The present disclosure relates to devices and methods for mixing components, such as powder and liquid components. More particularly, it relates to a mixing device, and related methods of use, facilitating convenient hand-mixing of components by a user and subsequent dispensing, for example in the preparation of a gelatinous, resorbable medical substance having hemostatic properties.
Many medical procedures, such as surgical procedures, entail application of a substance to a patient. In many instances, the substance to be applied is formed by a combination of two or more components, with the recommended protocol necessitating that some or all of the components not be combined with one another (e.g., mixed) until just prior to applying to the patient. In other words, the substance is provided to the caregiver in a partially complete form. One or more of the components may require special handling prior to mixing, the substance resulting from the combination may relatively quickly change states following mixing, etc. For example, bone or dental cement is commonly used to secure a prosthetic device to a bone of a patient, and is comprised of a powder polymer and a liquid monomer that polymerizes about the polymer powder; because the resultant bone cement will hardened shortly after mixing, the components are typically combined or mixed shortly before the surgical procedure.
For these and other medical procedures, the caregiver is required to perform the component mixing. While a mechanical mixing device may be appropriate, such devices are typically not available at a caregiver's site and/or require time and effort to properly operate. Further, it may be difficult to dispense the prepared substance from the device.
In light of the above, a need exists for a device that permits complete, manual mixing of components in forming a composition substance, such as a medical substance, and facilitates dispensing of the composition.
Aspects of the present disclosure relates to a pouch for mixing and dispensing a composition. The pouch includes a pouch body and a port body. The pouch body includes opposing, first and second major flexible walls sealed to one another along respective peripheries thereof to define an internal chamber and a pouch perimeter. In this regard, the pouch body has a C-like shape. The port body projects from the first wall and is fluidly open to the internal chamber. With this configuration, various components, such as a powder component and a liquid component, can be mixed by a user's hand(s) in pressing the walls in a kneading fashion, with the resultant composition being dispensed through the port body. In some embodiments, the pouch perimeter defines opposing, first and second end edges and opposing, first and second side edges, with the end edges being substantially linear, and the side edges being curved. In other embodiments, the port body extends from the first wall in a perpendicular fashion relative to a common plane defined by the pouch perimeter such that when the second wall is placed on a flat surface, the port body extends perpendicular relative to the flat surface. In other embodiments, the pouch is provided to a user with a powder component pre-loaded into the internal chamber.
Other aspects in accordance with principles of the present disclosure relate to a method of preparing a composition. The method includes providing a pouch including a pouch body and a port body as described above. At least two materials are placed into the internal chamber. The materials are mixed within the internal chamber by repeatedly pressing the side walls toward one another by a user's fingers to create a mixed composition. Finally, the composition is dispensed from the internal chamber via the port body. In some embodiments, the method entails forming the pouch body to include an open end, dispensing a powder component into the internal chamber via the open end, and sealing the open end to contain the powder component.
A pouch 10 in accordance with principles of the present disclosure for mixing and dispensing a composition is shown in
The pouch body 12 is defined, in some embodiments, by first and second major walls 30, 32 as best shown in
The walls 30, 32 are, in some embodiments, identical in terms of size and shape. With this in mind, the top view of
The pouch perimeter 36 defines the pouch body 12 to have the C-like shape as described above (relative to a top or bottom view of the pouch body 12 as shown). In this regard, the pouch perimeter 36 generally includes opposing, first and second side edges 40, 42, and opposing, first and second end edges 44, 46. The side edges 40, 42 extend between the end edges 44, 46 in a curved fashion. In this regard, an arc length of the first side edge 40 (in extension between the end edges 44, 46) is greater than an arc length of the second side edge 42. In other words, relative to a common plane defined by the pouch perimeter 36, the curved extension of the side edges 40, 42 establishes the C-like shape described above. From this description, then, a linear length of the first side edge 40 (i.e., linear length between the intersection points 48a, 48b) is greater than a linear length of second side edge 42 (i.e., linear length between the intersection points 49a, 49b). The linear lengths of the side edges 40, 42 can assume a variety of dimensions, but in some embodiments, a linear length of the first side edge 40 is optionally on the order of 3.2-4.2 inches, alternatively on the order of 3.5-4.0 inches. The end edges 44, 46 each extend in a generally linear fashion between the side edges 40, 42, and have an approximately identical length (e.g., within 5%). A length of the end edges 44, 46 can optionally be on the order of 1.15-2.05 inches, alternatively, 1.35-1.95 inches, for example. Alternatively, one or more of the edges 40-46 can be formed to have characteristics differing from those described above. In the configurations shown, the intersection points 48a, 48b, 49a, 49b are each formed as a rounded or radiused corner (as opposed to a sharp, 90 degree-type corner). With this optional construction, components being mixed within the internal chamber 18 are less likely to undesirably collect within the intersection points 48a, 48b, 49a, 49b.
