WO1999044515A1

WO1999044515A1 - Ultrasonic liposuction probe

Info

Publication number: WO1999044515A1
Application number: PCT/US1999/004470
Authority: WO
Inventors: Stephen Dimatteo
Original assignee: Mentor Corporation
Priority date: 1998-03-02
Filing date: 1999-03-02
Publication date: 1999-09-10

Abstract

A probe for ultrasonic tissue treatment includes a longitudinally extending body for transmitting ultrasonic vibrations. The body has a distal region including an indented surface that defines opposed surface regions. The opposed surface regions extend substantially transversely or parallel to the longitudinal extent of the body. A plurality of adjacently disposed transverse surfaces are defined by the distal region and located proximally from a distal end of the body.

Description

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ULTRASONIC LIPOSUCTION PROBE Background of the Invention This invention relates to a probe for generating ultrasonic vibrations to treat tissue, for example, adipose tissue.

Ultrasonic assisted liposuction is typically conducted using an ultrasonically vibrating probe extending through a portal to a surgical site. The surgeon carefully manipulates the ultrasonically vibrating probe to treat tissue to be removed while avoiding other bodily tissue such as muscles, body organs and blood vessels. As described in Parisi et al . , U.S. Patent No. 4,886,491, titled LIPOSUCTION PROCEDURE WITH ULTRASONIC PROBE, incorporated by reference herein, the ultrasonically vibrating probe acts to liquify or melt the adipose tissue. The liquified tissue is then aspirated from the body to produce a slimmer profile. Summary of the Invention

According to the invention, the efficiency of an ultrasonically vibrating probe is enhanced by increasing the surface area of the probe that is in contact with the adipose tissue. Some arrangements provide a plurality of transverse cavitation surfaces which contact the tissue to liquify the tissue.

In general , according to one aspect of the invention, a probe for ultrasonic tissue treatment includes a longitudinally extending body for transmitting ultrasonic vibrations. The body has a distal region including an indented surface that defines opposed surface regions .

Embodiments of this aspect of the invention may include one or more of the following features. - 2 -

The opposed surface regions extend substantially transversely to the longitudinal extent of the body. Alternatively, the opposed surface regions extend substantially parallel to the longitudinal extent of the body.

The distal region includes a plurality of indented surfaces. Each indented surface defines opposed surface regions. A first set of the plurality of indented surfaces is aligned along a first side of the body, and a second set of the plurality of indented surfaces is aligned along a second side of the body opposite the first side. A first of the plurality of indented surfaces is circumferentially offset from a second of the plurality of indented surfaces. In certain embodiments, the indented surface is defined in an outer surface of the distal region of the body. The body defines an interior lumen and the indentation is in fluid communication with the lumen. Alternatively, the indentation has a closed bottom. In other embodiments, the body defines an interior bore and the indentation is located on a surface of the bore.

The opposed surfaces can form an acute angle therebetween. The indentation can be defined by spaced bumps on an outer surface of the body. The distal region of the body can be located off axis from the longitudinal extent of the body.

According to another aspect of the invention, the body has a distal region defining a plurality of adjacently disposed transverse surfaces located proximally from a distal end of the body.

Embodiments of this aspect of the invention may include one or more of the following features.

The body defines an internal bore and the transverse surfaces are located on a surface of the bore. A transverse extent of a first transverse surface is larger than a transverse extent of an adjacent distally located transverse surface.

According to another aspect of the invention, a method of ultrasonically treating tissue includes applying ultrasonic vibrations to a proximal end of an ultrasonic probe and contacting tissue to be treated with the ultrasonically vibrating probe. The probe has a distal region including an indented surface that defines opposed surface regions for contacting the tissue. Among other advantages, the ultrasonic probe of the present invention enables the surgeon to remove treated tissue at an increased rate because the increased surface area of the tissue contacting region of the probe provides more surfaces for transmitting ultrasonic effects to adipose tissue. Further, the increased surface area enhances frictional effects between the probe and adipose tissue as the probe is manually rotated by the surgeon, thereby emulsifying the tissue at an increased rate. The treated tissue is less dense, and hence the chances of clogging the probe lumen are reduced. The various geometries of the distal end of the probe provide control over the directionality of the ultrasonic effects. In addition, certain embodiments of the present invention provide an increase in the number of cavitation surfaces for emulsifying adipose tissue. Other features and advantages of the invention will become apparent from the following detailed description and from the claims.

