Patent Description:
A variety of endoscopic treatments may result in defects (or wounds) that are too large for known closure procedures. An assembly including a needle and a suture coupled to the needle may be used to suture tissue together. The tissue attachment method often involves piercing tissue with the needle and pulling on the needle to pull a suture attached to the needle through the hole created in the tissue. One way to couple a suture to a needle involves threading the suture through a hole in the needle and tying a knot at one end of the suture to prevent the end from passing through the hole of the needle. However, knot size can be inconsistent and may, in some examples, pull through the hole in the needle and uncouple the needle and suture, increasing surgical operation times, as operators may need to reassemble the needle and suture. Thus, there is a need for alternative suture and needle assemblies. <CIT> relates to suture anchors used to attach soft tissue to bone.

The disclosure is directed to several alternative designs, materials and methods of devices for assembling a needle and suture. In an example, a medical device comprises a needle configured for use in suturing tissue, the needle comprising a cylindrical body extending along a longitudinal axis between first and second ends of the cylindrical body, a lumen extending through the cylindrical body transverse to longitudinal axis, the lumen having a first opening and a second opening opposite the first opening, and a first end portion at the first end of the cylindrical body, wherein the first end portion includes a first sharp point configured to pierce tissue, wherein an outer surface of the cylindrical body defines a first recess in communication with the first opening of the lumen and configured to receive an end region of a suture, and a sleeve configured to slide over the cylindrical body and compress the end region of the suture within the first recess.

Alternatively or additionally, the sleeve has a slot in an outer wall thereof, the slot sized to receive a portion of the suture extending from the second opening of the lumen.

In embodiments according to the invention, the first recess is a first channel extending longitudinally from the first opening of the lumen toward the first sharp point.

Alternatively or additionally, the first channel tapers such that a first end of the first channel adjacent the first opening of the lumen has a first depth that is greater than a second depth at a second end of the first channel opposite the first end of the first channel.

In embodiments according to the invention, the outer surface of the cylindrical body defines a second recess in communication with the first opening of the lumen, wherein the second recess is a second channel extending longitudinally from the first opening of the lumen in a direction away from the first sharp point.

Alternatively or additionally, the medical device further comprises a second end portion at the second end of the cylindrical body, wherein the second end portion includes a second sharp point configured to pierce tissue.

Alternatively or additionally, the cylindrical body and the first and second end portions are a single monolithic element.

Alternatively or additionally, the single monolithic element is made of metal.

Alternatively or additionally, the medical device further comprises a depression between the cylindrical body and the first sharp point.

Alternatively or additionally, the medical device further comprises a suture having a first end region including a first terminal end, the first end region extending through the lumen and into the first recess, wherein the first terminal end is disposed within the first recess, wherein the sleeve is disposed over and compresses at least a portion of the first end region within the first recess, and the suture extends from the second opening of the lumen.

Alternatively or additionally, the medical device further comprises a weld fixing the sleeve to the cylindrical body.

Alternatively or additionally, the first end region of the suture is fixed to the cylindrical body with an adhesive or resin.

Alternatively or additionally, the first end region of the suture within the first recess is deformed such that the suture conforms to a shape of the first recess.

Alternatively or additionally, the sleeve is made of a heat shrinkable material.

Alternatively or additionally, the sleeve includes a sharp point configured to pierce tissue.

Alternatively or additionally, the sleeve includes a cavity configured to receive the second end of the cylindrical body.

Alternatively or additionally, the cavity is configured to receive the second end of the cylindrical body in a friction fit.

Alternatively or additionally, the sleeve is configured to be swaged onto the cylindrical body.

Alternatively or additionally, the sleeve is configured to be fixed to the cylindrical body with an adhesive or weld.

The disclosure may be more completely understood in consideration of the following description of in connection with the accompanying drawings, in which:.

On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the scope of the appended claims.

Definitions of certain terms are provided below and shall be applied, unless a different definition is given in the claims or elsewhere in this specification.

Although some suitable dimensions, ranges and/or values pertaining to various components, features and/or specifications are disclosed, one of skill in the art, incited by the present disclosure, would understand desired dimensions, ranges and/or values may deviate from those expressly disclosed.

As used in this specification and the appended claims, the singular forms "a," "an," and "the" include or otherwise refer to singular as well as plural referents, unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally employed to include "and/or," unless the content clearly dictates otherwise. As used in this specification and the appended claims, the terms "approximately" and "substantially" may indicate a range of values within +/- <NUM>% of a stated value or position.

The disclosure pertains to needles and suture assemblies that are configured to be used in combination with an endoscope or a similar delivery device for closing wounds within the body. In some instances, the needles and suture assemblies described herein may be configured such that they may be used with a suture based closure device such as that described in <CIT>.

