WO2013110095A1

WO2013110095A1 - Umbilical cord phlebotomy stabilization device

Info

Publication number: WO2013110095A1
Application number: PCT/US2013/023888
Authority: WO
Inventors: Robert A. DRACKER
Original assignee: Dracker Robert A
Priority date: 2012-01-17
Filing date: 2013-01-30
Publication date: 2013-07-25

Abstract

A device for stabilizing the umbilical cord during manipulations such as phlebotomy. In one embodiment the ends of the device terminate in proximity to one another and can interact to form a closing/opening mechanism. The closing and opening of the interacting ends similarly open and close a space at the opposite end of the device which encloses the umbilical cord. When the two ends are in the Open' configuration the device comprises a space for the umbilical cord to enter the umbilical cord holding region of the device, and when the two ends are in the 'closed' configuration the umbilical cord holding region of the device closes around the umbilical cord, thereby holding the umbilical cord firmly in place.

Description

TITLE

UMBILICAL CORD PHLEBOTOMY STABILIZATION DEVICE

BACKGROUND

[0001] The present invention relates to umbilical cord collection and phlebotomy, and, more specifically, to a stabilization device for use during umbilical cord phlebotomy. 2. DESCRIPTION OF THE RELATED ART

[0002] Stem cells are master cells found in all multicellular organisms. These special cells are important to the human body, for example, because they are capable of: (i) differentiating into a multitude of different specialized cell types; and (ii) dividing to maintain a supply of stem cells. In humans there are two main types of stems cells: embryonic stem cells and adult stem cells. In a developing embryo stem cells differentiate into all types of cells, thereby creating specialized tissues, organs, and systems. In an adult human, stem cells are involved in the normal turnover of organs such as blood and skin.

[0003] Hematopoietic stem cells, for example, are used to treat blood and immune system diseases because they can differentiate into red blood cells, white blood cells, and platelets. However, some stem cell transplants have been performed for patients with genetic or metabolic diseases. Indeed, to date more than 80 different diseases have been treated using stem cell transplants. According to the National Cord Blood Program, there were over 15,000 through the end of 2009. The National Marrow Donor Program estimates that there will be 10,000 cord blood transplants per year by 2015, up from 2,000 per year in 2006.

[0004] In addition to known treatments involving stem cells, research continues into the promise of many potential future applications. Indeed, the ability of stem cells to differentiate into other types of cells holds significant promise for treating some of the world's most common diseases including heart disease, diabetes, stroke, hearing loss, blood disorders, Parkinson's disease, and Alzheimer's disease, just to name a few.

[0005] Umbilical cords and umbilical cord blood - blood which remains in the placenta and umbilical cord after childbirth - is one of the most common sources of stem cells. Since cord blood is collected from the placenta, which is normally discarded, the collection process is safe for both the mother and the newborn.

[0006] Umbilical cords are obtained by harvesting following delivery of the cord and/or placenta. Typically, a short segment of the umbilical cord is collected and stored or shipped for processing. In one use, cells are immediately or later harvested from the segment and used to grow additional cells. [0007] Cord blood is obtained by syringing out the placenta through the umbilical cord shortly after childbirth, after the cord has been detached from the newborn. The retrieved blood can then be frozen and stored indefinitely.

[0008] Although the amount of stem cells obtained from cord blood is generally enough to treat a child, there are generally not enough stem cells to treat an adult patient. The placenta is a better source of stem cells, since it can contain up to ten times more stem cells than cord blood. Still, even when blood is retrieved from both the umbilical cord and placenta using current collection methods, the amount of stem cells is often not suitable to treat an adult patient.

[0009] As a result, there is a continued need for umbilical cord and umbilical cord blood collection methods and devices that significantly increase the number of stem cells collected, facilitate the collection of stem cells, or allow for the collection of enough stem cells to treat at least one adult patient. Further, since the umbilical cord is a moist tissue, there is a continued need for devices that stabilize the umbilical cord during manipulation such as cutting or phlebotomy.

BRIEF SUMMARY

[0010] It is therefore a principal object and advantage to provide a method, device, and/or system for the collection of an umbilical cord and/or umbilical cord blood.

[0011] It is another object and advantage to provide a method, device, and/or system to increase the number of stem cells collected from cord blood.

[0012] It is yet another object and advantage to provide a device to stabilize the umbilical cord during harvesting of the umbilical cord and/or umbilical cord blood.

[0013] It is a further object and advantage to provide a specialized clamp to securely hold the umbilical cord during harvesting of the cord and/or the cord blood, or during infusing of solutions into or out of the umbilical cord.

[0014] Other objects and advantages will in part be obvious, and in part appear hereinafter.

