Patent Grant
10143811
This invention is related in general to systems, processes, and methods of harvesting and reinjecting adipose tissue. In particular, the invention pertains to a method and system for controlling and adjusting both the levels of tissue-reinjection pressure and tissue-flow rates in real-time in order to prevent a biological site (tissue) receiving the reinjected adipose tissue from being harmed and to continually maintain the viability of the adipose fat tissue at each point of its transfer from the beginning of the harvesting step to the end of the reinjection step.
Liposuction procedures have gained popularity, and more recently there has been an increase in industry demand for reinjecting the adipose fat tissue (that has been harvested or removed from one bodily part) to another bodily part. While such reinjection procedures are currently moderately successful in terms of completion, no attention has been paid to-date to the question of preventing build-up of pressure of the biological fluid (including the adipose tissue) not only during the propagation through the system used for transfer of such biological fluid from the initial location (or source, for short, such as a container or even the location of harvesting of the adipose tissue) to the final location (or target location, such as for example the reinjection site) but, more importantly, at the target location itself while the fluid is being delivered and injected there. The issue of lack of real-time control of pressure build up raises not only the question of whether the viability of the biological fluid (in this example—the adipose tissue) upon its transfer through the system and the re-injection is maintained or not: The lack of real-time pressure control and adjustment begs a more critical question of whether or not the tissue at the target location becomes distressed or is exposed to injury as a result of delivery of the biological fluid under possibly over-pressurized conditions. And that is all despite the reports in related art that detrimental effects of reinjection of adipose tissue (and even effects leading to extreme consequences) continue to accompany the adipose tissue reinjection in such a common-procedure circumstances as, for example, gluteal fat grafting. Instead, the industry and related art continue to focus on minimization of time required to complete a procedure under the circumstances that seemingly allow maintaining patient's safety.
A person of skill in the art would readily recognize that between these two questions, which are currently of interest to the industry, the one of ability to maintain the (target tissue of the) recipient of biological fluid reinjection safe while at the same time maintaining the fluid (adipose tissue) viable during the reinjection procedure (and, preferably, from the beginning of the harvesting step to the end of the reinjection step of the procedure) may be argued to be more critical, because in absence of the assurance of a real-time adjustment of the procedure as a function of pressure in the delivery channel such procedure is—at a minimum—detrimental to the patient, and should be avoided.
The present disclosure addresses the question of decisive importance to the fat grafting industry—the active, real-time control of pressure at which the adipose tissue is being transferred to the target location during the reinjection procedure and, in fact, immediate interruption and cessation of the bodily fluid grafting once the pre-determined pressure threshold is reached to prevent detrimental influence on the recipient biological tissue.
Embodiments of the invention provide a system configured to inject an adipose tissue to an injection location of a biological tissue. Such system includes tubing with first and second ends. The first end is structured to receive adipose tissue that has been harvested from a harvesting location, while the second end is fluidly connected to a reinjection cannula. The system includes a reinjection pump that in operation causes the adipose tissue to move through the flexible tubing from the first end to the reinjection cannula, as well as a pressure sensor employed to measure an internal pressure of the adipose tissue upon its propagating towards the injection location. The system may be also equipped a harvesting pump configured to temporally-continually supply the adipose tissue to the first end while the reinjection pump is causing the deposition of the adipose tissue to a side-wall opening of the reinjection cannula in a pulsed fashion.
The system is configured to modify the reinjection procedure when the internal pressure exceeds a threshold value. In one implementation, the reinjection pump is devoid of a portion that, in operation, contacts the adipose tissue in the tubing. The reinjection pump is preferably devoid of a movable part configured to impede a flow of the adipose tissue within the tubing by at least partially obstructing said flow internally to said flexible tubing. Additionally or in the alternative, the pressure sensor is devoid of a portion that, in operation, contacts the adipose tissue. In a specific case, the pressure sensor is configured to cause the system to interrupt the reinjection procedure when pressure of adipose tissue at a side-wall opening of the reinjection cannula exceeds a predetermined amount and/or the tubing is dimensioned to have, in absence of external force applied to said tubing, a substantially constant internal diameter at any point between the first and second ends. The he pressure sensor may be structured as an in-line sensor operably affixed to the tubing.
The reinjection pump may include a reinjection pump controller operably connected with the pressure sensor and configured to stop (cease) an operation of the reinjection pump at a first set point, the first set point representing a point in operation when pressure of adipose tissue at a side-wall opening of the reinjection cannula exceeds a predetermined amount. Alternatively or in addition, he reinjection pump includes a reinjection pump controller configured to operate the reinjection pump in a pulsed regime to cause the adipose tissue move in a pulsed fashion from the first end to the second end. The pressure sensor may a transducer configured to measure said internal pressure by measuring a change of a parameter of the flexible tubing caused by changes in said internal pressure.
In a related embodiment, the adipose-tissue transfer system additionally includes (i) a harvesting cannula; and (ii) a volume fillable, during an operation of the system, with the adipose tissue, such that the volume is disposed in fluid communication between the harvesting cannula and the tubing. Such specific system is configured to define a spatially-uninterrupted fluid passage between the first and second ends and to continuously transfer the adipose tissue to the injection location while, at the same time, harvesting the adipose tissue from the harvesting location and while maintaining at least one of (i) an internal pressure of adipose tissue in the tubing and (ii) a flow rate of the adipose tissue through the tubing and the reinjection cannula within a pre-determined range. Additionally or in the alternative, such specific system may be configured to temporally-continually transfer the adipose tissue from the first end to a side-wall opening of the reinjection cannula while maintaining each of the internal pressure and the flow rate within respectively-corresponding predetermined ranges.
