KR20220064381A - Barbed-shaped microcatheters having fluid outlet openings for injecting therapeutic fluid into tissue and methods of making and using the same - Google Patents

Abstract

A microcatheter 100 for delivering a therapeutic fluid to a patient, and methods of making and using the same. The barb-formed microcatheter is in fluid communication with a hollow tube 102 having an elongate lumen extending between a proximal end and a distal end, a plurality of barbs 108 protruding from the hollow tube, and the elongate lumen formed in the hollow tube. and a plurality of fluid outlet openings 110 . The fluid outlet openings are evenly spaced from each other along the length of the hollow tube. An anchor 112 is secured to the proximal end of the hollow tube and a surgical needle 114 is secured to the distal end of the hollow tube.

Description

Barbed-shaped microcatheters having fluid outlet openings for injecting therapeutic fluid into tissue and methods of making and using the same

Cross-reference to related applications

This patent application claims priority to U.S. Patent Application Serial No. 16/570,017, filed September 13, 2019, and U.S. Patent Application Serial No. 16/570,028, filed September 13, 2019.

BACKGROUND This patent application relates generally to medical devices, and more particularly, to a catheter implanted in a patient and a method of manufacturing the same.

Many medical treatment protocols involve injecting a therapeutic fluid into a selected area of a patient's body. The types of therapeutic fluids typically employed by physicians to treat patients include anesthetics, antibiotics, antimicrobials, chemotherapeutic agents, and growth factors.

Historically, therapeutic fluids have been delivered to patients using catheters that are temporarily implanted within the patient to deliver them during the treatment period. At the end of the treatment period, the catheter is removed from the patient. Unfortunately, catheter removal often results in wound rupture and pain for the patient.

In many cases, a linear catheter is used to treat the patient. Linear catheters are typically held in place using sutures or other fixation devices (eg, staples), which complicate the surgery, introduce additional foreign bodies into the patient, and restrict the flow of treatment fluid through the catheter. impairs catheter performance by interfering.

In some cases, rather than using a linear catheter, it is necessary to use a non-linear catheter that is arranged in a complex three-dimensional configuration inside the patient. For example, a non-linear catheter having a three-dimensional configuration may be used to extend around a subject positioned inside the body, such as a tumor, artificial joint, or complex surgical wound. Because of their non-linear shape, medical practitioners often have great difficulty removing non-linear catheters from patients.

Catheters implanted in a patient come in many different sizes. In some cases, it is desired for a healthcare practitioner to use a microcatheter, also referred to as a microcatheter, to deliver a therapeutic fluid to a patient. Creating a fluid passageway within a microcatheter can be extremely challenging due to the precise tolerances required to maintain uniform fluid flow over the length of the microcatheter.

When forming fluid passageways in larger sized catheters, a sharp hollow stainless steel tube may be used to core punch material from the wall of the catheter. This approach becomes more challenging as the size of the catheter decreases because there is a limit to the size of the sharp hollow stainless steel tubing that can be used to create a fluid passageway within the catheter. Although exceptionally fine steel tubing may be available to create the fluid passageway, the material that is core punched from the wall of the catheter to form the fluid passageway tends to become lodged inside the lumen of the catheter and must be removed from the lumen. . Removing punched material involves its own set of challenges.

A fluid passageway may be formed in the catheter tube using a laser to form the passageway. However, it is difficult to precisely control the power level of the laser to drill completely through the catheter tubing as opposed to the fluid passageway formed by the laser remaining on only one side of the catheter tube. The laser also vaporizes and removes material, which may re-condense on or within the catheter tube. In addition, the chemical structure of the ablated/vaporized material is often altered by the intense heat of the laser, such that the laser-drilled catheter is no longer readily quantifiable for purposes of design control and regulatory registration of medical devices or is biocompatible. won't make it Furthermore, lasers tend to locally heat the material and change the structure and molecular orientation of the catheter tube material, which results in catheters with inferior mechanical properties. Finally, lasers that provide a spot size of less than 30 um and sufficient power can be very expensive, which will increase manufacturing costs.

In view of the aforementioned drawbacks, there remains a need for systems, apparatus and methods for safely, effectively, economically and reliably mass-producing microcatheters with fluid outlet openings.

There also remains a need for a system, apparatus, and method for manufacturing a microcatheter having fluid outlet openings having different sizes along the length of the microcatheter to achieve uniform fluid delivery.

Additionally, there remains a need for microcatheters having fluid outlet openings of different sizes, including smaller fluid outlet openings located closer to the fluid source and larger fluid outlet openings positioned further away from the fluid source.

Furthermore, there remains a need for systems, devices, and methods for making microcatheters having fluid outlet openings without altering the molecular structure, properties, and/or chemical properties of the materials used to fabricate the microcatheters.

Additionally, there remains a need for automated systems and methods for safely, effectively, economically, and reliably mass-producing microcatheters with microfluid outlet openings for local delivery of therapeutic fluids to patients.

Additionally, there remains a need for an absorbable barbed microcatheter having a fluid outlet opening for delivering a treatment fluid to a patient such that the microcatheter is absorbable by the patient's body and does not need to be removed from the patient. there is.

In one embodiment, a microcatheter having fluid outlet openings for delivering therapeutic fluids to a patient is made of a bioabsorbable material, which eliminates the need for catheter removal at the end of the treatment period.

In one embodiment, a microcatheter having fluid outlet openings for delivering treatment fluids allows a healthcare practitioner (eg, a surgeon) to accurately place the microcatheter inside a patient without requiring additional securing mechanisms such as sutures or staples. Incorporate continuous fixation methods such as barbs. Such catheters (eg, barb-formed microcatheters) can be readily deployed around the surgical perimeter in any desired configuration with relative ease and with minimal additional procedure time.

In one embodiment, a microcatheter having fluid outlet openings for delivering treatment fluids preferably includes an elongate central lumen extending along the length of the catheter. The microcatheter preferably includes punched or cut anchoring barbs to hold the catheter in place within the patient's interior.

In one embodiment, a barb-shaped microcatheter for delivering fluids to a patient is preferably a hollow tube having a proximal end, a distal end, and an elongate lumen extending between the proximal and distal ends. , barbs projecting outwardly from the hollow tube, and a plurality of fluid outlet openings formed in the hollow tube in fluid communication with the elongate lumen of the hollow tube.

In one embodiment, the fluid outlet openings are spaced apart from each other between the proximal end and the distal end of the hollow tube.

In one embodiment, the fluid outlet openings may be evenly spaced from each other between the proximal end and the distal end of the hollow tube.

In one embodiment, each of the fluid outlet openings may be the same size.

In one embodiment, two or more of the fluid outlet openings may have different sizes. In one embodiment, the sizes of the fluid outlet openings may gradually increase in size between the end of the hollow tube closer to the fluid source and the end of the hollow tube further away from the fluid source.

In one embodiment, the fluid outlet openings are round holes.

In one embodiment, the fluid outlet openings are elongate slits. In one embodiment, the hollow tube has a longitudinal axis extending between the proximal end and the distal end of the hollow tube, and the elongate slits have lengths extending along a common axis parallel to the longitudinal axis of the hollow tube.

In one embodiment, the hollow tube preferably has an inner surface and an outer surface surrounding the elongate lumen. In one embodiment, the fluid outlet openings are formed in the hollow tube and extend from an outer surface of the hollow tube to an inner surface of the hollow tube for fluid communication with the elongate lumen.

In one embodiment, the inner surface of the hollow tube preferably defines an inner cross-sectional diameter of the hollow tube, and the outer surface of the cylindrical wall defines an outer cross-sectional diameter of the hollow tube that is about twice the inner cross-sectional diameter of the hollow tube. do.

In one embodiment, the hollow tube has a wall thickness of about 0.125 mm, the outer cross-sectional diameter of the hollow tube is about 0.50 mm, and the inner cross-sectional diameter of the hollow tube is about 0.25 mm.

In one embodiment, the barb-formed microcatheter is preferably made of an absorbable biocompatible polymer such that the barb-formed microcatheter will be absorbed and will not need to be removed from the patient at the end of the treatment period.

In one embodiment, a barb-shaped microcatheter for delivering fluids to tissue is a hollow tube, preferably having a proximal end and a distal end, disposed within the hollow tube and extending between the proximal and distal ends of the hollow tube. the hollow tube having an elongated lumen; barbs projecting outwardly from the outer surface of the hollow tube; and a plurality of fluid outlet openings formed in an outer surface of the hollow tube in fluid communication with the elongate lumen of the hollow tube. In one embodiment, the fluid outlet openings are evenly spaced from each other between the proximal end and the distal end of the hollow tube.

In one embodiment, each of the fluid outlet openings is the same size. In one embodiment, two or more of the fluid outlet openings have different sizes. In one embodiment, the fluid outlet openings have shapes selected from the group consisting of round holes and elongated slits.

In one embodiment, the elongate lumen of the hollow tube defines a cross-sectional diameter of about 0.25 mm, and the outer surface of the hollow tube defines a cross-sectional diameter of about 0.50 mm.

In one embodiment, an anchor is secured to the proximal end of the hollow tube.

In one embodiment, a surgical needle, such as a curved needle, is secured to the distal end of the hollow tube.

In one embodiment, a barb-shaped microcatheter for delivering therapeutic fluids to a tissue is a hollow tube, preferably having a proximal end and a distal end, disposed within the hollow tube and extending between the proximal and distal ends of the hollow tube. the hollow tube having an elongate lumen in which a plurality of barbs projecting outwardly from the outer surface of the hollow tube; and a plurality of fluid outlet openings formed in an outer surface of the hollow tube in fluid communication with the elongate lumen of the hollow tube, whereby the fluid outlet openings are uniformly spaced from each other between the proximal unit and the distal end of the hollow tube. fluid outlet openings of

In one embodiment, the barb-formed microcatheter preferably comprises an anchor secured to the proximal end of the hollow tube, and a surgical needle secured to the distal end of the hollow tube.

