Patent Description:
The disclosed embodiments relate generally to medical devices and more particularly to an insertion device for delivery of a mesh carrier into a body of a patient.

The disclosed embodiments have application to a wide variety of surgical procedures. For example, one such procedure is directed to urinary incontinence and includes fixing an implant to tissue within a body of a patient to provide support for the urethra. Another such procedure includes fixing an implant to bodily tissue of a patient to support a bladder of the patient.

Mesh carriers may be placed within a body of a patient to provide anchoring points for medical implants. In some procedures, it is necessary for a practitioner, such as a physician, to insert a mesh carrier into bodily tissue of the patient at a location not easily visible to the practitioner. In such procedures, known insertion devices can be used to position a mesh carrier at a first location within bodily tissue and to fix the mesh carrier to the tissue. However, when the mesh carrier is removed from the insertion device, the mesh carrier may be fixed to the tissue at a second location different from the first location. For example, when the mesh carrier is removed from the insertion device, it can be pushed to a location deeper within the tissue than its location when first inserted. In such an instance, over-insertion can occur resulting in misplacement of the mesh carrier. If misplacement of the mesh carrier occurs, the practitioner may remove or pull out the misplaced mesh carrier or implant, which can cause severe or unnecessary trauma to the patient. Document <CIT> relates to an apparatus for use in positioning an anchor. The apparatus includes a tubular outer member and an inner or pusher member. During use of the apparatus, a slot facilitates visualization of the position of the anchor relative to body tissue. An anchor retainer may be provided at one end of the tubular outer member to grip the anchor and hold the anchor in place during assembly. The anchor retainer also holds the anchor during movement of the apparatus from an assembly location to an operating room or other location where the apparatus is to be used. This document does not disclose a tissue anchor and a stylet configured for coupling of the tissue anchor to the stylet, wherein the coupling includes moving the stylet to its first position such that a distal end portion of the stylet extends beyond a distal end portion of the tissue anchor, wherein the coupling of the tissue anchor also includes inserting the stylet into a lumen defined by the tissue anchor such that a ridge defined by the distal end portion of the stylet interacts with the tissue anchor.

Thus, a need exists for an insertion device having a configuration that permits the mesh carrier to remain at a single location within bodily tissue once the mesh carrier has been inserted into the tissue and during removal from the insertion device. A need also exists for an insertion device having a configuration that facilitates deployment of the mesh carrier from the insertion device.

Any aspects and examples not covered by the claims are provided as supplementary information useful for understanding the invention.

The insertion device includes an elongate member and a stylet. The elongate member has a proximal end portion, a distal end portion, and defines a lumen between the proximal end portion and the distal end portion. The stylet has a distal end portion and a proximal end portion. The stylet is slidably coupled to the elongate member such that the stylet is configured to move from a first position to a second position with respect to the elongate member. The distal end portion of the stylet is configured to removably couple a tissue anchor thereto. A portion of the distal end portion of the stylet is disposed outside of the lumen of the elongate member when the stylet is in its first position and is disposed within the lumen when the stylet is in its second position.

The elongate member is configured to contact the tissue anchor and decouple the tissue anchor from the distal end portion of the stylet in response to the stylet moving from its first position to its second position.

The insertion device and mesh carrier described herein can be inserted into a body of a patient, such as into bodily tissue. For example, the insertion device can be configured to deliver a first mesh carrier configured to selectively retain an implant (also referred to herein as a "filament", "tape", "implant", "mesh", "sling", or "strap") with respect to bodily tissue. A plurality of such mesh carriers can be anchored within the body of a patient at spaced locations while retaining a filament between the plurality of mesh carriers to provide support for other portions of the body (e.g., organs or portions of organs).

The insertion device is configured to place, deposit, or otherwise insert a mesh carrier into a bodily tissue of a patient. The filament is configured to suspend or support a bodily tissue or organ when the filament is retained within the patient by one mesh carrier. Thus, in one embodiment, the insertion device can place the mesh carrier into the obturator externus muscle for incontinence treatment. Specifically, first and second mesh carriers are placed in the obturator externus muscle of a patient and the filament is extended between the first and second mesh carriers to support the urethra or bladder neck of the patient. The insertion device can be a variety of different configurations and can have a variety of different components.

