WO1992020312A1

WO1992020312A1 - Assembly and method for applying hemostatic agents

Info

Publication number: WO1992020312A1
Application number: PCT/US1992/004218
Authority: WO
Inventors: Ariel Ferdman; Richard Conley; Deborah Susalka
Original assignee: Medchem Products, Inc.
Priority date: 1991-05-21
Filing date: 1992-05-20
Publication date: 1992-11-26
Also published as: AU2143692A

Abstract

As assembly (10) is provided for use with an endoscope to deliver hemostatic agents (34) internally at a site of bleeding suffered by a mammal. The assembly (10) comprises a germ-proof protective cover (42) enclosing a cannula (12), adapted by size and configuration to pass through an endoscope barrel. A plunger rod (24) is also provided to slidingly fit within the lumen of a cannula (12), and to hold a hemostatic agent (34) in association with the rod (24), for delivery through an opening (14) in the cannula.

Description

ASSEMBLY AND METHOD FOR APPLYING HEMOSTATIC AGENTS

BACKGROUND OF THE INVENTION

Field of the Invention

The invention relates to apparatus and methods for applying hemostatic agents to wounds and in particular to internal bleeding wounds suffered by a mammal, including a human.

Brief Description of the Prior Art

Endoscopy is a developing art for minimizing trauma during invasive surgical procedures. Endoscopy is widely used to reach such internal structures as the lungs, major blood vessels, abdominal organs and portions of the gastrointestinal tract.

An example of endoscopy is peritoneoscopy (pelvic or abdominal endoscopy) commonly referred to as "laparoscopy".

Laparoscopy is often done when the diagnosis for abdominal or pelvic complaints is not clear after a thorough history, physical examination, ultrasound, and x-ray studies. It can help evaluate abdominal or pelvic mass or pain, abnormal menstrual periods, and female infertility. In cases of known abdominal cancer, laparoscopy is sometimes helpful in determining whether the cancer has spread to the abdominal organs. Laparoscopy may also be used to look for damage to internal organs following abdominal trauma.

In addition to its use as a diagnostic tool, laparoscopy is used for treatment such as removal of the gall bladder or sterilization by tubal ligation in women.

In addition to examining the internal organs, fluid specimens and small tissue samples (biopsies) may be collected, ovarian cysts may be drained, fibrous bands of tissue (adhesions) may be cut, and abnormal extra-uterine endometrial tissue may be treated with electrocautery.

The basic instrument-used in carrying out laparoscopy is the laparoscope. The laparoscope is a thin, lighted viewing instrument which is inserted into the abdomen through a small incision in the abdominal wall. Laparoscopy permits direct visual examination of the outer surface of the abdominal organs (intestines, liver, and spleen) and pelvic organs (uterus, fallopian tubes, and ovaries).

While under anesthesia, and after insertion of the laparoscope, other instruments such as small scissors, forceps, or probes may also be inserted through a trocar in a separate, smaller incision in the abdomen, usually at the pubic hairline but not limited to this location.

In many instances during laparoscopy, a site of bleeding is discovered or created within the abdomen. Currently this bleeding site is usually controlled through cautery or the like introduced through the separate incision described above.

The present invention provides a quick and effective means of applying a hemostatic agent to an intra- abdominal site of bleeding, through the barrel or trocar of a conventional endoscope such as a laparoscope, or other such surgical ports, for auxiliary instruments. This provides an improvement in surgical technique and offers an alternative means to control bleeding without thermal damage to tissues.

SUMMARY OF THE INVENTION The invention comprises a sterilized assembled kit for use in association with the barrel assembly or trocar of an endoscope, to apply a hemostatic agent to an internal site of bleeding suffered by a mammal, including a human, which comprises: a cannula having a first open end, a second open end and an open lumen providing fluid communication between the first and second open ends, said cannula being adapted by size and configuration to pass through the barrel of an endoscope; an elongate plunger rod having a first end, a second end and rod body extending between the rod first and second ends, said body having a first zone of a given body thickness and a second zone of reduced body thickness, said second zone being at a predetermined site located between the rod first and second ends, said rod being adapted by size and configuration to slidingly fit within the cannula lumen; or alternatively, an elongate plunger rod of single thickness configured as otherwise just described; said plunger rod being partially mounted in the cannula lumen; a hemostatic agent removably deposited in the site of reduced thickness of the plunger rod; and a germ-proof protective cover means enclosing under sterile conditions the^" cannula and the mounted plunger rod.

