BIPOLAR COAGULATING DEVICE WITH RIGIDLY RESILIENT POLYMERIC HANDPIECE AND METHODS OF USING SAME

Abstract

Conventional varicose vein techniques suffer from a number of disadvantages and potential complications, including, for example, a risk for the development of hematomas, swelling, and blood clots, post-surgical pain and nerve injury, a potential for spontaneous regeneration and undesired resumption of varicosity, a need for a highly skilled surgical professional, as well as, in certain instances, a prolonged recovery period, accompanied by severe limitations on post-surgical activity. The present invention overcomes the disadvantages and deficiencies of the prior art by providing devices and methods for percutaneously occluding and dividing a varicose vein or other problematic vessel, a rapid, reliable, less invasive therapy that may be readily, reliably, and successfully performed by minimally skilled personnel around the world in a variety of medical settings. Particularly described herein is a bipolar coagulating device provided with a rigidly resilient handpiece of unitary construction that is specifically adapted to the sealing of thicker tissue sections, whereby the stiffness of the handle material acts as a compressive spring to provide a predetermined clamping profile (i.e., force) and travel between the sealing jaws.

Description

TECHNICAL FIELD OF THE PRESENT INVENTION

The present invention relates generally to surgical instruments and methods for percutaneously, or through other surrounding tissue, sealing or otherwise occluding and dividing a vein, vessel, or other accessible duct or tissue of a patient. More particularly, the present invention relates to a novel polymeric handpiece for a bipolar coagulating device adapted to the sealing of thicker tissue sections, such as arise in the context of general surgery (e.g., for sealing an internal duct or lesion) as well as percutaneous surgical methods (e.g., for treating conditions associated with bulging, swollen dilated, and/or raised vessels, for example, superficial thrombophlebitis, also known as “varicosed veins”).

BACKGROUND OF THE PRESENT INVENTION

Varicose(d) veins occur when the walls of veins become weakened. This may be due to a variety of causes including hypertension, being overweight, restrictive clothing, or standing for extended periods of time, among others. As blood pressure in the vein increases, veins expand and may distort into twisted patterns as the vein length increases. This stretching of vein causes the valves in the vein to lose functionality. Failing valves cause sluggish blood to back up or pool in the vein, which, in turn, causes the vein to swell, bulge, twist and discolor.

While the condition of varicosity is largely chronic and incurable, available treatments can reduce the appearance of and relieve the discomfort associated with varicose veins. Examples of such conventional treatments include, but are not limited to, limb elevation (wherein legs are elevated above the waist multiple times a day to increase blood flow and decrease pressure in the veins) and compression techniques (wherein supportive stockings or socks compress the veins to prevent stretching, help blood flow, and reduce discomfort). In more severe cases, clinical interventions may be required to block the vein. In each case, the vein is blocked, becomes scar tissue, and is finally absorbed by the body.

For example, during injection therapy (“sclerotherapy”), a healthcare provider injects a solution into the vein that causes the vein walls to stick together. However, sclerotherapy has certain known side effects including:

• • Redness or bruising for a few days where a needle went into the skin;
  • Brown areas (for several months) on skin where the needle touched; and
  • Lumps or hardness for a few months;

An alternative, minimally invasive treatment option is endovenous thermal ablation (also known as endovenous “laser therapy” and “radiofrequency therapy”), a procedure in which a long thin catheter is used to guide a laser or radiofrequency tool into position, generate heat, and permanently seal off the damaged vein. As compared to invasive varicose vein surgery, endovenous thermal ablation has several benefits compared to varicose vein surgery, including:

• • Less pain;
  • Fewer complications;
  • Minimal scarring;
  • Positive cosmetic results (usually equal to or better than surgery); and
  • Shorter recovery (one can return to his/her normal routine sooner).

That being said, an invasive varicose vein surgery referred to as “ligation and stripping”, wherein a surgeon ties off the affected vein (ligation) to stop blood from pooling and then removes (strips) the vein through several incisions to prevent varicose veins from reappearing, is often the patient's best or only option. This stands in contrast to endovenous thermal ablation wherein the varicose vessel is sealed off but not removed. Accordingly, whereas endovenous thermal ablation is associated with a small incision, a relatively short recovery time and fewer complications, varicose vein surgery requires significant surgical skill and several weeks of recovery, and complications often result.

Unfortunately, all the presently available therapies have significant drawbacks. For example, in the context of sclerotherapy, new varicose veins can happen and need treatment. Similarly, half of the patients who undergo surgical stripping get varicose veins again within five years. Likewise, varicose veins can recur after endovenous thermal ablation as well. In addition, both of these treatments have a significant potential for negative side effects including:

• • Scarring;
  • Skin burns;
  • Infection;
  • Injury to a nerve; and
  • Deep vein thrombosis (a blood clot in a vein deep inside the body).

Accordingly, there is a need in the art for a varicose vein therapy that utilizes simplified instruments to occlude and divide the vein simply and quickly and with fewer steps and fewer post-surgical complications. To that end, the present invention addresses the ongoing need in the art for expeditious treatment methods that reduce scarring, burning and nerve injury, avoid the formation of hematomas and blood clots, minimize the potential for spontaneous regeneration and undesired resumption of varicosity, and negate the need for a highly skilled surgical professional, an extended procedure duration, and a prolonged recovery time. Furthermore, the present invention addresses the consistent preference in the art for methods that avoid the need for sharp instruments so that clinicians may limit their exposure to a patient's body fluids and thus operate on patients with infectious diseases such as HIV without risk of infection. Finally, in contrast to the prior art, the bipolar coagulating devices of the present invention are configured to deliver a compressive force sufficient to seal thicker tissues.

SUMMARY OF THE PRESENT INVENTION

The present invention addresses the afore-noted needs in the art by providing a novel and improved devices and methods for general and percutaneous surgery, particularly for occluding and dividing a vein, vessel, or other duct of a patient, more particularly a varicose vein, spider vein, or the like. Namely, using the bipolar coagulating devices and excising instruments described herein, a varicosity may be quickly, simply, and completely occluded, and optionally thereafter divided. For example, in the devices and methods of the present invention, a varicose vein or other duct or vessel in need of treatment is isolated within a fold of skin or other surrounding tissue portion using a non-conductive clamp and clamped between the jaws of a bipolar coagulating device afforded with a rigidly resilient handpiece of unitary construction that acts as a spring to imparts an improved seal strength. Coupling thermal RF energy with an optimized compressive pressure ensures sufficient travel between the jaws such that the portion of the fold of skin or other surrounding tissue portion and the vessel positioned therein that is clamped between the jaws is fused by coagulation so as to occlude (i.e., “seal”) the vessel in two places. Thereafter, the clamp and handpiece jaws are removed from the site. Coagulation of the tissue prevents blood flow to the central uncoagulated region. Because of this, tissue in this region will necrose and slough from the body so as to divide the vessel. Optionally, the center portion of uncoagulated tissue in the center of the coagulated region may be excised using the original clamp or another suitable instrument.

