JP2003501132A - Bone suturing device - Google Patents

Abstract

(57) Abstract: A device for boring a bone is a needle base, a pivot, and at least one curved needle having a tip at one end of the needle and rotatably mounted on the needle base. The needle and pivot are configured and adapted such that the needle is pushed into the bone when the tip is positioned against the bone tissue and the needle rotates about the pivot. Have been. Optionally, the at least one needle includes at least two needles.

Description

Detailed Description of the Invention

RELATED APPLICATION This application is related to US patent application Ser. No. 09/476, filed December 30, 1999.
, 682 is a partial continuation application. The disclosure content of the same application is incorporated herein by reference.

[0002]   (Field of the invention)   The present invention relates to the formation of channels through bone.

BACKGROUND OF THE INVENTION Adding sutures to bone is a well known task in the surgical field. A common solution is to thread a threaded thread through the bone. However, the screwdrivers used in performing this task are often complex and / or expensive. Another solution is described, for example, in US Pat. No. 5,520,700 to Beyar et al., Which involves inserting a threaded bone anchor into the bone. The disclosure content of the same application is incorporated herein by reference. A potential disadvantage of both this technique and the technique described above is that hard foreign bodies are embedded in the body.
In general, it is desirable to minimize the amount of foreign matter placed in the human bone. In addition, screw anchors and bone anchors typically cause a significant amount of damage to the bone,
Not desirable.

PCT Publication No. WO 97/47246 describes a suture insertion device that contemplates forming a channel in the bone and connecting a suture therethrough. In the present specification, the disclosure content of the document is incorporated by reference. The needles for forming the curved channels proposed in this PCT publication are either curvilinear or superelastic needles curving in bone. Generally, these needles are inserted perpendicular to the bone by pushing the needle along the appropriate hole. Another proposed method is to drill with a rotary drill along a curved path. However, it should be noted that such drills generally damage large amounts of bone.

Bioelectronic, Inc. Devices are commercially available from ("CurvTek") that use a pneumatically driven rotary drill bit to drill from both ends of the path along a curved path in bone.

SUMMARY OF THE INVENTION It is an object of some embodiments of the present invention to secure a suture to bone and to minimize damage to the bone and / or to minimize the amount of foreign material implanted. In particular,
A method of minimizing the embedding of hard objects.

One aspect of some embodiments of the invention relates to attaching a bone piercing needle to a rotating hinge. One desirable result from this structure is that it provides more efficient power transmission to the needle tip. Another desired result is
It is easy to build. Another desirable result is controllable and / or in bone
Or the point that the route that can be known increases. It should be noted that some or all of these desirable results (and other results described herein) may not be achieved in some embodiments of the present invention.

One aspect of some embodiments of the invention relates to piercing a channel in bone using two opposing needles. One desirable result is that more of the force exerted on the needle is used to pierce the bone rather than push it out of the bone. In some embodiments, the needles are in the same plane. If necessary, the needle is curved. Alternatively, the needle is straightened. In some embodiments, the bone-free but cont
The anvil that gives the other needles a ra-force) is one of those needles.
Replaced by a book.

An aspect of some embodiments of the invention relates to the cross section of a needle used for drilling bone. Needles are smooth as needed. Alternatively, the needle is provided with a groove. If necessary, the cross section is circular. However, other cross sections (eg, flat rectangles, triangles and ovals) may be used. If desired, the cross-sectional shape changes along the length of the needle, presenting, for example, a spiral cross-section.

An aspect of some embodiments of the invention relates to inserting a bone piercing needle into bone at an angle that is substantially different from vertical. Optionally, two or more needles are provided, the needles facing each other and simultaneously exerting forces on the bone in opposite directions and having a major force vector towards a common point.

Another consequence of inserting the bone at a non-perpendicular angle is that, even if the bone is flat or concave, the resulting path is not a perfect semicircle, but an arc. As described herein, in some cases it is possible to drill more than a half circle. Although arcuate paths are preferred, other curves may be formed in some embodiments of the invention. Further, although the curves are optionally planar, in some embodiments herein, the curves are non-planar, such as bi-planer (the bisection of the curve). Are on different planes).

An aspect of some embodiments of the invention relates to a method of drilling into bone.
In this method, a drill is used to penetrate the cortex of the bone and one or two needles are used to puncture the medulla of the bone. In one embodiment of the invention, the drill is straight and the needle is curved so that the needle meets inside the bone. If desired, the drill does not move other than rotate about its axis. Alternatively, the drill moves along a curved path (eg, the path defined by the needle). The needle may instead of or in addition to being curved,
It is a straight line. In one embodiment of the invention, the needle (and optionally the thread) passes through a drill bit. In some embodiments of the invention, the needle does not move over the hinge when drilling the cortex. In another embodiment of the invention, the drill bit pierces all or almost all medulla and meets inside the bone. In some embodiments, the drill bit is curvilinear. The needle can be curved or straight to complete a small portion of the drilling that the drill bit does not.

In one embodiment of the invention, there is only one needle extending from one drill bit to another. If desired, the needle has a removable tip at its end that mates with another drill bit. In one embodiment, the bit, when mated with the drill bit, rotates so that it does not disengage from the bone when the drill and tip are retracted. In some embodiments of the invention, the needle moves within the lumen defined by the drill bit. In other embodiments, the needle moves along a groove defined by the drill bit.

An aspect of some embodiments of the invention relates to a drill bit for piercing bone that includes an opening for passing a needle through an opening in the drill bit. Optionally, the opening is in the side of the drill bit. In one embodiment of the invention, the drill bit is mounted in the drill head. The drill head mechanically synchronizes the angular position of the drill bit with the extension path of the needle. Alternatively,
Advancement of the needle releases the drill bit to allow free rotation, which allows advancement of the needle to rotate the drill bit to the desired angular position. Alternatively, a method of electrical synchronization is also used, in which the drill bit is fully rotated a few times to properly align when the drill bit is stopped. Alternatively, the needle is delivered through the tip of the drill bit. If necessary, the needle forms a hole in the drill bit when extended. The drill bit performs a reciprocating motion instead of or in addition to rotating.

An aspect of some embodiments of the invention relates to a method of transmitting power from a power source to a tip of a bone piercing needle. If desired, power is provided using a lever. In one embodiment of the invention, the major leverage points are provided at or around the needle. If desired, a second leverage point is provided further away from the needle and away from the power source. In one embodiment of the invention, the power source is the human hand that moves the lever relative to the handle. If desired, movement of this handle lever is transmitted using a cable or bar to a second lever adjacent the bone piercing needle. One of the desirable results obtained by providing this action in the vicinity of the needle is that the structure may be less robust. Preferably, the bone drilling device is flexible rather than rigid.

An aspect of some embodiments of the invention relates to a method of threading to form holes. In one embodiment of the invention, two needles are inserted from both sides of the hole. These needles meet each other, and when retracting, one needle pulls the other needle, and the thread attached to the other needle also moves along the pulling. In one embodiment of the invention, the hole is formed when the needle is inserted, or the needle is first inserted after the hole is formed.

An aspect of some embodiments of the invention relates to a tip exchange mechanism, in which a sharpened tip attached to a thread is placed between two needles that meet within a bone. Replace with. In one embodiment of the invention, the tip is attached to the needle end to form a piercing tip. When these two needles meet, the tip is captured by the other needle and retracts with it, pulling the thread with its movement. Alternatively, the tip includes a long flexible extension to which the thread is attached. Optionally, this extension is a superelastic metal wire. Therefore, it is not necessary to place the thread inside the bone while the needle is in the bone, and the thread is less likely to be damaged. Further, such an extended portion is unlikely to be broken when being pulled in the hole having the tip portion formed therein. Also, in some embodiments, contact shear forces can be exerted on the yarn. Flexible metal extensions are expected to withstand such forces. Thus, the flexible extension may be provided not only for the tip replacement mechanism, but also for the needle retraction mechanism as described above, for example.

An aspect of some embodiments of the invention relates to a needle tip provided with an opening for engaging a sharpened tip of an opposing needle. In one embodiment of the invention, the apertured tip includes a hole in the needle that is optionally formed when the needle is straight. Alternatively or in addition to the above, a slot may be provided in the tip, if desired, whereby the tip is
It is elastically deformed (or plastically deformed) and engages with the opposite tip. In one embodiment of the invention, the holes are not provided along the axis of the needle so that the bone material that has entered the holes at one end exits at the other end.
Optionally, the bone material exits into the bone volume, but in some embodiments, the bone material exits inside the device holding the needle or outside the bone. Alternatively, blind holes are provided rather than through holes. If possible, provide a hole in the side of the needle to allow the bone material to enter and exit the opening.

An aspect of some embodiments of the invention relates to a retractable tip of a tip receiving needle. In one embodiment of the invention, a sharp mandrel is placed in the hole of the receiving needle. As the needle advances through the bone, this mandrel also advances as needed to act as a piercing tip for the needle. When these two needles meet, the mandrel is retracted as necessary, leaving an opening in the tip of the receiving needle, which allows the tip of the other needle to be carried and / or the other needle. A thread is received for engaging the needle.

An aspect of some embodiments of the invention relates to a method of forming a path for a thread in a pair of needles. In one embodiment of the invention, two needles are inserted into the hole and when they meet, along one end of the needle hole to the other end of the needle hole and / or one end of the needle hole. Through to the other end of the needle hole, a path is formed. Threads are then threaded through or along this path. In one embodiment of the invention, the needles meet end to end. Alternatively or in addition to the above, these needles meet side-to-side. At the point where these needles meet, one needle may be closer to the bone surface than the other needle, or both of these needles are the same distance from the bone surface, but with respect to the bone surface. It shifts laterally.

An aspect of some embodiments of the invention relates to providing bone drilling geometry that is not adversely affected by small errors in placement of the bone drilling head with respect to the bone. In one embodiment of the invention, this step is accomplished by providing a needle that rotates on a hinge and providing the resting point of the bone drilling head near the center of rotation of the needle. Alternatively or additionally, this constancy is achieved by providing a self-leveling bone drilling head that mechanically aligns itself with the bone area in which it is located. Alternatively or additionally, this constancy holds the entire bone drilling device by a hinged retainer, which causes the entire device to rotate around the hinge for optimal placement with respect to the bone. By achieving it.

An aspect of some embodiments of the invention relates to a safety feature that protects a sharpened tip of a bone drilling device until it is inserted into the bone. In one embodiment of the invention, this mechanism is controlled from the handle of the device to prevent the tip from being inadvertently exposed. In one embodiment of the invention, the safety feature is a shield that retracts by applying pressure to the handle of the device. If necessary, the applied pressure is also used in activating the device. Alternatively or additionally, the shield may be further protected by a safety latch, which may be "operable (
prevents the pressure from being transferred to the shield until the "armed)" condition is reached.
Instead of or in addition to retracting the shield, the sharp tip is selectively retracted and advanced with respect to the shield so that the sharp tip engages tissue until the desired procedure is performed. Try not to match.

In one embodiment of the invention, the device is designed to support the following procedure: First, the needle is advanced toward the bone so that the needle separates the needle and the bone. Try to compress any soft tissue between
The needle (if necessary) is then advanced through the soft tissue to puncture the bone.

An aspect of some embodiments of the invention relates to a safety feature for avoiding damage to or from a circular needle inserted into bone. . In one embodiment of the invention, when the device coupled to the needle is released, the releasing action causes the needle to first retract,
Only then can the device be moved.

An aspect of some embodiments of the invention relates to sensing and remotely indicating when a particular spatial configuration of a bone punch is achieved. In one embodiment of the invention, visual and / or audible notifications are communicated to the surgeon when these configurations are sensed. Alternatively or additionally, one of the features of the punch is locked and / or unlocked when these configurations are sensed. One example of a spatial configuration to be sensed is the angle of the punch head with respect to the bone. As another example, it may be determined whether two piercing needles meet in the desired manner in the bone.

Accordingly, according to an exemplary embodiment of the present invention there is provided a bone drilling device comprising:

A needle base; a pivot; and at least one curvilinear needle having a tip at one end and rotatably mounted on the needle base, wherein the needle and pivot are bone tissue having the tip. Is positioned relative to the bone, the needle is configured and adapted to advance into the bone as the needle rotates about the pivot. Optionally, the pivot includes a rotating hinge coupled to the needle base. Alternatively or additionally, the device comprises a rest point near the pivot and outside the device, the rest point adapted to be placed against the bone.

