. 7B and 7C . - Optionally, as indicated in
Step 4, the tissue sample material can be ejected out of the tissue collection tube of thesyringe device 2, and into an empty (no air) plastic bag for the purpose of delivering tissue material to tissue bank. - The flow chart of
FIG. 8 describes the primary steps carried out when practicing the method of harvesting, processing and re-injecting a tissue sample into a patient using the tissue sampling, processing and injection syringe device of the present invention, depicted inFIGS. 1 through 7D . These steps are a compilation of the steps previously described in the flow charts ofFIGS. 5 , 6 and 7, and will not be repeated here for sake of brevity. - The flow chart of
FIG. 9 describes the primary steps carried out when practicing the method of harvesting tissue samples from a patient using the 3-pack tissue sampling, processing and collection device of the present invention, shown inFIGS. 9A , 9B and 9C, while connected in-line with hand-held power-assistedtissue aspiration instrument 10 as disclosed in Applicant's copending U.S. application Ser. Nos. 12/850,786, 12/462,596 and 12/813,067, incorporated herein by reference incorporated herein by reference. However, before describing this method in detail, it is appropriate to describe the 3-pack tissue sampling, processing and collection device of the present invention, shown inFIGS. 9A , 9B and 9C. - As shown in
FIG. 9A , the 3-pack tissue sampling, processing andcollection device 30 comprises: an optically-transparent collection chamber 31 having closedend 31A with acentral aperture 32, and anopen end 31B with hollow inner chamber/space 31C disposed between theclosed end 31A and theopen end 31B; aremovable lid 33 for threaded connection to the open end of the collection chamber, and having acentral flow channel 34 terminated in a firstbarbed connector 35 for connecting the device to vacuumsource 36 by way of a section offlexible vacuum tubing 37; astationary suction plate 38 having threehollow projections 39A through 39C for supporting the open ends of three tissue collection tubes (i.e. syringe barrels) 5A through 5C, each having micro-pores orperforations 6 formed in the walls thereof (to allow fluid to flow and filter therethrough while in the collection chamber) and being keyed for registration with the collection chamber (to prevent rotation); and asecond connector 40 connected by threads to thehollow selector post 32 allowing the 3-pack tissue sampling, processing andcollection device 30 to be directly connected to the hand-held power-assistedtissue aspiration instrument 10, indirectly by way of a second section offlexible vacuum tubing 41, as may be desired by the surgeon. These components are assembled as shown inFIGS. 9C and 9D . - As indicated in
Step 1 ofFIG. 9 , thebarbed connector 35 on back of hand-heldtissue aspiration instrument 10 is removed, preparing the device for connection in-line with a hand-held power-assisted tissue aspiration instrument. - As indicated in
Step 2 ofFIG. 9 , the 3-pack tissue sampling, processing andcollection device 30 is attached (i.e. by threads) to the outlet port of the hand piece portion of a poweredtissue aspiration instrument 10, as described above. - 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 andcollection device 30 and avacuum source 36, as shown inFIG. 9C . Preferably, thecollection chamber 31 is labeled for orientation, indicating the side to patient and the side to vacuum source. Also, thesuction plate 38 hasnumbers 1 through 3 for each of the capped (i.e. stoppered) tissue collection tubes (i.e. syringe barrels) 5A through 5C connected to thesuction plate 38 and contained within thecollection chamber 31 - As indicated in
Step 4, the selected area is irrigated with fluid during tissue aspiration, as desired, as shown inFIG. 9D . - As indicated in
Step 5, fat tissue is aspirated from the patient as shown inFIG. 9D , until the three (3) tissue collection tubes 5A through 5C within thecollection chamber 31 are filled with fat tissue. As the collection chamber and tissue collection tubes are all made from optically transparent plastic material, the surgeon is able to visually detect the status of tissue filling operations at any moment in time with a simple visual glance at the tissue sampling, processing and collection device. - As shown in
