HANDLE AND CABLE ASSEMBLIES FOR ELECTROSURGICAL DEVICES AND CYST ABLATION TECHNIQUES
20200008865 ยท 2020-01-09
Assignee
Inventors
- John Crowder Sigmon, Jr. (Winston-Salem, NC, US)
- DEEPAK SATHYANARAYAN (Ormond Beach, FL, US)
- Kristin Murray (Minneapolis, MN, US)
Cpc classification
A61B18/1492
HUMAN NECESSITIES
A61B2018/00982
HUMAN NECESSITIES
International classification
Abstract
An electrosurgical medical device may include an elongate needle that is delivered to a gastrointestinal tract of a patient and inserted through the gastrointestinal wall and into a cyst. Fluid within the cyst may be aspirated through a lumen of the needle. The cyst may then be filled with conductive fluid by delivering the conductive fluid through the needle lumen. Radio frequency energy may then be delivered to the needle and transferred to the cyst to ablate the cyst. A handle assembly of the electrosurgical medical device may communicate the cyst and conductive fluids to and from the needle lumen, as well as communicate radio frequency energy to the needle and a temperature signal generated by a thermocouple. An electrical cable assembly adapted to communicate both the radio frequency energy and the temperature signal may be removably connectable with the handle assembly.
Claims
1. A method of ablating a cyst, the method comprising: delivering a distal portion of a needle of an electrosurgical medical device to a gastrointestinal tract location in a patient; from the gastrointestinal tract location, advancing the distal portion of the needle to within the cyst; and while the distal portion of the needle is within the cyst, transferring a predetermined amount of radio frequency (RF) energy from the distal portion of the needle to the cyst to ablate the cyst.
2. The method of claim 1, wherein the predetermined amount of RF energy is within a range from 165 Joules to 11,250 Joules.
3. The method of claim 2, wherein the predetermined amount of RF energy is between 165 Joules and 275 Joules when the cyst has a diameter of about one centimeter, wherein the predetermined amount of RF energy is between 900 Joules and 1,500 Joules when the cyst has a diameter of about two centimeters, and wherein the predetermined amount of RF energy is between 6,750 and 11,250 Joules when the cyst has a diameter of three centimeters.
4. The method of claim 1, wherein transferring the predetermined amount of RF energy comprises transferring the predetermined amount of RF energy from the distal portion of the needle to the cyst via a conductive fluid inside the cyst.
5. The method of claim of claim 4, wherein the needle comprises a hollow needle comprising a needle lumen extending through a needle body of the needle, the method further comprising: delivering the conductive fluid to inside the cyst via the needle lumen of the needle.
6. The method of claim 5, further comprising: aspirating cyst fluid inside the cyst through the needle lumen before delivering the conductive fluid to inside the cyst.
7. The method of claim 6, wherein the electrosurgical device comprises a handle assembly coupled to the hollow needle, the method further comprising: aspirating the cyst fluid through a coupling member lumen of a coupling member that couples the hollow needle to a housing of the handle assembly; delivering the conductive fluid through the coupling member lumen; and delivering the predetermined amount of RF energy through the coupling member.
8. The method of claim 7, further comprising: sensing, with a thermocouple, a temperature inside the cyst; transmitting, with the thermocouple, a temperature signal indicative of the sensed temperature to the handle assembly.
9. The method of claim 8, further comprising: transmitting the predetermined amount of RF energy from the needle body to a base of the handle assembly, the base supporting a first contact engaged with an electrical cable assembly delivering the predetermined amount of RF energy from a power source to the first contact; and transmitting, with the thermocouple, the temperature signal to the base, the base further supporting second and third contacts also engaged with the electrical cable assembly, the electrical cable assembly further delivering the temperature signal to a temperature measurement device.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
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DETAILED DESCRIPTION
[0053] The present description describes a handle assembly that integrates fluid delivery, radio frequency (RF) energy, and temperature sensing components and an associated electrical cable assembly. The handle assembly and the electrical cable assembly may be configured to be removably connectable with each other. The present description also describes endoscopic medical devices, systems, and methods for ablating cysts. The handle assembly and the electrical cable assembly may be components of the medical devices and systems and used to ablate the cysts. However, the handle assembly and electrical cable assembly may also or alternatively be used with medical devices and systems that perform electrosurgical procedures that involve fluid delivery, RF energy delivery, and temperature sensing other than cyst ablation.