Brief Description of the Drawings FIG. 1A is an illustration of an ultrasonic probe according to the invention; FIG. IB is an enlarged view of distal region IB of the probe of FIG. 1A; and FIG. 1C is an end view of the ultrasonic probe of FIG. IB taken along line 1C-1C. FIG. 2A is side view of an alternative embodiment of a distal region of an ultrasonic probe; and FIG. 2B is an end view of the ultrasonic probe of FIG. 2A taken along line 2B-2B. FIGS. 3A and 3B are side views of other alternative embodiments of distal regions of an ultrasonic probe.

FIG. 4 is a partial cross-sectional side view of another alternative embodiment of a distal region of an ultrasonic probe.

FIG. 5A is a side view of another alternative embodiment of a distal region of an ultrasonic probe; and FIG. 5B is an end view of the ultrasonic probe of FIG. 5A taken along line 5B-5B. FIG. 6A is a side view of another alternative embodiment of a distal region of an ultrasonic probe; and FIG. 6B is an end view of the ultrasonic probe of FIG. 6A taken along line 6B-6B.

FIG. 7 is a partial cross-sectional side view of another alternative embodiment of a distal region of an ultrasonic probe.

FIG. 8A is a partial cross-sectional side view of another alternative embodiment of a distal region of an ultrasonic probe; and FIG. 8B is an end view of the ultrasonic probe of FIG. 8A taken along the line 8B-8B.

FIG. 9A is a partial cross-sectional side view of another alternative embodiment of a distal region of an ultrasonic probe; and FIG. 9B is an end view of the ultrasonic probe of FIG. 9A taken along the line 9B-9B. FIG. 10A is a side view of another alternative embodiment of a distal region of an ultrasonic probe; and FIG.10B is a cross-sectional end view of the ultrasonic probe of FIG. 10A taken along the line 10B-10B.

FIG. 11 is a side view of another alternative embodiment of a distal region of an ultrasonic probe. - 5 -

FIGS. 12A, 12B and 12C are side views of other alternative embodiments of distal regions of an ultrasonic probe.

Detailed Description of the Preferred Embodiments The invention provides a variety of surface configurations at the distal region of an ultrasonic probe for enhancing the liquification and emulsification capabilities of the probe. The configurations includes indentations located in the exterior or interior surfaces of the probe, orientated transversely or parallel to a longitudinal extent of the probe. The indentations provide an increase in the surface area of the distal end of the probe thus increasing the area of the probe in contact with tissue, and, in some configurations, an increase in the number of cavitation surfaces.

Referring to FIGS. 1A-1C, an ultrasonic probe 10 for removing adipose tissue from a human or other animal body includes an enlarged distal region 12, a shank 13, a mid region 16, and a proximal end 14. Pressure waves produced by ultrasonic vibrations in probe 10 are transmitted from the probe's distal region 12 to a surgical site. Proximal end 14 is configured to releasably engage with a handpiece 19 of an ultrasonic liposuction system 21 for generating the ultrasonic vibrational energy. Probe 10 defines an interior lumen 22 extending from a distal opening 24 in distal region 12 to a proximal opening 32 in proximal end 14. An ultrasonic liposuction system is described, for example, in Podany et al . , U.S.S.N. 08/965,799, titled ULTRASONIC ASSISTED LIPOSUCTION SYSTEM, filed November 7, 1997, incorporated by reference herein.