As used in this specification, the words "proximal" and "distal" refer to the direction closer to and further away from, respectively, an operator (e.g., surgeon, physician, nurse, technician, etc.) who would use an insertion device or a therapeutic device during a procedure. For example, the end of an insertion device first to contact the patient's body would be the distal end, while the opposite end of the insertion device (e.g., the end of the insertion device being operated by the operator) would be the proximal end of the insertion device. Similarly, the end of a insertion device implanted the furthest within the patient's body would be the distal end, while the opposite end of the insertion device (e.g., the end of the insertion device that is implanted the least amount within the body or the end of the insertion device that is disposed outside of the body) would be the proximal end.

<FIG> is a schematic illustration of an insertion device <NUM> according to an embodiment of the invention. The insertion device <NUM> can be inserted into a body of a patient, such as into bodily tissue.

The insertion device <NUM> has a proximal end portion <NUM> and a distal end portion <NUM>. The insertion device <NUM> includes an elongate member <NUM> and a stylet <NUM>. At least a portion of the elongate member <NUM> and a portion of the stylet <NUM> are configured to be inserted into a body of a patient. The elongate member <NUM> includes a proximal end portion <NUM> and a distal end portion <NUM> and is configured to move with respect to the stylet <NUM>.

The stylet <NUM>, in some embodiments, includes a proximal end portion <NUM> and a distal end portion <NUM>. The distal end portion <NUM> is configured to interact with a mesh carrier. The stylet <NUM> is configured to move with respect to the elongate member <NUM> from a first position to a second position.

When the stylet <NUM> is in its first position, a portion of the distal end portion <NUM> of the stylet <NUM> extends beyond the distal end portion <NUM> of the elongate member <NUM>, and is configured to be coupled to the mesh carrier. As the stylet <NUM> is moved proximally from its first position to its second position, the distal end portion <NUM> of the elongate member <NUM> contacts the mesh carrier preventing further proximal movement of the mesh carrier. When the stylet <NUM> is in its second position, the portion of the distal end portion <NUM> of the stylet <NUM>, which extended beyond the distal end portion <NUM> of the elongate member <NUM> when the stylet <NUM> was in its first position, is disposed within a lumen of the elongate member <NUM>. Thus, as the stylet <NUM> is moved from its first position to its second position, the mesh carrier is decoupled or removed from the distal end portion <NUM> of the stylet <NUM> and is released in bodily tissue.

In some embodiments, the elongate member defines a lumen extending between the proximal end portion and the distal end portion. In such an embodiment, the lumen is configured to receive the stylet.

In some embodiments, the proximal end portion of the stylet can be configured to be coupled to a handle.

Although a mesh carrier is used with insertion device <NUM> as described in the above disclosed embodiment, it should be understood that in some embodiments, a tissue anchor can be used.

<FIG> and <FIG> illustrate one embodiment an insertion device. Insertion device <NUM> has a proximal end portion <NUM> and a distal end portion <NUM> (which includes a portion of both an elongate member <NUM> and a stylet <NUM>). The elongate member <NUM> and stylet <NUM> are configured to be at least partially inserted into a body of a patient.

The elongate member <NUM> includes a proximal end portion <NUM> and a distal end portion <NUM>, and defines a lumen <NUM> (shown, for example, in <FIG>) that extends between the proximal end portion <NUM> and the distal end portion <NUM> and is configured to receive at least a portion of the stylet <NUM>. In the illustrated embodiment, the elongate member <NUM> of the insertion device <NUM> comprises a substantially flexible material, thereby permitting the elongate member <NUM> to conform to the shape of the stylet <NUM>.

As shown in <FIG>, <FIG>, and <FIG>, the elongate member <NUM> includes a base member <NUM> coupled to its proximal end portion <NUM>. The base member <NUM> includes a distal end portion <NUM>, a proximal end portion <NUM>, and further defines a portion of the lumen <NUM> of the elongate member <NUM>. Specifically, the base member <NUM> is configured to be disposed around or to be slidably coupled to at least a portion of the stylet <NUM> (described in more detail below). The distal end portion <NUM> is configured to be fixedly coupled to the proximal end portion <NUM> of the elongate member <NUM>. The distal end portion <NUM> of the base member <NUM> can be fixedly coupled to the elongate member <NUM> by any suitable coupling mechanism. For example, in some embodiments, the base member <NUM> and the elongate member <NUM> can be monolithically constructed.

The proximal end portion <NUM> of the base member <NUM> is configured to be disposed proximate a distal end portion <NUM> of a handle <NUM> when the stylet <NUM> is in a first position (shown, for example, in <FIG> and <FIG>) and is configured to be spaced apart from the distal end portion <NUM> of the handle <NUM> when the stylet <NUM> is in a second position (shown, for example in <FIG> and <FIG>). In the illustrated embodiment, the base member <NUM> is disposed on and is slidably coupled to a proximal end portion <NUM> of the stylet <NUM>.

