Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES 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
  • A61M25/00—Catheters; Hollow probes
  • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
  • A61M25/0074—Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES 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
  • A61M25/00—Catheters; Hollow probes
  • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
  • A61M25/0082—Catheter tip comprising a tool
  • A61M25/0084—Catheter tip comprising a tool being one or more injection needles
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/34—Trocars; Puncturing needles
  • A61B17/3478—Endoscopic needles, e.g. for infusion
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
  • A61B90/03—Automatic limiting or abutting means, e.g. for safety
  • A61B2090/033—Abutting means, stops, e.g. abutting on tissue or skin
  • A61B2090/036—Abutting means, stops, e.g. abutting on tissue or skin abutting on tissue or skin
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES 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
  • A61M25/00—Catheters; Hollow probes
  • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
  • A61M25/0082—Catheter tip comprising a tool
  • A61M25/0084—Catheter tip comprising a tool being one or more injection needles
  • A61M2025/0089—Single injection needle protruding axially, i.e. along the longitudinal axis of the catheter, from the distal tip
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES 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
  • A61M25/00—Catheters; Hollow probes
  • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
  • A61M25/0082—Catheter tip comprising a tool
  • A61M2025/0096—Catheter tip comprising a tool being laterally outward extensions or tools, e.g. hooks or fibres

