Directional kyphoplasty device and method of using such a device
阅读说明:本技术 定向椎体后凸成形术装置及使用这种装置的方法 (Directional kyphoplasty device and method of using such a device ) 是由 W·阿博-奥达 C·C·克兰弗德 于 2018-12-28 设计创作,主要内容包括:一种用于矫正压缩型骨折的装置,包括位于该装置的近侧端部处的壳体、从壳体延伸并穿过定向球囊的套管、以及位于套管的远侧端部处的末端,其中套管具有用于向球囊供应流体的外管和定位在外管内的内管,内管用于通过至少一个开口供应粘合剂到套管的远侧端部中。一种使用该装置的方法,其中,将该装置插入骨折部位,使球囊膨胀以提升骨折的碎片,将粘合剂注入通过提升骨折的碎片而形成的开口中,并且将该装置从骨折部位移除。球囊可以在注入粘合剂之前或与粘合剂的注入同时被收缩。(A device for correcting a compression-type fracture comprising a housing at a proximal end of the device, a cannula extending from the housing and through a directional balloon, wherein the cannula has an outer tube for supplying fluid to the balloon and an inner tube positioned within the outer tube for supplying adhesive through at least one opening into a distal end of the cannula, and a tip at a distal end of the cannula. A method of using the device, wherein the device is inserted into a fracture site, the balloon is inflated to lift fractured fragments, an adhesive is injected into an opening formed by lifting the fractured fragments, and the device is removed from the fracture site. The balloon may be deflated prior to or simultaneously with the injection of the adhesive.)
1. A device for correcting a compression-type fracture, the device comprising:
a housing comprising a fluid portion containing a fluid and an adhesive portion containing an adhesive;
a sleeve extending from the housing and including a first channel and a second channel; and
a balloon engaged with a portion of the cannula,
wherein, when the device is in a first position, the first channel is in communication with the fluid portion such that the fluid can flow to the balloon, an
Wherein when the device is in a second position, the second channel is in communication with the adhesive portion such that the adhesive can flow out of a portion of the cannula.
2. The device of claim 1, wherein when the device is in a third position, the first channel is not in communication with the fluid portion and the second channel is not in communication with the adhesive portion.
3. The device of claim 1, wherein the second channel is not in communication with the adhesive portion when the device is in the first position.
4. The device of claim 1, wherein the first channel is not in communication with the fluid portion when the device is in the second position.
5. The device of claim 1, wherein the balloon is transitionable between an inflated state and a deflated state.
6. The device of claim 5, wherein the balloon is elongated such that a length of the balloon in a direction parallel to a longitudinal axis of the cannula is longer than a width of the balloon in a direction transverse to the longitudinal axis of the cannula.
7. The device of claim 1, wherein the second channel comprises a cap at a distal end thereof, and the cap has an axial opening and a radial opening.
8. The device of claim 7, wherein the second channel is in communication with the adhesive portion when the device is in the second position such that the adhesive can flow out of at least one of the radial opening and the axial opening.
9. The device of claim 8, wherein the radial opening and the axial opening are located between the balloon and the distal end of the sleeve.
10. The device of claim 1, further comprising a tip at a distal end of the cannula.
11. A device for correcting a compression-type fracture, the device comprising:
A housing located at a proximal end of the device;
a cannula extending from the housing and through the oriented balloon; and
a tip located at a distal end of the cannula,
wherein the sleeve comprises an outer tube for supplying fluid to the balloon and an inner tube positioned within the outer tube for supplying adhesive into the distal end of the sleeve through at least one of an axial opening and a radial opening.
12. The device of claim 11, wherein the inner tube is coaxial with the outer tube, and a first passage is defined through the inner tube and a second passage is defined between the inner tube and the outer tube.
13. The device of claim 11, wherein the inner tube is rotatable relative to the outer tube and the tip.
14. The device of claim 13, wherein the inner tube includes a cap at a distal end thereof, and the cap has an axial opening and a radial opening.