In the illustrated embodiment, the base member <NUM> includes projections <NUM> and <NUM> extending therefrom, (shown in <FIG>) for preventing excessive proximal or distal movement of the elongate member relative to the stylet <NUM> (discussed in more detail herein). The base member <NUM> can be constructed of any suitable material. In one embodiment, the base member <NUM> can be constructed of a polymer. For example, the base member <NUM> can be constructed of acrylonitrile butadiene styrene (ABS).

The stylet <NUM> includes a distal end portion <NUM> and a proximal end portion <NUM>. The stylet <NUM> is slidably disposed within the lumen <NUM> defined by the elongate member <NUM>. As shown in <FIG>, the distal end portion <NUM> of the stylet <NUM> defines a first ridge <NUM>, a second ridge <NUM>, a tip <NUM>, and a tapered portion <NUM> extending between the second ridge <NUM> and the tip <NUM>. The tip <NUM> can be a variety of shapes, for example, in one embodiment, the stylet tip is pointed. In another embodiment, the stylet tip can be sharp. In yet another embodiment, the tip is blunt.

The distal end portion <NUM> of the stylet <NUM> is configured to extend through a lumen <NUM> (shown, for example in <FIG>, <FIG>, <FIG>, and <FIG>) defined by the mesh carrier <NUM>. The first ridge <NUM> is configured to interact with a proximal end portion <NUM> of the mesh carrier <NUM>. The second ridge <NUM> is configured to be disposed outside of the lumen <NUM> and interact with a distal end portion <NUM> of the mesh carrier <NUM> (described in more detail below).

The proximal end portion <NUM> of the stylet <NUM> is slidably coupled to the elongate member <NUM> and extends through the lumen <NUM> of the elongate member <NUM>. In the illustrated embodiment, the proximal end portion <NUM> includes detents 231a and 231b and a lip <NUM> (shown, for example, in <FIG> and <FIG>). The detents 231a are configured to mate with the projections <NUM>, <NUM> of the base member <NUM> of the elongate member <NUM> when the stylet <NUM> is in its first position (shown in <FIG>). The detents 231b and the lip <NUM> are configured to interact and/or contact the projections <NUM>, <NUM> of the base member <NUM> when the stylet <NUM> is moved proximally from a first position to a second position (shown in <FIG>).

As shown in <FIG>, at least a portion of the stylet <NUM> defines a first diameter. A portion of the proximal end portion <NUM> defines a second diameter different from the first diameter of the distal end portion <NUM>. In the illustrated embodiment, the second diameter is greater than the first diameter.

The proximal end portion <NUM> of the stylet <NUM> is coupled to a handle <NUM>. The handle <NUM> includes a proximal end portion <NUM> and a distal end portion <NUM>. As shown, for example, in <FIG>, <FIG>, and <FIG>, the distal end portion <NUM> of the handle <NUM> is fixedly coupled to the proximal end portion <NUM> of the stylet. Thus movement of the handle in a proximal direction with respect to the elongate member <NUM> causes the stylet to move in a proximal direction, and movement in a distal direction with respect to the elongate member <NUM> causes the stylet to move in a distal direction.

The handle <NUM> can be coupled to the stylet <NUM> by any known coupling mechanism, including, but not limited to, a clip, adhesive, interference fit, mating recesses, or the like. In another embodiment, the handle is coupled to the delivery assembly by any combination of the foregoing known coupling mechanisms. In other embodiments, the handle and the stylet can be monolithically constructed. In yet other embodiments, for example, the handle can be insert-molded to the stylet.

Although the handle <NUM> is illustrated as defining a contoured shape (shown, for example, in <FIG> and <FIG>), the handle <NUM> can define a variety of shapes, sizes, and configurations, such as a cylindrical shape. The handle <NUM> can further be constructed of any suitable material. For example, in some embodiments, the handle <NUM> can be constructed of at least one polymer. In other embodiments, for example, the handle <NUM> can be constructed of acrylonitrile butadiene styrene (ABS). In other embodiments, the handle <NUM> can include a thermoplastic elastomer (TPE) material covering a portion its outer surface to provide a practitioner a comfortable or secure gripping area.

The stylet <NUM> has a first position (i.e., an extended position), shown, for example, in <FIG> and a second position (i.e., a retracted position), shown, for example, in <FIG>. When the stylet <NUM> is in its first position, at least a portion of the distal end portion <NUM> of the stylet <NUM> extends from the lumen <NUM> at the distal end portion <NUM> of the elongate member <NUM>.

