FINGER PROTECTION DEVICE FOR USE IN A MEDICAL PROCEDURE

Abstract

An apparatus for protecting a finger of a physician or practitioner during a medical procedure includes a generally tubular flexible member disposed about a longitudinal axis. The flexible member includes a first layer comprising a textile material, the first layer having an inner surface and an outer surface, and a second layer provided within the first layer on the inner surface of the first layer, the second layer comprising a cushion material. The flexible member further includes a guard section abutting the first layer and extending along a portion of the longitudinal axis, the guard section comprising a generally rigid material.

Description

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention pertains to a device for use in medical procedures that require one or more incisions which protects a physician or other caregiver from accidental cuts, and in particular, to a finger protection device for use in protecting the finger of a physician or other caregiver during a medical procedure that requires one or more incisions, such as, without limitation, a procedure for removing an implantable medical device such as an implantable medication delivery system.

2. Description of the Related Art

Numerous medical procedures require a physician or other caregiver to use a scalpel or similar device to make an incision in the skin of a patient. As will be appreciated, such procedures present a risk that the physician or caregiver will cut himself or herself accidentally with the scalpel during the procedure. One such procedure involves the removal of implantable medical devices such as an implantable medication delivery system.

Implantable medication delivery systems for automatically delivering medication to a patient subcutaneously are known. One such system is the ITCA 650 continuous subcutaneous delivery system that is being developed by Intarcia Therapeutics, Inc. for the treatment of type 2 diabetes. The ITCA 650 system is comprised of a small, matchstick-sized osmotic mini-pump in the form of a cylindrical titanium. alloy reservoir that is placed sub-dermally (just beneath the skin) to deliver a slow and consistent flow of medication to a patient. Once placed under the skin, water from the patient's extracellular fluid enters the device at one end by diffusing through a semi-permeable membrane and flows directly into a salt osmotic engine positioned in the device. When exposed to water in such a manner, the salt osmotic engine expands and drives a piston provided within the device at a controlled rate. The movement of the piston forces the medication to be released in a consistent fashion through a diffusion moderator positioned at the other end of the device.

When such a device delivers all of the medication contained therein, it must be removed by a physician or another caregiver such as a physician's assistant or nurse practitioner. In the case of the ITCA 650 device, to remove the device, the physician or caregiver may pinch the skin of the patient surrounding the device between his or her index finger and thumb so as to position the device longitudinally between those two fingers. The physician or caregiver then creates an incision in the patient's skin at a position that is in front of the front end of the device to allow the device to be pushed out of the skin by the index finger through the incision. The required location for such an incision is near the physician or caregiver's thumb. As will be appreciated, during such removal procedures, there is a risk of injury to the thumb of the physician or caregiver as a result of accidental scalpel slippage during creation of the incision.

SUMMARY OF THE INVENTION

As one aspect of the invention, an apparatus for protecting a finger during a medical procedure is provided. The apparatus comprises: a generally tubular flexible member disposed about a longitudinal axis, the flexible member having: (i) a first layer having an inner surface and an outer surface, and (ii) a second layer provided within the first layer on the inner surface of the first layer; and a guard section abutting the first layer and extending along a portion of the tubular flexible member generally parallel to the longitudinal axis, the guard section comprising a generally rigid material.

The first layer may comprise a textile material.

The guard section may extend over approximately ⅓ of a circumference of the generally tubular flexible member.

The guard section may comprise a plurality of rigid plate members provided on the outer surface of the first layer. Each of the plate members may be disposed perpendicular to the longitudinal axis. Each of the plate members may be made of a plastic material. Each of the rigid plate members may be made of one or more of: ABS, PVC, Acetal (Delrin), Acrylic, HDPE, CPVC, CTFE, Cast Nylon, Glass filled nylon and Kevlar filled nylon, PEEK, PETG, Polycarbonate, and PTFE.

The second layer may comprise a gel. The gel may be a mineral oil gel comprising a polymer gel impregnated with a medical grade mineral oil.

The first layer may be a woven fabric material.