15. The device of claim 14, wherein the tip comprises an axial opening and the outer tube of the cannula comprises a radial opening.
16. The device of claim 15, wherein at least one of the radial opening and the axial opening is blocked by the outer tube or the tip depending on a position of the inner tube relative to the outer tube and the tip.
17. The device of claim 15, further comprising a thumb wheel connected to the inner tube and for rotating the inner tube.
18. The device of claim 17, wherein the thumb wheel is capable of rotating the inner tube to one of three positions:
a first position in which the radial opening of the cap is not aligned with the radial opening of the outer tube and the axial opening of the cap is not aligned with the axial opening of the tip;
a second position in which the radial opening of the cap is aligned with the radial opening of the outer tube and the axial opening of the cap is not aligned with the axial opening of the tip; and
a third position in which the radial opening of the cap is not aligned with the radial opening of the outer tube and the axial opening of the cap is aligned with the axial opening of the tip.
19. The apparatus of claim 11, wherein the balloon is elongated such that a length of the balloon in a direction parallel to a longitudinal axis of the cannula is longer than a width of the balloon in a direction transverse to the longitudinal axis of the cannula.
20. The apparatus of claim 12, wherein the outer tube has an aperture through which fluid enters the balloon from the second channel.
21. The device of claim 11, further comprising a retractable shield coaxial with the cannula and covering the cannula and the balloon.
22. The device of claim 21, further comprising a handle associated with the housing and connected to a proximal end of the shield, wherein movement of the handle in a proximal direction moves the shield to expose a distal portion of the balloon and the cannula.
23. The device of claim 11, further comprising a regulator for controlling the flow of fluid and/or adhesive into the cannula.
24. A method of correcting a compression fracture, the method comprising:
inserting a device into a fracture site, the device having a housing, a cannula, and a balloon, the housing including a fluid portion containing a fluid and an adhesive portion containing an adhesive, the cannula extending from the housing and including a first channel and a second channel, the balloon engaged with a portion of the cannula, wherein when the device is in a first position, the first channel is in communication with the fluid portion such that the fluid can flow to the balloon, and wherein when the device is in a second position, the second channel is in communication with the adhesive portion such that the adhesive can flow out of a portion of the cannula,
Inflating the balloon with fluid supplied through the second channel to lift fragments of the fracture;
injecting cement from the first channel into an opening formed by lifting a fragment of the fracture; and
removing the device from the fracture site,
wherein the balloon is deflated prior to or simultaneously with the injection of the adhesive.
25. The method of claim 24, wherein the adhesive is injected in at least one of an axial direction and a radial direction.
26. The method of claim 24, wherein the balloon is elongated such that a length of the balloon in a direction parallel to a longitudinal axis of the cannula is longer than a width of the balloon in a direction transverse to the longitudinal axis of the cannula.
27. The method of claim 24, wherein the device further comprises a retractable shield coaxial with and covering the sleeve and the balloon, and wherein prior to inflating the balloon, the shield retracts to expose a distal portion of the balloon and the sleeve.
28. A method of correcting a compression fracture comprising:
Lifting fractured bone fragments to form a space; and
the space is filled with a bone cement,
wherein the space formed by the lifting of the bone fragments has directionality.
Technical Field
The present invention relates to a device for correcting a compression-type fracture, including intra-articular fractures in which the fracture spans into the surface of the joint, particularly at the ankle or heel, and methods of using such devices to correct a compression-type fracture.
Background
Ankle fractures are one of the most common persistent fractures, with over five million ankle injuries reported annually in the united states. Heel or calcaneus fractures, while less common, are often even more debilitating. These fractures are often of the intra-articular type, in which the fracture breaks across the joint into the surface, and therefore require particularly careful management. Although intra-articular fractures do not appear to be very different from fractures occurring outside the joint space, they are associated with long-term complications that are difficult to alleviate. The need to treat these fractures requires a thorough consideration and maintenance of bone fragment locations and associated ligament attachments, limiting intervention options. Without treatment, however, intra-articular injury can lead to stiffness, deformity, pain, and post-traumatic arthritis.
