US20110172696A1 - Catheter having a soft distal tip - Google Patents
Catheter having a soft distal tip Download PDFInfo
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- US20110172696A1 US20110172696A1 US12/983,504 US98350411A US2011172696A1 US 20110172696 A1 US20110172696 A1 US 20110172696A1 US 98350411 A US98350411 A US 98350411A US 2011172696 A1 US2011172696 A1 US 2011172696A1
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- Prior art keywords
- sleeve
- catheter
- distal
- distal end
- neck
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
- A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
- A61M25/0069—Tip not integral with tube
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/1006—Balloons formed between concentric tubes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/1027—Making of balloon catheters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/958—Inflatable balloons for placing stents or stent-grafts
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
- A61M25/008—Strength or flexibility characteristics of the catheter tip
- A61M2025/0081—Soft tip
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
- A61M2025/1093—Balloon catheters with special features or adapted for special applications having particular tip characteristics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/104—Balloon catheters used for angioplasty
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T29/00—Metal working
- Y10T29/49—Method of mechanical manufacture
- Y10T29/49826—Assembling or joining
Abstract
The present invention relates to a catheter having a soft distal tip that can be manufactured at lower cost than catheters in the prior art. In one embodiment, the catheter is produced by coupling a soft sleeve to the distal end of a catheter tube. The sleeve may affixed to the catheter tube under temperature and pressure conditions that cause the proximal end of the sleeve to taper against the outer surface of the catheter tube, avoiding or minimizing discontinuities in the insertion profile of the catheter, and that also cause the inner wall of the sleeve to taper against the distal end of the catheter tube, avoiding or minimizing discontinuities in the lumen of the catheter.
Description
- This application is a continuation of U.S. application Ser. No. 11/766,662, which is a continuation-in-part of U.S. application Ser. No. 10/296,252, filed Nov. 21, 2002, which claims priority to PCT application no. PCT/EP01/05893, filed on May 22, 2001, which claims priority to German application no. 200092049, filed on May 22, 2000, the entireties of which are incorporated herein by reference. U.S. application Ser. No. 11/766,662 is also the continuation-in-part of U.S. application Ser. No. 11/335,931, filed on Jan. 20, 2006, which claims priority to provisional application Ser. No. 60/646,118, filed on Jan. 21, 2005, the entireties of which are incorporated herein by reference.
- The present invention relates to a catheter having a soft distal tip and to methods of manufacture thereof. More particularly, the present invention relates to a catheter having a soft distal tip and to methods of manufacture, in which the soft distal tip is formed by affixing a soft sleeve to the distal end of a catheter tube.
- Since its introduction in 1977, angioplasty has become a widely used procedure for the treatment of vascular disease. A common forms of angioplasty is coronary angioplasty, also known as “percutaneous transluminal coronary angioplasty,” in which a balloon catheter is inserted into a blocked artery to remove a stenosis.
- During coronary angioplasty, the catheter is inserted into a blood vessel either at the elbow or at the groin. The catheter is then pushed inside the blood vessel until the point of blockage in the artery has been reached. A balloon disposed at the tip of the catheter then expands the narrowed artery and allows blood to flow normally through the artery after the procedure. Optionally, a stent is coupled to the balloon, so that the stent expands when the balloon is inflated, supporting the wall of the vessel after the balloon has been removed and maintaining patency.
- A catheter suitable for angioplasty procedures must be sufficiently flexible to wind through tight curvatures, for example, in the coronary arteries, but at the same time must be “pushable,” or be able to transmit a longitudinal pressure along its length, so that a clinician can force the catheter through the vascular system and to the target location by applying a controlled amount of pressure at the proximal end of the catheter. The development of new materials has brought to market a new generation of catheters that provide the desired degree of “pushability” and trackability while enabling a considerable reduction in cross-sectional diameter.
- A risk associated with catheters having an elevated degree of “pushability” is vessel injury or rupture. Additionally, a stiff catheter tip may cause endothelial abrasion by rubbing against the wall of the vessel.
