Over the wire inflatable balloon TAMP for unipedicular balloon kyphoplasty

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, a guidewire, wherein a distal end of the guidewire is inserted through the proximal end of the access cannula into a vertebral body, and an inflatable balloon tamp (IBT), wherein the IBT is fed on a proximal end of the guidewire and into the vertebral body.

Description

OVER THE WIRE INFLATABLE BALLOON TAMPFOR UNIPEDICULAR BALLOON KYPHOPLASTYBACKGROUND

[0001] The present disclosure is generally directed to surgical tools and relates more particularly to surgical tools capable of repairing vertebral bodies.BRIEF SUMMARY

[0002] Example aspects of the present disclosure include:

[0003] 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, a guidewire having a distal end, wherein the distal end of the guidewire is inserted through a proximal end of the access cannula into a vertebral body, and an inflatable balloon tamp (IBT), wherein the IBT is fed on a proximal end of the guidewire and into the vertebral body.

[0004] Any of the aspects herein, wherein the distal end of the guidewire includes an attachment mechanism that fixates the distal end of the guidewire to an internal portion of the vertebral body.

[0005] Any of the aspects herein, wherein a proximal end of the guidewire includes an attachment mechanism that attaches the guidewire to the proximal end of the access cannula.

[0006] Any of the aspects herein, wherein the guidewire comprises a pre-curved nitinol wire.

[0007] Any of the aspects herein, wherein the distal end of the access cannula has a straight portion.

[0008] Any of the aspects herein, wherein the IBT is coaxial straight relative to a straight portion of the access cannula during removal.

[0009] Any of the aspects herein, wherein once inserted, the distal end of the guidewire sits approximately symmetrically across a midline of the vertebral body.

[0010] Any of the aspects herein, wherein the distal end of the guidewire is curved.

[0011] Any of the aspects herein, wherein the distal end of the guidewire is positioned in a curved placement inside the vertebral body.

[0012] Any of the aspects herein, wherein the guidewire is inserted through the access cannula while fixated to a path creation tool (PCT).

[0013] A method for kyphoplasty on a bone structure according to at least one embodiment of the present disclosure includes inserting a guidewire through a proximal end of an access cannula into aportion of an anatomy, inserting an inflatable balloon tamp (IBT), wherein the IBT is inserted over the guidewire, inflating a balloon of the IBT, deflating the balloon of the IBT, removing the IBT, and removing the guidewire through the access cannula.

[0014] 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, a guidewire, wherein the guidewire is inserted through a proximal end of the access cannula and extends beyond the distal end of the access cannula into a bone structure, and an inflatable balloon tamp (IBT) deployable over the guidewire into the body structure.

[0015] Any aspect in combination with any one or more other aspects.

[0016] Any one or more of the features disclosed herein.

[0017] Any one or more of the features as substantially disclosed herein.

[0018] Any one or more of the features as substantially disclosed herein in combination with any one or more other features as substantially disclosed herein.

[0019] Any one of the aspects / features / embodiments in combination with any one or more other aspects / features / embodiments.

[0020] Use of any one or more of the aspects or features as disclosed herein.

[0021] 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.

[0022] The details of one or more aspects of the disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the techniques described in this disclosure will be apparent from the description and drawings, and from the claims.

[0023] 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 Xl-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).

[0024] 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.

[0025] 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.

[0026] 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, a guidewire, wherein a distal end of the guidewire is inserted through the proximal end of the access cannula into a vertebral body, and an inflatable balloon tamp (IBT), wherein the IBT is fed on a proximal end of the guidewire and into the vertebral body. 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

[0027] 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 used and 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.

[0028] Figs. 1 A-C illustrate various views of components of a surgical assembly according to at least one embodiment of the present disclosure;

[0029] Fig. 2 is a diagram depicting components of a surgical assembly entering an anatomical element according to at least one embodiment of the present disclosure;

[0030] Figs. 3 A-B illustrate a guidewire according to at least one embodiment of the present disclosure;

[0031] Figs. 4A-D illustrate steps of a method according to at least one embodiment of the present disclosure;

[0032] 4E illustrates an x-ray testing of the surgical assembly according to at least one embodiment of the present disclosure; and

[0033] Fig. 5 is a flowchart according to at least one embodiment of the present disclosure.DETAILED DESCRIPTION

[0034] It should be understood that various aspects disclosed herein may be combined in different combinations than the combinations specifically presented in the description and accompanying drawings. It should also be understood that, depending on the example or embodiment, certain acts or events of any of the processes or methods described herein may be performed in a different sequence, and / or may be added, merged, or left out altogether (e.g., all described acts or events may not be necessary to carry out the disclosed techniques according to different embodiments of the present disclosure). In addition, while certain aspects of this disclosure are described as being performed by a single module or unit for purposes of clarity, it should be understood that the techniques of this disclosure may be performed by a combination of units or modules associated with, for example, a computing device and / or a medical device.

