Devices and methods for minimally invasive tissue dissection and modification

Abstract

An electrosurgical lysis device and related methods. In some embodiments, the device may include a lysing tip comprised of one or more beads. The beads may include an at least substantially non-conductive surface and may at least partially define a distally facing recess and a proximally facing recess. At least one electrically conductive lysing member configured to provide electrosurgical energy may be adjacent to the at least one bead, the at least one lysing member defining at least one lysing segment that extends at least partially within the recess defined by the at least one bead.

Description

[0001] Related applications

[0002] This application claims the benefit under 35 U.S.C. §119(e) of U.S. Provisional Patent Application No. 62 / 821,985, filed on March 21, 2019, and entitled “DEVICES AND METHODS FOR MINIMALLY INVASION DISECTION AND MODIFICATION OF TISSUE.” This application is also a continuation-in-part of U.S. Patent Application No. 16 / 141,893, filed on March 20, 2017, entitled “Minimally Invasive Tissue Dissection Device and System,” which claims the benefit under 35 U.S.C. §119(e) of U.S. Provisional Patent Application No. 62 / 563,005, filed on September 25, 2017, entitled “Minimally Invasive Tissue Dissection Device and System,” and is a continuation-in-part of U.S. Provisional Patent Application No. 15 / 464,199, filed on March 20, 2017, entitled “Minimally Invasive Tissue Dissection Device, System, and Method,” which claims priority to U.S. Provisional Patent Application No. 62 / 313,707, filed on March 26, 2016, and U.S. Provisional Patent Application No. 62 / 409,575, filed on October 18, 2016. Each of the foregoing applications is hereby incorporated by reference.

[0003] summary

[0004] The term "dissection" may refer to the separation of a tissue or one tissue plane from another (reference: Free Online Medical Dictionary). Some people also consider dissection to include the division of a single tissue into several parts. Most of the body of animals and humans is formed by embryonic fusion planes. Many organs in the human or animal body may be classified from the embryonic fusion planes into which they enter. The interfaces between organs are often referred to as "tissue planes". These planes can be considered basic planes based on the size of the comparative plane organisms or inanimate objects (such as surgical instruments). The embodiments disclosed herein can simultaneously perform the functions of sharp dissection, blunt dissection, electrosurgical cutting and / or coagulation without the surgeon having to switch instruments. Tissue modification can also be performed, and in some preferred embodiments and implementations disclosed herein, a separate tissue modification instrument is used, which can be deployed to the target area through a path created using a tissue dissection instrument, as described in detail below. In some cases, the tissue plane of the target area can also be formed and / or processed with a tissue dissection instrument to facilitate subsequent tissue processing with a tissue processing / modification instrument.

[0005] Sharp dissection is sometimes referred to as the separation of tissue by the sharp edge of a knife or scalpel or the inner sharp edge of scissors. Webster defines blunt dissection as the surgical separation of tissue layers by means of a bladeless instrument or the fingers.

[0006] The term "lyse" means to dissect and may also mean to cut through, particularly through fibrous components, or to separate discrete structures that are in some way adhered to one another.

[0007] Some embodiments disclosed herein may include a cannula delivered tissue dissector (CDTD). Other embodiments disclosed herein may be used without a cannula and, therefore, may be considered non-cannula delivered tissue dissectors (non-CDTD). Some embodiments may be used with or without a cannula and, therefore, may be considered a CDTD or non-CDTD, depending on the system / process. Both the CDTD and non-CDTD embodiments disclosed herein may simultaneously perform the functions of sharp dissection, blunt dissection, electrosurgical cutting, and / or coagulation without the surgeon having to switch instruments. Tissue modification may also be performed.

[0008] The term "minimally invasive surgery" is used to describe a procedure (surgical or otherwise) that is less invasive than open surgery for the same purpose. Some minimally invasive procedures typically involve the use of laparoscopic and / or endoscopic devices and manual and / or remote / computerized manipulation of instruments with indirect visualization of the operative field through an endoscope or similar device, and are performed through the skin or through a body cavity or anatomical opening. This may shorten hospital stays or allow for outpatient treatment (reference: Wikipedia).

[0009] Minimally invasive surgery, sometimes referred to as "keyhole" surgery, may be performed using one or more trocars, one or more laparoscopes and / or endoscopes and / or cannulas to access tissue within the body.

[0010] The term "open surgery" is used to indicate cutting through the skin and tissue to "open the body" so that the surgeon can directly access the structures or organs involved. The size of the incision should be such that the surgeon's hands can be inserted into the patient's body. The involved structures and tissues can be seen and felt, and can be exposed directly to the operating room air.

[0011] As used herein, the term "cannula" is intended to encompass any tube or tubular structure configured to be inserted into the body of a human or animal during a surgical procedure and to facilitate the selective movement of a surgical device and / or related components. It is used to perform the delivery of surgical instruments and / or surgical procedures with surgical instruments. A tubular structure containing a fixed structure / element therein (e.g., a needle driver or grasping tool) is not considered a cannula as the term is used herein. Although "trocar" is often used in conjunction with cannula, the term "cannula" as used herein is intended to include only a trocar, provided that the trocar is capable of being used to insert a medical device into the body.

[0012] It may be advantageous to extend the spot coagulant from an embodiment of the CDTD to such a distance and / or position that allows for complete visualization and / or contact of the bleeding area with a portion of the spot coagulant (e.g., the distal point of the coagulant tip). It may be possible to use a probe that can derive electrical energy from a conductive element located between the lysing element at the tip and the plug.

[0013] According to some embodiments of the invention disclosed herein, various examples of instruments and devices are as follows:

[0014] 1. An electrosurgical lysis device comprising:

[0015] a lysing tip comprising at least one bead;

[0016] at least one lysing member configured to deliver electrosurgical energy from the lysing tip, the at least one lysing member defining at least one lysing segment extending within a recess at least partially defined by the at least one bead; and

[0017] A channel extends at least partially through the at least one bead, wherein the at least one lysing component extends at least partially through the channel.

[0018] 2. The electrosurgical lysis device of claim 1 , further comprising a non-conductive strut connected to the at least one bead.

[0019] 3. The electrosurgical lysis device of claim 2, further comprising a tissue deflection strut disposed between the proximal portion of the non-conductive strut and the proximal portion of the at least one bead.

[0020] 4. The electrosurgical lysis device of claim 2, wherein at least one lysis member is at least partially disposed within the non-conductive strut.

[0021] 5. The electrosurgical lysis device of claim 4, wherein the at least one lysis member is positioned entirely within the non-conductive strut such that no portion of the at least one lysis member protrudes beyond the non-conductive strut.

[0022] 6. The electrosurgical lysis device of claim 4, wherein at least one lysis member partially protrudes from the non-conductive strut to allow direct contact with tissue during tissue lysis.

[0023] 7. The electrosurgical lysis device of claim 1 further comprising a shaft, wherein the lysis tip is located at a distal end of the shaft.

[0024] 8. The electrosurgical lysis device of claim 1, wherein at least one lysis member is configured to perform forward or reverse lysis.

[0025] 9. The electrosurgical lysis device of claim 1, wherein individual beads of the at least one bead are configured to at least partially define proximally facing and distally facing lysis segments.

[0026] 10. A tissue modification apparatus for delivering tissue modification energy during a surgical procedure, comprising:

[0027] A shaft extending along an axis;

[0028] A tissue treatment tip is located at the distal end of the shaft, the tissue treatment tip comprising one or more energy delivery elements configured to deliver tissue-modifying energy, wherein the tissue treatment tip includes a non-branching tip extending away from the axis to define a tissue treatment region having a width greater than a width of the shaft.

[0029] 11. The tissue modification instrument of claim 10, wherein the tissue treatment tip comprises a curved tip.

[0030] 12. The tissue modification instrument of claim 10, wherein the cross-sectional dimension of the tissue treatment tip is at least substantially the same as the cross-sectional dimension of at least a portion of the shaft extending along an axis adjacent the tissue treatment tip.

[0031] 13. The tissue modification instrument of claim 12, wherein the cross-sectional dimension of the tissue treatment tip is at least substantially the same as the cross-sectional dimension of the shaft along the entire length of the shaft.

[0032] 14. The tissue modification instrument of claim 10, wherein the one or more energy delivery elements comprise a plurality of discrete energy delivery terminals.

[0033] 15. The tissue modification instrument of claim 10, wherein the one or more energy delivery elements are configured to deliver at least one of electrosurgery, laser, intense pulsed light, resistive heat, radiant heat, thermochromic, ultrasound, and microwaves.

[0034] 16. The tissue modification instrument of claim 10, wherein the tissue processing tip comprises an upper surface, a lower surface, and opposing side surfaces, wherein the opposing side surfaces comprise one or more curves, wherein each of the one or more curves is smooth and lacks any sharp points or edges.

[0035] 17. The tissue modification instrument of claim 16, wherein the tissue treatment tip defines an at least substantially circular shape extending from the shaft.

[0036] 18. The tissue modification instrument of claim 16, wherein the tissue manipulation tip has three sides and is at least substantially rectangular in shape.

[0037] 19. The tissue modification instrument of claim 18, wherein a corner between two adjacent sides of the three sides is a distal end of the tissue modification instrument.

[0038] 20. The tissue modification instrument of claim 10, wherein the tissue treatment tip comprises a first set of energy delivery elements of a first polarity and a second set of energy delivery elements of a second polarity.

[0039] 21. The tissue modification instrument of claim 20, wherein the tissue treatment tip comprises a first arm and a second arm located opposite the first arm, wherein the first set of energy delivery elements is disposed on the first arm and the second set of energy delivery elements is disposed on the second arm.

[0040] 22. The tissue modification instrument of claim 10 wherein the tissue treatment tip comprises a first portion separated from a second portion, the first portion comprising a first set of energy delivery elements, the second portion comprising a temperature sensor configured to sense a temperature of tissue being treated using the first set of energy delivery elements.

[0041] 23. The tissue modification instrument of claim 22, wherein the first portion is located on a first arm of the tissue treatment tip and the second portion is located on a second arm of the tissue treatment tip, with a space between the first arm and the second arm.

[0042] 24. Instruments for tissue dissection and / or modification, including:

[0043] A treatment tip comprising one or more protruding electrode tips, each of the one or more protruding electrode tips comprising:

[0044] a non-conductive base;

[0045] a non-conductive shell extending from a non-conductive base;

[0046] There is also a conductive core positioned within the non-conductive shell and terminating in an apex adjacent the tip of the non-conductive shell, wherein the apex is configured to transmit electrosurgical energy therethrough to adjacent tissue during a surgical procedure.

[0047] 25. The tissue dissection and / or modification instrument of claim 24, wherein the conductive core comprises a hollow chamber.

[0048] 26. The tissue dissection and / or modification instrument according to claim 25, wherein the hollow chamber tapers from a narrow portion at an upper end of the hollow chamber to a widened portion at a lower end of the hollow chamber.

[0049] 27. The tissue dissection and / or modification instrument of claim 24, wherein the apex comprises a depression.

[0050] 28. The tissue dissection and / or modification instrument of claim 24, wherein the apex comprises a protrusion.

[0051] 29. The tissue dissection and / or modification instrument of claim 28, wherein the protrusion extends from a recess formed at the apex.

[0052] BRIEF DESCRIPTION OF THE DRAWINGS

[0053] This disclosure describes non-limiting and non-exhaustive illustrative embodiments. Some illustrative embodiments are shown in the following figures:

[0054] FIG. 1 a is a side view 1 r of the bead of the embodiment shown in FIG. 1 .

[0055] FIG. 1 b is a rear perspective view 1 r of the bead of the embodiment shown in FIG. 1 a .

[0056] FIG. 1 c is a cross-sectional side view of the embodiment previously depicted in FIG. 1 a at the position shown in FIG. 1 b .

[0057] FIG. 1 d is a perspective view of a cracking rod assembly.

[0058] FIG. 1e is a top view 1r of the lysing tip of the embodiment shown in FIG. 1a.

[0059] FIG. 1f is a side perspective view 1r of the lysing tip of the embodiment shown in FIG. 1 .

[0060] FIG. 1g is an upper cross-sectional view 1r of the lysing tip connected to the lower jaw assembly of the embodiment shown in FIG. 1a.

[0061] FIG. 1 h is a side view 1 r of the lysing tip and distal portion of the grasping / controlling instrument of the embodiment shown in FIG. 1 .

[0062] FIG. 1i is a top view of the lysing tip and distal portion of the grasping / controlling instrument of the embodiment shown in FIG. 1 with the upper jaw removed 1r.

[0063] FIG. 1 j is a perspective view of the distal tip of the grasping / controlling instrument with a transparent jaw cover exposing the jaw tongue 1 r of the embodiment shown in FIG. 1 .

[0064] 1 k is a side view of the distal tip of the grasping / controlling instrument with a transparent jaw cover revealing the jaw tongue 1 r of the grasping / controlling instrument of the embodiment shown in FIG. 1 .

[0065] 1L is a perspective view 1r of the upper jaw cover of the grasping / controlling instrument of the embodiment shown in FIG. 1 .

[0066] FIG. 1m is a perspective view 1r of the upper jaw armature and jaw tongue of the gripping / controlling instrument of the embodiment shown in FIG. 1 .

[0067] FIG. 1 n is a perspective view 1 r of the lower jaw cover of the gripping / controlling instrument of the embodiment shown in FIG. 1 .

[0068] FIG. 10 is a perspective view 1r of the lower jaw armature and jaw tongue of the gripping / controlling instrument of the embodiment shown in FIG. 1 .

[0069] FIG. 1 p is a side cross-sectional view 1 r of the grasping / controlling instrument and lysing tip of the embodiment shown in FIG. 1 .

[0070] FIG. 1q is a perspective view 1r of the distal end of the embodiment of FIG. 1 with a portion of the upper jaw assembly removed to reveal the location of the lysing tip.

[0071] 1 r is a perspective view of an embodiment of a system delivering a lysing tip in a therapeutic configuration with the jaws closed.

[0072] 1s is a perspective view of an embodiment of a system delivering a lysing tip in a therapeutic configuration with the jaws open.

[0073] FIG. 1t is a side view of the handle assembly.

[0074] FIG. 1u is a perspective view of another type of handle assembly having a shaft and jaws.

[0075] FIG. 1v is a side cross-sectional view 1u of the embodiment shown in FIG. 1 .

[0076] 2a is a perspective view of an embodiment of a system for delivering a lysing tip in a therapeutic configuration.

[0077] FIG. 2b is a perspective view 2a of the lysing tip of the embodiment shown in FIG. 1a.

[0078] FIG. 2c is a top view 2a of the lysing tip of the embodiment shown in FIG. 1a.

[0079] 2d is a perspective view of the distal tip of the grasping / controlling instrument of the embodiment shown in FIG. 1 with the upper jaw member removed and the lysing tip having one bead 2a removed.

[0080] FIG. 2e is a perspective view 2a of the lower jaw assembly of the embodiment shown in FIG. 1 .

[0081] FIG2f is a top view of the distal end of the embodiment shown in FIG1a 2a with the sleeve retracted to expose the armature.

[0082] FIG. 2g is a top view 2a of the distal end of the embodiment shown in FIG. 1a, with a sleeve armature.

[0083] 2h is a side cross-sectional view of the grasping / controlling instrument and lysing tip 2a of the embodiment shown in FIG. 1 .

[0084] FIG. 2i is a perspective view 2a of the lower jaw cover of the embodiment shown in FIG. 1 .

[0085] FIG. 2j is a perspective view 2a of the lower jaw and tongue of the embodiment shown in FIG. 1 .

[0086] FIG. 2k is a perspective view of the distal end of the embodiment of FIG. 1a with the jaws open.

[0087] 2L is a perspective view of the lower jaw cover revealing the electrosurgical energy delivery opening 2a of the embodiment shown in FIG. 1 .

[0088] Figure 2m is a top view of a lysing tip with a ring.

[0089] FIG. 3 a is a top view of the lysing tip of the embodiment of FIG. 3 d .

[0090] 3b is an upper perspective view of the distal tip of the embodiment shown in FIG. 3d in a treatment configuration.

[0091] FIG. 3c is a perspective view of the embodiment previously depicted in FIG. 3a in a delivery configuration.

[0092] 3d is a perspective view of an embodiment of a system for delivering a lysing tip in a therapeutic configuration.

[0093] FIG. 3e is a perspective view of the embodiment shown in FIG. 3d in a delivery configuration.

[0094] 3f is a perspective view of the upper jaw cover of the embodiment shown in FIG. 3d.

[0095] 3g is a perspective view of the lower jaw cover of the embodiment shown in FIG. 3d.

[0096] FIG. 3h is a top view of additional features that may be added to the lysing tip of the embodiment shown in FIG. 3d.

[0097] FIG. 3i is a side perspective view of the bead of the embodiment shown in FIG. 3d.

[0098] 4a is a perspective view of an embodiment of a system for delivering a distal cannula in a therapeutic configuration, the cannula being positioned distally.

[0099] 4b is a perspective view of the embodiment previously depicted in FIG. 4a , with the sleeve positioned to proximally expose the armature and the jaws open.

[0100] FIG. 4c is a top view of the lysing tip of the embodiment shown in FIG. 4a.

[0101] FIG. 4d is a front view of the embodiment shown in FIG. 4a .

[0102] FIG. 4e is a perspective view of the lysing tip of the embodiment previously depicted in FIG. 4a.

[0103] 4f is a lower perspective view of the lysis member of the embodiment previously depicted in FIG. 4a.

[0104] FIG. 4g is a side view of a bead of the embodiment previously depicted in FIG. 4a.

[0105] FIG4h is a view of the other side of the bead depicted in FIG4g.

[0106] 4i is a cross-sectional view of the distal end of the grasping / controlling instrument of the embodiment shown in FIG. 4a.

[0107] 4j is a perspective view of the lower jaw cover of the embodiment shown in FIG. 4a.

[0108] 5a is a perspective view of an embodiment of a system for delivering an energy window in a therapeutic configuration with a sleeve located distally.

[0109] 5b is a perspective view of the embodiment depicted in FIG. 5a in a delivery configuration.

[0110] 5c is a side cross-sectional view of the gripping / controlling instrument of the embodiment shown in FIG. 5a.

[0111] FIG. 5 d is a top view of the TMT of the embodiment shown in FIG. 5 a .

[0112] FIG. 5 e is a front view of the TMT of the embodiment shown in FIG. 5 a .

[0113] FIG. 5f is a perspective view of the cover of the embodiment shown in FIG. 5a.

[0114] FIG5g is a perspective view of the energy window of the embodiment shown in FIG5a.

[0115] 5h is a perspective view of the lower jaw cover of the embodiment shown in FIG. 5a.

[0116] FIG. 6 a is a perspective view of a sleeve having an inflatable section.

[0117] FIG. 6 b is a front view of the sleeve shown in FIG. 6 a .

[0118] Figure 7a includes a perspective view of a lysing member / lysing rod having a circular cross-section.

[0119] 7b includes a perspective view of a lysing member / lysing rod having a triangular cross-section.

[0120] 7c includes a perspective view of a lysing member / lysing rod having a rectangular cross-section.

[0121] FIG7d includes a perspective view of a lysing member / lysing rod having a pentagonal cross-section.

[0122] FIG7dx includes a perspective view of a cleaving member / cleaving rod having a pentagonal cross-section that is twisted along its length.

[0123] Figure 7e includes a perspective view of a lysing member / lysing rod having a hexagonal cross-section.

[0124] Figure 7f includes a perspective view of a lysing member / lysing rod having a wedge-shaped cross-section.

[0125] Figure 7g includes a perspective view of a lysing member / lysing rod having a semi-circular cross-section.

[0126] 7h includes a perspective view of a spacer to a lysing tip, the spacer having a hole through its length, the hole having a circular cross-section and having non-beveled ends.

[0127] Figure 7i includes a perspective view of a spacer to a lysing tip, the spacer having a hole through its length, the hole having a circular cross-section with a beveled end.

[0128] 7j includes a perspective view of a spacer to a lysing tip, the spacer having a hole through its length, the hole having a circular cross-section with a beveled end and the hole.

[0129] Figure 7k includes a perspective view of a spacer to a lysing tip, the spacer having a hole through its length, the hole having a circular cross-section that is arcuate along its length.

[0130] 7L includes a perspective view of a spacer to a lysing tip with opposing rings connected by a rod in a relaxed state.

[0131] Figure 7m includes a perspective view of a spacer to lysing tip with opposing rings connected by a rod under stress.

[0132] FIG. 7n includes a perspective view of a spacer to a lysing tip having a hole with a triangular cross-section running through its length.

[0133] 7o includes a perspective view of a spacer to a lysing tip, the spacer having a hole with a rectangular cross-section throughout its length.

[0134] Figure 7p includes a perspective view of a spacer to a lysing tip, the spacer having a hole with a pentagonal cross-section throughout its length.

[0135] Figure 7px includes a perspective view of a spacer to a lysing tip having a hole running through its length with a pentagonal cross-section that is twisted along its length.

[0136] Figure 7q includes a perspective view of a spacer to a lysing tip, the spacer having a hole with a hexagonal cross-section throughout its length.

[0137] FIG. 7r includes a perspective view of a spacer to a lysing tip, the spacer having a hole through its length, the hole having a blade-shaped cross-section with rounded edges.

[0138] FIG. 7s includes a perspective view of a spacer to a lysing tip, the spacer having a hole through its length, the hole having a blade-shaped cross-section with flat edges.

[0139] FIG7t includes a perspective view of a spacer to a lysing tip having a hole with a mandrel cross section throughout its length.

[0140] FIG. 7aa is a perspective view of a bead having a spherical shape.

[0141] FIG7bb is a perspective view of a bead having a wheel shape.

[0142] FIG. 7cc is a perspective view of a bead having a dodecahedral shape.

[0143] Figure 7dd is a perspective view of a bead having a generally oval shape.

[0144] Figure 7ee is a perspective view of a bead having a generally oval shape with facets.

[0145] Figure 7ff is a perspective view of a bead having a generally oval shape and capable of receiving a sleeve.

[0146] Figure 7gg is a perspective view of a bead having a partial oval shape with a flat proximal end and facets.

[0147] 7hh is a perspective view of a bead having a partial oval shape with two flat surfaces at its proximal end.

[0148] Figure 7ii is a top view of a bead having a partially oval and convex proximal end.

[0149] Figure 7jj is a top view of a bead having a partial oval shape with an asymmetric proximal end having a facet.

[0150] Figure 7kk is a top view of a bead having a partial oval shape with an angled cutout at its proximal end.

[0151] 7LL is a top view of a bead having a partial oval shape with a concave proximal end.

[0152] FIG7 is a side view of an outer bead having a substantially annular shape, viewed from the outside.

[0153] Figure 7nn is a side view of the bead shown in Figure 7mm as seen from the inside.

[0154] Figure 7oo is a side view of a deformable bead having a generally annular shape.

[0155] FIG. 7pp is a side view of an intermediate bead having a generally annular shape and a protrusion on its proximal end.

[0156] Figure 7qq is a side view of a device having a generally annular central bead and a cross beam at its proximal end.

[0157] Figure 7rr is a side perspective view of a bead comprising a slot configured to engage a lysing element.

[0158] Figure 7ss is a perspective view of three beads of different lengths, which are in the shape of long strips with curved ends.

[0159] Figure 7tt is a perspective view of three beads of different lengths, which are in the shape of long strips with flat ends.

[0160] Figure 7uu is a perspective view of four beads of different lengths, having another shape.

[0161] Figure 7vv is a perspective view of four beads of different lengths, the shape of which is hollowed out along the axis.

[0162] Figure 7ww is a perspective view of four elongated beads having another shape.

[0163] Figure 7xx is a perspective view of four beads of different lengths, which are shaped in another way with both ends bent.

[0164] Figure 7yy is a perspective view of four beads of different lengths, which have a curved, elongated shape with flat sides.

[0165] Figure 7zz is a perspective view of a bead with an irregular surface.

[0166] Figure 7zzz is a perspective view of a bead with a regular surface.

[0167] 8a is a partial cross-sectional view of the lysing tip and grasping / control instrument being delivered within the body, the lysing tip being received and held by a second instrument until the grasping / control instrument grasps and controls the lysing tip for a surgical procedure.

[0168] Figure 8b is a perspective view of the interaction between the lysing tip, its gripping / controlling instrument and the temporary holding / gripping instrument.

[0169] FIG. 8c is a view of the abdomen illustrating the structure of the surgical apparatus to be used therein.

[0170] Figure 8d is a top view of the modular lysing tip illustrating the internal components of the locking mechanism.

[0171] 9a is a perspective view of an embodiment of a system for delivering a bipolar lysing tip in a therapeutic configuration with a sleeve located distally.

[0172] 9b is a perspective view of the embodiment depicted in FIG. 9a with the jaws open and the sleeve positioned proximally.

[0173] FIG. 9c is a front view of the embodiment shown in FIG. 9a .

[0174] 9d is a top view of a lysing tip coupled to the jaws of the embodiment depicted in FIG. 9a.

[0175] 9e is a perspective view of the bipolar lysing tip of the embodiment shown in FIG. 9a.

[0176] FIG. 9f is a perspective view of an electrode of the lysing tip of the embodiment shown in FIG. 9a.

[0177] FIG. 9g is a perspective view of an electrode opposite to the electrode shown in FIG. 9f.

[0178] 9h is a perspective view of the bipolar lysing tip of the embodiment depicted in FIG. 9a, with the crossbar transparent to expose the lysing section, and positioned in the lower jaw with the upper jaw removed.

[0179] 9i is a perspective view of the bipolar lysing tip of the embodiment depicted in FIG. 9a with the upper jaw removed, the crossbar positioned in the lower jaw, and the lysing section post exposed.

[0180] FIG9j is a cross-sectional view of the distal end of the embodiment shown in FIG9a in the position shown in FIG9c.

[0181] FIG. 9k is a cross-sectional view of the distal end of the embodiment shown in FIG. 9a at the position shown in FIG. 9c.

[0182] 9L is a perspective view of the jaw cover of the embodiment depicted in FIGs. 9j and 9k.

[0183] Figure 10a is a top view of a two-bead lyser.

[0184] FIG. 10 b is a top view of the embodiment shown in FIG. 10 a .

[0185] FIG. 10c is a perspective view of the embodiment shown in FIG. 10a.

[0186] FIG. 10 d is a top view of the electrode of the embodiment shown in FIG. 10 a .

[0187] FIG. 10e is a perspective view of the non-conductive body of the embodiment shown in FIG. 10a.

[0188] FIG. 10f is a side view of the lysing tip of the embodiment shown in FIG. 10a.

[0189] 10g is a cross-sectional view of the lower half of the embodiment shown in FIG. 10a taken along line 10g-10g of FIG. 10f.

[0190] 1Oh is a perspective view of an alternative embodiment of a non-conductive body.

[0191] 10i is a side view of the alternative embodiment lysing tip depicted in FIG. 10h.

[0192] 1Oj is a cross-sectional view of the lower half of the embodiment depicted in FIG1Oh, taken along line 1Oj-1Oj in FIG1Oi, wherein the electrodes are inserted into the non-conductive body.

[0193] 10k is a cross-sectional view taken along line 10k-10k of FIG. 10i of the lower half of an alternative embodiment having an improved electrode head.

[0194] 10L is a perspective view of a modified electrode of the alternative embodiment depicted in FIG. 10k .

[0195] Figure 11a is a perspective view of a three-bead lysis instrument according to some embodiments.

[0196] Figure 11b yes Figure 11a Perspective view of the lysing tip of the illustrated embodiment.

[0197] Figure 11c is Figure 11a Exploded view of the lysis tip of the embodiment depicted in FIG.

[0198] Figure 11d is Figure 11a Side view of the lysing tip of the illustrated embodiment.

[0199] Figure 11e It is taken along line 11e-11e in Figure 11d Figure 11a Cross-sectional view of the lysing tip of the illustrated embodiment.

[0200] Figure 11f is a perspective view of an alternative embodiment of a lysing tip.

[0201] Figure 11g is a side view of another alternative embodiment of a lysing tip comprising beads without channels.

[0202] Figure 11h It is along Figure 11g The line 11h-11h intercepted Figure 11g A cross-sectional view of an embodiment of the present invention.

[0203] Figure 11i is a side view of another alternative embodiment of a lysing tip in which the bead of the lysing tip is tilted relative to the axis of the instrument shaft.

[0204] 12 is a perspective view of a 2-bead lysing tip including a coated integral conductor according to other embodiments.

[0205] 13a is a perspective view of a three-bead lysis tip including a coated integral conductor according to other embodiments.

[0206] FIG. 13 b is a top view of the embodiment shown in FIG. 13 a .

[0207] FIG13c is a cross-sectional view taken along line 13c-13c in FIG13b.

[0208] 14a is a side view of an embodiment of a lysis instrument including a deflection system.

[0209] 14b is a perspective view of the distal end of the lysis instrument shown in FIG. 14a.

[0210] FIG. 14c is a front elevational view of the embodiment shown in FIG. 14a.

[0211] FIG. 14d is a perspective view of the deflector sleeve of the embodiment shown in FIG. 14a .

[0212] 15a is a perspective view of an embodiment of a bipolar lyser.

[0213] Figure 15b is a top view of the lysing tip of the embodiment of Figure 15a.

[0214] FIG. 15c is a side view of the embodiment of FIG. 15a .

[0215] FIG15d is a cross-sectional view taken along line 15d-15d in FIG15c.

[0216] Figure 16a is a perspective view of a tissue modification device in its therapeutic configuration.

[0217] Figure 16b It is in the middle structure Figure 16a A perspective view of the illustrated embodiment.

[0218] Figure 16c is in another intermediate configuration Figure 16a A perspective view of the embodiment shown.

[0219] Figure 16d is in its fully retracted configuration Figure 16aA perspective view of the illustrated embodiment.

[0220] Figure 16e is in its fully retracted configuration Figure 16a A cross-sectional view of the distal end of the embodiment.

[0221] Figure 16f is Figure 16a Exploded view of the illustrated embodiment.

[0222] Figure 17a is a perspective view of an alternative embodiment of a lysing tip.

[0223] Figure 17b yes Figure 17a Top view of the illustrated embodiment.

