EP-4489662-B1 - DEVICES FOR DEPLOYING TISSUE FASTENERS

EP4489662B1EP 4489662 B1EP4489662 B1EP 4489662B1EP-4489662-B1

Inventors

ROGERS, CHARLES H.
MILEA, Eduard Ulise
HATCH, ROBERT F.
LEINSING, KARL ROBERT
DURANT, Joseph Mark

Dates

Publication Date: 20260506
Application Date: 20230303

Claims (15)

A hand-held surgical device (100) for deploying bioabsorbable fasteners to close a wound or incision in tissue, the device comprising: a body (110) comprising a handle element including a user-actuatable trigger and a barrel element including a distal end for positioning one or more fasteners relative to a wound or incision in tissue; a tissue pinching and folding assembly positioned adjacent to the distal end of the barrel element (117) and operably coupled to the trigger, wherein, upon placement of the distal end of the barrel element relative to a wound or incision and in response to user actuation of said trigger, the tissue pinching and folding assembly is configured to temporarily secure and physically evert opposing edges of the wound or incision relative to the distal end of the barrel element in preparation for deployment of one or more of a plurality of fasteners; and a fastener delivery mechanism (140) operably coupled to the trigger and configured to deploy one or more of a plurality of bioabsorbable fasteners from the distal end of the barrel element in response to user actuation of said trigger, wherein the tissue pinching and folding assembly comprises: an introducer (135) positioned at, and extending from, the distal end of the barrel element, the introducer comprising an elongate body configured to directly contact opposing edges of the wound or incision; and a pair of opposing tissue holder elements positioned at the distal end of the barrel element and on opposing sides of the elongate body of the introducer, each tissue holder element comprising a pincer member (330a, 330b) and a foot member (340a, 340b) configured to cooperatively move with one another relative to the introducer in response to user actuation of the trigger, characterized in that the pincer member and foot member are movable relative to one another.
The device of claim 1, wherein the trigger is coupled to the pair of tissue holder elements and the fastener delivery mechanism by way of independent connections allowing for sequential operation thereof, wherein: user actuation of the trigger to an initial first position causes the pincer member of each tissue holder element to rotate inwardly toward the introducer and further pinch and secure a portion of a corresponding edge of the wound or incision against a corresponding side of the introducer; user actuation of the trigger to a subsequent second position causes the foot member of each tissue holder element to rotate inwardly toward the introducer and further evert a portion of the corresponding edge of the wound or incision to thereby position an inner surface thereof for subsequent receipt of a portion of a fastener; and user actuation of the trigger to a subsequent third position causes operation of the fastener delivery mechanism resulting in deployment of a fastener to bilaterally engage the opposing edges of the wound or incision and thereby hold said edges together.
The device of claim 1, wherein the elongate body of the introducer comprises a pair of pinch rails extending along the opposing sides of the elongate body, wherein, in response to user actuation of the trigger, the pincer member is adapted to pinch and secure a portion of a corresponding edge of the wound or incision against a corresponding pinch rail and the foot member is adapted to evert a portion of the corresponding edge of the wound or incision to thereby position an inner surface thereof for subsequent receipt of a portion of a fastener, wherein the introducer comprises an exit through which at least a fastener passes during operation of the fastener delivery system in response to user actuation of the trigger,.
The device of claim 3, wherein the foot member of each tissue holder element is adapted to expose the inner surface of the respective edge of the wound or incision relative to the exit of the introducer such that a deployed fastener passing through the exit is able to bilaterally engage the opposing edges of the wound or incision and thereby hold said edges together.
The device of claim 1, wherein each pincer member comprises one or more sharp protrusions.
The device of claim 1, wherein each tissue holder element is injection molded from a single material, wherein the pincer member and foot member of each tissue holder element are optionally monolithically formed with one another, or wherein the pincer member and foot member of each tissue holder element are formed from different materials and assembled to cooperatively form a given tissue holder element.
The device of claim 1, further comprising a pair of slider elements, each slider element having a proximal end operably coupled to the trigger and a distal end operably coupled to a respective one of the pair of tissue holder elements such that actuation of the trigger causes movement of the pair of slider elements which, in turn, causes corresponding movement of the pair of opposing tissue holder elements.
