Safety mechanism for balloon catheter

Abstract

A catheter may include a catheter body and a balloon coupled to the catheter body. The balloon may include a neck bonded to the catheter body at a bond site. The catheter also may include a safety mechanism configured to detect inflation media underneath the neck. The safety mechanism may include at least one of a wire or tube positioned to be exposed to the inflation media when the neck at least partially debonds from the catheter body.

Description

SAFETY MECHANISM FOR BALLOON CATHETER

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 587,788, filed October 4, the entire content of which is incorporated herein by reference.FIELD

[0002] The present technology is generally related to catheters, and more specifically to balloon catheters.BACKGROUND

[0003] Balloon catheters (e.g., cryogenic balloon catheters) commonly include a balloon that is coupled to a catheter body. The balloon includes proximal and distal ends each coupled to the catheter body via bonds. Such balloon catheters are often used during medical procedures such as renal denervation, where the balloon is inflated with an inflation media (e.g., a refrigerant such as nitrous oxide) to ablate surrounding tissue in the body, and then deflated. Balloon catheters also commonly include a console which controls a flow of the inflation media to and from the balloon.SUMMARY

[0004] The techniques of this disclosure generally relate to the use of a safety mechanism for a balloon catheter. The safety mechanism inhibits or substantially prevents inflation media from escaping from the balloon, due to rupture of a bond between the balloon and the catheter body. The safety mechanism may be configured to enable a console to detect and / or monitor inflation media within the balloon and / or the bond site between the balloon and the catheter body, and the catheter system (e.g., the console controlling flow of inflation media into the balloon) may be configured to automatically shut off a flow of inflation media to the balloon to prevent rupture of the bond. In some examples, the inflation media is a refrigerant (e.g., in liquid or gaseous form) and the balloon catheter is a cryogenic balloon catheter.

[0005] In one aspect, the disclosure provides a catheter having a catheter body, and a balloon coupled to the catheter body. The balloon includes a neck bonded to the catheter body at a bond site. The catheter also includes a safety mechanism configured to detect inflation media underneath the neck. The safety mechanism includes at least one of a wire or tube positioned to be exposed to the inflation media when the neck at least partially debonds from the catheter body.

[0006] Further disclosed herein is a catheter that includes a catheter body and a balloon coupled to the catheter body, wherein the balloon may include a neck bonded to the catheter body at a bond site, wherein the catheter also may include a safety mechanism configured to detect inflation media underneath the neck, and wherein the safety mechanism may include at least one of a wire or tube positioned to be exposed to the inflation media when the neck at least partially debonds from the catheter body.

[0007] 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.BRIEF DESCRIPTION OF THE DRAWINGS

[0008] FIG. l is a schematic view of an example balloon catheter having a catheter body and a balloon that is bonded to the catheter body along a proximal neck of the balloon and a distal neck of the balloon.

[0009] FIG. 2 is a partial schematic view of the balloon catheter of FIG. 1, illustrating an example flow of inflation media into and out of the balloon.

[0010] FIG. 3 is a partial schematic view of the balloon catheter of FIG. 2, illustrating an example of an increase in pressure within the balloon from the inflation media, causing a balloon cone of the balloon to roll outwards proximally and into the proximal neck of the balloon.

[0011] FIG. 4 is a partial schematic view of the balloon catheter of FIG. 3, illustrating an example of how, when the pressure is increased further within the balloon, the balloon cone and neck may roll out completely, exposing a bond where the proximal neck is bonded to the catheter body.

[0012] FIGS. 5 and 6 are schematic views of a first example of a safety mechanism for the balloon catheter of FIG. 1.

[0013] FIG. 7 is a schematic view of a second example of a safety mechanism for the balloon catheter of FIG. 1.

