Lipectomy apparatus, systems, and methods

Abstract

Improved lipectomy systems, apparatus, and methods. In one example a lipectomy apparatus has a cannulated reciprocating drive shaft with an aspirate outlet protruding from the apparatus body that is configured to connect directly to an aspirate collection flexible conduit, which improves the construction of the lipectomy apparatus and lessens if not eliminates the potential of aspirate leaking into or pooling in internal cavities of the apparatus. In some instances the lipectomy systems, apparatus, and methods alternatively or additionally may include improved flexible conduits and / or rotational alignment indicia.

Description

LIPECTOMY APPARATUS, SYSTEMS, AND METHODSCROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims priority to and the benefit of the filing date of United States provisional patent application serial number 63 / 747,549 filed January 21, 2025 for "Lipectomy Apparatus, Systems, And Methods," the entire contents of which are hereby incorporated by this reference.RELATED FIELDS

[0002] Apparatus, systems, and methods for lipectomy, such as but not limited to nutational infrasonic liposculpture ("NIL") apparatus, systems, and methods.BACKGROUND

[0003] Liposculpture is the excision of subcutaneous adipose tissue. NIL is a type of liposculpture in which nutational movement of a subcutaneously inserted cannula is used to remove adipose tissue. Examples of NIL systems and methods are described in United States Patent 9,700,475 B2, United States Patent 10,517,638 B2, and United States Patent Application Publication 2024 / 0099757 Al. The NIL systems and methods described in those publications allow relatively painless removal of adipose tissue with high efficiency and effectiveness. However, there remains room for improvement.SUMMARY

[0004] We described herein examples of improved lipectomy systems, apparatus, and methods. In some instances the lipectomy systems, apparatus, and methods include a lipectomy apparatus in which a cannulated reciprocating drive shaft of the apparatus has an aspirate outlet protruding from the apparatus body that is configured to connect directly to an aspirate collection flexibleconduit, which improves the construction of the lipectomy apparatus, allows for easier sterilization, and provides for improved flow of aspirate through the apparatus. In some implementations the reciprocating drive shaft provides a continuous, unbroken aspirate pathway through the apparatus from a lipectomy cannula connected at one end of the reciprocating drive shaft to an aspirate outlet at the other end of the reciprocating drive shaft which protrudes from the apparatus body and provides for direction connection of an aspirate collection flexible conduit (e.g. aspirate collection tubing). In some implementations the continuous, unbroken pathway provided by the reciprocating drive shaft lessens if not eliminates the potential of aspirate ingress into other portions of the apparatus and the potential for aspirate to pool in parts of the apparatus. In some implementations the continuous, unbroken, and straight pathways provided by the reciprocating drive shaft minimizes turbulence of the aspirate flowing through the pathway. In some instances the lipectomy systems, apparatus, and methods utilize one or more flexible conduits with at least one of the conduits including a portion configured to dampen transmission of a reciprocal force from the distal end of the reciprocating drive shaft, thereby lessening if not avoiding complications that may arise due to the high frequency reciprocal motion of the aspirate outlet during use. In some instances the lipectomy systems, apparatus, and methods include a lipectomy apparatus with rotational alignment indicia located on an external surface of the apparatus body, which may inform the user of the rotational orientation of adipose tissue collecting opening(s) located on a distal end of the lipectomy cannula used with the lipectomy apparatus, thereby improving the performance and usability of the system. In some instances the rotational alignment indica may facilitate procedures in which the user desires to orient or adjust the orientation of the adipose tissue collecting opening(s) in a predetermined orother definitive manner without having to remove the distal end of the cannula from the patient in order to visualize the rotation alignment of the opening(s).BRIEF DESCRIPTION

[0005] FIG. 1 shows an example of a lipectomy system.

[0006] FIG. 2 shows an example of a lipectomy apparatus in longitudinal cross section.

[0007] FIGS. 3-4 show end views of the lipectomy apparatus of FIG. 2.