[0224] Figure 17c is a side view of an alternative embodiment of a lysing tip in which the bead adjacent to the nose of the lysing instrument includes an opening adjacent to the lysing section / electrode.

[0225] Figure 17d yes Figure 17c A perspective view of the illustrated embodiment.

[0226] Figure 17e It is along Figure 17c A cross-sectional view taken along line 17e-17e in FIG.

[0227] Figure 18a is a perspective view of an alternative embodiment of a lysing tip.

[0228] FIG. 18b is a top view of the embodiment shown in FIG. 18a .

[0229] Figure 19a is a perspective view of an alternative embodiment of a lysing tip.

[0230] Figure 19b is Figure 19a Top view of the illustrated embodiment.

[0231] Figure 20a is a perspective view of an alternative embodiment of a lysing tip.

[0232] FIG. 20b is a top view of the embodiment depicted in FIG. 20a .

[0233] Figure 21a is a perspective view of another alternative embodiment of a lysing tip.

[0234] Figure 21b yes Figure 21a Side view of the illustrated embodiment.

[0235] Figure 21c is along Figure 21b A cross-sectional view taken along line 21c-21c.

[0236] Figure 22ais a perspective view of one embodiment of a 2-bead lysing tip with tissue deflecting struts.

[0237] Figure 22b yes Figure 22a Side elevation view of a lysis tip according to an embodiment described in .

[0238] Figure 22c It is along Figure 22b Shot on the 22c-22c line Figure 22a A cross-sectional view of the upper half of the embodiment described in .

[0239] Figure 22d yes Figure 22a A close-up perspective view of the rear portion of a tissue deflecting strut of the embodiment described in FIG.

[0240] Figure 22e yes Figure 22a A close-up, side, rear perspective view of a tissue deflecting strut of an embodiment described in .

[0241] 23a is a perspective view of one embodiment of a 3-bead lysing tip with tissue deflecting struts.

[0242] Figure 23b is a side elevation view of the lysing tip of the embodiment depicted in Figure 23a.

[0243] 23c is a cross-sectional view of the lower half of the embodiment depicted in FIG. 23a taken along line 23c-23c- in FIG. 23b.

[0244] 23d is a rear close-up perspective view of the tissue deflecting strut of the embodiment depicted in FIG. 23a.

[0245] 23e is a side, rear perspective view of the tissue deflecting strut of the embodiment depicted in FIG. 23a.

[0246] 24 is a perspective view of one embodiment of a single bead lysing tip.

[0247] 25a is a perspective view of another embodiment of a single bead lysing tip with the electrodes fully recessed within the struts from the shaft to the bead.

[0248] Figure 25b is a side elevation view of the lysing tip of the embodiment depicted in Figure 25a.

[0249] FIG25c is a cross-sectional view taken along line 25c-25c in FIG25b.

[0250] Figure 26a is a top plan view of one embodiment of a sol-gel device including an angled portion.

[0251] Figure 26b yes Figure 26aA perspective view of an embodiment described in .

[0252] Figure 26c is Figure 26a A side elevation view of the embodiment described in .

[0253] Figure 26d is along Figure 26b Shot on the 26d-26d line Figure 26a Cross-sectional view of the upper half of the embodiment described in .

[0254] Figure 26e is Figure 26a Another embodiment of the lysis device described in, wherein the shaft has no angle and no bend.

[0255] Figure 27a is a top view of another embodiment of a cleaving tool including an angled shaft and an angled cleaving tip.

[0256] Figure 27b yes Figure 27a Close-up perspective view of the lysis tip of the embodiment described in .

[0257] Figure 27c It is possible to adopt Figure 27a Description of potential tissue anatomical pathways for the devices described in.

[0258] 28a is a perspective view of a tissue modification device comprising an axial treatment tip having rounded edges.

[0259] 28b is a perspective view of a tissue modification device comprising an axial treatment tip having non-rounded edges.

[0260] Figure 29a is a perspective view of a tissue modification device including a curved treatment tip extending perpendicular to an axis and having rounded edges.

[0261] 29b is a perspective view of a tissue modification device including a curved treatment tip extending perpendicular to the axis and having non-rounded edges.

[0262] 30 is a perspective view of a tissue modification device having a continuously curved treatment tip.

[0263] 31 is a perspective view of a tissue modification device comprising a curved treatment tip having a sharpened distal end.

[0264] FIG. 32 is a perspective view of a bipolar TMT device.

[0265] FIG33a is a perspective view of an electrode tip with a recess.

[0266] Figure 33b is a side elevation view of the embodiment depicted in Figure 33a.

[0267] Figure 33c is a top plan view of the embodiment depicted in Figure 33a.

[0268] FIG33d is a cross-sectional view taken along line 33d-33d in FIG33c.

[0269] FIG34a is a perspective view of a cylindrical electrode tip with a hole.

[0270] Figure 34b is a side elevation view of the embodiment depicted in Figure 34a.

[0271] Figure 34c is a top view of the embodiment depicted in Figure 34a.

[0272] FIG34d is a cross-sectional view taken along line 34d-34d in FIG34c.

[0273] Figure 35a is a perspective view of an electrode terminal with a dome / protrusion island in the center of the dome.

[0274] Figure 35b is a side elevation view of the embodiment depicted in Figure 35a.

[0275] Figure 35c is a top view of the embodiment depicted in Figure 35a.

[0276] FIG35d is a cross-sectional view taken along line 35d-35d in FIG35c.

[0277] Figure 36a is a perspective view of an electrode tip having a tapered conductive core with a conical hole / opening.

[0278] Figure 36b yes Figure 36a A side elevation view of the embodiment described in .

[0279] Figure 36c is Figure 36a A top view of the embodiment described in FIG.

[0280] FIG36d is a cross-sectional view taken along line 36d-36d in FIG36c.

[0281] Figure 37 is a bottom view of a TMT instrument having an axis including a right angle relative to the axis.

[0282] 38 is a perspective view of a TMT instrument including a treatment window on one portion and a sensor window on another portion.

[0283] Figure 39a A perspective view of a dissector with flattened features.

[0284] FIG39b is a perspective view of a stripper having flattened features and cut surfaces.

[0285] Detailed description

[0286] More details regarding various embodiments are provided below with reference to the accompanying drawings.

[0287] 1a-1v depict an embodiment of a CDTD (catheter delivered tissue dissector) or non-CDTD system 100. The system 100 includes a plurality of protrusions 101 defined by beads 151 and jaw covers 193aa / 194aa, with recesses 102 located between adjacent beads 151 and jaw covers 193aa / 194aa. The system 100 includes a lysing tip 110 that is configured to be completely separable from any other element of the system, but the lysing tip 110 can be configured to work with the distal end of the jaw assembly 193 / 194 of the grasping / controlling instrument 190 because the rigid gripping member 161 can provide the desired spacing between the lysing tip 110 and the distal end of the jaws.

[0288] Lysing tip 110 may include two beads 151a / 151b located at opposite ends of lysing member 160. In alternative embodiments, beads 151a / b may be replaced by beads of any shape, including but not limited to those shown in Figures 7aa to 7zzz. Bead 151 may be composed of facets 152. In the depicted embodiment, lysing member 160 may be permanently or temporarily coupled to a rigid and / or substantially rigid gripping member 161 as shown in Figures 1d, 1e, 1f, 1g, and 1i. In the depicted embodiment, gripping member 161 comprises a gripping wire. However, other embodiments are contemplated in which gripping member may comprise, for example, a flat gripping member, such as a gripping plate. As also depicted, gripping member 161 extends at right angles relative to lysing member 160, although this need not be the case in alternative embodiments. In some embodiments, one or both of jaws 193 / 194 may include a slot 197 configured to receive rigid gripping member / wire 161. Slot 197 can be configured to snugly receive rigid gripping wire 161 to prevent, or at least inhibit, rotation. Alternatively, slot 197 can be slightly larger than the diameter of rigid gripping wire 161, or can be configured to allow a user to adjust the size of slot 197 by actuating one or both of jaw assemblies 193 / 194. For example, a user can provide a desired amount of rotation corresponding to the force transmitted to jaw assemblies 193 / 194. In other embodiments, gripping member / wire 161 can have a non-circular cross-section, and slot 197 can have a similar non-circular cross-section to inhibit rotation. Other features can be included to limit or selectively allow rotation of lysing tip 110 by inhibiting rotation of rigid lysing wire 161 (e.g., a weld) and / or modifying the end of gripping wire 161 (e.g., a weld / metal end 161a). For example, in some embodiments, end 161a can be shaped as an ellipsoid, ellipse, or other geometric shape that can be enlarged relative to gripping member / wire 161 (in the illustrated embodiment, end 161a comprises a conductive metal hemisphere). In some embodiments, the distal end 161a can be configured to be received in a terminal portion of a slot 197, such as an opening 187, which can hold the tip 110 in a fixed position relative to the instrument 190. As described below, in some embodiments, the distal end of the opening 187 can also include a conduit to allow electrosurgical energy to be transferred from the instrument 190 to the lysing member 160 of the tip 110. In some such embodiments, the distal end 161a can protrude through the opening 187 to allow direct contact with a conductive portion of the instrument 190, such as the tongue 194a'.

[0289] In other contemplated embodiments, spacers may be placed adjacent to opposing outer beads 151a / b such that the rigid gripping wire 161 intersects the lysis member / rod between two spacers (not shown), with a spacer positioned between each two adjacent beads, as described below in conjunction with the alternative embodiment in FIG. 2 . Such spacers may be used to inhibit or selectively limit rotation, for example, by their shape and / or proximity to the intersection point. In alternative embodiments, the spacers may be replaced by spacers of any shape, including but not limited to those depicted in FIG. 7h-7t . This alternative embodiment may be applied to other embodiments herein.

[0290] In this embodiment, beads 151a / b can rotate about lysis rod 160, thereby allowing the surgeon to dissect on one or more sides of the backhand dissection plane, potentially making the procedure more efficient by dissecting in opposite directions. In some embodiments, beads 151a / b can be configured to rotate about lysis rod 160 such that the distal end of the beads becomes the proximal end when the motion of the lysis tip is reversed. However, in other embodiments, the rotation can be limited to another predetermined range of motion.

[0291] For example, as can also be seen in FIG1g , lysing rod 160 defines both distally and proximally facing lysing segments. In other words, at the distal end of lysing tip 110, lysing rod 160 defines a distally facing lysing segment between beads 151a and 151b, and on the opposite side, defines a pair of lysing segments on either side of wire 161, between wire 161 and / or insulating object 161c and adjacent beads. Thus, beads 151a / 151b and the lysing members / components of lysing tip 110 are specifically configured to enable dissection in both distal and proximal directions during use.

[0292] It should also be understood that beads 151a and 151b are preferably non-conductive, or at least substantially non-conductive, at least along their respective surfaces. Thus, beads 151a and 151b can serve as a shield, allowing adjacent tissue to be isolated and / or electrocuted by adjacent lysing segments. Unless otherwise indicated, by providing adjacent protruding non-conductive surfaces, the lysing segments can be isolated from the tissue being treated, while the bead surfaces, preferably the distal and proximal protruding surfaces, can be used to stretch, spread, guide, and / or position the target tissue without directly transferring electrosurgical energy from the beads to the tissue being dissected. Transferring electrosurgical energy from the beads themselves could cause unnecessary tissue damage and inhibit this function.

[0293] In the depicted embodiment, a removable sheath 195 on the exterior of the grip control instrument 190 can reduce electrosurgical discharges by protecting the upper and lower conductive jaw armatures 193a / 194a from exposure to bodily fluids, charred material, and debris. The removable sheath 195 typically extends along a substantial length of the shaft 190a of the grip control instrument 190. The sheath 195 can be composed of plastic, silicone, ceramic, cermet, halogenated hydrocarbon, and / or other non-conductive materials. The sheath 195 can be disposable to facilitate cleaning and sheath replacement. Prior to use, the sheath 195 can be slid into position to expose the metal armature of the jaw assembly for easy cleaning. During delivery and use, the sheath 195 can be slid distally until the distal end of the sheath 195 contacts the distal-most rib 189b of the jaw cover 193aa / 194aa. The upper and lower jaw covers 193aa and 194aa can be non-conductive and have a special shape with one or more ribs 189a / 189b ridges and / or surface features to prevent the outer sheath 195 covering the shaft 190a from sliding into an undesirable position. When the sheath and ribs are properly positioned, they can also form a seal to prevent unwanted discharges from occurring. In some embodiments, the ribs 189a / 189b can also provide the surgeon with a physical end point for the extension of the sheath 195.

[0294] When electrosurgical energy is applied to the gripping / control instrument 190, the beads 151a / 151b and the upper and lower jaw covers 193aa and 194aa are preferably non-conductive to minimize unwanted discharges. Each upper and lower jaw assembly 193 / 194 can include upper and lower jaws 193a / 194a, respectively, which can be conductive and / or metallic, and upper and lower jaw covers 193aa / 194aa. The upper jaw 193a and lower jaw 194a can include respective distal jaw tongues 193a' / 194a'. One or both non-conductive jaw covers 193aa and 194aa can define one or more receiving chambers 188a and 188b, respectively, to accommodate their respective conductive tongues 193a' or 194a'. Conductive tongues 193a' and / or 194a' can have an area adjacent to openings 187 in one or more non-conductive jaw covers 193aa / 194aa to allow electrosurgical energy to flow from the one or more conductive tongues to 161a of the distal rigid grip wire 161. In some embodiments, a portion of tongue 194a' and / or 193a' can be configured to protrude into opening 187 to further facilitate this energy transfer, perhaps in lieu of protruding distal end 161a. However, in the depicted embodiment, tongues 194a' and / or 193a' can be relatively flat in this area. Non-conductive jaw covers 193aa / 194aa can be composed of ceramic, cermet, glass, various halogenated hydrocarbons, and any other suitable non-conductor. The movement of the non-conductive jaw covers 193aa / 194aa can be restricted and / or secured to the conductive tongues 193a' / 194a' by one or more cover welds placed in cover weld holes 193c / 194c, which can be secured to each tongue, thereby restricting the movement of the corresponding jaw cover. When the surgeon activates the electrosurgical generator, electrosurgical energy can be transmitted through the metal push rod 190p, through the connecting rod 190L, and through the upper and / or lower jaws 193a / 194a connected to the jaw tongues 193a' / 194a'. The pivot points along the electrical path can be coupled in a manner known in the art, such as by pins.

[0295] The jaw assembly 193 / 194 may be comprised of single or double action jaws that can, but need not, open more than 10 to 15 degrees relative to one another to receive / capture the end 161a of the rigid grip wire 161. The range of motion may reduce damage to the ceramic covering 193aa / 194aa.

[0296] The cleaving tip 110 can be configured to prevent or limit lateral movement of the outer beads 151a / b by bonding a metal sphere 160a to the cleaving rod 160 within the bead rod channel 154 via a weld 160w, where the corresponding bead holes 155 intersect. In some embodiments, other objects can be welded or glued to effectively couple the beads 151a / 151b to the cleaving rod 160. In the depicted embodiment, a metal bulb 160a, such as a ball bearing or other sphere, can be passed down the hole 155 and welded to the end of the cleaving rod 160 at the weld 160w. This can allow the beads to undergo rotational movement about the cleaving rod 160. Any suitable welding technique can be used, however, resistance welding may be preferred. In the depicted embodiment, the length of the bead 151 is approximately 4 mm, the diameter of the channel 154 is approximately 0.55 mm, the diameter of the containing cracking rod 160 is approximately 0.5 mm, and / or the diameter of the bead hole 155 is approximately 0.8 mm. This facilitates the transport and welding of the approximately 0.7 mm metal sphere 160a. The diameter of the metal sphere 160a is preferably smaller than the hole 155, but larger than the channel 154, so that the bulb / sphere 160a can be inserted through the channel 154 and, once welded, prevents the cracking rod 161 from falling through / out of the channel 154. In some embodiments, other geometric shapes can be used to prevent the cracking rod 161 from falling through / out of the channel 154. A spherical or polyhedral, roughly spherical shape can still allow the beads 151a / b to rotate, as long as the channel dimensions and weld dimensions allow. Alternatively, bulbs of other shapes and / or sizes can be used to inhibit or limit the rotation of the corresponding beads, as needed.

[0297] In an alternative embodiment, as described in U.S. patent application Ser. No. 15 / 464,199, entitled "Device, System, and Method for Minimally Invasive Dissection of Tissue," the entire contents of which are incorporated herein by reference, the dimensions of the lysis rod 160 can be modified to approximate the width and / or thickness of the previously described lysis plate. Additionally, in an alternative embodiment, the rigid gripping wire 161 can be modified in width and thickness to resemble a plate. The end 161a can also be modified so that a corresponding recess is required in the upper jaw to allow for proper blocking of the jaw.

[0298] In some embodiments, the exposed areas of the rigid gripping wire 161 can be covered with an insulating coating, such as ceramic, cermet, glass, halogenated hydrocarbon, diamond-like carbon coating, plastic, epoxy, and the like. However, in the depicted embodiment, one or more exposed areas of the rigid gripping wire 161, rather than a coating, can be covered with a non-conductive object 161c, which can be composed of ceramic, cermet, and glass and can be shaped like a sphere, cylinder, and / or capsule. Such dielectric objects 161c on the exposed areas of the rigid gripping wire 161 can, among other things, facilitate smooth tissue movement of the lysing tip and reduce tissue trauma while also reducing unwanted discharges. Non-conductive objects such as object 161c may be preferable to a simple coating because they enhance the ability to suppress unwanted electrosurgical energy transfer and can be used by sliding such objects over the gripping wire 161.

[0299] While conventional non-conductive coatings can be applied to the jaws and armature of the distal grasper, such coatings may not be as effective in preventing discharge after a certain number of uses and / or cleaning cycles. Using ceramic and / or stronger non-conductive materials to manufacture the jaw covering can allow for more cleaning cycles, thereby providing more cost-effectiveness to the surgeon and / or patient.

[0300] Bead 151 or any other bead described herein is preferably made of a suitable inert, biocompatible and non-conductive material, such as, for example, a suitable plastic, aluminum oxide, zirconium oxide, silicon nitride, silicon carbide, glass, graphite, silicate, diamond, carbon-containing compounds, cermet or ceramic material, or a combination of one or more of the foregoing.

[0301] In the depicted embodiment, the lysis rod / component 160 is positioned through the bead 151 in a position that makes the bead 151 asymmetric and / or eccentric relative to the tunnel 154. In other words, as best illustrated in FIG1c , the tunnel 154 is positioned more to extend through a non-central position within the bead 151. Furthermore, in the illustrated embodiment, the bead 151 is asymmetric relative to an axis extending through the left and right centers of the bead 151 (perpendicular to the long axis of the bead). Furthermore, as shown, the distal / forward tip of the bead 151 may have a narrower end to act more like a wedge, serving as a blunt separator between tissue and tissue planes. A narrower and / or larger proximal / non-distal / rear end may produce a desired dragging effect, thereby orienting the bead in a desired direction for dissection. However, the rear / proximal end of the bead 151 may take many shapes, which may be larger and / or more prominent than the shape of the front / distal end of the bead. As shown in FIG1a , the front tip may be narrowed by using facets 152; thus, the front tip may be narrowed. Three are visible and numbered, with the fourth on the side opposite the reader. As described later in Figures 7aa-zzz, a variety of alternative bead shapes are possible, including, for example, ovoid, spherical, wheel-shaped, bullet-shaped, or other shapes with flat ends (e.g., frustoconical). As can be seen from some of the examples shown in Figures 7aa-zzz, in some embodiments, the bead can be symmetrical with respect to the opening for receiving the rod. In some embodiments, the bead 151 can be faceted on the top, bottom, sides, front, and / or back. The facets are preferably formed on the distal / front / leading portion of the bead to facilitate the tip's passage through tissue layers or between tissues.

[0302] In some embodiments, the channel 154 can be positioned at a non-central location within the bead 151. For example, in some preferred embodiments, the channel 154 can be located in a forward or distal position relative to the central axis of the bead 151. It may be desirable to allow the lysing tip 110 to be guided through the tissue in a desired manner, e.g., without allowing the beads 151 to rotate in an undesirable manner on their respective channels. However, some embodiments may be configured to allow a certain amount of such rotation so that the tip can be steered through the patient's tissue in a flexible manner.

[0303] In some alternative embodiments, the bead may also or alternatively be wider relative to the front or distal portion 101 of the channel 154 so that the bead 151 has a tail end that may be longer and / or narrower, which may produce desired aerodynamic properties and / or maneuverability; this may be similar to a "kite tail" effect.

[0304] Preferably, the entire surface of the bead can be smooth, however, some faceted features can provide a less smooth surface. For example, providing a smooth leading end and a smooth trailing end can allow the lysing tip to move in a forward direction and then back and forth in a rearward direction without catching unwanted tissue on the bead to inhibit such movement. However, as mentioned elsewhere in this disclosure, in some embodiments, the trailing end can include a flat surface so that the entire bead comprises a truncated oval or another similar shape. Preferably, at least the leading or distal surface of the bead is smooth and defined as an oval or another shape having at least a substantially smooth leading surface. In alternative embodiments, various portions of the bead can be textured or given surface irregularities that can produce a desired anatomical orientation, such as making the non-proximal / rear portion of the bead roughened on the surface to create resistance from the rear.

[0305] Preferably, the entire surface of the bead can be smooth, however, some faceted features can provide a less smooth surface. For example, providing a smooth leading end and a smooth trailing end can allow the lysing tip to move in a forward direction and then back and forth in a rearward direction without catching unwanted tissue on the bead to inhibit such movement. However, as mentioned elsewhere in this disclosure, in some embodiments, the trailing end can include a flat surface so that the entire bead comprises a truncated oval or another similar shape. Preferably, at least the leading or distal surface of the bead is smooth and defined as an oval or another shape having at least a substantially smooth leading surface. In alternative embodiments, various portions of the bead can be textured or given surface irregularities that can produce a desired anatomical orientation, such as making the non-proximal / rear portion of the bead roughened on the surface to create resistance from the rear.

[0306] In some embodiments, it may be desirable to allow the beads 151 to rotate on the cleaving rod 160. Thus, the beads 151 may not be three-dimensionally fixed relative to the cleaving rod 160 and / or one or more other elements of the cleaving tip 110. In some such embodiments, the beads 151 may be at least partially rotatable relative to the entire cleaving tip 110. For example, when encountering tissue similar to a vegetable / fruit peeler, the beads may rotate about the rod. In embodiments where the beads 151 are rotatable in this manner, it may be desirable to use a cleaving rod having a circular cross-section. Other embodiments are contemplated in which the beads may be movable in other ways relative to one or more elements of the cleaving tip 110 rather than being rotatable. The cleaving rod and / or cleaving head.

[0307] Each bead can include a hole 155 that can be positioned perpendicular to the lysis rod hole 154; the hole 155 can be positioned perpendicular to the lysis rod hole 154. The hole 155 can be used as a platform / location to add other features / components, such as providing a location for connecting a flexible wire as described below in conjunction with other embodiments and / or positioning sensors and / or RFID positioning components and / or for placing light-emitting and / or luminous elements for visualization, such as tri, etc.

[0308] The shape of the lysis member / lysis rod 160 may also be important in the most effective and safe means of transferring electrosurgical energy from the lysis rod to the tissue. Because electrosurgical energy above / below the surface tends to migrate toward the edges of an object, a lysis rod having a circular cross-section may force the current to flow toward opposing lysis rod tips and / or protrusions, thereby creating hot spots near adjacent beads and / or protrusions. Therefore, it may be beneficial for the lysis rod 160 to include a non-circular cross-section having substantially uniform edges along its length, from which the electrosurgical energy can be uniformly transferred to the tissue. In contemplated embodiments, a pentagonal or hexagonal cross-sectional shape may be preferred. In other embodiments, a spacer having a non-circular cross-section may accumulate less debris and / or tar on the lysis rod and / or spacer because the debris may have a harder time adhering to the angled edges when force is applied to the debris.

[0309] In alternative embodiments, the system 100 may be delivered into the body via a cannula and / or trocar, as shown in Figures 8a-8d.

[0310] The grasping / controlling instrument 190 may include means for grasping and / or controlling the lysing tip 110. "Control" herein may be described as including, but not limited to, physical movement and conduction of the lysing tip in any direction and / or orientation. Electrosurgical Energy Lysing Tip.

[0311] The deployment assembly of system 100 may further include a handle assembly 60 that can be used to selectively deploy the lysis tip 110 via shaft 191 and control various aspects of its delivery and / or use during surgery. Handle assembly 60 includes a body 61 connected to a pistol handle 62. Shaft 191 can extend from and be connected to handle assembly 60. A rocker assembly 65 or another such control device can be provided for actuating various features / functions / elements in the system. For example, rocker assembly 65 can be connected to a cable (not depicted) such that when pressing along the rocker assembly 165 along the top of the assembly, one or more jaw assemblies 193 / 194 can be opened or closed.

[0312] An electrosurgical actuation button 167a can be provided that the surgeon can use to initiate the delivery of electrosurgical energy to the lysing tip 110. More specifically, the electrosurgical actuation button 167a can be used to deliver electrosurgical cutting or blending energy to the lysing tip 110. As shown in FIG. 1t, a second electrosurgical actuation button 167b can be positioned to enable another type of energy to be delivered to the lysing tip 110. If desired, the buttons 167a / b can be positioned on the rocker assembly 65 or in the location of button 167b, as shown in FIG. 1t. Pressing or otherwise actuating the buttons 167a / b can cause such energy to be generated from an electrosurgical generator coupled to the handle assembly 60. The handle assembly 60 can also be used in conjunction with any other embodiment disclosed herein.

[0313] Should be understood that handle assembly 60 can be used in combination with one or more other systems disclosed herein. Of course, those skilled in the art will understand that, as desired, any other handle assembly, gun or other available control mechanism may also be used.

[0314] The handle assembly 60 can be more advantageous for procedures in which the lysing tip is intended for use in an internal cavity of the body and / or through a cannula / trocar that serves as a passage from the outside of the body to the inside of the body. In an alternative embodiment, the hand assembly 60' depicted in Figures 1u-v can provide the surgeon with a more optimized and / or more comfortable device for manipulating the lysing tip 110 via shaft 191'. In this embodiment, as more precisely depicted in the cross-section of Figure 1v, a push rod 190p within shaft 191' can be reversibly or permanently connected to a connecting linkage mechanism 64. In an alternative embodiment, a connecting device 63 can be used to facilitate the connection between push rods 190p and 190p. When the user moves the toggle 65' back and forth, the connecting linkage 64 is also moved and transmits its directional motion to the push rod 190p, which opens and / or closes one or both jaw assemblies 193 / 194. The delivery of one or more energy types may be actuated via buttons 167a ′ and 167b ′ to cause the electrosurgical generator to deliver a particular type of electrosurgical energy to the lysing tip 110 via the handle assembly 60 ′ and shaft 191 .

[0315] 2a-2m depict an embodiment of a CDTD or non-CDTD system 200. System 200 includes a plurality of protrusions 201 defined by beads 251 and jaw covers 293aa / 294aa, and recesses 202 located between adjacent beads 251 and jaw covers 293aa / 294aa. System 200 includes a lysing tip 210 configured to be completely separable from any other element of the system, however, lysing tip 210 can be configured to work in conjunction with the generally oval distal end of a gripping / controlling jaw assembly 293 / 294. Instrument 290 acts as a "pseudo-bead" during electrosurgery. The gripping / controlling instrument can include a gripping channel 297 (which can further include an electrosurgical energy transmission opening 287). Channel 297 can be configured to receive and / or secure a lysing rod 260.

[0316] The lysis tip 210 may include two beads 251a / 251b located at opposite ends of the lysis member 260. The lysis member 260 can be divided into a lysis section 261a (covered by a spacer 262) and 261b. In other embodiments, other features may be included to limit or selectively allow rotation, such as welding and / or spacers (e.g., spacer 262 extends from the inside of the bottom bead, as shown in FIG2f, to the clamp assembly 293 / 294.). In some embodiments, the spacer can be positioned adjacent to the opposing outer beads so that the clamp can clamp the lysis rod between the two spacers. Such spacers can be used to, for example, inhibit or selectively limit rotation by their shape and / or proximity to the clamp assembly 293 / 294. This alternative embodiment can be applied to other embodiments herein. In alternative embodiments, the spacer 262 can be replaced by a spacer of any shape, including but not limited to those shown in FIG7h to FIG7t. In the depicted embodiment, the beads 251a / b can be rotated about the lysing rod 260, so that the surgeon may be able to dissect on one or more sides of the opposite-hand dissection plane, potentially making the procedure more efficient by reversing the dissection direction. The beads 251a / b can be configured to rotate about the lysing rod 260 such that the distal end of the bead becomes the proximal end when the motion of the lysing tip is reversed.

[0317] In the depicted embodiment, a removable sheath 295 on the exterior of the grip control instrument 290 reduces electrosurgical discharges by protecting the upper and lower conductive jaw armatures 293a / 294a from exposure to bodily fluids, charred material, and debris. The removable sheath 295 typically extends along a substantial length of the shaft 291 of the grip control instrument 290. The sheath 295 can be composed of plastic, silicone, ceramic, cermet, halogenated hydrocarbon, and / or other non-conductive materials. The sheath 295 can be disposable, facilitating instrument cleaning and sheath replacement. Prior to use, the sheath 295 can be slid into position to expose the metal armature of the jaw assembly for easy cleaning. During delivery and use, the sheath 295 can be slid distally until the distal end of the sheath 295 contacts the distal-most rib of the ribs 289a of the jaw cover 293aa / 294aa. The upper and lower jaw covers 293aa and 294aa can be non-conductive and have a special shape with ribs 289a / 289b and / or ridges and / or surface features to prevent the outer sheath 295 covering the shaft 291 from sliding into an undesirable position. When properly positioned, the sheath 295 and ribs 289a can also form a seal to prevent unwanted electrical discharge. In some embodiments, the ribs 289a / 289b can also provide the surgeon with a physical end point for the extension of the sheath 295.