The calcaneus is the tarsal bone that is most commonly injured, accounting for 60% of tarsal bone fractures in adults. Intra-articular fractures are the more common species of heel bone fractures following traumatic injury, accounting for 60-75% of all heel bone fractures. 72% of these fractures are the result of falls from high, a difficult injury to recover, and often result in lifelong disability. This further compromises the economic welfare of the patient, as symptoms may affect the ability to perform manual labor. The annual incidence of these fractures is approximately 11.5 per 100,000, with a majority of male patients.
Surgical management approaches for intra-ankle fractures have been the preferred method for the past two decades due to advanced surgical instrumentation and enhanced technology. The development of minimally invasive surgery has resulted in improved recovery time and long term symptom relief. Surgery for these fractures is mainly focused on avoiding deformities and stiffness. For these purposes, it is necessary to ensure anatomical reduction of the articular surfaces and to restore joint stability and normal axial alignment. Achieving this with a depressed joint fragment requires maintaining the correct height throughout the healing process. Currently, the most common support method is to fill the subchondral space with autologous or allogeneic bone grafts; this approach generally does not provide adequate weight support and does not allow the patient to bear weight at the wound site within 6-12 weeks after surgery. Donor site morbidity is another potential problem with bone graft surgery, which can lead to serious complications and longer recovery times.
Balloon kyphoplasty is a minimally invasive surgical procedure that is typically performed in place of percutaneous vertebroplasty for treating spinal compression-type fractures. This procedure utilizes a small, reinforced balloon that is guided into the vertebrae using fluoroscopy and then inflated to lift the bone fragments into their correct position. The balloon is then deflated and withdrawn, and the voids left by the balloon are filled with adhesive to hold the debris in place and stabilize the bone. This allows for better control in the correction and eliminates the need for implants, reducing the likelihood of surgical failure. In applying the principles of this procedure to fracture correction, it should be noted that balloon and device designs that emphasize the physical direction of correction significantly improve the level of control when an operator lifts a depressed joint fragment. Current kyphoplasty methods and devices provide poor directional reduction control. In addition, when performing kyphoplasty, the operator must replace the instruments in use relatively frequently for each step of the procedure; this lengthens the procedure time and introduces room for surgical error.
This kyphoplasty has several disadvantages. First, the balloon used to lift the bone fragments is non-directional (spherical). Second, more than one device is used during surgery, resulting in the need to replace the device multiple times during surgery. Third, the lifting of the fracture and the introduction of the cement cannot be controlled simultaneously.
Therefore, there is a need for a new method of safely, effectively and accurately correcting fractures within the ankle joint that corrects for these deficiencies.
Disclosure of Invention
The present invention relates to a device and method for correcting compression-type fractures, including intra-articular compression-type ankle or heel fractures, using adjustable and/or controllable directional balloon kyphoplasty. The device allows for the lifting of fragments and injection of bone cement into a fracture using a single device, thereby reducing the number of device replacements required to complete a procedure. Directionality of the lift of the debris may be obtained using a balloon, such as, but not limited to, an elliptical balloon. When the balloon is inflated, it provides a structural volume within the fracture into which specialized bone cement can be injected to optimally support the elevated bone fragments. Balloon inflation and adhesive injection are accomplished via a sleeve pre-loaded with a balloon, with a single mechanism facilitating both. The device utilizes an ergonomic handle for all steps of the procedure, allowing for one-handed operation of the device.
According to an embodiment of the present invention, a device for correcting an intra-articular compression fracture comprises: a housing comprising a fluid portion containing a fluid and an adhesive portion containing an adhesive; a sleeve extending from the housing and including a first channel and a second channel; and a balloon engaged with a portion of the cannula, wherein when the device is in the first position, the first channel is in communication with the fluid portion such that fluid can flow to the balloon, and wherein when the device is in the second position, the second channel is in communication with the adhesive portion such that adhesive can flow out of a portion of the cannula.