Embodiments of the invention also provide a system configured to inject an adipose tissue to an injection location of a biological tissue and including a storage volume (dimensioned to contain the adipose tissue), a hollow delivery channel with first and second ends, the first end fluidly connected with the storage volume, the second end fluidly providing fluid connection between the lumen of the delivery channel and the ambient; a reinjection pump structured to apply a positive-displacement pumping force to the delivery channel to cause a movement of the adipose tissue from the first end to the injection location; and a pressure sensor attached externally to a component of the system and configured to measure an internal pressure of the adipose tissue in the delivery channel and generate an output signal representative of such internal pressure. A processor may be further operably connected to the pressure sensor and programmed to stop an operation of the reinjection pump in response to a value of the output signal being in a pre-determined relationship with a threshold value. In a specific case, a component of the reinjection pump is configured to apply a contact force and only to an outer surface of the hollow delivery channel. Alternatively or in addition, the system is complemented with a reinjection cannula having a side-wall opening, while the reinjection pump is equipped with a pump controller configured to change an operation of the pump in response to indicia representing that pressure of the adipose tissue in a vicinity of said side-wall opening exceeded a threshold value. Such indicia is generated by the pressure sensor. The pump controller may further provide for a pulsed movement of the adipose tissue in the hollow delivery channel.
Embodiments further provide a related system configured to inject an adipose tissue to an injection location of a biological tissue. The system includes an aspiration cannula including an aspiration opening and an outlet; a collection container; a first flexible tubing fluidly connecting the outlet of the aspiration cannula to the collection container; an aspiration pump fluidly connected to the collection container and configured to cause adipose tissue to be sucked through the aspiration opening and deposited into the collection container; a reinjection cannula including a reinjection opening and an inlet; a second flexible tubing fluidly connecting the inlet of the reinjection cannula to the collection container; and a reinjection pump configured to create a positive displacement pumping action on the second flexible tubing causing movement of the adipose tissue through the second flexible tubing from the collection container to the reinjection cannula, while being devoid of a portion that is in direct contact with the adipose tissue. The system further includes a pressure sensor configured to measure an internal pressure of the adipose tissue contained in the second flexible tubing without directly contacting said adipose tissue. The system may be further equipped with a vibrating stage configured to vibrate the collection container and/or a scale disposed to support and carry the collection container and to indicate weight of a portion of said adipose tissue that is present in the collection container. The first flexible tubing and second flexible tubing have substantially equal inner lumen dimensions or, in the alternative, the inner dimensions of the inner lumen of the second tubing are no smaller than those of the inner lumen of the first tubing. In a specific case, the side-wall opening of the aspiration cannula and the side-wall opening of the reinjection cannula have at least one of (i) equal sizes and (ii) equal shapes. Alternatively or in addition, at least one of the following conditions is satisfied: (i) an area of the side-wall opening of the aspiration cannula is between 10% and 100% of an area of the side-wall opening of the reinjection cannula; preferably between 80% and 95% of an area of the side-wall opening of the reinjection cannula; (ii) a width of the side-wall opening of the aspiration cannula is between 10% and 100% of a width of the side-wall opening of the reinjection cannula, preferably between 80% and 95%; and (iii) a cross-sectional area of a lumen of the reinjection cannula is between 30% and 200% of an area of a side-wall opening of the aspiration cannula.
The invention will be more fully understood by referring to the following Detailed Description in conjunction with the generally-not-to-scale Drawings, in which similar elements are indicated with similar numbers and labels and of which:
The sizes and relative scales of elements in Drawings may be set to be different from actual size and scales to appropriately facilitate simplicity, clarity, and understanding of the Drawings. For the same reason, not all elements present in one Drawing may necessarily be shown and/or labeled in another.
The related art leaves unaddressed multiple problems concerning the handling of adipose tissue during the transfer and/or reinjection procedure(s). These problems include not only maintaining the viability of the harvested and subsequently reinjected adipose tissue but, more importantly, the issue of constant monitoring and adjustment of pressure associated with the reinjection process for the sake of the patient safety. The present invention, on the other hand, emphasizes these two related aspects of the fat adipose tissue (re-)injection procedure (which may also be referred as fat grafting): the safety of the biological body into which the adipose tissue is being reinjected and the safety or viability of the adipose tissue itself during and upon the transfer to the biological body from the source.
A person of skill in the art would readily recognize that the viability of the adipose tissue during the process of handling is jeopardized by several factors, such as excessive levels of pressure during the harvesting/reinjection steps, shearing forces, and blunt forces, to name just a few. Each of these traumatizes and more often than not damages the adipose tissue. The diversity of nature of the adipose tissue (which generally contains many small adipocytes or clusters held together by biological fibers in larger agglomerates) results not only in broad and unpredictable variations (from patient to patient) of, for example, pressures required to harvest the tissue but also in empirically-confirmed variations related to the target location of the procedure (that is, which bodily parts are being attended to). These unpredictable variations imply that the clinician each time has to guess when selecting, for example, a level of vacuum (during the harvesting of the adipose tissue) or another characteristic of the process in order to achieve optimum results for a given patient. In other words, there does not exist an industry-recognized reference and/or prescription of the parameters at which the management of the fluids has to occur as part of the handling of the adipose tissue.