[0318] When the grasping / control instrument 290 is energized with electrosurgical energy, the beads 251a / 251b and the upper and lower jaw covers 293aa and 294aa are preferably non-conductive to minimize unwanted electrical discharges. Thus, each upper jaw assembly 293a and lower jaw assembly 293a are comprised of an upper jaw 293a, a lower jaw 293a, a lower jaw 293a, and a lower jaw cover 293a, respectively. The upper jaw 293a and lower jaw 294a may include respective distal jaw tongues 293a' / 294a'. One or both of the non-conductive jaw covers 293aa and 294aa may each be formed with one or more receiving chambers 288a (the lower jaw cover shown, the upper jaw cover not depicted) to accommodate their respective conductive tongues 293a' or 294a'. The conductive tongues 293 a ′ and / or 294 a ′ may be configured to deliver electrosurgical energy through the electrosurgical energy delivery openings 287 in the one or more non-conductive jaw covers 293 aa / 294 aa to allow the electrosurgical energy to flow to the lysis rod 260 .

[0319] In this embodiment, the opening 287 and slot 297 can be formed such that a portion of the tongue 294a' protrudes into the slot 297 to allow direct contact between the lysis rod 260 and the tongue 294a', as best illustrated in the cross-section of FIG. 2h. The non-conductive jaw covers 293aa / 294aa can be composed of ceramic, cermet, glass, various halogenated hydrocarbons, and any other suitable non-conductor. The movement of the non-conductive jaw covers 293aa / 294aa can be restricted and / or secured to the conductive tongues 293a' / 294a' by one or more cap welds placed in cap weld holes 293c / 294c, which can be secured to each tongue, thereby restricting the movement of the corresponding jaw cover. When the surgeon activates the electrosurgical generator, electrosurgical energy can be transmitted through the metal push rod 290p, the connecting rod 290L, and the upper and / or lower jaws 293a / 294a coupled to the jaw tongues 293a' / 294a'. The pivot points along the electrical path may be connected by, for example, pins, in a manner known in the art and as previously described.

[0320] The jaw assembly 293 / 294 can be composed of single action or double action jaws that can, but need not, open more than 10 to 15 degrees relative to each other.

[0321] In some embodiments, the lysis tip 210 can be configured to prevent or limit lateral movement of the outer bead 251a / b by joining a sphere 260a or other sphere to the lysis rod 260 within a rod-shaped tunnel (tunnel 154a / 154b FIG. 15B shown in FIG. 15B ) and a corresponding bead hole (hole 155a / 155b intersecting the tunnel shown in FIG. 1c ) as previously described. In some embodiments, other objects can be welded or glued to effectively couple the bead 251a / 251b to the lysis rod 260. In the depicted embodiment, a metal sphere 260a, such as a ball bearing, can be passed down through the bead hole and welded to the end of the lysis rod 260. This can allow for rotational movement of the bead about the lysis rod 260. Any suitable welding technique can be used, however, resistance welding may be preferred. In the depicted embodiment, the beads 255a / b are approximately 4 mm in length, the bead tunnel is approximately 0.55 mm in diameter, contains a cracking rod 260 having a diameter of approximately 0.5 mm, and / or the bead hole has a diameter of approximately 0.8 mm, which can inhibit transport. And a metal sphere 260a of approximately 0.7 mm is welded. The diameter of the metal sphere 260a is preferably larger than the bead channel, so that once welded, the now welded metal sphere 260a prevents the cracking rod 260 from passing through / withdrawing from the tunnel. In some embodiments, other geometries can be used to prevent the cracking rod 260 from passing through / withdrawing from the tunnel. The spherical shape of the spherical bearing or the generally spherical shape of the polyhedron can still allow the weld beads 251a / b to rotate as long as the channel size and weld size allow.

[0322] In an alternative embodiment, as shown in Figures 4a-4j, the size of the cleavage rods 260 may be varied to approximate the width and / or thickness of the cleavage plate.

[0323] While conventional non-conductive coatings can be applied to the jaws and armature of the distal grasper, such coatings may not be as effective in preventing discharge after a certain number of uses and / or cleaning cycles. Using ceramic and / or stronger non-conductive materials to manufacture the jaw covering may allow for more cleaning cycles, thereby saving costs for the surgeon and / or patient.

[0324] In an alternative embodiment, such as that shown in FIG2m, the lysis rod 260 and / or lysis tip 210 can be manipulated within a trocar and / or cannula and / or body cavity by means of a loop 244, which can comprise a biodegradable material. In contemplated embodiments, the loop can comprise an absorbable suture material, including but not limited to polyglycidol, polyglycolic acid, polylactic acid, and polydioxanone. A relative grasping instrument can temporarily grasp the loop 244 to hold the lysis tip 210 in place while the jaws of the treatment / grasping instrument 290 lock onto the desired portion of the lysis rod 260 and / or lysis tip 210. Upon release of energy and the generation of significant temperature, the biodegradable loop 244 can be configured to melt or decompose, exposing the desired portion of the lysis rod 210 so that treatment can commence. A variety of loop 244 shapes can be used, ranging from the simplest tied suture knot to the blower shape shown in FIG2m, to a simple rectangular shape with a hole that allows passage like a luggage check cord. Alternatively, the ring 244 can be glued to the lysis rod 260 using a biocompatible glue that can be broken down at high electrosurgical temperatures, which can range from 100° C. to extreme discharges within the body. In other embodiments, the tabs can be coupled to the lysis tip to facilitate transfer to the grip control instrument in a manner similar to the tongue 860t shown in Figures 8a and 8b.

[0325] In other embodiments, the system 200 can be modified to include a tether permanently or reversibly attached to the lysis rod 260, which tether passes through an opening in one or both of the jaw assemblies 293 and / or 294. For example, prior to surgery, a biocompatible thread can be connected to the swelling rod 260 by tying a knot and passed through an opening in one of the jaws. The threaded lysis tip 210 can be introduced into the body through an incision or through a cannula / trocar, perhaps assisted by the jaws of the gripping / controlling instrument 290. Once the end of the gripping / controlling instrument 290 is in a position with sufficient space for coupling, the tether can be tightened manually or by some mechanism to guide the lysis rod 260 into the slot 297.

[0326] Figures 3a-3i depict another embodiment of a CDTD or non-CDTD system 300. System 300 includes a lysing tip 310 comprising a protrusion 301 and a recess 302 defined by the areas between adjacent beads 351a / b / c / d, and more specifically, a lysing member comprising a lysing plate 360 ​​extending along tip 310. System 300 includes lysing tip 310, which can be configured completely separate from any other components of the system. However, in some embodiments, lysing tip 310 can be configured to work in conjunction with the generally elliptical shape at the distal end of the jaw assembly 393 / 394 of a gripping / control instrument 390, as this preferred insulating shape can function with beads 351a / b / c / d as previously described. Thus, the shape of the distal end of gripping / control instrument 390 can mimic the shape of the distal end of each of the various beads 351. Lysing tip 310 includes four beads 351a / b / c / d. One of these beads 351 d is located at the first end of the lysis tip 310, and beads 351a-c extend in a row adjacent to bead 351 d along the lysis element 360. Rather than having a flange opposite to flange 351 d, a bulbous end 361 is provided at the opposite end. The bulbous end 361 can comprise, for example, a spherical or hemispherical (e.g., a truncated spherical) shape, as described below, which can be used to allow a suitable instrument (e.g., a gripping / controlling instrument 390) to hold and / or manipulate the lysis tip 310 during a surgical procedure. While it may be preferred to position the bulbous end 361 at the end of the lysis tip 310, other embodiments are contemplated in which a portion for gripping and / or positioning the bulbous end 361 at another location along the lysis member 360 and / or tip 310 may be used.

[0327] In system 300, cleavage plate 360 ​​can be inserted and / or inserted into beads 351 via widened channel 354 and held in place by welding, glue, or other fasteners placed in holes 355 at the rear of the truncated beads. In other embodiments, holes 355 for facilitating welding or otherwise attaching beads 351a / b / c / d (collectively, 351) to cleavage plate 360 ​​can be positioned at any number of locations away from beads 351a / b / c / d. The cleavage plate dimensions can be approximately 0.3 mm thick and approximately 2 mm wide by approximately 7 mm long. However, in further conceivable embodiments, these dimensions can be multiplied by 1 / 3 to 10x. System 300 can be configured to prevent or limit lateral movement of beads 351 by securing bead holes 355 within the beads and to corresponding cleavage plate welds. Alternatively, if corresponding holes are formed in cleavage plate 360, a substantially solid object such as a pin or glue can be inserted to effectively couple beads 351 to cleavage plate 360. In an alternative embodiment, the holes in the lysis plate 360 ​​may be replaced with grooves that can accommodate solid objects inserted through the retaining bead holes 355 .

[0328] In the depicted embodiment, the lysis member 360 includes a plate 360, which may include a proximal lysis plate 360p and a gripping end including a spherical end 361. In the depicted embodiment, the gripping end is a metal sphere 361, which may be configured to match the shape as described in more detail below, although the shape may allow for features of corresponding features of one or both jaws in the instrument 390. However, the shape may allow for some rotation / pivoting of the tip 310 while within the instrument 390, as described in more detail below, although other shapes are contemplated in which the shape may vary. Thus, the gripping and / or bulbous end 361 may include a geometrically shaped end 361, such as a sphere, a polyhedron, etc. In some embodiments, when grasped by the grasping / control instrument 390 to perform a surgical procedure, the distal end gripping / control instrument 390 of the jaw assembly 393 / 394 can substantially mimic the shape and / or function of the beads 351a / b / c / d, thereby defining a lysis segment between each bead 351a / b / c / d and between the jaw assembly 393 / 394 and the magnetic bead 351a. In some embodiments, the portion of the jaw assembly 393 / 394 extending onto or above the lysis plate 360 ​​can have a distal shape and size that is the same as, or at least similar to, the bead 351. For example, the distal end portion of the jaw assembly 393 / 394 can have a rounded / smooth surface that tapers toward a rounded tip similar to that of the bead. At a minimum, preferably, the shape and size of the distal end jaw assembly 393 / 394 allows an adjacent portion of the swelling plate 360 ​​to contact or nearly contact the target tissue. The bead 351 and the distal portion of the jaw assembly 393 / 394 together can be used as a blunt dissector to separate tissue without cutting. When the device is powered with electrosurgical energy, the bead 351 and the outer surfaces of the jaw assembly 393 / 394 are preferably non-conductive so as to perform the blunt dissection function. The interior of one or both jaw assemblies 393 / 394 and / or their corresponding lower jaws defines a receiving slot 397. In some embodiments, the receiving slot 397 can be formed in a cover, as previously described, which can be assembled on one or both jaws. However, alternative embodiments are contemplated in which the receiving slot 397 can be formed directly in one or both of the two jaws.

[0329] In the depicted embodiment, the receiving slot 397 may include a treatment locking portion 397a, which may include a flat recess that can be configured to mate with the shape of the lysing member 360 located near the distal end 361. The receiving slot 397 may further or alternatively include only a rotational portion 397b, which may include a circular opening that can be configured to rotationally engage the ball-shaped distal end 361 and allow rotation between the delivery and treatment configurations. In some embodiments, a similar rotational slot may be formed in the opposing jaw. In the depicted embodiment, the receiving slot 397 may also serve as an opening for transferring electrosurgical energy from the instrument 390 through the jaw cover to the lysing member 360. Thus, the rotational portion 397b may coincide with the opening 387 in the lower jaw cover 394aa. When the gripping / protruding distal end 361 is placed in the conductivity opening 387 of the receiving slot 397, if electrosurgical energy is applied to the gripping / control device 390, then, with appropriate access, electrosurgical energy can pass through the lysing plate 360 ​​and into the target tissue. Preferably, the ball end 361 , opening 387 and jaws 394 are configured to facilitate direct contact between the conductive jaws or jaw portions and the ball end 361 .

[0330] Figures 3b, 3c, and 3d depict the system 300 in a treatment configuration in which the lysis plate is locked between the jaw assemblies 393 / 394 and held in position on the proximal lysis plate 360p and gripping tip 361 due to their similar assembly, key and lock access receiving slot 397, and conductive conductive opening 387 in the lower jaw cover 394aa.

[0331] FIG3e depicts the system 300 in a delivery / deployment configuration in which the cleavage plate 360 ​​is positioned approximately parallel to the axis of shaft 390a. The proximal cleavage plate 360p is positioned between the slightly opened jaw assemblies 393 / 394. Because the spherical body at the gripping end 361 is captured by the conductive opening 387, and in some embodiments, the corresponding opening in the upper jaw assembly is captured, the proximal cleavage plate 360 ​​can be prevented from falling out of the jaws. 393 can accommodate the upper portion of the gripping end 361. Thus, after the cleavage tip 310 is delivered to the human body, for example, via a cannula, such as in the delivery configuration of FIG3e, the cleavage tip 310 can be rotated and swiveled. In the treatment configuration of FIG3d, it is positioned within the receiving slot 397.

[0332] In some embodiments, the lysis member 360 can comprise a rigid and / or substantially rigid wire. In such embodiments, one or both of the jaw assemblies 394 / 394 can be reshaped at the treatment position locking slot to accommodate the size of the rigid wire. In some embodiments, such a rigid wire can further comprise a gripping end that can be disposed at the distal end of the wire.

[0333] In some embodiments, a spacer can be positioned adjacent to the opposing bead 351 and / or between the bead 351a and the end 361 to allow for altered rotation or motion. Such spacers can be used to inhibit or selectively limit rotation, for example, by their shape and / or proximity to the jaw assembly 393 / 394. In this embodiment, the surgeon can perform dissections on one or more sides of the reverse hand, potentially making the procedure more efficient. In some preferred embodiments and implementations, reverse dissections are permitted.

[0334] In alternative embodiments, beads 351 can be replaced with beads of any shape, including but not limited to those depicted in Figures 7aa to 7zzz. In some embodiments where a spacer is located between the lysis rod and the gripping jaws, the tolerance between the lysis rod and the spacer can allow the lysis rod to rotate within the spacer, thereby allowing the beads to rotate relative to the spacer and / or the gripper. The tolerance can be adjusted to allow a predetermined amount of rotation.

[0335] In the depicted embodiment, a removable sheath 395 on the exterior of the grip control instrument 390 can reduce electrosurgical discharges by protecting the upper and lower conductive jaw armatures from exposure to bodily fluids, charred material, and debris. The removable sheath 395 can be slidably positioned along a substantial length of the shaft 390a of the grip control instrument 390. The sheath 395 can be composed of plastic, silicone, ceramic, cermet, halogenated hydrocarbon, and / or other non-conductive materials. The sheath 395 can be disposable to facilitate cleaning of the instrument 390 and / or replacement of the sheath 395. Prior to use, the sheath 395 can be slid into position to expose the metal armature of the jaw assembly to facilitate cleaning. During delivery and use, the sheath 395 can be slid distally until the distal end of the sheath 395 contacts one or both of the ribs 389a of the jaw covers 393aa / 394aa. The upper and lower jaw covers 393aa and 394aa can be non-conductive and have a special shape with ribs 389a and / or ridges and / or surface features to prevent the outer sheath 395 covering the shaft 390a from sliding into an undesirable position. When properly positioned, the sheath 390 and ribs 389a can also form a seal to prevent unwanted electrical discharge. Another feature of the ribs 389a is to provide the surgeon with a physical endpoint to the extension of the sheath 395.

[0336] While the grip / control instrument 390 is similar to the grip control instruments 190 and 290, the weld bead 351 and the upper and lower jaw covers 393aa and 394aa are preferably non-conductive when energized with electrosurgical energy to minimize unwanted discharges. Each upper and lower jaw assembly 393 / 394 can include upper and lower jaws 393a / 394a, respectively (which can be conductive and / or metallic) and upper and lower jaw covers 393aa / 394aa. The upper jaw 393 and lower jaw 394 can include respective distal jaw tongues, as previously described. One or both of the non-conductive jaw covers 393aa and 394aa can each be formed with one or more receiving chambers 388a (not shown for the lower jaw cover 394aa) to accommodate their respective conductive tongues. The conductive tongues and / or conductive tongues can be configured to transmit electrosurgical energy through electrosurgical energy delivery openings 387 in one or more non-conductive jaw covers 393aa / 394aa, allowing electrosurgical energy to flow to or from the one or more conductive tongues. The non-conductive jaw covers 393aa / 394aa can be composed of ceramic, cermet, glass, various halogenated hydrocarbons, or any other suitable non-conductor. The non-conductive jaw covers 393aa / 394aa can be restricted in movement and / or secured to the conductive tongues by one or more cover welds placed in cover weld holes 393c / 394c, which can be secured to each tongue, thereby restricting movement of the corresponding jaw cover. When the surgeon activates the electrosurgical generator, electrosurgical energy can be transmitted through the metal push rod and / or connecting rod, as previously described. Energy can then be transmitted through the upper and / or lower jaws 393 / 394 via their respective jaw tongues. Pivot points along the electrical path can be coupled in a manner known in the art, such as by pins.

[0337] The jaw assembly 393 / 394 can be composed of single-action or double-action jaws that can, but need not, open more than 10 to 15 degrees relative to each other in order to receive / capture the end 361 of the lysing member 360 .

[0338] In the depicted embodiment, 347 represents an antenna configured to transmit a signal to a receiver unit. In some embodiments, antenna 347 may comprise a radio frequency identification (RFID) tag. In some embodiments, the RFID tag may comprise an RFID transponder. In other embodiments, the RFID tag may comprise a passive tag. It should be understood that antenna 347 is not depicted in any of the other figures. Any embodiment described herein may include one or more such elements. Other embodiments may include one or more antennas in any other suitable location on the embodiment, including but not limited to on a protrusion or on a tip, as well as on a shaft. In embodiments where antenna 347 comprises an RFID transponder, the RFID transponder may comprise a microchip, such as one with rewritable memory. In some embodiments, the tag may be less than a few millimeters in size. In some embodiments, a reader may generate an alternating electromagnetic field that activates the RFID transponder and may transmit data via frequency modulation. In one embodiment, the position of the RFID tag or other antenna may be determined by an alternating electromagnetic field in the ultrahigh frequency range. This position may be related to a 3D map of the object. In one embodiment, the reader may generate an alternating electromagnetic field. In some such embodiments, the alternating electromagnetic field can be at a shortwave (13.56 MHz) or UHF (865-869 MHz) frequency. Examples of potentially useful systems and methods for mapping / tracking surgical instruments relative to a patient's body can be found in U.S. Patent Application Publication No. 2007 / 0225550, entitled "Systems and Methods for 3-D Tracking of Surgical Instruments Relative to a Patient," the entire contents of which are incorporated herein by reference.

[0339] In some embodiments, a transmission unit can be provided that can generate a high-frequency electromagnetic field that is configured to be received by the antenna of the RFID tag or another antenna. The antenna can be configured to induce a current from the electromagnetic field. This current can activate the tag's circuitry, which can result in the transmission of electromagnetic radiation from the tag. In some embodiments, this can be achieved by modulating the field created by the transmission unit. The frequency of the electromagnetic radiation emitted by the tag can be different from the frequency of the radiation emitted by the transmission unit. In this way, the two signals can be identified and distinguished. In some embodiments, the frequency of the signal from the tag can be within the range of the frequency of the radiation emitted from the transmission unit. Additional details regarding RFID technology that can be used in conjunction with one or more embodiments discussed herein can be found, for example, in U.S. Patent Application Publication No. 2009 / 0281419, entitled "System for Determining the Location of a Medical Device." The contents of which are incorporated herein by specific reference.

[0340] In other embodiments, the antenna 347 may include a Bluetooth antenna. In such embodiments, multiple corresponding Bluetooth receivers at known locations may be configured to sense the signal strength from the Bluetooth antenna 347 and triangulate this data to locate the signal from the Bluetooth antenna 347, thereby positioning the lysis tip within the patient's body. Other embodiments may be configured to use angle-based electronic positioning techniques and devices to locate the signal from the antenna 347. Some such embodiments may include the use of directional antennas, which may be used to increase the accuracy of positioning. Still other embodiments may include the use of other types of hardware and / or signals that may be useful for positioning, such as WIFI and cellular signals. The antenna 347 may be located within the aperture 355'.

[0341] One or more receiver units can be provided to receive signals from the tag. By evaluating, for example, the signal strength at each receiver unit, the distance to each receiver unit can be determined. By determining such distances in this manner, the precise location of the cleavage tip relative to the patient and / or a specific organ or other surgical site on the patient can be determined. In some embodiments, a display screen with appropriate software can be coupled with RFID or other positioning technology to allow the surgeon to visually see at least the approximate location of the tag / antenna and, therefore, the relative location of the cleavage tip in the patient's body.

[0342] Some embodiments may be further configured such that data from the antennas may be used in conjunction with sensor data from the device. For example, some embodiments including one or more sensors 348 may be further configured with one or more RFID tags. In this way, data from the one or more sensors may be paired or otherwise used with data from one or more RFID tags or other antennas. For example, some embodiments may be configured to provide the surgeon with information about one or more locations on the body where one or more sensor readings were obtained. In some embodiments, the temperature sensor may include a thermistor and / or a thermocouple. To further illustrate using another example, information about tissue temperature may be combined with the location from which such tissue temperature was obtained. In this way, the surgeon may be provided with specific information about which locations within the patient's body have been treated in an effective manner and, therefore, which locations do not require further treatment using the device.

[0343] In some such embodiments, a visual display can be provided that includes an image of the patient's body and / or an image of one or more selected regions of the patient's body. Such a system can be configured to provide a visual indication of one or more regions in the image that correspond to areas of the patient's tissue that have been adequately treated. For example, a display of a patient's liver may change color at locations on the display corresponding to areas of the liver that have undergone a sufficient degree of fibrosis or other treatment. In some embodiments, such regions can be configured so that pixels corresponding to a particular region illuminate only after the corresponding tissue in that region reaches a certain threshold temperature.

[0344] Such a sensor 348 can be coupled to an antenna that can send and / or receive one or more signals to / from a processing unit. Alternatively or additionally, data from such a sensor generated from tissue and / or fluid analysis using such a sensor can be stored locally and transmitted later. As another alternative, such a signal can be sent after the procedure. In such an embodiment, the signal does not necessarily have to be transmitted wirelessly. In fact, some embodiments can be configured to store data locally, after which a data module such as a memory stick can be removed from the device and uploaded to a separate computer for analysis. The sensor 348 can be located within the aperture 355'.

[0345] In alternative embodiments, the energy window 306 can be positioned within the bead aperture 355' or on the surface of the bead 351 and can be configured to deliver different types of energy in different directions. For example, in Figure 3h, the energy window 306 can direct energy perpendicular to the forward motion of the lysing tip 310 and / or can be configured to deliver another type of electrosurgical energy or a different form of energy, including, but not limited to, laser, intense pulsed light, resistive heating, radiant heat, thermochromic, ultrasound, mechanical, and / or microwave.

[0346] Figures 4a-4j depict an embodiment of a CDTD or non-CDTD system 400. System 400 includes a plurality of protrusions 401 defined by beads 451 and jaw covers 493aa / 494aa, with recesses 402 located between adjacent beads 451 and jaw covers 493aa / 494aa. System 400 includes a lysing tip 410 configured to be completely separable from any other system components; however, lysing tip 410 can be configured to operate in conjunction with the generally elliptical distal ends of the gripping / controlling jaw assemblies 493 / 494. Instrument 490 acts as a "pseudo-bead" during electrosurgery. Lysing tip 410 includes a plurality of beads 451 located on a lysing member 460, which includes a lysing plate 460. Lysing plate 460 can also include a gripping / controlling instrument interface 461a comprising a protruding conductive metal hemisphere or other hemispherical member configured to bend. Engage with corresponding features on one or both jaw assemblies 493 / 494. It should be noted that in the embodiments of 4a-4j, the bead 451 is laterally supported by the lysis plate 460. It should also be noted that the bead 451 lacks a base, such as the base of the system 100 detailed in U.S. patent application Ser. No. 105 / 464,199, and instead defines a lysis tip that lacks a support structure immediately behind the bead. It should also be noted that the lysis tip 410 includes the bead 451, which protrudes distally and proximally relative to the lysis plate 460.

[0347] The gripping / controlling instrument 490 may include a gripping channel 497 (which may further include an electrosurgical energy delivery opening 487). The channel 497 may be configured to receive and / or secure the lysis plate 460. The leading edge of the lysis plate 460 may include a beveled feature 460b that, if positioned on the bottom of the lysis tip 460, may cause the lysis tip 460 to rise when traversing tissue. The feature 460b may also be sharpened to facilitate transferring electrosurgical energy in a desired manner and / or to allow manual dissection in the absence of electrosurgical energy.

[0348] In the depicted embodiment, a removable sheath 495 on the exterior of the grip control instrument 490 can reduce electrosurgical discharge by protecting the upper and lower conductive jaw armatures 493a / 494a from exposure to bodily fluids, charred material, and debris. The removable sheath 495 typically extends along a substantial length of the shaft 491 of the grip control instrument 490. The sheath 495 can be comprised of plastic, silicone, ceramic, cermet, halogenated hydrocarbon, and / or other non-conductive materials. The sheath 495 can be disposable, facilitating cleaning and sheath replacement. Prior to use, the sheath 495 can be slid into position to expose the metal armature of the jaw assembly for easy cleaning. During delivery and use, the sheath 495 can be slid distally until the distal end of the sheath 495 contacts the distal-most rib 489a of the jaw cover 493aa / 494aa. The upper and lower jaw covers 493aa and 494aa can be non-conductive and have a special shape with ribs 489a and / or ridges and / or surface features to prevent the outer sheath 495 covering the shaft 491 from sliding into an undesirable position. When properly positioned, the sheath 495 and ribs 489a can also form a seal to prevent unwanted electrical discharge. In some embodiments, the ribs 489a can also provide the surgeon with a physical end point for the extension of the sheath 495.

[0349] When the grasping / control instrument 490 is energized with electrosurgical energy, the bead 451 and the upper and lower jaw covers 493aa and 494aa are preferably non-conductive to minimize unwanted electrical discharges. Each upper and lower jaw assembly 493 / 494 can therefore include upper and lower jaws 493a / 494a (which can be conductive and / or metallic) and non-conductive upper and lower jaw covers 493aa / 494aa, respectively. The upper jaw 493a and lower jaw 494a can include respective distal jaw tongues 493a / 494a'. One or both non-conductive jaw covers 493aa and 494aa can be formed with one or more receiving cavities 488a (the lower jaw cover shown, the upper jaw cover not shown) to accommodate their respective conductive tongues 493a' or 494a'. The conductive tongues 493 a ′ and / or 494 a ′ may be configured to deliver electrosurgical energy through the electrosurgical energy delivery openings 487 in the one or more non-conductive jaw covers 493 aa / 494 aa to allow the electrosurgical energy to flow to the lysis plate 460 .

[0350] In this embodiment, the opening 487 and slot 497 can be formed so that a portion of the tongue 494a' protrudes into the slot 497 to allow direct contact between the cleavage plate 460 and the tongue 494a', as best illustrated in the cross-section of FIG. 4i. The non-conductive jaw covers 493aa / 494aa can be composed of ceramic, cermet, glass, various halogenated hydrocarbons, and any other suitable non-conductor. The movement of the non-conductive jaw covers 493aa / 494aa can be restricted and / or secured to the conductive tongues 493a' / 494a' by one or more cap welds placed in cap weld holes 493c / 494c, which can be secured to each tongue, thereby restricting the movement of the corresponding jaw cover. When the surgeon activates the electrosurgical generator, electrosurgical energy can be delivered through the metal push rod 490p, through the connecting rod 490L, and through the upper and lower jaws 493a / 494a connected to the jaw tongues 493a / 494a'. The pivot points along the electrical path may be connected by, for example, pins, in a manner known in the art and as previously described.

[0351] The jaw assemblies 493 / 494 may be comprised of single action or double action jaws that can, but are not required to, open more than 10 to 15 degrees relative to each other.

[0352] In some embodiments, the cleaving tip 410 can be configured to prevent or limit lateral movement of the outer bead 451 by welding a spherical object or other object to the cleaving plate 460 at the intersection of the plate tunnel 454 and the bead hole 455, as previously described. In some embodiments, other objects can be welded or glued to effectively couple the bead 451 to the cleaving plate 460. In the depicted embodiment, a metal sphere 460a, such as a ball bearing, can be passed down the bead hole and welded to its end or top. Any suitable welding technique can be used, however, resistance welding may be preferred. In some embodiments, other geometries can be used to prevent the cleaving plate 460 from being withdrawn through the tunnel. The spherical shape of a ball bearing or the generally spherical shape of a polyhedron can still allow the weld bead 451 to rotate, as long as the channel dimensions and weld dimensions allow. In some embodiments, a pin, screw, rivet, or the like, or epoxy or metal weld, can extend through the vertical hole 455 to secure the two elements together. In alternative embodiments, the hole 455 can be replaced by a bevel. Thus, in some embodiments, horizontal and / or vertical tunnels may not be required. However, in other embodiments, plate 460 can include beveled surfaces or narrowed areas configured to fit within such tunnels formed within bead 451. Because the use of plate 460 can provide greater rigidity than certain other embodiments, the lysing tip 410 may not require the use of spacers. Bead 451 can include facets 452.

[0353] 5a-h depict a TMT system 500 comprising a free-floating tissue modification tip (TMT) 511 connectable to a grasping / controlling instrument 590. In this embodiment, the TMT 511 may comprise a grasping end having a bulbous portion 506a. In the depicted embodiment, the grasping end comprises a metal sphere 506a that may be configured to match the shape of a corresponding feature of one or both jaws of the instrument 590. Although this shape may allow for some rotation / pivoting of the tip 510 within it, as described in greater detail below, the instrument 590 contemplates other shapes that may vary in shape. Thus, the grasping and / or bulbous end 506a may comprise an end 506a having a geometric shape, such as a polyhedron. When grasped by the grasping / controlling instrument 590 to perform a surgical procedure, in some embodiments, energy, such as electrosurgical energy, may be transmitted from one or both of the jaw assemblies 593 / 594 of the instrument 591 (e.g., the tongues 593aa / 594aa of these jaws). As previously described, the interior of one or both of the jaws can define a receiving slot 597 that can be configured to engage the distal end 506a and allow contact with a conductive portion of one or both jaws, i.e., the electrosurgical energy delivery opening 587. In some embodiments, the receiving slot 597 can be formed in a cover that, as previously described, can be assembled over one or both jaws of the instrument 590. However, other embodiments are contemplated in which the receiving slot 597 can be formed directly in one or both jaws.