FIG. 9E , during tissue aspiration operations using the 3-pack tissue sampling, processing and collection device, aspirated fat tissue flows from the sampled region of the patient, through the hand-heldtissue aspiration instrument 10 throughtubing 41 and thehollow post 32, through passageway/flow 43, into the tissue collection tubes 5A through 5C supported on thestationary suction plate 38 and capped with cap portions 12A through 12C, respectively. Fat cells are concentrated within the tissue collection tubes while excess fluid is expressed and filtered throughmicro-pores 6 formed in the side walls of the tissue collection tubes, and passed out through thebarded connector 35 towards to vacuumsource 36, in a conventional manner. This process, occurring within the 3-pack device, leaves concentrated tissue samples in the tissue collection tubes, prepared for reinjection into the body of the donor patient, or other patient requiring tissue injection. - 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. - The flow chart of
FIG. 10 describes the steps carried out when practicing the method of processing aspirated tissue during harvesting using the 3-pack tissue sampling, processing and collection device of thepresent invention 30, coupled in-line to a hand-held poweredtissue aspiration instrument 10, described above. - 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 inSteps FIG. 9 , above. - As indicated in
Step 2, the vacuum tubing is removed from the 3-pack tissue sampling, processing andcollection device 30. - As indicated in
Step 3, the 3-pack tissue sampling, processing andcollection device 30 is disconnected from hand piece portion of the hand-held powertissue 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-assistedtissue aspiration instrument 10. - As indicated in
Step 4, thebarbed connector 35 is replaced on back of hand piece of thetissue aspiration instrument 10, as shown inFIG. 10A . - As indicated in
Step 5, the lid on the 3-pack tissue sampling, processing andcollection device 30 is removed, as shown inFIG. 10B , revealing the fat-filled tissue collection tubes 5A through 5C mounted on thesuction plate 38. - As indicated in
Step 6, the fat-filled tissue collection tubes 5A through 5C are removed from thecollection chamber 41, as shown inFIG. 10C , with the capped distal tips of the collection tubes facing downwardly. - As indicated in
Step 7, a plunger andpiston 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 inStep 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. - The flow chart of
FIG. 11 describes the primary steps carried out when practicing the method of injecting processed tissue samples into a patient using a fat-filled tissue injection syringe device of present invention, constructed by attaching a flanged micro-pore occluder onto a fat-filled tissue collection tube and inserting a plunger and piston into the proximal end opening of the tissue collection tube, as described below. - As indicated in
Step 1, the distal tip cap is removed from the fat-filled tissue collection tube. - As indicated in
Step 2, amicro-pore occluder 7 is slid over thetissue collection tube 5 so as to cover themicro-pores 6, and snapflange 11 in place, to form a tissueinjection syringe device 2, as shown inFIGS. 3B and 4A . - As indicated in
Step 3, aluer lock cannula 3 is screwed onto the distal tip portion of the tissueinjection syringe device 2 for reinjection of harvested and processed tissue sample, as shown inFIG. 11A . - As indicated in
Step 4, thecannula 3 is the inserted into the patient in the area of correction, as shown inFIG. 11C . - As indicated in
Step 5, plunger'spiston 8B is gently depressed into the tissue collection tube (i.e. syringe barrel) 5 as shown inFIG. 11B , to inject sufficient tissue into the patient to obtain the desired correction. - When all tissue has been emptied from the
syringe device 2, it will be configured as shown inFIG. 11D . - The flow chart of
FIG. 12 describes the primary steps carried out when practicing the 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, depicted inFIGS. 9 through 11D . As these steps are a compilation of the steps previously described in the flow charts ofFIGS. 9 , 10 and 11, they will not be repeated here for sake of brevity. - The flow chart of
