1. Technical Field
The present disclosure relates to the use of energy-based electrosurgical instruments. More particularly, the present disclosure is directed to the use of stand alone energy-based tissue clips to provide energy to seal, cauterize, ablate or destroy cells and/or tissue.
2. Background of the Related Art
Surgical staplers are widely used to join or bond tissues together and to provide hemostasis of adjacent tissues. These staples can be employed in combination with electrosurgical stapling apparatus where thermogenic energy is utilized to provide short-term hemostasis and sealing. One drawback of using staples is that staples generally remain inside the body.
Another method of joining or bonding tissue is based on radio frequency (RF) energy applied to tissue. Existing RF energy-based tissue sealing instruments utilize metal electrodes combined with jaws which grasp and hold sealed tissue. Energy-based tissue sealing involves compressing tissue to bring vessel walls together, heating compressed tissue by RF current up to the temperature of denaturizing and mixing of collagen and elastin, and cooling down and solidification of the melted collagen and elastin to form the seal.
This approach has several disadvantages which are inherent to most energy-based sealing instruments. Compressing and heating of tissue takes considerable time in which the surgeon has to hold the instrument and wait. This may interfere with the continuous flow of a surgical procedure. In order to reduce sealing time, power has to be increased that may result in higher risk of thermal damage and to more bulky instrument and generator designs. Additionally, after several cycles of successive sealing, the jaw members of the electrosurgical instrument may become overheated and a surgeon may need to wait until they cool to avoid poor quality sealing and thermal damage of adjacent tissues.
In an embodiment of the present disclosure, a tissue clip is provided having an arm with a first electrode and a body pivotally coupled to the arm. The body includes a power source and a second electrode. The arm is moveable from a first position relative to the body for approximating tissue and a second position closer to the body for grasping tissue therebetween.
The body may include an antenna configured to transfer energy from the power source to the first and/or second electrode. The body may also include an antenna configured to communicate with an external control unit. The tissue clip may further include a sensor array to determine tissue parameters of tissue between the arm and the body.
In one embodiment, the first electrode and/or second electrode may include a stainless steel layer and a copper layer. Alternatively, the first and/or second electrode may include at least one piezo electric sensor. In another embodiment, the first electrode may include an outer layer composed of a non-stick material and flex circuit having a coil formed thereon.
The first electrode and second electrode cooperate with the control unit and the power source to seal tissue. The tissue clip may also include a cutting element having an electrode configured to electrically cut tissue. The cutting element cooperates with a control unit to cut tissue after seal is completed. The tissue clip may also include at least one sensor configured to sense a completed seal and the control unit automatically activates the cutting element when the at least one sensor senses the completed seal.
In yet another embodiment, the first electrode includes a first pair of tissue contacting surfaces and an insulator disposed therebetween and the second electrode includes a second pair of tissue contacting surfaces and a pair of insulators disposed between the second pair of tissue contacting surfaces. A cutting element is disposed between the pair of insulators. The cutting element may be moveable to cut tissue before, during or after the formation of a tissue seal. The cutting element includes an electrode that is configured to electrically cut tissue
In another embodiment of the present disclosure, a tissue clip is provided that includes an arm having a fiber grating and a body pivotally coupled to the arm. The body includes a power source, a fiber grating and a light source coupled to the fiber grating in the arm and the fiber grating in the body. The arm is moveable from a first position relative to the body for approximating tissue and a second position closer to the body for grasping tissue therebetween.
The body may include a control unit configured to transfer energy from the power source to the light source to.
The fiber grating in the arm and the fiber grating in the body cooperate with the control unit and the power source to seal tissue.
The arm and/or the body includes a cutting mechanism configured to cut tissue disposed between the arm and the body wherein the cutting mechanism cuts the tissue disposed between the arm and the body before, during or after the tissue is sealed. The cutting mechanism may include an electrode configured to electrically cut tissue. The cutting mechanism cooperates with a control unit to cut tissue after seal is completed. Alternatively, the cutting mechanism may include a light source configured to emit a focused light to cut tissue.
