Medical device anchor and method of manufacture thereof
First Claim
1. A medical device anchor for use with electrical stimulation leads or catheters comprising:
- a gripping structure having a generally tubular configuration defining axial and radial directions, the gripping structure being defined by an annular shoulder and a plurality of compressible beams extending axially from the annular shoulder wherein the shoulder extends radially outwardly beyond the beams;
a body portion formed by molding around the gripping structure and retain the shoulder within the body portion, the gripping means and body portion defining a lumen extending in the axial direction for receiving a lead or catheter.
1 Assignment
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Accused Products
Abstract
A medical device anchor for use with electrical stimulation leads or catheters, and method of manufacture thereof. The anchor may include a gripping structure and a body portion molded on the gripping structure. The gripping structure forms a serpentine arrangement of a continuous nature with axial segments alternately interconnected between shoulder segments and bridging segments. The shoulder segments extend radially outward relative to the through hole further than the axial segments. The body portion may be formed by molding to securely capture the shoulder in the body portion, with the body portion being molded of material that is softer and more compliant than the gripping structure.
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Citations
38 Claims
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1. A medical device anchor for use with electrical stimulation leads or catheters comprising:
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a gripping structure having a generally tubular configuration defining axial and radial directions, the gripping structure being defined by an annular shoulder and a plurality of compressible beams extending axially from the annular shoulder wherein the shoulder extends radially outwardly beyond the beams;
a body portion formed by molding around the gripping structure and retain the shoulder within the body portion, the gripping means and body portion defining a lumen extending in the axial direction for receiving a lead or catheter. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 13)
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12. The medical device anchor of claim 111 wherein the bridging segments are substantially entirely radially outward of the first infinite cylinder.
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14. A medical device anchor for use with electrical stimulation leads or catheters comprising:
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a gripping structure forming a through hole having a circumference, wherein axial, circumferential and radial directions are defined relative to the through hole, the gripping structure having;
a plurality of compressible axial segments arranged in a generally parallel, spaced apart array along the circumference of the through hole, each axial segment having first and second ends; and
a plurality of shoulder segments separated from one another in alternating fashion by a plurality of shoulder gaps forming a generally annular array of shoulder segments and shoulder gaps, the first ends of the axial segments being alternately bridged or unbridged by the shoulder segments and shoulder gaps, the shoulder segments extending radially outward relative to the through hole further than the axial segments; and
a plurality of bridging segments separated from one another in alternating fashion by a plurality of unbridged gaps forming a generally annular array of bridging portions and unbridged gaps, the second ends of the axial segments being alternately bridged or unbridged by the bridging segments and unbridged gaps such that the gripping structure forms a serpentine arrangement of a continuous nature with the axial segments alternately interconnected between shoulder segments and bridging segments; and
a body portion formed by molding to retain the shoulders within the body portion, the gripping structure and body portion defining a lumen for receiving a lead or catheter. - View Dependent Claims (15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 29, 30, 31, 32)
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28. A suture sleeve assembly comprising a suture sleeve made of soft elastomeric material and means associated with the suture sleeve for enhancing gripping of a lead body by the suture sleeve, said suture sleeve comprising a tubular sleeve having a throughbore adapted to receive a lead body or catheter, the gripping enhancing means being made of a material that is different than the material of the suture sleeve and which is stiff but flexible, and said gripping enhancing means being positioned to extend within and longitudinally of an elongate axis of the suture sleeve in a suture-receiving area of the suture sleeve intended to receive one or more sutures thereby to disperse any stress placed upon said suture sleeve when sutures are tied along the suture-receiving area, and the suture sleeve assembly being radially compressible upon the placement and tying of a suture around the suture sleeve assembly in the suture-receiving area to facilitate generally uniform gripping of the lead body or catheter by the suture sleeve assembly along the length of the gripping enhancing means, the gripping enhancing means comprising a cylindrical flexible framework within a suture sleeve forming a cylindrical envelope, the framework being defined by an undulating or sinuous arrangement of a continuous rib extending in axial segments connected by arcuate segments wherein the arcuate segments define two shoulders extending radially outwardly relative to the through bore farther than the axial segments, and the two shoulders define the suture-receiving area.
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33. A method of manufacturing the medical device anchor, the method comprising:
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forming a gripping structure defining a through hole having a circumference, wherein axial, circumferential and radial directions are defined relative to the through hole, the gripping structure forming a continuous, serpentine arrangement having a plurality of compressible axial segments arranged in a generally parallel, spaced apart array along the circumference of the through hole, each axial segment having first and second ends; and
a plurality of shoulder segments separated from one another in alternating fashion by a plurality of shoulder gaps forming a generally annular array of shoulder segments and shoulder gaps, the first ends of the axial segments being alternately bridged or unbridged by the shoulder segments and shoulder gaps, the shoulder segments extending radially outward relative to the through hole further than the axial segments;
a plurality of bridging segments separated from one another in alternating fashion by a plurality of unbridged gaps forming a generally annular array of bridging portions and unbridged gaps, the second ends of the axial segments being alternately bridged or unbridged by the bridging segments and unbridged gaps such that the gripping structure forms a serpentine arrangement of a continuous nature with the compressible beams alternately interconnected between shoulder segments and bridging segments; and
molding a body portion on the gripping structure to securely capture the shoulder in the body portion, the body portion being molded of material that is softer and more compliant than the gripping structure. - View Dependent Claims (34, 35)
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36. A method of manufacturing the medical device anchor, the method comprising:
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forming a gripping structure defining a through hole having a circumference, wherein axial, circumferential and radial directions are defined relative to the through hole, the gripping structure forming a continuous, serpentine arrangement having a plurality of compressible axial segments arranged in a generally parallel, spaced apart array along the circumference of the through hole, each axial segment having first and second ends; and
a plurality of shoulder segments separated from one another in alternating fashion by a plurality of shoulder gaps forming a generally annular array of shoulder segments and shoulder gaps, the first ends of the axial segments being alternately bridged or unbridged by the shoulder segments and shoulder gaps, the shoulder segments extending radially outward relative to the through hole further than the axial segments;
a plurality of bridging segments separated from one another in alternating fashion by a plurality of unbridged gaps forming a generally annular array of bridging portions and unbridged gaps, the second ends of the axial segments being alternately bridged or unbridged by the bridging segments and unbridged gaps such that the gripping structure forms a serpentine arrangement of a continuous nature with the axial segments alternately interconnected between shoulder segments and bridging segments; and
stretching a body portion on the gripping structure with the shoulder segments securely captured by the body portion, the body portion being molded of material that is softer and more compliant than the gripping structure. - View Dependent Claims (37, 38)
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Specification