FIG. 13 describes the primary steps carried out when practicing the method of harvesting tissue samples from a patient using the 6-pack tissue sampling, processing and collection device of thepresent invention 60, shown inFIGS. 13A through 13E , while connected in-line with hand-held power-assistedtissue aspiration instrument 10 as disclosed in Applicant's copending U.S. application Ser. Nos. 12/850,786, 12/462,596 and 12/813,067, incorporated herein by reference incorporated herein by reference. However, before describing this method in detail, it is appropriate to describe the 6-pack tissue sampling, processing and collection device of the present invention, shown inFIGS. 13A through 13E . - As shown in
FIG. 13A , the 3-pack tissue sampling, processing andcollection device 60 comprises: an optically-transparent collection chamber 61 having closedend 61A with acentral aperture 62, and anopen end 61B with hollow inner chamber/space disposed 61C between theclosed end 61A and theopen end 61B; aremovable lid 63 for threaded connection to the open end of the collection chamber, and having acentral flow channel 64 terminated in a firstbarbed connector 65 for connecting the device to vacuumsource 36 by way of a section offlexible vacuum tubing 37; astationary suction plate 68 having six hollow projections 69A through 69H for supporting the open proximal ends of six tissue collection tubes (i.e. syringe barrels) 5A through 5H respectively, each having micro-pores (i.e. perforations) 6A, 6B formed in the side walls thereof (to allow fluid to flow and filter therethrough while in the collection chamber), capped with caps 12A through 12H, and being keyed for registration with the collection chamber 61 (to prevent rotation); arotatable selector 70, shown inFIG. 13A , for rotational engagement with thesuction plate 68 and having a hollowcentral post section 71 that passes throughcentral aperture 62 and establishes fluid communication with a passage/conduit 72 that extends from center of the to periphery to control the flow of aspirated fat sample from theinstrument 10 through the first section oftubing 79, through theselector 70 and into the selected collection tube/projection 69/5 combination; a turningknob 75 mounted on and engaging with thehollow selector post 71 and enabling the turning of therotatable selector 70 relative to thestationary suction plate 68 to select the collection tube/projection combination (5/69) into which an aspirated fat sample should flow for collection and indexing purposes during tissue sampling; aspring 76 mounted between the turningknob 75 and hollow selector post 71 to push up the turning knob and keeping theselector 70 at the bottom of thecollection chamber 71; and a secondbarbed connector 77 connected by threads to thehollow selector post 71 allowing the tissue sampling, processing andcollection device 60 to be connected to the hand-heldtissue aspiration instrument 10 by way of a second section offlexible vacuum tubing 79. - Surgeon installs the tissue sampling, processing and
collection device 60 inline between thefat aspiration instrument 10 and thevacuum source 36 as shown inFIG. 13F . Thecollection chamber 61 is labeled for orientation, indicating the side to patient and the side to vacuum source. The turningknob 75 has an arrow on it. Thesuction plate 69 has numbers 1-6 for each of the capped and perforated tissue collection tubes (i.e. syringe barrels) 5A through 5H mounted on the projections of thesuction plate 68. The surgeon then pushes down on turningknob 75 against the biasing force ofspring 76 and that pushes theselector 70 slightly forward so theknob 75 can be turned to select which tissue collection tube (i.e. syringe barrel) 5A through 5H to collect to, until it is full, counting from 1 to six. Theselector 70 has a passageway/flow director 80 which extends to the selected tissue collection tube to complete the fluid communication channel, set up by the selector and director, as shown inFIG. 13E . Thespring 76 maintains theselector 70 in its selected position. As shown inFIGS. 13C and 13D ,suction plate 68 has twoflanges 68A and 68B which snap over theselector 70, and grip agroove 70A that runs around it to secure it in place relative to theselector 70, as shown inFIG. 13E . - As shown in
