Devices for retrieving a ruptured medical balloon

Abstract

A retrieval device and method for collapsing a ruptured medical balloon is disclosed. The device comprises a sleeve, a capturing element having an insertion configuration within the sleeve and a deployed configuration outside of the sleeve, and a pushing member disposed within the sleeve and coupled to a proximal end portion of the capturing element. The pushing member extends the capturing element into the deployed configuration, enveloping the ruptured balloon. At least a portion of the capturing element is configured to radially collapse around the medical balloon for insertion into an opposing sheath for removal.

Description

Attorney Docket No: THVDL-23503WO01 DEVICES AND METHODS FOR RETRIEVING A RUPTURED MEDICAL BALLOON CROSS REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 636,494, filed April 19, 2024, which is incorporated by reference herein in its entirety. FIELD

[0002] The present disclosure relates to devices and methods for retrieving ruptured medical balloons from within a body. BACKGROUND

[0003] The human heart can suffer from various valvular diseases. These valvular diseases can result in significant malfunctioning of the heart and ultimately require repair of a native valve or replacement of the native valve with an artificial valve. There are a number of known repair devices (for example, stents) and artificial valves, as well as a number of known methods of implanting these devices and valves in humans. Percutaneous and minimally-invasive surgical approaches are used in various procedures to deliver prosthetic medical devices to locations inside the body that are not readily accessible by surgery or where access without surgery is desirable. In one specific example, a prosthetic heart valve can be mounted in a crimped state on the distal end of a delivery apparatus and advanced through the patient’s vasculature (for example, through a femoral artery and the aorta) until the prosthetic heart valve reaches the implantation site in the heart. The prosthetic heart valve is then expanded to its functional size, for example, by inflating a medical balloon on which the prosthetic valve is mounted.

[0004] Medical balloons can be inflated in the body during a plurality of medical procedures, for example, the expansion of prosthetic heart valves. In some instances, a medical balloon may rupture or burst.Attorney Docket No: THVDL-23503WO01 SUMMARY

[0005] Described herein are devices and methods for capturing and collapsing burst medical balloons and removing them from a body. In some instances, the burst balloon can be retrieved through an introducer sheath and removed from a body. The devices and methods can, for example, retrieve one or more pieces of a burst medical balloon. As such, the devices and methods disclosed herein can, among other things, overcome one or more of the deficiencies of typical devices and methods for burst balloon retrieval and removal.

[0006] A retrieval device for collapsing a ruptured medical balloon can comprise a sleeve and a capturing element. In addition to these components, a retrieval device can further comprise one or more of the components disclosed herein.

[0007] In some examples, the capturing element can have an insertion configuration within the sleeve and a deployed configuration outside of the sleeve.

[0008] In some examples, the capturing element can radially expand in the deployed configuration to envelop and collapse a medical balloon.

[0009] In some examples, the retrieval device can comprise a pushing member disposed within the sleeve, where the pushing member is coupled to a proximal end portion of the capturing element.

[0010] In some examples, the capturing element can envelop a full length of the balloon.

[0011] In some examples, the capturing element can be a braid.

[0012] In some examples, the capturing element can have a plurality of axially extending prongs.

[0013] In some examples, the capturing element can be radially biased into an expanded position.Attorney Docket No: THVDL-23503WO01

[0014] In some examples, the retrieval device can comprise a cinching mechanism configured to radially close at least a portion of the capturing element.

[0015] In some examples, the cinching mechanism can comprise a lasso wire, a stretching rod, or a twisting component.

[0016] In some examples, the capturing element can be radially biased into a collapsed position.

[0017] In some examples, the retrieval device can comprise an expanding mechanism configured to radially enlarge at least a portion the capturing element.

[0018] In some examples, the expanding mechanism can comprise a plurality of wires.

[0019] In some examples, a distal end portion of the capturing element can be collapsed to a first diameter, where the first diameter can be smaller than a second diameter of an opposing removal sheath.

[0020] In some examples, a retrieval device for collapsing a ruptured medical balloon comprises a sleeve and a capturing element having an insertion configuration within the sleeve and a deployed configuration outside of the sleeve, where the capturing element radially expands in the deployed configuration to envelop and collapse the medical balloon.

[0021] In some examples, a retrieval device for removing a ruptured medical balloon comprises a sleeve, a capturing element having an insertion configuration within the sleeve and a deployed configuration outside of the sleeve. A pushing member can be disposed within the sleeve and coupled to a proximal end portion of the capturing element, where the pushing member extends the capturing element into the deployed configuration to envelop and radially collapse the medical balloon for insertion into an opposing removal sheath.

[0022] In some examples, a retrieval device comprises one or more of the components recited in Examples 1-20 and 37 below.

[0023] A method of collapsing a ruptured medical balloon can comprise positioning a guide wire in a lumen of a body and advancing a retrieval device over the guide wire through theAttorney Docket No: THVDL-23503WO01 lumen. In addition to these steps, a method of collapsing a ruptured medical balloon can further comprise one or more of the steps disclosed herein.

[0024] In some examples, the retrieval device can comprise a sleeve and a capturing element disposed within the sleeve.

[0025] In some examples, the method can further comprise extending the capturing element outside of the sleeve.

[0026] In some examples, the method can further comprise positioning the retrieval device axially adjacent to a ruptured medical balloon before extending the capturing element.

[0027] In some examples, the method can further comprise enveloping the balloon with the capturing element.

[0028] In some examples, the method can further comprise collapsing at least a portion the capturing element around the balloon.

[0029] In some examples, the method can further comprise enveloping an entire length of the balloon.

[0030] In some examples, the method can further comprise radially collapsing at least a portion of the balloon.

[0031] In some examples, the method can further comprise deploying a cinching mechanism to radially collapse a distal end portion of the capturing element.

[0032] In some examples, the method can further comprise deploying an expanding mechanism to radially enlarge at least a portion of the capturing element.

[0033] In some examples the method can further comprise radially collapsing a distal end portion of the capturing element to a first diameter, wherein the first diameter can be smaller than a second diameter of an opposing removal sheath.Attorney Docket No: THVDL-23503WO01

[0034] In some examples, the method can further comprise inserting the collapsed capturing element with the balloon into the opposing removal sheath.

[0035] In some examples, the method can further comprise retracting the capturing element into the sleeve, leaving the balloon inside the opposing removal sheath.

[0036] In some examples, the method can further comprise removing the opposing removal sheath with the balloon from the body.

[0037] In some examples, the method can further comprise removing the retrieval device from the body.

[0038] In some examples, a method of collapsing a ruptured medical balloon comprises positioning a guide wire in a lumen of a body and advancing a retrieval device over the guide wire through the lumen, where the retrieval device comprises a sleeve and a capturing element disposed within the sleeve. The method further comprises extending the capturing element outside of the sleeve, enveloping the balloon with the capturing element, and collapsing at least a portion the capturing element around the balloon.

[0039] In some examples, a method of collapsing a ruptured medical balloon comprises one or more of the steps recited in Examples 21-36 below.

[0040] The various innovations of this disclosure can be used in combination or separately. This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The foregoing and other objects, features, and advantages of the disclosure will become more apparent from the following detailed description, claims, and accompanying figures.Attorney Docket No: THVDL-23503WO01 BRIEF DESCRIPTION OF THE DRAWINGS

[0041] FIG. 1 is a side view of an apparatus comprising an introducer sheath and a balloon for implanting a prosthetic heart valve, according to an example.

