METHODS AND DEVICES TO TREAT DISEASED OR INJURED MUSCULOSKELETAL TISSUE
A knotless suture anchoring system includes an outer anchor having a central channel and a distal tip adapted to penetrate tissue. An inner anchor is positionable in the central channel of the outer anchor and a locking feature on one or both of the inner and outer anchors retains the inner anchor within the central channel. A continuous length of suture is coupled with the inner and outer suture anchors and has a free end. At least one of the inner and the outer anchors also has a cinching mechanism that allows the suture to be tensioned by passage of the suture through the cinching mechanism in a first direction while movement of the suture through the cinching mechanism in a second direction opposite the first direction is constrained.
The present application is a non-provisional of, and claims the benefit of U.S. Provisional Patent Application No. 61/177,602 (Attorney Docket No. 028357-000110US, formerly 020979-003910US), filed May 12, 2009, the entire contents of which are incorporate herein by reference.
The present application is related to U.S. patent application Ser. No. 12/605,065 (Attorney Docket No. 028357-000120US, formerly 020979-003920US), filed Oct. 23, 2009, the entire contents of which are incorporated herein by reference.
BACKGROUND OF THE INVENTION1. Field of the Invention
The present disclosure relates to medical devices, systems and methods, and more specifically to methods, systems and devices used for knotless suturing of tissue.
Soft tissue such as tendons, ligaments and cartilage are generally attached to bone by small collagenous fibers which are strong, but which nevertheless still can tear due to wear or disease. Examples of musculoskeletal disease include a torn rotator cuff as well as a torn labrum in the acetabular rim of a hip joint or the glenoid rim in a shoulder joint.
Thus, treatment of musculoskeletal disease may involve reattachment of torn ligaments or tendons to bone. This may require the placement of devices such as suture anchors within bone. A suture anchor is a device which allows a suture to be attached to tissue such as bone. Suture anchors may include screws or other tubular fasteners which are inserted into the bone and become anchored in place. After insertion of the anchor, the tissue to be repaired is captured by a suture, the suture is attached to the anchor (if not already preattached), tension is adjusted, and then the suture is knotted so that the tissue is secured in a desired position. Frequently two or more anchors and multiple lengths of suture are required. This process can be time consuming and difficult to undertake in the tight space encountered during endoscopic surgery and sometimes even in conventional open surgery. Recently, knotless suture anchors having suture clamping mechanisms have been developed to eliminate the need to tie knots but they still can be difficult or awkward to use. Thus, it would be desirable to provide improved knotless suture anchors that are easier to use and also that may take up less space during deployment and that are easier to deploy.
In particular, treating musculoskeletal disease in a hip joint can be especially challenging. The hip joint is a deep joint surrounded by a blanket of ligaments and tendons that cover the joint, forming a sealed capsule. The capsule is very tight thereby making it difficult to advance surgical instruments past the capsule into the joint space. Also, because the hip joint is a deep joint, delivery of surgical instruments far into the joint space while still allowing control of the working portions of the instrument from outside the body can be challenging. Additionally, the working space in the joint itself is very small and thus there is little room for repairing the joint, such as when reattaching a torn labrum to the acetabular rim. Moreover, when treating a torn labrum, the suture anchor must be small enough to be inserted into the healthy rim of bone with adequate purchase, and the anchor also must be short enough so that it does not protrude through the bone into the articular surface of the joint (e.g. the acetabulum). Existing anchors can be too large. Thus, it would be desirable to provide suture anchors that have a small diameter and length.
Additionally, in most surgical procedures, a pilot hole is drilled at the implantation site prior to screwing in the suture anchor. In other cases a self-tapping device tip is used to screw in the device without a pilot hole. Alternatively, ultrasonic energy has been proposed in embedding bone anchors in bony tissue without pre-drilling a pilot hole. These methods of implanting a device in bone tissue, while commonly used in surgery today, are not optimal. Pre-drilling a pilot hole prior to placing the device requires the surgeon to exchange tools through the cannula and to locate the pilot hole after introducing the implant in the arthroscopic field. Self-tapping devices are limited to use at sites with the appropriate thickness of cortical bone. Ultrasonic energy based devices are susceptible to large energy losses with minor changes in device configuration, and rely on ultrasonic energy sources which can be expensive. Therefore, there is a need for improved devices, systems and methods which overcome some of the aforementioned challenges.
In addition, current arthroscopic devices are limited in that they generally approach a surgical site in a longitudinal manner. If it is necessary to implant a bone anchor at an angle, which is often the case, the current devices do not fully address the need for an off axis approach. Furthermore, there is a need for anchors to be compatible with a device that implants the anchors at an angle off of the longitudinal axis of the shaft of the driving device. At least some of these objectives will be met by the inventions described hereinbelow.
