Inflatable balloon tamp with deployable withdrawal tube

Abstract

A surgical tool for repairing vertebral bodies according to at least one embodiment of the present disclosure includes an access cannula having a proximal end and a distal end, an inflatable balloon tamp (IBT) deployable through the access cannula and extending beyond the distal end of the access cannula and a withdrawal tube integrally formed with the IBT and deployable beyond the distal end of the access cannula. The withdrawal tube is further deployable at least partially around the IBT to provide a buffer between the distal end of the access cannula and a distal end of the IBT as the IBT is retracted through the access cannula.

Description

INFLATABLE BALLOON TAMP WITH DEPLOYABLE WITHDRAWAL TUBECROSS-REFERENCE TO RELATED APPLICATIONS

[0001] The present application claims the benefit of and priority to U.S. Provisional Application No. 63 / 529,256 filed on July 27, 2023, entitled “INFLATABLE BALLOON TAMP WITH DEPLOYABLE WITHDRAWAL TUBE”, the entirety of which is hereby incorporated herein by reference.BACKGROUND

[0002] The present disclosure is generally directed to surgical tools and relates more particularly to surgical tools capable of repairing vertebral bodies.

[0003] Fractures such as vertebral compression fractures often result in episodes of pain that are chronic and intense. Aside from the pain caused by the fracture itself, the involvement of the spinal column can result in pinched and / or damaged nerves, causing paralysis, loss of function, and intense pain which radiates throughout the patient's body. Even where nerves are not affected, however, the intense pain associated with all types of fractures is debilitating, resulting in a great deal of stress, impaired mobility and other long-term consequences. For example, progressive spinal fractures can, over time, cause serious deformation of the spine (“kyphosis”), giving an individual a hunched-back appearance, and can also result in significantly reduced lung capacity and increased mortality.

[0004] Because patients with these problems are typically older, and often suffer from various other significant health complications, many of these individuals are unable to tolerate invasive surgery. Therefore, in an effort to more effectively and directly treat vertebral compression fractures, minimally invasive techniques such as, vertebroplasty and, subsequently, kyphoplasty, have been developed. Vertebroplasty involves the injection of a flowable reinforcing material, usually polymethylmethacrylate (PMMA — commonly known as bone cement), into a fractured, weakened, or diseased vertebral body. Shortly after injection, the liquid filling material hardens or polymerizes, desirably supporting the vertebral body internally, alleviating pain and preventing further collapse of the injected vertebral body.

[0005] Because the liquid bone cement naturally follows the path of least resistance within bone, and because the small-diameter needles used to deliver bone cement invertebroplasty procedure require either high delivery pressures and / or less viscous bone cements, ensuring that the bone cement remains within the already compromised vertebral body is a significant concern in vertebroplasty procedures. Kyphoplasty addresses this issue by first creating a cavity within the vertebral body (e.g., with an inflatable balloon) and then filling that cavity with bone filler material. The cavity provides a natural containment region that minimizes the risk of bone filler material escape from the vertebral body. An additional benefit of kyphoplasty is that the creation of the cavity can also restore the original height of the vertebral body, further enhancing the benefit of the procedure.BRIEF SUMMARY

[0006] Example aspects of the present disclosure include:

[0007] A device for kyphoplasty on a bone structure according to at least one embodiment of the present disclosure includes an access cannula having a proximal end and a distal end, an inflatable balloon tamp (IBT) deployable through the access cannula and extending beyond the distal end of the access cannula and a withdrawal tube integrally formed with the IBT and deployable beyond the distal end of the access cannula. The withdrawal tube is further deployable at least partially around the IBT to provide a buffer between the distal end of the access cannula and a distal end of the IBT as the IBT is retracted through the access cannula. In other words, the withdrawal tube straightens the distal end of the IBT and / or reduces friction between the distal end of the IBT and the distal end of the access cannula.

[0008] Any of the aspects herein, wherein the withdrawal tube is partially exposed through the access cannula while the IBT is being pushed beyond the distal end of the access cannula.

[0009] Any of the aspects herein, wherein a distal end of the IBT has one or more curved portions and the distal end of the access cannula has a straight portion.

[0010] Any of the aspects herein, wherein the withdrawal tube is maintained within the access cannula while the IBT is being pushed beyond the distal end of the access cannula.

[0011] Any of the aspects herein, wherein the withdrawal tube is radially expandable at its distal end to accommodate the distal end of the IBT including a balloon.

[0012] Any of the aspects herein, wherein the withdrawal tube is made of a material that is harder and / or stiffer than a material from which a shaft portion of the IBT is made. Providing a withdrawal tube with a material that is harder and / or stiffer than a material ofthe IBT enables the withdrawal tube to provide a buffer between the IBT and the access cannula. The withdrawal tube may reduce the friction of the IBT against the access cannula during withdrawal of the IBT from the access cannula.