The term "germ-proof" as used herein means the protective means is a barrier, inpenetrable by microorganisms such as pathogenic bacteria, viruses and like microorganisms, under room temperature conditions, for periods of at least a year or more.

Brief Description of the Drawings

Figure 1 is a side view, cross-sectioned-in-part, of an embodiment kit of the invention shown in disassembly.

Figure 2 is an end view of the cannula component shown in Figure 1.

Figure 3 is a side view of an alternate embodiment rod component, to the rod component shown in Figure 1.

Figure 4 is a cross-sectional side view of the rod operating means of an assembled cannula-rod embodiment of the invention. Figure 5 is a view as in Figure 4 of an alternate embodiment of the invention.

Figure 6 is a view as in Figure 4 of another embodiment of the invention.

Figures 7A and 7B are cross-sectional side views of still another embodiment of the invention.

Figure 8 is a cross-sectional side elevation of the hemostat delivery end of an alternate embodiment of the invention.

Figure 9 is a side view of another alternate assembly of the invention shown in disassembly.

Detailed Description of the Preferred Embodiments of the Invention

Those skilled in the art will gain an appreciation of the invention from a reading of the following description of preferred embodiments in conjunction with a viewing of the accompanying drawings of Figures 1 through 9 , inclusive.

Figure 1 is a side view of an embodiment kit assembly 10 of the invention, shown in disassembly with the kit components separated. The assembly 10 of the invention comprises a cannula 12 having a first open end 14 adapted by size and configuration to be received and carried in a sliding engagement within the barrel of an endoscope (the endoscope is not shown in Figure 1). The cannula 12 also includes a second open end 18 which bears an annularly disposed and integrally molded hub 20. Hub 20 functions as a finger grasping means. End 18 is open for fluid communication with lumen 22 (see Figure 2, and end 18 view of the cannula 12 shown in Figure 1) . Lumen 22 is defined by the interior walls of cannula 12 and extends from open end 18 to open end 14. The lumen 22 is adapted by size and configuration to receive in sliding fit within lumen 22 the elongate, rod 24 which has first end 26 and second end 28 and has a rod body 30 which communicates between the ends 26, 28. For use in association with a laparoscope, the length of cannula 12 (and therefore of lumen 22) will be about 30 cm. The cannula 12 will have an outer diameter of about 12 mm with an inner diameter of about 9 mm. For use in association with other, conventional endoscopes, appropriate sizes will be appreciated by the skilled artisan.

The rod 24 body 30 has a substantially uniform thickness (diameter) of about 9 mm so it will slidingly fit within the lumen 22. Proximal to the rod 24 end 28 is a body 30 site 32 of reduced thickness (about 4 mm reduction). Deposited in the site 32 of reduced thickness is a hemostatic agent 34. The site, about 50 mm in length, functions as a part of a receptacle for the agent 34 prior to delivery to a bleeding site, through a laparoscope or other endoscope, when rod 24 is fitted within lumen 22 of cannula 12. A portion of the lumen 22 wall adjacent to site 32 forms with other portions of the receptacle for confining agent 34. Disposed annularly about the end 26 of rod 24 is a finger-grasping integral hub 36 which also functions as a stop means to prevent end 26 from passing into the lumen 22 of cannula 12 when rod .24 is inserted fully in lumen 22.

The cannula 12 and the rod 24 may be fabricated from any materials conventionally used to fashion surgical instruments, including stainless steel, polymeric resins and the like. A preferred material is polycarbonate resin such as is described in U.S. Patent 4,880,850 (Nelson et al.). This particular resin is resistant to degradation by dry heat or other methods of sterilization.