In an exemplary embodiment of the invention, the curvilinear needle has a radius of curvature that matches the distance between the needle and the pivot. Alternatively or additionally, the device includes at least one drill bit that drills into the bone and defines a channel in the bone, and an opening extending from outside the bit to the channel. . The at least one needle is adapted to fit within the opening. Optionally, the drill comprises a bone drill adapted to provide a through hole in the cortical portion of the bone. Alternatively, the at least one needle is unsuitable for drilling cortical portions of the bone.

In an exemplary embodiment of the invention said at least one drill bit comprises 2
Including one drill bit. Alternatively, the at least one drill bit is 1
Including one drill bit.

In an exemplary embodiment of the invention, the drill bits are arranged substantially parallel to each other. If necessary, the drill bit rotates in the same direction. Alternatively, the drill bit rotates in the opposite direction.

In an exemplary embodiment of the invention, the at least one needle comprises at least two needles. Alternatively, the at least one needle comprises one needle. Optionally, the at least one needle, the channel, the opening and the drill bit are
Configured and adapted to pass through the channel in at least one of the two drill bits, exit through the opening, and meet another drill bit of the two drill bits. Optionally, the second drill bit defines a receiving opening therein, in which the needle meets the second drill bit. Optionally, the at least one needle includes a removable tip and the receiving opening is
Adapted to engage the removable tip. Optionally, the receiving opening includes a narrow portion of the opening radially inside a volume defined by the second drill bit. If necessary, the removable tip is
After the engagement, it is adapted to rotate inside the drill bit, whereby
Located in the volume section.

In an exemplary embodiment of the invention, the second drill bit defines an axial groove proximate its own drilling tip, the axial groove being attached to the removable tip. Large enough to accept the thread.

In an exemplary embodiment of the invention, the opening is formed inside the drill bit.

In an exemplary embodiment of the invention, the device includes a motor that rotates the drill bit. Optionally, the motor is a stepper motor adjusted to rotate the drill bit at full speed. Alternatively, the device includes a mechanical stop that stops the drill bit and causes the drill bit to be angularly aligned.

In an exemplary embodiment of the invention, the device includes a sensor that detects at least one angular position of the drill bit, and a controller that controls the motor in response to input from the sensor. .

In an exemplary embodiment of the invention, the at least one needle comprises a first needle and a second needle.

In an exemplary embodiment of the invention, the needle rotates about the same pivot and advances into the bone. Alternatively, the needles do not share a common hinge.

In an exemplary embodiment of the invention, the needle is adapted to meet at its end as it rotates about the pivot. If necessary, the needle is
The tips come in contact with each other. Alternatively, the needles meet side by side.

In an exemplary embodiment of the invention, the needle is formed with a conduit such that when the needle meets, a conduit is continuously formed along the needle.

In an exemplary embodiment of the invention, the first needle is adapted to engage the tip of the second needle. Optionally, the second needle is hollow and defines a conduit within itself. Alternatively, the second needle is
It has a groove defined along most of its length and describes a conduit.

In an exemplary embodiment of the invention, the device comprises a channel in substantial proximity to the conduit and is adapted to advance a thread through and along the conduit. Optionally, the device includes a yarn extruder that advances the yarn through the conduit and the channel. Optionally, the yarn extruder is long enough to extend through the channel and conduit to the outer device.

In an exemplary embodiment of the invention, the tip includes a removable tip to which the thread is attached. Optionally, the removable tip includes an extension to which a thread is attached, the extension being substantially longer than the second needle.

In an exemplary embodiment of the invention, the second needle is removable from the needle base. If necessary, when the needles meet, the second needle is removed. Optionally, the second needle is adapted to have the thread attached thereto.

In an exemplary embodiment of the invention, the first needle defines an opening at its tip such that the opening engages the tip of the second needle. Will be adapted. Optionally, the openings are openings for blind holes. Alternatively, the opening is an opening for a through hole passing through a side portion of the needle. Alternatively, the opening connects to a hollow volume along the axis of the needle. Optionally, the device includes a sharpened tip mandrel that fills the hollow volume for at least a portion of rotation of the needle about the pivot. If necessary, when the needles meet, the mandrel retracts.

In an exemplary embodiment of the invention, the opening connects to a hollow volume having an axis oblique to the axis of the needle. Alternatively, the opening is an opening for a volume extending into the needle and having a substantially constant inner diameter. Alternatively, the opening is an opening for a volume that extends into the needle and has an increasing inner diameter away from the opening. Alternatively, the opening is an opening for a capacity portion provided with a slot.

In an exemplary embodiment of the invention, the device comprises a handle. Optionally, the needle and the hinge are housed in a disposable cartridge and can be separated from the handle.

There is also provided, according to an exemplary embodiment of the invention, a bone drilling device comprising:

At least one needle adapted to drill a bone; a force delivery element for advancing the needle, remote from the needle; and coupled to the needle and adjacent to the needle A force amplifier for amplifying the force provided by the force supply element and supplying the amplified force to the needle, and optionally the at least one needle comprises: Two
A force amplifier including a book needle, or the needle mounted on a hinge, the needle rotating about the hinge by a force provided by the force amplifier, or the force amplifier including a lever. .

There is also provided, according to an exemplary embodiment of the invention, a bone drilling device comprising:

At least one curvilinear needle adapted to extend to pierce a bone; a base comprising the needle and comprising a portion on the outside of the device, the portion comprising the bone A base adapted to be positioned with respect to the base; a handle coupled to the base; and a force applied to the handle in a particular direction less than a predetermined amount, in response to the decrease in force, the A needle retractor for retracting the needle before the base retracts from the bone.

There is also provided, according to an exemplary embodiment of the invention, a bone drilling device comprising:

At least one curvilinear needle adapted to extend and pierce a bone; a base adapted to hold the needle and be positioned against the bone; coupled to the base A handle; and a needle advancer for advancing the needle only if the force exerted on the handle in a particular direction is greater than a predetermined amount, the predetermined force causing the base to advance against the bone. A needle advancer that ensures that.

Also provided in accordance with an exemplary embodiment of the invention is a removable tip for a needle, including:

A tip having a sharp end and adapted to make a hole in the bone; and facing the sharp end, substantially longer than the sharp tip and attached to the thread , A flexible extension of the tip. Optionally, the tip is adapted to be captured by a non-solid needle on the side of the extension. Alternatively, the sharp end is adapted to be captured by a hollow needle on the side of the sharp tip opposite the extension.

Also provided is a self-aligning device including the following for drilling in bone according to an exemplary embodiment of the present invention.

A piercing head having at least two piercing tips; a body; and a hinge connecting the head to the body at a position substantially equidistant from the piercing tips. Optionally, the piercing tip includes a drill bit. Alternatively or additionally, the piercing tip includes a piercing needle.

In an exemplary embodiment of the invention, the head includes a power source for activating the piercing tip. Alternatively or additionally, the piercing tip faces the handle.

Also provided is a method of forming a channel in bone, particularly in vitro bone, according to an exemplary embodiment of the invention, comprising:

Drilling two holes into the cortex of the bone; and advancing at least one needle through the drilled hole into the medulla of the bone. Optionally, the holes are perpendicular to the surface of the bone. Alternatively, the at least one needle comprises two needles that meet within the bone.

There is also provided, according to an exemplary embodiment of the present invention, a bone drilling device comprising:

At least one bone drilling drill bit that defines a needle path in the bone;
And at least one needle adapted to move along the needle path. Optionally, the needle path includes a lumen. Alternatively or additionally, the device includes a needle base and a pivot, the at least one needle having a tip at one end thereof and rotatably mounted on the needle base, The needle and pivot are configured and adapted such that the tip is placed against bone tissue and the needle advances into the bone as the needle rotates about the pivot. Alternatively or in addition to the above, the at least one needle comprises at least two needles. Alternatively or additionally, the at least one drill bit comprises at least two drill bits.

(Detailed Description of Some Embodiments) Hereinafter, some embodiments of the present invention will be described with reference to the following description of some embodiments of the present invention and in association with the drawings. In the figures, identical structures, elements or parts that appear in more than one figure are optionally labeled with the same or similar reference numbers in the figures in which such parts appear.

1A and 1B show a bone drilling device 10 according to an exemplary embodiment of the present invention.
FIG. 3 is a schematic diagram showing that 0 is an inactive configuration and an active configuration, respectively. The device 100 generally includes a base 102, which includes a bone drilling head 104, a handle 106, possibly a lever 108, and a shaft 110 with which the handle and base are interconnected. In FIG. 1A, the pair of needles 112 of the bone drilling head 104 are retracted. In FIG. 1B, the lever 108
Moving the needle toward the handle 106 causes the needle 112 to rotate and extend, piercing the adjacent bone.

The device shown in FIGS. 1A and 1B is suitable for applying sutures to the inner surface of the pubis. Therefore, the needle 112 extends toward the handle. In use, the piercing head 104 is placed opposite the pubis and upward pressure is applied to the handle 106 to allow the piercing head and bone to meet sufficiently, and then the lever 1
08 is pushed down and the needle 112 is advanced to make a hole. For devices for other applications, the bone drilling head 104 can be extended away from or at different angles with respect to the handle 106 and adjustable between multiple directions.

FIG. 2 is a schematic diagram of a hinged dual needle piercing head 120 according to an exemplary embodiment of the present invention. If desired, the head 120 may include a common hinge 12
6 includes a needle 122 and a needle 124. As the needles rotate about the hinge, they form channels 128 in the bone.

In an exemplary embodiment of the invention, these needles are configured to be inserted into bone at an angle that is not perpendicular to the bone. Therefore, the force exerted by these two needles on the bone assists in the process of drilling holes. In FIG. 2, as the needle 124 rotates about its hinge, the force vector FV1 is applied. This force vector FV1 can be represented by its components FX1 and FY1. Similarly, needle 122 has a force vector F represented by components FX2 and FY2.
Add V2. Further, when the physician pushes the piercing head 120 against the bone, the force FC is exerted by the needle (or resting point 134 in FIG. 3A below). The force FC is also found in needles that are oriented perpendicular to the bone. FC presses the needle against the bone. However, since bone has a large resistance to penetration by the needle, a large FC is required to allow the needle to enter. This force FC is given from outside the body. in addition,
The force applicator is not fixed, which results in the needle sliding and / or penetrating at an undesired angle and / or forming an undesired channel.

In the illustrated embodiment, the forces FX1 and FX2 are exerted in opposite directions, so that the head 120 remains stationary. Also note that the channel is not perpendicular to the bone surface but already contains a significant X component at its beginning. Therefore, after the needle has entered the bone or if the bone is not smooth, the FX force is
Drilling can be started immediately in the desired direction. Further, when the FX force is applied to the surface, the FY force can initiate piercing without FC force (or weak FC force) and hold the needle against the bone. This is because the bone, when placed on the needle, holds the needle in place. Further, when the needle is pressed into the soft tissue and pierces the soft tissue, the soft tissue helps hold the needle against the bone.

Moreover, the forces FY1 and FY2 are generated in the drilling head and are typically (but not necessarily) less than the force FC. The addition of forces FY1 and FY2 is at least somewhat decoupled from the FC forces, making them easier to control, so that increasing or decreasing these forces (eg, by sudden bending of the bone) may result in steering from the forces FC. The force given to is not necessarily affected. Therefore, the bone drilling head is more stable.

3A and 3B show the operation of a lever-like hinged dual needle piercing head 130 according to an exemplary embodiment of the present invention. In this embodiment, not only the bone penetrating forces generated near the head, but also any force amplification needed to generate these forces, is performed near the head, thereby reducing the force transmitted along the device. Fluctuations are reduced. Thus, a more stable and / or easy to use device is provided.

In the head 130, by transforming the substantially linear movement of the lever 136 and lever 138 into rotation of the needles 122 and 124, force amplification and / or
Or conversion provided. In one embodiment of the present invention, lever 136 and needle 122 are formed from a single piece of material, which enhances reliability and / or reduces cost where possible. In one embodiment of the invention, the anchors 140 and 1
42 (eg, a hole) is used to apply a linear force to levers 136 and 138.
The shield 132 avoids the needle tip engaging tissue when the needle is retracted, if desired. Alternatively (and as shown), the needle tip may extend out of the shield but, if possible, not beyond the rest point 134 (discussed below).

As can be seen from FIGS. 2 and 3A-3B, different needle tip force geometries have different mechanical properties for insertion into bone. Changes in the medical condition, bone type, bone surface and / or other considerations may require changes to the hole head configuration. The modifiable parameters include one or more of the following parameters. : (A) Angle of attack of the needle (particularly the tip of the needle). The angle of attack can affect the force vector at the tip when (i) the needle enters the bone and (ii) the needle moves through the bone. The effect of the angle of attack is, for example, neutral, pressing the needle against the hinge, pulling the needle away from the hinge, or pressing the needle in a plane perpendicular to the needle.

