WO2023107316A1

WO2023107316A1 - Catheter securement apparatus and method of manufacturing the apparatus

Info

Publication number: WO2023107316A1
Application number: PCT/US2022/051469
Authority: WO
Inventors: Garry DOUST; Christopher Perrey
Original assignee: Smiths Medical Asd, Inc.
Priority date: 2021-12-06
Filing date: 2022-12-01
Publication date: 2023-06-15

Abstract

Device for securing a catheter at a patient injection site has a base having one and other portions that are engageable with corresponding one and other covers. One of the portions has a slot to guide the catheter into a catch stop where the catheter may be redirected to lie onto the other portion and be fixedly held thereat when the other portion is lockingly engaged by its corresponding cover. The one portion where the catheter is guided into the device is lockingly engageable with its corresponding cover to maintain the catheter in the device. A window at the one cover enables the clinician to see into the one portion. A compressible pad having different sections fitted to the opposing surfaces of the covers and portions enable the catheter to be held fixedly but non-occludedly in the device when the covers and portions are removably locked to each other.

Description

CATHETER SECUREMENT APPARATUS AND METHOD OF MANUFACTURING THE APPARATUS

Field of the Invention

[001] The present invention relates generally to medical devices, and more particularly to a catheter securement device for inhibiting or preventing movement of a catheter relative to an insertion site of the catheter in a patient.

Background of the Invention

[002] Various types of catheters are used for managing the delivery and dispensation of a prescribed amount or dose of a drug, fluid, fluid-like substance, or medicament (herein, collectively, “infusate”) to patients. Typically, a portion of a catheter that is external to a patient is secured by means at the patient insertion site to inhibit or prevent movement of the catheter. In the case of an epidural catheter, such securing means typically included an epidural dressing or a coiled catheter with transparent adhesive dressing and tape. An example of a commercially available securing means is the “Locklt Plus” catheter securement device from Smiths Medical ASD, Inc.

Summary of the Invention

[003] To provide a more robust securement of the catheter at the patient insertion site, the present invention device has a base for placement onto the patient. The base has bonded or attached to its bottom surface a flexible sheet or layer that has adhesive at its surface that comes into contact with the patient for attachment to the patient. The base is divided into at least two areas or portions at its top surface. The same number of covers are attached to the base at a longitudinal edge thereof by means of respective hinged connections such that each cover is adapted to be pivotally moved to cover its corresponding portion at the base. The opposing surfaces of the covers and the portions have fitted, bonded or adhesively attached thereto a compressible pad. For the exemplar embodiment, the base and covers may be made of a medical grade hard plastics including polycarbonate and the compression pad may be a one piece material possibly made of thermoplastic elastomer (TPE) or compressible rubber that interconnects the various parts of the pad attached to the opposing surfaces of the portions and covers. Alternatively, the opposing surfaces of the covers and portions may each be fitted with its own compression pad.

[004] At one of the portions, a slot or channel extends from an edge of the base to a catch stop that may have a well-shaped configuration for accepting a catheter. The catch stop has a dimension sized to accept and frictionally hold the catheter without substantial pinching or obstructing the amount of fluid flow through the lumen of the catheter. The slot has a dimension that enables the catheter to be guidedly slid therealong into the catch stop. The respective dimensions of the catch stop well and the slot may be different for catheters or tubings of different sizes.

[005] An upright barrier possibly in the shape of a circular wall with a notch or opening is provided at the one portion to at least surround the catch stop and a portion of the slot that leads to the catch stop. For the flexible adhesive sheet that is attached to the bottom surface of the base, an open passage or channel extends from a front edge of the sheet along the line of sight of the slot such that the passage and the slot are in alignment along the base for enabling a catheter to pass along the passage into the slot.