[0014] FIG. 8 is a schematic, cross-sectional view of the second example of the safety mechanism.DETAILED DESCRIPTION

[0015] In general, this disclosure describes a balloon catheter that includes a safety mechanism configured to inhibit or substantially prevent inflation media (e.g., refrigerant in liquid or gaseous form) from escaping from the balloon, due to rupture of a bond between the balloon and the catheter body. In many balloon catheters, a balloon is bonded to a catheter body at a proximal bond site and / or a distal bond site. In some cases, if inflation media is introduced into the balloon to too high of a pressure, the bond between the balloon and catheter body may begin to separate and, ultimately, may fail. This may result in inflation media from within the balloon being introduced into the patient’s blood stream. In accordance with examples of this disclosure the safety mechanism may be configured to enable a console to detect and / or monitor inflation media within the balloon and / or the bond site between the balloon and the catheter body, and the catheter system (e.g., the console controlling flow of inflation media into the balloon) may be configured to shut off a flow of inflation media to the balloon in response to detection of inflation media at the bond site to prevent rupture of the bond and release of inflation media from the balloon into the patient’s blood stream. In some examples, the inflation media is a refrigerant (e.g., in liquid or gaseous form) and the balloon catheter is a cryogenic balloon catheter.

[0016] With reference to FIG. 1, a catheter 10 includes a catheter body 14 and a balloon 18 coupled to the catheter body 14. In the illustrated example, the catheter body 14 is an elongate, braided, nickel titanium (nitinol) shaft, although other examples include different types of catheter bodies 14, including catheter bodies 14 formed of different materials or combinations of materials. The balloon 18 may be compliant, semi-compliant or non- compliant, and is able to expand and contract (e.g., radially) relative to the catheter body 14. In the illustrated example, the balloon 18 is made at least partially of polyurethane, although other examples include other suitable materials commonly used for balloons. The balloon 18 is sized, shaped, and made of a material that facilitates expansion and contraction of the balloon 18 due to an inflow and outflow of inflation media (e.g., saline, distilled water, a mixture of saline and contrast, nitrous oxide or another refrigerant, including a refrigerant in a liquid or gaseous form) within the balloon 18. For clarity, the following description focuses on the example of the inflation media being a refrigerant. However, a person having ordinary skill in the art will understand that the inflation media may be any media used to inflate a balloon 18 of a balloon catheter 10. The catheter 10 may be used for any of a variety ofmedical procedures. In the illustrated example, the catheter 10 is a cryogenic balloon catheter for use in denervation procedures.

[0017] Although renal denervation is primarily described herein, devices, systems, and techniques described herein may be applied to other types of neuromodulation, such as neuromodulation performed on nerves other than the renal nerves, at sites other than within a renal vessel, or both. In general, the devices, systems, and techniques described herein may be used to perform neuromodulation (e.g., denervation) from within any suitable anatomical lumen that has nerves adjacent to the anatomical lumen. Example anatomical lumens include the celiac trunk and its branches (including the common hepatic artery and its branches (including the gastroduodenal artery and its branches, the right gastric artery and its branches, and the proper hepatic artery and its branches), the left gastric artery and its branches, and the splenic artery and its branches), the superior mesenteric artery and its branches, the gonadal artery and its branches, the inferior mesenteric artery and its branches, and the like. Further, although neuromodulation is primarily described as being performed from within an artery, neuromodulation also may be performed from within one or more veins, such as a renal vein and its branches, a hepatic vein and its branches, an intercostal vein and its branches, or the like. In some implementations the devices, systems, and techniques described herein may be used to perform neuromodulation from within two or more anatomical lumens, e.g., in the renal arteries and the common hepatic artery, or any other combination of two or more anatomical lumens. In addition, the systems, devices, and methods described herein may be useful for neuromodulation within a body lumen other than a vessel, for extravascular neuromodulation and / or for use in therapies other than neuromodulation.

[0018] With continued reference to FIG. 1, the balloon 18 includes a proximal neck 22, a distal neck 26, and a central body 30 positioned between the proximal neck 22 and the distal neck 26. The proximal neck 22 fits onto (e.g., circumferentially surrounds) an outer surface 34 of the catheter body 14. Similarly, the distal neck 26 fits onto (e.g., circumferentially surrounds) the outer surface 34 of the catheter body 14. The central body 30 more loosely extends around the catheter body 14, and is compliant, such that it may expand (e.g., radially and / or longitudinally) relative to the catheter body 14.

