tissue transfer and injection system

专利摘要:
TRANSFER SYSTEMS AND TISSUE INJECTION. Device and methods for tissue transfer are described where a cannula can be inserted into a subject's breast at one of several entry points. Insertion of the cannula into the breast can be performed using a guide system to distinguish between types of tissue. Once desirably positioned, the cannula can be removed from the breast while automatically (or manually) injecting the fat into various deposits of adipose tissue or fat so that the deposited fat remains within the tract formed by the removed cannula. Various tracts of deposited fat can be injected into the breast until the breast is desirably remodeled and / or enlarged.
公开号:BR112013020363B1
申请号:R112013020363-3
申请日:2012-02-10
公开日:2021-02-17
发明作者:Geoffrey C. Gurtner；Michael H. Rosenthal；Brian J. Domecus；Darin Gittings；Kinman HONG
申请人:Lifecell Corporation；
IPC主号:

专利说明:

[0001] This application claims priority benefit from US Provisional Patent Application Nos. 61 / 442,060 deposited on February 11, 2011; 61 / 489,811 deposited on May 25, 2011; and 61 / 510,967 deposited on July 22, 2011, each of which is incorporated herein by reference in its entirety. FIELD OF THE INVENTION
[0002] The present invention generally relates to medical devices and methods used to transfer tissue in a region of the body. More particularly, the present invention relates to the apparatus and methods for transferring fatty tissue in a region of the body, such as a breast, in a relatively controlled manner. BACKGROUND OF THE INVENTION
[0003] Lipomodeling is a procedure that is typically performed under general anesthesia. Adipose tissue or fat is usually harvested from a part of the body such as the abdomen, buttocks, thighs, etc., and purified to obtain adipocytes. The adipocytes or purified fat are then injected directly into a target region of a subject's body, for example, to treat the face or breasts for enlargement or to treat abnormalities. In the treatment of breasts, fat is typically injected, for example, a volume of 100-250 mL per breast, through 10-mL syringes directly to the breast and deposited by the various microtunnels to build or remodel the breast.
[0004] Examples of such procedures are described in Fat Injection to the Breast: Technique, Results, and Indications Based on 880 Procedures Over 10 Years, Delay, Emmanuel et al., Aesthetic Surgery Journal, vol. 29, no. 5, 360-376, Sept./Oct. 2009; Cell-Assisted Lipotransfer for Cosmetic Sinus Augmentation: Supportive Use of Adipose-Derived Stem / Stromal Cells, Yoshimura, Kotaro et al., Aesth. Plast. Surg., Vol. 32, 48-55, Sept. 2007; and Fat Grafting to the Breast Revisited: Safety and Efficacy, Coleman, Sydney et al., Plastic and Reconstructive Surgery, vol. 119, no. 3: 775-785, March 2007, each of these is incorporated herein by reference in its entirety.
[0005] During the injection of the adipocyte material, the doctor will typically inject small and discreet amounts into the patient's body using a reusable Byron-Coleman injection cannula. However, this technique is subject to variability in the physician's technique potentially resulting in inconsistent results and is also subject to improper placement of adipose tissue in undesirable regions within the breast.
[0006] The regions within the breast that are ideally avoided by the doctor, such as the muscles or ducts of the breast, can be difficult to perceive while the desirable locations for injecting fat (located between the pectoral muscles and sinus channels) are also difficult to detect. Previous attempts to precisely position the cannula for injection in the ideal locations within the sinuses have been made, but have encountered difficulties in use and adoption. Examples are described, for example, in A New Technique to Assist Epidural Needle Placement, Ting, Chien-Kun et al., Anesthesiology, vol. 112, no. 5: 1128-35, May 2010, which is incorporated herein by reference in its entirety.
[0007] There remains a need for the application of larger volumes implanted in the breast as well as improved instruments and methods to better allow the culture of fat, purification, and / or implantation of fat. In addition, there remains a need for instruments having improved guidance for placing precision viable adipocyte grafts in the sinus with respect to the surrounding sinus tissue. SUMMARY OF THE INVENTION
[0008] A cannula can be inserted into a subject's breast at one of several entry points. After insertion of the cannula into the breast, the cannula can be removed from the breast while injecting the fat into various deposits of adipose tissue or fat so that the deposited fat remains within the tract formed by the removed cannula. Various tracts of the deposited fat can be injected into the breast until the breast is desirably remodeled and / or enlarged.
[0009] In order to correctly position the cannula within the breast for fat injection, an instrument assembly that uses diffuse reflectance can be incorporated and can generally comprise a cannula optically coupled to a light source, for example, laser, etc. through an optical transmission fiber that is positioned through or adjacent to the cannula. A distal end of the transmitting fiber can emit light from the distal end of the cannula so that any light reflected by the tissue in the vicinity of the distal end can be detected by the distal end of a receiving optical fiber. The receiving fiber can be optically coupled to a photo detector which can, in turn, be electrically coupled to a processor and a screen for use by the physician.
[0010] By transmitting a light (such as laser light having a wavelength between 600 to 1550 µm) through the transmission fiber in the fabric, the reflected light by backscattering can be detected by the photo detector in a detection range that corresponds to the emission transmitted laser. Having the processor differentiated between the different light scattering properties of the tissue, the doctor can determine whether the cannula is located inside or away from a particular anatomical structure to inject or stop the injection of adipose tissue.
[0011] With the detection of the types of tissue that uses diffuse reflectance, the assembly can be programmed by the processor to automatically inject and / or stop the injection of cannula fat into the breast depending on the type of tissue detected. Using a closed circuit system, as the cannula is placed or removed from the breast, the different types of tissue can be automatically detected by the processor. When the presence of fat is detected, the cannula can automatically inject the cannula fat at a controlled volume and injection rate.
[0012] In addition to tissue identification, a cannula assembly can also be used for culture of fat as well as injection into the body. An optionally detachable culture cannula can be inserted into a region of the body containing fat to be harvested. The fat can be aspirated or, otherwise, extracted in the culture cannula and collected in a culture reservoir assembly having one or more individual cartridges. The collected fat can be processed individually or collectively and this processed fat can be fluidly coupled directly to the lever with another detachable injection cannula.
[0013] In addition to the detection of tissue types to facilitate the precise injection of fat, several instruments can be used inside or in conjunction with the cannula to administer precise volumes of fat in a controlled manner. An example is a screw-type injection mechanism having a fluted shaft. The screw mechanism can be rotatably positioned inside the cannula and can have a distal opening to inject the fat delivered through the cannula. As the screw mechanism rotates, any fat contained within a connected reservoir or within the cannula itself can be exerted through the distal opening. Starting or stopping the fat injection can be precisely controlled by starting or stopping the rotation of the mechanism. An optional retractable cap located at the distal end of the cannula can also be used.
[0014] An inlet port can be positioned along the lever in close proximity to the end close to the screw mechanism so that the injection grease introduced into the lever can be lifted by the mechanism. The entry door can open on a camera that is in fluid communication with the cannula and the screw mechanism to reduce any blockage or obstruction that may occur due to fat. Additionally and / or optionally, the bristle stop members can be incorporated into the lumen of the cannula to further reduce or inhibit any blockage of fat during injection to the patient.
[0015] In yet another variation, the injection assembly can optionally incorporate an impeller-stator assembly within the lever housing to help accelerate the fat to a speed sufficient for injection as well as to uniformly dispense the fat through the cannula for uniform breast injection. . In use, as the impeller rotates through a drive shaft, the fat contained within the housing or reservoir can be propelled distally through the assembly after the stator blades that remain static. As the fat is stimulated through the assembly, the flow can be uniform, as it is stimulated through the cannula for injection into the breast tissue.
[0016] Another variation may include a fat introduction chamber having a first diameter D1 from which the cannula extends having a second diameter D2 where the diameter of D1 is approximately twice the diameter of D2. In this variation, the camera can optionally incorporate a plunger to pressurize the fat for injection through the cannula while the mechanism rotates to eject the fat.
[0017] In yet another variation, a plunger can be positioned inside the housing to extend into a part close to the cannula. With the cannula filled with an amount of fat, the cannula can be placed percutaneously to the breast while it is under guidance. Since a suitable location has been located within the sinus, the housing and plunger can both be kept in a static position with respect to the sinus while the cannula can be retracted into the housing through the opening in the housing with respect to the sinus in the near future. Because the plunger remains static with respect to the cannula, the fat contained within the lumen of the cannula can be forced out through the distal opening so that the ejected fat is deposited by the tract previously formed by the cannula within the tissue.
[0018] Other mechanisms may incorporate a pressure-driven system in which a piston is slidable through the housing by introducing a gas or fluid into a near or distal inlet to stimulate the piston closely within the housing thereby retracting the cannula or distally outside the housing.
[0019] Instead of using a pressure driven assembly, another variation injection assembly can use a linear threaded member that is rotatably coupled to a motor positioned inside a housing. Here, the motor can rotate the threaded member in any direction to stimulate a transport that is threaded correspondingly to move distally or closely by the threaded member depending on the direction of rotation by the threaded member. The transport can be fixed at an end close to the cannula so that the transport travels along the threaded member the cannula can be retracted or extended as desired. BRIEF DESCRIPTION OF THE DRAWINGS