In yet another embodiment of the present disclosure, a tissue clip is provided that includes an electrode assembly, a first arm, a second arm moveable from a first position relative to the first arm to approximate tissue to a second position closer to the first arm for grasping tissue therebetween, a first electrode disposed on the first arm, a second electrode disposed on the second arm, and
The electrode assembly is configured to seal tissue and may cooperate with a control unit to seal tissue. The electrode assembly may also include a pair of first terminals coupled to the first electrode and the second electrode.
The tissue clip may also include a body having a power source, a control unit coupled to the power source and a pair of second terminals coupled to control unit, the pair of second terminals configured to receive the pair of first terminals. The electrode assembly may be removably coupled to the body.
The electrode assembly may be absorbable and the body may be reusable. In one embodiment, the power source may be removably coupled to the body. In another embodiment, the power source is included in the body. The power source may also be removably coupled to the electrode assembly.
In yet another embodiment of the present disclosure, a tissue clip is provided having an electrode assembly with a first electrode and a retaining clip. The tissue clip also includes a body having a second electrode and a power source. The retaining clip couples the electrode assembly to the body to grasp tissue between the first electrode and the second electrode.
The body may include a control unit coupled to the power source. The electrode assembly may further include a power source, and at least one sensor to determine a parameter of the tissue grasped between the first electrode and the second electrode. The electrode assembly may also include a control unit coupled to the power source wherein the control unit controls sealing of tissue.
The body further includes at least one sensor to determine a parameter of the tissue grasped between the first electrode and the second electrode. The power source in the body may provide energy to the first electrode.
In yet another embodiment of the present disclosure, a method for sealing tissue is provided. The method includes providing a tissue clip having a first portion having a first electrode and a second portion removably coupled to the first portion. The second portion includes a power source, a second electrode and a control unit configured to transfer energy from the power source to the first and/or second electrode. After providing the tissue clip, tissue is approximated between the first portion and the second portion. The tissue is grasped between the first portion and the second portion by moving the first portion from a first position relative to the second portion for approximating tissue to a second position closer to the second portion for grasping tissue therebetween. Then the power source is activated to seal tissue.
In yet another embodiment of the present disclosure, a tissue sealing system may be provided that includes an external control unit and a tissue clip. The external control unit includes a power source and a transmitting coil. The tissue clip includes a body, a first arm movable relative to the body to grasp tissue and a receiving coil operatively coupled to at least one electrode disposed in one of the body and/or first arm. The transmitting coil induces a current in the receiving coil that is supplied to the at least one electrode to thermally treat tissue.
In yet another embodiment, a tissue clip is provided that includes a control portion having a power source and a clip portion. The clip portion includes a first arm, a second arm, and at least one electrode. The clip portion may be removably coupled from the control portion. The control portion may also include a control unit configured to transfer energy from the power source to the at least one electrode.
In one embodiment, the clip portion includes a shape memory alloy, wherein the first arm moves relatively closer to the second arm when the tissue clip is heated. In another embodiment, the clip portion includes a spring member configured to bias the first arm toward the second arm. The first arm and the second arm apply a closure pressure to seal tissue between 3 kg/cm2 to 16 kg/cm2.
In yet another embodiment, a tissue clip is provided having a first arm, a second arm, and helical torsion spring. The first arm includes a power source and at least one electrode. The helical torsion spring is configured to couple the first arm to the second arm. The helical coil spring biases a proximal end of the first arm toward the proximal end of the second arm to grasp tissue therebetween. The helical torsion spring causes the first arm and the second arm to apply a closure pressure to seal tissue between 3 kg/cm2 to 16 kg/cm2. The tissue clip may also include at least one stop member configured to provide a gap between the first arm and the second arm during sealing in the range of 0.001 inches to 0.006 inches. The first arm may also include control unit configured to transfer energy from the power source to the at least one electrode.
In the embodiments described above, during a sealing procedure, the arms close with an appropriate closure pressure to seal tissue, e.g., 3 kg/cm2 to 16 kg/cm2.
As mentioned above, it is contemplated that the tissue clip embodiments described herein can use light, microwave, RF, or resistive energy to thermally treat tissue or seal tissue (as defined herein).
