Patent Application
20120277698
In certain circumstances, it may be desirable to harvest fat from one location of a patient's body and introduce the extracted fat into a second anatomic location of the patient. One common procedure for fat harvesting is the Coleman approach. In the Coleman approach, fat tissue is extracted from a source location (e.g., the buttocks) using a syringe. The tissue that is extracted is then centrifuged for a specified length of time at particular settings. After centrifuging, the high density portion is on the bottom and the low density portion is on top. The high density portion of the centrifuged matter is then selected (e.g. by skimming off the top one third or top one half and discarding the skimmed-off portion). The high density portion is then injected into the target site (e.g. a breast). The Coleman approach has a number of disadvantages, including the fact that it is difficult to obtain a large volume of tissue rapidly. Other possible sources of fat include fat that is obtained by a conventional liposuction technique e.g., Suction Assisted Lipoplasty (“SAL”) or Vaser-Ultrasonic Assisted Lipoplasty (“V-UAL”). But the fat that is obtained using these liposuction procedures is not ideal for reintroduction to the patient's body due to low-viability issues and other problems.
In other circumstances, it may be desirable to harvest adipose stem cells from a patient's body for subsequent use. This is sometimes referred to as stem cell isolation. One conventional approach for isolating stem cells is to start with a lipoaspirate from a conventional liposuction technique (e.g., SAL or V-UAL). The lipoaspirate is first gravity-separated into a supranatant (which contains mostly fat) and an infranatant (which contains mostly blood and fluids that were injected during the liposuction). The supranatant is then treated with the collagenase to separate the cells from each other. After the collagenase treatment, the supranatant is centrifuged, which separates the supranatant into three layers: a second generation supranatant on top, an infranatant beneath the supranatant, and a stromal vascular fraction (“SVF”) beneath the infranatant. The SVF contains adipose stem cells which can then be used for all permitted purposes. But this approach is problematic because it requires collagenase, which can be difficult to remove, and can be very dangerous.
With the methods and apparatuses described herein, portions of fatty tissue are drawn into orifices in a cannula, and a heated solution is impinged against those portions of tissue. The heated solution liquefies or gellifies parts of the fatty tissue, so they can be removed from the patient's body more easily. The fat that is so removed is better suited for reintroduction into a patient's body as compared to fat that is harvested using other approaches. The fat that is removes using the methods and apparatuses described herein can also be used as a raw material for stem cell isolation, without relying on the use of collagenase.
The embodiments described below generally involve the delivery of pressurized heated biocompatible fluid to heat targeted tissue and soften, gellify, or liquefy the target tissue for removal from a living body. The heated biocompatible fluid is preferably delivered as a series of pulses, but in alternative embodiments may be delivered as a continuous stream. After the tissue has been softened, gellified, or liquefied, it is sucked away out of the subject's body.
The interaction with the subject takes place at a cannula 30, examples of which are depicted in
The cannula also includes one or more fluid supply tubes 35 that direct the heated fluid onto the target tissue that has been drawn into the cavity. These fluid supply tubes are preferably arranged internally to the outside wall of the cannula (as shown in
The fluid delivery portion may be implemented using a fluid supply reservoir 4, a heat source 8 that heats the fluid in the reservoir 4, and a temperature regulator 9 that controls the heat source 8 as required to maintain the desired temperature. The heated fluid from the fluid supply 4 is delivered under pressure by a suitable arrangement such as a pump system 19 with a pressure regulator 11. Optionally, a heated fluid metering device 12 may also be provided to measure the fluid that has been delivered.
Pump 19 pumps the heated fluid from the reservoir or fluid supply source 4 down the fluid supply tubes 35 that run from the proximal end of the cannula 30 down to the distal end of the cannula. Near the distal tip of the cannula, these fluid supply tubes preferably make a U-turn so as to face back towards the proximal end of the cannula 30. As a result, when the heated fluid exits the supply tube 35 at the supply tube's delivery orifice 43, the fluid is traveling in a substantially distal-to-proximal direction. Preferably, the pump delivers a pressurized, pulsating output of heated fluid down the supply tube 35 so that a series of boluses of fluid are ejected from the delivery orifice 43, as described in greater detail below.
The vacuum source and the fluid source interface with the cannula 30 via a handpiece 20. The heated solution supply is connected on the proximal side of hand piece 20 with a suitable fitting, and a vacuum supply is also connected to the proximal side of handpiece 20 with a suitable fitting. Cannula 30 is connected to the distal side of hand piece 20 with suitable fittings so that (a) the heated fluid from the fluid supply is routed to the supply tubes 35 in the cannula and (b) the vacuum is routed from the vacuum source 14 to the cavity in the cannula, to evacuate material from the cavity.
More specifically, the pressurized heated solution that is discharged from pump 19 is connected to the proximal end of the handle 20 via high pressure flexible tubing, and routed through the handpiece 20 to the cannula 30 with an interface made using an appropriate fitting. The vacuum source 14 is connected to an aspiration collection canister 15, which in turn is connected to the proximal end of the handle via flexible tubing 16 or other fluid coupling, and then routed through the handpiece 20 to the cannula 30 with an interface made using an appropriate fitting.