[0020] Figure 1A shows a cross-sectional side view of a cannula inserted into a subject's breast and depositing adipose tissue. Figure 1B shows an anterior view of a representative sinus and possible percutaneous entry points and passages for depositing adipose tissue. Figures 1C and 1D show examples of how the cannula can be inserted through a single entry point under a breast to reshape the breast with deposited fat. Figure 1E shows a cross-sectional side view of a breast with areas of breast tissue that are typically avoided when depositing adipose tissue. Figures 1F to 1H illustrate transverse areas of a sinus where an injection cannula was placed at different angles and in different locations for deposition of potential fat. Figure 2A shows a representative assembly in a variation of an implantation instrument that can be guided inside the body by diffuse reflectance. Figure 2B shows another variation of a guide assembly having a fiber optic probe. Figure 2C shows an example of an optoelectronic module that can be integrated with the guide assembly. Figure 2D shows a perspective view of an example of an injection cannula having light transmission and light receiving fibers within the distal end for characterization of the tissue. Figure 2E shows a cross-sectional side view of another example of the cannula having the injection lumen that passes with one or more optical fibers positioned through the cannula. Figures 2F to 2I show final views of the exemplary embodiments for positioning the optical fibers for excitation as well as detection. Figures 2J to 2N show various configurations for the excitation source and detection assembly that can be used with the guide assembly. Figure 3A shows an example of the variance in signal strength when finding different types of tissue to facilitate the selective deposition of adipose tissue. Figure 3B shows a cross-sectional side view of an instrument that can be guided through the signal variance to selectively deposit adipose tissue. Figure 4A shows a perspective view of the assembly of a cannula assembly that can be used to harvest and collect fat from within a body. Figures 4B and 4C show the perspective and cross-sectional views of another variation of a cannula assembly used for culture and / or injection. Figure 4D shows side views of several culture cannulas. Figure 4E shows a view of the assembly of a culture vessel assembly having one or more individual vessels or cartridges. Figure 4F shows a perspective view of a variation of an instrument, having an internal screw-type mechanism to control the delivery of tissue to the body. Figure 5 shows a cross-sectional side view of another variation of an instrument having an internal screw-type mechanism coupled to a pressurizable reservoir. Figure 6 shows a cross-sectional side view of an instrument axis having a retractable distal tip. Figures 7A to 7C show perspective views of the instrument axis, lever, and tip, respectively, having a screw-type mechanism. Figures 8A to 8C show side views and detailed perspective views of an instrument having a screw-like mechanism. Figures 9A to 9C show detailed perspective views of an instrument axis that incorporates projections, such as bristles, within the cannula axis to function as a stop mechanism for the adipose material and to facilitate the linear movement of the material through the axis lumen. . Figure 10 shows a side view of a variation of an impeller and stator mechanism to facilitate the movement of adipose tissue within the instrument as well as to dispense the cannula material uniformly. Figure 11 shows a side view of another variation of an impeller and stator mechanism. Figures 12A to 12F show examples of various impeller configurations that can be used with the injection instrument. Figure 13 shows a representative example of another variation of an instrument having an introduction chamber for receiving adipose tissue for injection. Figure 14 shows a variation of a reservoir that can be used to introduce adipose material into an injection instrument. Figure 15 shows a detailed cross-sectional side view of an entrance port for receiving adipose material in the cannula for injection. Figure 16A shows a cross-sectional side view of another variation of an injection instrument having at least two sections with different diameters as well as a pressurization mechanism, such as a piston, to inhibit the blocking of adipose material during injection. Figure 16B shows a perspective view of a double-diameter injection instrument. Figure 16C shows a cross-sectional side view of another variation of a double-diameter injection instrument. Figures 17A and 17B show side views of another variation of an injection instrument having a retractable cannula. Figure 18A shows a cross-sectional side view of another variation of an injection instrument having a foldable inner liner within a cannula. Figures 18B and 18C show side views of a reconfigurable retraction mechanism within the cannula. Figure 19A shows a side view of another example of a needle cannula having a piston assembly. Figures 19B to 19D show side views of the needle cannula retracting with respect to a breast to deposit an adipose tissue tract within the breast. Figures 20A and 20B show side views of another variation of an injection instrument that can be driven by pressure. Figures 21A and 21B show side views of another variation where the injection instrument can be driven by a lead screw mechanism. Figure 22 shows another variation of an injection instrument using a pressurized mechanism. Figures 23A to 23C show side views and perspectives of another variation using a lead screw mechanism with a retractable needle cannula. Figures 24A and 24B show perspective views of the instrument having a retractable needle cannula. Figures 25A and 25B show detailed side views of the retractable needle cannula mechanism. Figures 26A to 26C show perspective views of another variation where the retractable needle can be reloaded once retracted. Figure 27 shows a cross-sectional side view of an in-line filtration system that can be integrated with an injection instrument. Figures 28A to 28C show perspective views of the instrument of alternative variations of injections configured to have several interchangeable cannulas and / or cannulas. Figures 29A and 29B show perspective views of another variation having several cannulas where each successive cannula may have a length that is shorter to facilitate injection into a contoured region of the body, such as a breast. Figures 30A and 30B show perspective views of yet another variation where the fiber optic connection can be detachable from the system and reconnected in an axial arrangement. Figure 31 shows a schematic illustration of an example of a complete culture processing and injection system that is coupled together so that a relatively low and consistent pressure can be maintained throughout the process and system. Figure 32 shows a view of assembling a combined fat culture and assembling the injection using a single lever and controller. Figure 33 shows an assembly view of another example that illustrates how the lever with a detachable culture cannula can be used to harvest the fat for processing and then also used for injection into the patient's body with a detachable injection cannula. Figure 34 shows an assembly view of another example of how an individual cartridge having processed fat can be coupled directly to the lever for injection into the body. Figures 35A and 35B show perspective views of another variation of a lever assembly attached to an injection cannula and still having an angled receiving section for receiving an individual cartridge having processed fat for injection. Figures 36A and 36B show perspective views of another variation of the lever assembly that illustrates how the lever can be separated into at least two components. Figures 37A and 37B illustrate perspective views of another variation of a lever assembly that can also comprise a reusable component as well as a disposable component having an inclined section. Figure 38A schematically illustrates an example of how individual cartridges can be filled with the fat collected from the culture cannula. Figure 38B schematically illustrates an example of how individual cartridges can be cleaned of air or other material and incorporated into the injection assembly. Figure 39 shows a perspective view of a cartridge configuration attached to a base dock. Figure 40 shows a cross-sectional side view illustrating a configuration for a piston and valve assembly incorporated into a cartridge. Figures 41A and 41B show perspective and cross-sectional views of a variation of a plunger that defines one or more openings through it. Fig. 42 shows a side view of a cartridge having a plunger and valve assembly incorporated. Figures 43A and 43B show cross-sectional side views of a plunger and valve assembly illustrating an open and closed configuration. Figure 44 shows a partial cross-sectional side view of a plunger and valve assembly coupled to a port adapter. Figure 45 shows a perspective view of another variation of a plunger and valve assembly integrated with a key to maintain a plunger position. Figure 46 shows a perspective view of an example of a port adapter. Figures 47A and 47B show respective side and schematic views of an example of a reversible pump assembly that can be integrated into any of the lever variations described here. Figure 48 shows a side view of another variation of the reversible pump assembly. Figure 49 shows a graph of the piston travel distance in relation to the current drawn by the engine. DETAILED DESCRIPTION OF THE INVENTION
[0021] As shown in the transverse side view and in the anterior view of figures 1A and 1B, a cannula 10 can be inserted into a subject's BR sinus at one of several entry points 14 in the vicinity of the BR nipple and circumference. After inserting the cannula 10 into the sinus, cannula 10 can be removed from the BR sinus while injecting the fat into various deposits of adipose tissue or fat 12 so that the deposited fat 12 remains within the tract 16 formed by the withdrawn cannula 10. Several Treatments 16 of the deposited fat 12 can be injected into the breast using the common entry points 14 until the breast is desirably remodeled and / or enlarged.
[0022] Figures 1C and 1D illustrate an example of how cannula 10 can be inserted into a single entry point 14 under the BR sinus and how fat 12 can be deposited by a tract defined by cannula 10. With cannula 10 positioned through the entry point 14 within the BR sinus, the cannula 10 can be repeatedly placed and removed by various treatments 16 through the common entry point 14 while depositing the fat to properly reshape the BR sinus.
[0023] However, the doctor may encounter difficulties that discern when and where fat can be deposited within the BR sinus. Figure 1E shows a cross-sectional side view of the BR sinus that illustrates areas of sinus tissue to be avoided 18, such as within the adjacent muscles or channels, and the target deposit area DA that is typically within the subcutaneous fat layer within the sinus. BR located between the pectoral muscles and the channels.
[0024] Figures 1F to 1H illustrate transverse areas of a BR sinus when cannula 10 has been placed at various angles and in different locations where fat may or may not be deposited. For example, figures 1F and 1G illustrate how the cannula was placed in the regions of tissue to be avoided 18, cannula 10 can detect the type of tissue (as discussed further here) and give an indication as to the convenience of the location for depositing the fat. Figure 1H illustrates an example of when cannula 10 can be placed in a desirable area within the BR sinus for fat deposition.
[0025] Thus, when correctly positioning the cannula within the breast for fat injection, an example of an instrument assembly 20 using diffuse reflectance is shown in the cross-sectional view of the assembly in figure 2A. As illustrated, assembly 20 can generally comprise a cannula 22 which can be optically coupled to a light source 24, e.g., laser, etc. through an optical transmission fiber 26 that is positioned through or adjacent to the cannula 22. A distal end of the transmission fiber 26 can emit light from the distal end 30 of the cannula so that any light reflected by the tissue in the vicinity of the distal end 30 can be detected by the distal end of a receiving optical fiber 28. The receiving fiber 28 can be optically coupled to a photo detector 32 which can in turn be electrically coupled to a processor 34 and a screen 36 for use by the physician.
[0026] By transmitting a light (such as laser light having a wavelength between 600 to 1550 µm) through the transmission fiber 26 in the fabric, the light reflected by backscattering can be detected by photo detector 32 in a detection range that corresponds that of the transmitted laser emission, for example, varying up to 50 mW or more. Other wavelengths suitable for laser light can vary, for example, between 630 to 1450 nm, as many biological tissues have a low absorption window that is far from the absorption of hemoglobin. In addition, such a strip can prevent water absorption in the NIR range. In addition, Rayleigh and Mie dispersion can allow diffuse reflectance of deep penetration and photodetails of backscatters. Another suitable range may include, for example, 920 ± 10 nm or 1210 ± 10 nm. The wavelengths of laser light in such a range can help differentiate against non-lipid containing tissues when combined with other wavelengths.
[0027] Various types of lasers can be used (for example, superluminescent emitting diode (SLED) lasers, etc.) at various wavelengths to highlight differences in tissue structures. The photo detector 32 can convert the input signal into an output voltage which is then transmitted to processor 34 which can be programmed to differentiate the physiological structures based on the light scattering properties and light reflectance intensity at various lengths of wave. Diffuse reflectance can optionally be used in combination with other detection modes such as ultrasound, optical coherence reflectometry, etc.