In one embodiment, the barb-formed microcatheter preferably has a first size, a first fluid outlet opening positioned adjacent the anchor, and a second size smaller than the first size of the first fluid outlet opening; and two or more fluid outlet openings having different sizes including a second fluid outlet opening positioned adjacent the surgical needle.

Infections associated with orthopedic implants are unfortunate for patients and can often have serious consequences including revision surgery, amputation or death. Delivery of antibiotics directly to the affected area at elevated doses that are dangerous if systemically delivered but safe when delivered locally can be achieved using the microcatheters disclosed herein.

Inoperable tumors often leave patients with limited options. Delivery of high-dose chemotherapeutic agents or immunotherapy (ie, modified T-cells) directly to tumors may provide previously unavailable benefits. The bioabsorbable microcatheters disclosed herein can be used to provide for local delivery of these types of therapeutic fluids.

Postoperative pain management with opioids is often not ideal for several reasons, including the risk of addiction, severe constipation, and cognitive impairment. Delivery of local anesthetics directly to the wound site using the microcatheters disclosed herein preferably provides a mechanism to reduce opioid use while minimizing patient pain and distress.

In one embodiment, the barb-formed microcatheter may be coated and/or impregnated with an antimicrobial agent to prevent bacterial colonization. In one embodiment, the preferred antimicrobial agent is triclosan. In one embodiment, a steam process may be used to apply the triclosan antimicrobial agent to a barbed microcatheter, such as a polymer barbed microcatheter made of polydioxanone or polycaprolactone. In one embodiment, antimicrobial agents used in barb-formed microcatheters may include, but are not limited to, triclosan, chlorhexidine, povidone iodine, and/or silver compounds.

In one embodiment, the method of manufacturing a barb-formed microcatheter preferably comprises a first prerequisite step for forming the fluid outlet openings (eg, fluid outlet passages) concurrently or alternatively to forming the fluid outlet openings. and forming a microcatheter blank (eg, a polymer tube) as a In one embodiment, the microcatheter blank may be formed and reinforced by methods well known in the polymer extrusion and polymer fiber drawing art. In one embodiment, the microcatheter blank may be planarized to varying degrees to create laterally flattened areas that may be used to form barbs projecting from the hollow tube.

In one embodiment, the sides of the microcatheter blank may be planarized, and the flattened sides may be sealed using heat or ultrasonic energy. The cross-sectional shape of the microcatheter blank having flattened sides may be thermoset prior to or during the barb forming step to create a microcatheter having an elliptical cross-section. In one embodiment, the microcatheter blank may be shielded from heat and bounce back to a predominantly circular cross-section after barb formation.

In one embodiment, the fluid outlet openings may be formed concurrently with any of the manufacturing steps disclosed herein, or may be achieved in one or more separate steps as described herein.

In one embodiment, the barb-formed microcatheter disclosed herein preferably provides control of therapeutic fluids from fluid outlet openings (eg, apertures, slits) located along the length of the hollow tube of the barbed microcatheter. to enable an equal distribution. In one embodiment, the fluid outlet openings/slits are formed on the upper side of the hollow tube of the barb-formed microcatheter. In one embodiment, the lower side of the hollow tube does not have fluid outlet openings/slits.

In one embodiment, the cross-sectional area of the fluid outlet openings may increase in size with increasing distance from the fluid source. In one embodiment, the fluid outlet openings closer to the fluid source may be smaller, and the fluid outlet openings further away from the fluid source may be larger. The sizes of the fluid outlet openings may gradually increase along the length of the barb-formed microcatheter.

In one embodiment, the fluid outlet openings formed in the hollow tube of the barb-formed microcatheter may include elongate slits. In one embodiment, the elongate slits may close substantially at lower fluid pressure levels (eg, zero fluid pressure), although the elongate slits may preferably close at a higher fluid pressure level, which may be created by a syringe or fluid pump. Opens when exposed to fluid pressure levels. Using elongate slits that open when exposed to higher pressure levels preferably allows the entire length of the microcatheter to be first loaded with treatment fluid at lower fluid pressure levels. Later, when higher fluid pressure levels are achieved, the elongate fluid outlet slits will open to release treatment fluid from the elongate fluid outlet slits.

In one embodiment, a barb-formed microcatheter may have an anchor secured at one end, and a needle (eg, a curved needle) secured at the opposite end. In one embodiment, the anchor is secured to the proximal or trailing end of the barbed microcatheter and the needle is secured to the distal or leading end of the barbed microcatheter. In one embodiment, an anchoring device such as loops or reverse oriented barbs may be used. In one embodiment, double-armed and loop barb-shaped symmetric catheters may also be fabricated.

In one embodiment, the barb-formed microcatheter may have fluid outlet openings/holes of the same size. In one embodiment, the barb-formed microcatheter may have fluid outlet openings/holes having various sizes.

In one embodiment, the barb-formed microcatheter may have fluid outlet slits of equal length. In one embodiment, the barb-formed microcatheter may have fluid outlet slits having various lengths.

In one embodiment, needles are used to form fluid outlet openings in the hollow tube of a barb-formed microcatheter. In one embodiment, the diameters of the respective needles may vary along the length of the microcatheter to change the diameters of the respective fluid outlet openings.

In one embodiment, the forming dies may be configured to receive the barb-formed microcatheter after the initial forming step and to hold the barb-formed microcatheter in a set position during the punching operation to form one or more fluid outlet openings. there is. In one embodiment, a fluid outlet opening die may be used to simultaneously form a barb-formed microcatheter while punching the fluid outlet openings.

In one embodiment, the forming die preferably has embedded hole punch needles positioned along the length of the barb-formed microcatheter received within the forming die. The insertion depth of the respective hole punch needles may be varied along the length of the forming die to control the sizes (ie, diameters) of the fluid outlet openings. In one embodiment, the further the tapered tip of the needle is inserted into the die, the larger the size of the fluid outlet opening formed in the hollow tube of the barb-formed microcatheter.

In one embodiment, the hole punch needles are not permanently attached to the die, but rather can be adapted to move into the die cavity after the microcatheter (or microcatheter blank) is inserted into the die. In one embodiment, the needles used to form the fluid outlet openings can all articulate together to move in and out of the die cavity, or they can be made to move into and out of the die individually.

In one embodiment, systems, devices, and methods of making barb-formed microcatheters include cutting the slits into a hollow tube using one or more cutting blades to form fluid outlet slits. can In one embodiment, the cutting blades may be attached to at least one half of the die, or may be configured to slide simultaneously or separately into and out of the die cavity. In one embodiment, the depth at which the cutting blade is inserted into the die can be controlled to create elongate slits of various lengths. Forming elongate slits in the hollow tubes of microcatheters will have minimal effect on the tensile strength of microcatheters. In one embodiment, the elongate slits preferably provide a mechanism for controlling the fluid flow rate whereby the slits remain closed at low fluid pressure levels and an incrementally higher fluid pressure for discharging the fluid. open at levels.

In one embodiment, systems, apparatuses and methods for forming elongate slits in hollow tubes of microcatheters include inserting a cutting edge of a cutting blade into an outer wall of a hollow tube of a microcatheter and an elongated tube in the hollow tube. moving the cutting edge relative to the hollow tube to form a slit. The cutting blade may articulate in two axes or it may be configured to move up and down while the die carrying the microcatheter is translated horizontally relative to the cutting blade.

In one embodiment, one or more cutting blades may be used to form barbs on the sides of the microcatheter. In one embodiment, the cutting blades may be used to form barbs that extend longitudinally, orthogonally, or at any angle between the longitudinal and orthogonal orientations. An intersection or “x-pattern” can also be created by multiple passes of the cutting blade or through the use of a specially shaped cutting blade.

In another embodiment, lasers and/or electron beams may be used to form the barbs of a barb-formed microcatheter.

In one embodiment, a method of making a barb-formed microcatheter having fluid outlet openings preferably comprises compressing first and second sides of a polymer blank to form a barb-formed microcatheter blank, comprising: The microcatheter blank has a first flattened area extending along a first side of the barb-formed microcatheter blank, a second flattened area extending along a second side of the barb-formed microcatheter blank, and a first flattened area and a hollow tube having an elongate lumen positioned between the second flattened region.

In one embodiment, a method of making a barb-formed microcatheter having fluid outlet openings comprises first and second flattened regions of a barb-formed microcatheter blank to form barbs protruding outwardly from opposite sides of a hollow tube. It may include removing material from them.

In one embodiment, a method of manufacturing a barb-formed microcatheter having fluid outlet openings may include forming fluid outlet openings in a wall of the hollow tube in fluid communication with an elongate lumen of the hollow tube.

In one embodiment, a method of making a barb-formed microcatheter having fluid outlet openings comprises compressing a proximal end of a polymeric blank to form a tissue anchor connected with a proximal end of a hollow tube, and a needle at the distal end of the hollow tube. It may include the step of fixing.

In one embodiment, at least one cutting element is used to form fluid outlet openings in the wall of the hollow tube.

In one embodiment, forming the fluid outlet openings comprises forming a first fluid outlet opening having a first size in a wall of the hollow tube, and greater than a first size of the first fluid outlet opening in the wall of the hollow tube. forming a second fluid outlet opening having a second large size.

In one embodiment, forming the fluid outlet openings may include forming a series of progressively larger fluid outlet openings in the wall of the hollow tube.

In one embodiment, the fluid outlet openings may be formed concurrently during the step of forming the fluid outlet openings.