The above and other aspects, features, and advantages of the present disclosure will become more apparent in light of the following detailed description when taken in conjunction with the accompanying drawings in which:
Particular embodiments of the present disclosure are described hereinbelow with reference to the accompanying drawings; however, the disclosed embodiments are merely examples of the disclosure and may be embodied in various forms. Well-known functions or constructions are not described in detail to avoid obscuring the present disclosure in unnecessary detail. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present disclosure in virtually any appropriately detailed structure.
Like reference numerals may refer to similar or identical elements throughout the description of the figures. As shown in the drawings and described throughout the following description, as is traditional when referring to relative positioning on a surgical instrument, the term “proximal” refers to the end of the apparatus that is closer to the user and the term “distal” refers to the end of the apparatus that is farther away from the user. The term “clinician” refers to any medical professional (e.g., doctor, surgeon, nurse, or the like) performing a medical procedure involving the use of embodiments described herein.
Electromagnetic energy is generally classified by increasing frequency or decreasing wavelength into radio waves, microwaves, infrared, visible light, ultraviolet, X-rays and gamma-rays. As used herein, the term “microwave” generally refers to electromagnetic waves in the frequency range of 300 megahertz (MHz) (3×108 cycles/second) to 300 gigahertz (GHz) (3×1011 cycles/second). As used herein, the term “RF” generally refers to electromagnetic waves having a lower frequency than microwaves. As used herein, the term “ultrasound” generally refers to cyclic sound pressure with a frequency greater than the upper limit of human hearing. The terms “tissue” and “vessel” may be used interchangeably since it is believed that the present disclosure may be employed to seal and cut tissue or seal and cut vessels utilizing the same principles described herein.
The present disclosure is directed to the use of tissue clips in electrosurgical procedures. The tissue clips can be installed and configured to operate independently. When a clip is used on a vessel, the clip can stop blood flow immediately after installation and lets a surgeon proceed without waiting until the installed clip completes the vessel sealing procedure.
The use of the tissue clips in a vessel sealing procedure involves providing a tissue clip that may be any one of the tissue clips described hereinbelow. The tissue clip is placed in the body of a patient approximately near tissue that will be sealed and/or cut. The tissue is then grasped by the tissue clip using one of the mechanisms described below. Energy is provided to the tissue from the power source and the grasped tissue is then sealed before the tissue clip is removed.
As will be described in more detail below, the clip can be positioned on a vessel and then set into the closed position using a suitable surgical instrument such as forceps. The closed position provides vessel deformation and stops the blood flow. After a clip is installed and detached from the forceps or like instrument, energy is applied to the grasped tissue and the sealing process begins.
When using the tissue clips of the present disclosure, sealing time is not as crucial as for typical energy-based instruments. Longer sealing time lowers the requirements for a power source and, as such, enables more compact designs and reduces risk of thermal damage. The use of such tissue clips also enables the use of different sealing mechanisms such as soldering and photochemical tissue bonding which require a longer time then RF based sealing.
Referring to
Tissue clip 100 includes electrodes 105a and 105b on arm 102 and body 101, respectively. A power source 106 and control unit 107 are provided in body 101 to provide the necessary voltage to electrodes 105a and 105b. Control unit 107 transfers electrical power from power source 106 to electrodes 105a and 105b and applies a 100 KHz to 10 MHz frequency to electrodes 105a and 105b. The voltage profile provided by control unit 107 may be predetermined and stored in control unit 107 or provided by an external control unit 202 (
In addition to the energy being applied to tissue grasped between body 101 and arm 102, body 101 and arm 102 applies a sealing pressure to tissue grasped therebetween. In one embodiment, the sealing pressure is in the range of 3 Kg/cm2 to 16 Kg/cm2. Sealing pressure may be applied using different methods as shown in
In
In
The tissue clips may be used with an external control unit 202, as shown in
Memory 223 may be volatile type memory (e.g., RAM) and/or non-volatile type memory (e.g., flash media, disk media, etc.) that stores programs or sets of instructions that may be used to control the vessel sealing procedure. Processor 224 may be an integrated circuit or may include analog and/or logic circuitry that may be used to: execute instructions according to inputs provided by the input device 221 or sensor array 170, execute instructions according to a program provided in memory 223; and control operation of control unit 202 and/or tissue clip 100. The processor 224 sends a control signal to tissue clip 100 via transceiver 225 and antenna 226.
