WO2025027419A1

WO2025027419A1 - Retainer and catheter system including same

Info

Publication number: WO2025027419A1
Application number: PCT/IB2024/056471
Authority: WO
Inventors: Mark W. SHEPLER; Maggie J. PISTELLA; Justin B. SEELEY
Original assignee: Medtronic Inc
Current assignee: Medtronic Inc
Priority date: 2023-07-28
Filing date: 2024-07-02
Publication date: 2025-02-06
Anticipated expiration: 2026-01-28

Abstract

Various embodiments of a retainer that can be utilized with a catheter system are disclosed. The retainer includes a body having a portion configured to be disposed on an upper surface of a proximal section of a catheter or an elongate shaft of the catheter. The retainer further includes a clip connected to the body and configured to be connected to an inflation fluid source of the catheter or a connector port of a handle portion of the catheter when the source is connected to the connector port. The retainer is configured to prevent a slitter tool from being directed along a longitudinal axis of the catheter from a proximal terminal end toward a distal tip of the catheter and slitting an elongate shaft of the catheter when the inflation fluid source is connected to the connector port.

Description

RETAINER AND CATHETER SYSTEM INCLUDING SAME

TECHNICAL FIELD

[0001] This Application claims priority from U.S. Provisional Patent Application 63/529,531 filed 28 July 2023, the entire content of which is incorporated herein by reference.

[0002] This disclosure generally relates to a retainer for a catheter system.

BACKGROUND

[0003] Catheter systems may be used in intravascular or other procedures to facilitate minimally invasive access to a target site. For example, an angioplasty catheter may include one or more balloons mounted to the catheter that may be advanced to the target site and inflated to clear or compress a blockage, e.g., a stenosis. As another example, a stent delivery catheter may include a stent positioned over a balloon, which may be inflated to deploy the stent. Further, an implantable medical device catheter can be utilized to deliver an implantable medical device such a lead to a target site. To remove from the patient an elongate shaft of the implantable medical device catheter that encloses the lead, a slitter tool can be directed along the elongate shaft as the catheter is withdrawn, thereby remove the shaft from the lead.

SUMMARY

[0004] In general, the present disclosure provides various embodiments of a retainer and a catheter system that includes such retainer. The retainer includes a body and a clip connected to the body. The body is configured to be disposed on a catheter, and the clip is configured to be connected to an inflation fluid source or a connector port of the catheter when the source is connected to the connector port. The retainer is configured to prevent a slitter tool from being directed along a longitudinal axis of the catheter from a proximal terminal end toward a distal tip of the catheter and slitting an elongate shaft of the catheter when the fluid source is connected to the connector port of the catheter. In one or more embodiments, the clip of the retainer includes one or more rings that are configured to be connected to a connector of the inflation fluid source or the connector port. By preventing the elongate shaft from being slit until the inflation fluid source is disconnected from the connector port of the catheter, the retainer helps ensure that an inflation subassembly of the catheter is at least partially deflated prior to removal of the catheter from a patient. [0005] This disclosure includes without limitation the following clauses:

[0006] Clause 1 : A slittable catheter system that includes a slittable catheter having a proximal section, a distal tip, an elongate shaft, and an inflation subassembly, the elongate shaft extending from the proximal section to the distal tip along a longitudinal axis and defining a longitudinally extending delivery lumen. The proximal section of the catheter includes a proximal terminal end; a handle portion including a connector port fluidly connected to an inflation lumen of the inflation subassembly that extends within the elongate shaft, where the connector port is configured to be connected to an inflation fluid source. The system further includes a retainer including a body and a clip connected to the body. A portion of the body is configured to be disposed on an upper surface of the proximal section of the catheter or the elongate shaft, and the clip is configured to be connected to the inflation fluid source or the connector port when the source is connected to the connector port. The retainer is configured to prevent a slitter tool from being directed along the longitudinal axis from the proximal terminal end toward the distal tip and slitting the elongate shaft of the catheter when the inflation fluid source is connected to the connector port.

[0007] Clause 2: The system of Clause 1, where the retainer is further configured to be removed from the catheter when the inflation fluid source is disconnected from the connector port such that the slitter tool can be directed along the longitudinal axis toward the distal tip and slit the shaft of the catheter.

[0008] Clause 3: The system of any one of Clauses 1-2, where the clip of the retainer includes a first ring connected to a first end of the body and a second ring connected to a second end of the body.

[0009] Clause 4: The system of Clause 3, where each of the first and second rings of the retainer is configured to slide onto a connector of the inflation fluid source that is configured to connect the inflation fluid source to the connector port.

[0010] Clause 5: The system of any one of Clauses 1-4, where the retainer includes a polymer material. [0011] Clause 6: The system of Clause 5, where the retainer includes a flexible polymer material.

[0012] Clause 7: The system of any one of Clauses 1-6, where the inflation fluid source includes a syringe having a luer configured to mechanically engage with the connector port.

[0013] Clause 8: The system of any one of Clauses 1-7, where the portion of the body of the retainer that is configured to be disposed on the upper surface of the proximal section or the elongate shaft is further configured to engage a leading edge feature of the slitter tool such that the slitter tool is prevented from being directed along the longitudinal axis toward the distal tip and slitting the shaft of the catheter when the inflation fluid source is connected to the connector port.

[0014] Clause 9: The system of any one of Clauses 1-8, where the inflation subassembly further includes a compliant sleeve member and an elongate tube, the sleeve member extending around an exterior surface of the shaft, in proximity to the distal tip. The sleeve member includes a proximal end, a distal end, and an inflatable section extending between the proximal and distal ends. The proximal and distal ends are secured to the shaft.

Further, the elongate tube defines the inflation lumen that extends within the shaft from a first opening in the proximal section to a second opening that communicates between the exterior surface of the shaft and an interior surface of the inflatable section of the sleeve. [0015] Clause 10: The system of Clause 9, where the tube of the inflation subassembly includes a section extending laterally from the shaft and into the handle portion such that the first opening of the inflation lumen is located in the connector port.

[0016] Clause 11 : The system of any one of Clauses 1-10, where the delivery lumen further includes a proximal port portion and a seal zone portion. The proximal port portion extends distally from a proximal opening along the longitudinal axis to the seal zone portion and has a perimeter divided into a first portion and a second portion. Further, the first portion is relatively soft and includes an exposed sealing area. The second portion is relatively hard and comprises a relatively thin wall section.

[0017] Clause 12: The system of any one of Clauses 1-11, where the clip is connected to the body of the retainer by a living hinge.

[0018] Clause 13: The system of any one of Clauses 1-12, further including the inflation fluid source. [0019] Clause 14: The system of Clause 13, where the inflation fluid source further includes a fluid filter that is configured to be disposed between an outlet of the inflation fluid source and the connector port of the handle portion when the inflation fluid source is connected to the connector port. The clip of the retainer is configured to be connected to the fluid filter.