In one embodiment, the fluid outlet openings are formed independently of each other and at different times during the step of forming the fluid outlet openings.

In one embodiment, the tissue anchor associated with the proximal end of the hollow tube comprises a flattened tab, preferably having a length and a width.

In one embodiment, compressing the first and second sides of the polymer blank comprises an upper pressing die part overlying the polymer blank and a lower pressing die opposite the upper pressing die part and positioned below the polymer blank. placing the polymer blank into a pressing die having the portion. In one embodiment, the pressing die is preferably moved to a closed position to compress the upper and lower surfaces of the first and second sides of the polymer blank to form the first and second flattened regions and the hollow tube. .

In one embodiment, the upper pressing die part preferably comprises a plurality of cutting elements projecting from the underside of the upper pressing die part. In one embodiment, when the pressing die is in the closed position, the cutting elements engage the hollow tube to form fluid outlet openings in the hollow tube.

In one embodiment, removing the material preferably comprises cutting the first and second flattened regions of the barb-formed microcatheter blank to form barbs projecting outwardly from opposite sides of the hollow tube. do.

In one embodiment, cutting a barb-formed microcatheter blank comprising first and second flattened regions and a hollow tube having an upper cutting die portion and a lower cutting die portion opposite the upper cutting die portion placing into the cutting die, and moving the cutting die to the closed position to cut the first and second flattened regions of the barb-formed microcatheter blank to form barbs projecting outwardly from opposite sides of the hollow tube. It may include the step of

In one embodiment, the upper cutting die portion preferably comprises a plurality of cutting elements projecting from the underside of the upper cutting die portion. In one embodiment, when the cutting die is in the closed position, the cutting elements engage the hollow tube to form fluid outlet openings in the hollow tube.

In one embodiment, on the polymer blank to compress the first and second flattened regions of the barb-formed microcatheter blank and the upper and lower surfaces of the first and second sides of the polymer blank to form a hollow tube. Pressing rollers may be used.

A method of making a barb-shaped microcatheter having fluid outlet openings preferably comprises a hollow tube having a proximal end, a distal end, and an elongate lumen extending between the proximal and distal ends, and along opposite sides of the hollow tube. obtaining a barb-formed microcatheter blank comprising first and second extending planarized regions.

In one embodiment, a method of manufacturing a barb-formed microcatheter removes material from first and second flattened regions of a barb-formed microcatheter blank to form barbs projecting outwardly from opposite sides of a hollow tube. using one or more cutting elements to form in a wall of the hollow tube fluid outlet openings in fluid communication with the elongate lumen of the hollow tube, forming a tissue anchor connected with the proximal end of the hollow tube, and securing the surgical needle with the distal end of the tube.

In one embodiment, a method of delivering a therapeutic fluid to a tissue comprises positioning a barb-formed microcatheter adjacent a wound, preferably having a first wound end and a second wound end, whereby the barb-formed microcatheter is The microcatheter is a hollow tube having an elongate lumen extending between a first end and a second end, barbs projecting outwardly from opposite sides of the hollow tube, a fluid outlet formed in the hollow tube, the fluid outlet in fluid communication with the elongate lumen. openings, a tissue anchor secured to a first end of the hollow tube, and a needle secured to a second end of the hollow tube.

In one embodiment, a method of delivering a therapeutic fluid to a tissue uses a needle to form a first tissue opening in a first end of a wound, and draws the hollow tube into contact with tissue at the first end of the wound until a tissue anchor abuts the tissue at the first end of the wound. pulling completely through the first tissue opening.

In one embodiment, a method of delivering a therapeutic fluid to a tissue uses a needle to form a second tissue opening in a second end of the wound, wherein barbs projecting outwardly from opposite sides of the hollow tube are provided at the first end of the wound. and pulling the hollow tube completely through the second tissue opening to engage tissue in the wound positioned between the second end.

In one embodiment, the method of delivering a therapeutic fluid to a tissue preferably comprises passing the needle through a layer of skin of the patient such that the needle and the second end of the hollow tube are positioned on the exterior of the patient.

In one embodiment, a method of delivering a therapeutic fluid to a tissue comprises cutting a second end of the hollow tube to separate a needle from the hollow tube, and introducing the therapeutic fluid into the cut second end of the hollow tube, thereby causing treatment allowing fluid to flow into the elongate lumen and passing through the fluid outlet openings to inject a therapeutic fluid into the wound.

In one embodiment, after the needle is passed through the skin layer to be placed on the exterior of the patient, the intermediate section of the hollow tube comprising the barbs and fluid outlet openings is preferably between the first and second ends of the wound. is located in

In one embodiment, after the barb-formed microcatheter is placed in the wound, the middle section of the hollow tube is placed in the closed wound.

In one embodiment, after the barb-formed microcatheter is positioned within the wound, an intermediate section of the hollow tube extends along a linear path between the first end and the second end of the wound.

In one embodiment, after the barb-formed microcatheter is positioned within the wound, an intermediate section of the hollow tube extends along a non-linear path between the first and second ends of the wound.

These and other preferred embodiments of the present patent application will be described in more detail herein.

1 is a plan view of a barb-formed microcatheter having fluid outlet openings, in accordance with an embodiment of the present patent application.
2A is a perspective view of a barb-formed microcatheter having fluid outlet openings, in accordance with an embodiment of the present patent application.
FIG. 2B is a plan view of the barb-formed microcatheter shown in FIG. 2A;
2C is a bottom view of the barb-formed microcatheter shown in FIGS. 2A and 2B;
2D is a proximal end view of the barb-formed microcatheter shown in FIGS. 2A-2C.
FIG. 2E is a left side view of the barb-formed microcatheter shown in FIGS. 2A-2D.
3 is a cross-sectional view of the barb-formed microcatheter shown in FIGS. 2A-2E.
4A is a perspective view of a microcatheter blank used to form a barb-formed microcatheter having fluid outlet openings, in accordance with one embodiment of the present patent application.
Fig. 4B is a cross-sectional view of the microcatheter blank shown in Fig. 4A;
5 is a perspective view of a pressing die used to form a microcatheter blank having flattened lateral regions extending along the length of the microcatheter blank, in accordance with an embodiment of the present patent application.
6 is a perspective view of a microcatheter blank having flattened lateral regions extending along the length of the microcatheter blank, in accordance with an embodiment of the present patent application.
7 is a perspective view of pressing rollers used to form a microcatheter blank having flattened lateral regions extending along the length of the microcatheter blank, in accordance with an embodiment of the present patent application.
8 is a perspective view of a cutting die used to cut barbs in planarized lateral regions extending along the length of a microcatheter blank, in accordance with an embodiment of the present patent application.
Fig. 9 is a perspective view of the microcatheter blank with barbs shown in Fig. 8;
10A is a perspective view of a needle used to form fluid outlet openings in the microcatheter blank of FIG. 9, in accordance with an embodiment of the present patent application;
Fig. 10B is an enlarged view of the distal end of the needle shown in Fig. 10A;
11 is a perspective view of a die used to form a barb-formed microcatheter having fluid outlet openings, in accordance with an embodiment of the present patent application.
12 is a plan view of a barb-formed microcatheter having fluid outlet openings formed on the upper side of a hollow tube, in accordance with an embodiment of the present patent application.
13 is a top view of a barb-formed microcatheter having a hollow tube with spaced fluid outlet openings having different sizes, in accordance with an embodiment of the present patent application.
14A is a perspective view of a die used to form spaced fluid outlet openings in the hollow tube of a barb-formed microcatheter, in accordance with an embodiment of the present patent application.
Fig. 14B is a side view of the die shown in Fig. 14A;
15A is a perspective view of a die used to form spaced fluid outlet openings in the hollow tube of a barb-formed microcatheter, in accordance with one embodiment of the present patent application.
Fig. 15B is a side view of the die shown in Fig. 15A;
16 is a top view of a barb-formed microcatheter with spaced fluid outlet openings, in accordance with an embodiment of the present patent application.
17A is a perspective view of a barb-formed microcatheter with spaced outflow slits, in accordance with an embodiment of the present patent application.
FIG. 17B is a top view of the barb-formed microcatheter shown in FIG. 17A .
17C is a bottom view of the barb-formed microcatheter shown in FIGS. 17A and 17B.
17D is a proximal end view of the barb-formed microcatheter shown in FIGS. 17A-17C.
17E is a left side view of the barb-formed microcatheter shown in FIGS. 17A-17D.
18 is a cross-sectional view of the barb-formed microcatheter shown in FIGS. 17A-17E.
19 is a perspective view of a die used to form spaced fluid outlet openings in the upper surface of the hollow tube of a barb-formed microcatheter, in accordance with an embodiment of the present patent application.
20A is a perspective view of a cutting blade used to form fluid outlet slits in the hollow tube of a barb-formed microcatheter, in accordance with an embodiment of the present patent application.
Fig. 20B is an enlarged view of the distal end of the cutting blade shown in Fig. 20A;
21 illustrates a first step of a method of forming a fluid outlet slit in a hollow tube of a barb-formed microcatheter, according to an embodiment of the present patent application.
22 illustrates a second step of a method of forming a fluid outlet slit in the hollow tube of a barb-formed microcatheter, according to an embodiment of the present patent application.
23 illustrates a third step of a method of forming a fluid outlet slit in the hollow tube of a barb-formed microcatheter, according to an embodiment of the present patent application.
24 illustrates a fourth step of a method of forming a fluid outlet slit in the hollow tube of a barb-formed microcatheter, according to an embodiment of the present patent application.
25A is a perspective view of the top side of a die used to form fluid outlet slits in the hollow body of a barb-formed microcatheter, in accordance with an embodiment of the present patent application;
Fig. 25B is another side perspective view of the die shown in Fig. 25A;
25C illustrates steps in a method of using the die of FIGS. 25A and 25B to form spaced-apart fluid outlet slits in the hollow tube of a barb-formed microcatheter, in accordance with an embodiment of the present patent application.
Fig. 25D is a side view of the die shown in Fig. 25C;
26 is a plan view of a barb-formed microcatheter comprising a hollow tube having spaced-apart fluid outlet slits formed on the upper side of the hollow tube, in accordance with an embodiment of the present patent application.
27A illustrates a first step of a method of using a barb-formed microcatheter to inject a therapeutic fluid into a wound, according to an embodiment of the present patent application.
27B illustrates a second step of a method of using a barb-formed microcatheter to inject a therapeutic fluid into a wound, according to an embodiment of the present patent application.
27C illustrates a third step of a method of using a barb-formed microcatheter to inject a therapeutic fluid into a wound, according to an embodiment of the present patent application.
28A illustrates a first step of a method of using a barb-formed microcatheter having a non-linear configuration for injecting a therapeutic fluid into a wound, according to an embodiment of the present patent application.
28B illustrates a second step of a method of using a barb-formed microcatheter having a non-linear configuration for injecting a therapeutic fluid into a wound, according to an embodiment of the present patent application.
27C illustrates a third step of a method of using a barb-formed microcatheter having a non-linear configuration for injecting a therapeutic fluid into a wound, according to an embodiment of the present patent application.