Control unit 202 transmits instructions to tissue clip 100, which receives the instructions through antenna 108. The instructions are decoded by control unit 107, which then transfers power from power source 106 to electrodes 105a and 105b according to the received instructions. Control unit 107 may apply energy to a terminal 105c that may be coupled to an electrode 1026 (
Control unit 107 may perform a diagnostic check on tissue clip 100. If the tissue clip is defective or malfunctioning, a red light emitting diode (LED) 182 may be illuminated. If the tissue clip is functioning properly, a green LED 184 may be lit. Tissue clip also includes a sensor array 170 that determines properties of tissue between electrodes 105a and 105b as well as output voltage, current, impedance and power from control unit 107. The detected tissue properties provide feedback to the control unit 107 or external control unit 202 to control the output of control unit 107 via an open loop or closed loop scheme.
Power source 106 may be a rechargeable battery and may be coupled to a terminal 160 that may be used to recharge power source 106. As shown on
As shown in
As mentioned above, the arm 102 and/or body 101 may include one or more stop members 190 which limit the movement of the arm 102 and/or body 101 relative to one another. The stop member(s) 190 may be configured to extend from the electrode 105a and/or 105b a predetermined distance according to the specific material properties (e.g., compressive strength, thermal expansion, etc.) to yield a consistent and accurate gap distance “G” during sealing. In some embodiments, the gap distance between the arm 102 and body 101 during sealing ranges from about 0.001 inches to about 0.006 inches and, in one particularly useful embodiment, between about 0.002 and about 0.003 inches. The non-conductive stop member(s) 190 may be molded onto the arm 102 and/or body 101 (e.g., overmolding, injection molding, etc.), stamped onto the arm 102 and/or body 101 or deposited (e.g., deposition) onto the arm 102 and/or body 101.
Turning to
Turning to
Circuit traces 812 include contacts 810 that may be made from copper, silver or any other electrical conductor. Contacts 810 may be made from the same material as circuit traces 812 or from a material different from circuit traces 812. Each contact 810 is operatively coupled to sensor array 820 via contact traces 816. Contacts 810 and contact traces 816 are formed using the same techniques that may be used to form circuit traces 812. The location of contacts 810 correspond to the location of piezo electric sensors 890. Accordingly, when piezo electric sensors 890 measure or detect a tissue property, piezo electric sensors 890 provide a signal to controller 820 indicative of tissue properties via contacts 810 and contact traces 816.
Electrode 805 includes a seal plate 802. Seal plate 802 is made from stainless steel, and as described above, has piezo electric sensors 890 disposed therein in locations 892. Seal plate 802 may be formed by any suitable method. For instance, a layer of stainless steel may be provided and shaped to form seal plate 802. Then, a photolithography mask is applied to seal plate 802 leaving locations 892 exposed. An etching solution is applied to seal plate 802 to etch away exposed locations 892. Then the mask is removed leaving seal plate 802 with locations 892 etched away. When electrode 805 is assembled, piezo electric sensors 890 are placed in locations 892 of seal plate 802 and are coupled to contacts 810 of insulative plate 804.
Turning to
Coil 910 may be made from copper, silver, or any other electrical conductor. Coil 910 may be formed by any suitable method. For instance, coil 910 may be formed by adhering a conductive layer to flexible plastic substrate 912. Using photolithography, a mask outlining coil 910 may be formed and then the conductive layer may be etched to leave coil 910. Coil 910 may be coupled to an energy source 920.
When energy is applied to coil 910 in electrode 905 and a steel plate (not shown) located on a body of a tissue clip (e.g., body 101 of tissue clip 100) is positioned within an electromagnetic field caused by the application of energy to coil 910, heat is generated in tissue disposed between electrode 905 and the steel plate. Electrode 905 may have one or more coatings of a non-stick material. Therefore, tissue would not touch hot metal surfaces and sticking would be reduced. Further, since no heat energy would be applied to the electrode 905 (heat is generated in the tissue) the efficiency and speed of the seal would increase.
