METHODS OF USING WOVEN RETENTION DEVICES AND SYSTEMS
A method of inserting a woven retention device into a bone hole includes providing a woven retention device with a tapered distal end and a proximal end to receive a fastener, providing a delivery tube with distal and proximal openings, and providing a push rod to push the woven retention device through the distal opening of the delivery tube. The delivery tube includes a compression portion over at least a distal end of the delivery tube. The method also includes positioning the distal opening of the delivery tube near an opening of the bone hole and advancing the woven retention device through the compression portion of the distal opening of the delivery tube and into the bone hole by pushing on an interior of the tapered distal end of the woven retention device using the distal end of the push rod.
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The present invention relates generally to methods of using woven retention devices and systems. More specifically, the present invention relates to methods of preparing, inserting, and using woven retention devices in bone.
BACKGROUNDIn orthopedic surgery it is common to secure a bone screw to a patient's bone. Bone fracture repair is surgery to fix a broken bone using plates, nails, screws, or pins. It is common in the treatment of fractures to attach a plate to the bone utilizing bone screws. The resulting construct prevents motion of the fractured bone so that the bone can heal. Alternatively, one or more screws may be inserted across the break to hold it place.
In the treatment of spinal disorders, pedicle screws are inserted into the patient's vertebrae to serve as anchor points that can then be connected with a rod. This construct prevents motion of the vertebral segments that are to be fused.
In the treatment of detached tendons, screw-like tissue anchors are inserted into the patient's bone to serve as an anchor for the reattachment of the tendon.
One complication with the use of bone screws is the loss of fixation or grip between the bone screw and the patient's bone. Another complication with the use of bone screws is the stripping of the hole in the bone when the bone screw is inserted. This results in the loss of purchase and holding strength of the bone screw.
The presence of osteoporotic bone can increase the likelihood of complications by reducing the purchase or grip of the bone screw to the patient's bone, resulting in a loss of holding strength and loosening of the bone screw or pullout of the bone screw.
Current solutions to secure bone screws have not adequately addressed screw failure and the underlying causes of screw failure. In addition, there exists a need for simple and effective methods of using and inserting such orthopedic devices and systems.
BRIEF SUMMARY OF THE INVENTIONAccording to an embodiment of the present invention, a method of inserting a woven retention device into a bone hole is provided. The method includes providing a woven retention device having a distal end that is tapered, a proximal end to receive a fastener, and a sleeve body between the distal and proximal ends. The method includes providing a delivery tube including a distal opening and a proximal opening, the distal opening having a compression portion over at least a distal end of the delivery tube. The method also includes providing a push rod having a distal end to push the woven retention device through the distal opening of the delivery tube. The method further includes positioning the distal opening of the delivery tube near an opening of the bone hole in a bone surface and advancing the woven retention device through the compression portion of the distal opening of the delivery tube and into the bone hole by pushing on an interior of the tapered distal end of the woven retention device using the distal end of the push rod.
According to some embodiments, the delivery tube has a side wall opening. The push rod may be arranged such that at least a portion of the push rod passes within the side wall opening of the delivery tube when advancing the woven retention device through the distal opening. The delivery tube can have an end slot at a distal portion of the delivery tube, and may have three end slots at the distal portion of the delivery tube. In an embodiment, the woven retention device is advanced into the bone hole until the proximal end of the woven retention device is substantially flush with the bone surface.
In an embodiment, the method further includes compressing the woven retention device at least near the distal opening of the delivery tube as the woven retention device is advanced through the distal opening, where the delivery tube includes a narrowed region near the distal opening for compressing the woven retention device. The narrowed region has an inner diameter that is less than an outer diameter of the sleeve body. The method may further include inserting the woven retention device into the delivery tube through a proximal opening of the delivery tube. In some embodiments, the method further includes inserting the fastener into the woven retention device through the proximal end of the woven retention device after the woven retention device is placed in the bone hole.