Referring particularly to FIG. IB, an outer surface 25 of distal region 12 defines a pair of spaced indentations in surface 25, for example, slots 26 located on one side 23 of distal region 12, and another pair of - 6 - spaced slots 28 located on an opposite side 27 of distal region 12. Slots 26, 28 extend substantially transversely to a longitudinal axis, A, of probe 10. Each of slots 26, 28 includes opposed generally parallel side surfaces 34, 36, and a curved bottom region 30. An opening 31 is defined in bottom region 30 such that slots 26, 28 are in fluid communication with lumen 22. Distal region 12 includes a distal most portion 15 and a main portion 17 having a diameter larger than distal portion 15. Alternatively, distal portion 15 may have the same diameter as main portion 17.

Ultrasonic vibrations applied to probe proximal end 14 produce a longitudinal standing wave in the probe causing distal end 12 to vibrate. A step-down section 18 between proximal end 14 and mid region 16, and another step-down section 20 between mid region 16 and shank 13 amplify the ultrasonic vibrations delivered from proximal end 14 to distal region 12. Alternatively, amplification can be achieved by modifying an internal wall of the probe, as described in Podany et al . , titled ULTRASONIC LIPOSUCTION PROBE, filed December 31, 1997, incorporated by reference herein.

Probe 10 can be made from, for example, titanium, aluminum, or stainless steel. Slots 26, 28 are typically machined into distal region 12 by, for example, milling or electro-discharge machining. Slots 26, 28 have a width, w, of about 0.06 inch, and a depth, d, of about 0.055 inch. The radius of curvature, R, of curved regions 30 is about 0.025 inch. Main portion 17 of distal region 12 and mid region 16 preferably have the same outer diameter, for example about 0.2 inch. Distal portion 15 of distal region 12 has a diameter of about 0.175 inch. Proximal end 14 and shank 13 have outer diameters of about 0.5 inch and 0.15 inch, respectively. Lumen 22 has a diameter of about 0.1 inch. The length of distal region 12 from distal opening 24 to a juncture 38 located between distal region 12 and shank 13 is in a range of about 0.25 to 0.4 inch.

In operation, a surgeon advances ultrasonic probe 10 to the surgical site. Ultrasonic liposuction system 21 is activated to provide ultrasonic vibrations which are transmitted to the surgical site from the probe's distal region 12. Vibration of distal end 12 generates pressure waves from each of opposed transverse cavitation surfaces 34, 36. As the pressure waves generated by opposed surfaces 34, 36 are directed back and forth between the opposed surfaces, the ultrasonic vibrational effects of the probe are enhanced because the adipose tissue disposed between the opposed sides is liquefied and emulsified at an increased rate. The tissue is broken down into small pieces which can be aspirated through lumen 22 without clogging the lumen (e.g., via slots 26, 28 and open distal end 24) . Suction is applied to remove treated tissue through slots 26, 28, distal opening 24, and lumen 22 by, for example, an aspirator of the ultrasonic liposuction system connected to proximal opening 32 of lumen 22.

FIGS. 2-11 illustrate alternative embodiments of ultrasonic probes having distal regions with increased surface area to provide enhanced emulsification of treated tissue.

Referring to FIGS. 2A and 2B, the slots in the distal region of the ultrasonic probe can be oriented in various configurations. For example, a distal region 112 of an ultrasonic probe defines a first pair of diametrically opposed slots 114, 116, and a second pair of diametrically opposed slots 118, 119. Slots 114, 116, 118, 119 extend substantially transversely to the longitudinal extent of the probe. Slots 118, 119 are rotated about 90° with respect to slots 114, 116. Each - 8 - slot includes opposed generally parallel side surfaces 126, 128 for enhanced emulsification of the adipose tissue as described above with reference to FIGS. 1A-1C, and a curved bottom region 130. An opening 124 is defined in bottom region 130 such that slots 114, 116, 118, 119 are in fluid communication with lumen 122. As in the prior embodiment, treated tissue is aspirated through the openings in the slots as well as a distal opening 120 of lumen 122. By offsetting the pairs of slots by 90°, cavitation surfaces are provided about the entire circumference of the distal region of the probe.

