LIGATION CLIP INCLUDING FLEXIBLE INSERT ASSEMBLY

A ligation clip(10) includes a hinge portion(300) having a flexible insert assembly(400) embedded in a body portion of the hinge portion(300). The flexible insert assembly(400) includes inserts(402, 404, 406) that are formed of a material that is more flexible than a material forming the body portion of the hinge portion(300). In this manner, plastic deformation in the hinge portion(300) of the ligation clip(10) is reduced or eliminated.

FIELD

The disclosure is generally related to surgical devices, and, more particularly, to a surgical ligation clip including a flexible insert assembly to reduce deformation in the surgical ligation clip.

BACKGROUND

Polymeric ligation clips typically include first and second beams that are coupled together at one end by a pivotable connection, e.g., living hinge, such that the first and second beams can be moved in relation to each other between open and clamped configurations. The ligation clips can be applied to tissue endoscopically through a small diameter incision or through a small diameter cannula positioned through the incision to minimize trauma to a patient during a surgical procedure.

Typically, when polymeric clips are applied to tissue through a cannula and/or stored within an endoscopic clip applier, the clips are supported in a compressed or partially compressed state to minimize an overall dimension of the clips and facilitate delivery of the clips through the cannula or incision. Storing polymeric clips in a compressed or partially compressed state may impact the condition of the clips which may impact the performance of the clips. More specifically, storing the polymeric clips in a compressed or partially compressed state causes strain and/or material creep in the material of the polymeric clip, especially in the region of the living hinge, which may adversely impact the condition and/or performance of the polymeric clip.

SUMMARY

In accordance with the disclosure, a ligation clip includes first and second arms and a hinge portion interconnecting the first and second arms. The first arm includes a first clamping surface and a first latching structure. The second arm includes a second clamping surface and a second latching structure. The hinge portion defines a bore and includes a body portion and a flexible insert assembly having first, second, and third inserts. The first and second arms are transitionable between an open configuration, in which, the first and second arms are spaced apart, and a clamped configuration, in which, the first and second latching structures of the first and second arms engage each other to clamp tissue between the first and second clamping surfaces. The first and second arms have a first rigidity. The body portion of the hinge portion has a second rigidity less than the first rigidity. One of the first, second, or third inserts of the flexible insert assembly of the hinge portion has a third rigidity less than the second rigidity.

In an aspect, the bore of the hinge portion may have a crescent shape when the first and second arms are in the open configuration.

In another aspect, the second and third flexible inserts of the flexible insert assembly may be disposed adjacent respective ends of the bore of the hinge portion.

In yet another aspect, the first insert of the flexible insert assembly may partially define the bore of the hinge portion.

In still yet another aspect, the first insert may include an anchor portion configured to inhibit movement of the first insert relative to the body portion of the hinge portion.

In an aspect, the anchor portion may have a shape of an arrow.

In another aspect, the first or second latching structure may be a hook.

In yet another aspect, the rigidity of the first insert may be different from the rigidities of the second or third insert.

In yet another aspect, the rigidities of the second and third inserts of the flexible insert assembly may be different.

In still yet another aspect, the first, second, or third inserts may be formed of a polymer.

In an aspect, the ligation clip may be formed of an absorbable polymer.

In another aspect, at least one of the second or third inserts may have a semi-circular shape.

In yet another aspect, the first or second clamping surfaces may include teeth to grip tissue.

In accordance with another aspect of the disclosure, a ligation clip includes first and second arms and a hinge portion interconnecting the first and second arms. The first and second arms includes first and second clamping surfaces, respectively. The first arm is movable in relation to the second arm to move the ligation clip from an open configuration, in which, the first and second clamping surfaces are spaced apart, to a clamped configuration, in which, at least portions of the first and second arms engage each other to clamp tissue between the first and second clamping surfaces. The hinge portion includes a body portion and flexible inserts embedded in the body portion. The flexible inserts have a rigidity less than a rigidity of the body portion. The flexible inserts are peripherally arranged about the hinge portion and spaced apart from each other.

In an aspect, the first and second arms may include respective latch portions engaging each other when the ligation clip is in the clamped configuration to retain the first and second arms in the clamped configuration.

In another aspect, the flexible inserts may include a pair of semi-circular inserts.