- To minimize these risks, catheters have been developed that include a soft distal tip, so to provide for a less traumatic contact with a vessel wall. Examples of prior art catheters having soft tips are disclosed U.S. Pat. Nos. 4,921,483 to Wijay et al.; 5,100,381 to Bums; 5,334,148 to Martin; 5,728,065 to Follmer et al.; 6,325,790 to Trotta; 6,368,301 and 6,837,869 to Hamilton et al.; 6,702,802 to Hancock et al.; 6,979,342 to Lee et al.; 6,999,809 to Currier et al.; and 7,115,137 to Duchamp. Such prior art catheters are manufactured by producing the tip as a separate component shaped for coupling with the catheter tube without discontinuities along the profile of the catheter, that is, without altering either the outer diameter or the lumen of the catheter, so that the insertion profile of the catheter is not modified and so that a guide wire reciprocating within the lumen does not encounter obstacles along its travel. The soft tips of those catheters are generally manufactured with a number of recesses that mate with the catheter body and with the distal end of the catheter balloon. Unfortunately, this process is costly because specially shaped tips must be produced and carefully coupled with the other components of the catheter, so that the various surfaces and recesses properly mate one with the other.
- In one embodiment, a catheter having a soft distal tip is manufactured by disposing a soft sleeve over the distal end of a catheter tube and by extending a portion of the sleeve beyond the distal end of the catheter tube. The sleeve is essentially free of recesses before being coupled with the distal end of the catheter tube. The sleeve is finally affixed to the surface of the catheter tube, under temperature and pressure conditions that cause the outer surface of the sleeve at its proximal end to taper against the outer surface of the catheter tube, avoiding or minimizing discontinuities in the insertion profile of the catheter tube. At the same time, process conditions also cause the inner wall of the sleeve to soften and taper against the distal end of the catheter tube, minimizing or eliminating discontinuities at the point of transition between the lumen of the catheter and the lumen of the sleeve.
- In another embodiment, the manufacturing process of a catheter having a soft distal tip according to the present invention also includes disposing an inflatable balloon over the distal end of the catheter tube. In variants of this embodiment, the proximal end of the sleeve may abut or overlay the distal neck of the balloon, or the distal neck of the balloon may overlay the sleeve partially or entirely. In another variant of this embodiment, the distal neck of the balloon is longitudinally spaced from the sleeve.
- Prior to coupling with the catheter tube, the sleeve may have an essentially cylindrical or essentially frusto-conical shape, or may have a frusto-conical shape stretched around the catheter tube to assume a cylindrical shape at the proximal end and a frusto-conical shape at the distal end. The thickness of the sleeve wall may be constant or variable, for example, may progressively taper from its proximal end to its distal end.
- In still another embodiment of the present invention, a catheter having a soft distal tip is manufactured by disposing a soft sleeve inside the catheter lumen and by extending a portion of the sleeve beyond the distal end of the catheter tube. The lateral wall of the sleeve is essentially free of recesses prior to coupling to the lateral wall of the lumen and is then affixed in the lumen, for example by welding. If welding is performed under appropriate temperature and pressure conditions, the proximal end of the sleeve tapers against the wall of the lumen, reducing or eliminating any steps between the lumen wall and the sleeve wall.
- In yet another embodiment of the present invention, a soft sleeve is affixed inside a catheter lumen and is aligned or offset at its proximal end from the distal end of a balloon. The soft sleeve may also be essentially cylindrical or frusto-conical in shape, or may be stretched to be cylindrical in shape at the proximal end and frusto-conical at the distal end. The thickness of the wall of the sleeve may be constant or variable, tapering from a larger thickness at the proximal end to a smaller thickness at the distal end of the sleeve.
- The drawings constitute a part of this specification and include exemplary embodiments of the invention, which may be embodied in various forms. It is to be understood that in some instances various aspects of the invention may be shown exaggerated or enlarged to facilitate an understanding of the invention.
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FIG. 1 is a schematic side view of a catheter having a soft distal tip. -
FIG. 2E is a cross-sectional cutaway view of the distal end of a catheter according to an embodiment of the invention. -
FIG. 2A is a cross-sectional view of the distal end of a catheter according to an embodiment of the invention, andFIGS. 2B-2D are different cross-sectional views of the distal end ofFIG. 2A . -
FIG. 3 is a cross-sectional view of the distal end of a catheter according to another embodiment of the invention. -
FIG. 4 is a cross-sectional view of the distal end of a catheter according to still another embodiment of the invention. -
FIG. 5 is a cross-sectional view of the distal end of a catheter according to yet another embodiment of the invention. -
FIGS. 6 and 6A are cross-sectional views of the distal end of a catheter according to more embodiments of the invention. -
FIG. 7 is a cross-sectional view of the distal end of a catheter according to still another embodiment of the invention. -
FIG. 8 is a cross-sectional view of the distal end of a catheter according to yet another embodiment of the invention. -
FIG. 9 is a cross-sectional view of the distal end of a catheter according to one more embodiment of the invention. - Detailed descriptions of embodiments of the invention are provided herein. It is to be understood, however, that the present invention may be embodied in various forms. Therefore, the specific details disclosed herein are not to be interpreted as limiting, but rather as a representative basis for teaching one skilled in the art how to employ the present invention in virtually any detailed system, structure, or manner.
