Patent Grant
12004767
The present invention generally relates to a soft tissue cutting device and soft tissue cutting methods. The present invention also relates generally to a transverse carpal ligament cutting device, a pulley cutting device, and soft tissue cutting methods.
Carpal tunnel syndrome affects approximately 3.7% of the general population and up to 7% of manual labor workers. Several varying surgical procedures are performed annually to treat patients with carpal tunnel syndrome. One of these surgical procedures is known as a carpal tunnel release procedure (“CTR procedure”). During the CTR procedure a transverse carpal ligament is cut in order to reduce median nerve compression and carpal tunnel pressures in the carpal tunnel region.
CTR procedures can be performed by accessing the carpal tunnel primarily from the outside, or accessing the carpal tunnel primarily from the inside. In the former, a palmar incision of various sizes is used to directly visualize and transect the transverse carpal ligament. In the latter, the transverse carpal ligament is visualized from within the carpal tunnel using either an endoscope advanced through a small palmar and/or proximal wrist incision, or ultrasound guidance. These visualization methods are important, as it is hard to visualize individual anatomical variations in the carpal tunnel region, as well as the transverse carpal ligament and at-risk structures nearby (e.g., a median nerve and an ulnar artery). Poor visualization can cause incomplete release of the transverse carpal ligament, or cause injuries to nearby structures.
While ultrasound guidance with CTR procedures enable better visualization of the carpal tunnel region during the procedure, there are still concerns associated with these procedures. One concern is that a sharp cutting instrument may be passed into the carpal tunnel without the ability to precisely control deployment of a sharp cutting instrument. Thus, the sharp cutting instrument presents a risk to both the patient and the operator. It would be desirable to provide an improved device that includes a sharp cutting instrument that is not exposed until the cutting of the transverse carpal ligament is required (i.e., after proper positioning).
Also, because cutting instruments often require the use of two hands, several operators use ultrasound guidance to place a sharp cutting instrument in position to cut the transverse carpal ligament, but then abandon the ultrasound visualization during the actual cutting, as they are unable to simultaneously hold the ultrasound probe, and cut the ligament. It would be desirable to provide an improved device that allows an operator to continue using ultrasound guidance during cutting.
Further, it would be desirable to provide such a device that is capable of administering an anesthetic. Prior to the commencement of the CTR procedure, an anesthetic is injected subcutaneously at the palmar incision site. Additionally, an anesthetic is injected with ultrasound guidance, intracarpally, and may also be injected to areas surrounding the carpal ligament. The anesthetic-containing syringe must be withdrawn from the carpal ligament area to enable the cutting device to be inserted into the wrist, with ultrasound guidance, to perform the CTR procedure. There exists a risk of nerve or artery damage when inserting instruments into the wrist and hand. This risk is increased by the insertion of two independent instruments, namely, the anesthetic-containing syringe, followed by the CTR cutting device. Thus, it would be desirable to provide a device that can perform both functions of delivering the anesthetic, and performing the ligament cutting.
The present disclosure provides a device for cutting soft tissue that is capable of administering an anesthetic to a cutting site.
A first aspect of the disclosure provides a soft tissue cutting device including an inner tubular member having an internal chamber extending between a distal end and a proximal end of the inner tube, an outer tubular member disposed over at least a portion of the inner tubular member and movable between an initial position and an extended position, a movement controller that controls movement of the outer tubular member between the initial position and the extended position, and an attachment mechanism for removably coupling the proximal end of the inner tubular member to a dispensing member. A distal end of the outer tubular member may include a cutting member
In some embodiments, the movement controller includes a thumb slide attached to a surface of the outer tubular member. In some embodiments, the outer tubular member movement mechanism further includes a housing disposed around a portion of the outer tubular member distal end; and the thumb slide extends through a portion of a surface of the thumb slide housing. In some embodiments, the handle is molded to allow for single handed use of the soft tissue cutting device. In some embodiments, the thumb slide is lockable.