In the fat harvesting embodiments discussed below, the aspiration collection canister 15, and the flexible tubing 16 are preferably sterile, and optionally disposable. Optionally, a cooling system (not shown) may be added to cool the matter that is suctioned into the collection container in order to extend the life of the fat cells. The cooling may take place using any conventional approach while the aspirated material is in the tubing on its way into the collection canister 15, or alternatively in the collection canister itself. A wide variety of cooling systems may be used, including but not limited to compressor/evaporator based systems, Peltier based systems, and ice or cold water-jacket based systems. In situations where the cooling takes place in the tubing 16, the degree of cooling is preferably not so severe so as to cause the aspirate to coagulate in the tubing.
The pressurized fluid supply line connection between the handle and the cannula 30 may be implemented using a high pressure quick disconnect fitting located at the distal end of the handle, and configured so that once the cannula is inserted into the distal end of the handle it aligns and connects with both the fluid supply and the vacuum supply. The cannula 30 may be held in place on the handle 20 by an attachment cap.
As best seen in
Once the targeted fatty tissue enters the suction orifice 37, it is repeatedly struck by the boluses of heated fluid that are exiting the supply tubes 35 via the delivery orifice 43. The target fatty tissue is heated by the impinging boluses of fluid and is softened, gellified, or liquefied. After that occurs, the loose material in the cavity (i.e., the heated fluid and the portions of tissue that were dislodged by the fluid) is drawn away from the surrounding tissue by the vacuum source 14, and is deposited into the canister 15 (shown in
Advantageously, fat is more readily softened, gellified, or liquefied (as compared to other types of tissue), so the process targets subcutaneous fat more than other types of tissue. Note that the distal-to-proximal direction of the boluses is the same as the direction that the liquefied/gellified tissue travels when it is being suctioned out of the patient via the cannula 30. By having the fluid stream flow in the distal to proximal direction, additional energy (vacuum, fluid thermal and kinetic) is transferred in the same direction, which aids in moving the aspirated tissues through the cannula. This further contributes to reducing clogs, which can reduce the time it takes to perform a procedure.
Notably, in the embodiments described herein, the majority of the fluid stays within the interior of the cannula during operation (although a small amount of fluid may escape into the subject's body through the suction orifices 37). This is advantageous because minimizing fluid leakage from the cannula into the tissue maximizes the energy transfer (thermal and kinetic) from the fluid stream to the tissue drawn into the cannula for liquefaction.
The fluid supply portion of the system will now be described with additional detail.
The supply tube 35 extends longitudinally along axis 33 from the proximal end 31 to the distal tip 32. Supply tube 35 includes U-bend 41, effectively turning the run of the supply tube 35 along the inner wall of the distal tip 32. Adjacent the terminal end of u-bend 41 is supply tube terminal portion 42, which includes delivery orifice 43. Delivery orifice 43 is configured to direct heated solution exiting supply tube 35 across suction orifice port 37. In this manner, supply tube 35 is configured to direct the fluid onto a target tissue that has entered the cannula 30 through the suction orifice port 37.
Heated solution supply tube 35 may be constructed of surgical grade tubing. Alternatively, in embodiments wherein the heated solution supply tube is integral to the construction of cannula 30, the supply tube 35 may be made of the same material as cannula 30. The diameter of supply tube 35 may be dependent on the target tissue volume requirements for the heated solution and on the number of supply tubes required to deliver the heated solution across the one or more suction orifice ports 37. The cannula 30 tube diameters vary with the cannula outside diameters and those can range from 2-6 mm. The fluid supply tube 35 diameters are dependent on the inside diameters of the tubes. A preferred range of supply tube 35 diameters is from about 0.008″ to 0.032″. In one preferred embodiment, the supply tube 35 is a 0.02″ diameter for the length of the cannula 30, with an exit nozzle formed by reducing the diameter to 0.008″ over the last 0.1″. The shape and size of delivery orifice 43 may vary, including reduced diameter and flattened configurations, with the reduced diameter being preferred.
In alternative embodiments, the cannula 30 may have a different number of heated solution supply tubes 35, each corresponding to a respective suction orifice port. For example, a cannula 30 with three suction orifice ports 37 would preferably include three heated solution supply tubes 35. Additionally, heated solution supply tubes may be added to accommodate one or more suction orifice ports, e.g., when four suction orifice ports are provided, four heated solution supply tubes may be provided. In another embodiment, a supply tube 35 may branch into multiple tubes, each branch servicing a suction orifice port. In another embodiment, one or more supply tubes may deliver the heated fluid to a single orifice port. In yet another embodiment, supply tube 35 may be configured to receive one or more fluids in the proximal portion of cannula 30 and deliver the one or more fluids though a single delivery orifice 43. In another embodiment, the cannula may be attached to an endoscope or other imaging device. In yet another embodiment depicted in
The heated fluid should be biocompatible, and may comprise a sterile physiological serum, saline solution, glucose solution, Ringer-lactate, hydroxyl-ethyl-starch, or a mixture of these solutions. The heated biocompatible solution may comprise a tumescent solution. The tumescent solution may comprise a mixture of one or more products producing different effects, such as a local anesthetic, a vasoconstrictor, and a disaggregating product. For example, the biocompatible solution may include xylocalne, marcaine, nesacaine, Novocain, diprivan, ketalar, or lidocaine as the anesthetic agent. Epinephrine, levorphonal, phenylephrine, athyl-adrianol, or ephedrine may be used as vasoconstrictors. The heated biocompatible fluid may also comprise saline or sterile water or may be comprised solely of saline or sterile water.