Referring to FIG. 1 , in one embodiment, a barb-formed microcatheter 100 preferably includes a hollow tube 102 having a proximal end 104 and a distal end 106 . In one embodiment, the barb-formed microcatheter 100 has a length (L ₁ ) of preferably about 2 to 12 inches, more preferably about 7 to 8 inches. The barb-formed microcatheter 100 preferably includes barbs 108 spaced apart from one another along the length of the hollow tube 102 and projecting from opposite sides of the hollow tube. In one embodiment, the barb-formed microcatheter includes a plurality of fluid outlet openings 110 formed in an outer wall of the hollow tube 102 and spaced apart from each other along the length of the hollow tube. In one embodiment, the hollow tube 102 has an elongate lumen that extends along the length of the hollow tube. The fluid outlet openings 110 are preferably in fluid communication with the elongate lumen, such that fluid flowing through the elongate lumen of the hollow tube may pass out of the hollow tube through the fluid outlet openings. In one embodiment, the barb-formed microcatheter 100 comprises a tissue anchor 112 secured to the proximal end 104 of the hollow tube 102 and a surgical anchor secured to the distal end 106 of the hollow tube 102 . It may include a needle 114 .

2A-2E , in one embodiment, the barb-shaped microcatheter 100 preferably includes a hollow tube 102 , wherein the fluid outlet openings 110 are on the outside of the hollow tube 102 . formed on the wall 116 . In one embodiment, the fluid outlet openings 110 are preferably spaced apart from each other along the length of the hollow tube 102 . In one embodiment, the fluid outlet openings 110 are round holes. In one embodiment, the outer wall 116 of the hollow tube 102 has an inner surface 120 and an outer surface 118 surrounding the elongate lumen 122 of the hollow tube 102 . The elongate lumen preferably extends along the length of the hollow tube and is in fluid communication with the spaced fluid outlet openings to allow a fluid (eg, therapeutic fluid) to be dispensed from the barb-formed microcatheter.

In one embodiment, the barb-formed microcatheter 100 preferably includes a plurality of barbs 108 extending from the sides of the hollow tube 102 . The plurality of barbs 108 are preferably spaced apart from each other along the length of the hollow tube 102 . In one embodiment, the barbs 108 may be arranged symmetrically in pairs of barbs spaced apart from each other along the length of the hollow tube, such that each pair of barbs 108 from each other on opposite sides of the hollow tube 102 . extended away from

Referring to FIG. 2B , in one embodiment, the fluid outlet openings 110 (eg, round holes having a diameter) are spaced apart from each other along the length of the hollow tube 102 of the barb-formed microcatheter 100 . In one embodiment, the distance D ₁ between adjacent spaced apart fluid outlet openings 110 may be about 4 to 25 millimeters, more preferably about 4 to 12 millimeters. In one embodiment, the spaced apart fluid outlet openings 110 may be the same size (ie, the same diameter). In one embodiment, the spaced-apart fluid outlet openings 110 may have different sizes (ie, different diameters).

2B and 2C , in one embodiment, the fluid outlet openings 110 are formed on the upper side of the hollow tube 102 of the preferably barb-shaped microcatheter 100 . In one embodiment, the fluid outlet openings are formed on the upper side of the hollow tube with no openings formed on the lower side of the hollow tube. 2C shows the underside of the hollow tube 102 of the barb-formed microcatheter, with no fluid outlet opening formed.

2D , in one embodiment, the hollow tube 102 of the barb-formed microcatheter 100 preferably has an inner surface 120 and an outer surface 118 surrounding the elongate lumen 122 . and an outer wall 116 with In one embodiment, the fluid outlet opening 110 is formed on the upper side of the outer wall 116 of the hollow tube 102 . In one embodiment, the fluid outlet opening 110 is in fluid communication with an elongate lumen 122 , which preferably extends along the length of the hollow tube, such that fluid within the elongate lumen may be dispensed through the fluid outlet opening 110 . make it possible

In one embodiment, the outer surface 118 of the outer wall 116 of the hollow tube 102 defines an outer diameter OD ₁ of about 0.5 millimeters. In one embodiment, the inner surface 120 of the outer wall 116 of the hollow tube 102 defines an inner diameter ID ₁ of about 0.25 millimeters. In one embodiment, the outer diameter OD ₁ defined by the outer wall of the hollow tube is about two times greater than the inner diameter ID ₁ defined by the inner surface of the outer wall of the hollow tube. In one embodiment, the outer wall 116 of the hollow tube preferably has a thickness T ₁ of about 0.125 millimeters.

2A-2E , in one embodiment, the barb-formed microcatheter 100 preferably includes barbs 108 protruding from opposite sides of the hollow tube 102 . The barbs are preferably spaced apart from the other barbs on each side of the hollow tube. In one embodiment, the barbs have a thickness T ₂ that is at least 10% of the size of the outer diameter OD ₁ of the hollow tube 102 . In one embodiment, the thickness T ₂ of the barbs 108 may be between about 0.05 and 0.20 millimeters. In one embodiment, a pair of barbs 108 may define a tip-to-tip width W ₁ of about 1-3 mm.

Referring to FIG. 3 , in one embodiment, the barb-formed microcatheter 100 ( FIGS. 2A-2E ) preferably comprises a hollow tube 102 , the hollow tube measuring the length of the hollow tube 102 . An outer wall 116 having an inner surface 120 and an outer surface 118 surrounding an elongate lumen 122 extending therethrough. The barb-formed microcatheter 100 preferably includes fluid outlet openings 110 spaced apart from one another along the length of the hollow tube 102 . In one embodiment, the fluid outlet openings 110 are formed in the upper side 124 of the hollow tube 102 . In one embodiment, the hollow tube 102 has a lower side 126 without a fluid outlet opening provided on the upper side 124 .

In one embodiment, the fluid outlet opening 110 passes completely through the thickness T ₁ of the outer wall 116 of the hollow tube 102 such that the fluid outlet opening 110 extends along the length of the hollow tube. to be in fluid communication with the elongate lumen 122 . In one embodiment, the barb-formed microcatheter 100 may be implanted into tissue, and a fluid, such as a therapeutic fluid, may be introduced into the elongate lumen 122 of the hollow tube 102 , such that the fluid is hollow It passes through the fluid outlet opening 110 to bathe the tissue in the bath surrounding the tube. In one embodiment, the barb-formed microcatheter 100 preferably includes barbs 108 spaced apart from one another along the length of the hollow tube 102 . In one embodiment, after the barb-formed microcatheter 100 is implanted into tissue, the barbs 108 protruding from the sides of the hollow tube 102 preferably surround the hollow tube to hold it in place within the tissue. engage with the organization

In one embodiment, the barb-formed microcatheter having fluid outlet openings is preferably made of an absorbent, biocompatible polymeric material. Absorbent polymers may include conventional biocompatible polymers such as lactide, polylactic acid, polyglycolic acid, glycolide, polydioxanone, polycaprolactone, copolymers and blends thereof, and the like.

In one embodiment, the barb-formed microcatheter may be coated and/or impregnated with an antimicrobial agent to prevent bacterial colonization. In one embodiment, the preferred antimicrobial agent is triclosan. In one embodiment, a steam process may be used to apply the triclosan antimicrobial agent to a barbed microcatheter, such as a polymer barbed microcatheter made of polydioxanone or polycaprolactone. In one embodiment, antimicrobial agents used in barb-formed microcatheters may include, but are not limited to, triclosan, chlorhexidine, povidone iodine, and/or silver compounds.

4A and 4B, in one embodiment, the barb-formed microcatheter 100 shown and depicted in FIGS. 1-3 may be fabricated by first forming a microcatheter blank 128, which The blank has an outer surface 132 , an outer wall 130 having an inner surface 134 , and an elongate lumen 136 extending along the length of the microcatheter blank 128 . As used herein, the term “blank” refers to an object (eg, hollow tube precursor) intended for further shaping or finishing to produce a final product (eg, a barb-formed microcatheter having fluid outlet openings). it means. The microcatheter blank may be drawn to control the molecular orientation of the particles of the microcatheter blank, which preferably improves the strength of the microcatheter blank. As described in greater detail herein, the microcatheter blank 128 may be subjected to additional processing steps (e.g., shaping, cutting, puncturing) to produce a final product or medical device, i.e., a barb-formed microcatheter having barbs and outlet openings. ) can be obtained.