[0019] The proximal neck 22 of the balloon 18 is bonded onto the catheter body 14 at a first bond site 38 using, for example, a balloon bond / tip seal laser bond. Alternatively, the bond may be accomplished using, e.g., solvent bonding, an adhesive, remelting, or the like. Similarly, the distal neck 26 of the balloon 18 is bonded onto the catheter body 14 at a secondbond site 42 using, for example, a balloon bond / tip seal laser bond. Alternatively, the bond may be accomplished using, e.g., solvent bonding, an adhesive, remelting, or the like. The first and second bond sites 38, 42 are intended, for example, to affix and / or seal the proximal and distal necks 22, 26 to the catheter body 14. Other examples include other numbers or positions of bond sites, or types of bond sites, than that illustrated.

[0020] With continued reference to FIG. 1, in the illustrated example the catheter 10 includes an inflow tube 46 that extends through the catheter body 14. The inflow tube 46 delivers inflation media (e.g., nitrous oxide, or other refrigerant) through the catheter body 14 to the interior of the balloon 18, to inflate the balloon 18. The catheter body 14 defines at least one inflow hole 54. In the illustrated example, the catheter body 14 defines multiple inflow holes 54 spaced circumferentially around the catheter body 14 along the outer surface 34 of the catheter body 14, although other examples may include other numbers and arrangements of inflow holes 54. An open flow path exists between each inflow hole 54 and the inflow tube 46. Inflation media (e.g., refrigerant in liquid or gaseous form) moves axially through the inflow tube 46, before exiting the inflow tube 46 and passing radially outwardly through the inflow holes 54 and into the balloon 18 (e.g., into a space underneath the central body 30 of the balloon) to inflate the balloon 18.

[0021] With continued reference to FIG. 1, the catheter body 14 also defines at least one exhaust hole 58 (e.g., a lumen that exhausts excess pressure within the balloon 18). In the illustrated example, the catheter body 14 defines multiple exhaust holes 58 spaced circumferentially around the catheter body 14 along the outer surface 34 of the catheter body 14, although other examples may include other numbers and arrangements of exhaust holes 58. An open flow path exists between each exhaust hole 58 an exhaust lumen in the interior of the catheter body 14, which extends toward or to a proximal end of catheter body 14.

[0022] The catheter 10 further may include a plug 62 within the catheter body 14. The inflow tube 46 passes through the plug 62. As illustrated in FIG. 1, the plug 62 is positioned between the exhaust holes 58 and the inflow holes 54. Once the inflation media has exited through the inflow holes 54, the inflation media enters the balloon 18, and then eventually exhausts back radially through the exhaust holes 58 and into the exhaust lumen in the catheter body 14, before moving proximally and axially back through the catheter body 14 (i.e., to the right as seen in FIG. 1). The plug 62 separates the exhaust holes 58 from the inlet holes 54, thereby facilitating the overall flow of inflation media through the interior of the balloon 18.

[0023] With continued reference to FIG. 1, the illustrated catheter 10 also includes a soft tip 66 located distal of the balloon 18. In other examples, the soft tip 66 is omitted, and / or the catheter 10 may additionally, or alternatively, include a guidewire, to facilitate guiding the catheter 10 within the body. As illustrated in FIG. 1, in some examples the catheter 10 also includes other components, such as a pressure tube 70, and / or a thermocouple 74. In other examples, certain components of the catheter 10 are omitted. For example, the catheter 10 may not include one or more of the pressure tube 70, the thermocouple 74, the plug 62, and / or the soft tip 66.