2. Description of the Background Art
Patents disclosing suture anchoring devices and related technologies include U.S. Pat. Nos. 7,390,329; 7,309,337; 7,144,415; 7,083,638; 6,986,781; 6,855,157; 6,770,076; 6,656,183; 6,066,160; 6,045,574; 5,810,848; 5,728,136; 5,702,397; 5,683,419; 5,647,874; 5,630,824; 5,601,557; 5,584,835; 5,569,306; 5,520,700; 5,486,197; 5,464,427; 5,417,691; and 5,383,905. Patent publications disclosing such devices include U.S. Patent Publication Nos. 2009/0069845 and 2008/0188854 and PCT Publication No. 2008/054814.
BRIEF SUMMARY OF THE INVENTIONThe present invention provides devices, systems and method for knotless suturing of tissue. Exemplary procedures where knotless suturing may be advantageous include repair of torn rotator cuffs, as well as a torn labrum in the acetabular rim of a hip joint or the glenoid rim in a shoulder joint.
In a first aspect of the present invention a knotless suture anchoring system comprises an outer anchor having a central channel and a distal tip adapted to penetrate tissue and an inner anchor positionable in the central channel of the outer anchor. The system also includes a locking feature on one or both of the inner and outer anchors and that is configured to retain the inner anchor within the central channel. A continuous length of suture is coupled with the inner and outer anchors and the suture has a free end. At least one of the inner and outer anchors further comprises a cinching mechanism that is adapted to allow the suture to be tensioned by passage of the suture through the cinching mechanism in a first direction while movement of the suture through the cinching mechanism in a second direction opposite the first direction is constrained.
In another aspect of the present invention, a knotless suture anchoring system comprises an outer anchor having a central channel and a distal tip adapted to penetrate tissue. An inner anchor is positionable in the central channel of the outer anchor and has a distal tip that is adapted to penetrate and be retained in tissue outside the outer anchor whereby the inner anchor may be positioned either in the outer anchor or in tissue apart from the outer anchor. The system also includes a locking feature on one or both of the inner and outer anchors that is configured to retain the inner anchor within the central channel and a continuous length of suture coupled with the inner and outer anchors. The suture has a free end. At least one of the inner and outer anchors further comprises a clamping mechanism adapted to clamp the suture under tension without knotting the suture.
Sometimes the central channel extends only partially through the outer anchor and the locking feature may comprise an annular recessed region in the central channel of the outer anchor. The outer anchor may comprise an outer surface having surface features that are adapted to anchor the outer anchor with the tissue or to promote tissue ingrowth.
The inner anchor locking feature may comprise a plurality of resilient fingers extending radially outward from the inner anchor. The clamping mechanism may comprise a cinching mechanism adapted to allow the suture to be tensioned by passage of the suture through the cinching mechanism in a first direction while movement of the suture through the cinching mechanism in a second direction opposite the first direction is constrained. The cinching mechanism may comprise a deflectable arm coupled to either the inner or the outer anchor. Additionally, the cinching mechanism often may be operative regardless of the position of the inner anchor relative to the outer anchor. The deflectable arm may be integral with either the inner or the outer anchor and the deflectable arm may be disposed in an aperture within either the inner or the outer anchor. The aperture may be in an axial channel extending at least partially through the inner anchor. The deflectable arm may move in a first radial direction when the suture is pulled in the first direction and the arm may move in a second radial direction when the suture is pulled in the second direction. The suture may be clamped between the arm and a wall of the aperture when the suture is pulled in the second direction. The arm may be resilient so as to return to an unbiased position after moving in either the first or the second radial directions. The arm may deflect radially inward when the suture is pulled in the second direction to clamp the suture between the arm and an opposing wall of the aperture, thereby constraining movement of the suture in the second direction.
The system may also comprise a delivery instrument having a longitudinal axis, and the delivery instrument may be adapted to carry both the inner anchor and the outer anchor simultaneously. The delivery instrument often may have an axial lumen, the inner and the outer anchors being releasably carried in the axial lumen. The delivery instrument may comprise a steering mechanism that is adapted to deflect a distal portion of the instrument. Also the delivery instrument may comprise a suture management feature that is adapted to releasably hold the length of suture and prevent tangling thereof. In some embodiments, the delivery instrument may be configured to receive a drill which is adapted to create an aperture in the tissue sized to receive the inner or the outer anchor. In still other embodiments, the delivery instrument may be adapted to deliver the inner anchor and the outer anchor at an angle transverse to the longitudinal axis of the delivery instrument. The delivery instrument may have a hammer element that is coupled with the delivery instrument and that is adapted to convert axial movement along the longitudinal axis of the delivery instrument into an impacting force transverse to the longitudinal axis of the delivery instrument. Each of the inner and the outer anchors have a longitudinal axis and the delivery instrument may carry the inner and the outer anchors such that the longitudinal axis of both anchors is transverse to the longitudinal axis of the delivery instrument.
The central channel of the outer anchor may be disposed at an angle transverse to a longitudinal axis of the outer anchor. Thus, the inner anchor may be disposed at an angle transverse to the longitudinal axis of the outer anchor when received in the central channel.