[0015] According to an aspect, a clamp for umbilical cord manipulation, the clamp comprising: (i) a clamp body comprising a first end and a second end, wherein the first end is adjacent to the second end, and further wherein the clamp body defines an umbilical cord space adapted to hold an umbilical cord when the clamp is in a closed configuration; (ii) a series of engaging ledges disposed on the second end, wherein the first end is adapted to reversibly engage at least one of the engaging ledges when the clamp is in the closed configuration; (iii) wherein the size of the umbilical cord space defined by the clamp body decreases as the first end of the clamp engages each additional engaging ledge in the series of engaging ledges.

[0016] According to an aspect, the clamp body is curvilinear.

[0017] According to an aspect, the umbilical cord space is defined by a first extension extending into the interior of the clamp body.

[0018] According to an aspect, the umbilical cord space is further defined by a second extension extending into the interior of the clamp body opposite the first extension, wherein a distance between the first and second extensions decreases as the first end of the clamp engages each additional engaging ledge in the series of engaging ledges.

[0019] According to an aspect, the clamp is composed of plastic.

[0020] According to an aspect, the umbilical cord space is sized to fit a human umbilical cord when the clamp is in the closed configuration.

[0021] According to an aspect, the clamp further comprises an exterior extension, the exterior extension extending outwardly from the exterior of the clamp body. According to an aspect, the exterior extension is a tubing clamp.

[0022] According to an aspect, a clamp for umbilical cord manipulation, the clamp comprising: (i) a curvilinear clamp body comprising a first end and a second end, wherein the first end is adjacent to the second end, and further wherein the curvilinear clamp body defines an umbilical cord space adapted to hold a human umbilical cord when the clamp is in a closed configuration, and further wherein the umbilical cord space is defined by: (1) a first extension extending into the interior of the clamp body and (2) a second extension extending into the interior of the clamp body opposite the first extension; (ii) a series of engaging ledges disposed on the second end, wherein the first end is adapted to reversibly engage at least one of the engaging ledges when the clamp is in the closed configuration; (iii) wherein the size of the umbilical cord space defined by the curvilinear clamp body decreases as the first end of the clamp engages each additional engaging ledge in the series of engaging ledges; (iv) wherein a distance between the first and second extensions decreases as the first end of the clamp engages each additional engaging ledge in the series of engaging ledges.

[0023] According to an aspect, the clamp is composed of plastic.

[0024] According to an aspect, the clamp further comprises an exterior extension, exterior extension extending outwardly from the exterior of the clamp body.

[0025] According to an aspect, the exterior extension is a tubing clamp. BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S)

[0026] The invention will be more fully understood and appreciated by reading the following Detailed Description in conjunction with the accompanying drawings, in which:

[0027] FIG. 1 is a side view of an umbilical cord phlebotomy stabilization device in an Open' configuration according to one embodiment;

[0028] FIG. 2 is a side view of an umbilical cord phlebotomy stabilization device in a

'closed' configuration according to one embodiment;

[0029] FIG. 3 is a perspective view of an umbilical cord phlebotomy stabilization device in an Open' configuration according to one embodiment; and

[0030] FIG. 4 is a perspective view of an umbilical cord phlebotomy stabilization device in a 'closed' configuration according to one embodiment

DETAILED DESCRIPTION

[0031] Referring now to the drawings, wherein like reference numerals refer to like parts throughout, there is seen in Figure 1 an embodiment of an umbilical cord phlebotomy stabilization device 100. The device is preferably is preferably a clamp that stabilizes and/or otherwise manipulates an umbilical cord. The device preferably comprises a rigid material such as plastic or metal, although a wide range of suitably rigid materials are possible.

[0032] Device 100 preferably comprises a single curvilinear piece of rigid material.

The two ends of the device, first end 110 and second end 120, terminate in proximity to one another, and according to the embodiment depicted in FIG. 2, they interact to form an closing/opening mechanism. The embodiment shown in FIGS. 1-4, for example, comprises a closing/opening mechanism whereby first end 110 terminates at a pointed or flattened region, and second end 120 comprises a series of ledges 130. The flattened region of first end 110, when pushed up along the ledges 130, sequentially interacts individual with each the ledges to lock device 100 into a particular configuration.

[0033] For example, device 100 depicted in FIGS. 1, 3, and 4 are in the 'open' configuration, whereby the flattened tip of first end 110 of the device is not interacting with the closing mechanism of second end 120. In contrast, the device shown in FIG. 2 is in the 'closed' configuration, whereby the flattened tip of first end 110 is interacting with the ledges or ridges 130 of second end 120.

[0034] In other embodiments, the first and second ends of device 100 can be secured by other means, including a latch, a lock, Velcro, tape, a clamp, a pin, a snap, and many other means. In yet another embodiment, device 100 is a single, closed component and the umbilical cord space is made bigger or smaller by other means including any means discussed herein and/or known in the art.

