Medical balloon device

Abstract

A balloon device (100) comprises a balloon catheter (200) comprising an inflatable body (202). The inflatable body (202) has a proximal portion (204) and a distal portion (205). An expandable implant (300) is mountable on the proximal portion (204) of the inflatable body (202) with the distal portion (205) of the inflatable body (202) being free of the expandable implant (300) when mounted on the proximal portion (204). A sheath (400) comprising a lumen (404) is configured to slidably receive the inflatable body (202) and expandable implant (300) when mounted on the proximal portion (204) of the inflatable body (202) in a deflated configuration. The sheath (400) has a first position in which the distal portion (205) of the inflatable body (202) is exposed from the sheath (400) and inflatable to dilate a vessel and in which the proximal portion (204) is received in the sheath (400) to prevent inflation of the proximal portion (204). The sheath (400) also has a second position in which the proximal portion (204) of the inflatable body (202) is exposed from the sheath (400) and inflatable to deploy the expandable implant (300) in the vessel.

Description

[0001] MEDICAL BALLOON DEVICE

[0002] TECHNICAL FIELD

[0003] The present disclosure relates to balloon devices suitable for medical procedures such as angioplasties . The present disclosure also relates to methods of assembling balloon devices and a methods of performing a medical procedure on a subj ect using a balloon device .

[0004] BACKGROUND

[0005] Medical procedures such as angioplasties require the use of a balloon catheter which is advanced through the vasculature of a subj ect to a target site , such as a plaque or narrowing in a vessel . Some medical procedures treat the target site in a two-step process . In a first step, the target site may be prepared by expanding a balloon outwards at the target site so that the balloon abuts and expands the target site . Once the target site has been expanded, in a second step an implant such as a stent may be delivered to the target site .

[0006] After the first step of such medical procedures , the balloon catheter used for preparing the target site is removed from the vasculature of the subj ect and a second device carrying the implant is inserted into the vasculature towards the target site in order to deliver the implant . The total required time for the procedure is longer due to the need to insert the balloon catheter, perform the preparation step, remove the balloon catheter and insert the second device to deliver the implant . Further, the use of multiple devices increases the risk of infection due to increase handling of devices which enter the vasculature .

[0007] There is a need for medical devices and methods having a shorter procedure time and with a reduced risk of infection caused by the procedure . SUMMARY OF THE INVENTION

[0008] According to a first aspect , there is provided a balloon device , comprising : a balloon catheter comprising an inflatable body, the inflatable body having a proximal portion and a distal portion; an expandable implant mountable on the proximal portion of the inflatable body, the distal portion of the inflatable body being free of the expandable implant when mounted on the proximal portion; and a sheath comprising a lumen configured to slidably receive the inflatable body and expandable implant when mounted on the proximal portion of the inflatable body in a deflated configuration; the sheath having a first position in which the distal portion of the inflatable body is exposed from the sheath and inflatable to dilate a vessel and in which the proximal portion is received in the sheath to prevent inflation of the proximal portion; and the sheath having a second position in which the proximal portion of the inflatable body is exposed from the sheath and inflatable to deploy the expandable implant in the vessel .

[0009] According to a second aspect , there is provided a method of assembling a balloon device , comprising : mounting an expandable implant on a proximal portion of an inflatable body of a balloon catheter, wherein a distal portion of the inflatable body is free of the expandable implant when the expandable implant is mounted; and slidably receiving the inflatable body in a deflated configuration within a lumen of a sheath, the sheath having : a first position in which the distal portion of the inflatable body is exposed from the sheath and inflatable to dilate a vessel and in which the proximal portion is received in the sheath to prevent inflation of the proximal portion; and a second position in which the proximal portion of the inflatable body is exposed from the sheath and inflatable to deploy the expandable implant in the vessel . According to a third aspect , there is provided a method of performing a medical procedure on a subj ect , comprising : inserting a balloon device into a vasculature of the subj ect , the balloon device comprising : a balloon catheter comprising an inflatable body having a proximal portion and a distal portion; an expandable implant mountable on the proximal portion of the inflatable body, the distal portion of the inflatable body being free of the expandable implant when mounted on the proximal portion; and a sheath comprising a lumen slidably receiving the inflatable body and expandable implant in a deflated configuration; the method further comprising : locating the distal portion of the inflatable body at a target site in the vasculature ; retracting the sheath to a first position in which the distal portion of the inflatable body is exposed and the proximal portion remains within the sheath; inflating the distal portion of the inflatable body with the sheath maintained in the first position; retracting the sheath to a second position in which the proximal portion of the inflatable body is exposed; locating the proximal portion of the inflatable body at the target site ; and inflating the proximal portion of the inflatable body to expand and deploy the implant .

[0010] BRIEF DESCRIPTION OF THE DRAWINGS

[0011] To enable better understanding of the present disclosure , and to show how the same may be carried into ef fect , reference will now be made , by way of example only, to the accompanying schematic drawings , in which :

[0012] Fig . 1 shows a schematic perspective view of a distal portion of a balloon catheter for use in a balloon device according to one or more embodiments shown and described herein .