[0028] Figure 2B shows another variation of a guide assembly 21 that can have a cannula 22 (for culture or tissue injection) by which the injection lumen 29, in this example, can be defined and a fiber optic probe 23, as described above. The assembly 21 may also include a flow sensor 25 as well as an actuator assembly 27 integrated with the assembly 21. An optical cable 31 can couple the fiber optic probe 23 to an optoelectronic (OE) module 33 containing the excitation source, for example example, laser source, as well as detection electronics. A cable 35 can couple the OE module 33 with a screen 36.
[0029] An example of an OE module 33 is shown schematically in figure 2C which illustrates the optical cable 31 connected to an assembly of the optical system 39 comprising the excitation source, optical circuit, detector (s), source driver, etc. An electronics assembly 41 (eg, interface bus, digital signal processor, buffer / memory, A / D converter, DAQ module (digital acquisition), etc.) can communicate with the assembly of the optical system 39 and a source of 37 feed can also be included. The cable 35 can be electrically coupled to the electronics assembly 41 leading to the screen or another module. In addition, the flow sensor 25 can also be seen in electrical communication with the electronics assembly 41.
[0030] Figure 2D illustrates a perspective view of an example of a cannula, where the transmission fiber 26 can emit light 27 in the adjacent tissue region. The receiving optical fiber 28 is also shown within the distal end of the cannula 30 that receives reflected light 29 with information indicative of the type of tissue.
[0031] Figure 2E shows a cross-sectional side view of another example of the cannula 22 having the injection lumen that passes with one or more optical fibers positioned through the cannula 22. Figures 2F to 21 show final views of exemplary embodiments for positioning the optical fibers for excitation as well as detection. Figure 2F shows an example where the fiber of excitation source 43 can be positioned adjacent to the fluorescence emission detection fiber 45. A diffuse reflectance detection fiber 47 can be positioned in proximity to the fiber of excitation source 43 to detect the reflected diffused light 49 as well as any fluorescence 51 that can be excited from the illuminated tissue.
[0032] Figure 2G shows another variation where the excitation source fiber 43 and the fluorescence emission detection fiber 45 can be combined into a single optical fiber or fiber assembly. Figure 2H shows another variation where the excitation source fiber 43 and the fluorescence emission detection fiber 45 can be combined again, but the reflectance detection fiber 47 can be positioned adjacent to the combined fiber or fiber assembly. Figure 21 shows a similar variation, where the excitation source fiber 43, fluorescence emission detection fiber 45, and reflectance detection fiber 47 can all be combined into a single fiber or fiber assembly.
[0033] Now returning to the assembly of the optical system 39, the excitation source and the detection assembly can be positioned in various configurations. Figure 2J shows a variation in the assembly of the optical system 39A where the excitation source can be combined into a single signal including λ-source (for example, from a first laser source LD1) and λex (for example, from a second source LD2 laser). The diffuse reflectance λRd as well as the emission of fluorescence λem can be received back to the assembly of the optical system 39 where the signal can be divided, for example, through dichroic mirrors, to detect the emission of fluorescence λem by a first DET1 detector and of diffuse reflectance λRd by a second DET2 detector for processing by mounting electronics 41.
[0034] Figure 2K shows another variation, where the emission of λem fluorescence can be filtered and detected, for example, by a DET1 line detector. Figure 2L shows another variation where the excitation source λ source, λex can be combined into a single signal and where the same fiber or fiber set can be used to detect the diffuse reflectance λRd that can be filtered for detection by DET1 while the emission fluorescence λem can be detected on a separate fiber or fiber bundle by the second DET2 detector. Figure 2M shows another variation, where the excitation source λ source, λex and diffuse reflectance λRd can be detected through a single fiber or set of fibers, as above, but where the emission of fluorescence λem can be detected in a similar way to the configuration shown in figure 2K above. Figure 2N shows another variation where the source of the excitation source λ source, λex and diffuse reflectance λRd and fluorescence emission λem can be combined into a single fiber or fiber set. The detected signal can be filtered for detection by DET1 and DET2 as shown.
[0035] The tissue guide assemblies described can be integrated into any culture and / or injection cannula described here to help distinguish between different types of tissue when tissue culture and / or tissue injection processed into the body.
[0036] Having the processor 34 differentiated between the different light scattering properties of the tissue, the physician can determine whether the cannula 20 is located within or away from a particular anatomical structure for injection or depriving the injection of adipose tissue. An example is illustrated in the graphical interface of figure 3A which shows the intensity of the reflectance 40 of the tissue found by the cannula 22. Such a graph 40 can be displayed to the doctor to provide a real-time indication of the position of the cannula during a procedure. In this example, as the cannula 22 approaches the skin surface, an initial noise floor 42 indicative of the presence of the cannula in the air can initially be shown, as shown in figure 3B.
[0037] As cannula 22 approaches and is inserted into skin 1, the intensity of the signal may increase indicating to the doctor that cannula 22 has entered skin 1. As cannula 22 is placed at the BR sinus, different layers of tissue can be detected and elaborated. For example, as cannula 22 enters adipose tissue or fat 2 within the breast, the signal strength may drop to a level between the initial signal 42 and the detected skin 1 signal. This detected level can indicate to the doctor that they are inside of a region of the BR sinus where fat can be injected. Other tissue structures such as ligament 3 or muscle 4 can be reflected and designed correctly where each different type of tissue can generate its own level of signal strength. In the event, cannula 22 detects tissue types other than fat 2, processor 34 can be programmed to signal any visual or auditory alarm indicating that cannula 22 may need to reposition itself. In the event that the signal falls to the noise floor 44, this may indicate that the cannula 22 has been placed or removed from the BR sinus.
[0038] With the detection of tissue types using diffuse reflectance, the assembly can be programmed by processor 34 to automatically inject and / or stop the injection of cannula fat 22 into the breast depending on the type of tissue detected. Using a closed circuit system, as cannula 22 is placed or removed from the breast, different types of tissue can be automatically detected by processor 34. When the presence of fat is detected, cannula 22 can automatically inject cannula fat 22 at a controlled volume and injection rate. In the event that the system detects a position of the cannula 22 in types of tissue other than fat, such as muscle, processor 34 can automatically stop injection to the breast until the presence of fat is detected again within the breast when processor 34 can automatically resume fat injection. Alternatively, instead of using an automated system, an alarm or indication can be indicated to the doctor who can manually inject and / or stop the injection of cannula fat into the breast.
[0039] In addition, with a cannula having a size ranging from 16-10 in size (or larger), a typical volume of fat ranging from, for example, 10-20 cc, can be performed. With such an injectable volume per cannula, the amount of fat injected during the entire procedure within, for example, a breast, can vary from, for example, 100-1000 cc per breast, or an average of, for example, 450 cc per breast. breast.
[0040] While cannula 22 can be passed through the body at various rates, for example, up to 10 cm / sec, withdrawal rates for cannula 22 can vary as well. For example, the cannula can be retracted at rates of, for example, 2 mm / sec to 5 cm / sec, and the cannulas can optionally incorporate a hydrophilic coating along its length to facilitate placement or removal through the tissue. In addition, the cannulae can optionally oscillate (automatically or manually) to facilitate fat injection.
[0041] Tissue type identification can be used not only for fat injection into the body, but can also be used to identify desirable regions of tissue for the culture of body fat to process before reinjection.
[0042] A variation is illustrated in the perspective view of the assembly of figure 4A showing the assembly of the cannula 31 which illustrates a lever 33 to provide culture of body fat as well as injection into the body. An optionally detachable culture cannula 35 is shown extending from lever 33 and defining one or more openings or fenestrations 37A to 37C through the cannula 35 near the distal end. Each of the openings 37A to 37C can be staggered or uniform with each other. In addition, although three openings are shown, this is merely exemplary and a greater or lesser number of openings can be defined by cannula 35. An internal rotating axis 39 can be positioned within the cannula with a number of cutting windows 41A to 41C that correspond in position and size with respect to the openings 37A to 37C through the cannula 35.
[0043] In use, the inner axis 39 can be rotated with respect to an immobile cannula 35 so that when the openings are aligned, the adjacent fat can be introduced into the openings and then cut or scraped into the cannula 35 as the inner axis 39 rotates and closes the openings in the fat in relation to the cannula 35. The cut or scraped fat can be extracted through the cannula 35 and the lever 33 and through a pipe 43 that is in fluid communication with a culture reservoir assembly 45 that can contain a or more reservoirs or individual cartridges 47. Individual cartridges 47 containing the collected fat and other tissue can be further processed and directly introduced into the patient's body, such as the breasts, to reshape the body.
[0044] Figures 4B and 4C show perspective views and partial side views of another variation of a cannula assembly 49 that can be used for culture and / or injection. Assembly 49 illustrates a culture cannula 35 with one or more openings 37 defined near the distal end of the cannula 35. Lever 33 in this variation further illustrates an opening 51 on the side of lever 33 into which a reservoir or cartridge 47 or tubing can be located. fluidly coupled to transfer and / or collect the aspirated fat for further processing or reinjection.
[0045] Figure 4D illustrates side views of various culture cannulas 35 that have a variable number of openings 53 for collecting fat. As shown, the number of openings 53 can be varied from a little, for example, three openings, to several openings 55, for example, six openings.
[0046] An example of the assembly of the culture vessel 45 is illustrated in the perspective view of figure 4E showing the assembly 45 fluidly coupled to a culture cannula. As described above, the reservoir assembly 45 may contain one or more individual reservoirs or cartridges 47 each fluidly coupled. The tubing 43 coupled to the culture cannula can extract from the collected fat 59 and other fluids or tissue 57 directly into one or more cartridges 47 thus increasing the viability of the collected fat by reducing exposure to air and mechanical trauma as well as reducing the amount of time spent outside the patient's body.
[0047] One or more cartridges 47 can be individually or collectively processed and the various fluids or fabric 57 can be removed from the cartridge 47, for example, through an opening 61 located along the cartridge 47. The resulting processed cartridge 47A can retain only the fabric desired fatty 59 for direct injection to the patient's body using the 47A cartridge directly with the injection assembly.