The pump 58 may be a piston-type pump that draws heated fluid from the fluid reservoir 54 into the pump chamber when the pump plunger travels in a backstroke. The fluid inlet to the pump has an in-line one-way check valve that allows fluid to be suctioned into the pump chamber, but will not allow fluid to flow out. Once the pump plunger backstroke is completed, the forward travel of the plunger starts to pressurize the fluid in the pump chamber. The pressure increase causes the one-way check valve at the inlet of the pump 58 to shut preventing flow from going out the pump inlet. As the pump plunger continues its forward travel the fluid in the pump chamber increases in pressure. Once the pressure reaches the preset pressure on the pump discharge pressure regulator the discharge valve opens. This creates a bolus of pressurized heated fluid that travels from the pump 58 through cannula handle 20 and from there into the supply tube 35 in the cannula 30. After the pump plunger has completed its forward travel the fluid pressure decreases and the discharge valve shuts. These steps are then repeated to generate a series of boluses. Suitable repetition rates (i.e., pulse rates) are discussed below.
One example of a suitable approach for implementing the positive displacement pump is to use an off-set cam on the pump motor that causes the pump shaft to travel in a linear motion. The pump shaft is loaded with an internal spring that maintains constant tension against the off-set cam. When the pump shaft travels backwards towards the off-set cam it creates a vacuum in the pump chamber and suctions heated saline from the heated fluid reservoir. A one-way check valve is located at the inlet port to the pump chamber, which allows fluid to flow into the chamber on the backstroke and shuts once the fluid is pressurized on the forward stroke. Multiple inlet ports can allow for either heated or cooled solutions to be used. Once the heated fluid has filled the pump chamber at the end of the pump shaft backwards travel, the off-set portion of the cam will start to push the pump shaft forward. The heated fluid is pressurized to a preset pressure (e.g. 1100 psi) in the pump chamber, which causes the valve on the discharge port to open, discharging the pressurized contents of the pump chamber to fluid supply tubes 35. Once the pump plunger completes its full stroke based on the off-set of the cam, the pressure in the pump chamber decreases and the discharge valve closes. As the cam continues to turn the process is repeated. The pump shaft can be made with a cut relief, which will allow the user to vary the boluses size. The cut off on the shaft will allow for all the fluid in the pumping chamber to be ported through the discharge path to the supply tubes or a portion of the pressurized fluid to be ported back to the reservoir.
The heated biocompatible solution in a tissue liquefaction system is preferably delivered in a manner optimized for softening, gellifying, or liquefying the target tissue. Variable parameters include, without limitation, the temperature of the solution, the pressure of the solution, the pulse rate or frequency of the solution, and the duty cycle of the pulses or boluses within a stream. Additionally, the vacuum pressure applied to the cannula through vacuum source 14 may be optimized for the target tissue.
It has been found that for liposuction procedures targeting subcutaneous fatty deposits within the human body, the biocompatible heated solution should preferably be delivered to the target fatty tissue at a temperature between 75 and 250 degrees F., and more preferably between 110 and 140 degrees F. A particular preferred operating temperature for the heated solution is about 120 degrees F., since this temperature appears very effective and safe. Also, for liquefaction of fatty deposits the pressure of the heated solution is preferably between about 200 and about 2500 psi, more preferably between about 600 and about 1300 psi, and still more preferably between about 900 and about 1300 psi. A particular preferred operating pressure is about 1100 psi, which provides the desired kinetic energy while minimizing fluid flow. The pulse rate of the solution is preferably between 20 and 150 pulses per second, more preferably between 25 and 60 pulses per second. In some embodiments, a pulse rate of about 40 pulses per second was used. And the heated solution may have a duty cycle (i.e., the duration of the pulses divided by the period at which the pulses are delivered) of between 1-100%. In preferred embodiments, the duty cycle may range between 30 and 60%, and more particularly between 30 and 50%.
In preferred embodiments, the rise rate (i.e., the speed with which the fluid is brought to the desired pressure) is about 1 millisecond or faster. This may be accomplished by having a standard relief valve that opens once the pressure in the pump chamber reaches the set point (which, for example, may be set to 1100 psi). As shown in
Returning now to the suction subsystem,
In some preferred embodiments, the aspiration vacuum that sucks the liquefied/gellified tissue back up through the cannula ranges from 0.33−1 atmosphere (1 atmosphere=760 mm Hg). Varying this parameter is not expected to effect any significant changes in system performance. Optionally, the vacuum level may be adjustable by the operator during the procedure. Because reduced aspiration vacuum is expected to lower blood loss, operator may prefer to work at the lower end of the vacuum range.
When the embodiments described herein are used for fat harvesting, as discussed below, the aspiration vacuum preferably ranges from 300-700 mm Hg. Exceeding 700 min Hg is not recommended during fat harvesting because it can have an adverse impact on the viability of the fat cells that are harvested.
Returning to
In some embodiments, a cooling fluid supply 6 may be used to dampen the heat effect of the heated fluid stream in the surgical field. In these embodiments, the handpiece also routes the cooling fluid into the cannula 35 using appropriate fittings at each end of the handpiece. In these embodiments, a cooling fluid metering device 13 may optionally be included. The hand piece 20 may optionally include operational and ergonomic features such as a molded grip, vacuum supply on/off control, heat source on/off control, alternate cooling fluid on/off control, metering device on/off control, and fluid pressure control. Hand piece 20 may also optionally include operational indicators including cannula suction orifice location indicators, temperature and pressure indicators, as well as indicators for delivered fluid volume, aspirated fluid volume, and volume of tissue removed. Alternatively, one or more of the aforementioned controls may be placed on a separate control panel.