In an embodiment, the method includes cutting the woven retention device, before inserting the woven retention device into the bone hole, to a desired length based on a depth of the bone hole. A proximal end portion of the woven retention device may be cut to achieve the desired length. The method according to some embodiments includes measuring a portion of the woven retention device to determine a location along a length of the woven retention device to perform the cutting. In some embodiments, the delivery tube includes indicia for measuring a desired length of the woven retention device, the indicia being on a wall of the delivery tube. The method can include measuring the desired length of the woven retention device using the indicia, and cutting the woven retention device to the desired length prior to inserting the woven retention device into the bone hole. The measuring of the desired length can include aligning the distal end of the woven retention device with the indicia indicating the desired length of the woven retention device, and also may include cutting a portion of the sleeve body that extends proximally to the proximal opening of the delivery tube. The method may also include measuring a desired length of the woven retention device using indicia provided on a packaging of at least one of the woven retention device, the delivery tube, and the push rod, and cutting the woven retention device to the desired length.
According to some embodiments, the method of using the woven retention device includes compressing the woven retention device with a compressing portion of the delivery lumen while inserting the woven retention device into the bone hole. The method may include cutting off an excess portion of the woven retention device based on measuring the desired length of the woven retention device. The method may include positioning the distal opening of the delivery tube near an opening of the bone hole. The measuring may include aligning a distal end of the woven retention device with a measuring tool, where the excess portion of the woven retention device can include a portion near a proximal end of the woven retention device. The measuring tool may include indicia on the delivery tube, and the excess portion includes a portion proximal to a proximal end of the delivery tube. The measuring may be performed while the distal end of the woven retention device is within the delivery tube. In an embodiment, the measuring includes using a slidable measuring apparatus that can hold the woven retention device and output a distance based on a distance relationship between two ends of the slidable measuring apparatus.
In an embodiment, a method of inserting a woven retention device into a bone hole includes positioning a distal opening of a delivery lumen near an opening of the bone hole, pushing the woven retention device through the distal opening using a push rod, a distal end of the push rod being arranged within the delivery lumen to push the woven retention device and at least a portion of a proximal end of the push rod remaining outside of the delivery lumen, and advancing the woven retention device to a desired depth within the bone hole using the push rod. In an embodiment, the portion of the push rod that remains outside of the delivery lumen is connected to a portion of the push rod that is within the delivery lumen via a slotted opening in a side wall of the delivery lumen. The method can also include applying a force to the portion of the proximal end of the push rod that remains outside of the delivery lumen to push the push rod.
In some embodiments, the method includes compressing the woven retention device with a compressing portion of the delivery lumen while inserting the woven retention device into the bone hole. The method can include cutting off an excess portion of the woven retention device based on the measuring. The method may also include positioning the distal opening of the delivery tube near an opening of the bone hole. The measuring can include aligning a distal end of the woven retention device with a measuring tool. The method may also include where the excess portion of the woven retention device includes a portion near a proximal end of the woven retention device. The measuring tool can have indicia on the delivery tube, and the excess portion includes a portion proximal to a proximal end of the delivery tube. The measuring may be performed while the distal end of the woven retention device is within the delivery tube. In an embodiment, the method includes using a slidable measuring apparatus that is configured to hold the woven retention device and output a distance based on a distance relationship between two ends of the slidable measuring apparatus.
According to an embodiment of the present invention, a method of inserting a woven retention device into a bone hole includes measuring a desired length of the woven retention device to be inserted into the bone hole, pushing the woven retention device through a distal opening of a delivery tube using a push rod, and advancing the woven retention device to a desired depth within the bone hole using the push rod.
In some embodiments, the method includes cutting off an excess portion of the woven retention device based on the measuring. The method may include positioning the distal opening of the delivery tube near an opening of the bone hole. The measuring can include aligning a distal end of the woven retention device with a measuring tool. The method may also include where the excess portion of the woven retention device includes a portion near a proximal end of the woven retention device. The measuring tool can be indicia on the delivery tube, and the excess portion can be a portion proximal to a proximal end of the delivery tube. The measuring can be performed while the distal end of the woven retention device is within the delivery tube and can use a slidable measuring apparatus that is configured to hold the woven retention device and output a distance based on a distance relationship between two ends of the slidable measuring apparatus.
Additional features, advantages, and embodiments of the invention are set forth or apparent from consideration of the following detailed description, drawings and claims. Moreover, it is to be understood that both the foregoing summary of the invention and the following detailed description are exemplary and intended to provide further explanation without limiting the scope of the invention as claimed.
