US20030161824A1 - Bulking agent needle apparatus and method of using the needle apparatus - Google Patents

Bulking agent needle apparatus and method of using the needle apparatus Download PDF

Info

Publication number
US20030161824A1
US20030161824A1 US10084240 US8424002A US2003161824A1 US 20030161824 A1 US20030161824 A1 US 20030161824A1 US 10084240 US10084240 US 10084240 US 8424002 A US8424002 A US 8424002A US 2003161824 A1 US2003161824 A1 US 2003161824A1
Authority
US
Grant status
Application
Patent type
Prior art keywords
needle
bulking agent
syringe
tissue
hypodermic needle
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Abandoned
Application number
US10084240
Inventor
Raymond Rackley
Dean Klein
Kristina Wittchow
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Carbon Medical Technologies Inc
Original Assignee
Carbon Medical Technologies Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date

Links

Images

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3286Needle tip design, e.g. for improved penetration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION, OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/12Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
    • A61L31/125Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix
    • A61L31/128Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix containing other specific inorganic fillers not covered by A61L31/126 or A61L31/127
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/46Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for controlling depth of insertion
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12181Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices
    • A61B17/12186Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices liquid materials adapted to be injected
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00743Type of operation; Specification of treatment sites
    • A61B2017/00805Treatment of female stress urinary incontinence
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/34Constructions for connecting the needle, e.g. to syringe nozzle or needle hub
    • A61M2005/341Constructions for connecting the needle, e.g. to syringe nozzle or needle hub angularly adjustable or angled away from the axis of the injector

Abstract

The present invention provides a syringe and a hypodermic needle having both linear and arcuate segments for injecting bulking agents into soft tissue planes between an organ and surrounding sphincter muscle to treat undesired sphincter-related deficiencies such as stress urinary incontinence, anal incontinence and esophageal reflux. A penetration depth shield or guide may be added to the hypodermic needle to limit the penetration of the needle and aid in the proper positioning of the needle. In one embodiment, a method for injecting a bulking agent into the soft tissue plane between the urethra and surrounding sphincter muscle and/or proximal urethral submucosa by using a hypodermic needle having both linear and arcuate segments, a penetration depth shield and a syringe containing a bulking agent is provided. The bulking agent may comprise a plurality of discrete carbon coated substrate particles that are carried in a fluid and lubricative biocompatible medium. In addition, a needle kit for treating stress urinary incontinence is provided.