[0042] FIG. 2 is a detail view of a distal end of the apparatus of FIG. 1.

[0043] FIG. 3 is a cross-sectional view of the apparatus of FIG. 2, where the balloon is shown with a radial tear.

[0044] FIG. 4 is a schematic view of the burst medical balloon and introducer sheath of FIG. 3 in a body, according to an example.

[0045] FIG. 5 is a cross-sectional view of a balloon retrieval device, according to an example.

[0046] FIG. 6 is a detail view of a distal end of the balloon retrieval device of FIG. 5.

[0047] FIG. 7 is a schematic view of the burst medical balloon and introducer sheath of FIG. 3 and the balloon retrieval device of FIG. 6 in a body, before deploying a capturing element.

[0048] FIG. 8 is a detail view of the body of FIG. 7, before deploying the capturing element.

[0049] FIG. 9A is a schematic view showing deployment of the capturing around the burst medical balloon of FIG. 3.

[0050] FIG. 9B is a schematic view showing collapsing of the burst medical balloon of FIG. 3.

[0051] FIG. 9C is a schematic view showing insertion of the burst balloon of FIG. 3 and the capturing element into the introducer sheath of FIG. 3.

[0052] FIG. 9D is a schematic view showing removal of the capturing element from around the burst balloon in the introducer sheath of FIG. 3.

[0053] FIG. 10 is a schematic view showing deployment of a cinching mechanism, according to an example.

[0054] FIG. 11 is a detail view of the body of FIG. 7 during removal of the burst balloon.Attorney Docket No: THVDL-23503WO01

[0055] FIG. 12 is a detail view of the body of FIG. 7 during removal of the burst balloon.

[0056] FIG. 13 is a schematic view showing deployment of an expanding mechanism, according to an example.

[0057] FIG. 14 is a schematic view showing deployment of a capturing element, according to an example. DETAILED DESCRIPTION General Considerations

[0058] For purposes of this description, certain aspects, advantages, and novel features of examples of this disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as being limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed examples, alone and in various combinations and sub-combinations with one another. The methods, apparatus, and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed examples require that any one or more specific advantages be present or problems be solved.

[0059] Although the operations of some of the disclosed examples are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular ordering is required by specific language set forth below. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed methods can be used in conjunction with other methods. Additionally, the description sometimes uses terms like “provide” or “achieve” to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations that correspond to these terms may vary depending on the particular implementation and are readily discernible by one of ordinary skill in the art.Attorney Docket No: THVDL-23503WO01

[0060] As used in this application and in the claims, the singular forms “a,” “an,” and “the” include the plural forms unless the context clearly dictates otherwise. Additionally, the term “includes” means “comprises.” Further, the term “coupled” generally means physically, mechanically, chemically, magnetically, and / or electrically coupled or linked and does not exclude the presence of intermediate elements between the coupled or associated items absent specific contrary language.

[0061] As used herein, the term “proximal” refers to a position, direction, or portion of a device that is closer to the user and further away from the implantation site. As used herein, the term “distal” refers to a position, direction, or portion of a device that is further away from the user and closer to the implantation site. Thus, for example, proximal motion of a device is motion of the device away from the implantation site and toward the user (for example, out of the patient’s body), while distal motion of the device is motion of the device away from the user and toward the implantation site (for example, into the patient’s body). The terms “longitudinal” and “axial” refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.

[0062] As used herein, “for example” means “for example,” and “e.g.” means “that is.” Examples of the Disclosed Technology

[0063] Described herein are examples of a delivery apparatus (sometimes referred to as a delivery catheter) that can be used to navigate a subject’s vasculature to deliver an implantable, expandable medical device (for example, a prosthetic heart valve), tools, agents, or other therapy to a location within the body of a subject. Examples of procedures in which the catheters are useful include neurological, urological, gynecological, fertility (for example, in vitro fertilization, artificial insemination), laparoscopic, arthroscopic, transesophageal, transvaginal, transvesical, transrectal, and procedures including access in any body duct or cavity. Particular examples include placing implants, including stents, grafts, embolic coils, and the like; positioning imaging devices and / or components thereof, including ultrasound transducers;Attorney Docket No: THVDL-23503WO01 positioning energy sources, for example, for performing lithotripsy, RF sources, ultrasound emitters, electromagnetic sources, laser sources, thermal sources, and the like; performing a valvuloplasty, angioplasty, or other remodeling procedures; and delivering agents, such as drugs, into a patient’s body.

[0064] Prosthetic valves disclosed herein can be radially compressible and expandable between a radially compressed configuration and a radially expanded configuration. Thus, the prosthetic valves can be crimped on or retained by an implant delivery apparatus in the radially compressed configuration during delivery, and then expanded to the radially expanded configuration once the prosthetic valve reaches the implantation site. It is understood that the prosthetic valves disclosed herein may be used with a variety of implant delivery apparatuses and can be implanted via various delivery procedures, examples of which will be discussed in more detail later. In some examples, the prosthetic valve can be deployed from the delivery apparatus at the implantation site (e.g., a native valve of a heart) via inflating an inflatable balloon of the delivery apparatus. When radially compressed onto the inflatable balloon of the delivery apparatus, inner surfaces of the frame of the prosthetic valve can face the balloon.

[0065] It should be noted that, although some examples disclosed herein are related to prosthetic heart valves, the devices and methods disclosed herein can be used with any type of medical implant and / or procedure that utilizes an inflatable balloon. For example, the disclosed devices and methods can be used with stents, valvuloplasty procedures, etc.

[0066] FIG. 1 is a side view showing an apparatus 10 configured to introduce a prosthetic implant (e.g., a prosthetic heart valve and / or stent) into a body and deliver the prosthetic implant. In some instances, the apparatus 10 can be used to deliver a prosthetic heart valve to a heart of a patient, such as described in U.S. Patent No. 9,339,384, which is incorporated by reference herein.

[0067] The apparatus 10 includes a delivery assembly 12 comprising a steerable guide catheter 14 and a balloon catheter 16 extending through the guide catheter 14. The guide catheter 14 andAttorney Docket No: THVDL-23503WO01 the balloon catheter 16 in the illustrated example are adapted to slide longitudinally relative to each other to facilitate delivery and deployment of a prosthetic valve, for example, at an implantation site in a patient's body. An inflatable balloon 18 is secured to a distal end of the balloon catheter 16. The guide catheter 14 comprises a handle portion 20 and an elongated guide shaft 22 extending from the handle portion 20. The balloon catheter 16 includes a proximal portion 24 adjacent the handle portion 20 and an elongated shaft 26 (also referred to herein as a “balloon shaft”) that extends from the proximal portion 24 and through handle portion 20 and the guide shaft 22. The distal end of the elongated shaft 26 comprises a nose cone 34.