In yet another aspect, the hinge portion may define a bore.

In yet another aspect, the bore of the hinge portion may have a crescent shape when the ligation clip is in the open configuration.

In still yet another aspect, the flexible inserts may include a central insert disposed adjacent the bore.

In still yet another aspect, the central insert may include an anchor portion configured to inhibit movement of the central insert relative to the body portion of the hinge portion.

DETAILED DESCRIPTION

The disclosed ligation clip will now be described in detail with reference to the drawings in which like reference numerals designate identical or corresponding elements in each of the several views. However, it is to be understood that the disclosed aspects of the ligation clip are merely exemplary of the disclosure and may be embodied in various forms. Well-known functions or constructions are not described in detail to avoid obscuring the disclosure in unnecessary detail. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the disclosure in virtually any appropriately detailed structure. In addition, directional terms such as upper, lower, top, bottom, and similar terms are used to assist in understanding the description and are not intended to limit the disclosure.

In this description, the term “endoscopic” is used generally to refer to endoscopic, laparoscopic, arthroscopic, and/or any other procedure conducted through a small diameter incision or cannula. Further, the term “clinician” is used generally to refer to medical personnel including doctors, nurses, and support personnel. Finally, the term “substantially” is used generally to refer to 90 percent to 110 percent of a referenced parameter.

A surgical ligation clip in accordance with the disclosure is generally shown inFIGS.1-5as a ligation clip10. The ligation clip10may be delivered to a surgical site for application to tissue, e.g., a body vessel. The ligation clip10includes the first and second arms100,200and a hinge portion300interconnecting the first and second arms100,200. The first and second arms100,200may be moved to a clamped configuration (FIG.5) during application of the ligation clip10to body tissue. The ligation clip further includes a flexible insert assembly400. In particular, the flexible insert assembly400is provided at, e.g., stress points along the hinge portion300(the stress points may be obtained through finite element analysis), as will be described below. The flexible insert assembly400reduces deformation of the ligation clip10during, e.g., clamping of tissue and storage of the ligation clip10.

FIG.1illustrates the ligation clip10in an open configuration (FIG.1), in which, the first and second arms100,200are spaced from each other to define a gap “G” to receive tissue, e.g., body vessel “BV.” The ligation clip10may be formed as a single unitary construct that has a V-shaped configuration. The first and second distal portions102,202have latch portions103,203that are movable into engagement with each other to retain the ligation clip10in the clamped configuration (FIG.5). The first distal portion102defines a recess104, and the second distal portion202has a hook portion204configured to be received in the recess104to secure the first and second arms100,200together in order to clamp tissue between the first and second arms100,200.

In addition, the first arm100includes an inner clamping surface120having a plurality of teeth122. The second arm200includes an inner clamping surface220defining a plurality of grooves222to receive the plurality of teeth122of the first arm100. Under such a configuration, slippage of the target tissue may be reduced. In some aspects of the disclosure, the first and second distal portions102,202may include posts405that have a substantially circular shape. The posts405may be received within recesses in jaws of a clip applier to retain the ligation clip10within the clip applier prior to application of the ligation clip10to tissue.

FIG.1further illustrates the hinge portion300interconnecting the first and second arms100,200. The hinge portion300defines a bore302having, e.g., a crescent or semi-circular shape, to improve flexing of the hinge portion300during clamping of tissue. In particular, the shape of the bore302may correspond to the curvature of the hinge portion300. The bore302may also be centrally defined with respect to the hinge portion300.