[0048] In addition to detecting tissue types to facilitate culture or precise fat injection, various instruments can be used inside or in conjunction with the cannula to deliver precise volumes of fat in a controlled manner. An example is shown in the perspective view of figure 4F which illustrates a screw-type injection mechanism 50, such as a screw mechanism 58 having a fluted shaft. The screw mechanism 58 can be rotatably positioned inside the cannula 52 which can also have a pointed drilling tip 54 and a distal opening 56 to inject the fat delivered through the cannula 52. As the screw mechanism 58 rotates, any fat contained within from a connected reservoir or within the cannula itself 52 can be ejected through the distal opening 56. Starting or stopping the fat injection can be precisely controlled by starting or stopping the rotation of the mechanism 58.
[0049] Another variation is illustrated in the cross-sectional side view of the injection instrument 60 shown in figure 5. In this variation, an outer part or cannula 62, for example, 20 gauges, which can vary from, for example, 6-12 inches in length, can be operably connected to a lever 68 and can also be in fluid communication with a reservoir 76 containing a volume of adipose tissue or fat 78. A fluted mechanism 64 can be rotatably positioned within a lumen defined through the cannula 62 and a piston 74 also can be incorporated into reservoir 76 to optionally pressurize fat 78 to facilitate injection through cannula 62. An air inlet port 70 and an air outlet port 72 can also be optionally included by lever 68 to control the air inside the device as piston 74 is activated.
[0050] Figure 6 shows a detailed cross-sectional side view of the cannula 62 of figure 5 with an optional retractable cap 82 located at the distal end 66 of the cannula 62. In use, since the cannula 62 has been placed and desirably positioned within the BR sinus for injection of fat using the transmission fiber 26 and the receiving fiber 28 described above, the piston 74 can be optionally driven and the fluted mechanism 64 can be driven to rotate so that the fat 78 is placed distally through the lumen 80 of the cannula 62. One or more members of the optional cover 82 (if present) can be retracted, as shown, to reveal the distal opening 84 of the lumen 80 allowing the injection of fat 78 into the breast tissue.
[0051] Another example of an injection assembly is shown in the perspective views of figures 7A to 7C. The cannula 62 is shown with the fluted mechanism 64 rotatingly positioned inside. The distal end 66 is shown having optionally retractable members 92 that form an atraumatic rounded tip when closed for placement through the fabric. However, when the fat is ejected from the cannula 62, the retractable members 92 can open to allow the fat to be injected. An entrance door 90 for introducing the adipose tissue to the lever 68 is also shown where the entrance door 90 can be located in close proximity at an end close to the fluted mechanism 64.
[0052] As shown in the side and perspective views of figures 8A to 8C, the inlet port 90 can be positioned by lever 68 in the vicinity of the close end of mechanism 64 so that the injection grease introduced in lever 68 can be raised by mechanism 64. Inlet port 90 can open on a camera that is in fluid communication with cannula 62 and mechanism 64 to reduce any blockage or obstruction that may occur due to fat.
[0053] To further reduce or inhibit any blockage of fat during injection to the patient, Figures 9A to 9C show side views and perspectives of one or more interrupt members of bristle 100 that can be positioned fixed along the cannum lumen 62. The limbs bristle interruption 100 can generally comprise bristles or projections 106 that are fixed by a fixing length 104 by the lumen and extend to the lumen and act as a fat reduction stop that reduces the radial path and can work to increase movement translational linear view of the fat through the cannula 62 without inhibiting the rotational movement of the mechanism 64 adjacent to the bristles 106. The bristles 106 can extend through the lumen in discrete segments, as shown in figure 9A, or as a continuous bristle member 102, as shown in figure 9B.
[0054] In another variation, the injection assembly can optionally incorporate an impeller-stator assembly 110, as shown in the partial cross-sectional view of figure 10, within the lever housing to help accelerate the fat at a speed sufficient for injection as well as for evenly dispense the fat through the cannula 62 for uniform injection to the breast. Generally, an impeller-stator assembly 110 may have an impeller 112 that has one or more blades that extend radially from a hub and is rotatable with respect to cannula 62. A stator 114 that remains static with respect to the assembly can be located distal to impeller 112 and may also have one or more blades of stator 116 that extend radially from its hub to facilitate uniform distribution of the fat passing through assembly 110.
[0055] In use, as shown in the example of figure 11, as the impeller 112 rotates through a drive shaft 120, the fat contained within the housing or reservoir can be propelled distally through the assembly after the stator 114 blades 116 that remain static. As the fat is stimulated through the assembly, the flow can be uniform as it is stimulated through the cannula 62 for injection into the breast tissue. Figures 12A to 12F show examples of various configurations of impeller 132, 134, 136, 138, 140 that can be used in the assembly of impeller-stator 110.
[0056] Figure 13 shows another variation of an injection assembly that incorporates a fat-introducing camera 150 into the lever housing. The introduction chamber 150 can be positioned close to the cannula 62 with an inlet port 152 that opens above an end close to the fluted mechanism 64 when the assembly is held upright. One or more introduction lumens 154 can open in the introduction chamber 150 to receive the fat from a reservoir 160, as shown in the side view of figure 14. The reservoir 160 can optionally be pressurized through, for example, a plunger 162, and fluidly coupled to the introduction chamber 150 through tube 158 which can optionally divide into one or more transfer lumens 156. As the mechanism 64 is driven by the drive shaft 120 (which can be automatically controlled by processor 34, as previously described), the fat can be stimulated from the pressurized reservoir 160 to transfer to the introduction chamber 150 and then in contact with the close end of the mechanism 64 through the inlet port 152, as shown in the detailed transverse side view of figure 15, for injection into the breast. subject.
[0057] Another variation is shown in the partial cross-sectional side view of figure 16A, which shows a fat introduction camera 170 having a first diameter D1 from which the cannula 62 extends having a second diameter D2 where the diameter of D1 is approximately twice the diameter D2. In this variation, camera 170 can optionally incorporate a plunger 172 to pressurize the fat for injection through the cannula 62 while the mechanism 64 rotates to eject the fat. Figure 16B shows a perspective view of the assembly and Figure 16C shows another variation in the partial cross-sectional side view that incorporates an optional port 174 to allow air to enter or exit during pressurization of the fat inside the chamber 170.
[0058] In another variation, figures 17 and 17B show partial cross-sectional views representative of an injection assembly 180 having a housing 182 with a retractable cannula 184 that can be removed partially or completely from housing 182 during fat injection. A plunger 186 can be positioned inside housing 182 to extend in a part close to cannula 184. With cannula 184 filled with a quantity of fat 78, cannula 184 can be placed percutaneously to the breast while under guidance (as previously described) . Since a suitable location has been located within the sinus, housing 182 and plunger 186 can both be held in a static position with respect to the sinus while cannula 184 can be retracted in housing 182 through opening 188 in housing 182 with respect to the sinus soon. Because the plunger 186 remains static with respect to the cannula 184, the fat 78 contained within the lumen of the cannula 192 can be forced out through the distal opening 190 so that the ejected fat 78 is deposited by the tract previously formed by the cannula 184 in. of the fabric.
[0059] Figure 18A shows another variation of the retractable cannula 184 having a drive shaft 200 positioned within the lumen of the cannula. The drive shaft 200 may have a support shaft 202 that extends through the cannula with one or more folding barbs 204 that extend radially from the axis 202. Grease pans 78 can be positioned between each of the barbs 204 which can help to compress the fat inside the cannula 184 and prevent any creation or introduction of air into the fat 78. Figures 18B and 18C show detailed side views of a variation of barbs 204 that can project at an acute angle to axis 202 so that the barbs 204 are angled to extend distally through the cannula 184. When the shaft 202 is retracted closely, each of the barbs 204 can rotate through a rotating fixture 206 to break against the shaft 202 to allow the injection of compacted fat 78 from the distal opening 190 to the breast tissue.
[0060] In another variation, Figure 19A shows a representative side of a retractable cannula 184 (for example, a 10-gauge needle cannula) having an internal piston shaft 210 that is translatable with respect to cannula 184. Piston shaft 210 can defining a lumen 212 in which a volume of fat 78 can be placed. An example of use is shown in the side views of figures 19B to 19D which illustrate how the needle cannula 184 can be retracted with respect to piston axis 210 before percutaneous insertion into the BR sinus, as shown in figure 19B. Before, during, or after cannula 184 is placed in the BR sinus and desirably positioned for injection (for example, using the devices and guide methods described here), cannula 184 can be extended with respect to axis 210 and a volume of fat 78 can be introduced to cannula 184 through lumen 212 of axis 210, as shown in figure 19C. Since the volume of fat 78 is ready for injection into the BR sinus, the cannula 184 can be retracted from the BR sinus while maintaining a position of the axis 210 with respect to the BR sinus so that a volume of fat 78 is injected into the BR sinus by tract formed by the removed cannula 184, as shown in figure 19D.
[0061] Figures 20A and 20B show side views of another variation of an injection assembly 220 comprising a pressure driven system. In this variation, the cannula 184 can be fixed in a fixation of the cannula 224 in a movable piston 226 that is slidable through the housing 182. A volume of fat can be introduced to the cannula 184 in its extended configuration that can be extended by the introduction of a gas or fluid to nearby inlet 222, as shown in figure 20B. Since cannula 184 has been desirably positioned within the BR sinus, cannula 184 can be retracted closely to housing 182 by introducing a gas or fluid to distal inlet 222 'to stimulate piston 226 closely within housing 182 thus retracting cannula 184, as shown in figure 20B.
[0062] Instead of using a pressure driven assembly, another variation of the injection assembly 230 shown in the side views of figures 21A and 21B may use a linear threaded member 232 that is rotatably coupled to a motor 234 positioned within a housing. Here, the motor 234 can rotate the threaded member 232 in any direction to stimulate a transport 236 which is threaded correspondingly to move distally or closely by the threaded member 232 depending on the direction of rotation by the threaded member 232. Transport 236 can be fixed at a close end of cannula 184 so that the conveyor 236 travels through threaded member 232, cannula 184 can be retracted, as shown in figure 21A, or extended, as shown in figure 21B, as desired. A reservoir 238 (which can be pressurized) can be fluidly coupled to an end near cannula 184 to provide a volume of fat for injection through cannula 184.
[0063] Figure 22 shows a partial cross-sectional side view of another variation of the injection assembly 240 that uses a pressurized cannula drive system. The lever housing 242 can comprise a pressurized line 244 that can be pressed into a nearby inlet 246 or into a distal inlet 246 'to drive a piston attached to the cannula 184. Depending on which inlet 246, 246' is pressurized, the cannula 184 it can be retracted or extended for placement into the breast and fat injection correctly.