Referring to FIG. 5 , in one embodiment, a microcatheter blank 128 is preferably disposed between an upper die 138 and a lower die 140 of a press or pressing die. In one embodiment, the upper and lower dies 138 , 140 move towards each other, preferably to compress and/or shape the microcatheter blank 128 therebetween. In one embodiment, when the upper and lower dies 138 , 140 are moved to the closed position, the die compresses the microcatheter blank 128 , thereby causing a first flattened first flattened extending along sides of the microcatheter blank 128 . A region 142 and a second planarized region 144 are formed. In one embodiment, the first and second planarized regions 142 , 144 preferably extend along the length of the microcatheter blank. In one embodiment, the upper and lower dies 138, 140 preferably form a central portion of the microcatheter blank 128 into the hollow tube ( 102) has opposite faces. The hollow tube 102 preferably includes an elongate lumen 122 extending along its length.

FIG. 6 shows an end view of the microcatheter blank 128 after being shaped and/or formed by the upper and lower dies 138 , 140 shown in FIG. 5 . The microcatheter blank 128 preferably has a first flattened area 142 extending along one side of the microcatheter blank 128 and a second flattened area extending along an opposite second side of the microcatheter blank. (144). The hollow tube 102 shown and described above in FIGS. 2A-2E and 3 preferably extends along the length of the microcatheter blank 128 . The hollow tube 102 preferably has an elongate lumen 122 extending along the length of the hollow tube 102 . The pressed microcatheter blank 128 having the first and second planarized regions 142 , 144 preferably has a width W ₂ of about 0.75 to 3 mm. The first and second flattened regions 142 , 144 preferably have a thickness T ₂ that is about 10-30% of the outer diameter OD ₁ of the hollow tube 102 .

Referring to FIG. 7 , in one embodiment, rather than using the upper and lower pressing dies 148 , 150 shown in FIG. 5 , the microcatheter blank 128 shown in FIG. 6 and described above is first and second The upper and lower sides of the microcatheter blank 128 to form the hollow tube 102 shown and described above in FIGS. 2A-2E and 3 as well as flattened regions 142 , 144 ( FIG. 6 ); It may be formed using opposing pressing rollers 138', 140' that engage.

Referring to FIG. 8 , in one embodiment, microcatheter blank 128 having planarized regions 142 , 144 ( FIG. 6 ) is an upper cutting die 148 and a lower cutting die having cutting teeth 149 . may be disposed into a cutting die 146 having 150 . In one embodiment, the upper and lower cutting dies 148 , 150 may be moved to a closed position such that the cutting teeth 149 extend along the length of the hollow tube 102 with barbs 108 (Fig. It engages the first and second planarized regions 142 , 144 ( FIG. 7 ) of the microcatheter blank 128 ( FIG. 6 ) to form 2a ). In one embodiment, rather than using a cutting die, the barbs 108 are razor blades that cut the first and second planarized regions 142 , 144 ( FIG. 6 ) of the microcatheter blank 128 to form barbs ( FIG. 6 ). It can be formed using a cutting tool such as a razor blade. In one embodiment, the barbs 108 may be formed using one or more lasers that cut the first and second planarized regions 142 , 144 ( FIG. 6 ) of the microcatheter blank 128 .

Referring to FIG. 9 , in one embodiment, after barbs 108 are formed from first and second flattened regions 142 , 144 ( FIG. 6 ), microcatheter blank 128 is preferably a hollow tube. and a hollow tube (102) having spaced apart barbs (108) projecting from opposite sides of (102). The hollow tube 102 preferably includes an outer wall 116 having an inner surface 120 and an outer surface 118 defining an elongate lumen 122 extending along the length of the hollow tube 102 . .

10A and 10B , in one embodiment, a needle having a pointed tip 154 for forming fluid outlet openings 110 ( FIG. 2A ) in the outer wall of the hollow tube 102 ( FIG. 9 ) ( FIG. 2A ). 152) can be used. The pointed tip 154 of the needle 152 preferably has a tapered region 156 such that the cross-sectional diameter of the needle 152 is the distalmost end of the tapered region 156 and the proximal of the tapered region 156 . It increases in size between the ends. The tapered region 156 of the pointed tip 154 allows fluid outlet openings to be formed in the hollow tube of the barb-shaped microcatheter, as described in more detail herein. Also, in one embodiment, the tapered region 156 of the pointed tip 154 allows for fluid outlet openings of different sizes (eg, different diameters) to be formed in the hollow tube of the preferably barb-shaped microcatheter. . Accordingly, the needle 152 may be used to form fluid outlet openings having the same size or fluid outlet openings having different sizes.

Referring to FIG. 11 , in one embodiment, a microcatheter blank 128 ( FIG. 9 ) having a hollow tube 102 and barbs 108 extending from its sides is provided in the hollow tube 102 with a fluid outlet opening ( 110 ) ( FIG. 2A ) into a fluid outlet opening die 158 . In one embodiment, one or more of the needles 152 , shown in FIGS. 10A and 10B and described above, are introduced into the fluid outlet opening die 158 , such that fluid outflows into the hollow tube 102 of the microcatheter blank 128 . Openings 110 may be made. In one embodiment, needles 152 may be slid in and out of a fluid outlet opening die and/or rotated about their longitudinal axis to form fluid outlet openings 110 in the hollow tube 102 of the microcatheter blank. .

Referring to FIG. 12 , in one embodiment, needles 152 ( FIG. 11 ) and fluid outlet opening die 158 of FIG. 11 are used to form fluid outlet openings 110 in hollow tube 102 . Thereafter, the microcatheter blank shown in FIG. 9 is converted into a barb-formed microcatheter 100 having preferably spaced fluid outlet openings 110 . In one embodiment, the fluid outlet opening 110 may be a round hole or a circular opening formed in the outer wall of the hollow tube 102 . The fluid outlet openings 110 may be evenly spaced from each other along the length of the hollow tube. The fluid outlet openings 110 may have the same size or may have different sizes. In one embodiment, the size of the fluid outlet openings increases between the distal and proximal ends of the hollow tube.

In one embodiment, the pressing die shown in FIG. 5 , the pressing roller shown in FIG. 7 , and the cutting die shown in FIG. 8 may have needles integrated therein such that the fluid outlet openings are first and second 2 The planarized regions 142 , 144 ( FIGS. 5 and 7 ) can be formed at the same time that they are formed, or the barbs 108 can be formed at the same time that they are cut ( FIG. 8 ).

Referring to FIG. 13 , in one embodiment, the barb-formed microcatheter 200 includes a hollow tube 202 having an elongate lumen 222 that preferably extends along its length. In one embodiment, the barb-formed microcatheter 200 includes fluid outlet openings 210 that are preferably spaced apart from each other along the length of the hollow tube 202 . In one embodiment, the diameters of the respective fluid outlet openings 210 are the proximal end of the hollow tube 202 (eg, the end proximal to the tissue anchor) and the distal end of the hollow tube 202 (eg, the end proximal to the surgical needle). ) can vary in size between In one embodiment, the first fluid outlet opening 210A closer to the proximal end 204 (the end closer to the tissue anchor) of the hollow tube 202 is a second fluid outlet opening having a second diameter D ₃ . and a first diameter D ₂ greater than 210B. The sizes of the fluid outlet openings are along the length of the hollow tube, with smaller openings near the fluid source and larger openings further away from the fluid source to maintain a constant flow of fluid from the fluid outlet openings. It can be progressively smaller (eg, progressively smaller between the proximal and distal ends of the hollow tube).

14A and 14B , in one embodiment, the fluid outlet opening die 158 shown and described above in FIG. 11 may be used to form fluid outlet openings in the hollow tube of a barb-formed microcatheter. In one embodiment, a pair of needles 152A, 152B having the same diameter may be used to puncture the hollow tube to form fluid outlet openings having different sizes. In one embodiment, the first needle 152A is inserted to a greater depth than the second needle 152B. The size of the hole will depend on how far the needle is pushed into the hollow tube. Consequently, the first fluid outlet opening 210A ( FIG. 13 ) formed by the first needle 152A has a larger diameter than the second fluid outlet opening 210B ( FIG. 13 ) formed by the second needle 152B. and/or size. In one embodiment, a plurality of needles (eg, 10 to 50) may be used to define a plurality of spaced apart fluid outlet openings extending along the length of the barbed-formed microcatheter. The needles may operate together or independently of one another to form spaced-apart fluid outlet openings.

15A and 15B , in one embodiment, a fluid outlet opening die 258 may be used to form a barb-formed microcatheter having fluid outlet openings having different sizes. In one embodiment, the fluid outlet opening die 258 may include a larger diameter needle 252A and a smaller diameter needle 252B. In one embodiment, the larger diameter needle 252A is advanced into the fluid outlet opening die 258 to puncture the hollow tube to provide a first, larger fluid outlet opening 210A (FIG. 13) to the barb-formed microcatheter. While forming, a smaller diameter needle 252B may be used to puncture the hollow tube to form a smaller second fluid outlet opening 210B in the barbed-shaped microcatheter. In one embodiment, the fluid outlet opening die applies a plurality of needles (eg, 10 to 50 needles) having progressively larger diameters to form fluid outlet openings having progressively larger sizes and/or diameters. may include

In one embodiment, the fluid outlet openings of the barb-formed microcatheter may include one or more elongate slits. Referring to FIG. 16 , in one embodiment, the barb-formed microcatheter 300 includes a hollow tube 302 preferably having a proximal end 304 and a distal end 306 . The barb-formed microcatheter 300 preferably has a plurality of barbs 308 protruding from opposite sides of the hollow tube 302 . The barbs 308 are spaced apart from each other along the length of the hollow tube 302 . In one embodiment, the barb-formed microcatheter 300 preferably includes fluid outlet slits 310 formed in the hollow tube 302 and spaced apart from each other along the length of the hollow tube 302 . In one embodiment, the spaced fluid outlet slits 310 are preferably elongate slits formed (eg, cut, perforated) in the outer wall of the hollow tube 302 , whereby the slits are preferably hollow. It is in fluid communication with an elongate lumen extending along the length of the tube 302 . The longitudinal axes of the respective fluid outlet slits 310 may extend along and/or be parallel to the longitudinal axis of the hollow tube 302 .