[0068] The apparatus 10 shown in FIG. 1 further comprises an introducer assembly 28 through which the guide shaft 22 extends. The introducer assembly 28 comprises an introducer housing assembly 30 and an introducer sheath 32 (also referred to herein as a “removal sheath” and a “sheath”) extending from the introducer housing assembly 30. The introducer assembly 28 is used to introduce or insert the delivery assembly 12 into a patient's body. In a transapical procedure, for example, the introducer sheath 32 is inserted through surgical incisions in the chest and the apex of the heart to position the distal end of the sheath in the left ventricle (such as when replacing the native aortic valve). However, in other instances, the introducer assembly 28 can be inserted into surgical incisions in other locations in the body with access to vasculature leading to the heart or other surgical sites for device implantation.

[0069] In lieu of or in addition to the apparatus 10, the devices and methods described herein can be used with other apparatuses comprising a balloon.

[0070] FIG. 2 a detail view of a distal end portion 40 of the apparatus 10 of FIG. 1, showing the balloon 18 intact and positioned on a distal end of the elongated shaft 26 of the balloon catheter 16. The balloon 18 is radially disposed around the balloon shaft 26 and secured thereto at a proximal end portion 36 and a distal end portion 38 of the balloon 18. The balloon 18, however, can be secured or bonded to any distal delivery structure, including a shoulder of the nose cone 34, so long as it is secured in place during delivery and deployment.Attorney Docket No: THVDL-23503WO01

[0071] A medical balloon (for example the balloon 18, or any other medical balloon described herein) can comprise a material that is flexible and securable to a delivery structure. Balloon materials can comprise, for example, a polyamide (PA) or co-polyamide, such as nylon (for example nylon 12), Pebax®, Grilamid L25, a polyester, such as polyethylene terephthalate (PET), polybutylene terephthalate, a thermoplastic elastomer copolyester (such as Hytrel®), or combinations thereof.

[0072] Medical balloons can be strong and compliant for insertion and deployment in a body, where the balloon can expand or inflate for a medical procedure. Medical balloons can, in some instances, rupture under various circumstances, including for example due to internal pressure or structural and / or material defects in the balloon. When a balloon fails, it can rupture in various modes and, in some examples, be split into multiple balloon pieces. The balloon can rupture forming an axial tear or a radial tear, for example. An axial tear extends longitudinally along an axial length of the balloon from a proximal end to a distal end of the balloon. In contrast, a radial tear can extend radially around a circumference of the balloon and can result in separate pieces (e.g., a distal piece and a proximal piece).

[0073] It is desirable to remove the pieces of the burst or ruptured balloon from the body intact while minimizing the likelihood of damage to the surrounding tissue during removal. By first pulling the pieces of the balloon into a sheath, for example into an introducer sheath, while the balloon is still in the body, the sheath can collapse and contain pieces of the burst balloon. When the burst balloon is contained with a sheath, the burst balloon can travel through the body without getting stuck or snagging on surrounding tissue.

[0074] In some examples, when a balloon ruptures axially with a longitudinal tear, the burst balloon can be more easily pulled into an introducer sheath without snagging portions of the balloon on an end of the sheath. On the other hand, a burst balloon with a radial rupture can be more difficult to fully sheath due to a circumferential orientation of the radial tear. FIG. 3 schematically shows the distal end portion 40 of FIG. 2 in cross-section, where the balloon 18Attorney Docket No: THVDL-23503WO01 has ruptured due to a radial tear 42. The burst balloon 18 is attached to the balloon shaft 26, which extends over an inner shaft 44. The nose cone 34 is shown disposed at a distal end of the inner shaft 44. The introducer sheath 32 (also referred to herein as a “removal sheath” or a “sheath”) is disposed over the balloon shaft 26 as previously described. In FIG. 3 the guide shaft 22 shown in FIGS. 1 and 2 is omitted for clarity. The radial tear 42 separates the burst balloon 18 into two pieces, a distal piece 18a and a proximal piece 18b.

[0075] To remove both the distal piece 18a and the proximal piece 18b of burst balloon 18 from the body, both the distal piece 18a and the proximal piece 18b can be inserted into the introducer sheath 32. When pulling the burst balloon 18 into the introducer sheath 32 for removal, it is possible that the tear 42 can snag on a distal edge 54 the introducer sheath 32 due to a proximal, circumferential edge 52 on the distal piece 18a of the radial tear 42. In some examples, as a result, the distal piece 18a can be left hanging over an exterior portion 56 of the introducer sheath 32, making complete sheathing of the burst balloon 18 difficult. It is therefore desirable to collapse and contain any torn edges of the burst balloon 18 into a low-profile configuration to facilitate insertion into a sheath, such as introducer sheath 32 for example, for removal.

[0076] FIG. 4 schematically shows the distal end portion 40 of FIG. 3 within an abdominal aorta 60 of a body 62 as it is retracted through a bifurcation 64 into a right common iliac artery 66. Although the burst balloon 18 in FIG. 3 is shown being retracted from a position in the heart 68 after deployment of a prosthetic heart valve (not shown in FIG. 4), such an example is only representative of many other applicable procedures for which a medical balloon is utilized. The method and devices of retrieval can therefore be applicable in those other procedures.

[0077] During a medical procedure, such as a procedure to deploy a prosthetic heart valve for example, a secondary guide wire 70 can be inserted into a body for deployment of any supporting hardware needed during the procedure. As such, the guide wire 70 is shown already positioned within a left common iliac artery 72 in FIG. 4. As the burst balloon 18 is retracted through the body for removal, as shown in FIG. 4, it can travel through the abdominal aorta 60,Attorney Docket No: THVDL-23503WO01 the bifurcation 64, and a section of the right common iliac artery 66. In some examples, the burst balloon 18 can reach a lumen of smaller diameter before exiting the body. It is desirable to sheath both the distal piece 18a and the proximal piece 18b of the burst balloon 18 within the introducer sheath 32 before reaching any such lumens of smaller diameter. It is also desirable to ensure that the pieces of the balloon do not detach from the delivery apparatus and / or embolize.

[0078] FIG. 5 is a cross-sectional view of a retrieval device 80. The retrieval device 80 can be used, for example, for collapsing the burst balloon 18 and inserting the collapsed balloon into the introducer sheath 32. The retrieval device 80 can also be used with other balloon and / or removal devices.

[0079] The retrieval device 80 is shown in FIGS. 5-6 in an insertion configuration for travel through a lumen (e.g., a blood vessel) of a body. The retrieval device 80 comprises an inner shaft 82 comprising a proximal handle element 83, a nose cone 84 disposed on a distal end portion 86 of the inner shaft 82, and an outer sleeve 88 (also referred to herein as a “sleeve”) extending over the inner shaft 82. The outer sleeve 88 comprises a proximal handle element 89. A capturing element 90 (also referred to herein as an “expandable element”) is shown in an insertion configuration in FIGS. 5-6. In the insertion configuration, the capturing element 90 is disposed within the outer sleeve 88 and over the inner shaft 82, in a position proximal to the nose cone 84. The capturing element 90 is shown only schematically in FIGS. 5-6 but, in an example, can take the form of a braid as will be described in more detail later herein in reference to FIGS. 9A-9D and 13.