[006] The one cover that flips in a clamshell fashion from its open position where it lies substantially in planar relationship to the base to its close position where it covers the one portion is configured to have a window, possibly a clear cover or an opening, that enables a clinician to visually view the upper surface of the one portion to see the catch stop and the portion of the slot that leads to the catch stop. The surface of the one cover that opposes the upper surface of the one portion has a downward wall barrier that surrounds the window. A gate at the downward barrier fits into the notch of the upright barrier when the downward and upright barriers close onto each other when the one cover closes over the one portion. When the one portion is in cover engagement with the one cover, the catheter is prevented from being removed from the device. [007] At the other of the portions at the base, the compressible pad attached thereto has a plurality of compression ribs or bars that work cooperatively with counterpart plurality of compression ribs or bars formed at the compressible pad attached to the opposing surface of the corresponding other cover. When a portion of the catheter is placed onto the compressible pad of the other portion and the other cover closes over the other portion, the plurality of coacting compression ribs would firmly hold the catheter in place. Due to the elasticity and/or compressibility of the material, even though the catheter is firmly held in place, it is not pinched or compressed to the extent that would substantially reduce the size of the lumen and obstruct the fluid flow therethrough.

[008] With the catheter inserted into the patient, the inventive device is positioned at the insertion site of the patient so that the portion of the catheter outside the patient may be guided by the slot into the catch stop at the one portion. The catheter may then be redirected to lie along the compressible pad of the other portion. The one and other covers each may then be pivoted to cover their respective one and other portions to lockingly hold the catheter. Locking mechanisms may be provided to the base and the covers to removably lock the covers to the portions. The device with the catheter fixedly held therein is adhered to the injection site of the patient by the adhesive sheet.

[009] The present invention is therefore directed to a catheter securement device, comprising: a base having a top surface and a bottom surface; at least one cover and an other cover each hingedly attached to a first longitudinal side of the base, the one cover pivotable to cover one portion of the top surface of the base and the other cover pivotable to cover an other portion of the top surface of the base; a slot sized to accept a catheter extending from an edge of the base to a catch stop in the one portion, the slot adapted to guide the catheter to the catch stop and be redirected in a direction toward the other portion along the top surface of the base; wherein the other cover is adapted to pivotally cover and engage with the other portion of the base to fixedly hold the catheter to the base.

[0010] The present invention is further directed to a method of making a catheter securement device, comprising the steps of: a) providing a base having a top surface and a bottom surface, the top surface having at least one portion and an other portion; b) hingedly attaching one cover to a first longitudinal side of the base such that the one cover is pivotable to cover the one portion of the base; c) hingedly attaching an other cover to the longitudinal side of the base such that the other cover is pivotable to cover the other portion of the base; and d) extending a slot sized to accept a catheter from an edge of the base to a catch stop in the one portion, the slot adapted to g uide the catheter to the catch stop.

[0011] The present invention is furthermore directed to an apparatus for securing a catheter at an injection site of a patient manufactured in accordance to the method noted above.

Brief Description of the Drawings

[0012] The present invention will become apparent and the invention itself will be best understood with reference to the following description of the invention taken in conjunction with the accompanying drawings, wherein:

[0013] Fig. 1 is a perspective view of the catheter securement device of the instant invention in an open position;

[0014] Fig. 2A is a plan view of the Fig. 1 Device;

[0015] Fig. 2B is a side view of the inventive catheter securement device looking in the direction of A- -A of Fig. 2A; [0016] Fig. 3A is a plan view of the inventive catheter securement device in the closed position having a flexible adhesive sheet attached to the bottom surface of the base of the device;

[0017] Fig. 3B is a side view of the inventive catheter securement device looking in the direction of A- -A of Fig. 3A; and

[0018] Fig. 4 is a perspective view showing the adhesive sheet and the catheter securement device in its closed position.

Detailed Description of the Invention

[0019] With reference to Figs. 1 and 2A-2B, the catheter securement device 2 is shown to include a base 4 that, for the purpose of discussion and explanation, is designated to have at least a first or one portion 4a and a second or other portion 4b. Base 4 has a first longitudinal side edge 4c whereat a number of integral knuckles 4d extend. Base 4 has a top surface 4e and a bottom surface 4f. T op surface 4e is divided by a number of upraised walls that form different compartments at base 4. For example as shown in Fig. 2A, walls 4g1 and 4g2 define a compartment that convergingly extends along other portion 4b into one portion 4a. The different compartment are configured to fittingly accept a compressible material as will be further discussed infra. Base 4 may be made for example via molding including extrusion molding from a clear medical grade hard plastics material such as polycarbonate as is conventionally known.