[0024] With continued reference to FIG. 1, the catheter 10 also includes a handle 78 coupled to the catheter body 14, and / or a console 82 that is coupled to the catheter body 14 and / or the handle 78. The handle 78 may be used, for example, to manually direct movement of the catheter 10, and / or to control a flow of inflation media moving through the catheter 10. The console 82 similarly may be used to control the catheter 10 and / the flow of inflation media (e.g., automatically). In some examples, the handle 78 and / or the console 82 may include a source of the inflation media (e.g., a pressurized source of nitrous oxide).

[0025] With reference to FIGS. 2-4, the balloon 18 may be designed to withstand pressures well above a nominal operating pressure of the catheter 10. However, when the pressure within the balloon 18 exceeds the nominal pressure by a certain percentage (which may be designed to suit the device and / or therapy), the balloon’s cone 86 (i.e., the inflated, curved portion of the balloon adjacent a neck seen in FIG. 2) and the neck itself (e.g., the proximal neck 22 or the distal neck 26) may begin to “roll out” and potentially expose a bond site (e.g., the first bond site 38 or the second bond site 42 shown in FIG. 1). The term “roll out” refers to the concept of the balloon 18 not only expanding radially, but also, or alternatively, starting to expand axially, such that a portion of the neck of the balloon 18 begins to become unseated or unbonded (radially) from the outer surface 34 of the catheter body 14, and such that inflation media begins to enter a gap formed between the neck of the balloon and the outer surface 34 of the catheter body 14. If the roll out continues to move axially down the catheter 10, the bond site itself (e.g., the first bond site 38) may be exposed, and if the roll out continues even further, the entire neck of the balloon may be displaced and / or the balloon 18 may become uncoupled from the catheter body 14, such that inflation media may exit out of the balloon 18 and the catheter 10 entirely. FIG. 3, for example, illustrates a state where the pressure inside the balloon 18 is high enough such that roll out has begun to occur at the proximal neck 22, and FIG. 4 illustrates a state where the pressure is high enough such thatthe cone 86 and the proximal neck 22 have rolled out (axially to the right), and the first bond site 38 is exposed.

[0026] High, undesirable pressures within the balloon 18 that generate roll out may occur, for example, due to blockage of the exhaust holes 58. For example, the exhaust holes 58 or an exhaust lumen to which the exhaust holes 58 fluidly connect may become blocked with debris, moisture, etc., causing an increase in pressure within the balloon 18. Additionally, or alternatively, the exhaust holes 58 or an exhaust lumen to which the exhaust holes 58 fluidly connect may become blocked due to a kink, or other bend or deformation of the catheter 10.

[0027] For these reasons, and with reference to FIGS. 5-8, the catheter 10 may include at least one additional safety mechanism (other than the first and second bond sites 38, 42 themselves) that inhibits or prevents the inflation media from escaping outside of the balloon 18 and the catheter 10. As described below, the safety mechanism may be shaped and / or positioned to detect roll out of the balloon 18, and may be positioned underneath the neck (e.g., the proximal neck 22 and / or the distal neck 26) to detect the presence of inflation media that has entered an area, or gap, between the neck and the catheter body 14 due to the roll out. The safety mechanism may also provide mechanical pressure relief, so that a pressure within the system stays below a maximum threshold. The safety mechanism may therefore not only provide detection, but also provide a passive pressure relief valve (e.g., through a lumen within the catheter body 14 which exhausts outside the catheter body 14).