The delivery instrument may comprise a jaw having first opposable member pivotably coupled with a second opposable member. The first opposable member may carry the inner anchor and the second opposable member may carry the outer anchor, and actuation of the jaw may insert the inner anchor into the outer anchor. The inner and the outer anchors may each have a longitudinal axis and the anchors may be carried by the opposable members such that the longitudinal axis of the anchors are transverse to a longitudinal axis of the opposable members.
In still another aspect of the present invention, a knotless suture anchoring system comprises a first anchor having a housing with a central channel sized to receive a suture therein. The system also has a cinching mechanism with a radially deflectable arm integral with the housing and disposed at least partially in the central channel. The suture passes through an opening in the arm and passes between a free end of the arm and the housing. The cinching mechanism is adapted to allow the suture to pass through the cinching mechanism in a first direction while movement of the suture through the cinching mechanism in a second direction opposite the first direction is constrained.
The cinching mechanism may comprise a deflectable arm coupled to the first anchor. The deflectable arm may be integral with the first anchor and it may be disposed in an aperture within the first anchor. The aperture may be in an axial channel extending at least partially through the first anchor. The arm may move in a first radial direction when the suture is pulled in the first direction and the arm may move in a second radial direction when the suture is pulled in the second direction. The suture may be clamped between the arm and a wall of the aperture when the suture is pulled in the second direction. The arm may be resilient so as to return to an unbiased position after moving in either the first or the second radial directions. The arm may deflect radially inward when the suture is pulled in the second direction to clamp the suture between the arm and an opposing wall of the aperture, thereby constraining movement of the suture in the second direction.
The housing may comprise a distal tip adapted to penetrate tissue. The housing may also comprise an outer surface having surface features adapted to anchor the first anchor in the tissue or to promote tissue ingrowth. The system may also include a second anchor having an inner channel configured to receive the first anchor. The inner channel may comprise a locking feature adapted to engage with the first anchor to retain the first anchor in the second anchor.
In yet another embodiment of the present invention, a knotless suture anchoring system may comprise a pin having a distal tip adapted to penetrate tissue, an anchoring bracket and a length of suture. The suture is adapted to be coupled to the pin and the bracket. The bracket may be L-shaped and may comprise a suture management feature adapted to receive and hold the suture. The suture management feature may comprise a slit in the bracket. The bracket may also have an anchoring pin that is adapted to penetrate the tissue thereby fixing the bracket to the tissue. The suture may be formed into a loop sized to capture tissue to be repaired and the tissue to be repaired may comprise a torn labrum. The anchoring bracket or the pin may further comprise a cinching mechanism adapted to allow the suture to be tensioned by passage of the suture through the cinching mechanism in a first direction while movement of the suture through the cinching mechanism in a second direction opposite the first direction is constrained.
In another aspect of the present invention, a knotless suture anchoring system comprises a delivery instrument having a longitudinal axis, a shaft axially movable along the longitudinal axis, and a hammer adapted to convert axial movement along the longitudinal axis into movement transverse thereto. A first anchor is carried by the delivery instrument and has a distal tip adapted to penetrate tissue. Axial movement of the slidable shaft along the longitudinal axis moves the hammer in a motion transverse thereto, thereby impacting the anchor, whereby the first anchor is driven into the tissue at an angle transverse to the longitudinal axis of the delivery instrument.
In still another aspect of the present invention, a method of knotless suturing comprises providing a delivery instrument carrying a first anchor and a second anchor, wherein a continuous length of suture is coupled with the first and the second anchors. The delivery instrument is advanced to a treatment region comprising treatment tissue and the first anchor is placed into a first region of the tissue. The suture is coupled to a portion of the treatment tissue and the second anchor is attached to the first anchor. The suture is tensioned and secured without knotting the suture. The suture is secured by moving the suture through a cinching mechanism in the first or the second anchor, wherein the cinching mechanism is adapted to allow the suture to move through the cinching mechanism in a first direction while movement of the suture through the cinching mechanism in a second direction opposite the first direction is constrained independently of the position of the second anchor relative to the first anchor.
The second anchor may be stationary relative to the first anchor during the entire step of securing the suture. The tissue may comprise bone and the step of placing the first anchor or the step of placing the second anchor may comprise drilling a pilot hole into the bone. The pilot hole may be sized to receive the first or the second anchor. The method may further comprise deflecting a distal portion of the delivery instrument. The first region of tissue may comprise the acetabulum and the treatment tissue may comprise an acetabular labrum.
The step of attaching the second anchor to the first anchor may comprise inserting the second anchor into a central channel of the first anchor and locking the two anchors together to prevent axial movement of the first anchor relative to the second anchor. The delivery instrument may further comprise an actuator mechanism near a proximal end of the instrument and the step of placing the first anchor or the step of placing the second anchor comprises actuating the actuator mechanism to expose the first or the second anchor from the delivery instrument. The step of securing may comprise clamping the suture between a deflectable arm and an inner wall of the first or the second anchor. The arm may be integral with either the first or the second anchor.