Description

    BACKGROUND
  • This invention provides an apparatus, method and kit for injecting bulking agents into tissues surrounding the sphincter regions of organs, such as injecting bulking agents into tissue planes between the esophagus, rectum or urethra and the adjacent or surrounding sphincter muscles, to treat sphincter deficiencies associated with these organs. For example, bulking agents may be injected into a soft tissue plane between the urethra and the surrounding sphincter muscles to treat stress urinary incontinence. Injecting or adding bulking agents to such tissues generally serves to augment the gastric, rectal or urinary sphincter mechanisms. [0001]
  • The percutaneous injection of bulking agents into tissues to augment, support, or reconfigure anatomic structure has been the subject of significant research and product development. Procedures have been reported in medical literature for correction of dermatological and otolaryngological problems and for treatment of urological disorders. For example, Walker et al., “Injectable Bioglass as a Potential Substitute for Injectable Polytetrafluoroethylene,” [0002] J. Urol., 148: 645-7 (1992) reports using a particular bioglass material as a bulking agent.
  • An example of this type of procedure using injectable bulking agents for treating urological disorders, particularly urinary incontinence, has been reported. Incontinence occurs when the resistance to urine flow has decreased to the point where the resistance can no longer withstand the intra-abdominal pressure. Nearly all procedures developed to restore continence are based on restoring the lost resistance to urine outflow. U.S. Pat. Nos. 5,007,940; 5,158,573; and 5,116,387 to Berg report biocompatible compositions comprising discrete, polymeric and silicone rubber bodies injectable into urethral tissue for the purpose of treatment of urinary incontinence by tissue bulking. Further, U.S. Pat. No. 5,451,406 to Lawin reports biocompatible compositions comprising carbon coated particulate substrates that may be injected into a tissue, such as the tissues of and that overlay the urethra and bladder neck, for the purpose of treatment of urinary incontinence by tissue bulking. [0003]
  • One concern or adverse consequence associated with methodologies or therapies of tissue bulking relates to the migration of solid particles in the bulking agents from the original site of placement into repository sites in various body organs and the subsequent chronic inflammatory response of tissue to particles that are too small. These adverse effects are reported in urology literature, specifically in Malizia, A. A., et al., “Migration and Granulomatous Reaction After Periurethral Injection of Polytef(Teflon),” [0004] JAMA, 251:3277-3281 (1984) and in Claes, H., Stroobants, D. et al., “Pulmonary Migration Following Periurethral Polytetrafluoroethylene Injection For Urinary Incontinence,” J. Urol., 142:821-822 (1989).
  • An important factor in assuring the absence of migration is the administration of properly sized particles. If particles are too small, they may be engulfed by the body's white cells (phagocytes) and carried to distant organs or may be carried away in the vascular system and travel until they reach a site of greater constriction. Target organs for particulate deposition include the lungs, liver, spleen, brain, kidney, and lymph nodes. The use of small diameter particulate spheres and elongate fibrils in an aqueous medium having biocompatible lubricant have been disclosed in Wallace et al., U.S. Pat. No. 4,803,075. While these materials showed positive, short term augmentation results, this result was short lived as the material had a tendency to migrate and/or be absorbed by the host tissue. Small diameter particles can also produce chronic inflammatory response in tissue, and have been associated with clinical complications. [0005]
  • Similarly, particles that are too large are also generally unsuitable. Because various treatment methods typically inject a specific tissue site with particles suspended in a carrier fluid using an hypodermic needle, large particles are typically more difficult to deposit. In particular applications or methods, large particles will not pass through an appropriately or suitably sized hypodermic needle, will require too much pressure to be placed at a specific tissue site or will be unevenly distributed in or separate from the carrier fluid at the injection site. [0006]
  • In addition, proper particle and bulking agent placement is also important to the success of tissue bulking procedures. For example, when treating stress urinary incontinence, the bulking agent is typically injected into the soft tissue plane between the urethra and the surrounding muscles using a hypodermic needle. In some cases, the needle may be difficult to place as it must be inserted past the external urethral sphincter while limiting its penetration depth so as to avoid penetrating the urethra or bladder. In other cases, the needle may be improperly placed in muscle tissue which results in excessive pressure to deposit the bulking agent or separates the bulking agent from the carrier fluid. In still other cases, the needle may be improperly placed in a vein or artery which may lead to migration of the bulking agent via the vascular system. In sum, the success of the procedure depends on accurate insertion and placement of the needle so as to inject the bulking agent into the desired soft tissue site. [0007]
  • Thus, there remains a need for a suitable methods and procedures that improve positional accuracy of the injected bulking agent in order to provide a lasting remedy for the treated patient. [0008]
  • SUMMARY OF THE INVENTION
  • This invention provides an apparatus for injecting bulking agents into tissues adjacent to or surrounding the sphincter regions of the esophagus, rectum or urethra. When used, such an apparatus enables injecting bulking agents into tissue planes between an organ and adjacent or surrounding sphincter muscles in order to treat sphincter deficiencies and related conditions associated with such deficiencies. The apparatus is a syringe and a hypodermic needle having both linear and arcuate segments. The hypodermic needle is sufficiently rigid so as to maintain both the linear and arcuate segments, but retains a minimal amount of flexure to aide in the proper insertion and positioning of the needle in the tissue. A penetration depth shield or guide may be added to the linear portion of the hypodermic needle to limit the penetration of the needle into the desired tissues or tissue planes and to aid insertion and control of the needle to aid in the proper positioning of the needle. In use, the syringe contains an injectable nonabsorbable bulking agent used to treat sphincter deficiencies and associated related undesired conditions. [0009]