As seen in
With respect to
One or all of the insulators 1014 and 1024 may be made from a ceramic material due to the hardness of the ceramic and inherent ability to withstand high temperature fluctuations. Alternatively, one or both of the insulators 1014 and 1024 may be made from a material having a high Comparative Tracking Index (CTI) having a value in the range of about 300 to about 600 volts. Examples of high CTI materials include nylons and syndiotaetic polystyrenes. Other suitable materials may also be utilized either alone or in combination, e.g., Nylons, Syndiotactic-polystryrene (SPS), Polybutylene Terephthalate (PBT), Polycarbonate (PC), Acrylonitrile Butadiene Styrene (ABS), Polyphthalamide (PPA), Polymide, Polyethylene Terephthalate (PET), Polyamide-imide (PAI), Acrylic (PMMA), Polystyrene (PS and HIPS), Polyether Sulfone (PES), Aliphatic Polyketone, Acetal (POM) Copolymer, Polyurethane (PU and TPU), Nylon with Polyphenylene-oxide dispersion and Acrylonitrile Styrene Acrylate.
Electrode 1005b includes an electrically conductive cutting element 1026 disposed substantially within insulators 1024. As described in detail below, the cutting element 1026 may play a dual role during the sealing and cutting processes, namely: 1) to provide the necessary gap distance between conductive surfaces 1012a, 1012b and 1022a, 1022b during the sealing process; and 2) to electrically energize the tissue along the previously formed tissue seal to cut the tissue along the seal. With respect to
During the so called “sealing phase”, the opposing electrodes 1005a and 1005b are closed about tissue and the cutting element 1026 may form the requisite gap between the opposing sealing surfaces 1012a, 1022a and 1012b, 1022b. During activation of the sealing phase, the cutting element 1026 is not necessarily energized such that the majority of the current is concentrated between opposing sealing surfaces, 1012a and 1022a and 1012b and 1022b, to effectively seal the tissue. Stop members (not shown) may also be employed to regulate the gap distance between the sealing surfaces in lieu of or in combination with cutting element 1026.
Cutting element 1026 may be configured to extend beyond the tissue contacting surfaces 1012a, 1012b and 1022a, 1022b such that cutting element 1026 acts as a stop member that creates a distance “d” between opposing conductive sealing surfaces 1012a, 1022a and 1012b, 1022b, which as mentioned above promotes accurate, consistent and effective tissue sealing. Distance “d” is typically within the above-mentioned gap range. In one embodiment, the distance “d” has a minimum distance of about 0.005 inches for proper effect without stopping the current flow between the cutting element 1026 and tissue contacting surfaces 1012a, 1012b and 1022a, 1022b. As can be appreciated, cutting element 1026 also prevents the opposing tissue contacting surfaces 1012a, 1022a and 1012b, 1022b from touching, which eliminates the chances of the forceps 10, 100 shorting during the sealing process.
During sealing, energy is applied to the tissue through the opposing sealing plates 1012a, 1022a and 1012b, 1022b to effect two tissue seals on either side of the insulators 1014 and 1024. During the cutting phase, sealing electrodes 1012a, 1012b and 1022a, 1022b are energized to a first potential “−” and cutting element 1026 is energized to the second electrical potential “+”. As a result thereof, during the cutting phase, energy is transferred between cutting element 1026 and sealing electrodes 1012a, 1012b and 1022a, 1022b thereby cutting tissue disposed between electrodes 1005a and 1005b.
In another embodiment, control unit 107 is configured to determine when tissue grasped by the tissue clip is sealed based on tissue properties detected by sensor array 170. When the control unit determines that the tissue has been sealed, control unit 107 automatically provides energy to terminal 105c, which is coupled to cutting element 1026, to cut the tissue grasped by the tissue clip.
As shown in
Alternatively, cutting mechanism 1350 may be an electrode coupled to control unit 1320. After a seal is completed, control unit 1320 transfers power from power source 1330 to cutting mechanism 1350 to electrically cut tissue. Cutting mechanism 1350 may also be a light source that emits a focused beam of light (i.e., a laser) to cut tissue. The light source may be a semiconductor laser or any other device that emits a focused beam of light.