[0020] Clause 15: The system of any one of Clauses 1-14, where the catheter further includes an external engagement feature disposed in the upper surface of the proximal section adjacent to the proximal terminal end, where the external engagement feature defines a gap configured to receive the slitter tool as the tool is directed along the longitudinal axis.

[0021] Clause 16: The system of Clause 15, where the portion of the body of the retainer is disposed adjacent to the external engagement feature.

[0022] Clause 17: The system of Clause 15, where the catheter further includes a secondary external engagement feature disposed on the upper surface of the proximal section distal to the external engagement feature.

[0023] Clause 18: The system of Clause 17, where the portion of the body of the retainer is disposed adjacent to the secondary external engagement feature such that the secondary external engagement feature is between the portion of the body and the external engagement feature.

[0024] Clause 19: The system of any one of Clauses 1-18, further including a slitter tool configured to engage the catheter along the longitudinal axis at the proximal terminal end and slit the catheter.

[0025] Clause 20: A method including disposing a portion of a body of a retainer on an upper surface of a proximal section of a catheter or an elongate shaft of the catheter, where the retainer is configured to prevent slitting the elongate shaft when the portion of the body is disposed on the upper surface of the proximal section or the elongate shaft; connecting a clip of the retainer to an inflation fluid source or a connector port of a handle portion of the proximal section of the catheter, where the clip is connected to the body of the retainer; and connecting the inflation fluid source to the connector port; and inflating an inflatable section of a compliant sleeve member of an inflation subassembly of the catheter that extends around an exterior surface of the elongate shaft of the catheter proximate a distal tip of the catheter, where the compliant sleeve member is fluidly connected to the connector port via an inflation lumen of the inflation subassembly and extends within the elongate shaft of the catheter. The method further includes deflating the inflatable section of the compliant sleeve member by disconnecting the inflation fluid source from the connector port, removing the clip of the retainer from the inflation fluid source or the connector port and the portion of the body of the retainer from the upper surface of the proximal section after the inflatable section of the elongate shaft has been deflated, and slitting the shaft of the catheter in a direction from the proximal section toward the distal tip along a longitudinal axis defined by the elongate shaft.

[0026] Clause 21 : The method of Clause 20, where inflating the inflatable section includes directing inflation fluid from the inflation fluid source through the connector port and into the inflation lumen of the inflation subassembly.

[0027] Clause 22: The method of any one of Clauses 20-21, where the clip of the retainer includes a first ring connected to a first end of the body and a second ring connected to a second end of the body. Connecting the clip includes disposing the first and second rings on at least a portion of a connector of the inflation fluid source.

[0028] Clause 23 : The method of any one of Clauses 20-22, where slitting the shaft of the catheter includes directing a slitter tool in the direction from the proximal section toward the distal tip along the longitudinal axis such that a blade of the slitter tool slits the elongate shaft of the catheter.

[0029] Clause 24: The method of Clause 23, where the portion of the body of the retainer that is configured to be disposed on the upper surface of the proximal section or the elongate shaft is further configured to engage a leading edge feature of the slitter tool such that the slitter tool is prevented from being directed along the longitudinal axis toward the distal tip and slitting the elongate shaft of the catheter when the inflation fluid source is connected to the connector port.

[0030] Clause 25: The method of any one of Clauses 20-24, further including advancing a guide wire into a proximal port portion of the catheter and into a delivery lumen of the elongate shaft of the catheter and through a distal opening of the delivery lumen to a target site, and advancing a lead over the advanced guide wire and through the proximal port portion and the delivery lumen prior to deflating the inflatable section of the compliant sleeve member. [0031] Clause 26: A retainer that includes a body having a portion configured to be disposed on an upper surface of a proximal section of a catheter or an elongate shaft of the catheter, and a clip connected to the body and configured to be connected to an inflation fluid source of the catheter or a connector port of a handle portion of the catheter when the source is connected to the connector port. The retainer is configured to prevent a slitter tool from being directed along a longitudinal axis of the catheter from a proximal terminal end toward a distal tip of the catheter and slitting an elongate shaft of the catheter when the inflation fluid source is connected to the connector port.

[0032] Clause 27: The retainer of Clause 26, where the retainer is further configured to be removed from the catheter when the inflation fluid source is disconnected from the connector port such that the slitter tool can be directed along the longitudinal axis toward the distal tip and slit the elongate shaft of the catheter.

[0033] Clause 28: The retainer of any one of Clauses 26-27, where the clip of the retainer includes a first ring connected to a first end of the body and a second ring connected to a second end of the body.

[0034] Clause 29: The retainer of Clause 28, where at least one of the first ring or second ring includes a slot disposed through a body of the ring such that the ring can be expanded. [0035] Clause 30: The retainer of any one of Clauses 28-29, where each of the first and second rings of the retainer is configured to slide onto a connector of the inflation fluid source that is configured to connect the inflation fluid source to the connector port.

[0036] Clause 31 : The retainer of any one of Clauses 26-30, where the retainer includes a polymer material.

[0037] Clause 32: The retainer of Clause 31, where the retainer includes a flexible polymer material.

[0038] Clause 33 : The retainer of Clause 31, where the body of the retainer includes a rigid polymer material and the clip includes a flexible polymer material.

[0039] Clause 34: The retainer of any one of Clauses 26-33, where the inflation fluid source includes a syringe comprising a luer configured to mechanically engage with the connector port.

[0040] Clause 35: The retainer of any one of Clauses 26-34, where the portion of the body of the retainer that is configured to be disposed on the upper surface of the proximal section or the elongate shaft is further configured to engage a leading edge feature of the slitter tool such that the slitter tool is prevented from being directed along the longitudinal axis from the proximal terminal end toward the distal tip of the catheter and slitting the shaft of the catheter when the inflation fluid source is connected to the connector port. [0041] Clause 36: The retainer of any one of Clauses 26-35, where the body of the retainer includes a first arm and a second arm that are connected at the portion of the body that is configured to be disposed on an upper surface of a proximal section of a catheter or an elongate shaft of the catheter.

[0042] Clause 37: The retainer of Clause 26, where the clip is connected to the body of the retainer by a living hinge.

[0043] Clause 38: The retainer of Clause 26, where the clip of the retainer includes a first ring connected to a first end of the body by a first living hinge and a second ring connected to a second end of the body by a second living hinge.

[0044] Clause 39: The retainer of Clause 26, where the body of the retainer includes a C shape.

[0045] Clause 40: The retainer of Clause 26, where the portion of the body of the retainer includes a living hinge.

BRIEF DESCRIPTION OF DRAWINGS

[0046] FIG. l is a schematic plan view of one embodiment of a catheter system that includes a catheter and a retainer.

[0047] FIG. 2 is a schematic plan view of a proximal section of the catheter system of FIG. 1.

[0048] FIG. 3 is a schematic plan view of the retainer of the catheter system of FIG. 1. [0049] FIG. 4 is a schematic perspective view of the proximal section of the catheter of the system of FIG. 1 and a slitter tool of the system.

[0050] FIG. 5 is a schematic cross-section view of a handle portion of the proximal section of the catheter of FIG. 1.