It is therefore an objective of the present invention to provide a device and method for occluding and dividing a vein, vessel, duct, or tissue in need thereof that includes the steps of:

• • (a) locating a bulging, swollen, raised or dilated length of said vein, vessel, or duct;
  • (b) positioning a surgical clamp about the vein, vessel, or duct so as to temporarily isolate the length;
  • (c) providing a coagulating bipolar device with a proximal handpiece that defines a longitudinal axis of said device and is characterized by a pair of rigidly resilient yet elastically deformable polymeric handle portions of unitary construction and an active distal portion characterized by a pair of opposingly-faced, upper and lower coagulating jaws configured to be positioned around said surgical clamp;
  • (d) tightly closing the jaws about the tissue-capturing distal portion of the surgical clamp to thereby define a first area of clamped tissue disposed between the closed jaws and a second area defined by the interior perimeter that includes the isolated length of vein, vessel or duct retained by the tissue-capturing distal portion of the surgical clamp; and
  • (e) activating the coagulating bipolar device so as to coagulate the first area of clamped tissue, whereby the stiffness of the polymeric handle portions augments travel between the jaws so as to optimize the clamping force and provide an improved seal strength.

In a preferred embodiment, the inventive method may optionally further include step (f), wherein both the coagulating device and surgical clamp are disengaged from the vein, vessel, duct, or tissue.

In certain preferred embodiments, the method may further include the step of sliding the tissue-capturing distal end of the surgical clamp relative to the jaws of the bipolar device in a direction normal to a plane defined by the coagulating jaws, whereby outer surfaces perimetral to the tissue-capturing distal end of the surgical clamp interact with the mating inner edges of the coagulating jaws of said bipolar device so as to excise some or all of the second area, including the isolated length of vein, vessel, duct, or tissue, to thereby divide the first area of clamped tissue into two coagulated and sealed proximal and distal ends.

In an alternative embodiment, the mating inner edges of the upper and lower coagulating jaws may include planar cutting edges and the outer edge surfaces perimetral to the tissue-capturing distal end of the surgical clamp may include curvilinear sharpened surfaces, whereby the excision of some or all of the second area of the vein tissue, including the isolated length of vein, is achieved through shearing action that arises from engagement of said sharpened curvilinear surface with said planar cutting edges.

It is a further objective of the present invention to apply the above-recited method steps to the treatment of varicose (d) veins. In a particularly preferred embodiment, a bulging, swollen, raised, or dilated length of a varicosed vein may be percutaneously manipulated into a surface fold of the patient's skin. In the context of this embodiment, the vein may be a superficial tributary vein, a spider vein, or thread vein.

In a preferred embodiment, the above methods may optionally further include the step of percutaneously manipulating the length of the vein, vessel, or duct into a fold of adjacent dermal tissue, particularly when the vein at issue is a varicosed tributary vein or spider vein.

In a preferred embodiment, the surgical clamp utilized in the above methods may be a ring forceps or a tenaculum.

In preferred embodiments, the upper and lower coagulating jaws are (i) movable between open and closed positions, and (ii) provided with mating distal tips and inner edges, whereby, when said jaws are in the closed position and viewed in a plan view, said mating inner edges engage to define an interior perimeter comprised of (1) an open central slot that terminates in (2) lateral opening sized to permit said distal clamping portion to be positioned around said surgical clamp.

In a further preferred embodiment, the upper and lower jaws as well as the first area of clamped tissue are arcuate in shape (e.g., comprising mirror-image “U-shaped” curves) such that the second area may include a convex region. In addition, the inner edges of the pair of opposingly-faced, upper and lower coagulating jaws may be optionally sharpened so as to enable direct excision of the second area that includes the isolated portion of the vein, vessel, or duct.

In a preferred embodiment, the coagulation of the first area of clamped tissue serves to occlude and divide the vein, vessel, or duct into separated sealed proximal and distal legs and, optionally, to deaden sensory nerves proximate to said first area of clamped tissue.

In a preferred embodiment, the mating distal tips are offset from the longitudinal axis of the device by about 30 to about 60 degrees, more preferably from about 40 to about 50 degrees.

In certain preferred embodiments, the methods of the present invention may employ an improved resilient radio-frequency device that finds particular utility in the percutaneous sealing of thick tissue. Radio frequency vessel sealers used in open or endoscopic surgery are well known in the art. Illustrative examples of such devices are depicted in FIGS. 70 and 71 and include, for example, the Artery Sealers Electro Surgery Vessel Sealing (Bi-Clamp) by Surgimpex (Sialkot, Punjab, Pakistan) and the Laparoscopic Biclamp Vessel Sealers by various medical device companies located in Mumbai, Maharashtra, India. These devices conventionally have oppositely opposed, pivotably joined metallic members with proximal handle portions with finger loops at the proximal end. Distal to the pivot point each member has formed thereon oppositely opposed clamping portions. The members are electrically isolated one from another so that RF energy supplied to each member at its proximal end is conducted to the uninsulated clamping surface at its distal end. In use, a vessel to be sealed is positioned between the uninsulated clamping surfaces. The clamp is closed tightly on the vessel and RF energy is applied so as to heat the vessel and form a seal. Devices of this prior art type are generally able to seal vessels up to seven millimeters in diameter, the vessel being largely free of surrounding tissue. The vessels readily compress when subjected to clamping force by the symmetrically opposed clamping surfaces. The thickness of the tissue mass through which RF energy must flow to make a seal is quite thin, the thickness varying depending on the vessel size and type.

In contrast, when performing percutaneous vessel sealing using methods of the present invention, the vessel is positioned within a fold of tissue. The thickness of the tissue to be sealed is much greater than that of vessel sealed by prior art devices. Clamping of the tissue prior to sealing may result in a tissue mass between the clamping surfaces that may be millimeters thick. Accordingly, RF sealing devices of the present invention are optimized for the percutaneous sealing of vessels.

Prior art vessel sealing devices are unsuitable for percutaneous sealing of vessels since the jaws are not configured for cooperative use with a clamp for maintaining the position of a vessel during treatment, the jaws being linear or only slightly curved. This is contrast to devices of the present invention wherein the jaws have angularly displaced slots configured for placement around a clamp. Improved sealing devices contemplated by the present invention preferably include oppositely opposed polymeric members pivotably joined, each member having a proximal handpiece and a distal active portion wherein are mounted metallic clamping jaws. Proximal handle portions of the handpiece are formed for resilient, elastic deformation so as to maintain clamping pressure on tissue positioned between the clamping jaws. The distal portion is characterized by jaws rigidly mounted at the distal end and a pivot region configured for transmitting a clamping force supplied by the handles to the jaws. At the proximal ends of the respective handle portions, elements of the handle portions engage to maintain a predetermined clamping force on the jaws when the device is in its clamped condition. The level of force applied to the jaws in this clamped position is partially determined by the degree of elastic deformation of the handles beyond that present with the device in its unclamped position with the jaws in contact. Other determining factors are the rigidity of the material from which the handles are formed, and by the cross-section of the handles, more particularly, by the area moment of inertia. The clamping force also affected by the distance from the pivot to the midpoint of the jaws. By manipulating these factors, a predetermined clamping force between the jaws when in the clamped position may be achieved. This may be achieved through handles with a high bending resistance and a low level of deformation of the handle when clamped. Alternatively, the handles may have a low resistance to bending and a higher degree of deformation when clamping. In the first case, the high rigidity of the handles will result in a high degree of compression of the tissue between the jaws prior to sealing. This generally results in reduced sealing times. Handles with reduced rigidity will provide a correspondingly reduced clamping force on the tissue before sealing, resulting in a larger tissue thickness between the jaws prior to sealing and increased sealing time.

These and other objectives can be accomplished by the invention herein disclosed. Further objects and features of the invention will become more fully apparent when the following detailed description is read in conjunction with the accompanying figures and examples. To that end, it is to be understood that both the foregoing summary of the invention and the following detailed description are of a preferred embodiment, and not restrictive of the invention or other alternate embodiments of the invention. In particular, while the invention is described herein with reference to a number of specific embodiments, it will be appreciated that the description is illustrative of the invention and is not constructed as limiting of the invention. For example, while methods of the present invention are described with regard to the treatment of varicose veins, the method may be used for the treatment of any subcutaneous condition requiring occlusion and dividing of veins and other ducts or tissues. All fall within the scope of this invention.