(B) Penetration depth, ie the position where the needle meets in the bone, and the resting point 134 of the hole head with respect to the bone surface (this is shown slightly away from the surface for clarity). (C) distance between insertion holes; (d) leverage (which is affected by the length of both the lever and needle); (e) removing the needle tip and needle. Its cross section when viewed as a unit (which will be described in detail below); (f) Needle threading operation (which will be described in detail below); (g) Radius of rotation; And (h) the degree of symmetry between the parameters of the two needles. This makes drilling easier, for example, with one needle than with the other.

In one embodiment of the invention, multiple replaceable piercing heads are provided, each head having a different parameter value. FIG. 3C illustrates a replaceable needle piercing head 150 according to one embodiment of the invention. Multiple aligned protrusions and recesses 154 and 152 are optionally provided on the base of the punching head and device to align the head and device. In one embodiment of the present invention, coupler 156 and coupler 158 are provided at the ends of the force transmission bar (shown in FIGS. 4A and 4B) to engage anchors 140 and 142. If desired, the coupler is a snap coupler that can be removed with sufficient force.

Alternatively, the piercing head comprises means for adjusting one or more of the above parameters. In one embodiment, the stationary point 134 and the hinge 126, for example using a screw mechanism.
It is possible to adjust the penetration depth by increasing the distance between and.
This also affects the distance between the needle insertion holes.

These two needles have different cross sections, different turning radii, different lever action,
Note that it may have different angles of attack (penetration of the tip) and / or other different properties. However, in some embodiments of the invention, the needles are substantially the same. In addition, these two needles may use different hinges, possibly with a controllable distance (in the X-axis and / or Y-axis) between the hinges, but are shown in embodiments of the invention. , These two needles share one hinge.

4A and 4B are schematic diagrams of a bone drilling device 200 according to another embodiment of the present invention. The device 200 includes a base 202 on which a piercing head (eg, piercing head 130) is mounted. The base 202 is connected to the shank 210, and the lever 206 is coupled to the shank 210. Reaction spring 214 couples lever 206 to shank 210. In use, the head 130 (actually the rest point 134) is placed against the pubis (not shown). The lever 206 is pulled away from the piercing head against the resistance of the spring 214. At this point, the movement of the lever 206 only pushes the rest point 134 against the pubis (ie, the force transmitted by the spring 214), causing the intermediate tissue to compress. If desired, movement of lever 206 does not cause the needle to extend. After traveling a short distance, the handle 206 engages an engagement portion (eg, a protrusion 216 provided on the force transfer element 212). Upon further movement of the lever 206 after engagement, the force is transmitted to the element 212 and thus also to the piercing head 130, resulting in needle extension. In one embodiment of the invention, pegs (
Or other type of latch) 218 further couples the lever 206 to the force transfer element 212 via a recess 219 in the element 212.

Element 212 includes one (possibly two) levers 220 and 222.
About its respective hinges 224 and 226, which causes
Bars 230 and 232 are coupled to these levers to move them along the base and transfer the force to the punch head levers (the punch head levers were described above with reference to FIGS. 3A and 3B). To move). As shown, the configuration of these two levers reduces the force transferred. However, in other embodiments of the invention, these levers increase the force transmitted and reduce the distance traveled.

When the lever 206 is released, the peg 218 retracts the needle and subsequently reduces the pressure exerted by the head 130 on the pubis. Thus, the likelihood of the needle damaging the bone after the bone has been drilled is reduced. In one embodiment of the invention, after the needle is retracted, the peg 218 can be separated (eg, by pressing the beveled portion 221 of the peg against the protrusion 223) to remove the device 200 from the pubis. Alternatively, the pegs 218 do not separate, so the device 20
0 is essentially a one-use device. Alternatively, peg 21
8 is separated using a specially provided control (eg a button) to prevent the device from being inadvertently reused before the physician is ready for another bone drilling process. To avoid.

Instead of or in addition to the specially provided control, lever 206 is moved sufficiently far along shank 210 to extend the needle until the latch is released. There may be provided a safety latch to prevent this. Therefore, the chances of inadvertent tissue damage by the needle are reduced. Alternatively or in addition to the safety latch, a pin (not shown) may be provided around the rest point 134. This pin, when pushed with sufficient force, causes the needle or its lever to engage bars 230 and 232. If the force is not sufficient, the needle will not connect to the bar and will not extend. If possible, a spring is provided on the needle, which retracts the needle from the bone when no reverse force is applied by the bar. Thus, if there is insufficient pressure on the pin, the needle will retract. Such pins may function in a purely mechanical fashion or may include electrical circuitry to alert the operator and / or actively retract the needle.

Note that the quiescent point 134 need not be specified. However, in many cases it is desirable to have the needle fully retracted, and usually some element will be required for intermediate soft tissue compression and / or perforation head fixation applications.

For devices not intended for pubic use or for devices in which the piercing head 130 can be directed away from the lever 206, the springs 214, protrusions 216 and pegs 218 can be replaced and / or The elements that perform similar functions are properly positioned in the opposite direction to provide spring 214, protrusion 216 and peg 2
It may be necessary to increase the number of 18. Additionally, handles of various designs may be provided (eg, handles that are axial or vertical to the device body).

Note that although the element 212 is illustrated as a bar, most of the force is applied when the needle is extended. Therefore, the element 212 is
The metal wire may be made to perform its own function, and if necessary, a retreat spring that retracts when the lever 206 is released may be provided.

Alternatively or additionally, the bars 230 and 232 may be replaced with metal wires. If possible, a pair of coaxial metal wires is used, of which the inner metal wire is attached to one lever and the outer metal wire is attached to the other lever. This allows the piercing head 130 to more easily twist and / or otherwise move about the base 202. If necessary, a spring is provided to extend the needle and then retract the needle.

As will be appreciated, the resistance of spring 214 is related to the amount of force exerted on the pubis. In one embodiment of the invention, the tension in spring 214 is adjusted so that
The doctor can simply place the desired minimum pressure on the pubis. Alternatively or in addition, the linearity of the spring and / or the force constant of the spring can be modified to match the desired force application characteristics for the needle and / or provide greater control of the force. In one embodiment, greater force is required for insertion into the bone, but after insertion into the bone, the additional force required to continue drilling is probably reduced. In general, it is possible to control the amount of compressive force exerted on the soft tissue before and after needle extension by appropriately modifying the spring parameters, lever 206 motion, and force amplification from the transmission mechanism to the needle. .

In some cases, it is desirable to tactilely inform the physician of needle extension status. This may be accomplished by adding protrusions at points corresponding to the extension of the needle on the shank 210 under the spring 214. Thus, as the lever is pulled, a "bump" is sensed at that point. Such protrusions may also be provided at other points on the shank (eg, the point at which the needle is fully extended and no more force is needed). Instead of these protrusions that communicate feedback to the physician, in addition to those protrusions that communicate feedback to the physician, these protrusions may be used to control the device, for example,
These protrusions may be used as a safety feature to allow needle extension or as a "fire" control of the thread (as described below). Alternatively or additionally, a large protrusion 217 is provided under spring 214 for frictionally engaging lever 206, which makes it more difficult to compress soft tissue than advancing the needle. To do. If possible, by subjecting the surface of the protrusion to appropriate machining, the friction imparted by the protrusion is greater when the lever is pulled than when the lever is released. In the exemplary device, various parameters (eg, spring constant,
The momentum and needle leverage) are adapted so that a force of 100 N is required to compress the soft tissue before stretching the needle. An additional 40 N of force is needed as needed to extend the needle into a typical pubic bone. The total momentum of the lever is 10 mm during tissue compression and 4 mm during needle extension.

Although one lever 206 is shown in this embodiment, a non-movable handle may be provided so that the non-movable handle can be gripped together with the lever 206. Also, instead of manually transmitting power to the needle head, a pneumatic power source, an electrical power source or other type of power source may be used.

After the needles meet, a channel is created in the bone through which the thread can be threaded. In one embodiment of the invention, threads are threaded through channels formed in and / or along the needle body.
Thread insertion can be during or after the needle has been drilled. Alternatively, the device may not be used to thread the thread but only to punch a hole in the channel, eg, if desired, the thread may be manually threaded after removing the needle, if desired.

FIG. 5A shows an end-to-end needle contact arrangement, according to an embodiment of the invention.
Needle 240 and needle 242 meet end to end. According to some embodiments of the present invention, these needles are rigidly attached to one hinge when the needles are not hinged and are attached to separate hinges. It should be appreciated that it is possible to have more control over the final position.

Needles 240 and 242 optionally include holes therein, which allow
A path 241 is formed in the needles 240 and 242 as they meet end to end.

FIG. 5B shows various suitable cross sections of needles 240 and 242. Cross section 24
8 and 246 are triangular cross-sections and have circular internal holes. The cross section 250 is circular and has a circular inner hole. The cross section 252 is an example of an open hole needle,
It has a "U" shaped cross section with holes inside the "U". In some embodiments, instead of a deep grooved cross section (eg, "U"), a side groove of a substantially solid needle is used. It should be noted that the cross section of the needle may vary along the needle, for example there is a groove for the thread along most needles and there is an internal hole only at the needle tip. Alternatively or additionally, the tip of one needle may be small enough to fit into the tip of the other needle to form an inner-outer alignment. In another embodiment described below, one needle may be provided with a removable tip to which the thread is attached and this tip may be captured by the other needle. The attachment method may be, for example, using a knot in a recess in the tip, or other method of attaching a thread to a metal object (eg, known in the art of bone anchors).

If necessary, the needle hole is cleaned using, for example, aspiration, jetting of saline solution, or advancement of the mandrel to remove the debris accumulated in the needle hole. The opening on the needle side may be provided with an outlet for such material, or such a hole may be defined when the two needles meet. Alternatively, a somewhat rigid thread extruder may be provided to push the bone debris forward of the thread extruder or form a channel in the debris.

6A and 6B are side and top views of a side-by-side needle configuration, according to one embodiment of the invention. In the embodiment shown in FIG. 6A, needle 254.
And the needle 252 overlaps in its area 256. Holes 258 are formed from the holes of the individual needles. In one embodiment of the present invention,
The tips of the individual needles may be solid because they do not reach the tip of the needle, but exit the needle on its side near the tip. When these two needles are properly overlapped, the holes exit with the holes meeting and a hole 258 is formed.

In some embodiments, as the two needles retract, the solid tip retracts, causing the thread to shear between the needles. One possible solution is to make the cross section of the tip smaller than the rest of the needle. Another possible solution is to provide a metallic or otherwise stiffer thread extruder or thread to make it less shearable. Instead of or in addition to the above, there is a method in which the inner surface of the tip portion is inclined to gradually reduce the shearing force applied to the yarn. Alternatively or additionally, the two needles may have different radii or rotations and / or a hinge may be provided at a location other than the center of the curved portion of the needles, so that the needles are The needle moves apart when retracted. This movement of the needle away is accomplished by using an asymmetric needle tip to generate a force normal to the line of motion of the needle as the needle is advanced and / or retracted into the bone. Can also be achieved.

In one embodiment, the hole in the needle faces rearward. Therefore, in order to bring these holes into alignment, the needle tips must be fed together. One method of forming such a needle is to fold the needle tip and provide a mandrel in the needle hole to avoid collapsing the hole. Another method is to remove a portion of the needle surface inside the bend of the needle to provide another hole for when the hole is crushed. If necessary, incline the needle portion near the hole as it moves away from the needle tip to lock the needles together and provide sufficient retract force to separate the needles. Help enable.

FIG. 7A shows a configuration of an upper needle and a lower needle according to one embodiment of the present invention. Arrange the needles on a plane perpendicular to the needle plane (side-
Instead of or in addition to the by-side configuration, the configuration of the needles is such that one needle is placed on top of the other (or inside the other needle as seen from the hinge side). Then, in the plane of the needle, the side surface of the needle is effectively contacted (side to side). In the illustrated embodiment, the needle 264 is inside the radius of the needle 262 and these two
Book needles overlap at overlap region 266. Figure 7
B shows various possible holes in the overlap region (eg, two opposing "U" shaped holes (268) or two opposing "V" shaped holes (270)). The holes may open the entire length of the needle or only in the overlap area.