At the same time, it remains unrecognized by a person of skill in the art that the safety of the recipient of the reinjected adipose tissue also critically depends on the pressure levels at which the adipose tissue is being delivered and reinjected into the target location. In fact, while reporting on statistics of fat embolism during the gluteal fat grafting procedure, related art admits the recurring problem of embolism but addresses it to and explains it with the specific aspects of the reinjection procedure—and only provides recommendations to avoid very peculiar elements of the fat grafting such as, for example, fat injections into the deep muscle with the use of cannulae of particular small dimensions (such as cannulae smaller than 4 mm in diameter) and pointing the injection cannula downwards during the reinjection procedure.
The current practice of re-injection of adipose tissue back into a body of the patient and associated methodologies fail to control, monitor, and react in real-time to changes in pressure of the adipose tissue that is being re-injected. And—while the current practices have been shown to have serious implications and often resulted in detrimental injury to the patient—the related art either simply does not recognize the importance of control of pressure during the adipose tissue transfer (advocating, instead, the specific and minute “fixes” of the overall procedure that may, under limited circumstances, alleviate the problem; see for example Mofid et al., in Aesthetic Surgery Journal 2017, pp. 1-11) or, even expressly asserts that the elimination of high-pressure states during fat transfer is not possible, and that the only certain way to avoid the risk of fat embolism is to avoid venous injury during fat transplantation (see, for example, Vecchio and Wall, in 51st Annual Baker Gordon Educational Symposium, 2017, Florida). Thus, there remains an unaddressed need for a device to effectively manage fluid pressure, in real-time, in both the re-injection system itself and the body of the patient. The present invention challenges these negative conclusions of the related art, which unavoidably redirect the attention of a skill artisan away from addressing the pressure-caused problems, and provides an adipose tissue transfer equipped with an external control unit configured to generate indicia of the fluid pressure in the system. Unless expressly defined otherwise, for the purposes of this disclosure and accompanying claims a real-time performance of a system is understood as performance which is subject to operational deadlines from a given event to a system's response to that event. For example, a real-time adjustment of pressure caused by the adipose tissue during the process of transfer of such tissue to the recipient site may be one triggered by the processor-controlled system (based on the feedback signal from the pressure-measuring means) and executed simultaneously with the process of adipose tissue transfer during which such feedback signal has been generated while resulting in a change of the process of the operation of the system.
Upon reading the disclosure, a skilled artisan will readily appreciate that avoiding such very specific circumstances does not—and simply cannot address a much more general problem of embolism during the injection procedure. Clearly, adipose tissue reinjection is not limited to deep muscle tissue but includes reinjection into much more sensitive and critical areas (such as, for example, areas around the eyes) and very often does require the use of cannulae that are very small (or needle-like in terms of inner diameter).
Despite the significance of the problem, and multiple metrics used to ascertain the safety of the adipose tissue reinjection procedure, there appears to be no recognition that what is required is a tissue-reinjection system and method that enables a clinician to at least match and control optimal levels of pressure selected during the reinjection procedure and the ability to interrupt the procedure when such levels are exceeded. The present disclosure attests to the empirical findings that the active pressure control overcomes the practical shortcomings of the existing systems, facilitates the reduction and elimination of the fat embolism during the adipose tissue reinjection and, therefore, ensures not only the safety of the patient but also the viability of the reinjected tissue.
The present invention provides solutions to the problem of ensuring the safety of the target location (the biological tissue that receives the adipose tissue during the reinjection procedure) by including pressure and/or flow-rate control(s) in an operationally closed system such as to stop the reinjection procedure once the pressure level at the recipient site exceeds a predetermined threshold value.
The un-addressed critical problem of maintaining the adipose tissue and associated fluids viable during the handling (harvesting and reinjection) procedure is solved by configuring an automatic fluid-management system of the invention to simultaneously control the levels of tissue-reinjection pressure and tissue-flow rates while, at the same time, judiciously matching the dimensions of the opening(s) in the reinjection cannula with those of the harvesting cannula. Here, embodiments of the invention are configured to ensure that the internal pressure levels in the channel of delivery of the adipose tissue (reinjection channel) from the source to the recipient site do not exceed at any point the pressure at which the adipose tissue has been harvested. This includes the configurations that prevent the transfer system from being clogged with the adipose tissue (which clogging immediately increases the internal pressure).
According to an idea of the invention, while configuring the biological fluid transfer system to achieve these goals, the embodiment of the system according to the invention can be made operationally-closed in that, in a specific implementation, the reinjection of the extracted adipose tissue into the targeted bodily part occurs during the same, temporally-uninterrupted real time process cycle or step or procedure that includes the removing/extraction of the material from the source bodily part. The configuration of the system advantageously avoids the use of and is devoid of a valve in contraptions that are utilized to push/pull the tissue through the path dedicated for transfer of the tissue from the site of harvesting to the site of reinjection. The configuration of the system also takes care of utilizing the tubing and/or hollow channels that, in their normal unchanged state, is characterized by a substantially constant value of inner diameter to transfer the tissue (that is, the tubing that is devoid of changes in corresponding diameter value while it is initial, unaffected by the external influence state).