[0354] In the depicted embodiment, the receiving slot 597 can include a treatment lock portion 597a, which can include a flat groove that can be configured to match the shape of the tip 511 at one end near the end 506a, such as at the flat area 506. 597 can further or separately include a rotation portion 597b, which can include a circular opening that can be configured to rotationally engage the ball-shaped end 506a and allow rotation between the delivery configuration of Figure 5b and the treatment configuration of Figure 5a. In some embodiments, a similar rotation slot can be formed in the opposing jaws. In the depicted embodiment, the receiving slot 597 can also serve as an opening for transferring electrosurgical energy from the instrument 590 through the jaw cover through the electrosurgical energy transfer opening 587 to the conductive portion of the tip 511.

[0355] More specifically, the tip 511 includes an energy window 508o, which can be positioned to face the upper and / or lower tissue planes that may have been lysed / dissected. The non-conductive cover 508 may have one or more windows 508o that allow the conductive element 506t to extend therethrough to provide energy delivery via electrosurgery or other means. In alternative embodiments, one or more rods or other structural elements may be formed in the cover 508 to separate the elongated energy window 506t into multiple, isolated energy windows. While the energy windows 506t are strip-shaped, various alternative shapes and sizes of energy windows and / or structures defining the emission areas of the energy windows may be provided as desired. In some embodiments, the cover 508 may be formed with multiple circular openings. The cover 508 may be overmolded onto the tip 511. The cover 508 may be manufactured in two pieces that are coupled around the metal member 506. In alternative embodiments, the region of the energy window 506t may include one or more energy emitters, positioned to optimize the desired tissue modification effect.

[0356] As previously described, the rotating portion 597b can coincide with the opening 587 in the lower jaw cover 594aa. When the grip / ball tip 506a is placed into the conductive portion 587 of the receiving slot 597, if electrosurgical energy is applied to the grip / control device 590, the electrosurgical energy can enter the target tissue through the energy window 506t when positioned downwardly. Preferably, the ball tip 506a, opening 587, and jaws 594 are configured to facilitate direct contact between the conductive jaws or jaw portions and the ball tip 506a. The grip / control instrument 590 can include a shaft 591, a push rod 592, and jaw assemblies 593 / 594, which can be covered by a removable non-conductive sheath 595.

[0357] In alternative embodiments, the energy window 506t can be configured to be positioned on the bottom of the device. However, in various embodiments, the surgeon can simply reverse the tip of the top-mounted energy window 506t so that it points in the opposite direction (e.g., away from the surface skin and toward the subcutaneous tissue). In the case of cellulite and other cosmetic conditions, it may be helpful to direct energy toward subcutaneous deposits.

[0358] Some embodiments may include an energy window 506t located proximal to the protrusion 201. In the depicted embodiment, the energy window system 506t may include electrode terminals that may be supplied with energy from an energy source via a conduit (not shown) that may include, for example, electrical wires and / or fiber optic filaments. The energy window 506t may be configured in any manner to accommodate any energy modality, including but not limited to laser, intense pulsed light, resistive heating, radiant heat, thermochromic, ultrasonic, mechanical, and / or microwave.

[0359] In other embodiments depicted in Figures 6a-b, the outer sheath 695, or in other embodiments, the outer surface gripping and / or control device, may include an expandable segment 698 along a portion of the shaft and / or sheath 695, preferably along the distal portion of the shaft and / or sheath 695. Longer cannulas may be difficult to control for applications farther from the entry wound. Therefore, these expandable segments 698 are particularly useful in cosmetic procedures, such as cellulite treatment, to more superficially press the clamps and swelling rods / segments against the underlying dermis. In the depicted embodiment, two balloon-like, tubular inflatable segments 698 may be present at the distal to mid-portion of the sheath. One or more supply tubes 698s may be connected to the expandable segments 698. The expandable segments 698 may measure half the diameter of the sleeve 695. However, in other embodiments, the expandable segments 698 may range from 1 / 10 to 10 times the sheath diameter. The inflatable segment 698 can expand in size (e.g., from about 10% to about 10,000%) when filled with a fluid, which can include a gas, water, carbon dioxide, nitrogen, or the like. The presence of the inflatable segment 698 can facilitate surgery from an entry wound to a more distal location. The inflatable segment 698 can be deflated prior to removal of the device. The balloon segment 698 can be part of the sheath or can be attached to the sheath, for example, by glue or heat sealing and / or ultrasonic sealing. Alternatively, as described above, where a sheath is not required, the balloon segment 698 can be connected to a portion of the device itself, such as a suitable outer surface of the device. On a given sheath, the inflatable segments 698 can be numbered from 1 to 10. The inflatable segments 698 can be composed of silicone, rubber, plastic, halogenated hydrocarbons, silicone rubber, vinyl, or the like.

[0360] In an alternative embodiment, the inflatable segment 698 can be replaced with another device for pressing a portion of the control instrument and / or the lysing tip against tissue to guide the lysing tip toward the desired treatment tissue in a direction perpendicular to, or at least substantially perpendicular to, the axis of the control instrument. For example, the inflatable segment 698 can be replaced with a mechanical jack or lift assembly, which can be similarly positioned on an outer surface of the sheath or instrument. Such a mechanical jack / lift assembly is another example of a device for pressing a portion of the control instrument and / or the lying tip against tissue to guide the lysing tip toward the desired treatment tissue in a direction perpendicular to, or at least substantially perpendicular to, the axis of the control instrument.

[0361] Figures 7a-7zzz depict the three general components and various possible shapes of a lysing tip: a lysing rod (Figures 7a-7g), a spacer (Figures 7h-7t), and a bead (Figures 7aa-7zzz).

[0362] Figure 7a-7g depicts various examples of the cross-sectional shape of wire or other cleavage members. In certain embodiments, these shapes can be formed by curling wire or other suitable cleavage members into a desired shape. The crimping of the cleavage member associated with certain embodiments and / or implementations of the present invention may be particularly useful because it can promote the preferred coupling between various other elements (e.g., beads and / or spacers) of the CDTD system. Crimping can also or alternatively be used to provide the preferred delivery of electrosurgical energy by wire / cleavage member. Other methods of shaping the cleavage member may include but are not limited to cutting, polishing, forging or forming by extrusion. In other embodiments, various coatings can be applied to the cleavage rod, which can reduce the adhesion of heated biomaterial to the cleavage rod or spacer.

[0363] Figure 7a includes a lysing rod having a circular cross-section. The shape of the lysing member / rod may also be important in achieving the most effective and safest means of delivering electrosurgical energy from the lysing member to the tissue. Electrosurgical energy on or below the surface may tend to migrate toward the edges of the object. This shape can be used to allow for efficient distribution of the coating across the surface of the lysing rod, which can be used to reduce char buildup and / or alter the ease with which the lysing tip can move through the tissue. Figure 7b includes a lysing rod having a triangular cross-section; this can be useful for maximizing electrosurgical energy delivery and minimizing char buildup around the lysing rod. Figure 7c includes a lysing rod having a square cross-section. Figure 7d includes a lysing rod having a pentagonal cross-section along its length, while Figure 7dx includes a lysing rod having a pentagonal cross-section that is twisted along its length. Figure 7e includes a lysing rod having a hexagonal cross-section. Figure 7f includes a lysing rod having a wedge-shaped cross-section. Figure 7g includes a lysing rod having a semicircular or truncated circular cross-section.

[0364] Figures 7h-7t depict various shapes of spacers that can be used in conjunction with one or more embodiments disclosed herein. Each can have a hole through which a lysis member can extend. As shown in these figures, Figure 7h describes a spacer having a flat end and a cylindrical shape. Figure 7i describes a spacer having a circular cross-section and a tapered end, which can be used to allow a desired distribution of a coating on the surface of the spacer to reduce the accumulation of coke and / or change the ease of movement of the lysis tip through tissue. Figure 7j includes various openings, such as holes, for transmitting electrosurgical energy therethrough. This can allow the spacer to be made of a non-conductive material and still transmit such energy therethrough. Figure 7k describes an alternative spacer that is arc-shaped. Figures 7L (at rest) and 7m (under force) describe a flexible connector having opposing rings and a central connector, wherein the rings have opposing rings, the opposing rings have a central opening, the central opening being configured to allow a wire or other lysis rod to be received therethrough, and the flexible connector extends between the two rings. As shown in Figure 7m, once coupled with adjacent beads (not described), the flexible connector can be bent to serve as a support and space adjacent beads apart. The spacer can also be configured so that the relative ring can be bent to the side, to allow the coupling of adjacent beads and the reception of a cracking rod therethrough (not described). Figure 7n describes a cross-sectional view of another spacer having a triangular cross-sectional shape and an opening for accommodating a cracking rod therethrough. Figure 7o describes a cross-sectional view of another spacer having a rectangular cross-sectional shape and an opening for accommodating a cracking rod therethrough. Figure 7p describes a cross-sectional view of another spacer having a pentagonal cross-sectional shape along its length, and an opening for accommodating a cracking rod therethrough, while Figure 7px describes a spacer with a pentagonal cross-sectional shape twisted along its length. An opening for receiving a cracking rod therethrough. A gasket with a twisted feature may absorb less debris along its surface and may rotate so that multiple sides of the gasket are exposed to the burnt tissue. Figure 7q depicts a cross-sectional view of another spacer having a hexagonal cross-sectional shape and an opening for accommodating a cracking rod therethrough. Figure 7r depicts a blade-style cross-sectional shape having smooth, rounded outer surfaces that meet at a distal edge and having an opening for receiving a cracking wire or other cracking rod therethrough. Figure 7s depicts a cross-sectional view of another spacer having a blade cross-sectional shape (unlike Figure 7r, the outer surface is formed by intersecting planes / flat surfaces) and an opening for receiving a cracking wire or other cracking rod therethrough. Figure 7t depicts a cross-sectional view of another spacer having a spindle-shaped cross-sectional shape and an opening for accommodating a cracking wire or other cracking rod therethrough.

[0365] The cross-sectional shape of the spacer's outer surface may also be important for the most effective and safe transfer of electrosurgical energy from the spacer to the tissue. Electrosurgical energy on or below the surface may tend to migrate toward the edges of an object, so a spacer having an outer surface with a circular cross-section may force current to flow toward opposing spacer ends, creating hot spots at or near adjacent magnetic beads. Therefore, it may be beneficial for the spacer to include an outer surface with a non-circular cross-section, which has one or more substantially uniform edges along its length, from which the electrosurgical energy can be uniformly transferred to the tissue. In contemplated embodiments, pentagonal or hexagonal cross-sectional shapes may be preferred. Additionally, spacers with non-circular cross-sections may result in less accumulation of debris and / or tar on the lysing rod and / or spacer, as debris may be less likely to adhere to angled edges. In some embodiments, one or more (and in some embodiments, all) spacers may include a leading edge for transferring electrosurgical energy from the lysing element. In some such embodiments, one or more spacers may include only a single such leading edge. In some such embodiments, one or more spacers may include a smooth, or at least substantially smooth, outer surface in addition to the single leading edge. For example, the spacer (or in some embodiments, the lysing member / rod itself) may include a circular or oval cross-section with a flat front end terminating in a leading edge, which may be useful for controlling the delivery of electrosurgical energy.

[0366] Because the spacer can be configured to receive a lysing element / rod therethrough, the spacer can also include an opening extending therethrough for receiving the lysing element / rod, and thus, the spacer can also have an internal cross-sectional shape that can be different from the shape of the outer surface. For example, it can be useful to form a spacer with an opening whose cross-sectional shape matches the cross-sectional shape of the lysing element / rod. Thus, if the cross-section of the lysing element / rod comprises a circle or a polygon, the spacer can include an opening having a similar cross-sectional shape. In some embodiments, the shape of the outer surface of the spacer can therefore be used primarily to indicate a preferred delivery location for electrosurgical energy.

[0367] Figure 7aa-7zzz shows other shapes of beads positioned along the cracking tip.As shown in these figures, the shape of the beads that may be useful may include spherical (Figure 7aa), wheel-shaped (Figure 7bb), dodecahedral (Figure 7cc).In other embodiments, the bead shape may be bullet-shaped or partially or substantially elliptical (Figure 7dd-7ff), and may have a small face (Figure 7ee and 7ff).In other expected embodiments, beads of various geometric shapes with flat or slightly curved proximal surfaces may be cut off, or further shaped (Figure 7gg-7LL) (here, this may be referred to as "truncated cone") by geometric incisions.In other expected embodiments, the bead shape and / or the tunnel passing through them may be uniformly spherical and / or centered.In other expected embodiments, the beads may have a skeleton feature supported by a hub, which may be adjacent to or adjacent to or formed around a ceramic sleeve with a cracking rod, and the cracking rod extends through the ceramic sleeve (Figure 7mm-7rr). In some contemplated embodiments, providing a roughened tail end can create frictional resistance on that portion of the bead, thereby helping to redirect the leading end of the bead for further tissue passage. Thus, in some embodiments, the trailing end can have a rougher surface than the leading end. For example, in some embodiments, the trailing end or at least a portion of the trailing end of one or more beads can be sanded with a rougher sandpaper material than the leading end, forming ridges, grooves, or other roughened element shapes, or can be made with a less smooth surface for this purpose. In some contemplated embodiments, such as those depicted in FIG. 7rr, the bead can include a slot that begins at its trailing end and terminates within bead 7rr to allow for the accommodation of a lysis rod therein. In some such embodiments, aperture 755 can be positioned to extend through the bead and can at least partially intersect slot 753. Thus, a weld, plug, glue, insert, or other securing method can be inserted through aperture 755 to attach to the lysis rod, thereby restricting movement of the bead and / or rotation of the bead relative to its lysis rod.

[0368] In alternative embodiments, the beads may comprise a conductive material such as metal and be coated with an insulator; for example, an insulating material. For example, a bead shaped as in FIG. 7rr but made of metal (inside) may be pressed against a cracking rod while increasing pressure to close the slot behind the cracking rod, holding the bead in place along the cracking rod.

[0369] In alternative embodiments such as Figures 7ss-7vv, the beads can be flattened, curved, hollowed out, or deformed in one or more axes. Curved beads such as those depicted in Figures 7xx and 7vv can allow the tip to be redirected in various tissues. Similarly, flat beads, such as the beads in Figure 7ww or other shapes depicted herein, can be tilted or constrained in one or more axes to adjust the angle of attack and / or tissue connection to the lysing tip by redirecting it to an angle different from the main axis of the lysing tip or the guide axis.

[0370] In other embodiments, beads having shapes as depicted in 7zz and 7zzz may include a surface regularity instance or one or more surface regularity instances, respectively.

[0371] In other embodiments, a particular lysing tip may include one or more bead shapes.

[0372] 8a-8b depict an embodiment of a system 800 and describe some of the steps involved in implementing a method for introducing a removable lysing tip 810 into a patient's body via a cannula 832, such as a grasping / controlling instrument 890 and / or a transfer / grasping instrument 896, which may be a trocar. The transfer / grasping instrument 896 may be delivered via a second cannula 835. As shown in FIG8a-b, the lysing tip 810 may be delivered via a first / primary cannula 832, which may comprise, for example, a trocar, and then coupled to a first surgical tool (e.g., a grasping / controlling instrument 890) that may be used to control and / or energize the lysing tip 810 within the patient's body during a surgical procedure. In some embodiments and implementations, the second cannula 835 may be used to deliver a second surgical tool, such as a transfer / grasping instrument 896, which may be used to facilitate connection of the lysing tip 810 to the grasping / controlling instrument 890. The "catheter" may be delivered via the same cannula 832 that delivers the lysing tip 810. In some embodiments, the grasping / controlling instrument 890 can have the same configuration as the grasping / transferring instrument 896. In alternative embodiments, the transfer / grasping instrument 896 can be configured differently than the grasping / controlling instrument 890, for example, it can lack the grasping / transferring instrument 896. It can be capable of delivering energy to the lysing tip 810 and / or can have a different jaw and / or tip design to facilitate grasping / holding the lysing tip 810 between two beads or other protrusions. Alternatively, the lysing tip 810 can be delivered through a second, unattached cannula 835 along with the grasping / transferring instrument 896 for coupling the lysing tip 810 to a first surgical tool delivered through the first / primary cannula, and other surgical tools can be used to control the lysing tip 810 and perform the surgical procedure. As shown in FIG. 8 a , the lysing tip 810 is positioned within the outer sleeve 832 with its axis extending between the beads 851 in the lysing tip 810 , aligned with the main axis of the sleeve 832 , and with the treated side of the lysing tip 810 facing the inner surface of the sleeve 832 .

[0373] In some embodiments of methods of using system 800, once the lysing tip is positioned outside the distal end of the cannula, the lysing tip can be reconfigured from the delivery configuration to the treatment configuration by delivering the lysing tip 810 through the cannula at least substantially along the treatment axis of the lysing tip extending between the opposing outer beads. In some such embodiments, the step of reconfiguring the lysing tip from the delivery configuration to the treatment configuration can further comprise grasping a portion of the lysing tip such that the axis of the lysing tip is at least substantially perpendicular to the axis of the grasping instrument.

[0374] As also shown in Figures 8a and 8b, the lysing tip 810 also includes gripping tabs 860t connected to the lysing rod 860 of the lysing tip 810. In some embodiments, the gripping tabs 860t can be configured to facilitate transfer of the lysing tip 810 from one delivery object to another. The therapeutic configuration is achieved by being configured to be gripped by the instrument 896 after the lysing tip 810 is advanced through the distal opening of the cannula 832. In a preferred embodiment, the gripping tabs 860t can be configured to lyse and / or biodegrade upon application of electrosurgical energy to the lysing rod 860. For example, the gripping tabs 860t can comprise a biodegradable material, which can also include absorbable suture, gelatin, wax, polyglycidyl ether, polyglycolic acid, polylactic acid, and / or polydioxanone. When the opposing gripping instrument 896 temporarily grips the tabs 860t, the jaws of the therapeutic / gripping instrument 890 can be locked onto the desired portion of the lysing rod 860 and / or another portion of the lysing tip 810. Once the electrosurgeon activates the device and discharges a discharge, if energy and significant temperature are generated, the tabs 860t can be configured to melt or disintegrate, thereby exposing the desired portion of the lysis rod 860 so that treatment can begin. Once the tabs 860t have melted or otherwise been removed from the lysis rod 860, the tabs 860t are preferably bioabsorbable and / or bioresorbable, and therefore do not need to be removed from the body after the procedure is completed.

[0375] In an alternative embodiment, a standard 3-5 mm diameter grasping instrument with a handle (without a lysing tip attached) can be introduced into a body cavity, perhaps through a trocar of acceptable diameter or through an incision in the skin, and then expelled externally through another trocar (e.g., a larger diameter at the umbilicus). The grasper can be angled to open and receive the lysing tip, allowing the grasper to be pulled into the body cavity through the larger trocar. Once in the body cavity, the lysing tip can be reconfigured from the delivery configuration to the treatment configuration.

[0376] In alternative embodiments, the transfer grasping instrument may include other methods for grasping the lysing tip 810 at the distal end, such as a hook and / or magnet and / or glue.

[0377] An alternative system for using a lysis tip 814t with a modular gripping instrument tip 814g is described in Figures 8c and 8d. In some embodiments, the modular instrument tip 814g and the lysis tip 814t can be permanently coupled to each other as described below. Alternatively, in other embodiments, the lysis tip 814t can be removed from the modular instrument tip 814g. When the instrument tip 814g and the lysis tip 814t can be combined, they can be referred to as modular grippers / tips 814 in this article. The modular instrument tip 814g includes a locking lumen 897' configured to be connected to the distal end of the push rod. The rod 896 of the modular gripping / control tool 90.

[0378] In an example of a procedure using the system of Figure 8c, the surgeon can first place the trocar 832' at the desired location, for example, through the incision 6' positioned through the umbilical cord 5. The second incision 6 can be a smaller incision. An incision wider than the incision 6' can be formed at a location spaced apart from the incision 6'. In some embodiments and implementations, the incision 6 can be between approximately 2.5 and 5 mm. The shaft 896 of the instrument 90 can then extend through the incision 6 and then through the incision 6' and the trocar 832'. The modular grasping instrument 814g can then be coupled to the distal end of the shaft 896 and the push rod 897. Once the lysis tip 814t is coupled to the modular grasping instrument tip 814g, the instrument 90 can be pulled proximally to introduce the lysis tip 814t into the patient 4. In embodiments where the lysing tip 814t is removable from the modular grasping instrument tip 814g, the lysing tip 814t can be connected to the distal end of the instrument tip 814g before the instrument 90 and its distal tip are proximally retracted into the cavity of the human or animal body 4. Once the modular instrument tip 814g is coupled to the instrument 90, the handle 91 can be used to control one or more aspects of the function of the lysing tip 814t. For example, actuation of the handle 91 can result in locking the lysing tip 814t in a particular rotational orientation relative to the shaft 896. Alternatively, the handle 91 or another actuation element of the instrument 90 can be used to rotate the lysing tip 814t between delivery and treatment configurations. The instrument 90 can also be used to transmit electrosurgical energy to the lysing tip 814t. For example, as shown in FIG8c, an energy connector 92, which can include a conductive post, can be used to facilitate electrical connection to an electrosurgical generator. As previously described, electrosurgical energy from the generator can be extended through the shaft 896 via the push rod 897 and coupled to one or more lysing members of the lysing tip 814t.

[0379] FIG8 d depicts a more detailed view of the interface between the modular grasping instrument 814g and the distal end of the shaft 896 and the push rod 897 of the instrument 90. As shown in this figure, the distal end of the shaft 896 can include a locking feature 898. The locking cavity 897′ slot within the modular instrument tip shaft 894 includes a slot 899s that is configured to receive the locking feature 898 in a predetermined rotational configuration. After aligning the locking feature 898 with the slot 899s, the shaft 896 and push rod 897 can be advanced into the locking cavity 899′. After the shaft locking feature 898 is advanced to its terminal end 898′ within the connecting rod 892, the locking feature 898 securely connects the shaft 896 to the connecting rod 892 after the modular instrument tip shaft 894 is rotated 2 degrees. At the same time, push rod 897 and its corresponding push rod locking feature 899n are advanced into locking chamber 899n', where push rod 897 and its accompanying push rod locking feature 899n may have been rotated to lock push rod locking feature 899n in place within locking chamber 899n'. Locking feature 899n preferably comprises flat or asymmetrical components such that rotation of shaft 896 causes locking feature 899n to engage a ledge or other locking feature of locking chamber 899n'. In some embodiments, the degree of rotation of push rod locking feature 899n may be the same as the degree of rotation of locking feature 898, which may be 90 degrees in some embodiments. In some embodiments, push rod locking feature 899n may comprise a plate, an elongated box, or any other feature that lacks rotational symmetry about axis push rod 897. Locking chamber 899n' may comprise, for example, a box or other similar feature that engages with the push rod. Push rod 897 locks feature 899n upon rotation.

[0380] The locking chamber 899n' is connected to the connecting rod 892, which in turn can be connected to one or both jaws. Thus, when the push rod 897 is advanced or retracted, the connecting rod 892 advances or retracts to open or close the jaws so as to capture the support member 870 within the jaws 893b.

[0381] Any of the systems discussed herein can be configured to deliver its corresponding lysing needle into the body using one or more of the methods described above.

[0382] Figures 9a through 9L depict an alternative embodiment of a CDTD system 900 comprising a plurality of protrusions 901 comprised of beads 951 and jaw covers 993aa / 994aa, and recesses 902 located between adjacent beads 951 and jaw covers 993aa / 994aa. System 900 comprises a bipolar electrosurgical system. System 900 is configured for bipolar electrosurgical energy delivery and comprises a lysing tip 910, which may comprise three protrusions of the tip of a laparoscopic grasping instrument, comprised of two outer beads 951 and a middle bead simulating the geometry of the tip, and two lysing segments 961cn / 961cp having two electrically insulated lysing elements 961p / 961n.

[0383] Electrosurgical gripping / control instrument 991 can be used to deliver electrosurgical energy to and control the lysing tip 910 during a surgical procedure. Instrument 991 can include one or more push rods 992 that can be used to control one or both of the jaws 993 and 994 and / or deliver electrosurgical energy to the tip 910. As previously described, the jaws 993 and 994 can each include a conductive core or tongue 993a' / 994a' and an insulating cover 993aa / 994aa. One or both of the upper jaw cover 993aa and the lower jaw cover 994aa can include an electrosurgical energy delivery opening configured to allow contact with the conductive portions of the tip. These portions can have opposite polarity and be electrically isolated from each other along their path. This may require, for example, that the entire housing and core of the upper jaw be made of ceramic or other non-conductors, perhaps using wires that are electrically isolated from the electrosurgical energy connected to the upper jaw. For example, energy can flow from the electrosurgical energy transfer opening 987 of the lower jaw into a lysing segment on one side that contacts the lower jaw 961n. The energy then flows from the lysing segment 961n into the target tissue, thereby cutting and / or coagulating the target tissue, and the energy returns to the opposite side lysing segment 961p, and then flows into, for example, the electrosurgical energy transfer opening 987 of the upper jaw assembly 993, and then flows to its electrically isolated wires and back to the electrosurgical generator.

[0384] As shown in Figure 9e, the cleaving tip 910 may include a strip or plate area 956 between the opposing beads to support the beads from the side. This area may include opposing wings 956w defined in part by a central gripping pad 956g, which may be recessed from the opposing wings 956w. The gripping pad 956g may be configured to engage one or both jaws 993 / 994. Preferably, the entire portion of the tip 910 shown in Figure 9e is made of ceramic or other non-conductive material. In some embodiments, the beads 951 can be coupled to the central portion of the cleaving tip 910. Alternatively, the beads can be made as an integral part of the non-conductive portion of the cleaving tip 910.

[0385] As shown in Figures 9f and 9g, isolated conductive cleavage members 961p and 961n can be positioned within a portion of the tip 910 shown in Figure 9e to form a complete cleavage tip. As shown in Figure 9e, slots 956sn and 956sp can be provided in the cleavage tip 910 to allow the cleavage edges 961cn and 961cp of the cleavage members 961p and 961n to protrude from the non-conductive body of the cleavage tip 910 and define cleavage segments. In addition, openings can be provided in the non-conductive body to allow electrosurgical energy to be received into the cleavage members 961p and 961n. More specifically, as shown in Figure 9e, an upper opening 956hp can be provided in the upper portion of the gripping pad 956g, through which protrusions and / or prongs of the cleavage element 961p, such as terminal studs 961tp, can extend. Although not visible in Figure 9e, similar openings can be formed in the lower surface of gripping pad 956g for accommodating posts 961tn of cleaving member 961n. The contact between these various posts and the conductive clamping tongues passing through openings in the non-conductive portion of cleaving tip 910 can be seen in Figures 9h-9L.

[0386] Preferably, each terminal or other projection of the cracking piece protrudes beyond the opposite side of gripping pad 956g so that they contact the conductive portion of relative jaws 993 / 994, for example, contact with conductive tongue 993a' / 994a'. As previously mentioned, opening 987 can be in the jaw cover 993aa / 994aa to allow this contact. In addition, slot 997 can be in the jaw cover of upper and lower jaws 993 and 994 to allow gripping pad 956g to be enclosed therein. Groove 997 can partially define opening 987, as shown in Figure 9 l.

[0387] Figures 9j and 9k depict two cross-sectional views of the system 900, one at the center of terminal post 961tp and the other at the center of terminal post 961tn, along the axis of the grip control instrument 990. Figure 9j depicts terminal post 961tp contacting upper jaw tab 993a', while Figure 9k depicts terminal post 961tn contacting lower jaw tab 994a'.

[0388] In some embodiments, a non-conductive cover or sleeve 995 can be positioned over the distal portion of the instrument 991 , as shown in FIG. 9a .

[0389] The relative dielectric constant of some ceramics may be in the range of about 5 to 10. During activation, this may cause current to leak in undesirable paths between opposing electrodes in close proximity. Using other materials, such as materials with a relative dielectric constant greater than 5, may undesirably change the resulting plasma field. The relative dielectric constant of the intermediate material containing the opposing electrodes can be increased by coating and / or surrounding and / or injection molding a low relative dielectric constant heat-resistant polymer in the housing and / or around one or more portions of the bipolar cleaving section 961n / 961p, which can reduce the effective electrostatic permittivity of the tip. In one embodiment, the heat-resistant polymer with a low relative electrostatic permittivity of 2.1 can be polytetrafluoroethylene. In other contemplated embodiments, the heat-resistant polymer may include polyetheretherketone (@3.3) and / or polysulfone (@3.1), etc., which may be useful.

[0390] In the depicted embodiment, the electrical insulator used to isolate or insulate the electrical path of one or more components or the electrosurgical generator may include polytetrafluoroethylene. In other contemplated embodiments, the electrical insulator may include a non-conductive polymer having a high melting temperature. In some embodiments, the non-conductive polymer may include, for example, polyetheretherketone and / or polysulfone. In other contemplated embodiments, the electrical insulator may include a polymer that is electrically and / or thermally non-conductive.

[0391] Since 2000, bipolar mode has traditionally been used primarily for coagulation (Reference: "Handbook of Biomedical Engineering, Electrosurgical Devices", J Eggleston, W Maltzahn, Chapter 81, CRC Press 2000). However, recent modifications to bipolar electrosurgical outputs may have promoted the use of bipolar cutting instruments (Reference: ValleyLab, Hotline, Volume 4, Page 4, Page 1), examples of which may include macrobipolar settings (Reference: ValleyLab ForceTriad User's Guide 2006, Sections / Chapters: 9-13, 9-16, 9-24).

[0392] After applying the TD and / or heater to the cellulite treatment area, approximately 2 to 8 months later, the surgeon may infuse fluids, including but not limited to tumescent fluids, into and around the treatment area to stretch the previously treated area. Inflating the treatment area with fluids and / or gases may tend to detach detached, stretched, or deformed unwanted tendrils or deposits, which may then reform or reform in the treated area following surgery. The amount of fluid required per square centimeter may vary from 0.5cc to 2.0cc. Depending on the clinical situation, even higher amounts of fluid may be used per square centimeter, as greater stretching results in longer-lasting results. Fluid injection can be performed via an injection needle, spatula cannula, or any suitable transcutaneous device. A long injection system, such as a 40cm spatula cannula, may be necessary to allow the cannula's entry wound to be placed in an inconspicuous location. Fluids can also be administered under pressure via a peristaltic pump, an overhead IV bag, or a mechanical injection mechanism. This procedure may be repeated every 2 to 8 months, or indefinitely, to help maintain the surgical results.

