Embodiments of the present invention generally relate to medical devices. Specifically, embodiments of the present invention relate to systems and devices for use during surgical procedures, such as, a thyroidectomy. Embodiments of the present invention also encompass related procedures.
It is generally desirable to minimize the invasiveness of medical procedures, including therapeutic or diagnostic procedures. Invasive “open” medical procedures are generally more expensive than minimally invasive “keyhole” procedures, and there is often a greater risk of complication and discomfort for the patient. Since open surgery typically requires relatively large incisions, blood loss can be high and the risk of infection or other post-operative complications may increase. Large incisions may require extended recovery times to heal and leave unsightly scarring. Internal and external scar tissue from open surgery can cause lifetime morbidities such as pain, hernias and bowel obstructions. Accordingly, methods, systems, and devices that reduce trauma to the patient, are less invasive, or enhance recovery are desirable.
A thyroidectomy is a surgical procedure whereby part or all of the thyroid gland is removed. Laparoscopic and robotic thyroidectomies have been developed that use rigid devices inserted near the axilla. A transaxillary approach has the advantage of leaving no cervical scarring, but suffers from several drawbacks. Rigid devices, laparoscopic or robotic, must be pivoted about the incision through which they are passed. Precise control of the distal end of a rigid device can be difficult due to this pivoting movement. One way to compensate for the “pivoting” phenomenon is to enlarge the access incision. Many current minimally invasive approaches result in larger overall incisions compared to open approaches. Visualization may also be complicated because a separate optical device is required. In addition to possibly requiring an extra incision, the optical device must be appropriately positioned to provide a useful field of view of the surgical site. Maintaining or adjusting the optical device relative to the rigid device is time consuming and may involve constant attention. Moreover, the transaxillary approach provides limited access to an ipsilateral (i.e., proximal) lobe, and even less access to a contralateral (i.e., distal) lobe.
Standard endoscopic devices are also unsuitable for thyroidectomies, in part, because the approach is not through a natural body cavity. Standard endoscopes are specifically designed to flex to pass through the lower gastrointestinal tract or the esophagus. Consequently, they are not configured for use in procedures requiring navigation past organs or through tissue without surrounding support structure to guide them. Standard endoscopic devices are too long or too flexible for such navigation. In addition, these devices are not configured for ergonomic control of instruments passed through them. Control of a standard endoscopic device often requires two hands to operate, meaning that only one device can be operated at a time by a surgeon. Nor can standard endoscopic devices be locked or moved incrementally relative to a patient. The present disclosure overcomes at least some of the limitations of prior art.
It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention.
In one aspect, a method of performing a medical procedure in a patient includes creating an incision in the patient, and inserting a flexible guide tube into the incision. The method also includes locating a flexible instrument and a flexible optical device within the guide tube, tunneling the distal tip of the guide tube through the incision to a sternal notch or a position proximate the sternal notch, and dissecting at least part of a thyroid using the instrument.
In another aspect, a method of performing a medical procedure in a patient includes creating a sub-xiphoid incision in the patient, passing a distal tip of a flexible guide tube through the incision, and positioning a distal tip of the guide tube in a lower subcutaneous location. The method also includes tunneling the distal tip of the guide tube from the lower subcutaneous location to an upper subcutaneous location, advancing a first flexible instrument and a second flexible instrument through the guide tube, and dissecting at least part of a thyroid using the first instrument and the second instrument.
In a further aspect, a method of performing a medical procedure in a patient includes creating an incision in an umbilicus of the patient, passing a distal end of a flexible guide tube and a distal end of a flexible instrument through the incision, and creating a pathway from the incision to a thyroid using at least one of the guide tube and the instrument, wherein a part of the pathway is subcutaneous. The method also includes positioning an optical device to visualize the thyroid and dissecting at least part of the thyroid from surrounding tissue using the instrument.
Additional objects and advantages of the invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention. The objects and advantages of the invention will be realized and attained by means of the elements and combinations particularly pointed out below.
It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention.
The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate several embodiments of the invention and together with the description, serve to explain the principles of the invention.