In addition, regarding the specific objectives recited above, it will be understood by those skilled in the art that one or more aspects of this invention can meet certain objectives, while one or more other aspects can meet certain other objectives. Each objective may not apply equally, in all its respects, to every aspect of this invention. As such, the objectives herein can be viewed in the alternative with respect to any one aspect of this invention.

BRIEF DESCRIPTION OF THE FIGURES

Various aspects and applications of the present invention will become apparent to the skilled artisan upon consideration of the brief description of figures and the detailed description of the present invention and its preferred embodiments that follows:

FIG. 1 is a plan view of a bipolar electrosurgical device of suitable for use in connection with the methods of the present invention.

FIG. 2 is a side elevational view of the objects of FIG. 1.

FIG. 3 is a perspective view of the objects of FIG. 1.

FIG. 4 is an expanded view of the objects of FIG. 1 at location B.

FIG. 5 is an expanded view of the objects of FIG. 3 at location A.

FIG. 6 is an expanded sectional view of the objects of FIG. 4 at location A-A.

FIG. 7 depicts a surgical system including the bipolar electrosurgical device of FIG. 1 connected to a suitable electrosurgical generator with optional foot pedal connected thereto for activation of the generator.

FIG. 8 is a perspective view of an isolating clamp in accordance with the present invention in a closed (clamped) condition.

FIG. 9 is an expanded view of the objects of FIG. 8 at location A.

FIG. 10 is a side elevational view of the objects of FIG. 19.

FIG. 11 is an expanded view of the objects of FIG. 10 at location C.

FIG. 12 is a plan view of the objects of FIG. 8.

FIG. 13 is an expanded view of the objects of FIG. 12 at location D.

FIG. 14 is a plan view of a portion of skin with a varicose vein in need of treatment positioned in a fold thereof.

FIG. 15 is a perspective view of the objects of FIG. 14.

FIG. 16 depicts the skin of FIG. 14 wherein the position of the vein is maintained by the isolating clamp of FIG. 8.

FIG. 17 is an expanded view of the objects of FIG. 16 at location A.

FIG. 18 is a plan view of the skin and clamp of FIG. 16 wherein the jaws of the bipolar handpiece of FIG. 1 are positioned around the clamp in preparation of sealing the tissue between the jaws by coagulation.

FIG. 19 is an expanded view of the objects of FIG. 18 at location A.

FIG. 20 is a perspective view of the objects of FIG. 18.

FIG. 21 is an expanded view of the objects of FIG. 20 at location A.

FIG. 22 is a perspective depiction of a skin portion wherein a varicose vein in heed of treatment has been divided and occluded according to methods of the present invention.

FIG. 23 is a plan view of the objects of FIG. 22.

FIG. 24 is an expanded view of the objects of FIG. 23 at location A.

FIG. 25 is a plan view of an alternate embodiment coagulating device (handpiece) suitable for use in connection with the methods of the present invention.

FIG. 26 is a side elevational view of the objects of FIG. 25.

FIG. 27 is an expanded view of the objects of FIG. 25 at location A.

FIG. 28 is a proximal perspective view of the objects of FIG. 25.

FIG. 29 is an expanded view of the objects of FIG. 28 at location B.

FIG. 30 is a distal perspective view of the objects of FIG. 25.

FIG. 31 is a side elevational view of the objects of FIG. 25 with the jaws in an open position in preparation for use.

FIG. 32 is a distal perspective view of the objects of FIG. 31.

FIG. 33 is a side elevational view of the handpiece of FIG. 25 clamped percutaneously on a duct in preparation for sealing.

FIG. 34 is an expanded view of the objects of FIG. 33 at location C.

FIG. 35 is a side elevational view of the handpiece and tissue of FIG. 33 with percutaneous sealing of the duct and adjacent tissue complete.

FIG. 36 is an expanded view of the objects of FIG. 35 at location D.

FIG. 37 is a schematic cross-section of skin depicting the layers of tissue types.

FIG. 38 is a schematic cross-section of scrotal tissue depicting the layers of tissue types.

FIG. 39 depicts a cross-section of a vas isolated in a fold of scrotal tissue.

FIG. 40 depicts the elements of FIG. 39 wherein a compressive force has been applied in preparation for RF sealing.

FIG. 41 depicts the elements of FIG. 40 wherein RF sealing is complete.

FIG. 42 is a plan view of a resilient polymeric RF sealing device of the present invention.

FIG. 43 is a side elevational view of the objects of FIG. 42.

FIG. 44 is an expanded view of the elements of FIG. 42 at location A.

FIG. 45 is an expanded view of the elements of FIG. 43 at location B.

FIG. 46 is an expanded view of the elements of FIG. 43 at location C.

FIG. 47 is a proximal perspective view of the elements of FIG. 42.

FIG. 48 is an expanded view of the elements of FIG. 47 at location D.

FIG. 49 is a plan view of a lower jaw for a resilient polymeric sealing device of the present invention.

FIG. 50 is a distal axial view of the jaw of FIG. 49.

FIG. 51 is a side elevational view of the jaw of FIG. 49.

FIG. 52 is a perspective view of the jaw of FIG. 49

FIG. 53 is a plan view of a top jaw for a resilient polymeric RF sealing device of the present invention.

FIG. 54 is a side elevational view of the jaw of FIG. 53.

FIG. 55 is a perspective view of the jaw of FIG. 53.

FIG. 56 is a plan view of an upper handle assembly for a resilient polymeric RF sealing device of the present invention.

FIG. 57 is a side elevational view of the objects of FIG. 56.

FIG. 58 is a upper proximal perspective view of the objects of FIG. 56.

FIG. 59 is an expanded view of the objects of FIG. 56 at location A.

FIG. 60 is an expanded view of the objects of FIG. 57 at location B.

FIG. 61 is an expanded view of the objects of FIG. 58 at location C.

FIG. 62 is a lower proximal perspective view of the objects of FIG. 56.

FIG. 63 is a cross-sectional view of the objects of FIG. 57 at location A-A.

FIG. 64 depicts the sealing device of the present invention of FIG. 42 in its clamped condition as in preparation for sealing.

FIG. 65 is an expanded view of the proximal portion of the objects of FIG. 64.

FIG. 66 is a side elevational view of the upper handle assembly of FIG. 56 wherein the handle portion has been modified to increase the rigidity of the handle.

FIG. 67 is a lower proximal view of the objects of FIG. 66.

FIG. 68 is an expanded sectional view of the objects of FIG. 66 at location A-A.

FIG. 69 is an expanded sectional view of of an alternate embodiment handle with increased flexular rigidity.

FIG. 70 depicts a prior art vessel sealing device.

FIG. 71 depicted a second prior art vessel sealing device.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Before the present materials and methods are described, it is to be understood that this invention is not limited to the specific devices, systems, methodologies, or protocols herein described, as these may vary in accordance with routine experimentation and optimization. It is also to be understood that the terminology used in the description is for the purpose of describing the particular versions or embodiments only, and is not intended to limit the scope of the present invention which will be limited only by the appended claims. Accordingly, unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the present invention belongs. However, in case of conflict, the present specification, including definitions below, will control.

The words “a”, “an”, and “the” as used herein mean “at least one” unless otherwise specifically indicated. Thus, for example, reference to an “opening” is a reference to one or more openings and equivalents thereof known to those skilled in the art, and so forth.