[0008] FIG. 5 illustrates the movement of certain components of the lipectomy apparatus of FIG.2 during operation.

[0009] FIG. 6 shows a prior art lipectomy apparatus in cross section.

[0010] FIG. 7 shows an example of a flexible conduit assembly.

[0011] FIGS. 8-9 show an example of a set of cannulas.

[0012] FIGS. 10-12 show an example of rotational alignment indicia of a lipectomy apparatus.DETAILED DESCRIPTION

[0013] FIG. 1 shows an example of a lipectomy system. In this example the lipectomy system includes a lipectomy apparatus 100, a lipectomy cannula 200, several flexible conduits (e.g. tubes) including an aspirate collection flexible conduit 302 and two drive fluid flexible conduits 304, and a controller 400. In this example air from a compressor (not shown) or other source of compressed air is controlled by the controller 400 to drive the lipectomy apparatus 100 such that a component of the lipectomy apparatus 100 reciprocates back and forth (e.g. at frequencies in the range of 10 hz to 120 hz, such as at 60 hz). In other implementations the reciprocating component of the lipectomy apparatus 100 may be driven in other manners (e.g. using an electrically powered actuator rather than compressed air). The reciprocating component in theapparatus drives motion of the lipectomy cannula 200 (e.g. a nutational motion), which is used to emulsify and remove adipose tissue from the body in the form of a liquid aspirate.

[0014] In the particular example shown in FIG. 1 drive fluid flexible conduits 304 flow compressed drive fluid (e.g. air) to and from the apparatus 100. In some implementations compressed air is supplied from the controller 400 to the lipectomy apparatus 100 at an input pressure in the range of 1-12 Bar, or 3-6 Bar to drive the lipectomy apparatus 100. In other implementations, other pressures and / or other drive fluids may be utilized.

[0015] Aspirate collection flexible conduit 304 collects aspirate from the apparatus 100 and directs it to a collection vessel (not shown). Vacuum suction may be supplied to the collection vessel and the aspirate collection flexible conduit 304.

[0016] FIGS. 2-5 show an example of a lipectomy apparatus 100. In this example, the lipectomy apparatus 100 includes a body 102 and a reciprocating drive shaft 104 mounted in the body 102. A proximal end of the reciprocating drive shaft includes a lipectomy cannula holder 106. A distal end of the reciprocating drive shaft 104 includes an aspirate outlet 108 protruding from the body 102. The distal end of the reciprocating drive shaft 104 is configured to connect directly to an aspirate collection flexible conduit. As shown in FIG. 2, the cannula of the reciprocating drive shaft 104 extends from a proximal end of the drive shaft 104 to a distal end of the drive shaft 104.

[0017] The cannula's extension along the entire length of the reciprocating drive shaft 104 from the lipectomy cannula holder 106 to the aspirate outlet 108 provides a uniform, smooth, and unbroken pathway for aspirate to flow from the lipectomy cannula holder 106 to the aspirate outlet 108. It improves the construction of the lipectomy apparatus 100, allows for easier sterilization, and provides for improved flow of aspirate through the apparatus 100. In someimplementations the reciprocating drive shaft 104 provides a continuous, unbroken aspirate pathway through the apparatus from a lipectomy cannula connected at one end of the reciprocating drive shaft 104 to the aspirate outlet 108 at the other end of the reciprocating drive shaft 104 which protrudes from the apparatus body 102 and provides for direct connection of an aspirate collection flexible conduit (e.g. aspirate collection tubing). In some implementations the continuous, unbroken pathway provided by the reciprocating drive shaft 104 lessens if not eliminates the potential of aspirate ingress into other portions of the apparatus and the potential for aspirate to pool in parts of the apparatus.