[0013] Fig . 2 shows a schematic cross-sectional view of the balloon catheter of Fig . 1 , taken along line 2-2 . Fig . 3 shows another schematic perspective view of the balloon catheter of Fig . 1 according to one or more embodiments shown and described herein .

[0014] Fig . 4 shows a schematic view of another balloon catheter for use in a balloon device according to one or more embodiments shown and described herein .

[0015] Fig . 5 shows a schematic cross-sectional view of another balloon catheter for use in a balloon device according to one or more embodiments shown and described herein .

[0016] Fig . 6A shows a schematic cross-sectional side view of a distal portion of a balloon device according to one or more embodiments shown and described herein .

[0017] Fig . 6B shows a schematic cross-sectional side view of a proximal portion of a balloon device according to one or more embodiments shown and described herein .

[0018] Fig . 7A shows a schematic side view of an inflatable body of a balloon catheter for use in a balloon device according to one or more embodiments shown and described herein .

[0019] Fig . 7B shows a schematic side view of another inflatable body of a balloon catheter for use in a balloon device according to one or more embodiments shown and described herein .

[0020] Fig . 7C shows a schematic side view of another inflatable body of a balloon catheter for use in a balloon device according to one or more embodiments shown and described herein . Fig . 8A shows a balloon device according to one or more embodiments shown and described herein in a first configuration .

[0021] Fig . 8B shows the balloon device of Fig . 8A in a second configuration .

[0022] Fig . 8C shows the balloon device of Fig . 8A in a third configuration .

[0023] Fig . 8D shows the balloon device of Fig . 8A in a fourth configuration .

[0024] DETAILED DESCRIPTION

[0025] Fig . 1 shows a schematic perspective view of a distal portion of a balloon catheter 10 for use in a balloon device according to one or more embodiments . The catheter 10 has a distal portion 11 with an inflatable body or balloon 12 mounted on a catheter tube 14 . Fig . 2 shows a schematic cross-sectional view of the balloon catheter 10 of Fig . 1 , taken along line 2-2 . Fig . 3 shows another schematic perspective view of the balloon catheter 10 of Fig . 1 . The balloon 12 has an intermediate section 16 , or "barrel" having a working surface W, and end sections 18 , 20 . In one embodiment , the end sections 18 , 20 , taper or reduce in diameter to j oin the intermediate section 16 to the catheter tube 14 ( and thus sections 18 , 20 are generally termed cones or cone sections ) . The balloon 12 is sealed to catheter tube 14 at balloon ends (proximal 15a and distal 15b ) on the end sections 18 , 20 to allow the inflation of the balloon 12 via one or more inflation lumens 17 extending within catheter tube 14 and communicating with the interior of the balloon 12 .

[0026] The catheter tube 14 also includes an elongated, tubular shaft 24 forming a guidewire lumen 23 that directs the guidewire 26 through the catheter 10. As illustrated in Fig.

[0027] 3, this guidewire 26 may be inserted through a first port 25 of a connector 27 into the lumen 23 to achieve an "over the wire" (OTW) arrangement, but could also be provided in a "rapid exchange" configuration in which the guidewire 26 enters the lumen 23 through a lateral opening 14a closer to the distal end (see Fig. 4) . A second port 29 may also be associated with catheter 10, such as by way of connector 27, for introducing a fluid (e.g., saline, a contrast agent, or both) into the interior of the balloon 12 via the inflation lumen 17.

[0028] Fig. 4 shows a schematic side view of an alternative balloon catheter 10 for use in a balloon device according to one or more embodiments. As in the case of the balloon catheter 10 of Fig. 1, the balloon catheter 10 of Fig. 4 comprises an inflatable body or balloon 12 mounted on a catheter tube 14. The balloon 12 has an intermediate section, or "barrel" having a working surface, and end sections. In one embodiment, the end sections, taper or reduce in diameter to join the intermediate section to the catheter tube 14. The balloon 12 is sealed to catheter tube 14 at balloon ends on the end sections to allow the inflation of the balloon 12 via one or more inflation lumens 17 extending within catheter tube 14 and communicating with the interior of the balloon 12.

[0029] The catheter tube 14 also includes an elongated, tubular shaft forming a guidewire lumen that directs the guidewire 26 through the catheter 10. As illustrated in Fig. 4, this guidewire 26 is provided in a "rapid exchange" configuration in which the guidewire 26 enters the lumen through a lateral opening 14a closer to the distal end (see Fig. 4) . A second port may also be associated with catheter 10, such as by way of a connector, for introducing a fluid (e.g., saline, a contrast agent, or both) into the interior of the balloon 12 via the inflation lumen 17. In the balloon catheters 10 of Figs . 1 and 4 , balloon 12 may include a single or multi-layered balloon wall 28 . The balloon 12 may be a non-compliant balloon ( i . e . made of a non-compliant material ) having a balloon wall 28 that maintains its si ze and shape in one or more directions when the balloon is inflated to a maximum si ze and shape . The balloon 12 in such case also has a pre-determined surface area that remains constant during and after inflation, also has a pre-determined length and pre-determined circumference that each, or together, remain constant during and after inflation . However, the balloon 12 could be semi-compliant or compliant instead ( i . e . made of a compliant or semi-compliant material ) , depending on the particular use .