[0013] Any of the aspects herein, wherein the withdrawal tube includes a handle provided at a proximal end of the withdrawal tube.

[0014] Any of the aspects herein, wherein the handle includes a locking mechanism configured to lock the handle in an initial state or a withdrawn state.

[0015] Any of the aspects herein, wherein the handle is pushed distally such that the withdrawal tube covers the one or more curved portions of the distal end of the IBT prior to the IBT being removed from the access cannula.

[0016] Any of the aspects herein, wherein the one or more curved portions of the distal end of the IBT is straightened by the distal end of the withdrawal tube prior to the IBT being removed from the access cannula. Straightening the IBT with assistance of the withdrawal tube may help align the IBT with the access cannula during withdrawal of the IBT through the access cannula, thereby reducing the risk and occurrence of the IBT getting caught on a distal end of the access cannula.

[0017] A method for kyphoplasty on a bone structure according to at least one embodiment of the present disclosure includes inserting an inflatable balloon tamp (IBT) having a curved distal end and a withdrawal tube integrally formed with the IBT through a substantially straight access cannula, inflating a balloon of the IBT, deflating the balloon, extending a portion of the withdrawal tube beyond the curved distal end of the IBT and withdrawing the IBT with the deflated balloon and the withdrawal tube through the access cannula, when the withdrawal tube is extended beyond the curved distal end of the IBT.

[0018] Any of the aspects herein, further comprising partially exposing the withdrawal tube through the access cannula while the IBT is being pushed beyond the distal end of the access cannula.

[0019] Any of the aspects herein, further comprising maintaining the withdrawal tube within the access cannula while the IBT is being pushed beyond the distal end of the access cannula.

[0020] Any of the aspects herein, further comprising pushing a handle of the withdrawal tube distally such that the withdrawal tube covers the curved distal end of the IBT prior to the withdrawal tube being removed from the access cannula.

[0021] Any of the aspects herein, further comprising straightening, by a distal end of the withdrawal tube, the curved distal end of the IBT prior to thelBT being removed from the access cannula.

[0022] Any of the aspects herein, wherein the withdrawal tube includes a handle and further comprising locking the handle in an initial state or a withdrawn state.

[0023] Any of the aspects herein, wherein the withdrawal tube is made of a material that is harder and / or stiffer than a material from which a shaft portion of the IBT is made.

[0024] A system for kyphoplasty on a bone structure according to at least one embodiment of the present disclosure includes an access cannula configured for penetrating into the bone structure, the access cannula having a proximal end and a distal end, an inflatable balloon tamp (IBT) deployable through the access cannula and extending beyond the distal end of the access cannula into the bone structure and a withdrawal tube integrally formed with the IBT and deployable beyond the distal end of the access cannula. The withdrawal tube is further deployable at least partially around the distal potion of the IBT to provide a buffer between the distal end of the access cannula and a distal end of the IBT as the IBT is retracted through the access cannula.

[0025] Any of the aspects herein, wherein a distal end of the IBT has one or more curved portions and the distal end of the access cannula has a straight portion.

[0026] Any of the aspects herein, wherein the withdrawal tube is maintained within the access cannula while the IBT is being pushed beyond the distal end of the access cannula.

[0027] Any aspect in combination with any one or more other aspects.

[0028] Any one or more of the features disclosed herein.

[0029] Any one or more of the features as substantially disclosed herein.

[0030] Any one or more of the features as substantially disclosed herein in combination with any one or more other features as substantially disclosed herein.

[0031] Any one of the aspects / features / embodiments in combination with any one or more other aspects / features / embodiments.

[0032] Use of any one or more of the aspects or features as disclosed herein.

[0033] It is to be appreciated that any feature described herein can be claimed in combination with any other feature(s) as described herein, regardless of whether the features come from the same described embodiment.

[0034] The details of one or more aspects of the disclosure are set forth in the accompanying drawings and the description below. Other features, objects, andadvantages of the techniques described in this disclosure will be apparent from the description and drawings, and from the claims.

[0035] The phrases “at least one”, “one or more”, and “and / or” are open-ended expressions that are both conjunctive and disjunctive in operation. For example, each of the expressions “at least one of A, B and C”, “at least one of A, B, or C”, “one or more of A, B, and C”, “one or more of A, B, or C” and “A, B, and / or C” means A alone, B alone, C alone, A and B together, A and C together, B and C together, or A, B and C together. When each one of A, B, and C in the above expressions refers to an element, such as X, Y, and Z, or class of elements, such as XI -Xn, Yl-Ym, and Zl-Zo, the phrase is intended to refer to a single element selected from X, Y, and Z, a combination of elements selected from the same class (e.g., XI and X2) as well as a combination of elements selected from two or more classes (e.g., Y1 and Zo).