The term "hemostatic agent" as used herein means a hemostyptic or agent which will coagulate and arrest the flow of blood from mammalian tissue. Representative of hemostatic agents are Wright's hemostat, finely divided fibrous collagen (see U.S. Patent 3,742,955), resorptive sheet materials of a glycoprotein matrix containing fibrinogen and thrombin (see U.S. Patent 4,606,337) and the like.

The cannula 12 and rod 24 and hemostatic agent 34 may be assembled together, secured and hermetically sealed in a moisture-proof, microorganism-impermeable container. Preferably, the components are sealed in pouches or trays, multiple containers such as overwraps or similar containers made of non-metallic materials which will effectively exclude infiltration of microorganisms, gas, vapor and moisture over a time period of several years. Such packaging materials are commercially available in numerous forms of polymeric films, including laminates of 2 or more films. For example, the pouches may be constructed of polyethylene, polypropylene, polyethyleneterephthalate, polyvinyl chloride and like polymeric films for forming hermetically sealed pouches. In Figure 1, a base sheet 40 and a top sheet 42 of a synthetic polymeric resin as described above are brought together and secured around the sheet periphery with a pressure-sensitive adhesive resin 44 to enclose between sheets 40, 42 the assembled components 12, 24, 34. It will be appreciated that the containers should be initially provided in clean, particulate free condition and they may be pre-sterilized to some extent employing conventional techniques such as exposure to sterilizing gases, heat, ultra-violet radiation, ionizing radiation and the like. After the molded articles are sealed in the above-described containers, they may be subjected to a sterilizing dose of an ionizing ray produced for example from a cobalt-60 source to effect full sterility.

Of course, other means of obtaining sterility such as ethylene oxide or ionizing radiation may be used.

The flange 46 bounding the outer periphery of top sheet 42 meets the adhesive 44 positioned on the periphery of bottom sheet 40 when the package assembly is sealed closed.

The package assembly -10 of the invention is employed as follows, when internal bleeding is observed through a laparoscope or other endoscope. The sealed, sterile assembly is opened by peeling top cover 42 away from the lower sheet 40, breaking the seal around the peripheral boundary of the sheets 40, 42 at sites of adhesive bonding with adhesive 44. Once opened, the assembly of cannula 12 and slidingly enclosed rod 24 is removed observing sterile techniques. The assembled cannula 12, rod 24 are inserted into the barrel of the laparoscope or other endoscopical surgical port with leading end 14 of cannula 12 being inserted first. The cannula 12 has a length exceeding the length of the conventional barrel of a laparoscope so that open end 14 is delivered to the observed site or source of bleeding. The operator then pushes rod 24 further into the cannula 12 so that the end 28 including hemostatic agent 34 is brought into proximity to the source of bleeding. When rod 24 is moved out of the end 14 of cannula 12, exposing the site 32 of hemostatic agent 34, the hemostatic agent 34 is released by gravity from its association with the rod 24. By rotation of rod 24, the operator can control to some extent the deposit of hemostatic agent 34 at the site of bleeding. In this manner, the hemostatic agent 34 is delivered where needed. Rod end 28 may then be used to tamponade the hemostat agent 34 on to the bleeding site. Thereafter, the assembled cannula 12 and enclosed rod 24 may be withdrawn from the barrel of the laparoscope and discarded or cleansed and sterilized for some future use. While rod 24 is within the lumen of cannula 12, the hemostatic agent 34 is confined to the recess site 32 and not allowed to discharge, as occurs when the rod 24 is pressed inward so that end 28 is outside of the open end 14 of the cannula 12. It will be appreciated by those skilled in the art that many modifications may be made to the above described preferred embodiments of the invention without departing from the spirit and scope of the invention. For example, referring now to Figure 3, one can see a side view of an alternate embodiment rod 24' component of the invention. The rod 24 is similar in all respects to rod 24 as previously described except that the rod body 30' is of a reduced thickness or diameter from the finger grasping hub 36' to a point 48 proximal to end 28' of the rod 24'. When inserted in a cannula 12, as described above, the additional space provided within lumen 22 can be filled with hemostatic agent, as described above, and not limited to a single site 32 of the rod. Again, by the force of gravity, contained hemostatic agent can be released at an internal site of bleeding when the end 28' of rod 24' is passed outward of the open 14 of a cannula 12.