[0030] Fig . 5 shows a schematic cross-sectional view of another balloon catheter for use in a balloon device according to one or more embodiments . The balloon catheter may have any of the features of the balloon catheters 10 disclosed with reference to Figs . 1-4 . In addition to the previously-disclosed features , the balloon catheter may comprise one or more radiopaque markers M on the shaft 24 of a radiopaque marker P at a distal end of the catheter . In some embodiments , the one or more markers M may have a location and / or length configured to indicate the location of a distal portion and / or proximal portion of the balloon 12 .

[0031] Fig . 6A shows a schematic cross-sectional side view of a distal portion of a balloon device 100 according to one or more embodiments . The device 100 comprises a balloon catheter 200 comprising an inflatable body 202 which may be a balloon and which comprises a proximal portion 204 and a distal portion 205 . The proximal portion 204 and distal portion 205 may be the same or di f ferent lengths , LPand LD. The balloon catheter 200 further comprises an inflation tube 240 connected to the balloon 202 . One or more inflation lumens (not shown) extend through the length of the inflation tube 240 and are fluidly connected to an interior of the inflatable body 202 so that the inflatable body 202 may be inflated when fluid is inserted into the one or more lumens of the inflation tube 240 at a proximal end of the device 100 . The inflatable body 202 comprises a working surface W configured to interact with the target site of the subj ect when inflated, which may include the proximal portion 204 and the distal portion 205 .

[0032] In some embodiments , the balloon catheter 200 may be any of the balloon catheters 10 described with reference to Figs . 1 to 4 .

[0033] The inflatable body 202 may comprise a compliant balloon or a non-compliant balloon, i . e . may be made of a compliant or non-compliant material . The inflatable body 202 may be configured to withstand outward pressures of up to 500 kPa, and in some embodiments up to 1000 kPa . Such pressures are preferable for performing angioplasties . In some embodiments the inflatable body 202 may be configured to withstand outward pressures of up to 3000 kPa

[0034] The device 100 further comprises an expandable implant 300 mountable on the proximal portion 204 of the inflatable body 202 . The expandable implant 300 is shown mounted on the proximal portion in Fig . 6A. The distal portion 205 remains free of the expandable implant 300 when mounted on the proximal portion 204 . In other words , the distal portion 205 is free to inflate radially outwards when the inflatable body 202 is filled with a fluid, without abutting outwardly onto the expandable implant 300 .

[0035] The device 100 further comprises a sheath 400 comprising a lumen 404 configured to slidably receive the ( e . g . entire ) inflatable body 202 and the implant 300 when mounted on the proximal portion 204 of the inflatable body 202 in a deflated configuration such as shown in Fig . 6A. The sheath 400 further has a first position ( see Fig . 8B ) in which the distal portion of the inflatable body 202 is exposed from the sheath 400 and inflatable to dilate a vessel and in which the proximal portion 204 is received in the sheath 400 to prevent inflation of the proximal portion 204 . In other words , in the first position, the proximal portion 204 , when the inflatable body 202 is filled with a fluid, abuts outwardly on the inner surface of the sheath 400 and i s therefore prevented from inflating . On the other hand, in the first position the distal portion 205 is exposed from the sheath 400 and is therefore not prevented from inflating ( see also Figs . 8A to 8D) . The sheath 400 also has a second position ( see Fig . 8C ) in which the proximal portion 204 of the inflatable body 202 is exposed from the sheath 400 and therefore inflatable to deploy the expandable implant 300 in the vessel as the sheath 400 no longer prevents inflation of the proximal portion 204 . Therefore , in the first position, the inflatable body 202 partially inflates in order to pre-treat the target site of a vessel , whilst in the second position the same inflatable body 202 can be further inflated to deploy the implant 300 . The two-step process is therefore provided by a single balloon device 100 .

[0036] The sheath 400 preferably is configured to withstand a maximum outward pressure matching or exceeding the maximum outward pressure of the inflatable body 202 so that the sheath 400 does not fail when in the first position in which the proximal portion 204 exerts an outward pressure on the sheath causes by the fluid inserted into the inflatable body 202 to inflate the distal portion 205 . Preferably, the sheath 400 is configured to withstand a maximum outward pressure o f at least 500 kPa, and preferably at least 1000 kPa and in some embodiments at least 3000 kPa . The sheath 400 may be made of or comprises materials such as any suitable polymer , for example high-density polyethylene (HDPE ) , low-density polyethylene ( LDPE ) , fluorinated ethylene propylene ( FEP ) or polytetrafluoroethylene ( PTFE ) , or composites thereof . The sheath may be made of or comprise a metal such as stainles s steel , for example a stainless-steel braid . In embodiments where the sheath 400 comprises a polymer, the sheath 400 may be reinforced with a metal such as a stainless-steel braid, at least at a proximal portion of the sheath 400 , to withstand the outward pressure of the inflatable body 202 .