[0064] In another variation, figures 23A to 23C show side views and perspectives of an injection assembly 250 variation using a rotating lead screw 232 to place or retract a conveyor 236 fixed at an end close to the cannula 184, similar to the variation described above in figures 21A and 21B. In this example, lever housing 252 can contain a power supply 254 for driving motor 234 to turn lead screw 232. Figures 24A and 24B show perspective views of assembly 250 and figures 25A and 25B show detailed side views of extension and retraction, respectively, of the transport 236 to extend and retract the cannula 184 within the housing 252 to inject the fat. The retractable cannula can be used in any number of various cannula embodiments as described here.
[0065] Figures 26A to 26C show perspective views of another variation of an injection assembly 260 which may comprise a housing of lever 262 to cannula 184 can be retracted using any of the mechanisms described herein. The housing 262 can incorporate a valve proximal to the opening 188 which can close since the cannula 184 has been retracted to the housing 262, as shown in figure 26B, to allow the cannula 184 to be refilled with fat. Since cannula 184 is ready to be retracted once more, the valve can be opened and cannula 184 extended. Any of the injector instrument's accomplishments described here, tissue detection assemblies can be incorporated as desired.
[0066] As previously mentioned, fat can be collected from a patient's first location (for example, periumbilical, lumbar, trochanteric, thigh, knee and arm, etc.) and this collected fat can be purified before injecting the patient again. When collecting the fat, the patient can be anesthetized and the liposuction procedure can be performed.
[0067] Extraction can be carried out using a suction cannula (for example, 3-4 mm Mercedes needle or 14 gauges connected to a syringe), suction can be carried out alternatively using a cannula, such as cannula 184, optionally having a configuration alternative tip depending on the desired culture configuration. Cannula 184 can be removed and / or replaced with another cannula for implantation, as previously described.
[0068] Additionally and / or alternatively, a cannula 184 that incorporates the tissue detection assembly described herein can be used to facilitate the culture and extraction of adipose tissue. In use, the cannula 184 can be placed on the patient's body and the detection system as previously described can be used to detect the presence of fat for extraction.
[0069] Since the fat has been collected, it can then be purified by extracting viable adipocytes from the liposuction material. Typically, the lipoaspirated material can undergo centrifugation to separate adipocytes from blood, serum, damaged cells, tumescent fluids, oil, etc. and the extracted fatty graft material can be transferred to standard syringes. Systems such as a VIAFILL ™ centrifuge (Lipose Corp., Maitland, FL) can be used to centrifuge and extract adipocytes. A syringe, such as a 20 cc short culture syringe, can be used to manually extract viable adipocytes where the plunger arm can be removed for centrifugation and the extracted fat can be transferred directly to any of the reservoirs described here, as reservoir 238 , for direct deployment using any of the devices described here.
[0070] In addition, an optionally disposable in-line filtration device such as LIPIVAGE ™ (Genesis Biosystems, Lewisville, TX) can be used to collect the fat. Such a device can be incorporated into the injection assembly to extract and purify the extracted material, for example, 20-25 cc of fat, automatically separating and washing the fat during the culture process using internal filters. An example is shown in the side view of figure 27 which illustrates an in-line filtration device 270 having an extraction reservoir 272 that one or more filters 274 integrated into the reservoir 272. The extracted material can be extracted into the patient's device and through the cannula. 184 where it can be separated and washed. The purified fat contained within reservoir 272 can then be removed from device 270 for implantation using the above devices and methods or it can simply be injected directly to the patient using filtering device 270 incorporated into the detection and injection assemblies described above.
[0071] Other examples of in-line filtration devices and methods that can be incorporated into the injection assemblies here are shown and described, for example, in U.S. Patents 4,753,634; 6,258,054; 7,588,732; 7,780, 649; and 7,794,449, each is incorporated herein by reference in its entirety.
[0072] Additionally and / or optionally, any injection assembly described here may use several injection needles or cannulas, for example, two or more, extending from a single housing to increase the volume and / or number of treatments per pass to increase the rate volume per injected surface. These various cannulas can be arranged in various configurations (for example, adjacent in a flat arrangement) and can use several cannulas as practiced. An example is illustrated in the perspective view of figure 28A showing the projection of two cannulas 184, 184 'of lever 252 adjacent to each other. Figure 28B shows another example of three cannulas 184, 184 ', 184 "projecting from lever 252. Additional cannulas can be incorporated as desired and practiced. In each example, the cannulas can be configured to be retractable within lever 252 and / or can incorporate a movable piston into each cannula as described here to facilitate the injection of fat into the body.
[0073] Another alternative variation is shown in the perspective view of figure 28C which illustrates an injection instrument having a cannula 184 which is interchangeable with a second cannula 184 '.
[0074] Figures 29A and 29B show perspective views of another variation having several cannulas where each successive cannula may have a length that is shorter to facilitate injection into a contoured region of the body like a breast. In this way, a single insertion and injection can be performed through the curved regions of the sinus without completely perforating. For example, figure 29A shows an assembly of the instrument having a first cannula 184 with a first length and an adjacent cannula 280 having a second length that is shorter than the first length. Fig. 29B shows another variation that incorporates a third cannula 282 that has a third length that is still shorter than the second length of the second cannula 280. Each length can be varied depending on the desired lengths and / or anatomy of the body part or breast to be injected. In addition, each of these variations may incorporate retractable cannulas and / or movable pistons within the cannulas as described above.
[0075] Figures 30A and 30B show perspective views of another variation where the culture assembly of the instrument can incorporate a reconfigurable optical fiber fixation. In this example, the optical fiber mount positionable through the instrument can have a connection that is attached to a cable assembly 300 in a first configuration, for example, extending on one side of the instrument. The cable assembly 300 can be detached from the instrument and re-coupled to an axial configuration 302. In this way, the optical fiber assembly within the instrument can be maintained as a modular system as long as the cable assembly 302 can reconnect to the optical fiber assembly inside the instrument.
[0076] In another variation, figure 31 shows a schematic illustration of a complete fat culture, processing, and injection system that is coupled together in a way that provides a relatively low and consistent pressure (for example, a maximum pressure of 700 mmHg) throughout the culture, processing, and injection procedure. As shown, fat 308 can be initially collected using the instrument 310 described here. The collected fat 308 can be extracted through a soft vacuum 312 and introduced into a pressurized processing reservoir 314. With the collected fat and processed inside the reservoir 314, a pressure 316 and a vacuum 318 can be simultaneously transmitted in the fat 308 contained within of the system so that the net force presented by the processed fat is low or almost zero. The low pressure transmitted in the fat helps to maintain the viability of the tissue.
[0077] With the fat extracted through the system, the processed fat can then be pressurized 320 for introduction 322 back to the selected region of the body. Certainly, the entire procedure for culture, processing, and injection can be contained within a common closed system that transmits a relatively low pressure to maintain tissue viability as well as providing a complete system that reduces or eliminates the various steps. In addition, the entire system still prevents the exposure of adipose tissue to ambient air and the environment to further reduce or minimize any additional trauma to the tissue. In addition, the system can measure pressure within the cannula, lever, or any other component during culture and / or injection, for example, through any of the processors or controllers described here, to ensure that any trauma to the tissue is reduced . In the event that the monitored pressure exceeds a predetermined level, the processor or controller can be programmed to reduce the pressure, stop the activity, or alert the user with a visual and / or audible indicator.
[0078] Other examples of a combined fat culture and injection assembly are shown in the assembly view of figure 32. In this variation, a single lever 33 can be used both with a culture cannula 35 having one or more openings 37 and with a cannula. fat injection 334 that can be detachable through interface 332 to lever 33. Lever 33 can be fluidly coupled through tube 43 to culture vessel 45 described above and the process can be controlled and / or monitored through a 336 processor which can control culture rates, pressures, flow rates, etc. as well as the injection parameters like tissue identification, injection rates, etc.
[0079] Additionally and / or alternatively, in this and other variations the detachable injection cannula 334 can be configured in a variety of ways. For example, the injection cannula 334 can be configured to have a plunger integrated within a lumen of the cannula 334 and a retractable cannula that can be translated in close proximity to lever 33 to deposit a known amount of fat in the body over a period of time. tract formed by the cannula itself. Examples of such a mechanism are described above, for example, in figures 23A to 23C.
[0080] Another example is shown in the assembly view of figure 33 which illustrates how the lever 33 with the culture cannula 35 can be used to collect one or more cartridges 47 of fat and tissue from the patient's body. This collected fat can be collected by assembling the reservoir 45 and controlled by the 336 processor. Once the fat has been desirably processed, the cartridge 47 can be fluidly connected to the same lever 33 or to a different lever and introduced to the patient's body using an injection cannula 334, as described above.
[0081] An example of a variation of lever 33 is illustrated in the assembly view of figure 34, which shows lever 33 with cartridge 47 coupled directly to the lever to introduce fat into the patient's body. Figures 35A and 35B show perspective views of another variation of a lever assembly 340 attached to an injection cannula 334 and still having an angled receiving section 342 for receiving an individual cartridge 47 having the processed fat for injection. The inclined section 342 can orient the cartridge 47 at an angle to the lever 340 to facilitate the manipulation of the lever 340 as well as to facilitate the insertion and removal of the cartridge 47 from the lever 340.
[0082] Figures 36A and 36B show perspective views of another variation of the lever assembly 340 which illustrate how the lever can be separated into at least two components. A reusable component 350 can contain the pumping mechanism, electronics, controller, etc. and it can be detachable coupled to a disposable part containing the inclined section 342 as well as the cartridge 47 and / or cannula 334.
[0083] Figures 37A and 37B illustrate perspective views of another variation of a lever assembly 360 which may also comprise a reusable component 362 as well as a disposable component 366 having an inclined section 364 that can retain cartridge 47 at a more acute angle with respect to lever 360.