[0036] The term “a” or “an” entity refers to one or more of that entity. As such, the terms “a” (or “an”), “one or more” and “at least one” can be used interchangeably herein. It is also to be noted that the terms “comprising”, “including”, and “having” can be used interchangeably.

[0037] The preceding is a simplified summary of the disclosure to provide an understanding of some aspects of the disclosure. This summary is neither an extensive nor exhaustive overview of the disclosure and its various aspects, embodiments, and configurations. It is intended neither to identify key or critical elements of the disclosure nor to delineate the scope of the disclosure but to present selected concepts of the disclosure in a simplified form as an introduction to the more detailed description presented below. As will be appreciated, other aspects, embodiments, and configurations of the disclosure are possible utilizing, alone or in combination, one or more of the features set forth above or described in detail below.

[0038] Numerous additional features and advantages of the present disclosure will become apparent to those skilled in the art upon consideration of the embodiment descriptions provided hereinbelow.BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

[0039] The accompanying drawings are incorporated into and form a part of the specification to illustrate several examples of the present disclosure. These drawings, together with the description, explain the principles of the disclosure. The drawings simply illustrate preferred and alternative examples of how the disclosure can be made and usedand are not to be construed as limiting the disclosure to only the illustrated and described examples. Further features and advantages will become apparent from the following, more detailed, description of the various aspects, embodiments, and configurations of the disclosure, as illustrated by the drawings referenced below.

[0040] Fig. 1 A is a view of components of a surgical assembly according to at least one embodiment of the present disclosure;

[0041] Fig. IB is a view of a surgical assembly with a surgical tool inserted into a cannula assembly according to at least one embodiment of the present disclosure;

[0042] Fig. 1C is a view of a surgical tool with the withdrawal tube in an initial state according to at least one embodiment of the present disclosure;

[0043] Fig. ID is a view of a surgical tool with the withdrawal tube in a withdrawn state according to at least one embodiment of the present disclosure;

[0044] Fig. IE is a view of a surgical tool (e.g., an inflatable balloon tamp (IBT)) with multiple bends at its distal end according to at least one embodiment of the present disclosure;

[0045] Fig. 2A is a view of a locking mechanism of a surgical tool in an initial state according to at least one embodiment of the present disclosure;

[0046] Fig. 2B is a view of a locking mechanism of a surgical tool in a deployment state according to at least one embodiment of the present disclosure;

[0047] Fig. 2C is a view of a locking mechanism of a surgical tool in a withdrawn state according to at least one embodiment of the present disclosure;

[0048] Fig. 3 is a diagram depicting components of a surgical assembly entering an anatomical element according to at least one embodiment of the present disclosure; and

[0049] Fig. 4 is a flowchart according to at least one embodiment of the present disclosure.DETAILED DESCRIPTION

[0050] Before any embodiments of the disclosure are explained in detail, it is to be understood that the disclosure is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the drawings. The disclosure is capable of other embodiments and of being practiced or of being carried out in various ways. Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of “including,” “comprising,” or “having” and variations thereof hereinis meant to encompass the items listed thereafter and equivalents thereof as well as additional items. Further, the present disclosure may use examples to illustrate one or more aspects thereof. Unless explicitly stated otherwise, the use or listing of one or more examples (which may be denoted by “for example,” “by way of example,” “e.g.,” “such as,” or similar language) is not intended to and does not limit the scope of the present disclosure.

[0051] The terms proximal and distal are used in this disclosure with their conventional medical meanings, proximal being closer to the operator or user of the system, and further from the region of surgical interest in or on the patient, and distal being closer to the region of surgical interest in or on the patient, and further from the operator or user of the system.

[0052] Surgical intervention of damaged or compromised bone sites has proven highly beneficial for patients, including, for example, patients with back pain associated with vertebral damage. The vertebral damage may be due to injury and / or a degenerative condition such as, for example, aging, cancer, benign lesions, and / or osteoporosis. Balloon kyphoplasty is a minimally invasive bone-related surgical procedure designed to repair vertebral compression fractures (VCFs) by reducing and stabilizing the fractures, restoring vertebral body height, and relieving pain.

[0053] Conventional balloon kyphoplasty typically involves a surgeon making a pair of small incisions (e.g., each approximately 1 centimeter in length) on the patient’s back using a needle and an access cannula to create a small pathway into each side of a fractured vertebral body. A surgical tool (e.g., an inflatable bone tamp (balloon), or IBT is guided through each access cannula into the fractured vertebra. Each of the balloons for the corresponding IBT is carefully inflated under volumetric control to create a void, raise the collapsed vertebra, and return the vertebra to its normal position. Inflating the balloons of the IBTs reduces the fracture of the vertebra and pushes endplates of the vertebrae apart, thereby partially restoring the vertebral height and correcting angular deformity.