[0051] FIG. 6 is a schematic cross-section view of a distal portion of an elongate shaft of the catheter of FIG. 1.

[0052] FIG. 7 is a schematic perspective view of a portion of the proximal section of the catheter of FIG. 1. [0053] FIG. 8 is a schematic perspective view of the catheter system of FIG. 1 with a guidewire of the system being delivered to a target site within a heart of a patient. [0054] FIG. 9 is a schematic perspective view of a lead of the catheter system of FIG. 1 being delivered to the target site over the guidewire of FIG. 8.

[0055] FIG. 10 is a schematic perspective view of the slitter tool being prevented by the retainer from being directed along a longitudinal axis of the elongate shaft of the catheter of FIG. 1.

[0056] FIG. 11 is a schematic perspective view of another embodiment of a retainer that can be utilized with the catheter system of FIG. 1.

[0057] FIG. 12 is a flowchart of one embodiment of a method of utilizing a retainer with the catheter system of FIG. 1.

DETAILED DESCRIPTION

[0058] In general, the present disclosure provides various embodiments of a retainer and a catheter system that includes such retainer. The retainer includes a body and a clip connected to the body. The body is configured to be disposed on a catheter, and the clip is configured to be connected to an inflation fluid source or a connector port of the catheter when the source is connected to the connector port. The retainer is configured to prevent a slitter tool from being directed along a longitudinal axis of the catheter from a proximal terminal end toward a distal tip of the catheter and slitting an elongate shaft of the catheter when the fluid source is connected to the connector port of the catheter. In one or more embodiments, the clip of the retainer includes one or more rings that are configured to be connected to a connector of the inflation fluid source or the connector port. By preventing the elongate shaft from being slit until the inflation fluid source is disconnected from the connector port of the catheter, the retainer helps ensure that an inflation subassembly of the catheter is at least partially deflated prior to removal of the catheter from a patient. [0059] For slittable catheter systems, an elongate shaft of the catheter may be withdrawn from the patient as the shaft is slit, thereby removing the shaft from a lead that has been implanted at the target site. An inflation subassembly of the catheter assembly may, however, preferably be deflated prior to withdrawal of the catheter from the target site. As a result, it may be preferred that the inflation subassembly be at least partially deflated prior to slitting and withdrawal of the elongate shaft of the catheter. [0060] In one or more embodiments described herein, a slittable catheter system can include a retainer that can help to prevent slitting of the elongate shaft of the delivery catheter until the inflation subassembly is at least partially deflated. In one or more embodiments, a clip of the retainer is removed from either an inflation fluid source (e.g., syringe) that is connected to a connector port of the catheter or from the connector port prior to slitting of the catheter. When the inflation fluid source is disconnected from the catheter, the inflation subassembly deflates. After the retainer is removed from the catheter, a clinician can slit the elongate shaft and remove it from the lead.

[0061] FIGS. 1-10 are various views of one embodiment of a slittable catheter system 10. The system 10 can include any suitable system. As used herein, the term “slittable catheter system” refers to a catheter system that includes an elongate shaft that can be slit and removed from an implanted lead that has been delivered to a target site through a delivery lumen of the elongate shaft.

[0062] The system 10 includes a slittable catheter 12 having a proximal section 14, a distal tip 16, an elongate shaft 18, and an inflation subassembly 20. The elongate shaft 18 extends from the proximal section 14 to the distal tip 16 along a longitudinal axis 2 and defines a longitudinally extending delivery lumen 22 (FIG. 7). The proximal section 14 of the catheter 12 includes a proximal terminal end 24, and a handle portion 26 that includes a connector port 28 fluidly connected to an inflation lumen 30 (FIG. 5) of the inflation subassembly 20 that extends within the elongate shaft 18. The connector port 28 is configured to be connected to an inflation fluid source 32 (FIGS. 8-9).

[0063] The system 10 further includes a retainer 34 having a body 36 (FIG. 3) and a clip 38 connected to the body. A portion 40 of the body 36 is configured to be disposed on an upper surface 42 of the proximal section 14 of the catheter 12 or the elongate shaft 18, and the clip 38 is configured to be connected to the inflation fluid source 32 or the connector port 28 when the source is connected to the connector port. The retainer 34 is configured to prevent a slitter tool 44 (FIGS. 4 and 10) from being directed along the longitudinal axis 2 from the proximal terminal end 24 toward the distal tip 16 and slitting the elongate shaft 18 of the catheter 12 when the inflation fluid source 32 is connected to the connector port 28.

[0064] The slittable catheter system 10 can include any suitable elements or components, e.g., the catheter 12, the slitting tool 44, the inflation fluid source 32, one or more syringes, stopcock tubing, one or more valve tools, a dilator, the retainer 34, a guide wire 76, a lead 80, an attachable adjustable valve, etc. Further, the system 10 can be utilized to deliver one or more implantable medical devices (e.g., lead 80 of FIG. 9) to one or more target sites within a patient’s body or provide treatment to a patient. For example, the catheter 12 can provide a conduit (i.e., delivery lumen 22) for the clinician to pass an elongate medical device such as a medical electrical lead 80 into the body to deliver a site-specific therapy from a medical device that is implanted in the patient or external to the patient.

[0065] The system 10 can include any suitable catheter 12 or catheters. The catheter 12 includes the delivery lumen 22 (FIG. 7) that extends along a length of the catheter, where the elongate shaft 18, which extends from the proximal section 14 of the catheter to the distal tip 16 of the catheter, defines at least a portion of the delivery lumen. The proximal terminal end 24 of the catheter 12 defines a perimeter 23 of a proximal opening 48 of the delivery lumen 22. In one or more embodiments, the delivery lumen 22 can further include a proximal port portion 50 (FIG. 1) and a seal zone portion 52, where the proximal port portion extends distally from the proximal opening 48 along the longitudinal axis 2 to the seal zone portion and has a perimeter divided into a first portion 110 (FIG. 7), which is relatively soft and includes exposed sealing area 54, and a second portion 112, which is relatively hard and includes a relatively thin wall section 56 (FIG. 7), which spans a gap 58 defined by one or more external engagement features 60. The external engagement features 60 can be disposed in or on the upper surface 42 of the proximal section 14 adjacent to the proximal terminal end 24. The gap 58 defined by the features 60 is configured to receive the slitter tool 44 as the tool is directed along the longitudinal axis 2 as is further described herein. In one or more embodiments, a leading-edge feature 84 (FIG. 4) of the slitter tool 44 can be directed into the gap 58 for an interlocking engagement between the tool and the proximal section 14. A blade 86 of the tool 44 can engage a proximal edge 55 (FIG. 7) of the relatively thin wall section 56 of the proximal port portion 50 of the delivery lumen 22 to slit the elongate shaft 18.

[0066] The catheter 12 can also include one or more secondary external engagement features 61 (FIG. 1) disposed on the upper surface 42 of the proximal section 14 distal to the external engagement features 60. The external engagement features 60 and secondary external engagement features 61 can take any suitable shape and have any suitable dimensions. The feature 84 of the slitter tool 44 can be constrained between opposing sides of the secondary external engagement features 61 as the tool is directed along the longitudinal axis 2.