The device of claim 1, wherein the introducer comprises a retraction finger positioned at one end of the elongate body and adapted to engage a first apex of the wound or incision to thereby provide traction opposing forces applied at a second apex of the wound or incision.
A hand-held surgical device for deploying bioabsorbable fasteners to close a wound or incision in tissue, the device comprising: a body comprising a handle element including a user-actuatable trigger and a barrel element including a distal end for positioning one or more fasteners relative to a wound or incision in tissue; a tissue pinching and folding assembly positioned adjacent to the distal end of the barrel element and operably coupled to the trigger, wherein, upon placement of the distal end of the barrel element relative to a wound or incision and in response to user actuation of said trigger, the tissue pinching and folding assembly is configured to temporarily secure and physically evert opposing edges of the wound or incision relative to the distal end of the barrel element in preparation for deployment of one or more of a plurality of fasteners; and a fastener delivery mechanism operably coupled to the trigger and configured to deploy one or more of a plurality of bioabsorbable fasteners from the distal end of the barrel element in response to user actuation of said trigger, characterized in that the fastener delivery mechanism is configured to cause a given fastener to extend outwardly and away from a distal-most end of the tissue pinching and folding assembly and the distal-most end of the barrel and subsequently penetrate opposing edges of the wound or incision such that the fastener is deployed entirely distal to the device and delivered below the surface of the tissue.
The device of claim 9, wherein the fastener delivery mechanism is configured to retain a plurality of fasteners and further comprises one or more insertion needles configured to releasably engage and deploy each of the plurality of fasteners in a one-by-one fashion in response to repeated user actuations of the trigger, and wherein each of the plurality of fasteners comprises a first partially-cannulated leg, a second partially-cannulated leg, and a flexible bridge member connecting the first and second partially-cannulated legs, wherein the first and second partially-cannulated legs are each configured to allow a respective insertion needle to pass within a portion of the partially-cannulated leg.
The device of claim 10, wherein the trigger is operably coupled to a plunger-needle assembly, the plunger-needle assembly comprising two insertion needles parallel to each other and configured to pass within a portion of a respective partially-cannulated leg of a fastener, and, in response to user actuation of the trigger, the plunger-needle assembly causes the insertion needles to engage a fastener and thereby cause each leg of the fastener to penetrate opposing edges of the wound or incision thereby inserting the fastener and, in response to user releasing the trigger, the plunger-needle assembly causes the insertion needles to leave the fastener completely distal to the device and below the tissue surface.
The device of claim 9, wherein the fastener delivery mechanism is configured to retain a plurality of fasteners and further comprises one or more insertion needles configured to releasably engage and deploy each of the plurality of fasteners in a one-by-one fashion in response to repeated user actuations of the trigger, and wherein each of the plurality of fasteners comprises a first cannulated leg, a second cannulated leg, and a flexible bridge member connecting the first and second cannulated legs, wherein the first and second cannulated legs are each configured to allow passage therethrough of a respective insertion needle that extends through the cannulated leg with sharp ends exposed distally.
The device of claim 12, wherein the trigger is operably coupled to a plunger-needle assembly, the plunger-needle assembly comprising two insertion needles parallel to each other and configured to pass through a respective leg of a fastener.
The device of claim 13, wherein, in response to user actuation of the trigger, the plunger-needle assembly causes the insertion needles to engage a fastener and simultaneously penetrate opposing edges of the wound or incision thereby inserting the fastener and, in response to user releasing the trigger, the plunger-needle assembly causes the insertion needles to leave the fastener completely distal to the device and below the tissue surface.
The device of claim 13, wherein the fastener delivery mechanism is configured to receive and retain a magazine comprising a plurality of stacked fasteners and the plunger-needle assembly is configured to releasably engage, by way of the pair of insertion needles, the front-most fastener arranged in the stack of fasteners for subsequent deployment.