The portion of the distal end portion <NUM> is further configured to extend through the lumen <NUM> and out an opening 291b defined by the mesh carrier <NUM>. Specifically the stylet <NUM> is configured to extend through the lumen <NUM> and out of opening 291b of the mesh carrier <NUM> (as shown, for example, in <FIG>, <FIG>, and <FIG>) such that the first ridge <NUM> interacts with the proximal end portion <NUM> of the mesh carrier <NUM>, and the second ridge <NUM> defined by the distal end portion <NUM> of the stylet <NUM> interacts with distal end <NUM> of the mesh carrier <NUM>. The interaction of the first ridge <NUM> and the second ridge <NUM> with the mesh carrier helps retain the mesh carrier <NUM> on the distal end portion <NUM> of the stylet <NUM>. As the stylet <NUM> is moved from its first position to its second position, the distal end portion <NUM> of the elongate member <NUM> contacts the proximal end <NUM> of the mesh carrier <NUM> and prevents proximal movement of the mesh carrier <NUM>. When the stylet <NUM> is in its second position, as illustrated, for example, in <FIG>, the portion of the distal end portion <NUM> of the stylet <NUM>, which was disposed outside the lumen <NUM> when the stylet <NUM> was its first position, is disposed within the lumen <NUM> of the elongate member <NUM>. Specifically, in the illustrated embodiment, when the stylet <NUM> is moved proximally from its first position, the distal end portion <NUM> of the elongate member <NUM> contacts the proximal end <NUM> of the mesh carrier <NUM> maintaining its location within bodily tissue. The mesh carrier <NUM> is thereby decoupled or removed from the distal end portion <NUM> of the stylet <NUM> and is released in bodily tissue.

The stylet <NUM> can be constructed of any material suitable for insertion into a body of a patient. For example, in some embodiment, the stylet can be constructed of stainless steel. In other embodiments, the stylet can be constructed of a polymer.

<FIG> and <FIG> are perspective views of a mesh carrier <NUM> that can be used with the insertion device <NUM> described above. The mesh carrier <NUM> has a proximal end <NUM> and a distal end <NUM> and defines a lumen <NUM> extending from the proximal end <NUM> to the distal end <NUM>. The mesh carrier <NUM> is removably coupled to the distal end portion <NUM> of the stylet <NUM>, as shown, for example, in <FIG>, <FIG>, <FIG>, and <FIG>. The proximal end portion <NUM> defines an opening 291a in communication with the lumen <NUM>. The opening 291a is configured to receive the distal end portion <NUM> of the stylet <NUM>. The proximal end <NUM> of the mesh carrier <NUM> is proximate the distal end portion <NUM> of the elongate member <NUM> of the insertion device <NUM> when the stylet <NUM> is in its first position. The proximal end <NUM> contacts the distal end portion <NUM> while the stylet <NUM> is moved from its first position to its second position. Thus, by moving the stylet <NUM> in a proximal direction from its first position to its second position, the mesh carrier <NUM> is decoupled from the stylet <NUM>, and fixed to bodily tissue.

The proximal end portion <NUM> of the mesh carrier <NUM> further includes a retention portion <NUM>, an anchor portion <NUM> and defines an aperture <NUM>. The retention portion <NUM> includes four projections 295a, 295b, 295c, and 295d extending therefrom. The retention portion <NUM> is configured to retain or secure at least a portion of a filament <NUM> with respect to the mesh carrier <NUM>. Specifically, in the illustrated embodiment, the projections 295a-295d are configured to help prevent movement of the filament <NUM> with respect to the aperture <NUM> of the mesh carrier <NUM> when the mesh carrier <NUM> is placed into bodily tissue. The projections 295a-295d are configured such that when a portion of the filament <NUM> extends into the aperture <NUM>, the projections 295a-295d pierce the filament <NUM> to secure the filament <NUM> within the aperture <NUM> of the mesh carrier <NUM>. Thus, the filament <NUM> is retained in place with respect to the mesh carrier <NUM> by its interaction with the retention portion <NUM>.

Although the retention portion <NUM> is illustrated and described as including four projections 295a-295b, in one embodiment, the retention portion <NUM> includes three projections. In another embodiment, the retention portion <NUM> includes one or two projections. Alternatively, the retention portion <NUM> can include five of more projections.