The C-like shape described above results in the pouch body 12 having a central portion 50, and first and second wing portions 52, 54 extending from opposite sides of the central portion 50. The wing portions 52, 54 are symmetrical relative to the central portion 50 in some embodiments, with the port assembly 14 being arranged within the central portion 50. With this construction, and as described in greater detail below, the wing portions 52, 54 can be deflected relative to the central portion 50, thereby forcing materials contained within the internal chamber 18 along the wing portions 52, 54 toward the central portion 50, and thus toward the port assembly 14. Further, the C-like shape promotes user handling of the pouch 10, with the wing portions 52, 54 effectively providing grasping surfaces or handles. In additional, the C-like shape has surprisingly been found to more readily direct materials contained within the internal chamber 18 toward the central portion 50/port assembly 14 upon folding of the wing portions 52, 54 as compared to a more linear geometric arrangement.
Regardless of an exact shape, the edge seal 34 renders the pouch perimeter 36 substantially inelastic. That is to say, while the pouch body 12 can be folded along the pouch perimeter 36 (e.g., into and out of the plane of
As indicated above, the first and second walls 30, 32 are identical in terms of size and shape. However, the first major wall 30 forms an aperture 60 (referenced generally in
Returning to
In some embodiments, the port body 70 includes a rim 80 and a stem 82. The rim 80 provides a surface for assembly of the port body 70 to the first wall 30, whereas the stem 82 establishes a conduit (i.e., the central passageway 74) through which materials can be dispensed into and from the internal chamber 18. With this in mind, and with specific reference to
The port body 70 can be assembled to the first wall 30 in a variety of fashions, such as mounting the rim 80 to the first wall 30 (e.g., welding, adhesive bonding, etc.). In other embodiments, the port body 70 can be homogenously formed with the first wall 30, and the rim 80 can be eliminated. Further, the port body 70 can be supported relative to the first wall 30 with additional structures, such as ribs formed in the first wall 30 and/or rim 80.
The cap 16 can assume a wide variety of forms commensurate with features of the port assembly 14. More particularly, the cap 16 is configured to be releasably assembled to the port assembly 14, selectively opening and closing the central passageway 74 (
The pouch 10 can be employed in mixing and dispensing a variety of compositions. In some embodiments, the pouch 10 is used in conjunction with a method of preparing a composition from two or more components. More particularly, in some embodiments, a first, powder component is mixed with a second, liquid component. By way of example, the powder component can be a carboxymethylcellulose (CMC) gel product in powder form, the liquid component is water, saline, or similar liquid, and the resulting composition is a bioresorbable material useful, for example, in medical procedures to prevent bleeding, tissue adhesion, etc. (e.g., the resultant composition has hemostatic properties and can be inserted into body cavities and/or orifices of a patient in the form of or applied to a stent). Alternatively, a wide variety of other compositions can be generated using the pouch 10. Regardless, with applications in which the pouch 10 is used to facilitate mixing of a powder component with a liquid component, the pouch 10 can be provided to a user “pre-loaded” with the powder component in the internal chamber 18.
In some embodiments, the powder component is placed into the internal chamber 18 during manufacture of the pouch 10. In particular, and with reference to
Regardless of the manner in which component(s) are delivered into the internal chamber 18,
A second component 104 can then be added to the internal chamber 18 as shown in
Once a desired volume of the second component (e.g., liquid) 104 has been dispensed into the internal chamber 18, the passageway 74 is closed, for example by securing the cap 16 (
The composition 110 can then be withdrawn or dispensed from the internal chamber 18 in a variety of fashions, such as to a delivery system configured for applying the composition 110 as desired (e.g., as part of a medical procedure). For example, and as shown in
The pouch of the present disclosure provides a marked improvement over previous designs. The C-like shape of the pouch body is inherently self-supporting, and promotes a more rapid, uniform mixing of contained components, as well as handling thereof by the hands of an adult human. Further, the port assembly arrangement promotes convenient introduction and removal of materials to and from the pouch body.
Although the present disclosure has been described with reference to preferred embodiments, workers skilled in the art will recognize that changes can be made in form and detail without departing from the spirit and scope of the present disclosure.
This application is a continuation of U.S. application Ser. No. 12/048,056, filed Mar. 13, 2008, and entitled “Flexible, Flat Pouch with Port for Mixing and Delivering Powder-Liquid Mixture”; the entire teachings of which are incorporated herein by reference.