[0020] There are two covers 6 for covering the one and other portions 4a and 4b at base 4. One of the covers 6a is adapted to cover one portion 4a, and the other of the covers 6b is adapted to cover other portion 4b. As best shown in Fig. 2A, walls 6e1 and 6e2 at the opposing surface of covers 6a and 6b form a converging compartment that mirrors the converging compartment in base 4. Each of covers 6a and 6b has at its side adjacent to base 4 two pins 6c that are coupleable to their counterpart knuckles 4d at the base so that the covers 6a and 6b are pivotable relative to portions 4a and 4b, respectively. In Figs. 1 and 2A-2B, knuckles 4d and pins 6c are shown not coupled for illustration purpose. The knuckles and their counterpart pins are shown coupled to each other in Figs. 3A-3B and 4 to form the hinge mechanism for the device.

[0021] One cover 6a has a locking finger 6d 1 and other cover 6b has a locking finger 6d2. The locking fingers are adapted to latch onto their counterpart latches or catches 4i 1 and 4i2 formed at the other longitudinal side edge 4j of base 4 when covers 6a and 6b are pivotally moved to close over portions 4a and 4b, respectively. With the covers lockingly latched to the portions, a catheter positioned onto the top surface 4e of base 4 is fixedly held to the device as will be further described below. Fingers 6d 1 and 6d2 are flexible so that they may be unlatched from catches 4i1 and 4i2, respectively, to remove covers 6a and 6b from portions 4a and 4b. Like portions 4a and 4b, covers 6a and 6b may be made from a clear medical grade hard plastics material such as polycarbonate.

[0022] With further reference to Figs. 1 and 2A, portion 4A is shown to have a channel or slot 4k that extends from the shorter edge 4I of base 4 to a catch stop 4m that may be in the shape of a well sized to non-occludedly hold a catheter 8 shown in dotted line, such that the catheter is not substantially pinched and the fluid flow in the lumen of the catheter is not obstructed. Slot 4k is sized to guide the catheter into the one portion 4a until the catheter is seated at catch stop 4m . The narrowing of the space between slot 4k and catch stop 4m allows the catheter to be squeezed into catch stop 4m and prevents the catheter from being accidentally removed from the catch stop 4m.

[0023] For the exemplar embodiment shown in the figures, parts of a compressible pad 10 are provided at the opposing surfaces of base 4 and covers 6a and 6b. Compressible pad 10 may be attached to the base and covers by having different sections that form fit to the various compartments at base 4 and covers 6a and 6b. To ensure that pad 10 is secured to base 4 and covers 6a and 6b, adhesive or other conventionally known attachment means may be used to permanently attach the pad to the compartments. Compressible pad 10 may be made from a flexible thermoplastic elastomer (TPE) material having a hardness of about 40 Shore.

[0024] As best shown in Figs. 1 and 2A, compressible pad 10 of the exemplar securement device may have a number of interconnected sections. Section 10a designates the part of the compressible pad that extends longitudinally along base 4. Section 10b is the part of the pad that extends along cover 6b. Section 10c is the bridge part that connects other cover 6b and other portion 4b. Section 10d is the bridge part connecting one cover 6a and one portion 4a. Section 10e is a circular upraised pad with a notch 10g that forms the upraised barrier or barrier wall at portion 4a. Section 10f forms the circular barrier or wall barrier at cover 6a. Notch 10g of section 10e aligns with slot 4k of base 4. Section 10f has a tooth or gate 10h that mates with notch 10g when cover 6a closes over portion 4a such that a catheter that is in catch stop 4m or slot 4k is prevented from being removed from securement device 2.

[0025] Sections 10a and 10b each have multiple compression cross ribs or bars that are substantially orthogonal to the longitudinal axis 12 of the securement device. The cross ribs or bars 10a1 of section 10a and the cross bars or ribs 10b1 of section 10b are formed on pad 10 such that when cover 6b closes over portion 4b, ribs 10a1 and 10b1 would interspace with each other so that each rib 10a1 is sandwiched by two adjacent ribs 10b1 and each rib 10b1 is sandwiched by two adjacent ribs 10a1. Given the elasticity and compressibility of pad 10 and ribs 10a1 and 10b1 , with a catheter redirected from portion 4a to lie onto section 10a, when cover 6b is pivotally moved to close over portion 4b, the compression ribs would non-occludedly compress and fixedly hold the catheter in place to prevent its further movement.