Although the retention portion <NUM> is illustrated as including projections 295a-295d configured to engage or secure a filament <NUM>, in one embodiment, the retention portion <NUM> includes a different mechanism for retaining the filament <NUM> with respect to the mesh carrier <NUM>. For example, in one embodiment, the retention portion <NUM> includes a clip, an adhesive or the like. In another embodiment, the retention portion <NUM> includes any combination of a projection, clip, adhesive, or the like.

The anchor portion <NUM> of the mesh carrier <NUM> is configured to help retain at least a portion of the mesh carrier <NUM> in a body of a patient. The anchor portion <NUM> is configured to help prevent the mesh carrier <NUM> from moving through the bodily tissue in which it is placed. For example, in one application, the anchor portion <NUM> is configured to retain or anchor the mesh carrier <NUM> in one of the obturator internus or obturator externus muscles. As illustrated in <FIG> and <FIG>, the anchor portion <NUM> is disposed on or proximate to the proximal end portion <NUM> of the mesh carrier <NUM>. The anchor portion <NUM> includes protrusions 298a, 298b, 298c, 298d. The protrusions 298a-298d are configured to help anchor the mesh carrier <NUM> in the bodily tissue of the patient once the mesh carrier <NUM> is placed within the bodily tissue.

In the embodiment illustrated in <FIG> and <FIG>, the protrusions 298a-298d are configured to extend outwardly from the mesh carrier <NUM> such that when the mesh carrier <NUM> is placed into bodily tissue and the insertion device is removed, bodily tissue may regress behind the mesh carrier <NUM>, thus helping to anchor the mesh carrier <NUM> in the bodily tissue.

The aperture <NUM> is configured to receive at least a portion of the filament <NUM> (shown in <FIG>) such that the filament <NUM> is disposed adjacent to the stylet <NUM> (not shown). The aperture <NUM> can be configured to provide little or no resistance to movement or adjustment of the filament <NUM>. For example, the aperture <NUM> can have an opening greater in size than the width or thickness of the filament <NUM>. In such an embodiment, the filament <NUM> can be readily placed within aperture <NUM>, meeting minimal or no resistance, before the filament <NUM> is pierced by the projections 295a-295d.

In an another embodiment, the aperture <NUM> can be configured to provide a friction fit with the filament <NUM> passed through (or received within) the aperture <NUM>. For example, the aperture <NUM> can be configured to be slightly less (or narrower) than the thickness of the filament <NUM>. In such an embodiment, a force must be applied to move the filament <NUM> through the aperture <NUM>. This configuration would allow the filament <NUM> to be further secured by the mesh carrier <NUM>.

The aperture <NUM> can have any suitable size or shape configured to receive the filament <NUM>, for example the shape can be a U-shape, square, rectangle, or any other shape configured to receive a filament <NUM>.

The mesh carrier <NUM> can be constructed of any material suitable for implantation into bodily tissue. For example, the mesh carrier <NUM> can be constructed of implantable grade polypropylene, implantable grade metal, a polymer, a biocompatible material, or any combination thereof. Suitable biocompatible materials include bioabsorbable, cadaveric, and bovine materials.

In some embodiments, the mesh carrier <NUM> can be preassembled with the filament <NUM> at a manufacturing facility. The preassembled set can include two mesh carriers <NUM> and <NUM> and a filament <NUM> of a specified or known length. For example, as shown in <FIG>, a first end portion 205a of the filament <NUM> can be inserted and secured with respect to a first mesh carrier <NUM> at the manufacturing facility. Additionally, a second end portion 205b of the filament <NUM> can be inserted and secured with respect to a second mesh carrier <NUM>. Specifically, in the illustrated embodiment, the first end portion 205a of the filament <NUM> is pierced by the projections 295a and 295b (others not shown) of the first mesh carrier <NUM> thereby retaining the first end portion 205a of the filament <NUM> within the retention portion <NUM> of the first mesh carrier <NUM>. The second end portion 205b of the filament <NUM> is pierced by the projections 395c and 395d (others not shown) of the second mesh carrier <NUM> thereby retaining the second end portion 205a of filament <NUM> within the retention portion <NUM> of the second mesh carrier <NUM>. The filament <NUM> extends between the first mesh carrier <NUM> and the second mesh carrier <NUM> creating a fixed length L of filament <NUM>.

The filament <NUM> as discussed above can be constructed of many different suitable materials and have many different suitable configurations. For example, in some embodiments, a polymer mesh implant can be used, which can be used to support the urethra. In other embodiments, a polyform material can be used.