In one configuration, when the device is in the third position, the first channel is not in communication with the fluid portion and the second channel is not in communication with the adhesive portion. In another configuration, the second channel is not in communication with the adhesive portion when the device is in the first position. In yet another configuration, the first channel is not in communication with the fluid portion when the device is in the second position. In one configuration, the balloon is transitionable between an inflated state and a deflated state. In another configuration, the balloon is elongate such that a length of the balloon in a direction parallel to the longitudinal axis of the cannula is longer than a width of the balloon in a direction transverse to the longitudinal axis of the cannula. In yet another configuration, the second channel includes a cap at a distal end thereof, and the cap has an axial opening and a radial opening. In one configuration, the second channel is in communication with the adhesive portion when the device is in the second position such that adhesive can flow out of at least one of the radial opening and the axial opening. In another configuration, the radial opening and the axial opening are located between the balloon and the distal end of the cannula. In yet another configuration, the device includes a tip at the distal end of the cannula.
According to another embodiment of the invention, a device for correcting an intra-articular compression fracture comprises: a housing located at a proximal end of the device; a cannula extending from the housing and through the orienting balloon; and a tip located at a distal end of the cannula, wherein the cannula includes an outer tube for supplying fluid to the balloon and an inner tube positioned within the outer tube for supplying adhesive into the distal end of the cannula through at least one of the axial opening and the radial opening.
In one configuration, the inner tube is coaxial with the outer tube, and the first passage is defined through the inner tube and the second passage is defined between the inner tube and the outer tube. In another configuration, the inner tube is rotatable relative to the outer tube and the tip. In yet another configuration, the inner tube includes a cap at a distal end thereof, and the cap has an axial opening and a radial opening. In one configuration, the tip includes an axial opening and the outer tube of the cannula includes a radial opening. In another configuration, at least one of the radial opening and the axial opening is blocked by the outer tube or the tip depending on the position of the inner tube relative to the outer tube and the tip. In yet another configuration, the device further comprises a thumb wheel connected to the inner tube and for rotating the inner tube. In one configuration, the thumb wheel may rotate the inner tube to one of three positions: a first position in which the radial opening of the cap is not aligned with the radial opening of the outer tube and the axial opening of the cap is not aligned with the axial opening of the tip; a second position in which the radial opening of the cap is aligned with the radial opening of the outer tube and the axial opening of the cap is not aligned with the axial opening of the tip; and a third position in which the radial opening of the cap is not aligned with the radial opening of the outer tube and the axial opening of the cap is aligned with the axial opening of the tip. In another configuration, the balloon is elongate such that a length of the balloon in a direction parallel to the longitudinal axis of the cannula is longer than a width of the balloon in a direction transverse to the longitudinal axis of the cannula. In yet another configuration, the outer tube has an aperture through which fluid enters the balloon from the second channel. In one configuration, the device includes a retractable shield coaxial with the cannula and covering the cannula and the balloon. In another configuration, the device includes a handle associated with the housing and connected to the proximal end of the shield, wherein movement of the handle in the proximal direction moves the shield to expose the balloon and the distal portion of the cannula. In yet another configuration, the device includes a regulator for controlling the flow of fluid and/or adhesive into the cannula.
In accordance with another embodiment of the present invention, a method of correcting a compression-type fracture (e.g., an intra-articular compression-type fracture) includes inserting the device into a fracture site; inflating the directional balloon with fluid supplied through the second channel to lift fragments of the fracture; injecting cement from a first channel into an opening formed by lifting a fragment of the fracture; and removing the device from the fracture site, wherein the balloon is deflated prior to or simultaneously with the injection of the adhesive.
In one configuration, the adhesive is injected in at least one of an axial direction and a radial direction. In another configuration, the balloon is elongate such that a length of the balloon in a direction parallel to the longitudinal axis of the cannula is longer than a width of the balloon in a direction transverse to the longitudinal axis of the cannula. In yet another configuration, the device includes a retractable shield coaxial with the cannula and covering the cannula and the balloon, the shield being retracted to expose the balloon and a distal portion of the cannula prior to inflating the balloon.
