SURGICAL SUTURES INCORPORATED WITH STEM CELLS OR OTHER BIOACTIVE MATERIALS
First Claim
1. A surgical suture or elongate linear tissue scaffold having an exterior surface and interior core, wherein:
- (i) said interior core is composed of one or more concentric inner zones, one or more of which contain a concentration of bioactive material selected from the group consisting of biological cells and therapeutic agents dispersed therethrough; and
(ii) said exterior surface is composed of one or more concentric outer zones or layers radially disposed about said interior core to control the migration of said bioactive material from said interior core to said exterior surface.
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Accused Products
Abstract
Materials and Methods for immobilizing bioactive molecules, stem and other precursor cells, and other agents of therapeutic value in surgical sutures and other tissue scaffold devices are described herein. Broadly drawn to the integration and incorporation of bioactive materials into suture constructs, tissue scaffolds and medical devices, the present invention has particular utility in the development of novel systems that enable medical personnel performing surgical and other medical procedures to utilize and subsequently reintroduce bioactive materials extracted from a patient (or their allogenic equivalents) to a wound or target surgical site.
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Citations
42 Claims
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1. A surgical suture or elongate linear tissue scaffold having an exterior surface and interior core, wherein:
- (i) said interior core is composed of one or more concentric inner zones, one or more of which contain a concentration of bioactive material selected from the group consisting of biological cells and therapeutic agents dispersed therethrough; and
(ii) said exterior surface is composed of one or more concentric outer zones or layers radially disposed about said interior core to control the migration of said bioactive material from said interior core to said exterior surface. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35)
- (i) said interior core is composed of one or more concentric inner zones, one or more of which contain a concentration of bioactive material selected from the group consisting of biological cells and therapeutic agents dispersed therethrough; and
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36. A surgical suturing kit comprising a surgical suture precursor construct in a sterilizable package in combination with one or more sutures, suture needles or other medical devices, said package having plurality of discrete compartments including (i) a first compartment comprising a reservoir and an infusion port through which a bioactive material may be introduced, wherein said reservoir houses a distal portion of said precursor construct comprised of an exposed section of interior core, (ii) a second compartment housing the proximal portion of said precursor construct comprising one or more woven sheathing layers;
- and (iii) an optional third compartment comprising said one or more sutures, suture needles or other medical devices.
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37. A surgical suturing kit comprising a surgical suture precursor construct in a sterilizable package in combination with one or more sutures, suture needles or other medical devices, said package having plurality of discrete compartments including (i) a first compartment comprising a reservoir and an infusion port through which a bioactive material may be introduced, wherein said reservoir retains in a deformed state a distal portion of a precursor construct having an exterior surface and an interior core and comprised of a matrix of interwoven filaments or a porous monofilament, such that the interstices between interwoven filaments or the pores of the monofilament are of a first size and shape sufficient to permit the migration of bioactive material introduced into said reservoir, across said exterior surface, and into said interior core;
- (ii) a transforming port through which a proximal portion of said precursor passes to form a surgical suture, wherein the port is of a design which induces said interstices or pores to take a second size and shape sufficient to restrict the migration of said bioactive material from said interior core across said exterior surface; and
(iii) an optional second compartment abutting said transforming port comprising said one or more sutures, suture needles or other medical devices.
- (ii) a transforming port through which a proximal portion of said precursor passes to form a surgical suture, wherein the port is of a design which induces said interstices or pores to take a second size and shape sufficient to restrict the migration of said bioactive material from said interior core across said exterior surface; and
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38. A surgical suturing kit comprising a surgical suture precursor construct in a sterilizable package in combination with one or more sutures, suture needles or other medical devices, said package having plurality of discrete compartments through which said precursor construct may be serially drawn and in which said precursor construct may be exposed to two or more different materials for incorporation into the assembled suture as a series of concentric layers.
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39. A method of making a surgical suture or an elongate linear tissue scaffold having an exterior surface and interior core comprised of a matrix of interwoven filaments or a porous monofilament, wherein a concentration of a bioactive material selected from the group consisting of biological cells and therapeutic agents is dispersed throughout said interior core, said method comprising the steps of:
- (a) compressing or otherwise manipulating said matrix along or around a longitudinal axis so as to deform the interstices between interwoven filaments or the pores of the monofilament to a first size and shape sufficient to permit the migration of said bioactive material from a surrounding media, across said exterior surface, and into said interior core; and
(b) manipulating said bioactive material-containing matrix along or around said longitudinal axis so as to shrink said interstices or pores to a second size and shape sufficient to restrict the migration of said bioactive material from said interior core across said exterior surface.
- (a) compressing or otherwise manipulating said matrix along or around a longitudinal axis so as to deform the interstices between interwoven filaments or the pores of the monofilament to a first size and shape sufficient to permit the migration of said bioactive material from a surrounding media, across said exterior surface, and into said interior core; and
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40. A method of making a surgical suture or an elongate linear tissue scaffold having an exterior surface of woven or film construct and an interior core comprised of multiple filaments or a porous monofilament, wherein a concentration of a bioactive material selected from the group consisting of biological cells and therapeutic agents is dispersed throughout said interior core, said method comprising the steps of:
- (a) providing an exposed section of said interior core without said surrounding sheath;
(b) contacting said exposed section with a media containing said bioactive material, such that said bioactive material is entrained in among said core fibers or in the pores of said core; and
(b) manipulating said core or said sheath to cause said core to be surrounded by said sheath with bioactive material present in the core.
- (a) providing an exposed section of said interior core without said surrounding sheath;
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41. A method for applying a target agent to a portion of a medical device and subsequently coating or covering the portion with additional agents or materials to yield a coated target agent-containing medical device, said method comprising the following steps:
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a. providing a sterile package comprising a reservoir housing a medical device or portion thereof, at least one infusion port configured to permit the sterile introduction of at least one target agent into said reservoir, and at least one aspiration port configured to permit the sterile expulsion of at least one target agent; b. optionally introducing a binding agent that facilitates the binding of a target agent to the medical device into said reservoir via said at least one infusion port and optionally expelling any excess binding agent from said reservoir via said at least one aspiration port; c. introducing a target agent into the reservoir through said at least one infusion port and permitting said medical device to bind, absorb, adsorb, or otherwise immobilize said target agent; d. expelling residual target agent from said reservoir through said at least one aspiration port; e. optionally introducing a flushing material said reservoir to facilitate dilution and removal of excess target agent and subsequently expelling said flushing material from said reservoir through said at least one aspiration port; and f. introducing one or more additional target agents or coating molecules into said reservoir via said at least one infusion port and permitting said medical device to bind, absorb, adsorb, or otherwise immobilize said additional target agents or coating materials.
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42. A method of serially exposing a medical device to multiple target agents or materials, the method comprising the following steps:
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a. providing a sterile package comprising two or more discrete compartments or zones, a first of which houses a medical device or portion thereof and includes at least one infusion port configured to permit the sterile introduction of at least one target agent into said compartment; b. introducing a target agent into said first compartment through said at least one infusion port and permitting said medical device to bind, absorb, adsorb, or otherwise immobilize said target agent; c. drawing the target agent-containing medical device into a second compartment and exposing said device to additional target agents or coating molecules contained therein; and d. optionally, drawing the target agent-containing medical device into one or more additional compartments and exposing said device to one or more additional target agents or coating molecules contained therein.
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Specification