[0028] FIGS. 5 and 6 illustrate a first example of a safety mechanism 90 for such purposes. The safety mechanism 90 includes at least one wire 94 (e.g., a thermocouple wire, a pressure wire, etc.) positioned along an exterior of or within the catheter body 14. The wire 94 includes a distal tip 98, and a proximal end (not shown) that is coupled for example to the handle 78 and / or the console 82. As illustrated in FIG. 6, the distal tip 98 is positioned at or near the first bond site 38. The wire 94 is positioned to be exposed to the inflation media when the proximal neck 22 at least partially debonds from the catheter body. In some examples, the wire 94 detects a change in temperature and / or pressure due to introduction of the inflation media into the area of the catheter 10 at or near the first bond site 38. For example, the distal tip 98 of the wire 94 may be positioned under the proximal neck 22, in an area radially between the catheter body 14 and the proximal neck 22. Once the balloon 18 rolls out due to high pressures, the proximal neck 22 will begin to pull away radially from the catheter body 14 and will eventually expose the first bond site 38 and the distal tip 98 of the wire 94 located at the first bond site 38. Once the distal tip 98 of the wire 94 is exposed, thewire 94 may be triggered. In some examples, the wire 94 includes a pressure sensor (e.g., at the distal tip 98). In other examples, and as noted above, the wire 94 is a thermocouple wire that detects a change in temperature, due to its exposure to the inflation media. In some examples, this triggering and / or detection of a change in pressure or temperature prompts the console 82 to shut off the flow of inflation media to the balloon 18, for example to prevent an inflow of pressure beyond an operating range.

[0029] In other examples, the wire 94 may be replaced with a pressure tube (e.g., a hollow tube) with an open distal tip at or near the first bond site 38, such that inflation media may flow into the open distal tip of the pressure tube when the distal tip of the pressure tube is exposed at the first bond site 38. This flow of inflation media into the pressure tube may prompt the console 82 to shut off the flow of inflation media to the balloon 18. For example, the catheter 10 may include at least one sensor 102 (e.g., positioned in the handle 78 as seen in FIG. 5, or elsewhere along the catheter 10) that detects the presence of inflation media that has moved into the pressure tube. Detection of the inflation media may then prompt the console 82 to shut off the flow of inflation media to the balloon 18.

[0030] With reference to FIG. 6, in some examples the safety mechanism 90 also includes an additional sleeve 106 positioned over (e.g., extending partially or entirely circumferentially around) a portion of the catheter body 14 and / or the wire 94. The sleeve 106 may, for example, be crimped on or otherwise secured over the catheter body 14 and / or the wire 94. In some examples, the sleeve 106 may overlap at least a portion of the proximal neck 22. The sleeve 106 may be made of a same material as the catheter body 14, or a different material, and may help to further reduce the likelihood of inflation media leaking out of the balloon 18. In other examples the sleeve 106 is omitted.

[0031] While the safety mechanism 90 is described in the context of being used at the proximal end of the balloon 18 and at the first bond site 38, the safety mechanism 90 may instead or additionally be used at the distal end of the balloon 18 and at the second bond site 42. In some examples, the catheter 10 includes a first safety mechanism 90 at the proximal end of the balloon 18, and a second safety mechanism 90 at the distal end of the balloon 18. In such an arrangement, the catheter 10 may include two wires 94 each extending axially back to the handle 78 and / or the console 82.

[0032] FIGS. 7 and 8 illustrate a second example of a safety mechanism 110. The safety mechanism 110 includes the catheter body 14. In the illustrated example, the catheter body 14 includes a central lumen 114 extending axially through the catheter body 14 (e.g., axiallyand centrally within the catheter body 14). The plug 62 is positioned within the central lumen 114 and is sealed against an inner wall 118 defining the central lumen 114. As illustrated in FIG. 7, the inflow tube 46 passes through the plug 62. The catheter body 14 includes inflow holes 54. The inflow tube 46 and the plug 62 are positioned such that inflation media is delivered through the inflow tube 46 and then exits outs a distal end of the inflow tube 46 into the central lumen 114 and passes through the inflow holes 54 and into the balloon 18. Inflation media may then return back through exhaust holes (such as exhaust holes 58 illustrated in FIG. 1) into the central lumen 114, where the inflation media may pass axially to a proximal end of the catheter 10 (i.e., to the right in FIG. 7), alongside the inflow tube 46.