FIG. 13H , during tissue aspiration operations using the system of the present invention, an aspirated fat sample flows from the sampled region of the patient, through the hand-heldtissue aspiration instrument 10, throughtubing 79 and thehollow selector post 71, through passageway/flow director 80, into the selected collection tube (i.e. syringe) 5A through 5H supported on thestationary suction plate 68 and capped with cap portion 12A and 12H, respectively. Fat cells are collected within the selected tissue collection tube (i.e. syringe barrel) 5A through 5H, while excess fluid is expressed through micro-pores 6A, 6B formed in the selected collection tube, and passed out through thebarded connector 65 towards to vacuumsource 36. - 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 andcollection device 60 is inserted (i.e. installed) between the hand piece of the hand-heldtissue aspiration instrument 10 and thevacuum source 36, as shown inFIG. 13F . Notably, the 6-pack tissue sampling, processing andcollection device 60 has six separate tissue collection tubes (i.e. chambers) which may be independently selected by the surgeon, and filled with tissue or aspirate from different areas within a patient during tissue sampling operations. To do so, the surgeon simply turns theselector knob 75 to control the passage of aspirated tissue into the selected tissue collection tube 5A through 5H, providing an unprecedented level of control over tissue sampling operations. - As indicated in
Step 2, the aspiration area is irrigated as desired, as shown inFIG. 13G . - As indicated in
Step 3, fat tissue is aspirated from the irrigated area in the patient, ass shown inFIG. 13G , until the six tissue collection tubes contained in itscollection chamber 61 are filled with aspirated fat tissue. As thecollection chamber 61 and tissue collection tubes 5A through 5H are all made from optically transparent plastic material, the surgeon is able to visually detect the status of tissue filling operations at any moment in time with a simple visual glance at the tissue sampling, processing andcollection device 60. - 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. -
FIG. 13H clearly shows the flow path of the fluid and cellular components of aspirated tissue through the 6-pack tissue sampling, processing andcollection device 60 during tissue aspiration and processing operations. As shown, aspirated tissue flows from the patient, through the fat aspiration instrument, to theselector component 70 of the tissue sampling, processing and collection device, then through the passageway/flow director 80, into the selected tissue collection tube (i.e. syringe barrel) 5A through 5H, whereupon fat cells are collected within the selected collection tube, while excess fluid (i.e. serum and tumescent solution) is expressed through micro-pores (i.e. holes) 6 in the selected collection tube, and passed out through thebarded connector 65 towards to vacuumsource 36, thereby leaving cellular components behind because concentrated adipocytes and stem cells are too big to pass throughmicro-pores 6 and remain within collection tube (i.e. syringe barrel) 5. - The flow chart of
FIG. 14 describes the primary steps carried out when practicing the method of processing aspirated tissue during harvesting using the six-pack tissue sampling, processing and collection device of the present invention, described in detail hereinabove. - As indicated in
Step 1, processing (i.e. filtration, cleansing and concentration) of tissue samples contained within thetissue collection tubes 5, occurs automatically during tissue aspiration and collection operations. Such processes have been detailed inSteps FIG. 13 , above. - As indicated in
Step 2,vacuum tubing 67 is removed from the six-pack tissue sampling, processing andcollection device 60. - As indicated in
Step 3, six-pack tissue sampling, processing andcollection 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, thebarbed connector 65 is replaced on the back of the hand piece of the hand-heldtissue aspiration device 10. - As indicated in
Step 5, the lid on the 3-pack tissue sampling, processing andcollection device 60 is removed, as shown inFIG. 14A , and the tissue collection tubes 5A through 5H mounted on the suction plate removed fromcollection chamber 61, as shown inFIG. 14B . - As indicated in
Step 6, the fat-filled capped tissue collection tubes 5A through 5H are removed from thecollection chamber 61, as shown inFIG. 14C , with the capped distal tips of the collection tubes faced downwardly. - As indicated in
Step 7, a plunger andpiston 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 inStep 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. - The flow chart of
