Systems and devices for inflatable bone TAMP procedures and methods of manufacturing the same

Abstract

A surgical tool for performing a surgical procedure includes a first tube having a first lumen through which a first material flows, and a second tube fitted over the first tube. A region between the first tube and the second tube defines a second lumen through which a second material flows. The surgical tool further includes a balloon attached to a distal end of the second tube and a distal end of the first tube and is configured to be inflated with the second material through the second lumen.

Description

SYSTEMS AND DEVICES FOR INFLATABLE BONE TAMP PROCEDURES ANDMETHODS OF MANUFACTURING THE SAMEBACKGROUND

[0001] The present disclosure is generally directed to surgical tools and relates more particularly to surgical tools capable of repairing bone, such as vertebral bodies.

[0002] Surgical robots may assist a surgeon or other medical provider in carrying out a surgical procedure or may complete one or more surgical procedures autonomously. Providing controllable linked articulating members allows a surgical robot to reach areas of a patient anatomy during various medical procedures.BRIEF SUMMARY

[0003] Example aspects of the present disclosure include: A surgical tool for performing a surgical procedure, comprising: a first tube having a first lumen through which a first material flows; a second tube fitted over the first tube, wherein a region between the first tube and the second tube defines a second lumen through which a second material flows; and a balloon attached to a distal end of the second tube and a distal end of the first tube and configured to be inflated with the second material through the second lumen.

[0004] Any of the aspects herein, wherein the distal end of the first tube comprises a sharp tip for penetrating bone.

[0005] Any of the aspects herein, wherein the distal end of the first tube comprises one or more openings through which the first material flows.

[0006] Any of the aspects herein, wherein the one or more openings are located between the tip and the balloon.

[0007] Any of the aspects herein, further comprising: an adapter attached to the first tube and the second tube and including a first port through which the first material is injected into the first lumen and a second port through which the second material is injected into the second lumen.

[0008] Any of the aspects herein, wherein the first port comprises a luer-lock connection.

[0009] Any of the aspects herein, wherein the second port comprises a luer-lock connection and a valve.

[0010] Any of the aspects herein, wherein the distal end of the first tube comprises a tip with an opening.

[0011] Any of the aspects herein, further comprising: a removable mandrel insertable into the first tube and comprising a sharp tip for penetrating bone that passes through the opening.

[0012] Any of the aspects herein, wherein the first material is enabled to flow through the opening when the mandrel is removed from the first tube.

[0013] Any of the aspects herein, wherein the first tube is made of a semi-rigid material.

[0014] Any of the aspects herein, wherein the semi-rigid material comprises nitinol.

[0015] Any of the aspects herein, wherein the distal ends of the first tube and the second tube have a curved state and are flexible into a straightened state.

[0016] Any of the aspects herein, wherein the first tube is made of a material that enables the curved state and the straightened state, and wherein the second tube is made of a material conforms to a curvature of the first tube.

[0017] Any of the aspects herein, wherein the second tube is made of polyurethane.

[0018] Example aspects of the present disclosure include: A surgical assembly for performing a surgical procedure, comprising: a surgical tool, comprising: a first tube having a first lumen through which a first material flows; a second tube fitted over the first tube, wherein a region between the first tube and the second tube defines a second lumen through which a second material flows; and a balloon attached to a distal end of the second tube and a distal end of the first tube and configured to be inflated with the second material through the second lumen; and an access cannula assembly through which the surgical tool is inserted during the surgical procedure.

[0019] Any of the aspects herein, wherein the access cannula assembly comprises a tip for penetrating hard tissue, soft tissue, or both.

[0020] Any of the aspects herein, wherein the first tube comprises a sharp tip for penetrating bone and one or more openings for distributing the first material into a void created by the balloon.

[0021] Any of the aspects herein, wherein the second lumen is dimensioned such that the second material is enabled to be withdrawn from the balloon within a predetermined deflation time period.

[0022] Example aspects of the present disclosure include: A method for manufacturing a surgical tool for performing a surgical procedure, the method comprising: inserting a first tube made of a first material into a second tube made of a second material; attaching a proximal end of the first tube and a proximal end of the second tube to an adapter configured to provide a first material to a lumen of the first tube and a second material to a lumen of the second tube; attaching a proximal end of a balloon to a distal end of the second tube to create a seal between the second tube and the balloon; and attaching a distal end of the balloon to a distal end of the first tube to create a seal between the first tube and the balloon, wherein the lumen of the second tube is defined by a region between an outer surface of the first tube and an inner surface of the second tube, and wherein the balloon is configured to be inflated with the second material through the lumen of the second tube.