As used herein, the noted directional terms relate to a human body in a standing position. For instance, “up” refers to the direction of the head, “down” refers to the direction of the feet. Likewise, herein, the “vertical” direction is parallel to the axis of the body and the “horizontal” direction is parallel to the floor. In a similar fashion, the term “lateral” refers to the direction extending away from the center of the body whereas “medial” refers to a direction extending toward the center of the body.

• • In the context of the present invention, the term “proximal” refers to that end or portion of a device or instrument which is situated closest to the body of the subject when the device is in use. Accordingly, the proximal end of an excising clamp or bipolar electrosurgical device of the present invention includes the handle portions.
  • In the context of the present invention, the term “distal” refers to that end or portion of a device or instrument that is situated farthest away from the body of the subject when the device is in use. Accordingly, the distal end of an excising clamp of the present invention includes the jaw components.

In the context of the present invention, the term “arcuate” is used herein to describe shapes forming or resembling an arch. It is used interchangeably with its synonym, arciform.

Reference may be made herein to “an arcuate sealed area” that contains one or more portions of the bulging, raised or dilated vessel, such as a varicosed vein. This “arcuate” area is exemplary only and not meant to be limiting. The sealed area may have a variety of regular or irregular shapes. Any sealed area formed by bipolar jaws positioned distal to a clamp located on swollen portion of the vessel falls within the scope of this invention. As such, the sealed region may be arcuate, linear, irregularly shaped, or a combination of linear and curvilinear segments.

In the context of present invention reference invention, the terms “coagulated” or “cauterized” are interchangeably used to describe a treated area of tissue. As used herein, coagulated or cauterized tissue is tissue that through the application of RF energy and pressure has been desiccated and fused to eliminate the flow of blood or other fluids.

In the context of the present invention, the term “convex” refers to a surface or boundary that curves outward, as the exterior of a sphere. Conversely, the term “concave” refers to a surface or boundary that curves inward, as to the inner surface of a sphere, or is hollowed or rounded inward like the inside of a bowl. Herein, the area of unclamped tissue defined by the U-shaped jaws of the bipolar coagulating device and the arcuate area of clamped scrotal tissue contained therein is referred to as convex in shape.

The present invention makes reference to percutaneously sealing and/or occluding and dividing a “vein, vessel or other duct” of a patient. In the biological context of the present invention, the term “vessel” refers to a tube or canal in the body (such as an artery, vein, or lymphatic vessel) in which a body fluid (such as blood or lymph) is contained and conveyed or circulated. Similarly, the term “duct” refers herein to a bodily tube or vessel, particularly one that carries the secretion of a gland. The term “vein” refers to a particular subset of blood vessels, namely any of the tubular branching vessels that carry blood from the capillaries toward the heart.

In the medical context, such as in the present invention, the terms “varicose” and “varicosed” are used interchangeably to mean abnormally swollen or dilated. Accordingly, in the context of the present invention, the terms “varicose (d) veins” and “superficial thrombophlebitis” are used interchangeably to refer to the condition wherein blood vessels that lie just under the skin, e.g., superficial tributary veins, become twisted and swollen. As discussed above, varicose (d) veins, or “varicosities”, are caused by an increase in blood pressure in the veins that can arise from a number of underlying conditions, from hypertension to obesity to pregnancy. Increased pressure leads to a weakening in the vessel wall or the one-way valves that move blood towards the heart that, in turn, causes the vessels to dilate and enlarge. When the valves or vessel walls become weakened or damaged, blood can collect in the veins and form “varicosities”. The condition occurs most frequently in the legs, with the raised veins being easily visible through the skin.

While varicose veins are only an aesthetic concern in some patients, for others they give rise to localized symptoms such as pain, limb heaviness, cramping, burning, swelling or itchiness that can be an indication of more serious health problems. Other symptoms include aching, heavy and uncomfortable legs, swollen feet and ankles, muscle cramps in the legs, and dry skin and color changes in the lower leg.

In the context of the present invention, the terms “spider veins” and “thread veins” are used interchangeably to refer to small, damaged veins, usually blue, red, or purple in color, that appear on the legs or face as thin lines or branched webs. Spider veins arise in capillaries close to the surface and thus tend to be easily visible through the skin. As with varicose veins, spider veins stem from malfunctioning valves in blood vessels: the blood moving through the vein does not move forward properly, causing an enlarged vein. However, where varicose veins are raised, swollen blood vessels that twist and turn beneath the skin, spider veins are smaller, more superficial blood vessels. Additionally, whereas varicose veins can be very painful, spider veins do not often cause pain or indicate worsening health conditions but rather are treated for purely cosmetic reasons.

The instant invention makes reference to certain surgical instruments that are configured both for clamping tissue or capturing a vessel, vein, or duct and for excision of clamped or captured tissue. The present invention additionally makes reference to instruments, often referred to herein as “excising” or “excision” clamps or hooks, designed for use in conjunction with such bipolar coagulating devices to facilitate the methods of the present invention, namely, to position a vessel, such as a varicosed vein, within the jaws of the bipolar coagulating device, to maintain that position during coagulation, and thereafter to optionally divide the vessel by excision. Of particular interest are the bipolar coagulating devices and associated clamps and hooks described in U.S. Utility U.S. Pat. Nos. 11,723,680, 11,291,581, and 11,291,493, U.S. Design Patent Nos. D903867S, D886297S, and D950055S, and U.S. Patent Publication No. 2023/0329736 A1, the contents of which are hereby incorporated by reference in their entirety.

Clamping devices in varicose vein treatment methods of the present invention are used solely to maintain the position of a vessel in a fold of skin or surrounding tissue for subsequent occlusion of the vessel. Because a clamping device may contact the jaws of a bipolar handpiece during use, in order to prevent shorting of the bipolar device these clamps are formed of a dielectric material, typically a polymer or ceramic, or are formed of a metallic material and are covered with a dielectric coating. Indeed, clamps having a wide variety of configurations may be used including a standard metal ring forceps and tenaculum to which a non-conductive coating has been applied.

As noted above, the present invention is characterized by substantial advantages not found in conventional methods and devices. For example, in the context of the present invention, nerves in the sealed region and closely adjacent thereto are destroyed or deadened by a process known as RF neurotomy so as to reduce the probability of post procedure pain. In addition, in those embodiments that avoid direct dissection and resulting bleeding, the present invention is able to eliminate the risk for development of massive hematomas and swelling and thereby reduce the risk of blood clots, a common complication of varicose vein surgery. In addition, the present invention allows for the separation of a vessel in such a manner that it is virtually impossible for the sealed ends of the vessel to contact each other and rejoin, reform, and/or recur. In addition, the vessel dissection procedure of the present invention, particularly as applied to varicose vein therapy, requires fewer steps than that of currently available techniques, thereby reducing opportunities for complications and medical errors. Furthermore, the inherent simplicity of the disclosed procedure and associated instruments simplifies training and allows clinicians with limited experience to master their use. Moreover, the procedures of the present invention reduce exposure to bodily fluids, which, in turn, reduces the risks of transmission of blood-borne diseases, such a HIV and Hepatitis, to performing clinicians.

Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the present invention, the preferred methods, devices, and materials are depicted in the accompanying figures and described hereinafter. However, the embodiments described herein are merely intended to illustrate the principles of the invention. Those skilled in the art will recognize that variations and modifications may be made to the embodiments without changing the principles of the invention herein disclosed. Accordingly, the accompanying figures, described in detail below that depict aspects of the invention are in no way intended to limit the scope of the present invention.