Reference will now be made in detail to exemplary embodiments of the invention, examples of which are illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts.
The terms “proximal” and “distal” are used herein to refer to the relative positions of the components of the exemplary endoscopic system 10. When used herein, “proximal” refers to a position relatively closer to the exterior of the body or closer to the surgeon using endoscopic system 10. In contrast, “distal” refers to a position relatively further away from the surgeon using endoscopic system 10 or closer to the interior of the body.
Although in the description that follows, endoscopic system 10 is described and shown as being inserted into the body through an incision in a patient, it should be emphasized that this description is exemplary only. For example, endoscopic system 10 may also be used for procedures in or near other body organs, such as trachea, larynx, or other cervical organs. Embodiments of the current disclosure may be used in, but are not limited to, single incision laparoscopic surgical (SILS) procedures, complex endoluminal surgeries or natural orifice transluminal endoscopic surgery (NOTES) procedures.
According to an exemplary embodiment, endoscopic system 10 may include a guide tube 20, one or more instruments 30, an optical device 40, and a platform 50. A distal region 12 of endoscopic system 10 may be inserted into a patient to perform various medical procedures as described herein. During these procedures, a proximal region 14 of endoscopic system 10 remains outside the patient and is manipulated by a surgeon to control components of distal region 12, as shown in
Endoscopic system 10 is configured to permit a surgeon to operate two instruments 30 simultaneously. In other embodiments, the surgeon may operate one instrument 30 while moving platform 50 or adjusting optical device 40. Generally, platform 50 and guide tube 20 are configured to permit simultaneous and independent operation of two instruments 30 using one hand on each instrument 30. Platform 50 can be rigidly coupled to an operating table, and thus be fixed relative to a patient during an operation. Platform 50 can also be locked and unlocked to permit movement relative to the operating table or patient.
Guide tube 20 and optical device 40 can be removably coupled to platform 50. Optical device 40 can include a commercially available endoscope or other imaging device. Other features and operations of the various components of endoscopic system 10 will be described below. Some exemplary embodiments of guide tube 20, instrument 30, optical device 40, and platform 50 (frame) are disclosed, for example, in U.S. patent application Ser. No. 11/946,790, entitled “Multi-Part Instrument Systems and Methods,” which is hereby incorporated by reference in its entirety.
As shown in
Guide tube 20 may include a region 26 and an articulating region 28. Region 26 can be flexible enough to bend around organs yet rigid enough to adequately transfer compressive force from proximal region 24 to distal region 22. For example, region 26 could be configured to bend to allow distal region 22 to be navigated from an incision in the umbilicus to an inferior surface of the diaphragm. Such navigation requires sufficient flexibility to flex in order to pass around organs in the abdominal cavity and sufficient rigidity to force distal region 22 through connective tissue supporting the abdominal organs.
Articulating region 28 may be controllably moved via a control mechanism 21 located at proximal region 24. For example, a first knob 23 could be rotated to move articulating region 28 left and right while a second knob 25 could be rotated to move articulating region 28 up and down. A brake 27 can be configured to lock or unlock the movement of articulating region 28. Controlled movement of articulating region 28 can control movement of distal region 22 of guide tube 20, a distal region 32 of instrument 30, or a distal region 42 of optical device 40 relative to a patient.
Optical device 40 can be moved relative to guide tube 20 to adjust a viewing angle, viewing distance, or location of distal end 42 relative to the patient or the surgical site. In some embodiments, an articulating region (not shown) can be configured to permit movement and repositioning of distal end 42 via movement of various controls located at a proximal region 44 of optical device 40 (
In some embodiments, optical device 40 may be embedded into or attached to guide tube 20 or instrument 30. For example, optical device 40 may be on a distal-facing, circumferential, or other outer surface near distal ends 22, 32. With such an “integral” optical device 40, the surgeon may move guide tube 20 or instrument 30 longitudinally, laterally, or rotationally to control the position of optical device 40 with respect to the patient.