[0023] Any aspect in combination with any one or more other aspects.

[0024] Any one or more of the features disclosed herein.

[0025] Any one or more of the features as substantially disclosed herein.

[0026] Any one or more of the features as substantially disclosed herein in combination with any one or more other features as substantially disclosed herein.

[0027] Any one of the aspects / features / embodiments in combination with any one or more other aspects / features / embodiments.

[0028] Use of any one or more of the aspects or features as disclosed herein.

[0029] 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.

[0030] 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.

[0031] 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).

[0032] 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.

[0033] 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.

[0034] A surgical tool for performing a surgical procedure includes a first tube having a first lumen through which a first material flows, and a second tube fitted over the first tube. A region between the first tube and the second tube defines a second lumen through which a second material flows. The surgical tool further includes a balloon attached to a distal end of the second tube and a distal end of the first tube and is configured to be inflated with the second material through the second lumen. 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 DRAWINGS

[0035] 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.

[0036] Fig. 1 A is a view of components of a surgical assembly according to at least one embodiment of the present disclosure.

[0037] Fig. IB illustrates a closeup view of the distal end of the surgical tool in Fig. 1 A and various cross-sectional views taken at different points along the surgical tool according to at least one embodiment of the present disclosure.

[0038] Fig. 1C illustrates views of a surgical tool, which differs from the surgical tool in Figs. 1 A and IB, according at least one embodiment of the present disclosure.

[0039] Fig. ID illustrates views of a surgical tool, which differs from the surgical tools in Figs. 1 A to 1C, according to at least one embodiment of the present disclosure.

[0040] Fig. 2 is a flowchart of a method for manufacturing a surgical tool according to at least one embodiment of the present disclosure.DETAILED DESCRIPTION

[0041] 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 todifferent 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.

[0042] 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).

[0043] 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.

[0044] 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 mayuse 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.

[0045] 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.

[0046] 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.

[0047] Balloon kyphoplasty (BKP) typically involves a surgeon making one or more 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 balloon of the IBT reduces the fracture of the vertebra and pushes endplates of the vertebrae apart, thereby partially restoring the vertebral height and correcting angular deformity. 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.

[0048] In view of the above, BKP procedures and other procedures that utilize IBTs generally involve a number of discrete steps, which include path creation, void creation, and stabilization - some or all of which require separate tooling to complete each step. Indeed, related art techniques for inserting filler material into bone may utilize separate tools which are inserted and removed through a cannula throughout the surgery. For example, a cannula may be inserted into an incision that leads to a region of interest and a shaft with a sharpened tip may be passed through the cannula to penetrate the region of interest (i.e., path creation). Thereafter, the shaft is removed from the cannula to make way for an IBT device that is inserted through the cannula and inflated and deflated to create the void (i.e., void creation). The IBT device may then beremoved from the cannula and a filler material may be injected into the void through another tube inserted into the cannula (i.e., stabilization). As may be appreciated, the use of multiple tools that need to be sterilized adds time, complexity, and cost to the procedure.

[0049] At least one embodiment of the present disclosure provides “all-in-one” surgical tool for conducting a BKP procedure or other similar procedures that involve IBTs. For path creation, the surgical tool may include an inner lumen defined by a tube having a sharp tip. For void creation, the surgical tool may comprise a balloon bonded to the inner lumen and to an outer sheath which is fitted over the inner lumen- the balloon may be inflated through an outer lumen that is defined by a region between the inner lumen and the outer sheath by injecting inflation material into one of the ports on a y-adapter of the surgical tool. For stabilization, bone cement may be injected through the inner lumen using another port on the y-adapter. Holes at the distal end of the tube that defines the inner lumen allow for the cement to dispense into the vertebral body. As may be appreciated, the surgical tool is “all-in-one” in that a single tool is used for path creation, void creation, and stabilization.

[0050] In one embodiment, a removable mandrel incorporates the sharp tip for path creation instead of the inner lumen having the sharp tip. The mandrel can then be removed post voidcreation to allow for bone cement to be injected through the inner lumen for stabilization.