Referring to FIG. 3A, another way to form the indentation in the surface of the probe is shown. Here, a distal region 212 of an ultrasonic probe includes a shelf 218 oriented transversely to the longitudinal extent of a lumen 216 of distal region 212 and a cone- shaped surface 220. Surfaces 218 and 220 intersect at an angle, c, of about 60°. Pressure waves produced by the ultrasonic vibrations are transmitted from surface 218 and reflected off of surface 220. The angle of intersection, a , between surfaces 218 and 220 determines the direction at which the pressure wave is deflected outward. Lumen 216 extends through head 212 to a distal opening 214. In this embodiment, the surface indent doe not intersect the lumen, and the liquified tissue is aspirated only via distal opening 214.

Alternatively, a portion of the region near the intersection between shelf 218 and surface 220 may communicate with lumen 214. For example, referring to FIG. 3B, a distal region 213 similar to that of distal region 212 (FIG. 3A) includes a pair of opposed openings 215, 217 near the intersection of a shelf 219 and a cone- shaped surface 221. Openings 215, 217 communicate with a lumen 223 so that treated tissue can be aspirated through openings 215, 217, as well as through a distal opening - 9 -

225 of lumen 223. There can be one, two or more openings near the intersection of shelf 219 and surface 221. Multiple openings may be equally or unequally spaced. Multiple indentations can be provided in the distal region of the probe by forming enlarged ridges on the outer surface of the probe. Referring to FIG. 4, a distal region 312 of an ultrasonic probe includes a plurality of circumferential ridges 314. Adjacent ridges define opposed cavitation surfaces, for example, surfaces 318 and 320. As similarly described for the embodiment illustrated in FIGS. 1A-1C, the transversely oriented opposed surfaces enhance the ultrasonic effects of the probe. A lumen 316 extends to a distal opening 322 to provide a channel to remove treated tissue. An increase in surface area of the probe can be provided by axially orienting the surface indents. For example, referring to FIGS. 5A and 5B, a distal region 412 of an ultrasonic probe includes a series of raised equally spaced longitudinal ridges 414. Ridges 414 extend proximally from a distal end 416 of distal region 412 to a juncture 413 located between distal region 412 and a shank 415. Adjacent ridges define a series of surface indents 418. A lumen 420 extends through distal region 412 to an opening 422 defined by distal end 416. Surface indents 418 provide increased surface area to contact and shear, by friction, adipose tissue disposed within the grooves, thereby emulsifying the tissue at an increased rate.

In addition to thrusting of the probe along its longitudinal extent during use, the probe can be manually rotated by the surgeon. Surface indents 418 act to provide better coupling between distal region 412 and the adipose tissue as the probe is rotated about its longitudinally axis. Additionally, the axially oriented indents can provide cavitation surfaces by vibrating the - 10 - probe torsionally such that pressure waves are generated from axially disposed surfaces of the indents, as described in Podany, titled ULTRASONIC PROBE, filed March 2, 1998, incorporated by reference herein. Referring to FIGS. 6A and 6B, the axially disposed indents can be circumferentially offset. Here, a distal region 512 of an ultrasonic probe includes a series of four equally circumferentially spaced ridges 514. Ridges 514 extend proximally from a distal end 516 of head 512 to a juncture 515 located between ridges 514 and another series of four equally circumferentially spaced ridges 518. Ridges 518 extend proximally from juncture 515 to a section 517 of distal region 512. Ridges 518 are rotated about 45° relative to ridges 514. Ridges 514, 518 define a series of surface indents 520, 522, respectively, extending substantially longitudinally along probe 512. Ridges 514, 518 are offset such that ridges 514 are longitudinally aligned with indents 522 and ridges 518 are aligned with indents 520. A lumen 524 extends proximally from an opening 526 defined by distal end 516 through head 512. Transverse surfaces 518a of ridges 518 provide additional cavitation surfaces.

Increased surface area and transversely oriented cavitation surfaces can be provided on an interior surface of the probe. For example, referring to FIG. 7, a wall 618 of a distal region 612 of an ultrasonic probe has three internal steps 620a, 620b and 620c near a distal end 619 of distal region 612. Steps 620a, 620b, 620c of wall 618 define a bore 614 which communicates with a lumen 616. Bore 614 increases in cross section as it extends distally from step 620a to 620c. For example, step 620a is located at a distance, L_1# of 0.075 inch from distal end 619, and has a width, W_lr of 0.125 inch; step 620b is located at a distance, L₂, of 0.05 inch from distal end 619, and has a width, W₂, of 0.15 inch; and - 11 - step 620c is located at a distance, L₃, of 0.025 inch from distal end 619, and has a width, W₃, of 0.175 inch.

