Cross-Reference to Related Application

This application claims priority to U.S. Provisional Application for Patent Serial No. 61/637,317 filed April 24, 2012, the disclosure of which is incorporated herein by reference in its entirety.

TECHNICAL FIELD

Described herein is a flexible medical insertion device that is rigid and capable of piercing tough tissue and having a flexible and maneuverable probe. The flexible insertion device permits sutures or medical items to be ins erted or manipulated in anatomic situations where flexibility during insertion is desired.

BACKGROUND

Various devices and methods are known for inserting medical items, such as sutures, in connection with arthroscopic, endoscopic, or other surgical procedures. Although many existing devices are satisfactory for their intended purposes, there is a need for devices that can pierce tough tissue and provide flexibility and maneuverability for exact placement or manipulation of the medical item. The devices described herein fulfill this unmet need.

SUMMARY

Described herein is a flexible medical insertion device that is rigid and capable of piercing tough tissue and having a flexible and maneuverable insertion tip. The flexible insertion device permits sutures or medical items to be inserted or manipulated in anatomic situations where flexibility during insertion is desired.

One embodiment described herein is a flexible insertion device comprising a handle; a shaft connected axially to the handle and extending distally from the handle; a flexible segment of the shaft, distal to the handle, and proximal to a probe tip; a means for stiffening the flexible segment of the shaft; a means for flexing or bending the flexible segment of the shaft; and a means for deploying a medical item through an orifice in the probe tip. One aspect described herein is a flexible insertion device wherein the flexible segment of the shaft comprises: a plurality of articulated interlocking components; a flexible, multilumen extrusion; a flexible, multi-lumen extrusion comprising a plurality of notches; or a flexible multi-lumen extrusion comprising a stiffening rib. Another aspect described herein is a flexible insertion device wherein the stiffening means comprises a solid rod; a hollow tube; or an external tube.

One aspect described herein is a flexible insertion device wherein the means for bending the flexible segment of the shaft comprises an articulation wire or a suture.

In other embodiments described herein, the flexible insertion device comprises a suture passer, a suture anchor placement device, graft insertion device, a medical implant insertion device, or a medical item manipulation device. Another embodiment described herein is a flexible insertion device comprising a suture passer, comprising a handle; a hollow shaft, proximately attached to the handle and having a distal flexible segment connected to a probe tip having an orifice; a multi-lumen extrusion contained within the hollow shaft and operatively attached to the handle; a stiffening means that traverses at least one lumen of the multi-lumen extrusion and is capable of (a) being deployed by extension into the shaft, thereby stiffening the flexible segment of the shaft or; (b) retracted into the handle, thereby de-stiffening the flexible segment of the shaft; an articulation wire that traverses at least one lumen of the multi-lumen extrusion and flexes the flexible and maneuverable segment of the shaft; a suture that traverses at least one lumen of the multi-lumen extrusion and is capable of being extended through the orifice of the probe tip; a means for deploying and retracting the stiffening tube; a means for articulating and flexing the flexible segment of the shaft; and a means for deploying and retracting the suture. Another embodiment described herein is a flexible insertion device comprising a suture passer, comprising a handle; a hollow shaft, proximately attached to the handle and having a distal flexible segment connected to a probe tip having an orifice; a multi-lumen extrusion contained within the hollow shaft and operatively attached to the handle; a stiffening means that externally encases the axis of hollow shaft and is capable of being (a) deployed by extension over the shaft, thereby encasing the flexible segment of the shaft or; (b) retracted into the handle, thereby exposing the flexible segment of the shaft; an articulation wire that traverses at least one lumen of the multi-lumen extrusion and flexes the flexible and maneuverable segment of the shaft; a suture that traverses at least one lumen of the multi-lumen extrusion and is capable of being extended through the orifice of the probe tip; a means for deploying and retracting the stiffening tube; a means for articulating and flexing the flexible segment of the shaft; and a means for deploying and retracting the suture. Another embodiment described herein is a method of using a flexible insertion device for inserting or manipulating a medical item comprising: inserting the insertion device tip into the tissue; flexing or maneuvering the insertion device tip into position for the procedure; deploying a medical item; manipulating the medical item; and removing the insertion device tip.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGURE 1 illustrates a means for flexing the flexible segment of the flexible insertion device.

FIGURE 2 illustrates three examples of stiffening means useful for the flexible insertion device.

FIGURE 3: illustrates how the flexible region of the flexible insertion device maintains rigidity when fully or partially flexed owing to contact and stacking between articulated segments.