In one embodiment, the barb-formed microcatheter is preferably a tissue anchor 312 secured to the proximal end 304 of the hollow tube 302 , and a surgical anchor secured to the distal end 306 of the hollow tube 302 . It may include a needle 314 . A surgical needle 314 may be used to place the barb-formed microcatheter 300 into tissue. After implantation in tissue, the barbs 308 preferably hold the barb-formed microcatheter in place within the tissue.

17A-17E , in one embodiment, the barb-formed microcatheter 300 preferably includes a hollow tube 102 , which includes an outer wall 316 of the hollow tube 302 . It has fluid outlet slits 310 extending through it. The barb-formed microcatheter 300 preferably includes pairs of barbs 308 extending from opposite sides of the hollow tube 302 . The pairs of barbs are preferably spaced apart from each other along the length of the hollow tube. Except for the fluid outlet slits 310 formed on the upper side of the hollow tube 302, the barb-formed microcatheter 300 shown and described in Figs. It may have dimensions and/or features similar to barb-formed microcatheters.

Referring to 17d, in one embodiment, the fluid outlet slits 310 are preferably hollow tubes to provide fluid communication between the elongate lumen 322 of the hollow tube 302 and the fluid outlet slits 310. It completely passes through the outer wall 316 of 302 . As a result, the fluid passing through the elongate lumen 322 of the hollow tube 302 flows through the fluid outlet slits 310 , the tissue surrounding the exterior of the hollow tube 302 having the fluid disposed within the elongate lumen. can be baked.

Referring to FIG. 18 , in one embodiment, the barb-formed microcatheter 300 ( FIGS. 17A-17E ) preferably comprises a hollow tube 302 , the hollow tube measuring the length of the hollow tube 302 . An outer wall 316 having an inner surface 320 and an outer surface 318 surrounding an elongate lumen 322 extending therethrough. The barb-formed microcatheter 300 preferably includes fluid outlet slits 310 formed on the upper side 324 of the hollow tube 302 and spaced apart from each other along the length of the hollow tube. In one embodiment, a fluid (eg, therapeutic fluid) flowing through the elongate lumen 322 preferably passes through the fluid outlet slits 310 to fluidize the tissue surrounding the barb-formed microcatheter. do. The barb-formed microcatheter 300 preferably includes outwardly extending barbs 308 spaced apart from one another along the length of the hollow tube 302 . In one embodiment, the barbs 308 may be pairs of symmetrical barbs projecting from opposite sides of the hollow tube 302 .

Referring to FIG. 19 , in one embodiment, a fluid outlet slit die 358 and a cutting blade to form fluid outlet slits ( FIG. 18 ) on the upper side of the hollow tube 302 of the barb-formed microcatheter 300 . (352) can be used. In one embodiment, the fluid outlet slit die 358 is preferably configured to seat the underside of the hollow tube 302 of the barb-formed microcatheter 300 , the barbs 308 and the tissue anchor 312 . The indentations have an upper surface 360 formed therein. In one embodiment, after the barb-formed microcatheter 300 is positioned over the die 358 , the sharp end is razed to form fluid outlet slits 310 ( FIG. 18 ) on the upper side of the hollow tube 302 . A cutting blade 352 with can be used.

20A and 20B, in one embodiment, cutting blade 352 preferably has a sharp tip 354 used to form fluid outlet slits in the outer wall of the hollow tube of a barbed-shaped microcatheter. have In one embodiment, sharp tip 354 has a cutting edge 362 and beveled sidewalls 365 , 366 extending proximally from cutting edge 362 . The exact length of the fluid outlet slit formed in the outer tube of a barbed-shaped microcatheter or microcatheter blank can be controlled by modifying the degree to which the sharp tip 354 of the cutting blade 352 is inserted into the hollow tube. In one embodiment, more insertion of a sharp tip will create a longer fluid exit slit and less insertion of a sharp tip will create a shorter fluid exit slit.

Referring to FIG. 21 , in one embodiment, after the barb-formed microcatheter 300 is positioned within the recesses formed in the upper surface 360 of the fluid outlet slit die 358 , the cutting blade 352 is ) is preferably juxtaposed with the upper side of the hollow tube 302 of the barb-formed microcatheter 300 .

Referring to FIG. 22 , in one embodiment, the cutting edge 362 at the lower end of the cutting blade 352 is on the outside of the hollow tube 302 to cut and/or perforate the outer wall of the hollow tube 302 . descends onto the surface.

Referring to FIG. 23 , in one embodiment, with the cutting edge 362 of the cutting blade 352 passing through the outer wall of the hollow tube 302 , the cutting blade 352 is the upper portion of the hollow tube 302 . It is moved in direction DIR1 relative to the hollow tube 302 and die 358 to form a fluid outlet slit 310 on the side. In an alternative embodiment, the cutting blade 352 may remain stationary, with the die 358 and barb-formed microcatheter forming a fluid outlet slit 310 on the upper side of the hollow tube 302 . can be moved relative to the cutting edge 362 of the cutting blade 352 to

24 , in one embodiment, after the cutting edge 362 of the cutting blade 352 forms an elongate fluid outlet slit 310 on the upper side of the hollow tube 302 , the cutting blade is inserted into the hollow tube 302 and die 358 can be retracted so that they can be indexed into a next position to form another fluid outlet slit in the hollow tube. The process may be repeated to form a plurality of fluid outlet slits (eg, 25 slits, 50 slits, 100 slits) along the length of the hollow tube 302 . In one embodiment, the slits may have the same length. In one embodiment, one or more of the fluid outlet slits may have different lengths.

25A and 25B , in one embodiment, the fluid outlet slits 310 ( FIGS. 17A-17E ) pass through openings provided in the body of the fluid outlet slit die 458 to the cutting blade 352 ( FIG. 20A ). ) can be formed in a barb-formed microcatheter by passing In one embodiment, the fluid outlet slit die 458 preferably has a top surface 360 formed therein with indentations 365 for seating a microcatheter blank 128 (FIG. 9) having barbs cut along the sides. ) is included. In one embodiment, the fluid outlet slit die 458 preferably has a first opening 466 configured to receive a first cutting blade 452A, and a second opening configured to receive a second cutting blade 452B ( 468). In one embodiment, the cutting edge of the respective cutting blades 452A, 452B is advanced into an indentation 468 formed in the upper face 460 of the die 458 such that the cutting edges leak fluid into the outer wall of the hollow tube. to engage the outer wall of the hollow tube of the catheter blank to form slits.

25C and 25D , in one embodiment, the first cutting edge 462A of the first cutting blade 452A is to a greater depth than the second cutting edge 462B of the second cutting blade 452B. is advanced As a result, the length of the fluid outlet slit formed by the first cutting blade 452A will be greater than the length of the fluid outlet slit formed by the second cutting blade 452B.

26 shows a barb-formed microcatheter 400 formed using the fluid outlet slit die 458 and cutting blades 452A, 452B described above and shown in FIGS. 25A-25D . In one embodiment, the barb-shaped microcatheter 400 includes a hollow tube 402 , with an elongate lumen 422 extending along the length of the hollow tube 402 . The barbs 408 protrude from the sides of the hollow tube 402 . An anchor 412 is secured to the proximal end 404 of the hollow tube 402 of the barb-formed microcatheter 400 . The barb-formed microcatheter has a first length (L ₂ ) greater than a second length (L ₃ ) of a second fluid outlet slit (410B) formed in the outer tube (402), the first length (L 2 ) formed in the outer tube (402). 1 includes a fluid outlet slit 410A. As described above, the respective lengths of the fluid outlet slits 410A, 410B can be controlled by the insertion depth of the cutting edges of the cutting blades 352 ( FIGS. 20A and 20B ), or the cutting edge of the cutting blade is A fluid outlet slit die seating the hollow tube of a microcatheter blank (e.g., microcatheter blank 128 shown in FIG. 9) and the length of the fluid outlet slit cut into the hollow tube 402 as it is moved relative to the hollow tube. It can be controlled by controlling.

In one embodiment, the therapeutic fluid flows in direction DIR2 through the elongate lumen 422 of the hollow tube 402 . The therapeutic fluid preferably flows from a fluid source located at the distal end of the hollow tube 402 spaced away from the proximal end 404 of the hollow tube. The first fluid outlet slit 410A adjacent the anchor 412 is longer than the second fluid outlet slit 410B distal to the first fluid outlet slit 410A.

Referring to FIG. 27A , in one embodiment, a barb-formed microcatheter 500 is preferably used to inject a therapeutic fluid into a patient's tissue, eg, into a patient's wound. In one embodiment, the barb-formed microcatheter 500 includes a hollow tube 502 preferably having a first end 504 and a second end 506 . The barb-formed microcatheter 500 preferably includes barbs 508 spaced apart from one another along the length of the hollow tube 502 and projecting from opposite sides of the hollow tube. In one embodiment, the barb-shaped microcatheter includes a plurality of fluid outlet openings 510 formed in the outer wall of the hollow tube 502 and spaced apart from each other along the length of the hollow tube. In one embodiment, the hollow tube 502 includes an elongate lumen (eg, elongate lumen 122 shown in FIG. 3 ) that extends along the length of the hollow tube and is configured to receive a therapeutic fluid to be injected into a patient's tissue. have The fluid outlet openings 510 are preferably in fluid communication with the elongate lumen such that fluid flowing through the elongate lumen of the hollow tube may pass out of the hollow tube through the fluid outlet openings 510 . In one embodiment, the barb-formed microcatheter 500 is secured to a tissue anchor 512 secured to a first end 504 of the hollow tube 502 , and secured to a second end 506 of the hollow tube 502 . and a surgical needle 514 .