[0084] Figure 38A schematically illustrates an example of how individual cartridges 47 can be filled with the fat collected from the culture cannula. As previously described, the culture assembly can use one or more individual cartridges 47 that are fluidly opened to receive the collected material, as shown. Each of the cartridges 47 can be detachable coupled to a base dock 370 and each cartridge 47 can incorporate a valve 374 with a plunger 372 that remains in an open position to receive the collected material introduced through the base dock 370.
[0085] Individual cartridges 47 can generally comprise conventional syringes arranged consecutively. The system can contain the base dock 370 with several ports that allow each of the connected 47 cartridges to be filled with grease. As individual cartridges fill, they can close their respective plunger 372 to close valve 374.
[0086] The fat can be transported to the cartridges 47 using a vacuum that is attached to the base dock 370. The doors can be placed in series allowing the filling of each consecutive syringe before moving to the next one. The configuration of the cartridges 47 can be placed in line or circularly, as long as it is in series, as shown in the perspective view of the assembly of figure 39. When the culture procedure is finished, the cartridges 47 can have their respective fat filling . The user can then remove the cartridge filler with grease 47 and clean the air, as shown in figure 38B.
[0087] Each cartridge 47 can integrate its own plunger 372 throughout the life of the device. Plunger 372 can allow for fat filling when cartridge 47 is engaged with base dock port adapter 370. Fat can flow through plunger 372 and around valve 374, as shown in the cross-sectional side view of figure 40. Another variation is shown in the cross-sectional and perspective views of figures 41A and 41B which illustrate a plunger 372 that defines one or more openings that can provide adequate space with a cross-sectional area between, for example, 0.15 to 0.20 in2 for the fat to flow , while maintaining integrity as a plunger.
[0088] Plunger 372 can also be used as a vacuum plunger when the device is placed on the injection device. As the injection device extracts the fat, the plunger 372 can move according to the vacuum rate, as shown in the side view of figure 42. The plunger 372 can incorporate 0-rings 380 that allow a dynamic seal, the ability to move while sealing against the corresponding surface. With the vacuum traction of the injection device operating at less than 20 inHg, the plunger can move with less than 2.0 LbF of traction.
[0089] Plunger 372 may further contain a piston valve 382 that is mechanically opened and automatically closed, as shown in the cross-sectional side views of figures 43A and 43B. The size of the sealing valve can be to allow fat to flow when opened during the culture procedure, but it also prevents air and liquid from leaking when closed during the injection procedure. The outside diameter of valve 382 can be greater than, for example, 0.626 inches, to provide a seal. The valve 382 can be smaller than, for example, 0.875 inches, to allow flow around it. The distance at which valve 382 is moved away from plunger 372 when opened is also to allow for easy filling of grease. A distance of at least 0.125 in, for example, from the gasket to the plunger 372 to allow the fat to flow. The valve 382 can also include a light gasket that can seal against the plunger of the opening 372.
[0090] Plunger 372 can be activated when cartridge 47 is attached to port adapter 384 which can be integrated with base dock 370 to attach to cartridges 47. The concept of the drawings incorporates the use of a spring that can close valve 382 in one state rest. When activated, the spring can compress, opening valve 372 to fill, as shown in the lateral cross-sectional view of figure 44. When released, the spring force can provide at least, for example, 2.0 LbF, to overcome the extraction of injection device. The force of the vacuum extraction to move the plunger 372 may be less than the force required to maintain an airtight seal on the valve or leakage may occur.
[0091] A wrench 390 can be incorporated into the design to hold plunger 372 in place while cartridge 47 is engaged with the adapter, as shown in the perspective view of figure 45. After filling, wrench 390 can be removed and unloaded to allow the plunger 372 move.
[0092] A perspective view of a port adapter 384 is shown in figure 46. The illustrated variation can incorporate flanges 392 to hold cartridge 47 against the base of port 370 due to counter spring forces, which can push cartridge 47 away from the adapter 384. A static 394 O-ring can be incorporated to provide a vacuum seal during fat filling. The bar can push the valve open when engaged.
[0093] An example of a reversible pump assembly 400 that can be integrated into any of the lever variations described here is shown in the side and schematic side views of figures 47A and 47B. The pump assembly 400 shown can be integrated into any of the lever assemblies for use with the detachable culture and / or injection cannula to provide continuous and uninterrupted removal of tissue from the body for culture or for uninterrupted infusion of tissue for injection , as described above. In both culture and injection, vacuum pressure or injection pressure can be generated directly inside the lever by mounting the pump 400 instead of relying on a separate pumping mechanism from the lever.
[0094] In addition, because of the assembly of the pump 400, aspirating and dispensing the tissue simultaneously with the pump 400 makes it possible to continuously administer the tissue with no waiting time and reduces the entire procedure time.
[0095] The assembly of the pump 400 is shown as generally comprising an assembly of the motor 404 coupled to the pump 402. A detachable reservoir 406, for example, cartridge 47, can be removably attached via connection 408 to pump 402. Pump 402 can also define an opening 410 into which tissue can be harvested from the body and pump 402 or injected from pump 402 and the body.
[0096] As illustrated in the detailed diagram of figure 47B, the motor assembly 404 can have a motor 412, for example, stepper motor, with an optional time delay or controller 414. Motor 412 can be rotatably fixed, for example, to a rotary lead screw 418, through a sealed motor coupling 416 where lead screw 418 is contained within a common camera. A plunger 420 translucently positioned on lead screw 418 can separate the common camera on a first camera 422A and second camera 422B that can be varied differently depending on the relative position of the plunger 420 with respect to engine 412. When the lead screw 418 is turned in a first direction, the plunger 420 can be forced to translate in a first direction inside the camera and when the lead screw 418 is rotated in a second opposite direction, the plunger 420 can correctly translate in a second direction inside the camera opposite the first direction.
[0097] In the case of tissue injection into the body, the detachable reservoir 406 having a volume of tissue collected for injection can be removable coupled to a fluid channel 424. Fluid channel 424 can be fluidly attached to the second chamber 422B through opening 426 and to the fluid channel 434 which is in communication with the opening 410. A valve 428, for example, one-way valve, located by the fluid channel 424 can allow the one-way flow of tissue to the second camera 422B and a valve 432, for example, the unidirectional valve, located by fluid channel 430 coupling reservoir 406 to fluid channel 434 can similarly allow unidirectional flow of tissue into and through fluid channel 434. A valve 436, for example, unidirectional valve, positioned through the flow channel fluid 434 can allow unidirectional flow of tissue from the first camera 422A into and through fluid channel 434 and out of cannula 442. A fluid channel 438 that contains fluidly connecting the second camera 422B to the fluid channel 434 may also have a valve 440, for example, one-way valve, which allows the one-way flow of tissue from the second camera 422B into and through the fluid channel 434.
[0098] In use, when reservoir 406 is initially attached to fluid channel 424, motor 412 can be driven to stimulate piston 420 in a first direction, for example, distally with respect to motor 412. As piston 420 moves in the first direction , a vacuum pressure generated within the second chamber 422B can extract the reservoir fabric 406 through channel 424 and through valve 428 and the second chamber 422B. Since the plunger 420 has been moved to a distal position by the lead screw 418, the motor 412 can be inverted to rotate the lead screw 418 in a second opposite direction to force the plunger 420 to move in a second opposite direction in the near direction. to the engine 412. The inverted movement of the plunger 420 can generate a vacuum pressure inside the first chamber 422A to then extract the reservoir tissue 406 through channel 430 and valve 432 and to the first chamber 422A. As the tissue is extracted into the first camera 422A, the volume of tissue contained within the second camera 422B can be forced into channel 438 and through valve 440 and channel 434 and outside the cannula 442 for injection into the body. The one-way valve 428 can close to prevent the reintroduction of tissue from the second camera 422B back to reservoir 406 and one-way valve 436 can similarly close to prevent the fabric from passing through channel 438 from being pulled back into the first camera 422A.
[0099] As the plunger 420 reaches the end of its travel, its direction can again be reversed to then clean the volume of tissue extracted inside the first chamber 422A through valve 436 and through cannula 442 and in the body while valves 432 and 440 can close to prevent reintroduction of tissue back to reservoir 406. This process can be repeated continuously so that reservoir tissue 406 can be injected into the body in a continuous, uninterrupted flow regardless of which direction the plunger 420 is moved. Alternatively, the valves can be inverted in the direction to provide culture of body tissue through cannula 442 (culture cannula) and pump 402 for collection in reservoir 406 also continuously and uninterrupted.
[0100] Figure 48 shows a side view of another variation of the assembly of the continuous pump 450. As shown, the first and second cameras 422A, 422B can be seen by the translatable plunger 420. In this example, the reservoir is detached and can be coupled via a separate channel as shown.
[0101] To ensure that a predictable amount of material is dispensed with each stroke, the full stroke of the plunger 420 can be detected. One method is to use feedback from an encoder or controller, for example, controller 414, attached to drive motor 412. Another method for evaluating piston position 420 is to monitor the current required to drive piston 420.
[0102] As shown in the exemplary graph in figure 49, the motor current can be drawn against a piston 420 travel distance within the cameras. As the piston travels between a near and distal end of travel (EOT) inside the chamber, the current to the 412 engine changes with the piston position. The signal moves up and down with changes in the energy required to move piston 420. For example, the current signal can increase when a large sample moves through the system and can drop when a sample with more fluid moves through the system. . However, when piston 420 reaches the EOT, piston 420 stops moving and engine 412 draws more current to try and overcome stopped piston 420. An internal electrical circuit can detect when this current exceeds a limit current 466 indicating that the piston 420 reached the EOT and reversed the direction of the 412 motor. The process repeats when the current limit 466 exceeds when the piston 420 reaches the EOT at the opposite end of the camera.
[0103] Other examples and variations of the culture instrument as well as processing and guidance and also the injection devices and methods are still described in the following description and figures, which are incorporated here in their entirety.
[0104] The applications of the disclosed invention discussed above are not limited to certain treatments or regions of the body, but can include any number of other treatments and areas of the body. Modification of the methods and devices described above to carry out the invention, and variations: of aspects of the invention that are obvious to those skilled in the art are directed to the scope of this disclosure. In addition, various combinations of aspects between the examples as well: are observed and are also considered within the scope of this disclosure.