The distal end 22 of hand piece 20 is configured to mate with the cannula 30. Cannula 30 comprises a hollow tube of surgical grade material, such as stainless steel, that extends from a proximal end 31 and terminates in a rounded tip at a distal end 32. The proximal end 31 of the cannula 30 attaches to the distal end 22 of hand piece 20. Attachment may be by means of threaded screw fittings, snap fittings, quick-release fittings, frictional fittings, or any other attachment connection known in the art. It will be appreciated that the attachment connection should prevent dislocation of cannula 30 from hand piece 20 during use, and in particular should prevent unnecessary movement between cannula 30 and hand piece 20 as the surgeon moves the cannula hand piece assembly in a back and forth motion approximately parallel to the cannula longitudinal axis 33.
The cannula may include designs of various diameters, lengths, curvatures, and angulations to allow the surgeon anatomic accuracy based upon the part of the body being treated, the amount of fat extracted as well as the overall patient shape and morphology. This would include cannula diameters ranging from the sub millimeter range (0.25 mm) for delicate precise liposuction of small fatty deposits to cannulas with diameters up to 2 cm for large volume fat removal (i.e. abdomen, buttocks, hips, back, thighs etc.), and lengths from 2 cm for small areas (i.e. eyelids, cheeks, jowls, face etc.) up to 50 cm in length for larger areas and areas on the extremities (i.e. legs, arms, calves, back, abdomen, buttocks, thighs etc.). A myriad of designs include, without limitation, a C-shaped curves of the distal tip alone, S-shaped curves, step-off curves from the proximal or distal end as well as other linear and nonlinear designs. The cannula may be a solid cylindrical tube, articulated, or flexible.
Each of the suction orifice ports 37 includes a proximal end 38, a distal end 39, and a suction orifice port perimeter 40. Although the illustrated suction orifices are oval or round, in alternative embodiments they may be made in other shapes (e.g., egg shaped, diamond or polygonal shaped, or an amorphous shape). As depicted in
In some embodiments, the suction orifice perimeter edge 40 is configured to present a smooth, unsharpened edge to discourage shearing, tearing or cutting of the target fatty tissue. Because the target tissue is liquefied/gellified/softened; the cannula 30 does not need to shear tissue as much as found in traditional liposuction cannulas. In these embodiments, the perimeter edge 40 is duller and thicker than typically found in prior-art liposuction cannulas. In alternative embodiments, the cannula may use shearing suction orifices, or a combination of reduced-shearing and shearing suction orifice ports. The suction orifice port perimeter edge 40 of any individualized suction orifice port may also be configured to include a shearing surface or a combination of shearing and reduced-shearing surfaces, as appropriate for the particular application.
Using between one and six suction orifices 37 is preferable, and using two or three suction orifices is more preferable. The suction orifices may be made in different shapes, such as round or oblong.
As shown in
For the embodiment shown in
The embodiments described above may also be used to selectively harvest viable fat cells (adipocytes) which can be extracted and processed for re-injection into other areas of the body (e.g., areas of fat deficiency). This would include, without limitation, areas around the face, brow, eyelids, tear troughs, smile lines, nasolabial folds, labiomental folds, cheeks, jaw line, chin, breast, chest abdomen, buttocks, arms, biceps, triceps, forearms, hands, flanks, hips, thighs, knees, calves, shin, feet, and back. A similar method may be used to address post liposuction depressions and/or concavities from over aggressive liposuction. Other procedures utilizing a similar method include; without limitation, breast augmentation, breast lifts, breast reconstruction, general plastic surgery reconstruction, facial reconstruction, reconstruction of the trunk and/or extremities.
It turns out that harvesting fat cells using the embodiments described above result in significant improvements in the cell viability in many respects as compared to other approaches for harvesting fat cells from a subject. Moreover, (1) the speed of harvesting and the quantity of fat cells that can be harvested is significantly better than with other approaches for harvesting fat cells; (2) the cells are in a state of cell suspension in small clumps with very little or no blood, which is advantageous for implantation; (3) it is easy to separate out a portion of the lipoaspirate that is rich in stem cells by simply centrifuging it; (4) the viability of the extracted fat cells is significantly better than with other approaches; and (5) the fact that the cells are in a state of cell suspension in small clumps makes it easier to inject the cells under lower pressure (and pressure during injection is known to damage the fat cells so that they do not “take” when injected). These benefits are explained in the paragraphs that follow.
Adipose tissue cell viability of four different fat harvesting modalities was compared by analyzing fresh tissue samples taken from one live human subject using all four different modalities. The four fat harvesting modalities were: (1) using the embodiments and methods described above (referred to herein as “Andrew” Lipoplasty, based on the name of the inventor of this application); (2) using a Coleman syringe (“CS”); (3) using standard Suction Assisted Lipoplasty (“SAL”); and (4) using Vaser-Ultrasonic Assisted Lipoplasty (“V-UAL”). Four samples from the Andrew modality and one sample from each of the other modalities were analyzed, making a total of seven samples.