[0393] Figures 10a-10k depict an embodiment of a lysis instrument 1000. The instrument 1000 may include a shaft 1090 and a bidirectional lysis tip 1033. The lysis tip 1033 is configured for bidirectional motion (i.e., forward / distally and backward / proximally) for the following reasons. As discussed below, there is a lysis segment that faces the forward / distal direction to facilitate the forward motion of the lysis tip 1033 through the tissue and another lysis segment that faces the backward / proximal direction to facilitate the backward / proximal motion of the lysis tip. The shaft 1090 can physically couple the lysis tip 1033 to an electrosurgical energy source, such as an electrosurgical pencil (not shown), via a conductive insert 1060s, which, in the depicted embodiment, includes a conductive rod that can be conductive and serves as a conduit for the electrosurgical energy to flow to the lysis tip 1033. In the illustrated embodiment, the conductive insert 1060s includes an integral extension from the electrode 1060. However, in other contemplated embodiments, the conductive insert 1060s may be coupled to the electrode 1060 directly or indirectly, such as by a wire.

[0394] Cracking tip 1033 comprises one or more cracking segments facing the distal end and one or more cracking segments facing the proximal end.Each of these various cracking segments can be made up of a single electrode, or each is made up of its own corresponding electrode.In the embodiment depicted, a single electrode 1060 is used to limit each in the various cracking segments, and the non-conductive body 1033b of shaping is used to limit various beads, protrusion and / or other performance, which limits the position of the depression into which the cracking segment is placed.Non-conductive body 1033b defines two (or more, as shown in other embodiments) distal end 1051d and distal recessed portion 1002d of beads 1051 that are limited forward distal projection 1001d (in other embodiments, more than one distal recessed portion can be provided), is positioned between the distal ends of beads 1051d.Cracking tip 1033 can also comprise one or more proximal projection / recessed cracking segments backward or cracking segment pairs, to promote the proximal movement of device 1000 by tissue. For example, the bead 1051 further defines a rearward protrusion defined by the proximal tip 1001p of the bead 1051 and a recess 1002p defined by the proximal tip 1001p and the shaft / neck of the lysing tip 1033.

[0395] The shaped non-conductive body 1033b can include one or more beads 1051, which can be supported and / or separated by one or more rigid or substantially rigid struts 1080, each of which can be permanently or temporarily coupled between adjacent beads 1051 and, in some embodiments, can be further coupled along the proximal region to the axis of the lysing tip 1033. In a preferred embodiment shown in Figures 10a-10g, the shaped non-conductive body 1033b can include a slot 1080 that can extend between the struts 1080. The slot 1080 can have a distal slot opening 1080sd with the struts 1080 on its upper and lower sides and one or more channels 1051t in the beads 1051 on its left and right sides.

[0396] In this embodiment, the electrode 1060 can be passed through the distal slot opening 1080sd and operably positioned and configured to lyse the segment 1060d defined by the exposed portion of the electrode 1060 to face distally through the distal slot opening 1080sd and allow the delivery of electrosurgical energy therethrough. The shaped non-conductive body 1033b can further include one or more proximal slot openings 1080sp through which the proximal lysing segment 1060p of the electrode 1060 can be exposed to allow the passage of electrosurgical energy therethrough and facilitate the retardation of the lysing tip 1033 through the tissue.

[0397] Beads 1051 and pillars 1080 may be composed of ceramics, cermets, glass, various halogenated hydrocarbons, and any other suitable non-conductors.

[0398] 10h-10j , in other embodiments, bead 1051′ may not include any tunnels or holes, effectively narrowing slit 1080s′ and reducing the width of distal lysing segment 1060d′ of electrode 1060. Lysing tip shaft 1033s′ may define the inner boundary of proximal lysing segment 1060p′, as best shown in FIG10j .

[0399] When the surgeon activates the electrosurgical generator, electrosurgical energy may be transmitted through the conductive insert 1060s, through the shaft 1090, to the electrode 1060, which activates the lysing segments 1060d and 1060p to deliver electrosurgical energy into the tissue.

[0400] In some embodiments, the conductive material of electrode 1060 may include steel, nickel, alloys, palladium, gold, tungsten, silver, copper, platinum, and / or another conductive metal that does not release toxic residues at operating temperatures. In some embodiments, electrode 1060 may be coated with a non-stick material that may include gold, silver, rhodium, titanium, titanium alloys, tungsten, certain cobalt alloys, and the like, as well as any combination of the foregoing.

[0401] In some embodiments, the width of the distal portion of the lysing tip 1033 (defined between the outermost portions of the outermost beads 1051) can be between about 4 mm and about 5 mm, and the length of the beads can be determined by the shape. The non-conductive body 1033b can be between about 3 mm and about 10 mm.

[0402] By providing the distal cleavage segment and the proximal cleavage segment to carry out the dissection and / or coagulation of tissue in an anterograde and / or retrograde manner, many benefits can be obtained. For example, dissection efficiency can be improved because tissue can be separated by moving the tip forward and the tip can also be separated by moving the tip in the opposite direction, rather than just preparing the tip for another forward pass. As another example, preferably recessed portions are used to provide the distal and proximal cleavage segments, which can reduce the necessary width / size of the surgical instrument so that various models can be suitable for cannulas and / or entry wounds / body openings of smaller diameters for minimally invasive surgery and / or entry wounds / scar minimization. In addition, providing retrograde dissection may be beneficial to various anatomical angles or styles when various force vectors are placed on the target tissue and / or target tissue plane.

[0403] It should be understood that the embodiments disclosed herein may have value and application in a variety of different types of surgeries. For example, the lysing tips, devices, and methods disclosed herein may be used in cosmetic surgeries, including facial dissection, neck dissection, and cellulite treatment, and may also be used in conjunction with internal surgeries (e.g., laparoscopic and / or endoscopic surgeries). Thus, the device may be introduced directly into the body through an opening in the skin, or may be introduced using a trocar and / or cannula during other types of surgical procedures.

[0404] When the device is powered with electrosurgical energy, the beads 1051 and struts 1080 are preferably non-conductive in order to perform a blunt dissection function.

[0405] In some embodiments, the lysis member / electrode assembly 1060 comprises a rigid and / or substantially rigid plate as shown in FIG10d. In such embodiments, one or both of the proximal lysis segment 1060p and / or distal lysis segment 1060d can be configured to be electrically connected to the electrode shaft 1060s. In some such embodiments, the electrode 1060 can comprise a single piece of suitable conductive material that performs each of these functions.

[0406] In alternative embodiments, any number of holes can be formed at any angle to intersect the electrode assembly 1060 and / or its tunnel 1051t or slot 1080sd to deposit the material that limits the lysis segment / electrode assembly within the bead 1051, the bead. Channel 1051t and / or slot 1080 (e.g., the material can include welding, glue, epoxy, plugs, etc.). In such an embodiment, the tunnel 1051t can be a blind tunnel that does not need to pass completely through the bead 1051. In other embodiments, the tunnel 1051t can be a complete tunnel. In alternative embodiments, the bead 1051 can be replaced by a bead of any shape, including but not limited to those depicted in Figures 7aa to 7zzz.

[0407] As previously described, the lysing tip 1033 includes a plurality of beads 1051 and a plurality of recessed, flat sections, which in turn can be defined by one or more electrodes. It should be noted that in the embodiment of Figures 10a-10g, the beads 1051 are laterally supported along their respective inner sides by struts 1080. In other words, the beads 1051 each define a main axis and / or elongated axis extending between their respective distal ends and proximal tips. In the embodiment shown, these axes extend at least substantially parallel to the axis of the instrument 1000. Rather than being supported from behind, such as by an element extending between the proximal ends of the beads 1051, the beads 1051 are supported along their respective sides. The elements (in the embodiment shown, the struts 1080) extend at least substantially perpendicularly relative to their respective main axes so that the shape of the beads remains visible from the structure of the lysing tip 1033.

[0408] It should also be noted that bead 1051 lacks a base, such as base 105 of system 100 described in detail in U.S. patent application Ser. No. 15 / 464,199, filed on March 20, 2017, entitled "Device, System, and Method for Minimally Invasive Dissection of Tissue," which is incorporated herein by reference in its entirety. Therefore, it should also be understood that bead 1051 lacks a support structure immediately behind the bead. It should also be noted that lysing tip 1033 includes bead 1051 that protrudes distally and proximally relative to support post 1080.

[0409] The shaft 1090 can be coupled to the tip 1033 to facilitate the transfer of electrosurgical energy in a desired manner and / or to allow manual dissection in the absence of electrosurgical energy. The shaft 1090 can be deformable, that is, it can be bent to tilt the lysing tip in a desired direction, for example, to ensure that the lysing tip is tilted upward by 3 to 10 degrees, thereby directing the cutting / lysing toward the dermis of the skin during a facelift procedure.

[0410] It should also be noted that the beads 1051 can have the same shape on the same instrument, can have different shapes, and / or can be angled upward or downward, for example, at an angle between about 3 degrees and about 15 degrees. This can assist in directing the tip toward the upper or lower tissue plane. In other embodiments, each bead can be angled in a different direction as desired, depending on the intended use of the device. In these embodiments, the struts 1080 can remain parallel to the top and / or bottom surfaces of the device, or can follow the same angle as their corresponding beads.

[0411] The shaped non-conductive body 1033b may include one or more sensor openings 1070 and 1070a (depicted only in Figures 10a and 10c), which can serve as locations for various sensors, including but not limited to temperature sensors, optical fibers, location sensors, RFID sensors / tags, and the like. Sensor openings 1070 and 1070a can be connected to one or more catheters that can pass through the shaped non-conductive body 1033b and exit at the proximal end of the lysing tip 1033. Alternatively, the sensors located in sensor openings 1070 and 1070a can be configured to transmit data wirelessly. It should be noted that sensor 1070a is located distal to bead 1051; sensor 1070a is located distal to bead 1051. The sensor located in opening 1070a can be used to measure temperature during the backstroke of the instrument, as the tissue being treated will typically pass adjacent to sensor 1070a during the backstroke. In some embodiments, temperature or other sensor measurements can be taken during RF activation or between RF pulses. In an alternative embodiment, the sensor exposed at sensor opening 1070a may be an optical fiber that can sense tissue color and / or the presence of blood.

[0412] When the instrument 1000 is energized with electrosurgical energy, the beads 1051 and struts 1080 are preferably non-conductive to minimize unwanted discharges. As previously described, the conductive electrode 1060 can be configured to deliver electrosurgical energy through various distal and / or proximal lysing segments.

[0413] The beads 1051 and the pillars 1080 can be composed of ceramics, cermets, glass, various halogenated hydrocarbons, and any other suitable non-conductors. The beads 1051 can be restrained from movement and / or secured to the pillars 1080 by direct coupling (i.e., continuous / monolithic ceramic) and / or conductive materials such as those comprising the electrodes 1060. Similarly, indirect sealing methods such as epoxy or ceramic can be used. Glues or potting compounds can be used to seal any unwanted seams or openings to maintain non-conductive integrity in the desired locations. When the surgeon turns on the electrosurgical generator, electrosurgical energy can be transmitted to the electrodes 1060 via any suitable electrical coupling element.

[0414] In yet another embodiment shown in Figures 10k-L, in the cross-section of line 10k-10k shown in Figure 10i, the electrode 1063 can be modified with a non-conductive lip 1063L that is intended to be positioned adjacent to the boundary formed by the edges of the pillars (not depicted) and the edges of the beads 1053 and bead tunnels 1053t (if present). The non-conductive lip 1063L can then define or substantially define the distal lysis segment 1063d. The non-conductive lip 1063L can help seal the internal components to prevent liquid intrusion, minimize the undesirable escape of RF energy, and / or reduce the surface area exposed by the lysis segment. The non-conductive lip 1063L can be made of various materials that adhere to the conductor and / or can be a suitable dielectric, such as a ceramic or porcelain material.

[0415] Figures 11a-11eDescribed the embodiment of cracking instrument 1100.Instrument 1100 can comprise axis 1190 and bidirectional cracking tip 1133.Cracking tip 1133 is configured to bidirectional motion (that is, forward / far and backward / near motion) due to the following reasons.As discussed below, there is the existence 1133 of the cracking segment of the forward motion of promoting cracking tip 1133 through tissue and the existence of other cracking segments of the backward / proximal direction to promote cracking tip backward / proximal motion through tissue.As shown in the figure, the backward / proximal cracking segment of instrument 1100 at least substantially perpendicular to the axis 1190 of instrument 1100 extends.In the embodiment shown, distal and proximal cracking segments all limit concave curve.However, the two points (bead on one end or near, and at or near the axis 1190 of the opposite end) that these cracking segments terminate end at these two points, and this line is perpendicular to or at least substantially perpendicular to axis 1190.And / or the major axis / major axis of bead. Similarly, at the center point, or at least substantially the center point, of each cleavage segment along the axis between the two previously cited endpoints, a tangent to the curvature is perpendicular or at least substantially perpendicular to the axis 1190 and / or the major axis of the bead. Thus, while the depicted cleavage segments are curved, they should each be considered to extend at least substantially perpendicular to the axis 1190 of the device 1100 and at least substantially perpendicular to the elongated axis and / or major axis of the bead 1151. The cleavage segments may be applicable to any other embodiment described and / or otherwise disclosed herein.

[0416] However, other embodiments are contemplated in which the lysing segments can extend at another angle relative to the main axis of the shaft 1190 and / or the instrument 1100. For example, in other embodiments, the proximal / posterior lysing segment can extend at an angle between about 60 degrees and about 120 degrees relative to the main axis of the shaft 1190 and / or the instrument 1100. The shaft 1190 can physically couple the lysing tip 1133 to a source of electrosurgical energy, such as an electrosurgical pencil (not shown), via a conductive insert 1160s. The depicted embodiment includes a conductive rod that can be electrically conductive and act as a conduit for the flow of electrosurgical energy to the lysing tip 1133. In the depicted embodiment, the conductive insert 1160s comprises an integral extension from the electrode 1160. The conductive insert 1160s can be coupled to the electrode 1160 directly or indirectly, such as via a wire or the like.

[0417] The cleavage tip 1133 includes one or more distal-facing cleavage segments and one or more proximal-facing cleavage segments. Each of these various cleavage segments can be defined by a single electrode, or each is defined by its own corresponding electrode. In the depicted embodiment, a single electrode 1160 is used to define each of the various cleavage segments, including a distal-facing cleavage segment configured to promote the forward / distal motion of the instrument 1100 and a proximal-facing cleavage segment configured to move the instrument 1100 forward / distal. This helps the instrument 1100 move backward / proximal. The non-conductive body 1133b can be used to define various beads, protrusions, and / or other features that define recesses in which the cleavage segments are positioned. In some embodiments, the recess can be defined by beads, struts, and / or cleavage segments. The non-conductive body 1133b defines three forward-facing distal protrusions 1101d defined by the distal tip 1151d of the bead 1151 and the nose 1136 of the shaft 1190, and a distal recess 1102d located between their distal tips (in other embodiments, more than one distal recess may be provided). The protrusions 1151d and nose 1136 are further defined. The lysing tip 1133 may further include one or more rearward-facing proximal protrusion / recess pairs to facilitate proximal movement of the device 1100 through tissue. For example, the bead 1151 further defines a rearward protrusion defined by the proximal tip 1101p of the bead 1151 and a recess 1102p defined by the proximal tip 1101p of the bead 1151, as well as the strut 1180.

[0418] The shaped non-conductive body 1133b may include one or more beads 1151, which may be supported by and / or separated by one or more rigid or substantially rigid struts 1180, each of which may be permanently or temporarily coupled between adjacent beads 1151 and / or between the outer protrusions and nose 1136 and / or shaft 1190 or shaft portion of the cleaving tip 1133. In some embodiments, the struts 1180 may be further coupled to the shaft of the cleaving tip 1133 along the proximal region. Figures 11a-11e In the preferred embodiment shown, the shaped non-conductive body 1133b may include one or more slots 1180 that may extend along each strut 1180. The slots 1180s may define distal slot openings 1180sd, which are defined on their upper and lower sides by the struts 1180 and / or nose 1136, as well as on their upper and lower sides, and one or more beads 1151 on the left and right sides.

[0419] In this embodiment, the electrode 1160 can pass through the distal slit opening 1180sd and can be operably positioned and configured to define a distal lysing segment 1160d, which can be defined by exposed portions of the electrode 1160 on either side of the nose 1136 to face distally through the distal slit opening 1180sd and allow electrosurgical energy or another suitable energy to be delivered therethrough to modify tissue. The shaped non-conductive body 1133b can further include one or more proximal slot openings 1180sp through which the proximal lysing segment 1160p of the electrode 1160 can be exposed to allow electrosurgical energy to pass therethrough and facilitate posterior / proximal movement of the lysing tip 1133 through tissue.

[0420] In the depicted embodiment, specifically FIG. 11c , an exploded view depicts how the electrode 1160 may be inserted into the distal slot 1180sd , which may also receive the nose 1136 therein, which may be glued or otherwise secured in place to complete the assembly.

[0421] In such Figure 11f In other embodiments, the nose defining the central protrusion may be fabricated to house a nasal insert 1136' therein, which may be secured in place by a bonding agent such as ceramic glue, fasteners, etc. In other embodiments, the nasal insert 1136' (the volume between the upper and lower portions of the nose) may be filled with a filler such as a high temperature epoxy or the like.

[0422] The shaped non-conductive body 1133b may include one or more sensor openings 1170a, 1170b, and 1170c (only in Figure 11b ), which can serve as locations for various sensors, including but not limited to temperature sensors, optical fibers, positioning sensors, RFID sensors / tags, and the like. Sensor openings 1170a, 1170b, and 1170c can be connected to one or more catheters that can pass through the shaped non-conductive body 1133b and exit on the proximal end of the lysis tip 1133. Alternatively, the sensors located in the sensor openings can be configured to transmit data wirelessly. . It should be noted that sensor opening 1070b can be located on the distal end of the bead 1151. Additionally, a sensor can be located in the nasal sensor opening 1170c. The sensors located in openings 1170b and 1170c can be used to measure the temperature during the instrument's rearward stroke. In some embodiments, the measurements can be made during or between RF pulses. In alternative embodiments, the sensors exposed at any sensor opening can be optical fibers that can sense tissue color and the presence of blood.

[0423] The bead 1151, nose 1136 and / or support 1180 may be composed of ceramic, cermet, glass, various halogenated hydrocarbons and any other suitable non-conductor.

[0424] like Figures 11g-11h As shown in FIG, in other embodiments, the bead 1151′ may not include any tunnels or holes 1151t, thereby effectively narrowing the required length of the slot 1180s′ and reducing the corresponding width of its distal lysing section 1160d′. The slot 1180s′ exposes the electrode 1160′. The lysing tip shaft 1133s′ may define the inner boundary of the proximal lysing section 1160p′, as shown in FIG. Figure 11h shown.

[0425] When the surgeon turns on the electrosurgical generator, electrosurgical energy may be transmitted through the conductive insert 1160s, through the shaft 1190 to the electrode 1160, which activates the lysing segments 1160d and 1160p to deliver electrosurgical energy into the tissue.

[0426] In some embodiments, the width of the distal portion of the lysing tip 1133 (defined between the outermost portions of the outermost beads 1151) can be between about 6 mm and about 12 mm, and the length of the beads can be defined by the shape. The non-conductive body 1133b can be between about 3 mm and about 10 mm.

[0427] It should be noted that the cleaving tips 1033 and 1133 may be more effective than unidirectional cleaving tips when dissecting in both anterior and posterior directions. Retrograde dissection may also facilitate the use of alternative tissue tension vectors adjacent to the target tissue and / or target tissue plane. The tissue tension vectors may be applied by the surgical assistant and / or the surgeon's non-instrumented hand. Similarly, retrograde dissection may allow for alternative dissection angles.

[0428] When the device is powered with electrosurgical energy, the bead 1151, nose 1136 and strut 1180 are preferably non-conductive in order to perform blunt dissection functions. However, in some embodiments, one or more of these elements may include a conductive core and a non-conductive coating or outer shell.

[0429] In some embodiments, the lysis member / electrode assembly 1160 comprises a rigid and / or substantially rigid plate as shown in FIG. 11c . In such embodiments, one or both of the proximal lysis segment 1160p and / or distal lysis segment 1160d can be configured to be electrically connected to the electrode shaft 1160s. In some such embodiments, the electrode 1160 can comprise a single piece of suitable conductive material that serves each of these functions. The slot 1180sd can be configured to tightly accommodate the lysis member electrode assembly 1160, thereby preventing or at least inhibiting movement or unwanted RF energy escape. As previously described, the lysis tip 1133 can comprise a plurality of beads 1151 and a plurality of recessed lying segments, which in turn can be defined by one or more electrodes. It should be noted that in Figures 11a-11h In the embodiment of the present invention, beads 1151 are laterally supported along their respective inner sides by struts 1180. It should also be noted that beads 1151 lack a base, such as base 105 of system 100 described in detail in U.S. Patent Application Serial No. 15 / 464,199, filed on March 20, 2017, entitled "Device, System, and Method for Minimally Invasive Dissection of Tissue," the entire contents of which are incorporated herein by reference. Therefore, it should also be understood that beads 1151 lack structure for support immediately behind the beads. It should also be noted that lysing tip 1133 includes beads 1151 that protrude distally and proximally relative to struts 1180.

[0430] The shaft 1190 can be coupled to the tip 1133 to facilitate the desired delivery of electrosurgical energy and / or to allow manual dissection in the absence of electrosurgical energy. The shaft 1190 can be deformable, that is, it can be bent to tilt the lysing tip in a desired direction, for example, to ensure that the lysing tip is tilted upward by 3 to 10 degrees to direct the cutting / lysing toward the blade 10190. Skin Reshaping

[0431] When the system 1100 is energized with electrosurgical energy, the beads 1151 and struts 1180, or at least a portion thereof (such as except for those surfaces exposed to define / expose the lysing segments), are preferably non-conductive to minimize unwanted electrical discharges. As previously described, the conductive electrodes 1160 can be configured to deliver electrosurgical energy through various distal and / or proximal lysing segments.

[0432] In some embodiments, the conductive material of electrode 1160 may include steel, nickel, alloys, palladium, gold, tungsten, silver, copper, platinum, and / or another conductive metal that preferably does not release toxic residues at typical operating temperatures. In some embodiments, electrode 1160 may be coated with a non-stick material that may include gold, silver, rhodium, titanium, titanium alloys, tungsten, certain cobalt alloys, and the like.

[0433] The bead 1151, nose 1136, and support 1180 can be composed of ceramic, cermet, glass, various halogenated hydrocarbons, and any other suitable non-conductor. The bead 1151 can be restrained from movement and / or secured to the support 1180 by direct coupling (i.e., continuous / monolithic ceramic) and / or conductive materials such as those comprising the electrode 1160. Similarly, indirect sealing methods such as epoxy or ceramic can be used. Glue or potting compound can be used to seal any unwanted seams or openings to maintain non-conductive integrity in the desired location. When the surgeon turns on the electrosurgical generator, electrosurgical energy can be transmitted to the electrode 1160 via any suitable electrical coupling element.

[0434] It should also be noted that the beads 1151 on the same instrument can have the same shape, can have different shapes, and / or can be angled / slanted upward or downward / angled between about 3 degrees and about 15 degrees to assist in directing the tip toward the upper or lower tissue plane. In other embodiments, each bead can be angled in a different direction. In some embodiments, the struts 1080 can remain parallel to the upper and / or lower surface of the device, or the struts 1080 can follow the same angle as their corresponding tilted beads, for example, with the tip of the device being positioned parallel to the upper and / or lower surface of the device. Figure 11i The angle of the bead 1154 coupled to the bent / angled shaft 1134 is the same as depicted in FIG.

[0435] In another embodiment, the lysing tip 1133 can be configured to oscillate in various planes, which can help reduce tar accumulation and mechanically aid movement of the lysing tip 1133 through tissue. In this embodiment, the shaft 1190 can include a piezoelectric or oscillation / vibration motor unit 1199, which can be placed in the handle or at another point between the handle and the distal tip to generate the necessary harmonic motion. High energy frequencies can be selected, such as in the ultrasonic region, but may be too powerful for multi-component devices. However, lower frequencies with lower energy, similar to those used in toothbrushes to aid cleaning, may provide the necessary energy to reduce tar and promote lysis. Lower frequencies can be achieved through the use of voice coils, but piezoelectric ceramics may be preferred. Higher frequencies in the ultrasonic range require smaller piezoelectrics. The frequency range may be from approximately 1 kHz to approximately 80 kHz, preferably between approximately 21 and approximately 40 kHz. Hard ceramic piezoelectric motors may be preferred, and for lower excursions, this can be expanded to include the Navy I type shown in the APC 840.

[0436] Figures 12 and 13a-c depict, respectively, a 2-bead lysis instrument 1200 and a 3-bead lysis instrument 1300. Instruments 1200 and 1300 each include a lysis tip 1233 / 1333, respectively.

[0437] The lysing tip 1233 includes a conductive, integral core 1260 (depicted in FIG. 12 at a cutout window through the non-conductive layer), which may comprise a suitable metal or other preferably conductive material. The conductive core 1260 may include an overall shape forming the structure depicted in the accompanying drawings, i.e., opposing beads 1250, struts 1280, a distal notch through which the lysing segment may extend, as described below, and two proximal notches through which the distal notch may extend. Two corresponding lysing segments may extend. As a final product, each surface of the lysing instrument 1200, with the exception of the lysing segments, may be coated, layered, or otherwise configured to prevent the delivery of electrosurgical or other energy therefrom. Thus, in some embodiments, the lysing tip 1233 may be coated with a suitable non-conductive material, such as a high melting point polymer, ceramic, and / or glass. Examples of ceramic coatings may include those from MetaCeram, which may be customized for specific applications and utilize raw materials such as high-purity chromium oxide, an aluminum oxide-zirconia composite, and / or a mixture of aluminum oxide and titanium oxide. Examples of suitable glass coatings include porcelain enamels (frits), "artistic" frits, commercial frits, and frits used in dental applications. Glass coatings can be applied by dipping, spraying, electrostatic application, and screening, along with other coatings. Application can be followed by curing and sintering to vitrify the glass. In alternative embodiments, PVD can also be used, in which case further vitrification may not be necessary.

[0438] In certain embodiments of the manufacturing method, the conductive core 1260 of the lysing tip 1233 can be completely coated with any of the above materials or another suitable material to form a shell 1256 to prevent or at least inhibit the transfer of electrosurgical energy or other energy from the conductive core. 1260 is moved to adjacent tissue during the surgical procedure. After the coating is applied, the coating / shell 1256 can be selectively removed from certain areas, such as areas within the distal and proximal recesses of the instrument 1200, which define the desired lysing segments 1260d and 1260p, by etching or another suitable method. In other embodiments, the desired lysing segments can be established by masking these areas before applying the coating / layer to the conductive core 1260, thereby eliminating the need for etching / removal of the shell 1256.

[0439] In some embodiments and implementations, the area defining the lysis segment can be further sharpened or otherwise formed with a shape configured to facilitate desired energy delivery therethrough and / or dissect tissue without applying energy. This sharpening can be accomplished in the same step as etching the non-conductive shell 1256 or in a separate step.

[0440] In FIG12 , the conductive integral form 1233 includes structural features similar to those of the embodiments previously described herein, however, these features / elements are preferably inextricably coupled as a unitary body. The distal protrusion 1201 d and distal recess 1202 d can be substantially defined by the plurality of distal tips 1250 d of the bead 1250, the distal cleaving element 1260 d, and / or the leading edge of the strut 1280. The proximal protrusion 1201 p and recess 1202 p can be defined by a portion of the proximal tip 1250 p of the bead 1250, the proximal cleaving element 1260 p, and / or the trailing edge of the strut 1280. As previously described, the conductive distal cleaving segment 1260 d and the conductive proximal cleaving segment 1260 p are exposed to facilitate the passage of energy therethrough.

[0441] As shown in Figures 13a-c, the lysis tip 1333 includes a conductive, one-piece core 1360, which may include a suitable metal or other preferably conductive material. The conductive core 1360 may include the overall shape of the structure depicted in the accompanying drawings, i.e., the opposing weld beads 1350, the struts 1380, and the shaft extension / nostril 1336. The weld beads 1350 define forward and rearward protrusions and partially define the corresponding forward protrusions. As previously described, the corresponding lysis segments may extend through the rearward-facing recesses. As a finished product, each surface of the lysis instrument 1300 other than these lysis segments (i.e., the distal-facing lysis segment 1360d and the proximal-facing lysis segment 1360p) may be coated, layered, or otherwise configured to avoid the transfer of energy, electrosurgery, etc. Therefore, in some embodiments, the lysis tip 1333 may be coated with a suitable non-conductive material, such as those listed for the embodiment depicted in Figure 12.

[0442] As best depicted in FIG13c, in certain embodiments of the manufacturing method, the conductive core 1360 of the lysing tip 1333 can be completely coated or otherwise coated with any of the aforementioned materials or another suitable material to form a coating and / or shell 1356 to prevent or at least inhibit the transfer of electrosurgical energy or other energy from the conductive core 1360 to adjacent tissue during the surgical procedure. After the coating is applied, the coating / shell 1356 can be selectively removed from certain areas, such as the areas within the distal and proximal recesses of the instrument 1300, which define the desired lysing sections 1360d and 1360p, by etching or another suitable method. In other embodiments, the desired lysing sections can be established by masking these areas before applying the coating / layer to the conductive core 1360, thereby eliminating the need to etch / remove the shell 1356.

[0443] In FIG13 a, the conductive integral form 1333 includes structural features similar to those of the embodiments previously described herein, however, these features / elements are preferably inextricably coupled as a unitary formation. The distal protrusion 1301 d and distal recess 1302 d can be substantially defined by the plurality of distal tips 1350 d of the bead 1350, the distal cleaving segments 1360 d, and / or the leading edge of the strut 1380. The proximal protrusion 1301 p and recess 1302 p can be defined by a portion of the proximal tip 1350 p of the bead 1350, the proximal cleaving element 1360 p, and / or the trailing edge of the strut 1380. As previously described, the conductive distal cleaving segments 1360 d and the conductive proximal cleaving segments 1360 p are exposed to facilitate the passage of energy therethrough.

