Patent Application
20230139073
The present technology is generally related to the field of surgical instruments. In particular, the disclosure relates to a multi-function transection device for use in open surgical procedures.
Bipolar vessel sealing and dissection devices use advanced radiofrequency to seal blood vessels and other tissue structures, and are commonly used in open, laparoscopic, and thoracoscopic procedures. These devices are often used for sealing and dividing blood vessels and other tissue structures through a combination of radiofrequency energy and pressure. Common procedures in which bipolar vessel sealing and dissection devices are used include hysterectomies, colectomies, splenectomies, gastrectomies, pancreatectomies, nephrectomies, adhesiolysis and endometriosis resection, among others.
With reference to
In operation, tissue is placed between the jaws 102A/B. A clinician or user then squeezes a lever 108 to close the jaws 102A/B and presses a trigger 110 to activate the generator 104. Thereafter, a high-frequency alternating current from the generator 104 causes hydrated tissue clamped between the jaws 102A/B to heat up, which in turn causes collagen and elastin molecules within the tissue to melt and fuse back together thereby creating a seal. Accordingly, bipolar vessel sealing and dissection devices are well adapted at sealing and dividing tissues that can be positioned between the pair of jaws 102A/B.
For treatment of broad plane tissues (e.g., tissue that is not readily positioned between the pair of jaws 102A/B), medical personnel may turn to other types of devices, for example, a device which employs transcoalition or another type of broad plane tissue sealing technology. Unlike bipolar vessel sealing, transcoalition enables pretreatment of tissue prior to dissection, as well as the treatment of blood vessels that have retracted into a surrounding broad plane of tissue.
With reference to
In operation, transcoalition can be affected through a painting motion of the device 150 upon the tissue to be treated while pressing an activation button 158 to seal broad tissue planes or spot treat bleeding vessels up to about 1 mm in diameter. Unlike traditional electrocautery, transcoalition provides low temperature hemostasis, with temperatures generally at or below 100° C., thereby reducing the likelihood of burning char or smoke.
Speed is a critical factor for reducing the amount of time patients are held under anesthesia, and for reducing the cost of time in the operating room. Bipolar vessel sealing devices 100 and transcoalition devices 150 have each proven extremely effective in this respect, particularly in comparison to manual dissection with sutures or electrocautery. Specifically, these devices have been found to reduce procedure times while reducing blood loss, hospital stays, recovery time, and postoperative pain. Moreover, these devices seal tissue without leaving any foreign objects, like sutures, staples or clips, in the body.
Although such devices have proven to work extremely well, the large handle associated with these devices, which is often in the form of a pistol grip, can present visibility issues, as well as generally having an unnatural feeling to an experienced surgeon who may have previously relied on a hemostat or scalpel. Moreover, the use of multiple tools during a surgical procedure increases the complexity and time required for the completion of a surgical procedure. The present disclosure addresses these concerns.
The techniques of this disclosure generally relate to a multifunction surgical instrument having a low-profile, ring handle configured to deliver both vessel dissection and sealing through a bipolar clamping mechanism and a combination of bipolar radiofrequency energy and saline to provide hemostatic sealing and coagulation of soft tissue and bone to address diffused bleeding during a surgical procedure.
One embodiment of the present disclosure provides a multifunction surgical instrument having a low-profile configuration to deliver both small vessel sealing through a bipolar clamping mechanism and transcollation sealing of diffused bleeding in a broad tissue plane, the multifunction surgical instrument including a reusable portion comprising a handle and an insertion portion, the insertion portion including a first jaw and a second jaw configured to transition between an open position and a closed position to serve as a clamp for sealing of tissue with a depth of up to about 7 mm, and a disposable electrode portion comprising a first conductive surface positioned in proximity to the first jaw and a second conductive surface positioned in proximity to the second jaw, the first and second conductive surfaces configured to emit a high-frequency alternating current sufficient to cause poaching of tissue clamped between the first and second jaws, and two or more electrodes and at least one saline port, wherein the two or more electrodes and the at least one saline port cooperate to affect transcollation sealing of diffused bleeding within a broad tissue plane.