The testing was performed under expert guidance, directed by a world authority on adipose tissue cell biology. A total of four PhDs in cell biology were present. Tissue sample preparation of all four fat harvesting modalities was identical, using standard centrifugation and collagenase protocols. The steps that were implemented are described below.
The waste containers containing the fat aspirates were brought from the third floor operating suite to the first floor lab. By the time the waste containers arrived in the lab, the material in the containers was already settling into an obvious supranatant layer (an upper layer) consisting of mainly fat tissue, and an infranatant layer (a lower layer) consisting mainly of a fluidic mixture of blood and/or saline. The difference between the Andrew containers and all the other containers was obvious and marked: the Andrew supranatant was light yellow in color, was clearly a homogeneous liquid, was devoid of chunks of connective tissue (“CT”) and clumps of fat tissue, and was devoid of blood—there was no hint of redness whatsoever. The Andrew infranatant was a thin, light salmon/pink colored liquid. All other non-Andrew lipo waste containers looked similar: the supranatant was reddish-orange in color and clearly contained blood, the SAL and V-UAL supranatants were not homogeneous liquids and contained obvious chunks of CT tissue and clumps of fat, the Coleman supranatant appeared thick and clumpy and was not a homogeneous liquid (but definitive appearing chunks of connective tissue were not discernible), and all the non-Andrew infranatants appeared to be a dark red, thick, blood-like fluid. The seven aspirate samples arrived in the lab sequentially, at 15-20 minute intervals from one to the next. As the samples arrived they were allowed to settle for a few minutes.
The first analysis that was done was to determine whether the lipoasprirate was in a state of cell suspension. To accomplish this, samples of the Coleman and Andrew supranatants (#1) were taken using a pipette and exposed to trypan blue stain. The stained samples were then placed on a hemocytometer cell counting slide and viewed under the microscope. Microscopically, the Andrew supranatant was observed to be in a state of cell suspension, and was observed to be almost a single cell suspension. (It was believed by all cell biologists present that the #1 Andrew sample could be gotten to a single cell suspension by diluting it.) The Coleman sample was in clumps and was not in a cell suspension state. Three of the cell biologists present observed that it was inconceivable that the SAL and V-UAL aspirates would be in a state of cell suspension, based on their obvious chunky and clumpy appearance, so they did not look at the fat tissues from the SAL and V-UAL aspirates under the microscope. The significance of the fact that the #1 Andrew sample was in a cell suspension state is discussed below.
Cell viability was then measured for all seven samples. A sample from the each supranatant was taken using a pipette and placed in a test tube and labeled. Then a smaller sample was taken using a pipette from the test tube and placed in a 2 ml centrifuge tube. (Epindorf centrifuge.) The sample was spun at 800 rpm for 5 minutes. Then a collagenase digestion was performed on that post-spun sample in a 37 degree C. water bath, using 1 mg/ml of collagenase (Worthington type 1) for 45 minutes. Then, post digestion, the sample was spun again in the centrifuge. Then a sample was taken using a pipette from the supranatant in the centrifuge tube and exposed to two fluorescent dyes for approximately 10 minutes. Then a small sample from that post fluorescent dye stained sample was placed onto the Vision Cell Analyzer slide, the slide was placed into the automated cell counter (a Vision Cell Analyzer from Nexcelom, Inc. of Lawrence, Mass.) and it was read. The identical process and procedure was done to all seven aspirate samples.
The Vision Cell Analyzer distinguishes adipocytes from lipid droplets; the fluorescent dyes stain only cells and not lipid droplets. (When reading the slides manually through a microscope it is very difficult to distinguish a lipid droplet from an adipocyte.) The first dye stains all cells present, alive, and dead cells. The second dye stains only dead cells. The automated cell counter counts all cells present and can distinguish between live and dead cells. The software in the Vision Cell Analyzer does a subtraction and gives you the percentage of live cells present. Four separate fields are read and averaged. The results for the four different modalities are tabulated on Table 1 below. All the samples were prepared identically (i.e., all were post centrifugation and post collagenase digestion). Note that four different samples using the Andrew modality were tested (at various temperature and pressure settings and two different anatomical locations).
Looking at the images from the Vision Cell Analyzer on the laptop screen which showed the field of cells being read, one field at a time, one of the cell biologists present commented that in all fields “it is clear that the majority of cells being read are adipocytes; from what we know of adipose tissue cellular biology, the other cells present are progenitor cells, pre-adipocytes, endothelial cells and macrophages . . . ”.
A review of the data in Table 1 reveals that the Andrew Lipoplasty modality had the best cell viability determination. The four Andrew samples ranged from 94.4% to 99.2% cell viability, with an average of 96.6%. The Andrew Lipoplasty system evidenced excellent cell viability at all machine settings, even at the highest temperature and pressure settings. The Coleman modality came in second, SAL third, and V-UAL fourth.
Note that in the cell viability procedure described above, collagenase was used to separate the cells from each other. This was done because the cell counter machines can only count cells when they are separated, and cell counter machines were required to measure cell viability. But in medical applications, when the fat is extracted and then reintroduced to a person's body, it is strongly preferably to avoid using collagenase in the process. Since collagenase will not be used, the configuration of cells in the matter that is extracted from the patient becomes very significant in determining how well the cells will take in their transplanted location. First of all, cells that are in a cell suspension are preferable for introduction in a patient as compared to cells that are not in a cell suspension state. And second of all, even within situations where the cells are in a cell suspension state, the size of the cell clumps in that suspension has a significant effect on how well the cells will take in their transplanted location. It turns out that the cells take better when the cells are in smaller clumps (as compared to cells that are in larger clumps). But the clumps should also not be too small. Some experts have indicated that a clump size is on the order of 200 cells per clump is ideal, and the Andrew system advantageously yields a large amount of clumps that contain between 100 and 400 cells per clump, which is a relatively small clump size that is also not too small.