In one embodiment of the invention, the radius of needle 264 is smaller than the radius of needle 262 as measured from the hinge side. Alternatively or additionally, these needles are not perfect arcs and / or the radius of the needles does not match the radius of gyration. Such a structure, when properly configured, causes the needles to engage one another (rather than slide together) when they meet at overlap 266. It is also possible to align the needles to achieve similar results, in which case the needles do not move in exactly parallel planes, so that once they meet, further movement of the needles is difficult or impossible.

8A-8C show a removable needle configuration 28, according to one embodiment of the invention.
0 and its use in drilling and threading the bone. Configuration 280 includes a non-removable needle 284 and a removable needle 282 mounted on base 286. Needle 284 includes tip 288 and
2 includes a tip 290. These tips are designed to engage after the needles meet. Although a particular engagement design is shown, other engagement designs (eg,
A design in which the tip portion 288 is inserted into a hole in the tip portion 290 and a design in which one or both of the tip portions are elastically or plastically deformed so that the tip portions are engaged may be used.

After inserting the needle into the bone, as shown in FIG. 8B, the needle punctures the channel and then meets and locks. When the needle retracts, the needle 282
Is latched to the needle 284 and is pulled along the path of the needle 284 rather than retracting along its own path. If necessary, the thread 292 may be attached to the needle 282 so that the thread 292 may move when the needle 282 advances.
82 so that it can be pulled. Many methods of attaching a thread to a needle are known in the art.

FIG. 8C shows the result of the above process, which is the path threaded by thread 292.

It should be noted that not all needles 282 need be removable, rather than that any attachment portion of the thread is removable. Thus, in some embodiments, only the tip of needle 282 is removed. If desired, grooves or holes are defined in the needle 282 to prevent the thread from being damaged by drilling into the bone. Also, although depicted as non-removable needle 284, in some embodiments it may be desirable to have needle 284 (eg, outside the body) replaceably removable. .

In one embodiment of the present invention, the needle 282 includes a safety latch that releases the needle 282 only when the needle 282 actually engages the needle 284, which causes the needle 282 to inadvertently contact the bone. Don't be left behind.

8D-8F show a safety latch according to one embodiment of the present invention, which safety latch is shown in FIG. 8A-only when these two needles 282 and 284 meet.
Release 8C removable needle. In the illustrated example latch, pin 294 is located in slot 295 in base 286. Pin 29 if possible
The base of No. 4 is pressed against the inclined portion 296 using, for example, a spring (not shown). Instead of the ramp, a flexible pin may be provided and attached in a fixed position.
When the needle 282 advances, the pin 294 is pressed against the inclined portion and the slot 2
Slide into 95. At a particular point, movement of pin 294 results in needle 282
To release. FIG. 8E illustrates a method of forming the opening 298 in the pin 294. As the pin shown in FIG. 8F moves, the needle may separate from the pin and be withdrawn by needle 284 engaging it.

Alternatively or in addition to the above, electrical sensors can be used for the mechanical latches. This sensor senses when the needles meet (eg, from the momentum of the needles). Alternatively, the sensor directly senses contact between the needles, for example by measuring the decrease in electrical resistance when the needles meet. The signal generated by this sensor may be used in one or more applications (eg ((
Use to tell the doctor that contact has been made (using light or sound as needed),
It may have an application for releasing a removable needle or for "firing" a thread, which will be described below.

In one embodiment of the invention, when the above needles are pushed into bone, they form channels by penetrating into the bone rather than removing bone material. Alternatively, if desired, the needle cross section can be selected such that the needle removes and / or crushes bone as the needle is advanced. If desired, the cross section of the needle (especially its tip) is aligned with the direction of the fibers in the bone so that the needle can be inserted into the bone without cutting the fibers. Smooth one or both needles as needed. Alternatively, the needle (particularly its tip) may be provided with a groove. If possible, define a spiral on the outside of the needle. It should be noted that the finish and geometry of the outer surface of the needle can affect the direction in which the needle advances into the bone. In a typical implementation,
The needle has a radius of curvature of about 6 mm, a cross-sectional diameter of 1-1.5 mm, and is formed of surgical instrument grade stainless steel or implant grade stainless steel. However, smaller sizes are also possible (eg radius 4 mm or 3 mm, diameter 0.75 mm or 0.5 mm).

In one embodiment of the invention, the needle is simply pushed into the bone. Alternatively, for example, a piezoelectric motor connected to the needle may be used to vibrate the needle (axially, transversely and / or rotationally, optionally in a reciprocating manner) to drive the needle into bone. The step of advancing may be supported.

In one embodiment of the invention, movement of lever 106 or 206 is used to advance and retract the needle to allow the physician to adjust the speed of the piercing and threading process. Alternatively or in addition to the above, the needle may include a self-retracting mechanism in which the needle is automatically retracted after the needle is pierced. This can be accomplished using a mechanism similar to that of FIGS. 8D-8F used in connecting the needle to the lever of the needle. If desired, this self-retraction occurs after the needle has been threaded.

In one embodiment of the invention, one of these two needles may be a non-penetrating needle (eg a flat (possibly angled) anvil). Optionally, the anvil includes a hole for receiving the other needle. Alternatively or in addition to the above, as the needle advances, this anvil also advances. Alternatively, the anvil is fixed. If needed, the anvil
Including small spikes or other gripping elements for engagement with bone,
This allows the anvil to be non-slip and / or assist in applying reaction forces to stabilize the needle.

9A and 9B schematically illustrate one hinge-like needle piercing head 300 without an anvil, according to one embodiment of the present invention. The head 300 includes a needle 302 connected to a hinge 304 via a needle arm 304. In one embodiment of the present invention, the needle arm 304 also functions as a needle stop to stop the needle from advancing after it has finished its path. FIG. 9B shows the appearance of one needle when the needle has finished drilling in the bone. Needle 302 (or the tip thereof) is needle arm 30
4 is removable and attached to the thread, after the needle exits the bone, the tip of the needle 302 may be captured (using friction, for example) with a capture device (not shown). It is possible.

In another embodiment of the invention, the mechanism of FIG. 9 is used with a pair of needles to eliminate the need to connect the needle tips. In one embodiment of the invention, puncturing is performed using two needles that meet in the bone. After the needles meet, lock the needle rotation mechanism, not the needle itself. Then, rotation of one of these needles is continued until greater than 90 ° (eg,
For the single needle in Figure 9B shown). The mechanism is locked so that the other needle retracts along its hole. Once the tip of the needle has advanced to the outside of the bone, engage the bone with the bone piercing device (see needle 28 in FIG. 8D).
Attached to the base of the needle (as in 2) so that when the bone drilling device is retracted, the thread attached to the advancing needle is threaded through the hole in the bone. If desired, only one of these needles is rotated by more than 90 °, but based on the geometry it may be necessary to move both of these needles at an angle of at least 110 °, for example. . At least during the bone drilling process, it is possible to grip the needle that travels the longer path midway, which avoids deformation of the needle. However, this is not mandatory.

A feature of some embodiments of the present invention is that the angle of incidence between the piercing head and the bone is invariant. This constancy has multiple aspects, one or more of which are provided by some embodiments of the invention.

[0111]   (A) The penetration depth is unchanged;   (B) the slipperiness is unchanged; and   (C) Permeability into bone is unchanged.

FIG. 10A illustrates the angular independence of the piercing head 130, according to one embodiment of the invention. Since the distance between the stationary point 134 and the hinge 126 is very short, the penetration depth is
Not only when the angle between the stationary point and the bone is small, but also when this angle is large, it is not affected. This is because, in some embodiments herein, rotation about the stationary point does not substantially affect the distance between the stationary point and the point where the needle meets. In one embodiment of the invention, this short distance is less than 60%, less than 40%, less than 20% or less than 10% of the radius of curvature of the path traveled by the needle. The slipping is lost because the bone is gripped simultaneously by the two opposing needles. Alternatively, the rest point 134 allows the needle to penetrate the bone at many different angles of attack, even though the needle is not in contact with the bone at the beginning of extension due to the rest point 134. In some embodiments, the resting point may be roughened or barbed at the resting point to aid in the engagement of the resting point with bone and / or the intervention of the resting point into soft tissue. . Alternatively or additionally, the gain of each needle may be different, which allows the needles to rotate at different speeds and provide different insertion angles.

FIG. 10B illustrates a self-aligning drilling head 320 according to one embodiment of the invention. In this embodiment, the head 320 is gimbaled over one or more hinges 326 so that the head 320 is always facing the bone so that both needles are substantially at the same angle and timing. You can put it in the bone with. In one embodiment of the invention, a pair of ballasts 322 and 3
24 contacts the bone and the straight head 320. Instead of a shaft hinge, an integral hinge as shown (e.g. made of silicone rubber) may be used. If possible, more than two ballasts are provided, which also provides stability in the plane perpendicular to the needle path. If possible, the tip of the stabilizer is elastic to avoid inadvertent damage to the soft tissue. In another embodiment of the present invention, head 320 is self-aligned and gimbaled by the disproportionate force on the needle without such a stabilizer. Alternatively, the needle rotation mechanism may only rotate one needle relative to the other needle. The absolute angular position of the needles is determined by the relative resistance placed on each needle.

Alternatively or in addition to the above, the head 320 may include one or more sensors to determine the correct configuration of the head for self-alignment. In one embodiment, a force sensor is provided at each ballast to determine contact force. The contact force should be about the same for any ballast. Alternatively or in addition to the above, the force sensor is connected to a needle, both of which are
You should measure approximately equal forces. If possible, display the results of the sensor measurements (eg, as go / no-go signals) to the user. Alternatively or additionally, the signal from the sensor is used to release the pin. With this release,
The needle can be extended. Alternatively, a mechanical structure may be provided to allow movement of the needle and / or force to the needle only if the pressure on the ballast and / or its alignment are nearly simultaneous.

Although the above discussion of angles was primarily with respect to the angle in the plane of the needle, similar considerations, measurement methods and devices are used to control the angle between the needle plane and the bone surface. Can be used for

Furthermore, the above description was primarily concerned with needles sharing a plane or moving parallel in a plane. In some embodiments of the invention, these needles may move in two diagonal planes. An extreme example is a corkscrew needle, which twists (and may be coaxial) about its own axis. Another example is a piercing head containing three needles that meet at a point inside the bone. Note that the hinge need not be centered around the needle rotation (provided the needle has one hinge).

11A and 11B show a self-aligning piercing device 400 according to one embodiment of the invention. The device 400 generally comprises a retainer 402, a piercing mechanism 404, and a piercing head 412 that is held toward the bone by the force exerted by the user on the handle 406. In the exemplary embodiment, mechanism 404.
Includes a power source (eg, a motor) and the head 412 includes a drill bit powered by the motor. A hinge 410 is optionally provided between the retainer 402 and the mechanism 404 proximate the piercing head 412, which causes the piercing head 412 to move from a force vector applied to the handle 406. It is possible to align itself substantially independently of the surface of the bone to be drilled. A second hinge 408 is provided to provide freedom of movement position for this second hinge 408 as needed to maintain the relative position of the retainer 402 and the mechanism 404, and / or
Alternatively, the second hinge 408 may be used as a safety function to apply excessive force to the head 4.
The distortion of 12 may be avoided. Alternatively or additionally, reference numeral 408 may represent a safety catch that prevents the needle from extending before it is released.

FIG. 11B is another perspective view of device 400, showing how retainer 402 and mechanism 404 rotate relative to hinge 410.

In one embodiment of the invention, the hinges are substantially equidistant from the tip of the drill bit so that a substantially equal force is exerted on the tip of the drill bit. The hinges may not be equidistantly arranged (eg, if it is desired to apply unequal forces on these two drill bits). Alternatively or additionally, such uneven force may be provided by a spring that resists the gimbal support of the head. The hinge may be provided in the head or its body, for example.

In some embodiments, the retainer 402 is used as an outer skeleton for existing features 404. This mechanism can also be used without the retainer 402. Alternatively or additionally, the retainer-type device may be used for other applications than drilling bone, such as stapling and / or tacking in the vagina or throat.

FIG. 11C illustrates another self-configuring piercing device 420 according to one embodiment of the invention.
Indicates. In device 420, piercing head 422 rotates about a hinge 428 between handle 426 and piercing head 422. In some embodiments, the hinge 428 has a small degree of angular freedom, eg, 5 °, 10 ° or 20 °.

In various embodiments of the invention, the thread can be threaded differently through the pathways drilled into the bone. As a first method, one of these needles pulls the thread through the path. Alternatively, the thread is pushed through the path. In yet another method, a separate threaded needle is fed through the path. After the thread has passed through the path, the suture ends are joined together (manually if necessary). Alternatively, clips are attached to the ends of these two threads to perform the function of knots. When the device is threading, the thread remains in the bone as the device retracts from one end of the thread. The suture can be quickly joined. In some cases, first some or all of the required bone hole is formed, followed by suture threading and / or suture coupling.