  • The present invention also includes a method for injecting a bulking agent into the soft tissue plane between an organ, such as an esophagus, rectum or urethra, and the surrounding muscle by using a hypodermic needle having both linear and arcuate segments and a syringe containing a bulking agent. The hypodermic needle may also include a penetration depth shield or guide located on the hub or on the linear segment of the needle. In one embodiment, the method includes injecting a bulking agent into the soft tissue planes between the urethra and the surrounding sphincter muscles and further includes locating the periurethral sinus and penetrating the tissue with a needle, then advancing and positioning the needle using the arcuate segment of the needle and the penetration depth shield or guide to aid proper placement of the needle at the desired tissue site. The method further includes attaching the syringe to the needle and injecting a suitable bulking agent into the soft submucosal tissue surrounding the urethra. In one embodiment of this method, the bulking agent may be comprised of a plurality of discrete, nonabsorbable carbon coated particles that are carried in a fluid and lubricative biocompatible medium. [0010]
  • In another embodiment, a needle kit for treating stress urinary incontinence is provided. The needle kit contains a syringe, a hypodermic needle having both linear and arcuate segments, a penetration depth shield or guide, and an injectable bulking agent. The bulking agent may be a plurality of discrete, carbon coated particles that are carried in a lubricative biocompatible medium.[0011]
  • BRIEF DESCRIPTION OF THE DRAWINGS
  • FIG. 1 is a perspective view of a needle and syringe in accordance with the present invention. [0012]
  • FIGS. 2 and 3 are perspective views of a needle and penetration depth shield or guide and a needle, penetration depth shield or guide and syringe in accordance with the present invention. [0013]
  • FIG. 4 is a perspective view of a suitable needle hub adapted to be secured to a mated syringe. [0014]
  • FIG. 5 is a diagram of a needle preparing to inject a bulking agent into soft tissues between an urethra and the surrounding muscle to treat stress urinary incontinence in accordance with one embodiment of the present invention.[0015]
  • DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
  • Referring to the drawings, FIG. 1 illustrates an apparatus [0016] 10 for injecting bulking agents into the soft tissue plane between an organ and the adjacent or surrounding muscle. In one example such an apparatus is used to inject a bulking agent into the soft tissue plane between the urethra and surrounding muscle to treat stress urinary incontinence in accordance with the present invention.
  • Apparatus [0017] 10 includes a syringe 11 and a hypodermic needle 12. Hypodermic needle 12 includes a linear segment 13 and an arcuate segment 14. The linear segment 13 extends from the hub 17 of the needle 12 to the arcuate segment 14 that is formed by about a five to about a forty-five degree bend 15 located within the portion of the needle 12 closest to the tip 16. The degree of the bend in the arcuate segment of the needle depends on the particular tissues or tissue sites that will be treated by bulking agent injection. In one embodiment, the bend 15 is about fifteen degrees and is generally located about 0.75 inches from the tip 16. In alternate embodiments, the bend 15 may be slightly more or slightly less than fifteen degrees, but is kept shallow to reduce the likelihood that the needle 12 will kink, preventing the bulking agent in the syringe 11 from being delivered effectively to the soft tissue site. Keeping the bend 15 shallow also allows for a more direct placement of the needle tip 16 at the preferred injection site and is compatible with both larger and smaller diameter needles. The needle 12 must be sufficiently rigid so as to maintain both the linear and arcuate segments, but preferably retains a minimal amount of flexure to aide in the proper insertion and positioning of the needle 12 in soft tissue. The hub 17 may be configured to mechanically attach or lock with the syringe to prevent separation under pressure and may be made of visually transparent or clear material to ensure that the needle has not been placed in vascular tissue. Once in place, slight back pressure on the syringe would draw back blood if the needle is improperly placed in the vascular system and any withdrawn blood is readily seen at the hub when it is a transparent or clear material.
  • FIGS. 2 and 3 illustrate the needle and apparatus [0018] 10 of FIG. 1 with the addition of a penetration depth shield or guide 18. The penetration depth shield 18 is generally located about 0.75 inches back from the bend 15 toward the hub 17. For needles having a length of about 1.5 inches the penetration shield may be at the hub or may be an integral part of the hub. For longer needles, the penetration depth shield may fit around the bore of the needle and may be sized to aid the handling and control of the needle with the fingers of the physician as it is placed at the desired tissue site. If the bend 15 is located 0.75 inches from the tip 16, the penetration depth shield 18 will limit the penetration of the needle 12 to about 1.5 inches. Limiting the penetration as such prevents the needle tip 16 from perforating the bladder or urethra and aides in proper placement of the needle 12 to inject the bulking agent at the desired soft-tissue site.
  • The total length of the needle [0019] 12 from hub 17 to tip 16 is at least 1.5 inches and for some procedures or uses is less than 5 inches. In alternative procedures or uses, the total length of the needle may be up to 60 inches. Appropriately sized needles for the apparatus and method of some of the embodiments of this invention are 18 gauge (OD-0.050 inches, ID-0.043 inches) or 19 gauge (OD-0.042 inches, ID-0.035 inches) stainless steel needles having a length of about 1.5 inches. The needle tip 16 may be of any one of a number of configurations, with the preferred tip being one that does not core the tissue. In some embodiments, an optional stylet may be used in combination with the needle. As illustrated in FIG. 3, the stylet is a solid shaft that fits into the needle and has a distal end that is cut flush with the needle's end. The proximate end of the stylet would contain a stop or finger grip. When in place, the stylet prevents tissue form entering the needle as the needle is placed at the tissue site. Once the needle is properly placed, the stylet is removed while the needle is retained at the injection site.