[0051] As may be appreciated, a surgical tool according to embodiments of the present disclosure may significantly reduce the procedure time for BKP procedures, significantly reduce exposure to radiation, and / or provide an easier procedure to physicians so that the procedure can be performed by more junior doctors. Thus, it may be said that embodiments of the present disclosure provide technical solutions to problems associated with (1) using multiple sterilized tools throughout the procedure, (2) the time required to conduct the procedure due to using multiple tools, and (3) the increased complexity and / or risk of the procedure to the patient.

[0052] 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 (BKP) or other similar procedure that involves an IBT at the surgical site. The surgical assembly 100 includes a surgical tool 102 and an access cannula assembly 106. The access cannula assembly 106 has a proximal end 114 and 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. 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 holdthe 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 patient). In some embodiments of the present disclosure, the access cannula tube 124 may include a trocar (not shown) or sharp tip 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) soft tissue (e.g., muscle) and / or hard tissue (e.g., bone).

[0053] 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 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, the surgical tool 102 may be used to perform balloon kyphoplasty.

[0054] The surgical tool 102 has a proximal end 104 and 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 102 positioned closer to the target surgical site and further away from the physician. The surgical tool 102 includes a section 153 that is inserted into the access cannula assembly 106. A balloon 150 or other suitable inflatable structure is at the distal end 108 of the surgical tool 102 and an adapter 115, comprising first and second ports 116 and 117, is at the proximal end 104 of the surgical tool 102. The adapter 115 is depicted as a “Y” adapter with two fittings or ports 116 and 117, but the adapter 116 can take any suitable shape or form. As discussed in more detail below, the surgical tool 102 comprises two hollow tubes, with one fitted over the other, and enables inflation and deflation of the balloon 150 through one tube to create a cavity within anatomical tissue and injection of a material into the cavity through the other tube. In this case, the adapter 115 is bonded, adhered, or otherwise attached the two tubes, and the adapter 115 comprises a first port 116 through which a first material is injected into a first lumen of a first tube and a second port 117 through which a second material is injected into a second lumen of a second tube. As shown in Fig. 1 A, the first port 116 may comprise a luer-lock connector 122 for attaching to a source (not shown) of the first material, which may be bone cement. Meanwhile, the second port 117 may comprise a luer-lock connector 121 for attachment to a source (not shown) of the second material. The second port 117 may also comprise a valve 119 (e.g., an EZ- prep valve) that controls flow of the second material from the source. The second material maybe used to inflate the balloon 150 before being withdrawn (e.g., by a pump or vacuum) from the surgical tool 102 to deflate the balloon 150.

[0055] The balloon 150 may be formed from any type of inflatable material, including non- compliant materials (e.g., nylon and polyethylene materials), semi-compliant materials (e.g., polyurethane materials), compliant materials (e.g., latex rubber), or any combination thereof. The balloon 150 may have any suitable size / shape. While a dual-lobed (“peanut shaped”) configuration is depicted for exemplary purposes, in various other embodiments of the present disclosure, the balloon 150 can be ovoid, spheroid, cylindrical, or any other suitable shape. In various other embodiments of the present disclosure, the balloon 150 and / or tubes within the section 153 can include radiopaque elements, markings, coatings, and / or patterns to facilitate visualization and / or positioning under fluoroscopic imaging. The balloon 150 shown in the figures is in a deflated state but may be inflated with a material to grow in volume by, for example, 25% to 75% compared to the deflated volume. It should be appreciated that the balloon 150 in the deflated state is sized to pass all the way through the access canula assembly 106 to reach the target surgical site. In addition, the balloon 150 may be formed of a material of sufficient durability to withstand forces experienced during the procedure, such as forces experienced when creating a path within anatomical tissue using the sharp tip 132 of the first tube 130.

[0056] Fig. IB illustrates a closeup view of the distal end 108 of the surgical tool 102 and various cross-sectional views taken at different points along the surgical tool 102 according to at least one embodiment of the present disclosure. Fig. 1C illustrates views of a surgical tool 102a, which differs from the surgical tool 102 in Figs. 1 A and IB in that the distal end 108 of the surgical tool 102a comprises a curved portion, which may flex into a straightened state when the surgical tool 102a is passed through the access cannula assembly 106 and return to the curved state upon exiting the distal end 118 of the access cannula assembly 106 at or near the target surgical site. Fig. ID illustrates views of a surgical tool 102b, which differs from the surgical tools in Figs. 1 A to 1C in that the surgical tool 102b in Fig. ID is constructed to utilize a removable mandrel 170. As may be appreciated, the same or similar access cannula assembly 106 may be used for any of the surgical tools shown and described herein.