In some embodiments, at least a portion of the filament can be reinforced, such as with a reinforcing material. The reinforcing material, or reinforced portion of the filament, can be configured to assist in suspending or supporting the bodily tissue or organ. In one embodiment, the filament can be reinforced by a suture.

In some embodiments, at least a portion of the filament can include tangs or a tanged portion to grip or attach to a portion of bodily tissue. The terms "tanged" or "tangs" as used herein mean roughened or jagged edges or areas, such as can result from cutting a woven or knit mesh material or filament. The tangs enhance anchoring of the filament within bodily tissue, such as pubo-urethral tissue. In one embodiment, the filament includes tangs on an edge along an entire length of the filament. In another embodiment, tangs are only on the end portions of the filament.

In other embodiments, the filament can be untanged, or detanged, such as by heating the tangs on a polymer mesh so that they fuse and bead up to form a smooth finish.

In some embodiments, the filament can include a coating. For example, the filament can include a polymeric coating. In another example, the filament can include a therapeutic agent coating.

In some embodiments, the filament can be porous. A porous filament defines openings, or pores, in the filament or between threads of material forming the filament. For example, in one embodiment, the filament is a mesh. The filament can be a micro-porous mesh in which the openings, or pores, are small.

<FIG> illustrates an example of the first mesh carrier <NUM> and the second mesh carrier <NUM> anchored in bodily tissue T of the pelvic region of a patient. A first end portion 205a of a filament <NUM> is retained by the first mesh carrier <NUM> and a second end portion 205b of the filament <NUM> is retained by the second mesh carrier <NUM>. Specifically, the filament <NUM> extends between the first mesh carrier <NUM> and the second mesh carrier <NUM> to provide support to the target tissue T or organ, such as the urethra.

Although the stylet <NUM> as illustrated in <FIG> has a curved configuration, it should be understood that other configurations are possible. As shown, for example in <FIG> and <FIG>, stylet <NUM> can have a substantially straight, or linear, configuration. In such embodiments, a portion of the distal end portion <NUM> is configured to extend through the mesh carrier (not shown). Specifically, the stylet <NUM> is configured to extend through the lumen and out of the opening of the mesh carrier such that the second ridge <NUM> defined by the distal end portion <NUM> of the stylet <NUM> interacts with distal end of the mesh carrier and helps retain the mesh carrier on the distal end portion <NUM> of the stylet <NUM>. As the stylet <NUM> is moved from its first position to its second position, the distal end portion <NUM> of the elongate member <NUM> contacts the proximal end of the mesh carrier and prevents proximal movement of the mesh carrier. When the stylet <NUM> is in its second position, as illustrated, for example, in <FIG>, at least a portion of the distal end portion <NUM> of the stylet <NUM> is disposed within the lumen of the elongate member <NUM>. Specifically, in the illustrated embodiment, when the stylet <NUM> is moved proximally from its first position, the distal end portion <NUM> of the elongate member <NUM> contacts the proximal end of the mesh carrier maintaining its location within bodily tissue. The mesh carrier is thereby decoupled or removed from the distal end portion <NUM> of the stylet <NUM> and is released in bodily tissue.

Further examples of such insertion devices with stylets having linear configurations are described in <CIT>and <CIT>. The disclosures of <CIT> and <CIT>. Additional variations in size, shape, and configurations are also described in the above noted publications.

<FIG> is a flowchart of a method <NUM> for delivering a mesh carrier into bodily tissue of a patient using an insertion device according to an embodiment of the invention.

At <NUM>, the mesh carrier is coupled to the stylet of the insertion device. For example, the distal end portion of the mesh carrier is engaged with the distal end portion of the stylet.

In some embodiments, at least a portion of a filament is inserted into the aperture defined by the mesh carrier prior to the coupling of the mesh carrier to the stylet,
In some embodiments, the mesh carrier is coupled to or engaged with the distal end portion of the stylet when the stylet is in its first position. In such an embodiment, the distal end portion of the stylet extends through the lumen defined by the mesh carrier and is disposed adjacent the filament retained in the retention portion (e.g., projections) of the mesh carrier.

At <NUM>, the insertion device is inserted into a body of a patient. For example, in one embodiment, the insertion device is inserted into the body of the patient through an incision made in bodily tissue. In a procedure for urinary incontinence, a transvaginal approach may be used to insert the delivery instrument into the body of the patient.