Furthermore, the system is configured to enable a reinjection of the tissue in a pulsed mode, when required, to address the need in spatially-uniform distribution of reinjected tissue across the target (reinjection) site, to provide the reinjected tissue with spatially-even supply of blood.
In one implementation, such external control unit includes a pressure sensor operably associated with the transfer channel(s) (tubing, for example) along which the harvested adipose tissue is being delivered to the injection site. The pressure sensor may be cooperated with the system at the system's pump or engine or, for example, as an in-line sensor (in a specific case—an external pressure sensor). To ensure that the adipose tissue is transferred in a completely sterile fashion, the pressure sensor may be configured to operate by way of clamping to the outside of the channel(s) tubing (that internally channels the adipose tissue) with a transducer (one version of which may employ a load cell), thereby completely eliminating the need to make any direct contacts with the fluid/adipose tissue being transferred through the channels/tubing. The control unit is configured to be in operable communication with the control mechanism that provides power to the pump used to push the adipose tissue into the injection site. An unacceptable rise in pressure in the tubing (which correlates to a rise in pressure in either (or both) the system itself and at the injection site) is advantageously employed to cause the reinjection pump to cease delivery of the adipose tissue, thereby effectively and unprecedently increasing patient safety.
For the purposes of this disclosure, and unless specifically defined otherwise, the term “positive displacement pump” refers to a pump with an expanding cavity on the suction side and a decreasing cavity on the discharge side. For example, during the use of a positive pressure pump, such as a peristaltic pump, liquid is caused to flow into the pump as the cavity on the suction side expands and to flow out of the discharge as the cavity collapses. The term “internal pressure” is used to refer to a measure of force exerted on the interior structure of a closed system. For example, the internal pressure of a flexible tube is the force exerted on the inside walls of the tube by the fluid or gas that is contained within the tube.
Examples of a Transfer System
A harvesting and reinjection procedure of viable soft tissue typically includes several different steps such as: infiltration of tumescent fluid; aspiration of viable soft tissue using liposuction; processing aspirated tissue to remove debris, oil, blood, infranate, and saline; and reinjection of viable tissue using a reinjection cannula.
For better understanding of the transfer system 100, a digression may be in order to outline some features of the cannulae of the system. To this end, features of atypical cannulae used on the aspiration (harvesting) side and the reinjection side of the system of the invention are discussed in reference to
Embodiments of Cannulae
Unless expressly defined otherwise, the terms “cannula”, “cannulae” and similar terms are used in this disclosure to refer to a narrow tubular element (whether substantially rigid or flexible) configured for insertion into a tissue to deliver to the tissue or remove from the tissue a predetermined material. In one example, the cannula is configured as a metallic tubular element insertable into the biological tissue for removal (“harvesting”) or delivery (“injection”/“reinjection”) of adipose tissue. (The latter is known to be a type of connective tissue containing tissue resembling fat, and adipose cells, which are specialized to produce and store large fat globules.) A schematic diagram of a unit 800 containing a cannula 802, fluidly connected to a distal end 804A of a handle or handle grip 804 and further to the typically flexible tubing 806 (for example, silicone or rubber tubing) is shown in
During the harvesting procedure, for example, the harvesting cannula 802 is moved within the target tissue as vacuum pressure, which is transferred to the cannula 802 through the tubing 806 and the handle 804 and creates a force that, by a pressure differential, attracts a substance (such as adipose tissue) from the tissue to the region of lower pressure, via suction at openings (not shown) formed in a body of the cannula 800 (such as, for example, in a side wall of the cannula 800).
According to the idea of the invention, and in reference to
An example of the units 1000, containing cannulae configured according to an embodiment of the invention, is shown in
It is appreciated that in an adipose tissue transfer system that includes the harvesting cannula and the (re)injection cannula, as well as the portions of the system connecting the one with the other, and that is configured to effectuate the real-time transfer of the just-harvested adipose tissue (to a location chosen for reinjection of such tissue), the openings in a side-wall and/or lumen of the harvesting cannula represent the most restrictive of all available fluid passages. Indeed, only those agglomerates of the adipose tissue are transferred down the stream of the transfer system towards the reinjection cannula that have passed through the inner lumen of the harvesting cannula. It has been empirically found that the appropriately size agglomerates are seamlessly transferred through the system and reinjected when the judiciously-chosen reinjection cannula is used.
Accordingly, one embodiment of the invention provides a kit or multiplicity or set of harvesting and reinjection cannulae (see
Specifically, and according to one embodiment of the invention, either of reinjection and harvesting cannulae are characterized by a blunt tip, closed end and one or more openings in a side wall of the cannula in a portion approaching the distal end of the cannula, through which openings the fluid communication is established, in operation of the cannula, between the inner lumen of the cannula and the medium surrounding the cannula. More specifically, however, an area of one or more opening in a side wall of the reinjection cannula is equal to or greater than 80% of an area of a side wall opening of a harvesting cannula. In a related embodiment, an area of one or more openings in a side wall of the harvesting cannula is between 10% and 100% percent of an area of a side wall opening of a reinjection cannula; preferably, between 80% and 95%; more preferably between 80% and 90%; and even more preferably between 80% and 85%.