WCSR 7743300vl FIGURE 4 illustrates how a suture can be deployed at any angle of flexion of the tip of the flexible insertion device.

FIGURE 5 illustrates a schematic of one exemplary embodiment of a flexible insertion device comprising a suture passer.

FIGURE 6 illustrates a schematic of the internal components of one exemplary embodiment of a flexible insertion device comprising a suture passer. FIGURE 7 illustrates a schematic of the internal components of one exemplary embodiment of the stiffening means of a flexible insertion device comprising a suture passer.

FIGURE 8 illustrates alternative aspects for the flexible segment of the shaft of a flexible insertion device.

FIGURE 9 shows photographs of a prototype flexible insertion device comprising a suture passer.

FIGURE 10 shows photographs of a prototype flexible insertion device comprising a suture passer demonstrating the flexibility of the flexible segment and showing that the suture can be deployed when the instrument tip is flexed.

DETAILED DESCRIPTION

Described herein is a flexible insertion device. When performing various medical or surgical procedures it is often necessary to puncture tough tissue to reach a placement site for a medical item. In addition, a flexible and rotatable tip is often useful for maneuvering a medical item in place for implantation, fixation, or manipulation. Accordingly, there is a need for an insertion device that is rigid for piercing tough tissue and that is flexible and maneuverable for delicate or exact placement or manipulation of a medical item.

In one embodiment, the flexible insertion device described herein can comprise a handle; a shaft connected axially to the handle and extending distally from the handle; a flexible a segment of the shaft, distal to the handle, and proximal to a probe tip; a means for stiffening the flexible segment of the shaft; a means for flexing or bending the flexible segment of the shaft; and a means for deploying a medical item through an orifice in the probe tip. In one embodiment described herein, the flexible insertion device can comprise a suture passer. In other embodiments, the flexible insertion device can comprise an insertion device for placing suture anchors, grafts, medical implants or other medical items. In other embodiments, the flexible insertion device can be used to manipulate medical items in situ. Referring to FIG. 1, an exemplary illustration of the distal insertion tip of a flexible insertion device as described herein is shown. FIG. 1 (A) shows the distal insertion tip of the flexible insertion device described herein when the stiffening means 105 is extended to the tip of the shaft 100, adjacent to the probe tip 110, and the flexible segment 125 of the shaft is rigid. As used herein, the phrase "insertion tip" comprises the flexible segment 125 of the shaft and the probe tip 110. The flexible segment of the shaft 125 may have cutouts 130 as shown in Panel (B) of FIG. 1, so that when the stiffening means 105 is partially retracted from the flexible segment and an articulation wire (or suture) 135 is tensioned by pulling toward the handle, the flexible segment of the shaft 125 begins to curve inward toward the cutouts 130. FIG. 1 (C) illustrates that when the stiffening means 105 is fully retracted from the flexible segment of the shaft 125 and as the articulation wire 135 is pulled toward the handle, the tension compresses the cutouts or articulated components 130 of the shaft and the flexible segment 125 curves at an approximately 90° angle. By varying the position of the stiffening means 105 and the tension of the articulation wire, the insertion tip can be flexed and maneuvered into a variety of positions for manipulation of a medical item.

FIG. 2 illustrates alternative stiffening means. For example, the stiffening means 105 can comprise (Panel A) a hollow tube 140 or (Panel B) a solid rod 145 encased within the hollow shaft 100. Alternatively, the stiffening means can be an external tube 150 (Panel C) that encloses the hollow shaft 100 and covers the flexible segment of the shaft 125 to rigidify it from the exterior. FIG. 3 il lustrates that stiffness is maintained in the insertion device shaft and tip after curving the flexible segment. (A) When the stiffening means 105 is fully retracted and the flexible segment of the shaft 125 is in a curved position, stiffness of the flexible region is maintained by contact among the flat edges of the cutouts or articulated components of the shaft 130. (B) Stiffness is also maintained when the stiffening means 105 is partially retracted and the flexible segment of the shaft 125 is partially curved. The stiffening means 105 imparts rigidity of the distal region of the flexible segment of the shaft 125 and the proximal region is rigidified by contact among the flat edges of the cutouts or articulated components of the shaft 130.