At <NUM>, the mesh carrier is positioned proximate to a desired portion of bodily tissue, and, the mesh carrier is inserted into the bodily tissue. For example, in a procedure for female urinary incontinence, the mesh carrier is inserted into one of the obturator internus or obturator externus muscles. In one embodiment, an anterior vaginal incision is made, and the mesh carrier is inserted into the bodily tissue through such incision.

At <NUM>, the stylet is moved from its first position to its second position. Specifically, in the illustrated embodiment, the stylet is moved in a proximal direction, from its first position to its second position, so that the distal end portion of the stylet is withdrawn from the lumen of the mesh carrier. By withdrawing the distal end portion of the stylet from the lumen of the mesh carrier and disposing the distal end portion within the lumen of the elongate member, the distal end portion of the elongate member contacts the proximal end portion of the mesh carrier thereby maintaining the mesh carrier's position within the bodily tissue as the stylet is removed from the lumen of the mesh carrier. Thus, the mesh carrier is decoupled or removed from the stylet thereby fixing the mesh carrier and filament within the bodily tissue. For example, in one procedure, a practitioner concurrently pulls the handle of the elongate member in a proximal direction while holding the base member of the elongate member substantially stationary.

In some embodiments, the elongate member is moved from a first position to a second position while maintaining the stylet substantially stationary. The elongate member moves relative to the stylet, in a distal direction, from a first position to a second position, such that the distal end portion of the elongate member contacts the proximal end portion of the mesh carrier to decouple the mesh carrier from the stylet. For example, in one procedure, a practitioner concurrently holds the handle of the stylet substantially stationary while pushing the base member of the elongate member in the distal direction to move the elongate member to its second position.

At <NUM>, the insertion device is withdrawn from the body of the patient.

Although the method of delivering a mesh carrier into bodily tissue has been illustrated and described in one order, the activities can occur in a different order. For example, in some embodiments, the mesh carrier is engaged with the stylet of the insertion device prior to inserting the filament into the aperture defined by the mesh carrier.

A method for delivering a mesh carrier into bodily tissue of a patient can include delivering more than one mesh carrier for securing a filament to bodily tissue. For example, in one embodiment, as illustrated in <FIG>, two mesh carriers are delivered into bodily tissue of the patient. Alternatively, three, four, or more mesh carriers can be delivered into bodily tissue of the patient. In an embodiment with two or more mesh carriers, the first mesh carrier is delivered as described above. The tension of the filament can be adjusted by inserting the second mesh carrier to a specific location within the patient.

In one embodiment, an insertion device includes an elongate member and a stylet. The elongate member has a proximal end portion, a distal end portion, and defines a lumen therethrough. The stylet has a distal end portion, a proximal end portion, and is slidably coupled to the elongate member. The stylet is configured to move from a first position to a second position with respect to the elongate member. The distal end portion of the stylet is configured to removably couple a mesh carrier thereto. A portion of the distal end portion of the stylet is disposed outside of the lumen of the elongate member when the stylet is in its first position and is disposed within the lumen when the stylet is in its second position.

In some embodiments, the stylet includes a curved portion. The distal end portion of the stylet has a first diameter and the proximal end portion of the stylet has a second diameter. The second diameter is greater than the first diameter. The distal end portion of the stylet defines a ridge, a tip, and a tapered portion extending between the ridge and the tip. The ridge is configured to interact with the mesh carrier and is configured to be disposed outside of and contact a distal end portion of the mesh carrier. The distal end portion of the stylet is configured to extend through a lumen defined by the mesh carrier and extend outside of a distal end portion of the mesh carrier.

In some embodiments, the proximal end portion of the elongate member includes a base portion having at least one protrusion. The proximal end portion of the stylet includes a stopping portion configured to engage the at least one protrusion of the base portion. The proximal end portion of the stylet includes a stopping portion having lip. The lip is configured to engage a protrusion of the elongate member when the stylet is moved from its first position to its second position.

In some embodiments, the insertion device includes a handle coupled to the stylet. The proximal end portion of the elongate member is configured to contact a distal end portion of the handle when the stylet is in its first position and is configured to be spaced apart from the distal end portion of the handle when the stylet is in its second position.

In some embodiments, the distal end portion of the elongate member is configured to contact the mesh carrier when the stylet is moved from its first position to its second position. The distal end portion of the elongate member is configured to contact a proximal end portion of the mesh carrier to decouple the mesh carrier from the stylet when the stylet is moved from its first position to its second position.

In some embodiments, the stylet includes stainless steel.