Base on the tests described above, it become apparent that the Andrew approach is superior to the other three approaches in many ways including: the speed of collection and the nature of the collected matter; the nature of the post-collection processing of lipoaspirate that must be done; and suitability for injection into a target location. Regarding speed, the Andrew, SAL, and V-UAL systems all remove tissue from a patient's body relatively quickly, but the Coleman approach is comparatively slow. As for the nature of the collected matter, the fat extracted using the Andrew system is in a cell suspension state with relatively small clump size; the fat extracted using the Coleman approach ends up in clumps of fat that are not in a cell suspension state; and the matter extracted using SAL and UAL was not in a cell suspension state at all. Fat that is in a cell suspension state with relatively small clump size is ideal for reintroduction into a target site in the patient's body, and the Andrew system is the only approach that provides rapid extraction of fat tissue that is in a cell suspension state with relatively small clump size. The Andrew approach is therefore superior to the other three approaches in this regard.
Another reason why the Andrew approach is superior to the other three approaches is because the cell viability is highest using the Andrew approach, as shown in the data presented above.
Yet another reason why the Andrew approach is superior to the other three approaches is because less processing of the lipoaspirate is required. The Andrew lipoaspirate gravity-separates relatively quickly and the supranatant appears to be devoid of blood. In contrast, the lipoaspirate from the UAL and SAL approaches contain a significant amount of blood in other undesirable components. As a result, the Andrew lipoaspirate will probably not need washing before it can be introduced into the patient's body (or, at the very least, will require less washing as compared to the other approaches).
Yet another reason why the Andrew approach is superior to the other approaches is its improved injectability. When fat is injected into a target site, it is known that squeezing the injection syringe too hard can kill or damage some of the fat cells that are being injected, which prevents them from taking in their new location. The Andrew lipoaspirate had a smoother consistency (possibly due to the fact that the Andrew lipoaspirate is in a cell suspension state with a relatively small clump size), and can therefore be pushed out of the injection syringe using lower pressure. In contrast, the fat cells in the Coleman approach was not as smooth (possibly due to the larger clump size) and would require a higher injection pressure to push out of the injection syringe. Since higher pressure can damage the fat being injected, the Andrew approach is superior in this regard as well.
Overall cell viability for the Andrew approach is superior to the other approaches because the cells in the extracted matter start off having the highest viability, as explained with the data presented above. This high initial viability is then compounded by the fact that fewer fat cells are damaged during the injection process, which means that the percentage of fat cells that actually take in the target location will go up even further.
For all these reasons, the Andrew Lipoplasty system described herein (i.e., the methods and embodiments described above) appears to be an ideal fat harvesting modality. The supranatant that is collected using the Andrew approach may be centrifuged in a manner that is similar to the centrifuging process described above in the background section in connection with the Coleman approach. The low density portion can be skimmed away and discarded and the remainder can be loaded into implantation syringes. Alternatively, the high density portion can be drained off the bottom into implantation syringes. The higher density portion, which contains viable fat cells and is also rich in adipose progenitor cells (i.e., stem cells), can then be used for implantation into the subject.
The fact that the Andrew supranatant is in a state of cell suspension also provides another major advantage: Since the supranatant automatically reaches a state of cellular suspension, it becomes possible to separate out the adipose progenitor cells (i.e., stem cells) from the rest of the fat using a centrifuge without using collagenase or other similar functioning enzymes or chemicals. Since adipose progenitor cells have the ability to differentiate into many different types of tissue, they can be very useful for many purposes. (Note that the G forces used to separate stem cells will be higher than the G forces that are used to separate the high density portion of the supranatant from the low density portion.) While the viability of the adipose stem cells was not tested separately, it is safe to assume that they are viable because adipose progenitor cells are hardier than adipocytes, and the overall viability was tested and found to be extremely high in the Andrew modality, as seen in Table 1 above. The Andrew approach, used together with a centrifuge, is therefore an excellent way to obtain adipose progenitor cells.
Note that when a doctor intends to reintroduce the fat that is being extracted from the body into another location, the fluid pressure and vacuum settings may be reduced to make the process more gentle, in order not to traumatize the fat tissue. On the other hand, when the fat will be discarded, this is not a concern and higher pressure and vacuum settings may be used.
One aspect of the invention relates to a method of harvesting fat tissue from a first anatomic location of a subject using a cannula that has an interior cavity and an orifice configured to permit fat tissue to enter the interior cavity. This method includes generating a negative pressure in the interior cavity so that a portion of the fat tissue is drawn into the interior cavity via the orifice. Fluid is delivered, via a conduit, so that the fluid exits the conduit within the interior cavity and impinges against the portion of the fat tissue that was drawn into the interior cavity. The fluid is delivered at a pressure and temperature that causes the fat tissue to soften, liquefy, or gellify. Matter is suctioned matter out of the interior cavity, and the matter includes at least some of the delivered fluid and at least some of the fat tissue that has been softened, liquefied, or gellified. The matter that was suctioned away is collected, and fat that is suitable for implantation in the subject is extracted from the collected matter.