[0018] This is an advantage and an improvement over earlier lipectomy apparatuses, such as the one shown in FIG. 6. The lipectomy apparatus 800 shown in FIG. 6 includes a reciprocating drive shaft 804 including an outlet end 808 inside the apparatus body 802. Because of this, there is a risk that aspirate could collect or pool inside chamber 810 and potentially leak into other internal cavities of the body 802. In the apparatus of FIGS. 2-5, because the distal end of the reciprocating drive shaft 104 protrudes from the body 102, this risk is mitigated substantially if not eliminated entirely. Additionally, the chamber at the outlet end 808 can be a source of undesirable turbulence to the aspirate flow as the drive shaft 804 (part of the aspirate flow pathway) reciprocates relative to the chamber at the outlet end 808 (with the chamber also forming part of the aspirate flow pathway). In other words, the apparatus in FIG. 8 has an aspirate flow pathway through it in which part of the pathway reciprocates and part of the pathway is stationary. This differential reciprocation / non-reciprocation of the pathway can cause turbulence and other undesired impact on aspirate flow through the apparatus, unlike the apparatus in FIGS.2-5 in which the entire flow pathway through the apparatus uniformly reciprocates along its entire length through the apparatus.

[0019] The reciprocating drive shaft 104 of the apparatus shown in FIGS. 2-5 also provides a continuous, straight linear aspirate evacuation pathway that may provide for improved usability of the system in comparison to lipectomy devices in which the aspirate evacuation pathway includes one or more bends or other divergences from a straight pathway. In some instances a non-straight aspirate evacuation pathway may impede the flow of aspirate in undesired manners, interfering with optimal suction. In some instances a non-straight aspirate evacuation pathway may result in associated tubing extending from the apparatus in ways that interfere with the operability by the user or that could potentially result in kinks or other undesired bending of the tubing.

[0020] Returning to FIG. 2, the body 102 of the lipectomy apparatus 100 includes a main body 110, a nose cone 112, a nose cone bushing 114, and air input and outlet barbs 118. The reciprocating drive shaft 104 is part of a sub-assembly including a lipectomy cannula holder 106 and a sliding piston 126 and bushing 128.

[0021] In this particular example the main body 110 provides a handle for manipulating the lipectomy apparatus 100 and is also the central structure of the apparatus to which everything else is connected.

[0022] The drive shaft 104 is configured to reciprocate back and forth in the main body 110. The drive shaft includes an inner diameter serving as a passage for extracted aspirate. The proximal end of the drive shaft 104 is threaded for securing the lipectomy cannula holder 106. The distalend of the drive shaft 104 is barbed to facilitate direction connection of the drive shaft 104 to an aspirate collection flexible conduit.

[0023] The air input and output barbs 118 thread into the main body 110 and provide connections for the drive fluid flexible conduits 304 to flow air into and out of the air passages formed by the main body 110 and main bushing 134.

[0024] The nose cone 112 supports the nose cone bushing 114. As discussed in further detail below, the nose cone 112 (or another portion of the apparatus body) may include indicia for informing the user of the rotational orientation of adipose tissue collection openings located on a distal end of the lipectomy cannula.

[0025] The sliding piston 126 and bushing 128 facilitate driving the reciprocating motion of the drive shaft 104. The assembly is designed to slide freely on the drive shaft 104.

[0026] The cannula holder 106 serves as the interface between the reciprocating drive shaft 104 and the lipectomy cannula. It threads onto the drive shaft 104 at one end (such that it reciprocates along with the drive shaft 104) and the lipectomy cannula threads into it at the other end.

[0027] The above components are described by way of example and illustration only, and the lipectomy apparatus 100 may use other components or otherwise be configured differently in other implementations.

[0028] FIG. 5 shows operation of the lipectomy apparatus 100 of FIGS. 2-4. Flowing compressed air into and out of the apparatus 100 via input and outer barbs 118 causes the drive shaft 104 and accordingly the cannula holder 106 to translate back and forth in a reciprocal fashion. The sliding piston 126 acts as a valve to switch the direction of translation, by intermittently closing and opening various air flow paths in the apparatus 100.