In some embodiments, the attachment mechanism is a locking mechanism. In some embodiments, the locking mechanism is a luer lock. In some embodiments, the cutting member is a blade having a cutting edge. In some embodiments, the dispensing member is a syringe. In some embodiments, the dispensing member includes a dispensing tube and a depressible member disposed within the dispensing tube, and the depressible member is movable from an initial position to an extended position within the dispensing tube to expel the fluid from the barrel into the inner tubular member. In some embodiments, the dispensing tube is removably attached to a distal end of the attachment mechanism.
In some embodiments, the inner tubular member further includes a ramp on the outer surface of the inner tubular member. In some embodiments, the outer tubular member is slidably movable over the ramp to elevate at least a portion of the outer tubular member above the inner tubular member. In some embodiments, the cutting member on the outer tubular member is elevated when the outer tubular member is in the extended position. In some embodiments, the soft tissue cutting device further includes one or more balloons coupled to the outer tubular member that expand radially inward from the outer tubular member.
A second aspect of the disclosure provides a soft tissue cutting device including: an inner tubular member including a ramp on an outer surface of the inner tubular member, and an internal chamber extending between an inner tube distal and an inner tube proximal end; an outer tubular member including a cutting member on a proximal end of the outer tubular member, wherein the outer tubular member is disposed around a portion of the inner tubular member, and is movable from an initial position to an extended position; a thumb slide attached to an outer surface of the outer tubular member; a locking mechanism removably attached on a proximal end to a distal end of the inner tubular member; and a syringe removably attached to a distal end of the locking mechanism. In some embodiments, the soft tissue cutting device further includes a thumb slide housing disposed around a portion of the inner tube distal end, wherein the thumb slide extends through a portion of a surface of the thumb slide housing.
A third aspect of the invention provides a method of using the soft tissue cutting device of the first or second aspect by: inserting a proximal end of the cutting device in a subject's body region; applying pressure to the dispensing member to release a medicinal agent into the subject's body region; moving the outer tubular member toward the proximal end of the cutting device, thereby causing the cutting member to elevate; cutting a soft tissue in the subject's body region; and moving the outer tubular member toward the distal end of the cutting device. In some embodiments, the medicinal agent is a local anesthetic. In some embodiments, the subject's body region is a subject's hand. In some embodiments, the soft tissue is a transverse carpal ligament or an annular ligament of the finger. In some embodiments, the annular ligament of the finger is an A1 pulley.
These and other embodiments are described in greater detail in the detailed description which follows. An object of the presently disclosed subject matter having been stated hereinabove, and which is achieved in whole or in part by the presently disclosed subject matter, other objects will become evident as the description proceeds when taken in connection with the accompanying drawings as best described herein below.
The presently disclosed subject matter, which will now be described more fully, can be embodied in different forms and should not be construed as limited to the embodiments set forth herein. The following detailed description is exemplary in nature and is not intended to limit the scope, applicability, or configuration of the disclosure in any way. Rather, the following description provides some practical illustrations for implementing examples of the present disclosure. Examples of constructions, materials, dimensions, and manufacturing processes are provided for selected elements, and all other elements employ that which is known to those of ordinary skill in the field of the disclosure. Those skilled in the art will recognize that many of the noted examples have a variety of suitable alternatives.
The cutting device disclosed herein is suitable for cutting soft tissue, and can be used to cut any desired soft tissue in the body. In certain embodiments, the soft tissue cutting device is a transverse carpal ligament cutting device that cuts a transverse carpal ligament in a carpal tunnel region. As described above, a CTR procedure involves cutting a transverse carpal ligament in order to reduce median nerve compression and carpal tunnel pressures in the carpal tunnel region. In some embodiments, the soft tissue cutting device is a pulley cutting device. In some examples, the pulley is an A1 pulley of a finger, and the soft tissue cutting device is a trigger release device that cuts the A1 pulley. While each finger has several pulleys, the A1 pulley is the pulley that is most often involved in a condition called trigger finger. The A1 pulley is an annular ligament of the finger that sits near the head of the metacarpal bone, and lies in the flexor groove in the deep transverse metacarpal ligament. The A1 pulley, together with other annular pulleys, and cruciate pulleys, governs the flexor mechanism of the hand and wrist. The A1 pulley provides biomechanical support to the underlying metacarpophalangeal joint, and maintains joint stability and flexor tendon alignment. In a patient with trigger finger, the A1 pulley becomes inflamed or thickened, making it harder for the flexor tendon to glide through it as the finger bends. Over time, the flexor tendon may also become inflamed and develop a small nodule on its surface. When the finger flexes and the nodule passes through the pulley, there is a sensation of catching or locking. This condition, known as trigger finger or stenosing tenosynovitis, can be accompanied by pain or stiffness. The trigger release procedure involves cutting or releasing the A1 pulley to enable the flexor tendon to glide freely.