<FIG> is a perspective view of an exemplary suture assembly <NUM> including a needle <NUM>, sleeve <NUM>, and suture <NUM>. The needle <NUM> may include a recess <NUM> in an outer surface configured to receive a first end region <NUM> of the suture <NUM>. The suture <NUM> may be threaded through a lumen <NUM> (shown in <FIG>) to extend substantially transverse to the needle <NUM> as illustrated in <FIG>. The sleeve <NUM> may slide over the needle <NUM> and compress the first end region <NUM> of the suture <NUM> within the recess <NUM>.

As shown in <FIG>, the needle <NUM> may have a cylindrical body <NUM> with a longitudinal axis X-X, a first end portion <NUM> with a first sharp point <NUM>, and a second end portion <NUM> with a second sharp point <NUM>. The first and second sharp points <NUM>, <NUM> are configured to pierce tissue such that the needle <NUM> may be used to suture tissue. In some examples, the needle <NUM> may include only the cylindrical body <NUM> and the first end portion <NUM> and only a single sharp point <NUM>. In such an example, the opposing end may be blunt. One or both of the first end portion <NUM> and second end portion <NUM> may include a depression <NUM>, <NUM>. The depressions <NUM>, <NUM> may have a curved outer surface that may curve radially inward relative to the longitudinal axis of needle <NUM>. In some examples, depressions <NUM>, <NUM> may be concavities with a curved exterior surface that may meet and be flush with cylindrical body <NUM> at an end of the curved surface. In some examples, depressions <NUM>, <NUM> may be hour-glass shaped and may have an exterior surface that curves radially-inward relative to the exterior surface of cylindrical body <NUM>. In some examples, depressions <NUM>, <NUM> may be equidistant from a lumen <NUM> of cylindrical body <NUM>. In some examples, each depression <NUM>, <NUM> may be configured to receive a bearing ball or other releasable securement member from a medical device. The region of each of the first and second end portions <NUM>, <NUM> on the opposite end of each sharp point <NUM>, <NUM>, may be coupled to the cylindrical body <NUM>. In some examples, first and second end portions <NUM>, <NUM> may be attached to cylindrical body <NUM> by welding, soldering, swaging, or with adhesive. In other examples, the cylindrical body <NUM>, and first and second end portions <NUM>, <NUM> may be formed as a single monolithic piece.

Needle <NUM> may also include a lumen <NUM> extending through cylindrical body <NUM> transverse to the longitudinal axis X-X. Lumen <NUM> may extend through a central portion of cylindrical body <NUM> and may extend substantially perpendicular to the longitudinal axis X-X of cylindrical body <NUM>, as shown in <FIG>. In other examples, lumen <NUM> may extend through a non-central portion of cylindrical body <NUM> and/or be at an angle transverse to the longitudinal axis, but not perpendicular. Lumen <NUM> includes a first opening <NUM> on one side of cylindrical body <NUM> and a second opening <NUM> (shown in <FIG>) on the opposite side of cylindrical body <NUM> from the first opening <NUM>. In embodiments according to the invention, cylindrical body <NUM> includes a first recess <NUM> and second recess <NUM> extending longitudinally from the lumen <NUM> on a radially-outer surface of cylindrical body <NUM>. In embodiments according to the invention, first and second recesses <NUM>, <NUM> extend from opposite sides of the lumen <NUM>. In some examples, the recess <NUM> is a channel that tapers such that a first end <NUM> of the recess <NUM> adjacent the first opening <NUM> of the lumen <NUM> has a first depth that is greater than a second depth at a second end <NUM> of the recess <NUM> opposite the first end <NUM>. The second recess <NUM> may be tapered in a similar manner as recess <NUM>. First opening <NUM> of lumen <NUM> may be positioned within or otherwise in communication with recesses <NUM>, <NUM>. The recesses <NUM>, <NUM> may be configured to receive a first end region <NUM> of a suture <NUM>, as shown in <FIG>.

<FIG> shows the bottom of the needle <NUM> in <FIG>. The lumen <NUM> is shown extending completely through the cylindrical body <NUM>. In some examples, the second opening <NUM> may include a bevel or counter bore <NUM>. In other examples, the second opening <NUM> may be flush with the exterior surface of the cylindrical body <NUM>.

<FIG> shows the sleeve <NUM> as a hollow cylinder with two open ends and a slot <NUM> extending through the sleeve wall in a longitudinal direction from one end towards the middle of the sleeve <NUM>. The slot <NUM> may have a rounded end <NUM> configured to engage the suture <NUM> without damaging or cutting the suture <NUM>.