[0057] With reference to Fig. IB, the surgical tool 102 may comprise a first tube 130 having a first lumen LI through which a first material flows. In some examples, the first material corresponds to bone cement or other suitable filler material used in BKP procedures to stabilize part of an anatomy such as bone. The lumen LI may have a substantially same diameter along an entire length of the first tube 130, or at least to the connection of the first tube 130 to the adapter 115. Stated another way, an inner diameter of the first tube 130 may be substantially the samealong the length of the first tube 130. In some examples, the first tube 130 is made of a semi-rigid material that has a stiffness suitable for the application. For example, the first tube 130 may be formed of stainless steel, nitinol, multiple layers of different materials, including braided materials, or any other desired construction and composition that can penetrate hard and / or soft anatomical tissue.

[0058] As shown in Fig. IB and 1C, the distal end of the first tube 130 may comprise a sharp tip 132 for penetrating bone or other anatomical tissue. In some examples, and as shown in Figs. IB and 1C, the distal end of the first tube 130 comprises one or more openings 134 out of which the first material delivered through lumen LI flows into a space or void created by inflation and subsequent deflation of the balloon 150. The one or more openings 134 are located between the tip 132 and a distal end 158 of the balloon 150. The tip 132 may be shaped in any suitable manner and the number of openings 134 may vary according to design preference. In some examples, the tip 132 may comprise two slanted surfaces that connect to form a sharp point, as shown in Fig. IB. In other examples, the tip 132 may comprise a single slanted surface that forms a sharp point as shown in Fig. 1C.

[0059] The surgical tool 102 may further comprise a second tube 160 fitted over the first tube 130 (see Fig. 1C for a view of the second tube 160 (shown as being transparent) fitted over the first tube 130). As such, the second tube 160 may have a larger inner diameter than the first tube 130 at least over an entire length of the first tube 130. In some examples, the second tube 160 has a substantially same inner diameter along its entire length, at least to the connection to the adapter 115. As may be appreciated from cross-sections A and B, a region (e.g., a space or a region than can be expanded to create a space) between the first tube 130 and the second tube 160 defines a second lumen L2 through which a second material flows to inflate and deflate the balloon 150. The second material may comprise a material such as contrast solution, saline, and / or water.

[0060] As shown by the progression from cross-sectional view B to cross-sectional view C, the lumen L2 may terminate at the proximal end of the balloon 150. For example, the lumen L2 leads directly to a cavity 156 within a main body 152 of the balloon 150. Here, the cavity 156 has an inner diameter that is greater than the inner diameter of the lumen L2 along at least one portion of the cavity 156.

[0061] The lumen L2 is dimensioned to enable the inflow of the second material to inflate the balloon to occur within an inflation time period or inflation time range as well as to enable the outflow or withdrawal of the second material to deflate the balloon 150 to occur within a deflation time period or deflation time range. Here, the deflation time period or deflation time range may be more relevant for determining dimensions of the lumen L2 and / or material of thetube 160 because deflating the balloon 150 too slowly may adversely affect the cavity or void created by inflation of the balloon 150.

[0062] In some examples and as shown in Fig. IB, a width of the lumen L2 (shown with white space between tube 130 and tube 160) remains substantially constant around the tube 130 along the length of the second tube 160 during inflow and outflow of the second material. In other examples, the width of the lumen L2 varies depending on the presence or absence of the second material. For example, the second tube 160 may be made of a material that collapses in the absence of the second material such that the lumen L2 contracts and causes the width thereof to shrink (e.g., the width of the lumen L2 shrinks so that the tube 160 contacts or nearly contacts tube 130). In this case, the second tube 160 may then expand in the presence of the second material such that the width of the lumen L2 expands up to a maximum allowed width to allow the flow of the second material therethrough. Example materials of the second tube 160 include polyurethane, nylon, PEBAX®, polyether ether ketone (PEEK), high density polyethylene (HDPE), and / or braided materials.