Tissue clip 1900 may be effective in emergency situations where access to hospitals is limited such as rural areas or combat situations. In operation, a user presses proximal ends 1931 and 1932 of first arm 1901 and second arm 1902, respectively, towards each other causing distal ends 1941 and 1942 to move away from each other. Tissue is placed between the distal ends 1941 and 1942 and then proximal ends 1931 and 1932 are released causing helical torsion spring 1920 to bias distal ends 1941 and 1941 toward each other to grasp tissue therebetween under the appropriate pressure to seal tissue. Stop members 1920 may be configured to extend from the electrode 1905a and/or 1905b a predetermined distance according to the specific material properties (e.g., compressive strength, thermal expansion, etc.) to yield a consistent and accurate gap distance during sealing. In some embodiments, the gap distance between the first arm 1901 and second arm 1902 during sealing ranges from about 0.001 inches to about 0.006 inches and, in one particularly useful embodiment, between about 0.002 and about 0.003 inches.
Helical torsion spring 1901 causes first arm 1901 and second arm 1902 to apply a sealing pressure to tissue grasped therebetween. In one embodiment, the sealing pressure is in the range of 3K g/cm2 to 16 Kg/cm2.
Clip portion 2020 may be made from a shape memory alloy 2021, e.g., copper-zinc-aluminum-nickel, copper-aluminum-nickel, and nickel-titanium (NiTi) alloys. Shape memory alloy 2021 may exhibit a one way effect or two-way effect. When outside the body, shape memory material is in an open shape with arm 2022 and arm 2023 spaced apart from each other. When tissue clip 2000 is placed inside a body, heat within the body causes clip portion 2020 to heat up past the austenitic start temperature (As) causing the shape memory alloy 2021 to change to its original shape where arm 2022 and arm 2023 are positioned relatively closer to each other to grasp tissue disposed therebetween.
Arm 2022 and arm 2023 include electrodes 2005a and 2005b, respectively. Electrodes 2005a and 2005b are disposed within insulators 2024 to electrically isolate electrodes 2005a and 2005b from shape memory alloy 2021. Insulator 2024 may be composed of any non-conductive material.
Arm 2022 and arm 2023 are configured to yield a consistent and accurate gap distance, which may range from 0.001 inches to about 0.006 inches, during sealing when clip portion 2020 is in its original shape. Further, arm 2022 and arm 2023 may apply a sealing pressure to tissue grasped therebetween when clip portion 2020 is placed in its original austenitic shape. In one embodiment, the sealing pressure is in the range of 3 Kg/cm2 to 16 Kg/cm2.
Although
Clip portion 2110 includes electrodes 2105a and 2105b that apply energy to tissue grasped between arms 2112 and 2114. A spring member 2130 is disposed in clip portion 2110 to bias arms 2112 and 2114 toward each other to grasp tissue therebetween. Arm 2112 and/or arm 2114 include stop members 2120 that are configured to yield a consistent and accurate gap distance, which may range from 0.001 inches to about 0.006 inches. Alternatively, spring member 2130 may be configured to achieve a desired gap between arm 2112 and arm 2114. Further, spring member 2130 may apply a sealing pressure to tissue grasped between arm 2112 and arm 2114. In one embodiment, the sealing pressure is in the range of 3 Kg/cm2 to 16 Kg/cm2.
Although
As shown in
Although specific examples of tissue clips have been described above, any one of the above described tissue clips may include features from any of the other described tissue clips. For instance, the use of an external power source as described in
As mentioned above, it is contemplated that the tissue clip embodiments described herein can use light, microwave, RF, or resistive energy to thermally treat tissue or seal tissue (as defined herein).
It should be understood that the foregoing description is only illustrative of the present disclosure. Various alternatives and modifications can be devised by those skilled in the art without departing from the disclosure. Accordingly, the present disclosure is intended to embrace all such alternatives, modifications and variances. The embodiments described with reference to the attached drawing figs. are presented only to demonstrate certain examples of the disclosure. Other elements, steps, methods and techniques that are insubstantially different from those described above and/or in the appended claims are also intended to be within the scope of the disclosure.