<FIG> is a cross-sectional view of the example suture assembly <NUM> taken along line <NUM>-<NUM> of <FIG>. The first end region <NUM> of the suture <NUM> is threaded into the second opening <NUM> and out the first opening <NUM> of the lumen <NUM> in the needle <NUM>, and then bent in an L shape such that the first end region <NUM> and terminal end <NUM> of the suture <NUM> reside within the recess <NUM>. Alternatively, the first end region <NUM> of the suture <NUM> may reside within recess <NUM>. The sleeve <NUM> slides over the needle <NUM> and over the first end region <NUM> of the suture <NUM>. The recess <NUM> may have a depth measured transverse to the longitudinal axis that is less than the width of the suture <NUM>, thereby compressing the suture <NUM> within the recess <NUM> and securing the suture <NUM> to the needle <NUM>. The tapered shape of the recess <NUM> may provide for additional compression of the suture <NUM>.

In some examples, the needle <NUM> and the sleeve <NUM> may be metal, and the sleeve <NUM> may be welded to the needle <NUM>. For example, a weld <NUM> may be formed between the needle <NUM> and the sleeve <NUM> on the bottom of the needle <NUM>, adjacent the second opening <NUM>. In other examples, the sleeve <NUM> and/or the suture <NUM> may be fixed to the needle <NUM> with adhesive or resin. Adhesive or resin may be particularly suitable for fixing the sleeve <NUM> and/or suture <NUM> to a needle <NUM> formed from polymer or other non-metal biocompatible material. In other examples, the sleeve <NUM> may be made of a heat shrinkable material. The heat shrink sleeve <NUM> may be slid over the needle <NUM> and first end region <NUM> of the suture <NUM>. Heat is then applied causing the heat shrink sleeve <NUM> to shrink and compress the first end region <NUM> of the suture <NUM> within the recess <NUM>. In some examples, the sleeve <NUM> and the needle <NUM> may be an interference fit. In some examples, the first end region <NUM> of the suture <NUM> may be deformed, e.g., melted, to conform to the shape of the recess <NUM> to provide additional securement of the suture to the needle <NUM>. With any of the suture securing mechanisms described above, the suture <NUM> is fixedly coupled to needle <NUM> such that suture <NUM> remains within lumen <NUM> when a pulling force is applied to the suture <NUM> exiting the second opening <NUM>, such as when using needle <NUM> to suture a patient.

As shown in <FIG>, when the sleeve <NUM> is disposed over the needle <NUM>, the rounded end <NUM> of the slot <NUM> engages the suture <NUM>. In some examples, the sleeve <NUM> may be advanced until the suture <NUM> is slightly pinched against a side of the lumen <NUM> and the rounded end <NUM> of the slot <NUM>.

<FIG> and <FIG> illustrate another example suture assembly <NUM> including a needle <NUM> and suture <NUM>. <FIG> and <FIG> show a top or bottom view, with the opposite side being identical. The needle <NUM> is similar to needle <NUM>, having a cylindrical body <NUM> and first and second end portions <NUM>, <NUM>, each having a sharp point <NUM>, <NUM> and a depression <NUM>, <NUM>. The first and second sharp points <NUM>, <NUM> are configured to pierce tissue such that the needle <NUM> may be used to suture tissue. The needle <NUM> may have a slot <NUM> extending through the cylindrical body <NUM> transverse to the longitudinal axis X-X, the slot <NUM> having a first opening on one side of the cylindrical body <NUM> and a second opening opposite the first opening. The slot <NUM> may include a central region <NUM> configured to receive the suture <NUM>, a first elongated region <NUM>, and a second elongated region <NUM>. The first and second elongated regions <NUM>, <NUM> may extend longitudinally in opposite directions from the central region <NUM>. The central region <NUM> may have a slightly rounded or semi-circular shape to match the outer shape of the suture <NUM>. The cylindrical body <NUM> may have walls <NUM> extending along the slot <NUM> that are deformable such that a radially inward force applied to the walls <NUM> in the direction of arrow <NUM>, at the central region <NUM>, causes the walls <NUM> to deform inwardly where the force is applied, as shown in <FIG>. In some examples, once deformed, the walls <NUM> remain in the deformed configuration shown in <FIG>, thereby permanently securing the suture <NUM> to the needle <NUM>. The walls <NUM> may be deformed due to their thickness being thinner than a radial thickness of the cylindrical body <NUM>. In other embodiments, the walls <NUM> may be formed from a material more easily deformed than the remainder of the cylindrical body <NUM> and/or first and second end portions <NUM>, <NUM>.