[0026] To enable a clinician to view the catheter, a window 14 having the circular shape of wall barrier 10f is provided at cover 6a. Window 14 may simply be an opening at the cover or a clear cover that forms part of the top surface of cover 6a. When cover 6a lockingly closes over portion 4a with its finger 6d 1 grasping catch 4i 1 , the clinician may be able to view slot 4k and catch stop 4m at base 4 to ensure that the catheter is correctly positioned in catch stop 4m .

[0027] With reference to Figs. 3A-3B and 4, the securement device 2 is shown in its closed position where covers 6a and 6b each have pivotally moved to lockingly cover portions 4a and 4b in a clamshell like fashion. Although not shown in Figs. 1 and 2A-2B, a flexible sheet 16 that may be made from a foam layer with an adhesive bottom surface covered by a peel away cover sheet (not shown) is non-removably attached or bonded to the bottom surface of base 4. Sheet 16 has a front edge 16a and a rear edge 16c. An open passage 16b extends from approximately the middle of front edge 16a to base 4 with passage 16b in alignment with slot 4k of base 4 to enable a catheter to pass through sheet 16 into slot 4k. In the closed position, the exemplar device 2 may have approximate length dimensions of 27 millimeters by 35 millimeters and an approximate height dimension of5.6 millimeters, and the adhesive sheet may have approximate length dimensions of 55 millimeters by 65 millimeters.

[0028] As shown in Fig. 4, the non-patient end of catheter 8 may be connected to a fluid providing device including an infusion pump system 18 such as any one of the range of ® ® ® infusion pumps sold under brand names MEDFUSION , CADD , GRASEBY and ®

PLUM

[0029] In operation, using as an example an epidural catheter, after the catheter is correctly positioned in the epidural space of the patient, the insertion needle is removed from the injection site. With the covers 6a and 6b not covering portions 4a and 4b, respectively, the clinician would guide catheter 8 along open passage 16b of sheet 16 and slot 8 into catch stop 4m of base 4 at the insertion site. The sheet covering the adhesive foam layer is peeled off so that the device may be adhesively attached to the patient 20. The clinician then redirects the portion of the catheter coming out of the catch stop 4m in the direction toward the rear edge 16c of sheet 16 and places the catheter onto compressible section 10a at portion 4b. Cover 6b then is moved to lockingly cover portion 4b so that the catheter is fixedly but non-occludedly held by compression ribs 10a1 and 10b1 of sections 10a and 10b. Cover 6a may be moved to close over portion 4a either before or after cover 6b engages portion 4b. The non-patient end of the catheter may then be attached to an infusion system to infuse medicament to the patient along the fixed in place catheter. It should be noted that the above described steps of operation may not be in the order as described and may in actual practice be different.

[0030] It is the intention of the inventors that all matter described throughout this specification and shown in the accompanying drawings be interpreted as illustrative only and not in a limiting sense. Accordingly, it is intended that the invention be limited only by the spirit and scope of the hereto appended claims.

Claims

1 . A catheter securement device, comprising: a base having a top surface and a bottom surface; at least one cover and an other cover each hingedly attached to a first longitudinal side of the base, the one cover pivotable to cover one portion of the top surface of the base and the other cover pivotable to cover an other portion of the top surface of the base; a slot sized to accept a catheter extending from an edge of the base to a catch stop in the one portion, the slot adapted to guide the catheter to the catch stop and be redirected in a direction toward the other portion along the top surface of the base; wherein the other cover is adapted to pivot into position to cover the other portion of the base to hold the catheter to the base.

2. The catheter securement device of claim 1 , wherein the one cover has a window to enable viewing of the one portion when the one cover is pivoted to cover the one portion of the base.

3. The catheter securement device of claim 2, wherein the window enables the viewing of the catheter secured to the catch stop when the one cover is lockingly engaged to the one portion of the base.

4. The catheter securement device of claim 1 , further comprising a compressible pad interconnecting the opposing surfaces of the one and other covers and the one and other portions of the base.