[0054] A cyst is a closed sac having a membrane that encloses and contains air, fluid, or other semi-solid material therein. Cysts may form on various parts of the body, such as the pancreas, liver, bile duct, lungs, diaphragm, and spleen, as examples. Cysts may be detected through X-ray computer tomography (X-ray CT or simply CT) scans. Typically, a patient undergoes periodic CT scans. Tomographic images produced from the CT scans may identify a cyst, where on or within the body the cyst is located, and the size (e.g., diameter) of the cyst. When a cyst is detected, its size may be monitored in order to determine whether the cyst should be removed. As long as the cyst remains smaller than a predetermined size, such as three centimeters in diameter for a pancreatic cyst, the physician monitoring the cyst may determine not to remove the cyst. However, if the cyst grows to the predetermined size and/or continues to grow beyond the predetermined size, the physician may determine to remove the cyst.
[0055] As mentioned in the background section, when a physician determines to remove the cyst, the physician may perform an invasive procedure. In particular, open surgery may be performed in which an incision in the patient's skin may be made in order to gain access into the patient's abdominal cavity. Once access is obtained, the cyst may be physically removed or detached from the body.
[0056] Rather than perform open surgery, the present description describes an endoscopic ablation procedure that may be performed to gain access to and remove the cyst. The endoscopic ablation procedure may be a minimally invasive procedure in which an incision into the patient's stomach to gain access into the abdominal cavity is not performed. Instead, an elongate tubular portion of an endoscope may be inserted into the patient's body endoscopically, such as into the mouth and moved through the esophagus until it reaches an area or location of the patient's gastrointestinal (GI) tract near the cyst and/or that has been identified as being advantageous for accessing the cyst. A distal tip of a hollow needle may then be endoscopically delivered (i.e., delivered through a working channel or lumen of the endoscope) to the GI tract area where the distal end of the endoscope is positioned. The distal tip may then be inserted through the GI wall and the membrane of the cyst to inside the cyst. After the distal tip is inserted into the cyst, fluid inside the cyst may be aspirated through the distal tip. After the fluid is aspirated, conductive fluid, such as saline, may be delivered through the distal tip into the cyst. RF energy may then be delivered to the distal tip, which may be transferred to the cyst membrane via the conductive fluid surrounding the distal tip. Application of the RF energy to the cyst may ablate the cyst membrane. In particular, the tissue may heat up in response to receiving the RF energy, killing the cyst membrane after passage of an amount of time. In sum, rather than physically excise the cyst membrane from the body, the cyst membrane may be removed by ablating it through application of RF energy.
[0057]
[0058] The electrosurgical device 106 may include an elongate insertion portion 114 for insertion into the patient that extends from a proximal portion 116 to a distal portion 118. The electrosurgical device 106 may also include a handle assembly 120 operatively coupled to the elongate insertion portion 114 and that a physician or operator may handle to control operation of the electrosurgical device 106. The electrosurgical device 106 may further include or be configured to be coupled to an electrical cable assembly 122 that electrically couples the power source 108 and the temperature measurement device 110 to the handle assembly 120.
[0059] The elongate insertion portion 114 may include an elongate tubular member 124, such as a catheter, that includes a body 126 and a lumen 128 longitudinally extending through the body 126. The elongate insertion portion 114 may further include a hollow needle 130 that longitudinally extends and is movably disposed within the lumen 128 of the elongate tubular member 124. The needle 130 may include a body 132 made of a conductive material (e.g., stainless steel) and a needle lumen 134 extending through the needle body 132. For some example configurations, the needle 130 may be a twenty-two gauge needle, although other sizes for the needle 130 may be possible. The hollow needle 130 may include a sharp and/or beveled distal tip 136. In addition, an outer surface 138 of the needle body 132 may include dimples 140, which may enhance ultrasound visibility and/or guidance of the needle 130 during operation.
[0060] The elongate insertion portion 114 may further include a thermocouple 142 configured to sense a temperature of the environment at and/or surrounding a distal end 144 of the thermocouple 142. As shown in
[0061] Also, as shown in
[0062] The handle assembly 120 may be coupled to a proximal end 146 of the elongate insertion portion 114. The handle assembly 120 may include a portion operatively coupled to the elongate tubular member 124 and the needle 130 and configured to longitudinally move the elongate tubular member 124 relative to the needle 130. In the example configuration shown in
[0063] As described in further detail below, fluid 154 contained within the cyst 102 may be drained from the cyst 102 by being aspirated through the needle lumen 134 and sent to the syringe 112. After the cyst fluid 154 is aspirated, a conductive fluid, such as saline, may be delivered through the needle lumen 134 into the cyst 102. Subsequently, RF energy may be delivered to the distal tip 136 of the needle 130 and transferred to the cyst 102 via the conductive fluid in order to ablate the cyst 102.