权利要求:
Claims (26)
[0001]
TISSUE TRANSFER SYSTEM, characterized by comprising: a lever assembly (340), the lever assembly (340) including (i) a lever (340) that extends in line with a tissue injection cannula (334), (ii) a drive mechanism, and ( iii) an inclined receiving section (342) configured to removably receive at least one tissue reservoir (47), the inclined receiving section (342) extending from the lever (340) at an acute angle; o at least one removable fabric reservoir (47) fixable from the inclined receiving section (342) so that at least the fabric reservoir (47) extends at an angle relative to the lever (340) to facilitate manipulation of the lever (340 ), in which an intersection between the lever (340) and the at least one tissue reservoir provides a grip section for a user, the tissue injection cannula (334) which extends in line with the lever (340) so that the at least one tissue reservoir (47) is inclined with respect to the tissue injection cannula (334), in which the tissue injection cannula (334) defines at least one opening near or at a distal end of the tissue injection cannula (334) and a proximal end of the tissue injection cannula (334) is removable and can be fixed to the lever (340), and wherein at least one tissue reservoir (47) and the tissue injection cannula (334) are in fluid communication with each other via the lever (340).
[0002]
SYSTEM according to claim 1, wherein the drive mechanism is characterized by comprising a pumping mechanism (400).
[0003]
SYSTEM according to claim 2, characterized in that the pumping mechanism (400) is a reversible pump (400) configured to provide continuous pressure through a pump (402).
[0004]
SYSTEM according to claim 3, characterized in that the pumping mechanism (400) includes a one-way valve (428).
[0005]
SYSTEM, according to claim 1, characterized in that the tissue injection cannula (334) is laterally displaced with respect to the lever (340).
[0006]
SYSTEM, according to claim 1, characterized in that it also comprises a collection reservoir assembly (45) that can be connected to the lever (340) through a pipe (43).
[0007]
SYSTEM, according to claim 3, characterized in that it further comprises a controller (336) in electrical communication with the pumping mechanism (400), in which the controller (336) is configured to receive the pumping response.
[0008]
SYSTEM according to claim 1, wherein the drive mechanism is characterized by comprising a lead screw (428) and a piston (420) linearly coupled to the lead screw (428).
[0009]
SYSTEM according to claim 1, characterized in that it further comprises a tissue detection sensor (25, 32, 39) positioned through or through the tissue injection cannula (334) and configured to distinguish a type of tissue.
[0010]
SYSTEM according to claim 9, wherein the tissue detection sensor (24, 32, 39) is characterized by comprising one or more optical fibers (26, 28) positioned near or at a distal end of the injection cannula fabric (334).
[0011]
SYSTEM, according to claim 9, further characterized by comprising a photo detector (32) in optical communication with one or more optical fibers (26, 28).
[0012]
SYSTEM, according to claim 11, further characterized by comprising a processor (34) in electrical communication with the photo detector (32), in which the processor (34) is programmed to distinguish the types of fabric.
[0013]
TISSUE INJECTION SYSTEM, characterized by comprising: a lever (33) having a drive mechanism; a removable injection cannula (334) attached to the lever (33) and extending in line with the lever (33); a reservoir (47) fluidly coupled to a proximal end of the injection cannula (334) via the lever (33), where the reservoir (47) is removable and can be fixed to the lever (33) so that the reservoir (47) extends in line with the lever (33) and the injection cannula (334), and the reservoir (47) comprises a collection reservoir assembly (45) fixed to the lever (33); a controller (336, 414) in electrical communication with the drive mechanism; and a tissue harvesting cannula (35) that defines at least one opening near or at a distal end of the tissue harvesting cannula (35), wherein a proximal end of the tissue harvesting cannula (35) is removable and can be fixed to the lever (33) so that the tissue collection cannula (35) is in fluid communication with the collection reservoir assembly (45) and is attachable to the drive mechanism; wherein the controller (336) is configured to receive the pumping response; and wherein the entire structure of the lever (33) extends in line with the injection cannula (334).
[0014]
SYSTEM according to claim 13, wherein the tissue harvesting cannula (35) is further characterized by comprising a rotating cutting member (58, 64) within at least one opening.
[0015]
SYSTEM, according to claim 13, characterized in that the reservoir (47) is fixable to the lever (33) through a pipe (43).
[0016]
SYSTEM according to claim 13, wherein the drive mechanism is characterized by comprising a pumping mechanism (400).
[0017]
SYSTEM according to claim 16, characterized in that the pumping mechanism (400) is a reversible pump (400) configured to provide continuous pressure through the pump (402).
[0018]
SYSTEM according to claim 17, characterized in that the pumping mechanism includes a one-way valve (428).
[0019]
SYSTEM, according to claim 13, characterized in that the collection tank assembly (45) is attachable to the lever (33) through a pipe (43).
[0020]
SYSTEM, according to claim 13, in which the pumping response is characterized by comprising a distance traveled by a piston (420) within the drive mechanism.
[0021]
SYSTEM, according to claim 13, wherein the drive mechanism is characterized by comprising a lead screw (428) on a piston (420) aligned with the lead screw (428).
[0022]
SYSTEM, according to claim 13, further characterized by comprising a tissue detection sensor (25, 32, 39) positioned through or by the injection cannula (334) and configured to distinguish a type of tissue.
[0023]
SYSTEM according to claim 22, wherein the tissue detection sensor (24, 32, 39) is characterized by comprising a photo detector (32) in optical communication with one or more optical fibers (26, 28) positioned near or at a distal end of the injection cannula (334).
[0024]
SYSTEM, according to claim 23, is further characterized by comprising a processor (34) in electrical communication with the photo detector (32), in which the processor (34) is programmed to distinguish the types of fabric.
[0025]
SYSTEM, according to claim 1, further characterized in that it comprises a tissue harvesting cannula (35) which defines at least one opening close to or at a distal end of the tissue harvesting cannula (35), wherein a proximal end of the tissue collection cannula (35) is removable and can be fixed to the lever (340) and can be attached to the drive mechanism.
[0026]
SYSTEM according to claim 25, wherein the tissue harvesting cannula (35) is further characterized by comprising a rotating cutting member (58, 64) within at least one opening.