[0054] Moreover, inflating the balloons of the IBTs creates a void (e.g., cavity) in the vertebra. Once the vertebra is in the correct position, the balloons of the IBTs are deflated and removed. The resultant cavities are filled with bone cement forming an internal cast to support the surrounding bone and prevent further collapse.

[0055] A unipedicular balloon kyphoplasty procedure has been introduced that reduces the number of incisions incurred by the patient. The unipedicular balloon kyphoplasty isperformed through access via a single pedicle of the vertebra, thus requiring only one incision. A single balloon of a curved-shaped IBT is positioned across or approximately across the vertebral body midline. When using the curved-shaped IBT to achieve this positioning of the balloon across the vertebral body midline, however, the curved portion at the distal end of the curved-shaped IBT rubs against the medial side of the edge of the access cannula when removing or withdrawing the curved-shaped IBT. The friction between the curved-shaped IBT and the edge of the access cannula during a withdrawal process, causes the curved-shaped IBT’s shaft and / or an inflatable structure to get caught, thus making withdrawal difficult or impossible.

[0056] According to at least one embodiment of the present disclosure, systems and methods utilize a curved-shaped IBT for unipedicular balloon kyphoplasty procedures. Embodiments of the present disclosure provide technical solutions to one or more of the problems of (1) withdrawing curved-shaped surgical tools along an access path from a target surgical site of a subject during surgery, (2) protecting the shaft of the curvedshaped surgical tools from friction during withdrawal of the curved-shaped surgical tools from the target surgical site, (3) straightening the curved-shaped surgical tools during withdrawal of the curved-shaped surgical tools from the target surgical site and (4) reducing or eliminating the possibility of an inflatable structure being caught / snagged on the access cannula when withdrawing the curved-shaped surgical tools.

[0057] Fig. 1 A is a view of components of a surgical assembly 100 according to at least one embodiment of the present disclosure. The surgical assembly 100 may be used to access a target surgical site and perform balloon kyphoplasty at the surgical site. The surgical assembly 100 includes a surgical tool 102 and an access cannula assembly 106. The access cannula assembly 106 extends from a proximal end 114 to a distal end 118. The proximal end 114 may be the end of the access cannula assemblyl06 that is positioned closer to the physician and further away from the target surgical site, while the distal end 118 may be the end of the access cannula assembly 106 positioned closer to the target surgical site and further away from the physician. The access cannula assembly 106 includes tools for accessing the target surgical site and may include an access cannula handle 120 and an access cannula tube 124. The access cannula handle 120 may enable the physician or surgeon to hold the surgical assembly 100 during use. The access cannula tube 124 may be a hollow tube attached to a distal end of the access cannula handle 120 and may be inserted into a target surgical site (e.g., a vertebra of the subject or patient). In some embodiments of the present disclosure, the access cannula handle 120 may include atrocar (not shown) that can cut through anatomical tissue to more efficiently reach the target surgical site. For instance, to access anatomical tissue within a vertebra, the physician or surgeon may hold the access cannula handle 120 and strike (e.g., using a surgical hammer) the top of the access cannula handle 120 such that the access cannula tube 124 enters (e.g., bores into) the vertebra.

[0058] In one embodiment of the present disclosure, the anatomical tissue within the vertebra may be accessed by hammering through the pedicle of the vertebra. Once the access cannula assembly 106 has been used to access the target surgical site, the surgical tool 102 may be passed through a hollow portion of the access cannula handle 120 and the access cannula tube 124 (as shown in Fig. IB) to permit the surgical tool 102 to access the target surgical site. After the target surgical site has been reached (e.g., the interior of the vertebra) by the surgical tool 102, balloon kyphoplasty may be performed.

[0059] The surgical tool 102 (e.g., an inflatable bone tamp (IBT)) extends from a proximal end 104 to a distal end 108. The proximal end 104 may be the end of the surgical tool 102 that is positioned closer to the physician and further away from the target surgical site, while the distal end 108 may be the end of the surgical tool positioned closer to the target surgical site and further away from the physician. The surgical tool 102 includes a shaft 153, an inflatable structure 150 (e.g., a balloon) at the distal end 108 of the surgical tool 102 and a connector 116 (e.g., a Luer Lock fitting) at the proximal end 104 of the surgical tool 102. Although the connector 116 is depicted as a “Y” connector (e.g., two fittings or ports) for exemplary purposes, connector 116 can take any shape and can include any number of fittings or ports. The shaft 153 includes two portions, a tubing member and a stylet provided within the tubing member as discussed in greater detail below. The shaft 153 extends from the connector 116 to the inflatable structure 150 and includes one or more curved-shaped portions 151.

