This disclosure relates generally to surgical instruments and, more particularly, to devices and methods for positioning a surgical instrument that is percutaneously inserted into a patient.
Surgical procedures are used to treat and cure a wide range of diseases, conditions, and injuries. Surgery often requires access to internal tissue through open or minimally invasive surgical procedures. The term “minimally invasive” refers to a wide range of surgical procedures including laparoscopic, arthroscopic, endoscopic, natural orifice intraluminal, and natural orifice transluminal procedures. Minimally invasive surgery can have numerous advantages compared to traditional open surgical procedures, including reduced trauma, faster recovery, reduced risk of infection, and reduced scarring. During some minimally invasive procedures, trocars can be used to provide a port through which endoscopic surgical instruments are passed into a patient's body.
Development in minimally invasive surgery has resulted in increasingly complex procedures that require multiple instruments and precise manipulations within the body. Because of the limited access space afforded by a trocar and the relatively larger wound size associated therewith, one solution has been the use of percutaneous surgical instruments inserted directly into a body cavity and used to supplement instruments introduced through one or more trocars. For example, procedures have been developed that involve additional percutaneous instruments to aid in retracting organs and structures. In other procedures, one or more percutaneous instruments having removable end effectors are utilized in combination with a trocar that can accommodate the passage of various end effectors. Inserting surgical instruments percutaneously, i.e., passing directly through tissue without an access device, can further reduce trauma and scarring to the patient by reducing the size of the wound created.
The increasing use of percutaneously inserted surgical instruments is not without challenges, however. For example, using an increasing number of these instruments can require an increased number of operators to handle and position the devices during a procedure. A surgeon or other user cannot, by way of further example, position an instrument as desired and then leave the instrument unattended while they attend to operating another, or several other, instruments.
Accordingly, there is a need for devices and methods that allow a user to selectively maintain a percutaneous surgical instrument in a desired position and/or orientation such that the user can free their hands for other tasks.
The present disclosure generally provides devices and methods for positioning and maintaining percutaneously inserted surgical instruments in fixed orientations without the need for an operator to maintain the orientation of the surgical instrument by hand. For example, in some embodiments the devices described herein can generally include a base, a shuttle, and a locking mechanism. The base can be placed on the patient, and the operator can place a surgical instrument within a lumen of the shuttle to allow for movement relative to the base. Moreover, the operator can adjust the angle of approach of the surgical instrument within the shuttle relative to the base and percutaneously insert a working end of the surgical instrument into the patient. In fact, the operator can move the instrument across six degrees of freedom. When the operator is satisfied with the working location of the surgical instrument, the operator can actuate the locking mechanism to restrict movement of the instrument across any or all degrees of freedom.
In one aspect, a surgical instrument positioning device can include a base configured to be placed against tissue such that the base does not move relative thereto, as well as a shuttle coupled to the base and including a lumen configured to receive an elongate shaft of a surgical instrument. The lumen can translate in at least two directions relative to the base and an orientation of the lumen relative to the base can be polyaxially adjusted. The device can further include a locking mechanism that, upon actuation, prevents both translational movement of the lumen relative to the base and polyaxial adjustment of the orientation of the lumen relative to the base.
The devices and methods described herein can include a variety of additional features or modifications, all of which are considered within the scope of the present invention. For example, in some embodiments, the base can have an adhesive disposed on a surface thereof that is placed against tissue to aid in preventing relative motion between the device and a patient. The base can also have any desired dimensions and/or rigidity. In certain embodiments, the length and width of the base can be greater than a thickness thereof.
The lumen can be capable of translation in at least two directions relative to the base. For example, the lumen can be capable of translating in a direction parallel to a length of the base and a direction parallel to a width of the base. Moreover, the locking mechanism can be configured to prevent translational or rotational movement of a surgical instrument received by the lumen relative to the lumen upon actuation. In certain embodiments, the locking mechanism can be configured to be actuated by a single motion to lock a surgical instrument received by the lumen across six degrees of freedom. Such a locking mechanism can be, in certain embodiments, a single cam lock.
In another aspect, a surgical instrument positioning device can include a base configured to be placed against tissue such that the base does not move relative thereto, as well as a socket coupled to the base and capable of translating in at least two directions relative to the base. The device can further include a ball configured to be seated within the socket with the ball including a lumen formed in it that is configured to receive an elongate shaft of a surgical instrument. The device can also include a locking mechanism that, upon actuation, prevents both movement of the ball within the socket and translation of the socket relative to the base.
In some embodiments, the base can include an adhesive disposed on a surface thereof that is placed against tissue to aid in preventing relative movement between the device and a patient's body. As noted above, the base can have any of a variety of shapes and sizes. In certain embodiments, a length and a width of the base can be greater than a thickness thereof.