An opening 624 of bore 614 is defined by distal end 619. Steps 620a, 620b, 620c define transverse surfaces 640a, 640b, 640c, respectively, which provide enhanced emulsification capabilities by increasing the surface area of the probe in contact with adipose tissue and providing additional cavitation surfaces. The treated tissue is drawn into bore 614 and subsequently through lumen 616 by a suction applied through lumen 616. Referring to FIGS. 8A and 8B, in this embodiment, the surface indents are disposed axially on the interior surface of the probe. A distal region 712 includes a wall 714 which defines a bore 716. Wall 714 has four equally spaced internal ridges 720. Ridges 720 extend distally from a distal end 722 of head 712 to a juncture 713 located between distal region 712 and a shank 715. Ridges 720 define a series of surface indents 724 which also extend distally from distal end 712 to juncture 713. Each surface indent 724 includes opposed sides 726, 728 to provide increased surface area for efficiently emulsify adipose tissue. Bore 716 extends proximally from an opening 730 defined by distal end 722 and communicates with a lumen 718. Suction is applied through lumen 718 thereby drawing adipose tissue into bore 716. Transverse surfaces 720a of ridges 720 provide additional cavitation surfaces.

The surface indents of FIG. 8A can be varied in shape. For example, referring to FIGS. 9A and 9B, four equally circumferentially spaced internal ridges 918 extend from a distal end 919 partially along the length of distal region 912 to about a mid-section 913 of distal region 912. Ridges 918 define a set of equally spaced surface indents 920. Indents 920 extend proximally from - 12 - a distal opening 924 of distal end 919 to a series of transverse surfaces 917.

The surface indents can be defined by a plurality of channels that vary in shape. For example, referring to FIGS. 10A and 10B, a distal region 812 includes a wall 814 which defines a bore 815. The surface indents are defined by three sets 825 of internal channels 816a, 816b, 816c disposed in wall 814. Channels 816a, 816b, 816c extend from a distal end 820 of distal region 812 to a juncture 813 located between distal region 812 and a shank 815. Each channel is displaced by about 40° from an adjacent channel. A pair of opposed surfaces 823a, 823b of each channel provides increased surface area for increased emulsification efficiency. Bore 815 communicates with a lumen 824 and extends from lumen 824 to an opening 826 defined by distal end 820. Suction is applied through lumen 824 to draw adipose tissue into bore 815. The tissue is emulsified within channels 816a, 816b, 816c and then aspirated through lumen 824. In other embodiments, the ultrasonic probe can include a cap abutted against the distal end of the probe to close off the lumen opening at the distal end. The probes of the various embodiments described above can have a solid shaft rather than include a lumen. Solid shaft probes or probes defining a lumen can be used in conjunction with a sheath to provide infiltration/irrigation capabilities to the ultrasonic liposuction procedure. In such a combination, the sheath is disposed about the probe, thereby defining a channel between the probe and the sheath through which the infiltration/irrigation fluid flows.

In a particular embodiment of a solid shaft probe, as shown for example in FIG. 11, a distal region 950 includes four equally spaced spherical surfaces 952 extending proximally from a distal end 954. Transverse - 13 - opposed portions 956, 958 of adjacent spherical surfaces 952 define a series of surface indents 960. Spherical surfaces of distal region 950 extend over a length of about 1 inch and all have the same diameter. Surface indents 960 provide increased emulsification efficiency by increasing the surface area of the probe in contact with the tissue and by providing additional transverse cavitation surfaces.