  • FIG. 4 illustrates a suitable system [0020] 40 for injecting suspended solids including a syringe 41 and a hypodermic needle assembly 42. Syringe 41 includes a generally cylindrical body having a distal portion 43 and a threaded region 44. Disposed within the syringe body is a plunger 45 having a distal portion 46 and rubber seals 47. Syringe 41 has a tapered, protruding male member 48 having a lumen 49 therethrough. Protruding member 48, in a preferred embodiment, has a standard Luer taper.
  • Hypodermic assembly [0021] 42 includes a proximal hub 50 and a needle 51. Needle 51 is commonly formed of hypotube and is illustrated having a protective sheath 52 disposed over the needle. Hub 50 includes a threaded cylindrical region 53 having a lumen 54 therethrough. Lumen 54 substantially defines the longitudinal axis of hypodermic needle assembly. Threaded cylindrical region 53 includes an inner wall surface 55, preferably having a standard Luer taper adapted to mate with syringe member 48. In the hub threaded region, a preferred embodiment has more than one start thread, to provide additional sealing force over the length of threaded regions 53 and 44 when tightened. In the embodiment of FIG. 4, the hub threaded region has two start threads, with one start indicated at 56 and the other disposed 180 degrees opposite. In this embodiment, each of the two threads wraps 1 and 12 turns about the hub. The hub includes two wings 57, each having a thinner, internal portion 58, and a thicker, rounded, peripheral rib portion.
  • FIG. 5 shows the needle [0022] 12 and penetration depth shield 18 of FIGS. 2 and 3 preparing to inject a bulking agent into the soft tissue plane between the urethra 20 and the sphincter muscle 21 to treat stress urinary incontinence according to one embodiment of this invention. To perform this particular procedure, the needle 12, penetration depth shield 18 and syringe, containing a suitable bulking agent, are prepared and primed. Using standard procedures, a patient is prepared for a cystoscopy and a cystoscope 22 is inserted into the urethra 20 up to the bladder neck 23. After locating the periurethral sinus 24 at the lateral border of the medial lip, the needle 12 is inserted into the tissue at either the 3 o'clock or 9 o'clock position of the periurethral sinus 24 and is advanced slowly until it penetrates past the external sphincter 25, using the cystoscope image as a guide. The bend 15 in the needle 12 is used to guide the needle 12 in an arc to the submucosal tissue 26 between the urethra 20 and the muscle plane 21.
  • To verify proper placement of the needle [0023] 12 within the submucosal tissue 26, the position of the penetration depth shield 18 should be noted close to the periurethral tissue 24 and the cystoscope image may be viewed while gently moving the needle 12 within the tissue. If only the local area at the needle tip 16 moves, the needle 12 is properly positioned within the submucosal tissue 26. If the entire urethra 20 moves, the needle tip 16 may be in muscle and must be repositioned by pulling back the needle 12 slightly and again verifying placement using the cystoscope 22 and the position of the penetration depth shield 18. After the needle 12 is properly positioned within the submucosal tissue 26, the syringe containing a bulking agent is attached to the needle 12 and the bulking agent is injected into the submucosal tissue 26, forming a bleb.
  • The bulking agent may be one of several compositions, but in one embodiment the bulking agent is a plurality of discrete, nonabsorbable, carbon coated particles in a carrier. The carrier itself is preferably a biocompatible medium having lubricative qualities and sufficient fluidity to carry and deliver the particles. One such carrier is β-glucan, a naturally occurring constituent of cell walls in essentially all living systems. β-glucan is rapidly removed from tissue sites through macrophage phagocytosis or by enzymatic destruction by serous enzymes, instigating an interaction between the particles and tissue. Aqueous solutions, suspensions, fluids, or gels of β-glucan may be produced that have favorable physical characteristics as a carrier for carbon-coated particles. The viscosity can vary from a thin liquid to a firm, self-supporting gel. Irrespective of viscosity, the β-glucan has excellent lubricity, thereby creating a particle-carrier composition that is easily administered by delivery to a predetermined tissue site through a small-bore needle. The rapid removal of β-glucan, as well as its available viscosity and lubricous nature, make it an optimum carrier for the particles. [0024]
  • The particles are microbeads or microparticles of a hard material serving as a substrate and having a thin coating or film of biocompatible, isotropic carbon deposited on their surfaces. Different types of carbon coating processes may be utilized, but the desired result is a smooth-coated particle with no substrate exposure on the surface of the particle or in contact with tissue when injected. The particles must be large enough so as to discourage local and distant migration once injected, yet small enough so as to be administered by hypodermic needle. Thus, particles with an average transverse cross-sectional dimension of between 100 and 1,000 microns, or between 200 and 500 microns if the particles are of generally rounded shape, are preferred. [0025]
  • To facilitate the treatment of stress urinary incontinence, a kit has been assembled in accordance with the present invention. The kit includes a syringe, a hypodermic needle having both linear and arcuate segments, a penetration depth shield, and an injectable bulking agent to be used to treat stress urinary incontinence by way of tissue bulking. The bulking agent is preferably a plurality of particles in a carrier, where the carrier is a biocompatible medium having lubricative qualities and sufficient fluidity to carry and deliver the particles. The particles themselves are preferably discrete carbon coated particles having an average transverse cross-sectional dimension of between 100 and 1,000 microns, or between 200 and 500 microns if the particles are of rounded shape. [0026]
  • Although the present invention has been described with reference to preferred embodiments, those skilled in the art will recognize that changes may be made in form and detail without departing from the spirit and scope of the invention.[0027]