The step of attaching may comprise placing the second anchor in a central channel within the first anchor. The cinching mechanism may be disposed in an inner channel of the second anchor. The delivery instrument has a longitudinal axis, and the step of placing the first anchor may comprise placing the first anchor into the first region at an angle transverse to the longitudinal axis of the delivery instrument. The step of attaching the second anchor to the first anchor may comprise actuating a jaw disposed on the delivery instrument.
In another aspect of the present invention, a method of knotless suturing comprises providing an anchoring device having an anchoring bracket, a length of suture and a pin, wherein the suture is coupled to the bracket and the pin. The bracket is anchored to a first tissue region and tissue to be treated is captured with the suture. The pin is secured to a structure selected from the bracket and a second tissue region and the suture is tensioned.
The step of anchoring the bracket may comprise inserting a pin coupled to the anchoring bracket into the first region. The step of capturing the tissue to be treated may comprise looping the suture around said tissue. The step of tensioning the suture may comprise passing the suture through a cinching mechanism in the pin or in the anchoring bracket. The cinching mechanism is adapted to allow the suture to pass through the cinching mechanism in a first direction while movement of the suture through the cinching mechanism in a second direction opposite the first direction is constrained. Tensioning the suture may comprise securing the suture without knotting the suture.
These and other embodiments are described in further detail in the following description related to the appended drawing figures.
Exemplary use of the devices, systems and methods of the present invention will be discussed primarily in terms of treatment of a hip joint. However, one of skill in the art will appreciate that other areas of the body including joints such as the shoulder joint, the ankle, wrist and other joints may also be treated. Thus, the exemplary usage described herein is not intended to be limiting.
The labrum L can tear or separate from the acetabular rim due to wear or disease and this can result in pain as well as loss of joint mobility.
Referring now to
Referring now to
The shaft 105 carries an inner impactor 102 and a suture anchor 101 is releasably coupled with the impactor. The suture anchor 101 has a pointed or sharpened distal tip in order to allow it to penetrate bone 104 or other tissue. Once the suture anchor 101 has been delivered to a desired anchor site, the proximal end of the impactor 102 may be hit with a hammer or other object in order to drive the anchor 101 into the bone 104. Alternatively, the impactor may be energized with other forms of energy, such as ultrasonic energy or other types of oscillating or vibrating energy in order to drive the anchor 101 into the bone 104. The impactor may drive the implant into bone at frequencies between 10 and 20 kHz, preferably between 20 and 1000 Hz, more preferably between 30 and 500 Hz. The amplitude at which the impactor is energized may be at amplitudes of 100 to 1000 microns, preferably 200 to 750 microns, more preferably 300-500 microns. A suture (not illustrated) may be attached to the anchor 101 by tying the suture to aperture 106, or the suture may be attached using other techniques well known in the art including crimping or bonding.
The embodiment of
There are numerous variations and elaborations on this approach, which may provide added benefits and enhance their applicability to a range of different clinical settings. For instance, each arm might additionally have a grasper near the end of each arm, which is configured to expand and grasp tissue (e.g. the rotator cuff). While holding the tissue, the device can then be repositioned (for example, repositioning the device over the humeral head to apply the appropriate tension to the rotator cuff). Then the anchor can be driven through this tissue into another tissue (such as the bone of the humeral head) to anchor the tissue. The grasper is then released. The grasper and arm may also have appropriate slots to allow the instrument to be removed while leaving the anchors in place with a tight suture connecting them, approximating the tissue to the bone with just the right amount of tension to allow rapid healing of the cuff to the bone.
The anchors may be driven parallel to the axis of the arms, or at a right angle to the axis of the instrument, or at a lesser angle depending on the angle necessary to drive into tissue and bone. For instance, a more linear arrangement may work well for labral reattachment in the shoulder and the hip, and a more right-angled arrangement might work better for reattaching the rotator cuff. The end configuration of the instrument may have the ability to articulate or be actively steered, to facilitate anchor placement while conforming to the various anatomies.
As described above, the suture between the two anchors might be appropriately tensioned simply by adjusting the initial separation of the jaws, and/or by the action of driving the anchors into the tissue. However, this system could also be combined with an anchor that has a suture lock mechanism so that the suture can be discretely tensioned after the anchor has been placed. This feature might be particularly useful in a knotless rotator cuff repair system. It might alternatively be preferable to have separate sutures on each of the anchors, which could then be tied together after the anchors are placed. Several embodiments of a suture locking mechanism are disclosed below and they may be combined with any of the anchor embodiments disclosed herein.
The distance between the anchors may be adjustable depending on the anatomy and amount of repair necessary. The distance can be varied through the grasper controls. One or more sets of anchors may be loaded on the device in a magazine fashion such that the anchors are loaded in a tubular magazine and advanced through the grasper. This would facilitate a complete tissue repair procedure without removing the instrument from the patient.