Similar to needle <NUM>, the needle <NUM> may include only the cylindrical body <NUM> and a single one of the first and second end portions <NUM>, <NUM> with the sharp point <NUM>, <NUM>. The opposite end may be blunt. In other examples, both the first and second end portions <NUM>, <NUM> and their respective sharp point <NUM>, <NUM> may be attached to the cylindrical body. In either case, the cylindrical body <NUM> may be attached to the first and/or second end portion <NUM>, <NUM> via welding, soldering, swaging or adhesive. The cylindrical body <NUM> may be made of the same or a different material from the first and/or second end portions <NUM>, <NUM>. In some examples, the first and/or second end portions <NUM>, <NUM> are made from a material that is more rigid than the material forming the cylindrical body <NUM>. In other examples, the entire needle <NUM> including the cylindrical body <NUM> and first and/or second end portion <NUM>, <NUM> may be a single monolithic structure. The cylindrical body <NUM> and the first and/or second end portion <NUM>, <NUM> may be solid, aside from the slot <NUM>. In some examples, the suture <NUM> may include a knot or deformed (e.g., melted) region disposed within the central region <NUM> of the slot <NUM> or above the slot <NUM>, adjacent the outer surface of the cylindrical body <NUM>. With any of the suture securing mechanisms described above, the suture <NUM> is fixedly coupled to needle <NUM> such that suture <NUM> remains within the central region <NUM> of the slot <NUM> when a pulling force is applied to the suture <NUM>, such as when using needle <NUM> to suture a patient.

<FIG> and <FIG> illustrate another example suture assembly <NUM> similar to suture assemblies <NUM> and <NUM>. The suture assembly <NUM> includes a suture <NUM> fixed to a needle <NUM>. The needle <NUM> is similar to needles <NUM> and <NUM>, having a cylindrical body <NUM> and first and second end portions <NUM>, <NUM>, each having a sharp point <NUM>, <NUM> and a depression <NUM>, <NUM>. The first and second sharp points <NUM>, <NUM> are configured to pierce tissue such that the needle <NUM> may be used to suture tissue. Needle <NUM> may also include a lumen <NUM> extending through cylindrical body <NUM>. Lumen <NUM> may extend through a central portion of cylindrical body <NUM> and may extend substantially perpendicular to the longitudinal axis X-X of cylindrical body <NUM>. In other examples, lumen <NUM> may extend through a non-central portion of cylindrical body <NUM> and/or be at an angle transverse to the longitudinal axis, but not perpendicular. Lumen <NUM> may include a first opening <NUM> on one side of cylindrical body <NUM> and a second opening (not shown) on the opposite side of cylindrical body <NUM> from the first opening <NUM>. The first and second openings <NUM> may be identical. The lumen <NUM> is shown extending completely through the cylindrical body <NUM>. In some examples, the first, and/or second opening <NUM> may include a bevel or counter bore <NUM>. In other examples, the first and/or second opening <NUM> may be flush with the exterior surface of the cylindrical body <NUM>.

The suture <NUM> may include a coupling member <NUM> fixed adjacent the terminal end <NUM> of the suture <NUM>. The coupling member <NUM> may be inserted through the lumen <NUM> and fixed therein. In the example shown in <FIG>, the coupling member <NUM> may be a metal crimp tube. The crimp tube <NUM> may be placed over the suture <NUM> and then squeezed or crimped to fix it to the suture <NUM>. The crimp tube <NUM> may then be inserted into the lumen <NUM> and fixed therein to secure the suture <NUM> to the needle <NUM>, as shown in <FIG>. In some examples, the cylindrical body <NUM> and the crimp tube <NUM> may be metal and the crimp tube <NUM> may be welded or soldered within the lumen <NUM>. In other examples, the crimp tube <NUM> may be fixed within the lumen <NUM> with adhesive. <FIG> shows an alternative coupling member in the form of a wire <NUM> wrapped around the suture <NUM>. As with the crimp tube <NUM>, the wire <NUM> may be welded or soldered within the lumen <NUM> or fixed with adhesive.

Similar to needle <NUM>, the needle <NUM> may include only the cylindrical body <NUM> and a single one of the first or second end portions <NUM>, <NUM> with the sharp point <NUM>, <NUM>. In some embodiments, the opposite end may be blunt. In other examples, both the first and second end portions <NUM>, <NUM> and their associated sharp points <NUM>, <NUM> may be attached to the cylindrical body <NUM>. The cylindrical body <NUM> may be made of the same or a different material from the first and/or second end portions <NUM>, <NUM>. In some examples, the first and/or second end portions <NUM>, <NUM> are made from a material that is more rigid than the material forming the cylindrical body <NUM>. In other examples, the entire needle <NUM> including the cylindrical body <NUM> and first and/or second end portion <NUM>, <NUM> may be a single monolithic structure. The cylindrical body <NUM> and the first and/or second end portion <NUM>, <NUM> may be solid.

In some examples, the suture <NUM> may include a knot or deformed (e.g., melted) region disposed within the coupling member <NUM> or above the coupling member <NUM>, adjacent the outer surface of the cylindrical body <NUM>. With any of the suture securing mechanisms described above, the suture <NUM> is fixedly coupled to needle <NUM> such that suture <NUM> remains within lumen <NUM> when a pulling force is applied to the suture <NUM>, such as when using needle <NUM> to suture a patient.