[0035] In one or more examples, the described methods, processes, and techniques may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functions may be stored as one or more instructions or code on a computer-readable medium and executed by a hardware-based processing unit. Alternatively or additionally, functions may be implemented using machine learning models, neural networks, artificial neural networks, or combinations thereof (alone or in combination with instructions). Computer-readable media may include non-transitory computer-readable media, which corresponds to a tangible medium such as data storage media (e.g., RAM, ROM, EEPROM, flash memory, or any other medium that can be used to store desired program code in the form of instructions or data structures and that can be accessed by a computer).

[0036] Instructions may be executed by one or more processors, such as one or more digital signal processors (DSPs), general purpose microprocessors (e.g., Intel Core i3, i5, i7, or i9 processors; Intel Celeron processors; Intel Xeon processors; Intel Pentium processors; AMD Ryzen processors; AMD Athlon processors; AMD Phenom processors; Apple A10 or 10X Fusion processors; Apple Al l, A12, A12X, A12Z, or A13 Bionic processors; or any other general purpose microprocessors),graphics processing units (e.g., Nvidia GeForce RTX 2000-series processors, Nvidia GeForce RTX 3000-series processors, AMD Radeon RX 5000-series processors, AMD Radeon RX 6000-series processors, or any other graphics processing units), application specific integrated circuits (ASICs), field programmable logic arrays (FPGAs), or other equivalent integrated or discrete logic circuitry. Accordingly, the term “processor” as used herein may refer to any of the foregoing structure or any other physical structure suitable for implementation of the described techniques. Also, the techniques could be fully implemented in one or more circuits or logic elements.

[0037] 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 herein is 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.

[0038] 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.

[0039] 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 (BKP) is a minimally invasive bone-related surgical procedure designed to repair vertebral compression fractures (VCFs) by reducing and stabilizing the fractures, relieving pain, and potentially restoring vertebral body height.

[0040] Conventional balloon kyphoplasty (e.g., bi-pedicular BKP) 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 (IBT), or ballon is guided through each access cannula into the fractured vertebra. Each of the balloons for the corresponding IBT iscarefully 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 compacts bone around the void, and reduces the fracture of the vertebra and pushes endplates of the vertebrae apart, thereby partially restoring the vertebral height and correcting angular deformity.

[0041] 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 may be filled with bone cement forming an internal cast to support the surrounding bone and prevent further collapse.

[0042] A unipedicular balloon kyphoplasty procedure has been introduced that reduces the number of incisions incurred by the patient. The unipedicular balloon kyphoplasty is performed through access via a single pedicle of the vertebra, thus requiring only one incision. A single balloon is positioned across or approximately across the vertebral body midline. In unipedicular approaches it is crucial to be able to place the balloon symmetrically across the midline of the vertebral body in order to safely create a uniform void in the middle of the vertebral body. Due to the need for placement of the balloon symmetrically across the midline of the vertebral body, a guidewire, which may be curved or positioned in a curved placement inside the vertebral body, ensures that the IBT can be placed through a straight access cannula and then be positioned about the midline of the vertebral body.

[0043] In embodiments, the guidewire may be attached to a path creation tool (PCT), thus being placed inside the vertebral body at the same time that the channel is created. The user may then release the guidewire via some mechanism in the path creation tool, and remove the tool while leaving the guidewire in place in a curved position across the midline. In other embodiments, the guidewire is placed after a channel has been created in the bone using the PCT, the guidewire is placed down the access cannula and along the channel created in the bone. Whether the guidewire is placed simultaneously with the PCT or after the channel is created, the guidewire is placed such that is sits symmetrically or approximately symmetrically across the midline of the vertebral body in an ideal position for balloon placement. The IBT is then fed onto the guidewire and inserted through the access cannula, following the guidewire as it exits the distal end of the access cannula into the vertebral body until it is positioned in the desired location. This will allow for a reliable and consistent balloon placement. In embodiments, the guidewire comprises a pre-curved guidewire, made of e.g. nitinol.