[0080] As shown in FIG. 5, the retrieval device 80 further comprises a pushing member 92 disposed over the inner shaft 82 and within the outer sleeve 88. The pushing member 92 comprises a proximal handle element 93. The pushing member 92 can slide axially relative to both the outer sleeve 88 and the inner shaft 82. The proximal handle elements 83, 89, and 93 remain located outside of a body and can be manipulated by a user to slide and adjust the relative axial positions of the inner shaft 82, the outer sleeve 88, and the pushing member 92. AlthoughAttorney Docket No: THVDL-23503WO01 the proximal handle elements 83, 89, and 93 are shown schematically in FIG. 5, it is understood that these handle elements can be configured such that the user can adjust the relative axial positions of the inner shaft 82, pushing member 92, and the outer sleeve 88.

[0081] FIG. 6 illustrates a detail view of a distal end portion 94 of the retrieval device 80 of FIG. 5, showing a distal end portion 96 of the pushing member 92 coupled to a proximal end portion 98 of the capturing element 90. The manner of coupling can comprise mechanical fastening or bonding, for example, or any combination thereof so long as the pushing member 92 is attached to the capturing element 90 and can move the capturing element 90 out of and into the outer sleeve 88.

[0082] In the insertion configuration shown in FIGS. 5-7, a distal end 100 of the outer sleeve 88 is in abutment with a proximal end 102 of the nose cone 84, thereby containing the capturing element 90 within the outer sleeve 88. In some examples, the retrieval device 80 can be advanced over a guide wire (e.g., the guide wire 70 (FIG. 4)) in a body. In some instances, the retrieval device 80 can be used without a guide wire.

[0083] FIG. 7 illustrates schematically both the distal end portion 94 of the retrieval device 80 and the distal end portion 40 of apparatus 10 within the body 62. The nose cone 34 of the distal end portion 40 is shown at the bifurcation 64 while the burst balloon 18 is positioned at a top section of the right iliac artery 66. The distal end portion 40 of apparatus 10 can be further retracted into the right iliac artery 66, allowing the guide wire 70 to pass the bifurcation 64 and enter the right iliac artery 66 into a position adjacent to the nose cone 34.

[0084] In some examples, the distal end portion 94 of the retrieval device 80 can be advanced over the guide wire 70 through a surgical incision in the body such that the distal end portion 94 of retrieval device 80 can enter the left iliac artery 72. The distal end portion 94 can advance further along the guide wire 70, past the bifurcation 64, and into the right iliac artery 66. To deploy the capturing element 90 over the burst balloon 18, the nose cone 84 of the distal end portion 94 can be arranged in an at least generally colinear orientation and axially adjacent to theAttorney Docket No: THVDL-23503WO01 nose cone 34 of the distal end portion 40. FIG. 8 shows a detail view illustrating a relative position of the distal end portion 94 of the retrieval device 80 with respect to the opposing sheath 32, the burst balloon 18, and the nose cone 34 of the distal end portion 40 of apparatus 10.

[0085] Once the distal end portions 40, 94 are adjacent, the capturing element 90 can be extended and deployed from the outer sleeve 88 to capture the burst balloon 18. The capturing element 90, when deployed, can envelop at least a portion of the burst balloon 18 and collapse the burst balloon 18 into a low-profile configuration for insertion and / or retrieval into the sheath 32.

[0086] FIGS. 9A-9D schematically illustrate deployment of the capturing element 90 from a distal end of the outer sleeve 88 and into position over the burst balloon 18. The capturing element can be, for example, a self-expanding, radially outwardly biased braid as shown in FIGS. 9A-9D. The braid can be configured to radially expand into an enlarged configuration as shown in FIG. 9A when not constrained within the outer sleeve 88. A length of the braid can be specified such that the braid can extend over distal and proximal pieces a burst balloon when deployed (e.g. the distal and proximal pieces 18a, 18b of the burst balloon 18). In some examples, the braid can be made of a material with shape memory properties, such as Nitinol, a polyamide, co-polyamide, polyethylene terephthalate, polybutylene terephthalate, thermoplastic elastomer copolyester, or combinations thereof. In addition to the material properties of the braid, a mesh or lattice structure of the braid, including the lattice / mesh spacing and size, can be specified such that the braid maintains shape and biasing ability. For clarity, the surrounding vasculature is not illustrated in FIGS. 9A-9D. It is understood that the steps depicted in FIGS. 9A-9D occur within the right common iliac artery 66 of FIGS. 7-8, in some examples, or any other lumen in the body comprising a burst medical balloon.

[0087] As seen in FIG. 9A, the outer sleeve 88 separates from a position in abutment with the nose cone 84, leaving a gap 104 therebetween. The pushing member 92 can be translated axially toward the nose cone 84, thereby forcing the capturing element 90 to likewise translate in theAttorney Docket No: THVDL-23503WO01 same direction through the gap 104. The capturing element 90 is pushed out of the outer sleeve 88 through the gap 104 as the capturing element 90 translates axially. While the outwardly biased capturing element 90 can be contained within the outer sleeve 88 in a collapsed or insertion configuration during insertion through a body lumen, without the outer sleeve 88 for containment, the braid expands into a deployed configuration as it is urged out of the outer sleeve 88 by the pushing member 92.

[0088] When the capturing element 90 is pushed through the gap 104 by the pushing member 92 and out of the sleeve 88, it extends and can expand to a first diameter D1 (also referred to herein as a “deployed diameter”). The first diameter D1 can be specified such that it can extend over the nose cones 84, 34 and the tear 42 in the burst balloon 18. As shown in FIG. 9A, the first diameter D1 is greater than a second diameter D2, where the second diameter D2 is defined by the circumferential edge 52 of the tear 42 of the burst balloon 18. Therefore, the capturing element 90 can envelop both the distal and proximal pieces 18a, 18b of the burst balloon 18 as the capturing element 90 is deployed axially out of the sleeve 88.

[0089] Both the first diameter D1 of the outwardly biased braid and the second diameter D2 of the burst balloon 18, are larger than a third diameter D3 (also referred to herein as an “inner diameter”), where the third diameter D3 is defined by the lumen of the opposing removal sheath 32. The capturing element 90 can be radially collapsed around the burst balloon 18 into a low- profile configuration, where the first and second diameters D1, D2 are smaller than (or at least approximately the same size as) the third diameter D3.

[0090] With the first and second diameters D1, D2 sufficiently reduced, the distal and proximal pieces 18a, 18b of the burst balloon 18 and the capturing element 90 can be inserted into the opposing sheath 32. This can be accomplished by pushing and / or pulling the balloon shaft 26 relative to the sheath 32, such as for example, by advancing the sheath 32 over the balloon shaft 26 and / or pulling the balloon shaft 26 into the sheath 32 at the same time. In some instances, the distal end portion 94 of the retrieval device 80 with the deployed capturing element 90 can beAttorney Docket No: THVDL-23503WO01 pushed while pushing and / or pulling the balloon shaft 26 and the sheath 32, facilitating insertion of the burst balloon 18 into the sheath 32.