<FIG> and <FIG> illustrate another example suture assembly <NUM> similar to suture assembly <NUM>. The suture assembly <NUM> includes a suture <NUM> fixed to a needle <NUM>. The needle <NUM> is similar to needle <NUM>, having a cylindrical body <NUM> and first and second end portions <NUM>, <NUM>, each having a sharp point <NUM>, <NUM> and a depression <NUM>, <NUM>. The first and second sharp points <NUM>, <NUM> are configured to pierce tissue such that the needle <NUM> may be used to suture tissue. Needle <NUM> may also include a lumen <NUM> extending through cylindrical body <NUM>. Lumen <NUM> may extend through a central portion of cylindrical body <NUM> and may extend substantially perpendicular to the longitudinal axis of cylindrical body <NUM>. In other examples, lumen <NUM> may extend through a non-central portion of cylindrical body <NUM> and/or be at an angle transverse to the longitudinal axis, but not perpendicular. Lumen <NUM> may include a first opening <NUM> on one side of cylindrical body <NUM> and a second opening (not shown) on the opposite side of cylindrical body <NUM> from the first opening <NUM>. The lumen <NUM> may extend completely through the cylindrical body <NUM>.

The cylindrical body <NUM> may include a recess <NUM> in an outer surface configured to receive the first end region <NUM> of the suture <NUM>. The suture <NUM> may be threaded through the lumen <NUM> and then the first end region <NUM> may be bent in an L shape and disposed within the recess <NUM>. The second end portion <NUM> may include a sleeve portion <NUM> configured to slide over the cylindrical body <NUM> and compress the first end region <NUM> of the suture <NUM> within the recess <NUM>. The recess <NUM> may be a channel that tapers as described for recess <NUM> in needle <NUM>. First opening <NUM> of lumen <NUM> may be positioned within or otherwise in communication with recess <NUM>. The sleeve portion <NUM> of the second end portion <NUM> may be a hollow cylinder or have a cavity configured to slide over the blunt end <NUM> of the cylindrical body <NUM>, with a slot <NUM> extending through the wall in a longitudinal direction from one end towards the middle of the sleeve portion <NUM>. The slot <NUM> may have a rounded end <NUM> configured to engage the suture <NUM> without damaging or cutting the suture <NUM>. The recess <NUM> may have a depth measured transverse to the longitudinal axis that is less than the width of the suture <NUM>. As the sleeve portion <NUM> slides over the cylindrical body <NUM> and over the first end region <NUM> of the suture <NUM>, the sleeve portion <NUM> compresses the first end region <NUM> within the recess <NUM>, thereby securing the suture <NUM> to the needle <NUM>. The tapered shape of the recess <NUM> may provide for additional compression of the suture <NUM>.

The sleeve portion <NUM> may then be swaged onto the cylindrical body <NUM> to secure the second end portion <NUM> to the cylindrical body <NUM>. As shown in <FIG>, the swaged region <NUM> of the sleeve portion <NUM> may include substantially the entire length of the sleeve portion <NUM>. In other examples, only an end region of the sleeve portion <NUM> is swaged onto the cylindrical body <NUM>. Swaging the sleeve portion <NUM> onto the cylindrical body <NUM> fixes the suture <NUM> to the needle <NUM> such that suture <NUM> remains within lumen <NUM> when a pulling force is applied to the suture <NUM>, such as when using needle <NUM> to suture a patient.

In addition to swaging the sleeve portion <NUM> onto the cylindrical body <NUM>, in some examples, the sleeve portion <NUM> may be welded or soldered to the cylindrical body <NUM>. In other examples, adhesive or resin may be used in addition to the swaging, soldering, and/or welding to fix the sleeve portion <NUM> and/or suture <NUM> to the needle <NUM>. In other examples, the sleeve portion <NUM> may be an interference fit with the cylindrical body <NUM>. In other examples, the first end region <NUM> of the suture <NUM> may be deformed, e.g., melted, to conform to the shape of the recess <NUM> to aid in securing the suture to the needle <NUM>.

<FIG> and <FIG> illustrate another example suture assembly <NUM> similar to suture assemblies <NUM>, <NUM>, <NUM>. The suture assembly <NUM> includes a suture <NUM> fixed to a needle <NUM>. The needle <NUM> is similar to needles <NUM>, <NUM>, <NUM> having a cylindrical body <NUM> and first and second end portions <NUM>, <NUM>, each having a sharp point <NUM>, <NUM> and a depression <NUM>, <NUM>. The first and second sharp points <NUM>, <NUM> are configured to pierce tissue such that the needle <NUM> may be used to suture tissue. Needle <NUM> may also include a first lumen <NUM> extending through cylindrical body <NUM>. First lumen <NUM> may extend through a central portion of cylindrical body <NUM> and may extend substantially perpendicular to the longitudinal axis of cylindrical body <NUM>. In other examples, first lumen <NUM> may extend through a non-central portion of cylindrical body <NUM>. The first lumen <NUM> is shown extending completely through the cylindrical body <NUM>. In some examples, the first lumen <NUM> may extend only part way through the cylindrical body <NUM>.