Claims (14)

    What is claimed is:
  1. 1. An apparatus for injecting a bulking agent into a tissue plane between an esophagus, rectum, or urethra and surrounding sphincter muscle comprising a syringe and a hypodermic needle, wherein said hypodermic needle is comprised of a linear segment extending from a hub of the syringe and an arcuate segment formed by about a 5-45 degree bend located within a position of the needle closest to a needle tip.
  2. 2. The apparatus of claim 1 wherein said hypodermic needle has an accurate segment formed by about a 15 degree bend.
  3. 3. The apparatus of claim 1 wherein said hypodermic needle has a length of about 1.5-60 inches.
  4. 4. The apparatus of claim 1 wherein said hypodermic needle has a length of about 1.5-5 inches.
  5. 5. The apparatus of claim 1 wherein said hypodermic needle is sufficiently rigid so as to maintain the arcuate segment while retaining a minimal amount of flexure to allow proper insertion of the needle into tissue.
  6. 6. The apparatus of claim 1 wherein a penetration depth shield is located on the linear segment of the hypodermic needle and limits tissue penetration of the needle.
  7. 7. The apparatus of claim 1 wherein said syringe contains an injectable solution comprising a bulking agent.
  8. 8. A method of using a needle, penetration depth shield, and syringe to inject a bulking agent into a tissue plane between an esophagus, rectum or urethra and surrounding sphincter muscle to treat sphincter deficiencies comprising the steps of
    preparing and priming a hypodermic needle comprised of a linear segment extending from a hub of the syringe and an arcuate segment formed by a 15 degree bend located within a portion of the needle closest to a tip of the needle, a penetration depth shield located on said linear segment, and a syringe containing a bulking agent;
    advancing the needle slowly until it penetrates past an external sphincter muscle using the 15 degree angle of the needle to guide it in an arc to submucosal tissue between the esophagus, rectum or urethra and a muscle plane;
    positioning the needle to confirm placement within the submucosal tissue; and
    attaching the syringe to the needle and injecting a bulking agent into the submucosal tissue.
  9. 9. The method of claim 8, wherein a cystoscope is inserted into the esophagus, rectum or urethra before penetrating the tissue with the needle to guide placement of the needle.
  10. 10. The method of claim 8, wherein said bulking agent is comprised of a plurality of discrete carbon coated particles in a carrier.
  11. 11. The method of claim 8, wherein said carbon coated particles are of rounded shape and said dimension is between 200 and 500 microns.
  12. 12. A needle kit for treating stress urinary incontinence, comprising:
    a syringe;
    a hypodermic needle, wherein said hypodermic needle is comprised of a linear segment extending from a hub of the syringe and an arcuate segment formed by a 15 degree bend located within a portion of the needle closest to a tip of the needle;
    a penetration depth shield; and
    an injectable bulking agent.
  13. 13. The kit of claim 12, wherein said bulking agent is comprised of a plurality of discrete carbon coated particles in a carrier.
  14. 14. The kit of claim 12, wherein said carbon coated particles are of rounded shape and have an average transverse cross-sectional dimension of between 200 and 500 microns.
US10084240 2002-02-27 2002-02-27 Bulking agent needle apparatus and method of using the needle apparatus Abandoned US20030161824A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
US10084240 US20030161824A1 (en) 2002-02-27 2002-02-27 Bulking agent needle apparatus and method of using the needle apparatus

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
US10084240 US20030161824A1 (en) 2002-02-27 2002-02-27 Bulking agent needle apparatus and method of using the needle apparatus
US10280163 US7491243B2 (en) 2002-02-27 2002-10-25 Method of modifying a lower esophagus
PCT/US2003/005691 WO2003072196A1 (en) 2002-02-27 2003-02-24 Lower esophagus tissue modifier
JP2003570938A JP2005524659A (en) 2002-02-27 2003-02-24 The lower esophageal tissue modifier
PCT/US2003/005692 WO2003072171A1 (en) 2002-02-27 2003-02-24 Bulking agent needle apparatus
EP20030713667 EP1487539A1 (en) 2002-02-27 2003-02-24 Lower esophagus tissue modifier

Related Child Applications (2)

Application Number Title Priority Date Filing Date
US10280163 Continuation US7491243B2 (en) 2002-02-27 2002-10-25 Method of modifying a lower esophagus
US10280163 Continuation-In-Part US7491243B2 (en) 2002-02-27 2002-10-25 Method of modifying a lower esophagus

Publications (1)

Publication Number Publication Date
US20030161824A1 true true US20030161824A1 (en) 2003-08-28

Family

ID=27753448

Family Applications (2)

Application Number Title Priority Date Filing Date
US10084240 Abandoned US20030161824A1 (en) 2002-02-27 2002-02-27 Bulking agent needle apparatus and method of using the needle apparatus
US10280163 Active 2023-09-19 US7491243B2 (en) 2002-02-27 2002-10-25 Method of modifying a lower esophagus

Family Applications After (1)

Application Number Title Priority Date Filing Date
US10280163 Active 2023-09-19 US7491243B2 (en) 2002-02-27 2002-10-25 Method of modifying a lower esophagus

Country Status (2)

Country Link
US (2) US20030161824A1 (en)
WO (1) WO2003072171A1 (en)

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060246033A1 (en) * 2005-03-02 2006-11-02 Cook Biotech Incorporated Injectable bulking agent compositions
US20070066944A1 (en) * 2005-09-22 2007-03-22 Nyte Christopher P Method and system for treatment of internal nasal valves
WO2011005615A1 (en) * 2009-07-07 2011-01-13 Vance Products Inc. D/B/A Cook Urological Incorporated Fluid injection device
US8147397B1 (en) 2006-05-19 2012-04-03 Carbon Medical Technologies, Inc. Urethral needle guide device
US20120136308A1 (en) * 2006-09-11 2012-05-31 Racz N Sandor Neural injection system and related methods
US20120136307A1 (en) * 2010-11-30 2012-05-31 Racz N Sandor Neural injection system and related methods
US20150141742A1 (en) * 2012-04-24 2015-05-21 Urogyn B.V. Bulking agent applicator for treating female urinary incontinence
US9480800B2 (en) * 2006-09-11 2016-11-01 Custom Medical Applications Neural injection system and related methods
US9616204B2 (en) 2012-03-02 2017-04-11 Cook Medical Technologies LLC. Dilation cap for endoluminal device
US9888940B2 (en) 2006-09-11 2018-02-13 Custom Medical Applications Neural injection system and related methods