[0060] Fig. IE is a view of a surgical tool (e.g., an inflatable balloon tamp (IBT)) with multiple bends or curved-shaped portions at its distal end. As illustrated in Fig. IE, the shaft 153 includes a tubing member 155 and a stylet 156. The stylet 156 is provided within the tubing member 155 and extends from the distal end of the connector 116 to the distal end 108 of the surgical tool 102. In other words, the stylet 156 extends from the distal end of the connector 116 to the distal end of the inflatable structure 150, traversing the inflatable structure 150. As illustrated in FIG. IE, the stylet 156 of the shaft 153 includes two partial bends 151a and 151b. Partial bend 151a is provided outside of the inflatable structure 150 while partial bend 151b is provided within the inflatable structure150. According to an embodiment of the present disclosure, the stylet 156 of the shaft 153 may include “n” bends or curved-shaped portions separated by “n-1” straight sections. According to another embodiment of the present disclosure, the stylet of the shaft 153 may include any type, any number and / or any combinations of bends without departing from the spirit and scope of the present disclosure. The tubing member 155 extends from the distal end of the connector 116 to the proximal end of the inflatable structure 150.

[0061] The inflatable structure 150 can be formed from any type of inflatable material, including non-compliant materials (e.g., many nylon and polyethylene materials), semi- compliant materials (e.g., many polyurethane materials), compliant materials (e.g., latex rubber), or any combination thereof. Inflatable structure 150 can also have any size / shape. While a dual-lobed (“peanut shaped”) configuration is depicted for exemplary purposes, in various other embodiments of the present disclosure, the inflatable structure 150 can be ovoid, spheroid, cylindrical, or any other shape. In various other embodiments of the present disclosure, the inflatable structure 150 and / or, the shaft 153 can include radiopaque elements, markings, coatings, and / or patterns to facilitate visualization and / or positioning under fluoroscopic imaging.

[0062] According to further embodiments of the present disclosure, the shaft 153 can likewise be formed from any material or combination of materials providing sufficient structural support to allow the inflatable structure 150 to be inflated within a target surgical site (e.g., a bone). For example, in various embodiments of the present disclosure, the tubing member 155 of the shaft 153 can be formed from a polymer, metal or any other material, while the stylet 156 of the shaft 153 can be formed from nylon, polyethylene, polyurethane, stainless steel, nitinol, multiple layers of different materials, including braided materials, or any other desired construction and composition.

[0063] The surgical tool 102 further includes a withdrawal tube 145. The withdrawal tube 145 is provided between the connector 116 and the inflatable structure 150 and is movably positioned around the shaft 153, traversing along the X-axis. According to an embodiment of the present disclosure, the withdrawal tube 145 moves distally from a proximal end of the curved-shaped portion 151 of the shaft 153, over the curved-shaped portion 151 of the shaft 153 and up to a proximal end of the inflatable structure 150. According to a further embodiment of the present disclosure, the withdrawal tube 145 moves proximally from either the proximal end of the inflatable structure 150 or a distal end of the inflatable structure 150, around the curved-shaped portion 151 of the shaft 153 and towards a distal end of the connector 116. According to embodiments of the presentdisclosure, the withdrawal tube 145 is radially expandable at its distal end to accommodate the inflatable structure 150, when the inflatable structure 150 is inflated for example.

[0064] The withdrawal tube 145 includes a handle 140 and a tube 141. Moreover, the tube 141 of the withdrawal tube 145 defines an internal lumen sized for accommodating the shaft 153. Moreover, by moving withdrawal tube 145 relative to the shaft 153 before or during withdrawal of the inflatable structure 150, the inflatable structure 150 can be retracted from the target surgical site and the curved-shaped portion 151 of the shaft 153 is provided into the internal lumen, thereby straightening the curved-shaped portion 151 of the shaft 153. According to further embodiments of the present disclosure, the withdrawal tube 145 is deployed for removal from the access cannula system 106 by pushing the withdrawal tube 145 distally over the shaft 153. The handle 140 includes a locking mechanism as discussed in greater detail below with Figs. 2A-2C.

[0065] Fig. 1C is a view of the surgical tool 102 with the withdrawal tube 145 in an initial state and Fig. ID is a view of the surgical tool 102 with the withdrawal tube 145 in a withdrawn state according to embodiments of the present disclosure. As illustrated in Fig. 1C, the withdrawal tube 145 is in the initial state (e.g., the handle 140 is provided at a position over the distal end of the connector 116), when the surgical tool 102 is placed in the access cannula (not shown), when the inflatable structure 150 (not shown) is being inflated and when the inflatable structure 150 has been deflated. As illustrated in Fig. ID, the withdrawal tube 145 is in the withdrawn state (e.g., the handle 140 is provided at a position farther distally over the distal end of the connector 116), when the surgical tool 102 is being withdrawn from the access cannula. According to embodiments of the present disclosure, the withdrawal tube 145 traverses the shaft 153 such that the tube 141 covers the curved-shaped portion 151 of the shaft 153 up until the proximal end of the inflatable structure 150. According to an alternative embodiment of the present disclosure, the withdrawal tube 145 traverses the shaft 153 such that the tube 141 covers the curved-shaped portion 151 of the shaft 153 and the inflatable structure 150, partially or totally. According to one embodiment of the present disclosure, the tube 141 covers the inflatable structure 150 such that the entire inflatable structure 150 is provided within the lumen defined by the tube 141 of the withdrawal tube 145.