[0029] As shown in FIG. 5, the reciprocating drive shaft 104 is translatable relative to the body 102 between a first state and a second state. In the first state the reciprocating drive shaft 104 is at a point of maximal translation towards the proximal end of the apparatus 100 (e.g. towards the nose cone 112). In the second state the reciprocating drive shaft 104 is at a point of maximal translation towards the distal end of the apparatus 100. When the reciprocating drive shaft is in the second state, the aspirate outlet 108 of the reciprocating drive shaft 104 protrudes further from the body 102 than when the reciprocating drive shaft 104 is in the first state.

[0030] As can also be seen in FIG. 5, the aspirate outlet 108 end of the reciprocating drive shaft 104 is adjacent to the air input and outlet barbs 118. In use, the aspirate outlet 108 and the air input and outlet bars 118 are all connected to flexible conduits (e.g. hoses). The high frequency reciprocal motion of the aspirate outlet 108 (and thus the associated flexible conduit) creates a risk of abrasion or other damage to the conduits that are in close proximity to one another. Additionally the high frequency reciprocal motion of the aspirate outlet 108 (and thus the associated flexible conduit) can cause undesired movement along the length of that flexible conduit or can otherwise interfere with performance of the lipectomy procedure.

[0031] FIG. 7 shows an example of a conduit assembly 300 including an aspirate collection flexible conduit 302 and drive fluid flexible conduits 304. The conduit assembly 300 is configured to reduce if not eliminate complications associated with the high frequency reciprocal motion of the aspirate outlet 108.

[0032] The conduit assembly 300 shown in FIG. 7 is a bundle of three conduits: the aspirate collection flexible conduit 302 and two drive fluid flexible conduits 304. The conduits 302, 304 each include a first end 306 where the conduits connect to the lipectomy apparatus 100 and asecond end 308. The second ends 308 of the drive fluid flexible conduits 304 connect to input and output ports of a controller (e.g. controller 400 shown in FIG. 1). The second end 308 of the aspirate collection flexible conduit 302 connects to an aspirate collection vessel. In the particular example shown, the three conduits are secured together towards the first end 306 by a tie wrap 310. In other implementations the three conduits may be secured together in other ways or not secured together at all.

[0033] In the example of FIG. 7 each of the conduits 302, 304 includes a first conduit portion 312 and a second conduit portion 314, with the first conduit portions 312 at the first end 306 of the conduits 302, 304 that connect to the lipectomy apparatus 100. In the example of FIG. 7 the first conduit portions 312 are configured to dampen transmission of a reciprocal force associated with the distal end of the reciprocating drive shaft 104, dampening transmission of such forces from the first conduit portions 312 to the second conduit portions 314. Although in the example of FIG.7 each of the conduits 302, 304 includes first and second conduit portions 312, 314, in other implementations the conduits may be configured differently from one another. For instance, the aspirate collection flexible conduit 302 may have first and second conduit portions 312, 314 while the drive fluid flexible conduits 304 are of a uniform material and / or configuration along their lengths.

[0034] As noted above, the first conduit portion 312 is configured to dampen transmission of a reciprocal force from the distal end of the reciprocating drive shaft 104 of the lipectomy apparatus 100 to the second conduit portion 314. In some implementations the force dampening is facilitated by use of a material and a configuration for the first conduit portion 312 that is of a relatively low flexural modulus. For instance, the first conduit portion 312 may have a lowerflexural modulus than a flexural modulus of the second conduit portion 314 (e.g. at least 25% less, or at least 50% less, or at least 75% less, or at least 90% less). In one particular example the first conduit portion 312 is silicone and the second conduit portion 314 is PVC. In at least some implementations the relative flexural moduli of the first and second conduit portions 312, 314 may be evaluated using a test standard such as ASTM D790.

[0035] The second conduit portion 314 may be more transparent than the first conduit portion 312. For instance, PVC may be relatively more transparent than silicone. The greater transparency in the second conduit portion 314 may facilitate visualization of aspirate during the procedure.