Examples

Methods of the present invention are now described with reference to the occlusion of a varicose vein. However, it will be understood that methods of the present invention may be used to treat any bulging, swollen, raised or dilated vessel without removal of the vessel from the surrounding tissue in which it is encased.

In an exemplary embodiment herein described, the vessel is a varicose vein. In methods of the present invention, a varicose vein in need of treatment is located percutaneously and manipulated into a fold of skin. The position of the vein in the fold is maintained using a clamp, the clamp being positioned just distal to the vein. Thereafter, the jaws of a bipolar coagulating device are positioned around the clamp and closed onto the tissue so as to compress a region of tissue surrounding the clamp. Radio Frequency (RF) energy from the bipolar outputs of an electrosurgical generator is applied to the jaws so as to coagulate the tissue compressed between the jaws of the handpiece. This seals the two vein portions clamped between the jaws along with dermal tissue clamped between the jaws. A small region of dermal tissue and a third vein portion between the two sealed portions remains uncoagulated. When coagulation is finished the handpiece and clamp are removed from the site to complete the procedure. The vein is now occluded in two locations with an uncoagulated portion between the occlusion sites. The uncoagulated tissue need not be immediately removed during the procedure. Because the coagulation has blocked the blood supply to this tissue, it will necrose and slough off naturally over time thereby dividing the vein. However, in certain instances, the practitioner may elect to actively excise the intervening tissue.

Referring now to the accompanying figures, a bipolar coagulating device (handpiece) 400 used in methods of the present invention is depicted in FIGS. 1 through 6 with the jaws in a first, closed or clamped position. Handpiece 400 is substantially similar to the equivalent electrosurgical device described in U.S. Pat. Nos. 8,220,464 and 8,561,615 and analogous to the coagulating bipolar devices described U.S. Pat. Nos. 11,723,680, 11,291,581, and 11,291,493, the contents of which are hereby incorporated by reference in their entirety. As such, the device operates by an analogous method. To wit, bipolar handpiece 400 has an upper handle assembly 402 with a proximal handle portion 404 and a distal portion 406 wherein is mounted lower jaw 408. Handpiece 400 has a lower handle assembly 422 with a proximal handle portion 424 and a distal portion 426 wherein is mounted upper jaw 428. Upper handle assembly 402 and lower handle assembly 422 are rotatably joined by element 401. Lower handle assembly 422 has located adjacent to its proximal end ratchet element 430 that, in cooperation with downward extending proximal portion 410 of upper handle assembly 402 maintains the clamping force of jaws 408 and 428, portion 432 of ratchet element 430 limiting the inter-jaw force that can be applied. Bipolar cable 440 is connected at its proximal end to the bipolar outputs of a suitable electrosurgical generator, and at its distal end, via wires 442 and 444 to upper jaw 428 and lower jaw 408, respectively, such that Radio Frequency (RF) energy from the generator is conducted to jaws 408 and 428 so as to coagulate tissue clamped therebetween. In a preferred embodiment, RF energy from the electrosurgical generator is modulated according to an algorithm in the generator for maximal coagulation of tissue between the jaws.

As best seen in the expanded view of FIGS. 4, 5 and 6, upper 428 and lower 408 jaws are mirror images, each including a proximal portion 413 that attaches to the distal end of the handpiece and a distal portion 415 that is off-set from the longitudinal axis 411 defined by the handpiece, preferably disposed at an angle 419 of about 45 degrees from the centerline 417 of slot 429. The angular offset affords the surgeon better visibility and access to the target surgical site. As best seen in FIG. 4, upper jaw 428 has a “U” shape with a central slot 429 of width 480, with lower jaw 408 having a corresponding shape so that tissue may be clamped between the U-shaped jaw portions of jaws 408 and 428.

Referring now to FIG. 6, the U-portions of jaws 408 and 428 have radiused outer circumferential portions 403 and 423, respectively, adjacent to their clamping surfaces to prevent cutting of tissue clamped between jaws 408 and 428. In a preferred embodiment, each offset central slot defined by each “U-shaped” distal portion is approximately 1-3 mm in width. Jaws 408 and 428 are preferably formed of a stainless steel or other suitable metallic material.

FIG. 7 depicts bipolar coagulating device 400 connected by cable 440 to the bipolar outputs of electrosurgical generator 13 for use in connection with the methods of the present invention. In the depicted preferred embodiment, generator 13 is activated by foot pedal 15.

In FIGS. 8 through 13, clamp 700 is formed of elements 740 having proximal portions that form finger holes 742, and whereon are formed mating ratchet portions 744. Elements 740 are pivotably joined by element 746. Distal to element 746, distal portions 748 of elements 740 have a distal-most portion 714 of width 716 (FIG. 13) that is less than width 480 of slots 429 and 409 of jaws 428 and 408 respectively (see FIG. 5). Distal-most portions 714 have at their distal ends jaw portions 718 with vertically opposed, planar jaw faces 720. Distal-most portions 714 have laterally opposed surfaces 715, and surfaces 722 that are perpendicular to surfaces 715, and that together define distal opening 750 of clamp 700. Clamp 700 may be made from a suitable dielectric material or from a metallic material with the distal portions 714 coated with a suitable dielectric coating so as to prevent shorting of bipolar handpiece 400 during use.

An exemplary procedure for treating varicose veins in accordance with the methods of the present invention is illustrated in FIGS. 14-24. Namely, in a first step, a first varicosed vein is manually identified and isolated in a fold of skin. See FIGS. 14 and 15 wherein vein 20 is located in a fold of skin 10. A local anesthesia is then injected at the treatment site. As shown in FIGS. 16 and 17, clamp 700 is applied to the fold of skin 10 with jaws 718 medial to vein 20 so as to maintain the position of vein 20 in the fold. Thereafter, upper and lower jaws 408 and 428 of handpiece 400 are positioned around distal portions 714 of clamp 700 and handpiece 400 is closed so as to apply compressive force to the tissue between jaws 408 and 428 as shown in FIGS. 18 through 21. The clamping force may be maintained by ratchet element 430 of lower handle assembly 422. Subsequently RF energy from electrosurgical generator 13 (FIG. 7) is supplied to jaws 408 and 428 by wires 442 and 444 and cable 440 so as to coagulate portions of skin 10 and varicose vein 20 that are compressed between jaws 408 and 428. When coagulation is complete, handpiece 400 is removed. The clamp 700 is then removed leaving site 15 as shown in FIGS. 22 through 24. Referring to FIG. 24, site 15 contains region 17 in which skin 10 and vein 20 are sealed by coagulation, and region 19 which remains uncoagulated since it was not compressed between bipolar jaws 408 and 428 of handpiece 400. Region 19 has no blood supply because it is surrounded by coagulated region 17. Because region 19 has no blood supply, it will necrose and slough off thereby dividing vein 20. Tissue adjacent to site 15 will subsequently heal over time. When healing is complete, the gap left by the necrosed tissue will blend into the normal contour of skin 10.

As noted above, in certain instances, the practitioner may elect to actively remove the intervening tissue. Thus, in some embodiments, region 19 is excised as part of the vein treatment procedure. In some of these embodiments, the excision may be accomplished using clamp 700.

In addition to the treatment of varicose veins, methods of the present invention may be applied to the occlusion and division of other swollen, bulging, raised or dilated vessels or ducts within the body of a patient. While handpiece 400 with its bulky pliers-like configuration is particularly well suited for the percutaneous treatment of tissues, accessing other locations within the body of a patient for treatment can be problematic. Accordingly, the present invention contemplates an alternate embodiment handpiece 100 of the present invention that is configured for the treatment of tissue in less accessible locations.