In one embodiment, the epidermis (E) of the patient has a surgical opening (SO) formed therein, having a wound tissue comprising a subcutaneous layer (SL) and a fascia layer (FL) Define the wound (W). The wound has a first end 575 and a second end 585 spaced apart from the first end 575 .

In one embodiment, the barb-formed microcatheter 500 preferably includes an intermediate section 555 that includes at least a portion of the barbs 508 and the fluid outlet opening 510 . In one embodiment, the barbs 508 in the middle section 555 of the barb-formed microcatheter 500 are preferably tissue within the wound W to secure the barbed microcatheter in place within the wound W. bite into In one embodiment, the second end 506 of the hollow tube 502 is preferably free of a fluid outlet opening. In one embodiment, the second end 506 of the hollow tube 502 is preferably passed out of the patient, allowing the needle 514 to be disengaged from the second end of the hollow tube, resulting in treatment Allow fluid to be directed to the second end of the hollow tube.

27A and 27B , in one embodiment, a method of delivering a therapeutic fluid to a tissue preferably includes positioning a barb-formed microcatheter 500 adjacent a first end 575 of a wound W. including the step of making In one embodiment, a needle 514 is used to form a first tissue opening 595 at the first end 575 of the wound, and a tissue anchor 512 fits the tissue at the first end of the wound W. The hollow tube 502 is pulled completely through the first tissue opening 595 until contacted.

In one embodiment, a needle 514 is used to form a second tissue opening 597 at the second end 585 of the wound W, and barbs projecting outwardly from opposite sides of the hollow tube 502 . The hollow tube 502 opens the second tissue opening 597 such that the 508 engages tissue in the wound W positioned between the first end 575 and the second end 585 of the wound W. Pulled through completely.

In one embodiment, the needle 514 is passed through the epidermis E of the patient, causing the needle 514 and the second end 506 of the hollow tube 502 to be positioned on the exterior of the patient.

Referring to FIG. 27B , in one embodiment, after a barb-formed microcatheter 500 is implanted in a wound W, of a hollow tube 502 comprising barbs 508 and fluid outlet openings 510 . The intermediate section 555 may extend along a linear path between the first end 575 and the second end 585 of the wound W. The barbs 508 preferably bite the tissue within the wound W, preventing the hollow tube 502 from sliding or moving in the direction denoted DIR3. The tissue anchor 512 preferably engages the tissue at the first end 575 of the wound W to prevent the hollow tube 502 from sliding or moving in the direction denoted DIR4.

In one embodiment, the second end 506 of the hollow tube 502 provides access to an elongate lumen extending through the hollow tube 502 and to separate the needle 514 from the hollow tube 502 . cut to do

Referring to FIG. 27C , in one embodiment, the wound W may be closed by using, for example, sutures, staples, tissue fasteners, and tissue adhesives. A container 599 holding a treatment fluid may be coupled with a cut second end 506 of the hollow tube 502 extending outside of the patient for introducing the treatment fluid into the hollow tube 502 . The therapeutic fluid preferably flows into the elongate lumen of the hollow tube and passes through the fluid outlet openings 510 ( FIG. 27B ) to inject the therapeutic fluid into the wound W .

Referring to FIG. 28A , in one embodiment, a barb-formed microcatheter 600 is preferably used to inject a therapeutic fluid into a patient's tissue, eg, into a patient's wound. In one embodiment, the barb-formed microcatheter 600 includes a hollow tube 602 preferably having a first end 604 and a second end 606 . The barb-formed microcatheter 600 preferably includes barbs 608 spaced apart from one another along the length of the hollow tube 602 and protruding from opposite sides of the hollow tube. In one embodiment, the barb-formed microcatheter includes a plurality of fluid outlet openings 610 formed in an outer wall of the hollow tube 602 and spaced apart from each other along the length of the hollow tube. In one embodiment, the hollow tube 602 has an elongate lumen (eg, elongate lumen 122 shown in FIG. 3 ) that extends along the length of the hollow tube and is configured to receive a therapeutic fluid to be injected into a patient's tissue. have The fluid outlet openings 610 are preferably in fluid communication with the elongate lumen, such that fluid flowing through the elongate lumen of the hollow tube may pass out of the hollow tube through the fluid outlet openings 610 . In one embodiment, the barb-formed microcatheter 600 is secured to a tissue anchor 612 secured to a first end 604 of the hollow tube 602 , and secured to a second end 606 of the hollow tube 602 . and a surgical needle 614 .

In one embodiment, the epidermis E of the patient has a surgical opening SO formed therein to define a wound W having a wound tissue comprising a subcutaneous layer SL and a fascia layer FL. The wound has a first end 675 and a second end 685 spaced apart from the first end 675 .

In one embodiment, the barb-shaped microcatheter 600 includes an intermediate section 655 that preferably includes at least some of the fluid outlet openings 610 and at least some of the barbs 608 . In one embodiment, the barbs 608 in the intermediate section 655 of the barb-formed microcatheter 600 are preferably tissue within the wound W to secure the barbed microcatheter in place within the wound W. bite into In one embodiment, the second end 606 of the hollow tube 602 preferably has no fluid outlet openings. In one embodiment, the second end 606 of the hollow tube 602 is preferably passed out of the patient, allowing the needle 614 to be disengaged from the second end of the hollow tube, resulting in treatment Allow fluid to be directed to the second end of the hollow tube.

28A and 28B , in one embodiment, the method of delivering a therapeutic fluid to a tissue preferably includes positioning a barb-formed microcatheter 600 adjacent a first end 675 of the wound W. including the step of making In one embodiment, the needle 614 is used to form a first tissue opening 695 at the first end 675 of the wound, and the tissue anchor 612 fits the tissue at the first end of the wound W. The hollow tube 602 is pulled completely through the first tissue opening 695 until contacted. The needle 614 is used to further bite into the tissue such that the hollow tube 602 follows a non-linear path between the first end 675 and the second end 685 of the wound W.

In one embodiment, a needle 614 is used to form a final tissue opening 697 at the second end 685 of the wound W, outwardly from opposite sides of the non-linearly configured hollow tube 602 . The hollow tube 602 is provided with a second tissue opening ( 697) is fully pulled through.

In one embodiment, the needle 614 is passed through the epidermis E of the patient, causing the needle 614 and the second end 606 of the hollow tube 602 to be positioned on the exterior of the patient.

Referring to FIG. 28B , in one embodiment, after a barb-formed microcatheter 600 is implanted in a wound W, of a hollow tube 602 comprising barbs 608 and fluid outlet openings 610 . The intermediate section 655 may extend along a non-linear path between the first end 675 and the second end 685 of the wound W. The barbs 608 preferably bite the tissue within the wound W, preventing the hollow tube 602 from sliding or moving in the direction denoted DIR5. The tissue anchor 612 preferably engages the tissue at the first end 675 of the wound W, preventing the hollow tube 602 from sliding or moving in the direction denoted DIR6.

In one embodiment, the second end 606 of the hollow tube 602 provides access to an elongate lumen extending through the hollow tube 602 and to separate the needle 614 from the hollow tube 602 . cut to do

Referring to FIG. 28C , in one embodiment, the wound W may be closed by using, for example, sutures, staples, tissue fasteners, and tissue adhesives. A container 699 holding a treatment fluid may be coupled with a cut second end 606 of the hollow tube 602 extending outside of the patient for introducing the treatment fluid into the hollow tube 602 . The therapeutic fluid preferably flows into the elongate lumen of the hollow tube and passes through the fluid outlet openings 610 ( FIG. 28B ) to inject the therapeutic fluid into the wound W .

While the foregoing relates to embodiments of the present invention, other and further embodiments of the present invention may be devised without departing from the basic scope of the present invention, which is limited only by the scope of the following claims. For example, the present invention may be disclosed in which any of the features shown in any of the embodiments described herein or incorporated herein by reference are shown or present in any of the other embodiments described herein. Any of the features incorporated herein by reference may be incorporated and are still considered to be within the scope of the present invention.