A general bone suturing process according to some embodiments of the present invention includes the following steps.

(A) pressing soft tissue against the bone (optional), (b) advancing the soft tissue and the bone through a needle to drill a channel in the bone, (c) Advancing the yarn along the path as needed while the needle is in the hole (or by the advancing the needle), and (d) (generally retracting the needle first). Removing the device, and (e) joining the yarn ends.

In various embodiments of the present invention, selected one of these steps can be performed sequentially or simultaneously. The transition between steps may be automatic (eg, advance the thread when the needle is fully extended) or manually (eg, user action (e.g. (If necessary to manually advance the thread) or permit (eg, to release the safety latch) .In one embodiment of continuous operation, the two needles are not at the same time, Continuous advancement In some embodiments, this continuous movement can be used to assist one needle in cleaning the groove (or thread) in the other needle.

As mentioned above, it is possible to push the thread through the needle hole after the needles meet. Generally, in order to push out the thread, whether the thread itself has hardness,
Alternatively, the thread must be attached to a rigid thread extruder. When the yarn extruder is pushed, the yarn extruder conveys the ductile yarn along itself. The stiffness of the thread / thread extruder depends, among other things, on the radius of the hole, the amount of bone material in the hole, and the type of mechanism used to advance the thread.

12A and 12B show the yarn extruder 330 in open and closed configurations, according to one embodiment of the present invention. In one embodiment of the present invention,
The pusher 330 is made of an elastic material or a superelastic material and has an eye portion 332 formed at one end thereof. Thread the thread through the eye and then insert the thread extruder into the channel (or needle hole). The volume of the channel presses against the eye, which causes the eye to grip the thread. Alternatively, two threads may be used, thereby separating the ends of the thread from the eye.

13A and 13B show a method of threading a thread through the hole of the needle of FIGS. 5A and 5B, according to one embodiment of the present invention. The channel 334 includes a yarn extruder 330. The lever 338 is coupled to the thread pusher 330 so that movement of the lever advances the thread pusher. Depending on the configuration used, reference numeral 336 may indicate an extension of the yarn pusher 330 or a yarn attached to the yarn pusher 330.

In FIG. 13A, the needles meet but the lever 338 holds the thread outside the needle hole. In FIG. 13B, the lever is pushed down and the thread advances through the needle hole. Engagement portion 340 (friction element if possible) as required
Are engaged with the thread pusher 330 and / or thread to prevent the engagement portion 340 from retracting when the needle is retracted and / or when the device is removed from the bone. In embodiments where the needle self-retracts as the thread passes through the hole, the engagement portion 340 may also release the sprung catch that retracts the needle.

In one embodiment of the invention, the yarn extruder 330 is (schematically illustrated)
The spring 342 pushes it forward. However, advancement of extruder 330 is blocked by lever 338. In other embodiments, pins such as those shown in Figures 8D-8F prevent the thread extruder from entering the needle hole even when the thread extruder is pushed forward by the spring. If necessary, the tip of the yarn pusher 330 is pre-assembled into the tip of the needle 242 so that the yarn pusher 33
Allow the 0 tip to move with the needle. Alternatively, the channel 334 may be configured so that the hole in the channel 334 is clearly visible only when the needle is fully extended. In some embodiments, the bar 232 and / or bar (shown in FIG. 4). When 230 has fully extended the needle, it continues its movement (slides along anchors 140 and 142 as needed) and, using bar 232 and / or bar 230, thread extrusion Retract the machine and / or advance the thread extruder.

14A-14D illustrate various stages in the use of the thread exchange needle assembly 350, according to one embodiment of the invention. The assembly 350 may optionally
Includes needle 352, needle 354, and tip 356 attached to needle 350 and attached to thread 358. The tips of needles 352 and 354 are shaped to engage tips 356 in the following manner. Tip 3
56 is frictionally engaged by a needle 352, if desired, which causes tip 356 to be retained (FIG. 14A). When these two needles come together,
A point on the tip 356 engages the internal bore (or other spatial configuration) of the needle 354 (FIG. 14B). When the needle retracts (FIG. 14C), the tip and needle 354
Engagement is greater than engagement by needle 356, which causes the tip to move with needle 354. When the device is removed, thread 358 remains in the hole (Fig. 14D). In some embodiments of the invention, the needle 354 is
Replace with an anvil (not in bone) or a tip engagement that is further from the bone but in the path of travel of the needle.

14E-14H illustrate a needle receiving tip (or needle tip) receiving tip according to various embodiments of the invention. For clarity, all of these drawings include perspective views and corresponding perspective axial cross-sectional views. FIG. 14E shows a needle 430 having an opening 432 formed at the tip. Within the needle is a hollow interior volume 438. The opening in outer lip 436 optionally (but not necessarily) has a smaller diameter than the opening in volume 438. The lip 436 is smoothed if desired, but this is not essential and the lip 43
6 can be knurled, for example. If necessary, the inclined portion 434 may be provided with the opening 4
Defined in the vicinity of 32, the ramp 434 spans the outer diameter of the needle 430 and the outer diameter of the lip 436.

If desired, the volume 438 may be longer than that shown to allow it to exit the side of the needle 438 at the location of the mark 439. Thus, any bone material that enters volume 438 can be pushed out at the receiving tip of the opposing needle.

FIG. 14F shows an opening 442 in the needle 440 in which one or more slots 447 are formed between the volume 448 defined in the needle and the ramp 444 on the outside of the needle. 14E, except that it is similar to the design shown in FIG. 14E. The slot 447 can function to expel strips from the volume 448 and / or add resilience to the opening 442 to assist engagement of opposing needle tips.

FIG. 14G shows a needle tip similar to the needle tip design of FIG. 14F, except that it defines two slots 457 between the volume 458 in the needle 450 and the beveled portion 454 of the needle. Show design. These two slots are adjacent and define a flexible tab 455 between them. The tab 455 can, for example, provide elasticity or plasticity to the opening 452 to engage the other needle tip.

FIG. 14H shows a modification of the design of FIG. 14G in which the pair of slots 467 do not extend to the lip 462 of the opening 466 defined in the needle 460, instead a small slot 463 is provided. , Straddling the ends of the slot 467,
The tab 465 is formed. Therefore, the lip 462 remains whole and the tab 465 is less likely to be distorted by movement in the bone than in the design of FIG. 14G.

15A-15D show a hollow needle piercing mechanism, according to one embodiment of the present invention, in which the hole in one of the needles is filled with a retracting mandrel.

FIG. 15A shows a needle piercing head 4 having two opposing hollow needles, a needle 472 carrying a tip 482 and a tip receiving needle 474.
70 is shown. In some embodiments, the needle 472 is not hollow, eg, as described above. These two needles may be hinged 476 as needed.
Rotate around. The tip 482 is attached to the thread 484 as needed. Thread 484 may be delivered to conduit 488 through hole 486 of needle 472. Conduit 488 optionally becomes an elastic conduit (eg, an axially flexible conduit). Mandrel 490 is provided in hole 475 of needle 474 as needed. The mandrel 490 is optionally retained (eg, using a stop clip 492) in an axial position relative to the needle 474. The stop clip 492 optionally includes a base 493 on which the mandrel 490 is disposed and an arm 494 that engages the protrusion 496 of the needle 474 so that the stop clip 492 positions the mandrel 490 in place. Hold. The stop clip 492 may also optionally be an extension 49 adapted to align with a protrusion 498 in the head 470.
1 also, which releases the stop clip 492.

FIG. 15A shows mandrel 490 and tip 482 inserted or pressed into cortical layer 478 of bone and overlying bone medulla 480. The tissue could have been removed or is not shown for clarity.

In FIG. 15B, the needle has rotated about hinge 476, which causes the needle to create a hole 499 through cortex 478 and medulla 480. While the needle 474 is advanced, the extension 491 is stopped by the protrusion 498 so that the stop clip 492 separates from the needle 474 and the mandrel 490 can be retracted. Accordingly, an opening appears in the tip of needle 474 into which tip 482 may enter, which may engage tip 482. If desired, a slot is provided in the tip of needle 474 as described above with reference to Figures 14F-14G. In one embodiment of the invention, as mandrel 490 is retracted, debris from medulla 480 fills holes 475 and prevents the formed opening from being blocked.

In FIG. 15C, the needle is retracted, which causes thread 484 to enter hole 499.

In FIG. 15D, piercing head 470 has moved away from the bone and thread 484 has holes 499.
Is passing through.

In some embodiments of the invention, what is illustrated as thread 484 is actually a metallic extension of tip 482, thread 484 comprising, for example, Nitinol, to which the thread is attached. You can Therefore, the thread is away from the tip 482 and is not in the vicinity of the bone during the drilling procedure. Note that a hollow needle with a mandrel may be used for one needle device (eg, the needle device in FIG. 9) to assist in engaging the needle, eg, when the needle has finished moving. I want to be done.

16A and 16B show a combination of drilling and needle drilling heads, according to one embodiment of the present invention. The combined drilling and drilling device 500 optionally includes a drilling and drilling head combination 502 attached to a handle 501. 16A shows the needle of the device 500 retracted, and FIG. 16B shows the needle of the device extended. As shown in FIG. 16A, two drill bits 504 are provided, each drill bit having one or more openings 506 therein, thereby allowing needle 5
One of the 08 and the needle 510 passes through the opening 506. The needles may share a single hinge, or each needle may be provided with a hinge 512, as shown in the figure, to couple each needle to the casing 514 of the head 502. Various types of levers can be used for the lever action for the extension movement of the needle. 9 illustrates a transmission mechanism 516 for advancing the needle. A transmission mechanism 518 for rotating the drill bit is shown.

FIG. 16B shows the head 502 when the piercing needle is extended, better showing the drive mechanism for rotating the drill bit. Although an exemplary drive mechanism is shown, many other mechanisms may be used within the scope of the invention. Transmission mechanism 518
Rotation is transmitted to the flat gear 520, which causes the gear 522 with the drill bit in the center to rotate. The second gear 524 transfers power from the gear 522 to the gear 526, which also has a drill bit in the center. In some embodiments, a single drill is used, possibly with a single needle extending through the drill bit. Shown is an optional peg 528 that provides the drill bit with some rotational freedom to allow the needle to more easily align with the opening 506.

In another embodiment, the position of peg 528 is detected using a sensor (not shown). The sensor electrically or mechanically stops the rotation of the drill bit so that the drill bit is properly aligned. Exemplary suitable sensors include optical and magnetic sensors. Alternatively or additionally, a rotary encoder is used to detect the drill bit position. The rotation can be stopped at any point between the motor and the drill bit, depending on the implementation. Alternatively, the motor may be controlled to produce full rotation, which allows the end of the drill bit to be desired. A step motor may be provided instead of or in addition to the above. Alternatively or in addition, an impulse motor controller may be provided to provide a power impulse to the motor so that the drill bit responds to a known number of impulses to complete rotation. May be. Alternatively or additionally, a mechanical stop may be provided to stop the drill bit at a particular position when no external power is provided, which allows the drill bit to reach its desired rotational position. You may make it proceed by inertia.

In one embodiment of the invention, these two drill bits rotate in the same direction and at the same speed. Alternatively, the two drill bits may be rotated in opposite directions and / or at different speeds. Alternatively, these two drill bits may have a reciprocating motion rather than a pure rotary motion. In some cases, axial or transverse vibration may be provided. If desired, spikes are provided between the drill bits to hold the bits in place before the drill bit penetrates the bone. This spike is retracted as needed as the bit advances.

17A-17E illustrate a method of using the device 500. Some of the elements of head 502 are not shown for clarity of presentation.

In FIG. 17A, the drill bit 504 faces the cortex 478 of the bone. The needle used in this exemplary embodiment is a perforated needle 508 having a removable tip 530 through which a thread 534 is threaded and a solid needle 520 having a through opening 532 defined in the tip, This perforated needle 508 is
It receives a removable tip 530. Other types of needles may be used instead, eg, as described above.

In FIG. 17B, pressure is applied to a handle (not shown) that pushes the drill bit 504 against the cortex 478. This causes the drill bit 504 to rotate sufficiently before forming a pair of cortical bores 540. In embodiments of the invention, the drill bits are not rotated unless a minimum pressure is applied to them, for example using a mechanical clutch. Alternatively or additionally, the number of revolutions of the drill bit is predetermined and the drilling stops at that number. Once the bore 540 is formed, the drill bit 504 is stuck by the base of the head 502. This is either due to contact with the bone or due to a suitable protrusion from the head 502 (not shown). The drilling depth can be set, for example, by moving the protrusion axially with respect to the drill bit.