FIGS. 25 through 30 depict alternate bipolar sealing device 100. Bipolar handpiece 100 has an upper handle assembly 102 with a proximal handle portion 104 and a distal portion 106 wherein is mounted lower jaw 108. Upper handle assembly 102 has formed at its proximal end finger loop 103. Handpiece 100 has a lower handle assembly 122 with a proximal handle portion 124 and a distal portion 126 wherein is mounted upper jaw 128. Lower handle assembly 122 has formed at its proximal end finger loop 123. Upper handle assembly 102 and lower handle assembly 122 are rotatably joined by element 101. Lower handle assembly 122 has located adjacent to its proximal end element 130 that, in cooperation with downward extending proximal portion 110 of upper handle assembly 102 maintains the clamping force of jaws 108 and 128, upper surface 132 of element 130 limiting the inter-jaw force that can be applied. Bipolar cable 140 is connected at its proximal end to the bipolar outputs of a suitable electrosurgical generator, and at its distal end, via wires 142 and 144 to upper jaw 128 and lower jaw 108 respectively such that RF energy from the generator is conducted to jaws 108 and 128 so as to coagulate tissue clamped therebetween.

As best seen in the expanded views of FIGS. 27 and 29, upper 128 and lower 108 jaws are mirror images, each including a proximal portion 113 that attaches to the distal end of the handpiece and a distal portion 115 that is angularly off-set from the longitudinal axis 111 defined by the handpiece, preferably disposed at an angle 119 from the centerline 117 of slot 129. In preferred embodiments angle 119 is between 30 and 60 degrees, optionally between 40 and 50 degrees. This offset angle 119 affords the surgeon better visibility and access to a target surgical site and, as such, angle 119 may be readily optimized for a given application and target location. As best seen in FIG. 27, upper jaw 128 has a “U” shape with a central slot 129 of width 180 and length 125, with lower jaw 108 having a corresponding shape so that tissue may be clamped between the U-shaped jaw portions of jaws 108 and 128. Referring to FIG. 27, the size and relative proportions of slot 180 may be optimized as required for specific applications. Length 125 may be increased or decreased for optimal tissue engagement. Width 180 may be increased or decreased depending on requirements for dividing a duct, and width 123 may be adjusted to achieve an optimal seal width.

In FIGS. 31 and 32, bipolar device 100 is depicted in an unclamped condition in preparation for placement of jaws 108 and 128 around clamp 700 or another suitably configured clamping device that is maintaining the percutaneous position of a vessel or duct to be treated (e.g., sealed and divided). In a preferred embodiment, the clamping device is constructed from or coated with a suitable dielectric material as previously described.

Device 100 is used in the same manner as device 400 previously herein described. Namely, a duct (or vessel) requiring occluding and dividing is located and isolated in a fold of skin or surrounding tissue. Isolation of the duct is maintained in the fold by a clamp placed distal to the duct. Jaws 108 and 128 are positioned around the clamp and closed onto the tissue until elements 110 and 130 engage to maintain closure, jaws 108 and 128 exerting a predetermined pressure on the tissue positioned therebetween. The electrosurgical generator is activated causing RF energy to flow between jaws 108 and 128 causing heating of the tissue. This heating, combined with compressive force from jaws 108 and 128 causes sealing of the tissue and occlusion of the duct.

FIGS. 33 and 34 depict bipolar device 100 percutaneously disposed on duct 10 in preparation for sealing by bipolar coagulation. Elements 130 and 110 (see FIG. 28) are engaged so that a predetermined clamping force is applied to tissue 10 and duct 20 between jaws 108 and 128. For clarity, positioning clamp 700 is not shown.

During bipolar sealing, heat is created within tissue 10 and duct 20 by RF energy flowing between jaws 108 and 128. This heat along with compressive force applied to tissue 10 and duct 20 by jaws 108 and 128 causes shrinking of the tissue and the formation of a seal. FIGS. 35 and 36 depict device 100, tissue 10 and duct 20 with sealing completed. The thickness of the tissue between jaws 108 and 128 has been reduced significantly.

FIG. 37 depicts skin 40 having three layers. The epidermis 42 is a thin layer that forms a barrier against environmental damage by heat, UV radiation, dehydration, pathogenic bacteria, fungi, parasites, and viruses. The dermis 44 contains vessels and nerves embedded in a tough fibroelastic tissue consisting of collagen (mainly types I and III) and elastic fibers. The thickness of the dermis 44 typically ranges from 0.6 millimeters in an eyelid to 3 millimeters in plantar and palmar tissue. Dermis 44 supports and adds strength and pliability to the skin. Due to the presence of blood vessels and nerves, it also plays an active role in thermoregulation and sensation. The hypodermis 46 is not part of the skin but is closely related thereto. Hypodermis 46 (also referred to as “subdermis”) is primarily fatty tissue that adds support, strength and pliability to the skin along with a cushioning effect. Due to the presence of blood vessels and nerves, it also plays an active role in thermoregulation and sensation. Hypodermis 46 connects the skin to muscle and bones. Thickness 48 of skin 40 can vary widely depending on the location on the body and has a significant effect on thermal sealing of subcutaneous ducts and other structures. The thickness of skin varies from 0.6 millimeters on the eyelids to 3 millimeters on plantar surfaces. Referring now to FIG. 38, scrotum 50 is formed of skin 40 (composed of epidermal 42, dermal 44, and subdermal 46 layers) and the dartos muscle 52 positioned beneath skin 40. Dartos muscle 52 helps regulate the temperature of the testicles by contracting in cool temperatures to reduce the surface area of the scrotum or relaxing in warm temperatures to increase the surface area of the scrotum to manage heat loss. Dartos muscle 52 causes wrinkling of overlying skin 40.

When performing a vasectomy using devices and methods of the present invention, a vas is positioned within a fold of scrotal tissue 51 as depicted in FIG. 39. Vas duct 60 with vas sheath 62 is surrounded by a scrotum portion 50 comprising dartos muscle 52 and skin 40. Thereafter, jaws 64 of a bipolar sealing device are positioned on the tissue fold 51 and vas duct 60 and sheath 62 contained therein, and clamped on the tissue fold 51 and clamped as depicted in FIG. 40 so as to compress tissue between jaws 64 to a first, clamped thickness 66. Thickness 66 is determined by the clamping force exerted by jaws 64, the clamping area of jaws 64, and the compressive strength of the tissue trapped between jaws 64. Sealing of duct 60 and sheath 62, and coagulation of dartos muscle 52 and skin 40 is accomplished by applying RF energy to jaws 64, energy passing through the tissue causing heating resulting in denaturation of collagen and elastin in the tissue. Heating of the tissue and compression supplied by jaws 64 causes fusion of collagen and elastin in the clamped tissue thereby forming seal. Shrinkage of collagen and elastin in the tissue results in thickness 68 at completion of the sealing process.

Creating a robust seal requires a suitable combination of thermal energy and compressive pressure on the tissue for sealing, the pressure being the applied compressive force divided by the contact area of the jaws. Roland K Chen, et. al, in “Bipolar electrosurgical vessel-sealing device with compressive force monitoring” (J Biomech Eng. 2014 June; 136(6):061001) describes the relationship between clamping pressure and seal strength when clamping porcine arteries and veins. Chen reports that arteries and veins each have a clamping pressure value below which the seal strength is decreased and unreliable. Chen also reports that each has an upper limit on clamping pressure above which seal quality and reliability are decreased. There exists, then, for bipolar RF sealing a range of effective clamping pressure with upper and lower boundaries.