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FIG. 1 schematically depicts a catheter having a soft distal tip, which is adapted for use in angioplasty procedures. It should be understood that the catheter ofFIG. 1 represents one of several possible embodiments of the invention, and that the present invention is equally applicable to catheters adapted for non-angioplasty procedures and also to catheters that do not include inflating balloons, for example, catheters structured for use with self-expanding stents. -
Catheter 10 includes acatheter tube 12 having aproximal end 14, adistal end 16, and alumen 18 extending betweenproximal end 14 anddistal end 16. “Distal end” is defined herein as the distal tip of the catheter tube and the portion of the catheter tube immediately adjacent thereto.Catheter tube 12 is configured to enable the passage and the longitudinal translation ofguide wire 20 withinlumen 18 during a surgical procedure. -
Outer tube 22 is disposed either concentrically or parallel tocatheter tube 12 and is configured to carry an inflation fluid (for example, a saline solution) to and frominflatable balloon 24. In turn,balloon 24 is formed by abody 26, configured to expand upon ingress of the inflation fluid, aproximal neck 28, affixed (for example, welded or bonded) toouter tube 22, and adistal neck 30, affixed tocatheter tube 12. -
Catheter tube 12 can be produced from a variety of materials, including metal, plastic and composite materials. In one embodiment,catheter tube 12 is manufactured as a metal tube, for example, as a stainless steel hypotube, and may be coated with a polymeric material such as PTFE. The metal tube may also be covered with a single or multilayered plastic material through one or more processes, including coextrusion, dipping, heat-shrinking, and electrostatic and thermal coating. - In another embodiment,
catheter tube 12 is manufactured as a plastic tube. Materials suitable for use in the catheter tube include but are not limited to Polyurethanes (PU), such as Tecoflex, Pellethene, Bionate, corethane, Elasteon, and blends thereof. Polyethylenes (PE), such as PET, PBT, PVDF, Teflon, ETFE, and blends thereof, Polyolefins, such as HDPE, PE, LDPE, LLDPE, Polypropylene, and blends thereof, Polyimides; Polyamides; all classes of Nylons, such as Nylon 11,Nylon 12, Nylon 6,6, Nylon 6, Nylon 7,11,Nylon 11,12, and blends thereof); block copolymers; PEBA-types polymers, such as ELY, PEBAX, Ubesta, and blends thereof, and biodegradable polymers. Suitable materials also include blends of the above mentioned materials as well as any composite materials, like dual-layers, tri-layers and multi-layers thereof. For example,catheter tube 12 may be produced from a tube comprising an outer layer made of Nylon and an inner layer made of a lubricious material such as polyethylene or PTFE. A metallic or nonmetallic braiding may also be included within or between layers of thecatheter tube 12. - Conversely,
Outer tube 22 may be produced from a material or a combination of materials equal or different from those ofcatheter tube 12. - Disposed at
distal end 16 ofcatheter tube 12 issoft tip 32, which provides for an atraumatic contact betweencatheter tube 12 and a wall against whichcatheter tube 12 may be pushed during a surgical procedure.Soft tip 32 is composed of a soft sleeve that is affixed on and that extends beyonddistal end 16, or, alternatively, that is affixed on and extends beyond the lumen ofcatheter tube 12. Typically,soft tip 32 is affixed through a welding process, but other affixing techniques are also included within the scope of the present invention, for example, adhesive bonding. Suitable materials for the sleeve can be chosen from any material suitable for producingcatheter tube 12, as described above. -
FIGS. 2A to 9 depict a number of representative embodiments of the invention, illustrating different, non-limiting arrangements ofsoft tip 32 in relation tocatheter tube 12 and ofballoon 24. - Referring first to
FIG. 2A ,balloon 24 is disposed overcatheter tube 12, withdistal neck 30 affixed to the outer wall ofcatheter tube 12 and ending proximally ofdistal end 16.Sleeve 34 is affixed todistal end 16 and abuts proximally againstdistal neck 30, extending distally beyonddistal end 16. -