A second lumen <NUM> may extend through the cylindrical body <NUM> transverse to and intersecting the first lumen <NUM>, as shown in <FIG>. The suture <NUM> may be inserted through the first lumen <NUM>. A first fixation member <NUM> may be inserted through the second lumen <NUM> from a first direction and a second fixation member <NUM> may be inserted through the second lumen <NUM> from a second direction. The first and second fixation members <NUM>, <NUM> may be advanced until they engage and pinch the suture <NUM> between them. In some examples, the first and second fixation members <NUM>, <NUM> may be screws that threadingly engage an internally threaded second lumen <NUM>. In other examples, the first and second fixation members <NUM>, <NUM> may engage the second lumen <NUM> with a friction fit. In some examples, the cylindrical body <NUM> and the first and second fixation members <NUM>, <NUM> may be metal and the first and second fixation members <NUM>, <NUM> may be welded or soldered within the second lumen <NUM>. In other examples, the first and second fixation members <NUM>, <NUM> may be fixed within the second lumen <NUM> with adhesive.

Similar to needle <NUM>, the needle <NUM> may include only the cylindrical body <NUM> and a single one of the first or second end portions <NUM>, <NUM> with the sharp point <NUM>, <NUM>. The opposite end may be blunt. In other examples, both the first and second end portions <NUM>, <NUM> and their respective sharp point <NUM>, <NUM> may be attached to the cylindrical body <NUM>. The first and second sharp points <NUM>, <NUM> are configured to pierce tissue such that the needle <NUM> may be used to suture tissue. In either case, the cylindrical body <NUM> may be attached to the first and/or second end portion <NUM>, <NUM> via welding, soldering, swaging, or adhesive. The cylindrical body <NUM> may be made of the same or a different material from the first and/or second end portions <NUM>, <NUM>. In some examples, the first and/or second end portions <NUM>, <NUM> are made from a material that is more rigid than the material forming the cylindrical body <NUM>. In other examples, the entire needle <NUM> including the cylindrical body <NUM> and first and/or second end portion <NUM>, <NUM> may be a single monolithic structure. The cylindrical body <NUM> and the first and/or second end portion <NUM>, <NUM> may be solid.

In some examples, the suture <NUM> may include a knot or deformed (e.g., melted) region disposed within the first lumen <NUM> or outside the first lumen <NUM>, adjacent the outer surface of the cylindrical body <NUM>. With any of the suture securing mechanisms described above, the suture <NUM> is fixedly coupled to needle <NUM> such that suture <NUM> remains within the first lumen <NUM> when a pulling force is applied to the suture <NUM>, such as when using needle <NUM> to suture a patient.

<FIG> and <FIG> illustrate another example suture assembly <NUM> similar to suture assembly <NUM>. The suture assembly <NUM> includes a suture <NUM> fixed to a needle <NUM>. The needle <NUM> is similar to needle <NUM>, having a cylindrical body <NUM> and first and second end portions <NUM>, <NUM>, each having a sharp point <NUM>, <NUM> and a depression <NUM>, <NUM>. The first and second sharp points <NUM>, <NUM> are configured to pierce tissue such that the needle <NUM> may be used to suture tissue. Needle <NUM> may also include a first lumen portion <NUM> extending part way into cylindrical body <NUM>, as shown by the dashed lines in <FIG>. First lumen portion <NUM> may extend into a central portion of cylindrical body <NUM> and may extend substantially perpendicular to the longitudinal axis of cylindrical body <NUM>. In other examples, first lumen portion <NUM> may extend through a non-central portion of cylindrical body <NUM> and/or be at an angle transverse to the longitudinal axis, but not perpendicular. The first lumen portion <NUM> may intersect a second lumen portion <NUM> extending longitudinally through the cylindrical body <NUM>. In other examples, the cylindrical body <NUM> may have a single lumen extending from the cavity <NUM> to an opening in the wall of the cylindrical body <NUM> (not shown). The single lumen may be curved or straight.

The cylindrical body <NUM> may include a cavity <NUM> in an end face <NUM> opposite the sharp point <NUM>. The cavity <NUM> is in communication with the second lumen portion <NUM> and may be configured to receive a protrusion <NUM> disposed on an end of the second end portion <NUM>. The protrusion <NUM> may be received in the cavity <NUM> with a friction fit. The combination of first and second lumen portions <NUM>, <NUM> and cavity <NUM> provide a pathway for the suture <NUM>. The suture <NUM> may be threaded through the first lumen portion <NUM>, second lumen portion <NUM>, and into the cavity <NUM>. The terminal end of the suture <NUM> may reside within the cavity <NUM>. As shown in <FIG>, the protrusion <NUM> is then inserted into the cavity <NUM>, thereby securing the suture <NUM> to the needle <NUM> such that suture <NUM> remains within the cavity <NUM> and the first and second lumen portions <NUM>, <NUM> when a pulling force is applied to the suture <NUM>, such as when using needle <NUM> to suture a patient.