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6591838B2 (en) 1998-07-06 2003-07-15 Scimed Life Systems, Inc. Implant system and method for bulking tissue
US8287554B2 (en) 1999-06-22 2012-10-16 Ethicon Endo-Surgery, Inc. Method and devices for tissue reconfiguration
US6663639B1 (en) 1999-06-22 2003-12-16 Ndo Surgical, Inc. Methods and devices for tissue reconfiguration
US7846180B2 (en) 1999-06-22 2010-12-07 Ethicon Endo-Surgery, Inc. Tissue fixation devices and methods of fixing tissue
US6835200B2 (en) 1999-06-22 2004-12-28 Ndo Surgical. Inc. Method and devices for tissue reconfiguration
US6821285B2 (en) 1999-06-22 2004-11-23 Ndo Surgical, Inc. Tissue reconfiguration
ES2435094T3 (en) 2000-05-19 2013-12-18 C.R. Bard, Inc. Device and method for capturing and suture tissue
US7737109B2 (en) 2000-08-11 2010-06-15 Temple University Of The Commonwealth System Of Higher Education Obesity controlling method
WO2006068970A3 (en) * 2004-12-21 2007-01-18 Mitchell Roslin Anastomotic outlet revision
US7736392B2 (en) * 2005-04-28 2010-06-15 Medtronic, Inc. Bulking of upper esophageal sphincter for treatment of obesity
US8852216B2 (en) 2007-03-23 2014-10-07 Ethicon Endo-Surgery, Inc. Tissue approximation methods
US20100160995A1 (en) * 2008-12-18 2010-06-24 Jerome Dargent Method for treating obesity

Citations (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US1569174A (en) * 1921-01-27 1926-01-12 Sanno & Hoskins Inc De Hypodermic needle
US4432758A (en) * 1982-08-30 1984-02-21 Finegold Aaron N Urethral anesthetic devices
US4518383A (en) * 1982-08-06 1985-05-21 Evans John M Instrument and method for epidural and spinal anaesthesia
US4803075A (en) * 1986-06-25 1989-02-07 Collagen Corporation Injectable implant composition having improved intrudability
US5007940A (en) * 1989-06-09 1991-04-16 American Medical Systems, Inc. Injectable polymeric bodies
US5026350A (en) * 1986-10-09 1991-06-25 Hakko Electric Machine Works Co., Ltd. Set of double needles for injecting liquid medicine
US5116387A (en) * 1989-06-09 1992-05-26 American Medical Systems, Inc. Preparation of injectable polymeric bodies
US5158573A (en) * 1989-06-09 1992-10-27 American Medical Systems, Inc. Injectable polymeric bodies
US5188617A (en) * 1989-10-17 1993-02-23 Triple L. Laboratories Ab Apparatus and a method for taking samples from gum pockets
US5204382A (en) * 1992-02-28 1993-04-20 Collagen Corporation Injectable ceramic compositions and methods for their preparation and use
US5258028A (en) * 1988-12-12 1993-11-02 Ersek Robert A Textured micro implants
US5284476A (en) * 1992-03-20 1994-02-08 Koch Paul S Nuclear hydrolysis cannula
US5451406A (en) * 1994-07-14 1995-09-19 Advanced Uroscience, Inc. Tissue injectable composition and method of use
US5628734A (en) * 1995-03-23 1997-05-13 Hatfalvi; Bela I. Spinal needle with curved distal end and method of using said needle in a spinal injection to prevent post dural puncture headache
US5792099A (en) * 1995-02-14 1998-08-11 Decamp; Dennis Syringe and cannula for insertion of viscoelastic material into an eye and method of using same
US5792478A (en) * 1996-07-08 1998-08-11 Advanced Uro Science Tissue injectable composition and method of use
US5893839A (en) * 1997-03-13 1999-04-13 Advanced Research And Technology Institute, Inc. Timed-release localized drug delivery by percutaneous administration
US6258067B1 (en) * 1998-12-08 2001-07-10 Smith & Nephew, Inc. Middle ear fluid aspirator
US6666848B2 (en) * 2001-06-14 2003-12-23 Artes Medical Usa, Inc. Medical injection apparatus