The handpiece portion of a bipolar sealing device 200 such as previously herein described is formed of a resiliently rigid polymeric material. When the bipolar device is in the clamped position with the proximal end ratchet mechanisms engaged, there is a predetermined compressive force between their respective jaws. This compressive force is sufficient to produce thermoelectric sealing of a subcutaneous vessel or other tissue, and skin and other tissue in which it is contained.

FIGS. 42 through 58 depicts the handpiece of bipolar sealing device 200 in its unclamped condition with jaws 308 and 328 in their closed position. In some embodiments, jaws 308 and 328 are in contact. In other embodiments, the jaws are separated by a predetermined distance. Handle assemblies 202 and 222 are pivotably jointed by element 201. With jaws 308 and 328 in their closed position, proximal portion 210 of upper handle assembly 202 is separated by distance 260 from portion 232 of ratchet element 230. In use, closure force is applied to handle portions 204 and 224 of device 200 until closure limit of the handles is reached, with proximal portion 210 of upper handle 202 contacting portion 232 of ratchet element 230 and constrained in that condition by cooperative interaction of ratchet element 230 and proximal portion 210, protruding tooth 211 of portion 210 engaging slot 231 of ratchet element 230. In this constrained condition, the closure force between jaws 308 and 328 is determined by distance 260 and characteristics of handle portions 204 and 224.

Handle assemblies 202 and 222 have resilient proximal portions 204 and 224 proximal to element 201, and distal rigid portions 206 and 226 distal to pivot element 201. Referring now to FIG. 44, jaw 328 has formed therein slot 329 of which line 217 is an axis of symmetry. Handle portions 204 and 224 of handle assemblies 202 and 222 have an axis of symmetry 211. Axis of symmetry 217 of slot 329 is angularly displaced from axis of symmetry 211 of handle portions 204 and 224 angle 219. In preferred embodiments, the angle 219 ranges from twenty degrees and 70 degrees. In more preferred embodiments, angle 219 is between 30 and 60 degrees. In still more preferred embodiments, angle 219 is approximately 45 degrees. Wires 242 and 244 are connected to jaws 308 and 328 respectively and conduct RF energy thereto during use.

FIGS. 49 through 52 depict an optimized jaw construction. In particularly preferred embodiments, rigid lower jaw element 300 is formed of a suitable metallic material, typically a stainless steel alloy. Lower jaw element 300 has a distal portion 302 forming lower jaw 308 with slot 309, a middle portion 304 and a proximal portion 306. Middle portion 304 and proximal portion 306 have formed therein perforations 312. Lower jaw element 300 is configured for rigid mounting in distal portion 206 of upper handle 202, jaw element 300 being encased in the polymeric material in a process known as “insert molding”. In insert molding, the metallic element, in this case jaw element 300, is precisely positioned in an injection mold, the mold halves close together, and thereafter molten polymer is injected into the mold and allowed to cool. The mold is then opened and the assembly removed, in this case handle 202 with bottom jaw element 300 mounted therein. Perforations 312 in bottom jaw element allow polymer material to flow therethrough during molding thereby increasing the rigidity of the assembly. Proximal portion 306 of element 300 increases the rigidity of the portion of 206 of handle 202, particularly in the region near pivot element 201. Referring now to FIG. 49, line 301 is the centerline of middle portion 304 and is aligned with centerline 211 of handle portion 204 of handle assembly 202 during molding of handle portion 204. Line 311 is the centerline for slot 309 of jaw 308. Lines 311 and 301 are angularly displaced one from another angle 313, angle 313 being equal to angle 219 (see FIG. 44).

Upper jaw element 320, depicted in FIGS. 53 through 55, is analogous in form and function to lower jaw element 300 with a distal portion 322 forming jaw 328 with slot 329, and middle portion 324, proximal portion 326 wherein are formed perforations 332.

Hereinafter, the construction and properties of handle assemblies 202 and 222 will be described with reference to upper handle assembly 202. It will be understood that features of handle portion 204 of handle assembly 202, and handle portion 224 of handle assembly 222 are symmetrically opposite and together determine the clamping force applied to jaws 308 and 328.

FIGS. 56 through 63 depict upper handle assembly 202 wherein lower jaw element 300 and wire 244 connected thereto are encased in the handle 204, the result of insert molding of assembly 202. As best seen in FIGS. 62 and 63, handle portion 204 of handle assembly 202 has a channel shape formed by upper portion 263 and side flanges 261, In this embodiment, upper portion 263 and side flanges 261 have a common thickness 265. In other embodiments, the thicknesses may not be common and may not be constant within each element, the configuration being optimized for specific applications. Handle portion 204 functions as a rigidly resilient member that, when device 200 is in its clamped condition, as depicted in FIGS. 64 and 65, produces a closing force between jaws 308 and 328. The magnitude of that force is determined by closure distance 260 (FIGS. 45 and 46), the rigidity of handle portions 204 and 244, and distance 299 (FIG. 64) between the center of the jaws 208 and 248 and pivoting element 201.

The resistance of a beam to elastic bending is determined by several factors. One of these factors is the modulus of elasticity (also known as the “Young's modulus”) of the material from which the beam is formed. The modulus of elasticity is the length change a material goes through as a result of a tensile or compressive stress. A beam (or handle) formed of a high modulus value polymer will bend less than one formed of a lower modulus material when subjected to a given force. The Young's Modulus values (in MegaPascals) for polymers commonly used for medical devices are given below.

Polypropylene                    1.3
Polyvinyl chloride (PVC)         2.1 to 2.7
Polycarbinate                    2.3 to 2.4
Acrylonitrile butadiene styrene (ABS) 2.0 to 2.6

For comparison, the Young's modulus of stainless steel used for surgical instruments is around 200 GigaPascals, approximately 100,000 times that of polymers used for bipolar sealing devices of the present invention.

The rigidity of a beam at any location along its length is proportional to the area moment of inertia of the cross-section of the beam at the location. The area moment of inertia is strongly affected by the height of the cross-section, and less strongly by the width of the cross-section. For example, the area moment of inertia (I) of a rectangular cross-section (BH³/12) where B is the width of the section's base and H is the height of the section. The resistance to bending can by doubled by doubling the width of the section or by increasing the height by 27%. Referring again to FIG. 63 depicting an expanded cross-section of handle 204, at location A-A, by assigning suitable numerical values to dimensions 261, 263 and 266 the effect changes in the configuration of the cross-section have on the area moment of inertia and the rigidity of handle 204. For this the following values will be used:

• • 265: 2.3 mm
  • 267: 13.8 mm
  • 269: 19 mmThe I value for the section is calculated by first determining the I value for the rectangle forming the channel and subtracting from it the I value for the inside of the channel.

$I=\left(19\times {13.8}^3\right)/12-\left(14.5\times {11.6}^3\right)/12$ $I=2,300{\mathrm{mm}}^4$

FIGS. 66 through 68 depict an upper handle assembly 203 in which handle 205 has been modified by the adding central rib 264 so as to increase the stiffness of handle 205. In all other aspects of form and function handle assembly 203 is identical to handle assembly 202 previously described. Width 266 of rib 264 is equal to width 265 of flange 261. Adding rib 264 increases the moment of inertia (I) to 4,000 mm⁴, an increase of 15%.