[0091] FIG. 10 illustrates an example of a cinching mechanism 110 employed to radially collapse the capturing element 90 over the burst balloon 18. The capturing element 90 is shown in FIG. 10 having a proximal end portion 112, a distal end portion 114, and a wall portion 116. In some examples, the cinching mechanism 110 can take the form of a lasso. The lasso can have a lead filament 118 coupled to the proximal end portion 112 of the capturing element 90 and extending along the wall portion 116 of the capturing element 90 to the distal end portion 114. The lasso material can comprise a polymeric material or any bio-compatible or bio-safe material. At a distal end of the lead filament 118 is a loop 120 encircling the distal end portion 114 of the capturing element 90. To radially close the outwardly biased capturing element 90, the lasso is actuated by tightening the loop 120 around the distal end portion 114, forcing the outwardly biased capturing element 90 into a collapsed orientation. When the lasso is actuated, both the distal end portion 114 and the wall portion 116 of the capturing element 90 can be collapsed or closed, thereby also collapsing and compressing the burst balloon 18 within the capturing element 90.

[0092] Although the cinching mechanism 110 is shown as a lasso of FIG. 10, the cinching mechanism 110 can be any mechanism that compresses or collapses the outwardly biased capturing element 90 and the burst balloon 18 within the capturing element 90. For example, a stretching rod or a twisting mechanism can be used to cinch the capturing element 90 and the burst balloon 18.

[0093] In some examples, a stretching rod can be disposed along a longitudinal axis of the self- expanding capturing element 90, extending from the proximal end portion 112 of the capturing element 90. The stretching rod can be coupled to the distal end portion 114 of the capturing element 90. When the stretching rod is axially translated in the direction of the distal end portionAttorney Docket No: THVDL-23503WO01 114, it can stretch and elongate the braid of the capturing element 90. As the braid of the capturing element 90 elongates, the first diameter D1 can decrease.

[0094] In some examples, the capturing element 90 can comprise a proximal twisting mechanism comprising an actuator disposed at a user handle. A user can engage the actuator to twist the braid of the capturing element 90. As the braid of the capturing element 90 twists, it can stretch and elongate. As the capturing element 90 elongates, the first diameter D1 can decrease.

[0095] Referring back to FIG. 9B, the capturing element 90 is schematically shown collapsed over the burst balloon 18 after actuating a cinching mechanism (any cinching mechanism herein, for example, a lasso, a stretching rod, and a twisting mechanism). The cinching mechanism can collapse the distal end portion 114 of the capturing element 90 to a fourth diameter D4. At least a portion of a sidewall of the capturing element 90 can also collapse. For example, at least a portion of the sidewall of the capturing element 90 can collapse uniformly along a longitudinal direction (e.g. axial direction) or a radial or circumferential direction of the capturing element 90. In some examples, at least a portion of the sidewall of the capturing element 90 can taper from the cinched distal end portion 114 toward the proximal end portion 112.

[0096] Depending on how the capturing element 90 collapses, the cinching mechanism can collapse the circumferential edge 52 of the burst balloon 18 to a fifth diameter D5. In some instances, the fifth diameter D5 can be different than the fourth diameter D4. In some instances, the fifth diameter D5 can be approximately the same size as the fourth diameter D4. The fourth diameter D4 at the distal end portion 114 of the capturing element 90 is shown smaller than the inner diameter D3 of the opposing introducer sheath 32, creating a lead-in for the capturing element 90 to be smoothly inserted into the sheath 32, as shown in FIG. 9C, without getting stuck. The fourth diameter D4 can also be at least approximately the same size as the inner diameter D3 of the opposing introducer sheath 32, where the opposing introducer sheath 32 canAttorney Docket No: THVDL-23503WO01 further collapse the capturing element 90 as the capturing element 90 is inserted into the sheath 32.

[0097] The capturing element 90 in the collapsed configuration of FIG. 9B is inserted into the removal sheath 32 as shown in FIG. 9C when the balloon shaft 26 is pushed and / or pulled axially relative to the sheath 32, pulling the burst balloon 18 with it into the sheath 32. Because the surrounding capturing element 90 fully captures the burst balloon 18, the capturing element 90 provides a lead-in for pulling the burst balloon 18 into the sheath 32. As the burst balloon 18 is pulled into the sheath 32, the circumferential edge 52 of the tear 42 can be contained within the capturing element. Both the capturing element 90 and the burst balloon 18 can be further collapsed and compressed to match the inner diameter D3 of the sheath 32. In this way, the circumferential edge 52 of the tear 42 can be prevented from snagging on the distal edge 54 of the sheath 32 by the surrounding capturing element 90 during insertion and the distal and proximal pieces 18a, 18b of the burst balloon 18 can be smoothly positioned within the sheath 32.

[0098] The capturing element 90 can be advanced (e.g. pushed) into the sheath 32 and / or the burst balloon 18 can be pushed / pulled into the sheath 32 until the distal and proximal pieces 18a, 18b of the burst balloon 18 are positioned within the sheath 32 as shown in FIG. 9C. Once the distal and proximal pieces 18a, 18b of the burst balloon 18 are located within sheath 32, the pushing member 92 can be retracted back into the outer sleeve 88, retracting the capturing element 90 from the sheath 32 with it. The distal and proximal pieces 18a, 18b of the burst balloon 18 are left behind within the sheath 32. As shown in FIG. 9D, the distal and proximal pieces 18a, 18b of the burst balloon 18 are stored within the sheath in a collapsed configuration and are ready for removal from the body.

[0099] As the capturing element 90 is retracted from the sheath 32, it is pulled back into the outer sleeve 88 through the gap 104 until it is stowed within the outer sleeve 88, schematically shown in FIG. 9D. The gap 104 between the nose cone 84 and the outer sleeve 88 can be closedAttorney Docket No: THVDL-23503WO01 by advancing the outer sleeve 88 into abutment with the nose cone 84 or by retracting the inner shaft 82. The distal end portion 94 of the retrieval device 80, in a closed configuration with the capturing element 90 stowed, can be retracted through the bifurcation 64 and into the left iliac artery 72 for removal from the body 62, as shown in FIGS. 11-12.

[0100] With the burst balloon 18 contained within the sheath 32 in the body 62, as shown in FIGS. 11-12, the sheath 32 with the burst balloon 18 can be pulled out of the right iliac artery 66. Within the sheath 32, the burst balloon 18 can be removed from the body 62 through reduced diameter lumens without damaging or snagging surrounding tissue.

[0101] In the examples shown in FIGS. 9A-9D and 10, the capturing, expandable element 90 is described as a radially outwardly biased, self-expanding braid with a cinching mechanism. In some examples, the capturing element can be a radially inwardly biased braid that is urged into a collapsed configuration.

[0102] FIG. 13 shows a retrieval device 130 comprising a capturing element 132 in the form of a radially inwardly biased braid. The capturing element 132 can be made of a material with shape memory properties, such as Nitinol, a polyamide, co-polyamide, polyethylene terephthalate, polybutylene terephthalate, thermoplastic elastomer copolyester, or combinations thereof that can bias the braid into a radially collapsed configuration. In addition to the material properties of the braid, a mesh or lattice structure of the braid, including the lattice / mesh spacing and size, can be specified such that the braid maintains shape and biasing ability.

[0103] When the capturing element 132 is an inwardly biased braid, an expanding mechanism 134 can be arranged to radially enlarge or expand at least a portion of the braid to a first diameter D1, so the braid can envelop the burst balloon 18. In an example, the expanding mechanism 134 can comprise a plurality of axially extending, outwardly biased wires 136. The wires 136 can be made of a material with shape memory properties, such as Nitinol. The wires 136 can be disposed along an inner sidewall surface 154 of the capturing element 132 and can extend to a distal end 140 of the capturing element 132. In some instances, the wires 136 can be spacedAttorney Docket No: THVDL-23503WO01 radially around a longitudinal axis of the sleeve 88 in even radial increments. Alternatively or additionally, the wires 136 can be spaced radially around a longitudinal axis of the sleeve 88 in varied radial increments. The number and spacing of the wires 136 can be specified such that the wires 136 provide a radially outward force to expand the capturing element 132.