In accordance with another embodiment of the present invention, a method of correcting a compression-type fracture (e.g., an intra-articular compression-type fracture) includes lifting a fractured bone fragment to form a space; and filling the space with a bone cement, wherein the space formed by the lifting of the bone fragments has directionality.
Drawings
The above-mentioned and other features and advantages of this disclosure, and the manner of attaining them, will become more apparent and the disclosure itself will be better understood by reference to the following description of embodiments of the disclosure taken in conjunction with the accompanying drawings, wherein:
fig. 1 is a perspective view of a device according to an embodiment of the invention.
Fig. 2 is a rear view of an apparatus according to an embodiment of the invention.
Fig. 3 is a bottom elevation view of an apparatus according to an embodiment of the present invention.
Fig. 4 is a side view of an apparatus according to an embodiment of the invention.
Fig. 5 is an exploded perspective view of a device according to an embodiment of the present invention.
FIG. 6 is an enlarged exploded perspective view of the device shown in circle 6 of FIG. 5, according to an embodiment of the present invention.
FIG. 7 is an enlarged exploded perspective view of the device shown in
FIG. 8 is an enlarged exploded perspective view of the device shown in circle 8 of FIG. 5, in accordance with an embodiment of the present invention.
Fig. 9 is a cross-sectional view of the device shown in fig. 4, in accordance with an embodiment of the present invention.
FIG. 10 is an enlarged exploded perspective view of the device shown in
FIG. 11A is a view of a first position of a thumb wheel of a device according to an embodiment of the invention.
FIG. 11B is a view of a second position of the thumb wheel of a device according to an embodiment of the invention.
FIG. 11C is a view of a third position of the thumb wheel of a device according to an embodiment of the invention.
Fig. 12 is a perspective view of a device and system according to an embodiment of the invention.
Fig. 13 is a perspective view of a first step in using the device of the present disclosure, according to an embodiment of the present invention.
Fig. 14 is a perspective view of a second step in using the device of the present disclosure, according to an embodiment of the present invention.
Fig. 15 is a perspective view of a third step in using the device of the present disclosure, according to an embodiment of the present invention.
Fig. 16 is a perspective view of a fourth step in using the device of the present disclosure, according to an embodiment of the present invention.
Fig. 17 is a perspective view of a fifth step in using the apparatus of the present disclosure, according to an embodiment of the present invention.
Fig. 18 is a perspective view of a sixth step in using the device of the present disclosure, according to an embodiment of the present invention.
Fig. 19 is a perspective view of a seventh step in using the device of the present disclosure, according to an embodiment of the present invention.
Fig. 20 is a perspective view of an eighth step using the apparatus of the present disclosure, in accordance with an embodiment of the present invention.
Fig. 21 is a perspective view of a ninth step in using the apparatus of the present disclosure, in accordance with an embodiment of the present invention.
FIG. 22 is a perspective view of a controller in a first position according to an embodiment of the present invention.
FIG. 23 is a perspective view of a controller in a second position according to an embodiment of the present invention.
FIG. 24 is a perspective view of a controller in a third position according to an embodiment of the present invention.
Fig. 25 is a perspective view of a balloon according to an embodiment of the invention.
Fig. 26 is a perspective view of a balloon according to another embodiment of the invention.
Corresponding reference characters indicate corresponding parts throughout the several views. The exemplifications set out herein illustrate exemplary embodiments of the disclosure, and such exemplifications are not to be construed as limiting the scope of the disclosure in any manner.
Detailed Description
The following description is presented to enable any person skilled in the art to make and use the described embodiments, which are intended to be useful in the practice of the invention. Various modifications, equivalents, changes, and substitutions will still be apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to fall within the spirit and scope of the present invention.
For purposes of the following description, the terms "upper", "lower", "right", "left", "vertical", "horizontal", "top", "bottom", "transverse", "longitudinal", and derivatives thereof shall relate to the invention as it is oriented in the drawing figures. It is to be understood, however, that the invention may assume various alternative variations, except where expressly specified to the contrary. It is also to be understood that the specific devices illustrated in the attached drawings, and described in the following specification, are simply exemplary embodiments of the invention. Hence, specific dimensions and other physical characteristics relating to the embodiments disclosed herein are not to be considered as limiting.