The socket coupled to the base can be capable of translating in at least two directions relative thereto. In some embodiments, the socket can be capable of translating in a first direction that is parallel to a length of the base and a second direction that is parallel to a width of the base.
Beyond preventing movement of the ball within the socket and translation of the socket relative to the base, in some embodiments the locking mechanism can be further configured to prevent translational or rotational movement of a surgical instrument received by the ball relative to the ball upon actuation. Moreover, the locking mechanism can be configured to be actuated by a single motion to lock a surgical instrument received by the ball across six degrees of freedom. As mentioned above, in certain embodiments, the locking mechanism can be a single cam lock.
In yet another aspect, a method for positioning a surgical instrument can include placing a base of a positioning device against tissue and passing a surgical instrument through a lumen formed in the positioning device. The method can further include translating the surgical instrument in at least two dimensions relative to the base and polyaxially adjusting an orientation of the surgical instrument relative to the base. The method can also include locking a position and orientation of the surgical instrument relative to the base.
In some embodiments, placing the base of the positioning device against tissue can include adhering a surface of the base to the tissue. In other embodiments, translating the surgical instrument in at least two dimensions relative to the base can include moving the surgical instrument along an axis parallel to a width of the base and moving the surgical instrument along an axis parallel to a length of the base.
In certain embodiments, locking a position and orientation of the surgical instrument relative to the base can include locking the instrument across six degrees of freedom. Moreover, in some embodiments, locking a position and orientation of the surgical instrument relative to the base can include operating an actuator with a single actuating movement to lock the surgical instrument across six degrees of freedom.
The various steps of the method described above can be performed before or after an instrument is inserted into a patient's body. Accordingly, in some embodiments, the method can further include passing the surgical instrument through the tissue positioned against the base.
Any of the features or variations described above can be applied to any particular aspect or embodiment of the invention in a number of different combinations. The absence of explicit recitation of any particular combination is due solely to the avoidance of repetition in this summary.
The aspects and embodiments of the invention described above will be more fully understood from the following detailed description taken in conjunction with the accompanying drawings, in which:
Certain exemplary embodiments will now be described to provide an overall understanding of the principles of the structure, function, manufacture, and use of the devices and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those skilled in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments and that the scope of the present invention is defined solely by the claims. The features illustrated or described in connection with one exemplary embodiment may be combined with the features of other embodiments. Such modifications and variations are intended to be included within the scope of the present invention.
The terms “proximal” and “distal” are used herein with reference to a clinician manipulating the handle portion of the surgical instrument, with the term “proximal” referring to the portion closest to the clinician and the term “distal” referring to the portion located away from the clinician. It will be further appreciated that, for convenience and clarity, spatial terms such as “vertical,” “horizontal,” “up,” and “down” may be used herein with respect to the drawings. However, surgical instruments are used in many orientations and positions, and these terms are not intended to be limiting and/or absolute. Still further, a person skilled in the art will recognize that a number of different terms can be used interchangeably while still being understood by the skilled person, for example, “instrument” and “tool.”
Additionally, to the extent that linear or circular dimensions are used in the description of the disclosed devices and methods, such dimensions are not intended to limit the types of shapes that can be used in conjunction with such devices and methods. A person skilled in the art will recognize that an equivalent to such linear and circular dimensions can easily be determined for any geometric shape. Further, sizes and shapes of the devices, and the components thereof, can depend at least on the anatomy of the subject in which the devices will be used, the size and shape of components with which the devices will be used, and the methods and procedures in which the devices will be used.
The present disclosure generally relates to positioning devices for selectively holding a surgical instrument in a fixed position and/or orientation relative to a patient. One advantage of such positioning devices can be allowing a surgeon to maintain certain surgical instruments in fixed orientations and freeing the surgeon to use both hands to proceed with other portions of the procedure. Another advantage of certain embodiments of the positioning devices described herein is that a surgical instrument can be manipulated in six degrees of freedom relative to the positioning device, namely, forward and backward, up and down, and left and right in the perpendicular axes, combined with rotation about three perpendicular axes, often referred to as pitch, roll, and yaw. Moreover, in some embodiments a single locking member can fix the orientation of the surgical instrument in all degrees of freedom.