In FIG. 17C, the needle is advanced so that bore 542 is formed in medulla 480 and removable tip 530 is engaged by opening 532.

In FIG. 17D, the needle is retracted leaving thread 534 in bore 542, which attaches to removable tip 530 in bore 542.

In FIG. 17E, the head 502 retracts, leaving the thread 534 (ie, tip 5).
Stretch 30) and thread the bone.

FIG. 18 shows a variation 550 of the device 500. It can be adapted to the local bone geometry. The piercing head 554 is attached to the main body 55 by the hinge 556.
It is installed on 2. When the head 554 is pressed against the bone, the head
Both drill bits 504 are adjusted to contact the bone.

19A-19E show an alternative use of a combination punching and punching head 602. In this, only one needle 608 is used for the two drill bits 604 and 605. FIG. 19A shows a device 600 having a piercing head 602 mounted on a handle 601. This device 6
00 is the same as the configuration of the device 500. However, other installation methods, such as that shown in FIG. 1 for attaching the drilling head to the handle, may also be used. A head 602 is shown that includes two drill bits 604 and 605. The drill bit 604 includes a path for a needle 608, which needle 608
Is optionally bent and extends through its path to reach the drill bit 605.
Unlike device 500, no needle extends from drill bit 605.
However, optionally, the distance between the drill bits may be smaller to compensate. Various methods of threading between the needle 608 and the drill bit 605 may be used. These methods include both tips, eg, as described above, which exchange threads pushed through a hollow conduit formed between the needle and the drill bit it reaches. In the particular embodiment shown in FIGS. 19A-19E, the needle 608 has a removable tip 630 to which a thread 634 is attached. The tip 630 is engaged by an opening 636 in the drill bit 605. At this time, the tip 630 reaches the drill bit 605.

FIG. 19B shows device 600 after drill bits 604 and 605 have been drilled through bone cortex 478.

FIG. 19C shows the advanced state of the needle 608. In this exemplary embodiment, needle power train 616 is activated by retracting internal element 620 of handle 601. However, other mechanisms for activating or driving needle retraction, such as those described with reference to the embodiments in FIGS. 1-18, may also be used. As a result, needle 608 rotates about hinge 610,
A needle 608 can be connected to this hinge 610 (which is connected, for example, by an arm as shown in the detail of FIG. 17), thereby passing through the medulla 480, so that the tip 630 opens the drill bit 605. Engage with section 636. Needle 608 may also be a straight needle, such as
It should be noted that there is a needle that can enter the bit from the side of the drill bit 604, rather than along the axis of the drill bit 604.

In FIG. 19D, the needle 608 is retracted, releasing the tip 630 engaged by the drill bit 605. Details of one embodiment for engagement and optional rotation of this tip 630 are shown in Figures 20A-20C.

In FIG. 19E, the head 602 has been retracted from the bone and the drill bits 604 and 6 have been removed.
05, leaving thread 634 in the lumen formed by needle 608.

20A-20C show close-up views of the drill bit and needle, which show engagement of the tip 630 by the opening 636 in the drill bit 605.

FIG. 20A corresponds to FIG. 19C and shows how the tip 630 is engaged by the opening 636. In one embodiment, the bit 605 includes an outer sheath 622 and an inner tube 624, as shown. In this embodiment, a slot is formed in outer sheath 622 and a narrower slot is formed in inner tube 624. Alternatively, the tip 630 may be pre-punched in one or both of the sheath 622 and the tube 624.
Alternatively, other gripping mechanisms may be provided, for example tube 624 may comprise an elastic material or a plastic material (eg, an elastomer). In the mechanism shown,
The tip 630 includes a conical head 632 and a rear tubular portion 633, which retains a thread 634, for example.

When the needle 608 is retracted, the head 632 is held in place by the lip of the slot in the inner tube 624, as shown in FIG. 20B.

In some implementations, the tube 633 can extend beyond the slot 636. Then, as the bit 605 is retracted, the tube 633 can strike and move against the bone. One solution is to make the tube 633 relatively short. An alternative solution is shown in Figure 20C. This corresponds to FIG. 19E. Figure 2
At 0C, the tip 630 rotates the internal slot 636 so that the tube 633 remains within the area of the bit 605. Alternatively or additionally, slot 6
26 is formed along the bit 605 to provide space for the thread 636 and prevent the thread from being cut between the bit 605 and the bone. Alternatively, or additionally, drill bit 605 may have a tapered diameter to provide clearance for tube 633.

One possible advantage of using only one needle is that FIG.
A to 20C. The gear 612 of the bit 604 directly engages the gear 614 of the bit 605, which here hits two opposing needles. Because
Because they may be closer to each other than the embodiment of FIG.

19 and 20 show an exemplary embodiment where the needle 608 has a center of rotation between the needle and the piercing head. The tip 630 strikes the bit 605 at an angle substantially perpendicular. Alternatively, tip 630 may strike bit 605 at an inclined angle toward head 602 or away from head 602. Alternatively, as described, needle 608 may be straight. Additionally or alternatively, the needle 608 may curve away from the head. Optionally, needle 608 is formed from a superelastic material, an elastic material or a shape memory material, and the needle can bend when head 602 is released.

21A and 21B show a drill bit 604 according to a particular embodiment of the invention.
It is a perspective view which shows and 605, respectively. FIG. 21A shows an opening 607 in the drill bit 604 through which the needle 608 extends and retracts. FIG. 21B shows an opening 636 for engaging the slot 626 for the tip 630 and thread 634.

22A-22E illustrate a method of threading a tip 630 and thread 636 into a device 600. However, it should be noted that substantially the same method can be used to thread the device 500 of FIG.

The thread 636 with the tip 630 attached thereto has a drill bit 604.
Of the needle 608 until the tip 630 reaches the needle 608. Optionally, the side of thread 636 distal from tip 630 is attached to a guide (eg, Nitinol wire) to help push the thread through device 600.

In one embodiment of the invention, device 640 is provided to assist in threading needle 608. As shown in FIG. 22A, device 640 includes a base 642 having openings 643 and 645 defined therein for receiving drill bits 604 and 605, respectively. A tube 646 having a lumen 648 is provided. The lumen 648 is aligned with the opening 607 and optionally advanced into the opening 607 to contact, for example, the needle 608. Alternatively, the needle 608 may be extended outside the opening 607. Lumen 646 can be provided with a further expanded opening 650 to assist in inserting thread 636 into lumen 648.

In this embodiment of device 640, extension 644 of base 642 is folded and retained around tube 646. The folds of extension 644 are optionally elastic so that tube 646 can be selectively advanced or retracted by pushing extension 644 toward base 642.

In FIG. 22B, tube 646 is in contact with needle 608 and thread 63
6 has been pushed through lumen 648, needle 608 and device 600. When the thread is present in the device 600, the thread may be pulled rather than pushed, eg, by hand or using forceps.

In FIG. 22C, the tip 630 is pulled all the way so that it is stopped by the needle 608.

[0173]   In FIG. 22D, tube 646 is retracted from opening 607.

[0174]   In FIG. 22E, device 640 has been removed from device 600.

Instead of threading each tip 630 through the device 600, one or more tips 63
Zero magazines are provided inside the head 602. In the illustrated embodiment, the tip 630 is positioned such that when the needle 608 is advanced, the needle carries with it along one tip 630. The next tip may bounce to the position where needle 608 was retracted. In this embodiment, the needle 608 may include a groove on the outside of the thread attached to the tip 630. Each such tip may be attached separately,
It can be a wound thread, or more than one may be loosely or firmly attached to the same thread. In one embodiment, the thread is double looped by the tip 630. In another embodiment, the ends of the thread are engaged by the tip.

One type of procedure in which the device 600 (or 500) may be used is an improved sling in which the urethral or bladder neck is suspended or supported by a sling material (eg, mesh or allograft). It is a procedure.

FIG. 23A shows a sling 650 pre-installed on the device 600, according to one embodiment of the invention. Drill bits 604 and 605 are shown inserted into the holes formed in the hooks 650. Such holes may be pre-formed or, if desired, the slings 650 may be drilled or cut. Alternatively, the slings 650 may be placed on the bone or may be perforated in the bone.

The device 600 with the slings 650 placed on the device 600 may be threaded and / or used to pierce bone as described above.

FIG. 23B shows a sling 650 on the surface of the cortex 478, threaded with thread 634. The sling 650 may be secured to the bone by a thread knot. Optionally, the knot may be tucked into the bone channel formed by the perforation.

The other end of the tether 650 may be secured in various ways. For example, it may be attached directly to the tether 650, eg, using an adhesive, sewn using a thread 636, or possibly through a reinforced portion or tether. May be attached to the bone in the same manner as for the first side of the sling that is installed in the device 600 or the device 600 that pierces therethrough, for example, through the pre-drilled holes in the bone. Generally, perforations are less likely to occur with piercing fingers than with staple tips or needles.

In many of the above fingers, the thread is shown progressing from the left needle to the right needle. It should be understood that this convention, as well as other conventions regarding mirroring and relative placement of device elements, are adapted for ease of explanation and shown embodiments (eg, The thread should not be configured to be limited to a needle on the side of the shank to a needle outside the device (which may be different than the one shown in FIG. 13).

In an embodiment of the invention, the device or part thereof is made for single or limited number of uses. Therefore, sterilization of the device can be better achieved. Furthermore, the occurrence of wear and maintainability is solved, which makes the device cheaper to manufacture. In one embodiment, the device is a one-time only (one-pa
device), the needle is a single use. Alternatively or additionally, the needle is a one-time use and the suture and / or thread pusher (t
A "thread pusher" (if any) is a single use. Alternatively, the device is a multi-use device and the piercing head is disposable. Figure 1
In the 2A embodiment, the thread and its channel may include a disposable cartridge. In embodiments where the lever 338 is not needed or is replaced with a latch pin and / or spring 342, the cartridge may include a plurality of prethreaded thread pushers, which thread pushers may include cartridges (FIG. 13B).
(Shown schematically as 343 therein) from the outside to the needle bore, one at a time. As one needle pusher is advanced, the next one is allowed to move and come into contact with spring 342. Optionally, although not necessarily, the disposable needle pusher is provided as an extension of needle pusher 330. The size of the cartridge 343 can, of course, be longer if, for example, a long disposable thread extruder is used. In the embodiment shown, retracting the needle optionally cocks spring 342.

In an embodiment of the invention, even in a single-use device, the device is optionally provided with a test material (if available on the body) after it is made or before it is used by a physician. Tested on a portion of live or dead bone (removed from) to ensure that the device works properly.

The above description focuses on forming a hole in the pubis, and in particular, threading it through the bladder sling or the hole for suspension of the bladder, or neck of the bladder. However, similar devices may be used for other applications. In one of a broad class of uses, the channel is used to attach soft tissue to the bone using a bone grasping thread, which is engaged by the channel. Examples of soft tissue attachments include shoulder dislocation correction (eg, Bankard treatment),
Includes hyoid bone suspension and cosmetic applications (eg, tightening loose meat by suturing it to bone).

FIG. 24 shows a bone-drilling head 360 installed at the end of an endoscope, catheter or trocar 362, according to an embodiment of the invention. FIG. 25 shows a bone-drilling head 360 placed laterally on an endoscope, catheter or trocar 362 according to an embodiment of the invention. It is expected that only a small amount of pressure will be needed to maintain the head 360 against the bone before the needle engages the bone. In a trocar, which is substantially rigid, pressure can be achieved by being pressed against the trocar. In an endoscope, which is usually somewhat rigid, pressure can be applied through the endoscope. In a flexible endoscope and / or a flexible catheter, pressure can be applied by advancing the endoscope and using surrounding body tissue to apply a reaction force. In some of these small diameter devices, levers may not be suitable due to space constraints, but other methods of rotating the needle (s) around the hinge may be used. . This uses, for example, screw mechanisms or motors.
In some cases, a clamp or suction nozzle (not shown) may be provided to hold the head 360 against the bone. The clamp may engage bone or may engage near soft tissue.

In an embodiment of the invention, a hole of minimum diameter is formed in the body, optionally in an unobtrusive position, especially when the endoscope or trocar is used in cosmetic surgery.
The piercing head 360 is then provided at the location where the soft tissue is to be attached to the bone. Sutures are applied and the threads tied through the holes, as described herein. The hole is then closed. This type of procedure may be a staple or screw implantation, or if a long incision may not be a viable option,
It may be particularly useful in facial surgery.