[0444] These coating / etching / shell principles can be applied to any other embodiments disclosed herein, or to other embodiments available to one of ordinary skill in the art after having the benefit of this disclosure, such as embodiments having different numbers of beads, distal protrusions, distal recesses and / or lysis segments, proximal protrusions and / or proximal recesses and / or lysis segments.

[0445] In some embodiments, such as those depicted in Figures 14a-d, a lysing tip 1433 of a lysing tip system similar to those already disclosed herein can utilize a device for depressing a portion of a control to modify the angle of attack of its cutting surface. The instrument and / or lysing tip is pressed against tissue to direct the lysing tip toward the desired treatment tissue in a direction perpendicular or at least substantially perpendicular to the axis of the instrument being controlled, such as deflection system 1400. Deflection system 1400 can be used to depress a portion of the instrument and / or lysing tip against tissue to direct the lysing tip toward the desired treatment tissue, such as in the illustrated embodiment in a direction perpendicular or at least substantially perpendicular to the axis of the instrument being controlled. In other embodiments, it is contemplated that deflection system 1400 can be configured to deflect or otherwise move the lysing tip away from or toward a specific tissue and / or treatment area, rather than in a direction perpendicular to the instrument axis. Longer cannulas can be difficult to control for treatment areas distal to the entry wound. Thus, one or more deflection legs 1490L or other suitable deflection devices may be useful, particularly in cosmetic procedures such as cellulite treatment, to, for example, press the lysing tip 1433 more superficially against the underlying dermis. The presence of deployed deflection legs 1490L may facilitate procedures from an entry wound to a more distal location. In the depicted embodiment, four arcuate segments, the deflection legs 1490L, may be present on the distal to mid-portion of the device shaft and may be deployed individually or in groups.

[0446] More specifically, the deflection legs 1490L can be part of a deflection sleeve 1490, which can include one or more slidable deployment members 1490a, each of which can be connected to one or more deflection legs 1490L. In the depicted embodiment, the upper deployment members 1490a are connected to two upper deflection legs 1490L, and the lower deployment members 1490a are connected to two lower deflection legs 1490L. In this manner, a surgical instrument used with the deflection system 1400 can be configured to deflect in any direction (or, in other embodiments, in any more precise direction) depending on the number of deflection legs 1490L and / or deployment members 1490a and on which deployment member 1490a is actuated. 14d, upon advancement of upper deployment member 1490a, which in the depicted embodiment defines a cylindrical surface configured to extend over (or within) a similarly shaped instrument shaft, the upper two deflection legs 1490L bend outwardly to provide a deflection force, as described above.

[0447] In the depicted embodiment, it will be assumed that the basic lysis device is similar to one previously disclosed (e.g., 1090 and 1190), wherein the lysis tip 1433 is supported and driven by the proximal shaft, thereby resulting in energy supply. The deflection system 1400 includes an outer sheath 1495, which may include slots 1495s configured to allow the deflection legs 1490L to extend / flex therethrough, and a deflector sleeve 1490. The deflector sleeve 1490 may include a collar 1490c, deflector legs 1490L, and one or more deployment members 1490a, which may include holes 1490h that can be coupled to a suitable handle and / or control device to separately actuate each of the individual deployment members 1490a. The collar 1490c effectively connects the deflector sleeve 1490 to the device shaft. Again, each deployment member 1490a is connected to a separate leg 1490L, and when pushed distally or pulled proximally an appropriate distance, the deployment member 1490a respectively expands or retracts the leg 1490L to which it is connected. The outer sheath 1495 includes slits 1495s, through which the deflector legs 1490L can also hold the deployment members 1490a in place for operation.

[0448] The deflection legs 1490L can be varied in number depending on the desired functionality, such as from 1 to 10 on a given assembly. The deflection legs 1490L can comprise silicone, rubber, plastic, halocarbon, silicone rubber, nylon, vinyl, polycarbonate, etc. The deflection legs 1490L can also be constructed of stainless steel, which in a preferred embodiment has a thickness of approximately 0.1 mm. In some embodiments, the shape of the deflection legs 1490L in a relaxed state can comprise a slightly curved shape such that when manipulated with a compressive force to extend the legs, the relaxed shape will allow for effective extension. In other embodiments, the shape of the deflection legs 1490L can be fully extended in a relaxed state and can be retracted using a pull-out force from the deployment member 1490a.

[0449] Figure 15 a to Figure 15 d have described the embodiment of bipolar lysis instrument 1500.Instrument 1500 can comprise shaft 1590 and bidirectional lysis tip 1533.Cleaving tip 1533 is configured for bidirectional motion (that is, forward / far and reverse / proximal motion).As mentioned above, owing to existence facing forward / distal direction to promote that lysis tip 1533 passes through tissue through the existence tip 1533 of the forward motion of tissue and facing backward / proximal direction to promote that lysis tip 1533 passes through tissue through the existence tip 1533 of other lysis segments of cracking backward / proximal motion.

[0450] In contrast to previous, similar embodiments that may be monopolar, instrument 1500 is bipolar and includes two isolated electrodes, each having opposite and alternating polarity, namely, electrodes 1560p and 1560n. Electrodes 1560p and 1560n can define distal lysing segments 1560pd and 1560nd, respectively, and can define proximal lysing segments 1560pp and 1560np, respectively. Shaft 1590 can physically couple lysing tip 1533 to a source of electrosurgical energy via the proximal shafts of electrodes 1560p and 1560n, respectively, which, in the depicted embodiment, include conductive rods that can be electrically conductive and serve as conduits for the flow of electrosurgical energy. In the illustrated embodiment, the proximal shafts of electrodes 1560p and 1560n include integral extensions from their respective electrode portions that extend into or are integrated with bead 1501. Of course, in alternative embodiments, the same can be said of wires 1561p and 1561n, or another suitable means for electrical coupling, which may instead extend all the way to their respective electrodes within lysis lip 1533.

[0451] As shown, the rearward / proximal cleaving section of the instrument 1500 extends at least substantially perpendicular to the axis 1590 of the instrument 1500, as previously described in connection with FIG. Figures 11a-11e As stated.

[0452] The lysing tip 1533 includes one or more distal-facing lysing segments and one or more proximal-facing lysing segments. The proximal-facing and distal-facing lysing segments on one side of the lysing tip 1533 can be defined by a single electrode, or each can be defined by its own respective electrode. Thus, in the depicted embodiment, a single positive electrode 1560p is used to define a distal-facing lysing segment 1560pd and a proximal-facing lysing segment 1560pp on the right half of the lysing tip 1533. Similarly, a single negative electrode 1560n is used to define a distal-facing lysing segment 1560nd and a proximal-facing lysing segment 1560np on the left half of the lysing tip 1533. Likewise, separate positive and negative electrodes can be used to define the distal-facing and proximal-facing lysing segments, respectively, if desired.

[0453] The non-conductive body 1533b can be used to define various beads, protrusions, and / or other features that define recesses into which the cleaving segments are positioned and / or extend. In some embodiments, as previously described, the recesses can be defined by the beads, struts, and / or cleaving segments. The non-conductive body 1533b defines three forward distal protrusions 1501d, which are defined by the distal tip 1551d of the bead 1551 and the nose 1536 of the shaft 1590 and / or in part by the distal recess 1502d (in other embodiments, more than two distal recesses can be provided). Between the distal tip of the bead 1551d and the nose 1536. The non-conductive body 1533b defines three rearward proximal protrusions 1501p, which are defined by the proximal tips of the bead 1551 and the shaft 1590 and / or in part by a proximal recess 1502p positioned between the distal tip of the bead 1551 (more than two distal recesses may be provided in other embodiments), located between the bead 1551d and the nose 1536.

[0454] The lysis tip 1533 and / or the shaft 1590 may further include an insulating barrier 1554, which may be positioned between the positive electrode 1560p and the negative electrode 1560n to keep these electrodes electrically isolated, or at least substantially electrically isolated, from each other. The insulating barrier 1554 preferably comprises a suitable non-conductive material, such as a non-conductive polymer, preferably having a relatively high melting temperature, such as greater than about 300°C. In some embodiments, the non-conductive polymer may include, for example, polytetrafluoroethylene, polyetheretherketone, polysulfone, etc. In other contemplated embodiments, the material may include a non-conductive and / or non-thermally conductive polymer. In other embodiments, a ceramic material may be used as the insulating barrier. For example, in some embodiments, the insulating barrier 1554 may comprise a portion of the non-conductive body 1533b (in some such embodiments, an integral portion).

[0455] While nose 1536 is present in the depicted embodiment, examples of which were previously discussed and depicted, it should be understood that in other embodiments, barrier 1554 can extend all the way to the tip of the central portion of lysing tip 1533. In the illustrated embodiment, it includes nose 1536.

[0456] The shaped non-conductive body 1533b can include one or more beads 1551, which can be supported and / or separated by one or more rigid or substantially rigid struts 1580, each of which can be permanently or temporarily coupled between adjacent beads 1551 and / or between the outer protrusions and nose 1536 and / or shaft 1590 or the shaft portion of the lysing tip 1533. In some embodiments, the struts 1580 can further couple to the shaft of the lysing tip 1533 along the proximal region. In the preferred embodiment shown in Figures 15a-15d, the shaped non-conductive body 1533b can include one or more slots that can extend along each strut 1580 to allow for exposure and / or positioning of an electrode / lysing segment therein. As previously described, in some embodiments, the one or more slots 1580 can define a distal slot opening defined on its upper and lower sides by the struts 1580 and / or nose 1536, and on its left and right sides by the one or more beads 1551.

[0457] In this embodiment, electrodes 1560p and 1560n can pass through distal slot openings formed in nose 1536 and / or strut 1580 and be positioned and configured to define respective positive and negative distal lysing segments 1560nd, which can be defined by exposed portions of electrode 1560p. Notches 1560n and 1560n on either side of nose 1536 face distally through slot 1580s and allow for the delivery of electrosurgical energy or another suitable energy therethrough for tissue modification. The shaped, non-conductive body 1533b can further include one or more similar proximal slot openings 1580sp through which the proximal lysing segments 1560n / pp of electrodes 1560p and 1560n can be exposed to allow for the passage of electrosurgical energy therethrough and facilitate posterior / proximal movement of lysing tip 1533 through tissue, as previously described.

[0458] In some embodiments, the nose 1536 defining the central protrusion can be manufactured to accommodate a nasal insert 1536 therein, which can be bonded in place via a bonding agent such as ceramic glue, fasteners, or the like.

[0459] The bead 1551, nose 1536 and / or support 1580 can be composed of ceramics, cermets, glass, various halogenated hydrocarbons and any other suitable non-conductor.

[0460] As previously described, in some embodiments, bead 1551 may include slots, holes, or tunnels for partially accommodating electrodes 1560p and 1560n therein. In other embodiments, as previously described, bead 1551 may not include any tunnels or holes.

[0461] When the surgeon turns on the electrosurgical generator, electrosurgical energy may be transmitted through wires 1561p and 1561n or another suitable conductive member to electrodes 1560p and 1560n, which activate lysing segments 1560d and 1560p to deliver bipolar electrosurgical energy into tissue.

[0462] In some embodiments, the width of the distal portion of the lysing tip 1533 (defined between the outermost portions of the outermost beads 1551) can be between about 6 mm and about 12 mm, and the length of the beads can be determined by the shape. The non-conductive body 1533b can be between about 3 mm and about 10 mm.

[0463] Retrograde dissection can also facilitate the use of alternative tissue tension vectors adjacent to the target tissue and / or target tissue plane. The tissue tension vectors can be applied by the surgical assistant and / or the surgeon's non-instrumented hand. Likewise, retrograde dissection may allow for alternative dissection angles.

[0464] When the device is powered with electrosurgical energy, the bead 1551, nose 1536 and strut 1580 are preferably non-conductive in order to perform blunt dissection functions. However, in some embodiments, one or more of these elements may include a conductive core and a non-conductive coating or outer shell.

[0465] In some embodiments, electrodes 1560p and / or 1506n ​​may comprise rigid or at least substantially rigid plates, as shown in FIG15c. In some such embodiments, electrodes 1560p and / or 1560n may comprise a single, block of suitable conductive material that performs each of the functions described above. The slots 1580s and / or tunnels in the beads 1551 may be configured to tightly contain the respective electrodes therein, thereby preventing or at least inhibiting movement or unwanted RF energy escape. As previously described, the lysing tip 1533 may comprise a plurality of beads 1551 and a plurality of recessed lying segments, which in turn may be defined by one or more electrodes. It should be noted that in the embodiments of FIG15a to FIG15d, the beads 1551 are laterally supported along their respective inner sides by struts 1580. It should also be noted that bead 1551 lacks a base, such as base 105 of system 100 described in detail in U.S. Patent Application Serial No. 15 / 464,199, filed on March 20, 2017, entitled "Device, System, and Method for Minimally Invasive Dissection of Tissue," the entire contents of which are incorporated herein by reference. Thus, it should also be understood that bead 1551 lacks a structure behind or along the rear end of bead 1551 for support. It should also be noted that lysing tip 1533 includes bead 1551 having opposing tips that project distally and proximally relative to support post 1580.

[0466] Shaft 1590 can be coupled to tip 1533 to facilitate the transfer of electrosurgical energy in a desired manner and / or to allow manual dissection in the absence of electrosurgical energy. Shaft 1590 or the shaft of tip 1533 can be deformable, that is, it can be bent to angle the lysing tip in a desired direction, for example, to ensure that the lysing tip is angled upward 3 to 10 degrees for directing cutting / lysing toward the skin during cosmetic surgery.

[0467] When lysing tip 1533 is energized with electrosurgical energy, bead 1551 and strut 1580, or at least a portion thereof (such as except for those surfaces exposed to define / expose the lysing segment), are preferably non-conductive, thereby minimizing unwanted discharges. As previously described, conductive electrode 1560 can be configured to deliver electrosurgical energy through various distal and / or proximal lysing segments.

[0468] Bead 1551, nose 1536, and support 1580 can therefore be composed of ceramic, cermet, glass, various halogenated hydrocarbons, and any other suitable non-conductor. Bead 1551 can be restrained from movement and / or secured to support 1580 by direct coupling (i.e., continuous / integral ceramic) and / or conductive materials such as those comprising electrodes 1560p and 1560n. Other sealing methods, such as epoxy or ceramic glue or potting compound, can be used to seal any unwanted seams or openings to maintain non-conductive integrity at the desired location. When the surgeon activates the electrosurgical generator, electrosurgical energy can be transmitted to electrode 1560 via any suitable electrical coupling element.

[0469] As previously described, the two or more sets of electrodes of the bipolar instrument 1500 can have opposite polarity and be electrically isolated from each other along their paths. This may require that the entire housing and core components of the instrument be made of ceramic or other non-conductors, perhaps using wires that are electrically isolated from each other and coupled to the corresponding electrodes or electrode groups.

[0470] Figure 16a -f depicts a TMT system 1600 that includes a tissue modification tip (TMT) 1610 that can be connected to a spindle 1690 that can be connected to a power source, such as an electrosurgical energy source. The TMT 1610 can include a non-conductive housing 1633 and one or more tissue modification arms 1611. The tissue modification arms 1611 can be configured to be positioned / deployed in various positions relative to the non-conductive housing 1633. For example, Figure 16c depicts a deployed position / configuration. Figures 16d and 16e depict a retracted position / configuration, and Figure 16c and 16e depict a retracted position / configuration, and Figure 16d ... Figure 16b The intermediate position is depicted in . Once deployed, the tissue modification arms 1611 may be rotated to a treatment configuration, as generally depicted in the exploded view of FIG 16f.

[0471] The modification arm 1611 may include a non-conductive arm body 1611b in which one or more electrodes may be located. For example, in some embodiments, a single electrode may be positioned within the non-conductive body 1611b, and the electrode (or, in other embodiments, multiple electrodes) may define one or more electrode terminals 1664 that may protrude and / or project from the body 1611b. These terminals may be exposed through openings formed in the non-conductive body 1611b. In some embodiments, non-conductive mounds 1611m may be positioned around these openings to expose the electrode terminals 1664.

[0472] Modification arm 1611 may further include a guide member 1612 that can be used to secure the position of arm 1611b in the deployed position relative to housing 1633. Guide member 1612 may include a protrusion protruding from body 1611b and may also include a flat surface on one side that can be configured to slide against an outer surface of housing 1633 adjacent to slide slot 1614. In this manner, guide member 1612 and slide slot 1614 can be configured to prevent rotation / pivoting of arm 1613, or at least to prevent such rotation beyond a predetermined range.

[0473] The housing 1633 includes an axial shaft slot 1615 and a lateral sliding slot 1614. The shaft slot 1615 can extend along the length of the housing 1633, or extend at least a suitable length along the distal end of the housing 1633 to allow the positioning arm 1613 to pass therethrough. The arm 1613 is axially advanced and can be further configured to facilitate coupling of one or more electrodes defining the electrode terminal 1664 with an energy conduit and / or source adjacent to the TMT 1610. The positioning arm 1613 can further include a knob 1613a, which can be positioned and configured to pivotally couple with an opening 1611h formed in the modified arm 1611. Preferably, this coupling also provides electrical or other energy coupling that allows electrosurgical energy or other energy to be transferred to the electrode tip 1614.

[0474] During use, the surgeon can use digital manipulation to rotate the arm 1611 after the arm 1611 has been axially passed through the slot 1615. The slide slot 1614 can then serve as a guide for positioning and reversibly securing the deformed arm 1611 during deployment and, in some embodiments, in an intermediate position. During the surgeon's reverse / retraction movement, the arm 1613 can be retracted and contact the proximal portion of the slot 1614, which can be used to pivot the arm 1611 so that its tip is more axial and ultimately rotated with sufficient force to return the arm 1613 to its axial configuration. However, through the interaction of the exterior of the slide slot 1614 and the guide 1612, the modified arm 1611 can remain relatively fixed, or at least fixed within a specific desired range of motion, during backhand manipulation of the instrument.

[0475] In alternative embodiments, the tips 1664 can be configured to be positioned on the bottom of the arms 1611 in addition to or in lieu of the positions of the tips 1664 in the figures. However, in various embodiments, the surgeon can simply reverse the tips of the top-mounted set of tips 1664 so that the tips point in the opposite direction (e.g., away from the surface skin and toward the subcutaneous tissue). This inward / subcutaneous direction of energy can be used to direct energy toward subcutaneous deposits of cellulite and other cosmetic and surgically modifiable conditions.

[0476] The electrode terminals can receive energy from an energy source via a conduit (not depicted) that can include, for example, electrical wires and / or fiber optic filaments and / or the like. The terminals 1664 can be configured in any manner to accommodate any energy modality, including but not limited to laser, intense pulsed light, resistive heating, radiant heat, thermochromic, ultrasonic, mechanical, and / or microwave.

[0477] Figures 17a-17e Another embodiment of a lysis instrument 1700 is depicted, comprising a lysis tip 1733 having a plurality of beads 1751 and a plurality of lysis segments. Although only a distal lysis segment is depicted in the figures, it should be understood that alternative embodiments are contemplated in which a proximal / posterior lysis segment may also be included, or alternatively, a distal lysis segment may be included. The lysis segment may be defined by two electrodes, a first electrode 1760a and a second electrode, wherein the first electrode 1760a extends through a lumen or other opening formed in the shaft 1790 and curves to the right side of the instrument 1700 (as viewed by the surgeon). 1760b extends through a lumen or other opening formed in the shaft 1790 (which may be the same or a different lumen / opening as the first electrode) and curves to the left side of the instrument 1700. Thus, one electrode 1760 forms two lysing segments on the right side of the lysing tip 1733 (one between the first outermost bead and the adjacent bead, and the other between the adjacent bead and the nose / tip 1701n of the lysing tip and / or shaft 1790), and another electrode forms two additional lysing segments on the other side of the device. However, it should be understood that in other contemplated embodiments, a single electrode can form each of the four lysing segments of the lysing tip 1733, or alternatively, four separate electrodes can be used to form each of the four lysing segments.

[0478] Lysing tip 1733 may further include one or more struts for separating beads and / or assisting in defining and / or exposing various lysis segments. For example, in the described embodiment, struts 1780 extend through openings and / or holes formed in each of the individual beads to provide spacing between the beads and between adjacent beads and / or bead-like structures (e.g., distal nostril / tip 1701n). Of course, separate struts may be used to define these features and / or provide such spacing if desired. The struts 1780 may include an elongated slot along its distal edge and / or surface to allow one or more electrodes 1760a / b therein to be exposed, thereby defining lysis segments along the distal portion of the lysis tip 1733. The electrodes 1760a / b may extend from or be recessed into the slot, depending on the desired lysis characteristics of the device and the type of energy used. As previously described, in other embodiments, similar slots may be formed along the rear of the struts 1780 to provide rearward lysis if desired.

[0479] exist Figure 17d and 17eIn some embodiments, one or more beads 1751a may further include a spacer 1751ao, which may be provided by increasing the diameter of the opening / tunnel through which the electrode 1760 and / or strut 1780 passes. Extensions, or in other embodiments, by forming a hollow region and / or cutout adjacent to the lysing segment and / or strut. This increased spacing may provide one or more desired functions, such as allowing the electrodes 1760a / b to cool. Such spacing may also accommodate / facilitate cleaning of the device, provide greater cutting efficiency, help determine if the device has been previously used, particularly for devices intended for single use, may allow discharge / spacing to occur within the hollow region and / or may provide a larger surface area for cutting and / or electrosurgical discharge.

[0480] However, if Figure 17a As shown, in other embodiments this spacer may be omitted and the openings / tunnels for receiving one or more pillars and / or one or more electrodes may be relatively tight so as not to accommodate any appreciable spacer adjacent thereto.

[0481] like Figure 17a and 17d As best described in , beads 1751 / 1751a can be slightly flattened, which can provide sufficient rigidity while still exposing the lysing segment to sufficient tissue as the device passes. This shape of the beads can further facilitate guidance of the beads through tissue.

[0482] In other embodiments, Figure 17a The basic shape of -d can be formed as a unitary component from a suitable conductive material with all components / features formed from the suitable conductive material, over which a shell of relatively non-conductive material is added to prevent energy release, except for the cleavage segments exposed by removal of the shell. This concept is similar to that depicted and described in Figures 12 and 13a-c.

[0483] 18a and 18b depict an alternative embodiment of a lysing tip 1833 of a lysing instrument. In this embodiment, the rear portion of the lysing tip 1833 includes a rearward lysing segment 1860r that is configured to facilitate rearward / proximal movement of the lysing tip 1833 through tissue. However, unlike the embodiments depicted in the previous figures, the lysing tip 1833 includes a rearward lysing segment 1860r that is not positioned within and / or extends from a groove formed along the rear portion of the lysing tip 1833. The lysing segment 1860r may be slightly recessed therein. A slit formed along the rear surface of the lysing tip 1833, or alternatively, may protrude slightly from these slits or other suitable openings formed in the non-conductive body of the lysing tip 1833.

[0484] While this embodiment may not be preferred for some applications, the lack of a groove along the rear portion may aid in other desired aspects of the maneuverability or functionality of the lysing tip during proximal movement of tissue and may be suitable for some applications.

[0485] The front portion of the lysis tip 1833 can be similar to the previously discussed embodiments. For example, the lysis segment 1860f, which can in turn be defined by a single electrode or a single electrode located within the body of the device, is located within a concave recess defined by adjacent protrusions 1801d along the front portion of the lysis tip 1833. The lysis device can be coupled and / or integrated with the lysis instrument in any suitable manner, including those discussed in conjunction with other embodiments disclosed herein.

[0486] Figure 19a and Figure 19b Another alternative embodiment of a cleaving tip 1933 is described. In this embodiment, the basic shape of cleaving tip 1933 is reversed relative to cleaving tip 1833. In other words, the forward-facing front portion of cleaving tip 1933 lacks a notch, and instead provides cleaving segments 1960f extending along two portions of the relatively flat front surface of cleaving tip 1933. As with cleaving tip 1833, cleaving tip 1933 may include cleaving segments 1960f that slightly protrude or are recessed from a cleavage opening within a slot or other opening formed in the non-conductive body of cleaving tip 1933.

[0487] Along the rear of the lysing tip 1933 , a similar lysing segment 1960 r can be formed which can be located within a concave recess formed by an adjacent protrusion extending proximally from the lysing lip 1933 .

[0488] Yet another embodiment of a cleaving tip 2033 can be seen in Figures 20a and 20b. This embodiment essentially combines the rear portion of cleaving tip 1833 with the front portion of cleaving tip 1933. In other words, cleaving tip 2033 lacks any recess defined by adjacent protrusions, but rather includes two sets of cleaving segments extending from or slightly recessed therein. The front surface (2060f) and rear surface (2060r) of cleaving tip 2033 are relatively flat along the front and rear portions, respectively. Thus, cleaving tip 2033 can be configured to provide forward and backward movement in substantially the same manner. In contrast, cleaving tips 1833 and 1933 can provide a difference in feel and / or maneuverability of the tip in the proximal and distal directions. While this difference may be preferred for certain procedures, a surgeon may prefer to avoid such a difference, in which case either the non-recessed embodiment of Figures 20a and 20b or an embodiment in which recessed grooves are formed along both the front and rear surfaces of Figures 20a and 20b. As previously discussed and described, a lysing tip may be preferred.

[0489] Figure 21a -21c depicts a three-bead oscillating lysing instrument 2100. The instrument 2100 includes a lysing tip 2133 and a main shaft 2190. The lysing tip 2133 includes a formed body that can be made of a durable material designed to withstand intense vibrational forces, such as titanium and / or suitable alloys thereof. The tip body 2133b can include a unitary shape that forms the structure depicted in the figures, i.e., opposing beads 2150, struts 2180, and two distal notches and two proximal notches corresponding to the lysing and / or cutting segments, respectively, as described above. As a final product, one or more surfaces of the lysing instrument 2100 can be coated. In some embodiments, the instrument 2100 can be configured to perform lysing without the use of electrosurgical energy, and thus the coating applied to the lysing tip 2133 can include a conductive or non-conductive material.

[0490] The oscillating cleaving tip 2133 includes structural features similar to those of the embodiments previously described herein, however, these features / elements are preferably inevitably coupled as a unitary formed body. The distal protrusion 2101d and distal recess 2102d can be substantially defined by the plurality of distal tips 2150d of the leading edge of the bead 2150, extension / nose 2136, distal cleaving element 2161d, and / or strut 2180. The proximal protrusion 2101p and recess 2102p can be defined by the proximal tip 2150p of the bead 2150, extension / nose 2136, proximal cleaving element 2161p, and / or strut 2180. The distal cleaving segment 2161d and proximal cleaving segment 2161p can be tapered along the edges to facilitate mechanical cutting / dissection.

[0491] The oscillating device 2199 can be positioned along the axis at a resonant point that causes the tip 2133 to vibrate as indicated. Power sources for driving the oscillating device 2199 are well known to those skilled in the art. In some embodiments, the oscillating device 2199 can operate in a range of about 23 kHz to about 40 kHz. The oscillating device 2199 can include a hard piezoelectric ceramic, which can have a higher Q factor, better linearity, and be more difficult to depolarize. An example of such a ceramic is a Naval Type III material, such as APC 880 from American Piezoceramics, Inc., McKee, Pennsylvania, USA.

[0492] Figure 21a The embodiment shown in -c can provide surgeons with unique lysis capabilities in certain procedures, such as cellulite and face / neck tightening procedures.

[0493] In some embodiments, liquid may be distributed in or within one or more recesses 2102d / 2102p via tubes 2194j, which may supply liquid via liquid channels 2194. Supplying liquid to the cutting site may reduce scorch and reduce heat.

[0494] In some embodiments, a skin protection device can be placed around the wound entry site to reduce friction at the entry incision. Such a device can be made of a rigid, low-friction plastic, such as Teflon or HDPE, in the form of a hollow shaft surrounding the main drive element.

[0495] Figure 22a -e depicts an embodiment of a lysing tip 2233 that can be attached to an instrument or used as a lysing instrument itself. The lysing tip 2233 can include a shaft 2233b and a bidirectional lysing / treatment tip 2233t including two beads 2250 defining a distal treatment recess 2202d and a proximal treatment recess 2202p along one side of the shaft 2233b. The lysing tip 2233 can be configured for bidirectional movement (i.e., forward / distal and reverse / proximal movement) because, as described below, there is a forward / distal lysing segment to facilitate forward movement of the lysing tip 2233 through tissue and another rearward / proximal lysing segment to facilitate rearward / proximal movement of the lysing tip 2233 through tissue in the opposite direction. The shaft 2233b of the lysing tip 2233 can be physically coupled to a source of electrosurgical energy, such as an electrosurgical pencil (not shown), via a conductive insert or conductive core 2260s in some embodiments, which can serve as a conduit for the flow of electrosurgical energy to the lysing tip 2233. In the depicted embodiment, the conductive core 2260s comprises an integral extension from the electrode 2260. However, in other contemplated embodiments, the conductive core 2260s can be connected directly or indirectly to the electrode 2260, such as by a wire or the like.

[0496] As previously described, the lysing tip 2233 includes a distally facing lysing segment 2261d and a proximally facing lysing segment 2261p. Each of these different lysing segments can be defined collectively by a single electrode, or by separate electrodes. In the depicted embodiment, a single electrode 2260 is used to define each different lysing segment, and a shaped non-conductive body is used to define the various beads, protrusions, and / or other features that define the recesses within which the lysing segments are contained. The non-conductive body of the tip 2233 defines two (or more, as shown in other embodiments) forward-facing distal protrusions 2201d, defined by the distal tips 2250d of the beads 2250, and a distal recess 2202d located between the distal tips 2250d of the beads 2250 (other embodiments may provide more than one distal recess). The lysing tip 2233 may further include one or more rearward-facing proximal protrusion / recess lysing segments or lysing segment pairs to facilitate proximal movement of the device / tip 2233 through tissue. For example, the bead 2250 further defines a rearward protrusion 2250p defined by the proximal tip 2201p of the bead 2250 and a recess 2202p defined by the proximal tip 2201p and the shaft / neck of the lysing tip 2233.