FIG. 15 describes the primary steps carried out when practicing the method of injecting processed tissue samples into a patient using a fat-filled tissue injection syringe device ofpresent invention 2, constructed by attaching aflanged micro-occluder 7 onto the tissue collection tube and inserting a plunger andpiston 8 into the proximal end opening of the tissue collection tube, 5A through 5H as described below. - As indicated in
Step 1, thedistal tip cap 12 is removed from the fat-filledtissue collection tube 5. - As indicated in
Step 2, amicro-pore occluder 7 is slid over thetissue collection tube 5 so as to cover themicro-pores 6, and snap theflange 11 in place, to form a tissueinjection syringe device 2, as shown inFIGS. 3B and 4A . - As indicated in
Step 3, aluer lock cannula 3 is screwed onto the distal tip portion of the tissueinjection syringe device 2 for reinjection of harvested and processed tissue sample, as shown inFIG. 15A . - As indicated in
Step 4, thecannula 3 is the inserted into the patient in the area of correction, as shown inFIG. 15C . - As indicated in
Step 5, plunger'spiston 8 is gently depressed into the syringe barrel (i.e. tissue collection tube) 5, as shown inFIG. 15B to inject sufficient tissue into the patient to obtain the desired correction. - When all tissue has been emptied from the
syringe device 2, it will be configured as shown inFIG. 15D . - The flow chart of
FIG. 16 describes the primary steps carried out when practicing the method of harvesting, processing and injecting a tissue sample into a patient using the tissue sampling, processing andinjection syringe device 2 of the present invention, depicted inFIGS. 13 through 15D . As these steps are a compilation of the steps previously described in the flow charts ofFIGS. 13 , 14 and 15, these steps will not be repeated here for sake of brevity. - 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.
Claims (19)
1. A tissue sampling, processing and injection syringe device to which a cannula can be connected via a Luer locking connector, comprising:
tissue collection tube having (i) distal end opening for receipt of distal tip cap, (ii) proximal end opening and (iii) interior volume;
a plunger connected to a push piston, for insertion into the interior volume;
micro-pores formed along one side of the collection tube for allowing fluids to pass therethrough and concentrating cellular material; and
micro-pore occluder for sliding on and fitting about said tissue collection tube, and being rotatably configured to occlude said micro-pores in an occluded state, or allow said micro-pores to remain exposed and open to the ambient environment in an non-occluded state; and
a cap adapted to fit over and close off the distal end opening, or tip portion of the tissue collection tube.
2. A method of harvesting a tissue sample from a patient or donor using a tissue sampling, processing and injection syringe device of claim 1 comprising the steps of:
(a) removing said cap from said syringe device;
(b) occluding said micro-pores by rotating said micro-pore occluder into place so that said micro-pores are occluded;
(c) attaching a cannula to said syringe device, and then inserting said cannula into donor site of patient.
(d) withdrawing said plunger to create vacuum and collecting fat tissue in said syringe device, until full of aspirated tissue.
3. The method of claim 2 , which further comprises:
(e) aspirating a volume of irrigation solution (e.g. insulin and/or growth factor enrichment solution) through said syringe device, containing a collection tissue sample, for the purpose of cleansing and conditioning the tissue sample after harvesting.
4. The method of claim 2 , which further comprises:
removing said cannula from the patient when said tissue collection tube is filled with tissue; and
attaching said cap onto the distal end opening of said tissue collection tube.
5. A method of processing an aspirated tissue sample using the tissue sampling, processing and injection syringe device of claim 1 , comprising the steps of:
(a) removing said cannula from the distal end portion of said tissue collection tube, and attaching said cap onto the tip thereof to close off the distal end opening; and
(b) exposing said micro-pores so that fluid in said collected tissue sample can be filtered/expressed through said micro-pores when said plunger is manually pushed into said collection tube while the micro-pores are non-occluded, so as to concentrate the collected tissue sample for re-injection into a patient, or subsequent processing at a tissue bank.