[0063] As may be appreciated from cross-sections B and D in Fig. IB, the balloon 150 is attached to a distal end of the second tube 160 and a distal end of the first tube 130. For example, as shown in cross-section B, the proximal end 154 of the balloon 150 is bonded, adhered, or otherwise attached to an outer surface of the tube 160 to create a seal SI between the tube 160 and the proximal end 154 of the balloon 150. Meanwhile, as shown in cross-section D, the distal end 158 of the balloon 150 is bonded, adhered, or otherwise attached to an outer surface of tube 130 to create a seal S2 between the tube 130 and the distal end 158 of the balloon 150. As such, the second tube 160 may terminate at the proximal end 154 of the balloon 150. In addition and as a result of the above-described attachment of the balloon 150 to the surgical tool 102, an inner diameter of the proximal end 154 of the balloon 150 may be greater than an inner diameter of the distal end 158 of the balloon 150. Although not explicitly shown, the same attachment configuration of the balloon 150 to the surgical tool 102 is true for Figs. 1C and ID.

[0064] As noted above, Fig. 1C illustrates the surgical tool 102a where the distal end 108 has a curved state that is capable of flexing into a straightened state. The curved portions of the first tube 130 and the second tube 160 are flexed into straightened state for passing through the access cannula assembly 106 before returning to the curved state upon exiting the distal end 118 of the access cannula assembly 106. In some examples, then, the first tube 130 is made of a material (e.g., nitinol) that enables the curved state and the straightened state. In this case, the second tube 160 is made of a material (e.g., polyurethane) that conforms to a curvature of the first tube 130. Stated another way, the second tube 160 is made of a material that conforms to the curved andstraightened states of the first tube 130. Thus, the stiffness and / or rigidity of the first tube 130 may be greater than the stiffness and / or rigidity of the second tube 160.

[0065] As alluded to above, Fig. ID illustrates an example of a surgical tool 102b that utilizes a separate, removable mandrel or stylet 170, instead of a sharpened tip 132 of the first tube 130 as in Figs. IB and 1C. In this case, the distal end of the first tube 130 comprises a blunt tip 132a with an opening 134a. Here, the portion of the first tube 130 that creates the opening 134a may have a substantially flat surface to create the blunt tip 132a. During a BKP procedure or other procedure that utilizes IBTs, the mandrel 170 may be inserted into the first tube 130 and comprises a sharp tip that passes through the opening 134a to penetrate bone or other anatomical tissue. Upon reaching the target surgical site, the mandrel 170 may be removed from the first tube 130, which enables the first material (e.g., bone cement) to flow through the opening 134a into a space or void within bone created by inflation and subsequent deflation of the balloon 150. The mandrel 170 may be formed from stainless steel, nitinol, multiple layers of different materials, including braided materials, or any other desired construction and composition that can penetrate hard and / or soft anatomical tissue.

[0066] Here, it should be appreciated that one or more features from a figure in Figs. 1 A to ID may be combined with one or more other features from other figures in Figs. 1 A to ID, and that such modifications are within the scope of the present disclosure. For example, the mandrel 170 and opening 134a of Fig. ID may be used in an embodiment of a surgical tool that comprises a curved portion like in Fig. 1C.

[0067] In a BKP procedure or similar procedure on another area of a patient’s body besides the spine, the surgical tools 102, 102a, and / or 102b are utilized to complete the main steps of path creation, void creation, and stabilization. For example, the surgical tool may be inserted into the access cannula assembly 106 where a sharp tip of tube 130 is used to create a path to the target site. Thereafter, and without removing the surgical tool 102 from the access cannula assembly 106, the balloon 150 may be inflated and deflated through lumen L2 to create a void at the target site. Still further and still without removing the surgical tool 102 from the access cannula assembly, bone cement is injected into the lumen LI and flows out of openings 134 into the void to stabilize the target site and / or surrounding areas.

[0068] Fig. 2 is a flowchart of a method 200 for manufacturing a surgical tool 102, 102a, and / or 102b according to at least one embodiment of the present disclosure.

[0069] While a general order for the steps of the method 200 is shown in Fig. 2, the method 200 can include more or fewer steps or can arrange the order of the steps differently than those shown in Fig. 2. The method 200 can be executed by one or more machines on a production line. For example, the method 200 may be carried out by an assembly machine (e.g., robotic assemblysystem, automation assembly system, computer aided drafting (CAD) machine, etc.) and include instructions encoded or stored on a computer readable medium and executed by one or more processors. Hereinafter, the method 200 shall be explained with reference to the components, devices, assemblies, environments, etc. described in conjunction with Figs. 1 A to ID.