In use, distal end 32 of instrument 30 may be articulated by moving articulating region 38. For example, actuators 31 (shown in
Instrument 30 can also include rigid region 35 configured for placement in a bearing tube 53 (
Each instrument 30 can also include end effector 37 located at distal region 32. Instrument 30 may include one or more control elements (not shown) connected to end effector 37 to allow the surgeon to control the movement of end effector 37. End effector 37 may be connected to articulating region 38 to allow end effector 37 to move up/down or left/right. Instrument 30 and end effector 37 may include a range of configurations for use with various medical procedures.
Platform 50 can be mounted to an operating table (not shown) using a mounting system 60. Mounting system 60 can include a clamp 61 configured to releasably couple to the operating table. A lever 63 may mechanically engage clamp 61 to provide locking/unlocking of select movement between mounting system 60 and clamp 61. In other words, locking lever 63 would limit movement and unlocking lever 63 would permit free movement of platform 60 in one or more directions. Alternatively, lever 63 could be moved to incrementally move (e.g., raise or lower) mounting system 60, and hence endoscopic system 10, relative to the operating table.
In addition to, or instead of, controlling movement using lever 63, a knob 65 may mechanically engage one or more mounting arms 66 to lock or free movement between two or more mounting arms 66. Alternatively, knob 65 could be moved to incrementally move two or more mounting arms 66 relative to each other.
In use, knob 76 may mechanically engage carriage 74 or rails 72 to provide locking/unlocking of movement between carriage 74 and rails 72. Alternatively, knob 76 could be moved to incrementally translate carriage 74 relative to rails 72. As explained above with respect to mounting system 60, slide assembly 70 can be used to selectively move guide tube 20 relative to the operating table.
Various combinations of one or more levers 63, knobs 65, 76 or other devices could be used to provide select movement of endoscopic system 10 relative to the patient. In other embodiments, endoscopic system 10 can include a gear, belt, pulley, or other type of drive system configured to provide selective movement. For example, various components of endoscopic system 10 could be configured for locking/unlocking, incremental, or other types of select movement. Select movement of one or more components of endoscopic system 10 can provide advantages to a surgeon performing a procedure on a patient, as described herein.
In accordance with an exemplary embodiment, a medical procedure may be performed as illustrated in the flow charts of
In some embodiments, a single incision can be created (Step 300). The incision may be formed in an abdominal wall, and more specifically, through an anterior surface of the abdominal wall. The incision may be sub-xiphoid, including, for example, through the umbilicus. The incision may also be made between left and right midclavicular lines 210. The purpose of the incision is to permit subcutaneous access to a region located anterior to sternum 240.
Distal region 22 of guide tube 20 can be inserted through the incision (Step 310). Guide tube 20, instrument 30, and optical device 40 may be configured to be at least partially inserted into an anatomic opening. Guide tube 20, instrument 30, and optical device 40 may be advanced together through tissue. Guide tube 20, instrument 30, and optical device 40 may also be advanced separately in various combinations as each component can be moved independent of movement of one or more other components. For example, guide tube 20 may be advanced along with optical device 40 while one or more instruments 30 remain fixed relative to the patient.
During a procedure, one or more instruments 30 or optical device 40 can be readily removed from guide tube 20 and quickly replaced with another or a different component. The ability to precisely and quickly reposition a component at the surgical site allows a surgeon to quickly respond to unexpected events. For example, grasper 37a and dissector 37b can be quickly replaced with electrocautery hook 37d and suction tube 37e to treat a ruptured blood vessel.
To create and navigate a pathway to thyroid 100, various combinations of instrument 30, optical device 40, and guide tube 20 may be used to dissect tissue. For example, distal end 29 of guide tube 20 may be rounded and configured to deflect bone structures or separate tissue. Optical device 40 could also be used in some capacity to dissect or retract tissue. One or more instruments 30 can be configured to cut, dissect, remove, or ablate tissue. For example, a dissector, scissors, or an electrocautery hook may be used to, respectively, dissect, cut, or ablate tissue. Various components may be used to advance distal end 29 of guide tube 20 to a subcutaneous or suprasternal space (Step 320), as explained below. These techniques could also be used to tunnel guide tube 20, or another component, over sternum 240 in a superior direction (Step 330).