FIG. 4 illustrates how a medical item 120 can be deployed at any angle of the flexible region 125 of the insertion tip and under various settings of the stiffening means 105. In the exemplary embodiment shown in FIG. 4, the flexible insertion device is a suture passer and the medical item is a suture. Panel (A) illustrates the flexible segment 125 in a straight position (~180°) with the stiffening means 105 fully deployed throughout the flexible segment 125. Panel (B) illustrates the flexible segment 125 in a partially curved position (~30 ^e angle) with the stiffening means 105 partially deployed in the flexible segment 125 and the articulation wire 135 partially tensioned. Panel (C) illustrates the flexible segment 125 in a fully curved position (~90 ^e angle) with stiffening means 105 fully retracted out of the flexible segment 125 and the articulation wire 135 fully tensioned. A medical item, such as a suture, may also be deployed by hand, or by manipulation with another instrument.

FIG. 5 illustrates a non-limiting, exemplary schematic of one embodiment of a flexible insertion device described herein. In this embodiment, the flexible insertion device is a suture passer. The flexible insertion device comprises a handle (160 and 165), a shaft 100 with an articulated, flexible segment 125, comprising cutouts or articulated components of the shaft 130, a probe tip 110 comprising an orifice 115, a stiffening means 105, a means for deploying or retracting 170 the stiffening means 105, and a means for deploying or retracting 185 an articulating wire 135 and/or a medical item, such as a suture, for example (not shown). FIG. 6 illustrates a non-limiting, exemplary schematic showing internal components of one embodiment of a flexible insertion device described herein. In this embodiment, the flexible insertion device is a suture passer. The means for deploying or retracting 180 a stiffening means 105, comprises a toggle wheel 170 spinning on an axis 180 and comprising a gear 190 that engages a geared slide 195 attached to the stiffening means 105, which can move forward or reverse within a manifold 200. The medical item, which in this example comprises a suture, 120 can be deployed by depressing a plunger 185 attached to a spring 205 within a manifold 210.

FIG. 7 illustrates a detailed exemplary view of a means for deploying or retracting 170 the stiffening means 105, consists of a toggle wheel 170 spinning on an axis 180 and comprising a gear 190 that engages a geared slide 195 attached to the stiffening means 105 and/or the articulation wire 135 which can move forward or reverse within a manifold 200. In panel A, the stiffening means (not shown) is fully retracted from the flexible segment 125 (not shown in diagram) and the articulation wire 135 is tensed, making the insertion tip flex a at an approximately 90° angle (not shown). As the toggle wheel 170 is rotated counterclockwise (toward the rear of the handle), the stiffening means 105 is deployed into the articulated segment of the shaft 125 (not shown) and the tension of the articulation wire 135 is relaxed. In panel B, the stiffening means 105 is fully deployed within the flexible segment 125, stiffening it (not shown in diagram) and the articulation wire 135 is fully relaxed.

FIG. 8 illustrates alternative embodiments of the flexible segment of the shaft 125. The flexible segment 125 of the shaft can comprise a: (A) flexible multi-lumen extrusion 215; (B) a laser-cut metal tubing with articulated, interlocking components 220; or (C) a stiffer, multi- lumen extrusion comprising a rib for increased rigidity 225.

Although one configuration of the insertion tip is shown in the drawings, the shape, size, and material of the insertion tip are not particularly limited. The shape and size of the insertion tip can be adapted depending on the surgical location and procedure. For example, the insertion tip can be straight, curved, angled, or corkscrewed. The insertion tip can be made of plastic, metal, PVDF, or other material that is suitable for use in surgical procedures and sufficiently rigid to pierce tissue. FIG. 9 shows photographs of a prototype flexible insertion device comprising a suture passer. In panel A, the flexible insertion device comprising a suture passer is shown. Panel B shows a close of up the flexible insertion device tip. The flexible segment 125 of the shaft, cutouts 130, probe tip 110, and a suture 120 are visible.

FIG. 10 shows photographs of a prototype flexible insertion device comprising a suture passer demonstrating the flexibility of the flexible segment and showing that the medical item, a suture, can be deployed when the insertion tip is flexed. Panel A shows the insertion tip when the stiffening means 105 (not visible) is fully retracted from the flexible segment 125 and the articulation wire 135 (not visible) is tensed, making the insertion tip flex a at an approximately 90° angle. The cutouts 130 are visible in the flexible segment of the shaft 125. Panel B shows a suture 120 being deployed by the operator depressing the plunger 185 (not visible) after the insertion tip had been flexed. Panel C shows the insertion tip flexed at an approximately 135° angle, near maximal tension of the articulation wire after deploying the suture 120. This sequence of photographs demonstrates that the insertion tip can be flexed before and/or after deploying a medical item.

The scope of the devices described herein includes all combinations of embodiments, aspects, examples, and preferences herein described.