The accompanying drawings, which are included to provide a further understanding of the invention and are incorporated in and constitute a part of this specification, illustrate preferred embodiments of the invention and together with the detailed description serve to explain the principles of the invention. In the drawings:
The devices, systems and methods described herein may be used in the area of orthopedics and, in particular, orthopedic repairs. These include various devices, systems and methods directed to fixing and/or retaining fasteners in orthopedic applications. Fixing or retaining fasteners to bone tissue is complicated by the underlining bone tissue. Understanding that an underlying cause of failure with internal fixation in bone tissue is the bone, the devices, systems and methods described herein provide for solutions that address the implant site. At the implant site, the hole and the bone benefit from an enhanced interface.
The fixation and/or retention devices, systems and methods described herein maximize fixation and/or retention in the bone tissue, including, osteoporotic bone, bone of a poor quality, and mechanically poor bone in addition to healthy bone tissue. The fixation and/or retention devices, systems and methods described herein may be used with any type of fixation including any types of screws, pins, or other fasteners.
The devices, systems and methods described herein enhance the interaction of a bone anchor to a bone hole to provide enhanced fixation. Additionally, the devices, systems and methods may repair the surface of the bone hole following damage to the bone hole as in the case of stripping of the hole in the bone when a bone screw is over-tightened. Also, the devices, systems and methods provide for an enhanced bone hole surface for the reattachment of tendons in, for example, anterior/posterior cruciate ligament repair procedures, rotator cuff repair procedures, etc. The devices enhance the surface of a bone hole to enhance fixation of a bone anchor to bone and permits bone ingrowth into its structure. The devices enhance the interaction between the surface of a bone hole and the fixation device. The devices interdigitate with the bony structure and interact with the fixation device. The device alone, as a single device, enhances the surface of a bone hole to enhance fixation of a bone anchor to bone and accommodates variations in the diameter and depth of the bone hole. The devices, systems and methods can enhance fixation without requiring the use of cement and/or adhesives. However, according to some embodiments, cements and/or adhesive can be used in addition to or in place of another bone anchor such as a screw, pin, or other orthopedic implant.
Also described herein are methods of using these devices and systems, including methods of inserting fixation devices into a bone hole of a patient. The methods may use insertion tools, kits, and/or device or system packaging that aid a user of the fixation devices to achieve a desired placement and fit of the fixation device within the bone hole of the patient, in order to achieve optimal performance of the fixation device.
Referring now to the figures,
In an embodiment, a method of inserting the woven retention device 100 into the bone hole 150 includes pushing the woven retention device 100 through the delivery tube 160 using the push rod 170. For example,
In some embodiments, the distal tip of the push rod may be shaped to at least partially conform to a shape of the interior surface of the distal tip of the tapered portion of the woven retention device. For example, the distal tip of the push rod may be tapered or otherwise shaped to contact the inner surface of the woven retention device. In some embodiments, the distal tip of the woven retention devices may be closed, while in other embodiments the distal tip may have an opening with a smaller diameter than the proximal opening of the woven retention device. In a case where the distal end of the woven retention device is open, the diameter at the distal tip may be small enough so that the push rod does not extend through the opening when pushing the woven retention device through the delivery tube and into the bone hole.
As shown in
According to an embodiment of the method of inserting a woven retention device into a bone, the distal opening 165 of the delivery tube 160 may be positioned at or near the opening 156 of the bone hole 150, as shown in
It is possible that the size of the bone hole 150 may prevent the woven retention devices 100, 100′ from fully returning to their relaxed state if the bone hole 150 has an inner diameter that is smaller than an outer diameter of the woven retention device in the relaxed state. Nonetheless, the woven retention device 100 will be biased to expand or return to the relaxed state. In one embodiment, the woven retention device can elastically expand and/or self-expand to the relaxed state. In expanding towards the relaxed state, the woven retention device will press against the bone surface 154 of the bone hole 150. It is also possible that the bone hole 150 has an inner diameter that is larger than the outer diameter of the woven retention device in a relaxed state. In such a case, the woven retention device may not fully contact the bone surface 154 of the bone hole 150 when the woven retention device is in the relaxed state. However, the woven retention device may transition to an expanded state when a fastener is later inserted into the woven retention device. Thus, in the expanded state, the woven retention device can provide the desired interaction between the fastener and the bone hole. Therefore, according to the properties of the woven retention device and the compression portion 168 of the delivery tube 160, a system and method may be provided which allows for easy insertion of the woven retention device 100, 100′ into the bone hole 150 while nonetheless ensuring the desired interaction between the woven retention device, the fastener, and the bone surface 154.
