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EP-4498930-B1 - SEALANT APPLICATORS HAVING MIXING AND SPRAYING ASSEMBLIES WITH MALLEABLE SECTIONS

EP4498930B1EP 4498930 B1EP4498930 B1EP 4498930B1EP-4498930-B1

Inventors

  • GUO, JIANXIN
  • GUO, XUELIN
  • LORICCO, Joseph
  • LAI, GWAN-YWAN

Dates

Publication Date
20260506
Application Date
20230315

Claims (12)

  1. A mixing and spraying assembly (106) for a tissue sealant comprising: a mixing assembly (108) located at a proximal end of said mixing and spraying assembly; a spray tip assembly (112) located at a distal end of said mixing and spraying assembly; a malleable section (110) having a proximal end connected with said mixing assembly and a distal end connected with said spray tip assembly for enabling said spray tip assembly to be angulated relative to said mixing assembly, wherein said malleable section comprises: a flexible shaft (172) having a proximal end, distal end, and a length that extends between the proximal and distal ends thereof; a malleable wire conduit (178) that extends along the length of said flexible shaft; a malleable wire (182) disposed in said malleable wire conduit of said flexible shaft, said malleable wire having a length that is greater than the length of said flexible shaft, wherein said malleable wire has a proximal end that extends beyond the proximal end of said flexible shaft and that is connected to said mixing assembly and a distal end that extends beyond the distal end of said flexible shaft and that is connected to said spray tip assembly.
  2. The mixing and spraying assembly as claimed in claim 1, wherein said mixing assembly comprises: a mixer housing (150) having a proximal end, a distal end and a mixer housing conduit (152) extending along a length of said mixer housing from the proximal end to the distal end of said mixer housing; a mixing element (158) disposed within said mixer housing conduit, wherein the proximal end of said malleable wire that extends beyond the proximal end of said flexible shaft is secured to said mixing element.
  3. The mixing and spraying assembly as claimed in claim 2, wherein said mixing element comprises: a static mixer having a center shaft that extends along a length of said static mixer; said center shaft of said static mixer having a proximal end and a distal end; a blind hole (202) formed in said center shaft of said static mixer that extends from the distal end of said center shaft toward the proximal end of said center shaft; the proximal end of said malleable wire being disposed in said blind hole formed in said center shaft of said static mixer for connecting the proximal end of said malleable wire to said static mixer.
  4. The mixing and spraying assembly as claimed in claim 3, wherein said mixing assembly further comprises: a proximal connector (162) having a proximal end that is configured for being inserted into an opening at a distal end of an elongated cannula (136) of a sealant applicator and a distal end having external threads (168); said mixer housing having internal threads located at the proximal end of said mixer housing that are configured to mesh with said external threads at the distal end of said proximal connector for securing said mixer housing to said proximal connector.
  5. The mixing and spraying assembly as claimed in claim 4, wherein said proximal connector comprises: a first fluid pathway (170A) extending from the proximal end to the distal end of said proximal connector, wherein said first fluid pathway is in fluid communication with the proximal end of said static mixer; a second fluid pathway (170B) extending from the proximal end to the distal end of said proximal connector, wherein said second fluid pathway is in fluid communication with the proximal end of said static mixer; a first flexible tube (138A) disposed in said first fluid pathway of said proximal connector for supplying a first fluid to the proximal end of said mixer housing; a second flexible tube (138B) disposed in said second fluid pathway of said proximal connector for supplying a second fluid to the proximal end of said mixer housing.
  6. The mixing and spraying assembly as claimed in claim 5, wherein said static mixer is adapted for mixing said first and second fluids, whereupon said first and second fluids react together to form a tissue sealant.
  7. The mixing and spraying assembly as claimed in claim 6, wherein said flexible shaft of said malleable section comprises one or more tissue sealant conduits (180A, 180B) extending along the length thereof for supplying said tissue sealant to said spray tip assembly, optionally wherein said malleable wire conduit extends along a central axis of said flexible shaft, and wherein said one or more tissue sealant conduits of said flexible shaft comprise first and second tissue sealant conduits that extend along opposite sides of said malleable wire conduit.
  8. The mixing and spraying assembly as claimed in claim 7, wherein said spray tip assembly comprises: a distal connector (190) having a proximal end and a distal end having external threads (196); the proximal end of said distal connector having a central opening that seats the distal end of said flexible shaft; the distal end of said malleable wire that extends beyond the distal end of said flexible shaft being connected with said distal connector; a spray cup (198) having a spray opening (200) for expressing said tissue sealant that is supplied through said first and second tissue sealant conduits of said flexible shaft, said spray cup having a tube-shaped proximal end with internal threads that are configured to mesh with the external threads at the distal end of said distal connector for securing said spray cup to said distal connector; optionally wherein the distal end of said malleable wire that is secured to said distal connector of said spray tip assembly comprises a paddle-shaped flange (188) having a width that is greater than the diameter of a section of said malleable wire that extends to the proximal end of said malleable wire.
  9. The mixing and spraying assembly of claim 1 for expressing a tissue sealant; wherein said mixing assembly is configured for mixing first and second fluids that chemically react together to form a tissue sealant; wherein said spray tip assembly is configured for expressing said tissue sealant; wherein said malleable section has one or more tissue sealant conduits (180A, 180B) extending along a length thereof for delivering said tissue sealant from said mixing assembly to said spray tip assembly.
  10. The mixing and spraying assembly as claimed in claim 9, further comprising: said mixing assembly including a mixer housing (150) having a proximal end, a distal end, and a mixer housing conduit (152) extending from the proximal end to the distal end of said mixer housing; said mixing assembly including a mixing element (158) disposed within said mixer housing conduit of said mixer housing; said spray tip assembly including a distal connector (190) coupled with the distal end of said flexible shaft and a spray cup having a spray opening secured to a distal end of said distal connector; the proximal end of said malleable wire being secured to said mixing element disposed within said mixer housing and the distal end of said malleable wire being secured to said distal connector of said spray tip assembly.
  11. The mixing and spraying assembly as claimed in claim 10, wherein said mixing element comprises: a static mixer having a center shaft that extends along a length of said static mixer; said center shaft of said static mixer having a proximal end and a distal end; a blind hole (202) formed in said center shaft of said static mixer that extends from the distal end of said center shaft toward the proximal end of said center shaft, wherein the proximal end of said malleable wire is disposed in said blind hole formed in said center shaft of said static mixer for connecting the proximal end of said malleable wire to said static mixer.
  12. The mixing and spraying assembly as claimed in claim 10, wherein (i) said mixer housing has a longitudinal axis that extends from the proximal end to the distal end of said mixer housing, and wherein said malleable section enables said spray tip assembly to be angulated relative to the longitudinal axis of said mixer housing; or (ii) said mixer housing has a first outer diameter and said spray tip assembly has a second outer diameter that is less than the first outer diameter of said mixer housing.