In one embodiment, the handle of the reusable portion defines a pair of rings, each of the rings shaped and sized to enable a clinician to pass a finger therethrough for manipulation of the multifunction surgical instrument. In one embodiment, the reusable portion is constructed of a metallic based material configured to withstand the temperature and pressure of an autoclave for sterilization. In one embodiment, the first and second jaws are configured to produce a clamping pressure within a range of about 3 kg/cm2 and about 16 kg/cm2 In one embodiment, the disposable electrode portion further comprises a contact switch configured to automatically energize the first and second conductive surfaces upon application of a predefined quantity of pressure thereupon. In one embodiment, the first and second conductive surfaces are configured to emit a high frequency alternating current in the range of between about 200 kHz and about 3.3 MHz. In one embodiment, the multifunction surgical instrument further includes a blade configured to selectively transition distally-proximally along at least one of the first or second jaw. In one embodiment, the blade is actuated by a blade trigger.
In one embodiment, at least a first electrode is positioned adjacent to the first conductive surface and at least a second electrode is positioned adjacent to the second conductive surface. In one embodiment, at least one saline port is configured to deliver saline at a rate matched to radiofrequency energy emitted by the two or more electrodes. In one embodiment, activation of at least one saline port and two or more electrodes are affected by applying pressure to both a sealing button and a contact switch in the closed position. In one embodiment, the two or more electrodes and the at least one saline port are configured to produce hemostatic sealing within the surgical site at a temperature at or below 100° C. In one embodiment, the multifunction surgical instrument further includes a light emitting diode configured to at least partially illuminate a surgical site.
Another embodiment of the present disclosure provides a surgical instrument including a handle, a pair of jaws comprising a first jaw and a second jaw configured to transition between an open position and a closed position, a first conductive surface positioned in proximity to the first jaw and a second conductive surface positioned in proximity to the second jaw, the first and second conductive surfaces configured to emit a high-frequency alternating current sufficient to cause poaching of tissue clamped between the first and second jaws, and two or more electrodes and at least one saline port configured to affect transcollation sealing of diffused bleeding within a broad tissue plane.
Yet another embodiment of the present disclosure provides a multifunction surgical instrument having a low-profile configuration to deliver both small vessel sealing through a bipolar clamping mechanism and transcollation sealing of diffused bleeding in a broad tissue plane, the multifunction surgical instrument including a reusable portion, constructed of a metallic based material configured to withstand a temperature and pressure of an autoclave for sterilization, the reusable portion comprising a handle and an insertion portion, the insertion portion including a first jaw and a second jaw configured to transition between an open position and a closed position to serve as a clamp for sealing of vessels or tissue with a diameter or maximum dimensions of up to about 7 mm, and wherein the handle of the reusable portion defines a pair of rings, each of the rings shaped and sized to enable a clinician to pass a finger therethrough for manipulation of the multifunction surgical instrument, a disposable electrode portion comprising a first conductive surface positioned in proximity to the first jaw and a second conductive surface positioned in proximity to the second jaw, the first and second conductive surfaces configured to emit a high-frequency alternating current sufficient to cause poaching of tissue clamped between the first and second jaws, a contact switch configured to automatically energize the first and second conductive surfaces upon application of a predefined quantity of pressure thereupon, a blade configured to selectively transition distally-proximally along at least one of the first or second jaws, and two or more electrodes and at least one saline port, wherein the two or more electrodes and the at least one saline port cooperate to affect transcollation sealing of diffused bleeding within a broad tissue plane, wherein activation of the at least one saline port and the two or more electrodes are affected by applying pressure to both a sealing button and a contact switch in the closed position.
The details of one or more aspects of the disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the techniques described in this disclosure will be apparent from the description in the drawings, and from the claims.
The disclosure can be more completely understood in consideration of the following detailed description of various embodiments of the disclosure, in connection with the accompanying drawings, in which:
While embodiments of the disclosure are amenable to various modifications and alternative forms, specifics thereof shown by way of example in the drawings will be described in detail. It should be understood, however, that the intention is not to limit the disclosure to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the subject matter as defined by the claims.