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JP6767317B2|2020-10-14|

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EP2673017A4|2016-12-07|

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JP2017192797A|2017-10-26|

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JP2020121190A|2020-08-13|

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CA2827034C|2019-02-26|

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EP2673017B1|2020-09-09|

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BR112013020363A2|2016-10-18|

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EP2673017A1|2013-12-18|

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WO2012109603A1|2012-08-16|

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CA2827034A1|2012-08-16|

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法律状态:
2016-10-25| B15I| Others concerning applications: loss of priority|Free format text: PERDA DAS PRIORIDADES US 61/442,060 DE 11/02/2011, US 61/489,811 DE 25/05/2011 E US 61/510,967 DE 22/07/2011 REIVINDICADAS NO PCT/US2012/024744 POR NAO ENVIO DE DOCUMENTO COMPROBATORIO DE CESSAO DAS MESMAS CONFORME AS DISPOSICOES PREVISTAS NA LEI 9.279 DE 14/05/1996 (LPI) ART. 166O, ITEM 27 DO ATO NORMATIVO 128/97 E NO ART. 28 DA RESOLUCAO INPI-PR 77/2013 UMA VEZ QUE DEPOSITANTE CONSTANTE DA PETICAO DE REQUERIMENTO DO PEDIDO PCT E DISTINTO DAQUELE QUE DEPOSITOU A PRIORIDADE REIVINDICADA. |

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2017-05-16| B25A| Requested transfer of rights approved|Owner name: TAUTONA INJECTOR, LLC (US) |

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2017-05-30| B25C| Requirement related to requested transfer of rights|Owner name: TAUTONA INJECTOR, LLC (US) |

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2018-01-30| B25A| Requested transfer of rights approved|Owner name: LIFECELL CORPORATION (US) |

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2018-03-13| B12F| Appeal: other appeals|

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2019-10-01| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

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2020-09-29| B07A| Technical examination (opinion): publication of technical examination (opinion) [chapter 7.1 patent gazette]|

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2021-01-05| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

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2021-02-17| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 10/02/2012, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

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申请号 | 申请日 | 专利标题

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US201161442060P| true| 2011-02-11|2011-02-11|

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US61/442,060|2011-02-11|

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US201161489811P| true| 2011-05-25|2011-05-25|

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US61/489,811|2011-05-25|

---

US201161510967P| true| 2011-07-22|2011-07-22|

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US61/510,967|2011-07-22|

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PCT/US2012/024744|WO2012109603A1|2011-02-11|2012-02-10|Devices and methods for tissue transfer|

---