[0033] With continued reference to FIGS. 7 and 8, the safety mechanism 110 includes at least one pressure tube 122 extending through the catheter body 14. In the illustrated example, the safety mechanism 110 includes two pressure tubes 122, although other examples include only a single pressure tube 122, or more than two pressure tubes 122. Each of the pressure tubes 122 extends (e.g., axially) through the catheter body 14 toward or to a proximal end of the catheter body 14. In the illustrated example each of the pressure tubes 122 extends substantially parallel to the central lumen 114, although in other examples, at least one of the pressure tubes 122 does not extend parallel to the central lumen 114. As seen in FIG. 8, each of the pressure tubes 122 may have a diameter DI that is smaller than a diameter D2 of the central lumen 114. In the illustrated example, each of the pressure tubes 122 has an identical diameter DI. In other examples, at least one of the pressure tubes 122 has a diameter that DI is different than a diameter DI of another pressure tube 122, and / or a diameter DI that is greater than the diameter D2 of the central lumen 114.

[0034] The safety mechanism 110 also includes at least one hole 126 that extends from one of the pressure tubes 122 to the outer surface 34 of the catheter body 14. In the illustrated example, the safety mechanism 110 includes a first hole 126 that extends to one of the two pressure tubes 122, and a second hole 126 that extends to the other pressure tube 122. Each of the holes 126 is sized and shaped to permit inflation media to pass (e.g., radially) through the hole 126 from outside the catheter body 14 (e.g., under the balloon 18) to one of the pressure tubes 122. Each hole 126 (or at least an opening to the hole 126 along the outer surface 34) may be positioned directly underneath the proximal neck 22 and / or the distal neck 26 of the balloon 18. In some examples, one or more of the holes 126 is positioned directly under or adjacent the first bond site 38 and / or the second bond site 42, along the proximal neck 22 and / or the distal neck 26. During use of the catheter 10, if the balloon 18 begins toroll out, one or more of the holes 126 may become exposed. Accordingly, inflation media may then begin to pass through one or more of the holes 126, and into one or more of the pressure tubes 122.

[0035] With continued reference to FIGS. 7 and 8, in the illustrated example the pressure tubes 122 each extend proximally (i.e., to the right in FIG. 7) to a proximal end of the catheter 10. In some examples, one or more of the pressure tubes 122 extend to the handle 78 and / or the console 82. In other examples, the pressure tubes 122 may combine prior to reaching the handle 78 and / or the console 82. As described above, the catheter 10 may include at least one sensor 102 (e.g., positioned in the handle 78 as seen in FIG. 5, or elsewhere along the catheter 10). The sensor 102 may detect whether inflation media is passing through the holes 126 and into the pressure tube or tubes 122. If the sensor 102 detects that inflation media is passing through the pressure tube or tubes 122, the console 82 may then be prompted to shut off the flow of inflation media to the balloon 18, for example to prevent an inflow of pressure beyond an operating range.

[0036] While the safety mechanisms 90, 110 have been described separately, it is understood that in some examples the catheter 10 may incorporate the use of both safety mechanisms 90, 110, or features thereof. For example, the catheter 10 may include the safety mechanism 90 at the proximal neck 22, and may include the safety mechanism 110, or at least a portion thereof, at the distal neck 26. In other examples, the catheter 10 may include the safety mechanism 90 at the proximal neck 22 and may include a similar safety mechanism 90 at the distal neck 26. In yet other examples, the catheter 10 may include the safety mechanism 90 at the proximal neck 22, and no safety mechanism (other than the common balloon bond / tip seal laser bond) at the distal neck 26. Overall, the safety mechanisms 90, 110 described above may be used to supplement the balloon bond sites already formed at the proximal neck 22 and distal neck 26, and to inhibit the passage and leaking of inflation media outside of the balloon 18 and the catheter 10.

[0037] 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, certain acts or events of any of the processes or methods described herein may be performed in a different sequence, may be added, merged, or left out altogether (e.g., all described acts or events may not be necessary to carry out the techniques). In addition, while certain aspects of this disclosure are described as being performed by a single module or unit for purposes ofclarity, 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 medical device.