As a general matter, reducing the number of tools or instruments that are used simultaneously during a surgical procedure is beneficial because each instrument obstructs access to the surgical site in some way, or requires a larger incision that would otherwise be required to provide access for the other instruments needed to perform the procedure. One solution to this problem is to change specialized tools throughout the procedure such that there are a limited number involved in the procedure at any given time. Changing tools, however, is a process that can present its own challenges.
As described herein, use of a single, multi-function device or instrument provides both clamping and small-vessel (e.g., diameters of between about 1 mm and about 2 mm, and in some cases up to a diameter of about 7 mm, etc.) sealing and coagulation of diffused bleeding without the need for instrument changes or a larger incision. Referring to
As used herein, the term “distal” refers to the portion of the instrument or component thereof that is being described that is further from a clinician or user, while the term “proximal” refers to the portion of the instrument or component thereof that is being described that is closer to a clinician or user. Further, to the extent consistent, any of the aspects described herein may be used in conjunction with any of the other aspects described herein. As used herein the term “tissue” is meant to include variously-sized vessels and broad planes of biological matter.
Further, it is to be appreciated that the term “clinician” refers to any individual configured to use or manipulate example embodiments described herein or alternative combinations thereof during a procedure. Similarly, the term “patient” or “subject,” as used herein is to be understood to refer to an individual or object in which the use of the device is to occur during a procedure, whether human, animal, or inanimate. Various descriptions are made herein, for the sake of convenience, with respect to the procedures being performed by a clinician on a patient or subject (the involved parties collectively referred to as a “user” or “users”) while the disclosure is not limited in this respect.
In some embodiments, the multifunction surgical instrument 200 can be disposable, in that the entire handpiece is considered a consumable item to be disposed of at the conclusion of a surgical procedure. In other embodiments, the multifunction surgical instrument 200 can be reposeable, in that at least one portion of the instrument 200 is reusable, while other portions of the instrument 200 are disposable. For example, with reference to
With continued reference to
With additional reference to
With additional reference to
With additional reference to
Accordingly, as depicted in
In some embodiments, an energy generator can provide radiofrequency controlled by an advanced algorithm for optimal tissue sealing. For example, in some embodiments, the conductive surfaces 218A/B can be configured to emit a high-frequency electrical current (e.g., between about 200 kHz to about 3.3 MHz), or other frequency above a range that would tend to cause nerve or muscle stimulation. In some embodiments, the conductive surfaces 218A/B can be configured to monitor an electrical resistance of the tissue to determine exactly how much radiofrequency energy is needed to affect sealing. Further, in some embodiments, at least one of the jaws 216A/B and/or conductive surfaces 218A/B can include a nonstick coating, for example in the form of a thin polymer, resulting in easier separation of the jaws 216A/B from the tissue (nonstick), less eschar at the surgical site, and with a decreased buildup of charred tissue on the instrument 200.
In addition to clamping and sealing of vessels, in embodiments, the instrument 200 can also employ transcollation technology for coagulation of diffused bleeding, thereby reducing the need for multiple instruments or exchange of instruments during a surgical procedure. For example, with additional reference to
In the disposable embodiment (as depicted in
Accordingly, with reference to
In some embodiments, a distance between the first and second electrodes 228A/B can be affected through manipulation of the handle rings 214A/B, thereby enabling medical personnel to selectively control an intensity and/or depth of the electrosurgical effect of the electrodes 228A/B. For example, a surgeon may establish a fixed distance between the electrodes 228A/B while manipulating the entire instrument 200, bringing the electrodes 228A/B into, and out of, contact with tissue to work the surgical site. In another example, a surgeon may bring the electrodes 228A/B into substantially continuous contact with tissue, and manipulate a distance between the electrodes 228A/B. In some embodiments, a distance between the electrodes 228A/B can be sensed by the contact switch 226 (e.g., pressure switch, etc.), which in communication with a system pump generator can dictate the magnitude of energy transmitted to the electrodes 228A/B and volume of saline delivered to the port 230.