[0067] The catheter 12 further includes a distal opening 62 formed in the distal tip 16 and that is in fluid communication with the delivery lumen 22. The guide wire 76 (FIGS. 8-9) and the lead 80 can be delivered to the target site within the patient through the distal opening 62.

[0068] The catheter 12 further includes the inflation subassembly 20 (FIG. 1) and the corresponding connector port 28 formed in the handle portion 26 of the proximal section 14, which projects laterally from the seal zone portion 52 on an opposite side of the longitudinal axis 2 from the relatively thin wall section 56. The inflation subassembly 20 includes a complaint sleeve member 64 that extends around an exterior surface 19 of the elongate shaft 18 proximate the distal tip 16. The sleeve member 64 can include any suitable material, e.g., a medical grade thermoplastic elastomer or a medical grade thermoset. The sleeve member 64 includes a proximal end 66, a distal end 68, and an inflatable section 70 extending between the proximal and distal ends. The proximal and distal ends 66, 68 can be secured to the elongate shaft 18 using any suitable technique. As shown in FIG. 6, which is a schematic cross-section view of a portion of the inflatable section 70 in a plane substantially parallel to the longitudinal axis 2, an interior of the inflatable section is in fluid communication with the inflation lumen 30 of the inflation subassembly 20, which extends from a first opening 72 (FIG. 5) within the handle portion 26 to a second opening 46 (FIG. 6) that communicates with the exterior surface 19 of the elongate shaft 18 and an interior surface of the inflatable section 70. The inflation lumen 30 may be formed by an elongate tube 74 that defines the inflation lumen 30 and that extends within the shaft 18 from the first opening 72 in the proximal section 14 to the second or distal opening 46 that communicates between the exterior surface 19 of the shaft 18 and an interior surface 71 of the inflatable section 70 of the sleeve member 64. The tube 74 includes a section 75 extending laterally from the shaft 18 and into the handle portion 26 such that the first opening 72 of the inflation lumen 30 is located in the connector port 28. The first opening 72 is in fluid communication with the connector port 28, which is configured to be connected to the inflation fluid source 32 (FIG. 8). When the inflation fluid source 32 is pressurized, the fluid therein, e.g., air, is moved through the inflation lumen 30 to inflate inflatable section 70 of the sleeve member 64. In one or more embodiments, once the catheter 12 has canulated, e.g., the patient’s coronary sinus (CS Os), such inflation can be useful for improved fluoroscopic visualization of the coronary venous system downstream of the distal tip 16, and/or for anchoring distal tip as shown in FIGS. 8-9.

[0069] The inflation fluid source 32 can include any suitable source for providing an inflation fluid to the inflation subassembly 20. In one or more embodiments, the source 32 can include a gas line that is connected to the connector port 28 using any suitable technique to provide gas (e.g., air) to the inflation subassembly 20. In one or more embodiments, the source 32 can includes a syringe 33 having a luer 108 (FIG. 8) that is configured to mechanically engage with the connector port 28. In one or more embodiments, the inflation fluid source 32 can include a fluid filter 31 (FIG. 2) that is configured to be disposed between an outlet 35 of the inflation fluid source and the connector port 28 when the inflation fluid source is connected to the connector port. In one or more embodiments, the clip 38 of the retainer 34 is configured to be connected to the fluid filter 31.

[0070] The system 10 further includes the retainer 34, which can take any suitable shape and have any suitable dimensions. The retainer 34 is configured to prevent the slitter tool 44 from being directed along the longitudinal axis 2 from the proximal terminal end 24 toward the distal tip 16 and slitting the elongate shaft 18 of the catheter when the inflation fluid source 32 is connected to the connector port 28. If the catheter 12 is withdrawn from the patient as the elongate shaft 18 is removed while the inflatable section 70 of the inflation subassembly 20 is inflated, the inflatable section may interact with internal structures of the patient. By preventing the slitter tool 44 from slitting the elongate shaft 18 until being removed, the retainer 34 can prevent the inflatable section 70 from remaining fully inflated as the catheter 12 is removed from the patient. Before the elongate shaft 18 is slit, the inflation fluid source 32 must be removed such that the source disengages with the clip 38 of the retainer 34 and the body 36 of the retainer is removed from the proximal section 14, thereby allowing the slitter tool 44 to advance along the longitudinal axis of the elongate shaft 18. In one or more embodiments, the retainer 34 is further configured to be removed from the catheter 12 when the inflation fluid source 32 is disconnected from the connector port 28 such that the slitter tool 44 can be directed along the longitudinal axis 2 toward the distal tip 16 and slit the shaft 18 of the catheter. [0071] The retainer 34 can include any suitable material, e.g., at least one of a metallic, polymeric, or ceramic material. In one or more embodiments, the retainer 34 includes a polymer material, e.g., PEBAX 72D (available from Arkema, Colombes Cedex, France). In one or more embodiments, the retainer 34 includes a flexible polymer material, e.g., PEBAX 72D.

[0072] The retainer 34 can be manufactured using any suitable technique, e.g., molding, insert molding, 3D printing, cast and cure molding, etc. In one or more embodiments, the body 36 can be integral with the clip 38, i.e., made as one part in the manufacturing process. In one or more embodiments, the body 36 and clip 38 can be manufactured separately and connected using any suitable technique, e.g., adhering, mechanically fastening, thermal bonding, over molding, chemical bonding, etc.

[0073] The retainer 34 includes the body 36 and the clip 38 connected to the body. The body 36 can take any suitable shape and have any suitable dimensions. In one or more embodiments, the body 36 includes a C shape.

[0074] Further, the body 36 can include any suitable material. In one or more embodiments, the body 36 includes the same material as a material of the clip 38. In one or more embodiments, a material of the body 36 is different from a material of the clip 38. In one or more embodiments, the body 36 of the retainer 34 includes a rigid polymer material (e.g., PEBAX 72D, PEBAX 63D, VESTAMID (available from Evonik, Essen, Germany), etc.) and the clip 38 includes a flexible polymer material (e.g., PEBAX 55D, PEBAX 40D, PEBAX 35D, PEBAX 25D, etc ).

[0075] The portion 40 of the body 36 of the retainer 34 is configured to be disposed on any suitable portion of the catheter 12 to prevent the slitter tool 44 from slitting the elongate shaft 18. In one or more embodiments, the portion 40 of the body 36 is configured to be disposed on the upper surface 42 of the proximal section 14 or the elongate shaft 18 of the catheter 12. The portion 40 of the body 36 can be disposed on any suitable portion of the upper surface 42. In one or more embodiments, the portion 40 is disposed adjacent to the external engagement features 60. In one or more embodiments, the portion 40 of the body 36 is disposed adjacent to the secondary external engagement features 61 such that the secondary external engagement features are between the portion of the body and the external engagement features 60. In one or more embodiments, such portion 40 is further configured to engage the leading edge feature 84 (FIG. 4) of the slitter tool 44 such that the slitter tool is prevented from being directed along the longitudinal axis 2 from the proximal terminal end 24 toward the distal tip 16 of the catheter 12 and slitting the shaft 18 of the catheter when the inflation fluid source 32 is connected to the connector port 28.