[0035] At the region of device 100 opposite the two ends, the device defines a rounded space 140 configured to hold an umbilical cord. In the embodiment shown in FIGS. 1-4, the umbilical cord space 140 is defined by the interior of the device, as well as two triangular extensions 150 and 160 that extend into the internal space of the device toward one another. As shown in FIG. 1, when device 100 is in the Open' configuration there is space between triangular extensions 150 and 160 to fit an average umbilical cord into upper rounded space 140 ("average" defined by the mammal from which the placenta will be taken) can comfortably reside. For example, space 140 can be sized to comfortably receive the average human placenta. Once the umbilical cord is in place, the two ends of the clamping device are brought into communication (i.e., the 'closed' configuration), and triangular extensions 150 and 160 come together, thereby closing the space between the triangular extensions and firmly holding the umbilical cord in place. See, for example, FIG. 2 where the two ends of the device are in the 'closed' configuration and the triangular extensions are almost directly touching, thereby gripping the device around the umbilical cord and holding it firmly in place for continued manipulation such as phlebotomy, among many other uses.

[0036] In another embodiment, the clamp comprises one or more tools or adaptations for additional functions. For example, in the embodiment shown in FIGS. 1-4, the device comprises a clamp-like structure 170 jutting outwardly from one side of the device. This structure can be used, for example, to hold tubing or an IV line in place during manipulation of the umbilical cord. Other configurations of this structure - and many other structures known in the art - can be added to the device to add additional functionality and purpose.

[0037] The structure of the embodiment shown in FIGS. 1-4 is provided only as an example of possible structure, and is not meant to limit the scope of the present invention. Further, although the present invention has been described in connection with a preferred embodiment, it should be understood that modifications, alterations, and additions can be made to the invention without departing from the scope of the invention as defined by the claims.

[0038] Note that the spatial terms used in reference to several embodiments of the device are used only to provide a frame of reference to the user.

[0039] Although the present invention has been described in connection with a preferred embodiment, it should be understood that modifications, alterations, and additions can be made to the invention without departing from the scope of the invention as defined by the claims.

Claims

CLAIMS What is claimed is:

1. A clamp for umbilical cord manipulation, the clamp comprising:

a clamp body comprising a first end and a second end, wherein said first end is adjacent to said second end, and further wherein said clamp body defines an umbilical cord space adapted to hold an umbilical cord when said clamp is in a closed configuration;

a series of engaging ledges disposed on said second end, wherein said first end is adapted to reversibly engage at least one of said engaging ledges when said clamp is in said closed configuration;

wherein the size of the umbilical cord space defined by the clamp body decreases as the first end of the clamp engages each additional engaging ledge in said series of engaging ledges.

2. The clamp of claim 1, wherein the clamp body is curvilinear.

3. The clamp of claim 1, wherein said umbilical cord space is defined by a first extension extending into the interior of said clamp body.

4. The clamp of claim 3, wherein said umbilical cord space is further defined by a second extension extending into the interior of said clamp body opposite said first extension, wherein a distance between said first and second extensions decreases as the first end of the clamp engages each additional engaging ledge in said series of engaging ledges.

5. The clamp of claim 1, wherein the clamp is composed of plastic.

6. The clamp of claim 1, wherein said umbilical cord space is sized to fit a human umbilical cord when said clamp is in said closed configuration.

7. The clamp of claim 1, wherein the clamp further comprises an exterior extension, said exterior extension extending outwardly from the exterior of said clamp body.

8. The clamp of claim 7, wherein said exterior extension is a tubing clamp.

9. A clamp for umbilical cord manipulation, the clamp comprising:

a curvilinear clamp body comprising a first end and a second end, wherein said first end is adjacent to said second end, and further wherein said curvilinear clamp body defines an umbilical cord space adapted to hold a human umbilical cord when said clamp is in a closed configuration, and further wherein said umbilical cord space is defined by: (i) a first extension extending into the interior of said clamp body and (ii) a second extension extending into the interior of said clamp body opposite said first extension; a series of engaging ledges disposed on said second end, wherein said first end is adapted to reversibly engage at least one of said engaging ledges when said clamp is in said closed configuration;

wherein the size of the umbilical cord space defined by the curvilinear clamp body decreases as the first end of the clamp engages each additional engaging ledge in said series of engaging ledges;

wherein a distance between said first and second extensions decreases as the first end of the clamp engages each additional engaging ledge in said series of engaging ledges.

10. The clamp of claim 9, wherein the clamp is composed of plastic.

11. The clamp of claim 9, wherein the clamp further comprises an exterior extension, said exterior extension extending outwardly from the exterior of said clamp body.

12. The clamp of claim 11, wherein said exterior extension is a tubing clamp.