Figure 4 is a cross-sectional side view of the cannula 12 with an assembled rod 24 of the invention, modified to provide a rod operating means. In the embodiment assembly 4, rod 24 bears along at least part of its body 30 surface a series of indentations 50, each of which cooperates with detent 52 positioned and integrally molded as a part of the finger grasping hub 20. Detent 52 provides for the sequential insertion and withdrawal of rod 24 within the lumen 22 of cannula 12. This is a convenience to the operator who may desire a controlled insertion and withdrawal of the rod 24, as indicated to him by engagement of the detent 52, periodically with the spaced apart indents 50.

Figure 5 is a view as in Figure 4 of an alternate embodiment of the invention, differing in that a ring grip 56 forms a part of the peripheral hub 20, further facilitating the operator's grip of the cannula 12 component of the assembly of the invention. Figure 6 is a view as in Figure 4 of yet another embodiment assembly of the invention. In Figure 6, a ring grip 58 is found on the end 26 of rod 24, again to facilitate grasping of rod 24 during its insertion and withdrawal from the cannula 12.

Figures 7A and 7B are cross-sectional side views of still another embodiment of the invention. Figure 7A illustrates inclusion of a 1-way stop 60 beneath the hub 36 at end 26 of rod 24. This 1-way stop 60 cooperates with an annularly disposed depression on the innermost aspect of the hub 20 on end 18 of cannula 12. Figure 7B illustrates that when pressed into this restriction, 1- way stop 60 prevents withdrawal of the rod 24 from the cannula 12, thereby preventing its reuse in an unsterile condition.

Figure 8 is a cross-sectional side elevation of the hemostat delivery and of an alternate embodiment of the invention. As shown in Figure 8, the end 28 or rod 24 has a tapered end 64 as a means of facilitating travel of the rod 24 through lumen 22 of cannula 12.

In the embodiment assembly of Figure 9, a cannula 12" differs from cannula 12 described above in that an aperture 70 is formed on the body of the cannula, at a point intermediate between end 14 and end 18. This aperture 70 permits communication between lumen 22 and the outside of cannula 12". When the rod 24 is inserted into lumen 20 of cannula 12", it can be inserted a distance so that the hemostatic agent 34 is brought into alignment with aperture 70. By a rotation of the rod 24, the hemostatic agent 34 can be released through aperture 70 and into close proximity with the site of internal bleeding.

Claims

WHAT IS CLAIMED:

1. An assembled kit for use in association with an endoscope, to apply a hemostatic agent to an internal site of bleeding suffered by a mammal, including a human, which comprises; a cannula having a first open end, a second open end and an open lumen providing fluid communication between the first and second open ends, said cannula being adapted by size and configuration to pass through the barrel of an endoscope; an elongate plunger rod having a first end, a second end and rod body extending between the rod first and second ends, said body having a first zone of a given body thickness and a second zone of reduced body thickness, said second zone being at a predetermined site located between the rod first and second ends, said rod being adapted by size and configuration to slidingly fit within the cannula lumen; said plunger rod being partially mounted in the cannula lumen; a hemostatic agent removably deposited in the site of reduced thickness of the plunger rod; and a germ-proof protective cover means enclosing under sterile conditions the cannula and the mounted plunger rod.

2. A kit of claim 1 wherein the endoscope is a laparoscope.

3. A kit of claim 1 wherein the cannula second end includes an annularly disposed means for finger grasping.

4. A kit of claim 1 wherein means is provided on the first end, for grasping with fingers.

5. A kit of claim 1 wherein the hemostatic agent is finely divided, fibrous collagen.

6. A kit of claim 1 which further comprises lock means for preventing withdrawal of the rod from the cannula lumen.

7. A kit of claim 1 wherein the cannula has an aperture communicating between the outside and the cannula lumen, at a point between said first and second ends.