[0076] In one or more embodiments, the body 36 of the retainer 34 can include a first arm 88 and a second arm 90 (FIG. 3) that are connected at the portion 40 of the body. In one or more embodiments, the portion 40 of the body 36 can include a living hinge 92. Such living hinge 92 can connect the first arm 88 to the second arm 90. Each of the first and second arms 88, 90 can take any suitable shape and have any suitable dimensions. Although depicted as having two arms 88, 90, the retainer 34 can include any suitable number of arms.

[0077] Connected to the body 36 of the retainer 34 is the clip 38. The retainer 34 can include any suitable number of clips 38, e.g., one, two, three, four, or more clips. The clip 38 can be connected to the body 36 using any suitable technique. In one or more embodiments, the clip 38 can be connected to the body 36 by a living hinge. In the embodiment illustrated in FIG. 3, the clip 38 includes a first ring 94 and a second ring 96. The first ring 94 can be connected to a first end 98 of the body 36, and the second ring 96 can be connected to a second end 99 of the body. In one or more embodiments, the first ring 94 can be connected to the first arm 88 of the body 36, and the second ring 96 can be connected to the second arm 90 of the body. In one or more embodiments, at least one of the first ring 94 or the second ring 96 can be connected to the body 36 by a living hinge. For example, as shown in FIG. 3, the first ring 94 is connected to the body 36 by a first living hinge 100, and the second ring 96 is connected to the body by a second living hinge 102. The first ring 94 defines an opening 104 and the second ring 96 defines an opening 106.

[0078] Each of the rings 94, 96 can take any suitable shape and have any suitable dimensions. In one or more embodiments, at least one of the rings 94, 96 can take an ovular shape in a plane substantially parallel to a plane defined by the respective opening 104, 106. In general, at least one of the first or second rings 94, 96 can be configured to connect the retainer 34 to (e.g., slide onto) a connector (e.g., luer 108 or the air filter 31) of the inflation fluid source 32 that is configured to connect the inflation fluid source to the connector port 28. In one or more embodiments, at least one of the first or second rings 94, 96 can be configured to connect the retainer 34 to (e.g., slide onto) the connector port 28. In one or more embodiments, the first ring 94 is configured to connect the retainer 34 to the inflation fluid source 32 (e.g., the luer 108 or the air filter 31) and the second ring 96 is configured to connect the retainer to the connector port 28. At least one of the first or second rings 94, 96 can be continuous such that the ring encloses the plane of the respective opening 104, 106. In one or more embodiments, at least one of the first or second rings 94, 96 can include one or more slots such that the ring is no longer continuous.

[0079] For example, FIG. 11 is a schematic perspective view of another embodiment of a retainer 234. All design considerations and possibilities described herein regarding retainer 34 apply equally to retainer 234. The retainer 234 includes a body 236 and a clip 238 connected to the body. The clip 238 includes a first ring 294 and a second ring 296.

[0080] One difference between retainer 234 of FIG. 11 and retainer 34 of FIG. 3 is that the first ring 294 includes a slot 202 and the second ring 296 includes a slot 204. The slot 202 is disposed through a body 206 of the first ring 294, and the slot 204 is disposed through a body 208 of the second ring 296. Although each ring 294, 296 includes a slot 202, 204, in one or more embodiments, only one ring includes a slot. The slots 202, 204 can be formed in the rings 294, 296 using any suitable technique. In one or more embodiments, the rings 294, 296 are initially formed to include slots 202, 204 respectively. In one or more embodiments, each ring 294, 296 is formed as a continuous shape, and the slots 202, 204 are formed by separating each ring, e.g., by cutting the ring or removing a portion of the ring. Such slots 202, 204 can allow the respective ring 294, 296 to expand to accommodate various sizes of inflation fluid source connectors, inflation sources, etc.

[0081] FIGS. 8-9 are schematic views of one embodiment of a technique for delivering an implantable medical electrical lead to a target site in the coronary vasculature. The retainer 34 has been removed from FIGS. 8-9 for explanatory purposes. In FIGS.8-9, a clinician has already maneuvered the catheter 12 within a patient’s venous system, for example, over the pre-positioned guide wire 76 so that distal tip 16 canulates the CS Os. In FIG. 8, the guide wire 76 has been advanced through the proximal port portion 50 of the catheter 12 alongside an inserted tip of syringe 78, and out through the distal opening of the delivery lumen 22, at the distal tip, and into the coronary sinus. The syringe 78 can be utilized to inject dye into the delivery lumen 22 of the catheter 12. [0082] FIG. 8 illustrates the inflation fluid source 32 (e.g., inflation syringe) connected to the connector port 28 and pressurized to inflate inflatable section 70 of sleeve member 64 FIG. 1), for example, which the clinician has coupled and then pressurized, when the catheter 12 canulates the CS Os. The inflated inflatable section 70 of the sleeve member 64 effectively blocks the CS Os to prevent backflow and/or dilution of injected radiopaque dye, thereby enhancing fluoroscopic visualization of the coronary vasculature downstream of distal tip 16, so that the clinician may effectively advance the guide wire 76 out through the distal tip 16 and to the target site, either during or following the injection of the dye from the inflation fluid source 32. The dashed line in FIG. 8 represents an optional inflated balloon mounted around a distal portion of the guide wire 76, which blocks downstream flow of the injected dye away from a discrete area of interest, just distal to the distal tip 16, to further enhance visualization the area, according to some techniques. The optional balloon may be an integral component of the guide wire 76 or part a relatively low-profile balloon catheter that is advanced over the advanced guide wire, and then removed from over the guide wire prior to advancing the lead to the target site.

[0083] Following the injection of dye for visualization, the clinician removes the syringe 78 from the proximal port portion 50 of the catheter 12 to make room for the advancement of a lead 80 over the guide wire 76, as illustrated in FIG. 9. The clinician may also deflate the compliant sleeve member 64 of the catheter 12 following the dye injection. FIG. 9 illustrates the guide wire 76 having been advanced to the target site in a downstream branching vein, and the lead 80 advanced thereover, following the fluoroscopic visualization and subsequent removal of the syringe 78. FIG. 9 further illustrates the inflatable section 70 of the sleeve member 64 being inflated, according to some techniques, during advancement of the lead 80 over the guide wire 76, for example, to anchor the distal tip 16 of the catheter 12 in the CS Os, which anchoring provides some back-up force for the advancement of the lead to the target site. The clinician may maintain the initial pressurization, prior to dye injection, to keep the compliant sleeve member 64 inflated for anchoring or may deflate the sleeve member after dye injection and then re-pressurize the inflation fluid source 32 to re-inflate sleeve member for anchoring.