Alternatively or in addition, a width of one or more side wall opening of a reinjection cannula is equal to or greater than 80% of a width of one or more of side wall openings of the harvesting cannula. Herein, the width of an opening is defined as the smallest dimension of the opening. In a related embodiment, a width of one or more side wall opening of a harvesting cannula is between 10% and 100% of a width of one or more of side wall openings of the reinjection cannula; preferably, between 80% and 95%; more preferably between 80% and 90%; and even more preferably between 80% and 85%.
Alternatively or in addition, an inner cross-sectional area of an inner lumen of a reinjection cannula is 30% or more of an area of a side wall opening of the harvesting cannula. In a related embodiment, a cross-sectional area of an inner lumen of a reinjection cannula is between 30% and 200% of an area of a side wall opening of the harvesting cannula; preferably, between 80% and 200%; more preferably between 120% and 200%; even more preferably between 150% and 200%; and most preferably between 180% and 200% of an area of a side-wall opening of the harvesting cannula.
It was empirically determined that the relationship(s) among these three features (the size of the inner lumen of a cannula, cannula, the area of the side-wall opening of a cannula, and the width of the opening of a cannula) influence the success of harvesting of agglomerates of the adipose tissue from the harvesting site and passing the harvested fatty agglomerates through the reinjection cannula into the reinjection site without clogging, while at the same time maintaining adipose tissue viability and procedural efficiency, and regardless of orientation of the fatty agglomerates. The multiplicity of the side-wall openings in either of the harvesting or reinjection cannulae ensures that the adipose tissue transfer process continues regardless of whether a particular opening on either cannula is clogged or not, while the appropriate choice of the dimensions of openings of the harvesting cannula ensures that the agglomerates of the adipose tissue not fitted to pass through the inner lumen of the harvesting cannula are not harvested to begin with. This “multiplication” of the openings is schematically illustrated in
Referring again to
The fat harvesting container 106 is fluidly connected to both the outlet 126 of the combination of the aspiration cannula and the handle, and the source of vacuum 104 by a section of flexible tubing 118, such that the adipose tissue sucked out from the first region of the target tissue 116 is deposited and/or stored in the harvesting container 106. The container 106 may include a suitable biocompatible and sterile storage volume or collection container configured to accept and/or store the bodily fluid. Similarly, the flexible tubing 118 may comprise any suitable hollow delivery channel with first and second ends, where the ends can be fluidly connected (i.e., connected in a fluid-tight configuration) with the storage volume (e.g., the fat harvesting container 106) and the aspiration cannula 102.
During the aspiration (harvesting) step of the adipose tissue transfer procedure, vacuum in the range from about 10 inHg to a negative one atmosphere of pressure (of vacuum of 29.9 inHg) is typically used, with 18 inHg of negative pressure mentioned in some related art publications to be a recommended maximum level of vacuum to assure cell viability. A skilled artisan will readily recognize that the negative pressure applied to the adipose tissue being aspirated should only reach such workable levels that are necessary to achieve fat removal from the harvested site—and no more. These levels, however, should not be “set in stone” and/or defined a priori (such as provided by the system discussed in U.S. Pat. No. 8,968,272, for example), as such levels vary from patient to patient and are often different from the arbitrarily chosen level (be it 18 inHg or a particular different fraction of one atmosphere). The levels of pressure applied to AT during the reinjection portions of the procedure should not be defined a priori for the same reason.
Moreover, it has been empirically found that even while levels of negative pressure required to harvest adipose tissue—as well as levels of positive pressure appropriate for reinjection of the AT—vary from patient to patient, such levels also vary from location to location in the target tissue (for example, in the body of the same patient). This finding unequivocally indicates to the skilled artisan that a clinician, performing the adipose tissue transfer, generally cannot rely on the unsubstantiated prescriptions of which level of vacuum (or positive pressure, in case of re-injection) is or is not appropriate for the procedure and should select such level(s) from a wide range of pressures that would be required to achieve optimal results. What is important to ensure the adipose tissue viability, however, is that the modulus of the value of pressure imposed onto the already harvested tissue does not exceed the pressure level at which such tissue was harvested to begin with. The system of the invention is judiciously dimensioned to ensure such result. At the same time, an embodiment of the invention is devoid of any additional fluid channels joining (merging, incorporated with) the reinjection portion of the AT delivery channel between the contained 106 and the output end of the cannula 110 with the purpose of pressuring the AT between these two points (contrary to what the system of US 2006/0224144 employed), thus ensuring that there is only one, single delivery channels in a reinjection portion of the system.
During the aspiration step of the procedure, a scale 112 and a vibrating table 114 can also be used. By placing the tissue harvesting container 106 on the scale 112, the amount of adipose tissue removed from the first region of a subject's body 116 can easily be tracked. Due to the nature of the adipose tissue, it naturally separates from the other material that is aspirated (e.g., debris, oil, blood, infranate) and is more or less separated, spatially from other material contents of the harvesting container 106. Vibrating or shaking the fat harvesting container 106 with, for example, a vibrating table 114, can be used to speed the process of separating the adipose tissue from debris, oil, blood, infranate, and saline.