[0037] The expandable implant 300 may be any medical implant which is configured to be mounted onto a balloon catheter and expanded and deployed by inflation of the balloon catheter . The implant 300 may be a stent . The length of the expandable implant , Ls, may be the same length as the length LPof the proximal portion 204 , or may be shorter . The expandable implant 300 may comprise a radiopaque portion ( for example may comprise radiopaque markers or a radiopaque coating) or may be made of a radiopaque material . The implant 300 itsel f may therefore be used as an indication of the location of the proximal portion 204 under radiographic imaging, at least approximately or even precisely if a proximal / distal end of the implant 300 is aligned with the proximal / distal end of the proximal portion 204 , or i f the proximal portion 204 is defined by and matches the length of the implant 300 .

[0038] The sheath 400 may comprise one or more radiopaque markers 402 proximal a distal end of the sheath 400 . The one or more radiopaque markers 402 may be made of any suitable radiopaque material and may take any shape . In some embodiment the one or more radiopaque markers 402 comprises a band of radiopaque material mounted proximal or at the distal end of the sheath 400 . The one or more radiopaque markers 402 may be provide at the distal end of the sheath 400 , or within a predetermined distance from the distal end of the sheath such that it can be determined when the proximal and / or distal portions 204 , 205 are inside of or exposed from the sheath 400 . It will be appreciated that the marker ( s ) 402 need not be exactly aligned with the distal end of the sheath 400 as the user may only need to know that the proximal / distal portion 204 / 205 is exposed, and not the exact position of the proximal / distal portion 204 / 205 relative to the distal end of the sheath 400 .

[0039] The inflatable body 202 may comprise one or more radiopaque markers 206 , 208 , 210 and 212 . One or more radiopaque markers 208 may correspond with or otherwise indicate the location of a proximal end of the inflatable body 202 . One or more radiopaque markers 210 may correspond with or otherwise indicate the location of a distal end of the inflatable body 202 . One or more radiopaque markers 212 may correspond with or otherwise indicate the location of a distal end of the balloon catheter 200 .

[0040] The radiopaque markers may be made of any radiopaque materials use in medicine , such as platinum-iridium, iodine , iopromide , gold or barium sulphate .

[0041] One or more radiopaque markers 206 on the inflatable body 202 may be configured to indicate the location of the distal portion 205 of the inflatable body 202 , and alternatively or additionally the proximal portion 204 . For example , as shown in Fig . 6A, the one or more radiopaque markers 206 may form a marking extending circumferentially around the inflatable body 202 at a location dividing the inflatable body 202 into the proximal portion 204 and the distal portion 205 . In other embodiments , the one or more radiopaque markers 206 may otherwise indicate the locations of the proximal and / or distal portions 204 and 205 . For example , the one or more radiopaque markers 206 may comprise bands indicating most proximal and most distal points o f the proximal portion 204 , and / or the most proximal and most distal points of the distal portion 205 , or the one or more radiopaque markers 206 may have a length extending along the length of the proximal portion 204 and / or 205 .

[0042] Radiopaque markers may be formed on the outer surface of the inflatable body 202 by any suitable technique as known in the art . For example , a radiopaque dye may be deposed or otherwise coated onto the outer surface of the inflatable body 202 in the required configuration .

[0043] In some embodiments , additionally or alternatively to one or more radiopaque markers 206 on the inflatable body 202 , the balloon catheter 200 may comprise one or more radiopaque markers elsewhere located on the balloon catheter 200 configured to indicate the location of the distal portion 204 and / or the proximal portion of the inflatable body 200 . For example , in embodiments where the balloon catheter 200 comprises an internal shaft extending across the length o f the inflatable body 200 , such as shaft 24 shown in Fig . 5 , the shaft may comprise one or more radiopaque markers such as markers M shown in Fig . 5 which are configured to indicate the location of the proximal portion and / or distal portion 204 , 205 of the inflatable body 202 . For example , the radiopaque marker ( s ) may correspond to the location of the most proximal and most distal points of the proximal portion 204 and / or the distal portion 205 when the balloon catheter 200 is inflated, or the one or more radiopaque markers on the shaft may have a length corresponding and matching with the length of the proximal portion 204 and / or distal portion 205 when the balloon catheter 200 is inflated . In yet other embodiments , the shaft may comprise one or more radiopaque markers , for example a radiopaque band, at a location corresponding to the midpoint between the proximal and distal portions 204 , 205 .

[0044] It will further be appreciated that such markers may be provided on any element which extends alongside the proximal and distal portions of the inflatable body 202 in the inflated configuration to indicate the positions of the proximal 204 and distal 205 portions .