The second layer may be a woven fabric material.

The guard section may comprises a single plate member provided on the outer surface of the first layer and extending along a portion of the flexible tubular member.

The plate member may have a first thickness and the plate member may include a saddle area comprising a recessed portion having a second thickness less than the first thickness. The saddle area may extend approximately ⅓ of a circumference of the generally tubular flexible member.

The plate member may be made of one or more of: ABS, PVC, Acetal (Delrin), Acrylic, HDPE, CPVC, CTFE, Cast Nylon, Glass filled nylon and Kevlar filled nylon, PEEK, PETG, Polycarbonate, and PTFE.

The guard section may comprise a single plate member provided on the inner surface of the first layer and extending along a portion of the longitudinal axis.

The outer surface of the first layer may comprise an indicia disposed thereon generally opposite the single plate member.

The plate member may have a first thickness and the plate member may include a saddle area comprising a recessed portion having a second thickness less than the first thickness. The saddle area may extend approximately ⅙ of a circumference of the generally tubular flexible member.

The plate member may be made of one or more of: ABS, PVC, Acetal (Delrin), Acrylic, HDPE, CPVC, CTFE, Cast Nylon, Glass filled nylon and Kevlar filled nylon, PEEK, PETG, Polycarbonate, and PTFE.

These and other objects, features, and characteristics of the present invention, as well as the methods of operation and functions of the related elements of structure and the combination of parts and economies of manufacture, will become more apparent upon consideration of the following description and the appended claims with reference to the accompanying drawings, all of which form a part of this specification, wherein like reference numerals designate corresponding parts in the various figures. It is to be expressly understood, however, that the drawings are for the purpose of illustration and description only and are not intended as a definition of the limits of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a top view of an apparatus for protecting a finger during a medical procedure in accordance with an example embodiment of the invention;

FIG. 2 is a sectional view of the apparatus of FIG. 1 taken along line 2-2 of FIG. 1;

FIG. 3 is a top view of the apparatus of FIG. 1 shown disposed on the right thumb of a user/practitioner;

FIG. 4 is a top view of the apparatus of FIG. 1 shown disposed on the right thumb of a user/practitioner during a procedure on a patient in accordance with an example embodiment of the invention;

FIG. 5 is an end view of the arrangement of FIG. 4 looking at the ends of the thumb and index finger of the user/practitioner;

FIG. 6 is a top view of an apparatus for protecting a finger during a medical procedure in accordance with another example embodiment of the invention;

FIG. 7 is a sectional view of the apparatus of FIG. 6 taken along line 7-7 of FIG. 6;

FIG. 8 is a top view of the apparatus of FIG. 6 shown disposed on the right thumb of a user/practitioner;

FIG. 9 is a top view of an apparatus for protecting a finger during a medical procedure in accordance with yet another example embodiment of the invention;

FIG. 10 is a sectional view of the apparatus of FIG. 9 taken along line 10-10 of FIG. 9; and

FIG. 11 is a top view of the apparatus of FIG. 9 shown disposed on the right thumb of a user/practitioner.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

As used herein, the singular form of “a”, “an”, and “the” include plural references unless the context clearly dictates otherwise. As used herein, the statement that two or more parts or components are “coupled” shall mean that the parts are joined or operate together either directly or indirectly, i.e., through one or more intermediate parts or components, so long as a link occurs.

As used herein, “directly coupled” means that two elements are directly in contact with each other.

As used herein, “fixedly coupled” or “fixed” means that two components are coupled so as to move as one while maintaining a constant orientation relative to each other.

As used herein, the term “unitary” means a component is created as a single piece or unit. That is, a component that includes pieces that are created separately and then coupled together as a unit is not a “unitary” component or body.

As used herein, the term “finger” or “digit” shall mean any of the terminal members of the hand, including but not limited to, the thumb.

As used herein, the term “textile” shall mean a material consisting of a network of interlaced or otherwise entangled natural or artificial fibers made by, for example and without limitation, weaving, knitting, spreading, crocheting, or bonding (e.g., by chemical, mechanical, heat or solvent treatment) the fibers to form the network, and may include, for example, and without limitation, woven and nonwoven fabric materials.