[0064] The handle assembly 120 may be configured to deliver fluid, including the cyst fluid and the conductive fluid between the syringe 112 and the needle lumen 134. In addition, the handle assembly 120 may be configured to deliver RF energy from the electrical cable assembly 122 to the needle 130 and to deliver temperature signals generated by the thermocouple 142 to the electrical cable assembly 122. To do so, the handle assembly 120 may be configured to engage with and/or couple to a proximal end or hub of the needle body 132 such that the needle lumen 134 is in fluid communication with a fluid delivery channel of the handle assembly 120, and at the same time the needle body 134 is electrically coupled to a portion of the handle assembly 120 that is configured to be electrically coupled to the power source 108. The handle assembly 120 may also be configured such that while the proximal end or hub of the needle body 132 is engaged with and/or coupled to the handle assembly 120, the thermocouple 142 may extend through the needle lumen 134 and proximally to within the handle assembly 120, where a proximal end of the thermocouple 142 is electrically connected to a portion of the handle assembly 120 that is configured to be electrically coupled to the temperature measurement device 110.
[0065]
[0066] Referring particularly to
[0067] The handle assembly 120 may also include a luer 212 and a coupling member 214 that couples and/or fixedly attaches the needle body 132 to the handle assembly 120. In some example configurations, each of the luer 212 and the coupling member 214 may be generally cylindrical structures, although other shaped structures may be possible. A distal end 216 of coupling member 214 may be connected to a proximal needle hub 218 of the needle body 132. By being connected to the needle hub 218, the coupling member 214, and the handle assembly 120 in general, may be in fluid communication with the needle 130. Each of the luer 212 and the coupling member 214 may include a respective lumen 220, 222. The lumens 220, 222 may each form a part of the fluid delivery channel 204.
[0068] The luer 212 may be made of a non-conductive material, such as plastic, and serve as a bridge between the valve 206 and the coupling member 214. Fluid passing from the syringe 212 through the valve stem 210 may also pass through the luer lumen 220 before flowing through the coupling member lumen 222. Similarly, fluid passing through the coupling member lumen 222 toward the syringe 112 may first pass through the luer lumen 220 before reaching the valve stem 210 and the syringe 112.
[0069] As mentioned, the coupling member 214 may be configured to couple and/or fixedly attach the needle body 132 to the handle assembly. To do so, the coupling member 214 may include a proximal portion 224 configured to couple to the housing 202 of the handle assembly 120 and a distal portion 226 configured to couple to the needle hub 218. In addition, the example configurations of the handle assembly 120 shown in
[0070] In addition, the handle assembly 120 may include a set of three conductive pins 234a, 234b, 234c configured to contact corresponding electrical contacts of the electrical cable assembly 122 in order to form an electrical connection between the handle assembly 120 and the electrical cable assembly 122. A wire 236 or other elongate conductive member may be connected to the washer 228 in order to electrically couple the washer 228 with a first pin 234a configured to deliver RF energy generated by the power source 108. The other two conductive pins, 234b and 234c, may be configured to communicate the temperature signals ultimately communicated to the temperature measurement device 110.
[0071] As shown in
[0072] Referring to
[0073] The housing 202 may also include a fifth portion 314 configured to engage and support at least a portion of the proximal portion 224 of the coupling member 214. For some example configurations, the fifth portion 314 of the housing 202 and the proximal portion 224 of the coupling member 214 may be configured to be threadingly engaged with each other. During assembly, the second planar surface 244 of the washer 228 may be positioned on the inner surface 312, and then the proximal portion 224 of the coupling member 214 may be inserted through the hole of the metal washer 228 and screwed into the fifth portion 314 until the shoulder 230 of the coupling member 214 securely biases the washer 228 against the inner surface 312.