5. The catheter securement device of claim 4, further comprising: compression ribs provided at least at the pad provided to the opposing surfaces of the other cover and the other portion such that when the other portion is covered by the other cover, the compression ribs act to prevent further movement of the catheter relative to the device.

6. The catheter securement device of claim 1 , further comprising: an upright barrier having a notch proximate to the edge of the base in alignment with the slot provided at the one portion, an other barrier working cooperatively with the upright barrier provided at the one cover, the other barrier having a gate that fits into the notch to prevent the removal of the catheter when the one portion is covered by the one cover.

7. The catheter securement device of claim 4, wherein the base and covers are made of a medical grade hard plastics including polycarbonate and the compressible pad is made from a thermoplastic elastomer (TPE) material or rubber.

8. The catheter securement device of claim 1 , wherein the one and other covers each having a finger adapted to latch onto a corresponding catch of the one and other portions to lockingly engage the one cover with the one portion and the other cover with the other portion when the one and other portions are covered by the one and other covers, respectively, the respective fingers of the one and other covers latching to their corresponding catches at the one and other portions.

9. The catheter securement device of claim 1 , further comprising a flexible sheet having one surface non-removably attached to the bottom surface of the base and an adhesive surface for attaching the securement device to a patient to whom the catheter is inserted.

10. The catheter securement device of claim 9, wherein the flexible sheet has an open passage extending from an edge of the sheet in alignment with the slot for the catheter to pass from the sheet to the slot.

11 . The catheter securement device of claim 6, wherein the device is adapted to be adhered to the patient to fixedly hold the catheter to the patient when the other cover lockingly engages with the other portion and the one cover lockingly engages with the one portion such that the catheter inserted into the patient is fixedly held by the securement device adhered to the patient.

12. A method of making a catheter securement device, comprising the steps of: a) providing a base having a top surface and a bottom surface, the top surface having at least one portion and an other portion; b) hingedly attaching one cover to a first longitudinal side of the base such that the one cover is pivotable to cover the one portion of the base; c) hingedly attaching an other cover to the longitudinal side of the base such that the other cover is pivotable to cover the other portion of the base; and d) extending a slot sized to accept a catheter from an edge of the base to a catch stop in the one portion, the slot adapted to g uide the catheter to the catch stop.

13. The method of claim 12, further comprising the step of: providing a window at the one cover to enable viewing of the one portion when the one cover is pivoted to cover the one portion of the base and the one cover is lockingly engaged to the one portion of the base.

14. The method of claim 12, further comprising the step of: attaching a compressible pad to the opposing surfaces of the one and other covers and the one and other portions of the base to interconnect the one and other covers and the one and other portions.

15. The method of claim 14, further comprising the step of: forming compression ribs to at least the opposing surfaces of the other cover and the other portion such that when the other portion is covered by the other cover, the compression ribs act to prevent further movement of the catheter relative to the device.

16. The method of claim 12, further comprising the steps of: providing an upright barrier having a notch proximate to the edge of the base in alignment with the slot at the one portion; and providing another barrier working cooperatively with the upright barrier at the one cover, the another barrier having a gate that fits into the notch to prevent the removal of the catheter when the one portion is covered by the one cover.

17. The method of claim 12, further comprising the steps of: providing a finger to each of the one and other covers; providing a catch to each of the one and other portions; configuring the finger of the one cover and the catch of the one portion to be latched to each other when the one portion is covered by the one cover; and configuring the finger of the other cover and the catch of the other portion to latch onto each other when the other portion is covered by the other cover.

18. The method of claim 12, further comprising the steps of: non-removably attaching one surface of a flexible sheet to the bottom surface of the base and an adhesive to other surface of the sheet for attaching the securement device to a patient into whom the catheter is inserted; and extending an open passage from an edge of the sheet in alignment with the slot for the catheter to pass from the sheet to the slot.

19. The method of claim 14, further comprising the step of: making the base and covers from a medical grade hard plastics including polycarbonate; and making the compressible pad from a thermoplastic elastomer (TPE) material or rubber.

20. Apparatus for securing a catheter at an injection site of a patient manufactured in accordance to the method of claim 12.