[0044] At this point, the guidewire could be removed. The balloon is inflated and a void is created inside the vertebral body. As there is no internal stiffness from the guidewire after deflation, the IBTis very flexible which will allow for an easy and safe withdrawal of the IBT through the access cannula.

[0045] According to at least one embodiment of the present disclosure, systems and methods utilize an over the wire IBT for unipedicular balloon kyphoplasty procedures. Embodiments of the present disclosure provide technical solutions to one or more of the problems of (1) placement of a ballon in unipedicular balloon kyphoplasty procedures; (2) withdrawing of the ballon along an access path from a target surgical site of a subject during surgery, and (3) reducing or eliminating the possibility of an inflatable structure being caught / snagged on the access cannula during removal.

[0046] 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 assembly 106 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.

[0047] 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. A trocar 132 may attach to the access cannula handle 120. 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). 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 trocar 132 attached to the top of the access cannula handle 120 such that the distal end 118 enters the vertebra. The trocar 132 includes a solid stainless steel stylet which is internal to the access cannula tube 124 and includes a sharp tip.

[0048] 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 (Fig. 2), a guidewire 301 is inserted into the access cannula. The surgical tool 102 may be inserted over the guidewire 301 and passed through a hollow portion of the access cannula assembly 106 through access cannula handle 120 and the access cannula tube 124 to permit the surgical tool 102 to access the target surgical site. After thetarget surgical site has been reached (e.g., the interior of the vertebra) by the surgical tool 102, balloon kyphoplasty may be performed.

[0049] 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.

[0050] Fig. IB illustrates a cross-sectional view (A- A) of the inflatable structure 150. The inflatable structure 150 has an internal lumen 151 that allows the IBT insertion over the guidewire 301, an inner shaft 152 and an outer shaft 153.

[0051] Fig. 1C is another view of a surgical tool 102. Surgical tool 102 further includes an EZ prep valve 154, a Luer cap 155, a locking Luer 156 and a Y-adapter 157.

[0052] 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.

[0053] 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 of the shaft 153 can be formed from a polymer, metal or any other material.

[0054] The guidewire 301 (shown in Fig. 3A) is inserted into the vertebral body through the access cannula tube 124 . The surgical tool 102 includes the inflatable structure 150 (also shown in Fig. 3B) in a relatively straight position. The inflatable structure 150 is inserted over the guidewire 301 (shown in Fig. 3B). According to an embodiment of the present disclosure, the guidewire 301 may have a curved distal end (as shown in Fig. 3 A) and once the inflatable balloon 150 is inserted over the guidewire 301, the inflatable balloon 150 follows the curve of the guidewire 301. Inembodiments, the guidewire 301 may have a straight distal end that is placed in a curved position inside the vertebral body. The guidewire 301 may 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.

[0055] Fig. 2 shows an illustrative method of accessing an anatomical element 204 according to at least one embodiment of the present disclosure. As illustrated in Fig. 2, a surgical instrument 208 (e.g., a surgical hammer, a surgical mallet, etc.) may be used by a physician to strike a trocar / bevel 132 mated to the access cannula handle 120 of the access cannula assembly 106, as illustrated by the arrow. By using the trocar / bevel 132, the access cannula tube 124 may be driven into the anatomical element 204 (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, including but not limited to extra pedicular access into the vertebral body.

[0056] Once the access cannula tube 124 is within the anatomical element 204, a guidewire 301 may be inserted through the access cannula tube 124 to the target surgical site. A surgical tool (e.g., a surgical tool 102 such as an IBT) may be inserted over the guidewire 301 and through the access cannula handle 120 and the access cannula tube 124 to interact with the target surgical site. For example, the surgical tool 102 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 212 may be used to capture video, images, x-rays, or other data associated with the entry of surgical tool 102 into the anatomical element 204, data from the imaging device 212 may be viewed by the surgeon to determine the location of the surgical tool 102 within the anatomical element 204 (Fig. 4E).

[0057] Fig. 5 is a flowchart of a method 500 for repairing one or more vertebral bodies using one or more surgical tools according to at least one embodiment of the present disclosure.

[0058] While a general order for the steps of the method 500 is shown in Fig. 5, the method 500 can include more or fewer steps or can arrange the order of the steps differently than those shown in Fig. 5. Generally, the method 500 starts with a START operation at step 504 and ends with an END operation at step 528. The method 500 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 500 shall be explained with reference to the components, devices, assemblies, environments, etc. described in conjunction with Figs. 4A-D.