In some embodiments, guide tube 20 can be selectively moved relative to the patient to retract or dissect tissue. Select movement can include moving guide tube 20 relative to platform 50 over relatively small distances, such as, for example, less than one inch. Moving platform 50 relative to the patient can include relatively large distance, such as, for example, advancing guide tube 20 several inches.
Movement over different relative scales can be combined with locked, free, incremental, or other types of select movement to provide improved retraction or dissection using endoscopic system 10. As such, the surgeon can precisely control retraction or dissection through small-scale and large-scale movement as endoscopic system 10 is progressively repositioned relative to the patient. The surgeon may also freely or incrementally move endoscopic system 10, or lock its position, during the procedure.
In use, a surgeon could initially position endoscopic system 10 relative to the patient. Once suitably positioned, platform 50 could be locked in a first position relative to the patient by, for example, mounting system 60. Then, the surgeon could operate slide assembly 70 to precisely move guide tube 20 relative to the patient and mounting system 60 from the first position to a second position superior to the first position. If necessary, endoscopic system 10 could be re-locked at the superior second position. The surgeon may be able to take his/her hands off one or more components of endoscopic system 10 to reposition another component or perform another task. For example, with guide tube 20 temporarily locked, bleeding vessels may be ligated or fine tissue dissection may be conducted using one or more instruments 30.
Such small-scale, large-scale, free, locked, or incremental control over the movement of endoscopic system 10 can be used to manipulate tissue generally not requiring fine dissection. This can include subcutaneous tissue located anterior to sternum 240 or manubrium 250. In general, instruments 30 can be used to perform fine dissection of, for example, nerves, vessels, or lymphatic ducts. Abdominal, thoracic, or cervical tissue may be retracted or dissected using a combination of guide tube 20 and instrument 30.
As described above, one or more different types of instruments 30 can be used in conjunction with endoscopic system 10. For example, a dissector and an electrocautery device can be used to dissect tissue and seal unwanted perforations. Alternatively, or in combination, a balloon dissector or other type of dissector may be used to create space between adjacent organs.
Insufflation may also be required to create or assist with creation of the pathway. Various parts of subcutaneous tissue may require insufflation, such as, part of the pathway encompassing the suprasternal region. Insufflation can include providing a pressurized gas, such as, for example, carbon dioxide at a pressure of 5 to 15 mmHg. Insufflation gas can be provided to a surgical site via guide tube 20 and port 18.
Once endoscopic system 10 has been navigated over sternum 240 and manubrium 250 to a location near thyroid 100 (Step 340), optical device 40 can be positioned to visualize thyroid 100. At this stage of the procedure, one or more instruments 30 may be located within guide tube 20 (Step 350). As explained above, one or more instruments 30 or optical device 40 can also be located within guide tube 20 during a prior step.
Instrument 30 can then be used to create anterior access to thyroid 100 (Step 360). This can include retracting or dissecting various organs located anterior to thyroid 100. For example, instrument 30 can be passed between a left sternothyroid muscle and a right sternothyroid muscle. Unlike prior art approaches, such retraction can be performed without penetrating a pectoralis major muscle or other major cervical and thoracic muscles.
It is possible that one or more cervical organs may require retraction during the procedures describe herein. Retraction may be necessary to access or visualize thyroid 100. For example, a Veress needle or similar device may be introduced through a lateral region of the neck to provide suitable retraction. Various other retraction techniques or devices could also be used.
In other embodiments, endoscopic system 10 could be used alone to retract one or more organs of the patient. For example, guide tube 20 or instrument 30 may be used in part to retract one or more organs. Because of their flexibility and ability to articulate, guide tube 20 or instrument 30 may be navigated around one or more organs. During such an approach, organs adjacent to thyroid 100 may be retracted via appropriate manipulation of guide tube 20 alone, or in combination with instrument 30 configured to expand or retract tissue.