Sleeve 34 may be manufactured from a material softer thancatheter tube 12, and may be formed from the same material asballoon 24 or from a different material, for example, from any of the materials or combinations of materials described with reference tocatheter tube 12. In one embodiment,sleeve 24 is manufactured from a material having the same basic composition but a lower Shore durometer hardness than the balloon material or the catheter tube material. In another embodiment,sleeve 34 may be manufactured from a blend of PEBAX 55D and PEBAX 63D polymers. One skilled in the art will recognize thatsleeve 34 may be manufactured from a variety of other materials according to the previous description of materials, for example, a polyurethane, a polyethylene, a polyolefin, a polyimide, a polyamide like Nylon, a block copolymer, or blends, or compositions or dual layers or multi-layers thereof. -
FIGS. 2B-2D illustrate the arrangement ofFIG. 2A in greater detail by depicting cross-sections of the assembly ofFIG. 2A at three different section planes. More particularly, the cross-section ofFIG. 2B illustrates the arrangement ofFIG. 2A proximally of the soft sleeve, and includescatheter tube 12 anddistal neck 30. The cross-section ofFIG. 2C illustrates the arrangement ofFIG. 2A in the proximal portion ofsleeve 34 and includes bothcatheter tube 12 andsleeve 34. Becausedistal neck 30 does not overlapsleeve 34, but rather one abuts against the other, no cross-section ofdistal neck 30 can be seen inFIG. 2C . The cross-section ofFIG. 2D illustrates the arrangement ofFIG. 2A in the distal portion ofsleeve 34 and only shows a cross-section ofsleeve 34, because atcross-section 2D sleevedistal end 16 ofcatheter tube 12. - Prior to coupling with
catheter tube 12,sleeve 34 may be essentially cylindrical in shape or have a frusto-conical profile. In one embodiment,sleeve 34 has an essentially frusto-conical profile but is stretchable enough so that, whensleeve 34 is disposed overdistal end 16, the proximal portion ofsleeve 34, in contact withdistal end 16, deforms to assume an essentially cylindrical configuration, while the distal part ofsleeve 34, extending beyonddistal end 16, retains an essentially frusto-conical profile. Regardless of its external profile,sleeve 34 includes alumen 36 defined by alateral wall 38, and prior to the coupling ofsleeve 34 withdistal end 16,sleeve 16 is essentially free of recesses, so thatsleeve 34 can be fitted and affixed overdistal end 16, for example, by a welding or a bonding process. In this respect,sleeve 34 is different from sleeves or soft tips employed in the prior art, the design of which is based on recesses on the lateral wall of the soft tip, in order to achieve a configuration of the catheter tube-sleeve assembly that guarantees that the lumen and the outer profile of the catheter retain a constant diameter. - Referring now to
FIG. 2E , an embodiment of a process for affixingsleeve 34 overdistal end 16 is shown.Catheter tube 12,balloon 24 andsleeve 34 are assembled over amandrel 40, and ashrink tube 42 is disposed at least over the assembly portion that includesdistal end 16,distal neck 30 and a proximal portion of thesleeve 34. In another embodiment, shrinktube 12 coversdistal end 16,distal neck 30 andsleeve 34. Shrinktube 42 may be manufactured from a material that will prevent a permanent adhesion ofshrink tube 42 againstneck 30 andsleeve 34, so thatshrink tube 42 can be easily removed (for example, by peeling off) at the end of the welding process. Equally,mandrel 40 may be manufactured from or coated with a material that will not adhere to the inner wall ofsleeve 34 during the welding process. During the successive welding process, shrinktube 42 applies pressure againstdistal neck 30 and at least a portion ofsleeve 34. Such a pressure may be applied either by havingshrink tube 42 contract overdistal neck 30 andsleeve 34, for example, due to the application of vacuum or heat, or shrinktube 42 may maintain a constant diameter whilemandrel 40 expands due to the application of heat, thereby applying pressure againstdistal neck 30 andsleeve 34. - In one embodiment,
sleeve 34 has an inner diameter substantially equal or nearly equal to the outer diameter ofcatheter tube 12, to facilitate positioning ofsleeve 34 over the distal portion ofcatheter tube 12. In this embodiment, shrinktube 42 will coverdistal end 16,distal neck 30 andsleeve 34, thereby forcing the sleeve down to the mandrel during welding process. This will result in a constant inner diameter of theguide wire lumen 18 as further described below. In another embodiment, the inner diameter of thesleeve 34 is equal to the inner diameter ofcatheter tube 12 and the proximal portion of thesleeve 34 is stretched over the distal end of the catheter tube whencatheter tube 12,balloon 24 andsleeve 34 are assembled on the mandrel. - The above described combination of heat and pressure causes the materials of