[0084] Following implementation of the lead 80, the shaft 18 of the catheter 12 can be slit using any suitable technique to remove the catheter from the body. The retainer 34, however, can prevent such slitting until the inflatable section 70 is at least partially deflated. FIG. 11 is a flowchart of one technique 300 of utilizing the retainer 34 with the catheter system 10. Although described in reference to retainer 34 and catheter system 10, the technique 300 can be utilized with any suitable retainer and catheter system. At 302, the portion 40 of the body 36 of the retainer 34 can be disposed on the upper surface 42 of the proximal section 14 of the catheter 12 or the elongate shaft 18 of the catheter. The retainer 34 is configured to prevent slitting of the elongate shaft 18 when the portion 40 of the body 36 is disposed on the upper surface 42 of the proximal section 14 or the elongate shaft 18. In one or more embodiments, the portion 40 of the body 36 of the retainer 34 that is configured to be disposed on the upper surface 42 of the proximal section 14 or the elongate shaft 18 is further configured to engage the leading edge feature 84 of the slitter tool 44 such that the slitter tool is prevented from being directed along the longitudinal axis 2 toward the distal tip 16 and slitting the elongate shaft 18 of the catheter when the inflation fluid source 32 is connected to the connector port 28.

[0085] At 304, the clip 38 of the retainer 34 can be connected to the inflation fluid source 32 or the connector port 28 of the handle portion 26 of the proximal section 14 of the catheter 12. In one or more embodiments, at least one of the first or second rings 94, 96 of the clip 38 can be disposed on at least a portion of the connector port 28 using any suitable technique. The inflation fluid source 32 can be connected to the connector port 28 at 306 using any suitable technique. At 308, the inflatable section 70 of the compliant sleeve member 64 of the inflation subassembly 20 of the catheter 12 can be inflated using any suitable technique. In one or more embodiments, the inflatable section 70 can be inflated by directing inflation fluid from the inflation fluid source 32 through the connector port 28 and into the inflation lumen 30 of the inflation subassembly 20.

[0086] The inflatable section 70 can be deflated at 310 by disconnecting the inflation fluid source 32 from the connector port 28. At 312, the clip 38 of the retainer 34 can be removed from the inflation fluid source 32 or the connector port 28. Further, the portion 40 of the body 36 of the retainer 34 can be removed from the upper surface 42 of the proximal section 14 after the inflatable section 70 has been deflated. Further, the shaft 18 of the catheter 12 can be slit in the direction from the proximal section 14 toward the distal tip 16 along the longitudinal axis 2 at 314 using any suitable technique. In one or more embodiments, the shaft 18 can be slit by directing the slitter tool 44 in the direction from the proximal section 14 toward the distal tip 16 along the longitudinal axis 2 such that the blade 86 of the slitter tool slits the elongate shaft 18. The leading-edge feature 84 of the slitter tool 44 can be directed for engagement with the external engagement features feature 60 of the proximal section 14 so that the blade 86 of the slitter tool contacts with a proximal edge 55 of relatively thin wall section 56. And, as the clinician begins to slit through wall section 56, feature 84 can be constrained in the gap 58 of the external engagement features 60. The slitter tool 44 can further engage with the secondary external engagement features 61 as the tool is directed along the longitudinal axis 2.

[0087] It should be understood that various aspects disclosed herein may be combined in different combinations than the combinations specifically presented in the description and accompanying drawings. It should also be understood that, depending on the example, certain acts or events of any of the processes or methods described herein may be performed in a different sequence, may be added, merged, or left out altogether (e.g., all described acts or events may not be necessary to carry out the techniques). In addition, while certain aspects of this disclosure are described as being performed by a single module or unit for purposes of clarity, it should be understood that the techniques of this disclosure may be performed by a combination of units or modules associated with, for example, a medical device.

[0088] In one or more examples, the described techniques may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functions may be stored as one or more instructions or code on a computer-readable medium and executed by a hardware-based processing unit. Computer-readable media may include computer-readable storage media, which corresponds to a tangible medium such as data storage media (e.g., RAM, ROM, EEPROM, flash memory, or any other medium that can be used to store desired program code in the form of instructions or data structures and that can be accessed by a computer).

[0089] Instructions may be executed by one or more processors, such as one or more digital signal processors (DSPs), general purpose microprocessors, application specific integrated circuits (ASICs), field programmable logic arrays (FPGAs), or other equivalent integrated or discrete logic circuitry. Accordingly, the term “processor” as used herein may refer to any of the foregoing structure or any other physical structure suitable for implementation of the described techniques. Also, the techniques could be fully implemented in one or more circuits or logic elements.

[0090] The following examples are illustrative of the techniques described herein.

[0091] Example 1. A slittable catheter system comprising: a slittable catheter comprising a proximal section, a distal tip, an elongate shaft, and an inflation subassembly, the elongate shaft extending from the proximal section to the distal tip along a longitudinal axis and defining a longitudinally extending delivery lumen, wherein the proximal section of the catheter comprises:a proximal terminal end; a handle portion comprising a connector port fluidly connected to an inflation lumen of the inflation subassembly that extends within the elongate shaft, wherein the connector port is configured to be connected to an inflation fluid source; and a retainer comprising a body and a clip connected to the body, wherein a portion of the body is configured to be disposed on an upper surface of the proximal section of the catheter or the elongate shaft and the clip is configured to be connected to the inflation fluid source or the connector port when the source is connected to the connector port, wherein the retainer is configured to prevent a slitter tool from being directed along the longitudinal axis from the proximal terminal end toward the distal tip and slitting the elongate shaft of the catheter when the inflation fluid source is connected to the connector port

[0092] Example 2. The system of example 1, wherein the retainer is further configured to be removed from the catheter when the inflation fluid source is disconnected from the connector port such that the slitter tool can be directed along the longitudinal axis toward the distal tip and slit the shaft of the catheter.

[0093] Example 3. The system of any one of examples 1-2, wherein the clip of the retainer comprises a first ring connected to a first end of the body and a second ring connected to a second end of the body.

[0094] Example 4. The system of example 3, wherein each of the first and second rings of the retainer is configured to slide onto a connector of the inflation fluid source that is configured to connect the inflation fluid source to the connector port.

[0095] Example 5. The system of any one of examples 1-4, wherein the retainer comprises a polymer material.

[0096] Example 6 .The system of examples 5, wherein the retainer comprises a flexible polymer material. [0097] Example 7. The system of any one of examples 1-6, wherein the inflation fluid source comprises a syringe comprising a luer configured to mechanically engage with the connector port.

[0098] Example 8. The system of any one of examples 1-7, wherein the portion of the body of the retainer that is configured to be disposed on the upper surface of the proximal section or the elongate shaft is further configured to engage a leading edge feature of the slitter tool such that the slitter tool is prevented from being directed along the longitudinal axis toward the distal tip and slitting the shaft of the catheter when the inflation fluid source is connected to the connector port.