This embodiment is useful for positioning multiple anchors simultaneously that are connected by suture or other means. The instrument may be used to re-attach the labrum in the shoulder or the hip or for other procedures. To accomplish this, a pair of anchors is positioned adjacent to one another and driven through the labrum into the bone below. A connection means between the anchors provides positive fixation of the labrum to the bony tissue below. The tissue grasper features of the previous embodiment may also be used with this embodiment. Thus, all of the features and permutations described previously for tissue attachment may be applied to this embodiment as well.
In another embodiment shown in
In another embodiment, anchor systems are disclosed which deliver multiple anchors with proper suture tensioning and locking capabilities.
Another embodiment for anchors placed with suture tensioning capabilities is shown in
In another embodiment shown in
In another embodiment,
In another embodiment a suture wedge lock system has an additional function for locking the anchor under the cortical shelf within a cancellous region of bone, such as in the head of the humerus.
Any of the embodiments disclosed herein my also be used for drug delivery. The suture and/or the suture anchor may be coated with or carry a therapeutic agent that can be released in a controlled manner. For example, the therapeutic agent may be time released and eluted into the bone or affected tissue in order to enhance healing. Multiple medicaments may be impregnated into or coated onto the anchors in a similar fashion as stents. Examples of coatings that produce a sustained-release are those made by SurModics Corporation and Angiotech. Examples of medicaments that could be eluted are anti-inflammatory medicaments, NSAIDs (non-steroidal anti-inflammatories), and hyaluronic acid. Stem cells or other bone or cell growth promoters may also be used in such coatings.
Some of the suture anchors may be fabricated from durable metals such as stainless steel, titanium or nitinol. Alternatively, a variety of polymers may be used. It would also be desirable to provide anchors that bioerode away after some period of time. Thus, any of the embodiments disclosed herein may be fabricated from bioerodable polymeric materials. Combinations of durable metals or polymers and bioerodable polymers may also be used and similarly bioerodable sutures and durable sutures may also be used. In an exemplary embodiment, a bioerodable anchor may be loaded onto a delivery core made from stainless steel or titanium. The anchor is driven into the bone and then the core is removed, leaving the anchor permanently implanted. The anchor has a suture attached and can be tensioned using any of the locking mechanisms described herein. The anchor may be fabricated from polymers such as PEEK or PMMA and polymers that are well known for bioerosion include PGA, PLGA, and PLA.
Still referring to
In some embodiments, the delivery instrument and anchors may have a central channel that extends the entire length of the device. This central channel is used to accommodate a drill bit or other drilling device (e.g. water jet or laser) which can be used to drill a pilot hole in the bone and facilitates placement of the anchor into the bone. Thus, the system may further include a drilling system such as a mechanical drill, a laser drill, water jet drill or other drilling mechanisms for creating the pilot hole. In some embodiments, the inner and intermediate shafts of the delivery instrument along with anchor 2104 may be removed and replaced with the drilling system and thus the outer shaft serves as a guide for drilling. Once the pilot hole has been created, keeping the outer shaft in place against the bone, the drill is removed and the interior shafts and suture anchor are replaced in the outer shaft to deliver the suture anchor into the drilled hole.
In
Referring back to
Outer anchor 2124 optionally may also have outer surface features that help secure it to tissue such as bone. For example, anchor 2124 may have wings similar to cutouts 1003 in
Thus, once both anchors have been secured and the target tissue captured by the suture, the free end F may be pulled through the cinching mechanism. As the free end F of the suture is pulled, the arm 2134 deflects outward (toward the sidewall of channel 2129 to which arm 2134 is attached), allowing the suture to pass through the cinching mechanism without being constrained. On the other hand, when the suture is pulled in the opposite direction, the suture will deflect arm 2134 radially toward the opposite sidewall of channel 2129, pinching the suture between the distal end 2131 of arm 2134 and the inner wall of the inner anchor, locking the suture in tension between the inner and outer anchors. Thus, the cinching mechanism allows the suture to move through the inner anchor in one direction without slipping in the opposite direction. Advantageously, the suture is locked without need for the operator to manually actuate a locking mechanism on the anchor. The cinching mechanism is capable of holding the suture and resisting a pullout force at least as large as the force required to tear tissue such as the labrum. In preferred embodiments, the cinching mechanism has a safety margin built into it and thus it can resist a suture pullout force at least 1.5 times greater than the force required to tear tissue such as the labrum. In exemplary embodiments, the cinching mechanism 2135 in the inner anchor is preferably capable of withstanding tension of 20-80 lbs on the suture S without allowing the suture to slip.
It should be noted that the cinching mechanism may alternatively be provided on the outer anchor 2124 with the suture being fixed to the inner anchor 2122, or cinching mechanisms may be provided on both anchors. For example, a cinching mechanism like that described above may be provided in channel 2121 of outer anchor 2124.