Description

BACKGROUND OF THE INVENTION Field of the Invention The present patent application is related to medical devices and is more particularly related to systems, devices, and methods for expressing tissue sealants and hemostats during surgical procedures. Description of the Related Art Mammals can suffer from bleeding due to wounds or during surgical procedures. In some instances, the bleeding is minor and will stop due to normal blood clotting functions or by using simple first aid techniques. In other instances, however, excessive bleeding can occur, which requires the use of specialized equipment and materials, as well as the services of trained personnel in order to administer effective aid. To address the more challenging circumstances noted above, various materials have been developed for controlling excessive bleeding. For example, topical absorbable hemostats (TAHs) are widely used in surgical applications. TAHs encompass products based on oxidized cellulose (OC), oxidized regenerated cellulose (ORC), gelatin, collagen, chitin, chitosan, starch, etc. To improve the hemostatic performance, scaffolds based on the above materials can be combined with biologically derived clotting factors, such as thrombin and fibrinogen. Controlling bleeding is essential and critical in surgical procedures to minimize blood loss, shorten the duration of the surgery, and reduce post-surgical complications. Recently, minimally invasive surgery (MIS) techniques have emerged as an alternative to conventional surgical techniques for performing a wide range of surgical procedures. MIS procedures differ from conventional surgical procedures in that a plurality of devices and/or surgical tools may be introduced into the body through cannulas and/or trocars, which are inserted into small incisions made in the body. As a result of using MIS techniques, trauma to the body is reduced, which decreases recovery time for patients. One type of minimally invasive surgery involves laparoscopic surgical procedures, which are used to treat hernias, colon dysfunctions, gastroesophageal reflux disease, gallbladder disorders, lung disorders, etc. Typically, a patient undergoing a laparoscopic surgical procedure is able to return home after a short recovery period (e.g., within hours after undergoing surgery). One challenge presented when performing MIS procedures relates to controlling bleeding at the surgical site. In contrast to conventional open surgical procedures, during a laparoscopic procedure a surgeon's access to a surgical site or surgical cavity is greatly reduced. In response, tissue sealants and other biological adhesive materials have been developed for use in closing incisions and wounds at surgical sites. Tissue sealants may include fibrin sealants, which comprise thrombin and fibrinogen material, although other formulations are available. Typically, the individual components of the tissue sealants (e.g., thrombin and fibrinogen) are stored separately in isolated reservoirs because the components will rapidly react once they come in contact with one another. In many instances, the two separate components are mixed together for the first time immediately prior to being applied to tissue. Once mixed, the components coagulate very quickly, yielding an adhesive gel within a short period of time (e.g., within 10-20 seconds). There have been some developments related to systems for expressing tissue sealants. For example, U.S. Patent No. 6,458,095 discloses a dispenser for simultaneously dispensing first and second components of an adhesive tissue sealant, wherein at least the first component is stored in the dispenser as dry powder that is dissolved prior to use by introduction of a solvent. The dispenser includes a first container having a first septum at one end, an open end opposite the first septum, and a first movable plug disposed therein. The first container holds a quantity of the first component in the form of a dry powder stored between the first septum and the first movable plug. The dispenser includes a second container having a second septum at one end, an open end opposite the second septum, and a second movable plug disposed therein, the second container containing a quantity of the second component. U.S. Patent No. 10,183,132, assigned to Ethicon LLC, teaches an integrated delivery device that is operable with one hand and provides co-delivery of a liquid medicant and a powder medicant onto a tissue or wound from a liquid medicant expression subunit and a powder medicant expression subunit. Each expression subunit has an actuator for the liquid medicant and the powder medicant contained therein, which are positioned near one other at proximal ends of the expression subunits and delivery cannulas for each of the said expression subunits that positioned near one other at distal ends of the expression subunits. U.S. Patent No. 10,507,293 to Goodman et al., assigned to Ethicon, Inc. of Somerville, New Jersey, teaches a devi