[0045] Figs . 7A to 7C possible configurations of the one or more radiopaque markers 206 configured to indicate the location of the proximal and / or distal portions 204 , 205 of the balloon catheter 200 .

[0046] In Fig . 7A, an inflatable body 202 ' comprises a set of radiopaque dots 260 forming a circumferential line coinciding with the midpoint between the proximal portion 204 and the distal portion 205 . The dots 260 are configured to both indicate the location of the proximal portion 204 and the distal portion 205 because they define the midpoint . When the sheath 400 is provided with one or more radiopaque markers 402 proximal the distal end 404 , the relative positions of the proximal portion 204 and the distal portion 205 can be determined by comparing the position of the radiopaque dots 260 and the marker ( s ) 402 under radiographic imaging . Thus it can be determined whether the sheath is in the first position .

[0047] In Fig . 7B, an inflatable body 202" comprises a set of radiopaque stripes 262 extending along, and coinciding with, the length of the distal portion 205 . Thus , the stripes 262 indicate the location of the distal portion 205 and the distal end of the proximal portion 204 . When the sheath 400 is provided with one or more radiopaque markers 402 proximal the distal end 404 , the relative position of the distal portion 205 can be determined by comparing the position of the stripes 262 and the marker ( s ) 402 under radiographic imaging . Thus it can be determined whether the sheath is in the first position by determining when the stripes 262 are distal to the marker ( s ) 402 in the image .

[0048] In Fig . 7C, an inflatable body 202"' comprises a set of radiopaque stripes 262 extending along, and coinciding with, the length of the proximal portion 204 . Thus , the stripes 262 indicate the location of the proximal portion 204 and the proximal end of the proximal portion 204 . When the sheath 400 is provided with one or more radiopaque markers 402 proximal the distal end 404 , the relative position of the proximal portion 204 can be determined by comparing the position of the stripes 262 and the marker ( s ) 402 under radiographic imaging . Thus it can be determined whether the sheath is in the first position or second position by determining when the stripes 262 are proximal or distal to the marker ( s ) 402 in the image .

[0049] In some embodiments , the balloon catheter 200 comprises a single inflation lumen fluidly connected to an interior o f the inflatable body and configured to inflate both the proximal portion and distal portion ( i . e . the inflatable body 202 comprises a single interior volume for inflating both the proximal portion 204 and the distal portion 205 of the inflatable body 202 , for example as shown in Fig . 4 . It will be appreciated that the inflatable body 202 may be inflated via multiple separate inflation lumens .

[0050] In some embodiments , an interior surface defining the lumen 404 of the sheath 400 is at least partially coated with a lubricious coating configured to reduce the friction between the inner surface of the sheath 400 and the balloon catheter 200 . Such reduced friction may be especially desired when moving the sheath 400 from the first position to the second position, because high amounts of friction may occur between the proximal portion 204 , which is abutting the inner surface of the sheath 400 with a high outward pressure , and the inner surface of the sheath 400 . The lubricious coating may be a hydrophilic coating . Examples of lubricious coatings include polyurethane , poly ( ethylene oxide ) , polyvinylpyrrolidone ( PVP ) and polytetrafluoroethylene ( PTFE ) , and hydrophobic coatings such as a Silicone coating .

[0051] In some embodiments , as shown in Fig . 6A, the sheath 400 may comprise a tube wall having an inner surface defining the lumen 404 , an outer surface , and a distal face . The tube wall may comprises a gradual atraumatic transition between the inner surface and the distal face as shown in Fig . 6A, for example a curved or ramped surface , which reduces the likelihood of the sheath 400 piercing the proximal portion 204 when the balloon catheter 200 is inflated to high pressures ( as opposed to , for example , a sheath having an inner surface which meets the distal face at 90 ° , in the manner that the outer surface of sheath 400 in Fig . 6A meets the distal face at 90 ° , forming a sharper edge on the inner side of the sheath) . In some embodiments , not shown in Fig . 6A, a gradual atraumatic transition between the distal face and the outer surface may also be provided . It will be appreciated that the atraumatic transition may be any suitable shape such as a curved or rounded shape , or a ramp which provides a more gradual transition between the inner surface and the distal face .