[0036] In the example of FIG. 7, the fist conduit portion 312 is significantly shorter than the second conduit portion 314. For instance, the first conduit portion 312 may be 1-10% of the total overall length of the conduit, or 1-5% of the total overall length of the conduit. The second conduit portion 314 may be at least 60% of the total overall length of the conduit, at least 70% of the total overall length of the conduit, at least 80% of the total overall length of the conduit, or at least 90% of the total overall length of the conduit. In one particular implementation the conduit may have an overall length of 12 feet and the first conduit portion may have a length of approximately 4 inches and the second portion may have a length of 11 feet and eight inches.

[0037] FIGS. 8 and 9 show an example of a set of three lipectomy cannulas 202, 204, 206 usable with the lipectomy apparatus 100 of FIGS. 2-5. The cannulas 202, 204, 206 include adipose tissue collection opening(s) 208 at their distal ends. As best seen in FIG. 9, the opening(s) 208 are asymmetrically arranged about the longitudinal axes of the cannulas 202, 204, 206. In other words, the relative alignment of the opening(s) 208 changes depending on the rotational orientation of the cannula 206. Cannula 202 has a single opening 208. Cannula 204 has twoopenings spaced at 180 degrees relative to one another. Cannula 206 has two openings spaced at 90 degrees relative to one another.

[0038] In at least some implementations, during operation of the lipectomy system, it may be desirable for the operator to be able to understand the relative rotational orientation of the one or more openings 208 while the distal end of the cannula 202, 204, 206 is inserted in the patient and not visible to the operator. The lipectomy apparatus 100 may include rotational alignment indicia on an external surface of the body 102 for this purpose. FIGS. 10-12 show one example of indicia 142 useful for indicating a rotational orientation of the asymmetric arrangement of the one or more openings when the lipectomy cannula is secured in the lipectomy cannula holder.

[0039] FIG. 10 shows the indicia 142 located on an external surface of the body 102 of a lipectomy apparatus. In this particular example, the indicia 142 are arranged about a proximal end of the body, more specifically about the nose cone 112 of the lipectomy apparatus 100. In other implementations, the indicia 142 can be located elsewhere on an external surface of the lipectomy apparatus's body 102. FIG. 11 shows an end view of the nose cone 112 with the indicia 142 arranged in an even spacing about the circumference of the nose cone 112 at forty-five degree increments. In other implementations the indicia 142 may be arranged differently and / or in different increments. In the example shown in FIGS. 10 and 11 the indicia 142 is a combination of graphical (lines) and alphanumeric (numbers) elements. In other implementations the indicia may be configured differently. As just one illustrative alternative example, the indicia may be an arrangement of lines or other graphic elements with different lengths, colors, and / or other characteristics.

[0040] FIG. 12 shows cannula 206 secured in the lipectomy cannula holder 106 and relative to nose cone 112. As noted earlier, the cannulas 202, 204, 206 may secure to the cannula holder 106 in a rotating fashion. After the user has secured the cannula 206 in the holder 106 he or she may note rotational alignment of the indicia 142 relative to the openings in the cannula 206 prior to inserting the cannula 206 distal end into the patient. In the particular example shown in FIG.12 one of the openings 208 is aligned with the "12" indicia and one of the openings is aligned with the "1.5" indica. During the procedure, the operator may therefore use the indicia 142 to understand the rotational orientation of the openings 208 even though the distal end of the cannula 206 is inserted in the patient and not visible. The user may use this information to confirm and / or adjust the orientation of the cannula 206 so that the opening(s) are located in desired / optimal orientations for performing the lipectomy.

[0041] The rotational alignment indica 142 may facilitate procedures in which the user desires to orient or adjust the orientation of the adipose tissue collecting opening(s) 208 in a predetermined or other definitive manner without having to remove the distal end of the cannula 200 from the patient in order to visualize the rotation alignment of the opening(s) 208.

[0042] The lipectomy apparatus, systems, and methods described above are presented by way of example only. Additions, deletions, substitutions, and other modifications may be made to the apparatus, systems, and methods described above without departing from the scope or spirit of the following claimed inventions.