[0099] Example 9. The system of any one of examples 1-8, wherein the inflation subassembly further comprises a compliant sleeve member and an elongate tube, the sleeve member extending around an exterior surface of the shaft, in proximity to the distal tip, the sleeve member including a proximal end, a distal end, and an inflatable section extending between the proximal and distal ends, the proximal and distal ends being secured to the shaft, and the elongate tube defining the inflation lumen that extends within the shaft from a first opening in the proximal section to a second opening that communicates between the exterior surface of the shaft and an interior surface of the inflatable section of the sleeve.

[0100] Example 10. The system of example 9, wherein the tube of the inflation subassembly comprises a section extending laterally from the shaft and into the handle portion such that the first opening of the inflation lumen is located in the connector port [0101] Example 11. The system of any one of examples 1-10, wherein the delivery lumen further comprises a proximal port portion and a seal zone portion, wherein the proximal port portion extends distally from a proximal opening along the longitudinal axis to the seal zone portion and has a perimeter divided into a first portion and a second portion, wherein the first portion is relatively soft and comprises an exposed sealing area, and wherein the second portion is relatively hard and comprises a relatively thin wall section.

[0102] Example 12. The system of any one of examples 1-11, wherein the clip is connected to the body of the retainer by a living hinge.

[0103] Example 13. The system of any one of examples 1-12, further comprising the inflation fluid source. [0104] Example 14. The system of example 13, wherein the inflation fluid source further comprises a fluid filter that is configured to be disposed between an outlet of the inflation fluid source and the connector port of the handle portion when the inflation fluid source is connected to the connector port, wherein the clip of the retainer is configured to be connected to the fluid filter.

[0105] Example 15. The system of any one of example 1-14, wherein the catheter further comprises an external engagement feature disposed in the upper surface of the proximal section adjacent to the proximal terminal end, wherein the external engagement feature defines a gap configured to receive the slitter tool as the tool is directed along the longitudinal axis.

[0106] Example 16 The system of example 15, wherein the portion of the body of the retainer is disposed adjacent to the external engagement feature.

[0107] Example 17. The system of example 15, wherein the catheter further comprises a secondary external engagement feature disposed on the upper surface of the proximal section distal to the external engagement feature.

[0108] Example 18. The system of example 17, wherein the portion of the body of the retainer is disposed adjacent to the secondary external engagement feature such that the secondary external engagement feature is between the portion of the body and the external engagement feature.

[0109] Example 19. The system of any one of examples 1-18, further comprising a slitter tool configured to engage the catheter along the longitudinal axis at the proximal terminal end and slit the catheter.

[0110] Example 20. A method comprising: disposing a portion of a body of a retainer on an upper surface of a proximal section of a catheter or an elongate shaft of the catheter, wherein the retainer is configured to prevent slitting the elongate shaft when the portion of the body is disposed on the upper surface of the proximal section or the elongate shaft; connecting a clip of the retainer to an inflation fluid source or a connector port of a handle portion of the proximal section of the catheter, wherein the clip is connected to the body of the retainer; connecting the inflation fluid source to the connector port; inflating an inflatable section of a compliant sleeve member of an inflation subassembly of the catheter that extends around an exterior surface of the elongate shaft of the catheter proximate a distal tip of the catheter, wherein the compliant sleeve member is fluidly connected to the connector port via an inflation lumen of the inflation subassembly and extends within the elongate shaft of the catheter; deflating the inflatable section of the compliant sleeve member by disconnecting the inflation fluid source from the connector port; removing the clip of the retainer from the inflation fluid source or the connector port and the portion of the body of the retainer from the upper surface of the proximal section after the inflatable section of the elongate shaft has been deflated; and slitting the shaft of the catheter in a direction from the proximal section toward the distal tip along a longitudinal axis defined by the elongate shaft.

[0111] Example 21. The method of example 20, wherein inflating the inflatable section comprises directing inflation fluid from the inflation fluid source through the connector port and into the inflation lumen of the inflation subassembly.

[0112] Example 22. The method of any one of example 20-21, wherein the clip of the retainer comprises a first ring connected to a first end of the body and a second ring connected to a second end of the body, wherein connecting the clip comprises disposing the first and second rings on at least a portion of a connector of the inflation fluid source. [0113] Example 23. The method of any one of example 20-22, wherein slitting the shaft of the catheter comprises directing a slitter tool in the direction from the proximal section toward the distal tip along the longitudinal axis such that a blade of the slitter tool slits the elongate shaft of the catheter.

[0114] Example 24. The method of example 23, wherein the portion of the body of the retainer that is configured to be disposed on the upper surface of the proximal section or the elongate shaft is further configured to engage a leading edge feature of the slitter tool such that the slitter tool is prevented from being directed along the longitudinal axis toward the distal tip and slitting the elongate shaft of the catheter when the inflation fluid source is connected to the connector port.

[0115] Example 25. The method of any one of example 20-24, further comprising: advancing a guide wire into a proximal port portion of the catheter and into a delivery lumen of the elongate shaft of the catheter and through a distal opening of the delivery lumen to a target site; and advancing a lead over the advanced guide wire and through the proximal port portion and the delivery lumen prior to deflating the inflatable section of the compliant sleeve member. [0116] Example 26. A retainer comprising: a body comprising a portion configured to be disposed on an upper surface of a proximal section of a catheter or an elongate shaft of the catheter; and a clip connected to the body and configured to be connected to an inflation fluid source of the catheter or a connector port of a handle portion of the catheter when the source is connected to the connector port; wherein the retainer is configured to prevent a slitter tool from being directed along a longitudinal axis of the catheter from a proximal terminal end toward a distal tip of the catheter and slitting an elongate shaft of the catheter when the inflation fluid source is connected to the connector port.

[0117] Example 27. The retainer of example 26, wherein the retainer is further configured to be removed from the catheter when the inflation fluid source is disconnected from the connector port such that the slitter tool can be directed along the longitudinal axis toward the distal tip and slit the elongate shaft of the catheter.

[0118] Example 28. The retainer of any one of examples 26-27, wherein the clip of the retainer comprises a first ring connected to a first end of the body and a second ring connected to a second end of the body.

[0119] Example 29. The retainer of example 28, wherein at least one of the first ring or second ring comprises a slot disposed through a body of the ring such that the ring can be expanded.

[0120] Example 30. The retainer of any one of examples 28-29, wherein each of the first and second rings of the retainer is configured to slide onto a connector of the inflation fluid source that is configured to connect the inflation fluid source to the connector port [0121] Example 31. The retainer of any one of examples 26-30, wherein the retainer comprises a polymer material.

[0122] Example 32. The retainer of example 31, wherein the retainer comprises a flexible polymer material.

[0123] Example 33. The retainer of example 31, wherein the body of the retainer comprises a rigid polymer material and the clip comprises a flexible polymer material. [0124] Example 34. The retainer of any one of examples 26-33, wherein the inflation fluid source comprises a syringe comprising a luer configured to mechanically engage with the connector port.