As shown in
According to some embodiments, a method of inserting a woven retention device may include removing an excess portion of the woven retention device 100 so that it fits as desired in a bone hole of a particular size.
According to some embodiments, a portion of the delivery tube 360 near the distal end 364 includes one or more distal slots 367 as shown in
According to some embodiments, there can be an odd number of distal slots 367 on the distal end 364 of the delivery tube 360. An odd number can provide more circumferentially uniform compression of the woven retention device because the distal slots are not aligned with each other. An even number of slits would have the slots aligned if the slots are placed symmetrically about the circumference of the delivery tube.
As shown in
The rod lever 378 of the push rod 370 has a substantially planer surface that is perpendicular to the longitudinal axis of the push rod 370.
Some embodiments may include additional systems for packaging, measuring, and preparing the woven retention device for use.
In some embodiments, multiple measurement windows 136 are provided in the packaging system 130. Each of the multiple measurement windows 136 may have measuring indices that are calibrated for woven retention devices of a certain type. For example, in an embodiment, the measurement windows 136 may each be calibrated for a woven retention device of a different size, diameter, or weave pattern. In one embodiment, as shown in
According to an embodiment, the packaging may also include mounting portions 134 for a push rod (not shown in
In some embodiments, as shown in packaging systems 230a and 230b, the woven retention devices 300a, 300b can be packaged within the delivery tubes 560a, 560b, respectively. This results in compact packaging and, in some embodiments, a woven retention device that can be immediately deployed from the delivery tube. Alternatively, even when packaged within the delivery tube, the woven retention device can be at least partially removed from the delivery tube for measuring and cutting. The push rod 470a also has a bent portion 479, which will be discussed further with respect to
Also in
In contrast, according to the embodiment shown in
The push guide 569 can be seen more clearly in
The foregoing descriptions include examples of embodiments of the woven retention devices and tools for using and inserting the woven retention devices. However, variations in these devices and system are contemplated within the scope of the invention. For example, in some embodiments, the distal tip of the woven retention devices may be closed, while in other embodiments the distal tip may have an opening with a smaller diameter than the proximal opening of the woven retention device.
Although the foregoing description is directed to the preferred embodiments of the invention, it is noted that other variations and modifications will be apparent to those skilled in the art, and may be made without departing from the spirit or scope of the invention. Moreover, features described in connection with one embodiment of the invention may be used in conjunction with other embodiments, even if not explicitly stated above.
Claims
1. A method of inserting a woven retention device into a bone hole, the method comprising:
- providing a woven retention device having a distal end that is tapered, a proximal end configured to receive a fastener, and a sleeve body between the distal and proximal ends;
- providing a delivery tube including a distal opening and a proximal opening, the delivery tube having a compression portion over at least a distal end of the delivery tube;
- providing a push rod having a distal end configured to push the woven retention device through the distal opening of the delivery tube;
- positioning the distal opening of the delivery tube near an opening of the bone hole in a bone surface; and
- advancing the woven retention device through the compression portion of the distal opening of the delivery tube and into the bone hole by pushing on an interior of the tapered distal end of the woven retention device using the distal end of the push rod.
2. The method according to claim 1, wherein:
- the delivery tube has a side wall opening, and
- the push rod is arranged such that at least a portion of the push rod passes within the side wall opening of the delivery tube when advancing the woven retention device through the distal opening.
3. The method according to claim 1, wherein the delivery tube has an end slot at a distal portion of the delivery tube.
4. The method according to claim 3, wherein the delivery tube has three end slots at the distal portion of the delivery tube.
5. The method according to claim 1, wherein the woven retention device is advanced into the bone hole until the proximal end of the woven retention device is substantially flush with the bone surface.
6. The method according to claim 1, further comprising compressing the woven retention device at least near the distal opening of the delivery tube as the woven retention device is advanced through the distal opening.
7. The method according to claim 6, wherein the delivery tube comprises a narrowed region near the distal opening for compressing the woven retention device, the narrowed region having an inner diameter that is less than an outer diameter of the sleeve body.