In another embodiment, an insertion device includes an elongate member and a stylet. The elongate member has a proximal end portion, a distal end portion, and defines a lumen therethrough. The stylet has a distal end portion and a proximal end portion and is configured to move from a first position to a second position. The distal end portion of the stylet is configured to removably couple a mesh carrier thereto. The distal end portion of the stylet is coupled to the mesh carrier when the stylet is in its first position. The elongate member is configured to contact the mesh carrier and decouple the mesh carrier from the distal end portion of the stylet when the stylet is moved from its first position to its second position.

In some embodiments, the distal end portion of the elongate member is configured to contact a proximal end portion of a mesh carrier when the stylet is in its first position. The distal end portion of the stylet defines a ridge, a tip, and a tapered portion extending between the ridge and the tip, the ridge being configured to interact with the mesh carrier. The proximal end portion of the elongate member includes a base portion. The base portion has at least one protrusion. The stylet has a stopping portion configured to engage the at least one protrusion of the base portion.

In yet another embodiments, a mesh carrier has a proximal end portion, a distal end portion, and defines a lumen between the proximal end portion and the distal end portion. The proximal end portion defines an aperture configured to receive a portion of a filament therein. The proximal end portion includes a retention portion to secure the portion of the filament with respect to the mesh carrier. The lumen is configured to receive a stylet therein wherein the stylet is disposed adjacent the filament. The distal end portion of the mesh carrier is configured to interact with the stylet.

In some embodiments, the retention portion of the proximal end portion of the mesh carrier includes projections configured to pierce the portion of the filament.

In some embodiments, the mesh carrier includes an anchor portion configured to anchor the mesh carrier in a bodily tissue of a patient.

In another embodiment, a method includes coupling a mesh carrier to a distal end portion of a stylet of an insertion device, wherein the stylet is movably coupled to an elongate member, inserting the insertion device into a body of a patient, moving the stylet with respect to the elongate member from a first position to a second position to decouple the mesh carrier from the stylet of the insertion device; and removing the insertion device from the body.

In some embodiments, the coupling of the mesh carrier includes moving the stylet to its first position such that a distal end portion of the stylet extends beyond a distal end portion of the elongate member. The coupling of the mesh carrier also includes inserting the stylet into a lumen defined by the mesh carrier such that a ridge defined by the distal end of the stylet interacts with the mesh carrier.

In some embodiments, the moving of the stylet to its second position includes moving the stylet in a distal direction.

In some embodiments, the method includes coupling a second mesh carrier to a distal end portion of the stylet and inserting the insertion device into the body of the patient, moving the stylet with respect to the elongate member from its first position to its second position to decouple the second mesh carrier from the insertion device, and removing the insertion device from the body.

While various embodiments of the invention have been described above, it should be understood that they have been presented by way of example only, and not limitation. Thus, the scope of the invention should not be limited by any of the above-described embodiments, but should be defined only in accordance with the following claims While the invention has been particularly shown and described with reference to specific embodiments thereof, it will be understood that various changes in form and details may be made.

Claim 1:
An insertion system comprising an insertion device (<NUM>) and additionally comprising a tissue anchor, the insertion device (<NUM>) comprising:
an elongate member (<NUM>) having a proximal end portion (<NUM>), a distal end portion (<NUM>), and defining a lumen (<NUM>) therethrough; and
a stylet (<NUM>) having a distal end portion (<NUM>), a proximal end portion (<NUM>), and being slidably coupled to the elongate member (<NUM>),
the stylet (<NUM>) being configured to move from a first position to a second position with respect to the elongate member (<NUM>),
the distal end portion (<NUM>) of the stylet (<NUM>) being configured to removably couple the tissue anchor thereto,
a portion of the distal end portion (<NUM>) of the stylet (<NUM>) being disposed outside of the lumen (<NUM>) of the elongate member (<NUM>) when the stylet (<NUM>) is in its first position, the portion of the distal end portion (<NUM>) of the stylet (<NUM>) being disposed within the lumen (<NUM>) when the stylet (<NUM>) is in its second position,
wherein the tissue anchor and the stylet (<NUM>) are configured for coupling of the tissue anchor to the stylet (<NUM>), wherein the coupling includes moving the stylet (<NUM>) to its first position such that a distal end portion (<NUM>) of the stylet (<NUM>) extends beyond a distal end portion of the tissue anchor, wherein the coupling of the tissue anchor also includes inserting the stylet (<NUM>) into a lumen defined by the tissue anchor such that a ridge (<NUM>) defined by the distal end portion (<NUM>) of the stylet (<NUM>) is configured to interact with the tissue anchor.