In addition to the friction fit of the protrusion <NUM> within the cavity <NUM>, the protrusion <NUM> may be welded or soldered to the cavity <NUM> or the end face <NUM> of the cylindrical body <NUM>. In other examples, the protrusion <NUM> and/or the suture <NUM> may be fixed to the needle <NUM> with adhesive or resin. In other examples, the end region of the suture <NUM> may be deformed, e.g., melted, to conform to the shape of one or more of the cavity <NUM>, first lumen portion <NUM>, or second lumen portion <NUM>, to aid in securing the suture <NUM> to the needle <NUM>.

<FIG> and <FIG> illustrate additional example suture assemblies <NUM>, <NUM> similar to suture assembly <NUM>. The suture assembly <NUM> shown in <FIG> includes a suture <NUM> fixed to a needle <NUM>. The needle <NUM> is similar to needle <NUM>, having a cylindrical body <NUM> and first and second end portions <NUM>, <NUM>, each having a sharp point <NUM>, <NUM> and a depression <NUM>, <NUM>. The first and second sharp points <NUM>, <NUM> are configured to pierce tissue such that the needle <NUM> may be used to suture tissue. Needle <NUM> may also include a lumen <NUM> extending through cylindrical body <NUM>. Lumen <NUM> may extend through a central portion of cylindrical body <NUM> and may extend substantially perpendicular to the longitudinal axis of cylindrical body <NUM>. In other examples, lumen <NUM> may extend through a non-central portion of cylindrical body <NUM> and/or be at an angle transverse to the longitudinal axis, but not perpendicular. Lumen <NUM> may include a first opening <NUM> on one side of cylindrical body <NUM> and a second opening <NUM> on the opposite side of cylindrical body <NUM> from the first opening <NUM>. The first and second openings <NUM>, <NUM> may be identical. The lumen <NUM> is shown extending completely through the cylindrical body <NUM>. In some examples, the first, and/or second opening <NUM>, <NUM> may include a bevel or counter bore as shown in <FIG>. In other examples, the first and/or second opening <NUM>, <NUM> may be flush with the exterior surface of the cylindrical body <NUM> as shown in <FIG>.

The suture <NUM> may be inserted through the lumen <NUM> and a knot <NUM> tied in the end to prevent the suture <NUM> from being removed from the lumen <NUM> through the second opening <NUM>, thereby securing the suture <NUM> to the needle <NUM>, as shown in <FIG>. In some embodiments, the suture <NUM> may have a bulbous end, such that the end <NUM> is larger than the lumen <NUM>. For example, the bulbous end may be formed by deforming, or melting. In some examples, the suture <NUM> may be fixed within the lumen <NUM> with adhesive or adhesive may be added to the knot <NUM> to secure the knot to the outer surface of the cylindrical body <NUM>.

<FIG> shows a suture assembly <NUM> similar to suture assembly <NUM> but with a second lumen <NUM> spaced apart longitudinally from the first lumen <NUM>. The suture assembly <NUM> shown in <FIG> includes a suture <NUM> fixed to a needle <NUM>. The needle <NUM> is similar to needle <NUM>, having a cylindrical body <NUM> and first and second end portions <NUM>, <NUM>, each having a sharp point <NUM>, <NUM> and a depression <NUM>, <NUM>. The first and second sharp points <NUM>, <NUM> are configured to pierce tissue such that the needle <NUM> may be used to suture tissue. Needle <NUM> includes a first lumen <NUM> and a second lumen <NUM> extending through cylindrical body <NUM>. Lumens <NUM>, <NUM> may extend through a central portion of cylindrical body <NUM> and may extend substantially perpendicular to the longitudinal axis of cylindrical body <NUM>. In other examples, lumens <NUM>, <NUM> may extend through a non-central portion of cylindrical body <NUM> and/or be at an angle transverse to the longitudinal axis, but not perpendicular. Lumens <NUM>, <NUM> may each include a first opening <NUM>, <NUM> on one side of cylindrical body <NUM> and a second opening <NUM>, <NUM> on the opposite side of cylindrical body <NUM> from the first opening <NUM>, <NUM>. The first openings <NUM>, <NUM> and second openings <NUM>, <NUM> may be identical. The first and second lumens <NUM>, <NUM> are shown extending completely through the cylindrical body <NUM>. In some examples, the first openings <NUM>, <NUM>, and/or second openings <NUM>, <NUM> may include a bevel or counter bore as shown in <FIG>. In other examples, the first and/or second openings may be flush with the exterior surface of the cylindrical body <NUM> as shown in <FIG>.