[0070] The method 200 may include inserting a first tube 130 made of a first material into a second tube 160 made of a second material (step 204). The method 200 may comprise attaching a proximal end of the first tube 130 and a proximal end of the second tube 160 to an adapter 115 configured to provide a first material to a lumen LI of the first tube 130 and a second material to a lumen of L2 the second tube 160 (step 208). As described herein, the first material may be bone cement that flows through lumen LI and the second material may comprise a suitable material for inflating and deflating the balloon 150 through lumen L2. The method 200 includes attaching a proximal end 154 of a balloon 150 to a distal end of the second tube 160 to create a seal SI between the second tube 160 and the balloon 150 (step 212). The method 200 also includes attaching a distal end 158 of the balloon 150 to a distal end of the first tube 130 to create a seal S2 between the first tube 130 and the balloon 150 (step 216). As may be appreciated, the lumen L2 of the second tube 160 is defined by a region between an outer surface of the first tube 130 and an inner surface of the second tube 160. In addition, the balloon 150 is configured to be inflated with the second material through the lumen L2 of the second tube 160 - with leakage of the second material being prevented by the seals SI and S2.

[0071] In general, the above described attaching steps may involve a suitable attachment technique, such as curing (heat or ultraviolet), and / or may utilize suitable attachment materials such as adhesives for medical devices.

[0072] It should be appreciated that the present disclosure encompasses methods with fewer than all of the steps identified in Fig. 2 (and the corresponding description of the method 200), as well as methods that include additional steps beyond those identified in Fig. 2 (and the corresponding description of the method 200). 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.

[0073] 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, asthe 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.

[0074] 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.

[0075] Example aspects of the present disclosure include:(1) A surgical tool for performing a surgical procedure, comprising: a first tube having a first lumen through which a first material flows; a second tube fitted over the first tube, wherein a region between the first tube and the second tube defines a second lumen through which a second material flows; and a balloon attached to a distal end of the second tube and a distal end of the first tube and configured to be inflated with the second material through the second lumen.(2) The surgical tool of (1), wherein the distal end of the first tube comprises a sharp tip for penetrating bone.(3) The surgical tool of one or more of (1) to (2), wherein the distal end of the first tube comprises one or more openings through which the first material flows.(4) The surgical tool of one or more of (1) to (3), wherein the one or more openings are located between the tip and the balloon.(5) The surgical tool of one or more of (1) to (4), further comprising: an adapter attached to the first tube and the second tube and including a first port through which the first material is injected into the first lumen and a second port through which the second material is injected into the second lumen.(6) The surgical tool of one or more of (1) to (5), wherein the first port comprises a luer-lock connection.(7) The surgical tool of one or more of (1) to (6), wherein the second port comprises a luer- lock connection and a valve.(8) The surgical tool of one or more of (1) to (7), wherein the distal end of the first tube comprises a tip with an opening.(9) The surgical tool of one or more of (1) to (8), further comprising: a removable mandrel insertable into the first tube and comprising a sharp tip for penetrating bone that passes through the opening.(10) The surgical tool of one or more of (1) to (9), wherein the first material is enabled to flow through the opening when the mandrel is removed from the first tube.(11) The surgical tool of one or more of (1) to (10), wherein the first tube is made of a semirigid material.(12) The surgical tool of one or more of (1) to (11), wherein the semi-rigid material comprises ni tinol.(13) The surgical tool of one or more of (1) to (12), wherein the distal ends of the first tube and the second tube have a curved state and are flexible into a straightened state.(14) The surgical tool of one or more of (1) to (13), wherein the first tube is made of a material that enables the curved state and the straightened state, and wherein the second tube is made of a material conforms to a curvature of the first tube.(15) The surgical tool of one or more of (1) to (14), wherein the second tube is made of polyurethane.(16) A surgical assembly for performing a surgical procedure, comprising: a surgical tool, comprising: a first tube having a first lumen through which a first material flows; a second tube fitted over the first tube, wherein a region between the first tube and the second tube defines a second lumen through which a second material flows; and a balloon attached to a distal end of the second tube and a distal end of the first tube and configured to be inflated with the second material through the second lumen; and an access cannula assembly through which the surgical tool is inserted during the surgical procedure.(17) The surgical assembly of (16), wherein the access cannula assembly comprises a tip for penetrating hard tissue, soft tissue, or both.(18) The surgical assembly of one or more of (16) to (17), wherein the first tube comprises a sharp tip for penetrating bone and one or more openings for distributing the first material into a void created by the balloon.(19) The surgical assembly of one or more of (16) to (18), wherein the second lumen is dimensioned such that the second material is enabled to be withdrawn from the balloon within a predetermined deflation time period.(20) A method for manufacturing a surgical tool for performing a surgical procedure, the method comprising: inserting a first tube made of a first material into a second tube made of a second material; attaching a proximal end of the first tube and a proximal end of the second tube to an adapter configured to provide a first material to a lumen of the first tube and a second material to a lumen of the second tube; attaching a proximal end of a balloon to a distal end of the second tube to create a seal between the second tube and the balloon; and attaching a distal end of the balloon to a distal end of the first tube to create a seal between the first tube and the balloon, wherein the lumen of the second tube is defined by a region between an outer surface of the first tube and an inner surface of the second tube, and wherein the balloon is configured to be inflated with the second material through the lumen of the second tube.