While the illustrated embodiments show an exemplary embodiment of a soft tissue cutting device, as noted above, it should be understood that the presently disclosed subject matter can be embodied in different forms and should not be construed as limited to the embodiments set forth herein below. Furthermore, the soft tissue cutting device of the current device may be used for other types of soft tissue cutting procedures.
Throughout the specification, in the embodiments generally shown herein, “distal” as used herein, shall generally refer to being closest to the target tissue when the soft tissue cutting device is inserted into the target tissue, and “proximal” as used herein, shall generally refer to being furthest from the target tissue when the soft tissue cutting device is inserted into the target tissue.
In some embodiments, the handpiece is configured to allow an operator to operate the device using a single hand only. In some embodiments, the single-hand handpiece is a handle that includes one or more controls on the handle (e.g., top, bottom, sides, etc.) such that the operator can use a finger to operate one or more controls. However, skilled artisans will understand that the single-hand handpiece is merely one embodiment of the present invention and is not required. Alternately, two hands or even two operators can operate the present device.
In some embodiments, the handpiece is molded. The handpiece can be molded in a configuration that provides a comfortable hold for the user when performing at least one of the cutting device injection or cutting functions. For example, finger grip indentations, raised ridges, etc. may be provided on the handpiece.
As shown in
As shown in
The dispensing member may, optionally, include or may be in communication with an actuator or controller that controls functions of the dispensing member. In some embodiments, the control may be positioned on the dispensing member. As shown in
In some embodiments, the controller may be positioned outside of the handle. For example, the control can be a lever, slider button, push button and/or clamp. In some embodiments, the controller is a slider button positioned on an external surface of the handpiece. The slider button can be coupled to a plunger to control movement of the plunger. In some embodiments, the slider button is directly connected to the plunger. In some embodiments, the controller is a clamp. In such cases, the clamp can be coupled to a plunger to control movement of the plunger. Optionally, the controller may be a motor that controls the movement of the plunger.
As shown in
The handpiece can be coupled to the outer tubular body using a variety of different configurations. In some cases, the handpiece and outer tubular body have a permanent junction. For example, the handpiece and outer tubular body can have a set angular junction or a set straight junction. In other cases, the handpiece and outer tubular body have an adjustable junction that can be adjusted to accommodate operator preference. In other cases, the handpiece and outer tubular body have a rotatable junction that can be rotated to accommodate operator preference. For example, the handpiece and outer tubular body can have a junction that is adjustable in length or angulation or rotation. In yet other cases, the handpiece and the outer tubular body can have a removable junction so that the handpiece and the outer tubular body are removable from one another.
As noted above, the handpiece can be arranged at any suitable angle from the outer tubular body. In some embodiments, the angle between the handpiece and the outer tubular body is adjustable. Examples of such angles can include, without limitation, between 175 degrees and 140 degrees, between 170 degrees and 150 degrees, or between 165 degrees and 155 degrees. In some embodiments, the angle between the handpiece and the outer tubular body is about 160 degrees.
The outer tubular body can also be provided as a single piece or as a plurality of different pieces. In some cases, the outer tubular body extends from the distal end to the proximal end as a single piece. In other cases, the outer tubular body extends from the distal end to the proximal end as a plurality of pieces. The outer tubular body is formed of any desired medically acceptable material.
