EXPANDABLE TAMPONADE

Abstract

A device designed to be packed into a wound that will expand to fill the voids of the wound to control bleeding is provided. The device is comprised of two or more individual pouches, linked together, and filled with an expandable material that will swell upon absorption of blood through the pouch walls.

Claims

1. An expandable tamponade for hemostasis control of wounds comprising: at least two sealed pouches connected together, wherein each of the at least two sealed pouches comprises an expandable material enclosed within a liquid-permeable exterior material and wherein the expandable material that expands upon being wetted with a liquid.

2. The expandable tamponade of claim 1 wherein the liquid-permeable exterior material is blood permeable and the expandable material is capable of expanding upon being wetted with blood.

3. The expandable tamponade of claim 1 wherein the expandable material is an absorbent material.

4. The expandable tamponade of claim 1 wherein the at least two sealed pouches are formed from one or more materials that have hemostatic properties.

5. The expandable tamponade of claim 1 wherein the at least two sealed pouches comprise a hemostatic coating on the liquid-permeable exterior material.

6. The expandable tamponade of claim 1 wherein the at least two sealed pouches are formed from a material that allows for blood transfer to the expandable material within the pouch.

7. The expandable tamponade of claim 1 comprising at least three sealed pouches connected together.

8. The expandable tamponade of claim 1 comprising at least four sealed pouches connected together.

9. The expandable tamponade of claim 1 wherein the at least two sealed pouches comprise an antimicrobial agent either on the liquid-permeable exterior or within the pouches.

10. The expandable tamponade of claim 1 wherein at least one of the pouches comprises a pocket to assist in inserting the tamponade into the wound.

11. The expandable tamponade of claim 10 wherein the pocket is configured to fit a human finger, swab, or other insertion utensil.

12. The expandable tamponade of claim 10 wherein more than one of the pouches comprises the pocket.

13. The expandable tamponade of claim 12 wherein all of the pouches comprise the pocket.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0019] FIG. 1 is a cross-section side view of an individual pouch useable according to the present invention and prior to the pouch being inserted into a wound and expanding.

[0020] FIG. 2 is a cross-section side view showing the pouch of FIG. 1 prior to the pouch being inserted into a wound and expanding and transitioned into an expanded pouch after the pouch is wetted, such as after insertion into a wound and after expanding.

[0021] FIG. 3 is cross-section top view of a series of pouches according to the present invention wherein individual pouches are connected via a connecting device.

[0022] FIG. 4 is cross-section side view of a series of pouches according to the present invention wherein individual pouches are connected via a tube from which the pouches have been formed with the tube portions being sealed between individual pouches.

[0023] FIG. 5 is a cross-section side view of the invention shown in FIG. 4 being inserted into a wound.

[0024] FIG. 6 is a side view of an embodiment of a series of individual pouches of the present invention.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

[0025] Reference now will be made in detail to the embodiments of the invention, one or more examples of which are set forth below. Each example is provided by way of explanation of the invention, not a limitation of the invention. In fact, it will be apparent to those skilled in the art that various modifications and variations can be made in the present invention without departing from the scope or spirit of the invention. For instance, features illustrated or described as part of one embodiment, can be used on another embodiment to yield a still further embodiment. The following embodiments and aspects thereof are described and illustrated in conjunction with systems, tools and methods which are meant to be exemplary and illustrative and not limiting in scope. In various embodiments one or more of the above-described problems have been reduced or eliminated while other embodiments are directed to other improvements.

[0026] Thus, it is intended that the present invention covers such modifications and variations as come within the scope of the appended claims and their equivalents. Other objects, features and aspects of the present invention are disclosed in or are obvious from the following detailed description. It is to be understood by one of ordinary skill in the art that the present discussion is a description of exemplary embodiments only, and is not intended as limiting the broader aspects of the present invention.

[0027] It should be understood that the examples and embodiments described herein are for illustrative purposes only and that various modifications or changes in light thereof will be suggested to persons skilled in the art and are to be included within the spirit and purview of this application and the scope of the appended claims. In addition, any elements or limitations of any invention or embodiment thereof disclosed herein can be combined with any and/or all other elements or limitations (individually or in any combination) or any other invention or embodiment thereof disclosed herein, and all such combinations are contemplated with the scope of the invention without limitation thereto.

[0028] The pouches of the present invention are connected in such a way that when one pouch is removed from the body, it pulls on the next pouch and so on, allowing all of the pouches to be removed without damaging the wound walls. The pouches are designed to simulate the size of the wound in which they are used. The individual pouches will prevent the swelling, due to the expanding polymer, from creating mass with a diameter that would damage the wound as it is removed.