Thereafter, a combination of radiofrequency energy provided by the electrodes 228A/B and saline provided by the one or more saline ports 230 can affect low temperature hemostasis to affect collation and general sealing within a broad tissue plane. Specifically, saline, or some other fluid or fluid like substance (e.g., deionized water, glycol, etc.) that is both a good conductor of electricity and not damaging to the surrounding tissues and structures, can be introduced into the surgical site by one or more saline ports 230, while the electrodes 228A/B provide electrical current sufficient to poach the bathed region. In this manner the one or more ports 230 deliver saline at a rate matched to the radiofrequency energy emitted by the electrodes 228A/B.
Thereafter, electrosurgical energy flows between the electrodes 228A/B forming a radiating pattern, which radiates between the electrodes 228A/B. In embodiments, manipulation of the handle rings 214A/B enables a clinician to apply transcollation technology to the surgical site with the painting motion to seal broad tissue planes, to spot treat bleeding vessels up to about 1 mm in diameter, as well as to treat bleeding vessels that have retracted into surrounding tissue that cannot be easily grasped by the jaws 216A/B. In some embodiments, the transcollation technology can be configured to produce hemostatic sealing without burning, char or smoke, wherein the presence of saline maintains temperatures within the surgical site at or below about 100° C.
Accordingly, embodiments of the present disclosure enable clamping and small vessel sealing, as well as coagulation of diffused bleeding within a tissue plane without a need for instrument changes or a larger incision, thus resulting in improved visibility for clinicians, shorter surgical procedure times, and improved patient outcomes (e.g., faster recovery rates, greater hemoglobin retention, etc.). With its ability to clamp vessels and other tissues for bipolar dissection and sealing, as well as to provide transcoalition of broad tissue planes, the multifunction surgical instruments 200 of the present disclosure are particularly adept at surgeries which otherwise require multiple instruments, including for example, solid organ resection, spinal surgery, trauma procedures, an orthopedic reconstruction of the hip and knee, just to name a few.
Moreover, embodiments of the present disclosure, employ a low-profile ring handle configuration with a form factor similar to a hemostatic or other instrument which surgeons are accustomed. Accordingly, in addition to reduced surgical times, reduced cost, higher hemoglobin retention for the patient, and reductions in postsurgical blood loss, embodiments of the present disclosure provide improved visibility of the surgical site, as well as a haptic familiarity to surgeons, particularly in comparison to pistol grip handle designs (such as that depicted in
It should be understood that various aspects disclosed herein may be combined in different combinations than the combinations specifically presented in the description and accompanying drawings. It should also be understood that, depending on the example, certain acts or events of any of the processes or methods described herein may be performed in a different sequence, may be added, merged, or left out altogether (e.g., all described acts or events may not be necessary to carry out the techniques). In addition, while certain aspects of this disclosure are described as being performed by a single module or unit for purposes of clarity, it should be understood that the techniques of this disclosure may be performed by a combination of units or modules associated with, for example, a medical device.
In one or more examples, the described techniques may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functions may be stored as one or more instructions or code on a computer-readable medium and executed by a hardware-based processing unit. Computer-readable media may include non-transitory computer-readable media, which corresponds to a tangible medium such as data storage media (e.g., RAM, ROM, EEPROM, flash memory, or any other medium that can be used to store desired program code in the form of instructions or data structures and that can be accessed by a computer).
Instructions may be executed by one or more processors, such as one or more digital signal processors (DSPs), general purpose microprocessors, application specific integrated circuits (ASICs), field programmable logic arrays (FPGAs), or other equivalent integrated or discrete logic circuitry. Accordingly, the term “processor” as used herein may refer to any of the foregoing structure or any other physical structure suitable for implementation of the described techniques. Also, the techniques could be fully implemented in one or more circuits or logic elements.
The present application claims the benefit of U.S. Provisional Application No. 63/274,454, filed Nov. 1, 2021, the contents of which are fully incorporated herein by reference.
| Number | Date | Country | |
|---|---|---|---|
| 63274454 | Nov 2021 | US |