Claims (42)

A barbed microcatheter for delivering fluids comprising:
a hollow tube having a proximal end, a distal end, and an elongated lumen extending between the proximal and distal ends;
barbs projecting outwardly from the hollow tube; and
and a plurality of fluid outlet openings formed in the hollow tube in fluid communication with the elongate lumen of the hollow tube. The barb-shaped microcatheter of claim 1 , wherein the fluid outlet openings are spaced apart from each other between the proximal end and the distal end of the hollow tube. The barb-shaped microcatheter of claim 1 , wherein the fluid outlet openings are evenly spaced from each other between the proximal end and the distal end of the hollow tube. 3. The barb-shaped microcatheter of claim 2, wherein each of the fluid outlet openings is the same size. The barb-shaped microcatheter of claim 2 , wherein at least two of the fluid outlet openings have different sizes. The barb-shaped microcatheter of claim 2 , wherein the fluid outlet openings include round holes. 3. The barb-shaped microcatheter of claim 2, wherein the fluid outlet openings comprise elongate slits. 8. The hollow tube of claim 7, wherein the hollow tube has a longitudinal axis extending between the proximal end and the distal end of the hollow tube, the elongate slits extending along a common axis parallel to the longitudinal axis of the hollow tube A barb-formed microcatheter having lengths that are The hollow tube of claim 1 , wherein the hollow tube includes an inner surface and an outer surface surrounding the elongate lumen, and wherein the fluid outlet openings are formed in the hollow tube and in fluid communication with the elongate lumen. and extending from the outer surface of the hollow tube to the inner surface of the hollow tube. 10. The hollow tube of claim 9, wherein the inner surface of the hollow tube defines an inner cross-sectional diameter of the hollow tube, and the outer surface of the cylindrical wall is about twice larger than the inner cross-sectional diameter of the hollow tube A barb-formed microcatheter defining an outer cross-sectional diameter of 11. The barb-shaped of claim 10, wherein the hollow tube has a wall thickness of about 0.125 mm, the outer cross-sectional diameter of the hollow tube is about 0.50 mm, and the inner cross-sectional diameter of the hollow tube is about 0.25 mm. microcatheter. The barb-formed microcatheter of claim 1 , wherein the barb-formed microcatheter comprises an absorbable biocompatible polymer. A barb-formed microcatheter for delivering fluids to a tissue, comprising:
a hollow tube having a proximal end and a distal end, the hollow tube having an elongate lumen disposed within the hollow tube and extending between the proximal and distal ends of the hollow tube;
barbs projecting outwardly from the outer surface of the hollow tube; and
in fluid communication with the elongate lumen of the hollow tube and comprising a plurality of fluid outlet openings formed in the outer surface of the hollow tube, the fluid outlet openings being mutually between the proximal end and the distal end of the hollow tube. A uniformly spaced, barb-formed microcatheter. The barb-shaped microcatheter of claim 13 , wherein each of the fluid outlet openings is the same size. The barb-shaped microcatheter of claim 13 , wherein at least two of the fluid outlet openings have different sizes. 14. The microcatheter of claim 13, wherein the fluid outlet openings have shapes selected from the group consisting of round holes and elongated slits. The barb-formed microcatheter of claim 13 , wherein the elongate lumen of the hollow tube defines a cross-sectional diameter of about 0.25 mm and the outer surface of the hollow tube defines a cross-sectional diameter of about 0.50 mm. 14. The method of claim 13,
an anchor secured to the proximal end of the hollow tube; and
and a surgical needle secured to the distal end of the hollow tube. A barb-formed microcatheter for delivering fluids to a tissue, comprising:
a hollow tube having a proximal end and a distal end, the hollow tube having an elongate lumen disposed within the hollow tube and extending between the proximal and distal ends of the hollow tube;
a plurality of barbs projecting outwardly from the outer surface of the hollow tube;
a plurality of fluid outlet openings in fluid communication with the elongate lumen of the hollow tube, the plurality of fluid outlet openings formed in the outer surface of the hollow tube, evenly spaced from each other between the proximal end and the distal end of the hollow tube fluid outlet openings of
an anchor secured to the proximal end of the hollow tube; and
a surgical needle secured to the distal end of the hollow tube;
wherein at least two of the fluid outlet openings have a first size, a first fluid outlet opening positioned adjacent the anchor and a second size smaller than the first size of the first fluid outlet opening. A barb-formed microcatheter having different sizes including a second fluid outlet opening positioned adjacent the needle. 20. The barbed microcatheter of claim 19, further comprising an antimicrobial agent coating or impregnated into the barbed microcatheter. The barb-formed microcatheter of claim 20 , wherein the antimicrobial agent is selected from the group of antimicrobial agents consisting of triclosan, chlorhexidine, povidone iodine, and a silver compound. A method of making a barb-formed microcatheter having fluid outlet openings, the method comprising:
compressing first and second sides of a polymer blank to form a barb-formed microcatheter blank, wherein the barb-formed microcatheter blank extends along a first side of the barb-formed microcatheter blank having a first flattened region, a second flattened region extending along a second side of the barb-formed microcatheter blank, and an elongate lumen positioned between the first flattened region and the second flattened region; comprising a hollow tube;
removing material from the first and second flattened regions of the barb-formed microcatheter blank to form barbs projecting outwardly from opposite sides of the hollow tube;
forming fluid outlet openings in a wall of the hollow tube in fluid communication with the elongate lumen of the hollow tube. 23. The method of claim 22,
compressing the proximal end of the polymer blank to form a tissue anchor connected with the proximal end of the hollow tube; and
and securing a needle to the distal end of the hollow tube. 23. The method of claim 22, further comprising using at least one cutting element to form the fluid outlet openings in the wall of the hollow tube. 25. The method of claim 24, wherein forming the fluid outlet openings comprises:
forming a first fluid outlet opening having a first size in the wall of the hollow tube;
forming a second fluid outlet opening in the wall of the hollow tube having a second size greater than the first size of the first fluid outlet opening. 25. The method of claim 24, wherein forming the fluid outlet openings comprises forming a series of progressively larger fluid outlet openings in the wall of the hollow tube. 23. The method of claim 22, wherein the fluid outlet openings are formed concurrently during the step of forming the fluid outlet openings. 23. The method of claim 22, wherein the fluid outlet openings are formed independently of each other and at different times during the step of forming the fluid outlet openings. 25. The method of claim 24, wherein the at least one cutting element comprises cutting elements selected from the group consisting of needles, needles having a tapered tip, and cutting blades. 24. The method of claim 23, wherein the tissue anchor associated with the proximal end of the hollow tube comprises a flattened tab having a length and a width. 23. The method of claim 22, wherein compressing the first and second sides of the polymer blank comprises:
placing the polymer blank into a pressing die having an upper pressing die part overlying the polymer blank and a lower pressing die part opposite the upper pressing die part and positioned below the polymer blank;
moving the pressing die to a closed position to compress the upper and lower surfaces of the first and second sides of the polymer blank to form the first and second flattened regions and the hollow tube; How to. 32. The method of claim 31, wherein the upper pressing die portion includes a plurality of cutting elements projecting from a lower side of the upper pressing die portion, and when the pressing die is in the closed position, the cutting elements are attached to the hollow tube. engaging the hollow tube to form the fluid outlet openings. 23. The method of claim 22, wherein removing the material cuts the first and second flattened regions of the barb-formed microcatheter blank to form the barbs projecting outwardly from the opposite sides of the hollow tube. A method comprising the step of The method of claim 33, wherein the cutting comprises:
placing the barb-formed microcatheter blank comprising the first and second flattened regions and the hollow tube into a cutting die having an upper cutting die portion and a lower cutting die portion opposite the upper cutting die portion step;
moving the cutting die to a closed position to cut the first and second flattened regions of the barb-formed microcatheter blank to form the barbs projecting outwardly from the opposite sides of the hollow tube; A method comprising 35. The method of claim 34, wherein the upper cutting die portion comprises a plurality of cutting elements protruding from a lower side of the upper cutting die portion, and when the cutting die is in the closed position, the cutting elements are attached to the hollow tube. engaging the hollow tube to form the fluid outlet openings. 23. The polymer blank of claim 22, wherein compressing the first and second sides of the polymer blank forms the hollow tube and the first and second flattened regions of the barb-formed microcatheter blank. using pressing rollers to compress the upper and lower surfaces of the first and second sides of A method of making a barb-formed microcatheter having fluid outlet openings, the method comprising:
A barb comprising a hollow tube having a proximal end, a distal end, and an elongate lumen extending between the proximal and distal ends, and first and second flattened regions extending along opposite sides of the hollow tube- obtaining a formed microcatheter blank;
removing material from the first and second flattened regions of the barb-formed microcatheter blank to form barbs projecting outwardly from the opposite sides of the hollow tube;
using one or more cutting elements to form in a wall of the hollow tube fluid outlet openings in fluid communication with the elongate lumen of the hollow tube;
forming a tissue anchor connected with the proximal end of the hollow tube;
securing a surgical needle with the distal end of the hollow tube. A method of delivering a therapeutic fluid to a tissue, comprising:
positioning a barb-formed microcatheter adjacent a wound having a first end and a second end, the barb-formed microcatheter comprising: a hollow tube having an elongate lumen extending between the first end and the second end; barbs projecting outwardly from opposite sides of the hollow tube, fluid outlet openings formed in the hollow tube in fluid communication with the elongate lumen, a tissue anchor secured to the first end of the hollow tube, and the comprising a needle secured to said second end of a hollow tube;
Using the needle to form a first tissue opening at the first end of the wound, and then inserting the hollow tube through the first tissue opening completely until the tissue anchor abuts the tissue at the first end of the wound. pulling through;
The needle is used to form a second tissue opening in the second end of the wound, and the barbs projecting outwardly from opposite sides of the hollow tube are disposed between the first and second ends of the wound. pulling the hollow tube completely through the second tissue opening to engage tissue within the wound to be positioned;
passing the needle through a layer of skin of the patient such that the needle and the second end of the hollow tube are positioned external to the patient;
cutting the second end of the hollow tube to separate the needle from the hollow tube;
introducing a therapeutic fluid into the cut second end of the hollow tube, causing the therapeutic fluid to flow into the elongate lumen and passing through the fluid outlet openings to inject the therapeutic fluid into the wound. , Way. 39. The method of claim 38, wherein after passing the needle through the skin layer, an intermediate section of the hollow tube comprising the barbs and the fluid outlet openings is between the first end and the second end of the wound. located in the method. 40. The method of claim 39, further comprising closing the wound such that the intermediate section of the hollow tube is placed within the closed wound. 40. The method of claim 39, wherein the intermediate section of the hollow tube extends along a linear path between the first end and the second end of the wound. 40. The method of claim 39, wherein the intermediate section of the hollow tube extends along a non-linear path between the first end and the second end of the wound.

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