As shown in
The shuttle 30 can include a slider 40 and a pivot joint 50 that, together, provide for translation in a plane (i.e., translation in two directions) parallel to a top surface of the base 20. For example, the slider 40 can slide along the X travel axis, as shown in
The locking mechanism 60 can be utilized to selectively inhibit movement of the surgical instrument 80 in any or all degrees of freedom. In some embodiments, the locking mechanism 60 can include a locking tab 62 that can be used to transition between locked and unlocked configurations. In an unlocked configuration, the locking mechanism 60 can permit movement of the tool 80 in at least six degrees of freedom and, in a locked configuration, the locking mechanism 60 can restrict all movement of the tool relative to the device 10. Movement of the locking tab 62 can transition the locking mechanism 60 from the unlocked orientation to the locked orientation. In the illustrated embodiment, movement of the locking tab 62 causes the slider 40 to be locked relative to the base 20 by compressing the slider 40 to create an interference fit between the slider and the base. Similarly, when the pivot joint 50 is compressed there is interference between the pivot joint 50 and the slider 40, thereby preventing relative movement between these components. The pivot joint 50 can further be compressed about the ball 70 such that an interference fit is created, thereby restricting polyaxial movement of the ball 70 relative to the socket 52. Still further, compression of the ball 70 can create an interference fit between inner walls 71 of the ball 70 that define the lumen 72 and the surgical tool 80, thereby preventing any translational or rotational movement of the surgical tool 80 relative to the lumen 72 of the ball. In some embodiments, movement of the locking tab 62 can be the only required action to prevent movement across all degrees of freedom of the surgical instrument 80. Alternatively, each degree of freedom, or combinations thereof, can be restricted individually with additional locking tabs 62 or other mechanisms known in the art.
The base 20 can further include a central opening 24 configured to receive the shuttle 30. The central opening 24 can be any suitable shape that permits relative movement between the shuttle 30 and the base 20. For example, the central opening 24 can have a rectangular shape, a square shape, a parallelogram shape, a circular shape, an elliptical shape, or any other shape that allows for movement of the shuttle 30 relative to the base 20. In the illustrated embodiment, the central opening 24 is generally rectangular. As shown in
While the size and shape can vary at least depending on the factors described above, in some exemplary embodiments, the length L of the base 20 can be approximately in the range of about 15 millimeters to about 25 millimeters, the width W can be approximately in the range of about 15 millimeters to about 25 millimeters, and the thickness T can be approximately in the range of about 5 millimeters to about 15 millimeters. In the illustrated embodiment the length is approximately about 25 millimeters, the width has a smallest dimension of about 15 millimeters and a largest dimension of about 25 millimeters, and the thickness is about 7 millimeters. Further, in some embodiments the base 20 can be made of materials that allow it to be rigid, thereby providing additional support to any surgical instrument 80 inserted within a patient, while in other embodiments, the base 20 can be made of more flexible materials. Some non-limiting examples of the types of materials that can be used to make the base 20 include various metals and polymers such as polycarbonate, nylon, ULTEM, liquid crystal polymer, surgical grade stainless steel, aluminum, or titanium.
In some embodiments, the base 20 can include an adhesive 28 disposed on a lower, body-facing surface of the base 20, as shown in
In the illustrated embodiment of
In some embodiments, the slider 40 can include features to allow the slider 40 to be selectively locked relative to the base 20 when the locking mechanism 60 is actuated. In the illustrated embodiment, for example, the slider can include two U-shaped slots 46a, 46b which can create a pivot joint around which the slider 40 can flex. The U-shaped slots 46a, 46b can extend through a portion of the body 42 and the mating features 44a, 44b. The U-shaped slots 46a, 46b can be axially aligned, or alternatively can be located at different positions along the width of the slider 40. The body 42 of the slider 40 can also include a central opening 48 that can increase the flexibility of the slider 40 and reduce the force required to flex the slider about the U-shaped slots 46a, 46b. Flexing of the slider 40 about the U-shaped slots 46a, 46b can be utilized to produce an interference fit between the base 20 and the slider when the locking mechanism 60 is actuated, as discussed further below.
In some embodiments, the dome portion 52 can include a spherical shaped socket 53, which can be sized to receive a ball 70. In addition, the pivot joint 50 can include a slot 58 extending from a top of the dome shaped portion 52 to a lower surface thereof. The two ends 52a, 52b of the pivot joint 50 that define the slot 58 can be configured to contract toward one another, thereby creating an interference fit between the dome shaped portion 52 and the ball 70 when the device 10 is moved to a locked configuration. Further, when the two ends 52a, 52b of the pivot joint are compressed toward or against one another, the mating tracks 54a, 54b can compress against the slider 40 to create an interference fit between the pivot joint 50 and the slider.