[0052] Fig . 6B shows a schematic cross-sectional side view of a proximal portion of a balloon device 100 according to one or more embodiments , which may be a proximal portion of any of the balloon devices 100 described herein, including with reference to Fig . 6A. A proximal portion of the balloon catheter 200 may be provided with one or more visual markers 250 for indicating a relative position of the sheath 400 relative to the balloon catheter 200 . The one or more visual markers 250 may be provided alternatively to , or additionally to , the radiopaque markers disclosed with reference to Fig . 6A. The visual marker ( s ) 250 may include a first visual marker 250a . In some embodiments , the first visual marker 250a, when aligned with the proximal end of sheath 400 , may correspond to the first position of the sheath 400 in which the distal portion 205 is exposed from the sheath 400 and the proximal portion 204 is retained in the sheath . The visual marker ( s ) 250 may include a second visual marker 250b . In some embodiments , the second visual marker 250b, when aligned with the proximal end of sheath 400 , may correspond to the second position of the sheath 400 in which the proximal portion 204 is exposed from the sheath 400 . Accordingly, the position of the sheath 400 may be moved between the first and second positions by visual markers provided on the proximal portion of the device 100 instead of or in addition to the use of radiopaque markers . The visual markers 250 may be for example mounted, printed or etched onto the inflation tube 240 of the balloon catheter 200 and may comprise any suitable mark such as a line , symbol or any alphanumeric code . The first and second visual markers 250a and 250b may be the same symbol or di f ferent . Further intermediate visual markers may be provided between the first and second visual markers 250a and 250b .

[0053] Any of the balloon devices 100 disclosed herein may further comprise a locking mechanism configured to connect to a proximal portion of the balloon catheter 200 and a proximal portion of the sheath 400 , the locking mechanism having an unlocked configuration allowing relative translation of the sheath 400 with respect to the balloon catheter 200 , and a lock configuration inhibiting relative translation of the sheath 400 with respect to the balloon catheter 200 . The locking mechanism may for example comprise a releasable clamp configured to simultaneously clamp the balloon catheter 200 and the sheath 400 to inhibit relative translation of the sheath 400 with respect to the balloon catheter 200 . Such a locking mechanism may assist in preventing the sheath 400 from sliding from the first position to the second position when the balloon catheter 200 is inflated in the first position, because the sheath 400 may experience a force in the proximal direction exerted by the inflated distal portion of the inflatable body 200 . It is noted that in some embodiments the device may not comprise a locking mechanism and the friction between the inner surface of the sheath 400 and the proximal portion 204 of the inflatable body 202 may be suf ficient to withstand a force exerted onto the sheath 400 in the proximal direction by the inflatable body 202 when the inflatable body 202 is inflated .

[0054] The balloon devices 100 disclosed herein may be assembled by : mounting an expandable implant on a proximal portion of an inflatable body of a balloon catheter, wherein a distal portion of the inflatable body is free of the expandable implant when the expandable implant is mounted, such as in the position of implant 300 shown in Fig . 6A; slidably receiving the inflatable body in a deflated configuration within a lumen of a sheath, the sheath having : a first position in which the distal portion o f the inflatable body is exposed from the sheath and inflatable to dilate a vessel and in which the proximal portion is received in the sheath to prevent inflation of the proximal portion; and a second position in which the proximal portion of the inflatable body is exposed from the sheath and inflatable to deploy the expandable implant in the vessel .

[0055] It is noted that the expandable implant may be mounted onto the proximal portion of the inflatable body before or after the inflatable body is slidably received with the sheath .

[0056] Figs . 8A to 8D show a balloon device 100 according to an embodiment in use . To perform a medical procedure such as an angioplasty on a subj ect , the balloon device 100 may be inserted into a vasculature V of the subj ect until a distal portion of the balloon device 100 is located at a target site T in the vasculature V, as shown in Fig . 8A. For example , the procedure may be to treat a plaque P at the target site . The balloon device may be located by viewing one or more of the radiopaque markers under radiographic imaging, or in embodiments where the radiopaque markers are not provided, the balloon catheter 200 may contain a radiocontrast agent such that the balloon catheter 200 is viewable under radiographic imaging .

[0057] Secondly, as shown in Fig . 8B, the sheath 400 may be retracted to a first position in which the distal portion 205 of the inflatable body 202 is exposed and the proximal portion remains within the sheath 400 , and the distal portion 205 of the inflatable body 202 may be inflated with the sheath 400 maintained in the first position ( i . e . without the sheath 400 moving in a proximal direction as the balloon catheter 200 is inflated; this may optionally be assisted by engaging a locking mechanism for inhibiting relative translation of the sheath 400 and balloon catheter 200 as previously described) . It may be veri fied that the sheath 400 is in the first position by comparing the positions of one or more radiopaque markers on the sheath 400 and on the balloon catheter 200 as previously described, or the positions of one or more radiopaque markers on the sheath 400 and the radiocontrast inside the balloon catheter 200 , or by the use of visual markers at a proximal end of the balloon device 100 as previously described . The target site T of the vasculature V is therefore prepared or pre-treated by the distal portion 205 of the inflatable body 202 , as it expands outwards and abuts the plaque P .

[0058] Next , as shown in Fig . 8C, the sheath 400 may be retracted to a second position in which the proximal portion 204 of the inflatable body 202 with the expandable implant 300 i s exposed from the sheath 400 . The proximal portion 204 may be located at the target site T . It is noted that the proximal portion 204 may be located at the target site T before retracting the sheath 400 to the second position, or afterwards . As in the case of the first position, it may be veri fied that the sheath 400 is in the second position by comparing the positions of one or more radiopaque markers on the sheath 400 and on the balloon catheter 200 as previously described, or the positions of one or more radiopaque markers on the sheath 400 and the radiocontrast inside the balloon catheter 200 , or by the use of visual markers at a proximal end of the balloon device 100 as previously described . When the proximal portion 204 of the inflatable body 202 i s expanded, the implant 300 is expanded to an expanded deployed configuration wherein the implant 300 outwardly abuts and is af fixed to the vessel wall of the vasculature V at the target site T .