[0074] The housing 202 may further include a sixth portion 316 that houses or surrounds the coupling member 214 and a proximal portion of the needle body 132, including the proximal needle hub 218. The sixth portion 316 may distally extend to the portion including the first and second members 148, 150 that move the elongate tubular member 124 relative to the needle (
[0075] For some example configurations, distal ends of the conductive pins 234a-234c may be mounted or secured in a base 322. The housing 202 may further include a seventh portion 324 that includes holes 326 coaxially aligned with areas 328 of the base 322 where the conductive pins 234a-234c are mounted. From the base 322, the pins 234a-234c may proximally extend in the holes 326. Proximal ends of the pins 234a-234c may proximally extend beyond the holes to outside of the housing 202. The side view of
[0076] An internal channel or passageway 330 may extend in the housing 202 from the coupling member 214 and the washer 228 to the base 322. As shown in
[0077] Referring back to
[0078] Also, as shown in
[0079] In addition, the electrical cable assembly 122 may be removably connectable with the handle assembly 120. In particular, the electrical cable assembly 122 may include a connector 338 that has cable-side contacts comprising conductive sockets or receptacles 340a, 340b, 340c configured to removably engage and form an electrical connection with the conductive pins 234a-234c. (The second receptacle 340b is not shown in
[0080] In addition, the electrical cable assembly 122 may include a first elongate conductive member 342, which may include a single wire or conductive path, that is connected to and extends from the first conductive receptacle 340a within a housing 344 of the connector 338. The first conductive member 342 may further extend to outside the connector housing 344 and terminate with a first plug 346 or other connector adapted to be removably connected to the power source 108.
[0081] The electrical cable assembly 122 may also include a second elongate conductive member 348, which may include two wires or conductive paths. The second conductive member 348 may be connected to and extend from the second and third conductive receptacles 340b, 340c within the connector housing 344. Each of the conductive paths may be connected to a different one of the receptacles 340b, 340c. In addition, each of the conductive paths of the first and second elongate conductive members 342, 348 may be electrically insulated from each other. Also, the second conductive member 348 may further extend to outside the connector housing 344 and terminate with a second plug 350 or other connector adapted to be removably connected to the temperature measurement device 110. As shown in
[0082] The electrical cable assembly 122 may additionally include an outer sheath 356 that encases the first and second elongate conductive members 342, 348 together outside of the connector housing 344. As shown in
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[0084] As shown in
[0085] Additionally, as shown in
[0086] In the example configuration shown in
[0087] Various other ways of configuring the RF energy delivery path and/or electrically coupling the needle body 132 to the RF delivery path of the handle assembly 120 may be possible. For example,
[0088] In other example configurations, the coupling member 214 may be made of a conductive material and part of the RF energy delivery path, but the washer 228 may not be made of a conductive material and/or not part of the RF energy delivery path. For these other example configurations, the wire 236 extending in the channel 330 may directly connect to the conductive coupling member 214. In still other example configurations, both the coupling member 214 and the washer 228 may not be part of the RF energy delivery path. For these configurations, the wire 236 may directly connect to the needle body 132. For example, the wire 236 may extend through the gap 238 and the coupling member lumen 222 of the coupling member 214 along with the thermocouple 142, and then connect to the needle body 132 distal the coupling member 214. In other configurations, the washer 228 may be sized so that the wire 236 can extend around or outside of the washer 228 and the coupling member 214 so that the wire 236 can directly connect to the needle body 132, similar to the path taken by the second wire 802 shown in
[0089] In addition, ways to couple the needle body 132 to the housing 202 other than through the coupling member 214 and/or the washer 228 may be possible. For example, in other configurations, the coupling member 214 and the washer 228 may be a single, integral component. In other example configurations, the washer 228 may not be included as a component of the handle assembly 120. In other example configurations, the needle body 132 may directly couple to the housing 202 without the use of the coupling member 214 and/or the washer 228. Other configurations may be possible.
[0090] A method of ablating a cyst within a patient using the electrosurgical system 100 described with reference to
[0091] Referring to
[0092] Referring to
[0093] Referring to
[0094] Referring to
[0095] Referring to
[0096] When the power source 108 is activated, RF energy may be delivered from the power source 108, through the electrical cable assembly 122, through RF energy delivery path of the handle assembly 120, and to the needle body 132. For the handle assembly configurations shown in
[0097] So that only the cyst 102 and not other portions of the patient (e.g., the GI tract location 156, the GI wall 158, or the internal anatomical portion 104) receive the RF energy, the portion of the needle 130 that is inserted into the cyst 102 may be exposed or uninsulated, and at least some of the needle 130 proximal the portion that is exposed or uninsulated may be covered or coated with an insulating material 162, such as parylene as an example. How much of the distal portion 151 is uninsulated may depend on the size of the cyst 102. In general, any portion of the needle 130 that is not inserted into the cyst 102 but that may still be exposed to outside of the elongate tubular member 124 may be covered with the insulating material 162. In some example configurations, a length of the exposed or uninsulated portion may be about one centimeter.