distal neck 30 and ofsleeve 34 to soften and weld tocatheter tube 12. At the same time, the combination of such softening and of the pressure applied ondistal neck 30 andsleeve 34 causes the joint betweendistal neck 30 andsleeve 34 to become essentially smooth, minimizing or preventing the formation of protrusions or steps whendistal neck 30 andsleeve 34 have walls with different or uneven thickness. Likewise, step 44 betweendistal end 16 andsleeve 34 is reduced and, under proper operating conditions, eliminated due to the softening of the sleeve material, facilitating the translation of guide wire 20 (not shown inFIG. 2A ) alonglumen 18. - The welding process is performed by applying heat or radiation to the assembly, for example, by laser welding, hot jaw welding, transition bonder welding, hot air welding arc welding, RF welding or white light welding as described in U.S. Patent Publication No. 2006/0071371, which is incorporated by reference herein in its entirety. Heat may be applied to this assembly from the outside by an external energy source and/or from the inside by
heating mandrel 40. -
FIG. 3 illustrates a second embodiment of the invention, in whichsleeve 36 overlays bothcatheter tube 12 anddistal neck 30. In this embodiment,distal neck 30 extends to the end ofdistal end 16, therefore,sleeve 36 is not welded tocatheter tube 12, but rather is welded todistal neck 30, which in turn is welded tocatheter tube 30. In this embodiment,sleeve 36 may be shaped in two main portions, a proximal portion having an essentially cylindrical shape that is welded todistal neck 30, and a distal portion having an essentially frusto-conical shape that extends beyonddistal end 16. Alternatively,sleeve 36 may have an essentially frusto-conical configuration that is partially stretched to an essentially cylindrical shape in the area of contact withdistal neck 30. - In order to achieve proper welding between
sleeve 36 anddistal neck 30, a mandrel and a shrink tube may employed as previously described. Also as previously described, one skilled in the art will recognize that the mandrel may be heated to achieve the desired welding, or heat may be provided from an external source, for example, by applying heat or radiation energy, also as previously described. The application of energy is adjusted in such a way that the proximal end ofsleeve 36 may soften to provide a smooth transition between balloon 24 (or distal neck 33) andsleeve 36, and step 46 betweencatheter tube 12 anddistal neck 30 on one side and the inner wall ofsleeve 36 on the other side may be eliminated by the softening ofsleeve 36 anddistal neck 30 during the welding process. -
FIG. 4 illustrates a third embodiment, in whichsleeve 38 is partially overlappingdistal neck 30, which does not extend as far asdistal end 16. In this embodiment, the softening ofsleeve 48 causes not only a smoothing of the transition between the outer surface ofballoon 24 andsleeve 48, but also causes a partial or total filling ofinterstice 50 between the inner wall ofsleeve 48 and the outer wall ofcatheter tube 12. As in the preceding embodiment,sleeve 48 may have a cylindrical or frusto-conical shape or a combination thereof, and may be stretchable from its original configuration to a modified configuration. -
FIG. 5 illustrates a further embodiment of the invention, in whichsleeve 52 is disposed distally ofdistal neck 30, and abuts the distal end ofdistal neck 30, similarly to the embodiment ofFIG. 2A . When the proximal portion ofsleeve 52 is welded against the outer wall ofdistal end 16, the combined action of the mechanical pressure exercised on sleeve 52 (for example, by applying a shrink tube againstdistal end 16 and by inserting a mandrel within lumen 18) and of thermal or radiation energy applied to the assembly causessleeve 52 to soften and to providecatheter 10 with a distal tip that is smooth both on its outer profile and at the transition betweendistal end 16 andsleeve 52. In this embodiment,sleeve 52 has a tapered wall, decreasing in thickness from its proximal end to its distal end. The above described application of heat and pressure, aimed at weldingsleeve 52 todistal end 16 and at avoiding steps betweendistal neck 30 andsleeve 52, may reduce or eliminate such tapered shape in the portion disposed overdistal end 16, and this effect is even more pronounced whensleeve 52 is stretchable. At the same time, the tapering of the distal portion ofsleeve 52 causes the distal tip ofsleeve 52 to be extremely soft, with softness decreasing as one moves proximally of the distal tip. -