The delivery system 2100 may be used to secure torn tissue to a bone. For example, in
The embodiments disclosed above may easily be modified in order to accommodate more than one suture and/or more than one anchor. For example, in
The suture anchors may be driven directly into bone or in some situations, it may be desirable to drill a pilot hole to help receive the anchor. For example, in
While the above is a complete description of the preferred embodiments of the invention, various alternatives, modifications, and equivalents may be used. The various features of the embodiments disclosed herein may be combined or substituted with one another. Therefore, the above description should not be taken as limiting in scope of the invention which is defined by the appended claims.
Claims
1. A knotless suture anchoring system comprising:
- an outer anchor having a central channel and a distal tip adapted to penetrate tissue;
- an inner anchor positionable in the central channel of the outer anchor;
- a locking feature on one or both of the inner and outer anchors configured to retain the inner anchor within the central channel; and
- a continuous length of suture coupled with the inner and outer anchors, the suture having a free end,
- wherein at least one of the inner and outer anchors further comprises a cinching mechanism adapted to allow the suture to be tensioned by passage of the suture through the cinching mechanism in a first direction while movement of the suture through the cinching mechanism in a second direction opposite the first direction is constrained.
2. The anchoring system of claim 1, wherein the central channel extends only partially through the outer anchor.
3. The anchoring system of claim 1, wherein the locking feature comprises an annular recessed region in the central channel of the outer anchor.
4. The anchoring system of claim 1, wherein the outer anchor comprises an outer surface having surface features adapted to anchor the outer anchor with the tissue or to promote tissue ingrowth.
5. The anchoring system of claim 1, wherein the locking feature comprises a plurality of resilient fingers extending radially outward from the inner anchor.
6. The anchoring system of claim 1, wherein the cinching mechanism comprises a deflectable arm coupled to either the inner or the outer anchor.
7. The anchoring system of claim 1, wherein the cinching mechanism is operative regardless of the position of the inner anchor relative to the outer anchor.
8. The anchoring system of claim 1, further comprising a delivery instrument having a longitudinal axis, wherein the delivery instrument is adapted to carry both the inner anchor and the outer anchor simultaneously.
9. The anchoring system of claim 8, wherein the delivery instrument is configured to receive a drill, wherein the drill is adapted to create an aperture in the tissue sized to receive the inner or the outer anchor.
10. The anchoring system of claim 1, wherein the central channel is disposed at an angle transverse to a longitudinal axis of the outer anchor such that the inner anchor is disposed at an angle transverse to the longitudinal axis of the outer anchor when received in the central channel.
11. A knotless suture anchoring system comprising:
- an outer anchor having a central channel and a distal tip adapted to penetrate tissue;
- an inner anchor positionable in the central channel of the outer anchor and having a distal tip adapted to penetrate and be retained in tissue outside the outer anchor whereby the inner anchor may be positioned either in the outer anchor or in tissue apart from the outer anchor;
- a locking feature on one or both of the inner and outer anchors configured to retain the inner anchor within the central channel; and
- a continuous length of suture coupled with the inner and outer anchors, the suture having a free end,
- wherein at least one of the inner and outer anchors further comprises a clamping mechanism adapted to clamp the suture under tension without knotting the suture.
12. The anchoring system of claim 11, wherein the central channel extends only partially through the outer anchor.
13. The anchoring system of claim 11, wherein the locking feature comprises an annular recessed region in the central channel of the outer anchor.
14. The anchoring system of claim 11, wherein the outer anchor comprises an outer surface having surface features adapted to anchor the outer anchor with the tissue or to promote tissue ingrowth.
15. The anchoring system of claim 11, wherein the inner anchor locking feature comprises a plurality of resilient fingers extending radially outward from the inner anchor.
16. The anchoring system of claim 11, wherein the clamping mechanism comprises a cinching mechanism adapted to allow the suture to be tensioned by passage of the suture through the cinching mechanism in a first direction while movement of the suture through the cinching mechanism in a second direction opposite the first direction is constrained.
17. The anchoring system of claim 16, wherein the cinching mechanism comprises a deflectable arm coupled to either the inner or the outer anchor.
18. The anchoring system of claim 16, wherein the cinching mechanism is operative regardless of the position of the inner anchor relative to the outer anchor.
19. The anchoring system of claim 17, wherein the deflectable arm is integral with either the inner or the outer anchor.
20. The anchoring system of claim 17, wherein the deflectable arm is disposed in an aperture within either the inner or the outer anchor.
21. The anchoring system of claim 20, wherein the aperture is in an axial channel extending at least partially through the inner anchor.
22. The anchoring system of claim 21, wherein the arm moves in a first radial direction when the suture is pulled in the first direction and the arm moves in a second radial direction when the suture is pulled in the second direction.
23. The anchoring system of claim 22, wherein the suture is clamped between the arm and a wall of the aperture when the suture is pulled in the second direction.
24. The anchoring system of claim 22, wherein the arm is resilient so as to return to an unbiased position after moving in either the first or the second radial directions.
25. The anchoring system of claim 22, wherein the arm deflects radially inward when the suture is pulled in the second direction to clamp the suture between the arm and an opposing wall of the aperture, thereby constraining movement of the suture in the second direction.
