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EP-4740873-A2 - CUTTING DEVICE FOR TRIGGER FINGER AND OTHER SOFT TISSUES

EP4740873A2EP 4740873 A2EP4740873 A2EP 4740873A2EP-4740873-A2

Abstract

A method of cutting soft tissue in a hand to treat trigger finger involves advancing an introducer shaft into the hand to position a distal end of the introducer shaft beyond a pulley in a finger of the hand, advancing a blade along a guiding channel on an upper surface of the introducer shaft, to position a distal end of the blade at or near the distal end of the introducer shaft, and rotating a cutting surface of the blade to an orientation at or near perpendicularrelative to the upper surface of the introducer shaft. The method further involves retracting the blade along the introducer shaft to cut the pulley and removing the introducer shaft and the blade from the hand.

Inventors

  • BARNES, DARRYL E.
  • SMITH, JAY
  • KEENAN, AARON
  • ARNAL, KEVIN

Assignees

  • Sonex Health, Inc.

Dates

Publication Date
20260513
Application Date
20220429

Claims (11)

  1. An introducer for advancing a cutting device into a patient and below a target tissue, the introducer comprising: a handle; and a shaft extending from the handle and having a flat shape with a guiding channel for guiding the cutting device along the shaft and below the target tissue.
  2. The introducer of claim 1, further comprising at least one ultrasound invisible region on the shaft, wherein the at least one ultrasound invisible region comprises multiple grooves in at least one of a top surface or a bottom surface of the shaft.
  3. The introducer of claim 1, further comprising a rotating channel within the guiding channel and deeper than the guiding channel, wherein the rotating channel is configured for receiving an edge of the cutting device in a rotated configuration.
  4. The introducer of claim 1, wherein the introducer further comprises the cutting device, and wherein the cutting device is removably attached to the handle of the introducer.
  5. The introducer of claim 4, wherein the handle of the introducer is attached to the cutting device by at least one break point, and wherein rotating the cutting device relative to the handle of introducer breaks the cutting device off the introducer at the at least one break point.
  6. The introducer of claim 1, further comprising a longitudinal groove disposed along at least a portion of the shaft, on a side of the shaft that is opposite the guiding channel.
  7. The introducer of claim 1, wherein the shaft is curved in an upward direction facing an upper surface of the handle.
  8. The introducer of claim 1, wherein a distal end of the shaft comprises a blade configured to cut soft tissue.
  9. The introducer of claim 1, wherein a distal end of the shaft is blunt.
  10. The introducer of claim 1, wherein the introducer is made of or coated with an echogenic material.
  11. The introducer of claim 1, wherein the handle of the introducer further comprises one or more grip-enhancing features.

Description

CROSS REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application No. 63/182,259, filed April 30, 2021 and U.S. Provisional Patent Application No. 63/231,029, filed August 9, 2021 and U.S. Provisional Patent Application No. 63/232,863, filed August 13. 2021 and is a Continuation in part of U.S. Design Application No. 29/803,594, filed August 13, 2021. the disclosures of which are incorporated herein by reference in their entirety for any and all purposes. TECHNICAL FIELD The present application is related generally to medical devices and methods. More specifically. the present application is directed to a surgical device for cutting soft tissue in the hand and potentially other parts of the body. BACKGROUND As minimally invasive surgery has evolved, numerous tools have been developed to treat medical conditions that have previously been treated with more invasive, open surgical techniques. Treatment of trigger finger is one such example. The first annular ("Al") pulley is a small band of tissue on the palmar side of a person's hand. (See Fig. 7.) In some cases, the flexor tendon in a finger thickens, and a nodule on the tendon can get caught on the Al pulley and cause irritation. The flexor tendon can then become locked in place when a person flexes his or her fingers. This condition is commonly referred to as "trigger finger." To treat trigger finger, the Al pulley is typically cut, to release the tendon, while leaving the A2-A5 pulleys intact. Carpal Tunnel Syndrome (CTS) is another example of a common hand/wrist condition that causes pain, weakness, numbness, and tingling in the hand and arm. CTS occurs when the median nerve is compressed by the surrounding tissue. Severe cases of CTS may be treated with a surgical technique. carpal tunnel release (CTR), where the transverse carpal ligament is cut to relieve pressure on the median nerve. One type of minimally invasive (or "less invasive") approach to treating trigger finger and CTS involves advancing a surgical blade through a small incision on the patient's wrist or palm and cutting the problematic tissue with the blade. Advancing a surgical blade through the patient's wrist, however, carries a risk of cutting non-target tissues and causing unwanted neurovascular injuries. Nerves, such as the median nerve or the ulnar nerve, and vascular structures, such as the superficial palmar arch, are just a few examples of tissues that may be accidentally damaged, potentially resulting in temporary or permanent nerve damage and paralysis. Damage to the tendons surrounding the surgical site, including bowstringing, lacerations and partial lacerations may also occur. With minimally invasive surgical techniques for addressing trigger finger and CTS, the incision is typically so small that the blade is advanced to the treatment site with minimal or no visualization, thus increasing the risk of unwanted tissue damage. To try to make such techniques safer, some currently available devices use a hook blade, which is advanced in a horizontal position to avoid cutting and then turned to a more vertical orientation to hook and cut target tissue. Although some of these devices work well for cutting, they typically still require some type of introducer device to ensure safe advancement of the blade to the target tissue site. The introducer devices can often be bulky, awkward to use or overly complex. Therefore, it would be advantageous to have improved soft tissue cutting devices for treating trigger finger and carpal tunnel syndrome. Ideally, such improved devices may also be used or adapted for use in other orthopedic procedures and/or surgical procedures in other parts of the body. BRIEF SUMMARY The present disclosure describes various examples of a device and method for treating trigger finger in a hand and/or cutting one or more soft tissues in other parts of the hand or body. The devices and methods typically include an introducer and a blade. In some cases, the introducer and blade may be separate devices, while in others they are included in one device. The method is performed minimally invasively (or "less invasively") than currently available techniques and may be performed with ultrasound visualization to facilitate the procedure. In one aspect of the present disclosure, an introducer is provided for advancing a cutting device into a patient and below a target tissue. The introducer includes a handle and a shaft extending from the handle and having a flat shape with a guiding channel for guiding the cutting device along the shaft and below the target tissue. Optionally, the introducer may also include at least one ultrasound invisible region on the shaft, where each ultrasound invisible region includes multiple grooves in a top surface and/or a bottom surface of the shaft. The device may also include a rotating channel within the guiding channel and deeper than the guiding channel. The rotating channel is configured