Claims

CLAIMSWhat is claimed is:

1. A surgical tool for performing a surgical procedure, comprising: a first tube having a first lumen through which a first material flows; a second tube fitted over the first tube, wherein a region between the first tube and the second tube defines a second lumen through which a second material flows; and a balloon attached to a distal end of the second tube and a distal end of the first tube and configured to be inflated with the second material through the second lumen.

2. The surgical tool of claim 1, wherein the distal end of the first tube comprises a sharp tip for penetrating bone.

3. The surgical tool of claim 2, wherein the distal end of the first tube comprises one or more openings through which the first material flows.

4. The surgical tool of claim 3, wherein the one or more openings are located between the tip and the balloon.

5. The surgical tool of one or more of claims 1 to 4, further comprising: an adapter attached to the first tube and the second tube and including a first port through which the first material is injected into the first lumen and a second port through which the second material is injected into the second lumen.

6. The surgical tool of claim 5, wherein the first port comprises a luer-lock connection.

7. The surgical tool of one or more of claims 5 to 6, wherein the second port comprises a luer-lock connection and a valve.

8. The surgical tool of claim 1, wherein the distal end of the first tube comprises a tip with an opening.

9. The surgical tool of claim 8, further comprising: a removable mandrel insertable into the first tube and comprising a sharp tip for penetrating bone that passes through the opening.

10. The surgical tool of claim 9, wherein the first material is enabled to flow through the opening when the mandrel is removed from the first tube.

11. The surgical tool of one or more of claims 1 to 10, wherein the first tube is made of a semi-rigid material.

12. The surgical tool of claim 11, wherein the semi-rigid material comprises nitinol.

13. The surgical tool of one or more of claims 1 to 12, wherein the distal ends of the first tube and the second tube have a curved state and are flexible into a straightened state.

14. The surgical tool of claim 13, wherein the first tube is made of a material that enables the curved state and the straightened state, and wherein the second tube is made of a material conforms to a curvature of the first tube.

15. The surgical tool of one or more of claims 1 to 14, wherein the second tube is made of polyurethane.

16. A surgical assembly for performing a surgical procedure, comprising: a surgical tool, comprising: a first tube having a first lumen through which a first material flows; a second tube fitted over the first tube, wherein a region between the first tube and the second tube defines a second lumen through which a second material flows; and a balloon attached to a distal end of the second tube and a distal end of the first tube and configured to be inflated with the second material through the second lumen; and an access cannula assembly through which the surgical tool is inserted during the surgical procedure.

17. The surgical assembly of claim 16, wherein the access cannula assembly comprises a tip for penetrating hard tissue, soft tissue, or both.

18. The surgical assembly of one or more of claims 16 to 17, wherein the first tube comprises a sharp tip for penetrating bone and one or more openings for distributing the first material into a void created by the balloon.

19. The surgical assembly of one or more of claims 16 to 18, wherein the second lumen is dimensioned such that the second material is enabled to be withdrawn from the balloon within a predetermined deflation time period.

20. A method for manufacturing a surgical tool for performing a surgical procedure, the method comprising: inserting a first tube made of a first material into a second tube made of a second material; attaching a proximal end of the first tube and a proximal end of the second tube to an adapter configured to provide a first material to a lumen of the first tube and a second material to a lumen of the second tube; attaching a proximal end of a balloon to a distal end of the second tube to create a seal between the second tube and the balloon; and attaching a distal end of the balloon to a distal end of the first tube to create a seal between the first tube and the balloon, wherein the lumen of the second tube is defined by a region between an outer surface of the first tube and an inner surface of the second tube, and wherein the balloon is configured to be inflated with the second material through the lumen of the second tube.

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