As used herein, the term “gel” shall mean a non-fluid cross-linked colloidal network or polymer network that is expanded throughout its whole volume by a fluid

As used herein, the term “foam” shall mean a substance that is formed by trapping pockets of gas in a solid material, and may include closed-cell foams wherein the gas forms discrete pockets each completely surrounded by the solid material, and open-cell foams, wherein the gas pockets connect with each other.

As used herein, the term “cushion material” shall mean any soft, flexible, cushiony, elastomeric material, such as, without limitation, silicone, an appropriately soft thermoplastic elastomer, a foam, a gel or any combination of such materials.

As used herein, the statement that two or more parts or components “engage” one another shall mean that the parts exert a force against one another either directly or through one or more intermediate parts or components.

As used herein, the word “number” shall mean one or an integer greater than one (i.e., a plurality).

Directional phrases used herein, such as, for example and without limitation, top, bottom, left, right, upper, lower, front, back, and derivatives thereof, relate to the orientation of the elements shown in the drawings and are not limiting upon the claims unless expressly recited therein.

The present invention will now be described, for purposes of explanation, in connection with numerous specific details in order to provide a thorough understanding of the subject invention. It will be evident, however, that the present invention can be practiced without these specific details without departing from the spirit and scope of this innovation.

An embodiment of an apparatus 10 for protecting a finger (i.e., a digit) during a medical procedure in accordance with an example embodiment of the invention will now be discussed in conjunction with FIGS. 1-5. Apparatus 10 is designed to provide a physician or other caregiver positive dexterity control of an implanted device (e.g., see 12 in FIGS. 4 and 5) which is targeted for removal. Referring first to FIGS. 1 and 2, apparatus 10 includes a generally tubular flexible member 14 disposed about a longitudinal axis A. Flexible member 14 includes a first layer 16, having an inner surface 16A and an outer surface 16B, a second layer 18 provided within first layer 16 on inner surface 16A thereof. In an example embodiment of the invention, first layer 16 is formed generally as a fabric sleeve, formed from a woven fabric material whereas second layer 18 in such example embodiment is formed from a gel material. In one example arrangement, a Silipos'® mesh and ribbed knit tubes fully lined with a mineral oil gel has been utilized to provide all around digital protection while absorbing shock and pressure. In another example embodiment, both first layer 16 and second layer 18 are formed from fabric materials.

Continuing to refer to FIGS. 1 and 2, apparatus 10 further includes a guard section 20 which abuts first layer 16 and extends along a portion of flexible member 14 generally parallel to longitudinal axis A. Guard section 20 is generally positioned and structured to prevent a physician or practitioner from accidentally cutting the digit on which apparatus 10 is worn during a procedure. Accordingly, guard section 20 is formed from a suitable generally rigid material which is generally resistant to being cut. Some examples of suitable materials include, without limitation, plastics, ABS, PVC, Acetal (Delrin), Acrylic, HDPE, CPVC, CTFE, Cast Nylon, Glass filled nylon and Kevlar filled nylon, PEEK, PETG, Polycarbonate, and PTFE. In the example embodiment illustrated in FIGS. 1-5, guard section 20 includes a plurality of rigid plate members 22 provided on outer surface 16B of first layer 16. In the example shown in FIGS. 1-5, each plate member is disposed generally perpendicular to longitudinal axis A, however, it is to be appreciated that plate members 22 may be disposed in other arrangements without varying from the scope of the invention. As can be appreciated from the sectional view of FIG. 2, each plate member 22 of guard section 20 extends over approximately ⅓ of the circumference of flexible member 14 so as to generally provide a protective guard for the digit on which apparatus 10 is disposed while still allowing for at least some flexibility of the digit.