As shown in
As noted above, and shown in
In some embodiments, the cutting member 2 is located on an upper region 37 (or outside) of the distal end 31 of the outer tubular body 4. The outer 4 and inner 5 tubular bodies are configured so that when the cutting member 2 is not in use, the inner surface of the outer tubular body 4 resides in close proximity to the outer surface of the inner tubular body 5, such that the cutting member 2 resides in close proximity to the outer surface of the inner tubular body 5 and is not exposed. By “close proximity” is meant that the inner surface of the outer tubular body 4 is sufficiently close to the outer surface of the inner tubular body 5, that when the soft tissue cutting device 11 is inserted into a body tissue, in the inactive position, the cutting member 2 will not cut the tissue, while at the same time, the inner surface of the outer tubular body 4 is sufficiently far from the outer surface of the inner tubular body 5, that the outer tubular body 4 can move freely over the inner tubular body 5. Thus, the proximity of the inner 5 and outer 4 tubular members in the inactive position serves to protect against premature cutting of the tissue, without hindering the movement of the outer tubular body 4. In some embodiments of the invention, in the inactive position, the inner surface of the outer tubular body is about 0.5 mm-3.5 mm, 0.5 mm-1 mm, 1 mm-1.5 mm, 1.5 mm to about 2 mm, about 1 mm to about 2.5 mm, 2.5 mm-3.5 mm, etc., from the outer surface of the inner tubular body.
The outer tubular body and the inner tubular body can have any desired cross-section shape, as long as the shape does not interfere with the functioning of the device. In some embodiments, at least one of the outer or inner tubular bodies has a circle-shaped tubular cross-section shape. In some embodiments, at least one of the outer or inner tubular body has a non-circle-shaped tubular cross section shape. For example, in some cases, at last one of the outer or inner tubular body has a square-shaped tubular cross section shape, rectangle-shaped tubular cross section shape or square-shaped tubular cross section shape with round edges. In some embodiments, the outer and inner tubular bodies have the same cross-section shape. In some embodiments, the outer and inner tubular bodies have a different cross-section shape
The outer tubular body and the inner tubular body have any desired size that does not interfere with the functioning of the device, and that is suitable for the medical procedure being performed. As the outer tubular body extends from the distal end to the proximal end, it can maintain the same diameter, or it can assume a different diameter. In some cases, as the outer tubular body extends from the distal end to the proximal end, it increases in diameter. In other cases, as the outer tubular body extends from the distal end to the proximal end, it increases in diameter. Optionally, the outer tubular body may either be coaxial with the inner tubular body and/or the central axis of inner tubular body may be offset from the outer tubular body.
The outer tubular body is movable from an initial position to an extended position. In the initial position, the soft tissue cutting device is in the inactive position, and the outer tubular body is in close proximity with the inner tubular body, as described above, and the cutting member is not exposed to cut tissue that the soft tissue cutting device comes into contact. In the extended position, the outer tubular body moves from its initial position to a position closer to the distal end of the soft tissue cutting device, and elevated away from the outer surface of the inner tubular body. In this elevated position, when the soft tissue cutting device is exposed to soft tissue it is oriented so that it will cut the tissue. The elevation of the cutting member can be achieved in any suitable manner, as described below.
As shown in
The ramp can be located at any suitable location along the length of the inner tubular body. In some embodiments, the ramp 3 is located toward the distal end 1 of the inner tubular body 5 (
In some embodiments, the soft tissue cutting device also has one or more balloons coupled to the outer tubular body that expand radially inward from the outer tubular body. In some cases, the outer tubular body is movable by inflating and deflating a blade balloon elevator. When inflated, the blade balloon elevator elevates the cutting member above the inner tubular body, and when deflated, it lowers the cutting member back to close proximity with the inner tubular body.