[0059] The method 500 may begin with the START operation at step 504 and proceeds to step 508 where a guidewire is inserted through a substantially straight access cannula (e.g., Fig. 4A Step 1 A or Fig. 4A Step IB + Fig. 4B Step 2). After the guidewire is inserted through a substantially straight access cannula at step 508, method 500 proceeds to step 512, where an IBT is inserted through the access cannula and over the guidewire (e.g., Fig. 4B Step 3). In step 516, a balloon of the IBT is inflated (Fig. 4C Step 4). After the balloon of the IBT is inflated at step 516, method 500 proceeds to step 520, where the balloon of the IBT is deflated (e.g., Fig. 4C Step 5) and removed (e.g., Fig. 4D Step 6). After the balloon of the IBT is deflated at step 520, method 500 proceeds to step 524, where the guidewire is removed from the access cannula (e.g., Fig. 4D Step 7). Once the guidewire is removed in step 524, bone cement may be inserted to stabilize the bone structure.

[0060] The present disclosure encompasses embodiments of the method 500 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.

[0061] As noted above, the present disclosure encompasses methods with fewer than all of the steps identified in Figs. 4A-D and Fig. 5 (and the corresponding description of the method 500), as well as methods that include additional steps beyond those identified in Figs. 4A-DE and Fig. 5 (and the corresponding description of the method 500). 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.

[0062] 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.

[0063] 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 such alternate, interchangeable and / or equivalent structures, functions, ranges or steps are disclosed herein, and without intending to publicly dedicate any patentable subject matter.

[0064] The following clauses relate to the disclosure:

[0065] A device, comprising: an access cannula having a proximal end and a distal end; a guidewire having a distal end, wherein the distal end of the guidewire is inserted through a proximal end of the access cannula into a vertebral body; and an inflatable balloon tamp (IBT), wherein the IBT is fed on a proximal end of the guidewire and into the vertebral body.

[0066] 2 The device of clause 1, wherein the distal end of the guidewire includes an attachment mechanism that fixates the distal end of the guidewire to an internal portion of the vertebral body.

[0067] 3. The device of clause 1, wherein the proximal end of the guidewire includes an attachment mechanism that attaches the guidewire to the proximal end of the access cannula.

[0068] 4. The device of clause 1, wherein the guidewire comprises a pre-curved nitinol wire.

[0069] 5. The device of clause 1, wherein the distal end of the access cannula has a straight portion.

[0070] 6. The device of clause 5, wherein the IBT is coaxial straight relative to the straight portion of the access cannula during removal.

[0071] 7. The device of clause 1, wherein once inserted, the distal end of the guidewire sits approximately symmetrically across a midline of the vertebral body.

[0072] 8. The device of clause 1, wherein the distal end of the guidewire is curved.

[0073] 9. The device of clause 1, wherein the distal end of the guidewire is positioned in a curved placement inside the vertebral body.

[0074] 10. A method, comprising: inserting a guidewire through a proximal end of an access cannula into a portion of an anatomy; inserting an inflatable balloon tamp (IBT), wherein the IBT is inserted over the guidewire; inflating a balloon of the IBT; deflating the balloon of the IBT; removing the IBT; and removing the guidewire through the access cannula.

[0075] 11. The method of clause 10, wherein a distal end of the guidewire includes an attachment mechanism that fixates the distal end of the guidewire to an internal portion of the portion of the anatomy.

[0076] 12. The method of clause 10, wherein a proximal end of the guidewire includes an attachment mechanism that attaches the guidewire to the proximal end of the access cannula.

[0077] 13. The method of clause 10, wherein the guidewire comprises a pre-curved nitinol wire.

[0078] 14. The method of clause 10, wherein a distal end of the access cannula has a straight portion.

[0079] 15. The method of clause 14, wherein the IBT is coaxial straight relative to the straight portion of the access cannula during removal.

[0080] 16. The method of clause 10, wherein once inserted, a distal end of the guidewire sits approximately symmetrically across a midline of a vertebral body.

[0081] 17. The method of clause 10, wherein a distal end of the guidewire is curved.

[0082] 18. The method of clause 10, wherein a distal end of the guidewire is positioned in a curved placement inside the portion of the anatomy.