[0066] The tube 141 of the withdrawal tube 145 can also be formed from nylon, polyethylene, polyurethane, stainless steel, nitinol, polyetheretherketone, multiple layers of different materials, including braided materials, or any other desired construction and composition, as long as the tube 141 of the withdrawal tube 145 is made of a material thatis harder and / or stiffer than a material of the shaft 153 such that the curved-shaped portion 151 of the shaft 153 bends when the tube 141 of the withdrawal tube 145 is deployed distally over the shaft 153. According to an alternative embodiment of the present disclosure, the tube 141 of the withdrawal tube 145 may be made of a material that is just as hard as and / or just as stiff as a material of the shaft 153 as long as the materials selected for each of the tube 141 of the withdrawal tube 145 and the shaft 153 aid in reducing friction and eliminating the risk of the IBT getting caught in the access cannula tube 124 when withdrawing the IBT from the access cannula tube 124. According to a further embodiment of the present disclosure, the tube 141 of the withdrawal tube 145 may be made of a material that is not harder and / or not stiffer than as a material of the shaft 153 as long as the materials selected for each of the tube 141 of the withdrawal tube 145 and the shaft 153 aid in reducing friction and eliminating the risk of the IBT getting caught in the access cannula tube 124 when withdrawing the IBT from the access cannula tube 124.

[0067] Figs. 2A-2C are views of a locking mechanism 200 of a surgical tool in an initial state, a deployment state and a withdrawn state, respectively, according to embodiments of the present disclosure. As illustrated in Fig. 2A, the handle 140 includes a locking mechanism 200 including a protrusion 220 protruding inwardly from the handle 140 and a slide bar 232 provided at a distal end of the connector 116 including a first recess 224 and a second recess 228. In the initial state, when the surgical tool 102 is placed in the access cannula (not shown), when the inflatable structure 150 (not shown) is being inflated and when the inflatable structure 150 has been deflated, the protrusion 220 is provided within the first recess 224 of the slide bar 232 which is provided at a proximal end of the locking mechanism 200. In the initial state, the withdrawal tube 145 cannot traverse the shaft 153 and is essentially in a locked position.

[0068] Fig. 2B illustrates the deployment state before the surgical tool 102 is in the withdrawn state. During the deployment state, the handle 140 is rotated around the distal end of the connector 116 such that the protrusion 220 is no longer accommodated within the first recess 224 and is provided within the slide bar 232. The handle 140 is then advanced by the surgeon towards the inflatable structure 150 (e.g., the protrusion 220 moves distally within the slide bar 232) such that the tube 141 of the withdrawal tube 145 advances towards the curved-shaped portion 151 of the shaft 153. Since the protrusion 220 is provided within the slide bar 232 (e.g., not provided in the first recess 224 or the second recess 228) the withdrawal tube 145 can freely traverse the shaft 153.

[0069] Fig. 2C illustrates the withdrawn state when the surgical tool 102 is ready to be withdrawn from the access cannula. At this point, the tube 141 of the withdrawal tube 145 covers the curved-shaped portion 151 of the shaft 153 up until the proximal end of the inflatable structure 150. According to an alternative embodiment of the present disclosure, the withdrawal tube 145 traverses the shaft 153 such that the tube 141 covers the curved-shaped portion 151 of the shaft 153 and the inflatable structure 150, partially or totally. According to one embodiment of the present disclosure, the tube 141 covers the inflatable structure 150 such that the entire inflatable structure 150 is provided within the lumen defined by the tube 141 of the withdrawal tube 145. The protrusion 220 is provided within the second recess 228 of the slide bar 232 which is provided at a distal end of the locking mechanism 200. Like the initial state, in the withdrawn state, the withdrawal tube 145 cannot traverse the shaft 153 and is essentially in a locked position. Although locking mechanism 200 is illustrated, other types of locking mechanisms can be employed such as, but not limited to a ratchet mechanism, a clamp, a releasable latch, a thread-based locking mechanism (e.g., rotating the withdrawal tube 145 around the connector 116 and the shaft 153, thereby the withdrawal tube 145 moves distally over the connector 116 and the shaft 153) or any other type of mechanism for limiting movement of the handle 140 of the withdrawal tube 145 relative to the connector 116 without departing from the spirit and scope of the present disclosure. According to an alternative embodiment of the present disclosure, the withdrawal tube 145 may not be provided with a locking mechanism. In this case, the withdrawal tube 145 would be deployed distally as far as determined by a physician in order to safely remove the IBT from the access cannula assembly 106.