Another class of uses attaches the implant either using sutures as described above or by inserting the protrusions of the implant into channels formed in the bone.

Another class of use is the treatment of bone fractures. In one example, small bones (eg, wrist bones) may be secured and tied together to prevent them from moving apart. Optionally, the channels are first formed in each bone and then the bones are attached to each other (or
Sutured to a soft tissue such as a ligament). In addition, if many bone fragments are present (eg, a skull injury or a crushed jaw fracture), the fragments should be sutured together (
stitch). In some cases, it is advantageous for the needles to face each other (180 degrees) and may proceed straight towards each other. Optionally, a large range of rotation about the hinge approaches such a straight line.

In an embodiment of the invention, bone fragments are attached to structural elements that hold them in place. FIG. 26 shows plate 374 sutured to fragmented bone 370 using a plurality of sutures 372. Optionally, the holes are preformed in the structural element that receives the needle. Alternatively, the holes in the structural element may be drilled in a single step, with the drilling of bone holes. Perhaps a biodegradable structural element is used so that it need not be removed after the bone heals. Alternatively or additionally, the needle may be biodegradable. Another related procedure is the suturing of the sternum, where the cut-open rig cage is closed and sutured. In a variation of the above embodiment, the plate 374 may be an intramedullary nail inside the bone (possibly acting like the plate 374 rather than the entire cross section).

The above description focused on drilling the bone through the bone. But,
It should be noted that various aspects of the invention may be applied to other medical applications, as well as similar medical applications. In one example, self-adjusting features and various safety features may be useful for screw drive devices and staplers, either separately or in combination, such as, for example, soft tissue slippage, false penetration and / or Or prevent inadvertent damage.

With respect to the stapler, the force transmission mechanism described above that advances the needle (eg, FIG. 1).
It is noted that can be used to advance staples and, unlike needles, staples remain in the body. Presumably, the staples are inserted side by side with a pair of needles, each of the needles including a groove for receiving the arm of the staple, and the needles actually piercing. Thus, the staple itself may contain little material and / or may be mechanically weak.

Furthermore, the device described above can be used for tacking, a method in which sutures or other objects are attached to the bone by being pushed between the tack and the bone. For a more complete description of tacking, see Applicant's Fluence Medi.
cal Systems Ltd. Filed on January 8, 2000 by
PCT Patent Application No. PCT / IL00 / 0 entitled "Tack Device"
0012, the disclosure of which is incorporated herein by reference.

Further, the device described above implants a bone anchor, and since the hole is pierced by the needle, the bone anchor is made of less material, less material, and / or less material.
Or it can be used to note that it can be made from bioabsorbable materials.

27A-27C show an alternative method of securing thread 634 to bone. As in some of the previous embodiments, the thread is retained by the bone itself. However, FIG.
In the seventh embodiment, only one hole is formed in the bone.

In FIG. 27A, V-shaped hole 660 is shown in chip section 67 as shown, for example.
Tool 668 with 0 is used to form cortex 478. The formed hole has a larger opening 662, eg, in the center of the “V” and thinner arm 664.

FIG. 27B shows a thread 634 having a knot 672 formed therein. The knot is inserted through the larger opening 662 and slipping the knot underneath the thinner portion 664 prevents it from falling out of the bone. In some cases, knots are not required, for example, thread 634 may be directly engaged by the bone, for example by arms 664 that define a thinner slot than thread 634. Alternatively or in addition to the knot 672, a fixed element such as a bead may be provided at the end of the thread 634. Alternatively or additionally, an inflating element, such as a plastic or metal element, may be provided at the end of the thread 634 and, once they inflate, may slip out of the openings 662 and / or 664 (in some embodiments). I can't.
The size and / or shape of the openings 662 and 64 may vary depending on the initial diameter of the suture (ie, the elements secured therein) and / or the method of fixation.

[0197]   FIG. 27C shows an exemplary completed suture thread.

Other hole configurations can be used as well. For example, a C-shaped hole is
It can be used to hold the thread in the bone in a manner similar to 26 above. The thread is on the loop and is placed on the two arms of C at the same time. Each end of the thread will attract a different tip C and will not slip. Alternatively, a simpler horizontal peg may be formed in the bone using the tool 668, with the thread attached to the peg.

Instead of using the tool 668 to form the hole 660, advancing a needle having the appropriate cross-sectional area may be used. The needle may also be used to attach a tip to a drill bit (FIG. 19) or when used to exchange tips between needles, such as using the same mechanism to attach threads to holes. Optionally, the removable tip of the needle defines a groove that engages the cortex of the bone when the needle is retracted, thereby retaining the tip inside the bone.

In some embodiments of the invention, the above-described mechanism for making holes in bone is used to insert an object, such as an anchor, into the bone at a non-perpendicular angle. No part of the inserted object needs to stick out of the bone.

The above method of forming a channel through the bone and tying the channel and the device with a thread is
It is understood that it is within the scope of the invention, although it can be varied in many ways. further,
There are a variety of different features and both methods and devices are described. It should be appreciated that different features may be combined in different ways. In particular, not all of the features illustrated in the particular embodiments above are required for each of the similar embodiments of the invention. Furthermore, the combination of the above features also
It is considered to be within the scope of some embodiments of the invention. Further within the scope of the present invention, a surgical kit includes a bone drilling device, a bone drilling head, a set of needles and / or sutures, and a device and / or method of using such a surgical kit. Including. As used in the claims, the terms "comprises", "includes"
, "Have" and their conjugations mean "including but not limited to".

Those skilled in the art will understand that the invention is not limited by what has been described above. Rather, the scope of the present invention is limited only by the claims.

[Brief description of drawings]

FIG. 1A schematically illustrates a bone piercing device in an inactive configuration and an active configuration, according to an exemplary embodiment of the present invention.

FIG. 1B schematically illustrates a bone piercing device in an inactive configuration and an active configuration, according to an exemplary embodiment of the present invention.

FIG. 2 is a schematic illustration of a hinged dual needle piercing head according to an exemplary embodiment of the present invention.

FIG. 3A illustrates leveraged action of a hinged dual needle piercing head according to an exemplary embodiment of the present invention.

FIG. 3B illustrates leveraged action of a hinged dual needle piercing head according to an exemplary embodiment of the present invention.

FIG. 3C illustrates a replaceable needle piercing head with the needle retracted, in accordance with an exemplary embodiment of the present invention.

FIG. 4A schematically illustrates a bone drilling device having a needle extension / retraction mechanism that matches a particular activation logic, according to an exemplary embodiment of the present invention.

FIG. 4B schematically illustrates a bone drilling device having a needle extension / retraction mechanism that matches a particular activation logic, according to an exemplary embodiment of the invention.

FIG. 5A illustrates an end-to-end needle configuration, according to an exemplary embodiment of the invention.

FIG. 5B   5B illustrates various needle cross sections of the configuration of FIG. 5A.

FIG. 6A is a side and top view of a side-by-side needle configuration, according to an exemplary embodiment of the invention.

6B is a side and top view of a side-by-side needle configuration, according to an exemplary embodiment of the present invention. FIG.

FIG. 7A   FIG. 7A illustrates an upper-lower needle configuration according to an exemplary embodiment of the invention.

7B is a cross-sectional view taken along the line BB in FIG. 7A, showing details of the needle configuration.

FIG. 8A illustrates a removable needle configuration and its use in piercing and threading bone, according to an exemplary embodiment of the present invention.

FIG. 8B illustrates a removable needle configuration and its use in piercing and threading bone, according to an exemplary embodiment of the present invention.

FIG. 8C illustrates a removable needle configuration and its use in piercing and threading bone, according to an exemplary embodiment of the present invention.

8D illustrates a safety latch that releases two removable needles of FIGS. 8A-8C only when they meet, according to an exemplary embodiment of the invention.

8E illustrates a safety latch that releases two removable needles of FIGS. 8A-8C only when they meet, according to an exemplary embodiment of the invention.

FIG. 8F illustrates a safety latch that releases two removable needles of FIGS. 8A-8C only when they meet, according to an exemplary embodiment of the invention.

FIG. 9A schematically illustrates a single hinged needle piercing head according to an exemplary embodiment of the present invention.

FIG. 9B schematically illustrates a single hinged needle piercing head, according to an exemplary embodiment of the present invention.

FIG. 10A illustrates angular independence of a piercing head according to an exemplary embodiment of the present invention.

FIG. 10B   FIG. 10B shows a self-configuring piercing head, according to an exemplary embodiment of the invention.

FIG. 11A   FIG. 11A illustrates a self-configuring punching device according to an exemplary embodiment of the present invention.

FIG. 11B   FIG. 11B illustrates a self-configuring punching device according to an exemplary embodiment of the present invention.

FIG. 11C illustrates another self-configuring piercing device according to an exemplary embodiment of the present invention.

FIG. 12A illustrates open and closed configurations of a yarn extruder according to an exemplary embodiment of the present invention.

FIG. 12B shows an open and closed configuration of a yarn extruder according to an exemplary embodiment of the present invention.

FIG. 13A illustrates a method of threading a thread through the hole in the needle of FIGS. 5A and 5B, according to an exemplary embodiment of the present invention.

FIG. 13A illustrates a method of threading a thread through the hole of the needle of FIGS. 5A and 5B, according to an exemplary embodiment of the present invention.

FIG. 14A illustrates various stages in the use of a thread exchange needle assembly according to an exemplary embodiment of the present invention.

FIG. 14B illustrates various stages in the use of a thread exchange needle assembly according to an exemplary embodiment of the present invention.

FIG. 14C illustrates various stages in the use of a thread exchange needle assembly according to an exemplary embodiment of the present invention.

FIG. 14D illustrates various stages in the use of a thread exchange needle assembly according to an exemplary embodiment of the present invention.

FIG. 14E   FIG. 14E illustrates a needle receiving tip according to various embodiments of the invention.

FIG. 14F   FIG. 14F illustrates a needle receiving tip according to various embodiments of the invention.

FIG. 14G   FIG. 14G illustrates a needle receiving tip according to various embodiments of the invention.

FIG. 14H   FIG. 14H illustrates a needle receiving tip according to various embodiments of the invention.

FIG. 15A illustrates a hollow needle piercing mechanism, according to an exemplary embodiment of the present invention, wherein the hole in one of the needles is filled with a retractable mandrel.

FIG. 15B shows a hollow needle piercing mechanism, according to an exemplary embodiment of the present invention, wherein the hole in one of the needles is filled with a retractable mandrel.

FIG. 15C illustrates a hollow needle piercing mechanism according to an exemplary embodiment of the present invention, wherein the hole in one of the needles is filled with a retractable mandrel.

FIG. 15D shows a hollow needle piercing mechanism according to an exemplary embodiment of the present invention, wherein the hole in one of the needles is filled with a retractable mandrel.

FIG. 16A illustrates a combination drilling and needle drilling head, according to an exemplary embodiment of the present invention.

FIG. 16B illustrates a combination drilling and needle drilling head according to an exemplary embodiment of the present invention.

FIG. 17A   FIG. 17A shows a method using the head combination of FIGS.

FIG. 17B   FIG. 17B shows a method using the combination of heads of FIGS.

FIG. 17C   FIG. 17C shows a method using the head combination of FIGS. 16A-16B.

FIG. 17D   Figure 17D shows a method using the head combination of Figures 16A-16B.

[FIG. 17E]   FIG. 17E illustrates a method using the head combination of FIGS. 16A-16B.

FIG. 18   FIG. 18 shows a modification of the combination of the punching heads of FIGS.

FIG. 19A shows the application of another combination of drilling and drilling heads, using only one needle for two drill bits, according to an exemplary embodiment of the present invention.

FIG. 19B illustrates the use of another combination of drilling and drilling heads, according to an exemplary embodiment of the present invention, using only one needle for two drill bits.

FIG. 19C illustrates the use of another combination of drilling and drilling heads, according to an exemplary embodiment of the present invention, using only one needle for two drill bits.

FIG. 19D illustrates the use of another combination of drilling and drilling heads, according to an exemplary embodiment of the present invention, using only one needle for two drill bits.

FIG. 19E illustrates the use of another combination of drilling and drilling heads, using only one needle for two drill bits, in accordance with an exemplary embodiment of the present invention.