The present invention relates to an apparatus and method for compression fracture correction, including but not limited to intra-articular compression fracture correction, using a dilator adapted for directional reduction. The present invention provides for lifting a fracture in one direction by using an inflatable balloon as will be described herein to avoid spreading fracture fragments in an undesired direction within the fracture. The device of the present invention may provide an integrated housing for balloon deployment and adhesive delivery as will be described herein, which may allow for a one-handed control procedure, which maximizes procedure success and reduces procedure time and the need for multiple device replacements. In certain embodiments, as will be described herein, maintaining fracture reduction by lifting during adhesive delivery to a site may be achieved. As will be discussed herein, simultaneous control of the balloon between the inflated and deflated states is associated with adhesive flow to the site guided by the fracture reduction pressure.
In the method of the invention, reduction of the fracture is directional, i.e., a non-spherical space is created in the fracture. The space formed by the directional dilator may have a different size in one direction than in another, or may include regions having a different shape and/or size than another region.
The device of the present invention allows a directional dilator to be placed in a fracture where it lifts fragments of the fracture creating a space into which bone cement is injected to stabilize the fracture, all using a single device, thereby reducing the number of separate instruments required for intra-articular compression type fracture correction using prior art kyphoplasty procedures. The device and method of the invention can be used to correct fractures of the heel and ankle, in particular fractures of the calcaneus, tibia, talus, ankle and of the pilot or Plafond type.
In addition, fracture reduction and adhesive delivery can be controlled simultaneously.
These and other features will become apparent from the following detailed description, wherein embodiments of the invention are shown and described, by way of illustration. As will be realized, the invention is capable of other and different embodiments and its several details are capable of modifications in various respects, all without departing from the invention. Accordingly, the drawings and description are to be regarded as illustrative in nature and not as restrictive or limiting.
As shown in fig. 1-10, the
The
The
The
The
Structural supports 64 are provided in the
The distal end 70 of the inner
The proximal end 80 of the inner
The
The
All
The
As shown in fig. 11A, in the closed position, the
As shown in fig. 11B, in the axial position, the
As shown in fig. 11C, in the radial position, the
Further, at least in the axial and radial positions, the
Referring to fig. 15, 25 and 26, in an exemplary embodiment,
Referring to fig. 15, 25 and 26, alternatively, in another exemplary embodiment, a biaxial or bipolar balloon having different sizes and/or shapes at different portions of the balloon may be provided. Such balloons are useful for correction of fractures requiring elevation of multiple compression planes, which would benefit from partial or full expansion in different directions. Such a balloon provides a more complete and accurate correction.
Referring to fig. 15, 25 and 26, in another exemplary embodiment, the
Referring to fig. 26, in the exemplary embodiment, four adhesive channels 106 are included having four corresponding adhesive outlets. In other exemplary embodiments, other configurations of the adhesive channels are contemplated to allow for flexible control of the delivery of adhesive C to the
The
The
Referring to fig. 15-24, in order to simultaneously control the fluid provided to the expander/balloon and the adhesive C provided to the
In one embodiment, the
Referring to fig. 12-21, the use of the
Referring to fig. 13, in operation, the
Referring to fig. 15, the
Referring to fig. 16-18, when the desired height has been reached, the flow of fluid to the
Referring to fig. 19-21, after the adhesive C is properly injected into the opening in the
The components of the device may be formed from any of several materials. While the shapes of the various components have been described as such, different shapes may be used while still complying with the general design principles of the invention.
In certain procedures, and with continued reference to fig. 15-21, the operator may effect fracture reduction in the target area by inflating
While this disclosure has been described as having an exemplary design, the present disclosure may be further modified within the spirit and scope of this disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the disclosure using its general principles. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this disclosure pertains and which fall within the limits of the appended claims.
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