The spherical surfaces can have different outer diameters. As shown in FIG. 12A, a distal region 970 of the probe includes four spaced spherical surfaces 972, 974, 976, 978 extending over a length of about 1.5 inches and having different outer diameters. Distal-most spherical surface 972 has the smallest outer diameter, and proximal- most spherical surface 978 has the largest diameter. Spherical surface 976 adjacent to spherical surface 978 has a larger diameter than spherical surface 974 which in turn has a larger diameter than 972. Thus the effective mass of distal region 970 decreases distally from proximal-most spherical surface 978 to distal-most spherical surface 972. The decreasing effective mass amplifies the velocity of the acoustic wave, as described in Podany et al . , filed December 31, 1997, supra. Some ultrasonic probes have a distal region angled away from the longitudinal extent of a main body portion of the probe. For example, referring to FIG. 12B, an ultrasonic probe 980 includes an angled distal region 981 and a main body portion 983. Distal region 981 and main body portion 983 intersect at an angle, γ, for example, of about 15°.

The distal region may be curved. For example, referring to FIG. 12C, an ultrasonic probe 990 includes a curved distal region 991, with a radius of curvature, r, - 14 - for example, of about 0.5 inch, extending from a main body portion 993.

The ultrasonic probe may be configured to treat tissue other than adipose tissue.

Other embodiments are within the scope of the following claims.

What is claimed is:

Claims

- 15 -

1. A probe for ultrasonic tissue treatment, comprising: a longitudinally extending body for transmitting ultrasonic vibrations, the body having a distal region including an indented surface that defines opposed surface regions .

2. The probe of claim 1 wherein the opposed surface regions extend substantially transversely to the longitudinal extent of the body.

3. The probe of claim 1 wherein the opposed surface regions extend substantially parallel to the longitudinal extent of the body.

4. The probe of claim 1 wherein the distal region includes a plurality of indented surfaces, each indented surface defining opposed surface regions.

5. The probe of claim 4 wherein a first set of the plurality of indented surfaces is aligned along a first side of the body, and a second set of the plurality of indented surfaces is aligned along a second side of the body opposite the first side.

6. The probe of claim 4 wherein a first of the plurality of indented surfaces is circumferentially offset from a second of the plurality of indented surfaces .

7. The probe of claim 1 wherein the indented surface is defined in an outer surface of the distal region of the body. - 16 -

8. The probe of claim 1 wherein the body defines an interior lumen and the indentation is in fluid communication with the lumen.

9. The probe of claim 1 wherein the indentation has a closed bottom.

10. The probe of claim 1 wherein the body defines an interior bore and the indentation is located on a surface of the bore.

11. The probe of claim 1 wherein the opposed surfaces form an acute angle therebetween.

12. The probe of claim 1 wherein the body has an outer surface, the outer surface including spaced bumps defining the indentation.

13. The probe of claim 1 wherein the distal region is located off axis from the longitudinal extent of the body.

14. A probe for ultrasonic tissue treatment, comprising : a longitudinally extending body for transmitting ultrasonic vibrations, the body having a distal region including a plurality of indented surfaces in an outer surface of the body, each of the plurality of indented surfaces defining opposed surface regions, the opposed surface regions extending substantially transverse to the longitudinal extent of the body, a first set of the plurality of indented surfaces is aligned along a first side of the body, and a second set of the plurality of indented surfaces is aligned along a second side of the body opposite the first side, - 17 - the body defines an internal lumen, each of the plurality of indented surfaces is in fluid communication with the lumen.

15. A probe for ultrasonic tissue treatment, comprising: a longitudinally extending body for transmitting ultrasonic vibrations, the body having a distal region defining a plurality of adjacently disposed transverse surfaces located proximally from a distal end of the body .

16. The probe of claim 15 wherein the body defines an internal bore and the transverse surfaces are located on a surface of the bore.

17. The probe of claim 15 wherein a transverse extent of a first transverse surface is larger than a transverse extent of an adjacent distally located transverse surface.

18. A method of ultrasonically treating tissue, comprising : applying ultrasonic vibrations to a proximal end of an ultrasonic probe, and contacting tissue to be treated with the ultrasonically vibrating probe, the probe having a distal region including an indented surface that defines opposed surface regions for contacting the tissue.