6. The method of claim 5 , which further comprises:
(c) occluding said micro-pores by manually rotating said micro-pore occluder into its micro-pore occlusion state; and
(d) ejecting said concentrated tissue from said tissue collection tube by depressing said plunger into said tissue collection tube while said micro-pores are occluded.
7. A method of injecting a processed tissue sample into a patient using a filled tissue sampling, processing and injection syringe device of claim 1 , comprising the steps of:
(a) removing said cap from said syringe device;
(b) occluding said micro-pores by rotating said micro-pore occluder to said occlusion state;
(c) attaching said cannula to the distal end opening of said tissue collection tube;
(d) inserting said cannula into a patient where correction is required, by depressing said plunger to inject fat into the patient as required.
8. A method of processing a tissue sample using a filled tissue sampling, processing and injection syringe device of claim 1 , comprising the steps of:
(a) removing said cap from said syringe device;
(b) occluding said micro-pores by rotating said micro-pore occluder to said occlusion state; and
(c) ejecting said tissue sample out of said tissue collection tube, and into a container for the purpose of delivering said tissue sample to a tissue bank.
9. A tissue sampling, processing and collection device comprises:
a collection chamber having closed end with a central aperture, and an open end with hollow inner chamber/space disposed between the closed end and the open end;
a removable lid for threaded connection to the open end of the collection chamber, and having a central flow channel terminated in a first connector for connecting the device to vacuum source by way of a first section of vacuum tubing;
a stationary suction plate having multiple hollow projections for supporting the open ends of multiple tissue collection tubes, each having micro-pores or perforations formed in the walls thereof to allow fluid to flow and filter therethrough while in said collection chamber; and
a second connector operably connected to said hollow selector post allowing said tissue sampling, processing and collection device to be directly connected to a hand-held power-assisted tissue aspiration instrument, or indirectly by way of a second section of vacuum tubing, as may be desired by the surgeon.
10. A method of sampling tissue from a patient using said tissue sampling, processing and collection device of claim 9 , in conjunction with a hand-held tissue aspiration instrument, comprising the steps of:
(a) preparing said tissue sampling, processing and collection device for connection in-line with said hand-held power-assisted tissue aspiration instrument;
(b) attaching said tissue sampling, processing and collection device to the outlet port of the hand piece portion of said powered tissue aspiration instrument;
(c) aspirating fat tissue from the patient, until at least one of said tissue collection tubes within said collection chamber are filled with fat tissue; and
(d) aspirating a volume of irrigation solution through said tissue sampling, processing and collection device so as to lavage (i.e. cleanse or wash) said tissue samples contained in said tissue connection tubes, while still contained within the device.
11. A method of processing aspirated tissue during harvesting using said tissue sampling, processing and collection device of claim 9 , coupled in-line to said hand-held powered tissue aspiration instrument, comprising the steps of:
(a) automatically processing (i.e. filtrating, cleansing and concentrating) tissue samples contained within said tissue collection tubes during said tissue aspiration and collection operations;
(b) removing vacuum tubing from said tissue sampling, processing and collection device;
(c) disconnecting said tissue sampling, processing and collection device from said hand-held power tissue aspiration instrument;
(d) removing fat-filled tissue collection tubes from said collection chamber of said tissue sampling, processing and collection device; and
(e) inserting a plunger and piston into the proximal end opening of each capped tissue collection tube, and returning said capped tissue collection tubes to the surgeon for immediate reinjection into the patient, or delivering, plunger up, said fat-filled tissue collection containers to a tissue banking facility.
12. A method of injecting processed tissue samples into a patient using a fat-filled tissue injection syringe device, constructed using a fat-filled tissue collection tube removed from the tissue sampling, processing and collection device of claim 9 , comprising the steps of:
(a) removing said cap from a fat-filled tissue collection tube;
(b) sliding a micro-pore occluder over said fat-filled tissue collection tube so as to cover said micro-pores and snap flange in place, to form a tissue injection syringe device;
(c) attaching a cannula onto the distal tip portion of said tissue injection syringe device for reinjection of harvested and processed tissue sample;.