[0104] In some examples, the proximal end portion 138 of the inwardly biased capturing element 132 can be coupled to a distal end 142 of a pushing member 144. The pushing member 144 can be disposed within the outer sleeve 88 and can slide with respect thereto. A proximal end of the expanding mechanism 134 can be coupled to a distal end 148 of an expansion shaft 150, where the expansion shaft 150 and the wires 136 of the expanding mechanism 134 can reside within the pushing member 144 when in a stowed position. When stowed within the pushing member 144, the pushing member 144 contains the expanding mechanism 134 in a compressed configuration. In the compressed configuration, an outer diameter of the expanding mechanism 134 can approximately match an inner diameter of the pushing member 144.

[0105] When the pushing member 144 is axially translated toward the nose cone 84 of the retrieval device 130 for deployment, the expansion shaft 150 is arranged to be likewise translated. The expansion shaft 150 can be configured to axially retract into the pushing member 144 in a proximal direction independently of the pushing member 144. The manner of coupling the expanding mechanism 134 to the distal end 148 of the expansion shaft 150 can comprise mechanical fastening or bonding, for example, or any combination thereof so long as the expanding mechanism 134 can be retracted into the pushing member 144 independently of the pushing member 144.

[0106] When the pushing member 144 and the expansion shaft 150 are translated axially toward the nose cone 84 of the retrieval device 130 as described above, both the capturing element 132 and the wires 136 of the expanding mechanism 134 are pushed out of the outer sleeve 88 through the gap 104 at the same time. Without constraints of the surrounding outer sleeve 88 and the pushing member 144, the outwardly biased wires 136 of the expanding mechanism 134 canAttorney Docket No: THVDL-23503WO01 expand within the capturing element 132 when deployed. The outwardly biased wires 136 can apply a radially outward force on an inner sidewall surface 154 of the capturing element 132. This outward force causes a distal end of the capturing element 132 to expand to a first diameter D1 as shown in FIG. 13. When the distal end 140 is expanded to the first diameter D1, the capturing element 132 can surround and envelop the burst balloon 18 as it is deployed.

[0107] Once expanded and disposed over the burst balloon 18, the expanding mechanism 134 can be retracted by the expansion shaft 150 back into the sleeve 88 and the pushing member 144, leaving the inwardly biased capturing element 132 to collapse over the burst balloon 18. The capturing element 132 and burst balloon 18 within can then be inserted into the removal sheath 32 for removal as described above with respect to FIGS. 9B-9D.

[0108] In some examples, a capturing element can comprise a braid without a specific radial bias. As such, both an expanding mechanism (any expanding mechanism herein, for example, the expanding mechanism 134) and a cinching mechanism (any cinching mechanism described herein, for example, the cinching mechanism 110), may be employed with for expansion and collapsing. In other words, an expanding mechanism can be used to radially enlarge a capturing element to a diameter to envelop the burst balloon 18 and a cinching mechanism can be used to radially collapse a capturing element over the burst balloon 18 to a diameter for insertion into the sheath 32.

[0109] In some examples, retrieval devices can comprise capturing elements in other forms. As shown in FIG. 14, a retrieval device 160 can comprise a capturing element 162 having a plurality of axially extending and outwardly biased prongs 164. In some examples, the prongs 164 can be spaced radially around a longitudinal axis of the sleeve 88 in even radial increments. Alternatively or additionally, the prongs 164 can be spaced radially around a longitudinal axis of the sleeve 88 in varied radial increments. The number and spacing of the prongs 164 can be specified such that the prongs 164 provide a radially inward force to collapse a balloon within.Attorney Docket No: THVDL-23503WO01

[0110] A length of the prongs 164 can be specified such that the prongs can extend over distal and proximal pieces a burst balloon when deployed (e.g. the distal and proximal pieces 18a, 18b of the burst balloon 18).

[0111] The prongs 164 can be made of a material with shape memory properties, such as Nitinol, a polyamide, co-polyamide, polyethylene terephthalate, polybutylene terephthalate, thermoplastic elastomer copolyester, or combinations thereof. The distal end portion 96 of the pushing member 92 is shown coupled to a proximal end portion 166 of the capturing element 162. The manner of coupling can comprise mechanical fastening, bonding, or combinations thereof, for example, so long as the pushing member 92 is attached to the prongs 164 and can move the prongs 164 out of and into the outer sleeve 88.

[0112] The pushing member 92 can be translated axially toward the nose cone 84 of the retrieval device 160, likewise translating the capturing element 162 in the same direction. As the pushing member 92 is translated, the capturing element 162 can be moved through the gap 104 and out of the sleeve 88 as described above in reference to the capturing element 90 in FIG. 9A. The outwardly biased prongs 164 are contained within the outer sleeve 88 in a collapsed or insertion configuration during passage through a body lumen. Without the sleeve 88 for containment, as the capturing element 162 is pushed, the prongs 164 expand into a deployed configuration as they are urged out of the sleeve 88 by the pushing member 92.

[0113] When the prongs 164 are pushed through the gap 104 by the pushing member 92 and out of the outer sleeve 88, they can expand to a first diameter D1 and can be arranged to extend over the nose cones 84, 34 and the tear 42 in the burst balloon 18. The first diameter D1 can be specified such that the prongs 164 at a distal end portion 168 of the capturing element 162 can envelop the distal and proximal pieces 18a, 18b of the burst balloon 18.

[0114] To radially collapse the prongs 164 around the distal and proximal pieces 18a, 18b of the burst balloon 18 for insertion into the sheath 32, a cinching mechanism (any cinching mechanism described herein, for example, the cinching mechanism 110), can be implemented in the sameAttorney Docket No: THVDL-23503WO01 manner as described above with respect to FIGS. 9B and 10. Once collapsed, the capturing element 162 with prongs 164 can collapse the burst balloon 18 into a low-profile configuration for a smooth lead-in and insertion into the sheath 32.

[0115] Although the capturing element 162 has an alternative configuration to the capturing element 90, the overall envelop can be similar or the same and, therefore, they can be used alternatively. As such, the capturing element 162 can be used in lieu of the capturing element 90 in a retrieval device (such as retrieval device 80, for example) with applicable steps shown in FIGS. 9A-9D.