[0038] The examples may be further described by reference to the following numbered paragraphs:

[0039] Example 1 : A catheter comprising: a catheter body; a balloon coupled to the catheter body, the balloon including a neck bonded to the catheter body at a bond site, and a safety mechanism configured to detect inflation media underneath the neck, wherein the safety mechanism includes at least one of a wire or tube positioned to be exposed to the inflation media when the neck at least partially debonds from the catheter body.

[0040] Example 2: The catheter of example 1, further comprising a console coupled to the catheter body, wherein the console is configured to stop an inflow of pressure beyond an operating range to the balloon in response to the safety mechanism being exposed to the inflation media underneath the neck.

[0041] Example 3: The catheter of example 1 or example 2, wherein the safety mechanism is sized and positioned so as to be exposed to the inflation media when the balloon rolls out and the bond site is exposed.

[0042] Example 4: The catheter of any one of examples 1 to 3, wherein the safety mechanism includes the wire to detect the inflation media, and wherein the wire comprises a thermocouple wire pair.

[0043] Example 5: The catheter of example 4, wherein the thermocouple wire pair extends along an exterior of the catheter body, and wherein a distal end of the thermocouple wire is positioned at the bond site.

[0044] Example 6: The catheter of example 4 or 5, further comprising a console coupled to the catheter body, wherein the console is configured to stop an inflow of pressure beyond an operating range to the balloon in response to detecting that the distal end of thermocouple wire pair is exposed to the inflation media underneath the neck.

[0045] Example 7: The catheter of any one of examples 4 to 6, wherein the safety mechanism further includes a sleeve crimped over a proximal portion of the neck.

[0046] Example 8: The catheter of any one of examples 1 to 3, wherein the safety mechanism includes the tube to detect the inflation media, and wherein the tube comprises a pressure tube.

[0047] Example 9: The catheter of example 8, wherein the pressure tube extends along an exterior of the catheter body, and wherein a distal end of the pressure tube is positioned at the bond site between the neck and the catheter body.

[0048] Example 10: The catheter of examples 8 or 9, further comprising a console coupled to the catheter body, wherein the console is configured to stop an inflow of pressure beyond an operating range to the balloon in response to detecting that the distal end of pressure tube is exposed to the inflation media underneath the neck.

[0049] Example 11 : The catheter of any one of examples 8 to 10, wherein the safety mechanism further includes a sleeve crimped over a proximal portion of the neck.

[0050] Example 12: The catheter of example 8, wherein the pressure tube extends within an interior of the catheter body, and wherein the catheter body defines a detection hole that extends from an exterior surface of the catheter body to the pressure tube.

[0051] Example 13: The catheter of example 12, wherein an opening to the detection hole, positioned along the exterior surface, is located underneath the neck.

[0052] Example 14: The catheter of example 12 or example 13, wherein the detection hole is a first hole, wherein the catheter further includes an inflow tube extending within the catheter body, and the catheter body defines a second, inflow hole extending from the exterior surface of the catheter body to the inflow tube, wherein the second, inflow hole is positioned distal to the first hole.

[0053] Example 15: The catheter of any one of examples 12 to 14, further comprising a console coupled to the catheter body, wherein the console is configured to stop an inflow of pressure beyond an operating range to the balloon in response to detecting that the detection hole is exposed to the inflation media underneath the neck.

[0054] Example 16: The catheter of any of examples 12 to 15, further comprising a handle, and a sensor positioned in the handle, wherein the pressure tube extends to the handle and the sensor, wherein the sensor is configured to detect the inflation media underneath the neck once the inflation media underneath the neck has passed through the detection hole, into the pressure tube, and to the sensor.

[0055] Example 17: The catheter of example 1, further comprising an inflow tube extending within the catheter body, wherein the catheter body defines an inflow hole along the exterior surface of the catheter body that is coupled to the inflow tube, wherein the catheter body further defines an exhaust hole along the exterior surface of the catheter body.

[0056] Example 18: The catheter of example 17, wherein the exhaust hole is positioned distal of the neck and the bond site, and is a lumen that exhausts excess pressure within the balloon.