FIG. 3 is an example wherein apparatus 10 is disposed on the right thumb 30 of a physician/practitioner. FIGS. 4 and 5 show a partially schematic example wherein apparatus 10 is disposed on the right thumb of a physician/practitioner and is being used in a procedure wherein a portion 32 of a patient's skin is generally pinched between apparatus 10 and the physician's/practitioner' s index finger 34. During such procedure an incision 36 has been made using a scalpel in order to insert or remove device 12. Although shown disposed protecting a thumb, it is to be appreciated that the embodiments of apparatus 10 may be employed to protect other fingers without varying from the scope of the invention. It is also to be appreciated that multiple apparatuses 10 may be employed to protect more than one finger at a given time without varying from the scope of the invention.

An embodiment of another apparatus 10′ for protecting a digit during a medical procedure in accordance with another example embodiment of the invention is shown in FIGS. 6-8. Apparatus 10 is a generally similar arrangement as apparatus 10 previously discussed except apparatus 10′ includes a guard section 20′ which is in the form of a single plate member 22′ which is provided on outer surface 16B of first layer 16 and extends along a portion of flexible tubular member 14, generally parallel to longitudinal axis A. Plate member 22′ is formed from a suitable cut-resistant material or materials such as previously described herein. Plate member 22′ includes a saddle portion 40 which is generally centrally located in plate member 22′. Referring to FIG. 6, plate member 22′ has a first thickness t₁ and a second thickness t₂ in saddle portion 40 which is less than first thickness t₁. As can be appreciated from FIG. 7, plate member 22′, as well as saddle portion 40 thereof, extends approximately ⅓ of the circumference of generally tubular flexible member 14. FIG. 8, similar to FIG. 3, shows an example of apparatus 10′ disposed on the right thumb 30 of a physician/practitioner.

An embodiment of yet another apparatus 10″ for protecting a digit during a medical procedure in accordance with yet another example embodiment of the invention is shown in FIGS. 9-11. Apparatus 10″ is a generally similar arrangement as apparatuses 10 and 10′ previously discussed except apparatus 10″ includes a guard section 20″ which is in the form of a single plate member 22″ which is provided abutting inner surface 16A of first layer 16 and extends along a portion of flexible tubular member 14, generally parallel to longitudinal axis A. Plate member 22″ is formed from a suitable cut-resistant material or materials such as previously described herein. Similar to plate member 22′, plate member 22″ includes a saddle portion 40′ which is generally centrally located in plate member 22″. Referring to FIG. 9, plate member 22″ has a first thickness t₁′ and a second thickness t₂′ in saddle portion 40′ which is less than first thickness t₁′. As can be appreciated from FIG. 10, plate member 22″, as well as saddle portion 40′ thereof, extends approximately ⅙ of the circumference of generally tubular flexible member 14. FIG. 11, similar to FIGS. 3 and 8, shows an example of apparatus 10″ disposed on the right thumb 30 of a physician/practitioner (although other fingers could be protected). As guard section 20″ is disposed within apparatus 10, an indicia 50 (shown with exaggerated thickness in FIGS. 9-11) may be provided on outer surface 16B of first layer 16 so as to ensure proper alignment of apparatus 10″ during a procedure. For example, without limitation, indicia 50 may be any suitable notifier (e.g., printing, dashed/solid line, graphics, etc.) and may be printed, stitched, or applied via any suitable process, without varying from the scope of the invention.

From the foregoing description of some exemplary embodiments, it is to be appreciated the guard section of the apparatus is generally designed to provide a wearer's digit (e.g., thumb, index finger, etc.) protection against injury from accidental scalpel slippage. The guard sections also provide a stable positioning platform for insertion or removal of the implanted device. It is also to be appreciated that the apparatus may be designed to be a one-time use instrument which is part of a pre-assembled implanted device removal kit. The general design of the apparatus allows for both right handed and left handed use.

While the device of the disclosed concept has been described herein in connection with the removal of an implantable medication delivery system, it will be appreciated that that is meant to be exemplary only, and that the device of the disclosed concept has application in other medical procedures which require one or more incisions to be made.