Once the adipose tissue is separated, the auxiliary fluids (blood, and infranate) can be bled off from the bottom of the harvesting container 106, through the use of a connected dual output port 202, shown in
Embodiments of the cannulae kit (aspiration and reinjection cannulae) for use with the transfer system are discussed above. The inventors are unaware of related art evidencing that the above-identified dimensional features of the cannulae for use with the AT transfer system described in this application (employed one at a time or in combination with one another) not only improve the efficiency of reinjection of AT that has (or is being) harvested at any appropriate vacuum pressure up to negative 1 atmosphere, but also ensure the uninterrupted transfer process free of clogging the system while, at the same, allowing the system to control the internal pressure in the delivery channel in real time and modify the transfer process once the pre-determined level of pressure has been crossed. In that, the implementation of such dimensional features was shown to achieve a result unexpected by related art.
The related art mentions a control of the flow rates and pressures during the aspiration (harvesting) step. However, during the aspiration of the tissue from the site 116 the vacuum level cannot be reduced below negative 1 atmosphere level, so regardless of how fast the flow rate is from the site 116 to the container 106, this pressure level cannot be exceeded. In contradistinction to this, during the reinjection step the pumping action is used to move the adipose tissue from the container 106 to the site 120, and extreme pressures in excess of 1 atmosphere (modulus value) can easily be reached in practice. The related art does not seem to appreciate that this difference between the pressure levels during the aspiration and reinjection steps of the procedure may and, in fact does, present complications for maintaining the viability of the reinjected adipose tissue and, in some cases, for the safety of the recipient tissue at the reinjection site.
In the case of a clog of the system, even greater—usually excessive—positive pressure is applied by the systems of related art to clear the clog. A clog occurs when oversized agglomerates occlude the pathway for adipose tissue. Clogs can be hard to locate, and both time consuming and labor intensive to clear, so current solutions includes increasing the internal pressure in the adipose-tissue transfer channel to force the occlusion to clear. Such positive pressures can reach 40 psi (about 80 inHg) or more in syringe-based systems, which is understandably substantially higher than the pressure levels used during the aspiration step of the overall procedure. When excessive pressures do not alleviate the clog in the system, a metal rod (referred to as a stylet) is often inserted into the inner lumen to dislodge the clog, which can cause damage to the adipose tissue. Therefore, judicious control of both flow rates and pressures when reinjecting adipose tissue is required. The reinjection pump 108, utilized in the system 100 according to the idea of the current invention, is configured to maximize the flow rate of the adipose tissue, while at the same time controlling and adjusting the positive pressure levels in the tubing 118, the reinjection cannula 110, and the injection site 120 in real-time.
The End Portion of the Transfer System
In further reference to
Referring now to
The peristaltic pump head 304 is connected to or even mounted to a DC motor contained in the housing 302. The DC motor is configured to rotate in both forwards (for example, clockwise) and backward (for example, counter-clockwise) directions. The external pressure sensor 306 comprises a base 310 and a hinged top 312. The external pressure sensor 306 is configured to monitor the internal pressure in the inner lumen 314 of the flexible tubing 118, as shown in the blown-up portion of
The operational advantage provided by the above-described sensor is that it is external with respect to the channel 118, and thus does not require any direct contact with the contents of the transferred fluid (the adipose tissue) located inside the flexible tubing 118. This facilitates maintaining sterility and the entire external pressure sensor 306 is reusable. Reusability increases the accuracy and ease of use by eliminating installment/reinstallment steps as well as repeated calibration steps, which are conventionally taken in operation of the system(s) of related art.
In further reference to
The embodiment, as described, is configured to maintain a constant, smooth, spatially continuous lumen or channel throughout the entire transfer system 100. After the adipose tissue leaves the harvesting container 106, the reinjection portion of the system transfers the adipose tissue along the flexible tubing 118 until it reaches the reinjection cannula 110. By configuring the system to avoid and/or to remove choke points and small orifices to squeeze through (such as leer lock fittings and one way valves, conventionally used in the systems of related art), the adipose tissue is aided in gently flowing along the path defined by the flexible tubing 118. The pump used to cause the adipose tissue to move through the flexible tubing 118, only contacts an outer surface of the flexible tubing 118, thus eliminating the need to sterilize a component of the pump. The system contains only one, single, unique biocompatible component that has an active role in contacting the adipose tissue while it is transferred from the harvesting container 106 to the reinjection cannula 110, and this is the flexible tubing 118. This flexible tubing 118 comes in disposable, pre-sterilized packs to allow a sterile environment for the adipose tissue.
Controlling Parameters of the Transfer Process
The controllable settings of the reinjection pump 108 allow a user to maximize the flow rate of the adipose tissue, while at the same time controlling the positive pressure levels in the tubing 118, the reinjection cannula 110, and the injection site 120 The setting for revolutions per minute (RPMs) is referred hereafter as the speed of the motor and relates to the revolutions per minute of the rollers (shown as 402A, 402B, 402C in
The pressure limit expressly set by the user for the reinjection pump is preferably the maximum internal pressure desired inside the flexible tubing 118. If the external pressure sensor 306 detects a pressure that exceeds this pressure limit, the programmable processor is programmed to stop the motor and to reverse the pumping direction until the internal pressure is reduced to near zero. The zero pressure value is defined as the internal pressure that exists in the flexible tubing 118 when the pressure sensor 306 is zeroed before the harvesting/reinjection procedure is started. In one embodiment, the user must release and press a switch to resume normal forward pumping. The observation of the pressure limit with the use of the external pressure sensor 306 automatically limits the pressure in the tubing 118, and allows the clinician to focus on more important matters, such as placement of reinjected tissue.