[0497] However, in Figures 22a-22e In the embodiment, the recess on one side of the shaft 2233b is filled by a tissue deflection strut 2281, which is configured to reversely treat the tissue on the opposite side while deflecting the tissue and / or avoiding grabbing the tissue on one side of the tissue deflection strut 2281. Figure 22d As best shown, the opposing upper and lower surfaces 2281f of the strut 2281 can be recessed from the body of the bead 2250, from the shaft 2233b, and / or from the strut 2280. However, other embodiments are contemplated in which the strut 2281 can be thicker, and thus can have the same or greater thickness as one or more of these adjacent elements. The strut 2281 is also preferably non-conductive, thereby protecting adjacent tissue from the underlying electrodes, thereby allowing reverse lysis / tissue processing to occur only on the other side of the device.

[0498] The beads 2250 may also be supported and / or spaced apart by one or more rigid or substantially rigid crossbars 2280, wherein each crossbar may be permanently or temporarily coupled between adjacent beads 2250 and, in some embodiments, may be further coupled to the shaft 2233b of the lysing tip 2233 along the proximal region. Figures 22a-22eIn the preferred embodiment shown, the non-conductive body of the shaped bead 2250 may further include one or more slots, such as slot 2280s, which may extend between struts 2280. Slot 2280s may define a distal notch defined on its upper and lower sides by struts 2280 and on its left and right sides by one or more tunnels 2250t in the bead 2250. In other embodiments, the non-conductive body of the shaped bead may not include slots.

[0499] In this embodiment, the electrode 2260 can be positioned within the distal notch and, in operation, positioned and configured to define a cleaving segment 2261d, which includes an exposed portion of the electrode 2260, facing distally through the distal notch and allowing electrosurgical energy to be delivered therethrough. The shaped non-conductive body can further include one or more proximal notches through which the proximal cleaving segment 2261p of the electrode 2260 can be exposed, thereby allowing electrosurgical energy to be delivered therethrough and facilitating posterior movement of the cleaving tip 2233 in the tissue. Similarly, due to the presence of struts 2281 on one side of the device, in the depicted embodiment, there is only one proximal cleaving segment 2261p.

[0500] Beads 2250 and struts 2280 and / or 2281 may be composed of ceramic, porcelain, glass, various halogenated hydrocarbons, and any other suitable non-conductor.

[0501] When the surgeon activates the electrosurgical generator, electrosurgical energy can be transmitted through the conductive core, insert or wire, such as through the shaft 2233b, to the electrode 2260, which activates the lysing segments 2261d and 2261p to deliver electrosurgical energy into the tissue.

[0502] In some embodiments, the conductive material of electrode 2260 may include steel, nickel, alloys, palladium, gold, tungsten, silver, copper, platinum, and / or another conductive metal that does not release toxic residues at operating temperatures. In some embodiments, electrode 2260 may be coated with a non-stick and / or relatively inert material, such as gold, silver, rhodium, titanium, titanium alloys, tungsten, certain cobalt alloys, and combinations of any of the foregoing.

[0503] In some embodiments, the width of the distal portion of the cleaving tip 2233 (defined between the outermost portions of the outermost beads 2250) can be between about 3 mm and about 5 mm, and the length of the beads, which can be defined by a non-conductive body having a certain shape, can be between about 3 mm and 10 mm.

[0504] By providing distal and proximal lysing segments to separate and / or coagulate tissue in a forward and / or retrograde manner, several benefits can be achieved. For example, the efficiency of the dissection can be improved because a forward pass can separate tissue, while moving the tip in the reverse direction can also separate tissue, rather than simply preparing for another forward pass. As another example, providing distal and proximal lysing segments, preferably using recesses, can reduce the necessary width / size of the operating tool so that various models can fit smaller diameter cannulas and / or entry wounds / body openings for minimally invasive surgery and / or entry wound / scar minimization. Additionally, providing retrograde dissection can facilitate various anatomical angles or styles when placing various force vectors on the target tissue and / or target tissue planes.

[0505] It should be understood that the embodiments disclosed herein may be valuable and applicable in a variety of different types of surgeries. For example, the disclosed lysing tips, devices, and methods may be used in cosmetic surgery, including facial dissection, neck dissection, pocket formation for implants, axillary hyperhidrosis treatment, and cellulite treatment, and may also be used in internal medical procedures, such as laparoscopic and / or endoscopic surgeries. Thus, the device may be introduced directly into the body through an opening in the skin, or may be introduced using a trocar and / or cannula during other types of surgical procedures.

[0506] When the device is energized with electrosurgical energy, the beads 2250 and struts 2280 and 2281 are preferably non-conductive.

[0507] As previously described, the lysing tip 2233 includes a plurality of beads 2250 and a plurality of recessed lysing segments, which may also be defined by one or more electrodes. Figures 22a-22e In the embodiment of the present invention, the beads 2250 are laterally supported along their respective inner sides by the struts 2280. In other words, the beads 2250 each define a major and / or elongated axis extending between their respective distal and proximal ends. In the described embodiment, these axes extend at least substantially parallel to the axis of the instrument 2200. The beads 2250 are not supported from behind, such as by an element extending between the proximal ends of the beads 2250, but are supported along their respective sides by an element (the struts 2280 in the described embodiment) that extends at least substantially relative to their respective major axes so that the shape of the beads remains readily apparent from the structure of the lysing tip 2233. In addition, although one of the beads 2250 is connected to the tissue deflection strut 2281 from behind, it can be seen from several of the figures, such as Figure 22d and 22e, the rearward / proximal facing portion of the bead and its shape can still be seen. It is also apparent from these figures that the bead shape of the proximal portion of the bead coupled to the strut 2281 is visible on at least a portion of the outer portion / surface of the bead (relative to the axis 2233b) and the inner portion / surface of the bead. Of course, in alternative embodiments where the bead is spherical, or at least substantially spherical, the bead need not define a major axis, but in some such embodiments, at least a portion of the proximal bead shape can be seen behind the intersecting struts that connect the bead or beads to the adjacent bead or axis of the instrument.

[0508] It should also be understood that the beads 2250 are preferably non-conductive, or at least substantially non-conductive, at least along their respective surfaces. Thus, the beads 2250 can serve as a shield, allowing adjacent tissue to be prepared for closed dissection and / or electrodecontamination by the adjacent lysing segments. Otherwise, by providing adjacent protruding non-conductive surfaces, the lysing segments can be isolated from the tissue being treated, while the bead surfaces, preferably the distal and proximal protruding surfaces, can be used to stretch, spread, guide, and / or position the target tissue without directly transferring electrosurgical energy from the beads to the tissue being dissected. Transferring electrosurgical energy from the beads could potentially cause unnecessary tissue damage.

[0509] The shaft 2290 can be coupled to the tip 2233 to facilitate the transfer of electrosurgical energy in a desired manner and / or to allow manual dissection in the absence of electrosurgical energy. The shaft 2290 can be deformable, that is, it can be bent to tilt the lysing tip in a desired direction, for example, to ensure that the lysing tip is tilted upward by 3 to 10 degrees to direct cutting / lysing toward the dermis of the skin during a cosmetic procedure. In some embodiments, the pliable conductor covered by the pliable dielectric cover can be deformed by a manually applied external force and then retain its deformed shape during the application of axial forces primarily associated with normal use to the pliable shaft.

[0510] In some embodiments, the shaped non-conductive body may include one or more sensors. In some such embodiments, these sensors may be positioned within one or more corresponding sensor openings, which can serve as locations for various sensors, including, but not limited to, temperature sensors, optical fibers, location sensors, RFID sensors / tags, and the like. Such sensor openings may be connected to one or more conduits that pass through the shaped non-conductive body of the tip 2233 and exit at the proximal end of the lysing tip 2233. Alternatively, the sensors positioned within such sensor openings may be configured to transmit data wirelessly. In some embodiments, sensors may be positioned at the distal end of one or both beads 2250 and may be used to measure temperature during the instrument's backstroke, during which the treated tissue typically passes near these sensors. Thus, distally positioned temperature sensors may be used to measure tissue temperature after treatment. Similarly, temperature sensors may be positioned proximally to measure tissue temperature during and / or after the forward stroke. In some embodiments, temperature or other sensor measurements may be taken during RF activation or between RF pulses. In another embodiment, the sensors exposed in the sensor openings may be optical fibers that can sense tissue color and / or the presence of blood.

[0511] When the instrument 2200 is energized with electrosurgical energy, the beads 2250 and struts 2280 and 2281 are preferably non-conductive to minimize unwanted discharges. As previously described, the conductive electrode 2260 can be configured to deliver electrosurgical energy through various distal and / or proximal lysing segments.

[0512] The beads 2250 and struts 2280 and 2281 can be composed of ceramic, porcelain, glass, various halogenated hydrocarbons, and any other suitable non-conductors. The movement of the beads 2250 can be restricted and / or secured to the struts 2280 and 2281 by direct coupling (i.e., continuous / monolithic ceramic) and / or conductive materials such as those comprising the electrodes 2260. Similarly, indirect sealing methods, such as epoxy or ceramic glue or potting compound, can be used to seal any unwanted seams or openings to maintain the non-conductive integrity of the desired location. When the surgeon activates the electrosurgical generator, electrosurgical energy can be transmitted to the electrodes 2260 via any suitable electrical coupling element.

[0513] It should also be understood that any lysing tip and / or instrument disclosed herein, including but not limited to Figures 22a-22e Those situations described in can also be coupled with another surgical system, such as a robotic surgical system or used in other ways.

[0514] Figures 23a-23e illustrate one embodiment of a lysis instrument 2300. Instrument 2300 can include a shaft 2390 and a bidirectional lysis tip 2333, including a shaft portion comprising a treatment tip 2333t and a tip 2333b. Lysing tip 2333 is configured for bidirectional movement (i.e., forward / backward and backward / proximally) because, as described below, there is a forward / backward facing lysis segment to facilitate forward movement of lysis tip 2333 through tissue, and a backward / proximally facing lysis segment to facilitate backward / proximally movement of lysis tip 2333 through tissue.

[0515] In the embodiment of Figures 23a-23e, the recess on one side of shaft 2333b is occupied by tissue deflection strut 2381, which is configured to allow reverse treatment of the opposing tissue while deflecting the tissue and / or avoiding catching tissue on one side of tissue deflection strut 2381. As best shown in Figure 23d, the opposing upper and lower surfaces 2381f of strut 2381 can be recessed from the body of bead 2350, from shaft 2333b, and / or from strut 2380. Thus, the proximal portion of bead 2350 coupled to strut 2381 remains visible from behind strut 2380. However, other embodiments are contemplated in which strut 2381 can be thicker, and thus have the same or greater thickness as one or more of these adjacent elements. Strut 2381 is also preferably non-conductive, thereby shielding adjacent tissue from the underlying electrodes, thereby allowing reverse lysis / tissue treatment to occur only on the opposite side of the device. Using a tissue deflection strut on one side, such as strut 2381, may be particularly useful when dissecting fatty and / or other particularly fibrous tissues, such as facial and / or neck tissues, particularly those that have undergone previous surgery or other trauma.

[0516] As shown, the rear / proximal cleavage segment of instrument 2300 extends at least substantially perpendicular to the axis 2390 of instrument 2300. In the described embodiment, both distal and proximal cleavage segments define a recessed portion, particularly a curved recessed portion. However, the two points at which these cleavage segments terminate (one end on or adjacent to the bead, the other end on or adjacent to the axis 2390) define a line that is perpendicular to, or at least substantially perpendicular to, the principal axis / major axis of the bead itself. Similarly, the center point of each cleavage segment between the two aforementioned termination points, or at least substantially the center point, has a tangent line of curvature perpendicular to or at least substantially perpendicular to the principal / elongation axis of the bead 2350. Therefore, although the described cleavage segments are curved, they should be considered to be at least substantially perpendicular to the axis 2390 of instrument 2300, and at least substantially perpendicular to the axis and / or principal axis of the elongation of the bead 2350. These aspects of the cleavage segments may be applicable to any other embodiment described herein and / or disclosed herein.

[0517] However, other embodiments are also contemplated in which the lysing segments may extend at other angles relative to the main axis of the shaft 2390 and / or the instrument 2300. In the depicted embodiment, the proximal / rear end lysing segment may extend perpendicularly, or at least substantially perpendicularly, to the axis of the shaft 2390, as shown in FIG23c. In other contemplated embodiments, the proximal / rear end lysing segment may extend at an angle of approximately 60 degrees to approximately 120 degrees from the main axis of the shaft 2390 and / or the instrument 2300. The shaft 2390 physically couples the lysing tip 2333 to a source of electrosurgical energy, such as an electrosurgical pencil (not shown), via a conductive core 2360s. In the depicted embodiment, the conductive core 2360s comprises a conductive rod that may be electrically conductive and serve as a conduit for the flow of electrosurgical energy to the lysing tip 2333. In the depicted example, the conductive core 2360s comprises an integral extension from the electrode 2360. However, in other contemplated embodiments, the conductive core 2360s may be connected directly or indirectly to the electrode 2360, such as by a wire or the like.

[0518] The cleavage tip 2333 includes one or more distal-facing cleavage segments and one or more proximal-facing cleavage segments. Each of these different cleavage segments can have a single electrode, or each has its own electrode. In the described embodiment, a single electrode 2360 is used to define various cleavage segments, including a distal-facing cleavage segment configured to promote forward / backward movement of the instrument 2300 and a proximal-facing cleavage segment configured to promote backward / proximal movement of the instrument 2300. In this particular embodiment, a single electrode 2360 defines distal-facing and proximal-facing cleavage segments. However, it is conceivable that in other embodiments, separate electrodes / dissolution components can be used to define the cleavage segments of one or more distal faces and one or more proximal faces, respectively. The non-conductor 2333b can be used to define various beads, protrusions and / or other features that define the depression in which the cleavage segment is located. In some embodiments, the depression can be defined using beads, struts and / or cleavage segments. The non-conductive body 2333b defines three forward-facing distal protrusions 2301d defined by the distal tip of the bead 2350d and the nose 2336 of the shaft 2390, and a distal recess 2302d (in other embodiments, more than one distal recess may be provided) located between the distal tip of the bead 2350d and the nose 2336. The lysing tip 2333 may further include one or more rearward-facing proximal protrusion / recess pairs to facilitate proximal movement of the device 2300 through tissue. For example, the bead 2350 further defines a rearward-facing protrusion defined by the proximal end 2301p of the bead 2350 and a recess 2302p defined by the proximal end 2301p of the bead 2350 in conjunction with the strut 2380. By providing distal and proximal facing lysing segments, and preferably also providing an adjacent bead surface to stretch and / or guide the target tissue without directly treating / electrifying the tissue (due to the non-conductive surface provided by the beads), the device can be configured to effectively prepare and ultimately dissect the target tissue in two directions with or without electrosurgical energy. Thus, it may be preferred to provide beads with sharp distal and / or proximal surfaces. As in the case of beads 2250 and 2550, the surfaces of these cusps can be curved in at least one plane (or more than one) and thus can be smooth rather than sharp.

[0519] Likewise, on the opposite side, instead of otherwise defining another recess and corresponding lytic segment, the tip 2333 includes a tissue deflecting strut 2381 extending from the rear end of the adjacent bead 2350 to the axis 2390, as shown, preferably in a curved manner without any sharp corners.

[0520] The shaped, electrically non-conductive body 2333b can include one or more beads 2350, which can be supported and / or spaced apart by one or more rigid or substantially rigid struts 2380, each of which can permanently or temporarily couple adjacent beads 2350 and / or between the outer beads and the nose 2336 and / or the shaft 2390 or shaft portion of the lysing tip 2333. In some embodiments, the struts 2380 can be further coupled to the shaft of the lysing tip 2333 along a proximal region. In a preferred embodiment shown in Figures 23a-23e, the shaped, electrically non-conductive body 2333b can include one or more grooves extending along each strut 2380. Such grooves can define a distal notch defined on its upper and lower sides by the struts 2380 and / or nose 2336 and on its left and right sides by the one or more beads 2350.

[0521] In this embodiment, the electrode 2360 can be positioned and configured through the distal notch to define a distal lysis segment 2360d, which can be defined by exposed portions of the electrode 2360 on either side of the nose 2336 to face distally through the distal notch and allow electrosurgical energy, or another suitable energy for modifying tissue, to be delivered therethrough.

[0522] In other embodiments, such as in Figure 23c, the nose defining the central protrusion can be fabricated to receive a nose insert 2336 therein, which can be coupled in place by a coupling agent such as ceramic glue, fasteners, or the like. In other embodiments, the nose insert 2336 (the volume between the upper and lower nose portions) can be filled with a filler, such as a high temperature epoxy or the like.

[0523] The molded non-conductive body 2333b may include one or more sensor openings that may serve as locations for various sensors, including but not limited to temperature sensors, optical fibers, positioning sensors, RFID sensors / tags, and the like. Such openings may be connected to one or more conduits that may pass through the molded non-conductive body 2333b and exit at the proximal end of the lysis tip 2333. Additionally, sensors, including but not limited to sensors disposed in the sensor openings, may be configured to transmit data wirelessly. It should be noted that one or more sensor openings may be located at the distal end of one or more beads 2350. Additionally, one or more sensors may be located in a sensor opening in the nose. In some embodiments and implementations, the sensor may be used to measure temperature during the return stroke of the instrument. In some embodiments, the measurement may be performed during a radio frequency pulse or between radio frequency pulses. In another embodiment, the sensor exposed at any sensor opening may be an optical fiber that may sense tissue color and the presence of blood.

[0524] The bead 2350, nose 2336, tissue deflecting struts 2381 and / or struts 2380 may be composed of ceramic, porcelain, glass, various halogenated hydrocarbons, and any other suitable non-conductor.

[0525] When the surgeon activates the electrosurgical generator, electrosurgical energy can be transmitted through the conductive core 2360s, through the shaft 2390, to the electrode 2360, which activates the lysing segments 2360d and 2360p, delivering electrosurgical energy into the tissue.

[0526] In some embodiments, the width of the distal portion of the cleaving tip 2333 (defined between the outermost portions of the outermost beads 2350) may be between about 6 mm and about 12 mm, while the length of the beads (between the proximal and distal ends) may be defined by the formed non-conductive body 2333b and may be between about 3 mm and about 10 mm.

[0527] It should be noted that the cleaving tips 2233 and 2333 are unique in that they can be dissected in both anterior and posterior directions, potentially more efficiently than unidirectional cleaving tips. Retrograde dissection can also facilitate the use of alternative tissue tensions adjacent to the target tissue and / or target tissue plane. Tissue tension vectors can be applied by the surgical assistant and / or the surgeon's non-instrumented hand. Similarly, retrograde dissection can allow the use of alternative dissection angles.

[0528] When the device is energized with electrosurgical energy, the bead 2350, nose 2336, tissue deflection struts 2381, and struts 2380 are preferably non-conductive in order to perform blunt dissection functions. However, in some embodiments, one or more of these components may include a conductive core and a non-conductive coating or shell.

[0529] In some embodiments, the lysis member / electrode assembly 2360 comprises a rigid and / or substantially rigid plate, as shown in FIG23c. In such embodiments, one or both of the proximal lysis segment 2360p and / or the distal lysis segment 2360d can be configured to be electrically coupled to the electrode shaft 2360s. In some such embodiments, the electrode 2360 can comprise a single piece of suitable conductive material that serves each of these functions. One or more grooves can be configured to tightly receive the lysis member electrode assembly 2360 to prevent or at least inhibit movement or unwanted RF energy escape. As previously described, the lysis tip 2333 can comprise a plurality of beads 2350 and a plurality of recessed sections, which can also be defined by one or more electrodes. It should be noted that in the embodiments of FIG23a-23e, the beads 2350 are laterally supported along their respective inner sides by struts 2380.

[0530] The shaft 2390 can be coupled to the tip 2333 to facilitate the transfer of electrosurgical energy in a desired manner and / or to allow manual dissection in the absence of electrosurgical energy. One or more portions of the shaft 2390 and / or the tip 2333 can be deformable, that is, they can bend to tilt the lysing tip in a desired direction, for example, to ensure that the lysing tip is tilted upward 3 to 10 degrees to cut / lyse the skin during cosmetic surgery.

[0531] When the system 2300 is powered, the beads 2350, tissue deflection struts 2381, and struts 2380, or at least a portion of one or more thereof (e.g., surfaces other than those used to define / expose the lysing segments), are preferably non-conductive, thereby minimizing unwanted discharges. As previously described, the conductive electrode 2360 can be configured to deliver electrosurgical energy through various distal and / or proximal lysing segments.

[0532] In some embodiments, the conductive material of electrode 2360 may include steel, nickel, alloys, palladium, gold, tungsten, silver, copper, platinum, and / or another conductive metal that preferably does not emit toxic residues at typical operating temperatures. In some embodiments, electrode 2360 may be coated with a non-stick material, which may include gold, silver, rhodium, titanium, titanium alloys, tungsten, certain cobalt alloys, and the like.

[0533] The bead 2350, nose 2336, tissue deflection strut 2381, and strut 2380 can be composed of ceramic, porcelain, glass, various halogenated hydrocarbons, and any other suitable non-conductor. The bead 2350 can be restricted in movement and / or affixed to the strut 2380 and / or strut 2381 by direct coupling (i.e., continuous / monolithic ceramic) and / or conductive materials, such as the material comprising the electrode 2360. Similarly, indirect sealing methods, such as epoxy or ceramic glue or potting compound, can be used to seal any unwanted seams or openings to maintain non-conductive integrity in the desired locations. When the surgeon activates the electrosurgical generator, electrosurgical energy can be transmitted to the electrode 2360 via any suitable electrical coupling element.

[0534] It should also be noted that on the same instrument, the beads 2350 can be of the same shape or of different shapes and / or can be tilted / slanted upwards or tilted / slanted downwards by about 3 degrees to about 15 degrees to assist in guiding the tip upwards or downwards to the tissue plane. In other embodiments, each bead can be angled in a different direction. In some embodiments, struts 2380 and / or 2381 can remain parallel to the upper and / or lower surfaces of the device, or can be aligned at the same angle as their respective tilted beads.

[0535] In another embodiment, the lysing tip 2333 can be configured to oscillate in various planes, which may help reduce eschar buildup and facilitate mechanical movement of the lysing tip 2333 within the tissue. In some such embodiments, the shaft 2390 may include a piezoelectric or oscillating / vibrating motor unit, which may be located in the handle or at another point between the handle and the distal tip to generate the necessary harmonic movement. High-energy frequencies, such as those in the ultrasonic region, can be selected but may be too powerful for a multi-component device. However, lower-energy frequencies, similar to those used in toothbrushes to aid cleaning, can provide the necessary energy to reduce eschar and assist in its dissolution. Lower frequencies can be achieved through the use of voice coils, although piezoelectric ceramics may be the preferred approach. Higher frequencies in the ultrasonic range require a smaller piezoelectric element. The frequency range may vary from approximately 1 kHz to approximately 80 kHz, with a range of approximately 21 kHz to approximately 40 kHz being preferred. A hard ceramic piezoelectric motor is preferred for lower amplitudes, exemplified by the APC 840, which can be expanded to include the Navy I type.

[0536] FIG24 depicts another alternative embodiment of a lysis instrument / tip 2400, comprising a single bead 2450 extending parallel to, or in related embodiments, at least substantially parallel to, the shaft 2433 of the instrument 2400. The proximal end of the shaft 2433 can be configured to connect to an electrosurgical instrument and / or a power source. The bead 2450 is connected to the shaft 2433 by a strut 2480, which can be similar to the strut 2380 described above. Grooves and / or openings can be formed in the strut 2480, the inner side of the bead 2450, and / or the adjacent outer side of the shaft 2433 to allow the distal lysis segment 2461d and the proximal lysis segment 2461p to extend from respective recesses defined by the bead 2450, the shaft 2433 (for the distal lysis segment 2461d at the shaft 2433 tip 2433d), and the strut 2480, respectively. Similarly, the various lysis segments can be defined by a single electrode or by separate, distinct electrodes, as desired.

[0537] With respect to the embodiment of Figure 24, again, the lysing tip is configured to allow for both distal and proximal therapeutic action and provides distal and proximal lysing segments for this purpose.

[0538] Figures 25a-25c depict a lysing tool / tip that is a modification of the embodiment of Figure 24 , in which the portions of lysing segments 2561d and 2561p defined by electrode 2561, rather than protruding from a recess, are recessed within respective recesses defined by shaft 2533, bead 2550, and strut 2580. Thus, as shown in Figure 25c , electrode 2561 is embedded within the distal and proximal recessed portions defined by strut 2580. As shown in Figure 25c , by recessing the electrode / lysing segments within the structure of the tip body, accuracy and / or safety can be improved, and therefore, for certain surgical procedures and / or for certain physicians, this variation may be preferred over an embodiment in which the electrode / lysing segments protrude from the tip body, as shown in the embodiment of Figure 24 . As mentioned in other embodiments, electrode 2561 can be electrically coupled to a source of electrosurgical or other therapeutic energy via shaft 2533 using a conductive core 2561c and / or wires or other electrical coupling means. Of course, in other alternative embodiments, the portion of the electrode defining the lysing segment may be flush with the end of the strut, shaft, and / or bead.

[0539] Figure 26a -26d also describes another embodiment of the lysis instrument 2600. The lysis instrument 2600 includes a shaft 2690 terminating in a lysis tip 2633, including a plurality of beads 2650 defining a plurality of adjacent protrusions 2601d / 2601p and lysis segments 2661d / 2661p positioned in recesses extending between adjacent protrusions 2601d / 2601p. As previously described, two struts 2680 are used to connect adjacent beads 2650. As previously described, although other alternative embodiments are also contemplated, in the described embodiment, each lysis segment is defined by a single electrode 2661, wherein multiple electrodes can be used, each electrode being used to define one or more lysis segments. A conductive core 2661c can be connected to the electrode 2661 to allow for delivery of electrosurgical or other therapeutic energy to each lysis segment.

[0540] The shaft 2690 also includes an angled portion 2690b that extends the shaft 2690 away from its proximal axis. In the depicted embodiment, the angled portion 2690b is configured to position the middle bead 2650 along, or at least substantially along, the proximal axis of the shaft 2690, allowing the opposing outer beads to each extend beyond the proximal portion of the shaft 2690 on opposing sides such that the treatment width defined by the opposing outer beads is wider than the shaft 2690.

[0541] like Figure 26b and Figure 26dAs best shown in the cross-sectional view of FIG, the distal end of the shaft 2690 is formed to mimic the distal end shape of the two beads 2650, thereby providing similar functionality to the beads 2650 by defining protrusions 2633d and adjacent recesses that partially define adjacent cleavage segments.

[0542] In some embodiments, comprising Figure 26a -26d, the tip comprises a non-slit tip configured to be inserted through a relatively small entry wound, such as an entry wound between about 2.5 mm and about 5 mm. Thus, in some embodiments, the length of the beads on the tip can be about 4 mm or no more than about 5 mm. This can allow the tip to be passed through the entry wound by inserting the beads farthest from the axis first and then passing the tip through the entry wound at an angle / uncovered position to minimize the necessary entry wound size. This can also avoid the use of hinges, rotating elements, etc., and can allow for a wider treatment area (typically defined between the outermost beads of the treatment tip) without the need for such a rotating element.

[0543] like Figure 26bAs described above, some embodiments may be configured with one or more dimensions below a threshold to allow for use in relatively small entry wounds. For example, a surgeon may introduce the device into an entry wound / incision via the distal end of the outermost bead 2650d, with one corner of the entry wound contacting an adjacent strut 2680 and / or lysing segment 2661d. Thus, in some preferred embodiments, a limiting distance D1, which in some embodiments may not exceed approximately 6 mm, and in more preferred embodiments may not exceed approximately 5 mm, allows the opposite end of the entry wound to contact the proximal end of the outermost bead 2650p. This process can then be repeated from bead to bead, ultimately resulting in the distal end of shaft 2633d contacting the opposite end of the entry wound, while the proximal inner strut 2680 and / or lysing segment contact the opposite end of the entry wound as the device is rotated in preparation for introducing shaft 2690b into the entry wound. Therefore, distance D2 also becomes a limiting factor related to the size of the entry wound. Therefore, in preferred embodiments, distance D2 may also be no more than approximately 6 mm, and more preferably no more than approximately 5 mm. As shown, distance D1 is measured along the three-dimensional surface of bead 2650 from the proximal end of outermost / distal bead 2650 to the distal-most portion of adjacent strut 2680 and the corner of outermost / distal bead 2650. Similarly, distance D2 is measured from distal tip 2601d of shaft 2690 to the corner between adjacent strut 2602d and shaft 2690, also measured along the arc and / or three-dimensional shape of the bead-like distal end of shaft 2690. This distance can correspond to the maximum preferred length of an entry wound for various cosmetic procedures, regardless of tissue stretching and the specific technique used to create the entry incision. Although not shown in the figure, this maximum threshold distance is preferably applied to each other similar element of the tip, such as central bead 2650 and adjacent struts.

[0544] Figure 26e describes a Figure 26a 26d. However, the instrument 2600' in FIG26e includes a tip 2633' that extends at a right angle to the shaft 2690'. Thus, the shaft portion 2690b' of the tip 2633' is straight and extends along the same axis as the shaft 2690'.

[0545] Figures 27a-27b Describes a Figure 26a -An embodiment similar to the embodiment described in 26d. The difference is that Figure 27a and 27bThe instrument 2700 described in the accompanying drawings includes an inclined shaft portion 2790b, providing another example of a non-curved tip 2733. In this embodiment, the non-curved tip extends outwardly relative to the shaft 2790. As previously described, the tip 2733 also includes a plurality of beads 2750 interconnected by struts 2780. In addition, distal and proximal recesses 2702d / 2702p are defined between adjacent beads 2750 and / or the distal ends of the shaft 2790b that mimic the shape of the beads. Figure 27a and 27b As shown, it provides an angled treatment tip that allows for a unique treatment technique, combined with Figure 27c Let’s discuss.