26. The anchoring system of claim 11, further comprising a delivery instrument having a longitudinal axis, wherein the delivery instrument is adapted to carry both the inner anchor and the outer anchor simultaneously.
27. The anchoring system of claim 26, wherein the delivery instrument has an axial lumen, the inner and the outer anchors being releasably carried in the axial lumen.
28. The anchoring system of claim 26, wherein the delivery instrument comprises a steering mechanism adapted to deflect a distal portion of the instrument.
29. The anchoring system of claim 26, wherein the delivery instrument comprises a suture management feature, said feature adapted to releasably hold the length of suture and prevent tangling thereof.
30. The anchoring system of claim 11, wherein the delivery instrument is configured to receive a drill, wherein the drill is adapted to create an aperture in the tissue sized to receive the inner or the outer anchor.
31. The anchoring system of claim 26, wherein the delivery instrument is adapted to deliver the inner anchor and the outer anchor at an angle transverse to the longitudinal axis of the delivery instrument.
32. The anchoring system of claim 31, wherein the delivery instrument comprises a hammer element coupled with the delivery instrument and adapted to convert axial movement along the longitudinal axis of the delivery instrument into an impacting force transverse to the longitudinal axis of the delivery instrument.
33. The anchoring system of claim 26, wherein each of the inner and the outer anchors have a longitudinal axis and the delivery instrument carries the inner and the outer anchors such that the longitudinal axis of both anchors is transverse to the longitudinal axis of the delivery instrument.
34. The anchoring system of claim 11, wherein the central channel is disposed at an angle transverse to a longitudinal axis of the outer anchor such that the inner anchor is disposed at an angle transverse to the longitudinal axis of the outer anchor when received in the central channel.
35. The anchoring system of claim 26, wherein the delivery instrument comprises a jaw having first opposable member pivotably coupled with a second opposable member, wherein the first opposable member carries the inner anchor and the second opposable member carries the outer anchor, and
- wherein actuation of the jaw inserts the inner anchor into the outer anchor.
36. The anchoring system of claim 35, wherein the inner and the outer anchors each have a longitudinal axis and wherein the anchors are carried by the opposable members such that the longitudinal axis of the anchors are transverse to a longitudinal axis of the opposable members.
37. A knotless suture anchoring system comprising:
- a first anchor having a housing with a central channel sized to receive a suture therein; and
- a cinching mechanism having a radially deflectable arm integral with the housing and disposed at least partially in the central channel, the suture passing through an opening in the arm and passing between a free end of the arm and the housing, wherein the cinching mechanism is adapted to allow the suture to pass through the cinching mechanism in a first direction while movement of the suture through the cinching mechanism in a second direction opposite the first direction is constrained.
38. The anchoring system of claim 37, wherein the cinching mechanism comprises a deflectable arm coupled to the first anchor.
39. The anchoring system of claim 38, wherein the deflectable arm is integral with the first anchor.
40. The anchoring system of claim 38, wherein the deflectable arm is disposed in an aperture within the first anchor.
41. The anchoring system of claim 40, wherein the aperture is in an axial channel extending at least partially through the first anchor.
42. The anchoring system of claim 41, wherein the arm moves in a first radial direction when the suture is pulled in the first direction and the arm moves in a second radial direction when the suture is pulled in the second direction.
43. The anchoring system of claim 42, wherein the suture is clamped between the arm and a wall of the aperture when the suture is pulled in the second direction.
44. The anchoring system of claim 42, wherein the arm is resilient so as to return to an unbiased position after moving in either the first or the second radial directions.
45. The anchoring system of claim 42, wherein the arm deflects radially inward when the suture is pulled in the second direction to clamp the suture between the arm and an opposing wall of the aperture, thereby constraining movement of the suture in the second direction.
46. The anchoring system of claim 37, wherein the housing comprises a distal tip adapted to penetrate tissue.
47. The anchoring system of claim 46, wherein the housing comprises an outer surface having surface features adapted to anchor the first anchor in the tissue or to promote tissue ingrowth.
48. The anchoring system of claim 37, further comprising a second anchor having an inner channel configured to receive the first anchor, wherein the inner channel comprises a locking feature adapted to engage with the first anchor to retain the first anchor in the second anchor.
49. A knotless suture anchoring system comprising:
- a pin having a distal tip adapted to penetrate tissue;
- an anchoring bracket; and
- a length of suture,
- wherein the suture is adapted to be coupled to the pin and the bracket.
50. The anchoring system of claim 49, wherein the bracket is L-shaped.
51. The anchoring system of claim 49, wherein the bracket comprises a suture management feature adapted to receive and hold the suture.
52. The anchoring system of claim 51, wherein the suture management feature comprises a slit in the bracket.
53. The anchoring system of claim 49, wherein the bracket comprises an anchoring pin adapted to penetrate the tissue thereby fixing the bracket to the tissue.