Definitions

• the present invention pertains generally to injection catheters. More particularly, the present invention pertains to systems and methods for injecting fluid medicaments into myocardial tissue, and other internal tissue of a patient.
• the present invention is particularly, but not exclusively, useful as a system and method having a catheter-based injection needle that incorporates mechanical means to limit needle insertion into tissue to within a predetermined depth and to prevent perforation of the catheter tip through the wall of the tissue.
• Injecting fluid medicaments into internal tissues of the body can be problematic. This is particularly so due to the fact there is no way for the surgeon to have a direct visualization of the injection site.
• indirect visualization techniques such as fluoroscopy
• fluoroscopy can significantly aid in advancing an injection needle to the intended injection site
• additional control at the site may be required in order to properly insert a needle into tissue for a precise injection. For instance, control over the depth to which an injection needle is inserted into the tissue may be a crucial consideration.
• perforation of the catheter tip through the heart wall causes blood to leak into the pericardial sack, which can be fatal.
• an object of the present invention to provide a system and method for performing an injection of fluid medicament into a target tissue of a patient that provides for tactile indications of a proper needle insertion. Another object of the present invention is to ensure that such a needle insertion is performed to within a precise depth into the target tissue and to prevent perforation of the tissue by the catheter tip. Still another object of the present invention is to provide a system and method for performing an injection of fluid medicament into a target tissue that is relatively simple to manufacture, is easy to use, and is comparatively cost effective.
• a catheter-based injection needle that controls the depth to which the needle can be inserted in an internal target tissue of a patient (e.g. the myocardium).
• a web member (barrier) is mounted onto the shaft of the needle at a distance "d", proximal to the distal end of the needle.
• this web member is caused (biased) to flare outwardly from the needle.
• an advancement (insertion) of the needle into the target tissue is limited.
• insertion of the needle is limited to the distance "d”. More specifically, this happens when the barrier makes contact with a surface of the target tissue.
• the distance "d" can be varied according to the particular procedure being employed and the desires of the user.
• a system in accordance with the present invention includes a hollow positioning catheter having a lumen that extends between a proximal end and a distal end of the catheter. Also included in the system is the injection needle mentioned above.
• the injection needle is dimensioned to be received into the lumen of the positioning catheter for back-and-forth (proximal-and-distal) movements in the lumen.
• the web member is dimensioned to pass through the lumen of the catheter along with the injection needle. To do this, the web member is confined by the positioning catheter to assume a folded configuration inside the lumen of the positioning catheter.
• the web member While the web member is held by the positioning catheter in its folded configuration, the web member is substantially cylindrical shaped and is oriented parallel to the co-axis of the needle and the catheter.
• the injection needle With the web member in this folded configuration, and with the positioning catheter pre-positioned in the vasculature of a patient, the injection needle can be advanced through the positioning catheter to the site of the target tissue. Alternatively, if the positioning catheter is not pre- positioned in the vasculature of that patient, the injection catheter can be advanced into the vasculature together with the positioning catheter. In either case, once the system is adjacent the target tissue site, the injection needle and web member are deployed form the distal end of the positioning catheter.
• the web member When the injection needle is deployed from the distal end of the positioning catheter, the web member is no longer constrained by the catheter, and it is biased into its flared configuration.
• a deployment of the injection needle (web member) can be accomplished either by withdrawing the catheter in a proximal direction relative to the injection needle, or by advancing the injection needle in a distal direction relative to the catheter. Regardless how it is deployed, when it is in its flared configuration, the web member establishes a disk-shaped barrier that is oriented substantially perpendicular to the co-axis of the catheter and the needle. As indicated above, this barrier is located at the selected distance "d" from the distal end of the injection needle.
• the purpose here is to limit the insertion depth of the injection needle to the distance "d". Also, when deployed, the barrier acts to prevent any distal movement of the catheter beyond the barrier, to thereby prevent the catheter tip from perforating the target tissue.
• the injection needle can be withdrawn into the lumen of the catheter. Inside the lumen, the web member will again assume its folded configuration. The system can then be removed from the patient.
• the web member comprises a plurality of elongated extensions, with each extension having a first end mounted on the injection needle.
• each extension is biased to move the opposite (second) end radially outward from the axis with a deflection of the extension.
• Another possible arrangement for the web member includes a plurality of interconnected straight wires. In this arrangement, a first plurality of base wires will each have an end attached to the needle. A second plurality of wires will then have each of their ends attached to a respective base wire to thereby interconnect the base wires.
• the web member may comprise a plurality of elongated wire loops.
• the barrier will have a diameter "D" in its flared configuration and, typically, "D/2" will be less than "d". As mentioned above, however, for some procedures it may be desirable for "d” to be less than "D/2".
• the barrier can be radiopaque and made of a material such as cobalt chromium, platinum, nitinol or stainless steel.
• the injection needle will preferably be smaller than 18 gauge, and the variously selected distance "d” will generally be less than 10 mm.
• Fig. 1 is a perspective view of a system of the present invention shown in an intended operational environment
• Fig. 2 is a perspective view of the system with the injection needle deployed from the distal end of a positioning catheter, and with the web member biased into its flared configuration;
• Fig. 3 is a perspective view of the system with the injection needle withdrawn into the lumen of the positioning catheter, and with the web member constrained by the positioning catheter into its folded configuration;
• Fig. 4 is a front elevation view of an alternate embodiment of the web member.
• Fig. 5 is a front elevation view of another alternate embodiment of the web member. DESCRIPTION OF THE PREFERRED EMBODIMENTS
• a system in accordance with the present invention is shown in its intended operational environment and is generally designated 10.
• the system 10 includes a catheter 12 that can be advanced into the vasculature of a patient 14.
• the system 10 includes a source 16 of a fluid medicament that is to be injected into an internal tissue of the patient 14 (e.g. the myocardium).
• the catheter 12 is preferably a positioning type catheter 12 having a distal end 18 and a proximal end 20, with a lumen 22 that extends along the length of the catheter 12 between the ends 18/20.
• the catheter 12 defines a longitudinal axis 24.
• Fig. 2 shows an injection assembly for the present invention that is generally designated 26. More specifically, the injection assembly 26 includes an injection needle 28 that has a distal end 30. Preferably, the injection needle 28 is smaller than 18 gauge (e.g. 21 gauge). Additionally, the injection assembly 26 includes a web member 32 that is fixedly mounted on the injection needle 28 at a distance "d" proximal to the distal end 30 of the injection needle 28. Typically, the distance “d” will be less than ten millimeters. In other embodiments, however, the distance “d” can be adjustable. Stated differently, the exact length for distance “d” can be varied as required for the particular procedure (e.g. 3-7 mm).
• the web member 32 includes a plurality of elongated extensions 34, of which the extension 34a, 34b and 34c are exemplary.
• an end of each extension 34 is affixed to the injection needle 28 at a location 36 (i.e. at the distance "d" from distal end 30).
• all of the extensions 34 of web member 32 are biased to assume the position shown in Fig. 2.
• each of the extensions 34 is biased to become oriented substantially perpendicular to the axis 24 when it is unrestrained. Consequently, under these unrestrained conditions, the web member 32 assumes a flared configuration that is generally disk-shaped, as shown in Fig. 2. In addition to its flared configuration, however, the web member 32 can be mechanically restrained to assume a folded configuration (see Fig. 3).
• the web member 32 can be selectively transitioned between its flared configuration (Fig. 2) and its folded configuration (Fig. 3).
• this transition can be accomplished in either of two ways.
• the catheter 12 can be withdrawn in a proximal direction (arrow 38) relative to the injection assembly 26.
• the injection assembly 26 can be advanced in a distal direction (arrow 40) relative to the catheter 12.
• FIG. 4 An alternate embodiment of a web member 32' is shown to include a plurality of base wires 42, and a plurality of interconnect wires 44. More specifically, for the web member 32', each base wire 42 will have an end that is connected directly onto the injection needle 28.
• the interconnect wire 44 on the other hand, will have its opposite ends connected to adjacent base wires 42 (e.g. base wires 42a and 42b).
• the web member 32" is shown to include a plurality of loops 46. For this embodiment, each loop 46 is connected to the injection needle 28. As shown in Fig. 4 and Fig.
• the respective web members 32' and 32" are shown in their respective flared configurations.
• all embodiments i.e. web member 32, web member 32" and web member 32" will establish a diameter "D" for its disk-shape.
• "D/2" will be less than "d”, but it may happen that it is desirable for "d” to be less than "D/2".
• the barrier that is created by the web member 32, 32' or 32" is radiopaque and is made of cobalt chromium, platinum, nitinol or stainless steel.
• the positioning catheter 12 can be pre-positioned in the vasculature of patient 14, or the injection assembly 26 can be inserted into the lumen 22 of the catheter 12 and this combination can be advanced into the vasculature.
• the injection assembly 26 is deployed from the catheter 12 (i.e. there is a transition of the injection assembly 26 as shown in Fig. 3 to how it is shown in Fig. 2).
• the web member 32 With this deployment, the web member 32 becomes unrestrained and is biased into its flared configuration (see Fig. 2).
• this flared configuration effectively establishes a barrier at the distance "d" from the distal end 30 of the injection needle 28.
• the injection needle 28 is inserted into the target tissue.
• the target tissue is envisioned as being either internal tissue, such as the myocardium, or external tissue like skin. Importantly, however, in each instance, the depth of this insertion into the target tissue is limited to the distance "d" by the barrier that is created when the web member 32 is biased into its flared configuration. Fluid medicament from the source 16 can then be injected into the patient 14.
• the injection needle 28 is withdrawn from the target tissue.
• the injection assembly 26 can then be retracted into the lumen 22 of catheter 12 until the barrier is collapsed when the web member 32 is returned to its folded configuration.
• the system 10 can then be removed from the patient 14.