[0125] Example 35. The retainer of any one of examples 26-34, wherein the portion of the body of the retainer that is configured to be disposed on the upper surface of the proximal section or the elongate shaft is further configured to engage a leading edge feature of the slitter tool such that the slitter tool is prevented from being directed along the longitudinal axis from the proximal terminal end toward the distal tip of the catheter and slitting the shaft of the catheter when the inflation fluid source is connected to the connector port.

[0126] Example 36. The retainer of any one of examples 26-35, wherein the body of the retainer comprises a first arm and a second arm that are connected at the portion of the body that is configured to configured to be disposed on an upper surface of a proximal section of a catheter or an elongate shaft of the catheter.

[0127] Example 37. The retainer of example 26, wherein the clip is connected to the body of the retainer by a living hinge.

[0128] Example 38. The retainer of example 26, wherein the clip of the retainer comprises a first ring connected to a first end of the body by a first living hinge and a second ring connected to a second end of the body by a second living hinge.

[0129] Example 39. The retainer of example 26, wherein the body of the retainer comprises a C shape.

[0130] Example 40. The retainer of example 26, wherein the portion of the body of the retainer comprises a living hinge.

Claims

WHAT IS CLAIMED IS:

1. A slittable catheter system comprising: a slittable catheter comprising a proximal section, a distal tip, an elongate shaft, and an inflation subassembly, the elongate shaft extending from the proximal section to the distal tip along a longitudinal axis and defining a longitudinally extending delivery lumen, wherein the proximal section of the catheter comprises: a proximal terminal end; a handle portion comprising a connector port fluidly connected to an inflation lumen of the inflation subassembly that extends within the elongate shaft, wherein the connector port is configured to be connected to an inflation fluid source; and a retainer comprising a body and a clip connected to the body, wherein a portion of the body is configured to be disposed on an upper surface of the proximal section of the catheter or the elongate shaft and the clip is configured to be connected to the inflation fluid source or the connector port when the source is connected to the connector port, wherein the retainer is configured to prevent a slitter tool from being directed along the longitudinal axis from the proximal terminal end toward the distal tip and slitting the elongate shaft of the catheter when the inflation fluid source is connected to the connector port.

2. The system of claim 1, wherein the clip of the retainer comprises a first ring connected to a first end of the body and a second ring connected to a second end of the body, wherein each of the first and second rings of the retainer is configured to slide onto a connector of the inflation fluid source that is configured to connect the inflation fluid source to the connector port.

3. The system of any one of claims 1-2, wherein the portion of the body of the retainer that is configured to be disposed on the upper surface of the proximal section or the elongate shaft is further configured to engage a leading edge feature of the slitter tool such that the slitter tool is prevented from being directed along the longitudinal axis toward the distal tip and slitting the shaft of the catheter when the inflation fluid source is connected to the connector port.

4. The system of any one of claims 1-3, wherein the clip is connected to the body of the retainer by a living hinge.

5. The system of any one of claims 1-4, further comprising the inflation fluid source, wherein the inflation fluid source further comprises a fluid filter that is configured to be disposed between an outlet of the inflation fluid source and the connector port of the handle portion when the inflation fluid source is connected to the connector port, wherein the clip of the retainer is configured to be connected to the fluid filter.

6. The system of any one of claims 1-5, wherein the catheter further comprises an external engagement feature disposed in the upper surface of the proximal section adjacent to the proximal terminal end, wherein the external engagement feature defines a gap configured to receive the slitter tool as the tool is directed along the longitudinal axis, wherein the portion of the body of the retainer is disposed adjacent to the external engagement feature.

7. The system of claim 6, wherein the catheter further comprises a secondary external engagement feature disposed on the upper surface of the proximal section distal to the external engagement feature, wherein the portion of the body of the retainer is disposed adjacent to the secondary external engagement feature such that the secondary external engagement feature is between the portion of the body and the external engagement feature.

8. The system of any one of claims 1-7, further comprising a slitter tool configured to engage the catheter along the longitudinal axis at the proximal terminal end and slit the catheter.

9. A method comprising: disposing a portion of a body of a retainer on an upper surface of a proximal section of a catheter or an elongate shaft of the catheter, wherein the retainer is configured to prevent slitting the elongate shaft when the portion of the body is disposed on the upper surface of the proximal section or the elongate shaft; connecting a clip of the retainer to an inflation fluid source or a connector port of a handle portion of the proximal section of the catheter, wherein the clip is connected to the body of the retainer; connecting the inflation fluid source to the connector port; inflating an inflatable section of a compliant sleeve member of an inflation subassembly of the catheter that extends around an exterior surface of the elongate shaft of the catheter proximate a distal tip of the catheter, wherein the compliant sleeve member is fluidly connected to the connector port via an inflation lumen of the inflation subassembly and extends within the elongate shaft of the catheter; deflating the inflatable section of the compliant sleeve member by disconnecting the inflation fluid source from the connector port; removing the clip of the retainer from the inflation fluid source or the connector port and the portion of the body of the retainer from the upper surface of the proximal section after the inflatable section of the elongate shaft has been deflated; and slitting the shaft of the catheter in a direction from the proximal section toward the distal tip along a longitudinal axis defined by the elongate shaft.

10. The method of claim 9, wherein slitting the shaft of the catheter comprises directing a slitter tool in the direction from the proximal section toward the distal tip along the longitudinal axis such that a blade of the slitter tool slits the elongate shaft of the catheter.

11. The method of claim 10, wherein the portion of the body of the retainer that is configured to be disposed on the upper surface of the proximal section or the elongate shaft is further configured to engage a leading edge feature of the slitter tool such that the slitter tool is prevented from being directed along the longitudinal axis toward the distal tip and slitting the elongate shaft of the catheter when the inflation fluid source is connected to the connector port.

12. A retainer compri sing : a body comprising a portion configured to be disposed on an upper surface of a proximal section of a catheter or an elongate shaft of the catheter; and a clip connected to the body and configured to be connected to an inflation fluid source of the catheter or a connector port of a handle portion of the catheter when the source is connected to the connector port; wherein the retainer is configured to prevent a slitter tool from being directed along a longitudinal axis of the catheter from a proximal terminal end toward a distal tip of the catheter and slitting an elongate shaft of the catheter when the inflation fluid source is connected to the connector port.

13. The retainer of claim 12, wherein the retainer is further configured to be removed from the catheter when the inflation fluid source is disconnected from the connector port such that the slitter tool can be directed along the longitudinal axis toward the distal tip and slit the elongate shaft of the catheter.

14. The retainer of any one of claims 12-13, wherein the clip of the retainer comprises a first ring connected to a first end of the body and a second ring connected to a second end of the body, wherein at least one of the first ring or second ring comprises a slot disposed through a body of the ring such that the ring can be expanded.

15. The retainer of any one of claims 12-14, wherein the portion of the body of the retainer that is configured to be disposed on the upper surface of the proximal section or the elongate shaft is further configured to engage a leading edge feature of the slitter tool such that the slitter tool is prevented from being directed along the longitudinal axis from the proximal terminal end toward the distal tip of the catheter and slitting the shaft of the catheter when the inflation fluid source is connected to the connector port.