[0116] The examples shown in FIGS. 1-14 schematically illustrate a medical balloon used for the deployment of a prosthetic heart valve. The devices and methods described herein can be used with other medical apparatuses comprising a balloon. As such, balloon retrieval devices (any retrieval device described herein, for example, retrieval devices 80, 130, and 160) and retrieval methods described herein can be used to envelop and retrieve various ruptured medical balloons. In this way, balloon retrieval devices can be used to collapse pieces of a burst balloon and insert the pieces into a sheath for removal from the body, thereby reducing the likelihood that pieces of the burst balloon get stuck, cause damage to surrounding tissue during removal, detach from the delivery apparatus, and / or embolize. Sterilization

[0117] Any of the systems, devices, apparatuses, etc. herein can be sterilized (for example, with heat / thermal, pressure, steam, radiation, and / or chemicals, etc.) to ensure they are safe for use with patients, and any of the methods herein can include sterilization of the associated system, device, apparatus, etc. as one of the steps of the method. Examples of heat / thermal sterilization include steam sterilization and autoclaving. Examples of radiation for use in sterilization include, without limitation, gamma radiation, ultra-violet radiation, and electron beam. Examples of chemicals for use in sterilization include, without limitation, ethylene oxide,Attorney Docket No: THVDL-23503WO01 hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Sterilization with hydrogen peroxide may be accomplished using hydrogen peroxide plasma, for example. Delivery Techniquesa prosthetic valve within the native aortic valve via a transfemoral delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral artery and are advanced into and through the descending aorta, around the aortic arch, and through the ascending aorta. The prosthetic valve is positioned within the native aortic valve and radially expanded (e.g., by inflating a balloon, actuating one or more actuators of the delivery apparatus, or deploying the prosthetic valve from a sheath to allow the prosthetic valve to self-expand). Alternatively, a prosthetic valve can be implanted within the native aortic valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart and the prosthetic valve is positioned within the native aortic valve. Alternatively, in a transaortic procedure, a prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the aorta through a surgical incision in the ascending aorta, such as through a partial J-sternotomy or right parasternal mini- thoracotomy, and then advanced through the ascending aorta toward the native aortic valve.

[0119] For implanting a prosthetic valve within the native mitral valve via a transseptal delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral vein and are advanced into and through the inferior vena cava, into the right atrium, across the atrial septum (through a puncture made in the atrial septum), into the left atrium, and toward the native mitral valve. Alternatively, a prosthetic valve can be implanted within the native mitral valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the leftAttorney Docket No: THVDL-23503WO01 ventricle through a surgical opening in the chest and the apex of the heart and the prosthetic valve is positioned within the native mitral valve.

[0120] For implanting a prosthetic valve within the native tricuspid valve, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral vein and are advanced into and through the inferior vena cava, and into the right atrium, and the prosthetic valve is positioned within the native tricuspid valve. A similar approach can be used for implanting the prosthetic valve within the native pulmonary valve or the pulmonary artery, except that the prosthetic valve is advanced through the native tricuspid valve into the right ventricle and toward the pulmonary valve / pulmonary artery.

[0121] Another delivery approach is a transatrial approach whereby a prosthetic valve (on the distal end portion of the delivery apparatus) is inserted through an incision in the chest and an incision made through an atrial wall (of the right or left atrium) for accessing any of the native heart valves. Atrial delivery can also be made intravascularly, such as from a pulmonary vein. Still another delivery approach is a transventricular approach whereby a prosthetic valve (on the distal end portion of the delivery apparatus) is inserted through an incision in the chest and an incision made through the wall of the right ventricle (typically at or near the base of the heart) for implanting the prosthetic valve within the native tricuspid valve, the native pulmonary valve, or the pulmonary artery.

[0122] In all delivery approaches, the delivery apparatus can be advanced over a guidewire previously inserted into a patient’s vasculature. Moreover, the disclosed delivery approaches are not intended to be limited. Any of the prosthetic valves disclosed herein can be implanted using any of various delivery procedures and delivery devices known in the art. Additional Examples of the Disclosed Technology

[0123] In view of the above described implementations of the disclosed subject matter, this application discloses the additional examples enumerated below. It should be noted that oneAttorney Docket No: THVDL-23503WO01 feature of an example in isolation or more than one feature of the example taken in combination and, optionally, in combination with one or more features of one or more further examples are further examples also falling within the disclosure of this application.

[0124] Example 1. A retrieval device for collapsing a ruptured medical balloon, the retrieval device comprising: a sleeve; and a capturing element having an insertion configuration within the sleeve and a deployed configuration outside of the sleeve, wherein the capturing element radially expands in the deployed configuration to envelop and collapse the ruptured medical balloon.

[0125] Example 2. The retrieval device of any example herein, particularly example 1, further comprising a pushing member disposed within the sleeve, wherein the pushing member is coupled to a proximal end portion of the capturing element.

[0126] Example 3. The retrieval device of any example herein, particularly examples 1 or 2, wherein the capturing element envelops a full length of the ruptured medical balloon.

[0127] Example 4. The retrieval device any example herein, particularly any one of examples 1-3, wherein the capturing element is a braid.

[0128] Example 5. The retrieval device of any example herein, particularly any one of examples 1-3, wherein the capturing element comprises a plurality of axially extending prongs.

[0129] Example 6. The retrieval device any example herein, particularly any one of examples 1-5, wherein the retrieval device further comprises a cinching mechanism configured to radially close at least a portion of the capturing element.

[0130] Example 7. The retrieval device of any example herein, particularly example 6, wherein the cinching mechanism comprises a lasso wire, a stretching rod, or a twisting component.

[0131] Example 8. The retrieval device of any example herein, particularly any one of examples 1-5, wherein the retrieval device further comprises an expanding mechanism configured to radially enlarge at least a portion the capturing element.Attorney Docket No: THVDL-23503WO01

[0132] Example 9. The retrieval device of any example herein, particularly example 8, wherein the expanding mechanism comprises a plurality of wires.

[0133] Example 10. The retrieval device of any example herein, particularly any one of examples 1-9, wherein the capturing element is made of Nitinol, a polyamide, co-polyamide, polyethylene terephthalate, polybutylene terephthalate, thermoplastic elastomer copolyester, or combinations thereof.

[0134] Example 11. A retrieval device for removing a ruptured medical balloon, the retrieval device comprising: a sleeve; a capturing element having an insertion configuration within the sleeve and a deployed configuration outside of the sleeve; and a pushing member disposed within the sleeve and coupled to a proximal end portion of the capturing element, wherein the pushing member extends the capturing element into the deployed configuration to envelop and radially collapse the ruptured medical balloon for insertion into an opposing removal sheath.

[0135] Example 12. The retrieval device of any example herein, particularly example 11, wherein the capturing element is radially biased into an expanded position.

[0136] Example 13. The retrieval device of any example herein, particularly example 12, further comprising a cinching mechanism configured to radially close a distal end portion of the capturing element.

[0137] Example 14. The retrieval device of any example herein, particularly example 13, wherein the cinching mechanism comprises a lasso wire, a stretching rod, or a twisting component.

[0138] Example 15. The retrieval device of any example herein, particularly example 11, wherein the capturing element is radially biased into a collapsed position.

[0139] Example 16. The retrieval device of any example herein, particularly example 15, further comprising an expanding mechanism configured to radially expand the capturing element.Attorney Docket No: THVDL-23503WO01

[0140] Example 17. The retrieval device of any example herein, particularly example 16, wherein the expanding mechanism a comprises a plurality of outwardly biased wires.

[0141] Example 18. The retrieval device of any example herein, particularly any one of examples 11-17, wherein a distal end portion of the capturing element is collapsed to a first diameter, wherein the first diameter is smaller than a second diameter of the opposing removal sheath.

[0142] Example 19. The retrieval device of any example herein, particularly any one of examples 11-18, wherein the capturing element comprises a braid.