The suture <NUM> may be inserted through the second opening <NUM>, into the first lumen <NUM>, out the first opening <NUM> of the first lumen <NUM>, across the outer surface of the cylindrical body <NUM>, into the first opening <NUM> of the second lumen <NUM>, through the second lumen <NUM> and out the second opening <NUM> of the second lumen <NUM>. A knot <NUM> may be tied in the end to prevent the suture <NUM> from being removed from the lumens <NUM>, <NUM> through the second opening <NUM>, thereby securing the suture <NUM> to the needle <NUM> such that suture <NUM> remains within lumens <NUM>, <NUM> when a pulling force is applied to the suture <NUM>, such as when using needle <NUM> to suture a patient. In some examples, the suture <NUM> may be fixed within the first and/or second lumen <NUM>, <NUM> with adhesive or adhesive may be added to the knot <NUM> to secure the knot to the cylindrical body <NUM>.

Similar to needle <NUM>, the needles <NUM>, <NUM> may include only the cylindrical body <NUM>, <NUM> and a single one of the first end portion <NUM>, <NUM> or second end portion <NUM>, <NUM> with its associated sharp point <NUM>, <NUM>, <NUM>, <NUM>. The opposite end may be blunt. In other examples, the needles <NUM>, <NUM> may include both the first and second end portions <NUM>, <NUM>, <NUM>, <NUM> and their associated sharp points, as illustrated. In either case, the cylindrical body <NUM>, <NUM> may be made of the same or a different material from the first and/or second end portions <NUM>, <NUM>, <NUM>, <NUM>. In some examples, the first and/or second end portions <NUM>, <NUM>, <NUM>, <NUM> are made from a material that is more rigid than the material forming the cylindrical body <NUM>, <NUM>. In other examples, the entire needle <NUM>, <NUM> including the cylindrical body <NUM>, <NUM> and first and/or second end portion <NUM>, <NUM>, <NUM>, <NUM> may be a single monolithic structure.

It will be appreciated that a variety of different materials may be used in forming the devices described herein. The suture <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> may be cylindrical and may be polyproplylene. In other examples, the suture may be polyester, nylon, polyglycolic acid, polylactic acid, polymer materials, or any other absorbable or non-absorbable biocompatible material. In some cases, variety of different metals may be used to make the needle <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>. Illustrative but non-limiting examples of suitable metals include titanium, stainless steel, magnesium, cobalt chromium and others. In some embodiments, for example, the devices described herein may include any suitable polymeric material, including biocompatible materials such as polyurethane or silicone. Other suitable polymers include but are not limited to polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, for example, DELRIN® available from DuPont), polyether block ester, polyurethane (for example, Polyurethane 85A), polypropylene (PP), polyvinylchloride (PVC), polyether-ester (for example, ARNITEL® available from DSM Engineering Plastics), ether or ester based copolymers (for example, butylene/poly(alkylene ether) phthalate and/or other polyester elastomers such as HYTREL® available from DuPont), polyamide (for example, DURETHAN® available from Bayer or CRISTAMID® available from Elf Atochem), elastomeric polyamides, block polyamide/ethers, polyether block amide (PEBA, for example available under the trade name PEBAX®), ethylene vinyl acetate copolymers (EVA), silicones, polyethylene (PE), Marlex high-density polyethylene, Marlex low-density polyethylene, linear low density polyethylene (for example REXELL®), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), poly paraphenylene terephthalamide (for example, KEVLAR®), polysulfone, nylon, nylon-<NUM> (such as GRILAMID® available from EMS American Grilon), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (for example, SIBS and/or SIBS 50A), polycarbonates, ionomers, biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers thereof, polymer/metal composites, and the like.

Claim 1:
A medical device (<NUM>) comprising:
a needle (<NUM>) configured for use in suturing tissue, the needle comprising:
a cylindrical body (<NUM>) extending along a longitudinal axis (X-X) between first and second ends of the cylindrical body;
a lumen (<NUM>) extending through the cylindrical body transverse to the longitudinal axis, the lumen having a first opening (<NUM>) and a second opening (<NUM>) opposite the first opening; and
a first end portion (<NUM>) at the first end of the cylindrical body, wherein the first end portion includes a first sharp point (<NUM>) configured to pierce tissue;
wherein an outer surface of the cylindrical body defines a first recess (<NUM>) in communication with the first opening of the lumen and configured to receive an end region (<NUM>) of a suture (<NUM>); and
a sleeve (<NUM>) configured to slide over the cylindrical body and compress the end region of the suture within the first recess,
wherein the first recess is a first channel extending longitudinally from the first opening of the lumen toward the first sharp point,
wherein the outer surface of the cylindrical body defines a second recess (<NUM>) in communication with the first opening of the lumen, wherein the second recess is a second channel extending longitudinally from the first opening of the lumen in a direction away from the first sharp point.