Another operational feature that is controlled by the programmable processor of the system includes configuring the mode of reinjection of the adipose tissue into the target reinjection site 120.
On the one hand, configured as described above, the system is structured to react to the pressure formed by the being-reinjected adipose tissue at the recipient (reinjection) site. Indeed, due to the limited compressibility of the adipose tissue, when and if the pressure at the distal end of the adipose-tissue-transfer channel (for example, in the vicinity of the side-wall opening of the reinjection cannula) exceeds the specified threshold established for the reinjection site, the pressure sensor kicks in and causes the system to modify the reinjection procedure. As was already alluded to above, different reinjection sites (that is, different portions of the recipient body) may and do required different pressure limits to ensure the reinjection site safety. The tolerance of the reinjection site to the pressure caused on the site by the being-reinjected adipose tissue is clearly very different for an extremely sensitive facial areas (such as those around the eyes, for example) and the buttocks tissue, and piercing of the former is likely to occur at a much lower pressure level than that of the latter.
To this end, the plots of
It may be beneficial to establish an empirical guideline based on which pressure limits should be established, as a function of a nature of a recipient site or of another parameter of interest during the reinjection procedure. To achieve this goal, it may be preferred to carry out the calibration procedure while measuring the pressure caused by the flow of the adipose tissue at end of the transfer channel that is close to the recipient tissue (as a non-limiting example, in the vicinity of the side-wall opening of the reinjection cannula).
On the other hand, in advantageous addition to a generally allowed continuous-flow mode of deposition of the adipose tissue to the reinjection site, in a specific case the system of the invention is configured to not only operate in a pulsed mode (that is, in a fashion when the continuity of the flow towards the reinjection site is interrupted according to a predetermined schedule) but also to allow, in such pulsed operation, to set a pulse frequency—for example, a number of pulses per minute—and/or a pulse duty cycle to form a desired pattern of the flow of the reinjected adipose tissue to the reinjection site 120. The desirability of such operation is suggested by the empirical results that indicated a more efficient blood-flow supply that the biological tissue at the reinjection site establishes to the so-deposited fat globules. The pulsed mode of reinjection is shaped and controlled with the programmable processor by maintaining the forward rotation of the peristaltic pump head 304 for a short period of time, followed by stopping the pump, and then repeating these two steps. When set correctly, the pulses propagate through the fluid in the flexible tubing 118, with the effect that the fluid exits the proximal (to the site 120) end of the reinjection cannula 110 in small boluses, or droplets, in a fashion that is maintained throughout the duration of the pulsed reinjection process. Setting the system 100 to operate in such a mode facilitates, but does not require, the elimination of the back-and-forth motion of the clinician's hand (with the use of which during a conventionally-carried-out reinjection procedure the desired reinjection results are achieved) by automatically placing a segmented array of boluses during a straight, non-reciprocal movement of the tip of the reinjection cannula 110. Controlling the bolus size is an important factor in maintaining adipose tissue viability by spacing out the agglomerates and maximizing vascularization. Accordingly to an embodiment of the invention, therefore, a method for reinjection of the adipose tissue is devoid of a reciprocating movement of the tip of the reinjection cannula.
It is recognized that the amount or degree of operation of the pump (in case of the peristaltic pump—the amount of rotation) during each single pulse affects the size of each droplet. Referring again to
References throughout this specification to “one embodiment,” “an embodiment,” “a related embodiment,” or similar language mean that a particular feature, structure, or characteristic described in connection with the referred to “embodiment” is included in at least one embodiment of the present invention. Thus, appearances of the phrases “in one embodiment,” “in an embodiment,” and similar language throughout this specification may, but do not necessarily, all refer to the same embodiment. It is to be understood that no portion of disclosure, taken on its own and in possible connection with a figure, is intended to provide a complete description of all features of the invention. In this disclosure, embodiments have been described in a way that enables a clear and concise specification to be written, but it is intended and will be appreciated that elements/components of related embodiments may be variously combined or separated without parting from the scope of the invention. In particular, it will be appreciated that all features described herein are applicable to all aspects of the invention.
In addition, it is to be understood that no single drawing is intended to support a complete description of all features of the invention. In other words, a given drawing is generally descriptive of only some, and generally not all, features of the invention. A given drawing and an associated portion of the disclosure containing a description referencing such drawing do not, generally, contain all elements of a particular view or all features that can be presented is this view, for purposes of simplifying the given drawing and discussion, and to direct the discussion to particular elements that are featured in this drawing. A skilled artisan will recognize that the invention may possibly be practiced without one or more of the specific features, elements, components, structures, details, or characteristics, or with the use of other methods, components, materials, and so forth. Therefore, although a particular detail of an embodiment of the invention may not be necessarily shown in each and every drawing describing such embodiment, the presence of this detail in the drawing may be implied unless the context of the description requires otherwise. In other instances, well known structures, details, materials, or operations may be not shown in a given drawing or described in detail to avoid obscuring aspects of an embodiment of the invention that are being discussed. Furthermore, the described single features, structures, or characteristics of the invention may be combined in any suitable manner in one or more further embodiments.