[0143] Example 20. The retrieval device of any example herein, particularly any one of examples 11-18, wherein the capturing element comprises a plurality of axially extending prongs.

[0144] Example 21. A method of collapsing a ruptured medical balloon, the method comprising: positioning a guide wire in a lumen of a body; advancing a retrieval device over the guide wire through the lumen, wherein the retrieval device comprises a sleeve and a capturing element disposed within the sleeve; extending the capturing element outside of the sleeve; enveloping the ruptured medical balloon with the capturing element; and collapsing at least a portion the capturing element around the ruptured medical balloon.

[0145] Example 22. The method of any example herein, particularly example 21, further comprising positioning the retrieval device axially adjacent to the ruptured medical balloon before extending the capturing element.

[0146] Example 23. The method of any example herein, particularly either of examples 21 or 22, wherein the retrieval device further comprises a pushing member disposed within the sleeve and coupled to a proximal end portion of the capturing element.Attorney Docket No: THVDL-23503WO01

[0147] Example 24. The method of any example herein, particularly example 23, further comprising moving the pushing member to extend the capturing element into a deployed configuration.

[0148] Example 25. The method of any example herein, particularly any one of examples 21- 24, further comprising enveloping an entire length of the ruptured medical balloon.

[0149] Example 26. The method of any example herein, particularly any one of examples 21- 25, further comprising radially collapsing at least a portion of the ruptured medical balloon.

[0150] Example 27. The method of any example herein, particularly any one of examples 21- 26, wherein the capturing element is radially biased into an expanded position.

[0151] Example 28. The method of any example herein, particularly example 27, further comprising deploying a cinching mechanism to radially collapse a distal end portion of the capturing element.

[0152] Example 29. The method of any example herein, particularly any one of examples 21- 26, wherein the capturing element is radially biased into a collapsed position.

[0153] Example 30. The method of any example herein, particularly example 29, further comprising deploying an expanding mechanism to radially enlarge at least a portion of the capturing element.

[0154] Example 31. The method of any example herein, particularly any one of examples 21- 30, further comprising radially collapsing a distal end portion of the capturing element to a first diameter, wherein the first diameter is smaller than a second diameter of an opposing removal sheath.

[0155] Example 32. The method of any example herein, particularly example 31, further comprising inserting the collapsed capturing element with the ruptured medical balloon into the opposing removal sheath.Attorney Docket No: THVDL-23503WO01

[0156] Example 33. The method of any example herein, particularly example 32, further comprising retracting the capturing element into the sleeve, leaving the ruptured medical balloon inside the opposing removal sheath.

[0157] Example 34. The method of any example herein, particularly example 33, further comprising removing the opposing removal sheath with the ruptured medical balloon from the body.

[0158] Example 35. The method of any example herein, particularly either of examples 33 or 34, further comprising removing the retrieval device from the body.

[0159] Example 36. A method comprising sterilizing the device, apparatus, and / or assembly of any example.

[0160] Example 37. A retrieval device of any one of examples 1-36, wherein the device is sterilized.

[0161] The features described herein with regard to any example can be combined with other features described in any one or more of the other examples, unless otherwise stated. For example, any one or more of the features of burst balloon retrieval device can be combined with any one or more features of another burst balloon retrieval device. As another example, any one or more steps of one burst balloon retrieval method can be combined with any one or more steps of burst balloon retrieval method.

[0162] In view of the many possible ways in which the principles of the disclosure may be applied, it should be recognized that the illustrated configurations depict examples of the disclosed technology and should not be taken as limiting the scope of the disclosure nor the claims. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents. We therefore claim all that comes within the scope and spirit of these claims.

Claims

Attorney Docket No: THVDL-23503WO01 CLAIMS:

1. A retrieval device for collapsing a ruptured medical balloon, the retrieval device comprising: a sleeve; and a capturing element having an insertion configuration within the sleeve and a deployed configuration outside of the sleeve, wherein the capturing element radially expands in the deployed configuration to envelop and collapse the ruptured medical balloon.

2. The retrieval device of claim 1, further comprising a pushing member disposed within the sleeve, wherein the pushing member is coupled to a proximal end portion of the capturing element.

3. The retrieval device of claims 1 or 2, wherein the capturing element envelops a full length of the ruptured medical balloon.

4. The retrieval device of any one of claims 1-3, wherein the capturing element is a braid.

5. The retrieval device of any one of claims 1-3, wherein the capturing element comprises a plurality of axially extending prongs.

6. The retrieval device of any one of claims 1-5, wherein the retrieval device further comprises a cinching mechanism configured to radially close at least a portion of the capturing element.Attorney Docket No: THVDL-23503WO01 7. The retrieval device of claim 6, wherein the cinching mechanism comprises a lasso wire, a stretching rod, or a twisting component.

8. The retrieval device of any one of claims 1-5, wherein the retrieval device further comprises an expanding mechanism configured to radially enlarge at least a portion the capturing element.

9. The retrieval device of claim 8, wherein the expanding mechanism comprises a plurality of wires.

10. A retrieval device for removing a ruptured medical balloon, the retrieval device comprising: a sleeve; a capturing element having an insertion configuration within the sleeve and a deployed configuration outside of the sleeve; and a pushing member disposed within the sleeve and coupled to a proximal end portion of the capturing element, wherein the pushing member extends the capturing element into the deployed configuration to envelop and radially collapse the ruptured medical balloon for insertion into an opposing removal sheath.

11. The retrieval device of claim 10, wherein a distal end portion of the capturing element is collapsed to a first diameter, wherein the first diameter is smaller than a second diameter of the opposing removal sheath.

12. A method of collapsing a ruptured medical balloon, the method comprising: positioning a guide wire in a lumen of a body;Attorney Docket No: THVDL-23503WO01 advancing a retrieval device over the guide wire through the lumen, wherein the retrieval device comprises a sleeve and a capturing element disposed within the sleeve; extending the capturing element outside of the sleeve; enveloping the ruptured medical balloon with the capturing element; and collapsing at least a portion the capturing element around the ruptured medical balloon.

13. The method of claim 12, further comprising positioning the retrieval device axially adjacent to the ruptured medical balloon before extending the capturing element.

14. The method of either of claims 12 or 13, wherein the retrieval device further comprises a pushing member disposed within the sleeve and coupled to a proximal end portion of the capturing element.

15. The method of claim 14, further comprising moving the pushing member to extend the capturing element into a deployed configuration.

16. The method of any one of claims 12-15, further comprising enveloping an entire length of the ruptured medical balloon.

17. The method of any one of claims 12-16, further comprising radially collapsing at least a portion of the ruptured medical balloon.Attorney Docket No: THVDL-23503WO01 18. The method of any one of claims 12-17, further comprising radially collapsing a distal end portion of the capturing element to a first diameter, wherein the first diameter is smaller than a second diameter of an opposing removal sheath.

19. The method of claim 18, further comprising inserting the collapsed capturing element with the ruptured medical balloon into the opposing removal sheath.

20. The method of claim 19, further comprising retracting the capturing element into the sleeve, leaving the ruptured medical balloon inside the opposing removal sheath.

21. The method of claim 20, further comprising removing the opposing removal sheath with the ruptured medical balloon from the body.

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