[0059] The balloon catheter 200 may then be deflated as shown in Fig . 8D, and the sheath 400 and balloon catheter 200 may be removed from the vasculature V, leaving the implant 300 deployed at the target site T .

[0060] In any of the uses of the balloon device 100 such as the uses described with reference to Figs . 8A- 8D, the balloon catheter 200 may comprise one or more radiopaque markers 206 configured to indicate the location of the distal portion 205 of the inflatable body 202 and distal portion 205 of the inflatable body 202 may be located at the target site by viewing a radiographic image of the position of the said one or more radiopaque portions in the subj ect . Similarly, the balloon catheter 200 may comprise one or more radiopaque markers 206 configured to indicate the location of the proximal portion 204 , and the proximal portion 204 of the inflatable body 202 is located at the target site T by viewing a radiographic image of the position of the said one or more radiopaque portions in the subj ect . Alternatively, as previously described, radiocontrast agent provided inside the inflatable body or visual markers on the proximal end of the device may be used to determine the relative positioning .

[0061] In any of the uses of the balloon device 100 such as the uses described with reference to Figs . 8A- 8D, the sheath 400 may be retracted to the first position by aligning a proximal end of the sheath 400 with a first visual marking ( such as marking 250a ) on a proximal portion of the balloon catheter 200 that corresponds to the first position . Similarly, the sheath 400 may be retracted to the second position by aligning a proximal end of the sheath 400 with a second visual marking ( such as marking 250b ) on a proximal portion of the balloon catheter 200 that corresponds to the second position .

[0062] In the methods disclosed herein, the order of presentation of the method steps do not denote a chronological order unless a subsequent step requires a previous step to be performed in order to enact the subsequent step .

[0063] All of the above are fully within the scope of the present disclosure , and are considered to form the basis for alternative embodiments in which one or more combinations of the above-described features are applied, without limitation to the speci fic combinations disclosed above .

[0064] In light of this , there will be many alternatives which implement the teaching of the present disclosure . It is expected that one skilled in the art will be able to modi fy and adapt the above disclosure to suit its own circumstances and requirements within the scope of the present disclosure , while retaining some or all technical ef fects of the same , either disclosed or derivable from the above , in light of his common general knowledge in this art . All such equivalents , modi fications or adaptions fall within the scope of the present disclosure .