8. The method according to claim 1, further comprising inserting the woven retention device into the delivery tube through a proximal opening of the delivery tube.
9. The method according to claim 1, further comprising inserting the fastener into the woven retention device through the proximal end of the woven retention device after the woven retention device is placed in the bone hole.
10. The method according to claim 1, further comprising:
- cutting the woven retention device, before inserting the woven retention device into the bone hole, to a desired length based on a depth of the bone hole.
11. The method according to claim 10, wherein the cutting comprises cutting off a proximal end portion of the woven retention device to achieve the desired length.
12. The method according to claim 10, further comprising measuring a portion of the woven retention device to determine a location along a length of the woven retention device to perform the cutting.
13. The method according to claim 1, wherein the delivery tube includes indicia for measuring a desired length of the woven retention device, the indicia being on a wall of the delivery tube.
14. The method according to claim 13, further comprising:
- measuring the desired length of the woven retention device using the indicia; and
- cutting the woven retention device to the desired length prior to inserting the woven retention device into the bone hole.
15. The method according to claim 14, wherein the measuring of the desired length comprises aligning the distal end of the woven retention device with the indicia indicating the desired length of the woven retention device.
16. The method according to claim 14, wherein the cutting comprises cutting a portion of the sleeve body that extends proximally to the proximal opening of the delivery tube.
17. The method according to claim 1, further comprising:
- measuring a desired length of the woven retention device using indicia provided on a packaging of at least one of the woven retention device, the delivery tube, and the push rod; and
- cutting the woven retention device to the desired length.
18. A method of inserting a woven retention device into a bone hole, the method comprising:
- positioning a distal opening of a delivery lumen near an opening of the bone hole;
- pushing the woven retention device through the distal opening using a push rod, a distal end of the push rod being arranged within the delivery lumen to push the woven retention device and at least a portion of a proximal end of the push rod remaining outside of the delivery lumen; and
- advancing the woven retention device to a desired depth within the bone hole using the push rod,
- wherein the portion of the push rod that remains outside of the delivery lumen is connected to a portion of the push rod that is within the delivery lumen via a slotted opening in a side wall of the delivery lumen, and
- wherein the pushing of the woven retention device comprises applying a force to the portion of the proximal end of the push rod that remains outside of the delivery lumen.
19. The method according to claim 18, further comprising:
- compressing the woven retention device to a compressed state with a compressing portion of the delivery lumen while inserting the woven retention device into the bone hole.
20. The method according to claim 19, further comprising:
- expanding the woven retention device to a relaxed state from the compressed state.
21. The method according to claim 20, wherein the expanding includes self-expanding the woven retention device.
22. A method of inserting a woven retention device into a bone hole, the method comprising:
- measuring a desired length of the woven retention device to be inserted into the bone hole;
- pushing the woven retention device through a distal opening of a delivery tube using a push rod; and
- advancing the woven retention device to a desired depth within the bone hole using the push rod.
23. The method according to claim 22, further comprising:
- cutting off an excess portion of the woven retention device based on the measuring; and
- positioning the distal opening of the delivery tube near an opening of the bone hole.
24. The method according to claim 23, wherein the measuring comprises aligning a distal end of the woven retention device with a measuring tool, and
- wherein the excess portion of the woven retention device comprises a portion near a proximal end of the woven retention device.
25. The method according to claim 24, wherein the measuring tool comprises indicia on the delivery tube, and the excess portion comprises a portion proximal to a proximal end of the delivery tube.
26. The method according to claim 25, wherein the measuring is performed while the distal end of the woven retention device is within the delivery tube.
27. The method according to claim 22, wherein the measuring includes using a slidable measuring apparatus that is configured to hold the woven retention device and output a distance based on a distance relationship between two ends of the slidable measuring apparatus.
Type: Application
Filed: Sep 16, 2014
Publication Date: Mar 17, 2016
Applicant: Woven Orthopedic Technologies, LLC (Manchester, CT)
Inventors: Christopher McDonnell (Sandy Hook, CT), Robert L. Richards (Hamden, CT), Nicole S. Sroka (Derby, CT), Ernest N. Corrao, JR. (Bethel, CT), Ronald G. Litke, JR. (Sandy Hook, CT)
Application Number: 14/487,895