In the claims, any reference signs placed between parentheses shall not be construed as limiting the claim. The word “comprising” or “including” does not exclude the presence of elements or steps other than those listed in a claim. In a device claim enumerating several means, several of these means may be embodied by one and the same item of hardware. The word “a” or “an” preceding an element does not exclude the presence of a plurality of such elements. In any device claim enumerating several means, several of these means may be embodied by one and the same item of hardware. The mere fact that certain elements are recited in mutually different dependent claims does not indicate that these elements cannot be used in combination.

Although the invention has been described in detail for the purpose of illustration based on what is currently considered to be the most practical and preferred embodiments, it is to be understood that such detail is solely for that purpose and that the invention is not limited to the disclosed embodiments, but, on the contrary, is intended to cover modifications and equivalent arrangements that are within the spirit and scope of the appended claims. For example, it is to be understood that the present invention contemplates that, to the extent possible, one or more features of any embodiment can be combined with one or more features of any other embodiment.

Claims

1. An apparatus for protecting a finger during a medical procedure, comprising: a generally tubular flexible member disposed about a longitudinal axis, the flexible member having: (i) a first layer having an inner surface and an outer surface, and(ii) a second layer provided within the first layer on the inner surface of the first layer; anda guard section abutting the first layer and extending along a portion of the tubular flexible member generally parallel to the longitudinal axis, the guard section comprising a generally rigid material.

2. The apparatus of claim 1, wherein the first layer comprises a textile material.

3. The apparatus of claim 1, wherein the guard section extends over approximately ⅓ of a circumference of the generally tubular flexible member.

4. The apparatus of claim 1, wherein the guard section comprises a plurality of rigid plate members provided on the outer surface of the first layer.

5. The apparatus of claim 4, wherein each of the plate members are disposed perpendicular to the longitudinal axis.

6. The apparatus of claim 5, wherein each of the plate members is made of a plastic material.

7. The apparatus of claim 6, wherein each of the rigid plate members is made of one or more of: ABS, PVC, Acetal (Delrin), Acrylic, HDPE, CPVC, CTFE, Cast Nylon, Glass filled nylon and Kevlar filled nylon, PEEK, PETG, Polycarbonate, and PTFE.

8. The apparatus of claim 1, wherein the second layer is a gel.

9. The apparatus of claim 8, wherein the gel is a mineral oil gel comprising a polymer gel impregnated with a medical grade mineral oil.

10. The apparatus of claim 1, wherein the first layer is a woven fabric material.

11. The apparatus of claim 1, wherein the second layer is a woven fabric material.

12. The apparatus of claim 1, wherein the guard section comprises a single plate member provided on the outer surface of the first layer and extending along a portion of the flexible tubular member.

13. The apparatus of claim 12, wherein the plate member has a first thickness and wherein the plate member includes a saddle area comprising a recessed portion having a second thickness less than the first thickness.

14. The apparatus of claim 13, wherein the saddle area extends approximately ⅓ of a circumference of the generally tubular flexible member.

15. The apparatus of claim 12, wherein the single plate member is made of one or more of: ABS, PVC, Acetal (Delrin), Acrylic, HDPE, CPVC, CTFE, Cast Nylon, Glass filled nylon and Kevlar filled nylon, PEEK, PETG, Polycarbonate, and PTFE.

16. The apparatus of claim 1, wherein the guard section comprises a single plate member provided on the inner surface of the first layer and extending along a portion of the longitudinal axis.

17. The apparatus of claim 16, wherein the outer surface of the first layer comprises an indicia disposed thereon generally opposite the single plate member.

18. The apparatus of claim 16, wherein the plate member has a first thickness and wherein the plate member includes a saddle area comprising a recessed portion having a second thickness less than the first thickness.

19. The apparatus of claim 18, wherein the saddle area extends approximately ⅙ of a circumference of the generally tubular flexible member.

20. The apparatus of claim 16, wherein the plate member is made of one or more of: ABS, PVC, Acetal (Delrin), Acrylic, HDPE, CPVC, CTFE, Cast Nylon, Glass filled nylon and Kevlar filled nylon, PEEK, PETG, Polycarbonate, and PTFE.