To assist organ retraction or confirm sufficient access to thyroid 100, one or more optical devices 40 may be used. As explained above, optical device 40 can include a traditional endoscope, laparoscopic imaging device, or various other types of optical systems. For example, a traditional laparoscopic imaging device (not shown) may be inserted through a cervical or thoracic puncture and positioned to view thyroid 100. Alternatively, or in combination with the laparoscopic imaging device, one or more optical devices 40 may be located within guide tube 20 and positioned to view thyroid 100 or another organ near thyroid 100. As such, various imaging systems or modalities could be used with the procedures described herein. Moreover, different imaging systems or modalities could be used at different times throughout the medical procedures described herein.
In general, one or more instruments 30 can be used to divide muscles, nerves, vessels, or other organs adjacent to thyroid 100. Guide tube 20 may be articulated to provide sufficient access to a region near thyroid 100. In addition, instrument 30 or optical device 40 may be articulated or repositioned to better access regions of tissue requiring retraction or dissection. The aim of these steps is to create anterior access to thyroid 100.
The present system can also maintain improved visualization of target organs compared with traditional techniques. Visualization can be difficult to maintain with traditional devices due to their inflexibility, lack of appropriate articulation, or other limitations. In contrast, endoscopic system 10 can provide improved flexibility and articulation to maintain sufficient visualization of the target organs. For example, endoscopic system 10 can be independently operated while insufflation or retraction is maintained using other devices. Decoupling instrument control from other devices used to maintain an operating space can free a surgeon to focus more on the tissue manipulation required, rather than maintaining tissue access. As such, endoscopic system 10 can accommodate a team of surgeons, increasing the speed, accuracy, or precision of a surgical procedure.
Once thyroid 100 has been sufficiently exposed, one or more components of endoscopic system 10 may be used to dissect at least part of thyroid 100 (Step 370). Endoscopic system 10 can permit significant improvement in performing dissections of thyroid 100 because of improvements in visualization, ergonomics, and fine dissection offered by instruments 30. For example, independent articulation of optical device 40 and instruments 30 provides improved triangulation of the thyroid region as well as essential traction-countertraction. Thyroid 100 can be at least partially dissected while substantially preserving parathyroid glands 160. And unlike previous techniques, left lobe 102 and right lobe 104 can be equally accessed using a single pathway. Consequently, endoscopic system 10 permits more symmetrical visualization, access, and dissection of both lobes 102, 104.
In some embodiments, two instruments 30 can be used for dissection of thyroid 100. Each instrument 30 can be independently positioned to access either side of lobes 102, 104 from an anterior approach. Moreover, each instrument 30 can readily manipulate either lobe 102, 104 with equal dexterity and control. Various different types of instruments 30 are easily interchangeable to perform fine dissection and precisely cut, separate, ablate, or remove tissue from thyroid 100.
Tissue surrounding thyroid 100 can be viewed at various angles and examined to determine if it should be removed or left intact. Blood vessels can be selectively ligated or ablated as required. Dissection using endoscopic system 10 can allow close control of vascular pedicles, preservation of parathyroid glands 160, and ready identification of the recurrent laryngeal nerve.
After thyroid 100 has been sufficiently dissected, guide tube 20 and instruments 30 may be removed from the patient (Step 380) along with the surgical specimen. The procedures described herein generally require minimal suturing or closure. Following removal of endoscopic system 10, the incision may be closed (Step 390).
Various other surgical steps may be required during the procedures described herein or similar operations. For example, division of major blood supply may be needed to reduce blood loss during an operation. Clips, ablative energy, ligation, or other devices or methods may be used to limit unwanted bleeding. Various imaging, space creation, closure, or other steps may also be needed based on the type of procedure.
It will be apparent to those skilled in the art that various modifications and variations can be made in the disclosed devices and methods without departing from the scope of the invention. Other procedures could be performed based on subcutaneous or suprasternal access to cervical tissue. For example, parathyroid, lymph node, or carotid artery surgeries could be performed similar to the thyroid surgeries described above. In general, any anterior neck or cervical organs could be treated using endoscopic system 10. Other embodiments of the invention will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. It is intended that the specification and examples be considered as exemplary only.
This application claims the benefit of priority from U.S. Provisional Application No. 61/736,117, filed on Dec. 12, 2012, the entirety of which is incorporated by reference herein.
Number | Date | Country | |
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61736117 | Dec 2012 | US |