Textiles: cloth finishing
Reexamination Certificate
1997-11-17
2001-08-14
Ortiz, Angela (Department: 1732)
Textiles: cloth finishing
C264S259000, C604S525000
Reexamination Certificate
active
06273404
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention pertains generally to the field of catheters and, more particularly, to hub or manifold assemblies connected to the proximal end thereof.
Catheters, such as guide catheters, diagnostic catheters and therapeutic catheters, for example, angioplasty and atherectomy catheters generally comprise a flexible tube having a permanently connected hub assembly at one end of the tube. The hub assembly often includes a hub and a strain relief. The hub generally includes a connector for connecting the catheter to a Y-adaptor, inflation device or the like. The strain relief generally extends from the hub along a portion of the catheter tube to provide a transition in flexibility between the hub and the tube.
Prior hub assemblies utilized a two piece construction, for example, the hub was attached to an end of the catheter tube and then the strain relief was attached in a secondary process. The primary reason for the two piece design was the different functions of the hub and strain relief required different materials or material properties. The hub is required to be harder material to withstand forces applied to the connector. The strain relief, however, must provide a stiffness transition from the hub to the catheter shaft. The strain relief material is typically soft and flexible to provide kink-resistance and added support to the catheter shaft proximate the hub.
One such hub assembly is disclosed by Wijkamp et al. in U.S. Pat. No. 5,167,647. In one embodiment, a tubular strain relief is injection molded around one end of the catheter. After the strain relief has hardened, a hub is secured to the strain relief. Alternately, an end of the catheter may be inserted into a hub. The hub and catheter can then be placed into a mold to form the strain relief around the end of the catheter and between the catheter and the hub. Wijkamp et al. also discloses simultaneously molding both the hub and the strain relief from two different materials.
Prichard et al., in U.S. Pat. No. 5,380,301, also disclose a prior hub assembly. Prichard et al. disclose a hub formed of a material having a relatively high durometer hardness in comparison to the catheter. The strain relief is preferably formed of a material having a flexibility and durometer hardness which is greater than that of the catheter, but less than that of the hub. The hub is first separately molded, then an end of the catheter is inserted into the hub. Then both the hub and the portion of the catheter proximal the hub are placed in a mold. As disclosed by Wijkamp et al., the strain relief is then molded around the catheter and between a portion of the hub and the catheter. The hub also includes openings into which molten strain relief material flows to form a mechanical bond between the strain relief and the hub.
SUMMARY OF THE INVENTION
The present invention pertains to a hub assembly including an integrally formed hub and strain relief. The hub assembly can be insert molded in a single mold using one injection process and a single material. The material can be sufficiently hard for use in forming the hub. The desired relatively greater flexibility of the strain relief is achieved by modifying the geometry of the strain relief.
In a preferred embodiment, the hub assembly in accordance with the present invention is for a catheter having a lumen therethrough. The hub assembly includes a hub portion having a proximal end and a distal end. An integral connection is disposed at the proximal end. A lumen defined through the hub portion extends from the proximal end to the distal end.
A strain relief having a proximal end and a distal end is disposed at the distal end of the hub portion. The proximal end of the strain relief is integrally connected to the distal end of the hub portion. The strain relief defines a passage configured to receive the catheter such that the lumen through the hub portion is in fluid communication with the catheter lumen.
The lumen extending through the hub includes a wall having an average wall thickness. The strain relief passage also has a wall having an average wall thickness. In a preferred embodiment, the average wall thickness of the hub portion is greater than the average wall thickness of the strain relief passage. In one embodiment, the wall thickness of the passage generally decreases from the strain relief proximal end toward the strain relief distal end.
In a preferred embodiment, a plurality of grooves extend into the passage wall generally transversely toward the passage. The grooves can extend through the wall into the passage. The grooves can be disposed in a plurality of sets, each set including two grooves. The two grooves within each set can be disposed generally within the same plane to define a point of flexibility or transverse hinge in the strain relief. In an alternate embodiment, the strain relief can include a generally helical portion. The helical portion preferably extends from proximate the proximal end of the strain relief to proximate the distal end of the strain relief.
In an alternate embodiment, the hub portion may include an angled port. The angled port, hub portion and strain relief portion can be integrally formed or connected by insert molding to form a manifold for an angioplasty catheter. The angled port defines a lumen in fluid communication with the lumen defined through the hub portion, and consequently the port is also in fluid communication with the lumen of the catheter tube held within the strain relief portion. If the angioplasty catheter is an over-the-wire catheter, a separate guide wire tube defining a guide wire lumen can extend through the catheter tube defining an inflation lumen between the catheter tube and the guide wire tube therein. The tube defining the guide wire lumen can include a separate hub portion connectable to the proximal end of the hub portion of the manifold.
The connector can be a threaded connector. The hub portion can include transversely extending wings. The hub portion, the strain relief portion and angled port can be made from the same material, such as nylon, PEBA (polyether block amide polymer, commercially available under the trade name PEBAX), polycarbonate or another material having similar properties.
REFERENCES:
patent: Re. 25788 (1965-06-01), Sheridan
patent: 2185741 (1940-01-01), Sorg et al.
patent: 3318335 (1967-05-01), Heller
patent: 3348544 (1967-10-01), Braun
patent: 3720210 (1973-03-01), Diettrich
patent: 3914002 (1975-10-01), Berliner et al.
patent: 3950052 (1976-04-01), Walter et al.
patent: 4154244 (1979-05-01), Becker et al.
patent: 4198983 (1980-04-01), Becker et al.
patent: 4354495 (1982-10-01), Bodicky
patent: 4489961 (1984-12-01), Laidig
patent: 4509877 (1985-04-01), Sobin et al.
patent: 4511163 (1985-04-01), Harris et al.
patent: 4602808 (1986-07-01), Herron et al.
patent: 4863441 (1989-09-01), Lindsay et al.
patent: 4874373 (1989-10-01), Luther et al.
patent: 4960412 (1990-10-01), Fink
patent: 5041095 (1991-08-01), Littrell
patent: 5085645 (1992-02-01), Purdy et al.
patent: 5125903 (1992-06-01), McLaughlin et al.
patent: 5143409 (1992-09-01), Lalikos
patent: 5167647 (1992-12-01), Wijkamp et al.
patent: 5181750 (1993-01-01), Reum
patent: 5226898 (1993-07-01), Gross
patent: 5248305 (1993-09-01), Zdrahala
patent: 5330449 (1994-07-01), Prichard et al.
patent: 5358493 (1994-10-01), Schweich, Jr. et al.
patent: 5376077 (1994-12-01), Gomringer
patent: 5380301 (1995-01-01), Prichard et al.
patent: 5395332 (1995-03-01), Ressemann et al.
patent: 5403292 (1995-04-01), Ju
patent: 5466230 (1995-11-01), Davail
patent: 5507728 (1996-04-01), Erskine
patent: 5545151 (1996-08-01), O'Connor et al.
patent: 5558635 (1996-09-01), Cannon
patent: 5558652 (1996-09-01), Henke
patent: 5695467 (1997-12-01), Miyata et al.
patent: 5803510 (1998-09-01), Dorsey, III
patent: 5830401 (1998-11-01), Prichard et al.
patent: 6113576 (2000-09-01), Dance et al.
Brochure, SciMed Life Systems, Inc., 1990, 1 page.
Brochure,Technical Notes,published on date even with or prior to Jun. 5, 1995, 2 pages.
Arnold, Jr. John E.
Berg Todd A.
Holman Thomas J.
Olson Gregory K.
Crompton Seager & Tufte LLC
Ortiz Angela
Sci-Med Life Systems, Inc.
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