FIG. 69 depicts a cross-section of an alternate embodiment handle 204 in which the stiffness of the handle is increased by increasing the height of side flanges 261. Height 268 of side flanges 261 is 16.9, an increase of 22 percent over height 267 of flanges 261 of FIG. 63. This increase in height increases the area moment of inertia (I value) by 65 percent.

Handles for bipolar coagulating devices of the present invention are of unitary construction formed of a polymeric material with cross-sections configured to provide a clamping force profile optimal for percutaneous sealing of vessels when the handles of the device are constrained in a predetermined position. The clamping force between jaws 308 and 328 is determined by 1) distance 299 between the center of jaws 308 and 328 and pivot element 201 (FIG. 64), 2) the stiffness of handles 204 and 224, and 3) closure distance 260 (see FIG. 46) that determines the degree of deflection of handles 204 and 224 when clamped. The stiffness of handles 204 and 224 is dependent on the Young's Modulus of the polymeric material of which the handles are formed, and on the cross-section (I value) of the handles as previously described.

Considering distance 299 to the center of jaws 308 and 328 from pivot 201 to be fixed, a required clamping force may be achieved through stiff handles 204 and 224 and a proportionately small closure distance 260. Under these conditions, clamped tissue thickness prior to sealing (66 in FIG. 40) will be small and the sealing time will be reduced since the tissue is compressed and the moisture content reduced. By reducing the stiffness of handles 204 and 224 and increasing closure distance 260, the same clamping force can be achieved; however the clamped tissue thickness 66 will be greater and the sealing time will be increased. When designing polymeric RF sealing devices of the present invention for use in sealing vessels surrounded by tissue of disparate types (epidermis, dermis and hypodermis, sheaths and the like) the sealing process may be optimized through the choice of handle stiffness, closure distance and clamping pressure. Increasing the clamped thickness prior to sealing may decrease bruising and injury to tissue adjacent to the site. The extended sealing times and increased compression/shrinkage of the tissue during sealing associated with this increased thickness may allow improved sealing through the increased time for transformation of collagen and elastin in the diverse tissue layers.

INDUSTRIAL APPLICABILITY

While the percutaneous sealing and dividing devices and methods have been described with regard to specific embodiments, namely the treatment of varicose veins, it is to be understood that foregoing description is exemplary and explanatory in nature and is intended to illustrate the invention and its preferred embodiments. Through routine experimentation, one skilled in the art will readily recognize that various changes and modifications can be made therein without departing from the spirit and scope of the invention. For example, the above-described materials and methods may be readily applied to the treatment of any subcutaneous vein, vessel, or other bulging, swollen, raised or dilated duct in need of sealing, occlusion, and division. To wit:

The devices and methods of treatment previously herein described address the sealing of a single duct or vein. In other treatment methods contemplated by the present invention, a plurality of veins supplying blood to a discrete region may be sealed so as to necrose tissues within that area. For instance, when treating a small tumor, a surgical clamp may be applied to the tumor or distally adjacent to the tumor. The bipolar coagulating jaws may then be positioned around the clamp as previously herein described, with the tumor positioned within the open central slot. Likewise, as previously described, activation of the bipolar jaws can cause the tissue disposed between the bipolar jaws to become coagulated and, in this manner, eliminate downstream blood supply to the tumor and adjacent tissue. Such a lack of a blood supply will cause the tumor to necrose.

In addition, while the above method is described with reference to a tumor, it will be readily apparent to the skilled artisan that any undesirable tissue structure may be treated in this manner. Likewise, the skilled artisan will recognize that the bipolar jaws described herein may be optimally configured to treat a variety of sizes and tissue types. For example, the width and/or length of the central slot may be increased as needed; similarly, the width of the sealing surfaces may be modified to suit a particular application or environment. Tissue structures treated in this manner may be disposed on or accessible via the skin surface or, alternatively, be internal to the body of a patient.

Other uses, advantages and features will become apparent from the claims filed hereafter, with the scope of such claims to be determined by their reasonable equivalents, as would be understood by those skilled in the art. All such applications fall within the scope of this invention. Thus, the invention is intended to be defined not by the above description, but by the following claims and their equivalents.

Claims

1. A bipolar coagulating device configured for percutaneous sealing of thick tissue, wherein said bipolar device comprises: a. a proximal handpiece assembly comprised of upper and lower handle portions pivotably joined together at a hinge point, wherein said proximal handpiece defines a longitudinal axis of the device that, when viewed in plan view, extends through the center of said handpiece proximal to said hinge; andb. a distal clamping assembly characterized by a pair of opposingly-faced, upper and lower coagulating jaws movable between an open position in which said jaws are separated by a predetermined distance and a closed position in which said jaws are brought into contact with said tissue tightly held in place therebetween;wherein:each of said handle portions is of unitary construction and formed from a rigidly resilient, elastically deformable polymeric material;each of said jaws is fabricated from a metallic material suitable for transmitting radio-frequency energy sufficient to coagulate and seal tissue held in contact therebetween;each handle portion is a mirror-image of the other, with each having a distal end to which one of said coagulating jaws is rigidly mounted and a proximal end provided with cooperative elements that lock the upper and lower handle portions in a clamped position when sufficient compressive pressure is applied to said handpiece,said pivot region is configured to translate the compressive closure force applied to said handpiece into a predetermined clamping force and transmit said force to said jaws in the closed position; andthe predetermined clamping force is determined by the degree of elastic deformation of the handles beyond that present with the device in its unclamped position with the jaws in contact.

2. The bipolar coagulating device of claim 1, wherein the stiffness of the polymeric handle portions augments travel between the jaws so as to optimize the clamping force and provide an improved seal strength.

3. The bipolar coagulating device of claim 1, wherein said cooperative elements comprise a pair of mating ratchet elements.

4. The bipolar coagulating device of claim 1, wherein, in the clamped position with the proximal end ratchet elements engaged, the predetermined compressive force present between the jaws is sufficient to produce a robust thermoelectric sealing of the tissue held therebetween.

5. The bipolar coagulating device of claim 1, wherein said upper and lower jaws are arcuate in shape.

6. The bipolar coagulating device of claim 1, wherein said upper and lower jaws comprise mirror-image U-shaped curves.

7. The bipolar coagulating device of claim 1, wherein said upper and lower coagulating jaws are provided with mating distal tips and inner edges, whereby, when said jaws are in the closed position and viewed in a plan view, said mating inner edges engage to define an interior perimeter comprised of (1) an open central slot that terminates in (2) a lateral opening sized to permit said distal clamping portion to be positioned around said surgical clamp.

8. The bipolar coagulating device of claim 7, wherein said mating distal tips are offset from the longitudinal axis of the device by about 45 degrees.

9. The bipolar coagulating device of claim 7, wherein said mating inner edges of said upper and lower coagulating jaws comprise planar cutting edges and outer edge surfaces having a curvilinear sharpened surfaces, whereby said sharpened curvilinear surfaces are configured to engage with said planar cutting edges to impart a shearing action capable of excising some or all of said tissue.

10. The bipolar coagulating device of claim 1, wherein each of said upper and lower coagulating jaws are characterized by a proximal portion that is insert molded with the distal end of the respective handle portion.

11. The bipolar coagulating device of claim 10, wherein each of said proximal jaw portions includes perforations that allow polymeric material to flow therethrough during molding.

12. The bipolar coagulating device of claim 11, wherein each of said proximal jaw portions is connected to a wire that extends through and to the proximal end of the opposite handle portion.

13. The bipolar coagulating device of claim 12, wherein each of said upper and lower handle portions is provided with a central rib that serves to increase the overall rigidity of the handpiece assembly.