[0070] Fig. 3 shows an illustrative method of accessing an anatomical element 304 according to at least one embodiment of the present disclosure. As illustrated in Fig. 3, a surgical instrument 308 (e.g., a surgical hammer, a surgical mallet, etc.) may be used by a physician to strike a trocar / bevel (not shown) mated to the access cannula handle 120 of the access cannula assembly 106, as illustrated by the arrow. By using the trocar / bevel, the access cannula tube 124 may be driven into the anatomical element 304 (e.g., a vertebra) to reach a target surgical site. Any other form of access cannula placement can be used to position the access cannula assembly 106 without departing from the spirit and scope of the present disclosure.

[0071] Once the access cannula tube 124 is within the anatomical element 304, a surgical tool (e.g., a surgical tool 102 such as an IBT) may be inserted through the access cannula handle 120 and the access cannula tube 124 to interact with the target surgicalsite. For example, the surgical tool may be used to repair one or more vertebral bodies at the target surgical site such as in a kyphoplasty procedure. In some embodiments, an imaging device 312 may be used to capture video, images, or other data associated with the entry of surgical tool 102 into the anatomical element 304, which data from the imaging device 312 may be viewed by the surgeon to determine the location of the surgical tool 102 within the anatomical element 304.

[0072] Fig. 4 is a flowchart of a method 400 for repairing one or more vertebral bodies using one or more surgical tools according to at least one embodiment of the present disclosure.

[0073] While a general order for the steps of the method 400 is shown in Fig. 4, the method 400 can include more or fewer steps or can arrange the order of the steps differently than those shown in Fig. 4. Generally, the method 400 starts with a START operation at step 404 and ends with an END operation at step 428. The method 400 can be executed as a set of computer-executable instructions executed by an assembly machine (e.g., robotic assembly system, automation assembly system, computer aided drafting (CAD) machine, etc.) and encoded or stored on a computer readable medium. Hereinafter, the method 400 shall be explained with reference to the components, devices, assemblies, environments, etc. described in conjunction with Figs. 1-3.

[0074] The method 400 may begin with the START operation at step 404 and proceed to step 408 where an inflatable balloon tamp (IBT) having a curved distal end is inserted through a substantially straight access cannula. The IBT includes a withdrawal tube extending slightly beyond the distal end of the access cannula. The withdrawal tube, however, does not extend over the curved distal end of the IBT. After the IBT having the curved distal end and the withdrawal tube is inserted through a substantially straight access cannula at step 408, method 400 proceeds to step 412, where a balloon of the IBT is inflated. After the balloon of the IBT is inflated at step 412, method 400 proceeds to step 416, where the balloon of the IBT is deflated. After the balloon of the IBT is deflated at step 416, method 400 proceeds to step 420, where the withdrawal tube is extended beyond the curved distal end of the IBT. According to an alternative embodiment of the present disclosure, the withdrawal tube is extended over the deflated balloon of the IBT, partially or totally. After the withdrawal tube is extended beyond the curved distal end of the IBT or over the deflated balloon of the IBT, partially or totally, at step 420, method 400 proceeds to step 424, where the deflated balloon together with the withdrawal tube is withdrawn through the access cannula, when the withdrawal tube is extended beyond thecurved distal end of the IBT or over the deflated balloon of the IBT, partially or totally. After the deflated balloon is withdrawn through the access cannula, when the withdrawal tube is extended beyond the curved distal end of the IBT or over the deflated balloon of the IBT, partially or totally at step 424, method 400 ends with the END operation at step 428.

[0075] The present disclosure encompasses embodiments of the method 400 that comprise more or fewer steps than those described above, and / or one or more steps that are different than the steps described above, which may include additional surgical tools.

[0076] As noted above, the present disclosure encompasses methods with fewer than all of the steps identified in Fig. 4 (and the corresponding description of the method 400), as well as methods that include additional steps beyond those identified in Fig. 4 (and the corresponding description of the method 400). The present disclosure also encompasses methods that comprise one or more steps from one method described herein, and one or more steps from another method described herein. Any correlation described herein may be or comprise a registration or any other correlation.

[0077] The foregoing is not intended to limit the disclosure to the form or forms disclosed herein. In the foregoing Detailed Description, for example, various features of the disclosure are grouped together in one or more aspects, embodiments, and / or configurations for the purpose of streamlining the disclosure. The features of the aspects, embodiments, and / or configurations of the disclosure may be combined in alternate aspects, embodiments, and / or configurations other than those discussed above. This method of disclosure is not to be interpreted as reflecting an intention that the claims require more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive aspects lie in less than all features of a single foregoing disclosed aspect, embodiment, and / or configuration. Thus, the following claims are hereby incorporated into this Detailed Description, with each claim standing on its own as a separate preferred embodiment of the disclosure.