Claims

Claims:

1. A lipectomy system comprising a lipectomy apparatus, the lipectomy apparatus comprising:(a) a body;(b) a reciprocating drive shaft mounted in the body, the reciprocating drive shaft comprising a cannulation extending from a proximal end of the reciprocating drive shaft to a distal end of the reciprocating drive shaft;(c) the proximal end of the reciprocating drive shaft comprising a lipectomy cannula holder; (d) the distal end of the reciprocating drive shaft comprising an aspirate outlet protruding from the body.

2. The lipectomy system of claim 1 wherein the reciprocating drive shaft is translatable relative to the body between a first state and a second state; and wherein, when the reciprocating drive shaft is in the second state, the aspirate outlet of the reciprocating drive shaft protrudes further from the body than when the reciprocating drive shaft is in the first state.

3. The lipectomy system of claim 2 wherein the distal end of the reciprocating drive shaft is configured to connect directly to an aspirate collection flexible conduit.

4. The lipectomy system of claim 2 wherein the lipectomy apparatus further comprises a drive fluid inlet; wherein flowing drive fluid into the drive fluid inlet causes the reciprocating drive shaft to translate in the body in a reciprocating fashion.

5. The lipectomy system of claim 4 wherein the lipectomy apparatus further comprises a sliding piston mounted in a sliding fashion to the reciprocating drive shaft.

6. The lipectomy system of claim 4 wherein the lipectomy apparatus further comprises a drive fluid outlet.

7. The lipectomy system of claim 4 wherein the aspirate outlet and the drive fluid inlet are adjacent.

8. The lipectomy system of claim 7 wherein the system further comprises an aspirate collection flexible conduit and a drive fluid flexible conduit.

9. The lipectomy system of claim 8 wherein, in use, the aspirate collection flexible conduit connects to an aspirate collection vessel and the drive fluid flexible conduit connects to a compressed air source.

10. The lipectomy system of claim 8 wherein the aspirate collection flexible conduit comprises a first conduit portion and a second conduit portion, wherein the first conduit portion is locatedat an aspirate outlet connecting end of the aspirate collection flexible conduit, wherein the first conduit portion is configured to dampen transmission of a reciprocal force from the distal end of the reciprocating drive shaft of the lipectomy apparatus to the second portion of the aspirate collection flexible conduit.

11. The lipectomy system of claim 10 wherein the first conduit portion comprises a first flexural modulus, wherein the second conduit portion comprises a second flexural modulus, wherein the first flexural modulus is lower than the second flexural modulus.

12. The lipectomy system of claim 11 wherein the first flexural modulus is at least 25% less than the second flexural modulus.

13. The lipectomy system of claim 10 wherein the second conduit portion comprises at least 60% of an overall length of the aspirate collection flexible conduit.

14. The lipectomy system of claim 10 wherein the second portion is more transparent than the first portion.

15. A lipectomy system comprising:(a) a lipectomy apparatus comprising:(i) a body;(ii) a reciprocating drive shaft mounted in the body;(iii) a proximal end of the reciprocating drive shaft comprising a lipectomy cannula holder; and (iv) a plurality of rotational alignment indicia located on an external surface of the body; and (b) a lipectomy cannula comprising an asymmetric arrangement of one or more adipose tissue collection openings at a distal end of the lipectomy cannula;(c) wherein, when the lipectomy cannula is secured in the lipectomy cannula holder, the plurality of rotational alignment indicia indicates a rotational orientation of the asymmetric arrangement of one or more adipose tissue collection openings .

16. The lipectomy system of claim 15 wherein the system further comprises a second lipectomy cannula and a third lipectomy cannula, wherein each of the cannulas comprise an asymmetric arrangement of one or more adipose tissue collection openings , wherein at least two of the cannulas has a different asymmetric arrangement of one or more adipose tissue collection openings.

17. The lipectomy system of claim 15 wherein the lipectomy cannula secures to the lipectomy cannula holder in a rotating fashion.

18. The lipectomy system of claim 15 wherein the plurality of rotational alignment indicia are arranged about a proximal end of the body.

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