FIGS. 6 and 6A depict different embodiments of the present invention, in whichsleeves 54 and 56 are partially disposed not over the outer wall ofcatheter tube 12, but instead within lumen 18 to extends outwards ofcatheter tube 12. The difference between the embodiments ofFIGS. 6 and 6A is that, in the embodiment ofFIG. 6 , the proximal end ofsleeve 54 is substantially laterally aligned with the distal end ofdistal neck 30, while in the embodiment ofFIG. 6A the proximal end of sleeve 56 is laterally offset from the distal end ofdistal neck 30, providing for a portion ofcatheter tube 12 to span between the distal end ofdistal neck 30 and the proximal end of sleeve 56. By comparing the embodiments ofFIGS. 6 and 6A , one skilled in the art will notice that the embodiment ofFIG. 6 provides for a more constant wall thickness of the catheter tip because at each point of distal end 16 a double wall is present, either provided bydistal neck 30 andcatheter tube 12, or bycatheter tube 12 andsleeve 54, while in the embodiment ofFIG. 6A a distance exists between the neighboring ends ofdistal neck 30 and of sleeve 56, in which only the wall ofcatheter tube 12 is present. Steps S8 and 60, at the joint betweensleeve 54 and respectively 56 and the inner wall oflumen 16, are minimized and possibly eliminated during the welding process ofsleeves 54 and respectively 56 against the wall oflumen 18, for example, by disposing a mandrel withinsleeves 54 or 56, and by causing the mandrel to expand radially by heating the mandrel or by imposing a shrink tube over the assembly, and by causing the shrink tube to shrink down by applying heat to the assembly. This reduction or elimination ofsteps lumen 16 by reducing or eliminating recesses, in which the guide wire may become entangled. Likewise, steps 62 and 64 also may be reduced or substantially eliminated during the welding process ofsleeves 54 and respectively 56 by the same deformation process ofsleeves 54 and respectively 56. In the embodiment depicted inFIG. 6 A, the input of welding energy can be adjusted in a way to causes the steps to be totally eliminated, thus providing a thinner wall thickness that with the embodiment depicted inFIG. 6 . In one embodiment,sleeves 54 and respectively 56 have the same inner diameter ascatheter tube 12. During assembly, the distal portion of the catheter tube will then be stretched and disposed over a proximal portion of thesleeve 54 and 56, respectively. - Referring now to the embodiment depicted in
FIG. 7 ,distal neck 30 extends beyonddistal end 16 ofcatheter tube 12, and entirely surrounds sleeve 66, extending beyond the distal end of sleeve 66. Therefore, the distal tip ofcatheter 10 in this embodiment exhibits a decreasing flexibility moving proximally from the distal end of catheter 12 (which corresponds to the distal end of distal neck 30) to a catheter portion, in whichdistal neck 30 encircles sleeve 66, and more proximally to a catheter portion, in whichdistal neck 30 encircles sleeve 66 and alsodistal end 16. As for the previous embodiments, step 68 at the junction point ofdistal end 16 with sleeve 66 is partially or entirely removed during the welding process of sleeve 66 tocatheter tube 12 anddistal neck 30, providing a smoother contour along the translation path of a guide wire withinlumen 18 and through the distal portion ofdistal neck 30.Step 70 may also be partially or completely removed during the welding process. - Referring now to
FIG. 8 , an additional embodiment of the present invention is depicted, in whichsleeve 72 is disposed betweendistal neck 30 andcatheter tube 12, and in whichsleeve 72 has a proximal end substantially aligned with the proximal end ofdistal neck 30, and a distal end extending beyonddistal end 16 ofcatheter tube 12. In variants of the present embodiment, the proximal end ofsleeve 72 may be offset proximally or distally in relation to the proximal end ofdistal neck 30. As in the previously described embodiments, the welding process ofsleeve 72 todistal neck 30 andcatheter tube 12 may cause a partial or total elimination of steps 74 and 76, due to the softening ofdistal neck 30 and/or ofsleeve 72. Also, as in the previous described embodiments, the inner diameter ofsleeve 72 may be equal to the inner diameter ofcatheter tube 12 and the proximal portion ofsleeve 72 will be stretched over the distal catheter tube portion, or inner diameter ofsleeve 72 may be close to the outer diameter of thecatheter tube 12, andsleeve 72 is shrunk down on a mandrel, to result in a constant inner diameter of the tube along the whole length by applying pressure with a shrink tube during the welding process. - Referring now to