[0057] Example 19: The catheter of example 17 or example 18, further comprising a plug positioned within the catheter body, wherein the inflow tube extends through the plug, wherein the exhaust hole is positioned proximal of the plug, and the inflow hole is positioned distal of the plug.

[0058] Example 20: The catheter of any one of the preceding examples, wherein the neck is a proximal neck and the bond site is a first bond site, wherein the balloon further includes a distal neck bonded to the catheter body at a second bond site.

[0059] Although various aspects and examples have been described in detail with reference to certain examples illustrated in the drawings, variations and modifications exist within the scope and spirit of one or more independent aspects described and illustrated.

Claims

CLAIMS1. A catheter comprising: a catheter body; a balloon coupled to the catheter body, the balloon including a neck bonded to the catheter body at a bond site, and a safety mechanism configured to detect inflation media underneath the neck, wherein the safety mechanism includes at least one of a wire or tube positioned to be exposed to the inflation media when the neck at least partially debonds from the catheter body.

2. The catheter of claim 1, further comprising a console coupled to the catheter body, wherein the console is configured to stop an inflow of pressure beyond an operating range to the balloon in response to the safety mechanism being exposed to the inflation media underneath the neck.

3. The catheter of claim 1 or 2, wherein the safety mechanism is sized and positioned so as to be exposed to the inflation media when the balloon rolls out and the bond site is exposed.

4. The catheter of any one of the preceding claims, wherein the safety mechanism includes the wire to detect the inflation media, and wherein the wire comprises a thermocouple wire pair.

5. The catheter of claim 4, wherein the thermocouple wire pair extends along an exterior of the catheter body, and wherein a distal end of the thermocouple wire is positioned at the bond site.

6. The catheter of claim 4 or 5, further comprising a console coupled to the catheter body, wherein the console is configured to stop an inflow of pressure beyond an operating range to the balloon in response to detecting that the distal end of thermocouple wire pair is exposed to the inflation media underneath the neck.

7. The catheter of any one of claims 1 to 3, wherein the safety mechanism includes the tube to detect the inflation media, and wherein the tube comprises a pressure tube.

8. The catheter of claim 7, wherein the pressure tube extends along an exterior of the catheter body, and wherein a distal end of the pressure tube is positioned at the bond site between the neck and the catheter body.

9. The catheter of claim 7 or 8, further comprising a console coupled to the catheter body, wherein the console is configured to stop an inflow of pressure beyond an operating range to the balloon in response to detecting that the distal end of pressure tube is exposed to the inflation media underneath the neck.

10. The catheter of claim 7, wherein the pressure tube extends within an interior of the catheter body, and wherein the catheter body defines a detection hole that extends from an exterior surface of the catheter body to the pressure tube.

11. The catheter of claim 10, wherein an opening to the detection hole, positioned along the exterior surface, is located underneath the neck.

12. The catheter of claim 10 or 11, wherein the detection hole is a first hole, wherein the catheter further includes an inflow tube extending within the catheter body, and the catheter body defines a second, inflow hole extending from the exterior surface of the catheter body to the inflow tube, wherein the second, inflow hole is positioned distal to the first hole.

13. The catheter of any one of claims 10 to 12, further comprising a console coupled to the catheter body, wherein the console is configured to stop an inflow of pressure beyond an operating range to the balloon in response to detecting that the detection hole is exposed to the inflation media underneath the neck.

14. The catheter of any one of claims 10 to 13, further comprising a handle, and a sensor positioned in the handle, wherein the pressure tube extends to the handle and the sensor, wherein the sensor is configured to detect the inflation media underneath the neck once theinflation media underneath the neck has passed through the detection hole, into the pressure tube, and to the sensor.

15. The catheter of claim 1, further comprising an inflow tube extending within the catheter body, wherein the catheter body defines an inflow hole along the exterior surface of the catheter body that is coupled to the inflow tube, wherein the catheter body further defines an exhaust hole along the exterior surface of the catheter body.

Images