Number | Name | Date | Kind |
---|---|---|---|
1304114 | Staples | May 1919 | A |
1343357 | Eggers | Jun 1920 | A |
3158188 | Esty | Nov 1964 | A |
3888288 | Hickle et al. | Jun 1975 | A |
3951127 | Watson et al. | Apr 1976 | A |
4097366 | Tanaka | Jun 1978 | A |
4177844 | Kuss et al. | Dec 1979 | A |
4193506 | Trindle | Mar 1980 | A |
4219137 | Hutchens | Aug 1980 | A |
4236264 | Britzman | Dec 1980 | A |
4316489 | Price | Feb 1982 | A |
4358466 | Stevenson | Nov 1982 | A |
4434712 | Ross et al. | Mar 1984 | A |
4451383 | Arrhenius | May 1984 | A |
4470164 | Soderstrom | Sep 1984 | A |
4673010 | Prufer | Jun 1987 | A |
4693400 | Frahm | Sep 1987 | A |
4860805 | Townsend | Aug 1989 | A |
4887912 | Stumpf | Dec 1989 | A |
5052813 | Latto | Oct 1991 | A |
5056171 | Larson | Oct 1991 | A |
5090075 | Larson | Feb 1992 | A |
5174162 | Miyake | Dec 1992 | A |
5230335 | Johnson et al. | Jul 1993 | A |
5257429 | Genis | Nov 1993 | A |
5314455 | Johnson, Jr. et al. | May 1994 | A |
5337962 | Erb | Aug 1994 | A |
5377838 | Segre | Jan 1995 | A |
5398848 | Padamsee | Mar 1995 | A |
5431308 | Tchen | Jul 1995 | A |
5451179 | LaRoi et al. | Sep 1995 | A |
5462526 | Barney et al. | Oct 1995 | A |
5566869 | Katz | Oct 1996 | A |
5669529 | Levit | Sep 1997 | A |
5676830 | Janik | Oct 1997 | A |
5731021 | Spector | Mar 1998 | A |
5855544 | Buchanan | Jan 1999 | A |
5938089 | Abreu-Marston | Aug 1999 | A |
5961210 | McCardel et al. | Oct 1999 | A |
5980482 | Tofighi et al. | Nov 1999 | A |
6000079 | Dranger | Dec 1999 | A |
6076967 | Beaudette | Jun 2000 | A |
6200295 | Burchett et al. | Mar 2001 | B1 |
6233767 | Horowitz | May 2001 | B1 |
6971550 | Kuge et al. | Dec 2005 | B2 |
20010028601 | Hiramatsu | Oct 2001 | A1 |
20020007155 | Freund et al. | Jan 2002 | A1 |
20020141664 | Matsuda et al. | Oct 2002 | A1 |
20030015452 | Su | Jan 2003 | A1 |
20030028971 | Chaffee | Feb 2003 | A1 |
20040007590 | Hedington et al. | Jan 2004 | A1 |
20040045842 | Matsuda et al. | Mar 2004 | A1 |
20040065315 | Fish | Apr 2004 | A1 |
20040106344 | Looney | Jun 2004 | A1 |
20040161504 | Daniels et al. | Aug 2004 | A1 |
20050126632 | Farrell et al. | Jun 2005 | A1 |
20050198969 | Scudder | Sep 2005 | A1 |
20050220721 | Kablik | Oct 2005 | A1 |
20060193540 | Borchardt | Aug 2006 | A1 |
20060257057 | Andersen | Nov 2006 | A1 |
20070068508 | York-Leung Wong | Mar 2007 | A1 |
20070127854 | Smith | Jun 2007 | A1 |
20070161932 | Pick et al. | Jul 2007 | A1 |
20070184087 | Voigts | Aug 2007 | A1 |
20070197950 | Flick et al. | Aug 2007 | A1 |
20080069857 | Yeo | Mar 2008 | A1 |
20080104764 | Chen | May 2008 | A1 |
20090036988 | Peckham | Feb 2009 | A1 |
20090121365 | Jacobs | May 2009 | A1 |
Number | Date | Country |
---|---|---|
2643906 | Sep 2004 | CN |
2691627 | May 1992 | FR |
09075425 | Mar 1997 | JP |
2000316951 | Nov 2000 | JP |
2005529685 | Oct 2005 | JP |
8400737 | Mar 1984 | WO |
03086887 | Oct 2003 | WO |
03105748 | Dec 2003 | WO |
Entry |
---|
PCT Search Report and Written Opinion for corresponding Int'l Application No. PCT/US09/035677 dated Jun. 17, 2009 (13 pgs). |
Non-Final Office Action dated Apr. 21, 2010 for corresponding U.S. Appl. No. 12/048,056 (9 pgs). |
Final Office Action dated Aug. 24, 2010 for corresponding U.S. Appl. No. 12/048,056 (11 pgs). |
Advisory Action dated Nov. 3, 2010 for corresponding U.S. Appl. No. 12/048,056 (3 pgs). |
Non-Final Office Action dated Jun. 26, 2012 for corresponding U.S. Appl. No. 12/048,056 (13 pgs). |
Final Office Action dated Oct. 16, 2012 for corresponding U.S. Appl. No. 12/048,056 (15 pgs). |
Advisory Action dated Jan. 11, 2013 for corresponding U.S. Appl. No. 12/048,056 (3 pgs). |
Examiner's Answer to Appeal Brief dated Apr. 24, 2013 for corresponding U.S. Appl. No. 12/048,056 (19 pgs). |
Patent Board Decision dated Dec. 17, 2015 for corresponding U.S. Appl. No. 12/048,056 (7 pgs). |
Number | Date | Country | |
---|---|---|---|
20160158102 A1 | Jun 2016 | US |
Number | Date | Country | |
---|---|---|---|
Parent | 12048056 | Mar 2008 | US |
Child | 15046153 | US |