[0098] While RF energy is being applied to the cyst 102, the distal end 144 of the thermocouple 142 may be sensing the temperature within the cyst 102 and surrounding the distal end 144. In response to the sensed temperature, the two conductors comprising the distal end 144 may generate a voltage between them, which may be proximally transmitted through the thermocouple 142 as a temperature signal. The temperature signal may be communicated through the thermocouple 142, through the second and third conductive pins 234b, 234c, through the second and third receptacles 340b, 340c engaged with the second and third conductive pins 234b, 234c, communicated through the second elongate conductive member 348, through the second plug 350, and to the temperature measurement device 110. Based on the received temperature signal, the temperature measurement device 110 may be measure a temperature sensed by the distal end 144 of thermocouple 142. In some methods, the temperature measurement device 110 may be monitored to determine when the sensed temperature in or around the cyst 102 reaches a predetermined temperature level. The sensed temperature reaching the predetermined temperature level may indicate that the cyst 102 has been successfully ablated and application of RF energy in the internal anatomical portion 104 should stop. For some example methods, the predetermined temperature level may be fifty-five degrees Celsius.
[0099] In addition or alternatively, activation of the power source 108 and/or application of the RF energy to the cyst 102 may cease after a predetermined threshold amount of RF energy has been applied to the cyst 102. The predetermined amount of RF energy may correspond to an amount that is sufficiently large enough to ablate the cyst 102 and small enough so as not to excessively heat the internal anatomical portion 104 and/or cause harm to the patient. For ablation of cysts, an example predetermined amount of RF energy may be in a range from 200 Joules to 10,000 Joules.
[0100] Additionally, the predetermined amount of RF energy may vary from cyst to cyst and may depend on the size or diameter of the cyst.
y=32.618e.sup.1.8557x
where y is the predetermined amount of RF energy and x is the size of the cyst in centimeters.
[0101] As indicated in the plot shown in
[0102] As previously described, the size or diameter of the cyst may be determined from initial CT scans performed prior to the ablation. Based on the determined size, selecting a known power setting (in Watts), and then using the plot in
[0103] The above-described ablation procedure may be performed to remove a cyst that a physician determines to remove (e.g., because it is too large or malignant) and as an alternatively to invasive or open surgery that involves cutting into the patient's abdominal cavity from the patient's skin. In addition or alternatively, the above-described ablation procedure may be performed prophylactically in the sense that it may be performed to remove the cyst before the cyst has grown to a size necessitating removal.
[0104] In addition, the above-described ablation procedure may be performed with an electrosurgical medical system other than the system 100 and/or the particular configurations of the handle and power cord assemblies 120, 122 shown in
[0105] In addition, the configurations of the handle assembly 120 and the electrical cable assembly 122 shown and described with reference to
[0106] Additionally, in many cases, electrosurgical devices may generally be one-time or limited use devices that are discarded after an electrosurgical procedure is performed. By configuring the electrical cable assembly 122 to be removably connectable with the handle assembly 120, the electrical cable assembly 122 may be detached or disconnected from the handle assembly 120 after the procedure is performed and before the rest of the electrosurgical device is discarded. The electrical cable assembly 122 may then be used with a different electrosurgical device and/or attached to a different handle assembly 120 for another procedure. As such, the removably connectable electrical cable assembly 122 provides a single, reusable cable assembly that can be simultaneously connected to both a power source that generates the RF energy and a temperature measurement device, and that can also be used with multiple electrosurgical devices for multiple procedures. Because the cable assembly 122 is reusable and not fixedly attached to the handle assembly 122, the electrical cable assembly 122 does not have to be discarded after a procedure is performed. As such, less of a single electrosurgical device is discarded after a procedure is performed.
[0107] Additionally, the removably connectable features of the handle assembly 120 and the cable assembly 122 may be used for electrosurgical medical devices that are connected to the power source 108 and the temperature measurement device 110 in order to deliver RF energy and sense temperature, respectively, but that do not communicate fluid, at least not through the elongate conductive member that receives RF energy. Handle assemblies for these other configurations may include the removably connectable features of the handle assembly 120 shown in
[0108] The foregoing description of various embodiments of the invention has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise embodiments disclosed. Numerous modifications or variations are possible in light of the above teachings. The embodiments discussed were chosen and described to provide the best illustration of the principles of the invention and its practical application to thereby enable one of ordinary skill in the art to utilize the invention in various embodiments and with various modifications as are suited to the particular use contemplated. All such modifications and variations are within the scope of the invention as determined by the appended claims when interpreted in accordance with the breadth to which they are fairly, legally, and equitably entitled.