The ball 70 can be housed within the socket 53 of the dome shaped portion 52 of the pivot joint 50. The ball 70 can include a through-hole 72, or lumen, which can receive a surgical tool 80 to allow for polyaxial movement of the tool relative to the base 20. When the ball 70 is housed within the pivot joint 50, the ball can move polyaxially and provide three rotational degrees of freedom, including pitch, roll, and yaw. The surgical tool 80 can additionally rotate (as shown by the arrow RA in
The pivot joint 50 can further include two lock support members 56a, 56b extending radially from the dome shaped portion 52 of the pivot joint 50. The lock support members 56a, 56b can be located on the two ends 52a, 52b, respectively, of the dome shaped portion 52 that define the slot 58, as shown in
In the illustrated embodiment of
As mentioned above, when the locking tab 62 is rotated downward from the unlocked position of
The forces F1, F2 applied by the tracks 54a, 54b can also cause the slider 40 to bend about the U-shaped slots 46a, 46b, as indicated by arrows R1, R2 in
In some embodiments, a single locking tab 62 can be included to restrain a surgical tool 80 across all degrees of freedom. In other embodiments, however, the device 10 can include multiple locking tabs 62 configured to restrict movement of the surgical instrument 80 in only a selected number of degrees of freedom (e.g., a separate locking tab to prevent translational motion along a length L of the base 20, a width W of the base, etc.). In still other embodiments, the device 10 can include a locking tab 62 (or locking mechanism actuating member) for every degree of freedom, such that each degree of freedom can be individually restricted. Still further, a person skilled in the art will recognize other configurations that can also be used to achieve the locked and unlocked configurations provided for herein without departing from the spirit of the present disclosure.
One skilled in the art will appreciate that the various components of device 10 can have any size, shape, and configuration that is appropriate given the size of the device 10 and the performance requirements of the procedure. For example, the slider 40 can have a variety of shapes and configurations, such as rectangular, circular, pentagonal, etc. The pivot joint 50 can have a variety of shapes and configurations, for example a dome shape, a pyramid shape, etc. The locking tab 62 of the locking mechanism 60 can have a variety of shapes and configurations, for example a “U” shape, a “C” shape, a “V” shape, etc. Further, the ball 70 can have a variety of shapes and configurations, for example a spherical shape, a dodecahedron shape, an icosahedron shape, etc. The particular shapes of the above noted components can, in some embodiments, be designed with the shapes of corresponding mating components in mind to achieve desired functional requirements.
Additionally, in some embodiments, the various components can be rigid, thereby providing additional support to any surgical instrument 80 inserted within a patient. Alternatively, the components of the device 10 can be flexible, or have any degree of rigidity required for a particular procedure. The components of the device 10 can be made from any suitable material, including, but not limited to, a metal (e.g. stainless steel, titanium, etc.), a rigid polymer, or a flexible polymer.
In an exemplary embodiment of a surgical procedure utilizing the device 10, a surgeon or other user can adhere, or otherwise position, the base 20 against tissue, e.g. a patient's skin. Note that the base 20 can be attached to, or positioned against, tissue using any of a variety of techniques including friction, adhesives, straps, suction, magnetism, etc. In one exemplary embodiment, the device 10 is positioned above the patient's abdomen. The surgeon can insert a surgical instrument 80 into the through-hole 72 of the ball 70, as shown in
While the devices described herein can be particularly useful in minimally invasive procedures employing percutaneously inserted surgical instruments, the disclosed devices and methods can also be utilized in other forms of minimally invasive, open, and/or robot-assisted procedures.
The devices disclosed herein can be designed to be disposed of after a single use, or they can be designed to be used multiple times. In either case, however, the device can be reconditioned for reuse after at least one use. Reconditioning can include any combination of the steps of disassembly of the device, followed by cleaning or replacement of particular pieces, and subsequent reassembly. In particular, the device can be disassembled, and any number of the particular pieces or parts of the device can be selectively replaced or removed in any combination. Upon cleaning and/or replacement of particular parts, the device can be reassembled for subsequent use either at a reconditioning facility, or by a surgical team immediately prior to a surgical procedure. Reconditioning of a device can utilize a variety of techniques for disassembly, cleaning/replacement, and reassembly. Use of such techniques, and the resulting reconditioned device, are all within the scope of the present application.
The devices described herein can be processed before use in a surgical procedure. First, a new or used instrument can be obtained and, if necessary, cleaned. The instrument can then be sterilized. In one sterilization technique, the instrument can be placed in a closed and sealed container, such as a plastic or TYVEK bag. The container and its contents can then be placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or high-energy electrons. The radiation can kill bacteria on the instrument and in the container. The sterilized instrument can then be stored in the sterile container. The sealed container can keep the instrument sterile until it is opened in the medical facility. Other forms of sterilization known in the art are also possible. This can include beta or other forms of radiation, ethylene oxide, steam, or a liquid bath (e.g., cold soak). Certain forms of sterilization may be better suited to use with different portions of the device due to the materials utilized, the presence of electrical components, etc.
All papers and publications cited herein are hereby incorporated by reference in their entirety. One skilled in the art will appreciate further features and advantages of the invention based on the above-described embodiments. Accordingly, the invention is not to be limited by what has been particularly shown and described, except as indicated by the appended claims.
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