54. The anchoring system of claim 49, wherein the suture is formed into a loop sized to capture tissue to be repaired.
55. The anchoring system of claim 54, wherein the tissue to be repaired comprises a torn labrum.
56. The anchoring system of claim 49, wherein the anchoring bracket or the pin further comprise a cinching mechanism adapted to allow the suture to be tensioned by passage of the suture through the cinching mechanism in a first direction while movement of the suture through the cinching mechanism in a second direction opposite the first direction is constrained.
57. A knotless suture anchoring system comprising:
- a delivery instrument having a longitudinal axis, a shaft axially movable along the longitudinal axis, and a hammer adapted to convert axial movement along the longitudinal axis into movement transverse thereto; and
- a first anchor carried by the delivery instrument and having a distal tip adapted to penetrate tissue, wherein axial movement of the slidable shaft along the longitudinal axis moves the hammer in a motion transverse thereto, thereby impacting the anchor, whereby the first anchor is driven into the tissue at an angle transverse to the longitudinal axis of the delivery instrument.
58. A method of knotless suturing comprising:
- providing a delivery instrument carrying a first anchor and a second anchor, wherein a continuous length of suture is coupled with the first and the second anchors;
- advancing the delivery instrument to a treatment region comprising treatment tissue;
- placing the first anchor into a first region of the tissue;
- coupling the suture to a portion of the treatment tissue;
- attaching the second anchor to the first anchor;
- tensioning the suture; and
- securing the suture without knotting the suture by moving the suture through a cinching mechanism in the first or the second anchor, wherein the cinching mechanism is adapted to allow the suture to move through the cinching mechanism in a first direction while movement of the suture through the cinching mechanism in a second direction opposite the first direction is constrained independently of the position of the second anchor relative to the first anchor.
59. The method of claim 58, wherein the second anchor is stationary relative to the first anchor during the entire step of securing the suture.
60. The method of claim 58, wherein the tissue comprises bone and the step of placing the first anchor or the step of placing the second anchor comprises drilling a pilot hole into the bone, the pilot hole sized to receive the first or the second anchor.
61. The method of claim 58, further comprising deflecting a distal portion of the delivery instrument.
62. The method of claim 58, wherein the first region of tissue comprises the acetabulum and the treatment tissue comprises an acetabular labrum.
63. The method of claim 58, wherein the step of attaching the second anchor to the first anchor comprises inserting the second anchor into a central channel of the first anchor and locking the two anchors together to prevent axial movement of the first anchor relative to the second anchor.
64. The method of claim 58, wherein the delivery instrument further comprises an actuator mechanism near a proximal end of the instrument and the step of placing the first anchor or the step of placing the second anchor comprises actuating the actuator mechanism to expose the first or the second anchor from the delivery instrument.
65. The method of claim 58, wherein the step of securing comprises clamping the suture between a deflectable arm and an inner wall of the first or the second anchor.
66. The method of claim 65, wherein the arm is integral with either the first or the second anchor.
67. The method of claim 58, wherein the step of attaching comprises placing the second anchor in a central channel within the first anchor.
68. The method of claim 67, wherein the cinching mechanism is disposed in an inner channel of the second anchor.
69. The method of claim 58, wherein the delivery instrument has a longitudinal axis, and wherein the step of placing the first anchor comprises placing the first anchor into the first region at an angle transverse to the longitudinal axis of the delivery instrument.
70. The method of claim 58, wherein the step of attaching the second anchor to the first anchor comprises actuating a jaw disposed on the delivery instrument.
71. A method of knotless suturing comprising:
- providing an anchoring device having an anchoring bracket, a length of suture and a pin, wherein the suture is coupled to the bracket and the pin;
- anchoring the bracket to a first tissue region;
- capturing tissue to be treated with the suture;
- securing the pin to a structure selected from the bracket and a second tissue region; and
- tensioning the suture.
72. The method of claim 71, wherein the step of anchoring the anchoring bracket comprises inserting a pin coupled to the anchoring bracket into the first region.
73. The method of claim 71, wherein the step of capturing the tissue to be treated comprises looping the suture around said tissue.
74. The method of claim 71, wherein the step of tensioning the suture comprises passing the suture through a cinching mechanism in the pin or in the anchoring bracket, wherein the cinching mechanism is adapted to allow the suture to pass through the cinching mechanism in a first direction while movement of the suture through the cinching mechanism in a second direction opposite the first direction is constrained.
75. The method of claim 71, wherein tensioning the suture comprises securing the suture without knotting the suture.
Type: Application
Filed: May 7, 2010
Publication Date: Nov 18, 2010
Applicant: Foundry Newco Xl, Inc. (Menlo Park, CA)
Inventors: Darin C. Gittings (Sunnyvale, CA), Mark Deem (Mountain View, CA), Michael Hendricksen (Redwood City, CA), Vivek Shenoy (Redwood City, CA), Hanson S. Gifford, III (Woodside, CA), Stephen Boyd (Murrieta, CA)
Application Number: 12/776,177
International Classification: A61B 17/04 (20060101);