Family Cites Families (25)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE346472C (en)
GB472952A (en) 1936-06-04 1937-10-04 Casper Morley Epstein Improvements in or relating to hypodermic needles
FR1296976A (en) 1960-08-04 1962-06-22 Amalgamated Dental Co Ltd Device hypodermic injection
FR1501120A (en) 1966-10-18 1967-11-10 dental needle for regional anesthesia spine spix
US7060287B1 (en) * 1992-02-11 2006-06-13 Bioform Inc. Tissue augmentation material and method
US6537574B1 (en) * 1992-02-11 2003-03-25 Bioform, Inc. Soft tissue augmentation material
DE9318938U1 (en) 1993-12-09 1994-03-24 Lai Shu Nu Disposable dental instrument
US7468060B2 (en) * 1998-02-19 2008-12-23 Respiratory Diagnostic, Inc. Systems and methods for treating obesity and other gastrointestinal conditions
US6190684B1 (en) * 1996-05-30 2001-02-20 University Of Florida Research Foundation, Inc. Injectable bio-active glass in a dextran suspension
DE19750090B4 (en) 1997-11-12 2011-11-03 Transcodent GmbH & Co. KG Cannula for a Luer or Luer lock
US6591838B2 (en) * 1998-07-06 2003-07-15 Scimed Life Systems, Inc. Implant system and method for bulking tissue
US6187318B1 (en) * 1998-10-29 2001-02-13 Innovative Chemical Corporation Anti-snoring composition
US6251064B1 (en) * 1998-12-11 2001-06-26 Enteric Medical Technologies, Inc. Method for creating valve-like mechanism in natural body passageway
US6098629A (en) * 1999-04-07 2000-08-08 Endonetics, Inc. Submucosal esophageal bulking device
US6565550B1 (en) * 1999-05-10 2003-05-20 Carbon Medical Technologies, Inc. Luer fitting injector
US6277392B1 (en) 1999-09-16 2001-08-21 Carbon Medical Technologies, Inc. Tissue injectable composition
US6250307B1 (en) * 1999-09-17 2001-06-26 Pi Medical, Inc. Snoring treatment
US6652883B2 (en) 2000-03-13 2003-11-25 Biocure, Inc. Tissue bulking and coating compositions
US6355275B1 (en) 2000-06-23 2002-03-12 Carbon Medical Technologies, Inc. Embolization using carbon coated microparticles
US6394965B1 (en) 2000-08-15 2002-05-28 Carbon Medical Technologies, Inc. Tissue marking using biocompatible microparticles
US6730014B2 (en) * 2001-01-05 2004-05-04 Peter J. Wilk Medical treatment method and device utilizing magnetic particles
US7047980B2 (en) * 2002-04-09 2006-05-23 Promethean Surgical Devices Llc Treatment for Gastroesophageal disease
EP1511522B1 (en) * 2002-06-12 2011-08-10 Boston Scientific Limited Bulking agents
US7175589B2 (en) * 2002-07-02 2007-02-13 The Foundry Inc. Methods and devices for luminal and sphincter augmentation
US20040028676A1 (en) * 2002-08-06 2004-02-12 Klein Dean A. Swallowing system tissue modifier

Patent Citations (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US1569174A (en) * 1921-01-27 1926-01-12 Sanno & Hoskins Inc De Hypodermic needle
US4518383A (en) * 1982-08-06 1985-05-21 Evans John M Instrument and method for epidural and spinal anaesthesia
US4432758A (en) * 1982-08-30 1984-02-21 Finegold Aaron N Urethral anesthetic devices
US4803075A (en) * 1986-06-25 1989-02-07 Collagen Corporation Injectable implant composition having improved intrudability
US5026350A (en) * 1986-10-09 1991-06-25 Hakko Electric Machine Works Co., Ltd. Set of double needles for injecting liquid medicine
US5258028A (en) * 1988-12-12 1993-11-02 Ersek Robert A Textured micro implants
US5007940A (en) * 1989-06-09 1991-04-16 American Medical Systems, Inc. Injectable polymeric bodies
US5116387A (en) * 1989-06-09 1992-05-26 American Medical Systems, Inc. Preparation of injectable polymeric bodies
US5158573A (en) * 1989-06-09 1992-10-27 American Medical Systems, Inc. Injectable polymeric bodies
US5188617A (en) * 1989-10-17 1993-02-23 Triple L. Laboratories Ab Apparatus and a method for taking samples from gum pockets
US5204382A (en) * 1992-02-28 1993-04-20 Collagen Corporation Injectable ceramic compositions and methods for their preparation and use
US5284476A (en) * 1992-03-20 1994-02-08 Koch Paul S Nuclear hydrolysis cannula
US5451406A (en) * 1994-07-14 1995-09-19 Advanced Uroscience, Inc. Tissue injectable composition and method of use
US5792099A (en) * 1995-02-14 1998-08-11 Decamp; Dennis Syringe and cannula for insertion of viscoelastic material into an eye and method of using same
US5628734A (en) * 1995-03-23 1997-05-13 Hatfalvi; Bela I. Spinal needle with curved distal end and method of using said needle in a spinal injection to prevent post dural puncture headache
US5792478A (en) * 1996-07-08 1998-08-11 Advanced Uro Science Tissue injectable composition and method of use
US5893839A (en) * 1997-03-13 1999-04-13 Advanced Research And Technology Institute, Inc. Timed-release localized drug delivery by percutaneous administration
US6258067B1 (en) * 1998-12-08 2001-07-10 Smith & Nephew, Inc. Middle ear fluid aspirator
US6666848B2 (en) * 2001-06-14 2003-12-23 Artes Medical Usa, Inc. Medical injection apparatus