[0546] Figure 27c An example of a method of using instrument 2700 to form a path to target tissue is described. This method may begin by inserting the tip 2733 through the entry wound E, as previously described. The surgeon / practitioner may then consider one of the following patterns of using the instrument 2700 to establish a path to the tissue treatment site. In a first example, a "short" sawtooth pattern may be used, in which the tip 2733 is advanced a first distance, which in a preferred embodiment may be about 2 centimeters, with the tip 2733 pointing in a first direction (e.g., to the right front). The tip 2733 may then be rotated / flipped 180 degrees at a fork point f, such that the tip 2733 is now pointing in a second direction, (e.g., to the left front), after which the tip 2733 may be advanced again a similar distance (e.g., more than 2 centimeters). This process may then be repeated as many times as desired until the tip 2733 is in the desired target treatment area T, as shown in FIG. Figure 27c As shown. In soft fat, a short zigzag pattern may be preferable. In soft fat, short rotational advancements result in a zigzag pattern, allowing the shaft to follow the path. Depending on the shaft's stiffness and the density and stiffness of the surrounding tissue, the shaft may still be able to apply the correct force vector to the tip, allowing the tip to be advanced in different directions within the treatment zone without having to readjust the shaft during dissection. Simple rotations after various advancements within the treatment zone can allow for relatively good dissection over a certain distance. In other approaches, surgeons may prefer to combine the two techniques.

[0547] In another example of a method for using instrument 2700 to create a path to a target tissue area, a long sawtooth pattern can be used, wherein the tip 2733 can be advanced a longer distance, for example, approximately 5 to 10 centimeters with the tip 2733 pointing in a first direction (e.g., pointing to the right front), after which the tip 2733 can be rotated / flipped 180 degrees so that it now points in a second direction (e.g., left front) and advanced another 5 to 10 centimeters. In some embodiments, the tip 2733 can be withdrawn by one or more backstrokes, possibly while energizing the proximal cleaving segment. Alternatively or additionally, the tip 2733 can be withdrawn and, as needed, forward strokes can be performed using the energized distal cleaving segment to reduce / clear any residual sawtooth beneath the surface tissue that represents the path of the device during initial movement and that is not visible. If the surgeon determines that the sawtooth has been sufficiently weakened and that potential future tension on the shaft has been minimized, the process can be repeated as many times as needed until the tip 2733 is located at the target treatment area T and / or a sufficient path has been established for subsequent treatment devices using the instrument 2700. Once the surgeon has determined their preferred path tissue density in terms of shaft stiffness and the distance the shaft must travel, the procedure can be performed using a long sawtooth pattern.

[0548] Figures 28a and 28b illustrate two examples of TMT for tissue modification, preferably after another device, such as any of the lysing and / or cutting devices disclosed herein, has dissected tissue, creating tissue planes and / or pathways, and / or accessing a target area within a patient. TMT device 2800a comprises a shaft 2890a and a treatment tip 2811a, which includes a plurality of isolated electrode tips 2864 through which energy can be delivered to tighten and / or treat tissue, such as the subcutaneous / epidermal / subcutaneous tissue layers and / or adjacent tissue layers. In this embodiment, shaft 2890a is adjacent to tip 2811a, and tip 2811a is defined by the presence of terminals 2864. Terminals 2864 can simply comprise portions through which the conductive core of TMT device 2800a is exposed, or located near the surface of such portions, for delivering therapeutic energy, such as radiative heating, resistive heating, thermochromic heating, microwaves, ultrasound, electrosurgery, intense pulsed light, laser, or any other form of therapeutic energy disclosed herein. When other non-electrical types of energy are used, the conductive core can therefore be replaced by another energy delivery conduit, such as a fiber optic bundle for LASER treatment energy or intense pulsed light. Alternatively, the terminal 2864 can protrude from the surface of the tip 2811a and still preferably be coupled to one or more wires and / or the conductive core to deliver energy through the shaft 2890a. The conductive protrusions 2893a / 2893b are used to couple the conductive core or another energy delivery conduit of the device to an energy delivery system (not shown). In other embodiments, the terminal 2864 may not protrude from the surface or be exposed, but may preferably define an isolated treatment terminal below the surface, such as in embodiments utilizing microwave treatment energy. The TMT device 2800a further includes a rounded edge 2892a, which may enhance the ability of the device to traverse a path preferably created by another device, which may include any of the lysis tips disclosed herein.

[0549] TMT device 2800b is similar to TMT device 2800a, except that edge 2892b is not curved / rounded. Thus, TMT device 2800b also includes a shaft 2890b and a treatment tip 2811b including a plurality of isolated treatment electrode terminals 2864.

[0550] Figure 29a, 29b, 30, and 31 depict additional embodiments of TMT devices. Each of these TMT devices includes a non-branching, non-curved treatment tip. Like TMT devices 2800a and 2800b, these TMT devices can be inserted into relatively small entry wounds in the skin or other organ systems and / or advanced through a tissue pathway, preferably created by one of the lysing tips / devices disclosed herein. Each of the TMT devices disclosed in Figures 28-31 is configured with the necessary dimensions to minimize the skin / skin entry wound and is therefore ideally configured for use in cosmetic procedures. For example, a 2 mm to 5 mm skin entry wound can be created in an area typically covered by bikini bottoms or undergarments, providing a less conspicuous area in which to perform tissue dissection using one or more lysing tips / devices, such as those disclosed herein. Therefore, in certain preferred embodiments, each of these described TMT devices can be configured such that a portion along the treatment tip and / or shaft can extend through a cross-section of the entry wound, not exceeding the size of the entry wound, which in preferred embodiments can also be 2-5 mm in size. As previously mentioned, each of the TMT devices depicted in these figures is also unbranched, which also allows the treatment device to be easily extended through relatively small entry wounds.

[0551] Thus, one or more of the various TMT devices described can be inserted into a relatively small entry wound and ultimately extended through a previously dissected tissue plane to treat adjacent tissue. The distal end of the tip can be inserted into / through the entry wound. The tip can then be snaked at various angles, if necessary, while being advanced into the entry wound, until portions of the shaft reach the entry wound and / or the tip is fully inserted into the patient's body. The shaft can then be advanced through the entry wound to allow a sufficient amount of the device to enter the area / volume between the tissue planes desired by the surgeon. The TMT device can then be directed to treat various portions of the exposed tissue planes as it passes in a variety of directions, including but not limited to fanning back and forth, straight back and forth, wipers, and even randomized surgical treatment. The TMT device, particularly when applied to the skin, can be monitored by instrumentation, including but not limited to the use of external infrared cameras, thermistors, thermocouples, ultrasound, and the like.

[0552] Any TMT device disclosed herein may include a device that can be inserted into an electrosurgical pencil and / or another suitable energy source or instrument, and thus can become part of an electrosurgical treatment system. Other instruments that can be coupled to TMT may include a grasping device.

[0553] With more particular reference to the described embodiments, Figure 29aIn the embodiments depicted in Figures 29 and 29b, the TMT 2900a / 2900b (the only difference being that TMT 2900a includes smooth / rounded edges, while TMT 2900b does not) further includes a shaft 2990a / 2990b that couples to a tissue modification tip (TMT) 2911a. As shown in Figure 29b, the instrument 2900b does include smooth curves along opposing surfaces of the device, including along the tip 2911b. However, in this particular embodiment, the edges transitioning from the side surfaces to the top and bottom surfaces are not smooth. Of course, in other embodiments, such as Figure 29aIn some embodiments, they may be smooth. However, in embodiments 2900a and 2900b, all curves transitioning from the shaft (2990a / 2990b) to the treatment tip (2911a / 2911b) are smooth and thus lack any sharp points or edges (even though the transitions between the surfaces defining these curves and the upper and lower surfaces in the embodiment of FIG. 29b are sharp / unsmooth). In these embodiments, more specifically, the tissue treatment tip of these two embodiments includes an upper surface, a lower surface, and opposing side surfaces, wherein the opposing side surfaces include one or more curves, and each of the one or more curves is smooth and lacks any sharp points or edges. Of course, in some embodiments, the cross-sectional shape of the shaft and / or tip may have other shapes, such as circular. However, the tip 2911a / 2911b includes a tip that extends away from the path of the shaft 2990a / 2990b to create a wider / larger treatment end. However, as previously described, in these embodiments, the cross-sectional dimensions of the treatment tip 2911a / 2911b are maintained at relatively small dimensions, without branches, to facilitate insertion into relatively small entry wounds. In the depicted embodiment, these dimensions are identical to those of the shaft 2990a / 2990b, although it is contemplated that in other embodiments, these dimensions may differ slightly from those of the shaft. Thus, the tip 2911a / 2911b comprises a non-branched, non-curved tip including a first straight portion 2912a / 2912b extending at an obtuse angle relative to the shaft 2990a / 2990b, a curved portion 2913a / 2913b, and a second straight portion 2914a / 2914b extending at a perpendicular, or at least substantially perpendicular, angle relative to the shaft 2990a / 2990b. The second straight portion 2914a / 2914b comprises the treatment terminal 2964. However, it is contemplated that in alternative embodiments, other portions of the tip 2911a / 2911b may also include an electrode therapy terminal, another type of therapy terminal, or another type of energy window and / or delivery means, such as an elongated strip disposed on the upper and / or lower surface of one or more portions of the tip 2911a / 2911b. By providing a non-branched, non-curved tip having a relatively constant cross-sectional dimension extending in this manner, a therapy width / dimension greater than the cross-sectional width / dimension of the shaft 2990a and the inlet winding may be provided. The conductive protrusions 2993a / 2993b are used to couple the conductive core of the device or another energy delivery conduit to an energy delivery system (not shown).

[0554] As previously described, the tip 2911a / 2911b may include an energy window, which may include one or more terminals 2964 that may be placed facing the upper and / or lower tissue planes that may have been lysed / dissected. Although the terminal 2964 or other energy window element may terminate on one side of the TMT tip, in alternative embodiments, the energy window element 2964 may terminate on one or more sides / surfaces / portions of the TMT tip, including but not limited to the upper and lower sides / surfaces / portions of the tip 2911b in alternative embodiments. A non-conductive cover and / or coating may be provided, which may include one or more windows that may allow a conductive core or other conductive element to extend therethrough to provide energy transmission therethrough for electrosurgery or other functions.

[0555] In another embodiment, the various distal portions of the TMT can be positioned in different planes, wherein the bend / curve of the tip can direct the various portions to different treatment planes. This can help force, for example, the treatment window / tip 2964 into a position so as to contact and / or deliver energy to the target tissue in a more ideal manner.

[0556] In some embodiments, the TMT system 2900a / b can be configured to use bipolar electrosurgical energy, rather than monopolar as shown in the figures. For example, in some bipolar embodiments, each other terminal 2946 can be reverse-charged from its adjacent (nearby) terminal. This allows current to flow between adjacent terminals, rather than sending RF energy through the body to a more distant return zone.

[0557] In some embodiments, the TMT instrument 2900a can be configured to use microwave energy, rather than monopolar energy as suggested by the accompanying drawings. Microwave energy can be used to heat tissue, and thus providing a suitable array of microwave emitters allows for controlled tissue heating and remodeling. In some such embodiments, a suitable microwave generator can be positioned at the proximal end of the tip using a shielded cable, preferably an integral wavelength in length. For example, National Electronics manufactures / distributes microwave sources. From the generator, a shielded cable, such as a coaxial cable, can deliver energy to the energy window region of the TMT tip 2911a, where one or more ends of the coaxial cable can be exposed, without insulation, to act as an antenna / emitter for the microwave energy.

[0558] In some embodiments, the TMT instrument 2900a can be configured to use resistive heating elements rather than monopolar energy as shown in the figures. Resistive heating can be used to heat tissue using appropriate surface-mount resistor arrays or small heating elements driven by AC or DC current from a conductive catheter.

[0559] The instrument 2900a may include one or more sensor openings that may serve as locations for various sensors, including but not limited to temperature sensors, optical fibers, positioning sensors, RFID sensors / tags, and the like. Such openings may be connected to one or more conduits that may pass through and exit the proximal end of the tip 2911a. Additionally, sensors, including but not limited to sensors disposed in the sensor openings, may be configured to provide data wirelessly. In some embodiments, sensors may be used to measure temperature as the instrument advances and / or retracts. In some embodiments, the measurement may be performed during a radio frequency pulse or between radio frequency pulses. In another embodiment, the sensor exposed at any sensor opening may be an optical fiber that may sense tissue color and the presence of blood. In an alternative embodiment, a temperature sensor utilizing ultrasonic methods may be used.

[0560] In some embodiments, a camera or other real-time sensing device may be incorporated into the instrument, such as placed in close proximity to the beads and / or treatment tip. Such sensing devices can be used to detect bleeding, the speed of the device through the tissue, inspect the tissue being treated, and precisely visualize the target area.

[0561] In another embodiment, the energy window can be configured to provide various modes of energy including, but not limited to, radiative heating, resistive heating, thermochromic, microwave, ultrasound, electrosurgery, intense pulsed light, laser, or any other form of therapeutic energy disclosed herein.

[0562] In another embodiment depicted in FIG30 , a TMT instrument 3000 includes a TMT tip 3011 and a shaft 3090. This embodiment is similar to Figure 29a The embodiment described in

[0015] is similar to the embodiment described in

[0016] in that it includes an angled tip 3011 connected to the shaft 3090 at a bend and an unbranched TMT tip 3011 having a constant cross-sectional dimension / size. However, the TMT tip 3011 is continuously curved with a constant radius of curvature, resulting in a circular path that extends in two directions / sideways beyond the path of the shaft 3090. In this embodiment, the pattern of the end 3064 is different from the other embodiments. The conductive protrusions 3093 serve to couple the conductive core of the device or another energy delivery conduit to an energy delivery system (not shown).

[0563] In another alternative embodiment depicted in FIG31 , a TMT instrument 3100 includes a TMT tip 3111 and a shaft 3190. This embodiment also includes an angled tip 3111 connected to the shaft 3190 at a bend 3112. The TMT tip 3111 includes a sharp distal tip comprised of multiple straight sections and multiple curved / angled sections connected to the multiple straight sections to create a terminal end 3164 arranged in a chevron shape. Conductive protrusions 3193 are used to connect the conductive core of the device or another energy delivery conduit to an energy delivery system (not shown).

[0564] In some embodiments, the length of the TMT shaft can vary from 1 cm to 40 cm, preferably around 10 cm to 20 cm, and the size of the TMT tip can vary from 5 mm to 30 mm, preferably 10 to 20 mm.

[0565] In another embodiment, the TMT tip can be rigid and comprised of ceramic, glass, metal, and / or plastic. In another embodiment, the TMT shaft can be rigid, or semi-rigid, or even flexible and can be comprised of both metal and plastic. Having a semi-rigid and / or flexible TMT shaft allows the surgeon to bend the device, thereby changing the position of the treatment tip so that the treatment area is relatively distant relative to the location of the entry wound. For example, a surgeon can treat a portion of cellulite in the lower thigh while entering the body through an entry incision in the relatively concealed underwear or bikini area. Since the surface of the thigh may have a curvature, if the treatment area is wider than the path formed from the entry wound to the treatment area, bending the shaft with or without the assistance of another external force can allow the treatment tip to contact all desired areas.

[0566] In various electrosurgical embodiments, the shaft and / or the contents therein can be conductive to facilitate transmission of electrosurgical energy from an electrosurgical generator to the TMT tip. The TMT tip may or may not be coupled to and / or continuous with the TMT shaft. However, in other embodiments, such as electrosurgical embodiments, the TMT tip and / or the contents therein may or may not be conductive or insulating.

[0567] In some embodiments, the energy window and / or energy delivery terminal can be positioned on the bottom surface of the tip in addition to, or as a different arrangement than, being positioned on the top surface of the tip. However, in various embodiments, the surgeon can simply flip the tip of the top-mounted energy window so that it points in the opposite direction (e.g., away from the surface skin and toward the subcutaneous tissue). This inward / subcutaneous direction of energy may be helpful in directing energy toward subcutaneous deposits of cellulite and other cosmetic conditions.

[0568] FIG32 depicts an embodiment of a bipolar TMT device. TMT device 3200 may include a non-branched, non-curved treatment tip. Like TMT devices 2900a and 2900b, this TMT device can be inserted into a relatively small entry wound in the skin or other organ system and / or can be advanced through a tissue path, preferably created by one of the lysing tips / devices disclosed herein. As previously described, the described TMT device is also non-branched, which can also facilitate the extension of the treatment device through a relatively small entry wound.

[0569] Thus, the described bipolar TMT device 3200 can be inserted into a relatively small entry wound and ultimately extended through a previously dissected tissue plane to treat adjacent tissue. The distal end of the tip can be inserted into / through the entry wound. The tip can then be snaked at various angles, if necessary, while being advanced into the entry wound until the central portion reaches the entry wound and / or the tip is fully inserted into the patient. The bipolar TMT device, particularly when applied to the skin, can be monitored by instrumentation including, but not limited to, external infrared cameras, thermistors, thermocouples, ultrasonic methods, and the like.

[0570] The TMT devices disclosed herein may include a device that can be inserted into an electrosurgical pencil and / or another suitable energy source or instrument, and thus can become part of an electrosurgical treatment system. Other instruments that can be coupled to the TMT may include a grasping device.

[0571] Tip 3211 comprises a non-branched, non-curved tip including a first distal straight portion 3214d that bends / zigzags at 3212b to become a relatively straight proximal portion 3214p that extends from curve 3212a and becomes or is connected to axis 3290. First distal straight portion 3214d is parallel to straight proximal portion 3214p. Both straight portions include therapeutic terminals. More specifically, portion 3214p includes therapeutic terminals 3264p, which may be of a first polarity, while straight portion 3214d includes terminals 3264n of a second polarity. An electrical signal can be passed through tissue and / or an ionic liquid between the oppositely charged terminals, thereby altering the tissue and / or fluid between the opposing terminals.

[0572] In another embodiment, one or more portions of the TMT tip can be positioned in a plane relative to the axis, wherein the bend / curve of the tip can direct the various portions to different treatment planes. This can help force, for example, the treatment window or terminal 3264n / 3264p into position to more ideally contact and / or deliver energy to the target tissue.

[0573] Figures 33a-33d illustrate various shaped protruding electrode tip assemblies 3311 that can be used with any of the TMT tips disclosed herein and can produce more favorable treatment outcomes by, for example, improving contact with adjacent tissue during treatment. Such terminal shapes can be beneficial because their surface projection can reduce unwanted arcing tendencies and make the discharge more predictable and / or uniform. In Figures 33a-33d, the base 3314 is relatively planar, preferably non-conductive, and can be continuous with the other materials of the TMT tip. In some embodiments, a non-conductive shell 3316, which can be conical, extends from the relatively planar base 3314 to a point slightly below the apex of a conductive cylindrical terminal core 3364, which emanates from a portion of the conductive base 3393 or a cavity in the non-conductive shell 3316. A recess 3364d can be formed at the apex of the conductive cylindrical terminal core 3364, which can be slightly rounded or have a sharper edge depending on the surgeon's desired discharge tendency. In some embodiments, the conductive cylindrical end core 3364 can be flat, rounded, or pointed at its distal end surface / protrusion, and / or can lack a depression / pit. In some embodiments, the conductive terminal core can be conical, cylindrical, domed, and / or can otherwise include a larger base portion tapering to a narrower tip. It is also contemplated that the various protruding electrode tips disclosed herein, including each of the embodiments described in Figures 33a-36d, can alternatively be used in other tissue treatment / modification devices, such as tissue dissection and / or modification devices including lysing tips, beads, and the like.

[0574] Figures 34a-34d depict another embodiment of a raised electrode terminal assembly 3411, comprising a cylindrical conductive terminal core 3464 defining a hollow opening or hole 3464h. The opening / hole may have a depth ranging from approximately 10% to 100% of the distance from the top of the conductive cylindrical terminal core 3464 to the conductive base 3493. In another embodiment, the opening / hole may extend further into the base 3493 to varying degrees. The embodiment depicted in Figures 34a-34d is similar in the following respects. Figures 34a-34d are similar in nearly all other respects to the embodiment depicted in Figures 33a-33d. With the exception of hole / opening 3464h, the embodiment depicted in Figures 34a-34d is similar in nearly all other respects to the embodiment depicted in Figures 33a-33d. This hole may allow for a larger discharge and enable determination of whether the device has been used previously. In alternative embodiments, the hole may be cylindrical, conical, V-shaped, or any other desired shape. Like non-conductive housing 3316 , non-conductive housing 3416 extends from non-conductive base 3414 .

[0575] Another embodiment of a raised electrode tip assembly 3511 is depicted in the figures. Figures 35a-35d are similar in almost all other respects to the embodiment depicted in Figures 33a-33d. However, the center of the dome formed by the terminal core 3564 is connected to the conductive base 3593, defining a dome / projection 3564n at the center of the pit, forming a sort of "island" in the depicted embodiment. This shape facilitates discharge not only at the edge of the conductive terminal core 3564, but also within the dome island 3564n itself. In alternative embodiments, the top of the dome island 3564n can be higher, equal to, or lower than the outer edge of the terminal core 3564 and / or the non-conductive conical shell 3516. Like the tips 3316 and 3416, the non-conductive shell 3516 extends from the non-conductive base 3514.

[0576] Figure 36a -36d illustrates another example of a raised electrode tip assembly 3611 including a tapered conductive tip core 3664 having a tapered hole / opening 3664h, which is shown extending downwardly to the conductive base 3693, but in alternative embodiments may extend only partially downwardly this length, for example terminating near the non-conductive base 3614 rather than extending completely downwardly to the base 3693. In other embodiments, the hole may penetrate the base 3693 to varying degrees. Figure 36a 36a-36d are similar in almost all other respects to the embodiment depicted in FIGs. 34a-34d, with a non-conductive housing 3616 extending from a non-conductive base 3614.

[0577] FIG37 depicts another example of a TMT instrument 3700 comprising a shaft 3790 terminating in a treatment tip 3711 including a treatment window defined by a plurality of energy-emitting treatment tips 3764. Tip 3711 extends from shaft 3790 at a bend 3712, extending at a right angle relative to shaft 3790. Tip 3711 further comprises a non-branching treatment tip having a constant, or at least substantially constant, tip diameter, which can also allow for insertion into relatively small entry wounds. In this embodiment, the tissue treatment tip comprises an upper surface, a lower surface, and opposing side surfaces, wherein the opposing side surfaces comprise an elbow, and the elbow is smooth and lacks any sharp points or edges. In the depicted embodiment, the edges transitioning between the side surfaces and the upper and lower surfaces are also smooth, lacking any sharp points / edges. However, as described above, other embodiments are also contemplated, including where these edges may be sharp.

[0578] 38 depicts yet another example of a TMT instrument 3800. Although the shape of instrument 3800, including tip 3811 of instrument 3800, is similar to the shape of instrument 3200, wherein tip 3811 comprises a non-branching, non-breaking treatment tip that can be inserted into a relatively small entry wound in the skin or other organ system and / or can be advanced through a tissue pathway preferably created by one of the lysing tips / devices disclosed herein, unlike instrument 3200, tip 3811 comprises a treatment window on one of its two straight portions and a sensor window on the other portion.

[0579] More specifically, proximal linear portion 3814p, which curves from axis 3890 at bend 3812a, includes a treatment window defined by multiple treatment terminals 3864. This window bends / curves at U-shaped bend 3812b to become a relatively straight distal portion 3814d. Distal linear portion 3814d includes sensor window 3898, which, in some embodiments, may include a temperature sensor. By positioning the sensor window on one arm / section and the treatment window on the other arm / section, the surgeon can sense the temperature of the tissue immediately after treatment. It should be understood that in other embodiments, the positioning of the treatment and sensor windows may be reversed. Thus, while the embodiment depicted in FIG. 38 may be configured to sense tissue temperature during supination, by reversing the positioning of the treatment and sensor windows, tissue temperature can be sensed during forward travel. In other embodiments, temperature sensors and tissue treatment elements may be provided on both arms of the device to allow for sensing of tissue being treated in either orientation.

[0580] Figure 39a 39b and 39c depict other embodiments of lysing tips 3933 / 3933' extending from a shaft 3990 / 3990' of an electrosurgical lysing instrument, respectively. Lysing tip 3933 includes a plurality of beads 3950 defining distal protrusions 3950d that collectively define a single recess 3902 therebetween. Distal lysing segment 3961d is positioned within recess 3902 and, as previously described herein, is configured to transmit electrosurgical energy therefrom to treat tissue during a surgical procedure. Similarly, each bead 3950 further defines a proximal-facing protrusion 3950p on either side of shaft 3990. Proximal lysing segment 3961p, which may be defined by a single lysing member or separate lysing members, may extend from and / or be positioned within a recess defined on the proximal end of lysing tip 3933 between proximal protrusion 3950p and an adjacent portion of shaft 3990.

[0581] The bead 3950 of the lysing tip 3933 differs from the beads of the embodiments described in the previous figures in that the bead 3950 includes a flat upper surface and a lower surface that form a plate-like bead structure. It should be understood that while the described embodiments include planar upper and lower surfaces that are parallel to each other, other contemplated embodiments may include flat upper and / or lower surfaces that are not strictly parallel to each other, but should still be considered to include "flat" surfaces. Similarly, in some embodiments, the upper and / or lower surfaces can be at least substantially flat, for example, having some protrusions, curves, or the like, but still forming a surface that, for purposes of this disclosure, should be considered to be "at least substantially flat or planar."

[0582] Lysing tip 3933' is similar to lysing tip 3933, but lysing tip 3933' includes a faceted bead 3950'. More specifically, bead 3950' includes facets 3975' on the distal end 3950d' and the proximal end 3950p' of the tip. Although optional, providing such facets 3975' can facilitate focusing pressure at certain angles, particularly more acute angles relative to the main axis of movement and / or axis 3990', which can facilitate tissue dissection in certain applications.

[0583] In some embodiments, a camera or other real-time sensing device can be incorporated into the instrument, such as in close proximity to the location of the beads and / or treatment tip. Such sensing devices can be used to detect bleeding, the speed of the device through the tissue, inspect the tissue being treated, precisely visualize the target area, etc.

[0584] Those skilled in the art will appreciate that the details of the above embodiments may be modified without departing from the basic principles set forth herein. Any suitable combination of various embodiments or features thereof may be considered.

[0585] Any method disclosed herein includes one or more steps or actions for performing the method. The steps and / or actions of the method may be interchanged with one another. In other words, unless a specific order of steps or actions is essential for the proper operation of the embodiment, the order and / or use of specific steps and / or actions may be modified.

[0586] Throughout this specification, any reference to "one embodiment," "an embodiment," or "the embodiment" means that a particular feature, structure, or characteristic associated with the embodiment is included in at least one embodiment. Therefore, phrases or variations thereof throughout this specification are not necessarily all referring to the same embodiment.

[0587] Likewise, it should be understood that in the description of the above embodiments, various features are sometimes combined in a single embodiment, figure, or description thereof for the purpose of simplifying the disclosure. However, this method of disclosure should not be interpreted as reflecting an intention that any claim requires more features than those expressly recited in the claim. Rather, the inventive aspects lie in the combination of fewer than all features of any of the aforementioned disclosed embodiments. It will be apparent to those skilled in the art that modifications may be made to the details of the above embodiments without departing from the general principles set forth herein.

[0588] Likewise, benefits, other advantages, and solutions to problems have been described above with respect to various embodiments. However, none of the benefits, advantages, solutions to problems, nor any elements that may render any benefit, advantage, or solution apparent or consequential, are to be construed as critical, required, or essential features or elements. Accordingly, the scope of the present invention should be determined solely by the following claims.

Claims

1. An electrosurgical lysis device comprising: a lysing tip comprising at least one bead, wherein the at least one bead comprises an at least substantially non-conductive surface, and wherein the at least one bead at least partially defines a distally facing recess and a proximally facing recess; at least one electrically conductive lysing member positioned adjacent to the at least one bead and configured to transmit electrosurgical energy from the lysing tip, the at least one electrically conductive lysing member defining at least one distally-facing lysing segment extending within at least a portion of the distally-facing recess defined by the at least one bead and defining at least one proximally-facing lysing segment extending within at least a portion of the proximally-facing recess defined by the at least one bead; a non-conductive support connected to the at least one bead; and a shaft, wherein the lysing tip is positioned at a distal end of the shaft; The proximally facing lysing section extends only within a proximally facing groove on a single side of the shaft.

2. The electrosurgical lysis device of claim 1 , further comprising a tissue deflection strut positioned between the proximal portion of the non-conductive strut and the proximal portion of the at least one bead.

3. An electrosurgical lysis device according to claim 1, wherein the at least one electrically conductive lysis member is at least partially positioned within the non-conductive support.

4. An electrosurgical lysis device according to claim 3, wherein the at least one electrically conductive lysis member is positioned entirely within the non-conductive support post such that no portion of the at least one electrically conductive lysis member protrudes from the non-conductive support post.

5. An electrosurgical lysis device according to claim 3, wherein the at least one electrically conductive lysis member partially protrudes from the non-conductive support so as to be able to directly contact the tissue during the tissue lysis procedure.

6. An electrosurgical lysis device according to claim 1, wherein the at least one electrically conductive lysis member is configured to be capable of antegrade or retrograde lysis.

7. An electrosurgical lysis device according to claim 1, wherein individual beads of the at least one bead are configured to at least partially define proximally and distally facing lysis segments.

8. The electrosurgical lysis device of claim 1, wherein the at least one bead comprises at least one of a flat upper surface and a flat lower surface.

9. An electrosurgical lysis device according to claim 8, wherein said at least one bead comprises two opposing flat surfaces forming a plate-like bead structure.

10. The electrosurgical lysis device of claim 1, further comprising a tunnel extending at least partially through at least one bead, wherein the at least one electrically conductive lysis member extends at least partially through the tunnel.

11. An electrosurgical lysis device comprising: a lysing tip comprising at least one bead, wherein the at least one bead is defined by an at least substantially non-conductive material along an entire outer surface of the at least one bead; and at least one electrically conductive lysing member configured to transmit electrosurgical energy from the lysing tip, the at least one electrically conductive lysing member defining at least one lysing segment extending within a groove at least partially defined by the at least one bead; a non-conductive support connected to the at least one bead; a shaft, wherein the lysing tip is positioned at a distal end of the shaft; and The splitting section extends within the groove only on one side of the shaft.

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