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• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Biophysics (AREA)
• Pulmonology (AREA)
• Engineering & Computer Science (AREA)
• Anesthesiology (AREA)
• Biomedical Technology (AREA)
• Heart & Thoracic Surgery (AREA)
• Hematology (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Infusion, Injection, And Reservoir Apparatuses (AREA)
• Media Introduction/Drainage Providing Device (AREA)

Priority Applications (5)

Applications Claiming Priority (2)

Publications (1)

Family

ID=46314337

Family Applications (1)

Country Status (7)

Cited By (3)

Families Citing this family (2)

Citations (4)

Family Cites Families (7)

• 2010
  • 2010-12-23 US US12/977,737 patent/US20120165785A1/en not_active Abandoned
• 2011
  • 2011-11-29 AU AU2011345221A patent/AU2011345221B2/en not_active Ceased
  • 2011-11-29 CA CA2818978A patent/CA2818978A1/en not_active Abandoned
  • 2011-11-29 JP JP2013546158A patent/JP5801903B2/ja not_active Expired - Fee Related
  • 2011-11-29 WO PCT/US2011/062458 patent/WO2012087507A1/en not_active Ceased
  • 2011-11-29 EP EP11852069.1A patent/EP2654862A4/en not_active Withdrawn
  • 2011-11-29 BR BR112013013890A patent/BR112013013890A2/pt not_active IP Right Cessation
• 2013
  • 2013-11-14 US US14/079,841 patent/US20140081207A1/en not_active Abandoned

Patent Citations (4)

Non-Patent Citations (1)

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