For the purposes of this disclosure and the appended claims, the use of the terms “substantially”, “approximately”, “about” and similar terms in reference to a descriptor of a value, element, property or characteristic at hand is intended to emphasize that the value, element, property, or characteristic referred to, while not necessarily being exactly as stated, would nevertheless be considered, for practical purposes, as stated by a person of skill in the art. These terms, as applied to a specified characteristic or quality descriptor means “mostly”, “mainly”, “considerably”, “by and large”, “essentially”, “to great or significant extent”, “largely but not necessarily wholly the same” such as to reasonably denote language of approximation and describe the specified characteristic or descriptor so that its scope would be understood by a person of ordinary skill in the art. In one specific case, the terms “approximately”, “substantially”, and “about”, when used in reference to a numerical value, represent a range of plus or minus 20% with respect to the specified value, more preferably plus or minus 10%, even more preferably plus or minus 5%, most preferably plus or minus 2% with respect to the specified value. As a non-limiting example, two values being “substantially equal” to one another implies that the difference between the two values may be within the range of +/−20% of the value itself, preferably within the +/−10% range of the value itself, more preferably within the range of +/−5% of the value itself, and even more preferably within the range of +/−2% or less of the value itself.
The use of these terms in describing a chosen characteristic or concept neither implies nor provides any basis for indefiniteness and for adding a numerical limitation to the specified characteristic or descriptor. As understood by a skilled artisan, the practical deviation of the exact value or characteristic of such value, element, or property from that stated falls and may vary within a numerical range defined by an experimental measurement error that is typical when using a measurement method accepted in the art for such purposes.
Notably—whether explicitly illustrated in the drawings or not—an embodiment of the reinjection system of the invention includes electronic circuitry (for example, a computer processor) controlled by instructions stored in a memory, to perform specific data collection/processing and calculation steps as disclosed above. The memory may be random access memory (RAM), read-only memory (ROM), flash memory or any other memory, or combination thereof, suitable for storing control software or other instructions and data. Those skilled in the art should would readily appreciate that instructions or programs defining the operation of the present invention may be delivered to a processor in many forms, including, but not limited to, information permanently stored on non-writable storage media (e.g. read-only memory devices within a computer, such as ROM, or devices readable by a computer I/O attachment, such as CD-ROM or DVD disks), information alterably stored on writable storage media (e.g. floppy disks, removable flash memory and hard drives) or information conveyed to a computer through communication media, including wired or wireless computer networks. In addition, while the invention may be embodied in software, the functions necessary to implement a method of the invention may optionally or alternatively be embodied in part or in whole using firmware and/or hardware components, such as combinatorial logic, Application Specific Integrated Circuits (ASICs), Field-Programmable Gate Arrays (FPGAs) or other hardware or some combination of hardware, software and/or firmware components.
The invention as recited in claims appended to this disclosure is intended to be assessed in light of the disclosure as a whole, including features disclosed in prior art to which reference is made.
Various changes in the details, steps and components that have been described may be made by those skilled in the art within the principles and scope of the invention. Disclosed aspects, or portions of these aspects, may be combined in ways not listed above. Accordingly, the invention should not be viewed as being limited to the disclosed embodiment(s).
The present application a continuation-in-part from the U.S. patent application Ser. No. 15/160,818 filed on May 20, 2016, which in turn claims priority from the U.S. Provisional Patent Application No. 62/179,885 filed on May 22, 2015. The present patent application also is a continuation-in-part from the U.S. patent application Ser. No. 15/132,947 filed on Apr. 19, 2016, which in turn claims priority from the U.S. Provisional Patent Application No. 62/179,885 filed on May 22, 2015 and from the U.S. Provisional Patent Application No. 62/178,756 filed on Apr. 20, 2015. The present application is, further, a continuation-in-part from the U.S. patent application Ser. No. 14/742,496 filed on Jun. 17, 2015. The application Ser. No. 14/742,496 in turn claims priority from the U.S. Provisional Patent Applications Nos. 62/179,885 filed on May 22, 2015, 62/178,756 filed on Apr. 20, 2015, and 62/177,503 filed on Mar. 17 2015. The disclosure of each of the above-identified patent applications is incorporated by reference herein.
| Number | Name | Date | Kind |
|---|---|---|---|
| 5813842 | Tamari | Sep 1998 | A |
| 20090269315 | Fraser | Oct 2009 | A1 |
| 20100204765 | Hall | Aug 2010 | A1 |
| 20130035660 | Anand | Feb 2013 | A1 |
| 20140228755 | Darrah | Aug 2014 | A1 |
| 20160361476 | Huang | Dec 2016 | A1 |
| Number | Date | Country | |
|---|---|---|---|
| 20170348493 A1 | Dec 2017 | US |
| Number | Date | Country | |
|---|---|---|---|
| 62179885 | May 2015 | US | |
| 62178756 | Apr 2015 | US | |
| 62177503 | Mar 2015 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 15160818 | May 2016 | US |
| Child | 15647736 | US | |
| Parent | 15132947 | Apr 2016 | US |
| Child | 15160818 | US | |
| Parent | 14742496 | Jun 2015 | US |
| Child | 15132947 | US |