(d) inserting said cannula into a patient in the area of correction; and
(e) depressing said plunger piston into said tissue collection tube to inject sufficient tissue into the patient to obtain the desired correction.
13. A tissue sampling, processing and collection device for connected in-line to a hand-held power-assisted tissue aspiration instrument, comprising:
a collection chamber having closed end with a central aperture, and an open end with hollow inner chamber/space disposed between the closed end and the open end;
a removable lid for connection to the open end of said collection chamber, and having a central flow channel terminated in a first connector connecting said tissue sampling, processing and collection device to a vacuum source by way of vacuum tubing;
a suction plate having multiple hollow projections for supporting the open proximal ends of multiple tissue collection tube, each having micro-pores formed in the side walls thereof to allow fluid to flow and filter therethrough while in said collection chamber, capped with caps;
a rotatable selector for rotational engagement with said stationary suction plate and having a hollow central post section that passes through central aperture and establishes fluid communication with a passage/conduit that extends from center to periphery to control the flow of aspirated fat sample from said hand-held tissue aspiration instrument through said selector and into said tissue collection tube; and
a turning knob mounted on and engaging with said hollow selector post and enabling the turning of said rotatable selector relative to said suction plate to select a tissue collection tube into which an aspirated fat sample should flow for collection and indexing purposes during tissue sampling.
14. The tissue sampling, processing and collection device of claim 13 , which further comprises:
a spring mounted between said turning knob and said hollow selector post to push up the turning knob and keeping said selector at the bottom of said collection chamber; and a second connector connected by threads to said hollow selector post allowing said tissue sampling, processing and collection device to be connected to said hand-held tissue aspiration instrument by way of a section of vacuum tubing.
15. The tissue sampling, processing and collection device of claim 13 , wherein said collection chamber is labeled for orientation, indicating the side to said patient and the side to said vacuum source.
16. The tissue sampling, processing and collection device of claim 13 , wherein said suction plate has numbers for each of the capped and perforated tissue collection tubes mounted on the projections of said suction plate.
17. The tissue sampling, processing and collection device of claim 14 , wherein when surgeon then pushes down on said turning knob against the biasing force of said spring and that pushes said selector slightly forward so said knob can be turned to select which tissue collection tube to collect to, until it is full.
18. The tissue sampling, processing and collection device of claim 13 , wherein said selector has a passageway/flow director which extends to the selected tissue collection tube to complete the fluid communication channel, set up by said selector and said director.
19. The tissue sampling, processing and collection device of claim 13 , wherein during tissue aspiration operations, an aspirated fat sample flows from the sampled region of the patient, through said hand-held tissue aspiration instrument, through said hollow selector post, through said director, into the selected tissue collection tube supported on said suction plate and capped with said cap; and wherein fat cells are collected within the selected tissue collection tube, while excess fluid is expressed through said micro-pores formed in the selected tissue collection tube, and passed out through said connector towards to said vacuum source.