Claims

CLAIMS1 . A balloon device , comprising : a balloon catheter comprising an inflatable body, the inflatable body having a proximal portion and a distal portion; an expandable implant mountable on the proximal portion o f the inflatable body, the distal portion of the inflatable body being free of the expandable implant when mounted on the proximal portion; and a sheath comprising a lumen conf igured to slidably receive the inflatable body and expandable implant when mounted on the proximal portion of the inf latable body in a deflated configuration; the sheath having a first position in which the distal portion of the inflatable body is exposed from the sheath and inflatable to dilate a vessel and in which the proximal portion is received in the sheath to prevent inflation of the proximal portion; and the sheath having a second position in which the proximal portion of the inflatable body is exposed from the sheath and inflatable to deploy the expandable implant in the vessel .2 . The balloon device according to claim 1 , wherein the expandable implant is a stent .3 . The balloon device according to claim 1 or 2 , wherein the expandable implant comprises a radiopaque portion .4 . The balloon device according to any preceding claim, wherein the sheath comprises one or more radiopaque markers proximal to a distal end of the sheath .5 . The balloon device according to any preceding claim, wherein the balloon catheter comprises one or more radiopaque markers configured to indicate the location of the distal portion and / or the proximal portion of the inflatable body .6 . The balloon device according to any preceding claim, wherein the balloon catheter comprises a single inflation lumen fluidly connected to an interior of the inflatable body and configured to inflate both the proximal portion and distal portion .7 . The balloon device according to any preceding claim, wherein the sheath is configured to withstand a maximum outward pressure exerted by the inflatable body of at least 500 kPa, and preferably at least 1000 kPa .8 . The balloon device according to any preceding claim, wherein an interior surface defining the lumen of the sheath is at least partially coated with a lubricious coating .9 . The balloon device according to any preceding claim, wherein a proximal portion of the balloon catheter comprises one or more visual markers for indicating a relative position of the sheath relative to the balloon catheter .10 . The balloon device according to any preceding claim, further comprising a locking mechanism configured to connect to a proximal portion of the balloon catheter and a proximal portion of the sheath, the locking mechanism having an unlocked configuration allowing relative translation of the sheath with respect to the balloon catheter, and a lock configuration inhibiting relative translation of the sheath with respect to the balloon catheter .11 . The balloon device according to any preceding claim, wherein the sheath comprises a tube wall having an inner surface defining the lumen, an outer surface and a distal face , wherein, the tube wall comprises a gradual atraumatic transition between the inner surface and the distal face , and optionally a gradual atraumatic transition between the distal face and the outer surface .12 . A method of assembling a balloon device , comprising : mounting an expandable implant on a proximal portion of an inflatable body of a balloon catheter, wherein a distal portion of the inflatable body is free of the expandable implant when the expandable implant is mounted; and slidably receiving the inflatable body in a deflated configuration within a lumen of a sheath, the sheath having : a first position in which the distal portion of the inflatable body is exposed from the sheath and inflatable to dilate a vessel and in which the proximal portion is received in the sheath to prevent inflation of the proximal portion; and a second position in which the proximal portion of the inflatable body is exposed from the sheath and inflatable to deploy the expandable implant in the vessel .13 . The balloon device according to claim 12 , wherein the expandable implant is a stent .14 . The balloon device according to claim 12 or 13 , wherein the expandable implant comprises a radiopaque portion .15 . The balloon device according to any of claims 12 to 14 , wherein the sheath comprises one or more radiopaque markers proximal to a distal end of the sheath .16 . The balloon device according to any of claims 12 to 15 , wherein the balloon catheter comprises one or more radiopaque markers configured to indicate the location of the distal portion and / or the proximal portion of the inflatable body .17 . The balloon device according to any of claims 12 to 16 , wherein the balloon catheter comprises a single inflation lumen fluidly connected to an interior of the inflatable bodyand configured to inflate both the proximal portion and distal portion .18 . The balloon device according to any of claims 12 to 17 , wherein the sheath is configured to withstand a maximum outward pressure of at least 500 kPa, and preferably at least 1000 kPa .19 . The balloon device according to any of claims 12 to 18 , wherein an interior surface defining the lumen of the sheath is at least partially coated with a lubricious coating .20 . The balloon device according to any of claims 12 to 19 , wherein a proximal portion of the balloon catheter comprises one or more visual markers for indicating a relative position of the sheath relative to the balloon catheter .21 . The balloon device according to any of claims 12 to 20 , further comprising a locking mechanism configured to connect to a proximal portion of the balloon catheter and a proximal portion of the sheath, the locking mechanism having an unlocked configuration allowing relative translation of the sheath with respect to the balloon catheter, and a lock configuration inhibiting relative translation of the sheath with respect to the balloon catheter .22 . The balloon device according to any of claims 12 to 21 , wherein the sheath comprises a tube wall having an inner surface defining the lumen, an outer surface and a distal face , wherein, the tube wall comprises a gradual atraumatic transition between the inner surface and the distal face , and optionally a gradual atraumatic transition between the distal face and the outer surface .23 . A method of performing a medical procedure on a subj ect , comprising :inserting a balloon device into a vasculature of the subj ect , the balloon device comprising : a balloon catheter comprising an inflatable body having a proximal portion and a distal portion; an expandable implant mountable on the proximal portion o f the inflatable body, the distal portion of the inflatable body being free of the expandable implant when mounted on the proximal portion; and a sheath comprising a lumen slidably receiving the inflatable body and expandable implant in a deflated configuration; the method further comprising : locating the distal portion of the inflatable body at a target site in the vasculature ; retracting the sheath to a first position in which the distal portion of the inflatable body is exposed and the proximal portion remains within the sheath; inflating the distal portion of the inflatable body with the sheath maintained in the first position; retracting the sheath to a second position in which the proximal portion of the inflatable body is exposed; locating the proximal portion of the inflatable body at the target site ; and inflating the proximal portion of the inflatable body to expand and deploy the implant .24 . The method according to claim 23 , wherein the balloon catheter comprises one or more radiopaque markers configured to indicate the location of the distal portion, and the distal portion of the inflatable body is located at the target site by viewing a radiographic image of the position of the said one or more radiopaque portions in the subj ect .25 . The method according to claim 23 or 24 , wherein the sheath is retracted to the first position by aligning a proximal end of the sheath with a first visual marking on a proximal portion of the balloon catheter that corresponds to the first position .26 . The method according to any of claims 23 to 25 , wherein the sheath is maintained in the first position when inflating the distal portion of the inflatable body by engaging a locking mechanism with the balloon catheter and the sheath to prevent relative translation of the sheath with respect to the balloon catheter .27 . The method according to any of claims 23 to 26 , wherein the sheath is retracted to the second position by aligning a proximal end of the sheath with a second visual marking on a proximal portion of the balloon catheter that corresponds to the second position .28 . The method according to any of claims 23 to 27 , wherein the balloon catheter comprises one or more radiopaque markers configured to indicate the location of the proximal portion, and the proximal portion of the inflatable body is located at the target site by viewing a radiographic image of the position of the said one or more radiopaque portions in the sub j ect .

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