Optionally, the extracted fat is introduced into a second anatomic location of the subject. The extraction may be implemented by centrifuging at least a portion of the collected matter. It may also be implemented by waiting for gravity to separate the matter into an upper portion and a lower portion, wherein the upper portion is primarily fat and the lower portion is primarily the fluid, then centrifuging the upper portion, and then extracting a high density portion of the centrifuged upper portion.
Optionally, the collected matter may be cooled. In some embodiments, the fluid is traveling in a substantially distal to proximal direction just before it impinges against the portion of the fat tissue that was drawn into the orifice.
Preferably, the fluid is delivered in pulses at a temperature between 98° F. and 140° F., and more preferably between 110° F. and 120° F. Preferably, the fluid is delivered at a pressure between 600 and 1300 psi, and more preferably between 900 and 1300 psi. Preferably, the matter is suctioned out of the interior cavity using a vacuum pressure between 300 and 700 mm Hg, and between 450 and 550 mm Hg may be a sweet spot within this range.
Another aspect of the invention relates to a method of harvesting fat tissue from a first anatomic location of a subject using a cannula that has an interior cavity and an orifice configured to permit fat tissue to enter the interior cavity. This method includes generating a negative pressure in the interior cavity so that a portion of the fat tissue is drawn into the interior cavity via the orifice. Fluid is delivered via a conduit, so that the fluid exits the conduit within the interior cavity and impinges against the portion of the fat tissue that was drawn into the interior cavity. The fluid is delivered in pulses at a temperature between 98° F. and 140° F. and at a pressure between 600 and 1300 psi, and is traveling in a substantially distal to proximal direction just before it impinges against the portion of the fat tissue that was drawn into the orifice. At least some of the fat tissue that was drawn into the interior cavity is softened, liquefied, or gellified. Matter is suctioned out of the interior cavity, and the matter includes at least some of the delivered fluid and at least some of the fat tissue that has been softened, liquefied, or gellified. The matter that was suctioned away is collected, and fat that is suitable for implantation in the subject is extracted from the collected matter.
Optionally, the extracted fat is introduced into a second anatomic location of the subject. The extraction may be implemented by centrifuging at least a portion of the collected matter. It may also be implemented by waiting for gravity to separate the matter into an upper portion and a lower portion, wherein the upper portion is primarily fat and the lower portion is primarily the fluid, then centrifuging the upper portion, and then extracting a high density portion of the centrifuged upper portion.
Optionally, the collected matter may be cooled. Preferably, the fluid is delivered at a temperature between 110° F. and 140° F., and more preferably between 110° F. and 120° F. Preferably, the fluid is delivered at a pressure between 900 and 1300 psi. Preferably, the matter is suctioned out of the interior cavity using a vacuum pressure between 300 and 700 mm Hg, and between 450 and 550 mm Hg may be a sweet spot within this range.
Another aspect of the invention relates to an apparatus for harvesting fat tissue from a subject. The apparatus includes a cannula configured for insertion into a subject's body, and the cannula has a proximal end and a distal end. The cannula also has sidewalls that define an interior cavity, wherein the cavity has a closed distal end, and wherein the sidewalls have at least one orifice configured to permit fat tissue to enter the interior cavity. The apparatus also includes a collection container configured to hold liquids, a suction source configured to generate a negative pressure in the collection container, and a fluid coupling configured to route the negative pressure from the collection container to the interior cavity of the cannula so that (a) fat tissue is drawn into the interior cavity via the orifice, and (b) loose matter that is located in the cavity is suctioned into the collection container. The apparatus also includes a cooling system configured to cool the matter that is suctioned into the collection container. The cannula also has a delivery tube with an input port and an exit port, with the exit port located within the cavity, wherein the delivery tube is configured to route fluids from the input port to the exit port, and wherein the delivery tube is configured with respect to the orifice so that fluid exiting the exit port impinges against fat tissue that has been drawn into the interior cavity via the orifice. The apparatus also includes a pump configured to pump a fluid, in pulses, into the input port of the delivery tube, and a temperature control system configured to regulate a temperature of the fluid to be between 98° F. and 140° F.
Preferably, the fluid travels in a substantially distal to proximal direction just prior to impinging against the fat tissue that has been drawn into the interior cavity via the orifice. Preferred parameters include a pump output pressure between 600 and 1300 psi and more preferably between 900 and 1300 psi, and a suction source generating a negative pressure between 300 and 700 mm Hg, and more preferably between 450 and 550 mm Hg. The temperature control system is preferably configured to regulate the temperature of the fluid to be between 110° F. and 140° F., and more preferably between 110° F. and 120° F.
The embodiments described above may be used in various liposuction procedures including, without limitation, liposuction of the face, neck, jowls, eyelids, posterior neck (buffalo hump), back, shoulders, arms, triceps, biceps, forearms, hands, chest, breasts, abdomen, abdominal etching and sculpting, flanks, love handles, lower back, buttocks, banana roll, hips, saddle bags, anterior and posterior thighs, inner thighs, mons pubis, vulva, knees, calves, shin, pretibial area, ankles and feet. They may also be used in revisional liposuction surgery to precisely remove residual fatty tissues and firm scar tissue (areas of fibrosis) after previous liposuction.