FIG. 9 , still another embodiment of the present invention is depicted that includes asleeve 78, disposed atproximal end 16 ofcatheter tube 12 and distally ofdistal neck 30. In this embodiment,distal neck 30 andsleeve 78 are spaced longitudinally one from the other resulting in a gap 90, to providecatheter 10 with a more flexible distal tip in comparison, for example, to the embodiment illustrated inFIG. 5 . As for the embodiment ofFIG. 5 , and for all other embodiments described herein,sleeve 78 has a tubular shape that may have a cylindrical or frusto-conical outer profile, and that may have an outer wall of constant or of narrowing thickness from the proximal end to the distal end ofsleeve 78.Sleeve 78 may also be welded todistal tip 16 using process conditions that reduce or eliminate the presence ofsteps 80 and/or 82, facilitating the translation of a guide wire withinlumen 18 and the sliding ofcatheter 10 within a vessel. By adjusting the input of heat,gap 84 can be eliminated to result in a smooth transition orgap 84 can be preserved with a reduced orrounded step 80, thereby providing a kind of hinge joint to the catheter tip. - While the invention has been described in connection with the above described embodiments, it is not intended to limit the scope of the invention to the particular forms set forth, but on the contrary, it is intended to cover such alternatives, modifications, and equivalents as may be included within the scope of the invention. Further, the scope of the present invention fully encompasses other embodiments that may become obvious to those skilled in the art and the scope of the present invention is limited only by the appended claims.
Claims (25)
1. A method of manufacturing a catheter having a soft distal tip, the method comprising:
providing a catheter tube having a proximal end, a distal end, and a catheter lumen therebetween, the catheter lumen being defined by a catheter lateral wall; and
disposing a sleeve over the distal end of the catheter tube and extending the sleeve beyond the distal end of the catheter tube, the sleeve having a proximal end, a distal end, and a sleeve lumen therebetween, the sleeve lumen being defined by a sleeve lateral wall,
wherein the sleeve is softer than the catheter tube,
wherein a portion of the sleeve is affixed on the distal end of the catheter tube, and
wherein the sleeve lateral wall is free of recesses prior to overlaying the distal end of the catheter tube.
2. The method of claim 1 , further comprising,
disposing an inflatable balloon over a portion of the catheter tube, the balloon comprising a balloon body, a proximal neck, and a distal neck, and
coupling an inflation tube to the catheter tube,
wherein the proximal neck couples the balloon body to the inflation tube, and
wherein the distal neck couples the balloon body to the catheter tube.
3. The method of claim 2 , wherein the proximal end of the sleeve abuts the distal neck.
4. The method of claim 2 , wherein the sleeve overlays the distal neck.
5. The method of claim 4 , wherein the sleeve completely overlays the distal neck.
6. (canceled)
7. The method of claim 2 , wherein the distal neck overlays the sleeve and extends beyond the distal end of the sleeve.
8. The method of claim 2 , wherein the distal neck overlays the proximal end of the sleeve, and wherein the distal end of the sleeve extends beyond the distal neck.
9. The method of claim 2 , wherein the proximal end of the sleeve is longitudinally spaced from the distal neck.
10-13. (canceled)
14. A method of manufacturing a catheter having a soft distal tip, the method comprising:
providing a catheter tube having a proximal end, a distal end, and a catheter lumen therebetween, the catheter lumen being defined by a catheter lateral wall; and
disposing a sleeve in the catheter lumen and extending the sleeve beyond the distal end of the catheter tube, the sleeve having a proximal end, a distal end, and a sleeve lumen therebetween, the sleeve lumen being defined by a sleeve lateral wall,
wherein the sleeve is softer than the catheter tube,
wherein a portion of the sleeve is affixed in the catheter lumen to the catheter lateral wall at the distal end of the catheter tube, and
wherein the sleeve lateral wall is free of recesses prior to affixing to the catheter lateral wall.
15. The method of claim 14 , further comprising,
disposing an inflatable balloon that comprises a balloon body, a proximal neck, and a distal necks, and
coupling an inflation tube to the catheter tube,
wherein the proximal neck couples the balloon body to the inflation tube, and
wherein the distal neck couples the balloon body to the catheter tube.
16. The method of claim 15 , wherein the distal end of the sleeve is substantially laterally aligned with a distal end of the distal neck.
17. The method of claim 15 , wherein the distal end of the sleeve is longitudinally offset from a distal end of the distal neck.