[0083] 19. 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; a guidewire, wherein the guidewire is inserted through the proximal end of the access cannula and extends beyond the distal end of the access cannula into the bone structure; and an inflatable balloon tamp (IBT) deployable over the guidewire into the bone structure.

[0084] 20. The system of clause 19, wherein a distal end of the guidewire includes an attachment mechanism that fixates the distal end of the guidewire to an internal portion of the bone structure.

[0085] 21. The system of clause 19, wherein a proximal end of the guidewire includes an attachment mechanism that attaches the guidewire to the proximal end of the access cannula.

[0086] 22. The system of clause 19, wherein the guidewire comprises a pre-curved nitinol wire.

[0087] 23. The system of clause 19, wherein the distal end of the access cannula has a straight portion, and, wherein the IBT is coaxial straight relative to the straight portion of the access cannula during removal.

[0088] 24. The system of clause 19, wherein once inserted a distal end of the guidewire sits approximately symmetrically across a midline of the bone structure.

[0089] 25. The system of clause 19, wherein a distal end of the guidewire is curved.

[0090] 26. The system of clause 19, wherein a distal end of the guidewire is positioned in a curved placement inside the bone.

[0091] 27. The device of clause 1, wherein the guidewire is inserted through the access cannula while fixated to a path creation tool (PCT).

[0092] 28. The method of clause 10, wherein the guidewire is inserted through the access cannula while fixated to a path creation tool (PCT).

[0093] 29. The system of clause 19, wherein the guidewire is inserted through the access cannula while fixated to a path creation tool (PCT).

Claims

CLAIMSWhat is claimed is:

1. A device, comprising: an access cannula having a proximal end and a distal end; a guidewire having a distal end, wherein the distal end of the guidewire is inserted through a proximal end of the access cannula into a vertebral body; and an inflatable balloon tamp (IBT), wherein the IBT is fed on a proximal end of the guidewire and into the vertebral body.2 The device of claim 1, wherein the distal end of the guidewire includes an attachment mechanism that fixates the distal end of the guidewire to an internal portion of the vertebral body.3 The device of any of the preceding claims, wherein the proximal end of the guidewire includes an attachment mechanism that attaches the guidewire to the proximal end of the access cannula.4 The device of any of the preceding claims, wherein the guidewire comprises a pre-curved nitinol wire.5 The device of any of the preceding claims, wherein the distal end of the access cannula has a straight portion.6 The device of claim 5, wherein the IBT is coaxial straight relative to the straight portion of the access cannula during removal.7 The device of any of the preceding claims, wherein once inserted, the distal end of the guidewire sits approximately symmetrically across a midline of the vertebral body.8 The device of any of the preceding claims, wherein the distal end of the guidewire is curved.

9. The device of any of the preceding claims, wherein the distal end of the guidewire is positioned in a curved placement inside the vertebral body.

10. A method, comprising: inserting a guidewire through a proximal end of an access cannula into a portion of an anatomy; inserting an inflatable balloon tamp (IBT), wherein the IBT is inserted over the guidewire; inflating a balloon of the IBT; deflating the balloon of the IBT; removing the IBT; and removing the guidewire through the access cannula.

11. The method of claim 10, wherein a distal end of the guidewire includes an attachment mechanism that fixates the distal end of the guidewire to an internal portion of the portion of the anatomy.

12. The method of any of the claims 10 or 11, wherein a proximal end of the guidewire includes an attachment mechanism that attaches the guidewire to the proximal end of the access cannula.

13. The method of any of the claims 10 to 12, wherein the guidewire comprises a pre-curved nitinol wire.

14. The method of any of the claims 10 to 13, wherein a distal end of the access cannula has a straight portion.

15. The method of claim 14, wherein the IBT is coaxial straight relative to the straight portion of the access cannula during removal.

16. The method of any of the claims 10 to 15, wherein once inserted, a distal end of the guidewire sits approximately symmetrically across a midline of a vertebral body.

17. The method of any of the claims 10 to 16, wherein a distal end of the guidewire is curved.

18. The method of any of the claims 10 to 17, wherein a distal end of the guidewire is positioned in a curved placement inside the portion of the anatomy.

19. 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; a guidewire, wherein the guidewire is inserted through the proximal end of the access cannula and extends beyond the distal end of the access cannula into the bone structure; and an inflatable balloon tamp (IBT) deployable over the guidewire into the bone structure.

20. The system of claim 19, wherein a distal end of the guidewire includes an attachment mechanism that fixates the distal end of the guidewire to an internal portion of the bone structure.

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