FIG. 20A shows the drill bit and needle of FIGS. 19A-19E in a blow up manner, wherein the needle tip is engaged by an opening in the drill bit, according to one embodiment of the invention. It

FIG. 20B shows the drill bit and needle of FIGS. 19A-19E expanded according to one embodiment of the present invention, wherein the needle tip is engaged by an opening in the drill bit. It

FIG. 20C shows the drill bit and needle of FIGS. 19A-19E in a blow up manner, wherein the needle tip is engaged by an opening in the drill bit, according to one embodiment of the invention. It

FIG. 21A shows a perspective view of the drill bit of FIGS. 20A-20C, according to one embodiment of the present invention.

FIG. 21B shows a perspective view of the drill bit of FIGS. 20A-20C, according to one embodiment of the present invention.

FIG. 22A illustrates a method of threading the device of FIGS. 19A-19E according to one embodiment of the present invention.

22B illustrates a method of threading the device of FIGS. 19A-19E, according to one embodiment of the present invention.

22C illustrates a method of threading the device of FIGS. 19A-19E according to one embodiment of the present invention.

22D illustrates a method of threading the device of FIGS. 19A-19E according to one embodiment of the present invention.

22E illustrates a method of threading the device of FIGS. 19A-19E, according to one embodiment of the present invention.

FIG. 23A shows a sling pre-mounted on device 600, according to one embodiment of the invention.

FIG. 23B illustrates a sling ready for suturing to bone according to an embodiment of the present invention.

FIG. 24 shows a bone drilling head attached to one end of an endoscope, catheter or trocar according to an exemplary embodiment of the present invention.

FIG. 25 shows a bone piercing head attached to one side of an endoscope, catheter or trocar according to an exemplary embodiment of the present invention.

FIG. 26   FIG. 26 illustrates a method of treating a fracture, according to an exemplary embodiment of the invention.

FIG. 27A   FIG. 27A illustrates another method of attaching a thread to bone according to one embodiment of the invention.

FIG. 27B   Figure 27B illustrates another method of attaching a thread to bone according to one embodiment of the invention.

FIG. 27C   FIG. 27C illustrates another method of attaching a thread to bone according to one embodiment of the invention.

─────────────────────────────────────────────────── ─── Continued front page    (31) Priority claim number 135832 (32) Priority date April 27, 2000 (April 27, 2000) (33) Israel, which claims priority (81) Designated countries EP (AT, BE, CH, CY, DE, DK, ES, FI, FR, GB, GR, IE, I T, LU, MC, NL, PT, SE), OA (BF, BJ , CF, CG, CI, CM, GA, GN, GW, ML, MR, NE, SN, TD, TG), AP (GH, GM, K E, LS, MW, MZ, SD, SL, SZ, TZ, UG , ZW), EA (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM), AE, AG, AL, AM, AT, AU, AZ, BA, BB, BG, BR, BY, CA, C H, CN, CR, CU, CZ, DE, DK, DM, DZ , EE, ES, FI, GB, GD, GE, GH, GM, HR, HU, ID, IL, IN, IS, JP, KE, K G, KP, KR, KZ, LC, LK, LR, LS, LT , LU, LV, MA, MD, MG, MK, MN, MW, MX, MZ, NO, NZ, PL, PT, RO, RU, S D, SE, SG, SI, SK, SL, TJ, TM, TR , TT, TZ, UA, UG, US, UZ, VN, YU, ZA, ZW (72) Inventor Bayer, Madeichai             Israel, 30600 Caesarea, Ha             Escholith Street 7 (72) Inventor Gloverman, Oren             State of Israel 46910 Kfar-Shma             Lyakh, Derici Haganin Street               30 F-term (reference) 4C060 BB01 LL08 MM24

Claims (78)

[Claims] 1. A needle base, a pivot, and at least one curved needle, comprising: a needle at one end of the needle, the needle being rotatably mounted on the needle base; The needle and pivot are configured and adapted to be pushed into the bone when the tip is placed against bone tissue and the needle rotates about the pivot. , Bone piercing device. 2. The device of claim 1, wherein the pivot includes a rotating hinge coupled to the needle base. 3. A support point adjacent to the pivot and external to the device, the support point adapted to be positioned opposite the bone. The device described in. 4. The device according to claim 1, wherein the curved needle has a radius of curvature that matches the distance of the needle from the pivot. 5. At least one drill bit defining at least one channel drilled into the bone and formed through the drill bit and an opening from the exterior of the bit to the channel. 5. A device according to any of claims 1 to 4, comprising one drill bit, the at least one needle being adapted to pass through the opening. 6. The device of claim 5, wherein the drill comprises a bone drill adapted to drill through a cortical portion of the bone. 7. The device of claim 5, wherein the at least one needle is not suitable for drilling through a cortical portion of the bone. 8. The device according to any of claims 5-7, wherein the at least one drill bit comprises two drill bits. 9. The device of any of claims 5-7, wherein the at least one drill bit comprises a single drill bit. 10. The device of claim 8, wherein the drill bits are arranged substantially parallel to each other. 11. The device according to claim 8 or 10, wherein the drill bits rotate in the same direction. 12. The device according to claim 8 or 10, wherein the drill bit rotates in opposite directions. 13. The device of any of claims 8-10, wherein the at least one needle comprises at least two needles. 14. The device of any of claims 8-10, wherein the at least one needle comprises a single needle. 15. The at least one needle, the channel, the opening and the drill bit, the at least one needle passing through the channel in the at least one of the two drill bits, 15. The device of claim 14, configured and adapted to exit through an opening and meet a second of the two drill bits. 16. The second drill bit defines a receiving opening on a side surface,
16. The device of claim 15, wherein the needle meets the second drill bit at the receiving opening. 17. The device of claim 16, wherein the at least one needle includes a removable tip and the receiving opening is adapted to engage the removable tip. 18. The device of claim 17, wherein the receiving opening has a constriction of the opening radially within a volume defined by the second drill bit. 19. The device of claim 18, wherein the removable tip is adapted to rotate within the drill bit to reside within the volume after the engagement. 20. The second drill bit defines an axial groove adjacent the piercing tip of the second drill bit and of a size sufficient to receive a thread attached to the removable tip. Item 20. The device according to any one of items 17 to 19. 21. The device according to claim 8, wherein the opening is formed in a side surface of the drill bit. 22. The device according to claim 1, comprising a motor for rotating the drill bit. 23. The device of claim 21, comprising a motor that rotates the drill bit. 24. The device of claim 23, wherein the motor is a stepper motor adjusted to rotate the drill bit an integer number of times. 25. The device of claim 23, comprising a mechanical stop that stops the drill bit such that the angles of the drill bit are aligned. 26. The device of claim 23, comprising a sensor that detects at least one angular position of the drill bit, and a controller that controls the motor in response to an input of the sensor. 27. The at least one needle comprises a first needle and a second needle.
5. The device according to any one of claims 1 to 4, including a needle. 28. The device of claim 13 or 27, wherein the needle rotates about the same pivot so as to be pushed into the bone. 29. The device of claim 13 or 27, wherein the needles do not share a common hinge. 30. The device of any of claims 13 and 27-29, wherein the needle is adapted to meet at an end of the needle when the needle rotates about the pivot. 31. The device of claim 30, wherein the needles meet tip to tip. 32. The device of claim 30, wherein the needles meet face to face at the ends of the needles. 33. The needle is formed from a conduit and, when encountered by the needle, forms a continuous conduit along the needle.
33. The device according to any of 3 and 27-32. 34. The device of any of claims 30-32, wherein the first needle is adapted to engage a tip of the second needle. 35. The device of claim 34, wherein the second needle is hollow and defines a conduit through the second needle. 36. The device of claim 34, wherein the second needle has a groove that defines a conduit along most of the length of the second needle. 37. A method according to any one of claims 33 to 36, comprising a channel substantially continuous with the conduit, the channel being adapted to pass a thread through the channel and along the conduit. The device described in. 38. The device of claim 37, comprising a thread push that advances the thread through the conduit and the channel. 39. The device of claim 38, wherein the thread push is long enough to extend through the channel and the conduit to the exterior of the device. 40. The device of any of claims 34-36, wherein the tip comprises a removable tip to which the thread is attached. 41. The device of claim 40, wherein the removable tip includes an extension to which a thread is attached, the extension being substantially longer than the second needle. 42. The device of claim 34, wherein the second needle is removable from the needle base. 43. The device of claim 42, wherein the second needle is removed upon encountering the needle. 44. The device of claim 43, wherein the second needle is adapted to attach a thread to the second needle. 45. The first needle defines an opening in a tip of the first needle, the opening being adapted to engage the tip of the second needle. Item 45. The device according to any one of items 34 to 44. 46. The opening of claim 45, wherein the opening opens into a blind hole.
The device described in. 47. The device of claim 45, wherein the opening opens into a through hole that exists through a side of the needle. 48. The device of claim 45, wherein the opening connects to a hollow volume along the axis of the needle. 49. A sharp tip mandrel filling the hollow volume for at least a portion of the rotation of the needle about the pivot.
8. The device according to 8. 50. The device of claim 49, wherein the mandrel retracts when the needle is encountered. 51. The device of claim 45, wherein the opening connects to a hollow space having an axis that is oblique to the axis of the needle. 52. The device of claim 45, wherein the opening extends into the needle and opens into a volume having a substantially constant inner diameter. 53. The device of claim 45, wherein the opening extends into the needle to a volume having an inner diameter that increases with distance from the opening. 54. The device of claim 45, wherein the opening opens into an elongated volume. 55. The device of any of claims 1-54, wherein the device comprises a handle. 56. The device of claim 55, wherein the needle and the hinge are configured in a disposable cartridge that is separable from the handle. 57. At least one needle adapted to puncture bone, a force providing element for advancing said needle, remote from said needle, a force coupled to said needle and adjacent said needle. An amplifier for amplifying the force provided by the force-providing element and supplying it to the needle, a device for piercing a bone. 58. The device of claim 57, wherein the at least one needle comprises two needles. 59. The needle is mounted on a hinge and the needle is rotated about the hinge by a force provided by the force amplifier.
7. The device according to 7. 60. The device of claim 57, wherein the force amplifier comprises a lever. 61. At least one curved needle adapted to extend for piercing bone, and holding the needle, external to the device and positioned opposite the bone. And a handle coupled to the base, and the base is responsive to the decrease in force when the force on the handle in a particular direction is less than a predetermined amount. And a needle retractor that retracts the needle prior to retracting from the bone. 62. At least one curved needle adapted to extend for piercing bone, a base adapted to retain the needle and be positioned opposite bone. A handle coupled to the base and a needle advancer for advancing the needle only if the force on the handle in a particular direction is higher than a predetermined amount, the predetermined force causing the base to move the bone A device for piercing bone with a needle advancer that ensures that it is pressed against. 63. A tip having a sharpened tip and adapted to drill a hole through bone, and a flexible extension of the tip, opposite the sharpened tip, the sharpened tip. Removable tip for the needle, which is substantially longer than and has an extension that attaches to the thread. 64. The tip of claim 63, wherein the tip is adapted to be grasped by a solid needle on a side of the extension. 65. The tip of claim 63, wherein the sharp end is adapted to be grasped by a hollow needle on the side of the sharp tip opposite the extension. 66. An automatic aligning device for drilling bone, comprising: a drilling head having at least two drilling tips; a body; and a body at positions substantially equidistant from the drilling tips. A hinge connecting the head to the body, and an automatic aligning device. 67. The device of claim 66, wherein the piercing tip comprises a drill bit. 68. The piercing tip comprises a piercing needle.
Or the device according to 67. 69. The device of any of claims 66-68, wherein the head includes a power supply that activates the piercing tip. 70. The piercing tip faces the handle.
The device described in. 71. Forming a channel in bone comprising drilling two holes in the cortical portion of the bone, and advancing at least one needle through the drilled hole and through the medulla of the bone. how to. 72. The method of claim 71, wherein the hole is perpendicular to the surface of the bone. 73. The at least one needle meets 2 in the bone
72. The method of claim 71, comprising one needle. 74. A bone piercing device comprising at least one bone drilling drill bit defining a needle path therein and at least one needle adapted to advance along the needle path. 75. The device of claim 74, wherein the needle path comprises a lumen. 76. A needle base and a pivot, wherein the at least one needle has a tip at one end of the at least one needle and is rotatably mounted on the needle base, the needle and the pivot comprising: When the tip is placed against bone tissue and the needle rotates about the pivot,
75. The needle is configured and adapted to be pushed into the bone.
Or the device according to 75. 77. The device of any of claims 74-76, wherein the at least one needle comprises at least two needles. 78. The device of any of claims 74-77, wherein the at least one drill bit comprises at least two drill bits.