As noted above, the outer tubular body is movable from an initial position to an extended position. The outer tubular body may be caused to move by any suitable means. In some embodiments, the outer tubular body can be moved by an outer tubular body movement mechanism. As show in
This disclosure also provides a method of using the soft tissue cutting device. As noted above, the cutting device is capable of cutting any soft tissue. A medicinal agent, such as for example a local anesthetic is drawn into the dispensing tube, for example, by inserting the distal end of a sterilized cutting device into a container of the agent, and moving the depressible member from the depressed position to the initial extended position. In some embodiments, the amount of medicinal agent drawn into the dispensing tube may be determined based on the intended use. The distal end of the soft tissue cutting device is then placed into a region of the subject's body, and advanced to the vicinity of the cutting location. The medicinal agent is injected into, and optionally around the soft tissue to be cut, by relocating the distal end of the cutting device to different locations and depressing the depressible member, thereby releasing at least a portion of the medicinal agent from the inner tubular body. The distal end of the cutting device is then positioned at the desired cutting site. After placement in a suitable position for cutting the soft tissue, the outer tubular body is caused to move toward the distal end of the cutting device to expose the cutting member. In some embodiments this movement of the outer tubular body is performed by using a finger or thumb to push forward a thumb slide connected to the outer tubular body. The outer tubular body is advanced in the distal direction of the cutting device, until the cutting member is caused to elevate. In some embodiments, this elevation is caused by the distal end of the outer tubular body rising at least partially over a ramp on the inner tubular body. As the outer tubular body is elevated, the cutting member at the distal end of the outer tubular body is exposed, and cuts the target tissue. As the cutting device is advanced through the soft tissue, it continues to cut the tissue. When the desired portion of the soft tissue has been cut, the outer tubular body is caused to move back toward the proximal end of the cutting device. In some embodiments this movement of the outer tubular body is performed by using a finger or thumb to pull back a thumb slide connected to the outer tubular body. The soft tissue cutting device is then safely removed from the subject's body.
The method can be performed with the aid of an ultrasound device that enables the user of the soft tissue cutting device to visualize the tissues below the epidermis and safely perform the procedure.
In some embodiments, the method is used to cut a transverse carpal ligament transverse carpal ligament. In some embodiments, the method is used to cut an annular ligament, such as for example, a pulley, such as for example, an A1 pulley in a subject's hand. As noted above, the A1 pulley overlies the metacarpophalangeal joint, and maintains joint stability and flexor tendon alignment. During a trigger release procedure, the A1 pulley is cut or released to enable the flexor tendon to glide freely.
While the above disclosure describes an embodiment of a soft tissue cutting device including a outer tube with a cutting member disposed around an inner tube configured to dispense fluid in a subject tissue, the disclosure is not so limiting.
For example,
It should be noted that while
It should be noted that while
While different embodiments of a soft tissue cutting device are described, skilled artisans will understand that any of the features of one embodiment can be incorporated into the other embodiments. Any combination of the features described in any of the embodiments can be included in the soft tissue cutting device and are within the scope of the invention. It should be noted that while the current disclosure describes use of the soft tissue cutting device for carpal tunnel surgery, the disclosure is not so limiting and the soft tissue cutting device can be used during, for example, surgery of extensor compartment of the wrist, surgery of retinacula tissue of the ankle, surgery of cubital tunnel of the elbow, or the like.
In some embodiments, the soft tissue cutting device of this disclosure may also be used during hydrodissection procedures to, for example, inject fluid around the anatomical structure (e.g., a compressed nerve). Such fluid may be a contrast agent that creates a visible working space between planes of tissue for enhanced ultrasound visibility, may be fluid that frees a compressed nerve from scar tissue or lesions that trap it, or the like.
Similarly, the soft tissue cutting device of this disclosure may also be used during electorsurgery (e.g., devices that perform cutting using bipolar electrodes) for, for example, injecting electrically conductive fluids such as saline in and/or around the target tissue.
It will be understood that various details of the presently disclosed subject matter may be changed without departing from the scope of the presently disclosed subject matter. Furthermore, the foregoing description is for the purpose of illustration only, and not for the purpose of limitation.
The present application claims priority U.S. Provisional Patent Application No. 63/135,352, filed Jan. 8, 2021, the entire contents of which are incorporated herein by reference.
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