Cited By (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060246033A1 (en) * 2005-03-02 2006-11-02 Cook Biotech Incorporated Injectable bulking agent compositions
US20070066944A1 (en) * 2005-09-22 2007-03-22 Nyte Christopher P Method and system for treatment of internal nasal valves
WO2007037895A2 (en) * 2005-09-22 2007-04-05 Christopher Philip Nyte Method and system for treatment of internal nasal valves
US9186247B2 (en) 2005-09-22 2015-11-17 E. Antonio Mangubarr Method and system for treatment of internal nasal valves
WO2007037895A3 (en) * 2005-09-22 2009-04-23 Christopher Philip Nyte Method and system for treatment of internal nasal valves
US8147397B1 (en) 2006-05-19 2012-04-03 Carbon Medical Technologies, Inc. Urethral needle guide device
US9808569B2 (en) 2006-09-11 2017-11-07 Custom Medical Applications Neural injection system and related methods
US9480800B2 (en) * 2006-09-11 2016-11-01 Custom Medical Applications Neural injection system and related methods
US8377005B2 (en) * 2006-09-11 2013-02-19 Custom Medical Applications Neural injection system and related methods
US20120136308A1 (en) * 2006-09-11 2012-05-31 Racz N Sandor Neural injection system and related methods
US9888940B2 (en) 2006-09-11 2018-02-13 Custom Medical Applications Neural injection system and related methods
WO2011005615A1 (en) * 2009-07-07 2011-01-13 Vance Products Inc. D/B/A Cook Urological Incorporated Fluid injection device
US8298187B2 (en) 2009-07-07 2012-10-30 Cook Medical Technologies Llc Fluid injection device
US20110009848A1 (en) * 2009-07-07 2011-01-13 Vance Products Inc. D/B/A Cook Urological Inc. Fluid injection device
US20120136307A1 (en) * 2010-11-30 2012-05-31 Racz N Sandor Neural injection system and related methods
US8449503B2 (en) * 2010-11-30 2013-05-28 Custom Medical Applications Neural injection system and related methods
US9616204B2 (en) 2012-03-02 2017-04-11 Cook Medical Technologies LLC. Dilation cap for endoluminal device
US9775622B2 (en) * 2012-04-24 2017-10-03 Urogyn B.V. Bulking agent applicator for treating female urinary incontinence
US20150141742A1 (en) * 2012-04-24 2015-05-21 Urogyn B.V. Bulking agent applicator for treating female urinary incontinence

Also Published As

Publication number Publication date Type
WO2003072171A1 (en) 2003-09-04 application
US20030161887A1 (en) 2003-08-28 application
US7491243B2 (en) 2009-02-17 grant

Similar Documents

Publication Publication Date Title
US6929631B1 (en) Method and apparatus for percutaneously accessing a pressure activated implanted port
US5871475A (en) Catheter system
US5411475A (en) Directly visualized method for deploying a detachable balloon at a target site in vivo
US4626240A (en) Dual lumen subclavian cannula
US5360397A (en) Hemodiaylsis catheter and catheter assembly
US5385561A (en) Apparatus and method for injecting a viscous material into the tissue of a patient
US4701166A (en) Valved two-way catheter
US5607407A (en) Catheter assembly
US20040028676A1 (en) Swallowing system tissue modifier
US6994693B2 (en) Tunneler-needle combination for tunneled catheter placement
US5052999A (en) Liposuction method and apparatus
US4549879A (en) Valved two-way catheter
US4650472A (en) Apparatus and method for effecting percutaneous catheterization of a blood vessel using a small gauge introducer needle
US4671796A (en) Valved two-way catheter
US5257979A (en) Instrument for catheterization
US5490845A (en) R-X safety catheter
Puri et al. Treatment of vesicoureteral reflux by endoscopic injection of dextranomer/hyaluronic acid copolymer: preliminary results
US20060025797A1 (en) Cannula for in utero surgery
US4813928A (en) Nozzle for tissue adhesive
US6595910B2 (en) Method for treating fecal incontinence
Ulitzsch et al. Breast abscess in lactating women: US-guided treatment
US7351233B2 (en) Subcutaneous vascular access port, needle and kit, and methods of using same
Zaontz The GAP (glans approximation procedure) for glanular/coronal hypospadias
US5405334A (en) Catheter apparatus with means for subcutaneous delivery of anesthetic agent or other fluid medicament
US20040147903A1 (en) Microcatheter having tip relief region

Legal Events

Date Code Title Description
AS Assignment

Owner name: CARBON MEDICAL TECHNOLOGIES, INC., MINNESOTA

Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:RACKLEY, RAYMOND R.;KLEIN, DEAN A.;WITTCHOW, KRISTINA M.;REEL/FRAME:012933/0793;SIGNING DATES FROM 20020515 TO 20020516