[0029] The expanding polymer may be a powder, fibrous material, or a combination of both. The exterior of the pouch or pouch-forming material could be a blood permeable material or a mesh that contains the expanding polymer and is strong enough to prevent tearing during expansion and/or removal. The exterior pouch material may incorporate or be coated with a hemostatic material or a material that interferes with the wetting rate of the expanding polymer.

[0030] The pouches may be square, round, oblong, or any other shape that is suitable for insertion into a wound. The pouches may be all the same shape or the leading pouch may be designed to be smaller or a more conical shape to allow for easier insertion into the wound.

[0031] The pouches may or may not be radiopaque. The purpose for radiopaque is to allow hospitals to electronically ensure that all of the material is removed from the wound prior to closing the wound surgically.

[0032] Examples of hemostat coatings for the pouches include, but are not limited to: Multi-Valent cation salts (Iron, Aluminum, Calcium); Thrombin; Fibrinogen; Chitosan; Calcium alginate; Kaolin; Activate cellulose; Polyvinyl alcohol (PVA); Polylactic acid; Vit C, collagen, zinc or other wound healing materials.

[0033] Examples of wetting retardation materials include, but are not limited to: Calcium alginate; Sugars; Polysaccharides; PVA; Often a very dry material can have hydrophobic properties until initial wetting; Hydrogels; Hydrocolloids; Starches; and Other oils or lubricants.

[0034] The pouches can be formed from various materials known in the art such as Cotton, Polyethylene, Polypropylene, Rayon, Teflon, Spandex, and Silk.

[0035] The expanding polymer materials include, but are not limited to: Any low cross-linked absorbent polymer such as Polyacrylates, Polysaccharides, and Ion exchange resins; Rayon; Cotton; and/or Cellulose. A cross-section top view of a pouch 10 according to the present invention, before insertion into the wound and expansion, is shown in FIG. 1. As shown therein, an expandable material 14, such as a polymer powder, fibrous material, or combination thereof, is enclosed within pouch 10 formed from an exterior material 12, which may comprise a mesh or other blood-permeable material.

[0036] FIG. 2 illustrates the expansion of the expandable material 14 within pouch 10 upon being wetted by blood or other bodily fluid after insertion into a wound. Pouch 20 has expanded to increase the area of the expandable material 14 housed within the exterior material 12 so that the space inside of a wound is at least partially filled so as to create compression inside the wound to stop bleeding.

[0037] As stated above, pouches 10 may be of different sizes, shapes. In addition, the number of individual pouches 10 connected together may vary for different usages.

[0038] As shown in the top views in FIG. 3, a series 50 of pouches 10 filled with expandable material 14 enclosed within an exterior material 12 are connected. The connections may be by any means to create a series of connected pouches 10, with one example being the use of strings 30 between each individual pouch 10 to connect the pouches together in a series 50.

[0039] Another means for connecting individual pouches 10 together in a series 60 is shown in the top views of FIG. 4. In this embodiment of the present invention, a series 60 of individual pouches 10 is created by placing expandable material 14 into a tube formed of a sealable material (such as a plastic) and then sealing the tube portions 40. The resulting series 60 of individual pouches 10 are connected and are able to be used for larger wounds that required more than just an individual pouch. The number of individual pouches 10 connected together in the series 50 or the series 60 is variable, depending on the particular need.

[0040] The pouches may be coated with or have incorporated therein, a control agent, or otherwise be designed, to slow the wetting of the expanding polymer. This would allow the wound to be properly packed before the polymer begins to expand. These retardants may also include an oil or other lubricant to help the device slide down the wound tract.

[0041] The devices also may incorporate an antimicrobial agent.

[0042] FIG. 5 illustrates the series 60 of expandable individual pouches 10 shown in FIG. 4 being inserted into a wound 70 in human tissue 72.

[0043] As shown in side view in FIG. 6, an individual pouch 10 may include a pocket 80, constructed of any material, including the mesh or blood-permeable material, to assist insertion of the expandable pouch 10 into the wound. One particular embodiment, as shown in FIG. 6, allows one's finger to be inserted into pocket 80 to push the pouch 10 into a wound. The pocket 80, or side-pouch, may be designed to fit a human finger or a swab or other utensil to insert the pouches. Pocket 80 may be included on all pouches in a series of individual pouches 10, or on only the first individual pouch 10 of the series.

[0044] These and other modifications and variations to the present invention may be practiced by those of ordinary skill in the art, without departing from the spirit and scope of the present invention, which is more particularly set forth in the appended claims. In addition, it should be understood that aspects of the various embodiments may be interchanged in whole or in part. Furthermore, those of ordinary skill in the art will appreciate that the foregoing description is by way of example only, and is not intended to limit the invention so further described in such appended claims. Therefore, the spirit and scope of the appended claims should not be limited to the description of the versions contained therein.