Description

Cross-Reference to Related Applications This application claims priority to, and the benefit of, U.S. Provisional Application No. 63/318,967, filed March 11, 2022. Field of the Invention The present invention generally relates to medical devices, and, more particularly, to medical devices that deploy bioabsorbable fasteners into tissue to secure two sides of an incision or wound in the skin of a patient. Background There are many examples of surgical staplers which deliver staples into tissue to hold an incision or cut closed for healing. Most surgical staplers deliver traditional metal staples which rely on the strength of the staple to pierce the tissue and to hold the tissue surfaces together. One of the disadvantages of the metal staple is that it must have a portion that remains exposed through the skin surface in order to allow a medical professional to remove the fastener once biological healing is complete. This exposed portion is unsightly, and the puncture points, where the fastener enters the skin, have a risk of infection. To address the disadvantages of metal staples, various inventors have proposed fasteners made of bioabsorbable materials which can be placed below the surface of the skin. This subcuticular skin closure avoids punctures through the epidermis and does not require follow-up removal of the staples. Such a solution is described, for example, in U.S. Patent No. 6,726,705 issued to Peterson et al. ("Peterson") titled "Mechanical Method and Apparatus for Bilateral Tissue Fastening". The apparatus proposed by Peterson uses a driving head positioned in the incision at least partially below the exterior surface. Tissue manipulators compress the two sides of the tissue into concave areas of the driving head so that piercing members can cut holes in the target tissue zones to insert the fastener. After the fastener is deployed, the driving head is removed, thereby leaving the fastener bilaterally engaged in the tissue. Fasteners embodying the Peterson invention are significantly thicker in cross section than a metal staple. This is necessary to enable the bioabsorbable fastener to be strong enough to maintain the traditional "U" shape of a staple during the healing process. This added bulk is undesirable and requires piercing members that can cut holes in the target tissue zones to insert the fastener. Such cutting of the tissue causes trauma and bleeding which can impact the healing process. Furthermore, staplers embodying the Peterson invention require that the driving head be partially inserted into the incision and the tissue compressed into concave areas of the driving head. For short incisions, such as those employed in minimally invasive surgery, devices based on Peterson are not suitable because the driving head can get trapped inside the incision once the fastener is deployed to hold the incision closed. Thus, staplers embodying the Peterson have drawbacks and limitations. More recently, a hand-held stapler that deploys bioabsorbable fasteners without placing a driving head inside the incision is described in U.S. Patent. No. 8,506,591 issued to Danielson et al. ("Danielson") titled "Tissue Fasteners and Related Insertion Devices, Mechanisms, and Methods". In addition, Danielson teaches surgical needles extending through the legs of a fastener, with sharp tips exposed distally, which aid the fastener to enter the tissue with minimal cutting and bleeding. However, such an insertion mechanism has not gained acceptance by the surgical community, possibly because it requires two people to operate the device, which includes a first person to use forceps in each hand to evert the two sides of the incision, and a second person needed to operate the stapler. US2015127046A1 discloses further relevant prior art. Summary The present invention addresses the drawbacks of current staplers. In particular, the surgical device of the present invention is operable by a single user and able to deploy bioabsorbable fasteners, of the type described by Danielson, which are very small and have low mass to thereby minimize foreign material in the wound and further able to close incisions or wounds as short as 10mm. Furthermore, in some embodiments, the device comprises surgical needles extending through the legs of the fastener, with sharp tips exposed distally, which aid the fastener to enter the tissue with minimal cutting, bleeding or trauma to the tissue when used to insert bioabsorbable fasteners for securing the two sides of an incision or wound. In particular, the surgical device of the present invention is capable of everting and holding tissue from each side of an incision or wound and inserting one or more bioabsorbable fasteners into the subcuticular tissue to hold the two edges together. For example, the device comprises a housing which orients and constrains other elements of the device. The housing comprises a body with a handle element and a barrel element. The barrel of the housing has a