18-20. (canceled)
21. A catheter comprising: a catheter tube having a proximal end, a distal end, and a catheter lumen therebetween, the catheter lumen being defined by a catheter lateral wall; and
a sleeve disposed over the distal end of the catheter tube and extending beyond the distal end of the catheter tube, the sleeve having a proximal end, a distal end, and a sleeve lumen therebetween, the sleeve lumen being defined by a sleeve lateral wall,
wherein the sleeve is softer than the catheter tube,
wherein a portion of the sleeve is affixed on the distal end of the catheter tube, and
wherein the sleeve lateral wall is free of recesses prior to overlaying the distal end of the catheter tube.
22. The catheter of claim 1 , further comprising,
an inflatable balloon disposed over a portion of the catheter tube, the balloon comprising a balloon body, a proximal neck, and a distal neck, and
an inflation tube coupled to the catheter tube,
wherein the proximal neck couples the balloon body to the inflation tube, and
wherein the distal neck couples the balloon body to the catheter tube.
23. The catheter of claim 22 , wherein the proximal end of the sleeve abuts the distal neck.
24. The catheter of claim 22 , wherein the sleeve overlays the distal neck.
25. The catheter of claim 24 , wherein the sleeve completely overlays the distal neck.
26. (canceled)
27. The catheter of claim 22 , wherein the distal neck overlays the sleeve and extends beyond the distal end of the sleeve.
28. The catheter of claim 22 , wherein the distal neck overlays the proximal end of the sleeve, and wherein the distal end of the sleeve extends beyond the distal neck.
29. The catheter of claim 22 , wherein the proximal end of the sleeve is longitudinally spaced from the distal neck.
30-40. (canceled)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US12/983,504 US20110172696A1 (en) | 2000-05-22 | 2011-01-03 | Catheter having a soft distal tip |
Applications Claiming Priority (9)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE20009204U DE20009204U1 (en) | 2000-05-22 | 2000-05-22 | Stent implantation catheter assembly |
DEDE200092049 | 2000-05-22 | ||
EPPCT/EP01/05893 | 2001-05-22 | ||
US10/296,252 US20030139761A1 (en) | 2000-05-22 | 2001-05-22 | Catheter system for use in stent implantation |
PCT/EP2001/005893 WO2001089620A2 (en) | 2000-05-22 | 2001-05-22 | Soft-tip catheter for implanting stents |
US64611805P | 2005-01-21 | 2005-01-21 | |
US11/335,931 US20070282367A1 (en) | 2005-01-21 | 2006-01-20 | Catheter having a soft distal tip |
US11/766,662 US7862541B2 (en) | 2000-05-22 | 2007-06-21 | Catheter having a soft distal tip |
US12/983,504 US20110172696A1 (en) | 2000-05-22 | 2011-01-03 | Catheter having a soft distal tip |
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US11/766,662 Continuation US7862541B2 (en) | 2000-05-22 | 2007-06-21 | Catheter having a soft distal tip |
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US12/983,504 Abandoned US20110172696A1 (en) | 2000-05-22 | 2011-01-03 | Catheter having a soft distal tip |
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US11904119B2 (en) | 2014-09-04 | 2024-02-20 | Abbott Cardiovascular Systems Inc. | Balloon catheter |
US20190015630A1 (en) * | 2015-03-19 | 2019-01-17 | Prytime Medical Devices, Inc. | System and method for low-profile occlusion balloon catheter |
US20220118221A1 (en) * | 2015-03-19 | 2022-04-21 | Prytime Medical Devices, Inc. | System and method for low-profile occlusion balloon catheter |
US11672951B2 (en) * | 2015-03-19 | 2023-06-13 | Prytime Medical Devices, Inc. | System and method for low-profile occlusion balloon catheter |
US11857737B2 (en) * | 2015-03-19 | 2024-01-02 | Prytime Medical Devices, Inc. | System and method for low-profile occlusion balloon catheter |
US10426933B2 (en) | 2015-05-19 | 2019-10-01 | Abbott Cardiovascular Systems Inc. | Catheter having monolithic multilayer distal outer member |
US10406318B2 (en) | 2015-05-19 | 2019-09-10 | Abbott Cardiovascular Systems, Inc. | Balloon catheter |
Also Published As
Publication number | Publication date |
---|---|
US7862541B2 (en) | 2011-01-04 |
US20080004568A1 (en) | 2008-01-03 |
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