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Application Number | Priority Date | Filing Date | Title |
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US12/955,420 US20110213336A1 (en) | 2009-08-05 | 2010-11-29 | Method of and apparatus for sampling, processing and collecting tissue and reinjecting the same into human patients |
US13/094,302 US20120068085A1 (en) | 2009-08-05 | 2011-04-26 | Method of and apparatus for photo-activating a collected sample of fat tissue including stem cells therein, contained in a tissue collection and processing device |
PCT/US2011/062346 WO2012074978A2 (en) | 2010-11-29 | 2011-11-29 | Method of and apparatus for sampling, processing and collecting tissue and reinjecting the same into human patients |
US13/315,235 US20120150145A1 (en) | 2009-08-05 | 2011-12-08 | Methods of tissue sampling, collection, processing and re-injection using modular, disposable tissue aspiration, processing, collection and/or re-injection components |
US13/315,248 US20120173262A1 (en) | 2009-08-05 | 2011-12-08 | Internet-based network for supporting the harvesting, photo-activation, cataloguing, tracking and managing aspirated fat tissue samples including stem cells therein |
US13/315,232 US9744274B2 (en) | 2009-08-05 | 2011-12-08 | Tissue sampling, processing and collection device and method of using same |
US13/315,246 US20120184919A1 (en) | 2009-08-05 | 2011-12-08 | Fat tissue re-injection system employing a photometrically-controlled photo-activation chamber installed about a tissue collection and processing device mounted on a hand-held tissue injector gun |
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US13/315,238 US9821096B2 (en) | 2009-08-05 | 2011-12-08 | Tissue sampling, processing and injection syringe device and methods of using the same |
US13/408,567 US20130006225A1 (en) | 2009-08-05 | 2012-02-29 | Twin-type cannula assemblies for hand-held power-assisted tissue aspiration instruments |
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US12/462,596 US8348929B2 (en) | 2009-08-05 | 2009-08-05 | Endoscopically-guided tissue aspiration system for safely removing fat tissue from a patient |
US12/813,067 US20110306950A1 (en) | 2010-06-10 | 2010-06-10 | Coaxially-Driven Tissue Aspiration Instruments |
US12/850,786 US8465471B2 (en) | 2009-08-05 | 2010-08-05 | Endoscopically-guided electro-cauterizing power-assisted fat aspiration system for aspirating visceral fat tissue within the abdomen of a patient |
US12/955,420 US20110213336A1 (en) | 2009-08-05 | 2010-11-29 | Method of and apparatus for sampling, processing and collecting tissue and reinjecting the same into human patients |
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US13/315,238 Continuation US9821096B2 (en) | 2009-08-05 | 2011-12-08 | Tissue sampling, processing and injection syringe device and methods of using the same |
US13/315,232 Continuation US9744274B2 (en) | 2009-08-05 | 2011-12-08 | Tissue sampling, processing and collection device and method of using same |
US13/315,235 Continuation US20120150145A1 (en) | 2009-08-05 | 2011-12-08 | Methods of tissue sampling, collection, processing and re-injection using modular, disposable tissue aspiration, processing, collection and/or re-injection components |
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US10099027B2 (en) | 2014-01-24 | 2018-10-16 | Cole Research & Design | Oral suction device |
US10792427B2 (en) | 2014-05-13 | 2020-10-06 | Allergan, Inc. | High force injection devices |
US10433928B2 (en) | 2015-03-10 | 2019-10-08 | Allergan Pharmaceuticals Holdings (Ireland) Unlimited Company | Multiple needle injector |
US11801060B2 (en) | 2015-05-07 | 2023-10-31 | Avitus Orthopaedics, Inc. | Systems and methods for bone and tissue harvesting |
US10596321B2 (en) | 2016-04-08 | 2020-03-24 | Allergan, Inc. | Aspiration and injection device |
US11890457B2 (en) | 2016-04-08 | 2024-02-06 | Allergan, Inc. | Aspiration and injection device |
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US11229779B1 (en) * | 2020-08-12 | 2022-01-25 | Enrico Guarino | Method for skin ligament injection to obtain a lifting effect |
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US9821096B2 (en) | 2017-11-21 |
US9814810B2 (en) | 2017-11-14 |
WO2012074978A3 (en) | 2012-09-27 |
US9744274B2 (en) | 2017-08-29 |
US20120150069A1 (en) | 2012-06-14 |
US20120150071A1 (en) | 2012-06-14 |
US20120150145A1 (en) | 2012-06-14 |
WO2012074978A2 (en) | 2012-06-07 |
US20120172834A1 (en) | 2012-07-05 |
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