Process and system employing a method to control pressures when removing, handling, and reinjecting adipose tissue

Abstract

The invention is a method and control system to manage pressure levels during reinjection procedures of viable soft tissue. Although this case specifically relates to its use in the reinjection of adipose fat and other tissue back into the body during harvesting and reinjection procedures, it can be applied to any medical procedure of introducing or re-introducing materials into the body.

Claims

1-20. (canceled)

21. Apparatus for regulating pressure levels of a reinjected adipose tissue after harvesting of said tissue from a patient during a liposuction procedure, comprising the following: an aspiration cannula; a filtration device for processing said tissue after aspiration thereof; a pump for pressurizing said tissue in a reinjection cannula; and a pressure sensor coupled to said reinjection cannula and adapted to control a pressure level in the reinjection cannula by varying operating parameters of said pump.

22. The apparatus of claim 1, wherein said pump is a peristaltic pump and said sensor is an in-line sensor.

23. The apparatus of claim 2, wherein said in-line sensor is configured to detect a pressure increase through an increased load on the pump.

Description

BRIEF DESCRIPTION OF THE FIGURES

[0035] The following descriptions briefly describe the nature of each figure.

[0036] FIG. 1: Shows a system flowchart which is a representative overview of the harvesting and reinjection process.

[0037] FIG. 2: Is a pictorial diagram and schematic showing the directional flow of the cannula and aspiration side of the liposuction

[0038] FIG. 3: Is a pictorial diagram of the peristaltic pump unit, external pressure created, and the pump head

[0039] FIG. 4: Is a cross-sectional diagram of the in-line sensor and transducer

[0040] FIG. 5: Is a schematic front view diagram of the peristaltic pump unit and pump head

[0041] FIG. 6: Is a schematic of the reinjection cannula and the representative external flow out of the reinjection grafting cannula side of the system

DETAILED DESCRIPTION OF THE INVENTION

[0042] The present invention is the method and control system for performing a harvesting and reinjection procedure where the positive pressures used in reinjection are controlled. The control system consists of a reinjection pump (119), flexible tubing (702) for pumping the adipose tissue, and a means of measuring the pressure of fluid in the tubing (702). The reinjection pump uses an electric motor to drive the pump, and a user interface that allows controls over speeds and pressures (FIG. 3).

[0043] The preferred embodiment of the control system is to use a peristaltic pump (120b.) with an external sensor for measuring pressure, wherein the external sensor for pressure is a load cell (FIG. 4). A load cell is defined as “a transducer that is used to create an electrical signal whose magnitude is directly proportional to the force being measured.” (See http://en.wikipedia.org/wiki/Load_cell) The load cell (FIG. 4) is pressed and held against the flexible tubing (702), and is capable of measuring the change in pressure inside the tubing (702).

[0044] The load cell is affixed to a base component, which has a channel for the tube to sit into. A rotating hinge with a locking mechanism is attached to the base component. This hinge also has a channel for the tubing (702) to rest into. When the hinge is rotated and locked in place, the two channels line up, holding the tubing (702) in place while pushing and holding it against the sensing component of the load cell. The sensing component is described as the part, or system of parts, that transfers the force from the load to the deforming component of the load cell. The deforming component has the strain gauge on it. This sensing component is typically metal and is firmly attached to the deforming component of the load cell. This allows the load cell and strain gauge to be safely enclosed while the sensing component protrudes from the enclosure.

[0045] With the sensing component pressed and held against the flexible tubing (702), the sensor is set to a zero point. Any change in positive or negative pressure inside the tubing (702) is translated to a force pushing on the sensing component of the load cell through the wall of the flexible tube. If the hinge and base are designed correctly, it will prevent the flexible tubing (702) from expanding except in the direction of the sensing component. The internal pressure of the fluid is a force over area, so this translates to a force pushing on the surface of the sensing component. This force is directly proportional to the pressure in the tubing (702), and by using test data, a relationship between internal pressure of the tubing (702) and force on the load cell is achieved. Since the load cell is a transducer, the electrical signal is sent to and used by the reinjection pump.

[0046] Another variation of an external sensor is to use a pressure sensor. A pressure sensor is another type of transducer, like the load cell. The pressure sensor will be affixed to a base, where the base has a chamber that is filled with a medium, such as a gas or a fluid. The pressure sensor will be in fluid communication with this chamber and sealed against it. The chamber will press against the outside of the flexible tubing (702). There will be a base and hinge similar to the one described above, with channels that the flexible tubing (702) will lay into. It utilizes the concept that the flexible tubing (702) expands and contracts when pressure is in the tubing (702). If the hinge and base are properly designed, the expansion of this tubing (702) can be directed towards the chamber, which will increase the pressure of the medium in this chamber. With test data, a relationship between the pressure change in the chamber and the pressure inside the flexible tubing (702) can be made. The electrical signal created by this pressure sensor is sent to and used by the reinjection unit.

[0047] The previous description leads to an in-line sensor that measures pressure inside the tubing (702). This is achieved by having a split or extra port in the flexible tubing (702) after the pump. A pressure sensor can be attached to the end of this port, or spliced into the tubing (702) to provide pressure measurements to the reinjection pump. The setup allows the sensing component of the sensor to come in direct contact, or at least separated by a thin membrane, with the fluid being pumped through the flexible tubing (702).

[0048] Another method of sensing pressure in the flexible tubing (702) is to monitor the pump itself. As the pressure increases in the flexible tubing (702), it will put an increased load on the pump to continue to push more fluid into the tubing (702). The flexible tubing (702) expands, so the increased resistance is more gradual than if the tubing (702) was rigid. This increased resistance can be measured in a number of ways. A simple method would be to monitor the current draw and voltage of the motor. Current can be monitored only, voltage can be monitored only, or a combination of the two. With a sensitive current and/or voltage monitor and some test data, a properly sized motor