FIGS.2and3illustrate the hinge portion300including a body portion350and the flexible insert assembly400. The flexible insert assembly400includes first, second, and third inserts402,404,406that are disposed on stress points on the body portion350that occur during clamping of the ligation clip10. Such stress points along the body portion350may be obtained through finite element analysis. The first, second, and third inserts402,404,406may be embedded in the body portion350through, e.g., injection molding. In particular, the first insert402is in communication with the bore302and at least partially extends around a peripheral portion of the bore302. The first insert402includes opposing wings407a,407bthat laterally extend from the bore302, and an inner wall409that defines part of the bore302. The opposing wings407a,407binclude respective anchoring portions403that inhibit relative movement between the first insert402and the body portion350of the hinge portion300. The second and third inserts404,406are spaced apart adjacent opposing sides of the bore302and define a portion of an outer surface of the ligation clip10. The second and third inserts404,406may be mirror images of each other. In particular, the second and third inserts404,406may have, e.g., semi-circular shape. The first and second arms100,200may be formed of a first material having a first rigidity or flexibility. The body350portion of the hinge portion300may be formed of a second material having a second rigidity or flexibility different from the first rigidity or flexibility. The flexible insert assembly400may be formed of a third material having a third rigidity or flexibility different from the first and/or second rigidity or flexibility. For example, the flexible insert assembly400may be formed of a material more flexible than the body portion350of the hinge assembly300. The body portion350may be more flexible than the first and second arms100,200. In addition, the first insert402may be more flexible than the second and third inserts404,406or vice versa. The second and third inserts404,406may be formed of the same material having the same flexibility. However, it is contemplated that the second and third inserts404,406may be formed of different materials having different flexibility. Under such a configuration, when the first and second arms100,200transition to the clamped configuration, the flexible insert assembly400facilitates flexing of the hinge portion300and reduces or eliminates, e.g., plastic, deformation of the ligation clip10, e.g., on the stress points occupied by the first, second, and third inserts402,404,406.

The ligation clip10described above is formed of a resilient material that enables transition of the ligation clip10between the open configuration, in which, the first and second distal portions102,202of the ligation clip10define a mouth or opening, and the clamped configuration, in which, the second distal portion202of the second arm200is releasably secured to the first distal portion102of the first arm100to clamp tissue between the first and second arms100,200. In the clamped configuration, the inner clamping surfaces120,220of the first and second arms100,200, respectively, are in juxtaposed alignment.

In some aspects of the disclosure, the ligation clip10is formed of a polymeric material such as polyethylene terephthalate (PET), polybutylene terephthalate (PBT), polyoxymethylene, or other thermoplastic materials having similar properties that can be injection molded, extruded, or otherwise processed. It is also envisioned that portion of the ligation clip10may be formed from other materials including metals. Each of the first and second arms100,200of the ligation clip10may be formed at least in part of a resilient bioabsorbable and/or biocompatible polymeric material. Examples of suitable bioabsorbable and/or biocompatible polymeric materials include acetal polyoxymethylene (POM), polyethylene terephthalate (PET), polybutylene terephthalate (PBT), polyoxymethylene, polyetheretherketone (PEEK), polypropylene, and polyethylene or other thermoplastic materials having similar properties that can be injection molded. The ligation clip10may also be made at least in part of a polymeric material or materials in combination with radiolucent metal alloys. Alternately, other materials may be used to form the ligation clip10including biocompatible metals, plastics and composites.

The ligation clip10may be utilized in, e.g., an anastomosis procedure. Anastomosis is an artificial connection of two vessel portions made by a surgeon and is required when a diseased portion of a vessel, e.g., artery, vein, or intestine, is removed from the vessel and the remaining vessel portions are rejoined. In use, it is envisioned that the first and second arms100,200will be delivered to a surgical site by a clip applier (not shown) with the first and second arms100,200of the ligation clip10supported in spaced relation to each other in the clip applier. It is also envisioned that the first and second arms100,200will be aligned by and within the clip applier (not shown) prior to application to tissue. As stated above, one or both of the posts405may be received within grooves or slots in the clip applier to support and/or guide the ligation clips10within and along the clip applier.

Initially, the ligation clip10may be in the open configuration (FIG.4) to receive a blood vessel “BV” between the first and second arms100,200. The latch portions103,203of the first and second arms100,200may engage each other, i.e., the hook portion204of the second arm200may be received in the recess104of the first arm100. The body vessel “BV” (FIG.5) is compressed between the inner clamping surfaces120,220of the first and second arms100,200to ligate the body vessel “BV.” At this time, the first, second, and third inserts402,4004,406flex to facilitate clamping of the ligation clap10without causing, e.g., plastic, deformation in the ligation clip10. In particular, when the first insert402is flexed, the wings407a,407bsubstantially oppose each other in a superposed relation, and the bore302conforms to the flexing of the hinge portion300. Such a configuration facilitates flexing of the ligation clip10to enhance transition between the open and clamped configurations without causing, e.g., plastic, deformation of the ligation clip10.