[0078] Moreover, though the foregoing has included description of one or more aspects, embodiments, and / or configurations and certain variations and modifications, other variations, combinations, and modifications are within the scope of the disclosure, e.g., as may be within the skill and knowledge of those in the art, after understanding the present disclosure. It is intended to obtain rights which include alternative aspects, embodiments, and / or configurations to the extent permitted, including alternate, interchangeable and / or equivalent structures, functions, ranges or steps to those claimed, whether or not suchalternate, interchangeable and / or equivalent structures, functions, ranges or steps are disclosed herein, and without intending to publicly dedicate any patentable subject matter.

Claims

CLAIMSWhat is claimed is:

1. A device, comprising: an access cannula having a proximal end and a distal end; an inflatable balloon tamp (IBT) deployable through the access cannula and extending beyond the distal end of the access cannula; and a withdrawal tube integrally formed with the IBT and deployable beyond the distal end of the access cannula, wherein the withdrawal tube is further deployable at least partially around the IBT to provide a buffer between the distal end of the access cannula and a distal end of the IBT as the IBT is retracted through the access cannula.

2. The device according to claim 1, wherein the withdrawal tube is partially exposed through the access cannula while the IBT is being pushed beyond the distal end of the access cannula.

3. The device according to any preceding claim, wherein a distal end of the IBT has one or more curved portions and the distal end of the access cannula has a straight portion.

4. The device according to any preceding claim, wherein the withdrawal tube is maintained within the access cannula while the IBT is being pushed beyond the distal end of the access cannula.

5. The device according to any preceding claim, wherein the withdrawal tube is radially expandable at its distal end to accommodate the distal end of the IBT including a balloon.

6. The device according to any preceding claim, wherein the withdrawal tube is made of a material that is harder and / or stiffer than a material from which a shaft portion of the IBT is made.

7. The device according to any preceding claim, wherein the withdrawal tube includes a handle provided at a proximal end of the withdrawal tube.

8. The device according to claim 7, wherein the handle includes a locking mechanism configured to lock the handle in an initial state or a withdrawn state.

9. The device according to claim 7 or 8, wherein the handle is pushed distally such that the withdrawal tube covers the one or more curved portions of the distal end of the IBT prior to the IBT being removed from the access cannula.

10. The device according to claim 9, wherein the one or more curved portions of the distal end of the IBT is straightened by the distal end of the withdrawal tube prior to the IBT being removed from the access cannula.

11. A method, comprising: inserting an inflatable balloon tamp (IBT) having a curved distal end and a withdrawal tube integrally formed with the IBT through a substantially straight access cannula; inflating a balloon of the IBT; deflating the balloon; extending the withdrawal tube beyond the curved distal end of the IBT; and withdrawing the IBT with the deflated balloon and the withdrawal tube through the access cannula, when the withdrawal tube is extended beyond the curved distal end of the IBT .

12. The method according to claim 11, further comprising partially exposing the withdrawal tube through the access cannula while the IBT is being pushed beyond the distal end of the access cannula.

13. The method according to claim 11 or 12, further comprising maintaining the withdrawal tube within the access cannula while the IBT is being pushed beyond the distal end of the access cannula.

14. The method according to any of claims 11 thru 13, further comprising pushing a handle of the withdrawal tube distally such that the withdrawal tube covers the curved distal end of the IBT prior to the IBT being removed from the access cannula.

15. The method according to any of claims 11 thru 14, further comprising straightening, by a distal end of the withdrawal tube, the curved distal end of the IBT prior to the IBT being removed from the access cannula.

16. The method according to any of claims 11 thru 15, wherein the withdrawal tube includes a handle and further comprising locking the handle in an initial state or a withdrawn state.

17. The method according to any of claim 11 thru 16, wherein the withdrawal tube is made of a material that is harder and / or stiffer than a material from which a shaft portion of the IBT is made.

18. A system configured to perform kyphoplasty on a bone structure, the system comprising:an access cannula configured for penetrating into the bone structure, the access cannula having a proximal end and a distal end; an inflatable balloon tamp (IBT) deployable through the access cannula and extending beyond the distal end of the access cannula into the bone structure; and a withdrawal tube integrally formed with the IBT and deployable beyond the distal end of the access cannula, wherein the withdrawal tube is further deployable at least partially around the IBT to provide a buffer between the distal end of the access cannula and a distal end of the IBT as the IBT is retracted through the access cannula.

19. The system according to claim 18, wherein a distal end of the IBT has one or more curved portions and the distal end of the access cannula has a straight portion.

20. The system according to claim 18 or 19, wherein the withdrawal tube is maintained within the access cannula while the IBT is being pushed beyond the distal end of the access cannula.

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