The embodiments described above may also be used in conjunction with other plastic surgery procedures in which skin, fat, fascia and/or muscle flaps are elevated and/or removed as part of the surgical procedure. This would include, but is not limited to facelift surgery (rhytidectomy) with neck sculpting and submental fat removal, jowl excision, and cheek fat manipulation, eyelid surgery (blepharoplasty), brow surgery, breast reduction, breast lift, breast augmentation, breast reconstruction, abdominoplasty, body contouring, body lifts, thigh lifts, buttock lifts, arm lifts (brachioplasty), as well as general reconstructive surgery of the head, neck, breast abdomen and extremities. It will be further appreciated that the embodiments described above have numerous applications outside the field of liposuction.
The embodiments described above may be used in skin resurfacing of areas of the body with evidence of skin aging including but not limited to sun damage (actinic changes), wrinkle lines, smokers' lines, laugh lines, hyper pigmentation, melasma, acne scars, previous surgical scars, keratoses, as well as other skin proliferative disorders.
The embodiments described above may target additional tissue types including, without limitation, damaged skin with thickened outer layers of the skin (keratin) and thinning of the dermal components (collagen, elastin, hyaluronic acid) creating abnormal, aged skin. The cannula would extract, remove, and target the damaged outer layers, leaving behind the healthy deep layers (a process similar to traditional dermabrasion, chemical peels (trichloroacetic acid, phenol, croton oil, salicyclic acid, etc.) and ablative laser resurfacing (carbon dioxide, erbium, etc.) The heated stream would allow for deep tissue stimulation, lightening as well as collagen deposition creating tighter skin, with improvement of overall skin texture and/or skin tone with improvements in color variations. This process would offer increased precision with decreased collateral damage over traditional methods utilizing settings and delivery fluids which are selective to only the damaged target tissue.
Other implementations include various distal tip designs and lighter pressure settings that may be used for tissue cleansing particularly in the face but also applied to the neck, chest and body for deep cleaning, exfoliation and overall skin hydration and miniaturization. Higher pressure settings may also be used for areas of hyperkeratosis, callus formation in the feet, hands knees, and elbows to soften, hydrate and moisturize excessively dry areas.
Additional uses include tissue removal in the spine or spinal nucleotomy. The cannula used in spinal nucleotomy procedures includes heated solution supply tubes within the cannula as described above. The cannula further includes a flexible tip capable of moving in multiple axes, for example, up, down, right and left. Because of the flexible tip, a surgeon may insert a cannula through an opening in the annulus fibrosis and into the central area, where the nucleus pulpous tissue is located. The surgeon can then direct the cannula tip in any direction. Using the cannula in this manner the surgeon is able to clean out the nucleus pulpous tissue while leaving the annulus fibrosis and nerve tissue intact and unharmed.
In another implementation, the present design can be incorporated in to an endovascular catheter for removal of vascular thrombus and atheromatous plaque, including vulnerable plaque in the coronary arteries and other vasculature.
In another implementation, a cannula using the present design can be used in urologic applications that include, but are not limited to, trans-urethral prostatectomy and trans-urethral resection of bladder tumors.
In another implementation, the present design can be incorporated into a device or cannula used in endoscopic surgery. An example of one such application is chondral or cartilage resurfacing in arthroscopic surgery. The cannula can be used to remove irregular, damaged, or torn cartilage, scar tissue and other debris or deposits to generate a smoother articular surface. Another example is in gynecologic surgery and the endoscopic removal of endometrial tissue in proximity to the ovary, fallopian tubes or in the peritoneal or retroperitoneal cavities.
In yet a further implementation to treat chronic bronchitis and emphysema (COPD), the cannula can be modified to be used in the manner a bronchoscope is used; the inflamed lining of the bronchial tubes would be liquefied and aspirated, thereby allowing new, healthy bronchial tube tissue to take its place.
The various embodiments described each provide at least one of the following advantages: (1) differentiation between target tissue and non-target tissue; (2) clog resistance, since the liquid projected in a distal-to-proximal direction across the suction orifices, which generally prevents the suction orifice or the cannula from clogging or becoming obstructed; (3) a reduction in the level of suction compared to traditional liposuction, which mitigates damage to non-target tissue; (4) a significant reduction in the time of the procedure and the amount of cannula manipulation required; (5) a significant reduction in surgeon fatigue; (6) a reduction in blood loss to the patient; and (7) improved patient recovery time because there is less need for shearing of fatty tissue during the procedure.
Although the present invention has been described in detail with reference to certain implementations, other implementations are possible and contemplated herein.
All the features disclosed in this specification may be replaced by alternative features serving the same, equivalent, or similar purpose, unless expressly stated otherwise. Thus, unless expressly stated otherwise, each feature disclosed is one example only of a generic series of equivalent or similar features.
This application claims the benefit of U.S. provisional application 61/480,747, filed Apr. 29, 2011; and this application is also a continuation-in-part of U.S. application Ser. No. 12/112,233, filed Apr. 30, 2008, which claims the benefit of U.S. provisional application 60/915,027, filed Apr. 30, 2007. Each of the applications identified above is incorporated herein by reference.
| Number | Date | Country | |
|---|---|---|---|
| 61480747 | Apr 2011 | US | |
| 60915027 | Apr 2007 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 12112233 | Apr 2008 | US |
| Child | 13457842 | US |
